ORCID Profile
0000-0002-5470-3567
Current Organisations
University of New South Wales
,
University of Applied Sciences and Arts of Southern Switzerland
,
George Institute for Global Health
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Publications
Intraoperative sub-areolar frozen section analysis for detecting nipple involvement in candidates for nipple-sparing mastectomy
Publisher: Wiley
Date: 09-04-2021
The impact of COVID-19 on proctologic practice in Italy
Publisher: Springer Science and Business Media LLC
Date: 10-08-2020
Lights and shadows in the management of old and new oral anticoagulants in the real world of atrial fibrillation by Italian internists. A survey from the Atrial Fibrillation Registry for Ankle-Brachia
Publisher: Elsevier BV
Date: 10-2015
Systematic review and meta‐analysis of anal motor and rectal sensory dysfunction in male and female patients undergoing anorectal manometry for symptoms of faecal incontinence
Publisher: Wiley
Date: 30-01-2022
DOI: 10.1111/CODI.16047
Abstract: Manometry is the best established technique to assess anorectal function in faecal incontinence. By systematic review, pooled prevalences of anal hypotonia/hypocontractility and rectal hypersensitivity/hyposensitivity in male and female patients were determined in controlled studies using anorectal manometry. Searches of MEDLINE and Embase were completed. Screening, data extraction and bias assessment were performed by two reviewers. Meta‐analysis was performed based on a random effects model with heterogeneity evaluated by I 2 . Of 2116 identified records, only 13 studies (2981 faecal incontinence patients 1028 controls) met the inclusion criteria. Anal tone was evaluated in 10 studies and contractility in 11 rectal sensitivity in five. Only three studies had low risk of bias. Pooled prevalence of anal hypotonia was 44% (95% CI 32–56, I 2 = 96.35%) in women and 27% (95% CI 14–40, I 2 = 94.12%) in men. The pooled prevalence of anal hypocontractility was 69% (95% CI 57–81 I 2 = 98.17%) in women and 36% (95% CI 18–53 I 2 = 96.77%) in men. Pooled prevalence of rectal hypersensitivity was 10% (95% CI 4–15 I 2 = 80.09%) in women and 4% (95% CI 1–7 I 2 = 51.25%) in men, whereas hyposensitivity had a pooled prevalence of 7% (95% CI 5–9 I 2 = 0.00%) in women compared to 19% (95% CI 15–23 I 2 = 0.00%) in men. The number of appropriately controlled studies of anorectal manometry is small with fewer still at low risk of bias. Results were subject to gender differences, wide confidence intervals and high heterogeneity indicating the need for international collective effort to harmonize practice and reporting to improve certainty of diagnosis.
Effect of COVID-19 containment measures on access to snakebite care in India.
Publisher: Rural and Remote Health
Date: 04-07-2023
DOI: 10.22605/RRH7881
Asthma and risk of infection, hospitalization, ICU admission and mortality from COVID-19: Systematic review and meta-analysis
Publisher: Informa UK Limited
Date: 04-2021
Prevalence of childhood maltreatment among people with opioid use disorder: A systematic review and meta-analysis
Publisher: Elsevier BV
Date: 02-2020
Residual malaria transmission dynamics varies across The Gambia despite high coverage of control interventions
Publisher: Public Library of Science (PLoS)
Date: 02-11-2017
Vital Signs During the COVID-19 Outbreak: A Retrospective Analysis of 19,960 Participants in Wuhan and Four Nearby Capital Cities in China.
Publisher: Ubiquity Press, Ltd.
Date: 13-07-2021
DOI: 10.5334/GH.913
A Systematic Review of Medical Costs Associated with Heart Failure in the USA (2014–2020)
Publisher: Springer Science and Business Media LLC
Date: 19-08-2020
Asthma and COVID-19 risk: a systematic review and meta-analysis
Publisher: European Respiratory Society (ERS)
Date: 12-08-2022
DOI: 10.1183/13993003.01209-2021
Abstract: In idual case series and cohort studies have reported conflicting results in people with asthma on the vulnerability to and risk of mortality from coronavirus disease 2019 (COVID-19). Are people with asthma at a higher risk of being infected or hospitalised or poorer clinical outcomes from COVID-19? A systematic review and meta-analysis based on five main databases including the World Health Organization COVID-19 database between 1 December 2019 and 11 July 2021 on studies with a control (non-asthma) group was conducted. Prevalence and risk ratios were pooled using Sidik–Jonkman random-effects meta-analyses. 51 studies with an 8.08% (95% CI 6.87–9.30%) pooled prevalence of people with asthma among COVID-19 positive cases. The risk ratios were 0.83 (95% CI 0.73–0.95, p=0.01) for acquiring COVID-19 1.18 (95% CI 0.98–1.42, p=0.08) for hospitalisation 1.21 (95% CI 0.97–1.51, p=0.09) for intensive care unit (ICU) admission 1.06 (95% CI 0.82–1.36, p=0.65) for ventilator use and 0.94 (95% CI 0.76–1.17, p=0.58) for mortality for people with asthma. Subgroup analyses by continent revealed a significant difference in risk of acquiring COVID-19, ICU admission, ventilator use and death between the continents. The risk of being infected with severe acute respiratory syndrome coronavirus 2 was reduced compared to the non-asthma group. No statistically significant differences in hospitalisation, ICU admission and ventilator use were found between groups. Subgroup analyses showed significant differences in outcomes from COVID-19 between America, Europe and Asia. Additional studies are required to confirm this risk profile, particularly in Africa and South America, where few studies originate.
Long-term clinical outcomes and cost-effectiveness analysis in multivessel percutaneous coronary interventions: comparison of drug-eluting stents, bare-metal stents and a mixed approach in patients at
Publisher: Europa Digital & Publishing
Date: 04-2010
DOI: 10.4244/EIJV5I8A160
Adjunctive efficacy of probiotics in the treatment of experimental peri‐implant mucositis with mechanical and photodynamic therapy: a randomized, cross‐over clinical trial
Publisher: Wiley
Date: 18-02-2017
DOI: 10.1111/JCPE.12689
Abstract: To evaluate the adjunctive clinical efficacy of probiotics in the treatment of peri-implant mucositis (p-iM) with professionally administered plaque removal (PAPR) and photodynamic therapy (PDT). Following p-iM induction, patients underwent PAPR + PDT and were randomly assigned to receive the professional and home-based administration of probiotics (Lactobacillus plantarum and Lactobacillus brevis) (test treatment) or placebo preparation (control treatment) according to a cross-over design. Clinical parameters were assessed at six sites for each implant before as well as at 2 and 6 weeks after professional treatment administration. Twenty patients contributing one dental implant each were included. Immediately before treatment and at 6 weeks, the median number of sites with bleeding on probing (BoP+) sites per implant unit was 4 (3-6) and 2 (0-2) (p < 0.001), respectively, for test treatment, and 3.5 (2-4) and 2 (0-3) (p = 0.03), respectively, for control treatment. No significant difference in clinical outcomes was observed between treatment groups. The combination of PAPR and PDT either alone or associated with probiotics determined a significant reduction in the number of BoP+ sites at 2 and 6 weeks around implants with p-iM. The adjunctive use of probiotics did not significantly enhance the clinical outcomes of PAPR + PDT.
Treatment decision-making and care among older adults with kidney failure: protocol for a multicentre, prospective observational cohort study with nested substudies and linked qualitative research (th
Publisher: BMJ
Date: 12-2022
DOI: 10.1136/BMJOPEN-2022-066156
Abstract: Shared treatment decision-making and planning of care are fundamental in advanced chronic kidney disease (CKD) management. There are limited data on several key outcomes for the elderly population including survival, quality of life, symptom burden, changes in physical functioning and experienced burden of healthcare. Patients, caregivers and clinicians consequently face significant uncertainty when making life-impacting treatment decisions. The Elderly Advanced CKD Programme includes quantitative and qualitative studies to better address challenges in treatment decision-making and planning of care among this increasingly prevalent elderly cohort. The primary component is OUTcomes of Older patients with Kidney failure (OUTLOOK), a multicentre prospective observational cohort study that will enrol 800 patients ≥75 years with kidney failure (estimated glomerular filtration rate ≤15 mL/min/1.73 m 2 ) across a minimum of six sites in Australia. Patients entered are in the decision-making phase or have recently made a decision on preferred treatment (dialysis, conservative kidney management or undecided). Patients will be prospectively followed until death or a maximum of 4 years, with the primary outcome being survival. Secondary outcomes are receipt of short-term acute dialysis, receipt of long-term maintenance dialysis, changes in biochemistry and end-of-life care characteristics. Data will be used to formulate a risk prediction tool applicable for use in the decision-making phase. The nested substudies Treatment modalities for the InfirM ElderLY with end stage kidney disease (TIMELY) and Caregivers of The InfirM ElderLY with end stage kidney disease (Co-TIMELY) will longitudinally assess quality of life, symptom burden and caregiver burden among 150 patients and 100 caregivers, respectively. CONsumer views of Treatment options for Elderly patieNts with kiDney failure (CONTEND) is an additional qualitative study that will enrol a minimum of 20 patients and 20 caregivers to explore experiences of treatment decision-making and care. Ethics approval was obtained through Sydney Local Health District Human Research Ethics Committee (2019/ETH07718, 2020/ETH02226, 2021/ETH01020, 2019/ETH07783). OUTLOOK is approved to have waiver of in idual patient consent. TIMELY, Co-TIMELY and CONTEND participants will provide written informed consent. Final results will be disseminated through peer-reviewed journals and presented at scientific meetings.
Nulliparity enhances the risk of second primary malignancy of the breast in a cohort of women treated for thyroid cancer
Publisher: Springer Science and Business Media LLC
Date: 12-08-2011
Spatial analysis of cluster randomised trials: a systematic review of analysis methods
Publisher: Springer Science and Business Media LLC
Date: 21-09-2017
Changes in sodium levels in Australian packaged foods between 2014 and 2019: an interrupted time series analysis of the impact of the Victorian Salt Reduction Partnership’s media advocacy strategy
Publisher: Springer Science and Business Media LLC
Date: 14-06-2023
DOI: 10.1186/S12966-023-01475-5
Abstract: The Victorian Salt Reduction Partnership (VSRP) implemented a media advocacy strategy (intervention) to stimulate food manufacturers to reduce sodium levels across targeted Australian packaged foods between 2017 and 2019. This study assessed changes in sodium levels of targeted and non-targeted packaged foods during the intervention (2017 to 2019) compared to before the intervention (2014 to 2016) in Australia. Annually collected branded-food composition data from 2014 to 2019 were used. Interrupted time series analyses was conducted to compare the trend in sodium levels in packaged foods during the intervention (2017–2019) to the trend in the pre-intervention period (2014–2016). The difference between these trends was derived to estimate the effect of the intervention. A total of 90,807 products were included in the analysis, of which 14,743 were targeted by the intervention. The difference in before and during intervention trends between targeted and non-targeted food categories was 2.59 mg/100 g (95% CI: -13.88 to 19.06). There was a difference in the pre-intervention slope (2014, 2015, 2016) and intervention slope (2017, 2018, 2019) for four of 17 targeted food categories. There was a decrease in sodium levels (mg/100 g) in one food category: frozen ready meals (-13.47 95% CI: -25.40 to -1.53), and an increase in three categories: flat bread (20.46 95% CI: 9.11 to 31.81), plain dry biscuits (24.53 95% CI: 5.87 to 43.19), and bacon (44.54 95% CI: 6.36 to 82.72). For the other 13 targeted categories, the difference in slopes crossed the line of null effect. The VSRP’s media advocacy strategy did not result in a meaningful reduction in sodium levels of targeted packaged food products during the intervention years compared to trends in sodium levels before the intervention. Our study suggests media advocacy activities highlighting the differences in sodium levels in packaged food products and industry meetings alone are not sufficient to lower average sodium levels in packaged foods in the absence of government leadership and measurable sodium targets.
Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia
Publisher: Elsevier BV
Date: 09-2023
Relationship between measured and prescribed dialysate sodium in haemodialysis: a systematic review and meta-analysis
Publisher: Oxford University Press (OUP)
Date: 26-12-2020
DOI: 10.1093/NDT/GFAA287
Abstract: Dialysate sodium (DNa) prescription policy differs between haemodialysis (HD) units, and the optimal DNa remains uncertain. We sought to summarize the evidence on the agreement between prescribed and delivered DNa, and whether the relationship varied according to prescribed DNa. We searched MEDLINE and PubMed from inception to 26 February 2020 for studies reporting measured and prescribed DNa. We analysed results reported in aggregate with random-effects meta-analysis. We analysed results reported by in idual s le, using mixed-effects Bland–Altman analysis and linear regression. Pre-specified subgroup analyses included method of sodium measurement, dialysis machine manufacturer and proportioning method. Seven studies, representing 908 dialysate s les from 10 HD facilities (range 16–133 s les), were identified. All but one were single-centre studies. Studies were of low to moderate quality. Overall, there was no statistically significant difference between measured and prescribed DNa {mean difference = 0.73 mmol/L [95% confidence interval (CI) −1.12 to 2.58 P = 0.44]} but variability across studies was substantial (I2 = 99.3%). Among in idually reported s les (n = 295), measured DNa was higher than prescribed DNa by 1.96 mmol/L (95% CI 0.23–3.69) and the 95% limits of agreement ranged from −3.97 to 7.88 mmol/L. Regression analysis confirmed a strong relationship between prescribed and measured DNa, with a slope close to 1:1 (β = 1.16, 95% CI 1.06–1.27 P & 0.0001). A limited number of studies suggest that, on average, prescribed and measured DNa are similar. However, between- and within-study differences were large. Further consideration of the precision of delivered DNa is required to inform rational prescribing.
Association of Low-Dose Triple Combination Therapy vs Usual Care With Time at Target Blood Pressure
Publisher: American Medical Association (AMA)
Date: 06-2022
Effects of salt substitutes on clinical outcomes: a systematic review and meta-analysis
Publisher: BMJ
Date: 09-08-2022
DOI: 10.1136/HEARTJNL-2022-321332
Abstract: The Salt Substitute and Stroke Study (SSaSS) recently reported blood pressure-mediated benefits of a potassium-enriched salt substitute on cardiovascular outcomes and death. This study assessed the effects of salt substitutes on a breadth of outcomes to quantify the consistency of the findings and understand the likely generalisability of the SSaSS results. We searched PubMed, Embase and the Cochrane Library up to 31 August 2021. Parallel group, step-wedge or cluster randomised controlled trials reporting the effect of salt substitute on blood pressure or clinical outcomes were included. Meta-analyses and metaregressions were used to define the consistency of findings across trials, geographies and patient groups. There were 21 trials and 31 949 participants included, with 19 reporting effects on blood pressure and 5 reporting effects on clinical outcomes. Overall reduction of systolic blood pressure (SBP) was −4.61 mm Hg (95% CI −6.07 to −3.14) and of diastolic blood pressure (DBP) was −1.61 mm Hg (95% CI −2.42 to −0.79). Reductions in blood pressure appeared to be consistent across geographical regions and population subgroups defined by age, sex, history of hypertension, body mass index, baseline blood pressure, baseline 24-hour urinary sodium and baseline 24-hour urinary potassium (all p homogeneity .05). Metaregression showed that each 10% lower proportion of sodium choloride in the salt substitute was associated with a −1.53 mm Hg (95% CI −3.02 to −0.03, p=0.045) greater reduction in SBP and a −0.95 mm Hg (95% CI −1.78 to −0.12, p=0.025) greater reduction in DBP. There were clear protective effects of salt substitute on total mortality (risk ratio (RR) 0.89, 95% CI 0.85 to 0.94), cardiovascular mortality (RR 0.87, 95% CI 0. 81 to 0.94) and cardiovascular events (RR 0.89, 95% CI 0.85 to 0.94). The beneficial effects of salt substitutes on blood pressure across geographies and populations were consistent. Blood pressure-mediated protective effects on clinical outcomes are likely to be generalisable across population subgroups and to countries worldwide. CRD42020161077.
Contemporary surgical practice in the management of anal fistula: results from an international survey
Publisher: Springer Science and Business Media LLC
Date: 31-07-2019
Inter-rater reliability of case-note audit: A systematic review
Publisher: SAGE Publications
Date: 07-2007
DOI: 10.1258/135581907781543012
Abstract: Objective: The quality of clinical care is often assessed by retrospective examination of case-notes (charts, medical records). Our objective was to determine the inter-rater reliability of case-note audit. Methods: We conducted a systematic review of the inter-rater reliability of case-note audit. Analysis was restricted to 26 papers reporting comparisons of two or three raters making independent judgements about the quality of care. Results: Sixty-six separate comparisons were possible, since some papers reported more than one measurement of reliability. Mean kappa values ranged from 0.32 to 0.70. These may be inflated due to publication bias. Measured reliabilities were found to be higher for case-note reviews based on explicit, as opposed to implicit, criteria and for reviews that focused on outcome (including adverse effects) rather than process errors. We found an association between kappa and the prevalence of errors (poor quality care), suggesting alternatives such as tetrachoric and polychoric correlation coefficients be considered to assess inter-rater reliability. Conclusions: Comparative studies should take into account the relationship between kappa and the prevalence of the events being measured.
Evaluating Cost-Effectiveness Models for Pharmacologic Interventions in Adults with Heart Failure: A Systematic Literature Review
Publisher: Springer Science and Business Media LLC
Date: 31-12-2019
Prevalence of gastroschisis at birth: retrospective study.
Publisher: BMJ
Date: 14-12-2002
DElayed COloRectal cancer care during COVID-19 Pandemic (DECOR-19): Global perspective from an international survey
Publisher: Elsevier BV
Date: 04-2021
Prevalence of human papillomavirus in head and neck cancers in European populations: a meta-analysis
Publisher: Springer Science and Business Media LLC
Date: 12-2014
Light-activated disinfection using a light-emitting diode lamp in the red spectrum: Clinical and microbiological short-term findings on periodontitis patients in maintenance. A randomized controlled split-mouth clinical trial
Publisher: Springer Science and Business Media LLC
Date: 09-11-2014
DOI: 10.1007/S10103-012-1225-X
Abstract: Eradication or suppression of pathogens is a major goal in periodontal therapy. Due to the increase in antibiotic resistance, the need of new disinfection therapies is raising. Photodynamic therapy (PDT) has demonstrated anti-infective potential. No data are available on the use of light-emitting diode (LED) lights as the light source in PDT. The aim of this study was to investigate the microbiological and clinical adjunctive outcome of a new photodynamic LED device, compared to scaling and root planing in periodontitis patients in maintenance [supportive periodontal therapy (SPT)]. In this masked, split-mouth design study, 30 treated chronic periodontitis subjects (mean age, 46.2 years 13 males) in SPT were included. Two residual interdental sites with probing pocket depth (PPD) ≥ 5 mm in two opposite quadrants, with positive bleeding on probing (BOP) and comparable periodontal breakdown, were selected. PPD, BOP and subgingival microbiological s les for real-time PCR analysis (Carpegen® PerioDiagnostics, Carpegen GmbH, Münster, Germany) were recorded at baseline and 1 week after treatment. Scaling and root planing was performed under local anesthesia. Randomly one of the sites was selected to receive adjunctive photodynamic therapy by inserting a photosensitizer (toluidine blue O solution) and exposing it to a LED light in the red spectrum (Fotosan, CMS Dental, Copenhagen, Denmark), according to the manufacturer's instructions. After 1 week, 73 % of the control sites and 27 % of the test sites were still BOP+. These differences compared to baseline values and in-between groups were statistically significantly different (p < 0.001). Mean PPD decreased from 5.47 mm (±0.68) to 4.73 mm (±0.74, p < 0.001) in control sites and from 5.63 mm (±0.85) to 4.43 mm (±1.25, p < 0.001, test vs control p = 0.01) in the test group. Microbiologically, higher reductions of relative proportions of red complex bacteria were observed in test sites (68.1 vs. 4.1 % p = 0.01). This study showed that adjunctive photodynamic treatment by LED light may enhance short-term clinical and microbiological outcome in periodontitis subjects in SPT.
The Gametocytocidal Efficacy of Different Single Doses of Primaquine with Dihydroartemisinin-piperaquine in Asymptomatic Parasite Carriers in The Gambia: A Randomized Controlled Trial
Publisher: Elsevier BV
Date: 11-2016
Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial
Publisher: Elsevier BV
Date: 07-2020
The factors affecting household transmission dynamics and community compliance with Ebola control measures: a mixed-methods study in a rural village in Sierra Leone
Publisher: Springer Science and Business Media LLC
Date: 13-02-2018
Balanced crystalloids compared to normal saline for fluid therapy in critically ill adult patients: Systematic review and meta-analysis protocol
Publisher: Cold Spring Harbor Laboratory
Date: 28-08-2021
DOI: 10.1101/2021.08.24.21262515
Abstract: The choice of intravenous fluid for fluid therapy in critically ill adult patients remains a matter of debate. Currently, crystalloids are used more often than colloids, with ongoing controversy over the relative efficacy and safety of buffered salt solutions (BSS) versus normal saline (0.9% sodium chloride). In 2021 two large pragmatic trials enrolling critically ill patients will add substantial new data to address this controversy. We will conduct a systematic review and meta-analysis of randomised controlled trials (RCTs) that will include the data from these two trials to provide clinicians with the most up to date evidence and robust evidence to guide their choice of crystalloid fluids. We will include RCTs that compare the effect of buffered salt solutions to normal saline for fluid resuscitation and/or fluid therapy in critically ill adults, on all-cause mortality and other patient centred outcomes. We will perform a search that includes the electronic databases MEDLINE and EMBASE, and clinical trial registries. Two reviewers will independently screen titles and abstracts, perform full article reviews and extract study data, with discrepancies resolved by a third reviewer. We will report study characteristics and assess risk of bias using the Cochrane Risk-of-Bias tool. We will perform Hartung-Knapp-Sidik-Jonkman random-effects aggregate data meta-analysis whenever it is feasible to do so. We will evaluate overall certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. This systematic review and meta-analysis does not require ethical approval as it does not involve primary data collection. We will publish our results in a peer-reviewed scientific journal and present them at national and international scientific conferences. CRD42021243399 This systematic review will provide up-to-date evidence to answer the focused clinical question: In adult patients who are critically ill, does administering balanced crystalloid solutions for fluid therapy reduce mortality and other patient-centered outcomes, compared with administering 0.9% sodium chloride? We will conduct a systematic review according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines, searching three electronic databases, clinical trial registries and published conference abstracts, with two independent reviewers evaluating studies and extracting data. A meta-analysis will assess the primary outcome of all-cause mortality at 90 days and secondary outcomes of ventilator and vasopressor free days, renal replacement therapy use, incidence of acute kidney injury, and patient quality of life outcomes. The limitations of this review include the clinical heterogeneity of the included trials, ersity of the targeted population receiving fluid therapy, variability in the composition of balanced crystalloid solutions, and timing of initiation of study crystalloids. We will address all limitations with the Grading of Recommendations, Assessment, Development and Evaluations framework.
What paradigm shifts occurred in the management of acute diverticulitis during the COVID-19 pandemic? A scoping review
Publisher: Baishideng Publishing Group Inc.
Date: 16-08-2021
The sodium‐glucose cotransporter‐2 inhibitor canagliflozin does not increase risk of non‐genital skin and soft tissue infections in people with type 2 diabetes mellitus: A pooled post hoc a
Publisher: Wiley
Date: 10-05-2023
DOI: 10.1111/DOM.15091
Abstract: To assess whether the sodium‐glucose cotransporter‐2 (SGLT2) inhibitor canagliflozin affects risk of non‐genital skin and soft tissue infections (SSTIs). We performed a post hoc pooled in idual participant analysis of the CANVAS Program and CREDENCE trials that randomized people with type 2 diabetes at high cardiovascular risk and/or with chronic kidney disease to either canagliflozin or placebo. Investigator‐reported adverse events were assessed by two blinded authors following predetermined criteria for non‐genital SSTIs. Risks of non‐genital SSTIs, overall and within prespecified subgroups, and risk of non‐genital fungal SSTIs, were analysed using Cox regression models. Factors associated with non‐genital SSTIs were assessed using multivariable Cox regression models. Overall, 903 of 14 531 participants (6%) experienced non‐genital SSTIs over a median follow‐up of 26 months. No difference was observed in non‐genital SSTI rates between canagliflozin and placebo (24.0 events/1000 person‐years vs. 23.9 events/1000 person‐years, respectively hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.85‐1.11 P = 0.70), with consistent results across subgroups (all P interaction 0.05). The risk of recurrent events and non‐genital fungal infection also did not differ significantly between canagliflozin and placebo (HR 1.06, 95% CI 0.94‐1.19 [ P = 0.32] and HR 1.18, 95% CI 0.88‐1.60 [ P = 0.27], respectively). Baseline factors independently associated with non‐genital SSTIs were younger age, male sex, higher body mass index, higher glycated haemoglobin, lower estimated glomerular filtration rate (eGFR), established peripheral vascular disease, and history of neuropathy. Canagliflozin did not affect risk of non‐genital SSTIs or non‐genital fungal SSTIs compared with placebo. These findings suggest that any SGLT2 inhibitor‐mediated change in skin microenvironment is unlikely to have meaningful clinical consequences.
Renal, Cardiovascular, and Safety Outcomes of Canagliflozin by Baseline Kidney Function: A Secondary Analysis of the CREDENCE Randomized Trial
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 24-04-2020
Abstract: The CREDENCE randomized trial demonstrated that canagliflozin reduces risk of cardiovascular and renal events in people with type 2 diabetes and substantial albuminuria. The authors analyzed CREDENCE data to assess whether canagliflozin’s benefits are safely preserved in people with reduced eGFR, finding that the relative benefits for renal and cardiovascular outcomes appeared consistent among subgroups with initial eGFR ranging from 30 to ml/min per 1.73 m 2 . Absolute benefit for renal outcomes was greater in subgroups with an initial eGFR of ml/min per 1.73 m 2 . Safety outcomes were generally consistent among eGFR subgroups. Canagliflozin led to an acute eGFR drop, followed by relative stabilization of eGFR loss across subgroups. Canagliflozin’s benefits and safety are apparent across the eGFR range, including among those initiating treatment with eGFR as low as 30 ml/min per 1.73 m 2 . Canagliflozin reduced renal and cardiovascular events in people with type 2 diabetes in the CREDENCE trial. We assessed efficacy and safety of canagliflozin by initial estimated glomerular filtration rate (eGFR). CREDENCE randomly assigned 4401 participants with an eGFR of 30 to ml/min per 1.73 m 2 and substantial albuminuria to canagliflozin 100 mg or placebo. We used Cox proportional hazards regression to analyze effects on renal and cardiovascular efficacy and safety outcomes within screening eGFR subgroups (30 to , 45 to , and 60 to ml/min per 1.73 m 2 ) and linear mixed effects models to analyze the effects on eGFR slope. At screening, 1313 (30%), 1279 (29%), and 1809 (41%) participants had an eGFR of 30 to , 45 to , and 60 to ml/min per 1.73 m 2 , respectively. The relative benefits of canagliflozin for renal and cardiovascular outcomes appeared consistent among eGFR subgroups (all P interaction .11). Subgroups with lower eGFRs, who were at greater risk, exhibited larger absolute benefits for renal outcomes. Canagliflozin’s lack of effect on serious adverse events, utations, and fractures appeared consistent among eGFR subgroups. In all subgroups, canagliflozin use led to an acute eGFR drop followed by relative stabilization of eGFR loss. Among those with an eGFR of 30 to ml/min per 1.73 m 2 , canagliflozin led to an initial drop of 2.03 ml/min per 1.73 m 2 . Thereafter, decline in eGFR was slower in the canagliflozin versus placebo group (–1.72 versus –4.33 ml/min per 1.73 m 2 between-group difference 2.61 ml/min per 1.73 m 2 ). Canagliflozin safely reduced the risk of renal and cardiovascular events, with consistent results across eGFR subgroups, including the subgroup initiating treatment with an eGFR of 30 to ml/min per 1.73 m 2 . Absolute benefits for renal outcomes were greatest in subgroups with lower eGFR. Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy (CREDENCE), NCT02065791.
A quality evaluation methodology of health web-pages for non-professionals
Publisher: Informa UK Limited
Date: 06-2004
Correction to: E‑consensus on telemedicine in colorectal surgery: a RAND/UCLA‑modified study
Publisher: Springer Science and Business Media LLC
Date: 21-09-2021
Blood Pressure Effects of Canagliflozin and Clinical Outcomes in Type 2 Diabetes and Chronic Kidney Disease
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-05-2021
DOI: 10.1161/CIRCULATIONAHA.120.048740
Abstract: People with type 2 diabetes and chronic kidney disease experience a high burden of hypertension, but the magnitude and consistency of blood pressure (BP) lowering with canagliflozin in this population are uncertain. Whether the effects of canagliflozin on kidney and cardiovascular outcomes vary by baseline BP or BP-lowering therapy is also unknown. The CREDENCE trial (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) randomized people with type 2 diabetes and chronic kidney disease to canagliflozin or placebo. In a post hoc analysis, we investigated the effect of canagliflozin on systolic BP across subgroups defined by baseline systolic BP, number of BP-lowering drug classes, and history of apparent treatment-resistant hypertension (BP ≥130/80 mm Hg while receiving ≥3 classes of BP-lowering drugs, including a diuretic). We also assessed whether effects on clinical outcomes differed across these subgroups. The trial included 4401 participants, of whom 3361 (76.4%) had baseline systolic BP ≥130 mm Hg, and 1371 (31.2%) had resistant hypertension. By week 3, canagliflozin reduced systolic BP by 3.50 mm Hg (95% CI, –4.27 to –2.72), an effect maintained over the duration of the trial, with similar reductions across BP and BP-lowering therapy subgroups (all P interaction ≥0.05). Canagliflozin also reduced the need for initiation of additional BP-lowering agents during the trial (hazard ratio, 0.68 [95% CI, 0.61–0.75]). The effect of canagliflozin on kidney failure, doubling of serum creatinine, or death caused by kidney or cardiovascular disease (hazard ratio, 0.70 [95% CI, 0.59–0.82]) was consistent across BP and BP-lowering therapy subgroups (all P interaction ≥0.35), as were effects on other key kidney, cardiovascular, and safety outcomes. In people with type 2 diabetes and chronic kidney disease, canagliflozin lowers systolic BP across all BP-defined subgroups and reduces the need for additional BP-lowering agents. These findings support use of canagliflozin for end-organ protection and as an adjunct BP-lowering therapy in people with chronic kidney disease. URL: www.clinicaltrials.gov Unique identifier: NCT02065791.
Effect of Salt Substitution on Cardiovascular Events and Death
Publisher: Massachusetts Medical Society
Date: 16-09-2021
Clinical and epidemiological performance of WHO Ebola case definitions: a systematic review and meta-analysis
Publisher: Elsevier BV
Date: 11-2020
Ready-to-use food supplement, with or without arginine and citrulline, with daily chloroquine in Tanzanian children with sickle-cell disease: a double-blind, random order crossover trial
Publisher: Elsevier BV
Date: 04-2018
Mixed adenoneuroendocrine carcinoma (MANEC) of the lower gastrointestinal tract: A systematic review with Bayesian hierarchical survival analysis
Publisher: Elsevier BV
Date: 11-2021
DOI: 10.1016/J.EJSO.2021.05.021
Abstract: Mixed adeno-neuroendocrine carcinomas (MANEC) are a subgroup of mixed neuroendocrine non-neuroendocrine neoplasms (MiNEN) described as mixed neoplasms containing dual neuroendocrine and non-neuroendocrine components. The aim of this study was to appraise the prevalence of MANEC in the lower gastrointestinal (GI) tract and provide reliable estimates of survival. A systematic review was undertaken in accordance with PRISMA guidelines using PubMed, Embase, Cochrane Library of Systematic Review, Web of Science, and Scopus databases, and a Bayesian hierarchical survival pooled analysis was performed. Of 182 unique records identified, 71 studies reporting on 752 patients met the inclusion criteria. Mean age was 64.2 ± 13.6, with a male-to-female ratio of 1.25. Overall, 60.3% of MANEC were located in the appendix, 29.3% in the colon, and 10.4% in the anorectum. More than a quarter (29%) of patients had stage IV disease at diagnosis, with higher prevalence in appendiceal than colonic and anorectal primaries. More than 80% had a high-grade (G3) endocrine component. Of the 152 patients followed up for a median of 20 months (interquartile range limits, 16.5-32), median overall survival was 12.3 months (95% credible interval [95%CrI], 11.3-13.7), with a 1.12 [95%CrI, 0.67-1.83] age-adjusted hazard ratio between metastatic and non-metastatic MANEC. Stage IV disease at diagnosis was more prognostically unfavorable in cases of colonic compared to anorectal origin. MANEC is a clinically aggressive pathological entity. The results of this study provide new insights for the understanding of tumor location within the lower GI tract and its prognosis in terms of overall survival.
Implant patient compliance varies by periodontal treatment history
Publisher: Wiley
Date: 09-2017
Abstract: This retrospective study aims to assess compliance to supportive periodontal therapy (SPT) among patients treated with dental implants with different periodontitis histories and the possible influence of their compliance on peri-implant marginal bone level. Dental records of 106 patients treated with at least one dental implant were reviewed. A single operator who did not provide care to the patients recorded the following during the first year of implant function (first year of follow-up), during the first 5 years of follow-up, and during the entire follow-up duration: 1) number of recalls 2) compliance, calculated from registered attendance 3) periodontal disease history 4) peri-implant radiographic bone level from most recent examination and 5) clinical parameters including probing depth and bleeding on probing. Clinical and radiographic parameters were assessed at site level and analyzed for possible associations among them and with demographic parameters. Collected data were based on 156 implants with an average of 6.5 ± 3.4 years (range: 1 to 13 years) in function. Patients with periodontitis history demonstrated greater compliance than patients without periodontitis history during the two longer follow-up times. Over time, the majority of patients demonstrated partial compliance (71% to 80% of patients). Peri-implant bone level averaged 0.9 ± 1.1 mm, without significant association with compliance level however, positive periodontitis history and more years in function were significantly associated with greater peri-implant bone loss. Patients with implants partially comply with scheduled SPT, regardless of periodontitis history. Patients who had received periodontal treatment demonstrated better compliance than those without prior periodontal therapy experiences.
Association between influenza vaccination, all-cause mortality and cardiovascular mortality: a protocol for a living systematic review and prospective meta-analysis
Publisher: BMJ
Date: 03-2022
DOI: 10.1136/BMJOPEN-2021-054171
Abstract: Influenza virus infection is known to increase the risk of cardiovascular events, especially in populations with pre-existing cardiovascular disease (CVD). Considering that influenza is vaccine preventable, international guidelines recommend high-risk populations with CVD receive an influenza vaccine every year. However, there are various classifications of recommendations and levels of evidence. Previous systematic reviews concluded uncertain evidence on influenza vaccine efficacy for preventing cardiovascular events in the general population or in populations with pre-existing CVD. Limited safety data of influenza vaccines were reported for populations with pre-existing CVD. Randomised controlled trials with larger s le sizes relative to previous studies are emerging, the findings of these trials are likely to be highly influential on summary efficacy estimates. We aim to perform a living systematic review and a prospective meta-analysis to evaluate the efficacy and safety of influenza vaccines compared with no vaccines or placebo for preventing mortality or CVD events in the general population and in populations with pre-existing CVD. Any types of randomised controlled trial and observational study meeting the Population, Intervention, Comparator, Outcome and Study design criteria for the research question will be selected for inclusion. The living systematic review status will be maintained for 3 years with an update for every 6 months. Mainstream medical literature databases will be independently searched by two authors with predefined strategies. Two authors will perform the risk of bias assessment with consensus. Narrative synthesis and meta-analyses will be performed to summarise the results. Formal ethical review is not required as this study does not involve primary data collection. We will publish results of the living systematic review and prospective meta-analysis in a peer-reviewed journal. Findings will also be presented at relevant meetings. CRD42021222519.
Erratum: Evaluating risk prediction models for adults with heart failure: A systematic literature review (PLoS ONE (2020) 15:1 (e0224135) DOI: 10.1371/journal.pone.0224135)
Publisher: Public Library of Science (PLoS)
Date: 02-07-2020
Does splitting a tablet obtain the accurate dose?: A systematic review protocol
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2019
Training healthcare providers to respond to intimate partner violence against women
Publisher: Wiley
Date: 31-05-2021
Prolonged infusion versus intermittent infusion dosing of beta-lactam antibiotics in critically ill patients with sepsis: a protocol for a systematic review and meta-analysis of randomised controlled
Publisher: Cold Spring Harbor Laboratory
Date: 16-05-2023
DOI: 10.1101/2023.05.15.23289889
Abstract: In vitro and in vivo pharmacokinetic harmacodynamic data describe improved activity of beta-lactam antibiotics when administered by prolonged infusion compared with standard intermittent infusion. There remains insufficient robust clinical trial data to support a widespread practice change. Patients with sepsis and septic shock are a population in whom prolonged infusion of beta-lactam antibiotics may improve survival. Two large multicentre randomised controlled trials (RCTs) comparing prolonged versus intermittent infusion of beta-lactam antibiotics in critically ill patients with sepsis or septic shock are due for completion in 2023. With existing RCT evidence, this systematic review and meta-analysis will include these new data to measure the clinical benefits of prolonged beta-lactam infusion in critically ill patients with sepsis. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA) statement. This systematic review and meta-analysis will include RCTs that compare prolonged infusion with intermittent infusion of beta-lactam antibiotics in critically ill adult patients with sepsis. Medline (via PubMed), CINAHL, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and other clinical trials registries will be searched to identify eligible RCTs for review. Two reviewers will perform the study selection and extraction processes with disagreements resolved by discussion or referral to a third reviewer if needed. The Cochrane Collaboration’s Risk-of-Bias Tool for Randomised Trials version 2 (RoB 2) will be used to evaluate the quality of included studies. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach will be used to evaluate the overall quality of evidence for each outcome measures The a priori primary outcome is all-cause 90-day mortality. Secondary outcomes include intensive care unit (ICU) mortality, ICU length of stay, clinical cure, microbiological cure, and the development of adverse events. Bayesian random-effects meta-analyses will be conducted, with frequentist analyses planned for sensitivity analysis. Human research ethics approval is not required as the study involves the use of existing collections of data that are de-identified. It is expected that findings will be presented at national and international intensive care and infectious diseases meetings, and will be submitted to a peer-reviewed journal for publication. PROSPERO Registration Number: CRD42023399434
Voriconazole: An audit of hospital-based dosing and monitoring and evaluation of the predictive performance of a dose-prediction software package
Publisher: Oxford University Press (OUP)
Date: 11-04-2020
DOI: 10.1093/JAC/DKAA098
Abstract: Therapeutic drug monitoring (TDM) is recommended to guide voriconazole therapy. To determine compliance of hospital-based voriconazole dosing and TDM with the Australian national guidelines and evaluate the predictive performance of a one-compartment population pharmacokinetic voriconazole model available in a commercial dose-prediction software package. A retrospective audit of voriconazole therapy at an Australian public hospital (1 January to 31 December 2016) was undertaken. Data collected included patient demographics, dosing history and plasma concentrations. Concordance of dosing and TDM with Australian guidelines was assessed. Observed concentrations were compared with those predicted by dose-prediction software. Measures of bias (mean prediction error) and precision (mean squared prediction error) were calculated. Adherence to dosing guidelines for 110 courses of therapy (41% for prophylaxis and 59% for invasive fungal infections) was poor, unless oral formulation guidelines recommended a 200 mg dose, the most commonly prescribed dose (56% of prescriptions). Plasma voriconazole concentrations were obtained for 82% (90/110) of courses [median of 3 (range: 1–27) obtained per course]. A minority (27%) of plasma concentrations were trough concentrations [median concentration: 1.5 mg/L (range: & .1 to & .0 mg/L)]. Of trough concentrations, 57% (58/101) were therapeutic, 37% (37/101) were subtherapeutic and 6% (6/101) were supratherapeutic. The dose-prediction software performed well, with acceptable bias and precision of 0.09 mg/L (95% CI −0.08 to 0.27) and 1.32 (mg/L)2 (95% CI 0.96–1.67), respectively. Voriconazole dosing was suboptimal based on published guidelines and TDM results. Dose-prediction software could enhance TDM-guided therapy.
Health Economic Evaluation Alongside Stepped Wedge Trials: A Methodological Systematic Review
Publisher: Springer Science and Business Media LLC
Date: 05-10-2021
Cardiorenal protective effects of canagliflozin in CREDENCE according to glucose lowering.
Publisher: BMJ
Date: 06-2023
DOI: 10.1136/BMJDRC-2022-003270
Abstract: Relationships between glycemic-lowering effects of sodium glucose co-transporter 2 inhibitors and impact on kidney and cardiovascular outcomes are uncertain. We analyzed 4395 in iduals with prebaseline and postbaseline hemoglobin A1c (HbA1c) randomized to canagliflozin (n=2193) or placebo (n=2202) in The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation trial. Effects on HbA1c were assessed using mixed models. Mediation of treatment effects by achieved glycemic control was analyzed using proportional hazards regression with and without adjustment for achieved HbA1c. End points included combined kidney or cardiovascular death, end-stage kidney disease or doubling of serum creatinine (primary trial outcome), and in idual end point components. HbA1c lowering was modified by baseline estimated glomerular filtration rate (eGFR). For baseline eGFR 60–90, 45–59, and 30–44 mL/min/1.73 m 2 , overall HbA1c (canagliflozin vs placebo) decreased by −0.24%, −0.14%, and −0.08% respectively and likelihood of .5% decrease in HbA1c decreased with ORs of 1.47 (95% CI 1.27 to 1.67), 1.12 (0.94 to 1.33) and 0.99 (0.83 to 1.18), respectively. Adjustment for postbaseline HbA1c marginally attenuated canagliflozin effects on primary and kidney composite outcomes: unadjusted HR 0.67 (95% CI 0.57 to 0.80) and 0.66 (95% CI 0.53 to 0.81) adjusted for week 13 HbA1c, HR 0.71 (95% CI 0.060 to 0.84) and 0.68 (95% CI 0.55 to 0.83). Results adjusted for time-varying HbA1c or HbA1c as a cubic spline were similar and consistent with preserved clinical benefits across a range of excellent and poor glycemic control. The glycemic effects of canagliflozin are attenuated at lower eGFR but effects on kidney and cardiac end points are preserved. Non-glycemic effects may be primarily responsible for the kidney and cardioprotective benefits of canagliflozin.22
Association between hepatitis delta virus with liver morbidity and mortality: A systematic literature review and meta-analysis.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 23-10-2023
Socio-economic difference in purchases of ultra-processed foods in Australia: an analysis of a nationally representative household grocery purchasing panel
Publisher: Springer Science and Business Media LLC
Date: 12-12-2022
DOI: 10.1186/S12966-022-01389-8
Abstract: Consumption of ultra-processed foods is associated with increased risk of obesity and non-communicable diseases. Little is known about current patterns of ultra-processed foods intake in Australia. The aim of this study was to examine the amount and type of ultra-processed foods purchased by Australian households in 2019 and determine whether purchases differed by socio-economic status (SES). We also assessed whether purchases of ultra-processed foods changed between 2015 and 2019. We used grocery purchase data from a nationally representative consumer panel in Australia to assess packaged and unpackaged grocery purchases that were brought home between 2015 to 2019. Ultra-processed foods were identified according to the NOVA system, which classifies foods according to the nature, extent and purpose of industrial food processing. Purchases of ultra-processed foods were calculated per capita, using two outcomes: grams/day and percent of total energy. The top food categories contributing to purchases of ultra-processed foods in 2019 were identified, and differences in ultra-processed food purchases by SES (Index of Relative Social Advantage and Disadvantage) were assessed using survey-weighted linear regression. Changes in purchases of ultra-processed foods between 2015 to 2019 were examined overall and by SES using mixed linear models. In 2019, the mean ± SD total grocery purchases made by Australian households was 881.1 ± 511.9 g/d per capita. Of this, 424.2 ± 319.0 g/d per capita was attributable to purchases of ultra-processed foods, which represented 56.4% of total energy purchased. The largest food categories contributing to total energy purchased included mass-produced, packaged breads (8.2% of total energy purchased), chocolate and sweets (5.7%), biscuits and crackers (5.7%) and ice-cream and edible ices (4.3%). In 2019, purchases of ultra-processed foods were significantly higher for the lowest SES households compared to all other SES quintiles ( P 0.001). There were no major changes in purchases of ultra-processed foods overall or by SES over the five-year period. Between 2015 and 2019, ultra-processed foods have consistently made up the majority of groceries purchased by Australians, particularly for the lowest SES households. Policies that reduce ultra-processed food consumption may reduce diet-related health inequalities.
The effect of canagliflozin on amputation risk in the CANVAS program and the CREDENCE trial
Publisher: Wiley
Date: 24-06-2020
DOI: 10.1111/DOM.14091
Estimated glomerular filtration rate progression in UK primary care patients with type 2 diabetes and diabetic kidney disease: a retrospective cohort study
Publisher: Hindawi Limited
Date: 25-05-2015
DOI: 10.1111/IJCP.12640
Abstract: To examine the rates of diabetic kidney disease (DKD) progression and associated factors, we undertook a study of estimated glomerular filtration rate (eGFR) in a historical cohort of UK primary care patients with type 2 diabetes mellitus (T2DM) and associated DKD from the Clinical Practice Research Datalink. Our eligible population were patients with definitive T2DM from a recorded diagnostic code with either a diagnosis of chronic kidney disease (CKD) or renal function test values and renal abnormalities consistent with a CKD diagnosis, identified between 1 October 2006 and 31 December 2011. Only patients with albuminuria results reported in mg/l were used for the longitudinal statistical analyses of the eGFR rate of change using multilevel models. We identified 111,030 patients with T2DM. Among them 58.6% (95% confidence interval (CI): 58.3-58.9) had CKD and 37.2% (95% CI: 36.9-37.5%) had presumed DKD at baseline. Only 19.4% of patients had urinary albumin test results expressed as mg/l in the year prior to index date. Almost two-thirds (63.8%) of patients with T2DM and presumed DKD received prescriptions for angiotensin-converting enzyme (ACE) inhibitors or angiotensin type 1 receptor blockers (ARB) or both. Time-dependent variables that predict subsequent eGFR decline include increased albuminuria, time from index date and older age. Only a minority of diabetic patients with DKD had quantitative albuminuria assessments. The relatively low proportion of DKD patients with ACEi or ARB prescriptions suggests a gap between healthcare practice and available scientific evidence during the study period. Increased albuminuria and older age were the most consistent predictors of subsequent eGFR decline.
Comparison of efficacy of antiplatelet treatments for patients with claudication
Publisher: Georg Thieme Verlag KG
Date: 2010
DOI: 10.1160/TH09-09-0635
Abstract: It was the aim of the present study to investigate if antiplatelet treatment reduced cardiovascular events in patients with claudication and/ or an ankle/brachial index (ABI) ≤0.99 and to analyse if specific antiplatelet treatment had a different impact on clinical outcome. We performed a meta-analysis of 29 clinical randomized trials on antiplatelet therapy for prevention of vascular death, myocardial infarction, and stroke in 10,735 peripheral artery disease patients. The primary end-point utilizing in the meta-analysis construction was Cardiovascular Adverse Event. We found 1,900 (17.70%) patients in trials with aspirin, 5,326 (49.61%) in those with thienopyridines, 2,324 (21.65%) in those with picotamide and 1,185 (11.04 %) in those with others antiplatelet drugs. A statistically significant effect of antiplatelet treatment [odds ratio (OR) 0.839 95% confidence interval (CI) 0.729–0.965 p=0.014] was observed. There was a statistically significant reduction of clinical outcome [OR 0.779 95% CI 0.639–0.950 p=0.014] in the thienopyridine-treated group vs. control. Patients treated with picotamide [OR 0.785 95% CI 0.495–1.243 p=0.302] or aspirin [OR 0.847 95%CI 0.653–1.097 p=0.084] showed reduced cardiovascular outcomes, that, however, did not reach significance. The study confirms that anti-platelet treatment reduces vascular outcome in claudicants. Significant reduction was observed with thienopyridines while data regarding aspirin and picotamide were inconclusive.
Potential Usefulness of a Combination of Inflammatory Markers in Identifying Patients With Sarcoidosis and Monitoring Respiratory Functional Worsening
Publisher: Oxford University Press (OUP)
Date: 03-2012
Selective Decontamination of the Digestive Tract in Invasively Ventilated Patients in an Intensive Care Unit: A protocol for a Systematic Review and Meta-Analysis
Publisher: Cold Spring Harbor Laboratory
Date: 20-03-2022
DOI: 10.1101/2022.03.18.22272586
Abstract: The use of Selective Decontamination of the Digestive Tract (SDD) as a preventative infection-control strategy in invasively ventilated patients in the intensive care unit (ICU) remains low despite numerous randomised controlled trials (RCTs) consistently reporting reductions in interval mortality rates and shorter durations of mechanical ventilation. The Selective Decontamination of the Digestive Tract in the Intensive Care Unit (SuDDICU) cluster cross-over RCT, that includes over 5500 participants randomised to receive a standardised commercial grade SDD interventions or standard care, will be reported in 2022 and will add substantive weight to previous RCT data assessing the effect of SDD on interval mortality compared to standard care. We will conduct an updated systematic review and prospective aggregate data meta-analysis of previous conducted and published RCTs, developed using a protocol and statistical analysis plan completed prior to the completion of the SuDDICU RCT and including the SuDDICU data to present the most current evidence available to guide clinical practice. We will include RCTs that compare the effect on hospital mortality and other patient-centred outcomes of treatment with SDD compared to standard care in invasively ventilated adults in the ICU. We will perform a search that includes the electronic databases MEDLINE and EMBASE and clinical trial registries. Two reviewers will independently screen titles and abstracts, perform full article reviews and extract study data, with discrepancies resolved by a third reviewer. We will report study characteristics and quantify risk of bias. We will perform random effects Bayesian meta-analyses to provide pooled estimates that SDD improves outcomes, whenever it is feasible to do so. We will evaluate overall certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation framework. This updated systematic review and prospective meta-analysis will provide clinicians with an expedited assessment of the totality of current evidence about the effect on mortality of using SDD in mechanically ventilated ICU patients.
Reply to M. Lv et al
Publisher: American Society of Clinical Oncology (ASCO)
Date: 2023
DOI: 10.1200/JCO.22.01571
Renin‐Angiotensin System Inhibitors in Patients With COVID‐19: A Meta‐Analysis of Randomized Controlled Trials Led by the International Society of Hypertension
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-09-2022
Abstract: Published randomized controlled trials are underpowered for binary clinical end points to assess the safety and efficacy of renin‐angiotensin system inhibitors (RASi) in adults with COVID‐19. We therefore performed a meta‐analysis to assess the safety and efficacy of RASi in adults with COVID‐19. MEDLINE, EMBASE, ClinicalTrials.gov , and the Cochrane Controlled Trial Register were searched for randomized controlled trials that randomly assigned patients with COVID‐19 to RASi continuation/commencement versus no RASi therapy. The primary outcome was all‐cause mortality at ≤30 days. A total of 14 randomized controlled trials met the inclusion criteria and enrolled 1838 participants (aged 59 years, 58% men, mean follow‐up 26 days). Of the trials, 11 contributed data. We found no effect of RASi versus control on all‐cause mortality (7.2% versus 7.5% relative risk [RR], 0.95 [95% CI, 0.69–1.30]) either overall or in subgroups defined by COVID‐19 severity or trial type. Network meta‐analysis identified no difference between angiotensin‐converting enzyme inhibitors versus angiotensin II receptor blockers. RASi users had a nonsignificant reduction in acute myocardial infarction (2.1% versus 3.6% RR, 0.59 [95% CI, 0.33–1.06]), but increased risk of acute kidney injury (7.0% versus 3.6% RR, 1.82 [95% CI, 1.05–3.16]), in trials that initiated and continued RASi. There was no increase in need for dialysis or differences in congestive cardiac failure, cerebrovascular events, venous thromboembolism, hospitalization, intensive care admission, inotropes, or mechanical ventilation. This meta‐analysis of randomized controlled trials evaluating angiotensin‐converting enzyme inhibitors/angiotensin II receptor blockers versus control in patients with COVID‐19 found no difference in all‐cause mortality, a borderline decrease in myocardial infarction, and an increased risk of acute kidney injury with RASi. Our findings provide strong evidence that RASi can be used safely in patients with COVID‐19.
Evaluating practical support stroke survivors get with medicines and unmet needs in primary care: a survey
Publisher: BMJ
Date: 03-2018
DOI: 10.1136/BMJOPEN-2017-019874
Abstract: To design a questionnaire and use it to explore unmet needs with practical aspects of medicine taking after stroke, predictors of medicine taking and to estimate the proportion of survivors who get support with daily medication taking. Four workshops with stroke survivors and caregivers to design the questionnaire. A cross-sectional postal questionnaire in primary care. 18 general practitioner practices in the East of England and London. Questionnaires posted between September 2016 and February 2017. 1687 stroke survivors living in the community outside institutional long-term care. The proportion of community stroke survivors receiving support from caregivers for practical aspects of medicine taking the proportion with unmet needs in this respect the predictors of experiencing unmet needs and missing taking medications. A five-item questionnaire was developed to cover the different aspects of medicine taking. 596/1687 (35%) questionnaires were returned. 56% reported getting help in at least one aspect of taking medication and 11% needing more help. 35% reported missing taking their medicines. Unmet needs were associated with receiving help with medications (OR 5.9, P .001), being on a higher number of medications (OR 1.2, P .001) and being dependent for activities of daily living (OR 4.9, P=0.001). Missing medication was associated with having unmet needs (OR 5.3, P .001), receiving help with medications (OR 2.1, P .001), being on a higher number of medicines (OR 1.1, P=0.008) and being older than 70 years (OR 0.6, P=0.006). More than half of patients who replied needed help with taking medication, and 1 in 10 had unmet needs in this regard. Stroke survivors dependent on others have more unmet needs, are more likely to miss medicines and might benefit from focused clinical and research attention. Novel primary care interventions focusing on the practicalities of taking medicines are warranted.
Intensive LDL cholesterol-lowering treatment beyond current recommendations for the prevention of major vascular events: a systematic review and meta-analysis of randomised trials including 327 037 participants
Publisher: Elsevier BV
Date: 2020
Change in mean salt intake over time using 24-h urine versus overnight and spot urine samples: a systematic review and meta-analysis
Publisher: Springer Science and Business Media LLC
Date: 12-2020
DOI: 10.1186/S12937-020-00651-8
Abstract: Little is known about the capacity of overnight and spot urine s les to estimate changes in mean salt intake over time. The objective of this review was to compare the estimates of change in mean population salt intake based on 24-h urine and overnight/spot urine s les. Studies were systematically identified through searches of peer-reviewed databases (Medline, Embase, Global Health, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews) and grey literature. Studies that reported estimates of mean salt intake for at least two time points based on both 24-h and overnight/spot urines were deemed eligible. The capacity of overnight/spot urine s les to estimate the change in mean salt intake was assessed both at the in idual-study level and overall through random-effects meta-analyses. The level of heterogeneity was assessed through the I 2 statistic. Subgroup and sensitivity analyses were conducted to explore possible sources of heterogeneity, and check the robustness of the findings from the primary analysis. A total of 1244 records were identified, 50 were assessed as full text, and 14 studies met the criteria, capturing data on 7291 participants from seven countries. Nine and five studies collected overnight and spot urines, respectively. The comparison of the change in mean salt intake between 24-h and overnight/spot urines showed some inconsistencies at the in idual study-level. The pooled mean change in salt intake was − 0.43 g/day (95% CI − 1.16 to 0.30 I 2 = 95%) using 24-h urines, and − 0.22 g/day (− 0.65 to 0.20 I 2 = 87%) using overnight/spot urines, with a pooled difference-in-differences between the two methods of 0.27 g/day (− 0.23 to 0.77 I 2 = 89%). Subgroup analyses showed substantial heterogeneity for most subgroups. Sensitivity analyses did not change the effect observed in the primary analysis. The evidence for the capacity of overnight/spot urines to estimate changes in mean salt intake over time is uncertain. More research where overnight/spot urines are collected in parallel with 24-h urines is needed to enable a more in-depth evaluation of these alternative approaches to estimating change in mean salt intake.
Proceedings of the First International Conference on Stepped Wedge Trial Design
Publisher: Springer Science and Business Media LLC
Date: 07-2016
Carotid plaque detection improves the predictive value of CHA2DS2-VASc score in patients with non-valvular atrial fibrillation: The ARAPACIS Study
Publisher: Elsevier BV
Date: 03-2017
DOI: 10.1016/J.IJCARD.2017.01.001
Abstract: Vascular disease (VD), as assessed by history of myocardial infarction or peripheral artery disease or aortic plaque, increases stroke risk in atrial fibrillation (AF), and is a component of risk assessment using the CHA We analysed data from the ARAPACIS study, an observational study including 2027 Italian patients with non-valvular AF, in whom CP was detected using Doppler Ultrasonography. VD was reported in 351 (17.3%) patients while CP was detected in 16.6% patients. Adding CP to the VD definition leaded to higher VD prevalence (30.9%). During a median [IQR] follow-up time of 36months, 56 (2.8%) stroke/TIA events were recorded. Survival analysis showed that conventional VD alone did not increase the risk of stroke (Log-Rank: 0.009, p=0.924), while addition of CP to conventional VD was significantly associated to an increased risk of stroke (LR: 5.730, p=0.017). Cox regression analysis showed that VD+CP was independently associated with stroke (HR: 1.78, 95% CI: 1.05-3.01, p=0.0318). Reclassification analysis showed that VD+CP allowed a significant risk reclassification when compared to VD alone in predicting stroke at 36months (NRI: 0.192, 95% CI: 0.028-0.323, p=0.032). In non-valvular AF patients the addition of ultrasound detection of carotid plaque to conventional VD significantly increases the predictive value of CHA
An electronic decision support-based complex intervention to improve management of cardiovascular risk in primary health care: a cluster randomised trial (INTEGRATE)
Publisher: AMPCo
Date: 26-04-2021
DOI: 10.5694/MJA2.51030
Cost-Effectiveness of a Household Salt Substitution Intervention: Findings From 20 995 Participants of the Salt Substitute and Stroke Study
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 17-05-2022
DOI: 10.1161/CIRCULATIONAHA.122.059573
Abstract: SSaSS (Salt Substitute and Stroke Study), a 5-year cluster randomized controlled trial, demonstrated that replacing regular salt with a reduced-sodium, added-potassium salt substitute reduced the risks of stroke, major adverse cardiovascular events, and premature death among in iduals with previous stroke or uncontrolled high blood pressure living in rural China. This study assessed the cost-effectiveness profile of the intervention. A within-trial economic evaluation of SSaSS was conducted from the perspective of the health care system and consumers. The primary health outcome assessed was stroke. We also quantified the effect on quality-adjusted life-years (QALYs). Health care costs were identified from participant health insurance records and the literature. All costs (in Chinese yuan [¥]) and QALYs were discounted at 5% per annum. Incremental costs, stroke events averted, and QALYs gained were estimated using bivariate multilevel models. Mean follow-up of the 20 995 participants was 4.7 years. Over this period, replacing regular salt with salt substitute reduced the risk of stroke by 14% (rate ratio, 0.86 [95% CI, 0.77–0.96] P =0.006), and the salt substitute group had on average 0.054 more QALYs per person. The average costs (¥1538 for the intervention group and ¥1649 for the control group) were lower in the salt substitute group (¥110 less). The intervention was dominant (better outcomes at lower cost) for prevention of stroke as well as for QALYs gained. Sensitivity analyses showed that these conclusions were robust, except when the price of salt substitute was increased to the median and highest market prices identified in China. The salt substitute intervention had a 95.0% probability of being cost-saving and a .9% probability of being cost-effective. Replacing regular salt with salt substitute was a cost-saving intervention for the prevention of stroke and improvement of quality of life among SSaSS participants.
Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial
Publisher: Elsevier BV
Date: 02-2022
DOI: 10.1053/J.AJKD.2021.05.005
Abstract: Canagliflozin reduced the risk of kidney failure and related outcomes in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) in the CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial. This analysis of CREDENCE trial data examines the effect of canagliflozin on the incidence of kidney-related adverse events (AEs). A randomized, double-blind, placebo-controlled, multicenter international trial. 4,401 trial participants with T2DM, CKD, and urinary albumin-creatinine ratio >300-5,000 mg/g. Participants were randomly assigned to receive canagliflozin 100 mg/d or placebo. Rates of kidney-related AEs were analyzed using an on-treatment approach, overall and by screening estimated glomerular filtration rate (eGFR) strata (30-<45, 45-<60, and 60-<90 mL/min/1.73 m Canagliflozin was associated with a reduction in the overall incidence rate of kidney-related AEs (60.2 vs 84.0 per 1,000 patient-years hazard ratio [HR], 0.71 [95% CI, 0.61-0.82] P < 0.001), with consistent results for serious kidney-related AEs (HR, 0.72 [95% CI, 0.51-1.00] P = 0.05) and acute kidney injury (AKI HR, 0.85 [95% CI, 0.64-1.13] P = 0.3). The rates of kidney-related AEs were lower with canagliflozin relative to placebo across the 3 eGFR strata (HRs of 0.73, 0.60, and 0.81 for eGFR 30-<45, 45-<60, and 60-<90 mL/min/1.73 m Kidney-related AEs including AKI were investigator-reported and collected without central adjudication. Biomarkers of AKI and structural tubular damage were not measured, and creatinine data after an AKI event were not available for all participants. Compared with placebo, canagliflozin was associated with a reduced incidence of serious and nonserious kidney-related AEs in patients with T2DM and CKD. These results highlight the safety of canagliflozin with regard to adverse kidney-related AEs. The CREDENCE trial and this analysis were funded by Janssen Research & Development, LLC, and were conducted as a collaboration between the funder, an academic steering committee, and an academic research organization, George Clinical. The CREDENCE trial was registered at ClinicalTrials.gov with identifier number NCT02065791.
Implantable Agents for Fecal Incontinence: An Age-Matched Retrospective Cohort Analysis of GateKeeper versus SphinKeeper
Publisher: SAGE Publications
Date: 16-06-2020
Abstract: Background. We aim to evaluate morphofunctional changes of the sphincter complex after GateKeeper (GK) and SphinKeeper (SK) procedures and correlate these with symptom improvement. Methods. Ten consecutive females undergoing SK implant were age-matched with a cohort of 10 females who previously underwent the GK procedure. Patients in the SK and GK groups underwent implantation of 10 and 6 prostheses, respectively. Muscle tension ( Tm), expressed in millinewtons per centimetre squared, mN (cm 2 ) −1 , was calculated using the equation Tm = P( r i )( tm) −1 , where P is the average maximum squeeze pressure and r i and tm the inner radius and thickness of the external anal sphincter, respectively. The pre- and postimplant changes in Tm and Cleveland Clinic Fecal Incontinence Score (CCFIS) were tested by linear and Poisson regression models, respectively. Results. The CCFIS significantly improved in both groups at 12-month postimplantation. Although not reaching statistical significance, symptom improvement after SK was 33% above that observed after GK ( P = .088). Compared to the baseline, a significant increase in Tm was observed in both groups at 12 months (GK, 508.1 [478.8-568.0] vs 864.4 [827.0-885.8] mN (cm 2 ) −1 SK, 528.0 [472.7-564.0] vs 858.6 [828.0-919.6] mN (cm 2 ) −1 , P = .005). Compared to the GK group, Tm was significantly higher in patients after SK implant (158.3 mN (cm 2 ) −1 [95% confidence interval, 109.6-207.0] P .001), after controlling for baseline values, at 12-month postimplantation. Conclusions. GK and SK are safe and effective treatments for FI with good short-term clinical outcomes. Comparative analysis showed superiority of SK over GK in terms of gain in Tm, with borderline significantly better improvement in symptoms. Larger studies are needed to confirm these findings.
Correction: Vital Signs During the COVID-19 Outbreak: A Retrospective Analysis of 19,960 Participants in Wuhan and Four Nearby Capital Cities in China
Publisher: Ubiquity Press, Ltd.
Date: 2022
DOI: 10.5334/GH.1172
Stroke in Africa: A systematic review and meta-analysis of the incidence and case-fatality rates
Publisher: SAGE Publications
Date: 14-01-2023
DOI: 10.1177/17474930221147164
Abstract: The burden of stroke (a leading cause of disability and mortality) in Africa appears to be increasing, but a systematic review of the best available data to support or refute this observation is lacking. To determine the incidence and 1-month case-fatality rates from high-quality studies of stroke epidemiology among Africans. We searched and retrieved eligible articles on stroke epidemiology among indigenous Africans in bibliographic databases (MEDLINE, ScienceDirect, Google Scholar, and Cochrane library) using predefined search terms from the earliest records through January 2022. Methodological assessment of eligible studies was conducted using the Newcastle–Ottawa scale. Pooling of incidence and case-fatality rates was performed via generalized linear models (Poisson-Normal random-effects model). Of the 922 articles retrieved, 14 studies were eligible for inclusion. The total number of stroke cases was 2568, with a population denominator (total s le size included in population-based registries or those who agreed to participate in door-to-door community studies) of 3,384,102. The pooled crude incidence rate of stroke per 100,000 persons in Africa was 106.49 (95% confidence interval (CI) = 58.59–193.55), I 2 = 99.6%. The point estimate of the crude incidence rate was higher among males, 111.33 (95% CI = 56.31–220.12), I 2 = 99.2%, than females, 91.14 (95% CI = 47.09–176.37), I 2 = 98.9%. One-month case-fatality rate was 24.45 (95% CI = 16.84–35.50), I 2 = 96.8%, with lower estimates among males, 22.68 (95% CI = 18.62–27.63), I 2 = 12.9%, than females, 27.57 (95% CI = 21.47–35.40), I 2 = 51.6%. The burden of stroke in Africa remains very high. However, little is known about the dynamics of stroke epidemiology among Africans due to the dearth of high-quality evidence. Further continent-wide rigorous epidemiological studies and surveillance programs using the World Health Organization STEPwise approach to Surveillance (WHO STEPS) framework are needed.
Interventions to prevent or delay the onset of type 2 diabetes in women with prior gestational diabetes mellitus: protocol for a living systematic review and prospective meta-analysis
Publisher: Cold Spring Harbor Laboratory
Date: 11-2021
DOI: 10.1101/2021.10.31.21265595
Abstract: Gestational diabetes mellitus (GDM), once considered a transient condition during pregnancy, is now a firmly established risk factor for type 2 diabetes mellitus (T2DM). Women whose blood glucose levels do not return to normal soon after giving birth are particularly at high risk of developing established diabetes and consequent heart and blood vessel disease. Lifestyle interventions are recommended for women with GDM to prevent or delay the subsequent development of T2DM. Recent systematic reviews and meta-analyses have suggested postpartum lifestyle interventions may be beneficial in reducing the risk of developing diabetes in women with GDM, however, included studies were generally small, many had a high risk of bias and subsequent data have become available with new trials likely to complete in the next couple of years. In addition, to the best of our knowledge, formal systematic review and meta-analysis of other approaches to preventing diabetes in this population (e.g. pharmacotherapy) has not been attempted. Therefore, an updated systematic review is needed and will be formulated as a living systematic review to ensure the inclusion of emerging studies. A living systematic review and a prospective meta-analysis to examine the effectiveness of postpartum interventions in reducing the risk of developing T2DM in women with recent GDM. Ethics committee approval is not required. The data included will be from published studies, and a continued living systematic review and prospective meta-analysis will occur once a year for the next five years. Results of the review will be disseminated at relevant meetings. CRD42021279891 A living systematic review will allow continuous surveillance of emerging literature on different lifestyle interventions in women with a history of GDM and allow identification of effective strategies for diabetes prevention. We estimate considerable heterogeneity of interventions which may limit our ability to make clear conclusions.
Renal haemodynamic response to sodium‐glucose cotransporter‐2 inhibition does not depend on protein intake: An analysis of three randomized controlled trials
Publisher: Wiley
Date: 14-05-2021
DOI: 10.1111/DOM.14411
Abstract: High protein intake may increase intraglomerular pressure through dilation of the afferent arteriole. Sodium‐glucose cotransporter‐2 (SGLT2) inhibitors may reduce intraglomerular pressure through activation of tubuloglomerular feedback. Given these opposing effects, we assessed whether the effect of dapagliflozin on glomerular filtration rate (GFR) and urinary albumin‐to‐creatinine ratio (UACR) was modified by estimated dietary protein intake using data from three separate randomized controlled trials (DELIGHT, IMPROVE and DIAMOND). The median protein intake was 58.4, 63.6 and 90.0 g/d, respectively. In the DELIGHT trial (n = 233), dapagliflozin compared to placebo caused an acute and reversible dip in GFR of 2.1 and 2.2 mL/min/1.73 m 2 , and reduced UACR by 20.5% and 28.4% in participants with high and low protein intake, respectively. Similarly, in IMPROVE (n = 30) and DIAMOND (n = 53), the effect of dapagliflozin on GFR and UACR was comparable in participants with high and low protein intake (all P for interaction 0.40). This post hoc, exploratory analysis of three clinical trials suggests that dietary protein intake does not modify the in idual response of clinical kidney variables to dapagliflozin.
Distribution and trends in mesothelioma mortality in Italy from 1974 to 2006
Publisher: Springer Science and Business Media LLC
Date: 22-05-2013
DOI: 10.1007/S00420-012-0780-6
Abstract: Using the epidemiological data of pleural cancer mortality, the authors estimated time trends and distribution of malignant mesothelioma in Italy during the period 1974-2006. To describe temporal trends of the standardized mortality ratios (SMRs) in all the 20 Italian regions, we applied the Joinpoint Regression Model, developed by the National Cancer Institute (USA). The 107 provincial SMRs are represented on maps by using the Arcview GIS software (version 3.2). The high values from mesothelioma mortality in construction and shipbuilding sectors, previously reported, are confirmed by our analyses. Furthermore, data show that the annual percentage change is still growing: statistically significant increments in time trends are observed for 11 of 20 Italian regions. Of additional concern has been the identification of changes in 9 of 20 trends partially due to the misdiagnosis in the past. Given the long latency of mesothelioma, preventive and legal measures with the ban of asbestos in Italy since 1992 are still not giving effects on mesothelioma mortality trends.
An assessment of knowledge and education about sepsis among medical students: A multi-university survey
Publisher: Elsevier BV
Date: 03-2021
DOI: 10.51893/2021.1.RL2
Abstract: Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection it affects 55 000 Australians and results in around 8700 deaths annually.1 Studies have shown that junior doctors have reduced awareness of the importance of sepsis as a time-critical illness.2 Whether this deficiency is a consequence of insufficient training on sepsis in medical schools is unknown. This study evaluated the knowledge of sepsis among medical students in two Australian universities
Systematic Characterization of Defecographic Abnormalities in a Consecutive Series of 827 Patients With Chronic Constipation
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 15-10-2021
DOI: 10.1097/DCR.0000000000001923
Abstract: Barium defecography can assess structural and functional abnormalities in patients with chronic constipation. The purpose of this study was to determine the prevalence of in idual and overlapping defecographic findings in this setting. This was a cross-sectional study. The study was conducted at a university hospital tertiary GI physiology department. Consecutive examinations of 827 consecutive patients presenting over a 30-month period with well-defined symptom severity (≥12 points on the Cleveland Clinic Constipation score) were included. Systematic evaluation of images with results stratified by sex is described. Six in idual functional or anatomic (intussusception, rectocele, enterocele, megarectum, excessive dynamic perineal descent) defecographic observations were defined a priori, thus permitting 2 6 possible combinations of findings (ie, 63 abnormal types + 1 normal). Patients with constipation (mean symptom score = 19) were predominantly female (88%), with median age of 49 years (range, 17–98 y) . All 6 in idual radiologic findings were identified with a total of 43 combinations found in the cohort the 14 most prevalent of these accounted for % of patients. Only 136 patients (16.4%) had a normal defecography (34.3% males vs 13.9% females p 0.0001). Overall, 612 patients (74.0%) had structural (n = 508 (61.4%)) or functional (n=104 (12.6%)) abnormalities in isolation, with 79 (9.6%) others exhibiting combinations of both. Functional abnormalities in isolation were more common in males compared with females (22.5% vs11.2% p = 0.025) as opposed to structural abnormalities (57.8% vs 85.7% p 0.0001). Expulsion time was longer in females compared with males (110 s (60–120 s) vs 90 s (60–120 s) p = 0.049). The study was limited by its lack of multiorgan opacification. These results provide a contemporary atlas of defecographic findings in constipation. Several in idual structural and functional features have been systematically classified, with overlap greater than previously acknowledged and profound differences among sexes that carry implications for tailoring management. See Video Abstract at links.lww.com/DCR/B552. ANTECEDENTES: La defecografía con bario puede evaluar anomalías estructurales y funcionales en pacientes con estreñimiento crónico. OBJETIVO: Determinar la prevalencia de hallazgos defecográficos in iduales y superpuestos en este entorno. DISEÑO: Transversal. ENTORNO CLINICO: Hospital Universitario de tercer nivel, departamento de fisiología gastrointestinal. PACIENTES: Exploraciones consecutivas de 827 pacientes consecutivos que se presentaron durante un período de 30 meses con una gravedad de los síntomas bien definida (≥12 puntos en la escala de estreñimiento de la Cleveland Clinic ): evaluación sistemática de imágenes con resultados estratificados por sexo. PRINCIPALES MEDIDAS DE VALORACION: Se definieron a priori seis observaciones defecográficas in iduales, funcionales o anatómicas (intususcepción, rectocele, enterocele, megarecto, descenso perineal dinámico excesivo), lo que permitió 26 combinaciones posibles de hallazgos (es decir, 63 tipos anormales + 1 normal). RESULTADOS: Los pacientes con estreñimiento (puntuación media de síntomas, 19) eran predominantemente mujeres (88%) con una edad mediana de 49 (17-98) años. Se identificaron 6 hallazgos radiológicos in iduales con un total de 43 combinaciones encontradas en la cohorte los 14 más predominantes de éstos representaron % de los pacientes.Solo 136 (16,4%) pacientes tuvieron una defecografía normal (34,3% hombres vs. 13,9% mujeres P 0,0001). En general, 612 (74,0%) pacientes tenían anomalías estructurales ( n = 508 [61,4%]) o funcionales ( n = 104 [12,6%]) de forma aislada, y otros 79 (9,6%) presentaban combinaciones de ambas. Las anomalías funcionales aisladas fueron más comunes en los hombres en comparación con las mujeres (22,5% vs. 11,2%, P = 0,025) en comparación con las anomalías estructurales (57,8 vs. 85,7%, P 0,0001). El tiempo de expulsión fue mayor en las mujeres en comparación con los hombres (110 [60-120] vs. 90 [60-120] segundos P = 0,049). LIMITACIONES: Falta de opacificación multiorgánica. CONCLUSIONES: Estos resultados proporcionan un atlas contemporáneo de hallazgos defecográficos en estreñimiento. Varias características in iduales, estructurales y funcionales se han clasificado sistemáticamente, con una superposición mayor que la reconocida anteriormente y con grandes diferencias entre los sexos que tienen implicaciones para adaptar su tratamiento. Consulte Video Resumen en links.lww.com/DCR/B552.
Correction to: Major adverse cardiovascular events in non-valvular atrial fibrillation with chronic obstructive pulmonary disease: the ARAPACIS study
Publisher: Springer Science and Business Media LLC
Date: 03-08-2018
DOI: 10.1007/S11739-018-1922-Y
Abstract: In the original publication, one of the ARAPACIS collaborators Dr. "Leonardo Di Gennaro" name has been erroneously mentioned as "Leonardo De Gennaro".
Cluster randomized trial of influenza vaccination in patients with acute heart failure in China: A mixed-methods feasibility study.
Publisher: Public Library of Science (PLoS)
Date: 16-06-2023
DOI: 10.1371/JOURNAL.PGPH.0001947
Abstract: Uncertainties about the efficacy of influenza vaccination for populations with heart failure (HF) in preventing cardiovascular outcomes, as well as lack of effective vaccination strategies, may contribute to low vaccine coverage rate (VCR) in China and globally. We assessed the feasibility of a strategy to promote influenza vaccines in patients hospitalized with acute HF in China and to inform the design of a hybrid effectiveness-implementation cluster randomized trial to evaluate this strategy on mortality and hospital re-admission. We conducted a cluster randomized pilot trial involving 11 hospitals in Henan Province in China, with mixed-methods evaluation between December 2020 and April 2021. A process evaluation involved interviews with 51 key informants (patients, health professionals, policy makers). The intervention included education about influenza vaccination and availability of free vaccines administered prior to hospital discharge for HF patients, while usual care included attending community-based points of vaccination (PoV) for screening and vaccination. Implementation outcomes focused on reach, fidelity, adoption, and acceptability. Recruitment rates were assessed for trial feasibility. Effectiveness outcomes were influenza VCR, HF-specific rehospitalizations and mortality at 90 days. A total of 518 HF patients were recruited from 7 intervention and 4 usual care hospitals (mean of 45 participants per hospital per month). VCR was 89.9% (311/346, 86.1–92.8%) in the intervention group and 0.6% (1/172, 0.0–3.7%) in the control group. The process evaluation demonstrated reach to patients with lower socioeconomic and education status. There was good fidelity of the intervention components, with education and PoV set up processes being adapted to local hospital workflow and workforce capacity. Intervention was acceptable and adopted by patients and health professionals. However, outside of a trial setting, concerns were raised around vaccination reimbursement costs, workforce accountability and capacity. The intervention strategy appears feasible and acceptable for improving VCR in HF patients at county-level hospitals in China. Trial registration: This pilot trial is registered with the acronym PANDA II Pilot (Population Assessment of Influenza and Disease Activity) at ChiCTR.org.cn ( ChiCTR2000039081 ).
Longitudinal assessment of utilities in patients with migraine: an analysis of erenumab randomized controlled trials
Publisher: Springer Science and Business Media LLC
Date: 12-11-2019
DOI: 10.1186/S12955-019-1242-6
Abstract: Cost-effectiveness analyses in patients with migraine require estimates of patients’ utility values and how these relate to monthly migraine days (MMDs). This analysis examined four different modelling approaches to assess utility values as a function of MMDs. Disease-specific patient-reported outcomes from three erenumab clinical studies (two in episodic migraine [NCT02456740 and NCT02483585] and one in chronic migraine [NCT02066415]) were mapped to the 5-dimension EuroQol questionnaire (EQ-5D) as a function of the Migraine-Specific Quality of Life Questionnaire (MSQ) and the Headache Impact Test (HIT-6™) using published algorithms. The mapped utility values were used to estimate generic, preference-based utility values suitable for use in economic models. Four models were assessed to explain utility values as a function of MMDs: a linear mixed effects model with restricted maximum likelihood (REML), a fractional response model with logit link, a fractional response model with probit link and a beta regression model. All models tested showed very similar fittings. Root mean squared errors were similar in the four models assessed (0.115, 0.114, 0.114 and 0.114, for the linear mixed effect model with REML, fractional response model with logit link, fractional response model with probit link and beta regression model respectively), when mapped from MSQ. Mean absolute errors for the four models tested were also similar when mapped from MSQ (0.085, 0.086, 0.085 and 0.085) and HIT-6 and (0.087, 0.088, 0.088 and 0.089) for the linear mixed effect model with REML, fractional response model with logit link, fractional response model with probit link and beta regression model, respectively. This analysis describes the assessment of longitudinal approaches in modelling utility values and the four models proposed fitted the observed data well. Mapped utility values for patients treated with erenumab were generally higher than those for in iduals treated with placebo with equivalent number of MMDs. Linking patient utility values to MMDs allows utility estimates for different levels of MMD to be predicted, for use in economic evaluations of preventive therapies. ClinicalTrials.gov numbers of the trials used in this study : STRIVE, NCT02456740 (registered May 14, 2015), ARISE, NCT02483585 (registered June 12, 2015) and NCT02066415 (registered Feb 17, 2014).
Long-term costs and cost-effectiveness of adjunctive corticosteroids for patients with septic shock in New Zealand.
Publisher: Elsevier BV
Date: 05-2021
DOI: 10.1016/J.AUCC.2021.05.006
Abstract: The aim of the study was to determine whether adjunctive hydrocortisone reduced healthcare expenditure and was cost-effective compared with placebo in New Zealand patients in the Adjunctive Glucocorticoid Therapy in Patients with Septic Shock (ADRENAL) trial. This is a health economic analysis using data linkage to New Zealand Ministry of Health databases to determine resource use, costs, and cost-effectiveness for a 24-month period. The study was conducted in New Zealand. Patients with septic shock were randomised to receive a 7-day continuous infusion of 200 mg of hydrocortisone or placebo in the ADRENAL trial. Healthcare expenditure was associated with all hospital admissions, emergency department presentations, outpatient visits, and pharmacy expenditure. Effectiveness outcomes included mortality at 6 months and 24 months and quality of life at 6 months. Cost-effectiveness outcomes were assessed with reference to quality-adjusted life years gained at 6 months and life years gained at 24 months. Of 3800 patients in the ADRENAL trial, 419 (11.0%) were eligible, and 405 (96.7% of those eligible) were included. The mean total costs per patient over 24 months were $143,627 ± 100,890 and $143,772 ± 97,117 for the hydrocortisone and placebo groups, respectively (p = 0.99). Intensive care unit costs for the index admission were $50,492 and $62,288 per patient for the hydrocortisone and placebo groups, respectively (p = 0.09). The mean number of quality-adjusted life years gained at 6 months and mean number of life years gained at 24 months was not significantly different by treatment group, and the probability of hydrocortisone being cost-effective was 55% at 24 months. In New Zealand, adjunctive hydrocortisone did not reduce total healthcare expenditure or improve outcomes compared with placebo in patients with septic shock.
Coronary calcium score as gatekeeper for 64-slice computed tomography coronary angiography in patients with chest pain: per-segment and per-patient analysis
Publisher: Springer Science and Business Media LLC
Date: 22-04-2009
DOI: 10.1007/S00330-009-1398-2
Abstract: We sought to investigate the performance of 64-slice CT in symptomatic patients with different coronary calcium scores. Two hundred patients undergoing 64-slice CT coronary angiography for suspected coronary artery disease were enrolled into five groups based on Agatston calcium score using the Mayo Clinic risk stratification: group 1: score 0, group 2: score 1-10, group 3: score 11-100, group 4: score 101-400, and group 5: score > 401. Diagnostic accuracy for the detection of significant (>/=50% lumen reduction) coronary artery stenosis was assessed on a per-segment and per-patient base using quantitative coronary angiography as the gold standard. For groups 1 through 5, sensitivity was 97, 96, 91, 90, 92%, and specificity was 99, 98, 96, 88, 90%, respectively, on a per-segment basis. On a per-patient basis, the best diagnostic performance was obtained in group 1 (sensitivity 100% and specificity 100%) and group 5 (sensitivity 95% and specificity 100%). Progressively higher coronary calcium levels affect diagnostic accuracy of CT coronary angiography, decreasing sensitivity and specificity on a per-segment base. On a per-patient base, the best results in terms of diagnostic accuracy were obtained in the populations with very low and very high cardiovascular risk.
The impact of canagliflozin on the risk of neuropathy events: A post-hoc exploratory analysis of the CREDENCE trial
Publisher: Elsevier BV
Date: 07-2022
DOI: 10.1016/J.DIABET.2022.101331
Abstract: Canagliflozin reduces the risk, and progression, of diabetic kidney disease. We hypothesized that it may improve the microvascular complication of neuropathy. The CREDENCE trial randomized participants with type 2 diabetes and kidney disease to canagliflozin 100 mg daily or placebo. Neuropathy events were defined post-hoc as any reported adverse event consistent with a peripheral or autonomic neuropathy event. The effect of canagliflozin and predictors of neuropathy events were estimated using Cox regression analysis. In sensitivity analyses the endpoint was restricted to sensorimotor polyneuropathy, diabetic neuropathy, and non-autonomic neuropathy events. Almost half (48.8%) of the 4401 participants had a diagnosis of neuropathy at baseline. Over a median of 2.45 years of follow up, 657 people experienced a neuropathy event (63.2 per 1000 patient-years). Independent factors associated with higher risk of experiencing neuropathy events were non-white race, younger age, higher glycated haemoglobin and lower estimated glomerular filtration rate. The incidence of neuropathy events was similar in people randomized to canagliflozin and placebo (334/2202 vs. 323/2199 HR 1.04, 95% CI 0.89 to 1.21, P = 0.66). Canagliflozin had no impact on sensorimotor polyneuropathy (HR 0.93, 95% CI 0.69 to 1.25, P = 0.63), diabetic neuropathy (HR 0.91, 95% CI 0.68 to 1.22, P = 0.52), or non-autonomic neuropathy (HR 1.03, 95% CI 0.87 to 1.21, P = 0.77). The lack of effect on neuropathy events was consistent in subgroup analyses. Canagliflozin did not affect the risk of neuropathy events in the CREDENCE trial. Future large randomized studies with prespecified neuropathy endpoints are required to determine the impact of sodium glucose cotransporter 2 inhibitors on diabetic neuropathy.
Carbon emissions and hospital pathology stewardship: a retrospective cohort analysis
Publisher: Wiley
Date: 20-08-2022
DOI: 10.1111/IMJ.15622
Abstract: As healthcare is responsible for 7% of Australia's carbon emissions, it was recognised that a policy implemented at St George Hospital, Sydney, to reduce non‐urgent pathology testing to 2 days per week and, on other days only if essential, would also result in a reduction in carbon emissions. The aim of the study was to measure the impact of this intervention on pathology collections and associated carbon emissions and pathology costs. To measure the impact of an intervention to reduce unnecessary testing on pathology collections and associated carbon emissions and pathology costs. The difference in the number of pathology collections, carbon dioxide equivalents (CO 2 e) for five common blood tests and pathology cost per admission were compared between a 6‐month reference period and 6‐month intervention period. CO 2 e were estimated from published pathology CO 2 e impacts. Cost was derived from pathology billing records. Outcomes were modelled using multivariable negative binomial, generalised linear and logistic regression. In total, 24 585 pathology collections in 5695 patients were identified. In adjusted analysis, the rate of collections was lower during the intervention period (rate ratio 0.90 95% confidence interval (CI), 0.86–0.95 P 0.001). This resulted in a reduction of 53 g CO 2 e (95% CI, 24–83 g P 0.001) and $22 (95% CI, $9–$34 P = 0.001) in pathology fees per admission. The intervention was estimated to have saved 132 kg CO 2 e (95% CI, 59–205 kg) and $53 573 (95% CI, 22 076–85 096). Reduction in unnecessary hospital pathology collections was associated with both carbon emission and cost savings. Pathology stewardship warrants further study as a potentially scalable, cost‐effective and incentivising pathway to lowering healthcare associated greenhouse gas emissions.
Multifaceted intervention to reduce haemodialysis catheter related bloodstream infections: REDUCCTION stepped wedge, cluster randomised trial
Publisher: BMJ
Date: 12-04-2022
Abstract: To identify whether multifaceted interventions, or care bundles, reduce catheter related bloodstream infections (CRBSIs) from central venous catheters used for haemodialysis. Stepped wedge, cluster randomised design. 37 renal services across Australia. All adults (age ≥18 years) under the care of a renal service who required insertion of a new haemodialysis catheter. After a baseline observational phase, a service-wide, multifaceted intervention bundle that included elements of catheter care (insertion, maintenance, and removal) was implemented at one of three randomly assigned time points (12 at the first time point, 12 at the second, and 13 at the third) between 20 December 2016 and 31 March 2020. The primary endpoint was the rate of CRBSI in the baseline phase compared with intervention phase at the renal service level using the intention-to-treat principle. 1.14 million haemodialysis catheter days of use were monitored across 6364 patients. Patient characteristics were similar across baseline and intervention phases. 315 CRBSIs occurred (158 in the baseline phase and 157 in the intervention phase), with a rate of 0.21 per 1000 days of catheter use in the baseline phase and 0.29 per 1000 days in the intervention phase, giving an incidence rate ratio of 1.37 (95% confidence interval 0.85 to 2.21 P=0.20). This translates to one in 10 patients who undergo dialysis for a year with a catheter experiencing an episode of CRBSI. Among patients who require a haemodialysis catheter, the implementation of a multifaceted intervention did not reduce the rate of CRBSI. Multifaceted interventions to prevent CRBSI might not be effective in clinical practice settings. Australia New Zealand Clinical Trials Registry ACTRN12616000830493.
Effect of Xpert MTB/RIF on clinical outcomes in routine care settings: individual patient data meta-analysis
Publisher: Elsevier BV
Date: 02-2019
Association Between Selective Decontamination of the Digestive Tract and In-Hospital Mortality in Intensive Care Unit Patients Receiving Mechanical Ventilation
Publisher: American Medical Association (AMA)
Date: 15-11-2022
Abstract: The effectiveness of selective decontamination of the digestive tract (SDD) in critically ill adults receiving mechanical ventilation is uncertain. To determine whether SDD is associated with reduced risk of death in adults receiving mechanical ventilation in intensive care units (ICUs) compared with standard care. The primary search was conducted using MEDLINE, EMBASE, and CENTRAL databases until September 2022. Randomized clinical trials including adults receiving mechanical ventilation in the ICU comparing SDD vs standard care or placebo. Data extraction and risk of bias assessments were performed in duplicate. The primary analysis was conducted using a bayesian framework. The primary outcome was hospital mortality. Subgroups included SDD with an intravenous agent compared with SDD without an intravenous agent. There were 8 secondary outcomes including the incidence of ventilator-associated pneumonia, ICU-acquired bacteremia, and the incidence of positive cultures of antimicrobial-resistant organisms. There were 32 randomized clinical trials including 24 389 participants in the analysis. The median age of participants in the included studies was 54 years (IQR, 44-60), and the median proportion of female trial participants was 33% (IQR, 25%-38%). Data from 30 trials including 24 034 participants contributed to the primary outcome. The pooled estimated risk ratio (RR) for mortality for SDD compared with standard care was 0.91 (95% credible interval [CrI], 0.82-0.99 I 2 = 33.9% moderate certainty) with a 99.3% posterior probability that SDD reduced hospital mortality. The beneficial association of SDD was evident in trials with an intravenous agent (RR, 0.84 [95% CrI, 0.74-0.94]), but not in trials without an intravenous agent (RR, 1.01 [95% CrI, 0.91-1.11]) ( P value for the interaction between subgroups = .02). SDD was associated with reduced risk of ventilator-associated pneumonia (RR, 0.44 [95% CrI, 0.36-0.54]) and ICU-acquired bacteremia (RR, 0.68 [95% CrI, 0.57-0.81]). Available data regarding the incidence of positive cultures of antimicrobial-resistant organisms were not amenable to pooling and were of very low certainty. Among adults in the ICU treated with mechanical ventilation, the use of SDD compared with standard care or placebo was associated with lower hospital mortality. Evidence regarding the effect of SDD on antimicrobial resistance was of very low certainty.
Gatekeeper Improves Voluntary Contractility in Patients With Fecal Incontinence
Publisher: SAGE Publications
Date: 14-12-2018
Abstract: Background. Gatekeeper (GK) has shown to be safe and effective in patients with fecal incontinence (FI). We aimed to understand its mechanism of action by comparing pre- and post-implant change in the external anal sphincter (EAS) contractility. Methods. Study of EAS contractility was conducted in 16 FI females (median age = 69 years) before and after implant of 6 GK prostheses. Muscle tension ( Tm), expressed in millinewtons per centimeter squared, mN(cm 2 ) −1 , was calculated using the equation Tm = P(r i )(tm) −1 , where P is the average maximum squeeze pressure and r i and tm the inner radius and thickness of the EAS, respectively. The effect of a predefined set of covariates on Tm was tested by restricted maximum likelihood models. Results. Compared with baseline, despite unchanged tm (2.7 [2.5-2.8] vs 2.5 [2.2-2.8] mm P = .31 mm), a significant increase in P (median = 45.8 [26.5-75.8] vs 60.4 [43.1-88.1] mm Hg P = .017), and r i (12.4 [11.5-13.4] vs 18.7 [17.3-19.6] mm P .001) resulted in an increase in Tm (233.2 [123.8-303.2] vs 490.8 [286.9-562.4] mN(cm 2 ) −1 P .001) at 12 months after GK implant. Twelve-month follow-up improvements were also observed on Cleveland Clinic FI score (8-point median decrease P = .0001), St Marks FI score (10-point median decrease P .0001), and American Medical Systems score (39-point median decrease P .0001). Restricted maximum likelihood models showed that years of onset of FI was negatively associated with change in Tm ( P = .048). Conclusions. GK-related EAS compression positively influences muscle contractility by increasing r i , with consequent increase in Tm (length-tension relationship). Further studies are needed to confirm the long-term effectiveness of GK.
The Effects of a Supermarket-Based Intervention on the Nutritional Quality of Private-Label Foods: A Prospective Study
Publisher: MDPI AG
Date: 05-06-2020
DOI: 10.3390/NU12061692
Abstract: Private-label products, products owned by supermarkets, are a growing area of the food supply. The aim of this study was to assess the effect of an intervention that provided an Australian supermarket (‘intervention supermarket’) with comparative nutrition data to improve the healthiness of their private-label range. Between 2015 and 2016, the intervention supermarket received reports that ranked the nutritional quality of their products against competitors. Changes in the nutrient content (sodium, sugar, saturated fat, energy and Health Star Rating) of products from the intervention supermarket between 2015 and 2018 were compared against changes achieved for three comparators (private-label products from two other supermarkets and branded products). The intervention supermarket achieved a significantly greater reduction in the sodium content of their products relative to all three comparators, which ranged between −104 and −52 mg/100 g (all p 0.05). Conversely, the three comparators each achieved a greater relative reduction in the sugar content of their products by between −3.5 and −1.6 g/100 g (all p 0.05). One of the comparators also had a greater relative reduction in the saturated fat and energy content of their products compared to the intervention supermarket (both p .05). There were negligible differences in the Health Star Rating of products between the intervention supermarket and comparators (all p 0.05). Providing comparative nutrition information to a supermarket may be ineffective in improving the healthiness of their private-label products, likely due to competing factors that play a role in the decision-making process behind product reformulation and product discontinuation/innovation.
Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: study protocol for a randomized controlled trial
Publisher: Springer Science and Business Media LLC
Date: 05-02-2018
Anoplasty for anatomical anal stenosis: systematic review of complications and recurrences
Publisher: Wiley
Date: 31-07-2022
DOI: 10.1111/CODI.16248
Abstract: The optimal surgical treatment for anatomical anal stenosis (AS) remains to be determined. The aim of this study was to determine the rates of complications and recurrence after anoplasty for anatomical AS and, wherever feasible, compare the outcomes for the various techniques. A PROSPERO‐registered systematic review was reported following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines. Medline, PubMed, Embase, Cochrane Library of Systematic Review, Scopus and Web of Science were searched for articles published up to May 2021. Studies that assessed the outcomes of anoplasty in adult patients with anatomical AS were selected. The primary outcomes were complications and recurrence. The methodological quality of studies was appraised using the Joanna Briggs Institute critical appraisal tools. From the total of 2705 unique screened records, 151 were assessed for eligibility. Only 29 studies (two prospective) met the inclusion criteria, reporting data on 556 patients [mean age 53 (18–83) years, 46% female]. Previous history of surgery for haemorrhoidal disease accounted for three quarters of cases. A total of 14 types of anoplasty were found, with the Y–V flap being the most performed technique [27% of cases ( n = 149)]. Complications frequently occurred, with a pooled prevalence of 10.2% (95% CI 3.9%–24.1%) after Y–V flap and 11.5% (5.3%–23.0%) after rhomboid/diamond flap. Patients undergoing house flap achieved better results in terms of clinical improvement, satisfaction and quality of life compared with Y–V flap and rhomboid/diamond flap. When considering only studies with at least 12 months of follow‐up, the pooled prevalence of recurrence was 4.7% (2.2%–9.8%), with significantly higher rates observed in the prospective versus retrospective series [pooled prevalence 18.9% (11.5%–29.5%) vs. 3.6% (1.7–7.8%), respectively p 0.001]. Both complications and recurrence were significantly lower after house flap compared with rhomboid/diamond and Y–V flap. Better designed multicentre studies with longer follow‐up are needed to confirm these findings. CRD42021239493.
Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses
Publisher: American Society of Clinical Oncology (ASCO)
Date: 10-07-2022
DOI: 10.1200/JCO.21.01171
Abstract: Ongoing supportive care using electronic health (eHealth) interventions has the potential to provide remote support and improve health outcomes for patients with breast cancer. This study aimed to evaluate the effectiveness of eHealth interventions on patient-reported outcomes (quality of life [QOL], self-efficacy, and mental or physical health) for patients during and after breast cancer treatment and patient-reported experience measures (acceptability and engagement). Systematic review with meta-analyses (random-effects model) of randomized controlled trials was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Nine databases were searched using a prespecified search strategy. Patient-directed eHealth interventions for adult patients during or after active breast cancer treatment measuring QOL, self-efficacy, and mental (depressive, anxiety, and distress symptoms) or physical (physical activity, nutrition, and fatigue) health outcomes were included. Data from eligible full-text articles were independently extracted by six observers. Thirty-two unique studies (4,790 patients) were included. All were health self-management interventions, and most were multicomponent (videos, forums, and electronic reminder systems) websites. Meta-analyses revealed a significant effect of eHealth interventions on QOL (standardized mean difference [SMD], 0.20 [95% CI, 0.03 to 0.36]), self-efficacy (SMD, 0.45 [95% CI, 0.24 to 0.65]), distress (SMD, –0.41 [95% CI,–0.63 to –0.20]), and fatigue (SMD, –0.37 [95% CI, –0.61 to –0.13]). Twenty-five studies (78.1%) measured patient-reported experience measures. Acceptability (n = 9) was high, with high ratings for satisfaction (range, 71%-100%), usefulness (range, 71%-95%), and ease-of-use (range, 73%-92%). Engagement (n = 25) decreased over time, but disease-focused information and interactive support were most engaging. eHealth interventions may provide an acceptable and effective strategy for improving QOL, distress, self-efficacy, and fatigue among patients with breast cancer.
E-consensus on telemedicine in proctology: A RAND/UCLA-modified study
Publisher: Elsevier BV
Date: 08-2021
A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms
Publisher: Elsevier BV
Date: 09-2018
DOI: 10.1016/J.JVS.2017.12.060
Abstract: This study investigated the outcomes of a current series of patients treated with fenestrated and branched endovascular aneurysm repair (F-BEVAR) or open surgical repair (OSR) for pararenal abdominal aortic aneurysms (pr-AAAs), including juxtarenal, suprarenal, and type IV thoracoabdominal aneurysms. This study compares the outcomes of these procedures from two high-volume centers without the bias induced by a learning curve. All patients with pr-AAAs undergoing repair at two centers between January 2010 and June 2016 were included in a prospective database. Patients undergoing F-BEVAR and OSR were propensity matched for age, sex, anatomic criteria (aortic cl site), coronary artery disease, chronic obstructive pulmonary disease, diabetes, smoking, chronic kidney disease, aneurysm diameter, and previous aortic surgery. The primary end points were mortality and dialysis. Secondary end points included any myocardial ischemia, respiratory and early procedural complications, acute kidney injury (AKI) according to RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage renal failure), spinal cord ischemia, a composite of these complications, and postoperative intensive care unit length of stay. During follow-up, all-cause survival and freedom from reintervention were compared, as was the patency of stented vessels and renal and visceral bypasses. Late renal function deterioration was evaluated. In this period, 157 F-BEVAR patients and 119 OSR patients were operated on. After 1:1 propensity matching, the study cohort consisted of 102 F-BEVARs and 102 OSRs. In the matched population, an average of 2.5 vessels were treated per patient. Univariate analysis demonstrated no significant difference in 30-day mortality (2.9% vs 2.0% P = .68), dialysis (4.9% vs 3.9% P = 1), cardiac ischemic complications (3.8% vs 5.9% P = .52), pulmonary complications (5.9% vs 5.9% P = 1), or any complications (28.4% vs 30.4% P = .63) in the F-BEVAR and OSR groups, respectively. AKI was significantly lower in the F-BEVAR group than in the OSR group (19.6% vs 52% P 50% decrease in glomerular filtration rate, 6.9% vs 16.7% P = .03). There was no spinal cord ischemia. The median intensive care unit length of stay was 1 day in both groups (P = .33). During follow-up, we found occlusions of five stented vessels and three surgical bypasses. Late renal function deterioration was comparable between the two groups. According to Kaplan-Meier estimates, all-cause survival at 24, 48, and 72 months was 85.6%, 66.8%, and 55.8% after F-BEVAR and 90.5%, 82.9%, and 68.5% after OSR (P = .04). Rates of freedom from reintervention were 97.6% vs 97.5% at 24 months, 90.1% vs 93.4% at 48 months, and 63.9% vs 93.4% at 72 months in the F-BEVAR and OSR groups (P = .05), respectively. Thus, both all-cause survival and freedom from reintervention were lower in the F-BEVAR group. This propensity score analysis in patients with pr-AAA undergoing F-BEVAR or OSR suggests no difference in terms of 30-day mortality, dialysis, or organ-specific postoperative complications, with the exception of AKI. Postoperative AKI was significantly higher after OSR, although most patients had recovered before discharge. Our data suggest similar outcomes after F-BEVAR or OSR for pr-AAA.
Football team performance efficiency and effectiveness in a corruptive context: the Calciopoli case
Publisher: Informa UK Limited
Date: 11-12-2019
The association between influenza vaccination, all-cause mortality and cardiovascular mortality: a protocol for a living systematic review and prospective meta-analysis
Publisher: Cold Spring Harbor Laboratory
Date: 02-09-2021
DOI: 10.1101/2021.08.31.21262935
Abstract: Influenza virus infection is known to increase the risk of cardiovascular events, especially in populations with pre-existing cardiovascular disease. Considering that influenza is vaccine preventable, international guidelines recommend high-risk populations with CVD receive an influenza vaccine every year, but there are various classifications of recommendations and levels of evidence. Previous systematic reviews concluded uncertain evidence on influenza vaccine efficacy for preventing cardiovascular events in the general population or in populations with pre-existing CVD. Limited safety data of influenza vaccines were reported for populations with pre-existing CVD. Randomized control trials with larger s le sizes relative to previous studies are emerging, the findings of these trials are likely to be highly influential on summary efficacy estimates. We aim to perform a living systematic review and a prospective meta-analysis to evaluate the efficacy and safety of influenza vaccines compared to no vaccines or placebo for preventing mortality or cardiovascular disease events in the general population and in populations with pre-existing CVD. Formal ethical review is not required as this study does not need primary data collection. We will publish results of the living systematic review and prospective meta-analysis in a peer-reviewed journal. Findings will also be presented at relevant meetings. CRD42021222519. The living systematic review will continually incorporate the latest research findings and keep the synthesized information updated. A prospective meta-analysis will better address this evolving evidence. Safety of influenza vaccines in populations with pre-existing cardiovascular diseases will be studied in particular to complete the current evidence base. Observational studies may affect the overall quality of the study results. We will stratify the analysis by study design and present both randomized and non-randomized results.
Diabetes and Obesity as Independent Risk Factors for Osteoporosis: Updated Results from the ROIS/EMEROS Registry in a Population of Five Thousand Post-Menopausal Women Living in a Region Characterized
Publisher: MDPI AG
Date: 11-2016
Do hotspots fuel malaria transmission: a village-scale spatio-temporal analysis of a 2-year cohort study in The Gambia
Publisher: Springer Science and Business Media LLC
Date: 14-09-2018
Statistical Analysis Plan for Balanced versus Saline trialists living systematic review individual patient and aggregated data meta-analysis of randomized controlled trials (BEST-Living Study)
Publisher: Cold Spring Harbor Laboratory
Date: 09-09-2022
DOI: 10.1101/2022.09.06.22279363
Abstract: The Balanced versus Saline Trialists (BEST) -Living Study is an ongoing living systematic review with aggregated and in idual patient data meta-analysis (IPDMA) from eligible trials that assessed the effects of using balanced solutions compared with saline in critically ill adults. We herein present the search strategies for the BEST-Living Study and provide details for future analysis and presentation. The report will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses of In idual Participant Data (PRISMA-IPD) recommendations. Search was performed in Pubmed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL). The primary endpoint will be hospital mortality, which will be analyzed using a Bayesian hierarchical model. Secondary endpoints include nurvival until longest follow-up available, use of kidney replacement therapy, and intensive care unit and hospital length-of-stay. Details on the analysis plan are provided in this statistical analysis plan. The study will provide the most up-to-date and comprehensive assessment using the best evidence available for the use of balanced solutions in critically ill patients. The undersigned and all authors have reviewed this plan and approve it as final. They find it to be consistent with the requirements of the protocol as it applies to their respective areas. They also find it to be compliant with ICH-E9 principles and, in particular, confirm that this analysis plan was final prior to any analysis of the aggregated data.
A worldwide survey on proctological practice during COVID‐19 lockdown (ProctoLock 2020): a cross‐sectional analysis
Publisher: Wiley
Date: 27-10-2020
DOI: 10.1111/CODI.15394
Minimally Invasive Carpal Tunnel Release
Publisher: Elsevier BV
Date: 10-2009
DOI: 10.1016/J.OCL.2009.06.002
Abstract: We prospectively compared the safety and effectiveness of mini-incision (group A) and a limited open technique (group B) for carpal tunnel release (CTR) in 185 consecutive patients operated between November 1999 and May 2001, with a 5-year minimum follow-up. Patients in Group A had a minimally invasive approach (<2 cm incision), performed using the KnifeLight (Stryker, Kalamazoo, Michigan) instrument. Patients in Group B had a limited longitudinal incision (3-4 cm). Patient status was evaluated with an Italian modified version of the Boston Carpal Tunnel questionnaire, administered preoperatively and at 19, 30, and 60 postoperative months. Mini-incision CTR showed advantages over standard technique in early recovery, pillar pain, and recurrence rate. The recovery period after mini-incision is shorter than after standard procedure.
How well do discrete choice experiments predict health choices? A systematic review and meta-analysis of external validity
Publisher: Springer Science and Business Media LLC
Date: 29-01-2018
DOI: 10.1007/S10198-018-0954-6
Abstract: Discrete choice experiments (DCEs) are economic tools that elicit the stated preferences of respondents. Because of their increasing importance in informing the design of health products and services, it is critical to understand the extent to which DCEs give reliable predictions outside of the experimental context. We systematically reviewed the literature of published DCE studies comparing predictions to choices made in reality we extracted in idual-level data to estimate a bivariate mixed-effects model of pooled sensitivity and specificity. Eight studies met the inclusion criteria, and six of these gave sufficient data for inclusion in a meta-analysis. Pooled sensitivity and specificity estimates were 88% (95% CI 81, 92%) and 34% (95% CI 23, 46%), respectively, and the area under the SROC curve (AUC) was 0.60 (95% CI 0.55, 0.64). Results indicate that DCEs can produce reasonable predictions of health-related behaviors. There is a great need for future research on the external validity of DCEs, particularly empirical studies assessing predicted and revealed preferences of a representative s le of participants.
The effect of low-dose corticosteroids and theophylline on the risk of acute exacerbations of COPD: the TASCS randomised controlled trial.
Publisher: European Respiratory Society (ERS)
Date: 17-12-2021
DOI: 10.1183/13993003.03338-2020
Abstract: The highest burden of chronic obstructive pulmonary disease (COPD) occurs in low- and middle-income countries. Low-cost oral medications, if effective, could enable affordable, accessible COPD treatment. In this randomised, three-arm, double-blind, double-dummy, placebo-controlled study conducted in 37 centres in China, symptomatic patients with moderate to very severe COPD were randomised 1:1:1 to placebo twice daily plus placebo once daily, low-dose theophylline 100 mg twice daily plus placebo once daily or low-dose theophylline 100 mg twice daily plus low-dose oral prednisone 5 mg once daily for 48 weeks. The primary end-point was annualised exacerbation rate. 1670 subjects were randomised and 1242 completed the study (1142 with acceptable data at week 48). Subjects (75.7% male) had a mean age of 64.4 years, with mean± sd baseline post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) 1.1±0.4 L (42.2% predicted) and St George's Respiratory Questionnaire (SGRQ) score 45.8±20.1. There were negligible differences between annualised exacerbation rates across the three treatments: 0.89 (95% CI 0.78–1.02) on theophylline plus prednisone, 0.86 (95% CI 0.75–0.99) on theophylline plus placebo and 1.00 (95% CI 0.87–1.14) on placebo. The rate ratio for theophylline plus prednisone versus pooled theophylline plus placebo and placebo was 0.96 (95% CI 0.83–1.12), for theophylline plus placebo versus placebo was 0.87 (95% CI 0.73–1.03 p=0.101) and for theophylline plus prednisone versus placebo was 0.90 (95% CI 0.76–1.06 p=0.201). Secondary outcomes of hospitalisations, FEV 1 , SGRQ and COPD Assessment Test score showed no statistically significant difference between treatment arms. Serious adverse events other than exacerbations were % and did not differ between treatment arms. Low-dose theophylline alone or in combination with prednisone did not reduce exacerbation rates or clinically important secondary end-points compared with placebo.
Efficacy of self-management mobile applications for patients with breathlessness: Systematic review and quality assessment of publicly available applications.
Publisher: Elsevier BV
Date: 09-2022
DOI: 10.1016/J.RMED.2022.106947
Abstract: Apps can play a role in self-management of symptoms such as breathlessness. This systematic review aims to evaluate the clinical efficacy of breathlessness apps and assess the quality of those publicly available. The full protocol for this systematic review is available on PROSPERO (CRD42021246277). Studies published between January 2010 to 2022 were obtained from six academic databases and included if they evaluated apps that offered breathlessness education and personalised feedback. Outcomes of interest included change in breathlessness and quality of life. Additionally, quality assessment was conducted on apps addressing breathlessness publicly available from Google Play, iOS app store, and regulatory agency libraries. A total of 2774 records were screened and 16 studies included in the systematic review. Disease groups addressed were chronic obstructive pulmonary disease, asthma, fibrotic lung disease, lung cancer, and heart failure. Use of mobile apps was found to result in clinical benefit especially when utilised for longer periods of time. For publicly available apps, a total of 776 apps were screened and 6 apps included. The mean quality rating using the Mobile App Rating Scale was 3.43 out of 5. Most apps were found to have good functionality and aesthetics however, they were lacking in their quality of information and engagement. This review suggests that apps may provide clinical benefit to patients with breathlessness and can support clinical practice. However, few of those researched are available for public use and those accessible publicly were lacking in quality and compliance with m-Health best practices.
Improving indoor air quality through an air purifier able to reduce aerosol particulate matter (PM) and volatile organic compounds (VOCs): Experimental results
Publisher: Elsevier BV
Date: 06-2021
Deadlock of proctologic practice in Italy during COVID-19 pandemic: a national report from ProctoLock2020
Publisher: Springer Science and Business Media LLC
Date: 08-08-2020
Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD
Publisher: BMJ
Date: 08-2021
DOI: 10.1136/BMJOPEN-2021-053446
Abstract: Heart disease in chronic obstructive pulmonary disease (COPD) is a common but neglected comorbidity. Patients with COPD are frequently excluded from clinical trials of treatments aimed at reducing cardiac morbidity and mortality, which has led to undertreatment of cardiovascular disease in patients with COPD. A particular concern in COPD is the underuse of beta (β)-blockers. There is observational evidence that cardioselective β-blockers are safe and may even reduce mortality risk in COPD, although some evidence is conflicting. There is an urgent need to answer the research question: Are cardioselective β-blockers safe and of benefit in people with moderately severe COPD? The proposed study will investigate whether cardioselective β-blocker treatment in patients with COPD reduces mortality and cardiac and respiratory morbidity. This is a double-blind, randomised controlled trial to be conducted in approximately 26 sites in Australia, New Zealand, India, Sri Lanka and other countries as required. Participants with COPD will be randomised to either bisoprolol once daily (range 1.25–5 mg, dependent on tolerated dose) or matched placebo, in addition to receiving usual care for their COPD over the study duration of 24 months. The study will enrol 1164 participants with moderate to severe COPD, aged 40–85 years. Participants will be symptomatic from their COPD and have a postbronchodilator forced expiratory volume in 1 s (FEV 1 ) ≥30% and ≤70% predicted and a history of at least one exacerbation requiring systemic corticosteroids, antibiotics or both in the prior 24 months. The study protocol has been approved by the Sydney Local Health District Human Research Ethics Committee at The Concord Repatriation General Hospital. NCT03917914 CTRI/2020/08/027322.
J-shape relation of blood pressure reduction and outcome in acute intracerebral hemorrhage: A pooled analysis of INTERACT2 and ATACH-II individual participant data
Publisher: SAGE Publications
Date: 05-01-2022
DOI: 10.1177/17474930211064076
Abstract: The aim of this study was to better define the shape of association between the degree (“magnitude”) of early ( 1 h) reduction in systolic blood pressure (SBP) and outcomes in patients with acute intracerebral hemorrhage (ICH) through pooled analysis of the second Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2) and second Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) datasets. Association of the continuous magnitude of SBP reduction described using cubic splines and an ordinal measure of the functional outcome on the modified Rankin scale (mRS) scores at 90 days were analyzed in generalized linear mixed models. Models were adjusted for achieved (mean) and variability (standard deviation, SD) of SBP between 1 and 24 h, various baseline covariates, and trial as a random effect. Among 3796 patients (mean age 63.1 (SD = 13.0) years female 37.4%), with a mean magnitude ( 1 h) of SBP reduction of 28.5 (22.8) mmHg, those with larger magnitude were more often non-Asian and female, had higher baseline SBP, received multiple blood pressure (BP) lowering agents, and achieved lower SBP levels in 1–24 h. Compared to those patients with no SBP reduction within 1 h (reference), the adjusted odds of unfavorable functional outcome, according to a shift in mRS scores, were lower for SBP reductions up to 60 mmHg with an inflection point between 32 and 46 mmHg, but significantly higher for SBP reductions 70 mmHg. Similar J-shape associations were evident across various time epochs across 24 h and consistent according to baseline hematoma volume and SBP and history of hypertension. A moderate degree of rapid SBP lowering is associated with improved functional outcome after ICH, but large SBP reductions over 1 h (e.g. from 200 to target 140 mmHg) were associated with reduction, or reversal, of any such benefit.
Communication to promote and support physical distancing for COVID-19 prevention and control
Publisher: Wiley
Date: 09-10-2023
A systematic review of the economic impact of rapid diagnostic tests for dengue
Publisher: Springer Science and Business Media LLC
Date: 12-2017
Erratum to: Distribution and trends in mesothelioma mortality in Italy from 1974 to 2006
Publisher: Springer Science and Business Media LLC
Date: 06-10-2013
Protocol for a novel sodium and blood pressure reduction intervention targeting online grocery shoppers with hypertension - the SaltSwitch Online Grocery Shopping randomized trial.
Publisher: Elsevier BV
Date: 10-2022
DOI: 10.1016/J.AHJ.2022.06.007
Abstract: High dietary sodium intake is a leading cause of hypertension. A major source of dietary sodium is salt added to processed food products available in retail food environments. The fast-growing online grocery shopping setting provides new opportunities for salt reduction interventions that support consumers in choosing healthier options. The SaltSwitch Online Grocery Shopping randomized controlled trial is investigating the feasibility, acceptability, and effectiveness of a novel intervention for lowering salt consumption and blood pressure amongst people with hypertension who shop for groceries online. The intervention is based on a bespoke web browser extension that interfaces with a major retailer's online store to highlight and interpret product sodium content and suggest similar but lower-sodium alternatives. The primary outcome of interest is change in mean systolic blood pressure between in iduals randomized (1:1) to the intervention and control (usual online shopping) arms at 12 weeks. Secondary outcomes are diastolic blood pressure, spot urinary sodium and sodium:potassium ratio, sodium purchases, and dietary intake. Intervention implementation and lessons for future uptake will be assessed using a mixed methods process evaluation. Participants with hypertension who shop online for groceries and exhibit high sodium purchasing behavior are being recruited across Australia. A target s le size of 1,966 provides 80% power (2-sided alpha = 0.05) to detect a 2 mm Hg difference in systolic blood pressure between groups, assuming a 15 mm Hg standard deviation, after allowing for a 10% dropout rate. This trial will provide evidence on an innovative intervention to potentially reduce salt intake and blood pressure in people with hypertension. The intervention caters to in idual preferences by encouraging sustainable switches to similar but lower-salt products. If effective, the intervention will be readily scalable at low cost by interfacing with existing online retail environments.
Frequency of Left Ventricular Hypertrophy in Non-Valvular Atrial Fibrillation
Publisher: Elsevier BV
Date: 09-2015
DOI: 10.1016/J.AMJCARD.2015.05.060
Abstract: Left ventricular hypertrophy (LVH) is significantly related to adverse clinical outcomes in patients at high risk of cardiovascular events. In patients with atrial fibrillation (AF), data on LVH, that is, prevalence and determinants, are inconsistent mainly because of different definitions and heterogeneity of study populations. We determined echocardiographic-based LVH prevalence and clinical factors independently associated with its development in a prospective cohort of patients with non-valvular (NV) AF. From the "Atrial Fibrillation Registry for Ankle-brachial Index Prevalence Assessment: Collaborative Italian Study" (ARAPACIS) population, 1,184 patients with NVAF (mean age 72 ± 11 years 56% men) with complete data to define LVH were selected. ARAPACIS is a multicenter, observational, prospective, longitudinal on-going study designed to estimate prevalence of peripheral artery disease in patients with NVAF. We found a high prevalence of LVH (52%) in patients with NVAF. Compared to those without LVH, patients with AF with LVH were older and had a higher prevalence of hypertension, diabetes, and previous myocardial infarction (MI). A higher prevalence of ankle-brachial index ≤0.90 was seen in patients with LVH (22 vs 17%, p = 0.0392). Patients with LVH were at significantly higher thromboembolic risk, with CHA2DS2-VASc ≥2 seen in 93% of LVH and in 73% of patients without LVH (p <0.05). Women with LVH had a higher prevalence of concentric hypertrophy than men (46% vs 29%, p = 0.0003). Logistic regression analysis demonstrated that female gender (odds ratio [OR] 2.80, p <0.0001), age (OR 1.03 per year, p <0.001), hypertension (OR 2.30, p <0.001), diabetes (OR 1.62, p = 0.004), and previous MI (OR 1.96, p = 0.001) were independently associated with LVH. In conclusion, patients with NVAF have a high prevalence of LVH, which is related to female gender, older age, hypertension, and previous MI. These patients are at high thromboembolic risk and deserve a holistic approach to cardiovascular prevention.
Associations between vision impairment and driving and the effectiveness of vision-related interventions: protocol for a systematic review and meta-analysis
Publisher: BMJ
Date: 11-2020
DOI: 10.1136/BMJOPEN-2020-040881
Abstract: Driving is one of the main modes of transport with safe driving requiring a combination of visual, cognitive and physical skills. With population ageing, the number of people living with vision impairment is set to increase in the decades ahead. Vision impairment may negatively impact an in idual’s ability to safely drive. The association between vision impairment and motor vehicle crash involvement or driving participation has yet to be systematically investigated. Further, the evidence for the effectiveness of vision-related interventions aimed at decreasing crashes and driving errors has not been synthesised. A search will be conducted for relevant studies on Medline (Ovid), EMBASE and Global Health from their inception to March 2020 without date or geographical restrictions. Two investigators will independently screen abstracts and full texts using Covidence software with conflicts resolved by a third investigator. Data extraction will be conducted on all included studies, and their quality assessed to determine the risk of bias using the Joanna Briggs Institute Critical Appraisal Tools. Outcome measures include crash risk, driving cessation and surrogate measures of driving safety (eg, driving errors and performance). The results of this review will be reported using the Preferred Reporting Items for Systematic Review and Meta-Analysis guideline. Meta-analysis will be undertaken for outcomes with sufficient data and reported following the Meta-analyses of Observational Studies in Epidemiology guideline. Where statistical pooling is not feasible or appropriate, narrative summaries will be presented following the Synthesis Without Meta-analysis in systematic reviews guideline. This review will only report on published data thus no ethics approval is required. Results will be included in the Lancet Global Health Commission on Global Eye Health, published in a peer-reviewed journal and presented at relevant conferences. CRD42020172153.
Evaluating risk prediction models for adults with heart failure: A systematic literature review
Publisher: Public Library of Science (PLoS)
Date: 15-01-2020
Agreement between 24-hour urine and 24-hour food recall in measuring salt intake in primary school children in Australia
Publisher: Springer Science and Business Media LLC
Date: 15-11-2022
DOI: 10.1186/S12937-022-00823-8
Abstract: Monitoring salt consumption in children is essential for informing and implementing public health interventions to reduce children’s salt intake. However, collection of 24-hour urines, considered as the most reliable approach, can be especially challenging to school children. This study aimed to assess the agreement between 24-hour urine (24hrU) and 24-hour food recall (24hrFR) in: (1) estimating salt intake in children (2) classifying salt intakes above the recommended upper level set for children, and (3) estimating change in mean salt intake over time. This study utilised data from two cross-sectional surveys of school children aged 8 to 12 years living in the state of Victoria, Australia. A single 24hrU and 24hrFR were collected from each participant. Suspected inaccurate urine collections and implausible energy intakes were excluded based on pre-defined criteria. The agreement between the two methods was assessed using Bland-Altman methodology, the intraclass correlation coefficient (ICC), and the kappa statistic. The difference between the measured change in salt intake over time using 24hrU and 24hrFR was derived using mixed effects linear regression analysis. A total of 588 participants provided a 24hrU and 24hrFR. Overall, there was no meaningful difference in mean estimated salt intake between the two methods (− 0.2 g/day, 95% CI − 0.5 to 0.1). The Bland-Altman plot showed wide 95% limits of agreement (− 7.2 to 6.8). The ICC between the two methods was 0.13 (95% CI 0.05 to 0.21). There was poor interrater reliability in terms of classifying salt intake above the recommended upper level for children, with an observed agreement of 63% and kappa statistic of 0.11. The change in mean salt intake over time was 0.2 g/day (− 0.4 to 0.7) based on 24hrU, and 0.5 g/day (− 0.0 to 1.1) based on 24hrFR, with a difference-in-differences of 0.4 g/day (− 0.3 to 1.1). 24hrFR appears to provide a reasonable estimate of mean salt intake as measured by 24hrU in Australian school children. However, similar to previous observations in adults, and of studies exploring other alternative methods for estimating salt intake, 24hrFR is a poor predictor of in idual-level salt intake in children.
Bayesian structural time series, an alternative to Interrupted Time Series in the right circumstances.
Publisher: Elsevier BV
Date: 10-2023
Controlled evaLuation of angiotensin receptor blockers for COVID-19 respiratory disease (CLARITY): Statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial
Publisher: Cold Spring Harbor Laboratory
Date: 22-08-2021
DOI: 10.1101/2021.08.17.21262196
Abstract: The CLARITY trial (Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease) investigates the effectiveness of angiotensin receptor blockers in addition to standard care compared to placebo (in Indian sites) with standard care in reducing the duration and severity of lung failure in patients with COVID-19. The CLARITY trial is a multi-centre, randomised controlled Bayesian adaptive trial with regular planned analyses where pre-specified decision rules will be assessed to determine whether the trial should be stopped due to sufficient evidence of treatment effectiveness or futility. Here we describe the statistical analysis plan for the trial, and define the pre-specified decision rules, including those that could lead to the trial being halted. The primary outcome is clinical status on a 7-point ordinal scale adapted from the WHO Clinical Progression scale assessed at Day 14. The primary analysis will follow the intention-to-treat principle. A Bayesian adaptive trial design was selected because there is considerable uncertainty about the extent of potential benefit of this treatment. ClinicalTrials.gov , NCT04394117 . Registered on 19 May 2020. t2/show/NCT04394117 Clinical Trial Registry of India: CTRI/2020/07/026831 Version 1.0. No revisions.
Real-world prognosis of eyes with diabetic macular oedema receiving treatment with vascular endothelial growth factor (VEGF) inhibitors
Publisher: Wiley
Date: 21-10-2021
Early persistent lymphopenia and risk of death in critically ill patients with and without sepsis.
Publisher: Research Square Platform LLC
Date: 27-06-2023
DOI: 10.21203/RS.3.RS-3084525/V1
Abstract: Purpose To determine the proportion of critically ill patients with and without sepsis who exhibit persistent lymphopenia and examine its relationship with hospital survival. Methods Database analysis of adult intensive care unit (ICU) patients at two hospitals in Queensland, Australia and the MIMIC III database from Boston, USA. Results We defined persistent lymphopenia at two thresholds (absolute lymphocyte count [ALC] .0 and .75 x 10 9 /L) based on two qualifying values recorded during the first four days in ICU. In the USA cohort 27,646/32,528 (85.0%) patients did not have two ALCs recorded with evidence that data were not missing at random consequently, we report the analysis of the Australian cohort. In the Australian cohort 7605/8507 (89.4%) patients had two ALCs recorded, of these 1482 (19.5%) had sepsis. Persistent lymphopenia (ALC .0) was present in 728/1482 (49.1%) and 2302/6123 (37.6%) of patients with and without sepsis, respectively. For ALC .75 the results were 487/1482 (32.9%) and 1125/6123 (18.4%), respectively. 562/3030 (18.5%) patients with persistent lymphopenia (ALC .0) died in hospital compared with 439/4575 (9.6%) patients without persistent lymphopenia. Persistent lymphopenia was an independent risk factor for in hospital death in all patients. The hazard ratio for death at ALC .0 was 1.89 (95%CI 1.31 – 2.85) and 1.17 (1.02 – 1.36) in patients with and without sepsis respectively. Conclusions Persistent lymphopenia is common in critically ill patients and associated with increased risk of death. The association is stronger in patients with sepsis. Trials testing the hypothesis that reversing lymphopenia reduces mortality should initially target patients with sepsis.
Training healthcare providers to respond to intimate partner violence against women
Publisher: Wiley
Date: 14-02-2017
Systematic review with meta‐analysis: defecography should be a first‐line diagnostic modality in patients with refractory constipation
Publisher: Wiley
Date: 11-11-2018
DOI: 10.1111/APT.15039
Abstract: Defecography is considered the reference standard for the assessment of pelvic floor anatomy and function in patients with a refractory evacuation disorder. However, the overlap of radiologically significant findings seen in patients with chronic constipation (CC) and healthy volunteers is poorly defined. To systematically review rates of structural and functional abnormalities diagnosed by barium defecography and/or magnetic resonance imaging defecography (MRID) in patients with symptoms of CC and in healthy volunteers. Electronic searches of major databases were performed without date restrictions. From a total of 1760 records identified, 175 full-text articles were assessed for eligibility. 63 studies were included providing data on outcomes of 7519 barium defecographies and 668 MRIDs in patients with CC, and 225 barium defecographies and 50 MRIDs in healthy volunteers. Pathological high-grade (Oxford III and IV) intussuscepta and large (>4 cm) rectoceles were diagnosed in 23.7% (95% CI: 16.8-31.4) and 15.9% (10.4-22.2) of patients, respectively. Enterocele and perineal descent were observed in 16.8% (12.7-21.4) and 44.4% (36.2-52.7) of patients, respectively. Barium defecography detected more intussuscepta than MRID (OR: 1.52 [1.12-2.14] P = 0.009]). Normative data for both barium defecography and MRID structural and functional parameters were limited, particularly for MRID (only one eligible study). Pathological structural abnormalities, as well as functional abnormalities, are common in patients with chronic constipation. Since structural abnormalities cannot be evaluated using nonimaging test modalities (balloon expulsion and anorectal manometry), defecography should be considered the first-line diagnostic test if resources allow.
Short-Term Outcomes of Polycarbophil and Propionibacterium acnes Lysate Gel after Open Hemorrhoidectomy: A Prospective Cohort Study
Publisher: MDPI AG
Date: 10-12-2020
DOI: 10.3390/JCM9123996
Abstract: Background: Pain is the most common complication after open excisional hemorrhoidectomy (OEH). We assessed the effectiveness of polycarbophil and Propionibacterium acnes lysate gel (Emorsan®Gel) on pain control after OEH. Research design and methods: Fifty consecutive patients undergoing OEH were included. All patients received stool softeners and oral analgesia in the post-operative period. Emorsan®Gel was also used topically by the last 25 patients (Emorsan®Gel group (EG)) until Post-Operative Day 20 (POD 20). The primary outcome was the effectiveness of Emorsan®Gel on pain relief using an 11-point visual analogue scale (VAS). Morbidity, wound healing (WH), and time to work were documented at POD 1, POD 10, POD 20, and POD 40. Results: Of the 50 patients enrolled, twenty-eight (56%) were males median age, 49 (range, 28–73) years. The VAS score decreased over time in all patients, with significantly lower scores at POD 20 in the EG (1.44 (SD, 1.16) vs. 2.12 (0.93) in the control group (CG) p = 0.045). All patients in the EG achieved complete WH at last follow-up, compared to only 17 (68%) in the CG (p = 0.004). The likelihood of WH was 66% higher in the EG (OR, 1.66 [95%CI, 0.80–3.44 p = 0.172). Conclusions: Emorsan®Gel is safe and effective at reducing pain after EOH, promoting earlier WH compared to standard care treatment.
Reply to the Letter of Terracini B. et al. “Comment on Piscitelli et al. Hospitalizations in Pediatric and Adult Patients for All Cancer Type in Italy: The EPIKIT Study under the E.U. COHEIRS Project
Publisher: MDPI AG
Date: 25-10-2017
The cost-effectiveness of digital health interventions: A systematic review of the literature
Publisher: Frontiers Media SA
Date: 11-08-2022
DOI: 10.3389/FPUBH.2022.787135
Abstract: Digital health interventions have significant potential to improve safety, efficacy, and quality of care, reducing waste in healthcare costs. Despite these premises, the evidence regarding cost and effectiveness of digital tools in health is scarce and limited. The aim of this systematic review is to summarize the evidence on the cost-effectiveness of digital health interventions and to assess whether the studies meet the established quality criteria. We queried PubMed, Scopus and Web of Science databases for articles in English published from January 1, 2016 to December 31, 2020 that performed economic evaluations of digital health technologies. The methodological rigorousness of studies was assessed with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2009 checklist. Search identified 1,476 results, 552 of which were selected for abstract and 35 were included in this review. The studies were heterogeneous by country (mostly conducted in upper and upper-middle income countries), type of eHealth intervention, method of implementation, and reporting perspectives. The qualitative analysis identified the economic and effectiveness evaluation of six different types of interventions: (1) seventeen studies on new video-monitoring service systems (2) five studies on text messaging interventions (3) five studies on web platforms and digital health portals (4) two studies on telephone support (5) three studies on new mobile phone-based systems and applications and (6) three studies on digital technologies and innovations. Findings on cost-effectiveness of digital interventions showed a growing body of evidence and suggested a generally favorable effect in terms of costs and health outcomes. However, due to the heterogeneity across study methods, the comparison between interventions still remains difficult. Further research based on a standardized approach is needed in order to methodically analyze incremental cost-effectiveness ratios, costs, and health benefits.
15-year incidence of driving cessation and associated risk factors: The Blue Mountains Eye Study
Publisher: Elsevier BV
Date: 11-2023
Surgical Management of Hemorrhoidal Disease in Inflammatory Bowel Disease: A Systematic Review with Proportional Meta-Analysis
Publisher: MDPI AG
Date: 28-01-2022
DOI: 10.3390/JCM11030709
Abstract: Surgical treatment of hemorrhoidal disease (HD) in inflammatory bowel disease (IBD) has been considered to be potentially harmful, but the evidence for this is poor. Therefore, a systematic review of the literature was undertaken to reappraise the safety and effectiveness of surgical treatments in this special circumstance. A MEDLINE, Web of Science, Scopus, and Cochrane Library search was performed to retrieve studies reporting the outcomes of surgical treatment of HD in patients with Crohn’s disease (CD) and ulcerative colitis (UC). From a total of 2072 citations, 10 retrospective studies including 222 (range, 2–70) patients were identified. Of these, 119 (54%) had CD and 103 (46%) UC. Mean age was between 41 and 49 years (range 14–77). Most studies lacked information on the interval between surgery and the onset of complications. Operative treatments included open or closed hemorrhoidectomy (n = 156 patients (70%)), rubber band ligation (n = 39 (18%)), excision or incision of thrombosed hemorrhoid (n = 14 (6%)), and doppler-guided hemorrhoidal artery ligation (DG-HAL, n = 13 (6%)). In total, 23 patients developed a complication (pooled prevalence, 9% (95%CI, 3–16%)), with a more than two-fold higher rate in patients with CD compared to UC (11% (5–16%) vs. 5% (0–13%), respectively). Despite the low quality evidence, surgical management of HD in IBD and particularly in CD patients who have failed nonoperative therapy should still be performed with caution and limited to inactive disease. Further studies should determine whether advantages in terms of safety and effectiveness with the use of non-excisional techniques (e.g., DG-HAL) can be obtained in this patient population.
Modeling the Long-term Persistence of Hepatitis A Antibody After a Two-Dose Vaccination Schedule in Argentinean Children
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2015
Handling Missing Data in Health Economics and Outcomes Research (HEOR): A Systematic Review and Practical Recommendations.
Publisher: Springer Science and Business Media LLC
Date: 25-07-2023
Use of RAAS Inhibitors and Risk of Clinical Deterioration in COVID-19: Results From an Italian Cohort of 133 Hypertensives
Publisher: Oxford University Press (OUP)
Date: 08-06-2020
DOI: 10.1093/AJH/HPAA096
Abstract: The effect of chronic use of renin–angiotensin–aldosterone system (RAAS) inhibitors on the severity of COVID-19 infection is still unclear in patients with hypertension. We aimed to investigate the association between chronic use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) and COVID-19-related outcomes in hypertensive patients. A single-center study was conducted on 133 consecutive hypertensive subjects presenting to the emergency department with acute respiratory symptoms and/or fever who were diagnosed with COVID-19 infection between 9 and 31 March 2020. All patients were grouped according to their chronic antihypertensive medications (ACEIs, N = 40 ARBs, N = 42 not on RAAS inhibitors, N = 51). There was no statistical difference between ACEIs and ARBs groups in terms of hospital admission rate, oxygen therapy, and need for noninvasive ventilation. Patients chronically treated with RAAS inhibitors showed a significantly lower rate of admission to semi-intensive/intensive care units, when compared with the non-RAAS population (odds ratio (OR) 0.25, confidence interval (CI) 95% 0.09–0.66, P = 0.006). Similarly, the risk of mortality was lower in the former group, although not reaching statistical significance (OR 0.56, CI 95% 0.17–1.83, P = 0.341). Our data suggest that chronic use of RAAS inhibitors does not negatively affect clinical course of COVID-19 in hypertensive patients. Further studies are needed to confirm this finding and determine whether RAAS inhibitors may have a protective effect on COVID-19-related morbidity and mortality.
A comparison of risk stratification schemes for stroke in 79 884 atrial fibrillation patients in general practice
Publisher: Elsevier BV
Date: 2011
DOI: 10.1111/J.1538-7836.2010.04085.X
Abstract: Anticoagulation management of patients with atrial fibrillation (AF) should be tailored in idually on the basis of ischemic stroke risk. The objective of this study was to compare the predictive ability of 15 published stratification schemes for stroke risk in actual clinical practice in the UK. AF patients aged ≥ 18 years in the General Practice Research Database, which contains computerized medical records, were included. The c-statistic was estimated to determine the predictive ability for stroke for each scheme. Outcomes included stroke, hospitalizations for stroke, and death resulting from stroke (as recorded on death certificates). The study cohort included 79,844 AF patients followed for an average of 4 years (average of 2.4 years up to the start of warfarin therapy). All risk schemes had modest discriminatory ability in AF patients, with c-statistics for predicting events ranging from 0.55 to 0.69 for strokes recorded by the general practitioner or in hospital, from 0.56 to 0.69 for stroke hospitalizations, and from 0.56 to 0.78 for death resulting from stroke as reported on death certificates. The proportion of patients assigned to in idual risk categories varied widely across the schemes, with the proportion categorized as moderate risk ranging from 12.7% (CHA(2) DS(2)-VASc) to 61.5% (modified CHADS(2)). Low-risk subjects were truly low risk (with annual stroke events < 0.5%) with the modified CHADS(2), National Institute for Health and Clinical Excellence and CHA(2) DS(2) -VASc schemes. Current published risk schemes have modest predictive value for stroke. A new scheme (CHA(2) DS(2) -VASc) may discriminate those at truly low risk and minimize classification of subjects as intermediate/moderate risk. This approach would simplify our approach to stroke risk stratification and improve decision-making for thromboprophylaxis in patients with AF.
Kidney and Cardiovascular Effects of Canagliflozin According to Age and Sex: A Post Hoc Analysis of the CREDENCE Randomized Clinical Trial
Publisher: Elsevier BV
Date: 07-2023
New treatments compared to established treatments in randomized trials
Publisher: Wiley
Date: 17-10-1996
Recalled stapler device, high complication rate, non validated scoring system and misquote from the STARR surgeons
Publisher: Springer Science and Business Media LLC
Date: 26-08-2019
Risk Factors for Fracture in Patients with Coexisting Chronic Kidney Disease and Type 2 Diabetes: An Observational Analysis from the CREDENCE Trial
Publisher: Hindawi Limited
Date: 27-05-2022
DOI: 10.1155/2022/9998891
Abstract: Background. The fracture pathophysiology associated with type 2 diabetes and chronic kidney disease (CKD) is incompletely understood. We examined in idual fracture predictors and prediction sets based on different pathophysiological hypotheses, testing whether any of the sets improved prediction beyond that based on traditional osteoporotic risk factors. Methods. Within the CREDENCE cohort with adjudicated fracture outcomes, we assessed the association of in idual factors with fracture using Cox regression models. We used the Akaike information criteria (AIC) and Schwartz Bayes Criterion (SBC) to assess six separate variable sets based on hypothesized associations with fracture, namely, traditional osteoporosis, exploratory general population findings, cardiovascular risk, CKD-mineral and bone disorder, diabetic osteodystrophy, and an all-inclusive set containing all variables. Results. Fracture occurred in 135 (3.1%) participants over a median 2.35 [1.88–2.93] years. Independent fracture predictors were older age (hazard ratio [HR] 1.04, confidence interval [CI] 1.01–1.06), female sex (HR 2.49, CI 1.70–3.65), previous fracture (HR 2.30, CI 1.58–3.34), Asian race (HR 1.74, CI 1.09–2.78), vitamin D therapy requirement (HR 2.05, CI 1.31–3.21), HbA1c (HR 1.14, CI 1.00–1.32), prior cardiovascular event (HR 1.60, CI 1.10–2.33), and serum albumin (HR 0.41, CI 0.23–0.74) (lower albumin associated with greater risk). The goodness of fit of the various hypothesis sets was similar (AIC range 1870.92–1849.51, SBC range 1875.60–1948.04). Conclusion. Independent predictors of fracture were identified in the CREDENCE participants with type 2 diabetes and CKD. Fracture prediction was not improved by models built on alternative pathophysiology hypotheses compared with traditional osteoporosis predictors.
Migraine day frequency in migraine prevention: longitudinal modelling approaches
Publisher: Springer Science and Business Media LLC
Date: 23-01-2019
Integrated Management of Diabetes and Tuberculosis in Rural India - Results From a Pilot Study.
Publisher: Frontiers Media SA
Date: 10-05-2022
DOI: 10.3389/FPUBH.2022.766847
Abstract: The World Health Organization and International Union against Tuberculosis (TB) recommends screening patients with TB for Diabetes Mellitus (DM) at the initiation of treatment. There are few pilot studies which screen TB patients for DM, but none of them have documented the feasibility of managing TB patients with DM in the Indian healthcare setting. Operational research is needed to determine the best way to manage in iduals with both conditions. This pilot study aimed to develop, and field test an integrated, multidisciplinary program addressing the management of in iduals with TB and DM and other associated chronic conditions in the Indian primary healthcare setting. This pilot study used a randomized controlled trial design with mixed-methods evaluation and was conducted in Guntur district of Andhra Pradesh, a southern state of India. All the 120 patients newly diagnosed with TB from 10 participating villages were screened for DM and associated cardiovascular risk factors. Non-physician health workers were trained to follow-up patients for a period of 8 months to encourage treatment adherence, monitor treatment response including blood glucose levels and provide lifestyle advice. The intervention was well-accepted by the providers and patients. However, there were no statistically significant variations observed for mean blood glucose levels (mean [SD]: 5.3 [−23.3 to 33.8]) of patients for both intervention and control group participants in this feasibility study. Awareness about diabetes and tuberculosis comorbidity and cardiovascular risk increased among the non-physician health workers in the intervention arm of the study. The co-management of TB-DM is acceptable to both the health providers and patients. With appropriate training, availability of infrastructure and planned intervention implementation, it is feasible to co-manage TB-DM within the existing primary health care system in India.
Associations of Early Systolic Blood Pressure Control and Outcome After Thrombolysis-Eligible Acute Ischemic Stroke: Results From the ENCHANTED Study
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2022
DOI: 10.1161/STROKEAHA.121.034580
Abstract: In thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure (SBP) lowering profile that provides an optimal balance of potential benefit (functional recovery) and harm (intracranial hemorrhage). We aimed to determine relationships of SBP parameters and outcomes in thrombolyzed acute ischemic stroke patients. Post hoc analyzes of the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study), a partial-factorial trial of thrombolysis-eligible and treated acute ischemic stroke patients with high SBP (150–180 mm Hg) assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) alteplase and intensive (target SBP, 130–140 mm Hg) or guideline-recommended (target SBP mm Hg) treatment. All patients were followed up for functional status and serious adverse events to 90 days. Logistic regression models were used to analyze 3 SBP summary measures postrandomization: attained (mean), variability (SD) in 1–24 hours, and magnitude of reduction in 1 hour. The primary outcome was a favorable shift on the modified Rankin Scale. The key safety outcome was any intracranial hemorrhage. Among 4511 included participants (mean age 67 years, 38% female, 65% Asian) lower attained SBP and smaller SBP variability were associated with favorable shift on the modified Rankin Scale (per 10 mm Hg increase: odds ratio, 0.76 [95% CI, 0.71–0.82] P .001 and 0.86 [95% CI, 0.76–0.98] P =0.025) respectively, but not for magnitude of SBP reduction (0.98, [0.93–1.04] P =0.564). Odds of intracranial hemorrhage was associated with higher attained SBP and greater SBP variability (1.18 [1.06–1.31] P =0.002 and 1.34 [1.11–1.62] P =0.002) but not with magnitude of SBP reduction (1.05 [0.98–1.14] P =0.184). Attaining early and consistent low levels in SBP mm Hg, even as low as 110 to 120 mm Hg, over 24 hours is associated with better outcomes in thrombolyzed acute ischemic stroke patients. URL: www.clinicaltrials.gov Unique identifier: NCT01422616.
Blood Eosinophils in Chinese COPD Participants and Response to Treatment with Combination Low-Dose Theophylline and Prednisone: A Post-Hoc Analysis of the TASCS Trial
Publisher: Informa UK Limited
Date: 02-2022
DOI: 10.2147/COPD.S339889
Impact of Hybrid Operating Rooms on Long-Term Clinical Outcomes Following Fenestrated and Branched Endovascular Aortic Repair
Publisher: SAGE Publications
Date: 04-03-2021
Abstract: Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms. Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center. A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups. Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.
Informative value of clinical research on multislice computed tomography in the diagnosis of coronary artery disease: A systematic review
Publisher: Elsevier BV
Date: 11-2008
DOI: 10.1016/J.IJCARD.2008.06.032
Abstract: Multislice Spiral Computed Tomography (MSCT) is an emerging non-invasive diagnostic modality to detect coronary artery disease, which may alter diagnostic pathways and change the current clinical role of conventional coronary angiography. To retrieve and critically assess information from the available literature on MSCT (>/=16-slice) concerning its diagnostic accuracy, safety, applicability, clinical impact and cost-effectiveness. Articles published between January 2002 and March 2007 were identified through searches of the Cochrane Library, MEDLINE, and other websites of manufacturers, cardiac professional societies, guidelines and abstracts from conference meetings. We identified 1768 potentially relevant articles: 262 out of these were considered eligible for full evaluation and 150 were selected (57 assessed diagnostic accuracy, 130 applicability, 103 safety, 1 clinical impact and none cost-effectiveness). The pre test probability of coronary artery disease was 56.7% (95% Confidence Interval: 55.1%-58.3%). A positive MSCT finding (pooled LR+: 5.4 (4.4-6.7)) increased the probability of CAD to 87.7% (84.3%-90.3%), whereas a negative MSCT result (pooled LR-: 0.09 (0.07-0.12)) reduced the probability of CAD to 10.7% (7.9%-14.4%). MSCT is a promising technology for the assessment of coronary artery stenosis. However, the available literature is of limited value in providing guidance to support the development of policies for its appropriate utilization in clinical practice.
Inequalities in prescription rates of anti-osteoporosis drugs in primary care in England: A practice-level prescribing data analysis in 2013-2018
Publisher: Elsevier BV
Date: 2020
DOI: 10.1016/J.BONE.2019.115125
Abstract: To investigate potential variations in prescription rates of anti-osteoporosis drugs at the general practitioner (GP) practice level in England, analysing associations of prescription rates with key demographic and socio-economic variables, and its evolution over time. A retrospective database analysis was conducted using prescription data from all GP practices in England between April 2013 and September 2018. Potential associations between prescription rates and other variables (sex, age, ethnicity, rural-urban classification and income deprivation) were analysed using mixed-effects Poisson regressions and concentration indices. Alendronic acid was the most frequently prescribed anti-osteoporosis drug. Exploratory and regression analyses showed the association between GP prescriptions and the characteristics of the population they serve. Income deprivation had a statistically significant and negative effect on prescription levels of alendronic acid, denosumab, ibandronic acid and risedronate sodium. Since 2013, denosumab prescriptions exhibited a steep surge in the least income-deprived areas, compared with a modest rise in the most income-deprived areas. Concentration indices indicated a disproportionate concentration of denosumab and, to a lesser extent, ibandronic acid prescriptions among the least income-deprived. The analyses demonstrated that different prescribing behaviours may exist across GPs according to the Clinical Commissioning Group (CCG) to which they belong. Variation in the prescription of anti-osteoporosis drugs exists across GPs and CCGs in England, this being more prominent for certain drugs (e.g. denosumab) compared with others (e.g. alendronic acid). Inequalities exist in English primary healthcare and we advocate our findings could support the efforts of decision-makers towards a more equitable system.
Normative values for region‐specific colonic and gastrointestinal transit times in 111 healthy volunteers using the 3D‐Transit electromagnet tracking system: Influence of age, gender, and body mass in
Publisher: Wiley
Date: 29-09-2019
DOI: 10.1111/NMO.13734
Abstract: The 3D-Transit electromagnet tracking system (Motilis Medica, SA, Lausanne, Switzerland) is an emerging tool for the ambulatory assessment of gastrointestinal (GI) transit and motility. Using this tool, we aimed to derive normative values for region-specific colonic and GI transit times and to assess the influence of age, gender, and body mass index (BMI). Regional and total colonic transit times (CTT), gastric emptying (GET), small intestinal (SITT), and whole gut (WGTT) transit times were extracted from 111 healthy volunteers from the United Kingdom and Denmark (58 female median age: 40 years [range: 21-88]). The effects of age, gender, and BMI were assessed using standard statistical methods. The ascending, transverse, descending, and rectosigmoid colon transit times accounted for 32%, 34%, 17%, and 17% of total CTT in females, and 33%, 25%, 14%, and 28% of total CTT in males. CTT and WGTT were seen to cluster at intervals separated by approximately 24 hours, providing further evidence of the non-continuous nature of these measurements. Increasing age was associated with longer CTT (P = .021), WGTT (P < .001) ascending (P = .004), transverse (P < .001), and total right (P < .001) colon transit times, but shorter rectosigmoid (P = .004) transit time. Female gender was significantly associated with longer transverse (P = .049) and descending (P < .001) colon transit times, but shorter rectosigmoid (P < .001) transit time. Increasing BMI was significantly associated with shorter WGTT (P = .012). For the first time, normative reference values for region-specific colonic transit have been presented. Age, gender, and BMI were seen to have an effect on transit times.
Diabetes and Obesity as Independent Risk Factors for Osteoporosis in Postmenopausal Women: A Population Study
Publisher: SAGE Publications
Date: 09-2014
DOI: 10.1177/1721727X1401200309
Abstract: We aimed to analyze bone mineralization and the effect of different risk factors for osteoporosis in postmenopausal women. We studied 2,756 postmenopausal subjects out of ≥10,000 records from the ROIS registry in the frame of the PROF Project, a population study carried out in Salento (Taranto, Brindisi, Lecce) from 2009 to 2012. All subjects were assessed by phalangeal Quantitative Ultrasound (QUS) to evaluate their bone mineralization (assessed by Amplitude Dependent Speed of Sound, AD-SoS) and the association between demineralization and the presence of other conditions or risk factors. Mean age was 64±9.5 years and mean BMI was 28.7±3.5 Kg/m 2 . Pearson correlation analyses revealed a negative association between bone mineralization (AD-SoS) and BMI (P .001). By using multivariate logistic regression analysis, we observed significant values of Odds Ratios of osteoporosis (adjusted for age, physical activity and the use of drugs known to increase the risk of fractures) in subjects with diabetes and obesity: 1.39 (CI: 1,05–1,83) and 1.46 (CI: 1.20–1.78), respectively. A statistically significant linear trend of higher Odds Ratios of osteoporosis was found for increasing values of BMI. The percent change in the odds of vertebral fractures per single SD decrease of AD-SoS was 47% (P .001). Diabetes and obesity in postmenopausal women are likely to represent independent risk factors for osteoporosis. Phalangeal QUS showed a good power of predictivity in identifying subjects with vertebral fractures.
Health State Utilities of Patients with Heart Failure: A Systematic Literature Review
Publisher: Springer Science and Business Media LLC
Date: 30-11-2020
Letter: limitations of defecography among patients with refractory constipation. Authors' reply
Publisher: Wiley
Date: 11-06-2019
DOI: 10.1111/APT.15309
Mass Drug Administration With Dihydroartemisinin-piperaquine and Malaria Transmission Dynamics in The Gambia: A Prospective Cohort Study
Publisher: Oxford University Press (OUP)
Date: 10-10-2018
DOI: 10.1093/CID/CIY870
Abstract: Mass drug administration (MDA) may further reduce malaria transmission in low-transmission areas. The impact of MDA on the dynamics of malaria transmission was determined in a prospective cohort study. Annual rounds of MDA with dihydroartemisinin-piperaquine (DP) were implemented were implemented in 2014 and 2015 in six village pairs before the malaria transmission season. Blood s les were collected from residents between July and December for microscopy and nested PCR. Incidence and prevalence of infection, clinical disease, and risk of malaria reinfection post-MDA were determined. Coverage of three DP doses was 68.2% (2014) and 65.6% (2015), compliance was greater than 80%. Incidence of infection was significantly lower in 2014 (incidence rate [IR] = 0.2 per person year [PPY]) than in 2013 (IR = 1.1 PPY P .01) monthly infection prevalence declined in the first three months post-MDA. Clinical malaria incidence was lower in 2014 (IR = 0.1 PPY) and 2015 (IR = 0.2 PPY) than in 2013 (IR = 0.4 PPY P .01), but remained higher in eastern Gambia. In iduals infected before MDA had a 2-fold higher odds of reinfection post-MDA (adjusted odds ratio = 2.5, 95% confidence interval 1.5–4.3 P .01). MDA reduced malaria infection and clinical disease during the first months. The reduction was maintained in low-transmission areas, but not in eastern Gambia. Annual MDA could be followed by focal MDA targeting in iduals infected during the dry season. Repeated MDA rounds, some during the dry season over larger geographical areas, may result in a more marked and sustained decrease of malaria transmission.
The gametocytocidal efficacy of primaquine in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine in The Gambia (PRINOGAM): study protocol for a randomised controlled trial
Publisher: Springer Science and Business Media LLC
Date: 03-2015
Costs of Acute Headache Medication Use and Productivity Losses Among Patients with Migraine: Insights from Three Randomized Controlled Trials
Publisher: Springer Science and Business Media LLC
Date: 30-10-2018
Neuroendocrine markers and psychological features in patients with irritable bowel syndrome
Publisher: Springer Science and Business Media LLC
Date: 02-02-2013
DOI: 10.1007/S00384-013-1646-4
Abstract: The key role of the brain-gut axis in the pathophysiology of irritable bowel syndrome (IBS) has been recognized. The aim of this study was to assess the possible association between IBS, neuroendocrine markers, and psychological features. One hundred and twenty-five consecutive IBS patients and 105 healthy subjects were enrolled. Plasma serotonin, plasma and urinary cortisol, and plasma neuropeptide Y levels were evaluated. All patients were given a questionnaire to assess IBS symptom severity. In 66 patients, a psychodiagnostic assessment was carried out. A high incidence of specific psychological features, including state anxiety (69.69 %), trait anxiety (54.54 %), obsessions and compulsions (28.78 %), was observed in IBS patients. A positive correlation between neuropeptide Y and state anxiety (r = 0.287, p = 0.024) and simulation/social ingenuity (r = 0.269, p = 0.039) was found in these patients. In diarrhea-predominant IBS, plasma cortisol was linearly related to plasma serotonin (r = 0.5663, p < 0.001). In IBS patients, a significant correlation was found between specific psychological features and neuroendocrine markers, especially plasma cortisol and neuropeptide Y in diarrhea-predominant IBS, a correlation between plasma cortisol and serotonin was found, although it needs to be confirmed in more extensive cohorts.
E-consensus on telemedicine in colorectal surgery: a RAND/UCLA-modified study
Publisher: Springer Science and Business Media LLC
Date: 26-07-2021
On-going malaria transmission in The Gambia despite high coverage of control interventions: a nationwide cross-sectional survey
Publisher: Springer Science and Business Media LLC
Date: 14-08-2015
Validation of a food-frequency questionnaire for the assessment of calcium intake in schoolchildren aged 9-10 years
Publisher: Springer Science and Business Media LLC
Date: 30-03-2013
DOI: 10.1007/S00223-013-9721-Y
Abstract: Bone mass increases steadily until age 20-30 years, when peak bone mass (PBM) is acquired. Nutrition plays a critical role in achievement of the optimal genetically programmed PBM, with reduction in the risk of osteoporosis later in life. Intake of nutrients can be estimated through the use of various tools typically, food-frequency questionnaires (FFQs) are used in epidemiologic studies. The aim of this study was to validate a 21-item, semiquantitative FFQ to assess important nutrient intakes for bone health in Italian schoolchildren 9-10 years of age. Relative validation was accomplished through comparison of the 7-days weighed food record (7D records) with an FFQ developed ad hoc, completed by a group of 75 Italian schoolchildren (36 females, 39 males). Agreement between the two methods was evaluated by Spearman's correlation test and Bland-Altman analysis applied on the data on intake of energy, macronutrients, and micronutrients. Particular attention was devoted to nutrients relevant for bone health. Good correlations between the two methods (FFQ and 7D records) were observed for all nutrients. In particular, mean dietary calcium intakes were 725.6 mg/day (95 % CI 683.2-768.1) from 7D records and 892.4 mg/day (95 % CI 844.6-940.2) from the FFQ. These results indicate that our FFQ for schoolchildren aged 9-10 years is highly acceptable as it is an accurate method that can be used in large-scale or epidemiological studies for the evaluation of nutrient intakes important for the prevention of osteoporosis in a similar population.
Associations between vision impairment and vision-related interventions on crash risk and driving cessation: systematic review and meta-analysis
Publisher: BMJ
Date: 08-2023
DOI: 10.1136/BMJOPEN-2022-065210
Abstract: To systematically investigate the associations between vision impairment and risk of motor vehicle crash (MVC) involvement, and evaluate vision-related interventions to reduce MVCs. Medline (Ovid), EMBASE and Global Health electronic databases were systematically searched from inception to March 2022 for observational and interventional English-language studies. Screening, data extraction and appraisals using the Joanna Briggs Institute appraisal tools were completed by two reviewers independently. Where appropriate, measures of association were converted into risk ratios (RRs) or ORs for meta-analysis. Drivers of four-wheeled vehicles of all ages with no cognitive declines. MVC involvement (primary) and driving cessation (secondary). 101 studies (n=778 052) were included after full-text review. 57 studies only involved older drivers (≥65 years) and 85 were in high-income settings. Heterogeneity in the data meant that most meta-analyses were underpowered as only 25 studies, further split into different groups of eye diseases and measures of vision, could be meta-analysed. The limited evidence from the meta-analyses suggests that visual field defects (four studies RR 1.51 (95% CI 1.23, 1.85) p .001 I 2 =46.79%), and contrast sensitivity (two studies RR 1.40 (95% CI 1.08, 1.80) p=0.01, I 2 =0.11%) and visual acuity loss (five studies RR 1.21 (95% CI 1.02, 1.43) p=0.03, I 2 =28.49%) may increase crash risk. The results are more inconclusive for available evidence for associations of glaucoma (five studies, RR 1.27 (95% CI 0.67, 2.42) p=0.47 I 2 =93.48%) and cataract (two studies RR 1.15 (95% CI 0.97, 1.36) p=0.11 I 2 =3.96%) with crashes. Driving cessation may also be linked with glaucoma (two studies RR 1.62 (95% CI 1.20, 2.19) p .001, I 2 =22.45%), age-related macular degeneration (AMD) (three studies RR 2.21 (95% CI 1.47, 3.31) p .001, I 2 =75.11%) and reduced contrast sensitivity (three studies RR 1.30 (95% CI 1.05, 1.61) p=0.02 I 2 =63.19%). Cataract surgery halved MVC risk (three studies RR 0.55 (95% CI 0.34, 0.92) p=0.02 I 2 =97.10). Ranibizumab injections (four randomised controlled trials) prolonged driving in persons with AMD. Impaired vision identified through a variety of measures is associated with both increased MVC involvement and cessation. Cataract surgery can reduce MVC risk. Despite literature being highly heterogeneous, this review shows that detection of vision problems and appropriate treatment are critical to road safety. CRD42020172153.
Angiotensin receptor blockers for the treatment of covid-19: pragmatic, adaptive, multicentre, phase 3, randomised controlled trial
Publisher: BMJ
Date: 16-11-2022
Abstract: To determine whether disrupting the renin angiotensin system with angiotensin receptor blockers will improve clinical outcomes in people with covid-19. CLARITY was a pragmatic, adaptive, multicentre, phase 3, randomised controlled trial. 17 hospital sites in India and Australia. Participants were at least 18 years old, previously untreated with angiotensin receptor blockers, with a laboratory confirmed diagnosis of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection who had been admitted to hospital for management of covid-19. Oral angiotensin receptor blockers (telmisartan in India) or placebo (1:1) for 28 days. The primary endpoint was covid-19 disease severity using a modified World Health Organization Clinical Progression Scale (WHO scale) at day 14. Secondary outcomes were WHO scale scores at day 28, mortality, intensive care unit admission, and respiratory failure. Analyses were evaluated on an ordinal scale in the intention-to-treat population. Between 3 May 2020 and 13 November 2021, 2930 people were screened for eligibility, with 393 randomly assigned to angiotensin receptor blockers (of which 388 (98.7%) to telmisartan 40 mg/day) and 394 to the control group. 787 participants were randomised: 778 (98.9%) from India and nine (1.1%) from Australia. The median WHO scale score at day 14 was 1 (interquartile range 1-1) in 384 participants assigned angiotensin receptor blockers and 1 (1-1) in 382 participants assigned placebo (adjusted odds ratio 1.51 (95% credible interval 1.02 to 2.23), probability of an odds ratio of (Pr(OR )=0.98). WHO scale scores at day 28 showed little evidence of difference between groups (1.02 (0.55 to 1.87), Pr(OR )=0.53). The trial was stopped when a prespecified futility rule was met. In patients admitted to hospital for covid-19, mostly with mild disease, not requiring oxygen, no evidence of benefit, based on disease severity score, was found for treatment with angiotensin receptor blockers, using predominantly 40 mg/day of telmisartan. ClinicalTrials.gov NCT04394117 .
Impact of COVID-19 Outbreak on Healthcare Workers in Italy: Results from a National E-Survey
Publisher: Springer Science and Business Media LLC
Date: 22-05-2020
DOI: 10.1007/S10900-020-00845-5
Abstract: Italy has been the first-hit European country to face the outbreak of coronavirus disease 2019 (COVID-19). Aim of this survey was to assess in depth the impact of the outbreak on healthcare workers (HCW). A 40-item online survey was disseminated via social media inviting Italian HCW, with questions exploring demographics, health status and work environment of respondents. A total of 527 were invited to take part in March 2020, of whom 74% (n = 388) responded to the survey. Of these, 235 (61%) were women. HCW were mostly physicians (74%), from high-prevalence regions (52%). 25% experienced typical symptoms during the last 14 days prior to survey completion, with only 45% of them being tested for COVID-19. Among the tested population, 18 (18%) resulted positive for COVID-19, with 33% being asymptomatic. Only 22% of HCW considered personal protective equipment adequate for quality and quantity. Females and respondents working in high-risk sectors were more likely to rate psychological support as useful (OR, 1.78 [CI 95% 1.14–2.78] P = 0.012, and 2.02 [1.12–3.65] P = 0.020, respectively) and workload as increased (mean increase, 0.38 [0.06–0.69] P = 0.018 and 0.54 [0.16–0.92] P = 0.005, respectively). The insights from this survey may help authorities in countries where COVID-19 epidemic has not yet broken out. Management strategies should be promptly undertaken in order to enhance safety and optimise resource allocation.
Economic Evaluations of Pharmacological Treatments in Heart Failure Patients: A Methodological Review with a Focus on Key Model Drivers
Publisher: Springer Science and Business Media LLC
Date: 26-08-2019
A Proposal of a Cost-Effectiveness Modeling Approach for Heart Failure Treatment Assessment: Considering the Short- and Long-Term Impact of Hospitalization on Event Rates.
Publisher: Springer Science and Business Media LLC
Date: 12-08-2022
DOI: 10.1007/S40273-022-01174-2
Abstract: The rate of events such as recurrent heart failure (HF) hospitalization and death are known to dramatically increase directly after HF hospitalization. Furthermore, the number of HF hospitalizations is associated with irreversible long-term disease progression, which is in turn associated with increased event rates. However, cost-effectiveness models of HF treatments commonly fail to capture both the short- and long-term association between HF hospitalization and events. The aim of this study was to provide a decision-analytic model that reflects the short- and long-term association between HF hospitalization and event rates. Furthermore, we assess the impact of omitting these associations. We developed a life-time Markov cohort model to evaluate HF treatments, and modeled the short-term impact of HF hospitalization on event rates via a sequence of tunnel states, with transition probabilities following a parametric survival curve. The corresponding long-term impact was modeled via hazard ratios per HF hospitalization. We obtained baseline event rates and utilities from published literature. Subsequently, we assessed, for a hypothetical HF treatment, how omitting the modeled associations (through a simple two-state model) affects incremental quality-adjusted life-years (QALYs). We developed a model that incorporates both short- and long-term impacts of HF hospitalizations. Based on an assumed treatment effect of a 20% risk reduction for HF hospitalization (and associated reductions in all-cause mortality of 15%), omitting the short-term, the long-term, or both associations resulted in a 5%, 1%, and 22% decrease in QALYs gained, respectively. For both modeling components, i.e., the short- and long-term implications of HF hospitalization, the impact on incremental outcomes associated with treatment was substantial. Considering these aspects as proposed within this modeling approach better reflects the natural course of this progressive condition and will enhance the evaluation of future HF treatments.
Improving adherence in osteoporosis: a new management algorithm for the patient with osteoporosis
Publisher: Informa Healthcare
Date: 13-01-2011
DOI: 10.1517/14656566.2011.537259
Abstract: Bisphosphonates are the first-choice treatment for osteoporosis. They effectively increase bone mineral density, reduce markers of bone resorption, and lower the incidence of new fractures in patients with osteoporosis-related fracture. However, the efficacy observed in clinical trials may not be realized in a real-life setting, partly due to poor adherence to therapy, with a significant worsening of clinical outcomes. Several issues contribute to poor adherence to osteoporosis medication, including inconvenient dosing regimens and concerns about possible adverse events. Although strategies to improve adherence have been investigated, new approaches are required. We review available data and propose a new approach to improve adherence to osteoporosis therapy in clinical practice. We present the current evidence and personal experience from a group of Italian osteoporosis experts. To improve adherence, we propose a multifaceted approach, which includes the Triad Model suggested by the World Health Organization, direct observed therapy and the use of drugs with longer administration intervals, e.g., zoledronic acid. The integration of these strategies may provide the basis for a marked increase in adherence to osteoporosis therapy, and improved clinical outcomes in a real-life scenario.
First trimester exposure to corticosteroids and oral clefts
Publisher: Wiley
Date: 12-2003
DOI: 10.1002/BDRA.10134
Abstract: The possible association between oral cleft in the newborn and maternal exposure to corticoids during pregnancy is still controversial. The aim of this study was to test this association by a case-control analysis using the large multicentric MADRE database. The MADRE database is a collection of information on malformed infants with a history of maternal first-trimester drug exposure. Nine malformation registries participate in the data collection. Cases were defined as infants presenting with a cleft palate or cleft lip, and exposure was defined by the use of corticosteroids during the first trimester of pregnancy. After 12 years of data collection, the database includes data on 11,150 malformed infants. A slight association is observed between exposure to corticoids for systemic use and the occurrence of cleft lip with or without cleft palate (OR, 2.59 95% CI, 1.18-5.67). If the observed association is real, an interpretation is suggested, based on a likely interaction between corticosteroids and environmental dioxins. It is indeed possible that human fetuses may become sensitive to the teratogenic effect of corticosteroids when they are exposed in utero to environmental pesticides as well.
Related Organisations
University Of Applied Sciences And Arts Of Southern Switzerland
Location: Switzerland
Related Funding Activities
Reactive Household-based Self-administered Treatment Against Residual Malaria Transmission: A Cluster Randomised Trial
Start Date: 2015
End Date: 2019
Funder: Medical Research Council
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