ORCID Profile
0000-0003-0450-1606
Current Organisations
University of Nottingham
,
Instituto de Investigación en Recursos Cinegéticos
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Publisher: Springer Science and Business Media LLC
Date: 27-11-2019
DOI: 10.1186/S13063-019-3731-7
Abstract: Bacterial vaginosis (BV) affects 30–50% of women at some time in their lives and is an embarrassing and distressing condition which can be associated with potentially serious comorbidities. Current antibiotic treatments such as metronidazole are effective but can result in side effects, and recurrence is common. This trial aims to investigate whether lactic acid gel is clinically effective and cost effective in the treatment of recurrent BV compared with metronidazole. VITA is an open-label, multicentre, parallel group randomised controlled trial for women with a clinical diagnosis of BV and at least one previous BV episode in the past 2 years. Participants will be randomised 1:1 to intravaginal lactic acid gel 5 ml once daily for 7 days or oral metronidazole tablets 400 mg twice daily for 7 days. All participants will be followed up for 6 months to assess health status and healthcare costs. A subgroup will be interviewed to further explore adherence, tolerability and acceptability of treatment. The estimated s le size is 1900 participants to detect a 6% absolute increase in response rate to 86% in those receiving lactic acid gel. The primary outcome is participant-reported resolution of BV at Week 2. Results from this trial will help inform UK treatment guidelines for BV and may provide an alternative effective treatment for recurrent episodes of this condition which avoids repeated exposure to antibiotics. ISRCTN, ISRCTN14161293 . Registered on 8 September 2017.
Publisher: MDPI AG
Date: 19-09-2019
Abstract: The poultry red mite (PRM), Dermanyssus gallinae, is a hematophagous ectoparasite of birds with worldwide distribution that causes economic losses in the egg-production sector of the poultry industry. Traditional control methods, mainly based on acaricides, have been only partially successful, and new vaccine-based interventions are required for the control of PRM. Vaccination with insect Akirin (AKR) and its homolog in ticks, Subolesin (SUB), have shown protective efficacy for the control of ectoparasite infestations and pathogen infection/transmission. The aim of this study was the identification of the akr gene from D. gallinae (Deg-akr), the production of the recombinant Deg-AKR protein, and evaluation of its efficacy as a vaccine candidate for the control of PRM. The anti-Deg-AKR serum IgY antibodies in hen sera and egg yolk were higher in vaccinated than control animals throughout the experiment. The results demonstrated the efficacy of the vaccination with Deg-AKR for the control of PRM by reducing mite oviposition by 42% following feeding on vaccinated hens. A negative correlation between the levels of serum anti-Deg-AKR IgY and mite oviposition was obtained. These results support Deg-AKR as a candidate protective antigen for the control of PRM population growth.
Publisher: BMJ
Date: 07-2015
Publisher: Public Library of Science (PLoS)
Date: 26-11-2018
Publisher: Human Kinetics
Date: 05-2014
Abstract: The current study investigated cross-sectional associations between maternal and paternal logistic and modeling physical activity support and the self-efficacy, self-esteem, and physical activity intentions of 11- to 12-year-old girls. 210 girls reported perceptions of maternal and paternal logistic and modeling support and their self-efficacy, self-esteem and intention to be physically active. Data were analyzed using multivariable regression models. Maternal logistic support was positively associated with participants’ self-esteem, physical activity self-efficacy, and intention to be active. Maternal modeling was positively associated with self-efficacy. Paternal modeling was positively associated with self-esteem and selfefficacy but there was no evidence that paternal logistic support was associated with the psychosocial variables. Activity-related parenting practices were associated with psychosocial correlates of physical activity among adolescent girls. Logistic support from mothers, rather than modeling support or paternal support may be a particularly important target when designing interventions aimed at preventing the age-related decline in physical activity among girls.
Publisher: Elsevier BV
Date: 10-2020
Publisher: Elsevier BV
Date: 05-2023
Publisher: SAGE Publications
Date: 12-04-2019
Publisher: BMJ
Date: 03-2016
Publisher: Elsevier BV
Date: 05-2021
Publisher: Springer Science and Business Media LLC
Date: 12-2015
Publisher: National Institute for Health and Care Research
Date: 04-2019
DOI: 10.3310/HTA23160
Abstract: People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital. To assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI. Multicentre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken. Community settings in nine sites in England. Participants were aged 18–69 years, had undergone a TBI 3 months prior to recruitment, reported memory problems, were able to travel to a site to attend group sessions, could communicate in English and gave informed consent. Clusters of four to six participants were randomised to the memory rehabilitation arm or the usual-care arm on a 1 : 1 ratio. Randomisation was based on a computer-generated pseudo-random code using random permuted blocks of randomly varying size, stratified by study site. Participants and therapists were aware of the treatment allocation whereas outcome assessors were blinded. In the memory rehabilitation arm 10 weekly sessions of a manualised memory rehabilitation programme were provided in addition to usual care. Participants were taught restitution strategies to retrain impaired memory functions and compensation strategies to enable them to cope with memory problems. The usual-care arm received usual care only. Outcomes were assessed at 6 and 12 months after randomisation. Primary outcome: patient-completed Everyday Memory Questionnaire – patient version (EMQ-p) at 6 months’ follow-up. Secondary outcomes: Rivermead Behavioural Memory Test – third edition (RBMT-3), General Health Questionnaire 30-item version, European Brain Injury Questionnaire, Everyday Memory Questionnaire – relative version and in idual goal attainment. Costs (based on a UK NHS and Personal Social Services perspective) were collected using a service use questionnaire, with the EuroQol-5 Dimensions, five-level version, used to derive quality-adjusted life-years (QALYs). A Markov model was developed to explore cost-effectiveness at 5 and 10 years, with a 3.5% discount applied. We randomised 328 participants (memory rehabilitation, n = 171 usual care, n = 157), with 129 in the memory rehabilitation arm and 122 in the usual-care arm included in the primary analysis. We found no clinically important difference on the EMQ-p between the two arms at 6 months’ follow-up (adjusted difference in mean scores –2.1, 95% confidence interval –6.7 to 2.5 p = 0.37). For secondary outcomes, differences favouring the memory rehabilitation arm were observed at 6 months’ follow-up for the RBMT-3 and goal attainment, but remained only for goal attainment at 12 months’ follow-up. There were no differences between arms in mood or quality of life. The qualitative results suggested positive experiences of participating in the trial and of attending the groups. Participants reported that memory rehabilitation was not routinely accessible in usual care. The primary health economics outcome at 12 months found memory rehabilitation to be £26.89 cheaper than usual care but less effective, with an incremental QALY loss of 0.007. Differences in costs and effects were not statistically significant and non-parametric bootstrapping demonstrated considerable uncertainty in these findings. No safety concerns were raised and no deaths were reported. As a pragmatic trial, we had broad inclusion criteria and, therefore, there was considerable heterogeneity within the s le. The study was not powered to perform further subgroup analyses. Participants and therapists could not be blinded to treatment allocation. The group memory rehabilitation delivered in this trial is very unlikely to lead to clinical benefits or to be a cost-effective treatment for people with TBI in the community. Future studies should examine the selection of participants who may benefit most from memory rehabilitation. Current Controlled Trials ISRCTN65792154. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 23, No. 16. See the NIHR Journals Library website for further project information.
Publisher: Elsevier BV
Date: 12-2018
Publisher: Elsevier BV
Date: 05-2021
Publisher: National Institute for Health and Care Research
Date: 2022
DOI: 10.3310/ZZKH4176
Abstract: Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur. The objective is to assess whether or not intravaginal lactic acid gel is clinically effective and cost-effective for treating recurrent bacterial vaginosis compared with oral metronidazole (Flagyl, Sanofi). This was an open-label, multicentre, parallel-arm, randomised (1 : 1) controlled trial. This took place in one general practice and 19 sexual health centres in the UK. Women aged ≥ 16 years with bacterial vaginosis symptoms and one or more episode(s) within the past 2 years took part. The interventions were 5 ml of intravaginal lactic acid gel taken once daily for 7 days (intervention) or 400-mg oral metronidazole tablets taken twice daily for 7 days (control). The primary outcome was the resolution of bacterial vaginosis symptoms 14 days after randomisation. The secondary outcomes were time to first recurrence of symptoms number of recurrences and treatment courses over 6 months microbiological resolution on microscopy of vaginal smears at week 2 time to resolution of symptoms tolerability, adherence and acceptability of the treatment prevalence of concurrent sexually transmitted infections quality of life and cost-effectiveness. Recruitment stopped prior to reaching the target of 1900 participants on recommendation from the Data Monitoring Committee and Trial Steering Committee after a planned review of the results indicated that the research question had been answered. Overall, 518 participants were randomised and primary outcome data were available for 409 participants (79% 204 in the metronidazole arm, 205 in the lactic acid gel arm). Participant-reported symptom resolution at week 2 was higher with metronidazole (143/204 70%) than with lactic acid gel (97/205 47%) (adjusted risk difference –23.2%, 95% confidence interval –32.3% to –14.0%). Recurrence in 6 months in a subset of participants who had initial resolution and were available for follow-up was similar across arms (metronidazole arm: 51/72, 71% lactic acid gel arm: 32/46, 70%). A higher incidence of some side effects was reported with metronidazole than with lactic acid gel (nausea 32% vs. 8% taste changes 18% vs. 1% diarrhoea 20% vs. 6%, respectively). At week 2, the average cost per participant with resolved symptoms was £86.94 (metronidazole), compared with £147.00 (lactic acid gel). Some participants preferred using lactic acid gel even if they perceived it to be less effective than metronidazole. Loss to follow-up for collection of the primary outcome data was 21% and was similar in both arms. There is a risk of bias owing to missing outcome data at 3 and 6 months post treatment. A higher initial response was seen with metronidazole than with lactic acid gel, but subsequent treatment failure was common with both. Lactic acid gel was less cost-effective than metronidazole. In general, women disliked taking repeated courses of metronidazole and preferred lactic acid gel, even when they were aware that it was less likely to provide symptom resolution. In the absence of effective curative therapy, further evaluation of non-antibiotic treatments to control the symptoms of recurrent bacterial vaginosis is required to improve quality of life for these patients. Further microbiological analysis of vaginal s les would be useful to identify additional factors affecting response to treatment. Current Controlled Trials ISRCTN14161293. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 26, No. 2. See the NIHR Journals Library website for further project information.
Publisher: Springer Science and Business Media LLC
Date: 04-09-2015
Publisher: Informa UK Limited
Date: 15-10-2014
DOI: 10.1080/10615806.2014.962023
Abstract: Peer victimization is ubiquitous across schools and cultures, and has the potential for long-lasting effects on the well-being of victims. To date, research has focused on the consequences of peer victimization during childhood but neglected adolescence. Peer relationships and approval become increasingly important during adolescence thus, peer victimization at this age may have a damaging psychological impact. Participants were 5030 adolescents aged 11-16 recruited from secondary schools in the UK. Self-report measures of victimization and symptoms of anxiety and depression were administered on three occasions over a 12-month period. Latent growth models examined concurrent and prospective victimization-related elevations in anxiety and depression symptoms above in idual-specific growth trajectories. Peer victimization was associated with a concurrent elevation of 0.64 and 0.56 standard deviations in depression and anxiety scores, respectively. There was an independent delayed effect, with additional elevations in depression and anxiety (0.28 and 0.25 standard deviations) six months later. These concurrent and prospective associations were independent of expected symptom trajectories informed by in idual risk factors. Adolescent peer victimization was associated with immediate and delayed elevations in anxiety and depression. Early intervention aimed at identifying and supporting victimized adolescents may prevent the development of these disorders.
Publisher: SAGE Publications
Date: 10-07-2020
Abstract: Central adjudication of outcomes is common for randomised trials and should control for differential misclassification. However, few studies have estimated the cost of the adjudication process. We estimated the cost of adjudicating the primary outcome in nine randomised stroke trials (25,436 participants). The costs included adjudicators’ time, direct payments to adjudicators, and co-ordinating centre costs (e.g. uploading cranial scans and general set-up costs). The number of events corrected after adjudication was our measure of benefit. We calculated cost per corrected event for each trial and in total. The primary outcome in all nine trials was either stroke or a composite that included stroke. In total, the adjudication process associated with this primary outcome cost in excess of £100,000 for a third of the trials (3/9). Mean cost per event corrected by adjudication was £2295.10 (SD: £1482.42). Central adjudication is a time-consuming and potentially costly process. These costs need to be considered when designing a trial and should be evaluated alongside the potential benefits adjudication brings to determine whether they outweigh this expense.
Publisher: Elsevier BV
Date: 09-2016
DOI: 10.1016/J.DRUGALCDEP.2016.06.032
Abstract: Adolescents who experience internalising symptoms may be susceptible to the use of alcohol and other substances in an attempt to alleviate or cope with these symptoms. We examined the hypothesised internalising pathway from symptoms of depression, generalised anxiety, social anxiety and panic, to incidence and frequency of cannabis use 18 months later. Longitudinal cohort study of participants (n=2508 45% female mean age 14.5 years) recruited from the 9th grade at 22 low-income secondary schools in Santiago, Chile. Baseline internalising symptoms were assessed using the Beck Depression Inventory and the Revised Child Anxiety and Depression Scale. Frequency of cannabis was assessed at baseline, 6 month and 18 month follow-up. High rates of use were observed in this s le, with 40.3% reporting cannabis use at least once over the study period. Adjusted for baseline cannabis use, symptoms of depression, panic and generalised anxiety were associated with greater cannabis use frequency 18 months later. When all predictors were considered simultaneously, only generalised anxiety symptoms showed an independent association with subsequent cannabis use frequency (OR: 1.23, 95% CI: 1.08-1.41). Generalised anxiety symptoms were also associated with a 25% increased risk of transitioning from non-user to use of cannabis during the study (OR: 1.25, 95% CI: 1.09-1.44). Internalising symptoms, and in particular symptoms of generalised anxiety, increase risk of cannabis use during adolescence. Targeted interventions that promote adaptive anxiety management among high-risk adolescents may represent a promising strategy to prevent uptake of cannabis use during adolescence.
Publisher: Wiley
Date: 03-11-2022
DOI: 10.1111/ALL.15555
Abstract: The effectiveness of emollients for preventing atopic dermatitis/eczema is controversial. The Barrier Enhancement for Eczema Prevention trial evaluated the effects of daily emollients during the first year of life on atopic dermatitis and atopic conditions to age 5 years. 1394 term infants with a family history of atopic disease were randomized (1:1) to daily emollient plus standard skin‐care advice (693 emollient group) or standard skin‐care advice alone (701 controls). Long‐term follow‐up at ages 3, 4 and 5 years was via parental questionnaires. Main outcomes were parental report of a clinical diagnosis of atopic dermatitis and food allergy. Parents reported more frequent moisturizer application in the emollient group through to 5 years. A clinical diagnosis of atopic dermatitis between 12 and 60 months was reported for 188/608 (31%) in the emollient group and 178/631 (28%) in the control group (adjusted relative risk 1.10, 95% confidence interval 0.93 to 1.30). Although more parents in the emollient group reported food reactions in the previous year at 3 and 4 years, cumulative incidence of doctor‐diagnosed food allergy by 5 years was similar between groups (92/609 [15%] emollients and 87/632 [14%] controls, adjusted relative risk 1.11, 95% confidence interval 0.84 to 1.45). Findings were similar for cumulative incidence of asthma and hay fever. Daily emollient application during the first year of life does not prevent atopic dermatitis, food allergy, asthma or hay fever.
Publisher: Wiley
Date: 13-08-2023
DOI: 10.1111/CEA.14381
Abstract: Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy. To determine the cost‐effectiveness of daily all‐over‐body application of emollient during the first year of life for preventing atopic eczema in high‐risk children at 2 years from a health service perspective. We also considered a 5‐year time horizon as a sensitivity analysis. A within‐trial economic evaluation using data on health resource use and quality of life captured as part of the BEEP trial alongside the trial data. Parents/carers of 1394 infants born to families at high risk of atopic disease were randomised 1:1 to the emollient group, which were advised to apply emollient (Doublebase Gel or Diprobase Cream) to their child at least once daily to the whole body during the first year of life or usual care. Both groups received advice on general skin care. The main economic outcomes were incremental cost‐effectiveness ratio (ICER), defined as incremental cost per percentage decrease in risk of eczema in the primary cost‐effectiveness analysis. Secondary analysis, undertaken as a cost‐utility analysis, reports incremental cost per Quality‐Adjusted Life Year (QALY) where child utility was elicited using the proxy CHU‐9D at 2 years. At 2 years, the adjusted incremental cost was £87.45 (95% CI −54.31, 229.27) per participant, whilst the adjusted proportion without eczema was 0.0164 (95% CI −0.0329, 0.0656). The ICER was £5337 per percentage decrease in risk of eczema. Adjusted incremental QALYs were very slightly improved in the emollient group, 0.0010 (95% CI −0.0069, 0.0089). At 5 years, adjusted incremental costs were lower for the emollient group, −£106.89 (95% CI −354.66, 140.88) and the proportion without eczema was −0.0329 (95% CI −0.0659, 0.0002). The 5‐year ICER was £3201 per percentage decrease in risk of eczema. However, when inpatient costs due to wheezing were excluded, incremental costs were lower and incremental effects greater in the usual care group. In line with effectiveness endpoints, advice given in the BEEP trial to apply daily emollient during infancy for eczema prevention in high‐risk children does not appear cost‐effective.
Publisher: SAGE Publications
Date: 15-06-2022
DOI: 10.1177/26320843221106950
Abstract: To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection. Twelve surgical RCTs were eligible. Interested sites (clusters) were randomised 1:1, with recruiting staff (surgeons and nurses) offered training or no training. The primary outcome was the feasibility of recruiting sites across multiple surgical trials simultaneously. Secondary outcomes included numbers/types of staff enrolled, attendance at training, training acceptability, confidence in recruiting and participant recruitment rates six months later. Four RCTs (33%) comprising 91 sites participated. Of these, 29 sites agreed to participate (32%) and were randomised to intervention (15 sites, 29 staff) or control (14 sites, 29 staff). Research nurses attended and found the training to be acceptable no surgeons attended. In the intervention group, there was evidence of increased confidence when pre- and post- training scores were compared (mean difference in change 1.42 95% CI 0.56, 2.27 p = 0.002). There was no effect on recruitment rate. It was feasible to randomise sites across four surgical RCTs in a simultaneous SWAT design. However, as small numbers of trials and sites participated, and no surgeons attended training, strategies to improve these aspects are needed for future evaluations.
Publisher: BMJ
Date: 03-2020
DOI: 10.1136/BMJOPEN-2019-034595
Abstract: Timing of cord cl ing and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord cl ing, and cord milking. In idual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. (1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. Systematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks’ gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials aggregate summary data will be included where IPD are unavailable. First, deferred cl ing and cord milking will be compared with immediate cl ing in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. Ethics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases. Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).
Publisher: BMJ
Date: 29-01-2013
DOI: 10.1136/BMJ.F43
Publisher: Springer Science and Business Media LLC
Date: 30-01-2014
Publisher: Elsevier BV
Date: 07-2022
Publisher: Wiley
Date: 27-02-2018
DOI: 10.1111/JVH.12869
Abstract: The United Kingdom has committed to eliminating viral hepatitis as a public health threat. Innovative interventions for marginalized populations are required to realize this goal. In 2016, the HepCATT study team implemented a complex hepatitis C (HCV) intervention in three English drug treatment services, with five controls. We report qualitative study findings from two intervention sites to explore intervention success and transferability potential. The intervention comprised multiple components, including a nurse facilitator, peer support and education initiatives. Qualitative data were generated at baseline (2014) and post-intervention (2016) at two sites through in-depth interviews, focus groups and observations. The 96 participants comprised drug service and intervention providers and clients with an injecting history. Data were triangulated and thematically analysed. Client engagement with a HCV treatment service rose from 16 at baseline to 147 in 2016. There was no comparable increase at the five control sites. Baseline testing and treatment barriers included the following: limited HCV knowledge fear of diagnosis and treatment precarious living circumstances and service-specific obstacles. Treatment engagement was aided by intervention timeliness improved communication structures personalized care streamlined testing and treatment pathways peer support. Multiple interrelated components influenced the increased levels of treatment engagement documented in HepCATT. The nurse facilitator, involved in implementation and innovation, was key to intervention success. Baseline barriers correspond with international literature-indicating transferability potential. Control data indicate that biomedical innovation alone is not sufficient to increase engagement among the most marginalized. Sustainable resourcing of community services is crucial to effect change.
Publisher: Elsevier BV
Date: 06-2023
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2019
DOI: 10.1161/STROKEAHA.119.026389
Abstract: Pilot trials suggest that glyceryl trinitrate (GTN nitroglycerin) may improve outcome when administered early after stroke onset. We undertook a multicentre, paramedic-delivered, ambulance-based, prospective randomized, sham-controlled, blinded-end point trial in adults with presumed stroke within 4 hours of ictus. Participants received transdermal GTN (5 mg) or a sham dressing (1:1) in the ambulance and then daily for three days in hospital. The primary outcome was the 7-level modified Rankin Scale at 90 days assessed by central telephone treatment-blinded follow-up. This prespecified subgroup analysis focuses on participants with an intracerebral hemorrhage as their index event. Analyses are intention-to-treat. Of 1149 participants with presumed stroke, 145 (13% GTN, 74 sham, 71) had an intracerebral hemorrhage: time from onset to randomization median, 74 minutes (interquartile range, 45–110). By admission to hospital, blood pressure tended to be lower with GTN as compared with sham: mean, 4.4/3.5 mm Hg. The modified Rankin Scale score at 90 days was nonsignificantly higher in the GTN group: adjusted common odds ratio for poor outcome, 1.87 (95% CI, 0.98–3.57). A prespecified global analysis of 5 clinical outcomes (dependency, disability, cognition, quality of life, and mood) was worse with GTN Mann-Whitney difference, 0.18 (95% CI, 0.01–0.35 Wei-Lachin test). GTN was associated with larger hematoma and growth, and more mass effect and midline shift on neuroimaging, and altered use of hospital resources. Death in hospital but not at day 90 was increased with GTN. There were no significant between-group differences in serious adverse events. Prehospital treatment with GTN worsened outcomes in patients with intracerebral hemorrhage. Since these results could relate to the play of chance, confounding, or a true effect of GTN, further randomized evidence on the use of vasodilators in ultra-acute intracerebral hemorrhage is needed. URL: www.controlled-trials.com . Unique identifier: ISRCTN26986053.
Publisher: Massachusetts Medical Society
Date: 19-07-2100
Publisher: Elsevier BV
Date: 02-2022
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2019
DOI: 10.1161/STROKEAHA.119.025019
Abstract: In randomized stroke trials, central adjudication of a trial’s primary outcome is regularly implemented. However, recent evidence questions the importance of central adjudication in randomized trials. The aim of this review was to compare outcomes assessed by central adjudicators with outcomes assessed by site investigators. We included randomized stroke trials where the primary outcome had undergone an assessment by site investigators and central adjudicators. We searched MEDLINE, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, and Google Scholar for eligible studies. We extracted information about the adjudication process as well as the treatment effect for the primary outcome, assessed both by central adjudicators and by site investigators. We calculated the ratio of these treatment effects so that a ratio of these treatment effects indicated that central adjudication resulted in a more beneficial treatment effect than assessment by the site investigator. A random-effects meta-analysis model was fitted to estimate a pooled effect. Fifteen trials, comprising 69 560 participants, were included. The primary outcomes included were stroke (8/15, 53%), a composite event including stroke (6/15, 40%) and functional outcome after stroke measured on the modified Rankin Scale (1/15, 7%). The majority of site investigators were blind to treatment allocation (9/15, 60%). On average, there was no difference in treatment effect estimates based on data from central adjudicators and site investigators (pooled ratio of these treatment effects=1.02 95% CI, [0.95–1.09]). We found no evidence that central adjudication of the primary outcome in stroke trials had any impact on trial conclusions. This suggests that potential advantages of central adjudication may not outweigh cost and time disadvantages in stroke studies if the primary purpose of adjudication is to ensure validity of trial findings.
Publisher: Public Library of Science (PLoS)
Date: 11-10-2013
Publisher: Springer Science and Business Media LLC
Date: 09-05-2023
DOI: 10.1186/S12905-023-02303-5
Abstract: Bacterial vaginosis is a common and distressing condition for women. Short-term antibiotic treatment is usually clinically effective, but recurrence is common. We assessed the effectiveness of intravaginal lactic acid gel versus oral metronidazole for treating recurrent bacterial vaginosis. We undertook an open-label, multicentre, parallel group, randomised controlled trial in nineteen UK sexual health clinics and a university health centre. Women aged ≥ 16 years, with current bacterial vaginosis symptoms and a preceding history of bacterial vaginosis, were randomised in a 1:1 ratio using a web-based minimisation algorithm, to 400 mg twice daily oral metronidazole tablets or 5 ml once daily intravaginal lactic acid gel, for 7 days. Masking of participants was not possible. The primary outcome was participant-reported resolution of symptoms within 2 weeks. Secondary outcomes included time to first recurrence of symptoms, number of recurrences and repeat treatments over 6 months and side effects. Five hundred and eighteen participants were randomised before the trial was advised to stop recruiting by the Data Monitoring Committee. Primary outcome data were available for 79% (204/259) allocated to metronidazole and 79% (205/259) allocated to lactic acid gel. Resolution of bacterial vaginosis symptoms within 2 weeks was reported in 70% (143/204) receiving metronidazole versus 47% (97/205) receiving lactic acid gel (adjusted risk difference -23·2% 95% confidence interval -32.3 to -14·0%). In those participants who had initial resolution and for whom 6 month data were available, 51 of 72 (71%) women in the metronidazole group and 32 of 46 women (70%) in the lactic acid gel group had recurrence of symptoms, with median times to first recurrence of 92 and 126 days, respectively. Reported side effects were more common following metronidazole than lactic acid gel (nausea 32% vs. 8% taste changes 18% vs. 1% diarrhoea 20% vs. 6%, respectively). Metronidazole was more effective than lactic acid gel for short-term resolution of bacterial vaginosis symptoms, but recurrence is common following both treatments. Lactic acid gel was associated with fewer reported side effects. ISRCTN14161293 , prospectively registered on 18 th September 2017.
Publisher: Cold Spring Harbor Laboratory
Date: 05-10-2019
DOI: 10.1101/19007708
Abstract: Timing of cord cl ing and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups such as those who usually receive immediate neonatal care. Previous and current trials compare various policies, including immediate cord cl ing, time- or physiology-based deferred cord cl ing, and cord milking. In idual participant data (IPD) enables exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. 1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis and 2) to evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. We will conduct a systematic search of Medline, Embase, clinical trial registries, and other sources for all planned, ongoing and completed randomised controlled trials comparing alternative cord management strategies at preterm birth (before 37 weeks’ gestation). IPD will be sought for all trials. First, deferred cl ing and cord milking will be compared with immediate cl ing in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for pre-specified subgroups of participants. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes intraventricular haemorrhage (any grade) and infant blood transfusions (any). Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. Approved by University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline-developers and policy-makers, and will be disseminated via publications, presentations, and media releases. Australian New Zealand Clinical Trials Registry: ACTRN12619001305112. This will be the most comprehensive review to date of interventions for umbilical cord management in preterm infants and the findings will be highly relevant to clinicians and guideline developers The use of in idual participant data will allow assessment of the best treatment option for key subgroups of participants Network meta-analysis will enable the comparison and ranking of all available treatment options using direct and indirect evidence For some of the trials it will not be possible to obtain in idual participant data, so published aggregate results will be used instead Risk of bias in the primary trials will be assessed using Cochrane criteria, and certainty of evidence for the meta-analyses will be appraised using the GRADE approach for the pairwise comparisons, and the CINeMA approach for the network meta-analysis
Publisher: National Institute for Health and Care Research
Date: 2020
DOI: 10.3310/HTA24040
Abstract: People with multiple sclerosis have problems with memory and attention. The effectiveness of cognitive rehabilitation has not been established. The objectives were to assess the clinical effectiveness and cost-effectiveness of a cognitive rehabilitation programme for people with multiple sclerosis. This was a multicentre, randomised controlled trial in which participants were randomised in a ratio of 6 : 5 to receive cognitive rehabilitation plus usual care or usual care alone. Participants were assessed at 6 and 12 months after randomisation. The trial was set in hospital neurology clinics and community services. Participants were people with multiple sclerosis who had cognitive problems, were aged 18–69 years, could travel to attend group sessions and gave informed consent. The intervention was a group cognitive rehabilitation programme delivered weekly by an assistant psychologist to between four and six participants for 10 weeks. The primary outcome was the Multiple Sclerosis Impact Scale – Psychological subscale at 12 months. Secondary outcomes included results from the Everyday Memory Questionnaire, the 30-Item General Health Questionnaire, the EuroQol-5 Dimensions, five-level version and a service use questionnaire from participants, and the Everyday Memory Questionnaire – relative version and the Modified Carer Strain Index from a relative or friend of the participant. Of the 449 participants randomised, 245 were allocated to cognitive rehabilitation (intervention group) and 204 were allocated to usual care (control group). Of these, 214 in the intervention group and 173 in the control group were included in the primary analysis. There was no clinically important difference in the Multiple Sclerosis Impact Scale – Psychological subscale score between the two groups at the 12-month follow-up (adjusted difference in means –0.6, 95% confidence interval –1.5 to 0.3 p = 0.20). There were no important differences between the groups in relation to cognitive abilities, fatigue, employment, or carer strain at follow-up. However, there were differences, although small, between the groups in the Multiple Sclerosis Impact Scale – Psychological subscale score at 6 months (adjusted difference in means –0.9, 95% confidence interval –1.7 to –0.1 p = 0.03) and in everyday memory on the Everyday Memory Questionnaire as reported by participants at 6 (adjusted difference in means –5.3, 95% confidence interval –8.7 to –1.9) and 12 months (adjusted difference in means –4.4, 95% confidence interval –7.8 to –0.9) and by relatives at 6 (adjusted difference in means –5.4, 95% confidence interval –9.1 to –1.7) and 12 months (adjusted difference in means –5.5, 95% confidence interval –9.6 to –1.5) in favour of the cognitive rehabilitation group. There were also differences in mood on the 30-Item General Health Questionnaire at 6 (adjusted difference in means –3.4, 95% confidence interval –5.9 to –0.8) and 12 months (adjusted difference in means –3.4, 95% confidence interval –6.2 to –0.6) in favour of the cognitive rehabilitation group. A qualitative analysis indicated perceived benefits of the intervention. There was no evidence of a difference in costs (adjusted difference in means –£574.93, 95% confidence interval –£1878.93 to £729.07) or quality-adjusted life-year gain (adjusted difference in means 0.00, 95% confidence interval –0.02 to 0.02). No safety concerns were raised and no deaths were reported. The trial included a s le of participants who had relatively severe cognitive problems in daily life. The trial was not powered to perform subgroup analyses. Participants could not be blinded to treatment allocation. This cognitive rehabilitation programme had no long-term benefits on quality of life for people with multiple sclerosis. Future research should evaluate the selection of those who may benefit from cognitive rehabilitation. Current Controlled Trials ISRCTN09697576. This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 24, No. 4. See the National Institute for Health Research Journals Library website for further project information.
Publisher: Cambridge University Press (CUP)
Date: 24-06-0006
DOI: 10.1017/S1352465814000241
Abstract: Background: Engaging clients from the outset of psychotherapy is important for therapeutic success. However, there is little research evaluating therapists’ initial attempts to engage clients in the therapeutic process. This article reports retrospective analysis of data from a trial of online cognitive behavioural therapy (CBT) for depression. Qualitative and quantitative methods were used to evaluate how therapists manage clients’ expectations at the outset of therapy and its relationship with client retention in the therapeutic intervention. Aims: To develop a system to codify expectation management in initial sessions of online CBT and evaluate its relationship with retention. Method: Initial qualitative research using conversation analysis identified three communication practices used by therapists at the start of first sessions: no expectation management, some expectation management, and comprehensive expectation management. These findings were developed into a coding scheme that enabled substantial inter-rater agreement (weighted Kappa = 0.78 95% CI: 0.52 to 0.94) and was applied to all trial data. Results: Adjusting for a range of client variables, primary analysis of data from 147 clients found comprehensive expectation management was associated with clients remaining in therapy for 1.4 sessions longer than those who received no expectation management (95% CI: -0.2 to 3.0). This finding was supported by a sensitivity analysis including an additional 21 clients (1.6 sessions, 95% CI: 0.2 to 3.1). Conclusions: Using a combination of qualitative and quantitative methods, this study suggests a relationship between expectation management and client retention in online CBT for depression, which has implications for professional practice. A larger prospective study would enable a more precise estimate of retention.
Publisher: Elsevier BV
Date: 02-2021
Publisher: BMJ
Date: 02-2020
DOI: 10.1136/BMJOPEN-2019-033655
Abstract: To investigate the effects of adding high-grade quantitative evidence of outcomes of treatments into relevant Wikipedia pages on further information-seeking behaviour by the use of routinely collected data. Wikipedia, Cochrane summary pages and the Cochrane Library. Randomised trial. Wikipedia pages which were highly relevant to up-to-date Cochrane Schizophrenia systematic reviews that contained a Summary of Findings table. Eligible Wikipedia pages in the intervention group were seeded with tables of best evidence of the effects of care and hyperlinks to the source Cochrane review. Eligible Wikipedia pages in the control group were left unchanged. Routinely collected data on access to the full text and summary web page (after 12 months). We randomised 70 Wikipedia pages (100% follow-up). Six of the 35 Wikipedia pages in the intervention group had the tabular format deleted during the study but all pages continued to report the same data within the text. There was no evidence of effect on either of the coprimary outcomes: full-text access adjusted ratio of geometric means 1.30, 95% CI: 0.71 to 2.38 page views 1.14, 95% CI: 0.6 to 2.13. Results were similar for all other outcomes, with exception of Altmetric score for which there was some evidence of clear effect (1.36, 95% CI: 1.05 to 1.78). The pursuit of fair balance within Wikipedia healthcare pages is impressive and its reach unsurpassed. For every person who sought and clicked the reference on the ‘intervention’ Wikipedia page to seek more information (the primary outcome), many more are likely to have been informed by the page alone. Enriching Wikipedia content is, potentially, a powerful way to improve health literacy and it is possible to test the effects of seeding pages with evidence. This trial should be replicated, expanded and developed. IRCT2017070330407N2 .
Publisher: Massachusetts Medical Society
Date: 25-02-2021
Publisher: Springer Science and Business Media LLC
Date: 17-10-2021
DOI: 10.1186/S12874-021-01388-6
Abstract: Vascular prevention trials typically use dichotomous event outcomes although this may be inefficient statistically and gives no indication of event severity. We assessed whether ordinal outcomes would be more efficient and how to best analyse them. Chief investigators of vascular prevention randomised controlled trials that showed evidence of either benefit or harm, or were included in a systematic review that overall showed benefit or harm, shared in idual participant data from their trials. Ordered categorical versions of vascular event outcomes (such as stroke and myocardial infarction) were analysed using 15 statistical techniques and their results then ranked, with the result with the smallest p -value given the smallest rank. Friedman and Duncan’s multiple range tests were performed to assess differences between tests by comparing the average ranks for each statistical test. Data from 35 trials (254,223 participants) were shared with the collaboration. 13 trials had more than two treatment arms, resulting in 59 comparisons. Analysis approaches (Mann Whitney U, ordinal logistic regression, multiple regression, bootstrapping) that used ordinal outcome data had a smaller average rank and therefore appeared to be more efficient statistically than those that analysed the original binary outcomes. Ordinal vascular outcome measures appear to be more efficient statistically than binary outcomes and provide information on the severity of event. We suggest a potential role for using ordinal outcomes in vascular prevention trials.
Publisher: Springer Science and Business Media LLC
Date: 2012
Publisher: SAGE Publications
Date: 26-11-2019
Abstract: To assess the clinical and cost-effectiveness of cognitive rehabilitation for attention and memory problems in people with multiple sclerosis. Multicentre, pragmatic, randomized controlled trial. Community People with multiple sclerosis aged 18–69 years, who reported cognitive problems in daily life and had cognitive problems on standardized assessment. A group cognitive rehabilitation programme delivered in 10 weekly sessions in comparison with usual care. The primary outcome was the Multiple Sclerosis Impact Scale Psychological subscale at 12 months after randomization. Secondary outcomes included measures of everyday memory problems, mood, fatigue, cognitive abilities and employment at 6 and 12 months after randomization. In all, 245 participants were allocated to cognitive rehabilitation and 204 to usual care. Mean Multiple Sclerosis Impact Scale Psychological at 12 months was 22.2 (SD = 6.1) for cognitive rehabilitation and 23.4 (SD = 6.0) for usual care group adjusted difference −0.6, 95% confidence interval (CI) = −1.5 to 0.3, P = 0.20. No differences were observed in cognitive abilities, fatigue or employment. There were small differences in favour of cognitive rehabilitation for the Multiple Sclerosis Impact Scale Psychological at 6 months and everyday memory and mood at 6 and 12 months. There was no evidence of an effect on costs (−£808 95% CI = −£2248 to £632) or on quality-adjusted life year gain (0.00 95% CI = −0.01 to 0.02). This rehabilitation programme had no long-term benefits on the impact of multiple sclerosis on quality of life, but there was some evidence of an effect on everyday memory problems and mood.
Publisher: Elsevier BV
Date: 2022
Publisher: Elsevier BV
Date: 02-2019
Publisher: Springer Science and Business Media LLC
Date: 03-08-2009
Publisher: Springer Science and Business Media LLC
Date: 06-01-2015
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2018
End Date: 2020
Funder: Medical Research Council
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