ORCID Profile
0000-0002-1039-5646
Current Organisations
Norwegian University of Life Sciences
,
University of Aberdeen
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Publisher: Springer Science and Business Media LLC
Date: 16-08-2012
Publisher: Elsevier BV
Date: 11-2022
DOI: 10.1016/J.EUF.2022.06.001
Abstract: Patient factors associated with urinary tract cancer can be used to risk stratify patients referred with haematuria, prioritising those with a higher risk of cancer for prompt investigation. To develop a prediction model for urinary tract cancer in patients referred with haematuria. A prospective observational study was conducted in 10 282 patients from 110 hospitals across 26 countries, aged ≥16 yr and referred to secondary care with haematuria. Patients with a known or previous urological malignancy were excluded. The primary outcomes were the presence or absence of urinary tract cancer (bladder cancer, upper tract urothelial cancer [UTUC], and renal cancer). Mixed-effect multivariable logistic regression was performed with site and country as random effects and clinically important patient-level candidate predictors, chosen a priori, as fixed effects. Predictors were selected primarily using clinical reasoning, in addition to backward stepwise selection. Calibration and discrimination were calculated, and bootstrap validation was performed to calculate optimism. The unadjusted prevalence was 17.2% (n = 1763) for bladder cancer, 1.20% (n = 123) for UTUC, and 1.00% (n = 103) for renal cancer. The final model included predictors of increased risk (visible haematuria, age, smoking history, male sex, and family history) and reduced risk (previous haematuria investigations, urinary tract infection, dysuria/suprapubic pain, anticoagulation, catheter use, and previous pelvic radiotherapy). The area under the receiver operating characteristic curve of the final model was 0.86 (95% confidence interval 0.85-0.87). The model is limited to patients without previous urological malignancy. This cancer prediction model is the first to consider established and novel urinary tract cancer diagnostic markers. It can be used in secondary care for risk stratifying patients and aid the clinician's decision-making process in prioritising patients for investigation. We have developed a tool that uses a person's characteristics to determine the risk of cancer if that person develops blood in the urine (haematuria). This can be used to help prioritise patients for further investigation.
Publisher: Wiley
Date: 08-09-2021
DOI: 10.1111/BJU.15483
Abstract: To evaluate the contemporary prevalence of urinary tract cancer (bladder cancer, upper tract urothelial cancer [UTUC] and renal cancer) in patients referred to secondary care with haematuria, adjusted for established patient risk markers and geographical variation. This was an international multicentre prospective observational study. We included patients aged ≥16 years, referred to secondary care with suspected urinary tract cancer. Patients with a known or previous urological malignancy were excluded. We estimated the prevalence of bladder cancer, UTUC, renal cancer and prostate cancer stratified by age, type of haematuria, sex, and smoking. We used a multivariable mixed‐effects logistic regression to adjust cancer prevalence for age, type of haematuria, sex, smoking, hospitals, and countries. Of the 11 059 patients assessed for eligibility, 10 896 were included from 110 hospitals across 26 countries. The overall adjusted cancer prevalence ( n = 2257) was 28.2% (95% confidence interval [CI] 22.3–34.1), bladder cancer ( n = 1951) 24.7% (95% CI 19.1–30.2), UTUC ( n = 128) 1.14% (95% CI 0.77–1.52), renal cancer ( n = 107) 1.05% (95% CI 0.80–1.29), and prostate cancer ( n = 124) 1.75% (95% CI 1.32–2.18). The odds ratios for patient risk markers in the model for all cancers were: age 1.04 (95% CI 1.03–1.05 P 0.001), visible haematuria 3.47 (95% CI 2.90–4.15 P 0.001), male sex 1.30 (95% CI 1.14–1.50 P 0.001), and smoking 2.70 (95% CI 2.30–3.18 P 0.001). A better understanding of cancer prevalence across an international population is required to inform clinical guidelines. We are the first to report urinary tract cancer prevalence across an international population in patients referred to secondary care, adjusted for patient risk markers and geographical variation. Bladder cancer was the most prevalent disease. Visible haematuria was the strongest predictor for urinary tract cancer.
Publisher: Massachusetts Medical Society
Date: 05-09-2019
Publisher: JMIR Publications Inc.
Date: 17-06-2019
Abstract: elapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. his study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. e will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. ecruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. he knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, s le size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. nternational Standard Randomized Controlled Trial Number (ISRCTN): 99559262 isrctn.com/ISRCTN99559262
Publisher: Springer Science and Business Media LLC
Date: 04-07-2019
Publisher: Springer Science and Business Media LLC
Date: 06-01-2016
Publisher: Springer Science and Business Media LLC
Date: 24-07-2014
Publisher: National Institute for Health and Care Research
Date: 04-2015
DOI: 10.3310/HTA19270
Abstract: Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term. To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins. A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation. Eleven UK specialist vascular centres. Seven hundred and ninety-eight patients with primary varicose veins (foam, n = 292 surgery, n = 294 EVLA, n = 212). Patients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres). Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. Quality of life at 6 weeks residual varicose veins Venous Clinical Severity Score (VCSS) complication rates return to normal activity truncal vein ablation rates and costs. The results appear generalisable in that participants’ baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size −1.74, 95% confidence interval (CI) −2.97 to −0.50 p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06 p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈ 5%). With regard to secondary outcomes, health gains at 6 weeks ( p 0.005) were greater for EVLA than for foam (EQ-5D, p = 0.004). There were fewer procedural complications in the EVLA group (1%) than after foam (7%) and surgery (8%) ( p 0.001). Participants returned to a wide range of behaviours more quickly following foam or EVLA than following surgery ( p 0.05). There were no differences in VCSS between the three treatments. Truncal ablation rates were higher for surgery ( p 0.001) and EVLA ( p 0.001) than for foam, and were similar for surgery and EVLA. Considerations of both the 6-month clinical outcomes and the estimated 5-year cost-effectiveness suggest that EVLA should be considered as the treatment of choice for suitable patients. Five-year trial results are currently being evaluated to compare the cost-effectiveness of foam, surgery and EVLA, and to determine the recurrence rates following each treatment. This trial has highlighted the need for long-term outcome data from RCTs on QoL, recurrence rates and costs for foam sclerotherapy and other endovenous techniques compared against each other and against surgery. Current Controlled Trials ISRCTN51995477. 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. 19, No. 27. See the NIHR Journals Library website for further project information.
Publisher: Elsevier BV
Date: 07-2012
DOI: 10.1016/J.JCLINEPI.2011.11.010
Abstract: To evaluate which of two invitation methods, e-mail or post, was most effective at recruiting general practitioners (GPs) to an online trial. Randomized controlled trial. Participants were GPs in Scotland, United Kingdom. Two hundred and seventy GPs were recruited. Using e-mail did not improve recruitment (risk difference=0.7% [95% confidence interval -2.7% to 4.1%]). E-mail was, however, simpler to use and cheaper, costing £3.20 per recruit compared with £15.69 for postal invitations. Reminders increased recruitment by around 4% for each reminder sent for both invitation methods. In the Scottish context, inviting GPs to take part in an online trial by e-mail does not adversely affect recruitment and is logistically easier and cheaper than using postal invitations.
Publisher: Springer Science and Business Media LLC
Date: 2013
DOI: 10.1186/CC13096
Publisher: Wiley
Date: 11-02-2022
DOI: 10.1111/GCB.16060
Abstract: Research in global change ecology relies heavily on global climatic grids derived from estimates of air temperature in open areas at around 2 m above the ground. These climatic grids do not reflect conditions below vegetation canopies and near the ground surface, where critical ecosystem functions occur and most terrestrial species reside. Here, we provide global maps of soil temperature and bioclimatic variables at a 1-km
Publisher: Elsevier BV
Date: 09-2021
Publisher: Springer Science and Business Media LLC
Date: 12-2019
DOI: 10.1186/S13063-019-3723-7
Abstract: Urinary incontinence (UI) is highly prevalent in nursing and residential care homes (CHs) and profoundly impacts on residents’ dignity and quality of life. CHs predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe and low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in CHs is not known. The ELECTRIC trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in CH residents and investigate the associated costs and consequences. This is a pragmatic, multicentre, placebo-controlled, randomised parallel-group trial comparing the effectiveness of TPTNS (target n = 250) with sham stimulation (target n = 250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff-reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-h Pad Weight Tests, post void residual urine (bladder scans), Patient Perception of Bladder Condition, Minnesota Toileting Skills Questionnaire and Dementia Quality of Life. Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors, and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers. TPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication. ClinicalTrials.gov, NCT03248362 . Registered on 14 August 2017. ISRCTN, ISRCTN98415244 . Registered on 25 April 2018.
Publisher: Elsevier BV
Date: 08-2019
Publisher: Oxford University Press (OUP)
Date: 25-01-2016
DOI: 10.1002/BJS.10081
Abstract: The aim of this study was to assess behavioural recovery from the patient's perspective as a prespecified secondary outcome in a multicentre parallel-group randomized clinical trial comparing ultrasound-guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA) and surgery for the treatment of primary varicose veins. Participants were recruited from 11 UK sites as part of the CLASS trial, a randomized trial of UGFS, EVLA or surgery for varicose veins. Patients were followed up 6 weeks after treatment and asked to complete the Behavioural Recovery After treatment for Varicose Veins (BRAVVO) questionnaire. This is a 15-item instrument that covers eight activity behaviours (tasks or actions an in idual is capable of doing in an idealized situation) and seven participation behaviours (what the in idual does in an everyday, real-world situation) that were identified to be important from the patient's perspective. A total of 798 participants were recruited. Both UGFS and EVLA resulted in a significantly quicker recovery compared with surgery for 13 of the 15 behaviours assessed. UGFS was superior to EVLA in terms of return to full-time work (hazard ratio 1·43, 95 per cent c.i. 1·11 to 1·85), looking after children (1·45, 1·04 to 2·02) and walks of short (1·48, 1·19 to 1·84) and longer (1·32, 1·05 to 1·66) duration. Both UGFS and EVLA resulted in more rapid recovery than surgery, and UGFS was superior to EVLA for one-quarter of the behaviours assessed. The BRAVVO questionnaire has the potential to provide important meaningful information to patients about their early recovery and what they may expect to be able to achieve after treatment.
Publisher: Cambridge University Press (CUP)
Date: 2005
DOI: 10.1017/S0266462305290190
Abstract: Objectives: A systematic review of the effectiveness and costs of different guideline development, dissemination, and implementation strategies wasundertaken. The resource implications of these strategies was estimated, and a framework for deciding when it is efficient to develop and introduce clinical guidelines was developed.
Publisher: National Institute for Health and Care Research
Date: 04-2014
DOI: 10.3310/HTA18250
Publisher: Springer Science and Business Media LLC
Date: 03-03-2011
Publisher: Springer Science and Business Media LLC
Date: 23-08-2010
Publisher: National Institute for Health and Care Research
Date: 05-2022
DOI: 10.3310/AWOI5587
Abstract: The role of fractional exhaled nitric oxide in guiding asthma treatment in children is uncertain. To compare treatment guided by both fractional exhaled nitric oxide and symptoms (intervention) with treatment guided by symptoms alone (standard care) in children with asthma who are at risk of an asthma exacerbation, in terms of the number of asthma exacerbations over 12 months. This was a pragmatic, multicentre, randomised controlled trial with embedded cost-effectiveness and qualitative process evaluations. Randomisation (1 : 1) was carried out using a remote web-based system and was minimised on recruitment centre, age, sex and British Thoracic Society treatment step. Clinical teams and participants were not blind to treatment allocation. The trial took place in 35 hospitals and seven primary care practices in the UK. Children aged 6–15 years with a diagnosis of asthma who were currently prescribed inhaled corticosteroids and who had one or more parent- atient-reported asthma exacerbation treated with oral corticosteroids in the 12 months prior to recruitment. Asthma treatment guided by symptoms alone (standard care) and asthma treatment guided by symptoms plus fractional exhaled nitric oxide (intervention). Treatment recommendations in both groups were protocolised within a web-based algorithm, incorporating inhaled corticosteroid adherence (objectively measured using an electronic logging device) and current treatment. The primary outcome measure was asthma exacerbations treated with oral corticosteroids in the year post randomisation. Secondary outcomes included time to first exacerbation, number of exacerbations, lung function, fractional exhaled nitric oxide, daily dose of inhaled corticosteroid, asthma control and quality of life. In total, 509 eligible participants were recruited and the primary outcome was available for 506 participants. The primary outcome occurred in 123 out of 255 (48.2%) participants in the intervention group and 129 out of 251 (51.4%) participants in the standard-care group (adjusted odds ratio 0.88, 95% confidence interval 0.61 to 1.27). There was algorithm non-compliance on 21% of assessments. Per-protocol and complier-average causal effect analysis did not change the interpretation. This non-statistically significant estimate was consistent across predefined subgroups. There were no differences between the groups in secondary outcomes. There were no serious adverse events or deaths. No meaningful differences in health service costs, direct patient costs or indirect costs to society were identified between the groups. The economic evaluation does not provide evidence to support the cost-effectiveness of the intervention. In the qualitative process evaluation, 15 trial staff and six families were interviewed. Overall, their experiences were positive. The intervention was broadly acceptable, with caveats around clinicians using the algorithm recommendation as a guide and wariness around extreme step ups/downs in treatment in the light of contextual factors not being taken into account by the algorithm. Potential limitations included the choice of cut-off point to define uncontrolled asthma and the change in fractional exhaled nitric oxide to trigger a change in treatment. Furthermore, the treatment decisions in the two groups may not have been sufficiently different to create a difference in outcomes. The RAACENO (Reducing Asthma Attacks in Children using Exhaled Nitric Oxide) trial findings do not support the routine use of fractional exhaled nitric oxide measurements as part of asthma management in a secondary care setting. The potential for other objective markers to guide asthma management in children needs to be evaluated. This trial was registered as ISRCTN67875351. This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and National Institute for Health and Care Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation Vol. 9, No. 4. See the NIHR Journals Library website for further project information.
Publisher: SAGE Publications
Date: 27-03-2020
Abstract: There is increasing evidence that access to critical care services is not equitable. We aimed to investigate whether location of residence in Scotland impacts on the risk of admission to an Intensive Care Unit and on outcomes. This was a population-based Bayesian spatial analysis of adult patients admitted to Intensive Care Units in Scotland between January 2011 and December 2015. We used a Besag–York–Mollié model that allows us to make direct probabilistic comparisons between areas regarding risk of admission to Intensive Care Units and on outcomes. A total of 17,596 patients were included. The five-year age- and sex-standardised admission rate was 352 per 100,000 residents. There was a cluster of Council Areas in the North-East of the country which had lower adjusted admission rates than the Scottish average. Midlothian, in South East Scotland had higher spatially adjusted admission rates than the Scottish average. There was no evidence of geographical variation in mortality. Access to critical care services in Scotland varies with location of residence. Possible reasons include differential co-morbidity burden, service provision and access to critical care services. In contrast, the probability of surviving an Intensive Care Unit admission, if admitted, does not show geographical variation.
Publisher: Elsevier BV
Date: 06-2022
Publisher: Elsevier BV
Date: 03-2014
DOI: 10.1016/J.JCLINEPI.2013.09.015
Abstract: To evaluate the robustness of the intervention modeling experiment (IME) methodology as a way of developing and testing behavioral change interventions before a full-scale trial by replicating an earlier paper-based IME. Web-based questionnaire and clinical scenario study. General practitioners across Scotland were invited to complete the questionnaire and scenarios, which were then used to identify predictors of antibiotic-prescribing behavior. These predictors were compared with the predictors identified in an earlier paper-based IME and used to develop a new intervention. Two hundred seventy general practitioners completed the questionnaires and scenarios. The constructs that predicted simulated behavior and intention were attitude, perceived behavioral control, risk perception/anticipated consequences, and self-efficacy, which match the targets identified in the earlier paper-based IME. The choice of persuasive communication as an intervention in the earlier IME was also confirmed. Additionally, a new intervention, an action plan, was developed. A web-based IME replicated the findings of an earlier paper-based IME, which provides confidence in the IME methodology. The interventions will now be evaluated in the next stage of the IME, a web-based randomized controlled trial.
Publisher: Springer Science and Business Media LLC
Date: 04-08-2022
Publisher: Springer Science and Business Media LLC
Date: 27-03-2018
Publisher: Springer Science and Business Media LLC
Date: 29-05-2008
Publisher: Springer Science and Business Media LLC
Date: 12-2016
Publisher: National Institute for Health and Care Research
Date: 06-2021
DOI: 10.3310/HTA25410
Abstract: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents’ dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. A total of 37 UK residential and nursing care homes. Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. Residents were randomised (1 : 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. Primary outcome – change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes – number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197 sham stimulation, n = 209) two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation, n = 167 sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of –5 ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and –66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants’ scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost–consequences analysis however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context. Completing 24-hour pad collections was challenging for care home staff, resulting in some missing primary outcome data. Research should investigate transcutaneous posterior tibial nerve stimulation in residents with urgency urinary incontinence to determine whether or not targeted stimulation is effective. Research should evaluate the effects of continence training for staff on continence care in care homes. Current Controlled Trials ISRCTN98415244 and ClinicalTrials.gov NCT03248362. 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. 25, No. 41. See the NIHR Journals Library website for further project information.
Publisher: JMIR Publications Inc.
Date: 09-01-2020
DOI: 10.2196/15058
Abstract: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, s le size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. International Standard Randomized Controlled Trial Number (ISRCTN): 99559262 isrctn.com/ISRCTN99559262 DERR1-10.2196/15058
Publisher: Wiley
Date: 23-09-2013
DOI: 10.1111/BJHP.12066
Abstract: Behaviour change interventions often target 'important' beliefs. The literature proposes four methods for assessing importance of attitudinal beliefs: elicitation frequency, importance ratings, and strength of prediction (bivariate and multivariate). We tested congruence between these methods in a Delphi study about selective decontamination of the digestive tract (SDD). SDD improves infection rates among critically ill patients, yet uptake in intensive care units is low internationally. A Delphi study involved three iterations ('rounds'). Participants were 105 intensive care clinicians in the United Kingdom, Canada, and Australia/New Zealand. In Round 1, semi-structured interviews were conducted to elicit beliefs about delivering SDD. In Rounds 2 and 3, participants completed questionnaires, rating agreement and importance for each belief-statement (9-point Likert scales). Belief importance was assessed using elicitation frequency, mean importance ratings, and prediction of global attitude (Pearson's correlations beta-weights). Correlations between indices were computed. Participants generated 14 attitudinal beliefs. Indices had adequate variation (frequencies: 4-94, mean importance ratings: 4.93-8.00, Pearson's correlations: ± 0.09 to ± 0.54, beta-weights: ± 0.01 to ± 0.30). SDD increases antibiotic resistance was the most important belief according to three methods and was ranked second by beta-weights (behind Overall, SDD benefits patients to whom it is delivered). Spearman's correlations were significant for importance ratings with frequencies and correlations. However, other indices were unrelated. The top four beliefs differed according to the measure used. Results provided evidence of congruence across three methods for assessing belief importance. Beta-weights were unrelated to other indices, suggesting that they may not be appropriate as the sole method. What is already known on this subject? Attitudinal beliefs (specific beliefs about the consequences of performing an action) are key to designing interventions to change intentions and behaviour. The literature reports four methods for assessing the importance of attitudinal beliefs: frequency of elicitation in interviews, importance ratings in questionnaires, and strength of prediction (bivariate and multivariate) of global attitude scores. The congruence between these measures of importance is not known. What does this study add? Four indices of importance were examined in a multi-professional, international study about the use of selective digestive decontamination to prevent infection in intensive care settings. Three indices were correlated with one another. Each method used to assess importance produced a different subset of the most important beliefs. Selection of the most important beliefs should use multiple assessment methods. This evidence suggests that multiple regression approaches may not be appropriate as the sole method for assessing belief importance.
Publisher: National Institute for Health and Care Research
Date: 04-2020
DOI: 10.3310/HTA24200
Abstract: Late-stage medial compartment knee osteoarthritis can be treated using total knee replacement or partial (unicompartmental) knee replacement. There is high variation in treatment choice and insufficient evidence to guide selection. To assess the clinical effectiveness and cost-effectiveness of partial knee replacement compared with total knee replacement in patients with medial compartment knee osteoarthritis. The findings are intended to guide surgical decision-making for patients, surgeons and health-care providers. This was a randomised, multicentre, pragmatic comparative effectiveness trial that included an expertise component. The target s le size was 500 patients. A web-based randomisation system was used to allocate treatments. Twenty-seven NHS hospitals (68 surgeons). Patients with medial compartment knee osteoarthritis. The trial compared the overall management strategy of partial knee replacement treatment with total knee replacement treatment. No specified brand or subtype of implant was investigated. The Oxford Knee Score at 5 years was the primary end point. Secondary outcomes included activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite ‘failure’ – defined by minimal Oxford Knee Score improvement and/or reoperation). Cost-effectiveness was also assessed. A total of 528 patients were randomised (partial knee replacement, n = 264 total knee replacement, n = 264). The follow-up primary outcome response rate at 5 years was 88% and both operations had good outcomes. There was no significant difference between groups in mean Oxford Knee Score at 5 years (difference 1.04, 95% confidence interval –0.42 to 2.50). An area under the curve analysis of the Oxford Knee Score at 5 years showed benefit in favour of partial knee replacement over total knee replacement, but the difference was within the minimal clinically important difference [mean 36.6 (standard deviation 8.3) ( n = 233), mean 35.1 (standard deviation 9.1) ( n = 231), respectively]. Secondary outcome measures showed consistent patterns of benefit in the direction of partial knee replacement compared with total knee replacement although most differences were small and non-significant. Patient-reported improvement (transition) and reflection (would you have the operation again?) showed statistically significant superiority for partial knee replacement only, but both of these variables could be influenced by the lack of blinding. The frequency of reoperation (including revision) by treatment received was similar for both groups: 22 out of 245 for partial knee replacement and 28 out of 269 for total knee replacement patients. Revision rates at 5 years were 10 out of 245 for partial knee replacement and 8 out of 269 for total knee replacement. There were 28 ‘failures’ of partial knee replacement and 38 ‘failures’ of total knee replacement (as defined by composite outcome). Beyond 1 year, partial knee replacement was cost-effective compared with total knee replacement, being associated with greater health benefits (measured using quality-adjusted life-years) and lower health-care costs, reflecting lower costs of the index surgery and subsequent health-care use. It was not possible to blind patients in this study and there was some non-compliance with the allocated treatment interventions. Surgeons providing partial knee replacement were relatively experienced with the procedure. Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates. Some patient-reported measures of treatment approval were significantly higher for partial knee replacement than for total knee replacement. Partial knee replacement was more cost-effective (more effective and cost saving) than total knee replacement at 5 years. Further (10-year) follow-up is in progress to assess the longer-term stability of these findings. Current Controlled Trials ISRCTN03013488 and ClinicalTrials.gov NCT01352247. 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. 24, No. 20. See the NIHR Journals Library website for further project information.
Publisher: National Institute for Health and Care Research
Date: 05-2022
DOI: 10.3310/HLZE0479
Abstract: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. Glasgow, UK, and Melbourne, Australia. Service users were aged 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use and had a positive impact on motivations and intentions in relation to mental health. Actual app usage was high, with 91% of users who completed the baseline period meeting our a priori criterion of acceptable engagement ( 33%). The median time to discontinuation of 33% app usage was 32 weeks (95% confidence interval 14 weeks to ∞). There were 8 out of 33 (24%) relapses in the EMPOWER arm and 13 out of 28 (46%) in the treatment-as-usual arm. Fewer participants in the EMPOWER arm had a relapse (relative risk 0.50, 95% confidence interval 0.26 to 0.98), and time to first relapse (hazard ratio 0.32, 95% confidence interval 0.14 to 0.74) was longer in the EMPOWER arm than in the treatment-as-usual group. At 12 months, EMPOWER participants were less fearful of having a relapse than those in the treatment-as-usual arm (mean difference –4.29, 95% confidence interval –7.29 to –1.28). EMPOWER was more costly and more effective, resulting in an incremental cost-effectiveness ratio of £3041. This incremental cost-effectiveness ratio would be considered cost-effective when using the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. This was a feasibility study and the outcomes detected cannot be taken as evidence of efficacy or effectiveness. A trial of digital technology to monitor early warning signs that blended with peer support and clinical triage to detect and prevent relapse is feasible. A main trial with a s le size of 500 (assuming 90% power and 20% dropout) would detect a clinically meaningful reduction in relapse (relative risk 0.7) and improvement in other variables (effect sizes 0.3–0.4). This trial is registered as ISRCTN99559262. This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 26, No. 27. See the NIHR Journals Library website for further project information. Funding in Australia was provided by the National Health and Medical Research Council (APP1095879).
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2015
End Date: 2019
Funder: National Health and Medical Research Council
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