Determining the sample size for a cluster-randomised trial using knowledge elicitation: Bayesian hierarchical modelling of the intracluster correlation coefficient.

BACKGROUND: The intracluster correlation coefficient is a key input parameter for sample size determination in cluster-randomised trials. Sample size is very sensitive to small differences in the intracluster correlation coefficient, so it is vital to have a robust intracluster correlation coefficient estimate. This is often problematic because either a relevant intracluster correlation coefficient estimate is not available or the available estimate is imprecise due to being based on small-scale studies with low numbers of clusters. Misspecification may lead to an underpowered or inefficiently large and potentially unethical trial. METHODS: We apply a Bayesian approach to produce an intracluster correlation coefficient estimate and hence propose sample size for a planned cluster-randomised trial of the effectiveness of a systematic voiding programme for post-stroke incontinence. A Bayesian hierarchical model is used to combine intracluster correlation coefficient estimates from other relevant trials making use of the wealth of intracluster correlation coefficient information available in published research. We employ knowledge elicitation process to assess the relevance of each intracluster correlation coefficient estimate to the planned trial setting. The team of expert reviewers assigned relevance weights to each study, and each outcome within the study, hence informing parameters of Bayesian modelling. To measure the performance of experts, agreement and reliability methods were applied. RESULTS: The 34 intracluster correlation coefficient estimates extracted from 16 previously published trials were combined in the Bayesian hierarchical model using aggregated relevance weights elicited from the experts. The intracluster correlation coefficients available from external sources were used to construct a posterior distribution of the targeted intracluster correlation coefficient which was summarised as a posterior median with a 95% credible interval informing researchers about the range of plausible sample size values. The estimated intracluster correlation coefficient determined a sample size of between 450 (25 clusters) and 480 (20 clusters), compared to 500-600 from a classical approach. The use of quantiles, and other parameters, from the estimated posterior distribution is illustrated and the impact on sample size described. CONCLUSION: Accounting for uncertainty in an unknown intracluster correlation coefficient, trials can be designed with a more robust sample size. The approach presented provides the possibility of incorporating intracluster correlation coefficients from various cluster-randomised trial settings which can differ from the planned study, with the difference being accounted for in the modelling. By using expert knowledge to elicit relevance weights and synthesising the externally available intracluster correlation coefficient estimates, information is used more efficiently than in a classical approach, where the intracluster correlation coefficient estimates tend to be less robust and overly conservative. The intracluster correlation coefficient estimate constructed is likely to produce a smaller sample size on average than the conventional strategy of choosing a conservative intracluster correlation coefficient estimate. This may therefore result in substantial time and resources savings.

Interventions for treating urinary incontinence after stroke in adults.

BACKGROUND: Urinary incontinence can affect 40% to 60% of people admitted to hospital after a stroke, with 25% still having problems when discharged from hospital and 15% remaining incontinent after one year.This is an update of a review published in 2005 and updated in 2008. OBJECTIVES: To assess the effects of interventions for treating urinary incontinence after stroke in adults at least one-month post-stroke. SEARCH METHODS: We searched the Cochrane Incontinence and Cochrane Stroke Specialised Registers (searched 30 October 2017 and 1 November 2017 respectively), which contain trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearched journals and conference proceedings. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials. DATA COLLECTION AND ANALYSIS: Two review authors independently undertook data extraction, risk of bias assessment and implemented GRADE. MAIN RESULTS: We included 20 trials (reporting 21 comparisons) with 1338 participants. Data for prespecified outcomes were not available except where reported below.Intervention versus no intervention/usual careBehavioural interventions: Low-quality evidence suggests behavioural interventions may reduce the mean number of incontinent episodes in 24 hours (mean difference (MD) -1.00, 95% confidence interval (CI) -2.74 to 0.74; 1 trial; 18 participants; P = 0.26). Further, low-quality evidence from two trials suggests that behavioural interventions may make little or no difference to quality of life (SMD -0.99, 95% CI -2.83 to 0.86; 55 participants).Specialised professional input interventions: One trial of moderate-quality suggested structured assessment and management by continence nurse practitioners probably made little or no difference to the number of people continent three months after treatment (risk ratio (RR) 1.28, 95% CI 0.81 to 2.02; 121 participants; equivalent to an increase from 354 to 453 per 1000, 95% CI 287 to 715).Complementary therapy: Five trials assessed complementary therapy using traditional acupuncture, electroacupuncture and ginger-salt-partitioned moxibustion plus routine acupuncture. Low-quality evidence from five trials suggested that complementary therapy may increase the number of participants continent after treatment; participants in the treatment group were three times more likely to be continent (RR 2.82, 95% CI 1.57 to 5.07; 524 participants; equivalent to an increase from 193 to 544 per 1000, 95% CI 303 to 978). Adverse events were reported narratively in one study of electroacupuncture, reporting on bruising and postacupuncture abdominal pain in the intervention group.Physical therapy: Two trials reporting three comparisons suggest that physical therapy using transcutaneous electrical nerve stimulation (TENS) may reduce the mean number of incontinent episodes in 24 hours (MD -4.76, 95% CI -8.10 to -1.41; 142 participants; low-quality evidence). One trial of TENS reporting two comparisons found that the intervention probably improves overall functional ability (MD 8.97, 95% CI 1.27 to 16.68; 81 participants; moderate-quality evidence).Intervention versus placeboPhysical therapy: One trial of physical therapy suggests TPTNS may make little or no difference to the number of participants continent after treatment (RR 0.75, 95% CI 0.19 to 3.04; 54 participants) or number of incontinent episodes (MD -1.10, 95% CI -3.99 to 1.79; 39 participants). One trial suggested improvement in the TPTNS group at 26-weeks (OR 0.04, 95% CI 0.004 to 0.41) but there was no evidence of a difference in perceived bladder condition at six weeks (OR 2.33, 95% CI 0.63 to 8.65) or 12 weeks (OR 1.22, 95% CI 0.29 to 5.17). Data from one trial provided no evidence that TPTNS made a difference to quality of life measured with the ICIQLUTSqol (MD 3.90, 95% CI -4.25 to 12.05; 30 participants). Minor adverse events, such as minor skin irritation and ankle cramping, were reported in one study.Pharmacotherapy interventions: There was no evidence from one study that oestrogen therapy made a difference to the mean number of incontinent episodes per week in mild incontinence (paired samples, MD -1.71, 95% CI -3.51 to 0.09) or severe incontinence (paired samples, MD -6.40, 95% CI -9.47 to -3.33). One study reported no adverse events.Specific intervention versus another interventionBehavioural interventions: One trial comparing a behavioural intervention (timed voiding) with a pharmacotherapy intervention (oxybutynin) contained no useable data.Complementary therapy: One trial comparing different acupuncture needles and depth of needle insertion to assess the effect on incontinence reported that, after four courses of treatment, 78.1% participants in the elongated needle group had no incontinent episodes versus 40% in the filiform needle group (57 participants). This trial was assessed as unclear or high for all types of bias apart from incomplete outcome data.Combined intervention versus single interventionOne trial compared a combined intervention (sensory motor biofeedback plus timed prompted voiding) against a single intervention (timed voiding). The combined intervention may make little or no difference to the number of participants continent after treatment (RR 0.55, 95% CI 0.06 to 5.21; 23 participants; equivalent to a decrease from 167 to 92 per 1000, 95% CI 10 to 868) or to the number of incontinent episodes (MD 2.20, 95% CI 0.12 to 4.28; 23 participants).Specific intervention versus attention controlPhysical therapy interventions: One study found TPTNS may make little or no difference to the number of participants continent after treatment compared to an attention control group undertaking stretching exercises (RR 1.33, 95% CI 0.38 to 4.72; 24 participants; equivalent to an increase from 250 to 333 per 1000, 95% CI 95 to 1000). AUTHORS' CONCLUSIONS: There is insufficient evidence to guide continence care of adults in the rehabilitative phase after stroke. As few trials tested the same intervention, conclusions are drawn from few, usually small, trials. CIs were wide, making it difficult to ascertain if there were clinically important differences. Only four trials had adequate allocation concealment and many were limited by poor reporting, making it impossible to judge the extent to which they were prone to bias. More appropriately powered, multicentre trials of interventions are required to provide robust evidence for interventions to improve urinary incontinence after stroke.

Stroke survivors' and carers' experiences of a systematic voiding programme to treat urinary incontinence after stroke.

AIMS AND OBJECTIVES: To explore the views and experiences of stroke survivors and carers about a systematic voiding programme for poststroke incontinence. BACKGROUND: Urinary incontinence after stroke is common and associated with poorer functional outcome. Structured assessment and management are potentially effective interventions, but it is important that there is a good understanding of stroke survivors' and carers' views of their acceptability and implementation. DESIGN: A qualitative study within a feasibility trial. METHODS: Sixteen participants (12 stroke survivors and four carers) were interviewed using a structured schedule shortly before discharge from one of six inpatient stroke units across six hospitals. Interviews were audio-recorded and transcribed verbatim, and thematic analysis was conducted. FINDINGS: Participants included seven male and five female stroke survivors (mean age 76 years) and four female carers (two wives and two daughters). Themes relating to the preliminary (assessment) phase of the programme were as follows: physical impact, psychological impact, beliefs about incontinence, and the assessment process itself. Main themes relating to the implementation of the programme included the following: timed voiding decisions, adapting the programme or the timed voiding schedule, and urinary incontinence management techniques. Participants felt that the programme helped them to re-establish a regular pattern of micturition and to regain autonomy. CONCLUSIONS: The effectiveness of a systematic voiding programme may partly lie in its educational component, challenging patients' and carers' assumptions that poststroke incontinence is inevitable. Individual adaptation of the programme and the ability to incorporate it alongside other aspects of care are likely to be key factors influencing implementation. RELEVANCE TO CLINICAL PRACTICE: Urinary incontinence is common after stroke. To maximise benefits from a systematic voiding programme, nurses should support stroke survivors to overturn erroneous beliefs, to participate in tailoring of the programme, and in self-management where appropriate.

Client and clinical staff perceptions of barriers to and enablers of the uptake and delivery of behavioural interventions for urinary incontinence: qualitative evidence synthesis.

AIM: To evaluate factors influencing uptake and delivery of behavioural interventions for urinary incontinence from the perspective of clients and clinical staff. BACKGROUND: Behavioural interventions are recommended as first-line therapy for the management of urinary incontinence. Barriers to and enablers of uptake and delivery of behavioural interventions have not been reviewed. DESIGN: Qualitative evidence synthesis. DATA SOURCES: MEDLINE, EMBASE, CINAHL, PsychInfo, AMED (inception to May 2013); Proceedings of the International Continence Society (ICS) (2006-2013). REVIEW METHODS: Studies where data were collected from clients or staff about their experiences or perceptions of behavioural interventions were included. Two reviewers independently screened records on title and abstract. Full-text papers were obtained for records identified as potentially relevant by either reviewer. Two reviewers independently filtered all full-text papers for inclusion, extracted findings and critically appraised studies. We used an approach akin to Framework, using a matrix of pre-specified themes to classify the data and facilitate its presentation and synthesis. RESULTS: Seven studies involving 200 participants identified clients' views. Findings identified from at least one study of moderate quality included increased fear of accidents and convenience of treatment. Factors enabling participation included realistic goals and gaining control. Six studies involving 427 participants identified staff views. Findings identified from at least one study of moderate quality included staff education and perceptions of treatment effectiveness. Enabling factors included teamwork and experience of success. CONCLUSION: There is little detailed exploration of clients' experiences of, and responses to, behavioural interventions. Evidence for staff relates predominantly to prompted voiding in long-term residential care. Studies of the uptake and delivery of other behavioural interventions in other settings are warranted.

Repetitive task training for improving functional ability after stroke.

BACKGROUND: Repetitive task training (RTT) involves the active practice of task-specific motor activities and is a component of current therapy approaches in stroke rehabilitation. OBJECTIVES: Primary objective: To determine if RTT improves upper limb function/reach and lower limb function/balance in adults after stroke. Secondary objectives: 1) To determine the effect of RTT on secondary outcome measures including activities of daily living, global motor function, quality of life/health status and adverse events. 2) To determine the factors that could influence primary and secondary outcome measures, including the effect of 'dose' of task practice; type of task (whole therapy, mixed or single task); timing of the intervention and type of intervention. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (4 March 2016); the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 5: 1 October 2006 to 24 June 2016); MEDLINE (1 October 2006 to 8 March 2016); Embase (1 October 2006 to 8 March 2016); CINAHL (2006 to 23 June 2016); AMED (2006 to 21 June 2016) and SPORTSDiscus (2006 to 21 June 2016). SELECTION CRITERIA: Randomised/quasi-randomised trials in adults after stroke, where the intervention was an active motor sequence performed repetitively within a single training session, aimed towards a clear functional goal. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts, extracted data and appraised trials. We determined the quality of evidence within each study and outcome group using the Cochrane 'Risk of bias' tool and GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria. We did not assess follow-up outcome data using GRADE. We contacted trial authors for additional information. MAIN RESULTS: We included 33 trials with 36 intervention-control pairs and 1853 participants. The risk of bias present in many studies was unclear due to poor reporting; the evidence has therefore been rated 'moderate' or 'low' when using the GRADE system. There is low-quality evidence that RTT improves arm function (standardised mean difference (SMD) 0.25, 95% confidence interval (CI) 0.01 to 0.49; 11 studies, number of participants analysed = 749), hand function (SMD 0.25, 95% CI 0.00 to 0.51; eight studies, number of participants analysed = 619), and lower limb functional measures (SMD 0.29, 95% CI 0.10 to 0.48; five trials, number of participants analysed = 419). There is moderate-quality evidence that RTT improves walking distance (mean difference (MD) 34.80, 95% CI 18.19 to 51.41; nine studies, number of participants analysed = 610) and functional ambulation (SMD 0.35, 95% CI 0.04 to 0.66; eight studies, number of participants analysed = 525). We found significant differences between groups for both upper-limb (SMD 0.92, 95% CI 0.58 to 1.26; three studies, number of participants analysed = 153) and lower-limb (SMD 0.34, 95% CI 0.16 to 0.52; eight studies, number of participants analysed = 471) outcomes up to six months post treatment but not after six months. Effects were not modified by intervention type, dosage of task practice or time since stroke for upper or lower limb. There was insufficient evidence to be certain about the risk of adverse events. AUTHORS' CONCLUSIONS: There is low- to moderate-quality evidence that RTT improves upper and lower limb function; improvements were sustained up to six months post treatment. Further research should focus on the type and amount of training, including ways of measuring the number of repetitions actually performed by participants. The definition of RTT will need revisiting prior to further updates of this review in order to ensure it remains clinically meaningful and distinguishable from other interventions.

Implementing a Systematic Voiding Program for Patients With Urinary Incontinence After Stroke.

We explored health professionals' views of implementing a systematic voiding program (SVP) in a multi-site qualitative process evaluation in stroke services recruited to the intervention arms of a cluster randomized controlled feasibility trial during 2011-2013. We conducted semi-structured group or individual interviews with 38 purposively selected nursing, managerial, and care staff involved in delivering the SVP. Content analysis of transcripts used normalization process theory (NPT) as a pre-specified organization-level exploratory framework. Barriers to implementing the SVP included perceived lack of suitability for some patient groups, patient fear of extending hospital stay, and difficulties with SVP enactment, scheduling, timing, recording, and monitoring. Enablers included the guidance provided by the SVP, patient and relative involvement, extra staff, improved nursing skill and confidence, and experience of success. Three potential mechanisms of consistency, visibility, and individualization linked the SVP process with improvements in outcome, and should be emphasized in SVP implementation.

Assessing fidelity to treatment delivery in the ICONS (Identifying Continence OptioNs after Stroke) cluster randomised feasibility trial.

BACKGROUND: The implementation of strategies to monitor and enhance treatment fidelity is of paramount importance in trials of complex interventions. A recent framework published by the National Institutes of Health Behavior Change Consortium recommends addressing five areas of treatment fidelity, one of which is delivery of treatment. This study aimed to explore fidelity to treatment delivery of the ICONS intervention (a systematic voiding programme [SVP]). This included exploring the feasibility of a method to assess fidelity to treatment delivery and collecting preliminary evidence of the level of fidelity to SVP delivery in order to inform strategies for improving fidelity in a future trial. METHODS: Delivery of treatment was recorded by nurses through completion of daily clinical logs, which included: a voiding interval, proposed voiding times and actual voiding times. The a priori method for assessment of fidelity - comparing actual voiding times with proposed voiding times - was trialled on a small amount of data. Due to errors in documentation of the voiding intervals and proposed voiding times it was not possible to assess fidelity directly as planned. A new method was devised, which included identification of 'key quality indicators'. RESULTS: This new approach to assessing fidelity used key quality indicators based upon presence of the data needed to make the comparison between proposed and actual voiding times. The proportion of clinical logs with correct documentation of voiding intervals and proposed voiding times was less than 40 %. For clinical logs with correct documentation, an actual voiding time within 30 min of the proposed voiding time was identified on approximately 55 % of occasions. CONCLUSIONS: Lessons learnt from this study have implications for the future ICONS definitive trial and for other trials of complex interventions. Implementation of a complex intervention may often deviate from what is intended. While careful consideration should be given to the best method of fidelity assessment, an iterative approach allowing flexibility to adapt pre-planned methods is recommended within feasibility trials. As fidelity to treatment delivery in the ICONS feasibility trial appeared to be relatively low, more attention to implementation strategies will be required in the definitive trial. TRIAL REGISTRATION: Identifier: ISRCTN08609907 ; date registered: 07/07/2010.

Interventions to improve patient access to and utilisation of genetic and genomic counselling services.

This is the protocol for a review and there is no abstract. The objectives are as follows. PRIMARY OBJECTIVE: The primary objective is to assess the effectiveness of interventions to improve patient identification, access to and utilisation of genetic and genomic counselling services when compared to: No intervention;Usual or current practice; andOther active intervention. SECONDARY OBJECTIVE: The secondary objective is to explore the resource use and costs associated with interventions aimed at improving patient identification, access to and utilisation of genetic and genomic counselling services from studies meeting the eligibility criteria. We will report on factors that may explain variation in the effectiveness of interventions aimed at improving patient identification, access to and utilisation of genetic and genomic counselling services from studies meeting the eligibility criteria. Another secondary objective is to explore how interventions which target improved patient identification, access to and utilisation of genetic and genomic counselling services affect the subsequent appropriate use of health services for the prevention or early detection of disease. It is also possible that the genetic counselling interaction itself will contribute to the possible use of preventative services.

Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial.

BACKGROUND: Urinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients. METHODS: We conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4).Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death. RESULTS: It was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09).No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence. CONCLUSIONS: The trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.

Study protocol: ICONS: identifying continence options after stroke: a randomised trial.

BACKGROUND: Urinary incontinence following acute stroke is common, affecting between 40%-60% of people in hospital after a stroke. Despite the availability of clinical guidelines for urinary incontinence and urinary incontinence after stroke, national audit data suggest incontinence is often poorly managed. Conservative interventions (e.g. bladder training, pelvic floor muscle training and prompted voiding) have been shown to have some effect with participants in Cochrane systematic reviews, but have not had their effectiveness demonstrated with stroke patients. METHODS/DESIGN: A cluster randomised controlled pilot trial designed to assess the feasibility of a full-scale cluster randomised trial and to provide preliminary evidence of the effectiveness and cost-effectiveness of a systematic voiding programme for the management of continence after stroke. Stroke services will be randomised to receive the systematic voiding programme, the systematic voiding programme plus supported implementation, or usual care. The trial aims to recruit at least 780 participants in 12 stroke services (4 per arm). The primary outcome is presence/absence of incontinence at six weeks post-stroke. Secondary outcomes include frequency and severity of incontinence, quality of life and cost-utility. Outcomes will be measured at six weeks, three months and (for participants recruited in the first three months) twelve months after stroke. Process data will include rates of recruitment and retention and fidelity of intervention delivery. An integrated qualitative evaluation will be conducted in order to describe implementation and assist in explaining the potential mediators and modifiers of the process. TRIAL REGISTRATION: ISRCTN: ISRCTN08609907

What can management theories offer evidence-based practice? A comparative analysis of measurement tools for organisational context.

BACKGROUND: Given the current emphasis on networks as vehicles for innovation and change in health service delivery, the ability to conceptualize and measure organisational enablers for the social construction of knowledge merits attention. This study aimed to develop a composite tool to measure the organisational context for evidence-based practice (EBP) in healthcare. METHODS: A structured search of the major healthcare and management databases for measurement tools from four domains: research utilisation (RU), research activity (RA), knowledge management (KM), and organisational learning (OL). Included studies were reports of the development or use of measurement tools that included organisational factors. Tools were appraised for face and content validity, plus development and testing methods. Measurement tool items were extracted, merged across the four domains, and categorised within a constructed framework describing the absorptive and receptive capacities of organisations. RESULTS: Thirty measurement tools were identified and appraised. Eighteen tools from the four domains were selected for item extraction and analysis. The constructed framework consists of seven categories relating to three core organisational attributes of vision, leadership, and a learning culture, and four stages of knowledge need, acquisition of new knowledge, knowledge sharing, and knowledge use. Measurement tools from RA or RU domains had more items relating to the categories of leadership, and acquisition of new knowledge; while tools from KM or learning organisation domains had more items relating to vision, learning culture, knowledge need, and knowledge sharing. There was equal emphasis on knowledge use in the different domains. CONCLUSION: If the translation of evidence into knowledge is viewed as socially mediated, tools to measure the organisational context of EBP in healthcare could be enhanced by consideration of related concepts from the organisational and management sciences. Comparison of measurement tools across domains suggests that there is scope within EBP for supplementing the current emphasis on human and technical resources to support information uptake and use by individuals. Consideration of measurement tools from the fields of KM and OL shows more content related to social mechanisms to facilitate knowledge recognition, translation, and transfer between individuals and groups.