Consent processes in cluster-randomised trials in residential facilities for older adults : a systematic review of reporting practices and proposed guidelines

Objective: To assess the quality of reported consent processes of cluster-randomised trials conducted in residential facilities for older people and to explore whether the focus on improving the general conduct and reporting of cluster-randomised trials influenced the quality of conduct and reporting of ethical processes in these trials. Design: Systematic review of cluster-randomised trials reports, published up to the end of 2010. Data sources: National Library of Medicine (Medline) via PubMed, hand-searches of BMJ, Journal of the American Medical Association, BMC Health Services Research, Age and Ageing and Journal of the American Geriatrics Society, reference search in Web of Knowledge and consultation with experts. Eligibility for selecting studies: Published cluster-randomised trials where the unit of randomisation is a part or the whole of a residential facility for older people, without language or year of publication restrictions. Results: We included 73 trials. Authors reported ethical approval in 59, obtaining individual consent in 51, and using proxies for this consent in 37, but the process to assess residents’ capacity to consent was clearly reported in only eight. We rated only six trials high for the quality of consent processes. We considered that individual informed consent could have been waived legitimately in 14 of 22 trials not reporting obtaining consent. The proportions reporting ethical approval and quality of consent processes were higher in recent trials. Conclusions: Recently published international recommendations regarding ethical conduct in cluster-randomised trials are much needed. In relation to consent processes when cognitively impaired individuals are included in these trials, we provide a six-point checklist and recommend the minimum information to be reported. Those who lack capacity in trials with complex designs should be afforded the same care in relation to consent as competent adults in trials with simpler designs

Cascade diagrams for depicting complex interventions in randomised trials

Clarity about how trial interventions are delivered is important for researchers and those who might want to use their results. A new graphical representation aims to help make complex interventions clearer. Many medical interventions—particularly non-pharmacological ones—are complex, consisting of multiple interacting components targeted at different organisational levels. Published descriptions of complex interventions often do not contain enough detail to enable their replication. Reports of behaviour change interventions should include descriptions of setting, mode, intensity, and duration, and characteristics of the participants. Graphical methods, such as that showing the relative timing of assessments and intervention components, may improve clarity of reporting. However, these approaches do not reveal the connections between the different “actors” in a complex intervention.8 Different audiences may want different things from a description of an intervention, but visualising relationships between actors can clarify crucial features such as the fidelity with which the intervention is passed down a chain of actors and possible routes of contamination between treatment arms. Here we describe a new graphical approach—the cascade diagram—that highlights these potential problems

A review of methodology for sample size calculations in cluster randomised trials

PMCID: PMC3287737This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.PMCID: PMC3287737PMCID: PMC3287737PMCID: PMC3287737PMCID: PMC3287737PMCID: PMC3287737PMCID: PMC328773

Multilevel survival analysis of health inequalities in life expectancy

<p>Abstract</p> <p>Background</p> <p>The health status of individuals is determined by multiple factors operating at both micro and macro levels and the interactive effects of them. Measures of health inequalities should reflect such determinants explicitly through sources of levels and combining mean differences at group levels and the variation of individuals, for the benefits of decision making and intervention planning. Measures derived recently from marginal models such as beta-binomial and frailty survival, address this issue to some extent, but are limited in handling data with complex structures. Beta-binomial models were also limited in relation to measuring inequalities of life expectancy (LE) directly.</p> <p>Methods</p> <p>We propose a multilevel survival model analysis that estimates life expectancy based on survival time with censored data. The model explicitly disentangles total health inequalities in terms of variance components of life expectancy compared to the source of variation at the level of individuals in households and parishes and so on, and estimates group differences of inequalities at the same time. Adjusted distributions of life expectancy by gender and by household socioeconomic level are calculated. Relative and absolute health inequality indices are derived based on model estimates. The model based analysis is illustrated on a large Swedish cohort of 22,680 men and 26,474 women aged 6569 in 1970 and followed up for 30 years. Model based inequality measures are compared to the conventional calculations.</p> <p>Results</p> <p>Much variation of life expectancy is observed at individual and household levels. Contextual effects at Parish and Municipality level are negligible. Women have longer life expectancy than men and lower inequality. There is marked inequality by the level of household socioeconomic status measured by the median life expectancy in each socio-economic group and the variation in life expectancy within each group.</p> <p>Conclusion</p> <p>Multilevel survival models are flexible and efficient tools in studying health inequalities of life expectancy or survival time data with a geographic structure of more than 2 levels. They are complementary to conventional methods and override some limitations of marginal models. Future research on determinants of health inequalities in the LE of the specific cohort on the household and individual factors could reveal some important causes over the marked household level inequalities.</p

Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS)

Introduction: Chronic musculoskeletal pain is a common condition that often responds poorly to treatment. Self-management courses have been advocated as a non-drug pain management technique, although evidence for their effectiveness is equivocal. We designed and piloted a self-management course based on evidence for effectiveness for specific course components and characteristics. Methods/analysis: COPERS (coping with persistent pain, effectiveness research into self-management) is a pragmatic randomised controlled trial testing the effectiveness and cost-effectiveness of an intensive, group, cognitive behavioural-based, theoretically informed and manualised self-management course for chronic pain patients against a control of best usual care: a pain education booklet and a relaxation CD. The course lasts for 15 h, spread over 3 days, with a –2 h follow-up session 2 weeks later. We aim to recruit 685 participants with chronic musculoskeletal pain from primary, intermediate and secondary care services in two UK regions. The study is powered to show a standardised mean difference of 0.3 in the primary outcome, pain-related disability. Secondary outcomes include generic health-related quality of life, healthcare utilisation, pain self-efficacy, coping, depression, anxiety and social engagement. Outcomes are measured at 6 and 12 months postrandomisation. Pain self-efficacy is measured at 3 months to assess whether change mediates clinical effect. Ethics/dissemination: Ethics approval was given by Cambridgeshire Ethics 11/EE/046. This trial will provide robust data on the effectiveness and cost-effectiveness of an evidence-based, group self-management programme for chronic musculoskeletal pain. The published outcomes will help to inform future policy and practice around such self-management courses, both nationally and internationally. Trial registration: ISRCTN24426731

Cost-effectiveness of Identification and Referral to Improve Safety (IRIS), a domestic violence training and support programme for primary care: a modelling study based on a randomised controlled trial

OBJECTIVE: The Identification and Referral to Improve Safety (IRIS) cluster randomised controlled trial tested the effectiveness of a training and support intervention to improve the response of primary care to women experiencing domestic violence (DV). The aim of this study is to estimate the cost-effectiveness of this intervention. DESIGN: Markov model-based cost-effectiveness analysis. SETTING: General practices in two urban areas in the UK. PARTICIPANTS: Simulated female individuals from the general UK population who were registered at general practices, aged 16 years and older. INTERVENTION: General practices received staff training, prompts to ask women about DV embedded in the electronic medical record, a care pathway including referral to a specialist DV agency and continuing contact from that agency. The trial compared the rate of referrals of women with specialist DV agencies from 24 general practices that received the IRIS programme with 24 general practices not receiving the programme. The trial did not measure outcomes for women beyond the intermediate outcome of referral to specialist agencies. The Markov model extrapolated the trial results to estimate the long-term healthcare and societal costs and benefits using data from other trials and epidemiological studies. RESULTS: The intervention would produce societal cost savings per woman registered in the general practice of UK£37 (95% CI £178 saved to a cost of £136) over 1 year. The incremental quality-adjusted life-year was estimated to be 0.0010 (95% CI -0.0157 to 0.0101) per woman. Probabilistic sensitivity analysis found 78% of model replications under a willingness to pay threshold of £20 000 per quality-adjusted life-year. CONCLUSIONS: The IRIS programme is likely to be cost-effective and possibly cost saving from a societal perspective. Better data on the trajectory of abuse and the effect of advocacy are needed for a more robust model. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN74012786

Effectiveness of financial incentives to improve adherence to maintenance treatment with antipsychotics: cluster randomised controlled trial

Objective: To test whether offering financial incentives to patients with psychotic disorders is effective in improving adherence to maintenance treatment with antipsychotics. Design: Cluster randomised controlled trial. Setting: Community mental health teams in secondary psychiatric care in the United Kingdom. Participants: Patients with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder, who were prescribed long acting antipsychotic (depot) injections but had received 75% or less of the prescribed injections. We randomly allocated 73 teams with a total of 141 patients. Primary outcome data were available for 35 intervention teams with 75 patients (96% of randomised) and for 31 control teams with 56 patients (89% of randomised). Interventions: Participants in the intervention group were offered £15 (€17; $22) for each depot injection over a 12 month period. Participants in the control condition received treatment as usual. Main outcome measure: The primary outcome was the percentage of prescribed depot injections given during the 12 month intervention period. Results 73 teams with 141 consenting patients were randomised, and outcomes were assessed for 131 patients (93%).⇓ Average baseline adherence was 69% in the intervention group and 67% in the control group. During the 12 month trial period adherence was 85% in the intervention group and 71% in the control group. The adjusted effect estimate was 11.5% (95% confidence interval 3.9% to 19.0%, P=0.003). A secondary outcome was an adherence of ≥95%, which was achieved in 28% of the intervention group and 5% of the control group (adjusted odds ratio 8.21, 95% confidence interval 2.00 to 33.67, P=0.003). Although differences in clinician rated clinical improvement between the groups failed to reach statistical significance, patients in the intervention group had more favourable subjective quality of life ratings (β=0.71, 95% confidence interval 0.26 to 1.15, P=0.002). The number of admissions to hospital and adverse events were low in both groups and did not show substantial differences. Conclusion: Offering modest financial incentives to patients with psychotic disorders is an effective method for improving adherence to maintenance treatment with antipsychotics

Prevalence and impact of chronic widespread pain in the Bangladeshi and White populations of Tower Hamlets, East London

The prevalence and impact of chronic pain differ between ethnic groups. We report a study of the comparative prevalence and impact of chronic pain in Bangladeshi, British Bangladeshi and White British/Irish people. We posted a short questionnaire to a random sample of 4,480 patients registered with 16 general practices in the London Borough of Tower Hamlets and conducted a longer questionnaire with patients in the waiting areas at those practices. We distinguished between Bangladeshi participants who were born in the UK or had arrived in the UK at the age of 14 or under (British Bangladeshi) and those who arrived in UK at the age of over 14 (Bangladeshi). We obtained 1,223/4,480 (27 %) responses to the short survey and 600/637 (94 %) to the long survey. From the former, the prevalence of chronic pain in the White, British Bangladeshi and Bangladeshi groups was 55, 54 and 72 %, respectively. The corresponding figures from the long survey were 49, 45 and 70 %. Chronic widespread pain was commoner in the Bangladeshi (16 %) than in the White (10 %) or British Bangladeshi (9 %) groups. People with chronic pain experienced poorer quality of life (odds ratio for scoring best possible health vs. good health (or good vs. poor health) 5.6 (95 % confidence interval 3.4 to 9.8)), but we found no evidence of differences between ethnic groups in the impact of chronic pain on the quality of life. Chronic pain is commoner and, of greater severity, in Bangladeshis than in Whites. On most measures in this study, British Bangladeshis resembled the Whites more than the Bangladeshis

Achieving change in primary care—causes of the evidence to practice gap : systematic reviews of reviews

Acknowledgements The Evidence to Practice Project (SPCR FR4 project number: 122) is funded by the National Institute of Health Research (NIHR) School for Primary Care Research (SPCR). KD is part-funded by the National Institute for Health Research (NIHR) Collaborations for Leadership in Applied Research and Care West Midlands and by a Knowledge Mobilisation Research Fellowship (KMRF-2014-03-002) from the NIHR. This paper presents independent research funded by the National Institute of Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Funding This study is funded by the National Institute for Health Research (NIHR) School for Primary Care Research (SPCR).Peer reviewedPublisher PD