Current practice in the measurement and interpretation of intervention adherence in randomised controlled trials: A systematic review.

BACKGROUND: Ideally all participants in a randomised controlled trial (RCT) should fully receive their allocated intervention; however, this rarely occurs in practice. Intervention adherence affects Type II error so influences the interpretation of trial results and subsequent implementation. We aimed to describe current practice in the definition, measurement, and reporting of intervention adherence in non-pharmacological RCTs, and how this data is incorporated into a trial's interpretation and conclusions. METHODS: We conducted a systematic review of phase III RCTs published between January 2018 and June 2020 in the National Institute for Health Research Journals Library for the Health Technology Assessment, Programme Grants for Applied Research, and Public Health Research funding streams. RESULTS: Of 237 reports published, 76 met the eligibility criteria and were included. Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis. Adherence measures varied between intervention types: behavioural change (n = 10, 43.5%), psychological therapy (n = 5, 83.3%) and physiotherapy/rehabilitation (n = 8, 66.7%) interventions predominately measured adherence based on session attendance. Whereas medical device and surgical interventions (n = 17, 73.9%) primarily record the number of participants receiving the allocated intervention, a third (n = 33, 67.3%) of studies reported a difference in findings between primary and sensitivity analyses. CONCLUSIONS: Although most trials report elements of adherence, terminology was inconsistent, and there was no systematic approach to its measurement, analyses, interpretation, or reporting. Given the importance of adherence within clinical trials, there is a pressing need for a standardised approach or framework.

Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus.

BACKGROUND: Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions. METHODS: We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice. RESULTS: In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice. CONCLUSIONS: Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials.

The psychosocial versus material hypothesis to explain observed inequality in disability among older adults: data from the West of Scotland Twenty-07 Study.

OBJECTIVES: The possible mechanisms for explaining health inequality are subject to debate. This study considers the roles of psychosocial and material mechanisms in observed inequalities in disability among older people. DESIGN: Cross-sectional analysis of cohort study. PARTICIPANTS: 723 respondents aged 63 years from the West of Scotland Twenty-07 Study. MAIN OUTCOME MEASURE: The Office of Population Census and Surveys Multidimensional Disability Severity Score. Respondents were dichotomised to the highest scoring tertile, and compared with the lowest and mid-tertiles combined. EXPLANATORY MEASURES: Socioeconomic position across adulthood was measured in three ways. Respondents reported perceptions of their own financial position (perceived financial hardship) across four decades of adult life. Data on possession of several indicators of material wealth (eg, ownership of television and washing machine; material conditions) during the same periods were also ascertained. Standard occupational classification was also recorded, based on longest held occupation. The relationship between the measures of socioeconomic position and disability was examined using logistic regression, adjusting for sex, morbidity and lifestyle factors. RESULTS: Perceived financial hardship and material conditions in earlier decades of life were found to be associated with reported disability. However, in the fully adjusted model, there was stronger evidence for material conditions as a predictor of disability: across four decades they remained an independent risk factor for disability after adjustment for sex, morbidity, lifestyle factors and perceived financial hardship. Those in the most deprived material conditions group had 2 1/2 times the odds of reporting severe disability than those in the reference group. After adjustment, evidence for an association between perceived financial hardship and reported disability was not convincing. CONCLUSION: The data provide evidence to support the "material" explanation for observed inequalities in reported disability among older people.

Are older people dying of depression? Findings from the Medical Research Council trial of the assessment and management of older people in the community.

OBJECTIVES: To examine the relationship between symptoms of depression and mortality in older people. DESIGN: Prospective longitudinal study. SETTING: Fifty-three general practices in the United Kingdom. PARTICIPANTS: Thirteen thousand ninety-seven people aged 75 and older participating in the Medical Research Council Trial of the Assessment and Management of Older People in the Community. MEASUREMENTS: Depression was measured using the 15-item Geriatric Depression Scale (GDS-15); the main outcome was all-cause mortality. RESULTS: Morbidity, disability, and lifestyle factors can explain most of the observed relationship between symptoms of depression and mortality (hazard ratio=1.75, 95% confidence interval (CI)=1.53-1.99), but after mutual adjustment for these factors, subjects who reported six or more symptoms of depression on the GDS-15 were still 27% more likely to have died by the end of the follow-up period than those below the threshold for depression (95% CI=1.11-1.45). CONCLUSION: The findings from this study suggest that depression confers a small risk for mortality in older people, not explained solely by poor health. The results support the encouragement of effective diagnosis, treatment, and support for individuals with depression as highlighted by the World Health Organization and the UK National Service Framework for older people.