Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effective. This does not always happen. The UK National Institute for Health and Care Research (NIHR) INCLUDE project identified many groups in the UK that are under-served by trials, including ethnic minorities.This guidance document presents four key recommendations for designing and running trials that include the ethnic groups needed by the trial. These are (1) ensure eligibility criteria and recruitment pathway do not limit participation in ways you do not intend, (2) ensure your trial materials are developed with inclusion in mind, (3) ensure staff are culturally competent and (4) build trusting partnerships with community organisations that work with ethnic minority groups. Each recommendation comes with best practice advice, public contributor testimonials, examples of the inclusion problem tackled by the recommendation, or strategies to mitigate the problem, as well as a collection of resources to support implementation of the recommendations.We encourage trial teams to follow the recommendations and, where possible, evaluate the strategies they use to implement them. Finally, while our primary audience is those designing, running and reporting trials, we hope funders, grant reviewers and approvals agencies may also find our guidance useful.

Objective To evaluate the effects of Quality and Outcomes Framework (QOF) incentivised case finding for depression on diagnosis and treatment in targeted and non-targeted long-term conditions. Design Interrupted time series analysis. Setting General practices in Leeds, UK. Participants 65 (58%) of 112 general practices shared data on 37 229 patients with diabetes and coronary heart disease targeted by case finding incentives, and 101 008 patients with four other long-term conditions not targeted (hypertension, epilepsy, chronic obstructive pulmonary disease and asthma). Intervention Incentivised case finding for depression using two standard screening questions. Main outcome measures Clinical codes indicating new depression-related diagnoses and new prescriptions of antidepressants. We extracted routinely recorded data from February 2002 through April 2012. The number of new diagnoses and prescriptions for those on registers was modelled with a binomial regression, which provided the strength of associations between time periods and their rates. Results New diagnoses of depression increased from 21 to 94/100 000 per month in targeted patients between the periods 2002–2004 and 2007–2011 (OR 2.09; 1.92 to 2.27). The rate increased from 27 to 77/100 000 per month in non-targeted patients (OR 1.53; 1.46 to 1.62). The slopes in prescribing for both groups flattened to zero immediately after QOF was introduced but before incentivised case finding (p<0.01 for both). Antidepressant prescribing in targeted patients returned to the pre-QOF secular upward trend (Wald test for equivalence of slope, z=0.73, p=0.47); the slope was less steep for non-targeted patients (z=−4.14, p<0.01). Conclusions Incentivised case finding increased new depression-related diagnoses. The establishment of QOF disrupted rising trends in new prescriptions of antidepressants, which resumed following the introduction of incentivised case finding. Prescribing trends are of concern given that they may include people with mild-to-moderate depression unlikely to respond to such treatment.

Objective To examine the process of case finding for depression in people with diabetes and coronary heart disease within the context of a pay-for-performance scheme. Design Ethnographic study drawing on observations of practice routines and consultations, debriefing interviews with staff and patients and review of patient records. Setting General practices in Leeds, UK. Participants 12 purposively sampled practices with a total of 119 staff; 63 consultation observations and 57 patient interviews. Main outcome measure Audio recorded consultations and interviews with patients and healthcare professionals along with observation field notes were thematically analysed. We assessed outcomes of case finding from patient records. Results Case finding exacerbated the discordance between patient and professional agendas, the latter already dominated by the tightly structured and time-limited nature of chronic illness reviews. Professional beliefs and abilities affected how case finding was undertaken; there was uncertainty about how to ask the questions, particularly among nursing staff. Professionals were often wary of opening an emotional ‘can of worms’. Subsequently, patient responses potentially suggesting emotional problems could be prematurely shut down by professionals. Patients did not understand why they were asked questions about depression. This sometimes led to defensive or even defiant answers to case finding. Follow-up of patients highlighted inconsistent systems and lines of communication for dealing with positive results on case finding. Conclusions Case finding does not fit naturally within consultations; both professional and patient reactions somewhat subverted the process recommended by national guidance. Quality improvement strategies will need to take account of our results in two ways. First, despite their apparent simplicity, the case finding questions are not consultation-friendly and acceptable alternative ways to raise the issue of depression need to be supported. Second, case finding needs to operate within structured pathways which can be accommodated within available systems and resources.

Reporting adherence to intervention delivery and uptake is a detailed way of describing what was actually delivered and received, in comparison to what was intended. Measuring and reporting adherence is not routinely done well in complex interventions. The OK Diabetes trial (ISRCTN41897033) aimed to develop and subsequently test the feasibility of implementing a supported self-management intervention in adults with a learning disability and type 2 diabetes. A key study objective was to develop a measure of adherence to the intervention. We conducted a systematic review of published literature, extracting data from included papers using a standardised proforma. We undertook a narrative synthesis of papers to determine the form and content of methods for adherence measurement for self-management interventions in this population that had already been developed. We used the framework and data extraction form developed for the review as the basis for an adherence measurement tool that we applied in the OK Diabetes trial. The literature review found variability in the quality and content of adherence measurement and reporting, with no standardised approach. We were able to develop an adherence measure based upon the review, and populate it with data collected during the OK Diabetes trial. The adherence tool proved satisfactory for recording and measuring adherence in the trial. There remains a need for a standardised approach to adherence measurement in the field of complex interventions. We have shown that it is possible to produce a simple, feasible measure for assessing adherence in the OK Diabetes trial.

Objective: Cancer remains one of the most enduring health crises of the modern world. Prehabilitation is a relatively new intervention aimed at preparing individuals for the stresses associated with treatment from diagnosis. Prehabilitation can include exercise, psychological and nutrition‐based interventions. The present systematic review aimed to assess the efficacy of prehabilitation on affective and functional outcomes for young to midlife adult cancer patients (18–55 years). Outcomes of interest included prehabilitation programme composition, duration, mode of delivery and measures used to determine impact on affective and functional outcomes.Methods: The following databases were searched with controlled and free text vocabulary; Psychological Information database (PsychINFO), Culmunated Index to Nursing and Allied Health Literature (CINAHL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE) and Public MEDLINE (PubMed). Abstract and full‐text screening was conducted with a secondary reviewer and final texts were subject to risk of bias analysis.Results: Thirteen texts were included at full‐text. These included data of 797 prehabilitation participants (mean age 53 years) and a large representation of female participants (71% average). Evidence was found for the efficacy of psychological prehabilitation for anxiety reduction. Prehabilitation did not significantly affect health related quality of life. Findings moderately supported the therapeutic validity of exercise prehabilitation for functional outcomes, both in terms of clinical and experimental improvement with respect to the quality of evidence. Variation between all prehabilitation types was observed. There was insufficient evidence to support the efficacy of psychological prehabilitation on stress, distress or depression.Conclusion: Implications for future research are highlighted and then discussed with respect to this young to midlife age group.

Background: People with learning disabilities (LD) have poor physical and mental health when compared with the general population. They are also likely to find it more difficult than others to describe their symptoms adequately. It is therefore harder for healthcare workers to identify the health needs of those with learning disabilities, with the danger of some problems being left unrecognised. Practice registers record only a proportion of those who are eligible, making it difficult to target improvements in their health care.Aim: To test a Read Code search supporting the identification of people with a mild-to-moderate learning disability who are not currently on the learning disability register.Design and setting: An observational study in primary care in West Yorkshire.Method: Read Code searches were created to identify individuals with a learning disability not on the LD register; they were field tested and further refined before testing in general practice.Results: Diagnostic codes identified small numbers of individuals who should have been on the LD register. Functional and service use codes often created large numbers of false-positive results. The specific descriptive codes ‘Learning difficulties’ and ‘Referral to learning disability team’ needed follow-up review, and then identified some individuals with LD who were not on the register.Conclusion: The Read Code search supported practices to populate their registers and was quick to run and review, making it a viable choice to support register revalidation. However, it did not find large numbers of people eligible for the LD register who were previously unidentified by their practice, suggesting that additional complementary methods are required to support practices to validate their registers.