Representation of South Asian people in randomised clinical trials: analysis of trials' data

Excluding patients of ethnic minority groups from clinical trials is unethical, introduces substantial bias, and means that findings are based on unrepresentative populations. The National Institutes of Health Revitalization Act 1993 requires that all minority groups be represented in the sample in research projects supported by the National Institutes of Health, unless there is a clear and compelling justification not to do so. In the United Kingdom no such legislation exists

Reasons for and consequences of missed appointments in general practice in the UK: questionnaire survey and prospective review of medical records

Background Missed appointments are a common occurrence in primary care in the UK, yet little is known about the reasons for them, or the consequences of missing an appointment. This paper aims to determine the reasons for missed appointments and whether patients who miss an appointment subsequently consult their general practitioner (GP). Secondary aims are to compare psychological morbidity, and the previous appointments with GPs between subjects and a comparison group. Methods Postal questionnaire survey and prospective medical notes review of adult patients missing an appointment and the comparison group who attended appointments over a three week period in seven general practices in West Yorkshire. Results Of the 386 who missed appointments 122 (32%) responded. Of the 386 in the comparison group 223 (58%) responded, resulting in 23 case-control matched pairs with complete data collection. Over 40% of individuals who missed an appointment and participated said that they forgot the appointment and a quarter said that they tried very hard to cancel the appointment or that it was at an inconvenient time. A fifth reported family commitments or being too ill to attend. Over 90% of the patients who missed an appointment subsequently consulted within three months and of these nearly 60% consulted for the stated problem that was going to be presented in the missed consultation. The odds of missing an appointment decreased with increasing age and were greater among those who had missed at least one appointment in the previous 12 months. However, estimates for comparisons between those who missed appointments and the comparison group were imprecise due to the low response rate. Conclusion Patients who miss appointments tend to cite practice factors and their own forgetfulness as the main reasons for doing so, and most attend within three months of a missed appointment. This study highlights a number of implications for future research. More work needs to be done to engage people who miss appointments into research in a meaningful way

Understanding experiences of participating in a weight loss lifestyle intervention trial: a qualitative evaluation of South Asians at high risk of diabetes

<b>Objective</b> To explore the reasons for enrolling, experiences of participating and reasons for remaining in a family-based, cluster randomised controlled trial of a dietitian-delivered lifestyle modification intervention aiming to reduce obesity in South Asians at high risk of developing diabetes.<p></p> <b>Design</b> Qualitative study using narrative interviews of a purposive sample of trial participants following completion of the intervention. Data were thematically analysed.<p></p> <b>Setting</b> The intervention was conducted in Scotland and resulted in a modest decrease in weight, but did not statistically reduce the incidence of diabetes.<p></p> <b>Participants</b> We conducted 21 narrative interviews with 24 participants (20 trial participants and four family volunteers).<p></p> <b>Results</b> Many participants were motivated to participate because of: known family history of diabetes and the desire to better understand diabetes-related risks to their own and their family's health; ways to mitigate these risks and to benefit from personalised monitoring. Home-based interventions, communication in the participant's chosen language(s) and continuity in dietitians supported their continuing engagement with the trial. Adaptations in food choices were initially accommodated by participants, although social and faith-based responsibilities were reported as important barriers to persevering with agreed dietary goals. Many participants reported that increasing their level of physical activity was difficult given their long working hours, physically demanding employment and domestic commitments; this being compounded by Scotland's challenging climate and a related reluctance to exercise in the outdoors.<p></p> <b>Conclusions</b> Although participants had strong personal interests in participation and found the information provided by dietitians useful, they nonetheless struggled to incorporate the dietary and exercise recommendations into their daily lives. In particular, increasing levels of physical exercise was described as an additional and in some cases unachievable burden. Consideration needs to be given to strengthening and supporting lifestyle interventions with community-based approaches in order to help overcome wider social and environmental factors

Facilitating the Recruitment of Minority Ethnic People into Research: Qualitative Case Study of South Asians and Asthma

Aziz Sheikh and colleagues report on a qualitative study in the US and the UK to investigate ways to bolster recruitment of South Asians into asthma studies, including making inclusion of diverse populations mandatory

'A light in a very dark place' : The role of a voluntary organisation providing support for those affected by encephalitis

Voluntary organisations are seen as contributing to the ‘democratisation’ of health and social care. Little, however, is written about their role and this paper, by focusing on the work of The Encephalitis Society, provides insights into the challenges facing voluntary organisations as they manage twin roles as service providers and advocates, of people with neurological disorders. Two studies are presented: a review conducted by the Society, focusing on patient’s experiences of neurological services; and an external evaluation of the Society’s current provision. The first, based on a postal survey of its members affected by encephalitis (n = 339), illustrates the Society’s advocacy role. The survey provided support for the Association of British Neurologists’ recommendation for nationally agreed standards of care. The second study, a postal survey of recent contacts (n = 76) and in-depth telephone interviews (n = 22), illustrates the Society’s value role as a service provider and supports its role in helping rehabilitate affected individuals and their families. These studies provided the Society with information for policy and service development. Importantly, providing the basis of informed action and partnership with stakeholders and informing the organisation’s sense of purpose, in the changing context of welfare provision in the UK

Effectiveness of enhanced diabetes care to patients of South Asian ethnicity : the United Kingdom Asian Diabetes Study (UKADS) : a cluster randomised controlled trial

Background: Delivering high quality and evidence based healthcare to deprived sectors of the community is a major goal for society. We investigated the effectiveness of a culturally sensitive enhanced care package in UK general practice in improving cardiovascular risk factors in South Asian patients with type 2 diabetes. Methods: 21 inner city practices were randomised to intervention (enhanced practice nurse time, link worker and diabetes specialist nurse support) (n=868) or control (standard care) (n=618) groups. Prescribing algorithms with clearly defined targets were provided for all practices. Main outcome measures comprised changes in blood pressure, total cholesterol and glycaemic control (HbA1c) after 2 years. Findings: At baseline, groups were similar with respect to age, sex and cardiovascular risk factors. Comparing treatment groups, after adjustment for confounders, and clustering, differences in diastolic blood pressure (1.91mmHg, P=0.0001) and mean arterial pressure (1.36mmHg, P=0.0180) were significant. There were no significant differences between groups for total cholesterol or HbA1c. Economic analysis indicates the nurse-led intervention was not cost-effective. Across the whole study population systolic blood pressure, diastolic blood pressure and cholesterol decreased significantly by 4.9mmHg, 3.8mmHg and 0.45mmol/L respectively, but there was no change in HbA1c. Interpretation: Additional, although limited, benefits were observed from our culturally enhanced care package over and above the secular changes achieved in the UK in recent years. Stricter targets in general practice and further measures to motivate patients are needed to maximise healthcare outcomes in South Asian patients with diabetes

The under-representation of minority ethnic groups in UK medical research

Objectives. The paper investigates differences in engagement with medical research between White British and Black, Asian and Minority Ethnic (BAME) groups in the UK, using data from the Wellcome Trust Monitor (WTM). Design. The WTM is nationally representative of the UK population and has collected data over two waves, 2009 and 2012. Data pooled from both waves (n = 2575) were used to examine associations between ethnic group and participation in medical research, and willingness to participate in medical research. Logistic regression analysis used models that controlled for socio-economic and demographic factors, and relevant outlooks and experiences that are, or could reasonably be assumed to be, associated with engagement with medical research. Results. Respondents from the BAME group were less likely to have participated in medical research compared to those from the White British group, but there was only patchy evidence of small ethnic group differences in willingness to participate. Influences on engagement in medical research varied somewhat between the White British and BAME groups, in particular in relation to occupation, education, health, attitudes to medical science and belief. Conclusions. These findings consolidate previously context-specific evidence of BAME group under-representation in the UK, and highlight the heterogeneity that exists with in the broad BAME group. Efforts to address the under-representation of those from BAME groups might benefit from targeted strategies for recruitment and advocacy, although improved datasets are required to fully understand ethnic differences in engagement with medical research

Strategies for improving patient recruitment to focus groups in primary care: a case study reflective paper using an analytical framework

<p>Abstract</p> <p>Background</p> <p>Recruiting to primary care studies is complex. With the current drive to increase numbers of patients involved in primary care studies, we need to know more about successful recruitment approaches. There is limited evidence on recruitment to focus group studies, particularly when no natural grouping exists and where participants do not regularly meet. The aim of this paper is to reflect on recruitment to a focus group study comparing the methods used with existing evidence using a resource for research recruitment, PROSPeR (Planning Recruitment Options: Strategies for Primary Care).</p> <p>Methods</p> <p>The focus group formed part of modelling a complex intervention in primary care in the Resources for Effective Sleep Treatment (REST) study. Despite a considered approach at the design stage, there were a number of difficulties with recruitment. The recruitment strategy and subsequent revisions are detailed.</p> <p>Results</p> <p>The researchers' modifications to recruitment, justifications and evidence from the literature in support of them are presented. Contrary evidence is used to analyse why some aspects were unsuccessful and evidence is used to suggest improvements. Recruitment to focus group studies should be considered in two distinct phases; getting potential participants to contact the researcher, and converting those contacts into attendance. The difficulty of recruitment in primary care is underemphasised in the literature especially where people do not regularly come together, typified by this case study of patients with sleep problems.</p> <p>Conclusion</p> <p>We recommend training GPs and nurses to recruit patients during consultations. Multiple recruitment methods should be employed from the outset and the need to build topic related non-financial incentives into the group meeting should be considered. Recruitment should be monitored regularly with barriers addressed iteratively as a study progresses.</p

How should we evaluate research on counselling and the treatment of depression? A case study on how NICE’s draft 2018 guideline considered what counts as best evidence

Background: Health guidelines are developed to improve patient care by ensuring the most recent and “best available evidence” is used to guide treatment recommendations (NICE Guidance, 2017). NICE’s revised guideline development methodology acknowledges that evidence needed to answer one question (treatment efficacy) may be different from evidence needed to answer another (cost effectiveness, treatment acceptability to patients; NICE, 2014/2017). This review uses counselling in the treatment of depression as a case study, and interrogates the constructs of ‘best’ evidence and ‘best’ guideline methodologies. Method: The review comprises six sections: (1) the implications of diverse definitions of counselling in research; (2) research findings from meta-analyses and randomised controlled trials (RCTs); (3) limitations to trials-based evidence; (4) findings from large routine outcome datasets; (5) the inclusion of qualitative research that emphasises service-user voices; and (6) conclusions and recommendations. Results: Research from meta-analyses and RCTs reviewed in the draft 2018 NICE guideline is limited but positive in relation to the effectiveness of counselling in the treatment for depression. The weight of evidence suggests little, if any, advantage to CBT over counselling once bias and researcher allegiance are taken into account. A growing body of evidence from large NHS datasets also evidences that counselling is both effective and cost-effective when delivered in NHS settings. Conclusion: Recommendations in NICE’s own updated procedures suggest that sole reliance on RCTs and meta-analyses as best methodologies is no longer adequate. There is a need to include large standardised collected datasets from routine practice as well as the voice of patients via high-quality qualitative research