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

How well do we currently care for our dying patients in acute hospitals: the views of the bereaved relatives?

Background The National Care of the Dying Audit—Hospitals (NCDAH) is used as a method to evaluate care for dying patients in England. An additional component to the 2013/2014 audit was the Local Survey of Bereaved Relatives Views using the ‘Care Of the Dying Evaluation’ (CODE) questionnaire. Aim Within the context of the NCDAH audit, to evaluate quality of care provided to dying patients and their families in acute hospitals from the perspective of bereaved relatives. Design Postbereavement survey to bereaved relatives. Setting/participants For acute hospitals wishing to participate, consecutive ‘expected’ adult deaths occurring between 1 May and 30 June 2013 were identified and the CODE questionnaire was sent to the next-of-kin. Results From 3414 eligible next-of-kin, 95 (2.8%) were excluded due to being involved in a complaint procedure and 1006 (29.5%) due to insufficient next-of-kin details. From the remaining 2313 potential participants, 858 returned a completed CODE questionnaire (37.1% response rate). Generally, symptoms were perceived to be well controlled with 769 (91%) participants reporting that either no pain was present or only there ‘some of the time’. Unmet information needs, however, was a recognised area for improvement, for example, 230 (29%) reporting having a discussion about hydration would have been beneficial. Conclusions Adopting a postbereavement survey to NCDAH appears to be feasible, acceptable and a valuable addition. On the whole, the majority of participants reported good or excellent care. A small but significant minority, however, perceived poor quality of patient care with clear and timely communication urgently needed

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

'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

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

Securing recruitment and obtaining informed consent in minority ethnic groups in the UK

Background: Previous health research has often explicitly excluded individuals from minority ethnic backgrounds due to perceived cultural and communication difficulties, including studies where there might be language/literacy problems in obtaining informed consent. This study addressed these difficulties by developing audio-recorded methods of obtaining informed consent and recording data. This report outlines 1) our experiences with securing recruitment to a qualitative study investigating alternative methods of data collection, and 2) the development of a standardised process for obtaining informed consent from individuals from minority ethnic backgrounds whose main language does not have an agreed written form. Methods: Two researchers from South Asian backgrounds recruited adults with Type 2 diabetes whose main language was spoken and not written, to attend a series of focus groups. A screening tool was used at recruitment in order to assess literacy skills in potential participants. Informed consent was obtained using audio-recordings of the patient information and recording patients' verbal consent. Participants' perceptions of this method of obtaining consent were recorded. Results: Recruitment rates were improved by using telephone compared to face-to-face methods. The screening tool was found to be acceptable by all potential participants. Audio-recorded methods of obtaining informed consent were easy to implement and accepted by all participants. Attrition rates differed according to ethnic group. Snowballing techniques only partly improved participation rates. Conclusion: Audio-recorded methods of obtaining informed consent are an acceptable alternative to written consent in study populations where literacy skills are variable. Further exploration of issues relating to attrition is required, and a range of methods may be necessary in order to maximise response and participation

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

Involving seldom-heard groups in a PPI process to inform the design of a proposed trial on the use of probiotics to prevent preterm birth: a case study

Background Patient and public involvement (PPI) is an important tool in approaching research challenges. However, involvement of socially and ethnically diverse populations remains limited and practitioners need effective methods of involving a broad section of the population in planning and designing research. Methods In preparation for the development of a pilot randomised controlled trial (RCT) on the use of probiotics to prevent preterm birth, we conducted a public consultation exercise in a socially disadvantaged and ethnically diverse community. The consultation aimed to meet and engage local service users in considering the acceptability of the proposed protocol, and to encourage their participation in future and ongoing patient and public involvement activities. Four discussion groups were held in the community with mothers of young children within the proposed trial region, using an inclusive approach that incorporated a modified version of the Nominal Group Technique (NGT). Bringing the consultation to the community supported the involvement of often seldom-heard participants, such as those from minority ethnic groups. Results The women involved expressed a number of concerns about the proposed protocol, including adherence to the probiotic supplement regimen and randomisation. The proposal for the RCT in itself was perceived as confirmation that probiotic supplements had potentially beneficial effects, but also that they had potentially harmful side-effects. The complexity of the women’s responses provided greater insights into the challenges of even quite simple trial designs and enabled the research team to take these concerns into account while planning the pilot trial. Conclusions The use of the NGT method allowed for a consultation of a population traditionally less likely to participate in medical research. A carefully facilitated PPI exercise can allow members to express unanticipated concerns that may not have been elicited by a survey method. Findings from such exercises can be utilised to improve clinical trial design, provide insight into the feasibility of trials, and enable engagement of often excluded population groups

The care of dying people in nursing homes and intensive care units: a qualitative mixed-methods study

Background In England and Wales the two most likely places of death are hospitals (52%) and nursing homes (22%). The Department of Health published its National End of Life Care Strategy in July 2008 (Department of Health. End of Life Care Strategy: Promoting High Quality Care For All Adults at the End of Life. London: Department of Health; 2008) to improve the provision of care, recommending the use of the Liverpool Care Pathway for the Dying Patient (LCP). Aim The original aim was to assess the impact of the LCP on care in two settings: nursing homes and intensive care units (ICUs). Design Qualitative, matched case study. Methods Data were collected from 12 ICUs and 11 nursing homes in England: (1) documentary analysis of provider end-of-life care policy documents; (2) retrospective analysis of 10 deaths in each location using written case notes; (3) interviews with staff about end-of-life care; (4) observation of the care of dying patients; (5) analysis of the case notes pertaining to the observed patient’s death; (6) interview with a member of staff providing care during the observed period; (7) interview with a bereaved relative present during the observation; (8) economic analysis focused on the observed patients; and (9) strict inclusion and selection criteria for nursing homes and ICUs applied to match sites on LCP use/non-LCP use. Results It was not possible to meet the stated aims of the study. Although 23 sites were recruited, observations were conducted in only 12 sites (eight using the LCP). A robust comparison on the basis of LCP use could not, therefore, take place. Although nurses in both settings reported that the LCP supported good care, the LCP was interpreted and used differently across sites, with the greatest variation in ICUs. Although not able to address the original research question, this study provides an unprecedented insight into care at the end of life in two different settings. The majority of nursing homes had implemented some kind of ‘pathway’ for dying patients and most homes participating in the observational stage were using the LCP. However, training in care of the dying was variable and specific issues were identified relating to general practitioner involvement, the use of anticipatory drugs and the assessment of consciousness and the swallowing reflex. In ICUs, end-of-life care was inextricably linked with the withdrawal of active treatment and controlling the pace of death. The data highlight how the decision to withdraw was made and, importantly, how relatives were involved in this process. The fact that most patients died soon after the withdrawal of interventions was reported to limit the appropriateness of the LCP in this setting. Limitations Although the recruitment of matched sites was achieved, variable site participation resulted in a skewed sample. Issues with the sample size and a blurring of LCP use and non-use limit the extent to which the ambitious aims of the study were achieved. Conclusions This study makes a unique contribution to understanding the complexity of care at the end of life in two very different settings. More research is needed into the ways in which an organisational culture can be created within which the principles of good end-of-life care become translated into practice. Funding The National Institute for Health Research Health Services and Delivery Research programme