Recruiting ethnic minority participants to a clinical trial: a qualitative study

MacNeill, Virginia; Nwokoro, Chinedu; Griffiths, Chris; Grigg, Jonathan; Seale, Clive

doi:10.1136/bmjopen-2013-002750

Cited by 18 publications

(16 citation statements)

References 25 publications

(20 reference statements)

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“… 9 27 36 38 41 42 45 The second most commonly reported strategies were incentives and reciprocal benefits 9 36–40 46 and demonstrated respect and knowledge of South Asian culture, traditions and ethics. 36–40 44 46 Multiple studies also mentioned the development of trust and personal relationships, 36 37 39 40 42 46 the use of visual aids and reduced reliance on verbal exchange, 29 38 43 providing language support and translated materials, 36 38 40 42 personal versus written contact, 39 42 43 training for staff in cultural competency, 9 27 36 conducting recruitment at places with high concentrations of South Asian attendance or residence 27 36 38 and improving flexibility of appointment scheduling, location, childcare and transportation. 36 39 40 Several additional strategies for recruiting South Asian populations reported by two or fewer studies, as well as those previously discussed are outlined in table 4 .…”

Section: Resultsmentioning

confidence: 99%

Barriers and facilitators to recruitment of South Asians to health research: a scoping review

et al. 2017

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ObjectivesPeople of South Asian ethnicity are under-represented in health research studies. The objectives of this scoping review were to examine the barriers and facilitators to recruitment of South Asians to health research studies and to describe strategies for improving recruitment.DesignScoping reviewMethodsUsing the Arksey and O’Malley framework for scoping reviews, we comprehensively searched electronic databases (MEDLINE via PubMed, Cochrane Library, CINAHL and PsycINFO). Studies that identified barriers and facilitators to recruitment, or recruitment strategies for South Asian populations were included. Recruitment barriers, facilitators and strategies were grouped thematically and summarised narratively.SynthesisOf 1846 potentially relevant articles, 15 met the inclusion criteria and were included in the thematic synthesis. Multiple facilitators and barriers to enrolment of South Asians in health research studies were identified; these most commonly related to logistical challenges, language and cultural barriers, concerns about adverse consequences of participating and mistrust of research. Several actionable strategies were discussed, the most common being engagement of South Asian communities, demonstration of cultural competency, provision of incentives and benefits, language sensitivity through the use of translators and translated materials and the development of trust and personal relationships.ConclusionThere is a growing awareness of the barriers and facilitators to recruitment of South Asian participants to health research studies. Knowledge of effective recruitment strategies and implementation during the grant funding stages may reduce the risk of poor recruitment and representation of South Asians.

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Section: Resultsmentioning

confidence: 99%

Barriers and facilitators to recruitment of South Asians to health research: a scoping review

et al. 2017

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“…Furthermore, the UK South Asian population is generally under-represented in clinical trials and recruitment poses a number of particular challenges. 98 Finally, although formal screening logs were requested, in keeping with other studies these were not kept well; however, based on known epidemiological data, we estimate that we have managed to include 34% of newly presenting patients over a recruitment period of 3 years and 2 months. This indicates a high level of acceptability of the trial among both families and clinicians.…”

Section: Discussionmentioning

confidence: 99%

Sixteen-week versus standard eight-week prednisolone therapy for childhood nephrotic syndrome: the PREDNOS RCT

Webb

Woolley

Lambe

et al. 2019

Health Technol Assess

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Background The optimal corticosteroid regimen for treating the presenting episode of steroid-sensitive nephrotic syndrome (SSNS) remains uncertain. Most UK centres use an 8-week regimen, despite previous systematic reviews indicating that longer regimens reduce the risk of relapse and frequently relapsing nephrotic syndrome (FRNS). Objectives The primary objective was to determine whether or not an extended 16-week course of prednisolone increases the time to first relapse. The secondary objectives were to compare the relapse rate, FRNS and steroid-dependent nephrotic syndrome (SDNS) rates, requirement for alternative immunosuppressive agents and corticosteroid-related adverse events (AEs), including adverse behaviour and costs. Design Randomised double-blind parallel-group placebo-controlled trial, including a cost-effectiveness analysis. Setting One hundred and twenty-five UK paediatric departments. Participants Two hundred and thirty-seven children presenting with a first episode of SSNS. Participants aged between 1 and 15 years were randomised (1 : 1) according to a minimisation algorithm to ensure balance of ethnicity (South Asian, white or other) and age (≤ 5 or ≥ 6 years). Interventions The control group (n = 118) received standard course (SC) prednisolone therapy: 60 mg/m2/day of prednisolone in weeks 1–4, 40 mg/m2 of prednisolone on alternate days in weeks 5–8 and matching placebo on alternate days in weeks 9–18 (total 2240 mg/m2). The intervention group (n = 119) received extended course (EC) prednisolone therapy: 60 mg/m2/day of prednisolone in weeks 1–4; started at 60 mg/m2 of prednisolone on alternate days in weeks 5–16, tapering by 10 mg/m2 every 2 weeks (total 3150 mg/m2). Main outcome measures The primary outcome measure was time to first relapse [Albustix® (Siemens Healthcare Limited, Frimley, UK)-positive proteinuria +++ or greater for 3 consecutive days or the presence of generalised oedema plus +++ proteinuria]. The secondary outcome measures were relapse rate, incidence of FRNS and SDNS, other immunosuppressive therapy use, rates of serious adverse events (SAEs) and AEs and the incidence of behavioural change [using Achenbach Child Behaviour Checklist (ACBC)]. A comprehensive cost-effectiveness analysis was performed. The analysis was by intention to treat. Participants were followed for a minimum of 24 months. Results There was no significant difference in time to first relapse between the SC and EC groups (hazard ratio 0.87, 95% confidence interval 0.65 to 1.17; log-rank p = 0.3). There were also no differences in the incidence of FRNS (SC 50% vs. EC 53%; p = 0.7), SDNS (44% vs. 42%; p = 0.8) or requirement for other immunosuppressive therapy (56% vs. 54%; p = 0.8). The total prednisolone dose received following completion of study medication was 5475 mg vs. 6674 mg (p = 0.07). SAE rates were not significantly different (25% vs. 17%; p = 0.1) and neither were AEs, except poor behaviour (yes/no), which was less frequent with EC treatment. There were no differences in ACBC scores. EC therapy was associated with a mean increase in generic health benefit [0.0162 additional quality-adjusted life-years (QALYs)] and cost savings (£4369 vs. £2696). Limitations Study drug formulation may have prevented some younger children who were unable to swallow whole or crushed tablets from participating. Conclusions This trial has not shown any clinical benefit for EC prednisolone therapy in UK children. The cost-effectiveness analysis suggested that EC therapy may be cheaper, with the possibility of a small QALY benefit. Future work Studies investigating EC versus SC therapy in younger children and further cost-effectiveness analyses are warranted. Trial registration Current Controlled Trials ISRCTN16645249 and EudraCT 2010-022489-29. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 26. See the NIHR Journals Library website for further project information.

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“…For example, the large proportion of participants reporting joint problems themselves might be indicative of a motivation to find out more about arthritis. Second, few participants from ethnic minority backgrounds chose to participate, and ethnic minority groups are often underrepresented in health studies . Future research should explore the views of minority groups in the context of the research questions addressed in this article.…”

Section: Discussionmentioning

confidence: 99%

Symptom Recognition and Perceived Urgency of Help‐Seeking for Rheumatoid Arthritis and Other Diseases in the General Public: A Mixed Method Approach

Simons

Belcher

Morton

et al. 2017

Arthritis Care & Research

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Objective Clinical outcomes in rheumatoid arthritis (RA) are improved if the disease is treated early. However, treatment is often significantly delayed as a result of delayed help‐seeking by patients who fail to recognize its symptoms or the need for rapid medical attention. Two studies were conducted to investigate the role of symptom recognition in help‐seeking for the symptoms of RA, and compared this to symptom recognition and help‐seeking in angina and bowel cancer. Methods A qualitative interview study with 31 individuals and a survey of 1,088 members of the general public (all without RA) were conducted. Both studies used vignettes describing the symptoms of RA, bowel cancer, and angina. Participants made causal attributions and rated the perceived seriousness of the symptoms and the urgency with which they would seek medical help if confronted with these symptoms. Results Only a small proportion of participants in both studies recognized the symptoms of RA, whereas the symptoms of bowel cancer and angina were readily recognized by many participants and considered to be more serious and to require more rapid medical attention (Z = 14.7–34.2, P < 0.001). Conclusion Accurate symptom attribution and the perception that symptoms are indicative of a serious underlying condition are both important drivers for rapid help‐seeking. In the case of angina and bowel cancer, recent campaigns have promoted not only recognition of symptoms and their seriousness, but also emphasized the consequences of not seeking timely help. Our results suggest that these consequences should also be addressed in any public health campaign for RA.

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Recruiting ethnic minority participants to a clinical trial: a qualitative study

Cited by 18 publications

References 25 publications

Barriers and facilitators to recruitment of South Asians to health research: a scoping review

Barriers and facilitators to recruitment of South Asians to health research: a scoping review

Sixteen-week versus standard eight-week prednisolone therapy for childhood nephrotic syndrome: the PREDNOS RCT

Symptom Recognition and Perceived Urgency of Help‐Seeking for Rheumatoid Arthritis and Other Diseases in the General Public: A Mixed Method Approach

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