Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials.

Abstract Background: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries, or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. Design: Two qualitative process evaluations of a United Kingdom-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting: NHS secondary care organisations throughout the United Kingdom. Interviews were undertaken via telephone. Participants: 37 trial recruiters (surgeons, physiotherapists, research nurses) and 22 patients were interviewed. Patients included those who agreed to participate in the ACTIVE and PRESTO studies and patients that declined participation in the ACTIVE study. Results: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. Conclusions: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. Trial registries: ACTIVE: (ISRCTN98152560) PRESTO: (ISRCTN12094890)

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Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Trials ◽

10.1186/s13063-021-05420-4 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Arabella Scantlebury ◽

Catriona McDaid ◽

Stephen Brealey ◽

Elizabeth Cook ◽

Hemant Sharma ◽

...

Keyword(s):

Systematic Review ◽

Mixed Methods ◽

Health Professionals ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Surgical Trials ◽

Link Type ◽

Patient Pathways ◽

Randomised Controlled ◽

The Impact

Abstract Background Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. Design Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone. Participants Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. Results We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. Conclusions A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. Trial registration ACTIVE: (ISRCTN98152560). Registered on 06/03/2018. PRESTO: (ISRCTN12094890). Registered on 22/02/2018,

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A mixed-methods systematic review of patients' experience of being invited to participate in surgical randomised controlled trials

Social Science & Medicine ◽

10.1016/j.socscimed.2020.112961 ◽

2020 ◽

Vol 253 ◽

pp. 112961

Author(s):

Emma Elizabeth Phelps ◽

Elizabeth Tutton ◽

Xavier Griffin ◽

Janis Baird

Keyword(s):

Systematic Review ◽

Mixed Methods ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Randomised Controlled ◽

Patients Experience

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Cannulation Technique of Vascular Access in Haemodialysis and the Impact on the Arteriovenous Fistula Survival: Protocol of Systematic Review

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph182312554 ◽

2021 ◽

Vol 18 (23) ◽

pp. 12554

Author(s):

Ricardo Peralta ◽

Luís Sousa ◽

António Filipe Cristóvão

Keyword(s):

Systematic Review ◽

Arteriovenous Fistula ◽

Randomised Controlled Trials ◽

Primary Patency ◽

Risk Of Bias ◽

Current Evidence ◽

Controlled Trials ◽

Cannulation Technique ◽

Randomised Controlled ◽

The Impact

Background: Based on a literature review of various studies, comparisons between BH and RL are inconclusive regarding some outcomes. However, in the last 5 years, some studies have been published that may contribute to clarifying which cannulation technique (CT) allows better fistula survival. Aim: To review which cannulation technique allows better primary patency of the arteriovenous fistula in haemodialysis patients. Methods: We will include all randomised controlled trials and observational studies that include comparisons among CTs and thus define the benefits and risks of each CT. A PRISMA-compliant systematic review and meta-analysis will be performed in accordance with the quality and homogeneity of studies. A comprehensive search strategy will be applied to the CINAHL, MEDLINE and Embase electronic databases from January 2000 to September 2021. The primary outcome is the arteriovenous fistula primary patency. To assess the risk of bias in randomised controlled trials or quasi-experimental studies, we will use the tool Revised Cochrane Risk-of-Bias Tool for Randomized Trials (RoB 2). For nonrandomised studies, the Risk of Bias In Non-Randomized Studies of Interventions (ROBINS-I) will be used. Discussion: The evidence generated from this systematic review of current evidence could inform the design and implementation of continuous quality improvement programs in cannulation techniques in haemodialysis patients, as well as contributing to improving the curricula within haemodialysis courses. This protocol was registered with the National Institute for Health Research PROSPERO database prior to commencement (registration number CRD42021237050).

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Impact of social distancing measures for preventing coronavirus disease 2019 [COVID-19]: A systematic review and meta-analysis protocol

10.1101/2020.06.13.20130294 ◽

2020 ◽

Cited By ~ 3

Author(s):

Krishna Regmi ◽

Cho Mar Lwin

Keyword(s):

Public Health ◽

Systematic Review ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

World Health ◽

Controlled Trials ◽

List Type ◽

Social Distancing ◽

Randomised Controlled ◽

The Impact

AbstractIntroductionSocial distancing measures (SDMs) protect public health from the outbreak of coronavirus disease 2019 (COVID-19). However, the impact of SDMs has been inconsistent and unclear. This study aims to assess the effects of SDMs (e.g. isolation, quarantine) for reducing the transmission of COVID-19.Methods and analysisWe will conduct a systematic review meta-analysis research of both randomised controlled trials and non-randomised controlled trials. We will search MEDLINE, EMBASE, Allied & Complementary Medicine, COVID-19 Research and WHO database on COVID-19 for primary studies assessing the effects of SDMs (e.g. isolation, quarantine) for reducing the transmission of COVID-19, and will be reported in accordance with PRISMA statement. The PRISMA-P checklist will be used while preparing this protocol. We will use Joanna Briggs Institute guidelines (JBI Critical Appraisal Checklists) to assess the methodological qualities and synthesised performing thematic analysis. Two reviewers will independently screen the papers and extracted data. If sufficient data are available, the random-effects model for meta-analysis will be performed to measure the effect size of SDMs or the strengths of relationships. To assess the heterogeneity of effects, I2 together with the observed effects (Q-value, with degrees of freedom) will be used to provide the true effects in the analysis.Ethics and disseminationEthics approval and consent will not be required for this systematic review of the literature as it does not involve human participation. We will be able to disseminate the study findings using the following strategies: we will be publishing at least one paper in peer-reviewed journals, and an abstract will be presented at suitable national/international conferences or workshops. We will also share important information with public health authorities as well as with the World Health Organization. In addition, we may post the submitted manuscript under review to bioRxiv, medRxiv, or other relevant pre-print servers.Strengths and limitations of this studyTo our knowledge, this study will be the first systematic review to examine the impact of social distancing measures to reduce transmission of COVID-19.This study will offer highest level of evidence for informed decisions, drawing a broader framework.This protocol reduces the possibility of duplication, provides transparency to the methods and procedures that will be used, minimise potential biases and allows peer-review.This research is not externally funded, and therefore time and resource will be constrained.If included studies will be variable in sample size, quality and population, which may open to bias, and the heterogeneity of data will preclude a meaningful meta-analysis to measure the impact of specific SDMs

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A systematic review of pharmacists’ interventions to support medicines optimisation in patients with visual impairment

International Journal of Clinical Pharmacy ◽

10.1007/s11096-019-00907-2 ◽

2019 ◽

Vol 41 (6) ◽

pp. 1400-1407 ◽

Cited By ~ 1

Author(s):

Basma Y. Kentab ◽

Heather E. Barry ◽

Sinaa A. Al-Aqeel ◽

Carmel M. Hughes

Keyword(s):

Systematic Review ◽

Visual Impairment ◽

Randomised Controlled Trials ◽

Grey Literature ◽

Cochrane Library ◽

Future Research ◽

Controlled Trials ◽

Medicines Optimisation ◽

Randomised Controlled ◽

The Impact

Abstract Background People with visual impairment often report poorer health and encounter many challenges when using medicines. Pharmacists can play a significant role in optimising medicines use for these patients. However, little is known about pharmacists’ current practices when providing services to this population nor the impact of such services, if any, on medicines optimisation-related outcomes. Aim of the review This systematic review aims to identify the types, and assess the effectiveness of, interventions provided by pharmacists on medicines optimisation-related outcomes. Method Systematic searches of the following electronic databases were carried out from date of inception to March 2018: Cochrane Library; MEDLINE; EMBASE; International Pharmaceutical Abstracts; Scopus; and Cumulative Index to Nursing and Allied Health Literature. Several trial registries and grey literature resources were also searched. Any randomised controlled trials, non-randomised controlled trials, controlled before-and-after studies, or interrupted time series analyses reporting on interventions provided by pharmacists to adult visually impaired patients and/or their caregivers in order to improve medicines optimisation-related outcomes of medicine safety, adherence, patient satisfaction, shared decision making, or quality of life were included. Results A total of 1877 titles/abstracts were screened, and 27 full text articles were assessed for eligibility. On examination of full texts, no studies met the inclusion criteria for this review. Conclusion This review highlights the need for future research that would be vital for promoting the safe and effective use of medicines and the delivery of pharmaceutical care services to people with visual impairment.

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The impact of whole-of-diet interventions on depression and anxiety: a systematic review of randomised controlled trials

Public Health Nutrition ◽

10.1017/s1368980014002614 ◽

2015 ◽

Vol 18 (11) ◽

pp. 2074-2093 ◽

Cited By ~ 91

Author(s):

Rachelle S Opie ◽

Adrienne O’Neil ◽

Catherine Itsiopoulos ◽

Felice N Jacka

Keyword(s):

Mental Health ◽

Systematic Review ◽

Health Outcomes ◽

Randomised Controlled Trials ◽

Mental Health Outcomes ◽

Controlled Trials ◽

Depression And Anxiety ◽

Dietary Interventions ◽

Randomised Controlled ◽

The Impact

AbstractObjectiveNon-pharmacological approaches to the treatment of depression and anxiety are of increasing importance, with emerging evidence supporting a role for lifestyle factors in the development of these disorders. Observational evidence supports a relationship between habitual diet quality and depression. Less is known about the causative effects of diet on mental health outcomes. Therefore a systematic review was undertaken of randomised controlled trials of dietary interventions that used depression and/or anxiety outcomes and sought to identify characteristics of programme success.DesignA systematic search of the Cochrane, MEDLINE, EMBASE, CINAHL, PubMed and PyscInfo databases was conducted for articles published between April 1971 and May 2014.ResultsOf the 1274 articles identified, seventeen met eligibility criteria and were included. All reported depression outcomes and ten reported anxiety or total mood disturbance. Compared with a control condition, almost half (47 %) of the studies observed significant effects on depression scores in favour of the treatment group. The remaining studies reported a null effect. Effective dietary interventions were based on a single delivery mode, employed a dietitian and were less likely to recommend reducing red meat intake, select leaner meat products or follow a low-cholesterol diet.ConclusionsAlthough there was a high level of heterogeneity, we found some evidence for dietary interventions improving depression outcomes. However, as only one trial specifically investigated the impact of a dietary intervention in individuals with clinical depression, appropriately powered trials that examine the effects of dietary improvement on mental health outcomes in those with clinical disorders are required.

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