A review of reporting of participant recruitment and retention in RCTs in six major journals

<p>Abstract</p> <p>Background</p> <p>Poor recruitment and retention of participants in randomised controlled trials (RCTs) is problematic but common. Clear and detailed reporting of participant flow is essential to assess the generalisability and comparability of RCTs. Despite improved reporting since the implementation of the CONSORT statement, important problems remain. This paper aims: (i) to update and extend previous reviews evaluating reporting of participant recruitment and retention in RCTs; (ii) to quantify the level of participation throughout RCTs.</p> <p>Methods</p> <p>We reviewed all reports of RCTs of health care interventions and/or processes with individual randomisation, published July–December 2004 in six major journals. Short, secondary or interim reports, and Phase I/II trials were excluded. Data recorded were: general RCT details; inclusion of flow diagram; participant flow throughout trial; reasons for non-participation/withdrawal; target sample sizes.</p> <p>Results</p> <p>133 reports were reviewed. Overall, 79% included a flow diagram, but over a third were incomplete. The majority reported the flow of participants at each stage of the trial after randomisation. However, 40% failed to report the numbers assessed for eligibility. Percentages of participants retained at each stage were high: for example, 90% of eligible individuals were randomised, and 93% of those randomised were outcome assessed. On average, trials met their sample size targets. However, there were some substantial shortfalls: for example 21% of trials reporting a sample size calculation failed to achieve adequate numbers at randomisation, and 48% at outcome assessment. Reporting of losses to follow up was variable and difficult to interpret.</p> <p>Conclusion</p> <p>The majority of RCTs reported the flow of participants well after randomisation, although only two-thirds included a complete flow chart and there was great variability over the definition of "lost to follow up". Reporting of participant eligibility was poor, making assessments of recruitment practice and external validity difficult. Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart.</p

General practitioners’ perceptions of effective health care

OBJECTIVES: To explore general practitioners’ perceptions of effective health care and its application in their own practice; to examine how these perceptions relate to assumptions about clinicians’ values and behaviour implicit in the evidence based medicine approach. DESIGN: A qualitative study using semistructured interviews. SETTING: Eight general practices in North Thames region that were part of the Medical Research Council General Practice Research Framework. PARTICIPANTS: 24 general practitioners, three from each practice. MAIN OUTCOME MEASURES: Respondents’ definitions of effective health care, reasons for not practising effectively according to their own criteria, sources of information used to answer clinical questions about patients, reasons for making changes in clinical practice. RESULTS: Three categories of definitions emerged: clinical, patient related, and resource related. Patient factors were the main reason given for not practising effectively; others were lack of time, doctors’ lack of knowledge and skills, lack of resources, and “human failings.” Main sources of information used in situations of clinical uncertainty were general practitioner partners and hospital doctors. Contact with hospital doctors and observation of hospital practice were just as likely as information from medical and scientific literature to bring about changes in clinical practice. CONCLUSIONS: The findings suggest that the central assumptions of the evidence based medicine paradigm may not be shared by many general practitioners, making its application in general practice problematic. The promotion of effective care in general practice requires a broader vision and a more pragmatic approach which takes account of practitioners’ concerns and is compatible with the complex nature of their work

The adoption space of early-emerging technologies: evaluation, innovation, gatekeeping (PATH). Final report. NIHR Service Delivery and Organisation programme

Aims: the research aims to provide an empirical, robust foundation for the broader task of identifying the factors involved in appropriate technology adoptive practice. It focuses on understanding and explaining adoptive behaviour in key early-emerging technologies. It provides a major set of documented case studies as resources for the NHS/Service Delivery & Organisation R&D community, and informs the development of a context-sensitive conceptual model for understanding and potentially planning adoption-evaluation pathways. It identifies alignments of factors in the early adoptive process that enable or control adoption in a variety of settings. This involves innovatory forces outside the NHS such as commercial device producers and the private healthcare sector. Methodology: in a 30-month multi-method project, we undertake a set of four detailed in-depth multi-method qualitative case studies (in wound care, chronic back pain, anticoagulation monitoring, and prostate cancer surgery), augmented by a further four less detailed case studies to extend generalisability. We will develop a typology of technologies, and in consultation with research-users and stakeholders, we will develop a new conceptual model of what we term the adoption space', validating it against the case study data. The model will identify the key parameters, and the salient drivers within them, through which early-emerging technologies take distinct pathways into healthcare. The initial conceptualisation of the model is based on actor-network theory/Science and Technology Studies and methodological health services research, and our own recent case studies of device innovation/governance. The model's core working parameters are: Technology, Network, Promotion, Gatekeeping, and Evidence. The research is distinct in giving artefactual technology itself due recognition as a factor shaping adoption pathways. Data collection: a baseline state of evidence and adoption' will be compiled for each case. It will document retrospectively key events that have shaped the early pathway, then developments will be tracked prospectively in real-time through the project's duration. A variety of ethnographic data-collection methods are used including observation, documents and semi-structured interviewing with key informants. There are two levels of data-collection: the technology-specific network', including extra-NHS actors, and the intra-NHS level, where fieldwork is undertaken in two separate organisational sites for each of the four technologies. For the additional four rapid appraisal' cases, key informant and documentary methods are used. Analysis: The key principle of the analysis is to provide for cycles of iteration between case study analysis and development of the adoption space model. The two levels of data-collection (wider network and adoptive NHS site) are an organising principle of the analysis. Mid-way through the project we will present interim analysis and model development to select research users, to debate the evolving model. Both descriptive and explanatory analytic techniques will be applied. We deploy standard qualitative case study data analysis techniques, and discourse analysis. The study design enables within-case and cross-case comparative analyses, including between organisational settings for the same technology; and inter-technology comparisons. Cross-case syntheses and comparisons will develop the conceptual model of the adoption space and strengthen its explanatory power for understanding the determinants of early adoption-evaluation pathways

Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent

Context: With the routinization of evidence-based medicine and of the randomized-controlled trial (RCT), more patients are becoming ‘sites of evidence production’ yet, little is known about how they are recruited as participants; there is some evidence that ‘substantively valid consent’ is difficult to achieve. Objective: To explore the views and experiences of nurses recruiting patients to randomized-controlled trials and to examine the extent to which their recruitment practices were patient-centred and patient empowering. Design: Semi-structured in-depth interviews; audio recording of recruitment appointments; thematic interactional analysis (drawing on discourse and conversation analysis). Setting and participants: Nurses recruiting patients to five publicly funded RCTs and patients consenting to the recording of their recruitment sessions. Main outcome measures: The views of recruiting nurses about their recruitment role; the extent to which nurse–patient interactions were patient-centred; the nature of the nurses’ interactional strategies and the nature and extent of patient participation in the discussion. Results: The nurses had a keen sense of themselves as clinicians and patient advocates and their perceptions of the trial and its interventions were inextricably linked to those of the patients. However, many of their recruitment practices made it difficult for patients to play an active and informed part in the discussion about trial participation, raising questions over the quality of consent decisions. Conclusion: Nurses working in patient recruitment to RCTs need to reconcile two different worlds with different demands and ethics. Evidence production, a central task in evidence-based medicine, poses a challenge to patient-centred practice and more research and relevant training are needed

Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness

Background Under-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness. Aim To evaluate reasons for under-recruitment in an RCT of patients with severe mental illness Methods Qualitative study during the recruitment phase of an RCT of supported employment. Trial staff and recruiting clinicians were interviewed. Data were analyzed thematically using constant comparative techniques. Results Recruitment rates were low. Five main reasons for recruitment difficulties were found. These included: (i) misconceptions about trials, (ii) lack of equipoise, (iii) misunderstanding of the trial arms, (iv) variable interpretations of eligibility criteria, (v) paternalism. Conclusion Reasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general, but others are more specific to these patients. Clinician and patient involvement in the study design may improve recruitment in future similar trials