Sharon McCann

Recruitment to clinical trials: a meta-ethnographic synthesis of studies of reasons for participation:

Objectives Randomized controlled trials are important for evaluating health care interventions, but recruitment can be difficult. Studies of potential participants’ perspectives on trial participation are accumulating, but their collective contribution is not obvious. In 2007, we conducted a meta-ethnographic synthesis of people’s reasons for accepting or declining participation. This paper reports a second synthesis, conducted separately on the same topic, using studies published subsequently. It discusses both the substantive findings and the methodological implications for updating meta-ethnographies. Methods Systematic searches identified relevant papers published between 1996 and 2005 (first synthesis), then 2005 and 2010 (second synthesis). We used a meta-ethnographic interpretive process of translation to examine the relationships between study findings. Findings The two syntheses were broadly compatible, but the line of argument developed in the second more clearly highlighted how potential participants’ health states and health care situations at the time of recruitment could interact with other considerations. In particular, they could influence the nature and significance for trial entry decisions of people’s judgements about: their communication and relationship with trial recruiters; the personal implications of trial interventions and processes; and the ‘common good’ (helping others) and what their non/participation might say about their identity. Conclusions Our work highlights the need for trialists to consider potential participants’ health and health care situations when designing recruitment approaches. It also provides the first empirical insights on the process of updating meta-ethnographies that we are currently aware of. Approaches to updating meta-ethnographies need further investigation.

Developing the clinical components of a complex intervention for a glaucoma screening trial: a mixed methods study

Background Glaucoma is a leading cause of avoidable blindness worldwide. Open angle glaucoma is the most common type of glaucoma. No randomised controlled trials have been conducted evaluating the effectiveness of glaucoma screening for reducing sight loss. It is unclear what the most appropriate intervention to be evaluated in any glaucoma screening trial would be. The purpose of this study was to develop the clinical components of an intervention for evaluation in a glaucoma (open angle) screening trial that would be feasible and acceptable in a UK eye-care service. Methods A mixed-methods study, based on the Medical Research Council (MRC) framework for complex interventions, integrating qualitative (semi-structured interviews with 46 UK eye-care providers, policy makers and health service commissioners), and quantitative (economic modelling) methods. Interview data were synthesised and used to revise the screening interventions compared within an existing economic model. Results The qualitative data indicated broad based support for a glaucoma screening trial to take place in primary care, using ophthalmic trained technical assistants supported by optometry input. The precise location should be tailored to local circumstances. There was variability in opinion around the choice of screening test and target population. Integrating the interview findings with cost-effectiveness criteria reduced 189 potential components to a two test intervention including either optic nerve photography or screening mode perimetry (a measure of visual field sensitivity) with or without tonometry (a measure of intraocular pressure). It would be more cost-effective, and thus acceptable in a policy context, to target screening for open angle glaucoma to those at highest risk but for both practicality and equity arguments the optimal strategy was screening a general population cohort beginning at age forty. Conclusions Interventions for screening for open angle glaucoma that would be feasible from a service delivery perspective were identified. Integration within an economic modelling framework explicitly highlighted the trade-off between cost-effectiveness, feasibility and equity. This study exemplifies the MRC recommendation to integrate qualitative and quantitative methods in developing complex interventions. The next step in the development pathway should encompass the views of service users.BackgroundGlaucoma is a leading cause of avoidable blindness worldwide. Open angle glaucoma is the most common type of glaucoma. No randomised controlled trials have been conducted evaluating the effectiveness of glaucoma screening for reducing sight loss. It is unclear what the most appropriate intervention to be evaluated in any glaucoma screening trial would be. The purpose of this study was to develop the clinical components of an intervention for evaluation in a glaucoma (open angle) screening trial that would be feasible and acceptable in a UK eye-care service.MethodsA mixed-methods study, based on the Medical Research Council (MRC) framework for complex interventions, integrating qualitative (semi-structured interviews with 46 UK eye-care providers, policy makers and health service commissioners), and quantitative (economic modelling) methods. Interview data were synthesised and used to revise the screening interventions compared within an existing economic model.ResultsThe qualitative data indicated broad based support for a glaucoma screening trial to take place in primary care, using ophthalmic trained technical assistants supported by optometry input. The precise location should be tailored to local circumstances. There was variability in opinion around the choice of screening test and target population. Integrating the interview findings with cost-effectiveness criteria reduced 189 potential components to a two test intervention including either optic nerve photography or screening mode perimetry (a measure of visual field sensitivity) with or without tonometry (a measure of intraocular pressure). It would be more cost-effective, and thus acceptable in a policy context, to target screening for open angle glaucoma to those at highest risk but for both practicality and equity arguments the optimal strategy was screening a general population cohort beginning at age forty.ConclusionsInterventions for screening for open angle glaucoma that would be feasible from a service delivery perspective were identified. Integration within an economic modelling framework explicitly highlighted the trade-off between cost-effectiveness, feasibility and equity. This study exemplifies the MRC recommendation to integrate qualitative and quantitative methods in developing complex interventions. The next step in the development pathway should encompass the views of service users.

A quest for patient-safe culture: contextual influences on patient safety performance

Objectives To use organizational change theory to explore the interplay of contextual influences on patient safety. Methods A multi-level comparative case study of eight National Health Service (NHS) acute hospital trusts in England, including 144 depth interviews with senior managers, staff involved with risk analysis and reporting, middle managers, and senior and junior clinicians, supplemented with documentary data and observation of nine meetings. Organizational change theory was used to identify content, contextual and process influences on patient safety. Results Organizational stability and staff engagement appeared to influence patient safety and specific contextual factors appeared to influence both organizational stability and staff engagement, both of which were important for patient safety. These contextual factors comprised: environmental shocks; cultural characteristics; processes and structures supportive of patient safety; and trust leadership style. A model is suggested that analyses the trusts in terms of these factors and then groups them into four trust types. Conclusion The study highlights the massive and unpredictable impact of both internal and external environmental shocks and how they destabilize trusts distracting attention from patient safety. It also underlines the importance of regular self-assessment of internal and external risks and awareness of context.

Patient-, organization-, and system-level barriers and facilitators to preventive oral health care: a convergent mixed-methods study in primary dental care

BackgroundDental caries is the most common chronic disease of adult and childhood, a largely preventable yet widespread, costly public health problem. This study identified patient-, organization-, and system-level factors influencing routine delivery of recommended care for prevention and management of caries in primary dental care.MethodsA convergent mixed-methods design assessed six guidance-recommended behaviours to prevent and manage caries (recording risk, risk-based recall intervals, applying fluoride varnish, placing preventive fissure sealants, demonstrating oral health maintenance, taking dental x-rays). A diagnostic questionnaire assessing current practice, beliefs, and practice characteristics was sent to a random sample of 651 dentists in National Health Service (NHS) Scotland. Eight in-depth case studies comprising observation of routine dental visits and dental team member interviews were conducted. Patient feedback was collected from adult patients with recent checkups at case study practices. Key informant interviews were conducted with decision makers in policy, funding, education, and regulation. The Theoretical Domains Framework within the Behaviour Change Wheel was used to identify and describe patient-, organization-, and system-level barriers and facilitators to care. Findings were merged into a matrix describing theoretical domains salient to each behaviour. The matrix and Behaviour Change Wheel were used to prioritize behaviours for change and plan relevant intervention strategies.ResultsTheoretical domains associated with best practice were identified from the questionnaire (N-196), case studies (N = 8 practices, 29 interviews), and patient feedback (N = 19). Using the study matrix, key stakeholders identified priority behaviours (use of preventive fissure sealants among 6–12-year-olds) and strategies (audit and feedback, patient informational campaign) to improve guidance implementation. Proposed strategies were assessed as appropriate for immediate implementation and suitable for development with remaining behaviours.ConclusionsSpecific, theoretically based, testable interventions to improve caries prevention and management were coproduced by patient-, practice-, and policy-level stakeholders. Findings emphasize duality of behavioural determinants as barriers and facilitators, patient influence on preventive care delivery, and benefits of integrating multi-level interests when planning interventions in a dynamic, resource-constrained environment. Interventions identified in this study are actively being used to support ongoing implementation initiatives including guidance, professional development, and oral health promotion.

What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges

BackgroundClinical trials oversight by a Trial Steering Committee (TSC) is mandated by Good Clinical Practice. This study used qualitative methods to explore the role and valued attributes of the TSC to inform planned updates of Medical Research Council guidance and TSC terms of reference.MethodsAn ethnographic study was conducted during 2013–2014. TSC and Trial Management Group meetings from eight trials were observed and audio-recorded, and semi-structured interviews conducted with purposively sampled key informants: independent and non-independent TSC members, trial sponsor representatives, funder representatives and chief investigators. The selected trials were currently recruiting and dealing with challenging scenarios. Data were analysed thematically and findings triangulated and integrated to give a multi-perspective account of the role and valued attributes of a TSC.ResultsEight TSC meetings and six Trial Management Group meetings were observed. Sixty-five interviews were conducted with 51 informants. The two main roles played by the TSC were quality assurance and patient advocacy. Quality assurance involved being a ‘critical friend’ or a provider of ‘tough love’. Factors influencing the ability of the TSC to fulfil this role included the TSC Chair, other independent TSC members and the model of the TSC and its fit with the trial subject. The role of the TSC as an advocate for patient well-being was perceived as paramount. Two attributes of TSC members emerged as critical: experience (of running a trial, trial oversight or in a clinical/methodological area) and independence. While independence was valued for giving impartiality, the lack of consensus about its definition and strict requirements of some funders made it difficult to operationalise.ConclusionsWe found tensions and ambiguities in the roles expected of TSCs and the attributes valued of TSC members. In particular, the requirements of independence and experience could conflict, impacting the TSCs’ quality assurance role. Concerns were raised regarding whose interests are served by funders’ criteria of independence; in particular, funders’ selection of TSC members was thought to potentially inhibit TSCs’ ability to fulfil their patient advocacy role. These findings should be incorporated in revising guidance and terms of reference for TSCs.

An ethnographic study of group decision making to understand and improve how trial steering committees contribute to trial conduct

According to the MRC Guidelines for Good Clinical Practice, the role of Trial Steering Committees (TSCs) is to provide overall supervision of a trial. While the HTA DAMOCLES project resulted in a charter for Data Monitoring Committees, there is currently little empirical evidence regarding how TSCs oversee trials and make decisions about trial conduct.

‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact

BackgroundThe oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines.MethodsUsing an ethnographic study design, we observed the oversight processes of eight trials and conducted semi-structured interviews with members of the trials’ TSCs and TMGs, plus other relevant informants, including sponsors and funders of trials. Data were analysed thematically, and findings triangulated and integrated to give a multi-perspective account of current oversight practices in the UK.ResultsEight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semi-structured interviews conducted with 52 purposively sampled key informants. Five themes are presented: (1) Collaboration within the TMG and role of the CTU; (2) Collaboration and conflict between oversight committees; (3) Priorities; (4) Communication between trial oversight groups and (5) Power and accountability. There was evidence of collaborative relationships, based on mutual respect, between CTUs, TMGs and TSCs, but also evidence of conflict. Relationships between trial oversight committees were influenced by stakeholders’ priorities, both organisational and individual. Good communication following specific, recognised routes played a central role in ensuring that relationships were productive and trial oversight efficient. Participants described the possession of power over trials as a shifting political landscape, and there was lack of clarity regarding the roles and accountability of each committee, the sponsor and funder. Stakeholders’ perceptions of their own power over a trial, and the power of others, influenced relationships between those involved in trial oversight.ConclusionsRecent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines.

The importance of rapport and relationship building when recruiting to clinical trials: a qualitative investigation of trial recruitment consultations in a surgical RCT

Results The key findings highlighted the importance of; a) the context to the recruitment consultation, b) the current health status of potential participants at the time of trial invitation, and c) the trial information exchange process. These findings were underpinned by an overarching theme relating to recruiter rapport and relationship building with potential participants. The recruiter demonstrated an important role in terms of being empathetic, reassuring, supportive and attentive when discussing the trial with the participants. Conclusions Previous studies have shown that exploring treatment preferences, within the context of recruitment consultations, facilitated recruitment. VUE-Qual has provided a rich insight into how information is discussed in recruitment consultations between potential participants and recruiter in the context of a surgical prolapse trial. It has also identified aspects of the recruitment consultation that should be explored more systematically in other trial recruitment settings to potentially improve the recruitment process.

Enhancing public involvement in trial oversight committees through qualitative research with eight trials facing challenges

Background Trial oversight committees (TOC) including Trial Steering Committees (TSCs) and Trial Management Groups (TMGs) are integral to trial conduct. Patient and public involvement (PPI) in trial design and conduct is frequently stipulated although there is little empirical evidence to optimise roles and inputs. We aimed to use qualitative research to understand the experiences of PPI involvement in TOCs to enhance PPI contributions to trial conduct.

Recruitment to trials: insights from a meta-ethnography of qualitative studies

It is well known that recruitment to trials can be difficult. A number of in-depth qualitative studies have been published that have examined patient experiences of recruitment and participation in trials. To understand the collective insights from these studies, we undertook a meta-ethnography (a formal synthesis method for constructing interpretations cumulatively across qualitative studies) of qualitative studies published between 1996 and 2010, focusing on people’s own accounts of their decisions to accept or decline trial participation. Our synthesis highlighted how key aspects of the context, recruitment approach and individual approached can interact to influence trial recruitment. The way potential participants were situated in terms of their health states and treatment junctures was particularly salient. Their perceptions of their situation at the time of being trial entry influenced their judgements about the implications of trial participation for both their own and the broader common good. These perceptions could mediate the influence of individuals communication and relationship with trial recruiters, of the nature of trial interventions and processes, their desire to help others, and of what their non/participation might say about them as persons. The synthesis and model of factors likely to affect recruitment will be presented.