What do we want to get out of this? a critical interpretive synthesis of the value of process evaluations, with a practical planning framework.

BACKGROUND: Process evaluations aim to understand how complex interventions bring about outcomes by examining intervention mechanisms, implementation, and context. While much attention has been paid to the methodology of process evaluations in health research, the value of process evaluations has received less critical attention. We aimed to unpack how value is conceptualised in process evaluations by identifying and critically analysing 1) how process evaluations may create value and 2) what kind of value they may create. METHODS: We systematically searched for and identified published literature on process evaluation, including guidance, opinion pieces, primary research, reviews, and discussion of methodological and practical issues. We conducted a critical interpretive synthesis and developed a practical planning framework. RESULTS: We identified and included 147 literature items. From these we determined three ways in which process evaluations may create value or negative consequences: 1) through the socio-technical processes of 'doing' the process evaluation, 2) through the features/qualities of process evaluation knowledge, and 3) through using process evaluation knowledge. We identified 15 value themes. We also found that value varies according to the characteristics of individual process evaluations, and is subjective and context dependent. CONCLUSION: The concept of value in process evaluations is complex and multi-faceted. Stakeholders in different contexts may have very different expectations of process evaluations and the value that can and should be obtained from them. We propose a planning framework to support an open and transparent process to plan and create value from process evaluations and negotiate trade-offs. This will support the development of joint solutions and, ultimately, generate more value from process evaluations to all.

Process evaluation within pragmatic randomised controlled trials: what is it, why is it done, and can we find it?-a systematic review.

BACKGROUND: Process evaluations are increasingly conducted within pragmatic randomised controlled trials (RCTs) of health services interventions and provide vital information to enhance understanding of RCT findings. However, issues pertaining to process evaluation in this specific context have been little discussed. We aimed to describe the frequency, characteristics, labelling, value, practical conduct issues, and accessibility of published process evaluations within pragmatic RCTs in health services research. METHODS: We used a 2-phase systematic search process to (1) identify an index sample of journal articles reporting primary outcome results of pragmatic RCTs published in 2015 and then (2) identify all associated publications. We used an operational definition of process evaluation based on the Medical Research Council's process evaluation framework to identify both process evaluations reported separately and process data reported in the trial results papers. We extracted and analysed quantitative and qualitative data to answer review objectives. RESULTS: From an index sample of 31 pragmatic RCTs, we identified 17 separate process evaluation studies. These had varied characteristics and only three were labelled 'process evaluation'. Each of the 31 trial results papers also reported process data, with a median of five different process evaluation components per trial. Reported barriers and facilitators related to real-world collection of process data, recruitment of participants to process evaluations, and health services research regulations. We synthesised a wide range of reported benefits of process evaluations to interventions, trials, and wider knowledge. Visibility was often poor, with 13/17 process evaluations not mentioned in the trial results paper and 12/16 process evaluation journal articles not appearing in the trial registry. CONCLUSIONS: In our sample of reviewed pragmatic RCTs, the meaning of the label 'process evaluation' appears uncertain, and the scope and significance of the term warrant further research and clarification. Although there were many ways in which the process evaluations added value, they often had poor visibility. Our findings suggest approaches that could enhance the planning and utility of process evaluations in the context of pragmatic RCTs. TRIAL REGISTRATION: Not applicable for PROSPERO registration.

Specialist nurses' perceptions of inviting patients to participate in clinical research studies: a qualitative descriptive study of barriers and facilitators.

BACKGROUND: Increasing the number of patients participating in research studies is a current priority in the National Health Service (NHS) in the United Kingdom. The role of specialist nurses in inviting patients to participate is important, yet little is known about their experiences of doing so. The aim of this study was to explore the perceptions of barriers and facilitators held by specialist nurses with experience of inviting adult NHS patients to a wide variety of research studies. METHODS: A cross-sectional qualitative descriptive study was conducted between March and July 2015. Participants were 12 specialist nurses representing 7 different clinical specialties and 7 different NHS Trusts. We collected data using individual semi-structured interviews, and analysed transcripts using the Framework method to inductively gain a descriptive overview of barriers and facilitators. RESULTS: Barriers and facilitators were complex and interdependent. Perceptions varied among individuals, however barriers and facilitators centred on five main themes: i) assessing patient suitability, ii) teamwork, iii) valuing research, iv) the invitation process and v) understanding the study. Facilitators to inviting patients to participate in research often stemmed from specialist nurses' attitudes, skills and experience. Positive research cultures, effective teamwork and strong relationships between research and clinical teams at the local clinical team level were similarly important. Barriers were reported when specialist nurses felt they were providing patients with insufficient information during the invitation process, and when specialist nurses felt they did not understand studies to their satisfaction. CONCLUSION: Our study offers several new insights regarding the role of specialist nurses in recruiting patients for research. It shows that strong local research culture and teamwork overcome some wider organisational and workload barriers reported in previous studies. In addition, and in contrast to common practice, our findings suggest research teams may benefit from individualising study training and invitation procedures to specialist nurses' preferences and requirements. Findings provide a basis for reflection on practice for specialist nurses, research teams, policymakers, and all with an interest in increasing patient participation in research.

More than meets the eye.

In my work as a research nurse for more than four years, I gained experience in a range of tasks and roles. These included recruiting patients, gaining informed consent, collecting research data, dispensing trial medication, collecting and overall study co-ordination (see box ).