Process Evaluations Of Complex Interventions Research Articles

Process evaluation of school-based high-intensity interval training interventions for children and adolescents: a systematic review and meta-analysis of randomized controlled trials

BackgroundSeveral systematic reviews have been published to investigate the effectiveness of high-intensity interval training (HIIT) in schools. However, there has been limited attention given to understanding the functioning of the intervention processes, which is of paramount importance for interpreting and translating the intervention effectiveness. The aim of this systematic review is to determine the extent to which process evaluation is measured in school-based HIIT interventions and to explore the effects of process evaluation and intervention characteristics on cardiorespiratory fitness (CRF), body composition, muscular strength, and blood pressure.MethodsA comprehensive search was conducted in SPORT Discus (EBSCOhost), Web of Science, Scopus, Medline (Ovid) and Cochrane Central Register of Controlled Trials. The extent to which process evaluation is measured was narratively reported, alongside with the guidance of process evaluation of complex interventions by UK Medical Research Council. Meta-analyses and meta-regressions were conducted to determine the effects of process evaluation and intervention characteristics to the intervention outcomes.ResultsThe literature search identified 77 studies reporting on 45 school-based HIIT interventions. In total, five interventions reported process evaluation in a section or in a separate study, and only one intervention adopted a process evaluation framework. On average, 6 out of 12 process evaluation measures were reported in all interventions. Subgroup analyses did not indicate any beneficial treatment effects for studies with process evaluation group, whereas all pooled data and studies without process evaluation group showed significant improvement for CRF and body composition.ConclusionProcess evaluation is frequently omitted in the literature of school-based HIIT in children and adolescents. Although reporting of process evaluation measures may not directly associate with better intervention outcomes, it allows accurate interpretation of intervention outcomes, thereby enhancing the generalisability and dissemination of the interventions.

Implementing a social innovation for community-based peer support for immigrant mothers in Sweden: a mixed-methods process evaluation.

A South African social innovation based on peer support for mothers was contextualized in southern Sweden. The objective of the project was to support expectant women and mothers of young children in immigrant communities to access public services that would benefit maternal and child health. This study aimed to assess how the intervention was implemented, what the contextual barriers and facilitators were, and how the implementation was perceived by those who delivered and received it. The study used mixed methods with a convergent parallel design and followed the Medical Research Council guidance on process evaluations of complex interventions. Semi-structured interviews (n = 19) were conducted with peer supporters, client mothers, and key stakeholders involved in the intervention. The qualitative data were analyzed using content analysis. Quantitative data on peer supporters' activities were collected during contacts with client mothers and were presented descriptively. The five peer supporters had 1,294 contacts with client mothers, of which 507 were first-time contacts. The reach was perceived as wide, and the dose of the intervention was tailored to individual needs. Barriers to implementation included community mistrust of social services, norms on gender roles and parenting, and funding challenges. The implementation was facilitated by the organization's reputation, network, experience, and third-sector affiliation. Peer supporters tended to prioritize linking clients to other services over the educational components of the intervention, sometimes doing more than what was originally planned. Implementation strategies used included building trust, using multiple outreach venues, using internal support structures, and providing practical assistance as an entry point to comprehensive psychosocial support. The personal connection between peer supporters and clients was highly valued, and the building of relationships enabled them to address sensitive topics. Peer supporters sometimes experienced a blurred line between professional and personal roles. Peer supporters used a variety of strategies to navigate identified barriers and facilitators. Trust was central both as a contextual factor and a strategy for implementation. It is valuable to maintain a balance between flexibility and adherence to the function of peer supporters. Further research is needed to evaluate the effects of the intervention.

Implementation of dementia care management in routine care (RoutineDeCM): a study protocol for process evaluation

IntroductionDementia care management is a complex intervention intended to support persons with dementia and their (caring) relatives in home-based care arrangements. Dementia care management was developed in the federal state...

Implementation of offering choice of pulmonary rehabilitation location to people with COPD: a protocol for the process evaluation of a cluster randomised controlled trial

BackgroundPulmonary rehabilitation (PR) is a core component of management people with chronic obstructive pulmonary disease (COPD); yet, people with COPD face significant barriers to attending centre-based PR programs. The emergence of new models of PR, remotely delivered directly into people’s homes, has the potential to improve rehabilitation access and completion by providing patients with a choice of rehabilitation location (centre or home). However, offering patients a choice of rehabilitation model is not usual practice. We are undertaking a 14-site cluster randomised controlled trial to determine whether offering choice of PR location improves rehabilitation completion rates resulting in reduced all-cause unplanned hospitalisation over 12 months. The aim of this paper is to describe the protocol for the process evaluation of the HomeBase2 trial.MethodsA mixed methods process evaluation, to be undertaken in real time, has been developed in accordance with UK Medical Research Council (MRC) recommendations on process evaluation of complex interventions. This protocol describes the intended use of two theoretical frameworks (RE-AIM framework (Reach; Effectiveness; Adoption; Implementation; Maintenance) and Theoretical Domains Framework (TDF)) to synthesise findings and interpret data from a combination of qualitative (semi-structured interviews) and quantitative (questionnaires, clinical outcome data, intervention fidelity) methodologies. Data will be collected at an intervention, patient and clinician level. Qualitative and quantitative data will be used to derive context-specific potential and actual barriers and facilitators to offering patients choice of rehabilitation location. Acceptability and sustainability of the intervention will be evaluated for future scale-up.DiscussionThe process evaluation described here will appraise the clinical implementation of offering a choice of rehabilitation program location for people with COPD. It will identify and evaluate key factors for future scale-up and sustainability and scale-up of offering choice of pulmonary rehabilitation program model for people.Trial registrationClinicalTrials.gov NCT04217330 Registration date: January 3 2020.

Process evaluation of complex interventions in non-communicable and neglected tropical diseases in low- and middle-income countries: a scoping review

ObjectivesThe aim of this review is to map out the use of process evaluation (PE) in complex interventions that address non-communicable diseases (NCDs) and neglected tropical diseases (NTDs) to identify...

Implementation of a Health Promotion Practice Using Individually Targeted Lifestyle Interventions in Primary Health Care: Protocol for the "Act in Time" Mixed Methods Process Evaluation Study.

BackgroundThere is growing evidence that noncommunicable diseases (NCDs) can be attributable to unhealthy lifestyle habits. However, there has been little application of this knowledge in primary health care (PHC).ObjectiveThis study aims to evaluate the process and outcomes of a multifaceted implementation strategy for a healthy lifestyle-promoting practice in a PHC setting. This practice is based on national guidelines targeting unhealthy lifestyle habits with a potential risk for NCDs.MethodsA pre-post implementation study design with a control group is used in a PHC setting in central Sweden. The Medical Research Council guidelines for process evaluation of complex interventions will be applied. The implementation process and outcomes will be assessed using a mix of qualitative and quantitative methods. A strategic sample of up to 6 PHC centers will be included as intervention centers, which will receive a 12-month multifaceted implementation strategy. Up to 6 matched PHC centers will serve as controls. Core components in the implementation strategy are external and internal facilitators in line with the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework and the Astrakan change leadership model. Data will be collected at baseline, during the implementation phase, and 4-6 months after the implementation strategy. Questionnaires will be sent to roughly 500 patients in every PHC center and 200 health care professionals (HCPs) before and after implementation. In addition, purposeful sampling will be used for interviews and focus group discussions with managers, HCPs, patient representatives, and internal and external facilitators. Use of data from medical records and activity logs will be an additional data source.ResultsRecruitment of PHC centers began in March 2021 and ended in Spring 2022. Based on the planned timeline with the 12-month implementation strategy and 4-6-month follow-up, we expect to collect the final data in Summer 2023.ConclusionsThis study will explain implementation process and outcomes using a multifaceted implementation strategy for a healthy lifestyle-promoting practice in a real-world PHC context. The study is expected to provide new knowledge about the role of facilitators and their contribution to implementation outcomes. These findings can guide policy makers, managers, and PHC staff to integrate health promotion and disease prevention in PHC and provide methodological support to facilitators.Trial RegistrationClinicalTrials.gov NCT04799860; https://clinicaltrials.gov/ct2/show/NCT04799860International Registered Report Identifier (IRRID)DERR1-10.2196/37634

The value of process evaluation for public health interventions: field-case studies for non-communicable disease prevention and management in five countries.

Complex interventions are needed to effectively tackle non-communicable diseases. However, complex interventions can contain a mix of effective and ineffective actions. Process evaluation (PE) in public health research is of great value as it could clarify the mechanisms and contextual factors associ-ated with variation in the outcomes, better identify effective components, and inform adaptation of the intervention. The aim of this paper is to demonstrate the value of PE through five case studies that span the research cycle. The interven-tions include using digital health, salt reduction strategies, use of fixed dose combinations, and task shifting. Insights of the methods used, and the implications of the PE findings to the project, were discussed. PE of complex interventions can refute or confirm the hypothesized mechanisms of action, thereby enabling intervention refinement, and identifying implementation strategies that can address local contextual needs, so as to improve service delivery and public health outcomes.

Wider considerations following evaluation of the STAR care pathway for patients with painful knee replacement.

In The Lancet Rheumatology, Vikki Wylde and colleagues 1 Wylde V Bertram W Sanderson E et al. The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial. Lancet Rheumatol. 2022; (published online Jan 27)https://doi.org/10.1016/S2665-9913(22)00003-0 Google Scholar present the results of a randomised controlled trial (RCT) investigating the clinical and cost-effectiveness of the Support and Treatment After Replacement (STAR) care pathway compared with usual care on pain severity and pain interference after total knee replacement. The first point of note for this new RCT is the research question and design—the trial is an excellent example of a pragmatic, pathway-based design (ie, a management or package-of-care comparison) rather than the standard head-to-head comparison of two highly prescriptive and specific treatments. This is a fairly new approach to testing the efficacy of complex interventions and one that usefully accounts for real-world variation in treatment content and fidelity. It is likely we will see more of these types of comparisons, as it is increasingly recognised that RCTs with tightly-defined, complex treatments—along with the mixed fidelity associated with these treatments—are difficult to conduct and interpret and, sadly, can be unrepresentative of patients in real-world practice. 2 Fletcher A Jamal F Moore G et al. Realist complex intervention science: applying realist principles across all phases of the Medical Research Council framework for developing and evaluating complex interventions. Evaluation. 2016; 22: 286-303 Google Scholar , 3 Moore GF Audrey S Barker M et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015; 350h1258 Google Scholar Clarification and understanding of this lack of representativeness also assists the research community on defining what an intervention (for an RCT) really is. A colleague highlighted that physiotherapy (or any such broad therapeutic treatment label) is too vague a term to be of any real use in defining treatment for RCTs, as it refers only to a profession or to a global notion of an intervention. Unlike assessments of prescribed drugs, for example, treatments involving behaviour modifications, practitioner skill and experience, and high content and delivery heterogeneity (as described in this study 1 Wylde V Bertram W Sanderson E et al. The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial. Lancet Rheumatol. 2022; (published online Jan 27)https://doi.org/10.1016/S2665-9913(22)00003-0 Google Scholar ) are not helped by such general labels. The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trialSTAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. Full-Text PDF Open Access

People with diabetes and ambulance staff perceptions of a booklet-based intervention for diabetic hypoglycaemia, \u201cHypos can strike twice\u201d: a mixed methods process evaluation

BackgroundHypoglycaemia is a potentially serious condition, characterised by lower-than-normal blood glucose levels, common in people with diabetes (PWD). It can be prevented and self-managed if expert support, such as education on lifestyle and treatment, is provided. Our aim was to conduct a process evaluation to investigate how ambulance staff and PWD perceived the “Hypos can strike twice” booklet-based ambulance clinician intervention, including acceptability, understandability, usefulness, positive or negative effects, and facilitators or barriers to implementation.MethodsWe used an explanatory sequential design with a self-administered questionnaire study followed by interviews of people with diabetes and ambulance staff. We followed the Medical Research Council framework for process evaluations of complex interventions to guide data collection and analysis. Following descriptive analysis (PWD and staff surveys), exploratory factor analysis was conducted to identify staff questionnaire subscales and multiple regression models were fitted to identify demographic predictors of overall and subscale scores.Results113 ambulance staff members and 46 PWD completed the survey. We conducted interviews with four ambulance staff members and five PWD who had been attended by an ambulance for a hypoglycaemic event. Based on surveys and interviews, there were positive attitudes to the intervention from both ambulance staff and PWD. Although the intervention was not always implemented, most staff members and PWD found the booklet informative, easy to read and to use or explain. PWD who completed the survey reported that receiving the booklet reminded and/or encouraged them to test their blood glucose more often, adjust their diet, and have a discussion/check up with their diabetes consultant. Interviewed PWD felt that the booklet intervention would be more valuable to less experienced patients or those who cannot manage their diabetes well. Overall, participants felt that the intervention could be beneficial, but were uncertain about whether it might help prevent a second hypoglycaemic event and/or reduce the number of repeat ambulance attendances.ConclusionsThe ‘Hypos may strike twice’ intervention, which had demonstrable reductions in repeat attendances, was found to be feasible, acceptable to PWD and staff, prompting reported behaviour change and help-seeking from primary care.Trial registrationRegistered with ClinicalTrials.gov: NCT04243200 on 27 January 2020.

Mechanisms and Contextual Factors Affecting the Implementation of Animal Health Surveillance in Tanzania: A Process Evaluation.

A strong animal health surveillance system is an essential determinant of the health of animal and human population. To ensure its functionality and performance, it needs to be evaluated regularly. Therefore, a process evaluation was conducted in this study to assess animal health surveillance processes, mechanisms and the contextual factors which facilitate or hinder uptake, implementation and sustainability of the system in Tanzania. A mixed-method study design was used to evaluate the national animal health surveillance system guided by a framework for process evaluation of complex interventions developed by Moore and others. The system was assessed against standard guidelines and procedures using the following attributes: fidelity, adherence, exposure, satisfaction, participation rate, recruitment and context. Quantitative and qualitative data were collected using a cross-sectional survey, key informant interviews, document review, site visits and non-participant observation. Data from questionnaires were downloaded, cleaned and analyzed in Microsoft™ Excel. Qualitative data were analyzed following deductive thematic and content analysis methods. Fidelity attribute showed that case identification is mainly based on clinical signs due to limited laboratory services for confirmation. Data collection was not well-coordinated and there were multiple disparate reporting channels. Adherence in terms of the proportion of reports submitted per month was only 61% of the target. District-level animal health officials spent an average of 60% of their weekly time on surveillance-related activities, but only 12% of them were satisfied with the surveillance system. Their dissatisfaction was caused by large area coverage with little to no facilitation, poor communication, and lack of a supporting system. The cost of surveillance data was found to be 1.4 times higher than the annual surveillance budget. The timeliness of the system ranged between 0 and 153 days from the observation date (median = 2 days, mean = 6 days). The study pointed out some deviations in animal health surveillance processes from the standard guidelines and their implication on the system's performance. The system could be improved by developing a user-friendly unified reporting system, the active involvement of subnational level animal health officials, optimization of data sources and an increase in the horizon of the financing mechanism.

Mechanisms of impact and contextual aspects of a dementia special care unit in long-term care: a process evaluation

BackgroundIn long-term care, persons with dementia are often cared for in specialised facilities, which are rather heterogeneous in regard to care concepts. Little information is available on how these facilities and care concepts bring about changes in the targeted outcomes. Such knowledge is needed to understand the effects of care concepts and to consciously shape further developments. This study aimed to explore the mechanisms of impact of a specific care concept from a dementia special care unit and the contextual aspects that influence its implementation or outcomes.MethodsUsing a qualitative approach to process evaluation of complex interventions, we conducted participating observations and focus groups with nurses and single interviews with ward and nursing home managers. Data were collected from two identical dementia special care units to enhance the contrasts in the analysis of two non-specialised nursing homes. We analysed the data thematically. We conducted 16 observations, three group interviews and eleven individual interviews.ResultsWe identified seven themes in three domains related to mechanisms that lead to outcomes regarding residents’ and nurses’ behaviour and well-being. The themes include the development of nurses’ skills and knowledge, the promotion of a positive work climate, adjusted spatial structures, adjusted personnel deployment strategy “dedicated time for activities”, promotion of relaxation, of engagement in activities and of engagement in social interaction of residents. The implementation and outcomes of the care concept are influenced by contextual aspects relating to the (target) population and cultural, organisational and financial features.ConclusionsThe study found expected and unexpected mechanisms of impact and contextual aspects. The care concept of the dementia special care unit results in higher levels of relaxation, activities, and social interaction of residents. Its implementation highly depends on the shared understanding of nursing and the skills of the nursing team. Changes in residents’ characteristics result in altered effects of the concept.Trial registrationDRKS00011513.

Facilitators and barriers to living donor kidney transplantation

Facilitators and barriers to living donor kidney transplantation

Theoretical approaches to process evaluations of complex interventions in health care: a systematic scoping review protocol

BackgroundComplex interventions in health care are characterized by multiple interacting components as well as by numerous nonlinear interactions with the social systems within which they are being implemented. The process of developing, evaluating and implementing complex interventions is therefore challenging. Established guidance such as the MRC (Medical Research Council) framework for developing and evaluating complex interventions refers to process evaluations as an integral part of the development of complex evidence-based interventions. Even though the need for process evaluations is recognized, the realization of such approaches is challenging because methodological instruction is sparse, and the phenomenon of interest is complex. A number of theoretical approaches indicating how to conduct process evaluations of complex interventions in health care exist, but a systematic and comprehensive overview of these is missing. Thus, the objective of the systematic scoping review described herein is to provide an overview and analysis of theoretical approaches suitable for the planning and conducting of process evaluations.MethodsThe design and conduct of this review will follow the procedures of a systematic scoping review. The search strategy will be developed following the BeHEMoTh (Behaviour of interest; Health context; Exclusions; Models or Theories) template which has been conceptualized for structured reviews of theory. The systematic search of the MEDLINE (via PubMed), CINAHL (via EBSCO) and PsycInfo (via EBSCO) electronic databases will be complemented by “hand searching” techniques. Study selection, data extraction, and data analysis will be performed by tandems of two researchers independently of each other. Divergent decisions and judgements between the two researchers will be discussed by the whole review team.DiscussionThe findings from this scoping review will provide an overview and comparison of theoretical approaches suitable for process evaluations of complex interventions in health care. The review results will support researchers in choosing the theoretical approach that best fits the respective focus of their process evaluation study.Systematic review registrationThis study has been registered with PROSPERO (International Prospective Register of Systematic Reviews) under registration number CRD42020211732.

Process evaluation of complex interventions in chronic and neglected tropical diseases in low- and middle-income countries\u2014a scoping review protocol

BackgroundThe use of process evaluations is a growing area of interest in research groups working on complex interventions. This methodology tries to understand how the intervention was implemented to inform policy and practice. A recent systematic review by Liu et al. on process evaluations of complex interventions addressing non-communicable diseases found few studies in low- and middle- income countries (LMIC) because it was restricted to randomized controlled trials, primary healthcare level and non-communicable diseases. Yet, LMICs face different barriers to implement interventions in comparison to high-income countries such as limited human resources, access to health care and skills of health workers to treat chronic conditions especially at primary health care level. Therefore, understanding the challenges of interventions for non-communicable diseases and neglected tropical diseases (diseases that affect poor populations and have chronic sequelae) will be important to improve how process evaluation is designed, conducted and used in research projects in LMICs. For these reasons, in comparison to the study of Liu et al., the current study will expand the search strategy to include different study designs, languages and settings.ObjectiveMap research using process evaluation in the areas of non-communicable diseases and neglected tropical diseases to inform the gaps in the design and conduct of this type of research in LMICs.MethodsScoping review of process evaluation studies of randomized controlled trials (RCTs) and non-RCTs of complex interventions implemented in LMICs including participants with non-communicable diseases or neglected tropical diseases and their health care providers (physicians, nurses, technicians and others) related to achieve better health for all through reforms in universal coverage, public policy, service delivery and leadership. The aspects that will be evaluated are as follows: (i) available evidence of process evaluation in the areas of non-communicable diseases and neglected tropical diseases such as frameworks and theories, (ii) methods applied to conduct process evaluations and (iii) gaps between the design of the intervention and its implementation that were identified through the process evaluation. Studies published from January 2008. Exclusion criteria are as follows: not peer reviewed articles, not a report based on empirical research, not reported in English or Spanish or Portuguese or French, reviews and non-human research.DiscussionThis scoping review will map the evidence of process evaluations conducted in LMICs. It will also identify the methods they used to collect and interpret data, how different theories and frameworks were used and lessons from the implementation of complex interventions. This information will allow researchers to conduct better process evaluations considering special characteristics from countries with limited human resources, scarce data available and limited access to health care.

Protocol for a process evaluation of a cluster randomised controlled trial to improve psychosocial treatment of patients with psychotic spectrum disorders: the IMPULSE trial

Objective: This paper describes the protocol of a process evaluation of a cluster randomised controlled trial designed to evaluate the effectiveness, cost-effectiveness and implementation of a digital mental health intervention, called DIALOG+, in five low- and middle-income countries in Southeast Europe (Bosnia and Herzegovina, Kosovo1, Montenegro, North Macedonia and Serbia). The objectives of the process evaluation are: a) to explore attributes of context that might impact on the implementation of the DIALOG+ intervention; b) to assess intervention fidelity and c) to explore patients’ and clinicians’ retrospective (i.e. experienced) acceptability of the intervention.Materials and methods: This is a mixed-method process evaluation nested within the cluster randomised controlled trial. We adopted the guidance on process evaluations of complex interventions published by the United Kingdom Medical Research Council. Data collected during and after the trial, but prior to awareness of trial outcomes, include transcripts, questionnaire responses, routinely collected monitoring data and audio-recordings of intervention and control sessions. Data analysis is descriptive and involves triangulation methods to compare findings across countries, stakeholder groups (healthcare provider, patient) and data type (qualitative, quantitative).Results: This work is part of a larger study entitled ‘Implementation of an effective and cost-effective intervention for patients with psychotic disorders in low and middle-income countries in Southeast Europe’ (IMPULSE). The study is funded by the European Union’s Horizon 2020 research and innovation programme. The IMPULSE trial recruited 81 clinicians and 458 patients. The clinician clusters were randomised to the intervention (six sessions of DIALOG+ over 12 months) or treatment-as-usual arm. Process data collection began in parallel with the trial, starting in April 2019. Data collection and analysis will be completed before the main trial findings are known. Process evaluation findings will be used to interpret the trial results including assessing the effect of context on outcomes. Conclusion: This process evaluation will explore the context, intervention fidelity and acceptability to contextualise the trial results, help in optimising sustainability of the intervention and inform its future dissemination. The methods described here may also inform the development and implementation of other complex psychosocial interventions in low-resource settings.

A Protocol of Process Evaluations of Interventions for the Prevention of Type 2 Diabetes in Women With Gestational Diabetes Mellitus: A Systematic Review

Background Process evaluations of randomised controlled trials (RCTs) can provide insight and inform us on the intervention implementation, the causal mechanisms and the contextual factors. This will inform about interventions’ success or failure due to their implementation or the interventions themselves. We aim to consolidate the methodology from previous process evaluations of complex interventions upon their findings on facilitators and barriers to address the prevention of type 2 diabetes mellitus among women with gestational diabetes mellitus (GDM). Methods Comprehensive search will be conducted on electronic databases and reference lists of recent reviews for RCTs of complex interventions which address process evaluations of diabetes prevention intervention (DPI) for women with GDM in healthcare settings. There is no restriction on the language of the papers and year of publication until December 2020. Data from each study will be extracted by two reviewers independently using standardised forms. Data extracted include descriptive items on the study design and the outcomes of process evaluations from the three dimensions: (1) implementation; (2) mechanism of impact and (3) context. The quality of the studies will be assessed using mixed methods appraisal tool which is designed for the appraisal of mixed studies in systematic reviews. A narrative and framework analysis of the findings will be presented to inform the contents of a new DPI for women with GDM. Discussion The findings from this process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts in future plan. It will give deeper understanding of potential challenges and solutions to aid in the implementation of effective DPIs for GDM in Malaysia.

How’The Daily Mile™’ works in practice: responses to implementation of a daily school-based physical activity intervention

Purpose: Physical inactivity is a leading cause of non-communicable disease and early death. Only one in four children in the UK currently achieve recommended levels of physical activity but school-based interventions offer opportunity to promote physical activity to large cohorts. Despite recommendation for all UK primary schools to adopt initiatives such as ́The Daily Milé, little is known about factors relating to implementation. This study represents the second phase of a pragmatic two-phase multi-method process evaluation utilising the MRĆs framework for process evaluation of complex interventions. Objectives were to explore responses of students, parents, teaching staff and governors, following a twelve-week implementation of ́The Daily Milé and consider unexpected pathways or consequences, mediators and contextual factors affecting implementation and to identify the barriers and facilitators of sustainable implementation.’

Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach

IntroductionThis protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER)...

Process evaluation of a randomised controlled trial of PBS-based staff training for challenging behaviour in adults with intellectual disability.

BackgroundPositive Behaviour Support (PBS) for challenging behaviour is a complex intervention. Process evaluation is pivotal in fully understanding the mechanisms and contextual factors that impact on participant outcomes.AimsTo conduct a process evaluation of a national clinical trial investigating the impact of PBS-based staff training on the level of challenging behaviour in adults with intellectual disability.MethodThe Medical Research Council guidance for process evaluation of complex interventions was followed. Semi-structured interviews with 62 stakeholders from the intervention arm (service users, family and paid carers, service managers, staff who delivered the intervention and PBS trainers), quantitative data from the study database and an external evaluation of the quality of the PBS plans were used.ResultsTwenty-one health staff volunteered to be trained in delivering PBS. Available log data from 17 therapists revealed that they worked with 63 participants a median of 11.50 hours (IQR 8–32). Only 33 out of 108 reports had included all elements of the intervention. Another 47 reports had some elements of the intervention. All PBS plans were rated weak, indicating insufficient quality to impact challenging behaviour. Stakeholders reported an appreciation of PBS and its potential to impact quality of care and engagement with the participant. However, they also identified important challenges including managing PBS-related caseloads, paid carer turnover and service commitment to the delivery of PBS.ConclusionsPBS-based staff training was well received, but therapists found it difficult to undertake all the elements of the intervention in routine care. Implementing a workforce training strategy is important to better define the active components of PBS, and resource implications if the intervention is no better than usual care.

Transition program for adolescents with congenital heart disease in transition to adulthood: protocol for a mixed-method process evaluation study (the STEPSTONES project)

IntroductionToday, the majority of young persons living with chronic conditions in high-income countries survive into adulthood and will need life-long medical follow-up. Therefore, transition programmes have been developed to facilitate...