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Background A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is “usual care.” The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants’ reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors. Methods Fifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur’s interpretation theory guided the analysis. Results The perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants’ feelings of control and their ability to cope. Other participants’ statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way. Conclusions RCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial. Trial registration ClinicalTrials.gov NCT02338869. Registered on October 4, 2014

Purpose: To perform a process evaluation of a stratified vocational advice intervention (SVAI), delivered by physiotherapists in primary care, for people on sick leave with musculoskeletal disorders participating in a randomised controlled trial. The research questions concerned how the SVAI was delivered, the content of the SVAI and the physiotherapists’ experiences from delivering the SVAI. Methods: We used qualitative and quantitative data from 148 intervention logs documenting the follow-up provided to each participant, recordings of 18 intervention sessions and minutes from 20 meetings with the physiotherapists. The log data were analysed with descriptive statistics. A qualitative content analysis was performed of the recordings, and we identified facilitators and barriers for implementation from the minutes. Results: Of 170 participants randomised to the SVAI 152 (89%) received the intervention and 148 logs were completed. According to the logs, 131 participants received the correct number of sessions (all by telephone) and 146 action plans were developed. The physiotherapists did not attend any workplace meetings but contacted stakeholders in 37 cases. The main themes from the recorded sessions were: ‘symptom burden’, ‘managing symptoms’, ‘relations with the workplace’ and ‘fear of not being able to manage work’. The physiotherapists felt they were able to build rapport with most participants. However, case management was hindered by the restricted number of sessions permitted according to the protocol. Conclusion: Overall, the SVAI was delivered in accordance with the protocol and is therefore likely to be implementable in primary care if it is effective in reducing sick leave. Open access funding provided by OsloMet - Oslo Metropolitan University. This study was funded by The Research Council of Norway, The Norwegian Labour and Welfare Administration (NAV), Oslo Metropolitan University and The Norwegian Fund for Post-Graduate Training in Physiotherapy.

Purpose The aim of this study was to evaluate potential barriers and facilitators for implementing motivational interviewing (MI) as a return to work (RTW) intervention in a Norwegian social insurance setting. Methods A mixed-methods process evaluation was conducted alongside a randomized controlled trial involving MI sessions delivered by social insurance caseworkers. The study was guided by the Reach, Efectiveness, Adoption, Implementation, and Maintenance framework using focus groups with the caseworkers. MI fdelity was evaluated through audio-recordings of MI sessions and questionnaires to sick-listed participants. Results Lack of co-worker and managerial support, time and place for practicing to further develop MI skills, and a high workload made the MI intervention challenging for the caseworkers. The MI method was experienced as useful, but difcult to master. MI fdelity results showed technical global scores over the threshold for “beginning profciency” whereas the relational global score was under the threshold. The sick-listed workers reported being satisfed with the MI sessions. Conclusions Despite caseworker motivation for learning and using MI in early follow-up sessions, MI was hard to master and use in practice. Several barriers and facilitators were identifed; these should be addressed before implementing MI in a social insurance setting. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/

The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method evidence from process evaluations. Despite a proliferation of methods for the synthesis of qualitative research, less attention has focused on how to integrate these syntheses within intervention effectiveness reviews. In this article, we report updated guidance from the group on approaches, methods, and tools, which can be used to integrate the findings from quantitative studies evaluating intervention effectiveness with those from qualitative studies and process evaluations. We draw on conceptual analyses of mixed methods systematic review designs and the range of methods and tools that have been used in published reviews that have successfully integrated different types of evidence. We outline five key methods and tools as devices for integration which vary in terms of the levels at which integration takes place; the specialist skills and expertise required within the review team; and their appropriateness in the context of limited evidence. In situations where the requirement is the integration of qualitative and process evidence within intervention effectiveness reviews, we recommend the use of a sequential approach. Here, evidence from each tradition is synthesized separately using methods consistent with each tradition before integration takes place using a common framework. Reviews which integrate qualitative and process evaluation evidence alongside quantitative evidence on intervention effectiveness in a systematic way are rare. This guidance aims to support review teams to achieve integration and we encourage further development through reflection and formal testing. Refereed/Peer-reviewed

Background Although proven feasible, rapid response services (RRSs) to support urgent decision and policymaking are still a fairly new and innovative strategy in several health systems, more especially in low-income countries. There are several information gaps about these RRSs that exist including the factors that make them work in different contexts and in addition what affects their uptake by potential end users. Methods We used a case study employing process evaluation methods to determine what contextual factors affect the utilization of a RRS in Uganda. We held in-depth interviews with researchers, knowledge translation (KT) specialists and policy-makers from several research and policy-making institutions in Uganda’s health sector. We analyzed the data using thematic analysis to develop categories and themes about activities and structures under given program components that affected uptake of the service. Results We identified several factors under three themes that have both overlapping relations and also reinforcing loops amplifying each other: Internal factors (those factors that were identified as over which the RRS had full [or almost full] control); external factors (factors over which the service had only partial influence, a second party holds part of this influence); and environmental factors (factors over which the service had no or only remote control if at all). Internal factors were the design of the service and resources available for it, while the external factors were the service’s visibility, integrity and relationships. Environmental factors were political will and health system policy and decision-making infrastructure. Conclusion For health systems practitioners considering RRSs, knowing what factors will affect uptake and therefore modifying them within their contexts is important to ensure efficient use and successful utilization of the mechanisms.

Background The Aortic Valve Replacement Readmission (AVRre) randomized control trial tested whether a telephone intervention would reduce hospital readmissions following surgical aortic valve replacement (SAVR). The telephone support provided 30 days of continuous phone-support (hotline) and two scheduled phone-calls from the hospital after discharge. The intervention had no effect on reducing 30-day all-cause readmission rate (30-DACR) but did reduce participants’ anxiety compared to a control group receiving usual care. Depression and participant-reported health state were unaffected by the intervention. To better understand these outcomes, we conducted a process evaluation of the AVRre trial to gain insight into the (1) the dose and fidelity of the intervention, (2) mechanism of impacts, and (3) contextual factors that may have influenced the outcomes. Methods The process evaluation was informed by the Medical Research Council framework, a widely used set of guidelines for evaluating complex interventions. A mix of quantitative (questionnaire and journal records) and qualitative data (field notes, memos, registration forms, questionnaire) was prospectively collected, and retrospective interviews were conducted. We performed descriptive analyses of the quantitative data. Content analyses, assisted by NVivo, were performed to evaluate qualitative data. Results The nurses who were serving the 24/7 hotline intervention desired to receive more preparation before intervention implementation. SAVR patient participants were highly satisfied with the telephone intervention (58%), felt safe (86%), and trusted having the option of calling in for support (91%). The support for the telephone hotline staff was perceived as a facilitator of the intervention implementation. Content analyses revealed themes: “gap in the care continuum,” “need for individualized care,” and “need for easy access to health information” after SAVR. Differences in local hospital discharge management practices influenced the 30-DACR incidence. Conclusions The prospective follow-up of the hotline service during the trial facilitated implementation of the intervention, contributing to high participant satisfaction and likely reduced their anxiety after SAVR. Perceived less-than-optimal preparations for the hotline could be a barrier to AVRre trial implementation. Integrating user experiences into a mixed-methods evaluation of clinical trials is important for broadening understanding of trial outcomes, the mechanism of impact, and contextual factors that influence clinical trials. Trial registration ClinicalTrials.gov, NCT02522663. Registered on 11 August 2015.

In Ontario, an online audit and feedback tool that provides primary care physicians with detailed information about patients who are overdue for cancer screening is underused. In the present study, we aimed to examine the effect of messages operationalizing 3 behaviour change techniques on access to the audit and feedback tool and on cancer screening rates. During May&ndash, September 2017, a pragmatic 2&times, 2&times, 2 factorial experiment tested 3 behaviour change techniques: anticipated regret, material incentive, and problem-solving. Outcomes were assessed using routinely collected administrative data. A qualitative process evaluation explored how and why the e-mail messages did or did not support Screening Activity Report access. Of 5449 primary care physicians randomly allocated to 1 of 8 e-mail messages, fewer than half opened the messages and fewer than 1 in 10 clicked through the messages. Messages with problem-solving content were associated with a 12.9% relative reduction in access to the tool (risk ratio: 0.871, 95% confidence interval: 0.791 to 0.958, p = 0.005), but a 0.3% increase in cervical cancer screening (rate ratio: 1.003, 95% confidence interval: 1.001 to 1.006, p = 0.003). If true, that association would represent 7568 more patients being screened. No other significant effects were observed. For audit and feedback to work, recipients must engage with the data, for e-mail messages to prompt activity, recipients must open and review the message content. This large factorial experiment demonstrated that small changes in the content of such e-mail messages might influence clinical behaviour. Future research should focus on strategies to make cancer screening more user-centred.

Background: Evaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis. Methods: This study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way. Results: The results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study. Conclusions: This evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity. The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7-PEOPLE-2013-COFUND) under grant agreement no 609020 - Scientia Fellows. The research has also been supported by a grant from the South-Eastern Norway Regional Health Authority (Project no 2013086) and a grant from the Extra Foundation (2015/FO13753). The University of Oslo, Oslo University Hospital, the Inland Norway University of Applied Sciences, and UiT, the Arctic University of Norway, Narvik have provided research time, administrative and organizational support and additional funding for the study.

Strengthening health systems to provide affordable, effective and accessible care in a lifecourse approach is necessary to address the growing global burden from non-communicable diseases (NCD). To address deficiencies in the health system, researchers have designed and trialled ‘complex interventions’ which are defined as interventions with multiple interacting components, and complexity in its implementation. Process evaluations alongside randomised controlled trials (RCT) of complex interventions are highly valuable. They explore implementation and different stakeholders’ perspectives as to for whom, how and why a complex intervention has an impact.

ObjectiveProcess evaluations (PEs) alongside randomised controlled trials of complex interventions are valuable because they address questions of for whom, how and why interventions had an impact. We synthesised the methods used in PEs of primary care interventions, and their main findings on implementation barriers and facilitators.DesignSystematic review using the UK Medical Research Council guidance for PE as a guide.Data sourcesAcademic databases (MEDLINE, SCOPUS, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, EMBASE and Global Health) were searched from 1998 until June 2018.Eligibility criteriaWe included PE alongside randomised controlled trials of primary care interventions which aimed to improve outcomes for patients with non-communicable diseases.Data extraction and synthesisTwo independent reviewers screened and conducted the data extraction and synthesis, with a third reviewer checking a sample for quality assurance.Results69 studies were included. There was an overall lack of consistency in how PEs were conducted and reported. The main weakness is that only 30 studies were underpinned by a clear intervention theory often facilitated by the use of existing theoretical frameworks. The main strengths were robust sampling strategies, and the triangulation of qualitative and quantitative data to understand an intervention’s mechanisms. Findings were synthesised into three key themes: (1) a fundamental mismatch between what the intervention was designed to achieve and local needs; (2) the required roles and responsibilities of key actors were often not clearly understood; and (3) the health system context—factors such as governance, financing structures and workforce—if unanticipated could adversely impact implementation.ConclusionGreater consistency is needed in the reporting and the methods of PEs, in particular greater use of theoretical frameworks to inform intervention theory. More emphasis on formative research in designing interventions is needed to align the intervention with the needs of local stakeholders, and to minimise unanticipated consequences due to context-specific barriers.PROSPERO registration numberCRD42016035572.

Background Group-based early parenting interventions delivered through community-based services may be a potentially effective means of promoting infant and family health and wellbeing. Process evaluations of these complex interventions provide vital information on how they work, as well as the conditions which shape and influence outcomes. This information is critical to decision makers and service providers who wish to embed prevention and early interventions in usual care settings. In this paper, a process evaluation protocol for an early years parenting intervention, the Parent and Infant (PIN) program, is described. This program combines a range of developmentally-appropriate supports, delivered in a single intervention process, for parents and infants (0–2 years) and aimed at enhancing parental competence, strengthening parent-infant relationships and improving infant wellbeing and adjustment. Methods The process evaluation is embedded within a controlled trial and accompanying cost-effectiveness evaluation. Building from extant frameworks and evaluation methods, this paper presents a systematic approach to the process evaluation of the PIN program and its underlying change principles, the implementation of the program, the context of implementation and the change mechanisms which influence and shape parent and infant outcomes. We will use a multi-method strategy, including semi-structured interviews and group discussions with key stakeholders, documentary analysis and survey methodology. Discussion The integration of innovations into existing early years systems and services is a challenging multifaceted undertaking. This process evaluation will make an important contribution to knowledge about the implementation of such programs, while also providing an example of how theory-based research can be embedded within the evaluation of community-based interventions. We discuss the strengths of the research, such as the adoption of a collaborative approach to data collection, while we also identify potential challenges, including capturing and assessing complex aspects of the intervention. Trial registration ISRCTN17488830 (Date of registration: 27/11/15). This trial was retrospectively registered. Electronic supplementary material The online version of this article (doi:10.1186/s12913-016-1737-3) contains supplementary material, which is available to authorized users.

BACKGROUND: Although care pathways are often said to promote teamwork, high-level evidence that supports this statement is lacking. Furthermore, knowledge on conditions and facilitators for successful pathway implementation is scarce. The objective of the European Quality of Care Pathway (EQCP) study is therefore to study the impact of care pathways on interprofessional teamwork and to build up understanding on the implementation process. Methods/design An international post-test-only cluster Randomised Controlled Trial (cRCT), combined with process evaluations, will be performed in Belgium, Ireland, Italy, and Portugal. Teams caring for proximal femur fracture (PFF) patients and patients hospitalized with an exacerbation of chronic obstructive pulmonary disease (COPD) will be randomised into an intervention and control group. The intervention group will implement a care pathway for PFF or COPD containing three active components: a formative evaluation of the actual teams' performance, a set of evidence-based key interventions, and a training in care pathway-development. The control group will provide usual care. A set of team input, process and output indicators will be used as effect measures. The main outcome indicator will be relational coordination. Next to these, process measures during and after pathway development will be used to evaluate the implementation processes. In total, 132 teams have agreed to participate, of which 68 were randomly assigned to the intervention group and 64 to the control group. Based on power analysis, a sample of 475 team members per arm is required. To analyze results, multilevel analysis will be performed. DISCUSSION: Results from our study will enhance understanding on the active components of care pathways. Through this, preferred implementation strategies can be defined. Trail registration NCT01435538. ispartof: Implementation Science vol:7 issue:47 pages:1-12 ispartof: location:England status: published

Background Randomised controlled trials (RCTs) of complex interventions in primary health care (PHC) are needed to provide evidence-based programmes to achieve the Declaration of Alma Ata goal of making PHC equitable, accessible and universal and to effectively address the rising burden from chronic disease. Process evaluations of these RCTs can provide insight into the causal mechanisms of complex interventions, the contextual factors, and inform as to whether an intervention is ineffective due to implementation failure or failure of the intervention itself. To build on this emerging body of work, we aim to consolidate the methodology and methods from process evaluations of complex interventions in PHC and their findings of facilitators and barriers to intervention implementation in this important area of health service delivery. Methods Systematic review of process evaluations of randomised controlled trials of complex interventions which address prevalent major chronic diseases in PHC settings. Published process evaluations of RCTs will be identified through database and clinical trial registry searches and contact with authors. Data from each study will be extracted by two reviewers using standardised forms. Data extracted include descriptive items about (1) the RCT, (2) about the process evaluations (such as methods, theories, risk of bias, analysis of process and outcome data, strengths and limitations) and (3) any stated barriers and facilitators to conducting complex interventions. A narrative synthesis of the findings will be presented. Discussion Process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts. Publishing this protocol serves to encourage transparency in the reporting of our synthesis of current literature on how process evaluations have been conducted thus far and a deeper understanding of potential challenges and solutions to aid in the implementation of effective interventions in PHC beyond the research setting. Systematic review registration PROSPERO CRD42016035572 Electronic supplementary material The online version of this article (doi:10.1186/s13643-016-0314-5) contains supplementary material, which is available to authorized users.