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Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

Background Intimate partner violence (IPV) is highly prevalent in the United States and impacts the physical and mental health and social well-being of those who experience it. Healthcare settings are important intervention points for IPV screening and referral, yet there is a wide range of implementation of IPV protocols in healthcare settings in the U.S., and the evidence of the usefulness of IPV screening is mixed. This process evaluation investigates the facilitators and barriers to implementing Coordinated Care for IPV Survivors through the M Health Community Network (“M Health Network”), an intervention that aimed to standardize IPV screening and referral in a multi-specialty clinic and surgery center (CSC). Two validated IPV screens were introduced and mandated to be done by rooming staff at least once every 3 months with all clinic patients regardless of gender; the Humiliation Afraid Rape Kick (HARK) for presence of IPV and the shortened Danger Assessment (DA-5) for lethality of IPV. Upon a positive screen, the patient was offered immediate informational resources and, if willing, was referred to a social worker for care coordination with a community organization. Methods Semi-structured, individual and group process interviews with clinic managers and clinic staff at 8 CSC clinics (N = 24) were undertaken at 3,12, and 27 months after intervention start. Semi-structured interviews were undertaken with the research team (N = 3) post-implementation. A Consolidated Framework for Implementation Research (CFIR) codebook was used to code data in two rounds. After each round, thick description was used to write detailed and contextual descriptions of each code. Facilitators and barriers to implementation were identified during the second round of thick description. Results Facilitators to implementation were clinic staff support, dedication, and flexibility and research team engagement. Barriers were lack of prioritization, loss of intervention champions, lack of knowledge about intervention protocol and resources, staff and patient discomfort discussing IPV, and operational issues with screen technology. Conclusions The IPV protocol was implemented, but faced common barriers. CFIR is a complex, but comprehensive, tool to guide process evaluation for IPV screening and referral interventions in health systems in the U.S.

BackgroundLow uptake of sexually transmitted infection testing by sexually active young people is a worldwide public health problem. Screening in non-medical settings has been suggested as a method to improve uptake. The “Test n Treat” feasibility trial offered free, on-site rapid chlamydia/gonorrhoea tests with same day treatment for chlamydia (and gonorrhoea treatment at a local clinic,) to sexually active students (median age 17 years) at six technical colleges in London. Despite high rates of chlamydia (6% prevalence), uptake of testing was low (MethodsIn 2016–17 we conducted a qualitative study in the interpretative tradition using face to face or telephone semi-structured interviews with students (n = 26), teaching staff (n = 3) and field researchers (n = 4). Interviews were digitally recorded, transcribed and thematically analysed.ResultsFrom the student perspective, feelings of embarrassment and the potential for stigma were deterrents to sexually transmitted infection testing. While the non-medical setting was viewed as mitigating against stigma, for some students volunteering to be screened exposed them to detrimental judgements by their peers. A small financial incentive to be screened was regarded as legitimising volunteering in a non-discrediting way. Staff and researchers confirmed these views. The very low level of knowledge about sexually transmitted infections influenced students to not view themselves as candidates for testing. There were also suggestions that some teenagers considered themselves invulnerable to sexually transmitted infections despite engaging in risky sexual behaviours. Students and researchers reported the strong influence peers had on uptake, or not, of sexually transmitted infection testing.ConclusionsThis study offers new insights into the acceptability of college-based sexually transmitted infection screening to young, multi-ethnic students. Future studies in similar high risk, hard to reach groups should consider linking testing with education about sexually transmitted infections, offering non stigmatising incentives and engaging peer influencers.

Background Intimate partner violence (IPV) affects almost one in three women worldwide. However, disclosing violence or seeking help is difficult for affected women. eHealth may represent an effective alternative to the standard support offers, which often require face-to-face interaction, because of easy accessibility and possibility of anonymous usage. In the Netherlands we are developing SAFE, an eHealth intervention for female victims of IPV, which will be evaluated in a randomized controlled trial and a process evaluation, followed by an open feasibility study to assess real-world user data. Methods/design The randomized controlled trial is a two-arm parallel design comparing an intervention arm and a control group. The groups both have access to eHealth but differ in the offer of interactive features compared to static information. Both groups complete questionnaires at three or four time points (baseline, three months, six months, 12 months) with self-efficacy at 6 months as the primary outcome, measured with the General Self-Efficacy (GSE) scale. The process evaluation consists of quantitative data (from the website and from web evaluation questionnaires) and qualitative data (from interviews) on how the website was used and the users’ experiences. Discussion eHealth has the potential to reach a large number of women who experience IPV. The internet-based design can lower access barriers and encourage help-seeking behavior ultimately reducing the lag time between subjective awareness and protective action. Trial registration Trial registered on 15 August 2017 at the Netherlands Trial Register NL7108 (NTR7313).

Background SEA Change Portland is a systems-based approach implemented in Portland, Victoria that utilises local community resources to sustainably prevent and reduce the prevalence of childhood obesity. Action is implemented by community-led task teams with differing priority areas, and supported by a steering committee representative of four collaborating organisations. This study examines the SEA Change Portland process to identify significant events, enablers and barriers of its development and implementation to date as reported by key stakeholders involved in implementation during the first 12 months. Methods Semi-structured interviews were conducted with eight steering group members and three community task team members. Data was collected utilising open ended interview questions to gather in-depth information regarding program implementation, and the individual attitudes, beliefs and experiences of key stakeholders. Results Data were analysed under three key themes: collective impact, systems thinking and asset based community development (ABCD). Participants gave perceptions of significant events; factors positively and negatively affecting the process; reasons for becoming involved in the process; perceived efficacy of task teams, principles of diversity and areas of concern. Themes emerged from participant responses allowing were categorisation of their responses into four key process stages: initial lead up; process development; establishing community ownership of the obesity system; and community action. Conclusion Collective impact was a crucial element in applying the systems thinking. Strong and equitable relationships between steering organisations and topic experts provided the initiative with a sustainable foundation, and ABCD promotes community ownership and future sustainability. Understanding the process of implementing a new whole-of-community systems approach to childhood obesity prevention such as SEA Change Portland has provided vital knowledge for other communities regarding enablers and barriers of this promising approach.

Background Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project-specific fidelity can be assessed using a truly mixed-methods approach when informed by qualitative insights. Design Semi-structured qualitative interviews carried out as part of a process evaluation. Interviews were analysed thematically. Setting Seven NHS trusts in the UK and a University podiatry school in Ireland. Interviews were undertaken face-to-face or over the telephone. Participants Twenty-one REFORM trial participants and 14 podiatrists who delivered the REFORM intervention. Results Factors affecting fidelity included: how similar the intervention was to routine practice; the challenges of delivering a multifaceted intervention to a heterogeneous older population; and practical issues with delivery such as time and training. Trial participants’ views of the intervention, whether falls prevention is a personal priority, their experience of being part of a trial and individual factors such as medical conditions may also have affected intervention fidelity. Conclusions Our process evaluation highlighted factors that were perceived to have affected the fidelity of the REFORM intervention and in doing so demonstrates the importance of considering fidelity when designing and evaluating pragmatic trials. We propose a number of recommendations of how important project-specific insights from qualitative work can be incorporated into the design of fidelity measurement of future trials, which build on existing conceptual fidelity frameworks. In particular, we encourage adopting a mixed-methods approach whereby qualitative insights can be used to suggest ways to enhance quantitative data collection facilitating integration through hypothesis generation, hypothesis testing and seeking explanation for trial findings. This will provide a framework of enabling measures of fidelity to be incorporated into the understanding of trial results which has been relatively neglected by existing literature. Trial registration ISRCTN Registry: ISRCTN68240461. Registered on 01/07/2011.

Background The administrative work of physicians, particularly documentation effort, consumes considerable time in surgical emergency departments. At the same time, the latter face an ever-growing influx of patients, leading to increasing waiting and flow times and thus patient dissatisfaction as well as overload of physicians and nurses. The deployment of medical documentation assistants, who specialize in and undertake documentation work currently performed by physicians, poses a solution to the problem. The goal of this study is to assess the impact of deploying medical documentation assistants on key performance indicators of a surgical emergency department, i.e. waiting and flow times of patients differentiated according to triage categories, utilization of physicians and time allocation of physicians. Methods The underlying study has analysed the processes of the surgical emergency department of a major university medical centre and modelled them in a discrete event simulation. Data on patient arrivals as well as processing times in the X-ray department and the laboratory were obtained from the clinical information system, while processing times in the emergency department were recorded using time–motion studies. Though the emergency department currently does not deploy medical documentation assistants, the simulation model includes a variable number of such assistants. Results The deployment of a medical documentation assistant frees up physician working time and decreases the waiting time and consequently the flow time of patients, in particular for standard and non-urgent patients. Adding additional documentation assistants leads to further improvements, however, with diminishing marginal returns. Under the assumption of medical documentation assistants being 35% more efficient than physicians in undertaking documentation work, one of the three physicians can be replaced in the analysed surgical emergency department with an average of 502 patient arrivals per week. Conclusions Medical documentation assistants are a viable way of improving the performance of surgical emergency departments. Depending on the goals of the hospital, medical documentation assistants can be used for an array of measures such as decreasing patients’ waiting and flow times or increasing physicians’ time spent on medical treatment.

Background Dental students are future dentists. Continuous assessment and improving of the educational curricula will ensure excellent academic performance of dental students and thus providing the community with the best treatment modalities. The aim of this study was to evaluate the root canal filling quality performed in extracted teeth by preclinical undergraduate Yemeni dental students. Methods Root canal treatment was performed by undergraduate preclinical dental students on 331 extracted human teeth including 741 roots. The teeth were then collected and evaluated radiographically based on three criteria of quality (length, density, and taper). Cohen’s Kappa test was used to assess the agreement between the examiners and Chi-squared test was used for the association between the study variables. The level of significant was set at α Results The results of the study revealed that the overall quality of roots canals fillings was poor. However, more than half of the study sample (53.4%) had adequate length, 13.1% had adequate density, and 14.2% had adequate taper. Anterior as well as single-rooted teeth had significantly better quality than posterior and multi-rooted teeth, respectively. The root canal fillings quality mandibular teeth was better than of maxillary teeth with no significant difference (P > 0.05). Conclusion The findings of the study emphasize the need of improving the endodontic course in the preclinical level and more advanced techniques and instruments should be incorporated.

Background: Process evaluation is increasingly recognized as an important component of effective implementation research and yet, there has been surprisingly little work to understand what constitutes best practice. Researchers use different methodologies describing causal pathways and understanding barriers and facilitators to implementation of interventions in diverse contexts and settings. We report on challenges and lessons learned from undertaking process evaluation of seven hypertension intervention trials funded through the Global Alliance of Chronic Diseases (GACD). Methods: Preliminary data collected from the GACD hypertension teams in 2015 were used to inform a template for data collection. Case study themes included: (1) description of the intervention, (2) objectives of the process evaluation, (3) methods including theoretical basis, (4) main findings of the study and the process evaluation, (5) implications for the project, policy and research practice and (6) lessons for future process evaluations. The information was summarized and reported descriptively and narratively and key lessons were identified. Results: The case studies were from low- and middle-income countries and Indigenous communities in Canada. They were implementation research projects with intervention arm. Six theoretical approaches were used but most comprised of mixed-methods approaches. Each of the process evaluations generated findings on whether interventions were implemented with fidelity, the extent of capacity building, contextual factors and the extent to which relationships between researchers and community impacted on intervention implementation. The most important learning was that although process evaluation is time consuming, it enhances understanding of factors affecting implementation of complex interventions. The research highlighted the need to initiate process evaluations early on in the project, to help guide design of the intervention; and the importance of effective communication between researchers responsible for trial implementation, process evaluation and outcome evaluation. Conclusion: This research demonstrates the important role of process evaluation in understanding implementation process of complex interventions. This can help to highlight a broad range of system requirements such as new policies and capacity building to support implementation. Process evaluation is crucial in understanding contextual factors that may impact intervention implementation which is important in considering whether or not the intervention can be translated to other contexts. Fil: Limbani, Felix. University of the Witwatersrand; Sudáfrica Fil: Goudge, Jane. University of the Witwatersrand; Sudáfrica Fil: Joshi, Rohina. University Of Technology Sydney.; Australia Fil: Maar, Marion A.. University of New South Wales; Australia Fil: Miranda, J. Jaime. Universidad Peruana Cayetano Heredia; Perú Fil: Oldenburg, Brian. University of Melbourne; Australia Fil: Parker, Gary. University College London; Estados Unidos Fil: Pesantes, Maria Amalia. Universidad Peruana Cayetano Heredia; Perú Fil: Riddell, Michaela A.. School Of Clinical Sciences At Monash Health; Australia Fil: Salam, Abdul. University of New South Wales; Australia Fil: Trieu, Kathy. University Of Technology Sydney.; Australia Fil: Thrift, Amanda G.. School Of Clinical Sciences At Monash Health; Australia Fil: Van Olmen, Josefien. Bernhard Nocht Institute For Tropical Medicine.; Alemania Fil: Vedanthan, Rajesh. University of New York; Estados Unidos Fil: Webster, Ruth. The George Institute For Global Health; Australia Fil: Yeates, Karen. Queens University; Canadá Fil: Webster, Jacqui. University Of Technology Sydney.; Australia Fil: Irazola, Vilma. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina

Background While schools have potential to contribute to children’s health and healthy behaviour, embedding health promotion within complex school systems is challenging. The ‘Healthy Primary School of the Future’ (HPSF) is an initiative that aims to integrate health and well-being into school systems. Central to HPSF are two top-down changes that are hypothesized as being positively disruptive to the Dutch school system: daily free healthy lunches and structured physical activity sessions. These changes are expected to create momentum for bottom-up processes leading to additional health-promoting changes. Using a programme theory, this paper explores the processes through which HPSF and the school context adapt to one another. The aim is to generate and share knowledge and experiences on how to implement changes in the complex school system to integrate school health promotion. Methods The current study involved a mixed methods process evaluation with a contextual action-oriented research approach. The processes of change were investigated in four Dutch primary schools during the development year (2014–2015) and the first two years of implementation (2015–2017) of HPSF. The schools (each with 15–26 teachers and 233–389 children) were in low socio-economic status areas. Measurements included interviews, questionnaires, observations, and analysis of minutes of meetings. Results Top-down advice, combined with bottom-up involvement and external practical support were key facilitators in embedding HPSF within the schools’ contexts. Sufficient coordination and communication at the school level, team cohesion, and feedback loops enhanced implementation of the changes. Implementation of the healthy lunch appeared to be disruptive and create momentum for additional health-promoting changes. Conclusions Initiating highly visible positive disruptions to improve school health can act as a catalyst for wider school health promotion efforts. Conditions to create a positive disruption are enough time, and sufficient bottom-up involvement, external support, team cohesion and coordination. The focus should be on each specific school, as each school has their own starting point and process of change. Trial registration The study was retrospectively registered in the ClinicalTrials.gov database on 14 June 2016 (NCT02800616).

Background Smoking in pregnancy causes harm to mother and baby. Despite evidence from trials of what helps women quit, implementation in the real world has been hard to achieve. An evidence-based intervention, babyClear©, involving staff training, universal carbon monoxide monitoring, opt-out referral to smoking cessation services, enhanced follow-up protocols and a risk perception tool was introduced across North East England. This paper presents the results of the qualitative analyses, reporting acceptability of the system changes to staff, as well as aids and hindrances to implementation and normalization of this complex intervention. Methods Process evaluation was used to complement an effectiveness study. Interviews with maternity and smoking cessation services staff and observations of training were undertaken. Normalization Process Theory (NPT) was used to frame the interview guides and analysis. NPT is an empirically-derived theory, developed by sociologists, that uses four concepts to understand the process of routinising new practices. Results Staff interviews took place across eight National Health Service trusts at a time of widespread restructuring in smoking cessation services. Principally interviewees worked in maternity (n = 63) and smoking cessation services (n = 35). Five main themes, identified inductively, influenced the implementation: 1) initial preparedness of the organisations; 2) staff training; 3) managing partnership working; 4) resources; 5) review and planning for sustainability. Conclusions NPT was used to show that the babyClear© package was acceptable to staff in a range of organisations. Illustrated in Themes 1, 2 & 3, staff welcomed ways to approach pregnant women about their smoking, without damaging their professional relationship with them. Predicated on producing individual behaviour change in women, the intervention does this largely through reorganising and standardising healthcare systems that are required to implement best practice guidelines. Changing organisational systems requires belief and commitment from staff, so that they set up and maintain practical adjustments to their practice and are reflective about adapting themselves and the work context as new challenges are encountered. The ongoing challenge is to identify and maintain the elements of the intervention package which are essential for its effectiveness and how to tailor them to local circumstances and resources without compromising its core ingredients. Electronic supplementary material The online version of this article (10.1186/s12913-019-4122-1) contains supplementary material, which is available to authorized users.

Background Few previous studies have applied the hybrid effectiveness-implementation design framework to illustrate the way in which an intervention was progressively implemented and evaluated across multiple studies in diverse settings. Methods We describe the design components and methodologies of three studies that sought to improve rates of colorectal cancer (CRC) screening using mailed outreach, and apply domains put forth by Curran et al.: research aims, research questions, comparison conditions, sample, evaluation methods, measures, and potential challenges. The Hybrid 1 study (emphasis on effectiveness) was a patient-level randomized trial of a mailed fecal test and stepped phone-outreach intervention program delivered in an integrated healthcare system (21 clinics, 4673 patients). The primary outcome was effectiveness (CRC screening uptake). Implementation outcomes included cost-effectiveness and acceptability. The Hybrid 2 study (shared emphasis on effectiveness and implementation) was a pragmatic cluster-randomized trial of mailed fecal immunochemical test (FIT) outreach implemented at safety net clinics (26 clinics, 41,000 patients). The intervention used electronic health record tools (adapted from Hybrid 1) and clinic personnel to deliver the intervention. Outcomes included effectiveness (FIT completion) and implementation (FIT kits delivered, clinic barriers and facilitators, cost-effectiveness). Hybrid 3 study (emphasis on implementation) is a demonstration project being conducted by two Medicaid/Medicare insurance plans (2 states, 12,000 patients) comparing two strategies for implementing mailed FIT programs that addressed Hybrid 2 implementation barriers. Outcomes include implementation (activities delivered, barriers) and effectiveness (FIT completion). Results The effectiveness-implementation typology successfully identified a number of distinguishing features between the three studies. Two additional features, program design and program delivery, varied across our studies, and we propose adding them to the current typology. Program design and program delivery reflect the process by which and by whom a program is designed and delivered (e.g., research staff vs. clinic/health plan staff). Conclusions We describe three studies that demonstrate the hybrid effectiveness to implementation continuum and make recommendations for expanding the hybrid typology to include new descriptive features. Additional comparisons of Hybrid 1, 2, and 3 studies may help confirm whether our hybrid typology refinements are generalizable markers of the pipeline from research to practice.

Background Audit and feedback (A&F) is a common quality improvement strategy with highly variable effects on patient care. It is unclear how A&F effectiveness can be maximised. Since the core mechanism of action of A&F depends on drawing attention to a discrepancy between actual and desired performance, we aimed to understand current and best practices in the choice of performance comparator. Methods We described current choices for performance comparators by conducting a secondary review of randomised trials of A&F interventions and identifying the associated mechanisms that might have implications for effective A&F by reviewing theories and empirical studies from a recent qualitative evidence synthesis. Results We found across 146 trials that feedback recipients’ performance was most frequently compared against the performance of others (benchmarks; 60.3%). Other comparators included recipients’ own performance over time (trends; 9.6%) and target standards (explicit targets; 11.0%), and 13% of trials used a combination of these options. In studies featuring benchmarks, 42% compared against mean performance. Eight (5.5%) trials provided a rationale for using a specific comparator. We distilled mechanisms of each comparator from 12 behavioural theories, 5 randomised trials, and 42 qualitative A&F studies. Conclusion Clinical performance comparators in published literature were poorly informed by theory and did not explicitly account for mechanisms reported in qualitative studies. Based on our review, we argue that there is considerable opportunity to improve the design of performance comparators by (1) providing tailored comparisons rather than benchmarking everyone against the mean, (2) limiting the amount of comparators being displayed while providing more comparative information upon request to balance the feedback’s credibility and actionability, (3) providing performance trends but not trends alone, and (4) encouraging feedback recipients to set personal, explicit targets guided by relevant information. Electronic supplementary material The online version of this article (10.1186/s13012-019-0887-1) contains supplementary material, which is available to authorized users.

Background There is a growing recognition that quality of care must improve in facility-based deliveries to achieve further global reductions in maternal and newborn mortality and morbidity. Better measurement of care quality is needed, but the unpredictable length of labor and delivery hinders the feasibility of observation, the gold standard in quality assessment. This study evaluated whether a measure restricted to actions at or immediately following delivery could provide a valid assessment of the quality of the process of intrapartum and immediate postpartum care (QoPIIPC), including essential newborn care. Methods The study used a comprehensive QoPIIPC index developed through a modified Delphi process and validated by delivery observation data as a starting point. A subset of items from this index assessed at or immediately following delivery was identified to create a “delivery-only” index. This delivery-only index was evaluated across content and criterion validation domains using delivery observation data from Kenya, Madagascar, and Tanzania, including Zanzibar. Results The delivery-only index included 13 items and performed well on most validation criteria, including correct classification of poorly and well-performed deliveries. Relative to the comprehensive QoPIIPC index, the delivery-only index had reduced content validity, representing fewer dimensions of QoPIIPC. The delivery-only index was also less strongly associated with overall quality performance in observed deliveries than the comprehensive QoPIIPC index. Conclusions Where supervision resources are limited, a measure of the quality of labor and delivery care targeting the time of delivery may mitigate challenges in observation-based assessment. The delivery-only index may enable increased use of observation-based quality assessment within maternal and newborn care programs in low-resource settings.

Background It is challenging to conduct and quickly disseminate findings from in-depth qualitative analyses, which can impede timely implementation of interventions because of its time-consuming methods. To better understand tradeoffs between the need for actionable results and scientific rigor, we present our method for conducting a framework-guided rapid analysis (RA) and a comparison of these findings to an in-depth analysis of interview transcripts. Methods Set within the context of an evaluation of a successful academic detailing (AD) program for opioid prescribing in the Veterans Health Administration, we developed interview guides informed by the Consolidated Framework for Implementation Research (CFIR) and interviewed 10 academic detailers (clinical pharmacists) and 20 primary care providers to elicit detail about successful features of the program. For the RA, verbatim transcripts were summarized using a structured template (based on CFIR); summaries were subsequently consolidated into matrices by participant type to identify aspects of the program that worked well and ways to facilitate implementation elsewhere. For comparison purposes, we later conducted an in-depth analysis of the transcripts. We described our RA approach and qualitatively compared the RA and deductive in-depth analysis with respect to consistency of themes and resource intensity. Results Integrating the CFIR throughout the RA and in-depth analysis was helpful for providing structure and consistency across both analyses. Findings from the two analyses were consistent. The most frequently coded constructs from the in-depth analysis aligned well with themes from the RA, and the latter methods were sufficient and appropriate for addressing the primary evaluation goals. Our approach to RA was less resource-intensive than the in-depth analysis, allowing for timely dissemination of findings to our operations partner that could be integrated into ongoing implementation. Conclusions In-depth analyses can be resource-intensive. If consistent with project needs (e.g., to quickly produce information to inform ongoing implementation or to comply with a policy mandate), it is reasonable to consider using RA, especially when faced with resource constraints. Our RA provided valid findings in a short timeframe, enabling identification of actionable suggestions for our operations partner. Electronic supplementary material The online version of this article (10.1186/s13012-019-0853-y) contains supplementary material, which is available to authorized users.

Background Psychosocial person-centred interventions are considered best practice for addressing complex behaviours and care needs such as agitation and anxiety, and for improving the quality of life of people with dementia in care homes. Dementia Care Mapping (DCM™) is an established practice development tool and process aimed to help care home staff deliver more person-centred care. To date, few studies have evaluated the efficacy of DCM™ and have found mixed results. These results are suggested to be the outcome of intervention implementation, which may be impacted by a range of factors. This study reports the barriers and facilitators to DCM™ implementation in care homes found during the process evaluation conducted as part of a randomized controlled trial. Methods Eighteen of the 31 DCM™ intervention care homes were recruited to participate in the embedded process evaluation. Semi-structured interviews were conducted with 83 participants, comprising care home managers, trained DCM™ users (mappers), expert external mappers, staff members, relatives, and residents. Results Barriers and facilitators to DCM™ implementation were found at the mapper level (e.g. motivation and confidence), the DCM™ intervention level (e.g. understanding of DCM™) and the care home level (e.g. staffing issues, manager support). Further barriers caused by the burden of trial participation were also identified (e.g. additional paperwork). Conclusions Implementing DCM™ is complex and a greater consideration of potential barriers and facilitators in planning future studies and in practice could help improve implementation. Trial registration Current Controlled Trials ISRCTN82288852, registered 16/01/2014.

Background Implementation science comprises a large set of theories suggesting interacting factors at different organisational levels. Development of literature syntheses and frameworks for implementation have contributed to comprehensive descriptions of implementation. However, corresponding instruments for measuring these comprehensive descriptions are currently lacking. The present study aimed to develop an instrument measuring care providers’ perceptions of an implementation effort, and to explore the instrument’s psychometric properties. Methods Based on existing implementation literature, a questionnaire was designed with items on individual and team factors and on stages of change in an implementation process. The instrument was tested in a Norwegian study on implementation of evidence based practices for psychosis. Item analysis, factor structure, and internal consistency at baseline were examined. Results The 27-item Implementation Process Assessment Tool (IPAT) revealed large variation between mean score of the items. The total scale scores were widely dispersed across respondents. Internal consistency for the total scale was high (Cronbach’s alpha: .962), and all but one item contributed positively to the construct. The results indicated four underlying constructs: individual stages for behavioural change, individual activities and perceived support, collective readiness and support, and individual perceptions of the intervention. Conclusions The IPAT appears to be a feasible instrument for investigating the implementation process from the perspective of those making the change. It can enable examination of the relative importance of factors thought to be essential for implementation outcomes. It may also provide ongoing feedback for leaders tailoring support for teams to improve implementation. However, further research is needed to detect the instrument’s properties later in the implementation process and in different contexts. Trial registration ClinicalTrials.gov code NCT03271242 (retrospective registered September 5, 2017).

Secondary school teachers have low levels of wellbeing and high levels of depression compared with the general population. Teachers are in a key position to support students, but poor mental health may be a barrier to doing so effectively. The Wellbeing in Secondary Education (WISE) project is a cluster randomised controlled trial (RCT) of an intervention to improve the mental health support and training available to secondary school teachers through delivery of the training package Mental Health First Aid and a staff peer support service. We will conduct a process evaluation as part of the WISE trial to support the interpretation of trial outcomes and refine intervention theory. The domains assessed will be: the extent to which the hypothesised mechanisms of change are activated; system level influences on these mechanisms; programme differentiation and usual practice; intervention implementation, including any adaptations; intervention acceptability; and intervention sustainability. Research questions will be addressed via quantitative and qualitative methods. All study schools (n = 25) will provide process evaluation data, with more detailed focus group, interview and observation data being collected from a subsample of case study schools (4 intervention and 4 control). Mechanisms of change, as outlined in a logic model, will be measured via teacher and student surveys and focus groups. School context will be explored via audits of school practice that relate to mental health and wellbeing, combined with stakeholder interviews and focus groups. Implementation of the training and peer support service will be assessed via training observations, training participant evaluation forms, focus groups with participants, interviews with trainers and peer support service users, and peer supporter logs recording help provided. Acceptability and sustainability will be examined via interviews with funders, head teachers, trainers and peer support services users, and focus groups with training participants. The process evaluation embedded within the WISE cluster RCT will illuminate how and why the intervention was effective, ineffective or conferred iatrogenic effects. It will contribute to the refinement of the theory underpinning the intervention, and will help to inform any future implementation. International Standard Randomised Controlled Trial Number: ISRCTN95909211 registered on 24 March 2016.

Background The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART. Methods The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health’s Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women’s health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively. Discussion The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings. Trial registration ClinicalTrials.gov ( NCT02407691 ) registered on 19 March 2015; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) ( DOH-27-0515-5048 ) NHREC number 4048 issued on 21/04/2015.

Background High-quality care delivery for frail older persons, many of whom have multiple complex needs, is among the greatest challenges faced by healthcare systems today. The Chronic Care Model (CCM) may guide quality improvement efforts for primary care delivery to frail older populations. Objectives of this study were to assess the implementation of interventions in CCM dimensions, and to investigate the quality of primary care as perceived by healthcare professionals, in practices following the Finding and Follow-up of Frail older persons (FFF) integrated care approach and those providing usual care. Methods Structured interviews were conducted with general practitioners (GPs) from 11 intervention practices and 4 control practices to assess the implementation of interventions. A longitudinal survey (12-month period, 2 measurement timepoints) was conducted to assess the quality of primary care as perceived by healthcare professionals (intervention and control GP practices) using the Assessment of Chronic Illness Care Short version (ACIC-S). Independent-samples t-tests were used to assess differences in ACIC-S scores between groups. Interviews were conducted with GPs from the intervention practices to gain a deeper understanding of their experiences with the FFF approach. Results Intervention practices implemented significantly more interventions congruent with (dimensions of) the CCM compared with control GP practices. With respect to the quality of primary care as perceived by healthcare professionals, mean ACIC-S scores for all CCM dimensions and overall mean ACIC-S scores were significantly higher in the intervention group than in the control group at the follow-up timepoint. The number of implemented interventions was associated positively with perceived quality of primary care (ACIC-S scores) at follow-up. Important motives of GPs to implement the FFF approach were the aging of the population and transformations in the primary care sector. Proactive care delivery and multidisciplinary collaboration were considered to be essential. Major challenges to the implementation and embedding of the FFF approach were structural financing and manpower, and the availability of a facilitating information and communication technology system. Conclusions Our study showed that proactive, integrated care that is based on (elements of) the CCM may be a step forward in improving quality of care for frail older persons.

Background: The Kenyan Ministry of Health- Department of Standards and Regulations sought to operationalize the Kenya Quality Assurance Model for Health. To this end an integrated quality management system based on validated indicators derived from the Kenya Quality Model for Health (KQMH) was developed and adapted to the area of Reproductive and Maternal and Neonatal Health, implemented and analysed. Methods: An integrated quality management (QM) approach was developed based on European Practice Assessment (EPA) modified to the Kenyan context. It relies on a multi-perspective, multifaceted and repeated indicator based assessment, covering the 6 World Health Organization (WHO) building blocks. The adaptation process made use of a ten step modified RAND/UCLA appropriateness Method. To measure the 303 structure, process, outcome indicators five data collection tools were developed: surveys for patients and staff, a self-assessment, facilitator assessment, a manager interview guide. The assessment process was supported by a specially developed software (VISOTOOL®) that allows detailed feedback to facility staff, benchmarking and facilitates improvement plans. A longitudinal study design was used with 10 facilities (6 hospitals; 4 Health centers) selected out of 36 applications. Data was summarized using means and standard deviations (SDs). Categorical data was presented as frequency counts and percentages. Results: A baseline assessment (T1) was carried out, a reassessment (T2) after 1.5 years. Results from the first and second assessment after a relatively short period of 1.5 years of improvement activities are striking, in particular in the domain ‘Quality and Safety’ (20.02%; p

Background Adherence to pharmacotherapeutic treatment guidelines in patients with heart failure (HF) is of major prognostic importance, but thorough implementation of guidelines in routine care remains insufficient. Our aim was to investigate prevalence and characteristics of HF in patients with coronary heart disease (CHD), and to assess the adherence to current HF guidelines in patients with HF stage C, thus identifying potential targets for the optimization of guideline implementation. Methods Patients from the German sample of the European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EuroAspire) IV survey with a hospitalization for CHD within the previous six to 36 months providing valid data on echocardiography as well as on signs and symptoms of HF were categorized into stages of HF: A, prevalence of risk factors for developing HF; B, asymptomatic but with structural heart disease; C, symptomatic HF. A Guideline Adherence Indicator (GAI-3) was calculated for patients with reduced (≤40%) left ventricular ejection fraction (HFrEF) as number of drugs taken per number of drugs indicated; beta-blockers, angiotensin converting enzyme inhibitors/angiotensin receptor blockers, and mineralocorticoid receptor antagonists (MRA) were considered. Results 509/536 patients entered analysis. HF stage A was prevalent in n = 20 (3.9%), stage B in n = 264 (51.9%), and stage C in n = 225 (44.2%) patients; 94/225 patients were diagnosed with HFrEF (42%). Stage C patients were older, had a longer duration of CHD, and a higher prevalence of arterial hypertension. Awareness of pre-diagnosed HF was low (19%). Overall GAI-3 of HFrEF patients was 96.4% with a trend towards lower GAI-3 in patients with lower LVEF due to less thorough MRA prescription. Conclusions In our sample of CHD patients, prevalence of HF stage C was high and a sizable subgroup suffered from HFrEF. Overall, pharmacotherapy was fairly well implemented in HFrEF patients, although somewhat worse in patients with more reduced ejection fraction. Two major targets were identified possibly suited to further improve the implementation of HF guidelines: 1) increase patients´ awareness of diagnosis and importance of HF; and 2) disseminate knowledge about the importance of appropriately implementing the use of mineralocorticoid receptor antagonists. Trial registration This is a cross-sectional analysis of a non-interventional study. Therefore, it was not registered as an interventional trial.

Background Pancreatic resections are among the most complex procedures in visceral surgery. While mortality has decreased substantially over the past decades, morbidity remains high. The volume-outcome correlation in pancreatic surgery is among the strongest in the field of surgery. The German Society for General and Visceral Surgery (DGAV) established a national registry for quality control, risk assessment and outcomes research in pancreatic surgery in Germany (DGAV SuDoQ|Pancreas). Methods Here, we present the aims and scope of the DGAV StuDoQ|Pancreas Registry. A systematic assessment of registry quality is performed based on the recommendations of the German network for outcomes research (DNVF). Results The registry quality was assessed by consensus criteria of the DNVF in regard to the domains Systematics and Appropriateness, Standardization, Validity of the sampling procedure, Validity of data collection, Validity of statistical analysis and reports, and General demands for registry quality. In summary, DGAV StuDoQ|Pancreas meets most of the criteria of a high-quality clinical registry. Conclusion The DGAV StuDoQ|Pancreas provides a valuable platform for quality assessment, outcomes research as well as randomized registry trials in pancreatic surgery. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1911-x) contains supplementary material, which is available to authorized users.

Background Around a fifth of children starting school in England are now overweight/obese. There is a paucity of interventions with the aim of obesity prevention in preschool-age children in the UK. Previous research has demonstrated some positive results in changing specific health behaviours, however, positive trends in overall obesity rates are lacking. Preschool settings may provide valuable opportunities to access children and their families not only for promoting healthy lifestyles, but also to develop and evaluate behaviour-change interventions. Methods This paper presents a cluster randomised feasibility study of a theory based behaviour-change preschool practitioner-led intervention tested in four preschool centres in the North East of England. The primary outcome measures were to test the acceptability and feasibility of the data collection measures and intervention. Secondary measures were collected and reported for extra information. At baseline and post intervention, children’s anthropometric, dietary and physical activity measures as well as family ‘active’ time data were collected. The preschool practitioner-led intervention included family intervention tasks such as ‘family goal-setting activities’ and ‘cooking challenges’. Preschool activities included increasing physical activity and providing activities with the potential to change behaviour with increased knowledge of and acceptance of healthy eating. The process evaluation was an on-going monthly process and was collected in multiple forms such as questionnaires, photographs and verbal feedback. Results ‘Gatekeeper’ permission and lower-hierarchal adherence were initially a problem for recruitment and methods acceptance. However, at intervention end the preschool teachers and parents stated they found most intervention methods and activities acceptable, and some positive changes in family health behaviours were reported. However, the preschool centres appeared to have difficulties with enforcing everyday school healthy eating policies. Conclusions The findings from the current study may have implications for nursery practitioners, nursery settings, Local Educational Authorities and policy makers, and contributes to the body of literature. However, further work with preschool practitioners is required to determine how personal attitudes and school policy application can be supported to implement successfully such an intervention. Trial registration ISRCTN12345678 (16/02/17) retrospectively registered.

Background Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. Methods/design A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period. The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience. The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. Methods: fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection of key data about intervention wards. Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework. Discussion This study will be one of the largest patient safety trials ever conducted, involving 32 hospital wards. The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level. Incorporating the ‘patient voice’ is critical if patient feedback is to be situated as an integral part of patient safety improvements. Trial registration ISRCTN07689702, 16 Aug 2013 Electronic supplementary material The online version of this article (doi:10.1186/1745-6215-15-420) contains supplementary material, which is available to authorized users.

Background Use of core outcome sets in research has been proposed as a method for countering the problems caused by heterogeneity of outcome measure reporting. Heterogeneity of outcome measure reporting occurs in Hirschsprung’s disease (HD) research and is limiting the development of a robust evidence base to support clinical practice. Methods Candidate outcome measures have been identified through a systematic review. These outcome measures will form the starting point for a three-phase online Delphi process to be carried out in parallel by three panels of experts. Panel 1 is a neonatal panel; panel 2 is a non-neonatal panel; and panel 3 is a lay panel. In round 1, experts will be asked to score the previously identified outcome measures from 1 to 9 based on how important they think the measures are in determining the overall success of their/their child’s/their patient’s HD. In round 2, experts will be presented with the same list of outcome measures and graphical representations of how their panel scored that outcome in round 1. They will be asked to re-score the outcome measure, taking into account how important other members of their panel felt it to be. In round 3, experts will again be asked to re-score each outcome measure, but this time they will receive a graphical representation of the distribution of scores from all three panels, which they should take into account when re-scoring. Following round 3 of the Delphi process, 40 experts will be invited to attend a face-to-face consensus meeting. Participants will be invited in a purposive manner to obtain balance between the different panels. Results of the Delphi process will be discussed, and outcomes will be re-scored. Outcome measures where >70% of participants at the meeting scored it 7–9 and

Background A number of registry studies have reported suboptimal adherence to guidelines for cardiovascular prevention during the first year after acute myocardial infarction (AMI). However, only a few studies have addressed long-term secondary prevention after AMI. This study evaluates prevention guideline adherence and outcome of guideline-directed secondary prevention in patients surviving 2 years after AMI. Methods Patients aged 18–85 years at the time of their index AMI were consecutively identified from hospital discharge records between July 2010 and December 2011 in Gothenburg, Sweden. All patients who agreed to participate in the study (16.2%) were invited for a structured interview, physical examinations and laboratory analysis 2 years after AMI. Guideline-directed secondary preventive goals were defined as optimally controlled blood pressure, serum cholesterol, glucose, regular physical activity, smoking cessation and pharmacological treatment. Results The mean age of the study cohort (n = 200) at the index AMI was 63.0 ± 9.7 years, 79% were men. Only 3.5% of the cohort achieved all six guideline-directed secondary preventive goals 2 years after infarction. LDL