Evidence Synthesis for Complex Interventions Using Meta-Regression Models.

A goal of evidence synthesis for trials of complex interventions is to inform the design or implementation of novel versions of complex interventions by predicting expected outcomes with each intervention version. Conventional aggregate data meta-analyses of studies comparing complex interventions have limited ability to provide such information. We argue that evidence synthesis for trials of complex interventions should forgo aspirations of estimating causal effects and instead model the response surface of study results to 1) summarize the available evidence and 2) predict the average outcomes of future studies or in new settings. We illustrate this modeling approach using data from a systematic review of diabetes quality improvement (QI) interventions involving at least 1 of 12 QI strategy components. We specify a series of meta-regression models to assess the association of specific components with the posttreatment outcome mean and compare the results to conventional meta-analysis approaches. Compared with conventional approaches, modeling the response surface of study results can better reflect the associations between intervention components and study characteristics with the posttreatment outcome mean. Modeling study results using a response surface approach offers a useful and feasible goal for evidence synthesis of complex interventions that rely on aggregate data.

Better Care, Same Cost - Reducing Unplanned Care for Multi-visit Patients: A Payer-Provider Model.

IMPORTANCE: Many interventions implemented for multi-visit patients (MVP) have been developed to address patient-centric needs of these individuals and reduce unplanned care for ambulatory-sensitive conditions. More rigorous research is needed to better understand the impact of these interventions on changes in care utilization including unplanned care. OBJECTIVE: To evaluate the impact of the Enhanced Care Program (ECP), a payer-provider collaborative model, on unplanned care use and cost of care. DESIGN: Using propensity methods, a comparison group was constructed using insurer membership files. Comparisons were performed using a difference-in-differences analysis. PARTICIPANTS: Patients enrolled in ECP through December 2019 were considered eligible for the study (n = 357). All patients had five or more ED visits in the past year or two or more inpatient hospitalizations in the past year prior to enrollment. EXPOSURES: ECP is a high-intensity outpatient intervention intended to reduce avoidable unplanned care such as ED visits and inpatient hospital stays through home visits, chronic/acute disease management, and intensive care coordination. MAIN MEASURES: The primary outcomes of interest were events per 100 members per year of ED use with return to home, unplanned inpatient and observational status admissions, and unplanned behavioral health inpatient admission, and cost of care per member per month. KEY RESULTS: Overall total unplanned care encounters were significantly reduced with a difference-in-difference of 320 unplanned care encounters per 100 members per year in the intervention group (p < 0.05). The ECP group showed statistically significant decreases in costs of unplanned ED, unplanned observation admission, and unplanned inpatient behavioral medicine costs, but statistically significant increases in overall pharmacy costs and lab costs. Changes in total costs of care for the ECP group were not statistically different than the control group (p = 0.55). CONCLUSIONS: ECP showed significant reduction of unplanned care for MVP patients.

Food Systems Interventions for Nutrition: Lessons from 6 Program Evaluations in Africa and South Asia.

Although there is growing global momentum behind food systems strategies to improve planetary and human health-including nutrition-there is limited evidence of what types of food systems interventions work. Evaluating these types of interventions is challenging due to their complex and dynamic nature and lack of fit with standard evaluation methods. In this article, we draw on a portfolio of 6 evaluations of food systems interventions in Africa and South Asia that were intended to improve nutrition. We identify key methodological challenges and formulate recommendations to improve the quality of such studies. We highlight 5 challenges: a lack of evidence base to justify the intervention, the dynamic and multifaceted nature of the interventions, addressing attribution, collecting or accessing accurate and timely data, and defining and measuring appropriate outcomes. In addition to more specific guidance, we identify 6 cross-cutting recommendations, including a need to use multiple and diverse methods and flexible designs. We also note that these evaluation challenges present opportunities to develop new methods and highlight several specific needs in this space.

Medical assistance in dying for mental illness: a complex intervention requiring a correspondingly complex evaluation approach.

Medical assistance in dying for mental illness as a sole underlying medical condition (MAiD MI-SUMC) is a controversial and complex policy in terms of psychosocial and ethical medical practice implications. We discuss the status of MAiD MI-SUMC in Canada and argue for the use of the UK Medical Research Council's framework on complex interventions in programme evaluations of MAiD MI-SUMC. It is imperative to carefully and rigorously evaluate the implementation of MAiD MI-SUMC to ensure an understanding of the multiple facets of implementation in contexts permeated by unique social, economic, cultural and historical influences, with a correspondingly diverse array of outcomes. This requires a complexity-informed programme evaluation focused on context-dependent mechanisms and stakeholder experiences, including patients, service providers and other people affected by the policy. It is also important to consider the economic impact on health and social welfare systems. Such evaluations can provide the data needed to guide evidence-informed decision-making that can contribute to safer implementation and refinement of MAiD MI-SUMC.

Effectiveness of care bundles for prevention and treatment of postpartum hemorrhage: a systematic review.

OBJECTIVE: Care bundles are a promising approach to reducing postpartum hemorrhage-related morbidity and mortality. We assessed the effectiveness and safety of care bundles for postpartum hemorrhage prevention and/or treatment. DATA SOURCES: We searched MEDLINE, Embase, Cochrane CENTRAL, Maternity and Infant Care Database, and Global Index Medicus (inception to June 9, 2023) and ClinicalTrials.gov and the International Clinical Trials Registry Platform (last 5 years) using a phased search strategy, combining terms for postpartum hemorrhage and care bundles. STUDY ELIGIBILITY CRITERIA: Peer-reviewed studies evaluating postpartum hemorrhage-related care bundles were included. Care bundles were defined as interventions comprising ≥3 components implemented collectively, concurrently, or in rapid succession. Randomized and nonrandomized controlled trials, interrupted time series, and before-after studies (controlled or uncontrolled) were eligible. METHODS: Risk of bias was assessed using RoB 2 (randomized trials) and ROBINS-I (nonrandomized studies). For controlled studies, we reported risk ratios for dichotomous outcomes and mean differences for continuous outcomes, with certainty of evidence determined using GRADE. For uncontrolled studies, we used effect direction tables and summarized results narratively. RESULTS: Twenty-two studies were included for analysis. For prevention-only bundles (2 studies), low-certainty evidence suggests possible benefits in reducing blood loss, duration of hospitalization, and intensive care unit stay, and maternal well-being. For treatment-only bundles (9 studies), high-certainty evidence shows that the E-MOTIVE intervention reduced risks of composite severe morbidity (risk ratio, 0.40; 95% confidence interval, 0.32-0.50) and blood transfusion for bleeding, postpartum hemorrhage, severe postpartum hemorrhage, and mean blood loss. One nonrandomized trial and 7 uncontrolled studies suggest that other postpartum hemorrhage treatment bundles might reduce blood loss and severe postpartum hemorrhage, but this is uncertain. For combined prevention/treatment bundles (11 studies), low-certainty evidence shows that the California Maternal Quality Care Collaborative care bundle may reduce severe maternal morbidity (risk ratio, 0.64; 95% confidence interval, 0.57-0.72). Ten uncontrolled studies variably showed possible benefits, no effects, or harms for other bundle types. Nearly all uncontrolled studies did not use suitable statistical methods for single-group pretest-posttest comparisons and should thus be interpreted with caution. CONCLUSION: The E-MOTIVE intervention improves postpartum hemorrhage-related outcomes among women delivering vaginally, and the California Maternal Quality Care Collaborative bundle may reduce severe maternal morbidity. Other bundle designs warrant further effectiveness research before implementation is contemplated.

A Complex Meta-Regression Model to Identify Effective Features of Interventions From Multi-Arm, Multi-Follow-Up Trials.

Network meta-analysis (NMA) combines evidence from multiple trials to compare the effectiveness of a set of interventions. In many areas of research, interventions are often complex, made up of multiple components or features. This makes it difficult to define a common set of interventions on which to perform the analysis. One approach to this problem is component network meta-analysis (CNMA) which uses a meta-regression framework to define each intervention as a subset of components whose individual effects combine additively. In this article, we are motivated by a systematic review of complex interventions to prevent obesity in children. Due to considerable heterogeneity across the trials, these interventions cannot be expressed as a subset of components but instead are coded against a framework of characteristic features. To analyse these data, we develop a bespoke CNMA-inspired model that allows us to identify the most important features of interventions. We define a meta-regression model with covariates on three levels: intervention, study, and follow-up time, as well as flexible interaction terms. By specifying different regression structures for trials with and without a control arm, we relax the assumption from previous CNMA models that a control arm is the absence of intervention components. Furthermore, we derive a correlation structure that accounts for trials with multiple intervention arms and multiple follow-up times. Although, our model was developed for the specifics of the obesity data set, it has wider applicability to any set of complex interventions that can be coded according to a set of shared features.

Process evaluation of a breastfeeding support intervention to promote exclusive breastfeeding and reduce social inequity: a mixed-methods study in a cluster-randomised trial.

BACKGROUND: Breastfeeding is a powerful public health intervention that produces long-term health benefits. However, in high-income countries such as Denmark, breastfeeding rates are suboptimal and unequally distributed across socio-economic positions. The 'Breastfeeding - a good start together' intervention, to promote longer duration of exclusive breastfeeding and reduce social inequity, was implemented in a cluster-randomised trial during 2022-2023 across 21 municipalities in two Danish regions. A process evaluation was conducted to assess the implementation, mechanisms of impact, and possible contextual factors affecting the intervention. METHODS: The study was guided by the Medical Research Council's guidance for conducting process evaluations and employed a mixed-methods approach in a convergence design. Quantitative data: contextual mapping survey (n = 20), health visitor survey (n = 284), health visitor records from 20 clusters and intervention website statistics. Qualitative data: dialogue meetings (n = 7), focus groups (n = 3) and interviews (n = 8). RESULTS: Overall, the intervention was delivered as planned to intended recipients, with few exceptions. Health visitors responded positively to the intervention, noting that it fitted well within their usual practice and enhanced families' chances of breastfeeding. Mothers expressed having received the intervention with few exceptions, and reacted positively to the intervention. Although health visitors were concerned about the potential stigmatisation of mothers receiving the intensified intervention, none of the interviewed mothers felt stigmatised. Contextual factors impacting the intervention implementation and mechanisms included staff and management turnover, project infrastructure and mothers' context, such as resources, social networks and previous experiences. The overall fidelity of the intervention delivery was high. CONCLUSIONS: Health visitors and families responded well to the intervention. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support, in alignment with support provided in other sectors of the health care system, may increase breastfeeding rates and reduce social inequity in breastfeeding, even in international contexts. TRIAL REGISTRATION: Clinical Trials: NCT05311631. First posted April 5, 2022.

Intervention for sleep problems in nursing home residents with dementia: a cluster-randomized study.

OBJECTIVE: To reduce sleep problems in people living with dementia using a multi-component intervention. DESIGN: Cluster-randomized controlled study with two parallel groups and a follow-up of 16 weeks. SETTING: Using external concealed randomization, 24 nursing homes (NH) were allocated either to the intervention group (IG, 12 clusters, 126 participants) or the control group (12 clusters, 116 participants). PARTICIPANTS: Participants were eligible if they had dementia or severe cognitive impairment, at least two sleep problems, and residence of at least two weeks in a NH. INTERVENTION: The 16-week intervention consists of six components: (1) assessment of sleep-promoting activities and environmental factors in NHs, (2) implementation of two "sleep nurses," (3) basic education, (4) advanced education for staff, (5) workshops to develop sleep-promoting concepts, and (6) written information and education materials. The control group (CG) received standard care. MEASUREMENTS: Primary outcome was ≥ two sleep problems after 16 weeks assessed with the Sleep Disorders Inventory (SDI). RESULTS: Twenty-two clusters (IG = 10, CG = 12) with 191 participants completed the study. At baseline, 90% of people living with dementia in the IG and 93% in the CG had at least two sleep problems. After 16 weeks, rates were 59.3% (IG) vs 83.8% (CG), respectively, a difference of -24.5% (95% CI, -46.3% - -2.7%; cluster-adjusted odds ratio 0.281; 95% CI 0.087-0.909). Secondary outcomes showed a significant difference only for SDI scores after eight and 16 weeks. CONCLUSIONS: The MoNoPol-Sleep intervention reduced sleep problems of people living with dementia in NH compared to standard care.

Process evaluation of implementation of the early stages of a whole systems approach to obesity in a small Island.

BACKGROUND: The small Atlantic island of St Helena is a United Kingdom Overseas Territory (UKOT) with a high prevalence of childhood obesity (over a quarter of 4-5 and 10-11 year olds) and, anecdotally, adulthood obesity and its associated health detriments. St Helena have taken a whole systems approach to obesity (WSAO) to address the issue. A WSAO recognises the factors that impact obesity as a complex system and requires a 'health in all policies' approach. UK academic and public health technical support was provided to the local St Helena delivery team. This process evaluation sought to explore the early stages of the WSAO implementation and implications for the transferability of the approach to other small island developing states and UKOT. METHODS: Data was collected via eight semi-structured interviews, paper based and online surveys, and document analysis. Thematic analysis was used to analyse the data. RESULTS: The analysis identified three factors which aided the first phase of WSAO implementation: (1) senior leaders support for the approach; (2) the academic support provided to establish and develop the approach; and (3) effective adaptation of UK Government resources to suit the local context. Key challenges of early implementation included: maintaining and broadening stakeholder engagement; limited local workforce capacity and baseline knowledge related to obesity and systems thinking; and limited capacity for support from the UK-based academic team due to contract terms and COVID-19 restrictions. CONCLUSIONS: Early stages of implementation of a WSAO in a UKOT can be successful when using UK's resources as a guide and adapting them to a small island context. All participants recommended other small islands adopt this approach. Continued senior support, dedicated leadership, and comprehensive community engagement is needed to progress implementation and provide the foundation for long-term impact. Small island developing states considering adopting a WSAO should consider political will, senior level buy-in and support, funding, and local workforce knowledge and capacity to enable the best chances of successful and sustainable implementation.

Longitudinal effectiveness of a woman-led, nurse delivered health promotion intervention for women who have experienced intimate partner violence: iHEAL randomized controlled trial.

BACKGROUND: Intimate partner violence (IPV) threatens the safety, health and quality of life of women worldwide. Comprehensive IPV interventions that are tailored, take a long-term view of women's needs, including health concerns, and maximize choice and control, have the potential to effectively address heath and safety concerns. Few such interventions have been tested, including in the Canadian context. METHODS: A parallel randomized controlled trial of adult (age 19 + years), English-speaking, Canadian women with histories of IPV randomized either to iHEAL, a tailored health promotion intervention delivered by Registered Nurses over 6-7 months, or to community service information (usual care control). Primary (Quality of Life, PTSD symptoms) and secondary outcomes (Depression, Confidence in Managing Daily Life, Chronic Pain, IPV Severity) were measured at baseline and 6, 12 and 18 months post-intervention via an online survey. Generalized estimating equations were used to test for differences by study arm in intention-to-treat (full sample) and per protocol (1 + iHEAL visit) analyses focussing on short-term (immediately post-intervention) and longer-term (1 year post-intervention) effects. Selected process evaluation data were summarized using descriptive statistics. RESULTS: Of 331 women enrolled, 175 were randomized to iHEAL (135 who engaged in 1 + visits) and 156 to control. Women who received iHEAL showed significantly greater short-term improvement in Quality of Life compared to the control group, with these effects maintained 1 year later. Changes in PTSD Symptoms also differed significantly by group, with weaker initial effects that were stronger 1 year post-intervention. Significant moderate, short- and longer-term group effects were also observed for Depression and Confidence in Managing Daily Life. IPV Severity decreased for both groups, with significant immediate effects in favour of the intervention group that grew stronger 1 year post-intervention. There were no changes in Chronic Pain. CONCLUSION: iHEAL is an effective, acceptable and safe intervention for diverse groups of women with histories of IPV. Trial results provide a foundation for implementation and ongoing evaluation in health care settings and systems. Delayed effects noted for PTSD Symptoms and IPV Severity suggest that longer-term assessment of these outcomes may be needed in trials of IPV interventions. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT03573778 (Registered on June 29, 2018).

Qualitative realist evaluation of an occupational therapy intervention programme (ABLE), addressing ability to perform activities of daily living among persons with chronic conditions.

BACKGROUND: Chronic conditions are associated with problems related to performance of activities of daily living (ADL) stressing a need to develop and evaluate intervention programmes addressing such problems. Hence, the ABLE programme was developed, and its feasibility evaluated. Implementing intervention programmes in community-based rehabilitation settings requires understanding of how the programme works in various contexts. Applying a realist evaluation approach, the aim of this study was to identify and evaluate interactions between contexts, mechanisms, and outcomes in the ABLE 2.0, to confirm, refine, or reject aspects of the initial programme theory. METHODS: Realist evaluation using qualitative data collected in the ABLE 2.0 randomised controlled trial (n = 78). Based on the ABLE 2.0 initial programme theory, qualitative realist interviews were conducted among receivers (n = 8) and deliverers (n = 3) of the ABLE 2.0 in a Danish municipality. Transcripts were coded, and context-mechanism-outcome configurations were extracted and grouped into contiguous themes. Results were then held up against the initial programme theory. RESULTS: Four contiguous themes were identified including a total of n = 28 context-mechanism-outcome configurations: building a foundation for the entire intervention; establishing the focus for further intervention; identifying and implementing relevant compensatory solutions; and re-evaluating ADL ability to finalise intervention. Overall, the ABLE 2.0 initial programme theory was confirmed. The evaluation added information on core facilitating mechanisms including active involvement of the client in the problem-solving process, a collaborative working relationship, mutual confidence, and a consultative occupation-based process using compensatory solutions. Several contextual factors were required to activate the desired mechanisms in terms of supportive management, referral procedures encouraging the problem-solving process, delivery in the client's home, skilled occupational therapists, and clients feeling ready for making changes. CONCLUSIONS: The ABLE 2.0 represents a coherent problem-solving occupational therapy process, applicable across sex, age, and diagnoses with the potential to enhance ADL ability among persons with chronic conditions, when delivered as part of community-based rehabilitation services. Knowledge about the interactions between contextual factors, mechanisms, and outcomes in the ABLE 2.0 is central in case of future implementation of the programme in community-based rehabilitation settings. TRIAL REGISTRATION: The trial was prospectively registered on www. CLINICALTRIALS: gov (registration date: 05/03/2020; identifier: NCT04295837 ) prior to data collection that occurred between August 2020 and October 2021.

Implementation of peer support for people with severe mental health conditions in high-, middle- and low-income-countries: a theory of change approach.

BACKGROUND: Stakeholder engagement is essential to the design, implementation and evaluation of complex mental health interventions like peer support. Theory of Change (ToC) is commonly used in global health research to help structure and promote stakeholder engagement throughout the project cycle. Stakeholder insights are especially important in the context of a multi-site trial, in which an intervention may need to be adapted for implementation across very different settings while maintaining fidelity to a core model. This paper describes the development of a ToC for a peer support intervention to be delivered to people with severe mental health conditions in five countries as part of the UPSIDES trial. METHODS: One hundred thirty-four stakeholders from diverse backgrounds participated in a total of 17 workshops carried out at six UPSIDES implementing sites across high-, middle- and low-income settings (one site each in India, Israel, Uganda and Tanzania; two sites in Germany). The initial ToC maps created by stakeholders at each site were integrated into a cross-site ToC map, which was then revised to incorporate additional insights from the academic literature and updated iteratively through multiple rounds of feedback provided by the implementers. RESULTS: The final ToC map divides the implementation of the UPSIDES peer support intervention into three main stages: preparation, implementation, and sustainability. The map also identifies three levels of actors involved in peer support: individuals (service users and peer support workers), organisations (and their staff members), and the public. In the UPSIDES trial, the ToC map proved especially helpful in characterising and distinguishing between (a) common features of peer support, (b) shared approaches to implementation and (c) informing adaptations to peer support or implementation to account for contextual differences. CONCLUSIONS: UPSIDES is the first project to develop a multi-national ToC for a mental health peer support intervention. Stakeholder engagement in the ToC process helped to improve the cultural and contextual appropriateness of a complex intervention and ensure equivalence across sites for the purposes of a multi-site trial. It may serve as a blueprint for implementing similar interventions with a focus on recovery and social inclusion among people with mental ill-health across diverse settings. TRIAL REGISTRATION: ISRCTN26008944 (Registration Date: 30/10/2019).

The development of a novel sexual health promotion intervention for young people with mental ill-health: the PROSPEct project.

BACKGROUND: Young people with mental ill-health experience higher rates of high-risk sexual behaviour, have poorer sexual health outcomes, and lower satisfaction with their sexual wellbeing compared to their peers. Ensuring good sexual health in this cohort is a public health concern, but best practice intervention in the area remains under-researched. This study aimed to co-design a novel intervention to address the sexual health needs of young people with mental ill-health to test its effectiveness in a future trial undertaken in youth mental health services in Melbourne, Australia. METHODS: We followed the 2022 Medical Research Council (MRC) guidelines for developing and evaluating complex interventions. This involved synthesising evidence from the 'top down' (published evidence) and 'bottom up' (stakeholder views). We combined systematic review findings with data elicited from qualitative interviews and focus groups with young people, carers, and clinicians and identified critical cultural issues to inform the development of our intervention. RESULTS: Existing evidence in the field of sexual health in youth mental health was limited but suggested the need to address sexual wellbeing as a concept broader than an absence of negative health outcomes. The Information-Motivation-Belief (IMB) model was chosen as the theoretical Framework on which to base the intervention. Interviews/focus groups were conducted with 29 stakeholders (18 clinicians, three carers, and eight young people). Synthesis of the evidence gathered resulted in the co-design of a novel intervention consisting of an initial consultation and four 60-90-minute sessions delivered individually by a young 'sex-positive' clinician with additional training in sexual health. Barriers and supports to intervention success were also identified. CONCLUSIONS: Using the MRC Framework has guided the co-design of a potentially promising intervention that addresses the sexual health needs of young people with mental ill-health. The next step is to test the intervention in a one-arm feasibility trial.

Building a programme theory of a specialist paediatric palliative and hospice care programme: development process and methodological reflection.

BACKGROUND: Paediatric palliative and hospice care aims to improve the quality of life of children with life-limiting and life-threatening conditions and their families. The number of these patients has risen significantly in recent years, resulting in an increased need for palliative care for this population. Although the need for paediatric palliative and hospice care is growing, meaningful outcome evaluation to demonstrate its effectiveness as a complex healthcare intervention is in its early stages. For complex interventions (programmes), theory-based evaluations have grown in prominence in recent years. They seek to understand how and why an intervention works by uncovering its underlying mechanisms by means of programme theory. To support both outcome evaluation in paediatric palliative care and a reflective practice of programme theorizing, we aimed to describe the construction of a programme theory for a specialist paediatric palliative and hospice care programme in Austria and to offer a reflective account of its development process. METHODS: We drew on a combination of theory-based evaluation frameworks to construct a programme theory consisting of an action and a change component. Through multiple iterations, incorporating different stakeholders' perspectives and drawing on different sources of knowledge and theory, we theorized how and why the programme likely achieves its intended outcomes. RESULTS: The programme theory outlines the proposed chains of events, causal mechanisms and outcomes of a specialist paediatric palliative and hospice care programme for children and families in several areas corresponding to its main conceptual tenets. Through a range of activities and interventions, the programme triggers coping and adaptation mechanisms that ultimately contribute to family and child wellbeing in physical, psychological, social, and spiritual dimensions. Established trust and partnership between children/families and healthcare professionals as well as a person-centered and family-centered approach were identified as enabling factors. CONCLUSIONS: Our findings provide insights into how a specialized paediatric palliative and hospice care programme works to achieve its intended outcomes for children and families. This helps demonstrate its impact, contributing to meaningful outcome evaluation and service improvement.

The Impact of Implementation Fidelity of a School-Based Multi-Component Smoking Prevention Intervention on Vocational Students' Smoking Behavior: A Cluster-Randomized Controlled Trial.

Preventing young people's cigarette smoking is a major public health priority, and smoking is especially prevalent in vocational schools. Well-enforced comprehensive school tobacco policies accompanied by preventive efforts show potential to reduce smoking, but the implementation process is crucial to achieve the intended effect. We investigate whether and how implementation fidelity of a multi-component smoking prevention intervention impacted student smoking outcomes after 4-5 months among students in Danish vocational education and training (national age range 15-65 years, mean 25.6) and preparatory basic education (national age range 15-25 years, mean 17.6) institutions using questionnaire data from a cluster-RCT. The intervention included a smoke-free school hours policy, educational curriculum, and class competition. We calculated an overall implementation fidelity measure combining staff-reported school-level delivery (fidelity) and student-reported receipt (participation, responsiveness), and used multilevel regression models to analyze associations with smoking outcomes (smoking daily, regularly, and during school hours). We supplemented the analysis with restricted cubic spline regression. Additionally, we stratified the analyses by school types and analyzed associations between implementation fidelity of the separate intervention components and smoking outcomes. High implementation was associated with lower odds of regular smoking (OR: 0.37, 95% CI: 0.18-0.78) and smoking during school hours, but not daily smoking, and these associations varied between the school settings. When analyzed separately, implementation fidelity of the components did not affect the outcomes significantly. Our findings underline the need to support the implementation process of school tobacco policy interventions to ensure the intended effects of reducing students' smoking.

Decisional needs in people with kidney failure, their relatives and health professionals about end-of-life care options: A qualitative interview study.

AIM: To investigate the decisional needs in Denmark of people with kidney failure, relatives, and health professionals when planning end-of-life care. DESIGN: A qualitative interview study. METHODS: Individual semi-structured interviews were carried out with people with kidney failure, relatives and health professionals from November 2021 to June 2022. Malterud's systematic text condensation was used to analyse transcripts. RESULTS: A total of 13 patients, 10 relatives, and 12 health professionals were interviewed. Overall, four concepts were agreed on: (1) Talking about end of life is difficult, (2) Patients and relatives need more knowledge and information, (3) Health professionals need more tools and training, and (4) Experiencing busyness as a barrier to conversations about end of life. CONCLUSION: People with kidney failure, relatives, and health professionals shared certain decisional needs while also having some different decisional needs about end-of-life care. To meet these various needs, end-of-life conversations should be systematic and organized according to the patients' needs and wishes. IMPACT: Non-systematic end-of-life care decision-making processes limit patients' involvement. Patients and relatives need more knowledge about end-of-life care, and health professionals need more competences and time to discuss decisional needs. A shared decision-making intervention for people with kidney failure when making end-of-life care decisions will be developed. REPORTING METHOD: This empirical qualitative research is reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist. PATIENT OR PUBLIC CONTRIBUTION: Patients, relatives, and health professionals have been involved throughout the research process as part of the research team and advisory board. The patients are people with kidney failure and the relatives are relatives of a person with kidney failure. For this study, the advisory board has particularly contributed to the validation of the invitation letter for participation, the interview guides and the preparation of the manuscript.

[What is health services research?] / Was ist Versorgungsforschung?

In health services research, the health care of the population is examined under everyday conditions. Scientific questions include medical, patient-oriented, system-, performance- and quality-related as well as health economics topics. In health services research, complex interventions, e.g., treatment concepts with multiple therapy components, and/or across multiple sectors, are often implemented. The design of studies in health services research is based on the research question, the setting, and the available data, which can come from a variety of sources.

Using a theoretically informed process evaluation alongside a trial to improve oral health for care home residents.

BACKGROUND: Poor oral health is common among older adults residing in care homes impacting their diet, quality of life, self-esteem, general health and well-being. The care home setting is complex and many factors may affect the successful implementation of oral care interventions. Exploring these factors and their embedded context is key to understanding how and why interventions may or may not be successfully implemented within their intended setting. OBJECTIVES: This methodology paper describes the approach to a theoretically informed process evaluation alongside a pragmatic randomised controlled trial, so as to understand contextual factors, how the intervention was implemented and important elements that may influence the pathways to impact. MATERIALS AND METHODS: SENIOR is a pragmatic randomised controlled trial designed to improve the oral health of care home residents in the United Kingdom. The trial uses a complex intervention to promote and provide oral care for residents, including education and training for staff. RESULTS: An embedded, theoretically informed process evaluation, drawing on the PAHRIS framework and utilising a qualitative approach, will help to understand the important contextual factors within the care home that influence both the trial processes and the implementation of the intervention. CONCLUSION: Utilising an implementation framework as the basis for a theoretically informed process evaluation provides an approach that specifically focuses on the contextual factors that may influence and shape the pathways to impact a given complex intervention a priori, while also providing an understanding of how and why an intervention may be effective. This contrasts with the more common post hoc approach that only focuses on implementation after the empirical results have emerged.

Setting the context for a complex dental intervention of role substitution in care homes: Initial process evaluation findings.

OBJECTIVES: SENIOR (uSing rolE-substitutioN In care homes to improve oRal health) is a randomised controlled trial designed to determine whether role substitution could improve oral health for this population. A parallel process evaluation was undertaken to understand context. This paper reports on the first phase of the process evaluation. BACKGROUND: The oral health and quality-of-life of older adults residing in care homes is poorer than those in the community. Oral health care provision is often unavailable and a concern and challenge for managers. The use of Dental Therapists and Dental Nurses rather than dentists could potentially meet these needs. MATERIALS AND METHODS: Semi-structured interviews were conducted with 21 key stakeholders who either worked or had experience of dependent care settings. Questions were theoretically informed by the: Promoting Action on Research Implementation in Health Services (PAHRIS) framework. The focus was on contextual factors that could influence adoption in practice and the pathway-to-impact. Interviews were fully transcribed and analysed thematically. RESULTS: Three themes (receptive context, culture, and leadership) and 11 codes were generated. Data show the complexity of the setting and contextual factors that may work as barriers and facilitators to intervention delivery. Managers are aware of the issues regarding oral health and seek to provide best care, but face many challenges including staff turnover, time pressures, competing needs, access to services, and financial constraints. Dental professionals recognise the need for improvement and view role substitution as a viable alternative to current practice. CONCLUSION: Although role substitution could potentially meet the needs of this population, an in-depth understanding of contextual factors appeared important in understanding intervention delivery and implementation.

Developing SSC program for disabled elderly to promote ADL independence in nursing home using MRC framework for complex interventions.

OBJECTIVE: To develop SSC program for promoting the independence of disabled elderly in Activities of Daily Living (ADL) care in nursing homes. METHODS: This intervention aligns with the Medical Research Council (MRC) Framework for complex interventions. The following three steps were undertaken: (1) identifying the evidence base; (2) identifying/developing theory; (3) modeling processes and outcomes. RESULTS: We successfully developed the complex intervention program of self-supporting care (SSC). The program comprises two integral parts: (1) self-supporting care interventions (SSC-i); (2) self-supporting care implementation interventions (SSC-ii). CONCLUSIONS: Through adherence to the MRC framework, an evidence-based SSC program for managing ADL among disabled elderly individuals in nursing homes was developed. These findings offer a detailed specification of the SSC intervention protocol, which can serve as a valuable resource for healthcare professionals and researchers in subsequent phases, particularly in pilot testing the efficacy of the intervention and promote independence among disabled elderly individuals.