Effectiveness and Cost-Effectiveness of Self-Management Interventions for Adults Living with Heart Failure to Improve Patient-Important Outcomes: An Evidence Map of Randomized Controlled Trials.

Self-management interventions (SMIs) may enhance heart failure (HF) outcomes and address challenges associated with disease management. This study aims to review randomized evidence and identify knowledge gaps in SMIs for adult HF patients. Within the COMPAR-EU project, from 2010 to 2018, we conducted searches in the databases MEDLINE, CINAHL, Embase, Cochrane, and PsycINFO. We performed a descriptive analysis using predefined categories and developed an evidence map of randomized controlled trials (RCTs). We found 282 RCTs examining SMIs for HF patients, comparing two to four interventions, primarily targeting individual patients (97%) globally (34 countries, only 31% from an European country). These interventions involved support techniques such as information sharing (95%) and self-monitoring (62%), often through a mix of in-person and remote sessions (43%). Commonly assessed outcomes included quality of life, hospital admissions, mortality, exercise capacity, and self-efficacy. Few studies have focused on lower socio-economic or minority groups. Nurses (68%) and physicians (30%) were the primary providers, and most studies were at low risk of bias in generating a random sequence for participant allocation; however, the reporting was noticeably unclear of methods used to conceal the allocation process. Our analysis has revealed prevalent support techniques and delivery methods while highlighting methodological challenges. These findings provide valuable insights for researchers, clinicians, and policymakers striving to optimize SMIs for individuals living with HF.

Assessment of a venous thromboembolism prophylaxis shared decision-making intervention (DASH-TOP) using the decisional conflict scale: a mixed-method study.

BACKGROUND: Venous thromboembolism (VTE) in pregnancy is a major cause of maternal morbidity and death. The use of low-molecular-weight heparin (LMWH), despite being the standard of care to prevent VTE, comes with some challenges. Shared decision-making (SDM) interventions are recommended to support patients and clinicians in making preference-sensitive decisions. The quality of the SDM process has been widely assessed with the decisional conflict scale (DCS). Our aim is to report participants' perspectives of each of the components of an SDM intervention (DASH-TOP) in relation to the different subscales of the DCS. METHODS: Design: A convergent, parallel, mixed-methods design. PARTICIPANTS: The sample consisted of 22 health care professionals, students of an Applied Clinical Research in Health Sciences (ICACS) master program. INTERVENTION: We randomly divided the participants in three groups: Group 1 received one component (evidence -based information), Group 2 received two components (first component and value elicitation exercises), and Group 3 received all three components (the first two and a decision analysis recommendation) of the SDM intervention. ANALYSIS: For the quantitative strand, we used a non-parametric test to analyze the differences in the DCS subscales between the three groups. For the qualitative strand, we conducted a content analysis using the decisional conflict domains to deductively categorize the responses. RESULTS: Groups that received more intervention components experienced less conflict and better decision-making quality, although the differences between groups were not statistically significant. The decision analysis recommendation improved the efficacy with the decision-making process, however there are some challenges when implementing it in clinical practice. The uncertainty subscale showed a high decisional conflict for all three groups; contributing factors included low certainty of the evidence-based information provided and a perceived small effect of the drug to reduce the risk of a VTE event. CONCLUSIONS: The DASH-TOP intervention reduced decisional conflict in the decision -making process, with decision analysis being the most effective component to improve the quality of the decision. There is a need for more implementation research to improve the delivery of SDM interventions in the clinical encounter.

Does the duration of ambulatory consultations affect the quality of healthcare? A systematic review.

BACKGROUND: The objective is to examine and synthesise the best available experimental evidence about the effect of ambulatory consultation duration on quality of healthcare. METHODS: We included experimental studies manipulating the length of outpatient clinical encounters between adult patients and clinicians (ie, therapists, pharmacists, nurses, physicians) to determine their effect on quality of care (ie, effectiveness, efficiency, timeliness, safety, equity, patient-centredness and patient satisfaction). INFORMATION SOURCES: Using controlled vocabulary and keywords, without restriction by language or year of publication, we searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Database of Systematic Reviews and Scopus from inception until 15 May 2023. RISK OF BIAS: Cochrane Risk of Bias instrument. DATA SYNTHESIS: Narrative synthesis. RESULTS: 11 publications of 10 studies explored the relationship between encounter duration and quality. Most took place in the UK's general practice over two decades ago. Study findings based on very sparse and outdated evidence-which suggested that longer consultations improved indicators of patient-centred care, education about prevention and clinical referrals; and that consultation duration was inconsistently related to patient satisfaction and clinical outcomes-warrant low confidence due to limited protections against bias and indirect applicability to current practice. CONCLUSION: Experimental evidence for a minimal or optimal duration of an outpatient consultation is sparse and outdated. To develop evidence-based policies and practices about encounter length, randomised trials of different consultation lengths-in person and virtually, and with electronic health records-are needed. TRIAL REGISTRATION NUMBER: OSF Registration DOI:10.17605/OSF.IO/EUDK8.

Financial Toxicity in the Clinical Encounter: A Paired Survey of Patient and Clinician Perceptions.

Objective: To compare the agreement between patient and clinician perceptions of care-related financial issues. Patients and Methods: We surveyed patient-clinician dyads immediately after an outpatient medical encounter between September 2019 and May 2021. They were asked to separately rate (1-10) patient's level of difficulty in paying medical bills and the importance of discussing cost issues with that patient during clinical encounters. We calculated agreement between patient-clinician ratings using the intraclass correlation coefficient and used random effects regression models to identify patient predictors of paired score differences in difficulty and importance of ratings. Results: 58 pairs of patients (n=58) and clinicians (n=40) completed the survey. Patient-clinician agreement was poor for both measures, but higher for difficulty in paying medical bills (intraclass correlation coefficient=0.375; 95% CI, 0.13-0.57) than for the importance of discussing cost (-0.051; 95% CI, -0.31 to 0.21). Agreement on difficulty in paying medical bills was not lower in encounters with conversations about the cost of care. In adjusted models, poor patient-clinician agreement on difficulty in paying medical bills was associated with lower patient socioeconomic status and education level, whereas poor agreement on patient-perceived importance of discussing cost was significant for patients who were White, married, reported 1 or more long-term conditions, and had higher education and income levels. Conclusion: Even in encounters where cost conversations occurred, there was poor patient-clinician agreement on ratings of the patient's difficulty in paying medical bills and perceived importance of discussing cost issues. Clinicians need more training and support in detecting the level of financial burden and tailoring cost conversations to the needs of individual patients.

Decision Analysis in SHared decision making for Thromboprophylaxis during Pregnancy (DASH-TOP): a sequential explanatory mixed-methods pilot study.

OBJECTIVES: To gain insight into formal methods of integrating patient preferences and clinical evidence to inform treatment decisions, we explored patients' experience with a personalised decision analysis intervention, for prophylactic low-molecular-weight heparin (LMWH) in the antenatal period. DESIGN: Mixed-methods explanatory sequential pilot study. SETTING: Hospitals in Canada (n=1) and Spain (n=4 sites). Due to the COVID-19 pandemic, we conducted part of the study virtually. PARTICIPANTS: 15 individuals with a prior venous thromboembolism who were pregnant or planning pregnancy and had been referred for counselling regarding LMWH. INTERVENTION: A shared decision-making intervention that included three components: (1) direct choice exercise; (2) preference elicitation exercises and (3) personalised decision analysis. MAIN OUTCOME MEASURES: Participants completed a self-administered questionnaire to evaluate decision quality (decisional conflict, self-efficacy and satisfaction). Semistructured interviews were then conducted to explore their experience and perceptions of the decision-making process. RESULTS: Participants in the study appreciated the opportunity to use an evidence-based decision support tool that considered their personal values and preferences and reported feeling more prepared for their consultation. However, there were mixed reactions to the standard gamble and personalised treatment recommendation. Some participants could not understand how to complete the standard gamble exercises, and others highlighted the need for more informative ways of presenting results of the decision analysis. CONCLUSION: Our results highlight the challenges and opportunities for those who wish to incorporate decision analysis to support shared decision-making for clinical decisions.

More work needed on decision analysis for shared decision-making: A scoping review.

OBJECTIVE: To explore and characterize published evidence on the ways decision analysis has been used to inform shared decision-making. STUDY DESIGN AND SETTING: For this scoping review, we searched five bibliographic databases (from inception until February 2021), reference lists of included studies, trial registries, a thesis database and websites of relevant interest groups. Studies were eligible if they evaluated the application of decision analysis in a shared decision-making encounter. Pairs of reviewers independently screened and selected studies for inclusion, extracted study information using a data extraction form developed by the research team and assessed risk of bias for all studies with an experimental or quasi-experimental design. Data were narratively synthesized. RESULTS: We identified 27 studies that varied greatly with regard to their patient population, design, content and delivery. A range of outcomes were evaluated to explore the effectiveness and acceptability of decision analytic interventions, with little information about the implementation process. Most studies found that decision analysis was broadly beneficial. CONCLUSION: Despite the compelling rationale on the potential for decision analysis to support shared decision-making, rigorous randomized controlled trials are needed to confirm these interventions' effectiveness, while qualitative studies should seek to understand their potential implementation.

Decision Analysis in SHared decision making for Thromboprophylaxis during Pregnancy (DASH-TOP): a sequential explanatory mixed methods pilot study protocol.

INTRODUCTION: Decision analysis is a quantitative approach to decision making that could bridge the gap between decisions based solely on evidence and the unique values and preferences of individual patients, a feature especially important when existing evidence cannot support clear recommendations and there is a close balance between harms and benefits for the treatments options under consideration. Low molecular weight heparin (LMWH) for the prevention of venous thromboembolism (VTE) during pregnancy represents one such situation. The objective of this paper is to describe the rationale and methodology of a pilot study that will explore the application of decision analysis to a shared decision-making process involving prophylactic LMWH for pregnant women or those considering pregnancy who have experienced a VTE. METHODS AND ANALYSIS: We will conduct an international, mixed methods, explanatory, sequential study, including quantitative data collection and analysis followed by qualitative data collection and analysis. In step I, we will ask women who are pregnant or considering pregnancy and have experienced VTE to participate in a shared decision-making intervention for prophylactic LMWH. The intervention consists of three components: a direct choice exercise, a values elicitation exercise and a personalised decision analysis. After administration of the intervention, we will ask women to make a treatment decision and measure decisional conflict, self-efficacy and satisfaction. In step II, which follows the analysis of quantitative data, we will use the results to inform the qualitative interview. Step III will be a qualitative descriptive study that explores participants' experiences and perceptions of the intervention. In step IV, we will integrate findings from the qualitative and quantitative analyses to obtain meta-inferences. ETHICS AND DISSEMINATION: Site-specific ethics boards have approved the study. All participants will provide informed consent. The research team will take an integrated approach to knowledge translation.

Over half of the WHO guidelines published from 2014 to 2019 explicitly considered health equity issues: a cross-sectional survey.

OBJECTIVE: To evaluate how and to what extent health equity considerations are assessed in World Health Organization (WHO) guidelines. STUDY DESIGN AND SETTING: We evaluated WHO guidelines published between January 2014 and May 2019. Health equity considerations were assessed in relation to differences in baseline risk, importance of outcomes for socially disadvantaged populations, inclusion of health inequity as an outcome, equity-related subgroup analysis, and indirectness in each recommendation. RESULTS: We identified 111 WHO guidelines, and 54% (60 of 111) of these used the Evidence to Decision (EtD) framework. For the 60 guidelines using an EtD framework, the likely impact on health equity was supported by research evidence in 28% of the recommendations (94 of 332). Research evidence was mostly provided as differences in baseline risk (23%, 78/332). Research evidence less frequently addressed the importance of outcomes for socially disadvantaged populations (11%, 36/332), considered indirectness of the evidence for socially disadvantaged populations (2%, 5/332), considered health inequities as an outcome (2%, 5/332) and considered differences in the magnitude of effect in relative terms between disadvantaged and more advantaged populations (1%, 3/332). CONCLUSION: The provision of research evidence to support equity judgements in WHO guidelines is still suboptimal, suggesting the need for better guidance and more training.

Community and health staff perceptions on non-communicable disease management in El Salvador's health system: a qualitative study.

BACKGROUND: Non-communicable Diseases (NCDs) are the leading cause of global mortality and disability with a rising burden in low- and middle-income countries. Their multifactorial aetiology, and their requirement of long-term care, implies the need for comprehensive approaches. From 2009, the Ministry of Health (MoH) in El Salvador has developed a national public health system based on comprehensive primary health care. This study aims to describe the different stakeholders' perceptions about the management of NCDs along the pathways of care in this health system. METHODS: During three fieldwork periods in 2018, three complementary qualitative data collection methods were deployed and conducted in settings with high prevalence of NCDs within El Salvador. First, illness narrative methodology was used to document the life histories of people living with a chronic disease and being treated in second and third level health facilities. Second, through social mapping, support resources that NCD patients used throughout the process of their illness within the same settings were analysed. Third, semi-structured interviews were conducted in the same locations, with both chronic patients and health personnel working at different levels of the primary health care setting. Participants were recruited through purposive and snowball sampling, and a deductive approach was implemented for coding during the analysis phase. After grouping codes into potential themes, a thematic framework was developed using a reflexive approach and following triangulation of the data. RESULTS: This innovative approach of combining three well-defined qualitative methods identified key implications for the implementation of a comprehensive approach to NCD management in resource-poor settings. The following elements are identified: 1) social risk factors and barriers to care; 2) patient pathways to NCD care; 3) available resources identified through social connections mapping; 4) trust in social connections; and 5) community health promotion and NCD prevention management. CONCLUSIONS: The Salvadoran public health system has been able to strengthen its comprehensive approach to NCDs, combining a clinical approach - including long-term follow-up - with a preventive community-based strategy. The structural collaboration between the health system and the (self-) organised community has been essential for identifying failings, discuss tensions and work out adapted solutions.

Comprehensive primary health care and non-communicable diseases management: a case study of El Salvador.

BACKGROUND: One of today's greatest challenges in public health worldwide - and especially its key management from Primary Health Care (PHC) - is the growing burden of non-communicable diseases (NCDs). In El Salvador, since 2009 the Minister of Health (MoH) has scaled up a national public health system based on a comprehensive PHC approach. A national multi-sectorial strategic plan for a comprehensive approach to NCDs has also been developed. This analysis explores stakeholders' perceptions related to the management of NCDs in PHC and, in particular, the role of social participation. METHODS: A case-study was developed consisting of semi structured interviews and official document reviews. Semi-structured interviews were developed with chronic patients (14) and PHC professionals working in different levels within PHC (12). Purposive sampling was used to recruit participants. A non-pure, deductive approach was implemented for coding. After grouping codes into potential themes, a thematic framework was elaborated through a reflexive approach and the triangulation of the data. The research was conducted between March and August of 2018 in three different departments of El Salvador. RESULTS: The structure and the functioning of the Salvadoran PHC system and its intersectoral approach is firstly described. The interdisciplinary PHC-team brings holistic health care closer to the communities in which health promoters play a key role. The findings reflect the generally positive perception of the PHC system in terms of accessibility, quality and continuity of care by chronic patients. Community engagement and the National Health Forum are ensuring accountability through social controllership mechanisms. However, certain challenges were also noted during the interviews related to the shortage of medication and workforce; coordination between the levels of care and the importance of prevention and health promotion programmes for NCDs. CONCLUSIONS: The Salvadoran PHC and its comprehensive approach to NCDs with an emphasis on intersectoral participation has been positively perceived by the range of stakeholders interviewed. Social engagement and the NHF works as a driving force to ensure accountability as well as in the promotion of a preventive culture. The challenges identified provide keys to amplify knowledge for addressing inequalities in health by strengthening PHC and its NCDs management.

Community engagement to promote health and reduce inequalities in Spain: a narrative systematic review.

OBJECTIVES: Over the past decade, increasing attention has been paid to community engagement in health (CEH) across Europe. This study aimed to identify and review CEH interventions to promote health and reduce inequalities within the Spanish context and the key facilitators for these community processes. METHODS: A systematic search in six databases, followed by a forward citation search, was conducted to identify implementation literature on CEH in Spain. Articles were included when engagement occurred in at least two stages of the interventions and was not limited to information or consultation of stakeholders. RESULTS: A total of 2023 results were identified; 50 articles were reviewed full text. Five articles were finally selected for inclusion. Data were extracted on various factors including details of the interventions, results achieved, stakeholders involved and their relationships. A narrative synthesis was performed to present results and support the discussion. CONCLUSIONS: Three main points are discussed: the role of professionals and citizens in CEH interventions, providing training to enable a reorientation towards a CEH practice and the relevance of contexts as enablers for community engagement processes to thrive.