ABSTRACT
Self-management interventions (SMIs) may improve disease management in adults living with obesity. We formulated evidence-based recommendations for SMIs within the context of the COMPAR-EU project. The multidisciplinary panel selected critical outcomes based on the COMPAR-EU core outcome set and established decision thresholds for each outcome. Recommendations were informed by systematic reviews of effects, cost-effectiveness, and a contextual assessment. To assess the certainty of the evidence and formulate the recommendations, we used the GRADE approach guidance. Overall, SMIs were deemed to have a small impact, but the absence of harmful effects and potential cumulative benefits indicated a favourable balance of effects, despite low certainty. SMIs showed variations in structure, intensity, and resource utilisation, but overall are likely to be cost-effective. Adapting SMIs to local contexts would enhance equity, acceptability, and feasibility, considering patients' values, and availability of resources and teamwork. Consequently, the panel made conditional recommendations favouring SMIs over usual care. The rigorous and explicit recommendations demonstrated the effectiveness of SMIs for adults living with obesity. However, the gaps in the literature influenced the panel to make only conditional recommendations in favour of SMIs. Further research is needed to strengthen the evidence base and improve recommendations' certainty and applicability.
Subject(s)
Obesity , Self-Management , Humans , Obesity/therapy , Self-Management/methods , Adult , Cost-Benefit Analysis , Evidence-Based MedicineABSTRACT
INTRODUCTION: Empowering people living with multimorbidity (multiple chronic conditions) to gain greater confidence in managing their health can enhance their quality of life. Education focused on self-management is a key tool for fostering patient empowerment and is mostly provided on an individual basis. Virtual communities of practice (VCoP) present a unique opportunity for online education in chronic condition self-management within a social context. This research aims to evaluate the effectiveness/cost-effectiveness of individualised, online self-management education compared with VCoP among middle-aged individuals living with multiple chronic conditions. METHODS AND ANALYSIS: People aged 30-60, living with ≥2 chronic conditions and receiving care in primary care (PC) centres and outpatient hospital-based clinics in Madrid and Canary Islands will enrol in an 18-month parallel-design, blinded (intervention assessment and data analysts), pragmatic (adhering to the intention-to-treat principle), individually randomised trial. The trial will compare two 12-month web-based educational offers of identical content; one delivered individually (control) and the other with online social interaction (VCoP, intervention). Using repeated measures mixed linear models, with the patient as random effect and allocation groups and time per group as fixed effects, we will estimate between-arm differences in the change in Patient Activation Measure from baseline to 12 months (primary endpoint), including measurements at 6-month and 18-month follow-up. Other outcomes will include measures of depression and anxiety, treatment burden, quality of life. In addition to a process evaluation of the VCoP, we will conduct an economic evaluation estimating the relative cost-effectiveness of the VCoP from the perspectives of both the National Health System and the Community. ETHICS AND DISSEMINATION: The trial was approved by Clinical Research Ethics Committees of Gregorio Marañón University Hospital in Madrid/Nuestra Señora Candelaria University Hospital in Santa Cruz de Tenerife. The results will be disseminated through workshops, policy briefs, peer-reviewed publications and local/international conferences. TRIAL REGISTRATION NUMBER: NCT06046326.
Subject(s)
Empowerment , Multimorbidity , Quality of Life , Humans , Middle Aged , Adult , Self-Management/methods , Self-Management/education , Cost-Benefit Analysis , Patient Education as Topic/methods , Female , Male , Spain , Randomized Controlled Trials as Topic , Community of PracticeABSTRACT
Background: The incorporation of shared decision making (SDM) is a central part of empowerment processes, as it facilitates greater activation on the part of patients, increasing the likelihood of them gaining control over their healthcare and developing skills to solve their health problems. Despite these benefits, there are still difficulties in the implementation of SDM among healthcare professionals due to internal and external factors related to the context and health systems. Aim: To explore primary care professionals (PCPs)' perceptions of the SDM model, based on their preconceptions and experience in clinical practice. Methods: A framework analysis was conducted on qualitative data derived from a virtual community practice forum, within a cluster-randomized clinical trial developed in the e-MPODERA project. Results: The most important points in the opinions of the PCPs were: exploring the patients' values, preferences and expectations, providing them with and checking their understanding of up-to-date and evidence-based health information. The analysis revealed three themes: determinants of the implementation process of SDM, lack of consistency and dilemmas and benefits of PCP active listening, motivation and positive expectations of SDM. Discussion: In our initial analysis, we examined the connections between the categories of the TDC model and its application in the primary care context. The categories related to the model reflect the theoretical understanding of professionals, while those related to perceptions of its application and use show certain discrepancies. These discrepancies could indicate a lack of understanding of the model and its real-world implications or insufficient commitment on the part of professionals or the organization to ensure its effective implementation. Conclusions: Specific targeted training that addresses knowledge, attitudes and practice may resolve the aforementioned findings.
Antecedentes: La incorporación de la toma de decisiones compartida (TDC) es una parte central del empoderamiento del paciente, ya que facilita una mayor activación, ganar control sobre la atención que recibe y desarrollar habilidades para resolver sus problemas de salud. A pesar de estos beneficios, todavía existen dificultades para implementar la TDC entre los profesionales sanitarios debido a factores internos de los propios profesionales y externos, relacionados con el contexto y los sistemas sanitarios. Objetivo: Explorar en el foro de una comunidad virtual de práctica (CVdP) las percepciones de los profesionales de atención primaria (PAP) sobre el modelo de TDC en función de sus ideas preconcebidas y su experiencia en la práctica clínica. Métodos: Se realizó un análisis de marco desde un abordaje cualitativo de las intervenciones hechas por los PAP en el foro de una CVdP. Esta CVdP se implementó dentro de un ensayo clínico aleatorizado por grupos desarrollado en el proyecto e-MPODERA. Resultados: Los aspectos más importantes relacionados con la TDC desde la perspectiva de los PAP incluyeron: explorar los valores, preferencias y expectativas de los pacientes, proporcionarles información actualizada y basada en la evidencia, y comprobar su comprensión. En el análisis posterior, tres categorías emergieron como los temas más relevantes: determinantes de la implementación del TDC, falta de consistencia y dilemas, y beneficios de la escucha activa de los PAP, motivación y expectativas positivas de la TDC. Discusión: En nuestro análisis inicial, examinamos las conexiones entre las categorías del modelo de TDC y su aplicación en el contexto de atención primaria. Las categorías relacionadas con el modelo reflejan la comprensión teórica de los profesionales, mientras que las relativas a las percepciones de su aplicación y uso muestran ciertas discrepancias. Estas discrepancias podrían indicar una falta de comprensión del modelo y de sus implicaciones en el mundo real o un compromiso insuficiente por parte de los profesionales o de la organización para garantizar su aplicación efectiva. Conclusión: Una formación específica que aborde los conocimientos, las actitudes y la práctica puede resolver los hallazgos mencionados.
ABSTRACT
Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterization by a multifactorial approach. The general purpose of this study is to determine the effectiveness, comfort, and experience of the patient catheterized with T-Control® compared with patients with a conventional Foley catheter. Study Design: This trial is a mixed-method study comprising a two-arm, pilot comparative study with random allocation to T-Control catheter or traditional Foley catheter in patients with long-term catheterization and a study with qualitative methodology, through discussion groups. Endpoints: The comfort and acceptability of the T-Control® device (qualitative) and the quality of life related to self-perceived health (quantitative) will be analysed as primary endpoints. As secondary endpoints, the following will be analysed: magnitude and rate of infections (symptomatic and asymptomatic); days free of infection; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterization's healthcare resources; and level of satisfaction and workload of health professionals. Patients and Methods: Eligible patients are male and female adults aged ≥18 years, who require a change of long-term bladder catheter. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 4 weeks later, plus the time until the discussion groups take place.
ABSTRACT
BACKGROUND: Healthcare professionals traditional education reflects constraints to face the complex needs of people with chronic diseases in primary care settings. Since more innovative and practical solutions are required, Virtual Community of Practices (vCoP) seem to better respond to learning updates, improving professional and organizational knowledge. However, little is known about the value created in vCoPs as social learning environments. The objective of this project was to explore the value creation process of a gamified vCoP ("e-mpodera vCoP") aimed at improving the knowledge and attitudes of primary healthcare professionals (PCPs) (nurses and general practitioners) to the empowerment of people with chronic conditions. METHODS: A framework analysis assessed the value creation process using a mixed methods approach. The framework provided awareness about knowledge and usefulness in a learning community through five cycles: (1) immediate value, (2) potential value, (3) applied value, (4) realized value, and (5) reframing value. Quantitative data included vCoP analytics such as logins, contributions, points, badges, and performance metrics. Qualitative data consisted of PCPs' forum contributions from Madrid, Catalonia, and Canary Islands over 14 months. RESULTS: A total of 185 PCPs had access to the e-mpodera vCoPs. The vCoP showed the dynamic participation of 146 PCPs, along 63 content activities posted, including a total of 3,571 contributions (including text, images, links to webpages, and other files). Regarding the value creation process, the e-mpodera vCoP seems to encompass a broad spectrum of value cycles, with indicators mostly related to cycle 1 (immediate value - activities and interactions) and cycle 2 (potential value - knowledge capital); and to a lesser extent for cycle 3 (applied value - changes in practice) and for cycle 4 (realized value - performance improvement). The presence of indicators related to cycle 5 (reframing value), was minimal, due to few individual redefinitions of success. CONCLUSION: To reach a wider range of value possibilities, a combination of learning objectives, competence framework, challenged-based gamified platform, and pathway model of skill development seems crucial. However, additional research is required to gain clearer insights into organizational values, professionals' lifelong educational needs in healthcare, and the long-term sustainability of performance improvement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02757781. Registered on 02/05/2016.
Subject(s)
Education, Professional , General Practitioners , Humans , Community of Practice , Attitude , Primary Health CareABSTRACT
Self-management interventions (SMIs) offer a promising approach to actively engage patients in the management of their chronic diseases. Within the scope of the COMPAR-EU project, our goal is to provide evidence-based recommendations for the utilisation and implementation of SMIs in the care of adult individuals with type 2 diabetes mellitus (T2DM). A multidisciplinary panel of experts, utilising a core outcome set (COS), identified critical outcomes and established effect thresholds for each outcome. The panel formulated recommendations using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, a transparent and rigorous framework for developing and presenting the best available evidence for the formulation of recommendations. All recommendations are based on systematic reviews (SR) of the effects and of values and preferences, a contextual analysis, and a cost-effectiveness analysis. The COMPAR-EU panel is in favour of using SMIs rather than usual care (UC) alone (conditional, very low certainty of the evidence). Furthermore, the panel specifically is in favour of using ten selected SMIs, rather than UC alone (conditional, low certainty of the evidence), mostly encompassing education, self-monitoring, and behavioural techniques. The panel acknowledges that, for most SMIs, moderate resource requirements exist, and cost-effectiveness analyses do not distinctly favour either the SMI or UC. Additionally, it recognises that SMIs are likely to enhance equity, deeming them acceptable and feasible for implementation.
ABSTRACT
Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterisation by a multifactorial approach. The general purpose of this study is to evaluate the effectiveness and cost-effectiveness of the T-Control catheter versus the Foley-type catheter in patients with Acute Urine Retention (AUR). Study design: This is a pragmatic, open, multicentre, controlled clinical trial with random allocation to the T-Control catheter or a conventional Foley-type catheter in patients with AUR. Endpoints: The magnitude of infections will be analysed as a primary endpoint. While as secondary endpoint, the following will be analysed: rate of symptomatic and asymptomatic infections; days free of infection; quality of life-related to self-perceived health; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterisation's healthcare resources; level of satisfaction and workload of health professionals and acceptability of the T-Control device as well as the patient experience. Patients and methods: Eligible patients are male adults aged ≥50 years, with AUR and with an indication of bladder catheterisation for at least 2 weeks. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 2 weeks later, plus 2 weeks after this time when the patient will be called for an in-depth interview.
ABSTRACT
OBJECTIVES: This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain. DESIGN: Prospective, multicentre pre-post study. SETTING: Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up. PARTICIPANTS: 156 patients were included. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention's total cost was estimated by multiplying health resource usage with unit costs. RESULTS: In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (-0.46%; 95% CI -0.69% to -0.23%), 6 months (-0.49%; 95% CI -0.73% to -0.25%) and 12 months (-0.43%; 95% CI -0.68% to -0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (-0.37; 95% CI -0.62 to -0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss. CONCLUSIONS: The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.
Subject(s)
Diabetes Mellitus, Type 1 , Hypoglycemia , Child , Humans , Adolescent , Diabetes Mellitus, Type 1/drug therapy , Blood Glucose/analysis , Glycated Hemoglobin , Glucose/therapeutic use , Blood Glucose Self-Monitoring , Prospective Studies , Quality of Life , Spain , Hypoglycemic Agents/therapeutic use , Hypoglycemia/chemically inducedABSTRACT
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.
Subject(s)
Decision Making , Venous Thromboembolism , Female , Humans , Pregnancy , Conflict, Psychological , Heparin, Low-Molecular-Weight , UncertaintyABSTRACT
Introduction: Identifying stakeholders' needs is crucial to informing decisions and policy development. This study aims to identify healthcare and social-related needs and effective strategies associated with COVID-19 from the first-person perspectives of patients and healthcare providers. Methods: Cross-sectional online survey design including qualitative open-ended questions, conducted in primary care and hospital settings across Spain, with 12 out of 19 regions represented. Adults aged 18 years and older, who (a) resided in Spain and had a history of COVID-19 or (b) worked as healthcare providers delivering direct or indirect care for people with COVID-19 in Spanish primary care or hospitals during 2020 were eligible to participate. Recruitment was conducted via social-media networks (Twitter, LinkedIn, and WhatsApp) and communication channels of key organizations including patient and professional associations and groups. A total of 182 people were invited to complete the surveys and 76 people completed the surveys (71% women), of which 33 were home-isolated patients, 14 were hospitalized patients, 16 were primary care professionals, and 13 were hospital care professionals. Results: A total of 327 needs and 86 effective strategies and positive aspects were identified across surveys and classified into the following overarching themes: (i) Accessibility, (ii) Basic needs, (iii) Clinical care, (iv) Person-and-family centered care, (v) Caring for the healthcare professional, (vi) Protocolization, information, health campaigns, and education, (vii) Resource availability, (viii) and Organizational needs/strategies. Discussion: Findings indicate the Spanish health and social care systems were generally unprepared to combat COVID-19. Implications for research, practice, and policy focus on integrating first-person perspectives as best practice to identify, prioritize and address needs to increase health and social care systems capacity and preparedness, as well as providing well-co-coordinated responses across government, healthcare, and non-government sectors to promote and protect the physical and mental health of all.
Subject(s)
COVID-19 , Adult , Humans , Female , Male , Cross-Sectional Studies , COVID-19/epidemiology , COVID-19/therapy , Delivery of Health Care , Health Personnel/psychology , PatientsABSTRACT
BACKGROUND: Depression is a significant public health issue that can lead to considerable disability and reduced quality of life. With the rise of technology, mobile health (mHealth) interventions, particularly smartphone apps, are emerging as a promising approach for addressing depression. However, the lack of standardized evaluation tools and evidence-based principles for these interventions remains a concern. OBJECTIVE: In this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of mHealth interventions for depression and identify the criteria and evaluation tools used for their assessment. METHODS: A systematic review and meta-analysis of the literature was carried out following the recommendations of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Studies that recruited adult patients exhibiting elevated depressive symptoms or those diagnosed with depressive disorders and aimed to assess the effectiveness or safety of mHealth interventions were eligible for consideration. The primary outcome of interest was the reduction of depressive symptoms, and only randomized controlled trials (RCTs) were included in the analysis. The risk of bias in the original RCTs was assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials. RESULTS: A total of 29 RCTs were included in the analysis after a comprehensive search of electronic databases and manual searches. The efficacy of mHealth interventions in reducing depressive symptoms was assessed using a random effects meta-analysis. In total, 20 RCTs had an unclear risk of bias and 9 were assessed as having a high risk of bias. The most common element in mHealth interventions was psychoeducation, followed by goal setting and gamification strategies. The meta-analysis revealed a significant effect for mHealth interventions in reducing depressive symptoms compared with nonactive control (Hedges g=-0.62, 95% CI -0.87 to -0.37, I2=87%). Hybrid interventions that combined mHealth with face-to-face sessions were found to be the most effective. Three studies compared mHealth interventions with active controls and reported overall positive results. Safety analyses showed that most studies did not report any study-related adverse events. CONCLUSIONS: This review suggests that mHealth interventions can be effective in reducing depressive symptoms, with hybrid interventions achieving the best results. However, the high level of heterogeneity in the characteristics and components of mHealth interventions indicates the need for personalized approaches that consider individual differences, preferences, and needs. It is also important to prioritize evidence-based principles and standardized evaluation tools for mHealth interventions to ensure their efficacy and safety in the treatment of depression. Overall, the findings of this study support the use of mHealth interventions as a viable method for delivering mental health care. TRIAL REGISTRATION: PROSPERO CRD42022304684; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=304684.
ABSTRACT
Introduction: The aim of this systematic review is to assess the relationship between patient empowerment and other empowerment-related constructs, and affective symptoms and quality of life in patients with type 2 diabetes. Methods: A systematic review of the literature was conducted, according to the PRISMA guidelines. Studies addressing adult patients with type 2 diabetes and reporting the association between empowerment-related constructs and subjective measures of anxiety, depression and distress, as well as self-reported quality of life were included. The following electronic databases were consulted from inception to July 2022: Medline, Embase, PsycINFO, and Cochrane Library. The methodological quality of the included studies was analyzed using validated tools adapted to each study design. Meta-analyses of correlations were performed using an inverse variance restricted maximum likelihood random-effects. Results: The initial search yielded 2463 references and seventy-one studies were finally included. We found a weak-to-moderate inverse association between patient empowerment-related constructs and both anxiety (r = -0.22) and depression (r = -0.29). Moreover, empowerment-related constructs were moderately negatively correlated with distress (r = -0.31) and moderately positively correlated with general quality of life (r = 0.32). Small associations between empowerment-related constructs and both mental (r = 0.23) and physical quality of life (r = 0.13) were also reported. Discussion: This evidence is mostly from cross-sectional studies. High-quality prospective studies are needed not only to better understand the role of patient empowerment but to assess causal associations. The results of the study highlight the importance of patient empowerment and other empowerment-related constructs such as self-efficacy or perceived control in diabetes care. Thus, they should be considered in the design, development and implementation of effective interventions and policies aimed at improving psychosocial outcomes in patients with type 2 diabetes. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020192429, identifier CRD42020192429.
Subject(s)
Diabetes Mellitus, Type 2 , Quality of Life , Adult , Humans , Affective Symptoms , Patient Participation , Cross-Sectional StudiesABSTRACT
The diagnosis of breast cancer (BC) can make the affected person vulnerable to suffering the possible consequences of the use of low-quality health information. Massive open online courses (MOOCs) may be a useful and efficient resource to improve digital health literacy and person-centred care in this population. The aim of this study is to co-create a MOOC for women with BC, using a modified design approach based on patients' experience. Co-creation was divided into three sequential phases: exploratory, development and evaluation. Seventeen women in any stage of BC and two healthcare professionals participated. In the exploratory phase, a patient journey map was carried out and empowerment needs related to emotional management strategies and self-care guidelines were identified, as well as information needs related to understanding medical terminology. In the development phase, participants designed the structure and contents of the MOOC through a Moodle platform. A MOOC with five units was developed. In the evaluation phase, participants strongly agreed that their participation was useful for the MOOC's development and participating in the co-creation process made the content more relevant to them (experience in the co-creation); most of the participants positively evaluated the content or interface of the MOOC (acceptability pilot). Educational interventions designed by women with BC is a viable strategy to generate higher-quality, useful resources for this population.
Subject(s)
Breast Neoplasms , Education, Distance , Health Literacy , Humans , Female , Patient-Centered CareABSTRACT
Aims: Although digital decision aids (DAs) have been developed to improve shared decision-making (SDM), also in the cardiovascular realm, its implementation seems challenging. This study aims to systematically review the predictors of successful implementation of digital DAs for cardiovascular diseases. Methods and results: Searches were conducted in MEDLINE, Embase, PsycInfo, CINAHL, and the Cochrane Library from inception to November 2021. Two reviewers independently assessed study eligibility and risk of bias. Data were extracted by using a predefined list of variables. Five good-quality studies were included, involving data of 215 patients and 235 clinicians. Studies focused on DAs for coronary artery disease, atrial fibrillation, and end-stage heart failure patients. Clinicians reported DA content, its effectivity, and a lack of knowledge on SDM and DA use as implementation barriers. Patients reported preference for another format, the way clinicians used the DA and anxiety for the upcoming intervention as barriers. In addition, barriers were related to the timing and Information and Communication Technology (ICT) integration of the DA, the limited duration of a consultation, a lack of communication among the team members, and maintaining the hospital's number of treatments. Clinicians' positive attitude towards preference elicitation and implementation of DAs in existing structures were reported as facilitators. Conclusion: To improve digital DA use in cardiovascular diseases, the optimum timing of the DA, training healthcare professionals in SDM and DA usage, and integrating DAs into existing ICT structures need special effort. Current evidence, albeit limited, already offers advice on how to improve DA implementation in cardiovascular medicine.
ABSTRACT
BACKGROUND: Venous thromboembolism (VTE) in pregnancy is an important cause of maternal morbidity and mortality. Low-molecular-weight heparin (LMWH) is the cornerstone of prophylaxis and treatment of thrombotic events during pregnancy. LMWH has fewer adverse effects than other anticoagulants, does not cross the placenta, and is safe for the fetus. However, the use of LMWH during pregnancy is sensitive to womens' underlying preferences. The objective of this review is to systematically assess women's values and preferences research evidence on this topic. METHODS: We searched four electronic databases from inception to March 2022, and included studies examining values and preferences of using LMWH among pregnant women at risk of VTE. We followed a convergent integrated mixed-methods design to compare and contrast quantitative outcomes (utility and non-utility measures) and qualitative findings. We assessed the certainty of the values and preferences evidence with the GRADE approach for quantitative findings, and with GRADE-CERqual for qualitative evidence. Results were presented in a conjoint display. RESULTS: We screened 3,393 references and identified seven eligible studies. The mixed methods analysis resulted in four themes. Datasets confirmed each other in that: 1) the majority of women consider that benefits of treatment outweigh the inconveniences of daily injections; and 2) main concerns around medication are safety and injections administration. Quantitative outcomes expanded on the qualitative findings in that: 3) participants who perceived a higher risk of VTE were more willing to take LMWH. Finally, we found a discrepancy between the datasets around: 4) the amount of information preferred to make the decision; however, qualitative data expanded to clarify that women prefer making informed decisions and receive support from their clinician in their decision-making process. CONCLUSIONS: We are moderately confident that in the context of pregnancy, using LMWH is preferred by women given its net beneficial balance. Integrating data from different sources of evidence, and representing them in a jointly manner helps to identify patient's values and preferences. Our results may inform clinical practice guidelines and support shared decision-making process in the clinical encounter for the management of VTE in the context of pregnancy.
Subject(s)
Pregnancy Complications, Cardiovascular , Thrombosis , Venous Thromboembolism , Anticoagulants/adverse effects , Female , Heparin/adverse effects , Heparin, Low-Molecular-Weight/adverse effects , Humans , Pregnancy , Pregnancy Complications, Cardiovascular/drug therapy , Pregnancy Complications, Cardiovascular/prevention & control , Venous Thromboembolism/drug therapy , Venous Thromboembolism/prevention & controlABSTRACT
OBJECTIVE: The aim of the present study is to identify factors associated with patient empowerment in people living with type 2 diabetes mellitus (T2DM) in the Canary Islands (Spain). METHODS: Secondary cross-sectional analysis was carried out of data obtained in the INDICA study: A 24-month cluster randomized-controlled trial evaluating the effectiveness of educational interventions supported by new technology decision tools for T2DM patients. Sociodemographic variables, clinical data (years since diagnosis, glycated haemoglobin level, creatine, triglycerides, waist hip index, body mass index and number of comorbidities), diabetes knowledge (DIATEK), affective outcomes (Beck Depression Inventory-II, the State subscale of the State-Trait Anxiety Inventory and The Diabetes Distress Scale) and diabetes-related quality of life (The Audit of Diabetes-Dependent Quality of life) were assessed as potential correlates of patient empowerment, assessed using the Diabetes Empowerment Scale-Short Form. Multilevel mixed linear regression models on patient empowerment were developed. RESULTS: The analysis included the baseline data of 2334 patients. Results showed that age (B = -0.14; p < .001), diabetes knowledge (B = 0.61; p < .001) and state-anxiety (B = -0.09; p < .001) are significantly associated with patient empowerment. Sex, education level, living alone, employment status, country of birth, time since diagnosis, number of comorbidities, glycated haemoglobin level, depression and distress were not independently associated with patient empowerment in the multivariate analyses. CONCLUSION: Younger age, lower state-anxiety and greater diabetes-specific knowledge are important correlates of patient empowerment. In line with the results of the INDICA study, interventions based on patient-centred care might be effective in improving patient empowerment in adults with T2DM. Understanding the factors associated with empowerment may help clinicians and policymakers to identify high-risk groups, prioritize resources and target evidence-based interventions to better support people with T2DM to be actively involved in their own care. PATIENT OR PUBLIC CONTRIBUTION: Patients with T2DM were actively involved in the design of the INDICA study. Two patient associations were included as part of the research team and actively participated in designing the interventions and selecting outcome measures.
Subject(s)
Diabetes Mellitus, Type 2 , Adult , Humans , Diabetes Mellitus, Type 2/therapy , Diabetes Mellitus, Type 2/psychology , Glycated Hemoglobin/analysis , Patient Participation , Cross-Sectional Studies , Quality of LifeABSTRACT
OBJECTIVE: To assess gender differences in the decision-making process for treatment of knee osteoarthritis (OA). METHODS: A secondary analysis of a randomized trial was conducted (n = 193). Knowledge of OA and total knee replacement (TKR), decisional conflict, satisfaction with the decision-making process, treatment preference and TKR uptake 6 months later were compared by gender. Multivariate regression models were developed to identify gender-specific predictors. RESULTS: Women showed less knowledge (MD = -7.68, 95% CI: -13.9, -1.46, p = 0.016), reported less satisfaction (MD = -6.95, 95% CI: -11.7, -2.23, p = 0.004) and gave more importance to avoiding surgery (U = 2.09, p = 0.019). In women, more importance attributed to the time needed to relieve symptoms significantly reduced the odds of surgery (OR = 0.76, p = 0.016). CONCLUSION: The provision of information and/or promotion of shared decision-making could be of lower quality in female patients, although other explanations such as differences in information needs or preference for involvement in decision-making cannot be ruled out with the current evidence. Given the study's limitations, especially regarding the sample size, further confirmation is needed. PRACTICE IMPLICATIONS: A systematic, shared decision-making approach in consultation is needed to avoid potential gender-based biases.
Subject(s)
Arthroplasty, Replacement, Knee , Osteoarthritis, Knee , Female , Humans , Decision Making , Decision Making, Shared , Knowledge , Osteoarthritis, Knee/surgery , Sex FactorsABSTRACT
The COVID-19 pandemic has exposed gaps and areas of need in health systems worldwide. This work aims to map the evidence on COVID-19-related healthcare needs of adult patients, their family members, and the professionals involved in their care during the first year of the pandemic. We searched the databases MEDLINE, Embase, and Web of Science. Two reviewers independently screened titles and abstracts and assessed full texts for eligibility. Disagreements were resolved by consensus. Descriptive data were extracted and inductive qualitative content analysis was used to generate codes and derive overarching themes. Thirty-six studies met inclusion criteria, with the majority reporting needs from the perspective of professionals (35/36). Professionals' needs were grouped into three main clusters (basic, occupational, and psycho-socio-emotional needs); patients' needs into four (basic, healthcare, psycho-socio-emotional, and other support needs); and family members' needs into two (psycho-socio-emotional and communication needs). Transversal needs across subgroups were also identified and grouped into three main clusters (public safety, information and communication, and coordination and support needs). This evidence map provides valuable insight on COVID-19-related healthcare needs. More research is needed to assess first-person perspectives of patients and their families, examine whether needs differ by country or region, and evaluate how needs have evolved over time.
Subject(s)
COVID-19 , Pandemics , Adult , COVID-19/epidemiology , Delivery of Health Care , Family/psychology , Health Facilities , HumansABSTRACT
BACKGROUND: Generalized anxiety disorder (GAD) is one of the most prevalent mental health problems. Patients with GAD have unmet needs related to the information received about their disorder, its treatments and their participation in the decision-making process. The aim of this study is to develop and assess the acceptability of a patient decision aid (PtDA) for patients with GAD. METHOD: The PtDA was developed following the International Patient Decision Aid Standards. The recommendations of the Spanish clinical practice guideline (CPG) for patients with GAD were used as the basis. The first prototype was developed by an expert committee, further improvements were made with patients (n = 2), clinical experts (n = 13) and the project management group (n = 7). The acceptability of this second draft was assessed by patients non-involved in the previous phases (n = 11). RESULTS: The final PtDA version included a brief description of GAD and its treatments. Most participants agreed that the PtDA was easy to use, visually appealing and useful. At least half of the participants learned new things about treatments and adverse effects. CONCLUSIONS: A PtDA was developed for patients with GAD based on recommendations from the Spanish CPG. It was improved and accepted by patients and clinical experts involved. An evaluation of its effectiveness on the shared decision-making process during the clinical encounter is planned.