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OBJECTIVES: To assess the inclusion of individuals' perspectives in the development of osteoporosis Clinical Practice Guidelines (CPGs) for primary fracture prevention in postmenopausal women. STUDY DESIGN AND SETTING: We performed a comprehensive systematic search across guideline databases and (CPGs) developing organizations websites. Using the AGREE II tool, we assessed the quality of the guidelines, with particular emphasis on the inclusion of patients, or representatives in the development process. We also examined if women's perspectives were considered at the recommendations level and explored the potential association between the inclusion of patients' values and preferences with the quality of the CPGs. RESULTS: We retrieved a total of 491 eligible CPGs, of which 33 were finally included. The majority of the CPGs were developed by scientific societies (63.6%), primarily from Europe (39.4%) and North America (30.3%). One in every four (24.2%) guidelines explicitly included individuals' perspectives in their development, and one in ten (12.1%) included research evidence about this aspect to support their recommendations. The domains with the lowest mean scores in the quality assessment were applicability (42.4%), rigor of development (44.7%), and stakeholder involvement (45.7%), and 61% were recommended for use according to our assessment. Guidelines of higher quality were more likely to include women's perspective in their development (mean difference 39.31, P = .003). CONCLUSION: The incorporation of women's perspectives into the process of developing guidelines for primary fracture prevention in osteoporosis remains inadequate. Our findings serve as a call for guideline developers to improve this situation, and for users, and policymakers to be aware of these limitations, when using or implementing guidelines in this field.
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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.
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Obesidad , Automanejo , Humanos , Obesidad/terapia , Automanejo/métodos , Adulto , Análisis Costo-Beneficio , Medicina Basada en la EvidenciaRESUMEN
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.
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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.
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INTRODUCTION: Randomized controlled trials (RCTs) are the cornerstone of systematic reviews and other evidence synthesis. RCT identification remains challenging because of limitations in their indexation in major databases and potential language bias. Scientific production in Latin American nursing is steadily increasing, but little is known about its design or main features. We aimed to identify the extent of evidence from RCTs in nursing conducted by Latin American research teams and evaluate their main characteristics, including potential risk of bias. DESIGN: Scoping review with risk of bias assessment. METHODS: We conducted a scoping review including a comprehensive electronic search in five relevant databases. We completed a descriptive data analysis and a risk of bias assessment of eligible studies using Cochrane's guidance. RESULTS: We identified 1784 references of which 47 were RCTs published in 40 journals. Twenty (42.6%) RCTs were published in journals in English. Chronic diseases were the most common health conditions studied (29.7%). Fifteen (31.9%) RCTs had a high risk of bias. Thirty (75%) journals were included in the Journal Citation Report (JCR) catalog and 5 (16.7%) were journals classified under nursing category. Twenty-one (52.5%) journals explicitly required CONSORT checklist recommendations for RCTs reporting. CONCLUSION: Publication of RCTs in nursing by Latin American authors has increased. Most journals where RCTs are published are in English and not specific to nursing. Searches in journals of other disciplines may be necessary to facilitate identification of RCTs in nursing. CONSORT statements need to be actively promoted to facilitate rigorous methodology and reporting of RCTs. CLINICAL RELEVANCE STATEMENT: This study highlights the need for an increased research focus on RCTs in nursing in Latin America, and the importance of enhancing the reporting quality of these studies to support evidence-based nursing practice.
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Enfermería , Proyectos de Investigación , Humanos , América Latina , Ensayos Clínicos Controlados Aleatorios como Asunto , Revisiones Sistemáticas como AsuntoRESUMEN
Self-management interventions (SMIs) may be promising in the treatment of Diabetes Mellitus Type 2 (T2DM). However, accurate comparisons of their relative effectiveness are challenging, partly due to a lack of clarity and detail regarding the intervention content being evaluated. This study summarizes intervention components and characteristics in randomized controlled trials (RCTs) related to T2DM using a taxonomy for SMIs as a framework and identifies components that are insufficiently incorporated into the design of the intervention or insufficiently reported. Following evidence mapping methodology, we searched MEDLINE, CINAHL, Embase, Cochrane, and PsycINFO from 2010 to 2018 for randomized controlled trials (RCTs) on SMIs for T2DM. We used the terms 'self-management', 'adult' and 'T2DM' for content. For data extraction, we used an online platform based on the taxonomy for SMIs. Two independent reviewers assessed eligible references; one reviewer extracted data, and a second checked accuracy. We identified 665 RCTs for SMIs (34% US, 21% Europe) including 164,437 (median 123, range 10-14,559) adults with T2DM. SMIs highly differed in design and content, and characteristics such as mode of delivery, intensity, location and providers involved were poorly described. The majority of interventions aimed to improve clinical outcomes like HbA1c (83%), weight (53%), lipid profile (45%) or blood pressure (42%); 27% (also) targeted quality of life. Improved knowledge, health literacy, patient activation or satisfaction with care were hardly used as outcomes (<16%). SMIs most often used education (98%), self-monitoring (56%), goal-setting (48%) and skills training (42%) to improve outcomes. Management of emotions (17%) and shared decision-making (5%) were almost never mentioned. Although diabetes is highly prevalent in some minority groups, in only 13% of the SMIs, these groups were included. Our findings highlight the large heterogeneity that exists in the design of SMIs for T2DM and the way studies are reported, making accurate comparisons of their relative effectiveness challenging. In addition, SMIs pay limited attention to outcomes other than clinical, despite the importance attached to these outcomes by patients. More standardized and streamlined research is needed to better understand the effectiveness and cost-effectiveness of SMIs of T2DM and benefit patient care.
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BACKGROUND/OBJECTIVES: To identify and assess the main characteristics and the potential risk of bias of randomised controlled trials (RCTs) in nursing conducted by Spanish research teams. METHODS: Scoping review of an electronic search in three major databases (date of search: October 2021). For the eligible studies, both descriptive data, and data to assess the potential risk of bias, were collected and analysed. RESULTS: Of 3391 references retrieved, 199 were eligible. These RCTs were published in 122 journals, most of them in English (101, 82.1%) and were included in the Journal Citation Report (JCR) (107, 87.7%). Moreover, 32 (26.2%) of those included in the JCR were classified under nursing. Two thirds (81, 66.4%) of the journals followed the CONSORT guidelines. A total of 65 RCTs (33.7%) had a high overall risk of bias. DISCUSSION: Most of the identified RCTs were published in journals not specific to nursing and in English language. Also, shortcomings in RCT design and reporting were observed despite recommendations to adhere the CONSORT guidelines. CONCLUSION: Comprehensive identification of RCTs in nursing may require searching in journals other than nursing-related. RCTs from Spanish research teams are more likely to be published in international journals published in English. CONSORT should be strongly advised to encourage proper design and reporting of RCTs.