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BACKGROUND & OBJECTIVES Food-based dietary guidelines (FBDGs) have been developed to promote healthy diets and prevent chronic diseases. However, the methodological quality of Spanish FBDGs has not been systematically assessed yet. The objective of this review is to identify and assess the methodological quality of Spanish FBDGs, as well as to describe their food guides and key recommendations. METHODS We conducted a systematic search to identify Spanish FBDGs targeted at the general population using multiple sources. Two authors independently screened the references, extracted data, and assessed the quality of the FBDGs using the Appraisal of Guidelines for Research and Evaluation (AGREE) II and the Recommendation Excellence (AGREE-REX) instruments. We performed a descriptive analysis of the FBDGs. RESULTS We included 19 FBDGs, published between 2007 and 2019. The median scores for each AGREE II domain were: "scope and purpose" 44% (Q1-Q3: 33-61%); "Stakeholder involvement" 31% (11-44%), "rigor of development" 3% (1-14%); "clarity of presentation" 42% (33-47%), "applicability" 0% (0-6%); and "editorial independence" 0% (0-8%). Six FBDGs (32%; 6/19) were categorized as "recommended with modifications", and the rest (68%; 13/19) as "not recommended". None of the FBDGs scored ≥60% in three or more domains, including the "rigor of development" domain. FBDGs indexed in literature databases scored significantly higher in overall rating than those not indexed (P = 0.023). The majority of FBDGs (74%; 14/19) used the pyramid as a food guide representation with a larger number of food levels (3-7 levels). The majority of FBDGs recommended a daily intake of cereals and grains, vegetables, fruits, olive oil and dairy products; a weekly intake of vegetable and animal proteins; and the occasional and limited intake of other food groups (e.g., ultraprocessed foods). CONCLUSIONS Overall, the methodological quality of FBDGs is poor showing that only 32% of FBDGs are "recommended for use with modifications". Our results highlight the need to revise, systematize and improve FBDG development processes in Spain. more...

Background Self-management (SM) interventions are supportive interventions systematically provided by healthcare professionals, peers, or laypersons to increase the skills and confidence of patients in their ability to manage chronic diseases. We had two objectives: (1) to summarise the preferences and experiences of patients and their caregivers (informal caregivers and healthcare professionals) with SM in four chronic diseases and (2) to identify and describe the relevant outcomes for SM interventions from these perspectives. Methods We conducted a mixed-methods scoping review of reviews. We searched three databases until December 2020 for quantitative, qualitative, or mixed-methods reviews exploring patients’ and caregivers’ preferences or experiences with SM in type 2 diabetes mellitus (T2DM), obesity, chronic obstructive pulmonary disease (COPD), and heart failure (HF). Quantitative data were narratively synthesised, and qualitative data followed a three-step descriptive thematic synthesis. Identified themes were categorised into outcomes or modifiable factors of SM interventions. Results We included 148 reviews covering T2DM (n = 53 [35.8%]), obesity (n = 20 [13.5%]), COPD (n = 32 [21.6%]), HF (n = 38 [25.7%]), and those with more than one disease (n = 5 [3.4%]). We identified 12 main themes. Eight described the process of SM (disease progression, SM behaviours, social support, interaction with healthcare professionals, access to healthcare, costs for patients, culturally defined roles and perceptions, and health knowledge), and four described their experiences with SM interventions (the perceived benefit of the intervention, individualised care, sense of community with peers, and usability of equipment). Most themes and subthemes were categorised as outcomes of SM interventions. Conclusion The process of SM shaped the perspectives of patients and their caregivers on SM interventions. Their perspectives were influenced by the perceived benefit of the intervention, the sense of community with peers, the intervention’s usability, and the level of individualised care. Our findings can inform the selection of patient-important outcomes, decision-making processes, including the formulation of recommendations, and the design and implementation of SM interventions. more...

Background Diagnostic mammography projections (DxMM) have been traditionally used in the assessment of women recalled after a suspicious screening mammogram. Digital breast tomosynthesis (DBT) reduces the tissue overlap effect, thus improving image assessment. Some studies have suggested DBT might replace DxMM with at least equivalent performance. Objective To evaluate the replacement of DxMM with DBT in women recalled at screening. Methods We searched PubMed, EMBASE, and the Cochrane Library databases to identify diagnostic paired cohort studies or RCTs comparing DBT vs DxMM, published in English that: reported accuracy outcomes, recruited women recalled for assessment at mammography screening, and included a reference standard. Subgroup analysis was performed over lesion characteristics. We provided pooled accuracy estimates and differences between tests using a quadrivariate model. We assessed the certainty of the evidence using the GRADE approach. Results We included ten studies that reported specificity and sensitivity. One study included 7060 women while the remaining included between 52 and 738 women. DBT compared with DxMM showed a pooled difference for the sensitivity of 2% (95% CI 1%–3%) and a pooled difference for the specificity of 6% (95%CI 2%–11%). Restricting the analysis to the six studies that included women with microcalcification lesions gave similar results. In the context of a prevalence of 21% of breast cancer (BC) in recalled women, DBT probably detects 4 (95% CI 2–6) more BC cases and has 47 (95%CI 16–87) fewer false‐positive results per 1000 assessments. The certainty of the evidence was moderate due to risk of bias. Conclusion The evidence in the assessment of screen‐recalled findings with DBT is sparse and of moderate certainty. DBT probably has higher sensitivity and specificity than DxMM. Women, health care providers and policymakers might value as relevant the reduction of false‐positive results and related fewer invasive diagnostic procedures with DBT, without missing BC cases., This systematic review found that in women of average risk of breast cancer with suspicious lesions at mammography screening, DBT probably has higher specificity difference (6%) than diagnostic views of 2D mammography in women recalled for assessment (moderate certainty evidence). The sensitivity is also probably higher with DBT; however, the difference was not so large (2%). The clinical impact of these results in a screening program is a probable reduction of 47 false positive results, including related invasive procedures, and most likely a small increase of 4 additional true BC lesions per 1000 women recalled for assessment. Our results were consistent in women with calcified lesions, but with a larger imprecision in the sensitivity differences. These results were taken into account by the GDG, together with other considerations (ie, feasibility) to issue a conditional recommendation in favor of DBT which is available on the ECIBC website (https://healthcare‐quality.jrc.ec.europa.eu/european‐breast‐cancer‐guidelines/diagnosis/DBT). more...

Background: Venous thromboembolism (VTE) is a common complication among patients with cancer. Patients with cancer and VTE are at a markedly increased risk for morbidity and mortality. Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in their decisions about the prevention and treatment of VTE in patients with cancer. Methods: ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The guideline development process was supported by updated or new systematic evidence reviews. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to assess evidence and make recommendations. Results: Recommendations address mechanical and pharmacological prophylaxis in hospitalized medical patients with cancer, those undergoing a surgical procedure, and ambulatory patients receiving cancer chemotherapy. The recommendations also address the use of anticoagulation for the initial, short-term, and long-term treatment of VTE in patients with cancer. Conclusions: Strong recommendations include not using thromboprophylaxis in ambulatory patients receiving cancer chemotherapy at low risk of VTE and to use low-molecular-weight heparin (LMWH) for initial treatment of VTE in patients with cancer. Conditional recommendations include using thromboprophylaxis in hospitalized medical patients with cancer, LMWH or fondaparinux for surgical patients with cancer, LMWH or direct oral anticoagulants (DOAC) in ambulatory patients with cancer receiving systemic therapy at high risk of VTE and LMWH or DOAC for initial treatment of VTE, DOAC for the short-term treatment of VTE, and LMWH or DOAC for the long-term treatment of VTE in patients with cancer. more...

Background and Objective Guideline development groups or other health care decision makers frequently encounter situations that require a simultaneous comparison of multiple interventions. This sometimes becomes apparent either when they identify questions of interest, before they formulate recommendations, or it may surface only when recommendations have already been formulated based on pairwise comparisons. Methods Using examples from the World Health Organization, the European Commission, and a professional society, we developed a flexible approach to developing recommendations when a multiple-intervention comparison (MC) is needed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence to decision (EtD) frameworks. We iteratively refined this approach through user testing and then included a module in GRADE's official software GRADEpro to test the approach in two real and one theoretical guideline recommendations. Results We found the approach feasible and that all EtD criteria should be considered in an MC approach. We judged that guideline development groups and other decision makers will benefit from the availability of a network meta-analyses (NMA) of intervention effects to support decisions; however, NMA supports only one of many criteria, that is, the balance of health benefits and harms, and is therefore helpful, but not essential to the approach we propose. When similar but not identical comparators are used to address MC, challenges may arise with intransitivity and the relative rankings of interventions. Conclusion We successfully applied the MC approach and software module in generating recommendations across different scenarios and identified challenges. The MC approach allows guideline groups and other decision makers to transparently and critically assess multiple options for a given health question. Application of the approach by others may lead to refinement and allow for better understanding of its impact in developing recommendations and making choices. more...

The significant increase in international cross-border migrations remains a global public health concern; therefore, the need for migrant-specific evidence-based interventions is critical. We assessed the methodological and reporting quality of systematic reviews (SRs) focused on migrant healthcare interventions. We systematically searched in five electronic databases from 2007 to April 2020 to identify SRs on migrant health. Two independent reviewers assessed risk of bias, methodological and reporting quality in included systematic reviews (SRs) using ROBIS, AMSTAR-2 and PRISMA checklist, respectively. We included 57 systematic reviews. The quality in 30 SRs (52.6%) was either low or critically low due to limitations in AMSTAR-2 items 4, 7, 8 and 10–16. The overall risk of bias was high in 23 SRs (40.4%), particularly in domains—data collection and study quality—20 SRs (35.1%), synthesis and findings—19 SRs (33.3%), and study identification and selection 13 SRs (22.8%). The quality of reporting in 36 SRs (63.2%) was moderate, with 19.74 ± 4.67 items fulfilled. While 19 SRs (33.3%) had 10–18 PRISMA items satisfied. Sixteen SRs (28.1%) reported a research protocol and registration. The overall quality of migrant SRs is suboptimal, with critical gaps linked to low protocol registrations, assessment of risk of bias and publication bias, additional analysis of synthesized evidence and available funding. These findings reflect current deficiencies in the development of SR on migrant healthcare. more...

Purpose Clinical guidelines' (CGs) adherence supports high-quality care. However, healthcare providers do not always comply with CGs recommendations. This systematic literature review aims to assess the extent of healthcare providers' adherence to breast cancer CGs in Europe and to identify the factors that impact on healthcare providers' adherence. Methods We searched for systematic reviews and quantitative or qualitative primary studies in MEDLINE and Embase up to May 2019. The eligibility assessment, data extraction, and risk of bias assessment were conducted by one author and cross-checked by a second author. We conducted a narrative synthesis attending to the modality of the healthcare process, methods to measure adherence, the scope of the CGs, and population characteristics. Results Out of 8137 references, we included 41 primary studies conducted in eight European countries. Most followed a retrospective cohort design (19/41; 46%) and were at low or moderate risk of bias. Adherence for overall breast cancer care process (from diagnosis to follow-up) ranged from 54 to 69%; for overall treatment process [including surgery, chemotherapy (CT), endocrine therapy (ET), and radiotherapy (RT)] the median adherence was 57.5% (interquartile range (IQR) 38.8-67.3%), while for systemic therapy (CT and ET) it was 76% (IQR 68-77%). The median adherence for the processes assessed individually was higher, ranging from 74% (IQR 10-80%), for the follow-up, to 90% (IQR 87-92.5%) for ET. Internal factors that potentially impact on healthcare providers' adherence were their perceptions, preferences, lack of knowledge, or intentional decisions. Conclusions A substantial proportion of breast cancer patients are not receiving CGs-recommended care. Healthcare providers' adherence to breast cancer CGs in Europe has room for improvement in almost all care processes. CGs development and implementation processes should address the main factors that influence healthcare providers' adherence, especially patient-related ones. Registration: PROSPERO (CRD42018092884)., The systematic review was carried out by the Iberoamerican Cochrane Center under Framework Contract 443094 for procurement of services between European Commission Joint Research Centre and Asociacion Colaboracion Cochrane Iberoamericana. YS is funded by China Scholarship Council (No. 201707040103). MR is funded by Sara Borrell contract (CD16/00157). AVM received a training Grant D43 TW007393 Fogarty International Centre of the US National Institutes of Health for the Emerging Diseases and Climate Change Research Unit of the School and Public Health Administration at Universidad Peruana Cayetano Heredia. more...

Background Although mammography screening is recommended in most European countries, the balance between the benefits and harms of different screening intervals is still a matter of debate. This review informed the European Commission Initiative on Breast Cancer (BC) recommendations. Methods We searched PubMed, EMBASE, and the Cochrane Library to identify RCTs, observational or modelling studies, comparing desirable (BC deaths averted, QALYs, BC stage, interval cancer) and undesirable (overdiagnosis, false positive related, radiation related) effects from annual, biennial, or triennial mammography screening in women of average risk for BC. We assessed the certainty of the evidence using the GRADE approach. Results We included one RCT, 13 observational, and 11 modelling studies. In women 50–69, annual compared to biennial screening may have small additional benefits but an important increase in false positive results; triennial compared to biennial screening may have smaller benefits while avoiding some harms. In younger women (aged 45–49), annual compared to biennial screening had a smaller gain in benefits and larger harms, showing a less favourable balance in this age group than in women 50–69. In women 70–74, there were fewer additional harms and similar benefits with shorter screening intervals. The overall certainty of the evidence for each of these comparisons was very low. Conclusions In women of average BC risk, screening intervals have different trade-offs for each age group. The balance probably favours biennial screening in women 50–69. In younger women, annual screening may have a less favourable balance, while in women aged 70–74 years longer screening intervals may be more favourable. more...

Background. In addition to social and environmental determinants, people’s values and preferences determine daily food choices. This study evaluated adults’ values and preferences regarding unprocessed red meat (URM) and processed meat (PM) and their willingness to change their consumption in the face of possible undesirable health consequences. Methods. A cross-sectional mixed-methods study including a quantitative assessment through an online survey, a qualitative inquiry through semi-structured interviews, and a follow-up assessment through a telephone survey. We performed descriptive statistics, logistic regressions, and thematic analysis. Results. Of 304 participants, over 75% were unwilling to stop their consumption of either URM or PM, and of those unwilling to stop, over 80% were also unwilling to reduce. Men were less likely to stop meat intake than women (odds ratios &lt, 0.4). From the semi-structured interviews, we identified three main themes: the social and/or family context of meat consumption, health- and non-health-related concerns about meat, and uncertainty of the evidence. At three months, 63% of participants reported no changes in meat intake. Conclusions. When informed about the cancer incidence and mortality risks of meat consumption, most respondents would not reduce their intake. Public health and clinical nutrition guidelines should ensure that their recommendations are consistent with population values and preferences. more...

Background Myocardial injury after noncardiac surgery (MINS) is common and of prognostic importance. Little is known about MINS in orthopaedic surgery. The diagnostic criterion for MINS was a level of ≥0.03 ng/mL on a non-high-sensitivity troponin T (TnT) assay due to myocardial ischemia. Methods We undertook an international, prospective study of 15,103 patients ≥45 years of age who had inpatient noncardiac surgery; 3,092 underwent orthopaedic surgery. Non-high-sensitivity TnT assays were performed on postoperative days 0, 1, 2, and 3. Among orthopaedic patients, we determined (1) the prognostic relevance of the MINS diagnostic criteria, (2) the 30-day mortality rate for those with and without MINS, and (3) the probable proportion of MINS cases that would go undetected without troponin monitoring because of a lack of an ischemic symptom. Results Three hundred and sixty-seven orthopaedic patients (11.9%) had MINS. MINS was associated independently with 30-day mortality including among those who had had orthopaedic surgery. Orthopaedic patients without and with MINS had a 30-day mortality rate of 1.0% and 9.8%, respectively (odds ratio [OR], 11.28; 95% confidence interval [CI], 6.72 to 18.92). The 30-day mortality rate was increased for patients with MINS who had an ischemic feature (i.e., symptoms, or evidence of ischemia on electrocardiography or imaging) (OR, 18.25; 95% CI, 10.06 to 33.10) and for those who did not have an ischemic feature (OR, 7.35; 95% CI, 3.37 to 16.01). The proportion of orthopaedic patients with MINS who were asymptomatic and in whom the myocardial injury would have probably gone undetected without TnT monitoring was 81.3% (95% CI, 76.3% to 85.4%). Conclusions One in 8 orthopaedic patients in our study had MINS, and MINS was associated with a higher mortality rate regardless of symptoms. Troponin levels should be measured after surgery in at-risk patients because most MINS cases (>80%) are asymptomatic and would go undetected without routine measurements. Level of evidence Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence. more...

Five biologicals have been approved for severe eosinophilic asthma, a well-recognized phenotype. Systematic reviews (SR) evaluated the efficacy and safety of benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab (alphabetical order) compared to standard of care for severe eosinophilic asthma. PubMed, Embase and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthma-related outcomes were evaluated for each of the biologicals. The risk of bias and the certainty of the evidence were assessed using GRADE. 19 RCTs (three RCTs for benralizumab, three RCTs for dupilumab, three RCTs for mepolizumab, five RCTs for omalizumab and five RCTs for reslizumab), including subjects 12 to 75 years old (except for omalizumab including also subjects 6-11 years old), ranging from 12 to 56 weeks were evaluated. All biologicals reduce exacerbation rates with high certainty of evidence: benralizumab incidence rate ratio (IRR) 0.53 (95% CI 0.39 to 0.72), dupilumab (IRR) 0.43 (95% CI 0.32 to 0.59), mepolizumab IRR 0.49 (95% CI 0.38 to 0.66), omalizumab (IRR) 0.56 (95% CI 0.40 to 0.77) and reslizumab (IRR) 0.46 (95% CI 0.37 to 0.58). Benralizumab, dupilumab and mepolizumab reduce the daily dose of oral corticosteroids (OCS) with high certainty of evidence. All evaluated biologicals probably improve asthma control, QoL and FEV1 , without reaching the minimal important difference (moderate certainty). Benralizumab, mepolizumab and reslizumab slightly increase drug-related adverse events (AE) and drug-related serious AE (low to very low certainty of evidence). The incremental cost-effectiveness ratio per quality-adjusted life year value is above the willingness to pay threshold for all biologicals (moderate certainty). Potential savings are driven by decrease in hospitalizations, emergency and primary care visits. There is high certainty that all approved biologicals reduce the rate of severe asthma exacerbations and for benralizumab, dupilumab and mepolizumab for reducing OCS. There is moderate certainty for improving asthma control, QoL, FEV1 . More data on long-term safety are needed together with more efficacy data in the paediatric population. more...

Background Vitamin D has been widely promoted for bone health through supplementation and fortification of the general adult population. However, there is growing evidence that does not support these strategies. Our aim is to review the quality and recommendations on vitamin D nutritional and clinical practice guidelines and explore predictive factors for their direction and strength. Methods We searched three databases and two guideline repositories from 2010 onwards. We performed a descriptive analysis, a quality appraisal using AGREE II scores (Appraisal of Guidelines Research and Evaluation) and a bivariate analysis evaluating the association between direction and strength of recommendations, AGREE II domains' scores and pre-specified characteristics. Results We included 34 guidelines, 44.1% recommended, 26.5% suggested, and 29.4% did not recommend vitamin D supplementation. Guidelines that scored higher for "editorial independence" and "overall quality score" were less likely to recommend or suggest vitamin D supplementation (median 68.8 vs. 35.4; p=0.001), and median 58.3 vs. 37.5; p=0.02). Guidance produced by government organizations and those that reported source of funding were associated with higher AGREE II scores. Unclear role of source of funding was associated with recommending or suggesting vitamin D supplementation (p=0.034). Editorial independence was an independent predictor for recommending or suggesting vitamin D supplementation (OR 1.09; CI95% 1.02 to 1.16; p=0.006). Conclusions Policymakers, clinicians and patients should be aware that lower quality guidelines, and those reporting conflicts of interest are more likely to promote vitamin D supplementation. Guideline organizations should improve the quality of their recommendations' development and the management of conflicts of interest. Users and editors should be aware of these findings when using and appraising guidelines. more...

In the context of a pandemic, the rapid development of clinical practice guidelines (CPGs) is critical to guide dental staff towards the safe provision of dental care; detailed knowledge of the recommendations will help to achieve the intended results. We carried out a systematic review of the recommendations in clinical practice guidelines (CPGs) on the provision of dental care issued during the first year of the COVID-19 pandemic. A systematic database search was performed in MEDLINE, EMBASE, LILACS, Epistemonikos, and Trip databases to identify documents with recommendations intended to minimize the risk of COVID-19 transmission during dental care. The selection process and data extraction were carried out by two researchers independently. The majority of CPGs recommended the use of rubber dam, high-volume evacuator, mouthwash prior to dental care, four-handed work, and mechanical barriers. The use of aerosol-generating equipment should be avoided whenever possible. In aerosol-generating procedures, the use of a N95 respirator (or similar) is recommended, in addition to a face protector, an impermeable disposable apron/gown, a cap, and gloves. The CPGs developed during the first year of the pandemic offer recommendations which guide dental staff in providing safe dental care, minimizing exposure to SARS-CoV-2 and reducing the risk of COVID-19 infection in the clinical environment. Such recommendations must, however, be updated as new evidence arises. more...

This systematic review evaluates the efficacy and safety of biologicals for chronic rhinosinusitis with nasal polyps (CRSwNP) compared to the standard of care.Pubmed, EMBASE and Cochrane Library were searched for RCTs. Critical and important CRSwNP-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. RCTs evaluated (dupilumab-2, omalizumab-4, mepolizumab-2, reslizumab-1) included 1236 adults, with follow-up 20-64 weeks. Dupilumab reduces the need for surgery (NFS) or oral corticosteroid (OCS) use (RR 0.28; 95%CI 0.20-0.39, moderate certainty) and improves with high certainty smell evaluated with UPSIT score (mean difference (MD) +10.54; 95%CI +9.24 to +11.84) and quality of life (QoL) evaluated with SNOT-22 (MD -19.14; 95%CI -22.80 to -15.47), with fewer treatment-related adverse events (TAEs) (RR 0.95; 95%CI 0.89-1.02, moderate certainty). Omalizumab reduces NFS (RR 0.85; 95%CI 0.78 to 0.92, high certainty), decreases OCS use (RR 0.38; 95%CI 0.10-1.38, moderate certainty), improves with high certainty smell (MD +3.84; 95%CI +3.64 to +4.04) and QoL (MD -15.65; 95%CI -16.16 to -15.13), with increased TAE (RR 1.73; 95%CI 0.60-5.03, moderate certainty). There is low certainty for mepolizumab reducing NFS (RR 0.78; 95%CI 0.64 to 0.94) and improving QoL (MD -13.3; 95% CI -23.93 to -2.67) and smell (MD +0.7; 95%CI -0.48 to +1.88), with increased TAEs (RR 1.64; 95%CI 0.41-6.50). The evidence for reslizumab is very uncertain. more...

Self-management interventions (SMIs) can improve the life of patients living with obesity. However, there is variability in the outcomes used to assess the effectiveness of SMIs and these are often not relevant for patients. In the context of COMPAR-EU, our aim was to develop a core outcome set (COS) for the evaluation of SMIs for patients with obesity. We followed a four steps multimethod approach: (1) the development of the initial catalogue of outcomes; (2) a scoping review of reviews on patients' values and preferences on outcomes of self-management (SM); (3) a Delphi survey including patients and patient representatives to rate the importance of outcomes; and (4) a 2-day consensus workshop with patients, patient representatives, healthcare professionals and researchers. The initial catalogue included 82 outcomes. Ten patients and patient's representatives participated in the Delphi survey. We identified 16 themes through the thematic synthesis of the scoping review that informed 37.80% of the outcomes on initial catalogue. Five patients, five healthcare professionals, and four researchers participated in the consensus workshop. After the consensus process, 15 outcomes were selected to be part of the final COS, and five supplementary outcomes were also provided. We developed a COS for the evaluation of SMIs in obesity with a significant involvement of patients and other key stakeholders. This COS will help improving data synthesis and increasing the value of SM research data in healthcare decision making. more...

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. more...

Objective To assess the overall effect of delayed antibiotic prescribing on average symptom severity for patients with respiratory tract infections in the community, and to identify any factors modifying this effect. Design Systematic review and individual patient data meta-analysis. Data sources Cochrane Central Register of Controlled Trials, Ovid Medline, Ovid Embase, EBSCO CINAHL Plus, and Web of Science. Eligibility criteria for study selection Randomised controlled trials and observational cohort studies in a community setting that allowed comparison between delayed versus no antibiotic prescribing, and delayed versus immediate antibiotic prescribing. Main outcome measures The primary outcome was the average symptom severity two to four days after the initial consultation measured on a seven item scale (ranging from normal to as bad as could be). Secondary outcomes were duration of illness after the initial consultation, complications resulting in admission to hospital or death, reconsultation with the same or worsening illness, and patient satisfaction rated on a Likert scale. Results Data were obtained from nine randomised controlled trials and four observational studies, totalling 55 682 patients. No difference was found in follow-up symptom severity (seven point scale) for delayed versus immediate antibiotics (adjusted mean difference −0.003, 95% confidence interval −0.12 to 0.11) or delayed versus no antibiotics (0.02, −0.11 to 0.15). Symptom duration was slightly longer in those given delayed versus immediate antibiotics (11.4 v 10.9 days), but was similar for delayed versus no antibiotics. Complications resulting in hospital admission or death were lower with delayed versus no antibiotics (odds ratio 0.62, 95% confidence interval 0.30 to 1.27) and delayed versus immediate antibiotics (0.78, 0.53 to 1.13). A significant reduction in reconsultation rates (odds ratio 0.72, 95% confidence interval 0.60 to 0.87) and an increase in patient satisfaction (adjusted mean difference 0.09, 0.06 to 0.11) were observed in delayed versus no antibiotics. The effect of delayed versus immediate antibiotics and delayed versus no antibiotics was not modified by previous duration of illness, fever, comorbidity, or severity of symptoms. Children younger than 5 years had a slightly higher follow-up symptom severity with delayed antibiotics than with immediate antibiotics (adjusted mean difference 0.10, 95% confidence interval 0.03 to 0.18), but no increased severity was found in the older age group. Conclusions Delayed antibiotic prescribing is a safe and effective strategy for most patients, including those in higher risk subgroups. Delayed prescribing was associated with similar symptom duration as no antibiotic prescribing and is unlikely to lead to poorer symptom control than immediate antibiotic prescribing. Delayed prescribing could reduce reconsultation rates and is unlikely to be associated with an increase in symptoms or illness duration, except in young children. Study registration PROSPERO CRD42018079400. more...

AimTo evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against COVID-19 in Spain.DesignWe will carry out a two-week, individually randomised, parallel group, controlled trial. Participants will be individually randomised to receive the PsyCovidApp intervention or control App intervention.MethodsThe PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended COVID-19 patients will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the two weeks intervention period. Measures will include stress, depression and anxiety (DASS-21 questionnaire – primary endpoint), insomnia (ISI), burnout (MBI-HSS), post-traumatic stress disorder (DTS), and self-efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation.DiscussionDespite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence regarding the effectiveness of this type of intervention on this specific population and context.ImpactDespite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits.Clinical trial registrationNCT04393818 (ClinicalTrials.gov identifier) more...

Background Evidence to Decision (EtD) frameworks bring clarity, structure and transparency to health care decision making. The interactive Evidence to Decision (iEtD) tool, developed in the context of the DECIDE project and published by Epistemonikos, is a stand-alone online solution for producing and using EtD frameworks. Since its development, little is known about how organizations have been using the iEtD tool and what characterizes users’ experiences with it. This missing information is necessary for any teams planning future developments of the iEtD tool. Methods This study aimed to describe users’ experiences with the iEtD and identify main barriers and facilitators related to use. We contacted all users registered in the iEtD via email and invited people who identified themselves as having used the solution to a semi-structured interview. Audio recordings were transcribed, and one researcher conducted a directed content analysis of the interviews guided by a user experience framework. Two researchers checked the content independently for accuracy. Results Out of 860 people contacted, 81 people replied to our introductory email (response rate 9.4%). Twenty of these had used the tool in a real scenario and were invited to an interview. We interviewed all eight users that accepted this invitation (from six countries, four continents). ‘Guideline development’ was the iEtD use scenario they most commonly identified. Most participants reported an overall positive experience, without major difficulties navigating or using the different sections. They reported having used most of the EtD framework criteria. Participants reported tailoring their frameworks, for instance by adding or deleting criteria, translating to another language, or rewording headings. Several people preferred to produce a Word version rather than working online, due to the burden of completing the framework, or lack of experience with the tool. Some reported difficulties working with the exportable formats, as they needed considerable editing. Conclusion A very limited number of guideline developers have used the iEtD tool published by Epistemonikos since its development. Although users’ general experiences are positive, our work has identified some aspects of the tool that need improvement. Our findings could be also applied to development or improvement of other solutions for producing or using EtD frameworks. more...

Objectives Mammography screening is generally accepted in women aged 50–69, but the balance between benefits and harms remains controversial in other age groups. This study systematically reviews these effects to inform the European Breast Cancer Guidelines. Methods We searched PubMed, EMBASE and Cochrane Library for randomised clinical trials (RCTs) or systematic reviews of observational studies in the absence of RCTs comparing invitation to mammography screening to no invitation in women at average breast cancer (BC) risk. We extracted data for mortality, BC stage, mastectomy rate, chemotherapy provision, overdiagnosis and false-positive-related adverse effects. We performed a pooled analysis of relative risks, applying an inverse-variance random-effects model for three age groups (Results We identified 10 RCTs including 616,641 women aged 38–75. Mammography reduced BC mortality in women aged 50–69 (relative risk (RR) 0.77, 95%CI (confidence interval) 0.66–0.90, high certainty) and 70–74 (RR 0.77, 95%CI 0.54–1.09, high certainty), with smaller reductions in under 50s (RR 0.88, 95%CI 0.76–1.02, moderate certainty). Mammography reduced stage IIA+ in women 50–69 (RR 0.80, 95%CI 0.64–1.00, very low certainty) but resulted in an overdiagnosis probability of 23% (95%CI 18–27%) and 17% (95%CI 15–20%) in under 50s and 50–69, respectively ( moderate certainty). Mammography was associated with 2.9% increased risk of invasive procedures with benign outcomes ( low certainty). Conclusions For women 50–69, high certainty evidence that mammography screening reduces BC mortality risk would support policymakers formulating strong recommendations. In other age groups, where the net balance of effects is less clear, conditional recommendations will be more likely, together with shared decision-making. more...

Introduction: Self-management (SM) interventions are complex interventions and one of the main components of high-quality chronic disease care for which the incorporation of the perspectives of patients and their informal caregivers is crucial. We aim to identify, appraise and synthesise the evidence exploring patients’ and caregivers’ perspectives on SM interventions. More precisely, we aim to 1) describe how they value the importance of outcomes of SM interventions, and 2) identify the factors that might impact on acceptability and feasibility of SM interventions based on their preferences and experiences. Methods and analysis: We will conduct four mixed-methods overviews as part of COMPAR-EU, a European Union (EU) funded project aimed to identify the most effective and cost-effective SM interventions for chronic obstructive pulmonary disease (COPD), heart failure (HF), obesity, and type 2 diabetes mellitus (T2DM). We will search in MEDLINE, CINAHL, and PsycINFO for systematic reviews of studies addressing patients’ preferences on outcomes, or their experiences with SM alongside their disease trajectory or with SM interventions, published in English. Selection of studies and data extraction will be conducted in pairs. We will assess the overlap of studies and methodological quality. We will follow a three-step synthesis process: 1) narrative synthesis for quantitative evidence, 2) thematic synthesis for qualitative evidence, and 3) integration of findings in the interpretation phase. Additionally, we will consult on the relevance of findings with patients and their caregivers. Systematic review registration: PROSPERO CRD42019117867 more...

IntroductionDecision 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 analysisWe 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 disseminationSite-specific ethics boards have approved the study. All participants will provide informed consent. The research team will take an integrated approach to knowledge translation. more...

OBJECTIVES: To assess the effectiveness and safety of delayed antibiotic prescription (DAP) compared to immediate antibiotic prescription (IAP) and no antibiotic prescription (NAP) in children with uncomplicated respiratory infections. METHODS: Randomized clinical trial comparing 3 antibiotic prescription strategies. The participants were children with acute uncomplicated respiratory infections attended to in 39 primary care centers. Children were randomly assigned into prescription arms as follows: (1) DAP, (2) IAP, or (3) NAP. Primary outcomes were symptom duration and severity. Secondary outcomes were antibiotic use, parental satisfaction, parental beliefs, additional primary care visits, and complications at 30 days. RESULTS: In total, 436 children were included in the analysis. The mean (SD) duration of severe symptoms was 10.1 (6.3) for IAP, 10.9 (8.5) for NAP, and 12.4 (8.4) for DAP (P = .539), although the differences were not statistically significant. The median (interquartile range) of the greatest severity for any symptom was similar for the 3 arms (median [interquartile range] score of 3 [2–4]; P = .619). Antibiotic use was significantly higher for IAP (n = 142 [96%]) compared to DAP (n = 37 [25.3%]) and NAP (n = 17 [12.0%]) (P < .001). Complications, additional visits to primary care, and satisfaction were similar for all strategies. Gastrointestinal adverse effects were higher for IAP. CONCLUSIONS: There was no statistically significant difference in symptom duration or severity in children with uncomplicated respiratory infections who received DAP compared to NAP or IAP strategies; however, DAP reduced antibiotic use and gastrointestinal adverse effects. more...

Objective To evaluate the impact of preoperative MRI in the management of Ductal carcinoma in situ (DCIS). Methods We searched the PubMed, EMBASE and Cochrane Library databases to identify randomised clinical trials (RCTs) or cohort studies assessing the impact of preoperative breast MRI in surgical outcomes, treatment change or loco-regional recurrence. We provided pooled estimates for odds ratios (OR), relative risks (RR) and proportions and assessed the certainty of the evidence using the GRADE approach. Results We included 3 RCTs and 23 observational cohorts, corresponding to 20,415 patients. For initial breast-conserving surgery (BCS), the RCTs showed that MRI may result in little to no difference (RR 0.95, 95% CI 0.90 to 1.00) (low certainty); observational studies showed that MRI may have no difference in the odds of re-operation after BCS (OR 0.96; 95% CI 0.36 to 2.61) (low certainty); and uncertain evidence from RCTs suggests little to no difference with respect to total mastectomy rate (RR 0.91; 95% CI 0.65 to 1.27) (very low certainty). We also found that MRI may change the initial treatment plans in 17% (95% CI 12 to 24%) of cases, but with little to no effect on locoregional recurrence (aHR = 1.18; 95% CI 0.79 to 1.76) (very low certainty). Conclusion We found evidence of low to very low certainty which may suggest there is no improvement of surgical outcomes with pre-operative MRI assessment of women with DCIS lesions. There is a need for large rigorously conducted RCTs to evaluate the role of preoperative MRI in this population. Key Points • Evidence of low to very low certainty may suggest there is no improvement in surgical outcomes with pre-operative MRI. • There is a need for large rigorously conducted RCTs evaluating the role of preoperative MRI to improve treatment planning for DCIS. more...

Background: Systematic reviews (SR) can be classified by type depending on the research question they are based on. This work identifies and describes the most relevant methodological resources to conduct high-quality reviews that answer clinical questions regarding prevalence, prognosis, diagnostic accuracy and efficacy of interventions. Methods: Methodological resources have been identified from literature searches and consulting guidelines from institutions that develop SRs. The selected resources are organized by type of SR, and stage of development of the review (formulation of the research question, development of the protocol, literature search, risk of bias assessment, synthesis of findings, assessment of the quality of evidence, and report of SR results and conclusions). Results: Although the different types of SRs are developed following the same steps, each SR type requires specific methods, differing in characteristics and complexity. The extent of methodological development varies by type of SR, with more solid guidelines available for diagnostic accuracy and efficacy of interventions SRs. This methodological toolkit describes the most up-to-date risk of bias instruments: Quality in Prognostic Studies (QUIPS) tool and Prediction model study Risk Of Bias Assessment Tool (PROBAST) for prognostic SRs, Quality assessment of diagnostic accuracy studies tool (QUADAS-2) for diagnostic accuracy SRs, Cochrane risk of bias tool (ROB-2) and Risk of bias in non-randomised studies of interventions studies tool (ROBINS-I) for efficacy of interventions SRs, as well as the latest developments on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Conclusions: This structured compilation of the best methodological resources for each type of SR may prove to be a very useful tool for those researchers that wish to develop SRs or conduct methodological research works on SRs. more...

BackgroundBreast cancer (BC) clinical guidelines offer evidence-based recommendations to improve quality of healthcare for patients with or at risk of BC. Suboptimal adherence to recommendations has the potential to negatively affect population health. However, no study has systematically reviewed the impact of BC guideline adherence -as prognosis factor- on BC healthcare processes and health outcomes. The objectives are to analyse the impact of guideline adherence on health outcomes and on healthcare costs.MethodsWe searched systematic reviews and primary studies in MEDLINE and Embase, conducted in European Union (EU) countries (inception to May 2019). Eligibility assessment, data extraction, and risk of bias assessment were conducted by one author and crosschecked by a second. We used random-effects meta-analyses to examine the impact of guideline adherence on overall survival and disease-free survival, and assessed certainty of evidence using GRADE.ResultsWe included 21 primary studies. Most were published during the last decade (90%), followed a retrospective cohort design (86%), focused on treatment guideline adherence (95%), and were at low (80%) or moderate (20%) risk of bias. Nineteen studies (95%) examined the impact of guideline adherence on health outcomes, while two (10%) on healthcare cost. Adherence to guidelines was associated with increased overall survival (HR=0.67, 95%CI 0.59-0.76) and disease-free survival (HR=0.35, 95%CI 0.15-0.82), representing 138 more survivors (96 more to 178 more) and 336 patients free of recurrence (73 more to 491 more) for every 1000 women receiving adherent CG treatment compared to those receiving non-adherent treatment at 5years follow-up (moderate certainty). Adherence to treatment guidelines was associated with higher costs, but adherence to follow-up guidelines was associated with lower costs (low certainty).ConclusionsOur review of EU studies suggests that there is moderate certainty that adherence to BC guidelines is associated with an improved survival. BC guidelines should be rigorously implemented in the clinical setting.Trial registrationPROSPERO (CRD42018092884)., The systematic review was carried out by the Iberoamerican Cochrane Center under Framework contract 443094 for procurement of services between European Commission Joint Research Centre and Asociacion Colaboracion Cochrane Iberoamericana.; AVM received a training grant D43 TW007393 Fogarty International Centre of the US National Institutes of Health for the Emerging Diseases and Climate Change Research Unit of the School and Public Health Administration at Universidad Peruana Cayetano Heredia. more...

This systematic review evaluates the efficacy and safety of omalizumab for chronic spontaneous urticaria (CSU). PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CSU-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Ten RCTs including 1620 subjects aged 12 to 75 years old treated with omalizumab for 16 to 40 weeks were evaluated. Omalizumab 150 mg does not result in clinically meaningful improvement (high certainty) of the urticaria activity score (UAS)7 (mean difference (MD) -5; 95%CI -7.75 to -2.25), and the itch severity score (ISS)7 (MD -2.15; 95% CI -3.2 to -1.1) does not increase (moderate certainty) quality of life (QoL) (Dermatology Life Quality Index (DLQI); MD -2.01; 95%CI -3.22 to -0.81) and decreases (moderate certainty) rescue medication use (MD -1.68; 95%CI -2.95 to -0.4). Omalizumab 300 mg results in clinically meaningful improvements (moderate certainty) of the UAS7 (MD -11.05; 95%CI -12.87 to -9.24), the ISS7 (MD -4.45; 95%CI -5.39 to -3.51), and QoL (high certainty) (DLQI; MD -4.03; 95% CI -5.56 to -2.5) and decreases (moderate certainty) rescue medication use (MD -2.04; 95%CI -3.19 to -0.88) and drug-related serious AEs (RR 0.77; 95%CI 0.20 to 2.91). more...

This systematic review evaluates the efficacy, safety and economic impact of dupilumab compared to standard of care for uncontrolled moderate-to-severe atopic dermatitis (AD). Pubmed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important AD-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Seven RCTs including 1845 subjects >12 years treated with dupilumab 16 to 52 weeks were evaluated. For adults, there is high certainty that dupilumab decreases SCORAD (MD -30,72; 95% CI -34,65% to -26,79%) and EASI-75 (RR 3.09; 95% CI 2.45 to 3.89), pruritus (RR 2.96; 95% CI 2.37 to 3.70), rescue medication (RR 3.46; 95% CI 2.79 to 4.30), sleep disturbance (MD -7.29; 95% CI -8.23 to -6.35) and anxiety/depression (MD -3.08; 95% CI -4.41 to -1.75) and improves quality of life (MD -4.80; 95% CI -5.55 to -4.06). The efficacy for adolescents is similar. Dupilumab-related adverse events (AEs) slightly increase (low certainty). The evidence for dupilumab-related serious AE is uncertain. The incremental cost-effectiveness ratio ranged from 28 500 pound (low certainty) to 124 541 US$ (moderate certainty). More data on long-term safety are needed both for children and for adults, together with more efficacy data in the paediatric population.Registration: PROSPERO (CRD42020153645). more...

Background: A key impact measure of COVID-19 pandemic is the case fatality rate (CFR), but estimating it during an epidemic is challenging as the true number of cases may remain elusive. Objective: To estimate the CFR applying a delay-adjusted method across countries, exploring differences to simple methods and potential correlation to country level variables. Methods: Secondary analysis of publicly available data from countries with ≥500 cases by April 30th. We calculated CFR adjusting for delay time from diagnosis to death and using simple methods for comparison. We performed a random effects meta-analysis to pooling CFRs for all countries and for those with high testing coverage and low positivity rate. We explored correlation of adjusted CFR with age structure and health care resources at country level. Results: We included 107 countries and the Diamond Princess cruise-ship. The overall delay adjusted CFR was 2.8% (95%CI: 2.1 to 3.1) while naive CFR was 5.1% (95%CI: 4.1 to 6.2). In countries with high testing coverage/low positivity rate the pooled adjusted CFR was 2.1% (95%CI: 1.5 to 3.0), there was a correlation with age over 65 years (β = 0.12; 95%CI: 0.06 to 0.18), but not with number of physician or critical care beds. Naive method underestimated the CFR of the CFR with a median of 1.3% across countries. Conclusion: Our best estimation of CFR across countries is 2% and varies according to the aged population size. Modelers and policy makers may consider these results to assess the impact of lockdowns or other mitigation policies. more...

Background Rapid reviews (RRs) have emerged as an efficient alternative to time-consuming systematic reviews—they can help meet the demand for accelerated evidence synthesis to inform decision-making in healthcare. The synthesis of diagnostic evidence has important methodological challenges. Here, we performed an international survey to identify the current practice of producing RRs for diagnostic tests. Methods We developed and administered an online survey inviting institutions that perform RRs of diagnostic tests from all over the world. Results All participants (N = 25) reported the implementation of one or more methods to define the scope of the RR; however, only one strategy (defining a structured question) was used by ≥90% of participants. All participants used at least one methodological shortcut including the use of a previous review as a starting point (92%) and the use of limits on the search (96%). Parallelization and automation of review tasks were not extensively used (48 and 20%, respectively). Conclusion Our survey indicates a greater use of shortcuts and limits for conducting diagnostic test RRs versus the results of a recent scoping review analyzing published RRs. Several shortcuts are used without knowing how their implementation affects the results of the evidence synthesis in the setting of diagnostic test reviews. Thus, a structured evaluation of the challenges and implications of the adoption of these RR methods is warranted. more...

Key Points Question Is it possible to create a tool to specifically evaluate the quality of clinical practice guideline recommendations? Findings In this cross-sectional study of 322 international stakeholders, the Appraisal of Guidelines Research and Evaluation–Recommendations Excellence (AGREE-REX) tool was developed to appraise guidelines for clinical practice. All participants rated the tool as usable and agreed that it represents a valuable addition to the clinical practice guidelines enterprise. Meaning A panel of stakeholders agrees that the AGREE-REX tool may provide information about the methodologic quality of guideline recommendations and may help in the implementation of clinical practice guidelines., Importance Clinical practice guidelines (CPGs) may lack rigor and suitability to the setting in which they are to be applied. Methods to yield clinical practice guideline recommendations that are credible and implementable remain to be determined. Objective To describe the development of AGREE-REX (Appraisal of Guidelines Research and Evaluation–Recommendations Excellence), a tool designed to evaluate the quality of clinical practice guideline recommendations. Design, Setting, and Participants A cross-sectional study of 322 international stakeholders representing CPG developers, users, and researchers was conducted between December 2015 and March 2019. Advertisements to participate were distributed through professional organizations as well as through the AGREE Enterprise social media accounts and their registered users. Exposures Between 2015 and 2017, participants appraised 1 of 161 CPGs using the Draft AGREE-REX tool and completed the AGREE-REX Usability Survey. Main Outcomes and Measures Usability and measurement properties of the tool were assessed with 7-point scales (1 indicating strong disagreement and 7 indicating strong agreement). Internal consistency of items was assessed with the Cronbach α, and the Spearman-Brown reliability adjustment was used to calculate reliability for 2 to 5 raters. Results A total of 322 participants (202 female participants [62.7%]; 83 aged 40-49 years [25.8%]) rated the survey items (on a 7-point scale). All 11 items were rated as easy to understand (with a mean [SD] ranging from 5.2 [1.38] for the alignment of values item to 6.3 [0.87] for the evidence item) and easy to apply (with a mean [SD] ranging from 4.8 [1.49] for the alignment of values item to 6.1 [1.07] for the evidence item). Participants provided favorable feedback on the tool’s instructions, which were considered clear (mean [SD], 5.8 [1.06]), helpful (mean [SD], 5.9 [1.00]), and complete (mean [SD], 5.8 [1.11]). Participants considered the tool easy to use (mean [SD], 5.4 [1.32]) and thought that it added value to the guideline enterprise (mean [SD], 5.9 [1.13]). Internal consistency of the items was high (Cronbach α = 0.94). Positive correlations were found between the overall AGREE-REX score and the implementability score (r = 0.81) and the clinical credibility score (r = 0.76). Conclusions and Relevance This cross-sectional study found that the AGREE-REX tool can be useful in evaluating CPG recommendations, differentiating among them, and identifying those that are clinically credible and implementable for practicing health professionals and decision makers who use recommendations to inform clinical policy., This cross-sectional study examines a tool for assessing the credibility and implementability of clinical practice guidelines. more...

Background Red blood cell (RBC) transfusions are essential in health care. The quality of recommendations included in clinical practice guidelines (CPG), regarding this intervention, has not been systematically evaluated. This paper systematically assessed CPGs for RBC‐transfusion, to appraise their methodological quality, to explore changes in quality over time, and to assess the consistency of the hemoglobin threshold (HT) recommendations. Methods We searched for CPGs that included recommendations of RBC‐transfusion in generic databases, compiler entities, registries, clearinghouses and guideline developers. Three reviewers extracted data on CPGs characteristics and HT recommendations, independently appraised the quality of the studies using AGREE II and resolved disagreements by consensus. Results We examined 16 CPGs. Mean scores (mean ± SD) were: scope and purpose (59.4% ± 19.8%), stakeholder involvement (43.2% ± 22.6%), rigor of development (50% ± 25%), clarity of presentation (74.4% ± 12.6%), applicability (19.4% ± 18.8%), and editorial independence (41% ± 30%). Seven CPGs recommended a restrictive strategy for RBC transfusion; four CPGs gave a guarded statement considering an HT of 7 g/dL, as safe to prescribe an RBC transfusion. Eight CPGs did not provide an HT stating that RBC transfusions should not be prescribed by HT alone. Conclusions Only 3 out of the 16 evaluated CPGs were “recommended” by the independent evaluators. Four domains “stakeholder involvement,” “rigor of development,” applicability,” and “editorial independence” had serious shortcomings. Recommendations about the use of an HT for RBC‐transfusion were heterogeneous among guidelines. Greater efforts are needed to provide high‐quality CPGs in the RBC‐transfusion practice. more...

Objectives To identify, describe, and map contemporary nutrition guidelines (NGs) from reviews that used the Appraisal of Guidelines, Research and Evaluation (AGREE) tool. Study Design and Setting We performed an overview of reviews that systematically assessed the quality of NGs using the AGREE tool. We searched MEDLINE and EMBASE from inception to February 2018. Two authors independently selected and assessed reviews and extracted data. Results We included nine evaluations with a total of 67 NGs. The higher median AGREE scores were for the domains “scope and purpose” (80%, Q1–Q3: 59–89%) and “clarity and presentation” (69%, Q1–Q3: 53–89%), while the lower were for “rigor of development” (58%, Q1–Q3: 31–84%), “editorial independence” (53%, Q1–Q3: 19–79%), “stakeholder involvement” (50%, Q1–Q3: 28–72%), and “applicability” (22%, Q1–Q3: 11–50%). The median AGREE overall rating was 5 (Q1–Q3: 4–6), and most were recommended for use (75%; 30/40). Twenty-nine NGs (43.3%; 29/67) scored ≥60% in three or more domains, including “rigor of development” domain. The methodological quality of NGs did not improve over time. Conclusion The methodological quality of NGs varies widely, but there is general need for improvement in most AGREE domains. NG developers could incorporate available tools to ensure the development of high-quality NGs. more...

To assess the quality of clinical practice guidelines (CPGs) on screening and diagnosis of oral cancer and to describe the characteristics of their recommendations. We systematically searched EMBASE, MEDLINE, CPG’ websites, and dentistry and oncology scientific societies to identify CPGs that were related to screening and diagnosis of oral cancer. The quality of selected CPGs was independently assessed by four appraisers using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument. The inter-appraiser agreement was assessed. We performed a descriptive analysis of the recommendations included in the selected CPGs. Eight CPGs were selected. The overall agreement among reviewers was considered very good (ICC: 0.823; 95% CI: 0.777–0.861). The median scores of the six AGREE II domains were as follows: “scope and purpose” 97.9% (IQR: 96.2–100.0%); “stakeholder involvement” 86.1% (IQR: 69.8–93.1%); “rigor of development” 75.3% (IQR: 64.2–94.3%); “clarity of presentation” 91.7% (IQR: 82.6–94.4%); “applicability” 53.1% (IQR: 19.3–74.2%); and “editorial independence” 83.3% (IQR: 67.2–93.8%). Four CPGs were assessed as “recommended”, four “recommended with modifications”, and none “not recommended”. Twenty-three recommendations were provided, mostly with a low or very low level of evidence. The methodological quality of CPGs on screening and diagnosis of oral cancer is moderate. The “applicability” domain scored the lowest. Most recommendations were based on a low o very low level of evidence. Greater efforts are needed to provide healthcare based on high-quality evidence-based CPGs in this field. more...

Background Myocardial injury after non-cardiac surgery (MINS) is the most common perioperative cardiovascular complication and is independently associated with 30-day mortality. We aimed to assess the association between preoperative glucose concentration and postoperative MINS and mortality. Methods The VISION study is a prospective cohort study done at 12 centres in eight countries. Patients aged 45 years or older who required at least one overnight hospital admission for non-cardiac surgery were enrolled from Aug 6, 2007, to Jan 11, 2011. In the GlucoVISION analysis, we assessed the relations between preoperative casual or fasting glucose concentration and MINS within 3 days after surgery using logistic regression, and 30-day mortality using Cox proportional regression, in people with and without diabetes. Findings 11954 patients were included in this analysis, of whom 2809 (23%) had diabetes. Within the first three postoperative days, MINS occurred in 813 (7%) patients. 249 (2%) patients died by day 30. More patients with diabetes had MINS (odds ratio [OR] 1.98 [95% CI 1.70-2.30]; p more...

ObjectiveThis study aims to better understand the current practice of clinical guideline adaptation and identify challenges raised in this process, given that published adapted clinical guidelines are generally of low quality, poorly reported and not based on published frameworks.DesignA qualitative study based on semistructured interviews. We conducted a framework analysis for the adaptation process, and thematic analysis for participants’ views and experiences about adaptation process.SettingNine guideline development organisations from seven countries.ParticipantsGuideline developers who have adapted clinical guidelines within the last 3 years. We identified potential participants through published adapted clinical guidelines, recommendations from experts, and a review of the Guideline International Network Conference attendees’ list.ResultsWe conducted ten interviews and identified nine adaptation methodologies. The reasons for adapting clinical guidelines include developingde novoclinical guidelines, implementing source clinical guidelines, and harmonising and updating existing clinical guidelines. We identified the following core steps of the adaptation process (1) selection of scope and source guideline(s), (2) assessment of source materials (guidelines, recommendations and evidence level), (3) decision-making process and (4) external review and follow-up process. Challenges on the adaptation of clinical guidelines include limitations from source clinical guidelines (poor quality or reporting), limitations from adaptation settings (lacking resources or skills), adaptation process intensity and complexity, and implementation barriers. We also described how participants address the complexities and implementation issues of the adaptation process.ConclusionsAdaptation processes have been increasingly used to develop clinical guidelines, with the emergence of different purposes. The identification of core steps and assessment levels could help guideline adaptation developers streamline their processes. More methodological research is needed to develop rigorous international standards for adapting clinical guidelines. more...

Background The Checklist for the Reporting of Updated Guidelines (CheckUp) was recently developed. However, so far, no systematic assessment of the reporting of updated clinical guidelines (CGs) exists. We aimed to examine (1) the completeness of reporting the updating process in CGs and (2) the inter-observer reliability of CheckUp. Methods We conducted a systematic assessment of the reporting of the updating process in a sample of updated CGs using CheckUp. We performed a systematic search to identify updated CGs published in 2015, developed by a professional society, reporting a systematic review of the evidence, and containing at least one recommendation. Three reviewers independently assessed the CGs with CheckUp (16 items). We calculated the median score per item, per domain, and overall, converting scores to a 10-point scale. Multiple linear regression analyses were used to identify differences according to country, type of organisation, scope, and health topic of updated CGs. We calculated the intraclass coefficient (ICC) and 95% confidence interval (95% CI) for domains and overall score. Results We included in total 60 updated CGs. The median domain score on a 10-point scale for presentation was 5.8 (range 1.7 to 10), for editorial independence 8.3 (range 3.3 to 10), and for methodology 5.7 (range 0 to 10). The median overall score on a 10-point scale was 6.3 (range 3.1 to 10). Presentation and justification items at recommendation level (respectively reported by 27 and 38% of the CGs) and the methods used for the external review and implementing changes in practice were particularly poorly reported (both reported by 38% of the CGs). CGs developed by a European or international institution obtained a statistically significant higher overall score compared to North American or Asian institutions (p = 0.014). Finally, the agreement among the reviewers on the overall score was excellent (ICC 0.88, 95% CI 0.75 to 0.95). Conclusions The reporting of updated CGs varies considerably with significant room for improvement. We recommend using CheckUp to assess the updating process in updated CGs and as a blueprint to inform methods and reporting strategies in updating. Electronic supplementary material The online version of this article (10.1186/s13012-017-0651-3) contains supplementary material, which is available to authorized users. more...

Despite the frequency of new clinically important atrial fibrillation (AF) after noncardiac surgery and its increased association with the risk of stroke at 30 days, there are limited data informing their prediction, association with outcomes, and management.We used the data from the PeriOperative ISchemic Evaluation trial to determine, in patients undergoing noncardiac surgery, the association of new clinically important AF with 30-day outcomes, and to assess management of these patients. We also aimed to derive a clinical prediction rule for new clinically important AF in this population. We defined new clinically important AF as new AF that resulted in symptoms or required treatment. We recorded an electrocardiogram 6 to 12 hours postoperatively and on the 1st, 2nd, and 30th days after surgery.A total of 211 (2.5% [8351 patients]; 95% confidence interval, 2.2%-2.9%) patients developed new clinically important AF within 30 days of randomization (8140 did not develop new AF). AF was independently associated with an increased length of hospital stay by 6.0 days (95% confidence interval, 3.5-8.5 days) and vascular complications (eg, stroke or congestive heart failure). The usage of an oral anticoagulant at the time of hospital discharge among patients with new AF and a CHADS2 score of 0, 1, 2, 3, and ≥4 was 6.9%, 10.2%, 23.0%, 9.4%, and 33.3%, respectively. Two independent predictors of patients developing new clinically important AF were identified (ie, age and surgery). The prediction rule included the following factors and assigned weights: age ≥85 years (4 points), age 75 to 84 years (3 points), age 65 to 74 years (2 points), intrathoracic surgery (3 points), major vascular surgery (2 points), and intra-abdominal surgery (1 point). The incidence of new AF based on scores of 0 to 1, 2, 3 to 4, and 5 to 6 was 0.5%, 1.0%, 3.1%, and 5.3%, respectively.Age and surgery are independent predictors of new clinically important AF in the perioperative setting. A minority of patients developing new clinically important AF with high CHADS2 scores are discharged on an oral anticoagulant. There is a need to develop effective and safe interventions to prevent this outcome and to optimize the management of this event when it occurs. more...

Background To date there is no consensus about the optimal strategy for keeping clinical guidelines (CGs) up-to-date. The aims of this study were (1) to develop a continuous surveillance and updating strategy for CGs and (2) to test the strategy in a specific CG. Methods The main steps were as follows: (1) recruiting members for the CG Updating Working Group, (2) mapping the CG, (3) identifying new evidence from the CG Updating Working Group, (4) designing and running restricted literature searches, (5) reviewing drugs and medical devices alerts, (6) screening and assessing the new evidence, (7) reviewing and, if necessary, modifying clinical questions and recommendations, and (8) updating the CG document. Results The Pregnancy CG Updating Working Group consisted of 29 members, including clinicians, patients and caregivers, and clinical guideline methodology experts. We selected 69 clinical questions (123 recommendations) from the “Assistance during pregnancy” section. For the first update cycle (32-month duration), 9710 references were identified. Of these, 318 were pertinent, 289 were relevant, and 55 were classified as potential key references. For the second and third update cycles (6-month duration each), 2160 and 2010 references were retrieved, respectively. The continuous surveillance and updating strategy has not yet been completely implemented. Conclusions Further resources are needed in updating the CG field, both for implementing updating strategies and for developing methodological research. more...

Objectives The aim of the study was to identify and describe strategies to prioritize the updating of systematic reviews (SRs), health technology assessments (HTAs), or clinical guidelines (CGs). Study Design and Setting We conducted an SR of studies describing one or more methods to prioritize SRs, HTAs, or CGs for updating. We searched MEDLINE (PubMed, from 1966 to August 2016) and The Cochrane Methodology Register (The Cochrane Library, Issue 8 2016). We hand searched abstract books, reviewed reference lists, and contacted experts. Two reviewers independently screened the references and extracted data. Results We included 14 studies. Six studies were classified as descriptive (6 of 14, 42.9%) and eight as implementation studies (8 of 14, 57.1%). Six studies reported an updating strategy (6 of 14, 42.9%), six a prioritization process (6 of 14, 42.9%), and two a prioritization criterion (2 of 14, 14.2%). Eight studies focused on SRs (8 of 14, 57.1%), six studies focused on CGs (6 of 14, 42.9%), and none were about HTAs. We identified 76 prioritization criteria that can be applied when prioritizing documents for updating. The most frequently cited criteria were as follows: available evidence (19 of 76, 25.0%), clinical relevance (10 of 76; 13.2%), and users' interest (10 of 76; 13.2%). Conclusion There is wide variability and suboptimal reporting of the methods used to develop and implement processes to prioritize updating of SRs, HTAs, and CGs. more...

Objectives In systematic reviews of studies of patients' values and preferences, the objective of the study was to summarize items and domains authors have identified when considering the risk of bias (RoB) associated with primary studies. Study Design and Setting We conducted a systematic survey of systematic reviews of patients' values and preference studies. Our search included three databases (MEDLINE, EMBASE, and PsycINFO) from their inception to August 2015. We conducted duplicate data extraction, focusing on items that authors used to address RoB in the primary studies included in their reviews and the associated underlying domains, and summarized criteria in descriptive tables. Results We identified 42 eligible systematic reviews that addressed 23 items relevant to RoB and grouped the items into 7 domains: appropriate administration of instrument; instrument choice; instrument-described health state presentation; choice of participants group; description, analysis, and presentation of methods and results; patient understanding; and subgroup analysis. Conclusion The items and domains identified provide insight into issues of RoB in patients' values and preference studies and establish the basis for an instrument to assess RoB in such studies. more...

Background:Methods for the development of clinical guidelines have advanced dramatically over the past 2 decades to strive for trustworthiness, transparency, user-friendliness, and rigor. The American Society of Hematology (ASH) guidelines on venous thromboembolism (VTE) have followed these advances, together with application of methodological innovations.Objective:In this article, we describe methods and methodological innovations as a model to inform future guideline enterprises by ASH and others to achieve guideline standards. Methodological innovations introduced in the development of the guidelines aim to address current challenges in guideline development.Methods:We followed ASH policy for guideline development, which is based on the Guideline International Network (GIN)-McMaster Guideline Development Checklist and current best practices. Central coordination, specialist working groups, and expert panels were established for the development of 10 VTE guidelines. Methodological guidance resources were developed to guide the process across guidelines panels. A methods advisory group guided the development and implementation of methodological innovations to address emerging challenges and needs.Results:The complete set of VTE guidelines will include >250 recommendations. Methodological innovations include the use of health-outcome descriptors, online voting with guideline development software, modeling of pathways for diagnostic questions, application of expert evidence, and a template manuscript for publication of ASH guidelines. These methods advance guideline development standards and have already informed other ASH guideline projects.Conclusions:The development of the ASH VTE guidelines followed rigorous methods and introduced methodological innovations during guideline development, striving for the highest possible level of trustworthiness, transparency, user-friendliness, and rigor. more...

Dupilumab, a fully human monoclonal antibody against interleukin-4 receptor α, is approved as add-on maintenance treatment for inadequately controlled type 2 severe asthma. This systematic review evaluated the efficacy, safety and economic impact of dupilumab compared to standard of care for uncontrolled severe asthma. PubMed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important asthma-related outcomes were evaluated. The risk of bias and the certainty of the evidence were assessed using GRADE. Three RCTs including 2735 subjects >12 years old and 24-52 weeks of follow-up were included. Dupilumab reduced with high certainty severe asthma exacerbations (Incidence rate ratio 0.51; 95% CI 0.45-0.59) and the percentage use of oral corticosteroid use (mean difference (MD) -28.2 mg/d; 95% CI -40.7 to -15.7). Asthma control (ACQ-5), quality of life (AQLQ) and rescue medication use [puffs/d] improved, without reaching the minimal important clinical difference: ACQ-5 MD -0.28 (95% CI -0.39 to -0.17); AQLQ MD +0.28 (95% CI 0.20-0.37); and rescue medication MD -0.35 (95% CI -0.73 to +0.02). FEV1 increased (MD +0.15; 95% CI +0.11 to +0.18) (moderate certainty). There was an increased rate of dupilumab-related adverse events (AEs) (moderate certainty) and of drug-related serious AEs (low certainty). The incremental cost-effectiveness ratio of dupilumab versus standard therapy was 464 000$/QALY (moderate certainty). More data on long-term safety are needed both for children and for adults, together with more efficacy data in the paediatric population. more...

IntroductionPopulation ageing and increasing chronic illness burden have sparked interest in innovative care models. While self-management interventions (SMIs) are drawing increasing attention, evidence of their efficacy is mostly based on pairwise meta-analysis, generally derived from randomised controlled trials comparing interventions versus a control or no intervention. As such, relevant efficacy data for comparisons among different SMIs that can be applied to specific chronic conditions are missing. Therefore, the relevance of the available evidence for decision-making at clinical, organisational and policy levels is limited.AimTo identify, compare and rank the most effective and cost-effective SMIs for adults with four high-priority chronic conditions: type 2 diabetes, obesity, chronic obstructive pulmonary disease,and heart failure.Methods and analysisAll activities will be conducted as part of the cost-effectiveness of self-management interventions in four high-priority chronic conditions in Europe(COMPAR-EU, Comparing effectiveness of self-management interventions in 4 high priority chronic diseases inEurope) Project, an European Union (EU)-funded project designed to bridge the gap between current knowledge and practice on SMIs. In the first phase of the project, we will develop and validate a taxonomy, and a Core Outcome Set for each condition. These activities will inform a series of systematic review and network meta-analysis about the effectiveness of SMIs. We will also perform a cost-effectiveness analysis of the most effective SMIs and an evaluation of contextual factors. We will finally develop tailored decision-making tools for the different relevant stakeholders.Ethics and disseminationEthical approval was obtained from the local ethics committee (University Institute for Primary Care Research - IDIAP Jordi Gol). All patients and other stakeholders will provide informed consent prior to participation. This project has been funded by the EU Horizon 2020 research and innovation programme (grant agreement no. 754936). Results will be of interest to relevant stakeholder groups (patients, professionals, managers, policymakers and industry), and will be disseminated in a tailored multi-pronged approach that will include deployment of an interactive platform. more...

BACKGROUND: Postoperative atrial fibrillation (POAF) is associated with clinically significant short- and long-term complications after noncardiac surgery. Our aim was to describe the incidence of clinically important POAF after noncardiac surgery and establish the prognostic value of N-terminal pro–brain-type natriuretic peptide (NT-proBNP) in this context. METHODS: The Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study was a prospective cohort study involving patients aged 45 years and older who had inpatient noncardiac surgery that was performed between August 2007 and November 2013. We determined 30-day incidence of clinically important POAF (i.e., resulting in angina, congestive heart failure, symptomatic hypotension or requiring treatment) using logistic regression models to analyze the association between preoperative NT-proBNP and POAF. RESULTS: In 37 664 patients with no history of atrial fibrillation, we found that the incidence of POAF was 1.0% (95% confidence interval [CI] 0.9%–1.1%; 369 events); 3.2% (95% CI 2.3%–4.4%) in patients undergoing major thoracic surgery, 1.3% (95% CI 1.2%–1.5%) in patients undergoing major nonthoracic surgery and 0.2% (95% CI 0.1%–0.3%) in patients undergoing low-risk surgery. In a subgroup of 9789 patients with preoperative NT-proBNP measurements, the biomarker improved the prediction of POAF risk over conventional prognostic factors (likelihood ratio test p < 0.001; fraction of new information from NT-proBNP was 16%). Compared with a reference NT-proBNP measurement set at 100 ng/L, adjusted odds ratios for the occurrence of POAF were 1.31 (95% CI 1.15–1.49) at 200 ng/L, 2.07 (95% CI 1.27–3.36) at 1500 ng/L and 2.39 (95% CI 1.26–4.51) at 3000 ng/L. INTERPRETATION: We determined that the incidence of clinically important POAF after noncardiac surgery was 1.0%. We also found that preoperative NT-proBNP levels were associated with POAF independent of established prognostic factors. Trial registration: ClinicalTrials.gov, no. NCT00512109 more...