Randomized controlled trials in nursing conducted by Latin American research teams: A scoping review.

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.

A Framework for the Development of Living Practice Guidelines in Health Care.

BACKGROUND: Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence. OBJECTIVE: To develop a framework that characterizes the processes of development of living practice guidelines in health care. DESIGN: First, 3 background reviews were conducted: a scoping review of methods papers, a review of handbooks of guideline-producing organizations, and an analytic review of selected living practice guidelines. Second, the core team drafted the first version of the framework. Finally, the core team refined the framework through an online survey and online discussions with a multidisciplinary international group of stakeholders. SETTING: International. PARTICIPANTS: Multidisciplinary group of 51 persons who have experience with guidelines. MEASUREMENTS: Not applicable. RESULTS: A major principle of the framework is that the unit of update in a living guideline is the individual recommendation. In addition to providing definitions, the framework addresses several processes. The planning process should address the organization's adoption of the living methodology as well as each specific guideline project. The production process consists of initiation, maintenance, and retirement phases. The reporting should cover the evidence surveillance time stamp, the outcome of reassessment of the body of evidence (when applicable), and the outcome of revisiting a recommendation (when applicable). The dissemination process may necessitate the use of different venues, including one for formal publication. LIMITATION: This study does not provide detailed or practical guidance for how the described concepts would be best implemented. CONCLUSION: The framework will help guideline developers in planning, producing, reporting, and disseminating living guideline projects. It will also help research methodologists study the processes of living guidelines. PRIMARY FUNDING SOURCE: None.

Quality appraisal of clinical guidelines for recurrent urinary tract infections using AGREE II: a systematic review.

INTRODUCTION AND HYPOTHESIS: Recommendations for preventing and diagnosing recurrent urinary tract infection (UTI) tend to vary between clinical practice guidelines (CPGs) because of low-quality scientific evidence, potentially leading to practice variation and suboptimal care. We assessed the quality of existing CPGs for recurrent UTI. METHODS: A systematic search was performed from January 2000 to June 2021 in PubMed and EMBASE for CPGs on recurrent UTI prevention or hospital diagnostics in Dutch, English, and Spanish. Each CPG was assessed by four appraisers in a multidisciplinary review team, using the Appraisal of Guidelines, Research, and Evaluation II (AGREE II) instrument. RESULTS: We identified and assessed eight CPGs published between 2013 and 2021. The scope and purpose (mean and standard deviation: 67.3 ± 21.8) and clarity of presentation (74.8 ± 17.6) domains scored highly. However, issues with methods, patient participation, conflict of interests, and facilitators and barriers were common and resulted in lower scores for the rigour of development (56.9 ± 25.9), applicability (19.6 ± 23.4), stakeholder involvement (50.4 ± 24.6), and editorial independence (62.1 ± 23.1) domains. Overall, two CPGs were recommended, three were recommended with modifications, and three were not recommended. CONCLUSIONS: Significant room for improvement exists in the quality of CPGs for recurrent UTI, with most displaying serious limitations in the stakeholder involvement, rigour of development, and applicability domains. These aspects must be improved to decrease diagnostic and therapeutic uncertainty. Developers could benefit from using checklists and following guidelines when developing de novo CPGs.

Finding and evaluating randomised controlled trials in nursing conducted by Spanish research teams: A scoping review.

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.

Talking the same language on patient empowerment: Development and content validation of a taxonomy of self-management interventions for chronic conditions.

CONTEXT: The literature on self-management interventions (SMIs) is growing exponentially, but it is characterized by heterogeneous reporting that limits comparability across studies and interventions. Building an SMI taxonomy is the first step towards creating a common language for stakeholders to drive research in this area and promote patient self-management and empowerment. OBJECTIVE: To develop and validate the content of a comprehensive taxonomy of SMIs for long-term conditions that will help identify key characteristics and facilitate design, reporting and comparisons of SMIs. METHODS: We employed a mixed-methods approach incorporating a literature review, an iterative consultation process and mapping of key domains, concepts and elements to develop an initial SMI taxonomy that was subsequently reviewed in a two-round online Delphi survey with a purposive sample of international experts. RESULTS: The final SMI taxonomy has 132 components classified into four domains: intervention characteristics, expected patient/caregiver self-management behaviours, outcomes for measuring SMIs and target population characteristics. The two-round Delphi exercise involving 27 international experts demonstrated overall high agreement with the proposed items, with a mean score (on a scale of 1-9) per component of 8.0 (range 6.1-8.8) in round 1 and 8.1 (range 7.0-8.9) in round 2. CONCLUSIONS: The SMI taxonomy contributes to building a common framework for the patient self-management field and can help implement and improve patient empowerment and facilitate comparative effectiveness research of SMIs. Patient or public contribution. Patients' representatives contributed as experts in the Delphi process and as partners of the consortium.

Vitamin D recommendations in clinical guidelines: A systematic review, quality evaluation and analysis of potential predictors.

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 to 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 = .001 and 58.3 vs 37.5; P = .02). Guidance produced by government organisations 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 = .034). Editorial independence was an independent predictor for recommending or suggesting vitamin D supplementation (OR 1.09; CI95% 1.02 to 1.16; P = .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 organisations 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.

Feeding modifications and additional primary caregiver support for infants exposed to Zika virus or diagnosed with congenital Zika syndrome: a rapid review of the evidence.

OBJECTIVE: Infants exposed to Zika virus (ZIKV) or diagnosed with congenital Zika syndrome (CZVS) may present dysphagia, regurgitation and other feeding difficulties. They may require special feeding practices to minimise the risk of mortality, morbidity and developmental problems. Improving knowledge, skills and behaviours of caregivers may preserve health, maximise development and promote quality of life among affected infants. We reviewed intervention studies of modified feeding practices and additional primary caregiver support to improve outcomes among infants 0 to 12 months of age exposed to ZIKV or diagnosed with CZVS. METHODS: Rapid review and meta-analysis. We searched PubMed/MEDLINE and contacted experts. The search is current to 18 July 2020. We planned a meta-analysis using fixed-effect models; if unfeasible, we intended to summarise studies narratively. We planned to assess risk of bias of included studies and quality of evidence using Cochrane guidance. RESULTS: We identified 42 records for title and abstract screening; 14 were eligible for full-text assessment. Among these, no intervention studies were found. Eight observational studies reported on the nutritional status, feeding practices and outcomes among infants affected by ZIKV or diagnosed with CZVS. They are presented and discussed to provide a basis for future research. CONCLUSIONS: While no intervention studies were found, evidence from eight observational studies highlights the need for early nutrition interventions and caregiver support among infants affected by ZIKV or diagnosed with CZSV. More research is needed to assess whether modifications of feeding practices and provision of additional primary caregiver support will impact outcomes of interest.

OBJECTIF: Les nourrissons exposés au virus Zika (VZIK) ou diagnostiqués avec le syndrome congénital Zika (SCZ) peuvent présenter une dysphagie, des régurgitations et d'autres difficultés d'alimentation. Ils peuvent nécessiter des pratiques alimentaires spéciales pour minimiser le risque de mortalité, de morbidité et de problèmes de développement. L'amélioration des connaissances, des compétences et des comportements des soignants peut préserver la santé, maximiser le développement et promouvoir la qualité de vie des nourrissons affectés. Nous avons examiné les études d'intervention sur les pratiques d'alimentation modifiées et le soutien additionnel aux principaux soignants pour améliorer les résultats chez les nourrissons de 0 à 12 mois exposés au VZIK ou diagnostiqués avec le SCZ. MÉTHODES: Revue rapide et méta-analyse. Nous avons effectué des recherches dans PubMed/MEDLINE et contacté des experts. La recherche a été mise à jour au 18 juillet 2020. Nous avons prévu une méta-analyse utilisant des modèles à effets fixes; si cela n'était pas réalisable, nous avions l'intention de résumer les études de manière narrative. Nous avons prévu d'évaluer le risque de biais des études incluses et la qualité des données en utilisant les directives Cochrane. RÉSULTATS: Nous avons identifié 42 reports pour la recherche des titres et des résumés; 14 étaient éligibles pour une évaluation en texte intégral. Parmi ceux-ci, aucune étude d'intervention n'a été trouvée. Huit études observationnelles ont rapporté sur l'état nutritionnel, les pratiques d'alimentation et les résultats chez les nourrissons atteints du VZIK ou diagnostiqués avec le SCZ. Elles sont présentées et discutées pour fournir une base pour les futures recherches. CONCLUSIONS: Bien qu'aucune étude d'intervention n'ait été trouvée, les données de huit études observationnelles mettent en évidence la nécessité d'interventions nutritionnelles précoces et de soutien des soignants des nourrissons atteints de VZIK ou diagnostiqués avec le SCZ. Des recherches supplémentaires sont nécessaires pour évaluer si les modifications des pratiques d'alimentation et la fourniture d'un soutien additionnel aux principaux soignants auront un impact sur les résultats d'intérêt.

Systematic review on women's values and preferences concerning breast cancer screening and diagnostic services.

BACKGROUND: There is still lack of consensus on the benefit-harm balance of breast cancer screening. In this scenario, women's values and preferences are crucial for developing health-related recommendations. In the context of the European Commission Initiative on Breast Cancer, we conducted a systematic review to inform the European Breast Guidelines. METHODS: We searched Medline and included primary studies assessing women's values and preferences regarding breast cancer screening and diagnosis decision making. We used a thematic approach to synthesise relevant data. The quality of evidence was determined with GRADE, including GRADE CERQual for qualitative research. RESULTS: We included 22 individual studies. Women were willing to accept the psychological and physical burden of breast cancer screening and a significant risk of overdiagnosis and false-positive mammography findings, in return for the benefit of earlier diagnosis. The anxiety engendered by the delay in getting results of diagnostic tests was highlighted as a significant burden, emphasising the need for rapid and efficient screening services, and clear and efficient communication. The confidence in the findings was low to moderate for screening and moderate for diagnosis, predominantly because of methodological limitations, lack of adequate understanding of the outcomes by participants, and indirectness. CONCLUSIONS: Women value more the possibility of an earlier diagnosis over the risks of a false-positive result or overdiagnosis. Concerns remain that women may not understand the concept of overdiagnosis. Women highly value time efficient screening processes and rapid result delivery and will accept some discomfort for the peace of mind screening may provide.

A systematic review of how patients value COPD outcomes.

Our objective was to summarise systematically all research evidence related to how patients value outcomes in chronic obstructive pulmonary disease (COPD).We conducted a systematic review (systematic review registration number CRD42015015206) by searching PubMed, Embase, PsycInfo and CINAHL, and included reports that assessed the relative importance of outcomes from COPD patients' perspective. Two authors independently determined the eligibility of studies, abstracted the eligible studies and assessed risk of bias. We narratively summarised eligible studies, meta-analysed utilities for individual outcomes and assessed the certainty of evidence using the Grading of Recommendations, Assessment, Development and Evaluations approach.We included 217 quantitative studies. Investigators most commonly used utility measurements of outcomes (n=136), discrete choice exercises (n=13), probability trade-off (n=4) and forced choice techniques (n=46). Patients rated adverse events as important but on average, less so than symptom relief. Exacerbation and hospitalisation due to exacerbation are the outcomes that COPD patients rate as most important. This systematic review provides a comprehensive registry of related studies.

Interventions for infantile haemangiomas of the skin.

BACKGROUND: Infantile haemangiomas (previously known as strawberry birthmarks) are soft, raised swellings of the skin that occur in 3% to 10% of infants. These benign vascular tumours are usually uncomplicated and tend to regress spontaneously. However, when haemangiomas occur in high-risk areas, such as near the eyes, throat, or nose, impairing their function, or when complications develop, intervention may be necessary. This is an update of a Cochrane Review first published in 2011. OBJECTIVES: To assess the effects of interventions for the management of infantile haemangiomas in children. SEARCH METHODS: We updated our searches of the following databases to February 2017: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, LILACS, and CINAHL. We also searched five trials registries and checked the reference lists of included studies for further references to relevant trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) of all types of interventions, versus placebo, active monitoring, or other interventions, in any child with single or multiple infantile haemangiomas (IHs) located on the skin. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. The primary outcome measures were clearance, a subjective measure of improvement, and adverse events. Secondary outcomes were other measures of resolution; proportion of parents or children who consider there is still a problem; aesthetic appearance; and requirement for surgical correction. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. MAIN RESULTS: We included 28 RCTs, with a total of 1728 participants, assessing 12 different interventions, including lasers, beta blockers (e.g. propranolol, timolol maleate), radiation therapy, and steroids. Comparators included placebo, an active monitoring approach, sham radiation, and interventions given alone or in combination.Studies were conducted in a number of countries, including China, Egypt, France, and Australia. Participant age ranged from 12 weeks to 13.4 years. Most studies (23/28) included a majority of females and different types of IHs. Duration of follow-up ranged from 7 days to 72 months.We considered most of the trials as at low risk of random sequence generation, attrition bias, and selective reporting bias. Domains such as allocation concealment and blinding were not clearly reported in general. We downgraded evidence for issues related to risk of bias and imprecision.We report results for the three most important comparisons, which we chose on the basis of current use. Outcome measurement of these comparisons was at 24 weeks' follow-up.Oral propranolol versus placeboCompared with placebo, oral propranolol 3 mg/kg/day probably improves clinician-assessed clearance (risk ratio (RR) 16.61, 95% confidence interval (CI) 4.22 to 65.34; 1 study; 156 children; moderate-quality evidence) and probably leads to a clinician-assessed reduction in mean haemangioma volume of 45.9% (95% CI 11.60 to 80.20; 1 study; 40 children; moderate-quality evidence). We found no evidence of a difference in terms of short- or long-term serious adverse events (RR 1.05, 95% CI 0.33 to 3.39; 3 studies; 509 children; low-quality evidence), nor in terms of bronchospasm, hypoglycaemia, or serious cardiovascular adverse events. The results relating to clearance and resolution for this comparison were based on one industry-sponsored study.Topical timolol maleate versus placeboThe chance of reduction of redness, as a measure of clinician-assessed resolution, may be improved with topical timolol maleate 0.5% gel applied twice daily when compared with placebo (RR 8.11, 95% CI 1.09 to 60.09; 1 study; 41 children;low-quality evidence). Regarding short- or long-term serious cardiovascular events, we found no instances of bradycardia (slower than normal heart rate) or hypotension in either group (1 study; 41 children; low-quality evidence). No other safety data were assessed, and clearance was not measured.Oral propranolol versus topical timolol maleateWhen topical timolol maleate (0.5% eye drops applied twice daily) was compared with oral propranolol (via a tablet taken once per day, at a 1.0 mg/kg dose), there was no evidence of a difference in haemangioma size (as a measure of resolution) when measured by the proportion of patients with a clinician-assessed reduction of 50% or greater (RR 1.13, 95% CI 0.64 to 1.97; 1 study; 26 participants; low-quality evidence). Although there were more short- or long-term general adverse effects (such as severe diarrhoea, lethargy, and loss of appetite) in the oral propranolol group, there was no evidence of a difference between groups (RR 7.00, 95% CI 0.40 to 123.35; 1 study; 26 participants; very low-quality evidence). This comparison did not measure clearance.None of our key comparisons evaluated, at any follow-up, a subjective measure of improvement assessed by the parent or child; proportion of parents or children who consider there is still a problem; or physician-, child-, or parent-assessed aesthetic appearance. AUTHORS' CONCLUSIONS: We found there to be a limited evidence base for the treatment of infantile haemangiomas: a large number of interventions and outcomes have not been assessed in RCTs.Our key results indicate that in the management of IH in children, oral propranolol and topical timolol maleate are more beneficial than placebo in terms of clearance or other measures of resolution, or both, without an increase in harms. We found no evidence of a difference between oral propranolol and topical timolol maleate with regard to reducing haemangioma size, but we are uncertain if there is a difference in safety. Oral propranolol is currently the standard treatment for this condition, and our review has not found evidence to challenge this. However, these results are based on moderate- to very low-quality evidence.The included studies were limited by small sample sizes and risk of bias in some domains. Future trials should blind personnel and participants; describe trials thoroughly in publications; and recruit a sufficient number of children to deduce meaningful results. Future trials should assess patient-reported outcomes, as well as objective outcomes of benefit, and should report adverse events comprehensively. Propranolol and timolol maleate require further assessment in RCTs of all types of IH, including those considered problematic, as do other lesser-used interventions and new interventions. All treatments should be compared against propranolol and timolol maleate, as beta blockers are approved as standard care.

Identification and description of controlled clinical trials in Spanish language dental journals.

BACKGROUND: To identify controlled clinical trials (CCTs) published in Spanish and in Latin American dental journals, and provide access to this body of evidence in a single source. METHODS: Handsearching, following Cochrane Collaboration guidelines, of CCTs published in Spanish dental journals from Spain and Latin America. For each eligible trial, we collected the dental specialty, the interventions evaluated, whether and how randomisation was achieved, and the corresponding bibliographic reference. RESULTS: We handsearched 107 journals published in Spain and Latin America in Spanish. Over 17 051 articles, 244 (1.43%) were CCTs. These studies focused mainly on periodontics (70, 29.0%) and oral and maxillofacial surgery (66, 27.0%), assessing mostly pharmacological interventions (112, 46.0%). One hundred fifty-three studies (62.7%) used a random allocation of participants to study arms. CONCLUSIONS: A significant number of dental journals published in Spain and Latin America in Spanish language present original research relevant to inform clinical practice. These journals are not indexed in the major electronic databases. PRACTICAL IMPLICATIONS: References to the identified CCTs are now available in CENTRAL, the Cochrane Collaboration repository for these studies. We call for adherence to the CONSORT statement in dentistry to improve reporting of CCTs in journals published in Spanish language.

Evidence mapping based on systematic reviews of therapeutic interventions for gastrointestinal stromal tumors (GIST).

BACKGROUND: Gastrointestinal Stromal Tumours (GISTs) are the most common mesenchymal tumours. Currently, different pharmacological and surgical options are used to treat localised and metastatic GISTs, although this research field is broad and the body of evidence is scattered and expanding. Our objectives are to identify, describe and organise the current available evidence for GIST through an evidence mapping approach. METHODS: We followed the methodology of Global Evidence Mapping (GEM). We searched Pubmed, EMBASE, The Cochrane Library and Epistemonikos in order to identify systematic reviews (SRs) with or without meta-analyses published between 1990 and March 2016. Two authors assessed eligibility and extracted data. Methodological quality of the included systematic reviews was assessed using AMSTAR. We organised the results according to identified PICO questions and presented the evidence map in tables and a bubble plot. RESULTS: A total of 17 SRs met eligibility criteria. These reviews included 66 individual studies, of which three quarters were either observational or uncontrolled clinical trials. Overall, the quality of the included SRs was moderate or high. In total, we extracted 14 PICO questions from them and the corresponding results mostly favoured the intervention arm. CONCLUSIONS: The most common type of study used to evaluate therapeutic interventions in GIST sarcomas has been non-experimental studies. However, the majority of the interventions are reported as beneficial or probably beneficial by the respective authors of SRs. The evidence mapping is a useful and reliable methodology to identify and present the existing evidence about therapeutic interventions.

Development and use of a content search strategy for retrieving studies on patients' views and preferences.

BACKGROUND: Identifying scientific literature addressing patients' views and preferences is complex due to the wide range of studies that can be informative and the poor indexing of this evidence. Given the lack of guidance we developed a search strategy to retrieve this type of evidence. METHODS: We assembled an initial list of terms from several sources, including the revision of the terms and indexing of topic-related studies and, methods research literature, and other relevant projects and systematic reviews. We used the relative recall approach, evaluating the capacity of the designed search strategy for retrieving studies included in relevant systematic reviews for the topic. We implemented in practice the final version of the search strategy for conducting systematic reviews and guidelines, and calculated search's precision and the number of references needed to read (NNR). RESULTS: We assembled an initial version of the search strategy, which had a relative recall of 87.4% (yield of 132/out of 151 studies). We then added some additional terms from the studies not initially identified, and re-tested this improved version against the studies included in a new set of systematic reviews, reaching a relative recall of 85.8% (151/out of 176 studies, 95% CI 79.9 to 90.2). This final version of the strategy includes two sets of terms related with two domains: "Patient Preferences and Decision Making" and "Health State Utilities Values". When we used the search strategy for the development of systematic reviews and clinical guidelines we obtained low precision values (ranging from 2% to 5%), and the NNR from 20 to 50. CONCLUSIONS: This search strategy fills an important research gap in this field. It will help systematic reviewers, clinical guideline developers, and policy-makers to retrieve published research on patients' views and preferences. In turn, this will facilitate the inclusion of this critical aspect when formulating heath care decisions, including recommendations.

Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults.

BACKGROUND: Inadvertent perioperative hypothermia is a phenomenon that can occur as a result of the suppression of the central mechanisms of temperature regulation due to anaesthesia, and of prolonged exposure of large surfaces of skin to cold temperatures in operating rooms. Inadvertent perioperative hypothermia has been associated with clinical complications such as surgical site infection and wound-healing delay, increased bleeding or cardiovascular events. One of the most frequently used techniques to prevent inadvertent perioperative hypothermia is active body surface warming systems (ABSW), which generate heat mechanically (heating of air, water or gels) that is transferred to the patient via skin contact. OBJECTIVES: To assess the effectiveness of pre- or intraoperative active body surface warming systems (ABSW), or both, to prevent perioperative complications from unintended hypothermia during surgery in adults. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 9, 2015); MEDLINE (PubMed) (1964 to October 2015), EMBASE (Ovid) (1980 to October 2015), and CINAHL (Ovid) (1982 to October 2015). SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared an ABSW system aimed at maintaining normothermia perioperatively against a control or against any other ABSW system. Eligible studies also had to include relevant clinical outcomes other than measuring temperature alone. DATA COLLECTION AND ANALYSIS: Several authors, by pairs, screened references and determined eligibility, extracted data, and assessed risks of bias. We resolved disagreements by discussion and consensus, with the collaboration of a third author. MAIN RESULTS: We included 67 trials with 5438 participants that comprised 79 comparisons. Forty-five RCTs compared ABSW versus control, whereas 18 compared two different types of ABSW, and 10 compared two different techniques to administer the same type of ABSW. Forced-air warming (FAW) was by far the most studied intervention.Trials varied widely regarding whether the interventions were applied alone or in combination with other active (based on a different mechanism of heat transfer) and/or passive methods of maintaining normothermia. The type of participants and surgical interventions, as well as anaesthesia management, co-interventions and the timing of outcome measurement, also varied widely. The risk of bias of included studies was largely unclear due to limitations in the reports. Most studies were open-label, due to the nature of the intervention and the fact that temperature was usually the principal outcome. Nevertheless, given that outcome measurement could have been conducted in a blinded manner, we rated the risk of detection and performance bias as high.The comparison of ABSW versus control showed a reduction in the rate of surgical site infection (risk ratio (RR) 0.36, 95% confidence interval (CI) 0.20 to 0.66; 3 RCTs, 589 participants, low-quality evidence). Only one study at low risk of bias observed a beneficial effect with forced-air warming on major cardiovascular complications (RR 0.22, 95% CI 0.05 to 1.00; 1 RCT with 12 events, 300 participants, low-quality evidence) in people at high cardiovascular risk. We found no beneficial effect for mortality. ABSW also reduced blood loss during surgery but the magnitude of this effect seems to be irrelevant (MD -46.17 mL, 95% CI -82.74 to -9.59; I² = 78%; 20 studies, 1372 participants). The same conclusion applies to total fluids infused during surgery (MD -144.49 mL, 95% CI -221.57 to -67.40; I² = 73%; 24 studies, 1491 participants). These effects did not translate into a significant reduction in the number of participants being transfused or the average amount of blood transfused. ABSW was associated with a reduction in shivering (RR 0.39, 95% CI 0.28 to 0.54; 29 studies, 1922 participants) and in thermal comfort (standardized mean difference (SMD) 0.76, 95% CI 0.29 to 1.24; I² = 77%, 4 trials, 364 participants).For the comparison between different types of ABSW system or modes of administration of a particular type of ABSW, we found no evidence for the superiority of any system in terms of clinical outcomes, except for extending systemic warming to the preoperative period in participants undergoing major abdominal surgery (one study at low risk of bias).There were limited data on adverse effects (the most relevant being thermal burns). While some trials included a narrative report mentioning that no adverse effects were observed, the majority made no reference to it. Nothing so far suggests that ABSW involves a significant risk to patients. AUTHORS' CONCLUSIONS: Forced-air warming seems to have a beneficial effect in terms of a lower rate of surgical site infection and complications, at least in those undergoing abdominal surgery, compared to not applying any active warming system. It also has a beneficial effect on major cardiovascular complications in people with substantial cardiovascular disease, although the evidence is limited to one study. It also improves patient's comfort, although we found high heterogeneity among trials. While the effect on blood loss is statistically significant, this difference does not translate to a significant reduction in transfusions. Again, we noted high heterogeneity among trials for this outcome. The clinical relevance of blood loss reduction is therefore questionable. The evidence for other types of ABSW is scant, although there is some evidence of a beneficial effect in the same direction on chills/shivering with electric or resistive-based heating systems. Some evidence suggests that extending systemic warming to the preoperative period could be more beneficial than limiting it only to during surgery. Nothing suggests that ABSW systems pose a significant risk to patients.The difficulty in observing a clinically-relevant beneficial effect with ABSW in outcomes other than temperature may be explained by the fact that many studies applied concomitant procedures that are routinely in place as co-interventions to prevent hypothermia, whether passive or active warming systems based in other physiological mechanisms (e.g. irrigation fluid or gas warming), as well as a stricter control of temperature in the context of the study compared with usual practice. These may have had a beneficial effect on the participants in the control group, leading to an underestimation of the net benefit of ABSW.

Exercise for people with high cardiovascular risk.

BACKGROUND: When two or more cardiovascular risk factors occur in one individual, they may interact in a multiplicative way promoting cardiovascular disease. Exercise has proven to be effective in controlling individual risk factors but its effect on overall cardiovascular risk remains uncertain. OBJECTIVES: To assess the effects of exercise training in people with increased cardiovascular risk but without a concurrent cardiovascular disease on general cardiovascular mortality, incidence of cardiovascular events, and total cardiovascular risk. SEARCH METHODS: A search was conducted in CENTRAL (The Cochrane Library 2013, Issue 10 of 12), Ovid MEDLINE (1946 to week 2 November 2013), EMBASE Classic + EMBASE via Ovid (1947 to Week 47 2013), CINAHL Plus with Full Text via EBSCO (to November 2013), Science Citation Index Expanded (SCI-EXPANDED) (1970 to 22 November 2013), and Conference Proceedings Citation Index - Science (CPCI-S) (1990 to 22 November 2013) on Web of Science (Thomson Reuters). We did not apply any date or language restrictions. SELECTION CRITERIA: Randomized clinical trials comparing aerobic or resistance exercise training versus no exercise or any standard approach that does not include exercise. Participants had to be 18 years of age or older with an average 10-year Framingham risk score of 10% for cardiovascular disease over 10 years, or with two or more cardiovascular risk factors, and no history of cardiovascular disease. DATA COLLECTION AND ANALYSIS: The selection of studies and subsequent data collection process were conducted by two independent authors. Disagreements were solved by consensus. The results were reported descriptively. It was not possible to conduct a meta-analysis because of the high heterogeneity and high risk of bias in the included studies. MAIN RESULTS: A total of four studies were included that involved 823 participants, 412 in the exercise group and 411 in the control group. Follow-up of participants ranged from 16 weeks to 6 months. Overall, the included studies had a high risk of selection, detection, and attrition bias. Meta-analysis was not possible because the interventions (setting, type and intensity of exercise) and outcome measurements were not comparable, and the risk of bias in the identified studies was high. No study assessed cardiovascular or all­cause mortality or cardiovascular events as individual outcomes. One or more of the studies reported on total cardiovascular risk, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol, blood pressure, body mass index, exercise capacity, and health-related quality of life but the available evidence was not sufficient to determine the effectiveness of exercise. Adverse events and smoking cessation were not assessed in the included studies. AUTHORS' CONCLUSIONS: Evidence to date is entirely limited to small studies with regard to sample size, short-term follow-up, and high risk of methodological bias, which makes it difficult to derive any conclusions on the efficacy or safety of aerobic or resistance exercise on groups with increased cardiovascular risk or in individuals with two or more coexisting risk factors. Further randomized clinical trials assessing controlled exercise programmes on total cardiovascular risk in individuals are warranted.

The life and death of living systematic reviews: a methodological survey.

OBJECTIVES: The objectives of this study are to describe the characteristics of living systematic reviews (LSRs) and to understand their life cycles. STUDY DESIGN AND SETTING: We conducted a comprehensive search up to April 2021 then selected articles and abstracted data in duplicate and independently. We undertook descriptive analyses and calculated delay in version update and delay since the last published version. RESULTS: We included 76 eligible LSRs with a total of 279 eligible versions. The majority of LSRs was from the clinical field (70%), was COVID-19 related (63%), and had a funding source specified (62%). The median number of versions per LSR was 2 (interquartile range (IQR) 1-4; range 1-19). The median and IQR for the ratio of the actual period of update to the planned period of update was 1.12 (0.81; 1.71). Out of all reviews with a 'planned period of update' and at least one update (N = 19), eight LSRs (42%) had a period since last published version greater than 3 times the planned period of update. No LSR included a 'retirement notice' in their latest published version. CONCLUSION: While most LSR complied with the planned period of producing updates, a substantive proportion lagged since their last update.

Stakeholder views of services for children and adolescents with obesity: Mega-ethnography of qualitative syntheses.

OBJECTIVE: The efficacy of services for children and adolescents with obesity is well researched, but this review describes what actually matters to stakeholders (children, caregivers, and professionals) in relation to such services. METHODS: A mega-ethnography, an innovative review-of-reviews approach that uses conceptual findings as primary data, was performed. Twelve bibliographic databases (2010-2020) were searched for reviews that considered the values and preferences of stakeholders concerning services or interventions (diet, exercise, lifestyle) that targeted children and adolescents with obesity. RESULTS: From 485 citations, 17 relevant reviews were identified. The synthesis found that the perceived need to address obesity is determined by subjective norms of weight and interactions with health professionals. Children's and caregivers' participation in obesity management services is shaped by their response to content, acceptability, and perceived benefits and demands. Whether they continue with and complete an intervention are determined by its perceived success, beyond just weight loss, including behavior change, enhanced self-esteem, and the provision of timely and relevant support. CONCLUSIONS: Obesity management services must be promoted in a sensitive manner and must be tailored, be varied, and make positive use of family and schools if children and caregivers are to seek and actively engage with them.

Theoretical approaches to the engagement with patients in case-management programmes and assertive outreach teams: A systematic review of the literature.

WHAT IS KNOWN ON THE SUBJECT?: It is generally accepted that all interventions carried out by mental health nurses involve engagement with the patient; this engagement is a process that is gradually constructed and is not immediate. In Spain during last decade, nurses working in assertive outreach teams have gradually replaced the traditional institutional setting in favour of environments that are more familiar to the patient. In contrast, when patients and nurses interact outside institutional settings, a new approach and skillset is required in order to adapt to the new environment. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: We have systematically identified and assessed the available evidence on how nurses work in assertive outreach team programmes. The therapeutic link is not just assistance; it is actually a construct, which is established between nurse and patient, with the aim of favouring, fostering and strengthening the therapeutic relationship. Only a few studies have discussed the nurse-patient therapeutic link in assertive outreach services. However, it seems important that nurses use a standardized language, that is, a language promoted as a model of correct use and used for functions of greater prestige, especially in public administration and teaching, to integrate it into the theoretical framework. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: With the synthesis that we present, we hope that it promote a more consistent use of the engagement concept in research on this topic. In turn, this will enhance staff support and training and will foster evidence-based practice. The conceptualization of nursing language and its use by professionals helps to improve practice and the lack of a theoretical framework with a nurse perspective. It is necessary to establish a consensus between mental health nurses around the engagement' meaning in the programmes of assertive outreach teams. ABSTRACT: Introduction During last decade in Spain, nurses working in assertive outreach programmes have replaced the traditional institutional setting in favour of the patient's own environment. Engagement with patients requires a different skillset when the axis of the nurse-patient interaction is the patient's own environment. The engagement alone could be associated with the innate concept of patient's care and the helping relationship. However, in the individualized care models, the engagement seems to be an instrument with its own characteristics for the purpose of providing mental health care. Aim/Question To systematically identify and assess the empirical evidence on the relationships and engagement between patients with mental illness (schizophrenia, psychotic disorders, schizoaffective disorders, mood disorders and disorders of adult personality) and nursing mental health nurses. Method Systematic literature review based on PRISMA guidance. Results We identified and reviewed seven primary research studies. Following the analytic processes, three themes emerged: existence of different engagement levels, training needs and skills in the creation and consolidation of the engagement, and engagement as process. Discussion The engagement of nurse and patient is understood as a process that incorporates different stages. Whilst it is established, the engagement is subject to positive and negative influences. For the creation of the engagement and its maintenance specialized skills, knowledge and personal attributes (resilience, psychosocial skills, compressive knowledge of mental health illnesses, capacity to build effective relationships, adaptability and problem-solving) are necessary, but the main focus is on context where it develops, selected by the patient himself, for example, his home. Implications for Practice Administrators may have questions about appropriate hiring practices for assertive outreach teams since certain skills are necessary to obtain un engagement process, and staff training should be considered a key issue to provide specific skills for enhancing engagement and the therapeutic relationship. Conclusion The engagement must be understood as a long-term process. For the creation of the engagement and its maintenance, specialized skills, knowledge and personal attributes are necessary.

GRADE summary of findings tables enhanced understanding of values and preferences evidence.

OBJECTIVES: We conceptualize patient values and preferences as the relative importance of health outcomes (RIO) which are often obtained through utility elicitation research. A transparent and structured approach to present synthesized RIO evidence and the certainty of this evidence is needed. This study aims to adapt the summary of findings (SoF) table to describe the RIO. STUDY DESIGN AND SETTING: We performed three interactive workshops with a protype version of the SoF table for RIO, evidence adapted from the SoF table for intervention effects. We then tested the new format through semi-structured interviews with professionals who interpret RIO evidence (e.g., systematic review authors and guideline developers). RESULTS: We adapted the SoF table for the presentation of RIO evidence. This SoF table may be easy to use, but bears one risk: some participants misunderstood the utility information and the variability around the RIO. We added a visual analogue scale to clarify the concept of utilities. CONCLUSION: Through a multi-stage process including brainstorming sessions and interviews, we adapted the SoF table to present RIO evidence. This table may enhance understanding of evidence synthesis of values and preferences, facilitating the incorporation of this type of evidence in decision-making.