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The essence of clinical practice guidelines lies in their recommendations. It is common to find strong recommendations supported by low-quality evidence in current published guidelines. There is a typical misunderstanding among medical professionals that without high-quality evidence, it is impossible to develop high-quality guidelines or only expert consensus can be developed. Based on the GRADE approach, this paper explains the concept and clinical significance of low-quality evidence, and introduces the methods for formulating recommendations based on low-quality evidence in guidelines, with the aim to provide reference for guideline developers and users in China.

Abstract Objective This study aimed to evaluate the effectiveness of massage for postoperative rehabilitation after total knee arthroplasty (TKA). Data sources The PubMed, Web of Science, EMBASE, Cochrane Library, and China National Knowledge Infrastructure (CNKI) databases were systematically searched from inception to May 2024. Study selection Any randomized controlled trials on the use of massage for postoperative TKA rehabilitation were included. Data extraction A meta-analysis of outcomes, including postoperative pain, knee range of motion (ROM), postoperative D-dimer levels, and length of hospital stay, was performed. The Cochrane Risk of Bias Assessment Tool was used to assess the risk of bias, and the data for each included study were extracted independently by two researchers. Data synthesis Eleven randomized controlled clinical trials with 940 subjects were included. The results showed that compared with the control group, the massage group experienced more significant pain relief on the 7th, 14th and 21st days after the operation. Moreover, the improvement in knee ROM was more pronounced on postoperative days 7 and 14. In addition, the massage group reported fewer adverse events. However, there was no statistically significant difference in the reduction in postoperative D-dimer levels between the patients and controls. Subgroup analysis revealed that massage shortened the length of hospital stay for postoperative patients in China but not significantly for patients in other regions. Nevertheless, the heterogeneity of the studies was large. Conclusions Increased massage treatment was more effective at alleviating pain and improving knee ROM in early post-TKA patients. However, massage did not perform better in reducing D-dimer levels in patients after TKA. Based on the current evidence, massage can be used as an adjunctive treatment for rehabilitation after TKA.

Objective: This study aimed to evaluate the effectiveness of massage for postoperative rehabilitation after total knee arthroplasty (TKA). Data sources: The PubMed, Web of Science, EMBASE, Cochrane Library, and China National Knowledge Infrastructure (CNKI) databases were systematically searched from inception to May 2024. Study selection: Any randomized controlled trials on the use of massage for postoperative TKA rehabilitation were included. Data extraction: A meta-analysis of outcomes, including postoperative pain, knee range of motion (ROM), postoperative D-dimer levels, and length of hospital stay, was performed. The Cochrane Risk of Bias Assessment Tool was used to assess the risk of bias, and the data for each included study were extracted independently by two researchers. Data synthesis: Eleven randomized controlled clinical trials with 940 subjects were included. The results showed that compared with the control group, the massage group experienced more significant pain relief on the 7th, 14th and 21st days after the operation. Moreover, the improvement in knee ROM was more pronounced on postoperative days 7 and 14. In addition, the massage group reported fewer adverse events. However, there was no statistically significant difference in the reduction in postoperative D-dimer levels between the patients and controls. Subgroup analysis revealed that massage shortened the length of hospital stay for postoperative patients in China but not significantly for patients in other regions. Nevertheless, the heterogeneity of the studies was large. Conclusions: Increased massage treatment was more effective at alleviating pain and improving knee ROM in early post-TKA patients. However, massage did not perform better in reducing D-dimer levels in patients after TKA. Based on the current evidence, massage can be used as an adjunctive treatment for rehabilitation after TKA. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) have traditionally been considered the gold standard for medical evidence. However, in light of emerging methodologies in data science, many experts question the role of RCTs. Within this context, experts in the USA and Canada came together to debate whether the primacy of RCTs as the gold standard for medical evidence, still holds in light of recent methodological advances in data science and in the era of big data. The purpose of this manuscript, aims to raise awareness of the pros and cons of RCTs and observational studies in order to help guide clinicians, researchers, students, and decision-makers in making informed decisions on the quality of medical evidence to support their work. In particular, new and underappreciated advantages and disadvantages of both designs are contrasted. Innovations taking place in both of these research methodologies, which can blur the lines between the two, are also discussed. Finally, practical guidance for clinicians and future directions in assessing the quality of evidence is offered. [ABSTRACT FROM AUTHOR]

Objective: This narrative review was performed to evaluate the correct timing of umbilical cord clamping for term infants. It was intended to determine any advantages or disadvantages from early or delayed cord clamping for newborns, infants or mothers. Methods: A systematic search on two databases was conducted using the PICO pattern to define a wide search. Out of 43 trials, 12 were included in this review. Three of the included studies are meta-analyses, nine are randomized controlled trials. Results: Early or delayed cord clamping was defined differently in all the included trials. However, there are many advantages from delayed cord clamping of at least > 60 s for newborns and infants up to 12 months of age. The trials showed no disadvantages for newborns or mothers from delayed cord clamping, except for a lightly increased risk of jaundice or the need for phototherapy. Conclusion: Delayed umbilical cord clamping for term infants should be performed. Further research is needed to improve knowledge on physiological timing of umbilical cord clamping in term infants, which also leads to the same advantages as delayed cord clamping. [ABSTRACT FROM AUTHOR]

Abstract Background The evaluation of clinical evidence takes account of health benefit (efficacy and safety) and the degree of certainty in the estimate of benefit. In orphan indications practical and ethical challenges in conducting clinical trials, particularly in paediatric patients, often limit the available evidence, rendering structured evaluation challenging. While acknowledging the paucity of evidence, regulators and reimbursement authorities compare the efficacy and safety of alternative treatments for a given indication, often in the context of the benefits of other treatments for similar or different conditions. This study explores the feasibility of using the Institute for Clinical and Economic Review (ICER) Evidence Rating Matrix for Comparative Clinical Effectiveness in structured assessment of both the magnitude of clinical benefit (net health benefit, NHB) and the certainty of the effect estimate in a sample of orphan therapies for paediatric indications. Results Eleven systemic therapies with European Medicines Agency (EMA) orphan medicinal product designation, licensed for 16 paediatric indications between January 2017 and March 2020 were identified using OrphaNet and EMA databases and were selected for evaluation with the ICER Evidence Rating Matrix: burosumab; cannabidiol; cerliponase alfa; chenodeoxycholic acid (CDCA); dinutuximab beta; glibenclamide; metreleptin; nusinersen; tisagenlecleucel; velmanase alfa; and vestronidase alfa. EMA European Public Assessment Reports, PubMed, EMBASE, the Cochrane Library, Clinical Key, and conference presentations from January 2016 to April 2021 were searched for evidence on efficacy and safety. Two of the identified therapies were graded as “substantial” NHB: dinutuximab beta (neuroblastoma maintenance) and nusinersen (Type I SMA), and one as “comparable” NHB (CDCA). The NHB grade of the remaining therapies fell between “comparable” and “substantial”. No therapies were graded as having negative NHB. The certainty of the estimate ranged from “high” (dinutuximab beta in neuroblastoma maintenance) to “low” (CDCA, metreleptin and vestronidase alfa). The certainty of the other therapies was graded between “low” and “high”. The ICER Evidence Rating Matrix overall rating “A” (the highest) was given to two therapies, “B+” to 6 therapies, “C+” to five therapies, and “I” (the lowest) to three therapies. The scores varied between rating authors with mean agreement over all indications of 71.9% for NHB, 56.3% for certainty and 68.8% for the overall rating. Conclusions Using the ICER Matrix to grade orphan therapies according to their treatment benefit and certainty is feasible. However, the assessment involves subjective judgements based on heterogenous evidence. Tools such as the ICER Matrix might aid decision makers to evaluate treatment benefit and its certainty when comparing therapies across indications.

Several systematic review studies highlight exercise's positive impact on brain health outcomes for frail individuals. This study adopts a Comprehensive Review of reviews (CRs) approach to amalgamate data from existing reviews, focusing on exercise's influence on brain health outcomes in older frail and pre-frail adults. The methodology involves a thorough search of Portuguese, Spanish, and English-indexed databases (i.e., Ebsco Health, Scielo, ERIC, LILACS, Medline, Web of Science, SportDiscus) from 1990 to 2022, with the AMSTAR-2 tool assessing evidence robustness. The search terms "physical exercise", "elderly frail", and "systematic review" were employed. Results: Out of 12 systematically reviewed studies, four presented high-quality (with metanalyses), while eight exhibit critically low quality. Positive trends emerge in specific cognitive and neuromotor aspects, yet challenges persist in psychosocial domains, complex cognitive tasks, and ADL outcomes. This study yields reasonable and promising evidence regarding exercise's influence on quality of life and depression in frail older individuals. However, the impact on biochemical markers remains inconclusive, emphasizing the need for standardized methodologies. Conclusions: The findings highlight the importance of acknowledging methodological nuances for clinicians and policymakers when translating these results into impactful interventions for aging populations. This emphasizes the necessity for a comprehensive and customized approach to exercise interventions aimed at fostering the sustainability of overall well-being in older individuals, aligning with United Nations Sustainable Development Goal 3. [ABSTRACT FROM AUTHOR]

Introduction: How the launch delay of drugs and other factors of interest can influence the length of the review period by drug agencies is still unknown, and understanding this can help better strike the trade-off related to review speed. Methods: We included all new oncology drug applications submitted to China’s National Medical Product Administration (NMPA) between 1 January 2018 and 31 December 2021, and ultimately succeeded in achieving marketing approval. For each drug, the length of the NMPA review process and other major characteristics were collected, including the registration class, approval class, priority review designation, and launch delay relative to the United States, as well as the number of patients enrolled, comparator, and primary endpoint of the pivotal trials supporting the approval. Linear regression model was employed to analyze the effects of factors of interest on the NMPA review time. Results: From 2018 to 2021, NMPA received 137 oncology applications that were ultimately approved. Half of the approvals [76 (55.5%)] were first licensed in the US, leaving a median launch delay of 2.71 years (IQR, 1.03–5.59) in China. In the pivotal studies, the median enrollment was 361 participants (IQR, 131–682), and the use of control groups [90 (65.7%)] and surrogate endpoints [101 (73.7%)] was prevalent. The median review time was 304 days (IQR, 253–376). Multivariate analysis for log-transformed review time showed that larger enrollment ( > 92) was associated with a drop of 20.55% in review time (coefficient = −0.230; 95% CI, −0.404 to −0.055; p = 0.010); and a short delay (0 < delay ≤ 1.95 years) was associated with a drop of 17.63% in review time (coefficient = −0.194; 95% CI, −0.325 to −0.062; p = 0.004). Discussion: The short launch delay relative to the US was one important driver to the review speed of NMPA, which might suggest its latent regulatory reliance on the other global regulator during the post-marketing period when new information on the drug’s clinical benefit was still lacking. [ABSTRACT FROM AUTHOR]

Background: Sudden cardiac death (SCD) is the leading medical cause of death in athletes. To prevent SCD, screening for high‐risk cardiovascular conditions (HRCC) is recommended. Screening strategies are based on a limited number of studies and expert consensus. However, evidence and efficacy of athlete HRCC screening is unclear. Objective: To determine methodological quality and quality of evidence of athlete screening, and screening efficacy to detect HRCC in a systematic review. Methods: We performed a systematic search of Medline, Embase, Scopus and Cochrane Library up to June 2021. We included articles containing original data of athlete cardiovascular screening, providing details of screening strategies, test results and HRCC detection. We assessed methodological quality of the included articles by QUADAS‐2, quality of evidence of athlete HRCC screening by GRADE, and athlete HRCC screening efficacy by SWiM. Results: Of 2720 citations, we included 33 articles (1991–2018), comprising 82 417 athletes (26.7% elite, 73.4% competitive, 21.7% women, 75.2% aged ≤35). Methodological quality was 'very low' (33 articles), caused by absence of data blinding and inappropriate statistical analysis. Quality of evidence was 'very low' (33 articles), due to observational designs and population heterogeneity. Screening efficacy could not be reliably established. The prevalence of HRCC was 0.43% with false positive rate (FPR) 13.0%. Conclusions: Methodological quality and quality of evidence on athlete screening are suboptimal. Efficacy could not be reliably established. The prevalence of screen detected HRCC was very low and FPR high. Given the limitations of the evidence, individual recommendations need to be prudent. [ABSTRACT FROM AUTHOR]

Background and Objectives System navigation programs are becoming more available to meet the needs of patients with complex care needs. The aim of this review was to systematically assess the outcomes of navigation programs for persons with dementia and their family caregivers. Research Design and Methods A systematic review methodology was employed. Ten databases were searched for all relevant articles published until October 30, 2021. English-language full-text articles were included if they focused on implemented navigation program(s) that primarily supported persons with dementia who were aged 50 or older. Methodological quality was assessed by 2 independent raters using the Physiotherapy Evidence Database Scale, the STrengthening the Reporting of OBservational studies in Epidemiology checklist, and the Mixed Methods Appraisal Tool. Results Fourteen articles were included in the review. There was Level 1 evidence for the benefits of system navigation programs on delaying institutionalization, wherein benefits appeared to be specific to interventions that had an in-person component. There was Level 1 (n = 4) and Level 3 (n = 1) evidence on service use from time of diagnosis to continued management of dementia. Finally, Level 1 to Level 5 evidence indicated a number of benefits on caregiver outcomes. Discussion and Implications There is strong evidence on the benefits of system navigation for people with dementia on delaying institutionalization and caregiver outcomes, but outcomes across other domains (i.e. functional independence) are less clear, which may be due to the varied approaches within system navigation models of care. [ABSTRACT FROM AUTHOR]

To analyse the scientific evidence about the efficacy of Syntonic phototherapy for producing changes in visual function. A systematic review was performed to obtain studies on the effects of Syntonic phototherapy on vision. A search in health science databases (Medline, Scopus, Web of Science and PsycINFO) for studies published between 1980 and 2022 was conducted in accordance with the principles of Cochrane approach. The search identified 197 articles. Only clinical studies which used the Syntonic phototherapy as a vision therapy for any visual condition were included. Clinical cases and case series were excluded. Following the inclusion criteria, 8 clinical studies met inclusion, 5 of them being pseudo-experimental studies with an equivalent control group and 3 pre-post pseudo-experimental studies. GRADE tool was used to assess the certainty of the evidence of the studies. The GRADE evidence profile for the studies through the Soft table was made to analyse data. The studies analysed seven outcomes: visual symptoms, functional visual fields, visual acuity, contrast sensitivity, deviation (phoria/tropia), stereopsis and reading abilities. Finding table about results (Soft Table) showed that for all outcomes reviewed, all studies yielded very low certainty of evidence. Results revealed a lack of scientific evidence of the efficacy of Syntonic optometric phototherapy to produce changes in the visual function. This systematic review found no consistent evidence for the efficacy of Syntonic phototherapy to cause changes in visual function. There is no scientific evidence to support its clinical use for treating any type of visual anomalies. [ABSTRACT FROM AUTHOR]

Background: The evaluation of clinical evidence takes account of health benefit (efficacy and safety) and the degree of certainty in the estimate of benefit. In orphan indications practical and ethical challenges in conducting clinical trials, particularly in paediatric patients, often limit the available evidence, rendering structured evaluation challenging. While acknowledging the paucity of evidence, regulators and reimbursement authorities compare the efficacy and safety of alternative treatments for a given indication, often in the context of the benefits of other treatments for similar or different conditions. This study explores the feasibility of using the Institute for Clinical and Economic Review (ICER) Evidence Rating Matrix for Comparative Clinical Effectiveness in structured assessment of both the magnitude of clinical benefit (net health benefit, NHB) and the certainty of the effect estimate in a sample of orphan therapies for paediatric indications. Results: Eleven systemic therapies with European Medicines Agency (EMA) orphan medicinal product designation, licensed for 16 paediatric indications between January 2017 and March 2020 were identified using OrphaNet and EMA databases and were selected for evaluation with the ICER Evidence Rating Matrix: burosumab; cannabidiol; cerliponase alfa; chenodeoxycholic acid (CDCA); dinutuximab beta; glibenclamide; metreleptin; nusinersen; tisagenlecleucel; velmanase alfa; and vestronidase alfa. EMA European Public Assessment Reports, PubMed, EMBASE, the Cochrane Library, Clinical Key, and conference presentations from January 2016 to April 2021 were searched for evidence on efficacy and safety. Two of the identified therapies were graded as "substantial" NHB: dinutuximab beta (neuroblastoma maintenance) and nusinersen (Type I SMA), and one as "comparable" NHB (CDCA). The NHB grade of the remaining therapies fell between "comparable" and "substantial". No therapies were graded as having negative NHB. The certainty of the estimate ranged from "high" (dinutuximab beta in neuroblastoma maintenance) to "low" (CDCA, metreleptin and vestronidase alfa). The certainty of the other therapies was graded between "low" and "high". The ICER Evidence Rating Matrix overall rating "A" (the highest) was given to two therapies, "B+" to 6 therapies, "C+" to five therapies, and "I" (the lowest) to three therapies. The scores varied between rating authors with mean agreement over all indications of 71.9% for NHB, 56.3% for certainty and 68.8% for the overall rating. Conclusions: Using the ICER Matrix to grade orphan therapies according to their treatment benefit and certainty is feasible. However, the assessment involves subjective judgements based on heterogenous evidence. Tools such as the ICER Matrix might aid decision makers to evaluate treatment benefit and its certainty when comparing therapies across indications. [ABSTRACT FROM AUTHOR]

Purpose: This inquiry aims to develop an appraisal tool to offer greater granularity in weighing evidence in the field of healthcare design research. Background: In evidence-based design (EBD), the goal is to implement interventions that result in a meaningful and optimal effect based on current best evidence. Although multiple appraisal tools (many adopted from medical disciplines) have been instrumental in evaluating studies in the field of healthcare design research to identify the best evidence, they do not necessarily consider the unique contexts of healthcare design research, and methodologies appropriate to the field. Methods: Five basic types of studies are ranked based on the level of confidence that they offer regarding the estimate of an effect: (1) meta-analysis studies, (2) causal studies, (3) correlational studies, (4) descriptive studies, and (5) anecdotal evidence. Causal studies are further divided into four levels based on the interaction of two factors: (1) type of intervention and (2) groups' equivalency and extraneous variable control. Results: An eight-level hierarchy of evidence for healthcare design research is proposed that is expected to improve upon previous hierarchies in three major ways: (a) including research methods that are more relevant to healthcare design research, (b) enhancing evaluation accuracy and reliability by providing a clearer definition of studies based on their key components rather than using study labels alone, and (c) distinguishing different levels of evidence, particularly in causal studies. Conclusions: The proposed appraisal tool is developed specifically for EBD by reflecting on the unique context of healthcare design research and practice. [ABSTRACT FROM AUTHOR]

Objective: Little is known about the economic value of clinical interventions for delirium. This review aims to synthesise and appraise available economic evidence, including resource use, costs, and cost‐effectiveness of interventions for reducing, preventing, and treating delirium. Methods: Systematic review of published and grey literature on full and partial economic evaluations. Study quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). Results: Fourteen economic evaluations (43% full, 57% partial) across nine multicomponent and nonpharmacological intervention types met inclusion criteria. The intervention costs ranged between US$386 and $553 per person in inpatient settings. Multicomponent delirium prevention intervention and the Hospital Elder Life Program (HELP) reported statistically significant cost savings or cost offsets somewhere else in the health system. Cost savings related to inpatient, outpatient, and out‐of‐pocket costs ranged between $194 and $6022 per person. The average CHEERS score was 74% (±SD 10%). Conclusion: Evidence on a joint distribution of costs and outcomes of delirium interventions was limited, varied and of generally low quality. Directed expansion of health economics towards the evaluation of delirium care is necessary to ensure effective implementation that meets patients' needs and is cost‐effective in achieving similar or better outcomes for the same or lower cost. [ABSTRACT FROM AUTHOR]

Background: Evidence-based medicine (EBM), as originally conceived, used all types of peer-reviewed evidence to guide medical practice and decision-making. During the SARS-CoV-2 Coronavirus disease (COVID-19) pandemic, the standard usage of EBM, modeled by the Evidence-Based Medicine Pyramid, undermined EBM by incorrectly using pyramid levels to assign relative quality. The resulting pyramid-based thinking is biased against reports both in levels beneath randomized control trials (RCTs) and those omitted from the pyramid entirely. Thus, much of the evidence was ignored. Our desire for a more encompassing and effective medical decision-making process to apply to repurposed drugs led us to develop an alternative to the EBM Pyramid for EBM. Herein, we propose the totality of evidence (T-EBM) wheel. Objectives: To create an easily understood graphic that models EBM by incorporating all peer-reviewed evidence that applies to both new and repurposed medicines, and to demonstrate its potential utility using ivermectin as a case study. Methods: The graphics were produced using Microsoft Office Visio Professional 2003 except for part of the T-EBM wheel sunburst chart, which was produced using Microsoft 365 Excel. For the case study, PubMed® was used by searching for peer-reviewed reports containing “ivermectin” and either “covid” or “sars” in the title. Reports were filtered for those using ivermectin-based protocols in the treatment of COVID-19. The resulting 265 reports were evaluated for their study design types and treatment outcomes. The three-ringed graphical T-EBM wheel was composed of two inner rings showing all types of reports and an outer ring showing outcomes for each type. Findings-Conclusions: The T-EBM wheel avoids the biases of the EBM Pyramid and includes all types of reports in the pyramid along with reports such as population and mechanistic studies. In both early and late stages of medical emergencies, pyramid-based thinking may overlook indications of efficacy in regions of the T-EBM wheel beyond RCTs. This is especially true when searching for ways to prevent and treat a novel disease with repurposed therapeutics before RCTs, safety assessments, and mechanisms of action of novel therapeutics are established. As such, T-EBM Wheels should replace the EBM Pyramids in medical decision-making and education. T-EBM Wheels can be expanded upon by implementing multiple outer rings, one for each different kind of outcome (efficacy, safety, etc.). A T-EBM Wheel can be created for any proprietary or generic medicine. The ivermectin (IVM) T-EBM Wheel displays the efficacy of IVM-based treatments of COVID-19 in a color-coded graphic, visualizing each type of evidence and the proportions of each of their outcomes (positive, inconclusive, negative).

Large-scale societal issues such as public health crises highlight the need to communicate scientific information, which is often uncertain, accurately to the public and policy makers. The challenge is to communicate the inherent scientific uncertainty — especially about the underlying quality of the evidence — whilst supporting informed decision making. Little is known about the effects that such scientific uncertainty has on people’s judgments of the information. In three experimental studies (total N=6,489), we investigate the influence of scientific uncertainty about the quality of the evidence on people’s perceived trustworthiness of the information and decision making. We compare the provision of high, low, and ambiguous quality-of-evidence indicators against providing no such cues. Results show an asymmetric relationship: people react more strongly to cues of low quality of evidence than they do to high quality of evidence compared to no cue. While responses to a cue of high quality of evidence are not significantly different from no cue; a cue of low or uncertain quality of evidence is accompanied by lower perceived trustworthiness and lower use of the information in decision making. Cues of uncertain quality of evidence have a similar effect to those of low quality. These effects do not change with the addition of a reason for the indicated quality level. Our findings shed light on the effects of the communication of scientific uncertainty on judgment and decision making, and provide insights for evidence-based communications and informed decision making for policy makers and the public.

• One-third of systematic reviews in rehabilitation assess the certainty of evidence • The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) was the most common approach used • High uptake of approaches such as GRADE is recommended To determine how many systematic reviews (SRs) of the literature in rehabilitation assess the certainty of evidence (CoE) and how many apply the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to do this. For this meta-research study, we searched PubMed and Cochrane Database of Systematic Reviews databases for SRs on rehabilitation published in 2020. Two reviewers independently selected the SRs and extracted the data. Reporting characteristics and appropriate use of the GRADE system were assessed. The search retrieved 827 records: 29% (239/827) SRs evaluated CoE, 68% (163/239) of which applied the GRADE system. GRADE was used by SRs of randomized controlled trials (RCTs, 88%; 144/163), non-randomized intervention studies (NRIS, 2%; 3/163), and both RCT and NRIS (10%; 16/163). In the latter case, a separate GRADE assessment according to the study design was not provided in 75% (12/16). The reasons for GRADE judgment were reported in 82% (134/163) of SRs. One-third of SRs in rehabilitation assessed CoE with the GRADE system. GRADE assessment was presented transparently by most SRs. Journal editors and funders should encourage the uptake of the GRADE system when considering SRs in rehabilitation for publication. The authors should pre-define GRADE assessment in a registered and/or published protocol. [ABSTRACT FROM AUTHOR]

Objective To investigate the methodological issues related to the quality of evidence and strength of recommendations of 2019 Chinese clinical practice guidelines (hereafter referred to as 'guidelines') published in journals, so as to provide reference for standardization of recommendations. Methods We searched and analyzed information on Chinese guidelines published in 2019, evaluated the quality of evidence, and graded the strength of recommendations. Information on grading methods, grading descriptions, phrases for the quality of evidence, and the strength of recommendation was extracted. Results A total of 226 Chinese clinical practice guidelines were published in journals in 2019, of which 106 guidelines (87 Chinese guidelines, 19 English guidelines) were included in this study. There were 18 grading methods adopted, with the GRADE(Grading of Recommendations Assessment, Development and Evaluation) system being the most used(35.8%, 38/106). A total of 6 grading descriptions were used; the most frequently used symbol for grading the quality of evidence was letters (39.6%, 42/106); the most frequently used symbol for grading the strength of recommendations was text (34.9%, 37/106). The most common word used in the guidelines to describe the recommended strength was 'may'. Among the 38 guidelines that used the GRADE system, only 15 followed the presentation recommended by the GRADE working group. There were 250 clearly graded recommendations included, with 60.4% (151/250) being strong recommendations and 44.8% (112/250) citing low or very low-quality evidence. There were 96 recommendations(38.4%, 96/250) that were supported by systematic reviews. Conclusions Chinese guidelines published in journals in 2019 that used the grading system accounts for a small proportion compared with those that did not use. And the quality of evidence and strength of recommendations used in guidelines remains incomplete, inconsistent and irregular. The GRADE system is underused. Very few guidelines present grading criteria and details in accordance with the requirements of the GRADE Working Group.We recommend the use of the GRADE system to promote the rigorous, transparent and rational development of guideline recommendations.

A large body of literature shows that living near greenery supports healthy lifestyles and improves mental health. Much of this research has used greenery measured from a bird's eye perspective. Street view images (SVI) are an important alternative data source that could assess visible greenery experienced by residents in daily life. The current review is the first to systematically critique and synthesize the evidence relating to greenery and bluespace in SVI and its associations with mental health outcomes. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to conduct this review. First, we identified relevant articles published as of April 2023 in PubMed, Web of Science, Scopus, and CINAHL. Articles meeting inclusion criteria were narratively synthesized. Quality assessments were conducted with the Newcastle-Ottawa Scale (NOS). Based on our search, we identified 35 articles on greenery and bluespace measured with SVI and mental health outcomes. Two-thirds of the included papers found positive associations between greenery in SVI and mental health. The average score for risk of bias was good. Association between visible greenery in SVI and all 10 of the mental health outcomes studied were low or very low quality of evidence and showed limited or inadequate strength of evidence. SVI is likely to be an increasingly used and a validated instrument for estimating health-promoting exposure to greenery. Future research would benefit from the standardization of SVI datasets and computational processes, and studies conducted outside of China and high-income countries. Such advancements would improve the generalizability and robustness of associations between visible greenery and mental health outcomes., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Inc.)

Fei-Yi Zhao,1– 3,&ast; Wen-Jing Zhang,3,&ast; Gerard A Kennedy,1,4,5 Russell Conduit,1 Zhen Zheng,1 Qiang-Qiang Fu6 1School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, 3083, Australia; 2Department of Nursing, School of International Medical Technology, Shanghai Sanda University, Shanghai, 201209, People’s Republic of China; 3Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, People’s Republic of China; 4School of Science, Psychology and Sport, Federation University, Mount Helen, Victoria, Australia; 5Institute for Breathing and Sleep, Austin Health, Heidelberg, Victoria, 3084, Australia; 6Department of General Practice, Yangpu Hospital, School of Medicine, Tongji University, Shanghai, 200090, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Zhen ZhengSchool of Health and Biomedical Sciences, RMIT University, PO Box 71, Bundoora, Victoria, 3083, AustraliaTel +61 3 9925 7167Fax +61 3 9925 7178Email zhen.zheng@rmit.edu.auQiang-Qiang FuDepartment of General Practice, Yangpu Hospital, School of Medicine, Tongji University, Shanghai, 200090, People’s Republic of ChinaTel +86 21-6569 0520Fax +86 21-6569 0520-813Email 286852271@qq.comObjective: To summarize and critically assess the reliability of the methodological quality and outcome measures from systematic reviews (SRs)/meta-analyses (MAs) and provide an overall verdict about the therapeutic value of acupuncture for perimenopausal insomnia (PMI).Methods: We conducted a comprehensive literature search for SRs/MAs of seven major databases (English and Chinese). For each included review, the methodological quality was appraised according to the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), the evidence quality was classified on the basis of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE), and reporting quality was evaluated complying with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2009 (PRISMA-2009). Veritas plots were used to quantify the quality of included SRs/MAs.Results: Nine SRs/MAs were deemed eligible for the present overview. Considering the assessment of results from the AMSTAR-2 checklist, the methodological quality of one SR/MA was considered low, and the remaining eight were critically low. Major methodological deficiencies were concentrated on item 2 (the lack of protocol and/or registration information), item 7 (the lack of a list of excluded studies), and item 10 (the lack of reports on funding sources for individual studies included in the SRs/MAs). For the GRADE system, of the 25 outcomes, only three (12%) were rated as moderate-quality, while the remaining 22 were rated between low- and very low-quality. The PRISMA-2009 statement indicated three major reporting quality limitations in most SRs/MAs, namely: 1) only search terms without specific retrieval strategy; 2) incomplete descriptions for study characteristics, particularly the specific dosage and frequency of interventions in treatment/control groups; and 3) inadequate investigation and explanation of the source of high heterogeneity among original randomized control trials included. According to Veritas plots, quality rank scores of included SRs/MAs ranged from 3.3 to 8.3, with an average score of 6.4 ± 1.7.Conclusion: Acupuncture appears to be beneficial for PMI management, but the quality of evidence is weakened by the unsatisfactory quality of both SRs/MAs and original trials included.Keywords: acupuncture, perimenopausal insomnia, systematic review, meta-analysis, methodological quality, quality of evidence

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A structured and transparent approach is instrumental in translating research evidence to health recommendations and evidence informed clinical decisions. The aim was to conduct an overview and analysis of principles and methodologies for health guideline development. A literature review on methodologies, strategies, and fundamental steps in the process of guideline development was performed. The clinical practice guideline development process and methodology adopted by the European Society for Vascular Surgery are also presented. Sophisticated methodologies for health guideline development are being applied increasingly by national and international organisations. Their overarching principle is a systematic, structured, transparent, and iterative process that is aimed at making well informed healthcare choices. Critical steps in guideline development include the assessment of the certainty of the body of evidence; evidence to decision frameworks; and guideline reporting. The goal of strength of evidence assessments is to provide well reasoned judgements about the guideline developers' confidence in study findings, and several evidence hierarchy schemes and evidence rating systems have been described for this purpose. Evidence to decision frameworks help guideline developers and users conceptualise and interpret the construct of the quality of the body of evidence. The most widely used evidence to decision frameworks are those developed by the GRADE Working Group and the WHO-INTEGRATE, and are structured into three distinct components: background; assessment; and conclusions. Health guideline reporting tools are employed to ensure methodological rigour and transparency in guideline development. Such reporting instruments include the AGREE II and RIGHT, with the former being used for guideline development and appraisal, as well as reporting. This guide will help guideline developers/expert panels enhance their methodology, and patients/clinicians/policymakers interpret guideline recommendations and put them in context. This document may be a useful methodological summary for health guideline development by other societies and organisations. [ABSTRACT FROM AUTHOR]

• Updated guidelines reported after 2017 improved quality. • Well-designed randomized clinical trials remain an unmet need. • Overall quality of CPG about bronchiectasis was noteworthy. • Three guidelines reported after 2017 obtained an "excellent" score. Guidelines aim to standardize and optimize diagnosis and management. We evaluated the quality of evidence supporting recommendations from different international adult guidelines on bronchiectasis, and classified with the GRADE system. Quality of eligible clinical practice guidelines was assessed for six domains using the AGREE II tool, with ≥ 80% rating as excellent. Seven guidelines (283 recommendations) were analyzed, and four of them were considered "recommended for use" (three reported after 2017 as excellent). Overall, 144 (50.9%) recommendations were based on low-quality evidence, representing 81.5% in diagnosis and 36.2% in therapy. In contrast, 5/92 (5.4%) and 40/191 (20.9%) recommendations regarding diagnostic and treatment (respectively) were based on high-quality evidence. Quality agreement ratings were significantly (p < 0.05) higher for guidelines delivered after 2015, progressing from 27.7% to 58.3%, qualifying as excellent. Highest scores were documented in the domains of "scope and purpose" followed by "clarifying of presentation" and "editorial independence". Updated guidelines reported after 2017 improved quality, although well-designed randomized clinical trials remain an unmet need. AGREE II quality assessment identified four guidelines qualified as recommended for use. Improvements are required in stakeholder involvement and applicability. [ABSTRACT FROM AUTHOR]

The GRADE (Grading of Recommendation, Assessment, Development and Evaluation) methods was developed to evaluate the quality of evidence and make recommendations, which has been widely adopted in clinical practice guidelines. The GRADE methods address the classification of outcomes, systematic collection, appraisal and synthesis of research evidence based on each outcome, evaluate the overall quality of the evidence, and making recommendations. This essay summarized the GRADE methods and its use in clinical practice guidelines of traditional, complementary, and integrative medicine as well as highlighting some of the challenges.

Background: The American College of Obstetricians and Gynecologists publishes practice bulletins and committee opinions to serve as clinical guidelines for physicians. The objective of this study was to quantify the frequency that randomized controlled trials become incorporated into the American College of Obstetricians and Gynecologists documents (either practice bulletins or committee opinions). Methods: Original research articles published in The American Journal of Obstetrics and Gynecology, The Journal of the American Medical Association, The New England Journal of Medicine, and Obstetrics and Gynecology between 2009 and 2014 were examined and randomized controlled trials (RCT) in obstetrics and gynecology were identified. Adjusted odds ratio (aOR) with 95% confidence intervals (CI) were calculated to examine the factors associated with a citable RCT being referenced versus not in ACOG documents. Results: Of the 306 randomized controlled trials identified 248 (81.0%) met the inclusion criteria, with 128 (51.6%) of eligible RCT being cited The factors which increased the likelihood of a RCT being referenced, versus not being, were: if device or surgery was the intervention (aOR 3.60; 95% CI 1.85–7.00) and if the sample size of the trial was 500–999 (aOR 3.70 (1.39–9.82). The following factors were not associated with whether the RCT was or was not referenced in the ACOG documents: topic was obstetric or gynecologic, the trial was conducted in the US or abroad, multi- or single center, year of publication and the journal. Conclusion: Since about half of the citable randomized controlled trials published in obstetrics and gynecology are incorporated into ACOG practice bulletins and committee opinions a greater transparency is warranted as to why RCTs are or are not referenced.

Electrical and magnetic brain stimulation techniques present distinct mechanisms and efficacy in the acute treatment of depression. This was an umbrella review of meta-analyses of randomized controlled trials of brain stimulation techniques for managing acute major depressive episodes. A systematic review was performed in the PubMed/MEDLINE databases from inception until March 2020. We included the English language meta-analysis with the most randomized controlled trials on the effects of any brain stimulation technique vs. control in adults with an acute depressive episode. Continuous and dichotomous outcomes were assessed. A Measurement Tool to Assess Systematic Reviews-2 was applied and the credibility of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation framework. Seven meta-analyses were included (5,615 patients), providing evidence for different modalities of brain stimulation techniques. Three meta-analyses were evaluated as having high methodological quality, three as moderate, and one as low. The highest quality of evidence was found for high frequency-repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation, and bilateral rTMS. There is strong clinical research evidence to guide future clinical use of some techniques. Our results confirm the heterogeneity of the effects across these techniques, indicating that different mechanisms of action lead to different efficacy profiles.

Background: The World Health Organization (WHO) and the International Labour Organization (ILO) have produced the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury (WHO/ILO Joint Estimates). For these, systematic reviews of studies estimating the prevalence of exposure to selected occupational risk factors have been conducted to provide input data for estimations of the number of exposed workers. A critical part of systematic review methodology is to assess the quality of evidence across studies. In this article, we present the approach applied in these WHO/ILO systematic reviews for performing such assessments on studies of prevalence of exposure. It is called the Quality of Evidence in Studies estimating Prevalence of Exposure to Occupational risk factors (QoE-SPEO) approach. We describe QoE-SPEO’s development to date, demonstrate its feasibility reporting results from pilot testing and case studies, note its strengths and limitations, and suggest how QoE-SPEO should be tested and developed further. Methods: Following a comprehensive literature review, and using expert opinion, selected existing quality of evidence assessment approaches used in environmental and occupational health were reviewed and analysed for their relevance to prevalence studies. Relevant steps and components from the existing approaches were adopted or adapted for QoE-SPEO. New steps and components were developed. We elicited feedback from other systematic review methodologists and exposure scientists and reached consensus on the QoE-SPEO approach. Ten individual experts pilot-tested QoE-SPEO. To assess inter-rater agreement, we counted ratings of expected (actual and non-spurious) heterogeneity and quality of evidence and calculated a raw measure of agreement (Pi) between individual raters and rater teams for the downgrade domains. Pi ranged between 0.00 (no two pilot testers selected the same rating) and 1.00 (all pilot testers selected the same rating). Case studies were conducted of experiences of QoE-SPEO’s use in two WHO/ILO systematic reviews. Results: We found no existing quality of evidence assessment approach for occupational exposure prevalence studies. We identified three relevant, existing approaches for environmental and occupational health studies of the effect of exposures. Assessments using QoE-SPEO comprise three steps: (1) judge the level of expected heterogeneity (defined as non-spurious variability that can be expected in exposure prevalence, within or between individual persons, because exposure may change over space and/or time), (2) assess downgrade domains, and (3) reach a final rating on the quality of evidence. Assessments are conducted using the same five downgrade domains as the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach: (a) risk of bias, (b) indirectness, (c) inconsistency, (d) imprecision, and (e) publication bias. For downgrade domains (c) and (d), the assessment varies depending on the level of expected heterogeneity. There are no upgrade domains. The QoE-SPEO’s ratings are “very low”, “low”, “moderate”, and “high”. To arrive at a final decision on the overall quality of evidence, the assessor starts at “high” quality of evidence and for each domain downgrades by one or two levels for serious concerns or very serious concerns, respectively. In pilot tests, there was reasonable agreement in ratings for expected heterogeneity; 70% of raters selected the same rating. Inter-rater agreement ranged considerably between downgrade domains, both for individual rater pairs (range Pi: 0.36–1.00) and rater teams (0.20–1.00). Sparse data prevented rigorous assessment of inter-rater agreement in quality of evidence ratings. Conclusions: We present QoE-SPEO as an approach for assessing quality of evidence in prevalence studies of exposure to occupational risk factors. It has been developed to its current version (as presented here), has undergone pilot testing, and was applied in the systematic reviews for the WHO/ILO Joint Estimates. While the approach requires further testing and development, it makes steps towards filling an identified gap, and progress made so far can be used to inform future work in this area.

When interpreting results and drawing conclusions, authors of systematic reviews should consider the limitations of the evidence included in their review. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach provides a framework for the explicit consideration of the limitations of the evidence included in a systematic review, and for incorporating this assessment into the conclusions. Assessments of certainty of evidence are a methodological expectation of systematic reviews. The certainty of the evidence is specific to each outcome in a systematic review, and can be rated as high, moderate, low, or very low. Because it will have an important impact, before conducting certainty of evidence, reviewers must clarify the intent of their question: are they interested in causation or association. Serious concerns regarding limitations in the study design, inconsistency, imprecision, indirectness, and publication bias can decrease the certainty of the evidence. Using an example, this article describes and illustrates the importance and the steps for assessing the certainty of evidence and drawing accurate conclusions in a systematic review., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.)

Introduction. In order to improve the applicability of clinical practice guidelines, their authors assign recommendations with grades denoting the degree of conviction regarding their practical application. Nevertheless even within one branch of medicine, significant differences between the grading systems arise. Material and methods. To identify these systems, websites of societies and institutions publishing oncology guidelines were searched. Only high-quality, regularly updated guidelines were included. Results. Five systems were analysed - all incorporate quality of evidence and strength of recommendation, but vary in the methods of their assessment and structure of the scales. Discussion. The described systems depend on the review of data, the quality of which supports the ascribed strength. Systems differ with regard to the methods of assessing the quality, quantity and consistency of evidence, potentially leading to assigning different grades of strength to recommendations based on the same studies. Conclusions. The introduction of unified grading systems across each branch of medicine could aid the development of unambiguous recommendations that are easy to introduce within the healthcare system. [ABSTRACT FROM AUTHOR]

This paper describes the information retrieval step in Casama (Contextualized Semantic Maps), a project that summarizes and contextualizes current research papers on driver mutations in non-small cell lung cancer. Casama׳s representation of lung cancer studies aims to capture elements that will assist an end-user in retrieving studies and, importantly, judging their strength. This paper focuses on two types of study metadata: study objective and study design. 430 abstracts on EGFR and ALK mutations in lung cancer were annotated manually. Casama׳s support vector machine (SVM) automatically classified the abstracts by study objective with as much as 129% higher F-scores compared to PubMed׳s built-in filters. A second SVM classified the abstracts by epidemiological study design, suggesting strength of evidence at a more granular level than in previous work. The classification results and the top features determined by the classifiers suggest that this scheme would be generalizable to other mutations in lung cancer, as well as studies on driver mutations in other cancer domains.

Electrical and magnetic brain stimulation techniques present distinct mechanisms and efficacy in the acute treatment of depression. This was an umbrella review of meta-analyses of randomized controlled trials of brain stimulation techniques for managing acute major depressive episodes. A systematic review was performed in the PubMed/MEDLINE databases from inception until March 2020. We included the English language meta-analysis with the most randomized controlled trials on the effects of any brain stimulation technique vs. control in adults with an acute depressive episode. Continuous and dichotomous outcomes were assessed. A Measurement Tool to Assess Systematic Reviews-2 was applied and the credibility of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation framework. Seven meta-analyses were included (5,615 patients), providing evidence for different modalities of brain stimulation techniques. Three meta-analyses were evaluated as having high methodological quality, three as moderate, and one as low. The highest quality of evidence was found for high frequency-repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation, and bilateral rTMS. There is strong clinical research evidence to guide future clinical use of some techniques. Our results confirm the heterogeneity of the effects across these techniques, indicating that different mechanisms of action lead to different efficacy profiles. [ABSTRACT FROM AUTHOR]

Abstract Background Systematic reviews of randomised trials guide policy and healthcare decisions. Yet, we observed that some reviews judge randomised trials as high or unclear risk of bias (ROB) for sequence generation, potentially introducing bias. However, to date, the extent of this issue has not been well examined. We evaluated the consistency in the ROB assessment for sequence generation of randomised trials in Cochrane and non-Cochrane reviews, and explored the reviewers’ judgement of the quality of evidence for the related outcomes. Methods Cochrane intervention reviews (01/01/2017–31/03/2017) were retrieved from the Cochrane Database of Systematic Reviews. We also searched for systematic reviews in ten general medical journals with highest impact factors (01/01/2016–31/03/2017). We examined the proportion of reviews that rated the sequence generation domain as high, low or unclear risk of selection bias. For reviews that had rated any randomised trials as high or unclear risk of bias, we examined the proportion that had assessed the quality of evidence. Results Overall, 100 systematic reviews were included in our analysis. We evaluated 64 Cochrane reviews which comprised of 984 randomised trials; 0.8% (n = 8) and 52.2% (n = 514) were rated as high and unclear ROB for sequence generation respectively. We further evaluated 36 non-Cochrane reviews which comprised of 1376 trials; 5.8% (n = 80) and 39.6% (n = 545) were rated as high and unclear ROB respectively. Ninety percent (n = 10) of non-Cochrane reviews which rated randomised trials as high ROB for sequence generation did not report an underlying reason. All Cochrane reviews assessed the quality of evidence (GRADE). For the non-Cochrane reviews, only just over half had assessed the quality of evidence. Conclusion Systematic reviews of interventions frequently rate randomised trials as high or unclear ROB for sequence generation. In general, Cochrane reviews were more transparent than non-Cochrane reviews in ROB and quality of evidence assessment. The scientific community should more strongly promote consistent ROB assessment for sequence generation to minimise selection bias and support transparent quality of evidence assessment. Consistency ensures that appropriate conclusions are drawn from the data.

Evidence hierarchies are investigative strategies ordered with regard to the claimed strength of evidence. They have been used for a couple of decades in EBM, particularly in assessing evidence for treatment recommendations, but remain controversial. An under-investigated question is what the order in the hierarchy means. Four interpretations are discussed here. The two most credible are “typically stronger” or “ideally stronger.” The well-known GRADE framework seems to assume some “typically stronger” reading. Even if the interpretation of an evidence hierarchy were established, hierarchies are rather unhelpful for the task of evidence aggregation. Specifying the intended order relation may help to sort out disagreements.

Rationale, Aims, and Objectives: Though strong evidence‐based medicine is assertive in its claims, an insufficient theoretical basis and patchwork of arguments provide a good case that rather than introducing a new paradigm, EBM is resisting a shift to actually revolutionary complexity theory and other emergent approaches. This refusal to pass beyond discredited positivism is manifest in strong EBM's unsuccessful attempts to continually modify its already inadequate previous modifications, as did the defenders of the Ptolemaic astronomical model who increased the number of circular epicycles until the entire epicycle‐deferent system proved untenable. Methods: Narrative Review. Results: The analysis in Part 1 of this three part series showed epistemological confusion as strong EBM plays the discredited positivistic tradition out to the end, thus repeating in a medical sphere and vocabulary the major assumptions and inadequacies that have appeared in the trajectory of modern science. Paper 2 in this series examines application, attending to strong EBM's claim of direct transferability of EBM research findings to clinical settings and its assertion of epistemological normativity. EBM's contention that it provides the "only valid" approach to knowledge and action is questioned by analyzing the troubled story of proposed hierarchies of the quality of research findings (especially of RCTs, with other factors marginalized), which falsely identifies evaluating findings with operationally utilizing them in clinical recommendations and decision‐making. Further, its claim of carrying over its normative guidelines to cover the ethical responsibilities of researchers and clinicians is questioned. [ABSTRACT FROM AUTHOR]

Clinicians use general practice guidelines as a source of support for their intervention, but how much confidence should they place on these recommendations? How much confidence should patients place on these recommendations? Various instruments are available to assess the quality of evidence of research, such as the revised Wong scale (R-Wong) which examines the quality of research design, methodology and data analysis, and the revision of the assessment of multiple systematic reviews (R-AMSTAR), which examines the quality of systematic reviews.The Grading of Recommendation Assessment, Development, and Evaluation (GRADE) Working Group developed an instrument called the GRADE system in order to grade the quality of the evidence in studies and to evaluate the strength of recommendation of the intervention that is proposed in the published article. The GRADE looks at four factors to determine the quality of the evidence: study design, study quality, consistency, and directness. After combining the four components and assessing the grade of the evidence, the strength of recommendation of the intervention is established. The GRADE, however, only makes a qualitative assessment of the evidence and does not generate quantifiable data.In this study, we have quantified both the grading of the quality of evidence and also the strength of recommendation of the original GRADE, hence expanding the GRADE. This expansion of the GRADE (Ex-GRADE) permits the creation of a new instrument that can produce tangible data and possibly bridge the gap between evidence-based research and evidence-based clinical practice.

Introduction: Drug-induced QT prolongation is associated with higher cardiovascular mortality.Material and Methods: We conducted a protocol-based comprehensive review of antidepressant-induced QT prolongation in people with mental disorders.Results: Based on findings from 47 published randomized controlled trials (RCTs), 3 unpublished RCTs, 14 observational studies, 662 case reports of torsades de pointes, and 168 cases of QT prolongation, we conclude that all antidepressants should be used only with licensed doses, and that all patients receiving antidepressants require monitoring of QT prolongation and clinical symptoms of cardiac arrhythmias. Large observational studies suggest increased mortality associated with all antidepressants (RR = 1.62, 95% CI: 1.60-1.63, number of adults: 1,716,552), high doses of tricyclic antidepressants (OR = 2.11, 85% CI 1.10-4.22), selective serotonin reuptake inhibitors (OR = 2.78, 95% CI: 1.24-6.24), venlafaxine (OR = 3.73, 95% CI: 1.33-10.45, number of adults: 4,040), and nortriptyline (OR = 4.60, 95% CI: 1.20-18.40, number of adults: 5,298).Conclusions: Evidence regarding the risk of QT prolongation in children is sparse. [ABSTRACT FROM AUTHOR]

This summary of the brief reports notes common themes, activities, and directions in health literacy practices across diverse settings, organizations, and populations. The summary also discusses how a 'best practices' approach could help build an evidence base, solidify evidence of impact, and advance the use of health literacy techniques. [ABSTRACT FROM AUTHOR]

Background: Chronic sinusitis is a common otolaryngologic complaint with a significant impact on patients' quality of life. There is current debate and differences in quality of evidence regarding the best surgical management approach to pediatric chronic sinusitis. Objective: To investigate changes in publishing trends over time in surgical management of pediatric chronic sinusitis. Methods: A systematic literature review was conducted in January 2019 using Embase, PubMed, and Web of Science, of all articles that included surgical treatments for pediatric chronic sinusitis. Publications were grouped into 3 time periods: pre-1998, 1999–2008, and 2009–2018. In addition, a subgroup of publications pertaining to endoscopic sinus surgery, balloon sinuplasty, and adenoidectomy were grouped into 2-year periods since 1988 to compare the number of publications on each topic and to examine overall trends. Results: A total of 327 abstracts were included in the data collection and analysis. There was an overall significant increase in total number of publications (P <.0001), total number of authors (P =.001), and comparison studies (P =.003) from pre-1989 to 2018. Relative number of prospective studies, systemic review, and case studies/expert opinions have not significantly increased over time when comparing decades (P >.05). Among the surgery types, functional endoscopic sinus surgery has the most amount of publications regardless of year despite a statistically significant increase in publications pertaining to balloon sinuplasty in the pediatric literature from 1999–2008 to 2009–2018 (P =.001). Conclusions: Studies on pediatric chronic sinusitis have increased significantly during each of the last 2 decades with an increase in the concomitant number of authors and comparison studies. Although most publications are still Level C or D evidence, there has been a nonsignificant increase in Level A evidence in the past decade. Endoscopic sinus surgery still remains the most studied procedure despite the recent increase in publications on balloon sinuplasty. [ABSTRACT FROM AUTHOR]

Clinical practice guidelines (CPGs) are intended to support clinical decisions and should be based on high-quality evidence. The objective of the study was to evaluate the quality of evidence supporting the recommendations issued in CPGs for therapy, diagnosis, and prevention of hospital-acquired and ventilator-associated pneumonia (HAP/VAP). CPGs released by international scientific societies after year 2000, using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology, were analyzed. Number and strength of recommendations and quality of evidence (high, moderate, low, and very low) were extracted and indexed in the aforementioned sections. High-quality evidence was based on randomized control trials (RCT) without important limitations and exceptionally on rigorous observational studies. Eighty recommendations were assessed, with 7 (8.7%), 24 (30.0%), 29 (36.3%), and 20 (25.0%) being supported by high, moderate, low, and very low-quality evidence, respectively. Highest evidence degree was reported for 26 prevention recommendations, with 7 (26.9%) supported by high-quality evidence and no recommendation based on very low-quality evidence. In contrast, among 9 recommendations for diagnosis and 45 for therapy, none was supported by high-quality evidence, in spite of being recommended as strong in 33.3% and 46.7%, respectively. Among HAP/VAP diagnosis recommendations, the majority of evidence was rated as low or very low-quality (55.6% and 22.2%, respectively) whereas among HAP/VAP therapy recommendations, 4/5 were rated as low and very low-quality (40% each). In conclusion, among HAP/VAP international guidelines, most recommendations, particularly in therapy, remain supported by observational studies, case reports, and expert opinion. Well-designed RCTs are urgently needed. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate if the authors of published systematic reviews (SRs) reported the level of quality of evidence (QoE) in the top 5 impact factor infertility journals and to analyze if they used an appropriate wording to describe it. Methods: This is a cross-sectional study. We searched in PubMed for SRs published in 2017 in the five infertility journals with the highest impact factor. We analyzed the proportion of SRs published in the top 5 impact factor infertility journals that reported the SRs' QoE, and the proportion of those SRs in which authors used consistent wording to describe QoE and magnitude of effect. Results: The QoE was reported in only 21.4% of the 42 included SRs and in less than 10% of the abstracts. Although we did not find important differences in the report of QoE of those that showed statistically significant differences or not, p value was associated with the wording chosen by the authors. We found inconsistent reporting of the size the effect estimate in 54.8% (23/42) and in the level of QoE in 92.9% (39/42). Whereas the effect size was more consistently expressed in studies with statistically significant findings, QoE was better expressed in those cases in which the p value was over 0.05. Conclusion: We found that in 2017, less than 25% of the authors reported the overall QoE when publishing SRs. Authors focused more on statistical significance as a binary concept than on methodological limitations like study design, imprecision, indirectness, inconsistency, and publication bias. Authors should make efforts to report the QoE and interpret results accordingly. [ABSTRACT FROM AUTHOR]

Objectives: Prophylactic antibiotics are recommended routinely for preterm prelabor rupture of membranes (PPROM), but there is an abundance of potential treatments and a paucity of comparative information. The aims of this network meta-analysis were to compare the efficiency of different antibiotic regimens on perinatal outcomes and to assess the quality of the current evidence.Methods: This was a network meta-analysis of randomized controlled trials comparing prophylactic antibiotics, or regimens of antibiotics, with each other or with placebo/no treatment, in women with PPROM. MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, US Registry of Clinical Trials ( www.ClinicalTrials.gov) and gray literature sources were searched. The primary outcomes were neonatal mortality and chorioamnionitis; secondary outcomes included other measures of perinatal morbidity. Relative effect sizes were estimated using risk ratios (RR) and the relative ranking of the interventions was obtained using cumulative ranking curves. The quality of evidence for the primary outcomes was assessed according to GRADE guidelines, adapted for network meta-analysis.Results: The analysis included 20 studies (7169 participants randomized to 15 therapeutic regimens). For the outcome of chorioamnionitis, clindamycin + gentamycin (network RR, 0.19 (95% CI, 0.05-0.83)), penicillin (RR, 0.31 (95% CI, 0.16-0.6)), ampicillin/sulbactam + amoxicillin/clavulanic acid (RR, 0.32 (95% CI, 0.12-0.92)), ampicillin (RR, 0.52 (95% CI, 0.34-0.81)) and erythromycin + ampicillin + amoxicillin (RR, 0.71 (95% CI, 0.55-0.92)) were superior to placebo/no treatment. Erythromycin was the only effective drug for neonatal sepsis (RR, 0.74 (95% CI, 0.56-0.97)). Clindamycin + gentamycin (RR, 0.32 (95% CI, 0.11-0.89)) and erythromycin + ampicillin + amoxicillin (RR, 0.83 (95% CI, 0.69-0.99)) were the only effective regimens for respiratory distress syndrome, whereas ampicillin (RR, 0.42 (95% CI, 0.20-0.92)) and penicillin (RR, 0.49 (95% CI, 0.25-0.96)) were effective in reducing the rates of Grade-3/4 intraventricular hemorrhage. None of the antibiotics appeared significantly more effective than placebo/no treatment in reducing the rates of neonatal death, perinatal death and necrotizing enterocolitis. No network RR could be estimated for neonatal intensive care unit admission. The overall quality of the evidence, according to GRADE guidelines, was moderate to very low, depending on the outcome and comparison.Conclusions: Several antibiotics appear to be more effective than placebo/no treatment in reducing the rate of chorioamnionitis after PPROM. However, none of them is clearly and consistently superior compared to other antibiotics, and most are not superior to placebo/no treatment for other outcomes. The overall quality of the evidence is low and needs to be updated, as microbial resistance may have emerged for some antibiotics, while others are underrepresented in the existing evidence. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]