Aim: This study aims to describe the citation patterns of Cochrane systematic reviews (CSR) in guidelines for managing breast cancer.
Methods: We searched for systematic reviews on breast cancer in The Cochrane Library from the date of inception to November 15, 2023, and identified guidelines that cited them. We described how systematic reviews were cited by the guidelines in each database and each year. Additionally, we presented the relationships between the conclusions of the systematic reviews and guideline recommendations and compared the consistency of the recommendations on the same topic across different guidelines.
Results: A total of 64 systematic reviews and 228 guidelines were included in this study. The average number of the 64 systematic reviews cited by the guidelines was 5.91. We found that the guideline recommendations were irrelevant or inconsistent with the conclusions of the systematic reviews in 56 (38.36%) cited entries. We grouped recommendations on the same topic across different guidelines into one group, of which only 5 groups (15.15%) had completely consistent recommendations, and the other 28 groups (84.85%) had inconsistent recommendations.
Conclusion: The average number of citations for CSR on breast cancer in the guidelines was 5.91. There were also situations in which the guideline recommendations were inconsistent with the conclusions of the included systematic reviews, and recommendations on the same topic across different guidelines were inconsistent.
Aim: To create a systematic digital health process mapping framework for full-life-cycle noncommunicable disease management grounded in key stakeholder engagement.
Methods: A triphasic, qualitative methodology was employed to construct a process mapping framework for digital noncommunicable disease management in Shanghai, China. The first phase involved desk research to examine current guidance and practices. In the second phase, pivotal stakeholders participated in focus group discussions to identify prevalent digital touchpoints across lifetime noncommunicable disease management. In the final phase, the Delphi technique was used to refine the framework based on expert insights and obtain consensus.
Results: We identified 60 digital touchpoints across five essential stages of full-life-cycle noncommunicable disease management. Most experts acknowledged the rationality and feasibility of these touchpoints.
Conclusions: This study led to the creation of a comprehensive digital health process mapping framework that encompasses the entire life cycle of noncommunicable disease management. The insights gained emphasize the importance of a systemic strategic, person-centered approach over a fragmented, purely technocentric approach. We recommend that healthcare professionals use this framework as a linchpin for efficient disease management and seamless technology incorporation in clinical practice.
Background: Plantar warts are common infectious cutaneous growths causing severe physiological and psychological discomforts in patients and heaving global financial burdens. However, paucity of clear-cut guidelines for plantar warts, selecting appropriate treatments for plantar warts remains challenging. The objective of the study is to evaluate the efficacy and safety of common treatments for plantar warts.
Methods: PubMed, EMbase, and The Cochrane Library were searched from inception to March 1, 2023 for randomized controlled trials (RCTs) of plantar warts. The primary outcome (complete response) and secondary outcome (recurrence and pain) were extracted and combined using Bayesian network meta-analysis (NMA) with random-effect and fixed-effect models.
Results: Totally, 33 RCTs were included in the systematic review and quantitative NMA. In NMA of complete response, topical application of 1% cantharidin, 20% podophylotoxin, 30% salicylic acid (CPS), microneedles plus bleomycin (MNB), and intralesional bleomycin injection (INB) were the only three treatments significantly superior to no treatment (NT) and CPS was of the highest possibility to be the top-ranked treatment (SUCRA = 0.9363). However, traditional warts treatments, salicylic acid (SA) and cryotherapy were not superior to NT.
Conclusions: The NMA has produced evidence for using CPS, MNB, and INB, which are all topical antimitotic treatments, to improve the management of plantar warts. The classic treatment modalities for plantar warts, including SA and cryotherapy, may play a less important role in the clinical practice of plantar warts.
Objective: To evaluate the sole impact of blinding patients and outcome assessors in acupuncture randomized controlled trials (RCTs) on treatment effects while considering the type of outcome measures.
Methods: We searched databases for the meta-analyses on acupuncture with both blinded and non-blinded RCTs. Mixed-effects meta-regression models estimated the average ratio of odds ratios (ROR) and differences in standardized mean differences (dSMD) for non-blinded RCTs versus blinded mixed-effects meta-regression model.
Results: The study included 96 meta-analyses (1012 trials). The average ROR for lack of patient blinding was 1.08 (95% confidence intervals 0.79–1.49) in 18 meta-analyses with binary patient-reported outcomes. The average ROR for lack of outcome assessor blinding was 0.98 (0.77–1.24) in 43 meta-analyses with binary subjective outcomes. The average dSMD was −0.38 (−0.96 to 0.20) in 10 meta-analyses with continuous patient-reported outcomes. The average dSMD was −0.13 (−0.45 to 0.18) in 25 meta-analyses with continuous subjective outcomes. The results of the subgroup analysis were consistent with the primary analysis findings.
Conclusions: Blinding of participants and outcome assessors does not significantly influence acupuncture treatment efficacy. It underscores the practical difficulties of blinding in acupuncture RCTs and the necessity to distinguish between trials with and without successful blinding to understand treatment expectations’ effects. Enhancing blinding procedures’ quality and assessment in future research is crucial for improving RCTs’ internal validity and reliability.
Aim: Myocarditis is a recognized safety concern following COVID-19 mRNA vaccination. However, there is limited research quantifying the risk associated with the third dose or comparing the risk between the three doses. The US Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance system that monitors rare adverse events after US-licensed vaccination. However, studies analyzing VAERS data have often faced criticism for underreporting cases and lacking a control group to assess the increase in baseline risk.
Methods: The temporal association between myocarditis onset and COVID-19 vaccination was studied. To overcome limitations, a novel modified self-controlled case series method was employed, explicitly modeling the case reporting process in VAERS data.
Results: We found an increased risk of myocarditis during the 1- to 3-day period following the second and third doses of both the BNT162b2 vaccine and the mRNA-1273 vaccine. Following the second dose, the relative incidence (RI) was 4.89 (95% confidence interval (CI), 2.39–10.08) for the BNT162b2 vaccine and 2.86 (95% CI: 1.18–7.03) for the mRNA-1273 vaccine. Similarly, following the third dose, the RI was 9.04 (95% CI: 2.79–40.99) for the BNT162b2 vaccine and 4.71 (95% CI: 1.42–19.09) for the mRNA-1273 vaccine. No significant increase in risk was observed during other periods. Notably, our analysis also identified a similar increased risk of myocarditis among individuals aged below 30.
Conclusions: These findings raise safety concerns regarding COVID-19 mRNA vaccines, provide insights into the quantification of myocarditis risk at different postvaccination periods, and offer a novel approach to interpreting passive surveillance system data.
Objective: Elective-emergency admission control referred to allocating available inpatient bed capacity between elective and emergency hospitalization demand. Existing approaches for admission control often excluded several complex factors when making decisions, such as uncertain bed capacity and unknown true probability distributions of patient arrivals and departures. We aimed to create a data-driven newsvendor framework to study the elective-emergency admission control problem to achieve bed operational efficiency and effectiveness.
Methods: We developed a data-driven approach that utilized the newsvendor framework to formulate the admission control problem. We also created approximation algorithms to generate a pool of candidate admission control solutions. Past observations and relevant emergency demand and bed capacity features were modeled in a newsvendor framework. Using approximation algorithmic approaches (sample average approximation, separated estimation and optimization, linear programing-LP, and distribution-free model) allowed us to derive computationally efficient data-driven solutions with tight bounds on the expected in-sample and out-of-sample cost guaranteed.
Results: Tight generalization bounds on the expected out-of-sample cost of the feature-based model were derived with respect to the LP and quadratic programing (QP) algorithms, respectively. Results showed that the optimal feature-based model outperformed the optimal observation-based model with respect to the expected cost. In a setting where the unit overscheduled cost was higher than the unit under-scheduled cost, scheduling fewer elective patients would replace the benefit of incorporating related features in the model. The tighter the available bed capacity for elective patients, the bigger the difference of the schedule cost between the feature-based model and the observation-based model.
Conclusions: The study provides a reference for the theoretical study on bed capacity allocation between elective and emergency patients under the condition of the unknown true probability distribution of bed capacity and emergency demand, and it also proves that the approximate optimal policy has good performance.
Background: Clinical trials of traditional Chinese medicine (TCM) and Western medicine showed there was heterogeneity of outcome reporting in myocardial infarction (MI). Developing a core outcome set (COS) might improve the consistency of outcome reporting in future clinical trials.
Methods: A list of outcomes was developed based on a systematic review of randomized controlled trials (RCTs) of MI and semistructured interviews with MI patients. Two rounds of Delphi survey for clinicians, researchers, journal editors, and methodologists were conducted. An online questionnaire sent to nurses. After an online consensus meeting, a COS for MI RCTs was developed.
Results: After extracted data from clinical trials and discussed, 216 outcomes were included in round 1 of the Delphi survey. Seventy-four participants completed round 1 of the Delphi survey. Sixty-five participants completed round 2 of the Delphi survey. Twenty-two nurses completed the online questionnaire. Fifteen participants attended the online consensus meeting, and 14 of them voted and determined the final COS. For all types of MI, it was recommended that left ventricular ejection fraction and quality of life be measured and reported. For acute MI, the participants in the consensus meeting recommended the following core outcomes: death from cardio-cerebrovascular disease, cardiogenic shock, heart failure, troponin I, troponin T, creatine kinase isoenzyme, Killip class, target vessel revascularization, and emergency CABG. For previous MI, recurrent MI, recurrent angina pectoris, and heart failure readmission were recommended.
Conclusions: The COS for MI in RCTs provides recommendations for clinical trials that seek to improve outcomes for patients with MI.
Objective: Time-varying treatments are common in observational studies. However, when assessing treatment effects, the methodological framework has not been systematically established for handling time-varying treatments. This study aimed to examine the current methods for dealing with time-varying treatments in observational studies and developed practical recommendations.
Methods: We searched PubMed from 2000 to 2021 for methodological articles about time-varying treatments, and qualitatively summarized the current methods for handling time-varying treatments. Subsequently, we developed practical recommendations through interactive internal group discussions and consensus by a panel of external experts.
Results: Of the 36 eligible reports (22 methodological reviews, 10 original studies, 2 tutorials and 2 commentaries), most examined statistical methods for time-varying treatments, and only a few discussed the overarching methodological process. Generally, there were three methodological components to handle time-varying treatments. These included the specification of treatment which may be categorized as three scenarios (i.e., time-independent treatment, static treatment regime, or dynamic treatment regime); definition of treatment status which could involve three approaches (i.e., intention-to-treat, per-protocol, or as-treated approach); and selection of analytic methods. Based on the review results, a methodological workflow and a set of practical recommendations were proposed through two consensus meetings.
Conclusions: There is no consensus process for assessing treatment effects in observational studies with time-varying treatments. Previous efforts were dedicated to developing statistical methods. Our study proposed a stepwise workflow with practical recommendations to assist the practice.
Background: International guidelines recommend cyclin-dependent kinase 4/6 inhibitor (CDK4/6i)-based first-line therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC). However, direct drug comparisons are lacking. We aimed to identify the most effective and safe therapy through network meta-analysis (NMA).
Methods: We searched PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and OpenGrey up to September 30, 2023. Eligible studies included randomized controlled trials (RCTs) assessing endocrine therapy alone or in combination with CDK4/6i as first-line endocrine treatment for HR+/HER2− ABC patients. The hazard ratios for progression-free survival (PFS) and overall survival (OS) and relative risks for objective response rate and adverse events (AEs) were available in selected trials. We performed a Bayesian NMA following PRISMA guidelines.
Results: Thirteen RCTs, involving 10 treatments, were included. Most studies were at low risk of bias. Regarding PFS, ribociclib+fulvestrant ranked first with a surface under the cumulative ranking curve (SUCRA) of 85.0%, followed by dalpiciclib+nonsteroidal aromatase inhibitor (NSAI) (SUCRA = 78.9%). Considering OS, the top three ranked treatments were ribociclib+fulvestrant (SUCRA = 94.1%), abemaciclib+NSAI (SUCRA = 69.9%), and ribociclib+NSAI (SUCRA = 68.5%). Out of four CDK4/6is, ribociclib minimized the grade 3/4 AEs, while dalpiciclib demonstrated the worst safety. Publication bias could not be ignored in our analyses, and the certainty of evidence was downgraded primarily due to imprecision.
Conclusions: Ribociclib+fulvestrant probably represents the best option in a first-line setting. When combined with NSAI, dalpiciclib likely showed the best efficacy but the worst safety. Abemaciclib+NSAI and ribociclib+NSAI could also be promising treatments, while palbociclib presented inferiority. (PROSPERO Registration No. CRD42022370271)
Objective: Accumulating evidence has demonstrated that fractional flow reserves (FFRs) derived from invasive coronary angiograms (CA-FFRs) and coronary computed tomography angiography-derived FFRs (CT-FFRs) are promising alternatives to wire-based FFRs. However, it remains unclear which method has better diagnostic performance. This systematic review and meta-analysis aimed to compare the diagnostic performances of the two approaches.
Methods: The Cochrane Library, PubMed, Embase, Medline (Ovid), the Chinese China National Knowledge Infrastructure Database (CNKI), VIP, and WanFang Data databases were searched for relevant studies that included comparisons between CA-FFR and CT-FFR, from their respective database inceptions until January 1, 2023. Studies where both noninvasive FFR (including CA-FFR and CT-FFR) and invasive FFR (as a reference standard) were performed for the diagnosis of ischemic coronary artery disease and were designed as prospective, paired diagnostic studies, were pulled. The diagnostic test accuracy method and Bayesian hierarchical summary receiver operating characteristic (ROC) model for network meta-analysis (NMA) of diagnostic tests (HSROC-NMADT) were both used to perform a meta-analysis on the data.
Results: Twenty-six studies were included in this NMA. The results from both the diagnostic test accuracy and HSROC-NMADT methods revealed that the diagnostic accuracy of CA-FFR was higher than that of CT-FFR, in terms of sensitivity (Se; 0.86 vs. 0.84), specificity (Sp; 0.90 vs. 0.78), positive predictive value (PPV; 0.83 vs. 0.70), and negative predictive value (NPV; 0.91 vs. 0.89) for the detection of myocardial ischemia. A cumulative ranking curve analysis indicated that CA-FFR had a higher diagnostic accuracy than CT-FFR in the context of this study, with a higher area under the ROC curve (AUC; 0.94 vs. 0.87).
Conclusions: Although both of these two commonly used virtual FFR methods showed high levels of diagnostic accuracy, we demonstrated that CA-FFR had a better Se, Sp, PPV, NPV, and AUC than CT-FFR. However, this study provided only indirect comparisions; therefore, larger studies are warranted to directly compare the diagnostic performances of these two approaches.
Objective: With the increasing number of patients with cognitive impairment, nonpharmacological ways to delay cognitive impairment have attracted people's attention, such as lifestyle changes and nutritional supplementation. Folic acid supplementation appears to be a promising treatment option. However, it remains controversial whether folic acid supplementation is effective in delaying adult's cognitive impairment. Therefore, we conducted a meta-analysis to analyze the effects of folic acid supplementation on different cognitive impairments.
Methods: We systematically searched PubMed, Web of Science, EMbase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure (CNKI), WanFang and VIP databases for randomized controlled trials on January 22, 2024. The included population comprised those diagnosed with cognitive impairment. We included trials that compared folic acid treatment with placebo, other dosing regimens, or other intervention controls. Conducting quality evaluation of included studies according to the Cochrane Risk of Bias tool. Statistical analyses were performed using Review Manager software.
Results: Twenty-two trials, including 3604 participants, met inclusion criteria. Compared with controls, the cognitive function of Alzheimer's disease (AD) patients showed improvement with folic acid supplementation: supplementation with < 3 mg (standardized mean differences (SMD) = 0.15, 95% confidence interval (CI) –0.10 to 0.41), and supplementing with ≥ 3 mg folic acid could improve cognitive function in AD patients (SMD = 1.03, 95% CI 0.18 to 1.88). Additionally, it reduced homocysteine (HCY) levels (mean differences (MD) = –4.74, 95% CI –8.08 to –1.39). In mild cognitive impairment (MCI) patients, cognitive function improved with folic acid supplementation: supplementation with > 400 μg (SMD = 0.38, 95% CI 0.13 to 0.63), and supplementation with ≤ 400 μg (SMD = 1.10, 95% CI 0.88 to 1.31). It also reduced HCY levels at intervention ≤ 6 months (MD = –3.93, 95% CI –5.05 to –2.82) and intervention > 6 months (MD = –4.38, 95% CI –5.15 to –3.61). However, supplementing with folic acid did not improve cognitive function in vascular cognitive impairment (VCI) patients, with folic acid supplements < 3 mg (SMD = –0.07, 95% CI –0.23 to –0.08), folic acid supplements ≥ 3 mg (SMD = 0.46, 95% CI –0.57 to 1.49), however, it reduced HCY levels at intervention > 6 months (MD = –5.91, 95% CI –7.13 to –4.69) and intervention ≤ 6 months (MD = –11.15, 95% CI –12.35 to –9.95).
Conclusions: Supplement folic acid is beneficial to the cognitive profile of patients with MCI, supplementation with ≥ 3 mg folic acid can improve cognitive function in AD patients.
Background: Fractures have serious health consequences in older adults. While some medications are individually associated with increased risk of falls and fractures, it is not clear if this holds true for the use of many medications (polypharmacy). We aimed to identify what is known about the association between polypharmacy and the risk of fractures in adults aged ≥65 and to examine the methods used to study this association.
Methods: We conducted a systematic review with narrative synthesis of studies published up to October 2023 in PubMed, Embase, CINAHL, PsychINFO, Cochrane Library, Web of Science, and the grey literature. Two independent reviewers screened titles, abstracts, and full texts, then performed data extraction and quality assessment.
Results: Among the 31 studies included, 11 different definitions of polypharmacy were used and were based on three medication counting methods (concurrent use 15/31, cumulative use over a period 6/31, daily average 3/31, and indeterminate 7/31). Overall, polypharmacy was frequent and associated with higher fracture risk. A dose–response relationship between increasing number of medications and increased risk of fractures was observed. However, only seven studies adjusted for major confounders (age, sex, and chronic disease). The quality of the studies ranged from poor to high.
Conclusions: Polypharmacy appears to be a relevant modifiable risk factor for fractures in older individuals that can easily be used to identify those at risk. The diversity of medication calculation methods and definitions of polypharmacy highlights the importance of a detailed methodology to understand and compare results.
Chronic inflammatory diseases (CIDs) are debilitating and potentially lethal illnesses that affect a large proportion of the global population. Osteopathic manipulative treatment (OMT) is a manual therapy technique developed and performed by osteopathic physicians that facilitates the body's innate healing processes. Therefore, OMT may prove a beneficial anti-inflammatory modality useful in the management and treatment of CIDs. This work aims to objectively evaluate the therapeutic benefits of OMT in patients with various CIDs. In this review, a structured literature search was performed. The included studies involving asthma, chronic obstructive pulmonary disease, irritable bowel syndrome, ankylosing spondylitis, and peripheral arterial disease were selected for this work. Various OMT modalities, including lymphatic, still, counterstain, and muscle energy techniques, were utilized. Control treatments included sham techniques, routine care, or no treatment. OMT utilization led to variable patient outcomes in individuals with pathologies linked to CID.
Background: Lumbar disc herniation (LDH), as one of the most common causes of lower back pain, imposes a heavy economic burden on patients and society. Conservative management is the first-line choice for the majority of LDH patients. Traditional Chinese medicine (TCM) is an important part of conservative treatment and has attracted more and more international attention.
Study design: Evidence-based guideline.
Methods: We formed a guideline panel of multidisciplinary experts. The clinical questions were identified on the basis of a systematic literature search and a consensus meeting. We searched the literature for direct evidence on the management of LDH and assessed its certainty-generated recommendations using the grading of recommendations, assessment, development, and evaluation (GRADE) approach.
Results: The guideline panel made 20 recommendations, which covered the use of Shentong Zhuyu decoction, Shenzhuo decoction, Simiao San decoction, Duhuo Jisheng decoction, Yaobitong capsule, Yaotongning capsule, Osteoking, manual therapy, needle knife, manual acupuncture, electroacupuncture, Chinese exercise techniques (Tai Chi, Baduanjin, or Yijinjing), and integrative medicine, such as combined non-steroidal anti-inflammatory drugs, neural nutrition, and traction. Recommendations were either strong or weak, or in the form of ungraded consensus-based statement.
Conclusion: This is the first LDH treatment guideline for TCM and integrative medicine with a systematic search, synthesis of evidence, and using the GRADE method to rate the quality of evidence. We hope these recommendations can help support healthcare workers caring for LDH patients.
Postoperative gastrointestinal disorder (POGD) was a common complication after surgery under anesthesia. Strategies in combination with Traditional Chinese Medicine and Western medicine showed some distinct effects but standardized clinical practice guidelines were not available. Thus, a multidisciplinary expert team from various professional bodies including the Perioperative and Anesthesia Professional Committees of the Chinese Association of Integrative Medicine (CAIM), jointly with Gansu Province Clinical Research Center of Integrative Anesthesiology/Anesthesia and Pain Medical Center of Gansu Provincial Hospital of Traditional Chinese Medicine and WHO Collaborating Center for Guideline Implementation and Knowledge Translation/Chinese Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Center/Gansu Provincial Center for Medical Guideline Industry Technology/Evidence-based Medicine Center of Lanzhou University, was established to develop evidence-based guidelines. Clinical questions (7 background and 12 clinical questions) were identified through literature reviews and expert consensus meetings. Based on systematic reviews/meta-analyses, evidence quality was analyzed and the advantages and disadvantages of interventional measures were weighed with input from patients’ preferences. Finally, 20 recommendations were developed through the Delphi-based consensus meetings. These recommendations included disease definitions, etiologies, pathogenesis, syndrome differentiation, diagnosis, and perioperative prevention and treatment.
Background: Low back pain (LBP) is a common condition causing disability and high healthcare costs. Alberta faces challenges with unnecessary referrals to specialists and long wait times. A province-wide standardized clinical care pathway based on evidence-based best practices can improve efficiency, reduce wait times, and enhance patient outcomes. Implementing such pathways has shown success in other areas of healthcare in Alberta. This study developed a clinical decision-making pathway to standardize care and minimize uncertainty in assessment, diagnosis, and management.
Methods: A systematic rapid review identified existing tools and evidence that could support a comprehensive LBP clinical decision-making tool. Forty-seven healthcare professionals participated in four rounds of a modified Delphi approach to reach consensus on the assessment, diagnosis, and management of patients presenting to primary care with LBP in Alberta, Canada. This project was a collaborative effort between Alberta Health Services’ Bone and Joint Health Strategic Clinical Network (BJHSCN) and the Alberta Bone and Joint Health Institute (ABJHI).
Results: A province-wide expert panel consisting of professionals from different health disciplines and regions collaborated to develop an LBP clinical decision-making tool. This tool presents clinical care pathways for acute, subacute, and chronic LBP. It also provides guidance for history-taking, physical examination, patient education, and management.
Conclusions: This clinical decision-making tool will help to standardize care, provide guidance on the diagnosis and management of LBP, and assist in clinical decision-making for primary care providers in both public and private sectors.