Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial.

BACKGROUND: Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence. METHODS: Five hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline. EXPECTED RESULTS AND CONCLUSION: We will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients. TRIAL REGISTRATION: Clinicaltrials.gov (NCT05069467).

Oral pharmacological treatments for chronic prostatitis/chronic pelvic pain syndrome: A systematic review and network meta-analysis of randomised controlled trials.

Background: Pharmacological treatments for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) are empirically used. However, the quantitative comparative effectiveness and safety of multiple pharmacological treatments is lacking. Methods: PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science were searched from inception to March 22, 2022. Randomised controlled trials comparing two or more oral pharmacological treatments for patients with CP/CPPS were included. Title, abstract, and full-text screening were independently screened by four reviewers. Primary outcomes were efficacy (the National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI] total score, pain score, urinary score, and quality of life score [QoL]) and safety (adverse events). This study was registered with PROSPERO, CRD42020184106. Findings: 25 studies (3514 patients) assessed 26 treatments. Low to very low quality evidence indicated that doxazosin (Mean difference [MD], -11.4, 95% Credible interval [CrI], -17.5 to -5.1) and the doxazosin, ibuprofen, and thiocolchicoside combination (MD, -11.6, CrI, -18.1 to -5.3) were significantly more effective than placebo in the NIH-CPSI total score. Other NIH-CPSI relative outcomes (pain, urinary, and QoL scores) showed a similar pattern. Low and very low quality evidence suggested that combination treatment including doxazosin, ibuprofen, and thiocolchicoside (odds ratios [OR], 3.2, CrI, 0.5 to 19.3) and the tamsulosin and dapoxetine combination (OR, 6.0, CrI, 0.7 to 67.3) caused more adverse events. In half of all comparisons regarding NIH-CPSI pain scores and quality of life scores, heterogeneity was minimal or low. Heterogeneity was high in both NIH-CPSI total symptom scores (I2  = 78.0%) and pain scores (I2  = 87. 0%) for tamsulosin versus placebo. There was also high heterogeneity in NIH-CPSI urine scores for the combination of tamsulosin and ciprofloxacin versus tamsulosin (I2  = 66.8%), tamsulosin and levofloxacin versus tamsulosin (I2  = 93.3%), and tamsulosin versus placebo (I2  = 83%). Interpretation: Pharmacological treatments have little evidence supporting efficacy in CP/CPPS. Future studies could personalise therapy for individuals according to specific symptoms and identify non-pharmacological targets for CP/CPPS. Funding: Dr Jiani Wu received funding for this project from the China Association for Science and Technology (2017QNRC001), the China Academy of Chinese Medical Sciences (ZZ13-YQ-027), and the National Natural Science Foundation of China (82105037).

Effects of Acupressure on Anxiety: A Systematic Review and Meta-Analysis.

Objectives: The research aim was to perform a systematic review and meta-analysis evaluating the ability of acupressure to reduce anxiety. Design: Randomized controlled trials were obtained through a search of electronic medical databases (four in English and one in Chinese) from inception to October 5, 2020. Two authors searched the databases, evaluated studies' methodological quality, and performed data extraction independently. The final studies for analysis were identified after discussion with the third author. Results: We obtained 27 studies for our systematic review and meta-analysis. Eight studies had a low overall risk of bias, and 13 had some bias concerns with methodological quality. According to the results, acupressure significantly reduced patient anxiety (standardized mean difference = 1.152; 95% confidence interval: 0.847-1.459, p < 0.001), and the study heterogeneity was high (Q = 299.74, p < 0.001, I2 = 91.333%). Two studies reported acupressure-associated adverse events. We also performed a sensitivity analysis by omitting one outlier study, which had the largest effect size; however, high heterogeneity remained (I2 = 87.816%). A subgroup analysis revealed significant differences between participant types (Q = 46.573, p < 0.001), levels of methodological quality (Q = 6.228, p = 0.044), and massage equipment (Q = 4.642, p = 0.031). Conclusions: Our meta-analysis suggests that acupressure can alleviate anxiety. Acupressure was more effective for inpatients and preoperative patients when finger massage was applied. In individuals with anxiety and a stable hemodynamic status, acupressure could be a promising treatment option. However, the substantial heterogeneity across studies means that any inference from the results should be performed cautiously.

Rapid evidence synthesis approach for limits on the search date: How rapid could it be?

Rapid reviews have been widely employed to support timely decision-making, and limiting the search date is the most popular approach in published rapid reviews. We assessed the accuracy and workload of search date limits on the meta-analytical results to determine the best rapid strategy. The meta-analyses data were collected from the Cochrane Database of Systematic Reviews (CDSR). We emulated the rapid reviews by limiting the search date of the original CDSR to the recent 40, 35, 30, 25, 20, 15, 10, 7, 5, and 3 years, and their results were compared to the full meta-analyses. A random sample of 10% was drawn to repeat the literature search by the same timeframe limits to measure the relative workload reduction (RWR). The relationship between accuracy and RWR was established. We identified 21,363 meta-analyses of binary outcomes and 7683 meta-analyses of continuous outcomes from 2693 CDSRs. Our results suggested that under a maximum tolerance of 5% and 10% on the bias of magnitude, a limit on the recent 20 years can achieve good accuracy and at the same time save the most workload. Under the tolerance of 15% and 20% on the bias, a limit on the recent 10 years and 15 years could be considered. Limiting the search date is a valid rapid method to produce credible evidence for timely decisions. When conducting rapid reviews, researchers should consider both the accuracy and workload to make an appropriate decision.

Methodological quality for systematic reviews of adverse events with surgical interventions: a cross-sectional survey.

BACKGROUND: An increasing number of systematic reviews assessed the safety of surgical interventions over time. How well these systematic reviews were designed and conducted determines the reliability of evidence. In this study, we aimed to assess the methodological quality of systematic reviews on the safety of surgical interventions. METHODS: We searched PubMed for systematic reviews of surgical interventions with safety as the exclusive outcome from 1st-Jan, 2015 to 1st-Jan, 2020. The methodological quality of eligible systematic reviews was evaluated according to the AMSTAR 2.0 instrument. The primary outcomes were the number of methodological weaknesses and the global methodological quality. The proportion of each methodological weakness among eligible systematic reviews was compared by three pre-defined stratification variables. The absolute difference of the proportion (PD) was used as the effect estimator, with the two-tailed z-test for the significance. RESULTS: We identified 127 systematic reviews from 18,636 records. None (n = 0, 0.00%) of them could be rated as "high" in terms of the global methodological quality; in contrast, they were either rated as "low" (n = 18, 14.17%) or as "critically low" (n = 109, 85.83%). The median number of methodological weaknesses of these systematic reviews was 8 (interquartile range, IQR: 6 to 9), in which 4 (IQR: 2 to 4) were critical weaknesses. Systematic reviews that used any reporting guideline (e.g., domain 13, PD = -0.22, 95% CI: - 0.39, - 0.06; p = 0.01) and developed a protocol in advance (e.g., domain 6, PD = -0.20, 95% CI: - 0.39, - 0.01; p = 0.04) were less likely to have methodological weakness in some domains but not for the rest (e.g., domain 8, PD = 0.04, 95% CI: - 0.14, 0.21; p = 0.68; with protocol vs. without). CONCLUSIONS: The methodological quality of current systematic reviews of adverse events with surgical interventions was poor. Further efforts, for example, encouraging researchers to develop a protocol in advance, are needed to enhance the methodological quality of these systematic reviews.

Methodological issues of systematic reviews and meta-analyses in the field of sleep medicine: A meta-epidemiological study.

An increasing number of systematic reviews and meta-analyses (SRMAs) have been published in the field of sleep medicine. We evaluated the methodological issues of these SRMAs. A protocol was developed in advance. Three databases were searched from inception to October 2019 for SRMAs published in major academic journals of sleep medicine that assessed healthcare interventions. The AMSTAR 2.0 instrument was used to evaluate the methodological issues and a multivariable regression analysis was conducted to investigate potential measures associated with methodological validity. We identified 163 SRMAs. The median number of missing safeguards of these SRMAs was 7 out of 16 (Interquartile range, IQR: 6-9), and on average, two of these missing safeguards were critical weaknesses. Our regression analysis suggested that SRMAs published in recent years (ß = 0.16; 95%CI: 0.08, 0.24; p = 0.002), with the first author from Europe (ß = 0.08; 95%CI: 0.02, 0.14; p = 0.013) tend to have higher relative methodological ranks. In conclusion, the methodological validity for current SRMAs in sleep medicine was poor. Further efforts to improve the methodological validity are needed.

Inconsistencies in study eligibility criteria are common between non-Cochrane systematic reviews and their protocols registered in PROSPERO.

The author should give careful consideration to the study eligibility criteria of systematic reviews (SRs) and follow it after review protocol development to reduce the possibility of manipulation of inclusion. Our aim was to investigate the prevalence of differences in study eligibility criteria between non-Cochrane SRs and their pre-registered protocols on PROSPERO, and determined what changes were involved as well as whether those changes were explained. We searched the protocols registered on PROSPERO platform in the year of 2018 and then selected these protocols which full-text have been published up to June 9, 2020. A random sample (n = 100) was included. Published full-texts were identified through the protocol's final publication citation. The following five key components of study eligibility criteria were compared: participants, intervention(s)/exposure(s), comparator(s), types of study design, and outcome(s). A total of 90% of included SRs exhibited differences in study eligibility criteria, and 59/90 altered in no less than two key components. Only one SR reported and explained the rationale for changes to the individual key component (the definition of exposure). The "Outcome(s)" exhibited the greatest variation, with changes in 61% of the SRs. The "Comparator(s)/control" exhibited the smallest variation, with changes in 20% of the SRs. Differences in study eligibility criteria between the non-Cochrane SRs and their protocols registered on PROSPERO were widespread but were seldom explained. Authors themselves, PROSPERO platform, as well as peer-review journals and their peer-reviewers should play a role in further improving transparency.

The reporting checklist for public versions of guidelines: RIGHT-PVG.

BACKGROUND: Public or patient versions of guidelines (PVGs) are derivative documents that "translate" recommendations and their rationale from clinical guidelines for health professionals into a more easily understandable and usable format for patients and the public. PVGs from different groups and organizations vary considerably in terms of quality of their reporting. In order to address this issue, we aimed to develop a reporting checklist for developers of PVGs and other potential users. METHODS: First, we collected a list of potential items through reviewing a sample of PVGs, existing guidance for developing and reporting PVGs or other similar evidence-based patient tools, as well as qualitative studies on original studies of patients' needs about the content and/or reporting of information in PVGs or similar evidence-based patient tools. Second, we conducted a two-round Delphi consultation to determine the level of consensus on the items to be included in the final reporting checklist. Third, we invited two external reviewers to provide comments on the checklist. RESULTS: We generated the initial list of 45 reporting items based on a review of a sample of 30 PVGs, four PVG guidance documents, and 46 relevant studies. After the two-round Delphi consultation, we formed a checklist of 17 items grouped under 12 topics for reporting PVGs. CONCLUSION: The RIGHT-PVG reporting checklist provides an international consensus on the important criteria for reporting PVGs.

Many meta-analyses of rare events in the Cochrane Database of Systematic Reviews were underpowered.

BACKGROUND AND OBJECTIVE: Meta-analysis is a statistical method with the ability to increase the power for statistical inference, while it may still face the problem of being underpowered. In this study, we investigated the power to detect certain true effects for published meta-analyses of rare events. METHODS: We extracted data from the Cochrane Database of Systematic Reviews for meta-analyses of rare events from January 2003 to May 2018. We retrospectively estimated the power to detect a 10-50% relative risk reduction (RRR) of eligible meta-analyses. The proportion of meta-analyses achieved a sufficient power (≥0.8) were estimated. RESULTS: We identified 4,177 meta-analyses. The median power to detect 10%, 30%, and 50% RRR were 0.06 (interquartile range [IQR]: 0.05 to 0.06), 0.08 (IQR: 0.06 to 0.15), and 0.17 (IQR: 0.10 to 0.42), respectively); the corresponding proportion of meta-analyses that reached sufficient power were 0.32%, 3.68%, and 11.81%. Meta-analyses incorporating data from more studies had higher probability to achieve a sufficient power (rate ratio = 2.49, 95% CI: 1.76, 3.52, P < 0.001). CONCLUSION: Most of the meta-analyses of rare events in Cochrane systematic reviews were underpowered. Future meta-analysis of rare events should report the power of the results to support informative conclusions.

Quality of interventional animal experiments in Chinese journals: compliance with ARRIVE guidelines.

BACKGROUND: In view of the inadequacy and incompleteness of currently-reported animal experiments and their overall poor quality, we retrospectively evaluated the reporting quality of animal experiments published in Chinese journals adhering to the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines. RESULTS: The databases CNKI, WanFang, VIP, and CBM were searched from inception until July 2018. Two appropriately-trained reviewers screened and extracted articles independently. The ARRIVE guidelines were used to assess the quality of the published reports of animal experiments. The compliance rate of every item was analyzed relative to their date of publication. A total of 4342 studies were included, of which 73.0% had been cited ≤5 times. Only 29.0% (1261/4342) were published in journals listed in the Chinese Science Citation Database. The results indicate that the compliance rate of approximately half of the sub-items (51.3%, 20/39) was less than 50%, of which 65.0% (13/20) was even less than 10%. CONCLUSIONS: The reporting quality of animal experiments in Chinese journals is not at a high level. Following publication of the ARRIVE guidelines in 2010, the compliance rate of the majority of its requirements has improved to some extent. However, less attention has been paid to the ethics and welfare of experimental animals, and a number of specific items in the Methods, Results, and Discussion sections continue to not be reported in sufficient detail. Therefore, it is necessary to popularize the ARRIVE guidelines, advocate researchers to adhere to them in the future, and in particular promote the use of the guidelines in specialized journals in order that the design, implementation, and reporting of animal experiments is promoted, to ultimately improve their quality.

Protocols for meta-analysis of intervention safety seldom specified methods to deal with rare events.

OBJECTIVES: Meta-analyses of rare events often generate unstable results, and selective reporting of the results may mislead the health care decision. Developing a synthesis plan for rare events in protocol may help to formulate the reporting. We aim to investigate whether existing protocols specified methods to deal with rare events. STUDY DESIGN AND SETTING: Protocols (not including Cochrane protocols) for systematic reviews of health care interventions focused on the safety registered in PROSPERO were included. The proportion of protocols that specified methods to deal with rare events and the detailed methods were summarized. We compared the difference of proportions (PD) across different settings. RESULTS: We identified 1,004 eligible protocols, of which, 119 (11.85%, 95% confidence interval (CI): 9.92%, 14.01%) specified methods to deal with rare events. The three most commonly planned methods were the Mantel-Haenszel, Peto's odds ratio, and continuity correction. Protocols planned a quantitative analysis (PD = 0.07, 95% CI: 0.02, 0.12; P = 0.004) and listed safety as a primary outcome (PD = 0.07, 95% CI: 0.01, 0.12; P = 0.018) were more likely to specify methods to deal with rare events. CONCLUSION: Protocols for systematic reviews of intervention safety seldom specified methods to deal with rare events. Future systematic reviewers should provide a detailed and rigorous synthesis plan for rare events in their protocols.

The diagnostic role of diffusional kurtosis imaging in glioma grading and differentiation of gliomas from other intra-axial brain tumours: a systematic review with critical appraisal and meta-analysis.

PURPOSE: We aim to illustrate the diagnostic performance of diffusional kurtosis imaging (DKI) in the diagnosis of gliomas. METHODS: A review protocol was developed according to the (PRISMA-P) checklist, registered in the international prospective register of systematic reviews (PROSPERO) and published. A literature search in 4 databases was performed using the keywords 'glioma' and 'diffusional kurtosis'. After applying a robust inclusion/exclusion criteria, included articles were independently evaluated according to the QUADAS-2 tool and data extraction was done. Reported sensitivities and specificities were used to construct 2 × 2 tables and paired forest plots using the Review Manager (RevMan®) software. A random-effect model was pursued using the hierarchical summary receiver operator characteristics. RESULTS: A total of 216 hits were retrieved. Considering duplicates and inclusion criteria, 23 articles were eligible for full-text reading. Ultimately, 19 studies were eligible for final inclusion. The quality assessment revealed 9 studies with low risk of bias in the 4 domains. Using a bivariate random-effect model for data synthesis, summary ROC curve showed a pooled area under the curve (AUC) of 0.92 and estimated sensitivity of 0.87 (95% CI 0.78-0.92) in high-/low-grade gliomas' differentiation. A mean difference in mean kurtosis (MK) value between HGG and LGG of 0.22 (95% CI 0.25-0.19) was illustrated (p value = 0.0014) with moderate heterogeneity (I2 = 73.8%). CONCLUSION: DKI shows good diagnostic accuracy in the differentiation of high- and low-grade gliomas further supporting its potential role in clinical practice. Further exploration of DKI in differentiating IDH status and in characterising non-glioma CNS tumours is however needed.

The Quality of Clinical Practice Guidelines and Consensuses on the Management of Primary Aldosteronism: A Critical Appraisal.

Background: Several guidelines and expert consensuses have been developed for management of primary aldosteronism (PA). It is important to understand the detailed recommendations and quality of these guidelines to help physicians make informed and reliable decision. Methods: PubMed, EMBASE, and three websites were searched for practice guidelines or consensuses of PA from inception to January 24, 2019. We summarized the major recommendations on the management of PA from these guidelines and consensuses. The Appraisal of Guidelines for Research and Evaluation II was used to assess quality of the included guidelines and consensuses. Results: We identified three clinical practice guidelines and three consensus statements. Most of the recommendations on the diagnosis and treatment of PA from these guidelines and consensuses were consistent. Some minor conflicts were recorded for patient's screen and confirmation test. All included guideline documents have a good quality (score, >70%) on the scope and purpose (mean score, 81.02%) and clarity of presentation of the recommendations (mean score, 86.88%). However, the reporting for the stakeholder involvement (mean score, 54.32%) and applicability (mean score, 47.92%) were insufficient. There was an insufficient rigorousness in most of the guideline documents (mean score, 45.56%) on the development process. The Endocrine Society practice guideline 2016 ranked highest in quality (score, 81.13%). Conclusions: Existing guideline documents provided valuable recommendations on the management of PA, but further efforts are needed to improve the methodological quality. The Endocrine Society practice guideline 2016 was recommended for use.

Risk factors associated with the severity of adverse drug reactions by Xiyanping injection: A propensity score-matched analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Xiyanping injection (XYP), extraction of Andrographis paniculate (Andrographis paniculata (Burm. f.) Nees, chuan xin lian), is a Chinese patent medicine approved to treat bronchitis in China. In 2017, safety incidents associated with treatment of XYP began to emerge throughout China. However, the risk factors of severity of adverse reactions by XYP remain uncertain. AIM OF THE STUDY: To determine risk factors for the severity of XYP-associated adverse drug reactions (ADRs). MATERIALS AND METHODS: We analyzed a total of 26,317 cases of ADRs linked to the use of XYP injection in the China National Adverse Drug Reaction Monitoring Information System from 2004 to 2017. Data were analyzed with respect to age, gender, ethnicity, previous ADRs, family history of ADRs, dosage specification, medication frequency specification, body weight, route of administration, herb-drug interactions (ribavirin, cefatriaxone, penicillin sodium, ambroxol hydrochloride, clindamycin, cefoxitin sodium, azithromycin, ceftazidime, amoxicillin sodium and clavulanate potassium, levofloxacin, cefazolin sodium pentahydrate, acyclovir) by univariate analysis and multivariate analysis. Propensity score matching was used to compare severity of (general or serious) ADRs. RESULTS: We included 24,911 cases of general ADRs and 1406 cases of serious ADRs. Univariate analysis identified age (p â€‹< â€‹0.001), body weight (p â€‹< â€‹0.001), route of administration (p â€‹= â€‹0.008), co-administration of XYP with ribavirin (p â€‹= â€‹0.031) as risk factors of severity of ADRs. Multivariate analysis identified XYP â€‹+ â€‹ribavirin combination (p â€‹= â€‹0.048) and age (p â€‹< â€‹0.001) as the independent risk factors. Upon propensity score matching, the variables were relatively balanced amongst the two groups of patients with general or severe ADRs, and the level of severity in patients who received treatment of XYP â€‹+ â€‹ribavirin increased (p â€‹= â€‹0.020). CONCLUSIONS: Age and co-administration of ribavirin may be potential risk factors for the severity of XYP-associated ADRs. This reminds us to pay more attention to the safety of elderly medication. Minimizing the herb-drug-interaction effects of XYP and ribavirin is a viable treatment target for healthcare professionals in managing serious ADRs amongst patients receiving XYP injection.

Acupuncture vs Noninsertive Sham Acupuncture in Aging Patients with Degenerative Lumbar Spinal Stenosis: A Randomized Controlled Trial.

BACKGROUND: Acupuncture is commonly used to treat degenerative lumbar spinal stenosis in Asian countries. However, rigorous data regarding the efficacy and safety of acupuncture for aging patients are currently lacking. METHODS: Eighty patients older than 50 years were assigned randomly to the acupuncture group or the noninsertive sham acupuncture for 24 treatments over an 8-week period. Measurements were obtained at baseline and 4 and 8 weeks of treatment; and 3 and 6 months after completion of treatment. The primary outcome was a change in the 24-point Roland Morris Disability Questionnaire scores at the end of treatment. The secondary outcomes included disability, pain intensity, symptoms, and dysfunction. RESULTS: At the end of treatment, mean changes in the Roland Morris Disability Questionnaire were -4.1 (95% CI, -4.9 to -3.3) in the acupuncture group and -1.5 (95% CI, -2.3 to -0.7) in the sham group, with a statistically significant between-group difference: -2.6 (95% CI, -3.7 to -1.4). Acupuncture was superior to sham acupuncture in reducing pain intensity (between-group difference: -2.9 [95% CI, -3.8 to -2.0] in leg and buttock pain, vs -2.3 [95% CI, -3.0 to -1.5] in back pain), symptoms and dysfunction (between-group difference: -0.9 [95% CI, -1.2 to -0.6] in symptom subscale, and -0.8 [95% CI, -1.1 to -0.5] in dysfunction subscale). CONCLUSIONS: Acupuncture provides immediate functional recovery and pain relief for degenerative lumbar spinal stenosis. However, current evidence is insufficient to support the suggestion that acupuncture could offer clinical benefits as compared with noninsertive sham acupuncture for degenerative lumbar spinal stenosis.

CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM) : Recommendations, explanation and elaboration.

BACKGROUND: N-of-1 trial is a desired and appropriate approach to assessing the efficacy and safety of traditional Chinese medicine (TCM) interventions. There have been an increasing number of N-of-1 trials for TCM published. However, a lack of preferred reporting guidance led in the general poor reporting quality of these trials. Due to the unique characteristics of TCM, the working group developed this CONSORT Extension for reporting N-of-1 Trials for Traditional Chinese Medicine (CENT for TCM) to assist TCM researchers in reporting N-of-1 trials for TCM. METHODS: We registered CENT for TCM at the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network (available at equator-network.org). The development was a comprehensive process through collection of the initial reporting items, two-round scientific Delphi consensus survey with 17 panelists, revision and formation of the final reporting checklist. RESULTS: The checklist includes 25 items within six domains, eight items in which were extended and elaborated on the items of the CENT 2015 checklist. Explanation of the items were listed adequately considering the nature of TCM, introducing the concept of TCM syndrome differentiation and TCM interventions. CONCLUSIONS: CENT for TCM can be used to assess the completeness of the reporting of N-of-1 trials for TCM. The working group expect that CENT for TCM could be a practical tool to enhance the comprehensiveness and transparency of the design, implementation and reporting of N-of-1 trials for TCM.

Assessment of the abstract reporting of systematic reviews of dose-response meta-analysis: a literature survey.

BACKGROUND: There is an increasing number of published systematic reviews (SR) of dose-response meta-analyses (DRMAs) over the past decades. However, the quality of abstract reporting of these SR-DRMAs remains to be understood. We conducted a literature survey to investigate the abstract reporting of SR-DRMAs. METHODS: Medline, Embase, and Wiley online Library were searched for eligible SR-DRMAs. The reporting quality of SR-DRMAs was assessed by the modified PRISMA-for-Abstract checklist (14 items). We summarized the adherence rate of each item and categorized them as well complied (adhered by 80% or above), moderately complied (50 to 79%), and poorly complied (less than 50%). We used total score to reflect the abstract quality and regression analysis was employed to explore the potential influence factors for it. RESULTS: We included 529 SR-DRMAs. Eight of 14 items were moderately (3 items) or poorly complied (5 items) while only 6 were well complied by these SR-DRMAs. Most of the SR-DRMAs failed to describe the methods for risk of bias assessment (30.2, 95% CI: 26.4, 34.4%) and the results of bias assessment (48.8, 95% CI: 44.4, 53.1%). Few SR-DRMAs reported the funding (2.3, 95% CI: 1.2, 3.9%) and registration (0.6, 95% CI: 0.1, 1.6%) information in the abstract. Multivariable regression analysis suggested word number of abstracts [> 250 vs. ≤ 250 (estimated ß = 0.31; 95% CI: 0.02, 0.61; P = 0.039)] was positively associated with the abstract reporting quality. CONCLUSION: The abstract reporting of SR-DRMAs is suboptimal, substantial effort is needed to improve the reporting. More word number may benefit for the abstract reporting. Given that reporting of abstract largely depends on the reporting and conduct of the SR-DRMA, review authors should also focus on the completeness of SR-DRMA itself.

Transcatheter versus surgical aortic valve replacement in low and intermediate risk patients with severe aortic stenosis: systematic review and meta-analysis of randomized controlled trials and propensity score matching observational studies.

BACKGROUND: To compare the outcome of transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in low and intermediate risk patients with severe aortic stenosis (AS). Randomized controlled trials (RCT) and propensity score matching (PSM) studies compare TAVR with SAVR in patients at low and intermediate surgical risk. METHODS: Two authors searched relevant literature independently, then extracted data from the included studies, and assessed risk of bias and quality of study separately according to different study designs, besides that, the extracted data was analyzed via utilization of GRADE system to evaluate the quality of evidence separately. RESULTS: Overall 15 studies (5 RCTs, 10 PSM studies) with total 12,057 patients were selected. Mortality and disabling stroke during follow-up period were comparable between TAVR and SAVR (RR 1.09, 95% CI: 0.81 to 1.46; RR 0.7, 95% CI: 0.45 to 1.07, respectively), TAVR revealed to be superior to SAVR regarding acute kidney injury (AKI), and onset of new atrial fibrillation (AF) (RCT: high certainty; AKI in PSM: moderate certainty, AF in PSM: low certainty). These results of RCT and PSM studies are consistent. In RCT review, SAVR was better in the following aspects: aortic valve (AV) re-intervention (high certainty), vascular complications, pacemaker implantation (moderate certainty), but comparable in the following aspects: myocardial infarction (MI), aortic insufficient (AI) (moderate certainty), major bleeding (low certainty). In PSM review, SAVR revealed a better result in AI and vascular complications (high certainty), but in the aspects of AV re-intervention, pacemaker implantation, major bleeding and MI (low certainty), it was comparable. CONCLUSIONS: TAVR is comparable to SAVR in terms of mortality and disabling stroke in severe AS patients at low and intermediate risk, but higher proportion of AV re-intervention observed in TAVR. Those results should encourage caution when extending the indications of TAVR into low risk patients, especially for young low risk patients. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD 42018112626.