Using GRADE as a framework to guide research on the sexual and reproductive health and rights (SRHR) of women living with HIV – methodological opportunities and challenges

In March 2016, WHO reviewed evidence to develop global recommendations on the sexual and reproductive health and rights (SRHR) of women living with HIV. Systematic reviews and a global survey of women living with HIV informed the guideline development decision-making process. New recommendations covered abortion, Caesarean section, safe disclosure, and empowerment and self-efficacy interventions. Identification of key research gaps is part of the WHO guidelines development process, but consistent methods to do so are lacking. Our method aimed to ensure consistency and comprised the systematic application of a framework based on GRADE (Grading of Recommendations, Assessment, Development and Evaluation) to the process. The framework incorporates the strength and quality rating of recommendations and the priorities reported by women in the survey to inform research prioritisation. For each gap, we also articulated: (1) the most appropriate and robust study design to answer the question; (2) alternative pragmatic designs if the ideal design is not feasible; and (3) the methodological challenges facing researchers through identifying potential biases. We found 12 research gaps and identified five appropriate study designs to address the related questions: (1) Cross-sectional surveys; (2) Qualitative interview-driven studies; (3) Registries; (4) Randomised controlled trials; and (5) Medical record audit. Methodological challenges included selection, recruitment, misclassification, measurement and contextual biases, and confounding. In conclusion, a framework based on GRADE can provide a systematic approach to identifying research gaps from a WHO guideline. Incorporation of the priorities of women living with HIV into the framework systematically ensures that women living with HIV can shape future policy decisions affecting their lives. Implementation science and participatory research are appropriate over-arching approaches to enhance uptake of interventions and to ensure inclusion of women living with HIV at all stages of the research process.     

Cryotherapy in reducing pain,trismus, and facial swelling after third-molar surgery: Systematic review and meta-analysis of randomized clinical trials

Background

The aim of this systematic review and meta-analysis was to evaluate the efficacy of cryotherapy in reducing pain, trismus, and facial swelling in patients undergoing third-molar surgery.

复方斑蝥胶囊联合不同放化疗方案治疗原发性肝癌有效性与安全性的Meta分析及试验序贯分析

目的:系统评价复方斑蝥胶囊联合不同放化疗方案治疗原发性肝癌(PHC)的有效性和安全性,旨在为临床用药提供循证参考。方法:计算机检索中国生物医学文献数据库、中国知网、万方数据、维普网、PubMed、Embase、Cochrane图书馆等,检索时限均为各数据库建库起至2020年9月,收集复方斑蝥胶囊联合不同放化疗方案(试验组)对比不同放化疗方案(对照组)的随机对照试验(RCT)、队列研究。筛选文献、提取资料后,采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具对RCT进行质量评价;采用纽卡斯尔-渥太华量表对队列研究进行质量评价;采用Rev Man 5.3软件进行Meta分析,采用TSA 0.9.5.10 Beta软件进行试验序贯分析,采用GRADE Profiler 3.6.1证据等级质量评价工具对RCT和队列研究进行证据质量等级评价。结果:共纳入15项RCT,共计1148例患者。Meta分析结果显示,试验组患者的治疗有效率显示高于对照组[RR=0.80,95%CI(0.73,0.88),P<0.00001];按化疗方案不同进行亚组分析的结果显示,试验组联合肝动脉化疗栓塞术(TACE)介入治疗方案、三维适形放疗方案患者的治疗有效率均显著高于对照组(P<0.05)。试验组患者的生存率显著高于对照组[RR=0.81,95%CI(0.74,0.89),P<0.0001];按生存时间不同进行亚组分析的结果显示,试验组患者1年、2年、3年生存率均显著高于对照组(P<0.05)。试验组患者骨髓抑制发生率显著低于对照组,自然杀伤细胞计数、T细胞亚群计数均显著高于对照组(P<0.05);而两组患者甲胎蛋白含量、肝功能指标比较,差异均无统计学意义(P>0.05)。试验序贯分析结果显示,复方斑蝥胶囊联合TACE介入治疗的治疗有效率更优的证据确切。GRADE评价结果显示,治疗有效率的证据等级为中级,生存率及骨髓抑制发生率的证据等级为低级,其余指标均为极低级。结论:复方斑蝥胶囊联合不同放化疗方案用于PHC的疗效显著且安全性较好,尤以联合TACE介入治疗的疗效最佳,且治疗有效率的证据等级为中级。     

Effects of Tai Chi on health outcomes in patients with type 2 diabetes mellitus: A systematic review and meta-analysis

ObjectiveTo explore the effects and dose–response relationship of Tai Chi for type 2 diabetes mellitus (T2DM) and to evaluate the methodological quality of the included trials and evidence quality of the outcomes.MethodsNine major English and Chinese databases were searched for randomized controlled trials of Tai Chi for T2DM from inception to December 2021. The effects and dose–response relationships were assessed with a meta-analysis and meta-regression using Stata.16. The methodological quality of the included studies was assessed using the risk of bias tool. The evidence quality of the outcomes was assessed using the GRADE tool.ResultsA total of 24 studies with 1314 patients were included. Compared with the usual care, Tai Chi improved HbA1c (MD = ?0.80%, 95% CI [?1.05, ?0.54], P < .001, I² = 18.29%, very low–quality evidence), FBG (SMD = ?0.58, 95% CI [?0.86, ?0.31], P < .001, I² = 53.2%, low-quality evidence), fasting insulin (FIN), diastolic blood pressure, BMI, and the outcomes of quality of life (QoL) in patients with T2DM. However, when Tai Chi was compared with other exercise, there was no between-group difference in the HbA1c, FBG, TC, TG, HDL, LDL, BMI, and waist circumference (WC). Furthermore, the findings showed that an increase at every 18 weeks in length or an 823-h increase in the total time of Tai Chi intervention resulted in approximately a one unit reduction in the SMD of FBG.ConclusionCompared with usual care, Tai Chi may improve HbA1c (with clinical significance), FBG, FIN, BMI, diastolic blood pressure, and outcomes of QoL in T2DM patients. The effects of Tai Chi were similar to those of other exercises on the HbA1c, FBG, TC, TG, HDL, LDL, BMI, and WC. Given the overall poor methodological quality and evidence quality, these findings should be treated cautiously.     

丹参多酚酸盐注射液联合西医常规治疗对慢性心力衰竭疗效及安全性的系统评价及试验序贯分析

目的 系统评价丹参多酚酸盐注射液联合西医常规治疗对慢性心力衰竭的有效性和安全性。方法 计算机检索中国知网、万方、维普、PubMed等数据库中相关随机对照试验(randomized controlled trials,RCTs),检索时间限定为建库至2022年3月20日。采用偏倚风险评估工具进行文献质量评价,使用RevMan 5.3、Stata 15.0软件进行Meta分析,通过TSA 0.9.5.10 Beta软件进行试验序贯分析,并按照GRADE标准进行证据质量评价。结果 最终共纳入23个RCTs,共计2421例患者,纳入研究的整体方法学质量较低。Meta分析结果显示,与西医常规治疗相比,联合丹参多酚酸盐注射液可显著提高临床总有效率[OR=3.95,95% CI(2.92,5.35),P<0.000 01],降低Lee心衰评分[MD=−0.95,95% CI(−1.37,−0.52),P<0.000 1],提高6 min步行距离[MD=44.50,95% CI(32.02,56.97),P<0.000 01],降低血浆B型脑钠肽(B-type natriuretic peptide,BNP)浓度[MD=−74.78,95% CI(−89.24,−60.33),P<0.000 01];改善心功能指标,包括提高射血分数(left ventricular ejection fraction,LVEF)[MD=5.33,95% CI(4.33,6.32),P<0.000 01],降低左室收缩末期内径(left ventricular end systolic diameter,LVESD)[MD=−5.73,95% CI(−8.04,−3.43),P<0.000 01]、左室舒张末期内径(left ventricular end-diastolic diameter,LVEDD)[MD=−5.12,95% CI(−7.16,−3.08),P<0.000 01]及室间隔厚度(interventricular septal thickness,IVST)[MD=−1.12,95% CI(−1.60,−0.64),P<0.000 01],提高心输出量(cardiac output,CO)[MD=1.12,95% CI(1.00,1.23),P<0.000 01]、心脏指数(cardiac index,CI)[MD=1.12,95% CI(1.00,1.25),P<0.000 01]及每搏量(stroke volume,SV)[MD=9.34,95% CI(5.39,13.29),P<0.000 01];降低炎症指标,包括白细胞介素-6(interleukin-6,IL-6)[MD=−1.84,95% CI(−2.36,−1.31),P<0.000 01]、肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)[MD=−0.74,95% CI(−0.83,−0.66),P<0.000 01]及超敏C反应蛋白(high-sensitivity C-reactive protein,hs-CRP)[MD=−0.97,95% CI(−1.27,−0.67),P<0.000 01];降低心型脂肪酸结合蛋白(heart fatty acid binding protein,H-FABP)表达[MD=−9.74,95% CI(−12.21,−7.27),P<0.000 01]。在不良反应发生率方面,两组比较差异无统计学意义[RR=0.63,95% CI(0.18,2.17),P=0.47]。试验序贯分析进一步肯定了联合丹参多酚酸盐注射液对慢性心力衰竭患者的疗效。GRADE证据质量分级显示临床总有效率为中等质量证据,Lee心衰评分、LVESD等8项结局指标均为低质量证据,其余均为极低质量证据。结论 与西医常规治疗相比,联合丹参多酚酸盐注射液能显著提高临床疗效,无明显不良反应,然而证据等级不高,期待开展更多高质量、大样本、多中心的RCTs,为丹参多酚酸盐注射液治疗慢性心力衰竭提供更充分的循证证据。     

针刺治疗血管性认知障碍的系统评价再评价

目的:对针刺治疗血管性认知障碍的系统评价(SR)进行方法学质量、报告质量和证据质量等级的再评价。方法:计算机检索PubMed、Cochrane Library、EMbase、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(SinoMed)、万方数据库(Wanfang)、维普数据库(VIP)收录的中英文公开发表的针刺治疗血管性认知障碍的SR,检索时限均为建库至2020年9月24日。采用PRISMA声明、AMSTAR 2工具和GRADE分级系统分别评价所纳入SR的报告质量、方法学质量和证据质量。结果:最终纳入22篇SR,包含102个结局指标。方法学质量整体偏低,得分较差的条目为条目2、5、7、10、14、15、16。22篇SR的报告质量较好,得分在19～24.5分,报告质量问题主要体现在结构式摘要、方案与注册、其他分析及资金支持方面。SR结局指标的等级大部分为低或极低,导致降级的最主要因素为局限性,其次为不一致性和不精确性。结论:针刺治疗血管性认知障碍有低质量循证医学证据支持,但相关系统评价的方法学质量及证据质量较差,规范性仍有待提高。     

中药治疗特发性肺纤维化系统评价/Meta分析的再评价＊

目的 对中药治疗特发性肺纤维化系统评价/Meta分析进行再评价研究，以期为临床医师及研究者提供更科学的决策支持。方法 检索中药治疗特发性肺纤维化系统评价/Meta分析的文献，筛选文献后提取资料，采用AMSTAR2（A Measurement Tool To Assess Systematic Reviews 2）量表和GRADE（Grade of Recommendation，Assessment，Development，and Evaluation）系统工具进行评估。结果 共纳入14篇文献，106次结局指标；AMSTAR2量表结果示3篇属于低质量，11篇属于极低质量；GRADE分级显示，10次结局指标证据质量等级中等，83次等级低，13次等级极低。结论 中药治疗特发性肺纤维化系统评价/Meta分析的方法学质量为低、极低，结局指标的证据质量等级多为低，高质量、证据强度高级别的系统评价亟需开展，从而作为高级别证据来指导临床。     

Evidence-based consensus for treating incipient enamel caries in adults by non-invasive methods: recommendations by GRADE guideline

Remineralization treatment, which offers the advantage of being non-invasive, is increasingly being used as a minimal intervention treatment in managing incipient enamel caries. The aim of this review was to develop EBM guideline for optimized strategies for non-invasive treatment of incipient enamel caries.Japanese Society of Conservative Dentistry (JSCD) guideline committee formulated a Guideline for treating incipient enamel caries using the GRADE system, which is the global, mainstream standard for guideline development. The committee selected the most frequent clinical questions (CQs) in treating incipient enamel caries and identified clinically important outcomes in evaluating the efficacy of treatments. Using extensive electronic and manual searches, relevant randomized controlled trials and controlled clinical trials were identified. Based on evidence profiles produced by the committee, the panel discussed the effects, benefits and disadvantages of the selected treatments, as well as their cost effectiveness and feasibility, in order to achieve a consensus in treating incipient enamel caries non-invasively. A recommendation was made for each clinical question after voting by the panel members. Based on the evidence profile and panel discussions for each CQ, the experts strongly recommended application of topical fluoride to inhibit cavitation of incipient enamel caries, and to diminish white spot lesions.