Objective To assess the reporting quality of noninferiority and equivalence randomized controlled trials (RCTs) related to Traditional Chinese Medicine (TCM). Methods The noninferiority and equivalence RCTs related to TCM were searched, and the quality of the included RCTs was identified in accordance with the extended version of CONSORT statement which refers to the reporting standard of noninferiority and equivalence RCTs. Results A total of 13 noninferiority and equivalence RCTs were included. Except for the common questions of RCTs in reporting quality, some contents related to noninferiority and equivalence trials in reporting were not enough: a) The title of RCTs did not reflect the most important content of the literature; b) The introduction of background was quite simple. The rationale about noninferiority and equivalence trials, and the effectiveness of positive control were not clearly defined; c) All literatures did not indicate whether the subjects, interventions and outcomes in the noninferiority and equivalence trials were identical or similar to those in previous trials of defining the effectiveness of control treatment; d) Most literatures did not define the critical value of noninferiority and equivalence, and did not estimate the sample size; e) Only half of literature described the statistical methods of noninferiority test and equivalence test; and f) Some literature had mistakes in noninferiority and equivalence conclusion. Conclusion The researchers still need deeper understanding of the theoretical basis of noninferiority and equivalence trials. The reference to the extended version of CONSORT statement, which refers to the reporting standard of noninferiority and equivalence RCTs, is helpful for researchers to identify the key points of the design, performance and reporting of the noninferiority and equivalence RCTs, to lay stress on the related contents of noninferiority and equivalence trial reporting, and to radically improve the reporting quality of such clinical trials.
Objective To evaluate the methodological and reporting quality of randomized controlled trials involving traditional Chinese medicine in the treatment of cholelithiasis. Methods We searched CNKI (1994 to 2007), CMCC (1994 to 2007), VIP (1989 to 2007), MEDLINE (1966 to April 2007) and The Cochrane Library (Issue 4, 2006). Data from randomized controlled trials (RCTs) and quasi-RCTs were extracted by two reviewers independently. The methodological quality of included trials was assessed by using the quality assessment criteria recommended by The Cochrane Collaboration, and the reporting quality was assessed by using the CONSORT for TCM checklist. Results Seventeen studies including 16 RCTs and one quasi-RCT were included. The methodological and reporting qualities of included studies were generally low. All studies were graded C. The highest score evaluated by the CONSORT for TCM checklist was 18. Conclusion The quality of RCTs and quasi-RCTs involving traditional Chinese medicine for cholelithiasis is generally low, with a high risk of biases. The reporting of these trials is also incomplete, which would affect a reader’s understanding and evaluation of the validity, importance and applicability of the study results. Therefore, new randomized controlled trials of high quality are required to provide reliable evidence.
With the development of health technology assessments, the public are increasingly aware of the importance of assessing timeliness for health decision-making, which emerges the requirement for early and timely assessment for emerging health technologies. Providing early and timely assessments prior to a technology accesses the market or prior to implementation can provide decision-makers with sufficient time to develop an application program for a new technology. This paper mainly summarizes the profiles of three emerging health technology horizon scanning systems in Canada, Australia, New Zealand and Sweden, and compares and analyzes their related contents, thus providing reference experience for the construction of emerging health technology horizon scanning system in China.
ObjectiveTo evaluate the methodological quality of clinical practice guidelines and expert consensus of chronic heart failure domestically and abroad.MethodsPubMed, EMbase, SinoMed, CNKI, WanFang Data, and VIP databases, and related websites were searched to collect guidelines and expert consensus on chronic heart failure published from January 1st, 2011 to December 31st, 2020. Four reviewers evaluated the methodological quality of the guidelines and expert consensus with the AGREE Ⅱ tool after the consistency evaluation training.ResultsA total of 17 studies were included (consisting of 11 English and 6 Chinese studies). The recommended levels were B level (recommend after modification) for 10 studies and C level (not recommended) for 7 studies. The AGREE Ⅱ standardized mean scores for various fields were 69.61% (scope and purpose), 34.20% (stakeholder involvement), 33.13% (rigor of development), 84.53% (clarity and presentation), 42.40% (applicability), and 37.09% (editorial independence). The methodological quality of English guidelines was generally high (level B for 10 and level C for 1), while all scores of Chinese guidelines or consensus in the 6 fields were mostly lower than the average (level C for 6).ConclusionsThe guidelines for the diagnosis and treatment of chronic heart failure requires further improvement in terms of stakeholder involvement and rigor of development. It should develop standards and methods to improve the quality for Chinese guidelines and expert consensus to better serve clinical practice.
Objective To systematically review venous thromboembolism (VTE) risk assessment tools. Methods The Embase, PubMed, CNKI, CBM, WanFang Data, VIP databases and 22 relevant institutions and associations were searched to identify all VTE assessment tools from inception to December 31, 2022. Two researchers independently screened the literature, extracted data, and cross-checked the data. A qualitative analysis was used to describe the country's essential characteristics, publishing organization, year, applicable disease type, applicable population, tool formation method, etc. Key elements and techniques were compared in terms of evaluation dimension, methods, and procedures to form the tool, risk stratification ability, and whether to verify. Results A total of 42 VTE risk assessment tools were included, of which 16 were in the United States, and only 4 were in China. They were released between 1996 and 2021, and the applicable disease types and populations differ. Nineteen tools were constructed based on case-control or retrospective cohort studies, 16 were conducted using prospective cohort studies, and 5 were based on cross-sectional and RCT studies; Additionally, 20 tools were built based on logistic regression models; The evaluation dimensions of each tool differed, and the most common frequency of occurrences were VTE history, age, BMI value, and confirmed tumor, accounting for 64.29%, 54.76%, 54.76%, and 47.62%, respectively. Thirty-three tools were stratified for risk, and 30 tools were presented in the form of risk scores; Some tools lacked clinical validation data, and only 12 tools were analyzed for specificity, sensitivity, NPV, PPV, and AUC. Conclusion The evaluation dimensions and evidence sources of existing VTE risk assessment tools are not completely consistent, the implementation methods and results presentation forms of the tools are not completely the same, and the scope of application is different; Some tool construction methods and processes are not clear enough, and there is a lack of validation research on external validity, which has certain limitations in promoting clinical practice in China.
Objective
To explore the effect of self-assessment of pain in perioperative pain management of total knee arthroplasty (TKA).
Methods
A total of 140 patients undergoing TKA from March 2016 to March 2017 were randomly divided into the control group and the trial group. The patients in the two groups were received the same education relating to pain knowledge. The intensity of pain was assessed by nurses in the control group, while in the trial group, it was assessed by patients themselves. According to the assessment of pain, treatments were given to both groups. Time of pain assessment, types and frequencies of temporary rescue medicine, pain intensity, the score of Self-efficacy for Rehabilitation Outcome Scale (SER) and the range of motion (ROM) of knee were observed and recorded.
Results
There were 132 patients who completed the final observation, with 67 in the trial group and 65 in the control group. There were significant differences between the two groups in evaluation time of pain (t=–2.736, P=0.007), types and frequencies of temporary rescue medicine (χ2=10.276, P<0.05), the overall postoperative pain score (Z=–2.146, P=0.032), average hospitalization time after surgery (t=–2.468, P=0.015), SER scores 7 days after surgery (F=2.390, P=0.018) and 14 days after surgery (F=3.427, P=0.001), and ROM at the postoperative day 7 (F=2.109, P=0.037); there were no significant differences in postoperative daily pain scores (Z=–1.779, P=0.077), SER scores at the postoperative day 3 (F=1.010, P=0.314), ROM at the postoperative day 1 (F=1.319, P=0.189) and day 14 (F=1.603, P=0.111).
Conclusion
Self-assessment of pain can motivate TKA patients to take part in pain management, and more accurate response to the pain intensity will help to optimize the management of perioperative pain and reduce the workload of the health staff, thereby contributing to enhanced recovery.
Objective To evaluate reporting and methodological quality of systematic reviews or meta-analyses in nursing field in China. Methods CNKI database was searched for systematic reviews or meta-analyses in nursing field from the establishment date to December 2011. Two reviewers independently identified the literature according to inclusion and exclusion criteria, and then extracted the data using Excel software. The PRISMA and AMSTAR checklists were used to assess reporting characteristics and methodological quality, respectively. Results A total of 63 systematic reviews or meta-analyses involving 21 systematic reviews and 42 meta-analyses were identified. These articles were published on 13 journals such as The Chinese Nursing Research, the Chinese Journal of Nursing, and the Chinese Journal of Evidence-Based Medicine. The deficiencies of methodological quality mainly contained literature search, heterogeneity handling, recognition and assessment of publication bias. In addition, the deficiencies of reporting characteristics were reflected on incomplete reporting of literature search, quality assessment, risk of bias and results (some studies lacked forest plot, estimated value of pooled results, 95%CI or heterogeneity). Conclusion As a whole, the included reviews and meta-analyses have more or less flaws with regard to the quality of reporting and methodology based on the PRISMA and AMSTAR checklists. Focusing on the improvement of reporting and methodological quality of systematic review or meta-analysis in nursing field in China is urgently needed in order to increase the value of these studies.
ObjectiveTo understand the current evaluation methods and treatment progress of low anterior resection syndrome (LARS) after rectal cancer surgery.MethodThe recent literatures on the progress of LARS studies were reviewed.ResultsThe occurrence mechanism of LARS was closely related to the function state of anus before operation, the nerve and muscle injuries around the anus and rectum during the operation, as well as the new rectal volume and compliance. For this symptom group, there were various clinical evaluation methods, including the various quality of life score scales, fecal incontinence related scales, LARS score scale, anorectal pressure measurement, and imaging examination of anal sphincter, etc. The treatment included the anal lavage, comprehensive rehabilitation training, sacral nerve stimulation, traditional Chinese medicine therapy, and other treatment methods.ConclusionLARS might be prevented or alleviated through accurately preoperative evaluation, standardized and reasonable surgery and adjuvant therapy, and effective postoperative intervention.
ObjectiveTo investigate the reporting and methodological quality of systematic reviews/ meta-analyses conducted by hospital pharmacists in China, so as to improve the quality of systematic reviews/ meta-analyses in this field. MethodsThe literatures were retrieved from CNKI, WanFang Data, VIP, CBM, CMCI, PubMed, EMbase, The Cochrane Library from the establishment date to March 17th, 2016. According to the inclusive and exclusive criteria, authors independently screened and extracted the published information. Reporting and methodological quality of included reviews were evaluated by PRIMSA statements and AMSTAR checklists. Data analysis was conducted by using Excel 2013 software and SPSS 20.0 software. ResultsOne thousand and eighteen systematic reviews/ meta-analyses were included, including 871 Chinese literatures and 147 English literatures. The average score of PRIMSA was 18.41±2.84, and the average score of AMSTAR was 7.38±1.28. The main problems of PRIMSA were structured summary, objectives, protocol and registration, additional analyses and funding. The main problems of AMSTAR were priori design, status of publication and list of studies (included and excluded). Univariate analysis showed that some factors could improve the quality of methodology and reporting, including studies in English (P<0.000 1), published after checklists' (P<0.000 1), hospital in higher-level (P<0.000 1), illuminating the funding or interest conflict (P<0.000 1). Pearson analysis indicated that linear correlation were detected between PRISMA scores and AMSTAR scores (P<0.000 1), as well as citations and AMSTAR scores (P=0.045). ConclusionEvidenced-based pharmacy in hospital has developed rapidly, the quality of methodology and reporting have increaseed year by year, but further improvement should be considered in different aspects. The methods to evaluate the clinical application of these systematic reviews/ meta-analyses should be developed in the future.
