ArticleLiterature Review

Assessment of Completeness of Reporting in Randomized Controlled Trials of Acupuncture Therapy for Chronic Obstructive Pulmonary Disease

Authors:
To read the full-text of this research, you can request a copy directly from the authors.

Abstract

Objective: To assess the completeness of reporting in randomized controlled trials (RCTs) of acupuncture therapy (AT) for chronic obstructive pulmonary disease (COPD). Methods: We systematically searched PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), WANFANG Data, and China Biology Medicine (CBM) for studies published from their inception to May 8, 2021. The completeness of reporting was evaluated by CONSORT statement and STRICTA guidelines. Univariate and multivariate regression analyses were performed to preliminarily explore the factors related to completeness of reporting. Results: A total of 44 RCTs were included. The overall quality score (OQS) based on the CONSORT statement and STRICTA guidelines ranged from 3 to 26 and 7 to 14, with a median of 10 and 11, respectively. Among the 35 items of the CONSORT statement, 10 items were fully reported with reporting rate > 70%, and 11 items were poorly reported at a rate < 5%. Among the 17 items of the STRICTA guidelines, 10 items were adequately reported with > 70%, and only 3 items were incompletely reported at a rate < 20%. The agreement of most items was determined as "good", "substantial", or "moderate". By regression analysis, publication language (β coefficient: 6.432, 95% CI: 3.202 to 9.663, P <0.001) and funding source (β coefficient: 3.159, 95% CI: 1.045 to 5.273, P =0.004) acted as independent predictors of completeness of reporting according to the CONSORT statement. However, no variables associated with the STRICTA guidelines were identified. Conclusion: The completeness of reporting of AT for COPD was inadequate. The condition relatively improved for trials with publication in the English language and funding source. By recommendation, reports should be strictly standardized in accordance with the CONSORT statement and STRICTA guidelines to improve the clinical research evidence of AT for COPD.

No full-text available

Request Full-text Paper PDF

To read the full-text of this research,
you can request a copy directly from the authors.

ResearchGate has not been able to resolve any citations for this publication.
Article
Full-text available
As a traditional Chinese alternative health care approach, acupuncture is gaining increasing attention and reputation in China and overseas. While becoming increasingly popular globally, some consumers and professionals still know little about the therapy and underlying mechanisms of acupuncture. Due to local superiority, there are large numbers of both clinical applications and mechanistic studies performed in China compared to countries overseas. Herein, this review attempts to give a comprehensive profile of the development, application, and mechanisms of acupuncture in treating major diseases. The number of clinical publications concerning acupuncture-treated neurological diseases, endocrine and metabolic diseases, circulatory diseases, respiratory diseases, etc. is first counted, and then, the application and therapeutic mechanisms of acupuncture on the predominant diseases in each category, including obesity, facial paralysis, sciatica, depression, hypertension, asthma, etc., are specifically discussed in this paper. The evolution of acupuncture tools and the rationality of acupoints are also discussed. This review not only summarizes the mechanisms of acupuncture but also provides useful information, such as specific acupoints and acupuncture procedures, for treating common diseases. Therefore, the current study provides useful information for both investigators and acupuncturists.
Article
Full-text available
Background: The completeness of reporting of acupuncture interventions is critical to ensure the applicability and reproducibility of acupuncture clinical trials. In the past, different publications have evaluated the completeness of reporting of acupuncture interventions for different clinical situations, such as knee osteoarthritis, neurological diseases or cancer. However, this has not been done for acupuncture trials for chronic obstructive pulmonary disease (COPD). Objective: To assess the completeness of reporting of acupuncture interventions in trials for COPD. Methods: A total of 11 English and Chinese databases were screened up until May 2019 for randomised or quasi-randomised control trials of acupuncture for COPD. The STRICTA checklist was used to determine the quality of the reporting of acupuncture interventions. Results: A total of 28 trials were included in our review. Out of the 16 STRICTA checklist subitems analysed, only 4 were considered appropriately reported in more than 70% of the trials, while 7 were correctly reported in less than 30%. Conclusion: The adherence to STRICTA guidelines of acupuncture trials for COPD is suboptimal, and future efforts need to be addressed to improve the completeness of reporting.
Article
Full-text available
Objective: To explore the methods for improving the reporting quality of randomised controlled trials (RCTs) on acupuncture through evaluating the reporting quality in RCTs of acupuncture for acute herpes zoster by the CONSORT statement and STRICTA guidelines. Methods: English and Chinese databases were searched from database creation until October 2018 and updated to July 2019. The basic characteristics and methodological quality of the literatures included were evaluated based on the CONSORT statement and the STRICTA guidelines. Descriptive statistical analysis was used in this study. The agreement between the two researchers of all items was calculated by Cohen's kappa statistics. Results: A total of 40 RCTs were included. Based on the CONSORT statement, items "Background," "Randomised" in the title or abstract," "Statistical methods," and "Outcomes and estimation" were good reporting, with positive rates >80%. However, the quality of reporting in items "Sample size," "Allocation concealment," "Implementation," "Blinding," "Flow chart," "Intent-to-treat analysis," "Ancillary analyses," and "Clinical Trials Register" was very poor, with positive rates <10%. Based on the STRICTA guidelines, good reporting existed in items "Acupuncture rational," "Points used," "Needle stimulation," "Needle retention time," "Course of treatment," "Control intervention," and "Treatment frequency," with positive ratings >80%. The reporting quality of items "Numbers of needles inserted," "Depth of insertion," "Responses elicited," and "Practitioner background" was lower, with positive rates <50%. The agreement of most items was judged as moderate, substantial, or good. Conclusion: The reporting quality of RCTs in acupuncture for acute HZ is generally inadequate. It is necessary that researchers and journal editors learn and raise the adoption of the CONSORT statement and STRICTA guidelines to enhance the reporting quality of the RCTs in acupuncture.
Article
Full-text available
Background: Lack of information about economic burden of COPD, is a major cause of lack of attention to this chronic condition from governments and policymakers. Objective: To find the economic burden of COPD in Asia, USA and Europe, and to identify the key cost driving factors in management of COPD patients. Methodology: Relevant studies assessing the cost of COPD from patient perspective or societal perspective were retrieved by thoroughly searching PUBMED, SCIENCE DIRECT, GOOGLE SCHOLAR, SCOPUS, and SAGE Premier Databases. Results: In USA annual per patient direct medical cost and hospitalization cost were reported as $10367 and $6852 respectively. In Asia annual per patient direct medical cost in Iran, Korea and Singapore was reported as $1544, $3077, and $2335 respectively. Whereas, annual per patient hospitalization cost in Iran, Korea, Singapore, India, China, and Turkey was reported as $865, $1371, $1868, $296, $1477 and $1031 respectively. In Europe annual per patient direct medical cost was reported as $11787, $10552, $8644, $8203, $7760, $3190, $1889, $2162, and $2254 in Norway, Denmark, Germany, Italy, Sweden, Greece, Spain, Belgium, and Serbia respectively. Conclusion: Limiting the disease to early stage and preventing exacerbations may reduce the cost of management of COPD.
Article
Full-text available
Background: This study evaluates the reporting quality of randomized controlled trials (RCTs) on acupuncture use for the treatment of postherpetic neuralgia and explores related factors. Methods: The following six databases PubMed, Embase, Cochrane Library, VIP, CNKI, and SinoMed, were systematically searched from their inception to December 2018. RCTs using acupuncture as an intervention for postherpetic neuralgia were selected and incorporated in this study. The reporting quality was assessed based on the CONSORT statement and the STRICTA guidelines. Regression analyses were also conducted on pre-specified study characteristics searching for factors associated with reporting quality. Results: A total of 137 RCTs were included in this study. The CONSORT based median OQS was 12 (minimum 3, maximum 29). Of the items comprised in the statement, ten were sufficiently reported (reported in over 70% of trials). The remaining fifty-five items were poorly reported (reported by fewer than 5% of trials). The STRICTA based median OQS was 9 (minimum 2, maximum 15). The results showed that eight of the comprised items were well reported (reported in over 70% of trials), and only three were incompletely reported (reported in fewer than 20% of trials). Based on the CONSORT statement related analysis, a post-2010 publication (β coefficient 2.394, 95% confidence interval [CI] 1.168–3.620) and funding (β coefficient 4.456, 95% CI: 3.009–5.903) represented independent and significant predictors of a high overall reporting quality. However, only a funding source (β coefficient 1.305, 95% CI 0.219–2.391) was associated with an increased OQS based on STRICTA analysis. Conclusion: The findings indicated that RCTs on acupuncture for PHN generally had a sub-optimal reporting quality, a situation that improved for those published after 2010 or with funding sources. Therefore, rigorous adherence to the CONSORT statement and the STRICTA guidelines should be emphasized in future studies.
Article
Full-text available
Background Clear and unambiguous reporting is essential for researchers and clinicians to be able to assess the quality of research. To enhance the quality of reporting, consensus-based reporting guidelines are commonly used. Objectives To update and extend previous research by evaluating the more recent impact of STRICTA (STandards for Reporting Interventions in Controlled Trials of Acupuncture) and CONSORT (CONsolidated Standards Of Reporting Trials) guidelines on the quality of reporting of acupuncture trials. Methods By random sampling, approximately 45 trials from each of five 2-year time periods between 1994 and 2015 were included in the study. Using scoring sheets based on the STRICTA and CONSORT checklist items (range 0 to 7 and 0 to 5, respectively), the distribution of items reported over time was investigated, with changes shown using scatterplots. The primary analysis used a before-and-after t-test to compare time periods. A meta-analysis investigated whether or not trials published in journals that endorsed STRICTA were associated with better reporting. Results The study included 207 trials. Improved reporting of items over time was observed, as represented by changes in the scatterplot slope and intercept. The mean STRICTA score increased from 4.27 in the 1994–1995 period to 5.53 in 2014–2015, an 18% improvement. The mean CONSORT score rose from 1.01 in the 1994–1995 period to 3.32 in 2014–2015, an increment of 46%. There was proportionately lower reporting for items related to practitioner background (STRICTA) and for randomisation implementation and allocation concealment (CONSORT). Trials published in journals that endorsed STRICTA had statistically significantly superior reporting of both STRICTA and CONSORT items overall. Conclusion This study has provided evidence of an improvement in reporting of STRICTA and CONSORT items over the time period from 1994 to 2015. Journals that endorse STRICTA have a better record in terms of reporting quality. Some evidence suggests that the publication of STRICTA has had a positive impact on reporting quality.
Article
Full-text available
Objective This study aimed to evaluate the efficacy and safety of acupuncture therapy (AT) for improving functional effects and quality of life in COPD patients. Methods PubMed, Embase, Cochrane Library, Web of Science, Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), and Wanfang Data were searched. The randomized controlled trials (RCTs) evaluating the effect of AT on COPD patients were included. Primary outcome measures included six-minute walk distance (6MWD) and St. George's Respiratory Questionnaire (SGRQ). Study selection, data extraction, and risk of bias assessment were independently conducted, respectively. Statistical analysis was conducted by RevMan software (version 5.3) and Stata software (version 12.0). Results Nineteen studies (1298 participants) were included. 6MWD improved more (MD: 47.84; 95% CI: 23.33 to 72.35; Z = 3.83, P = 0.0001) and effective rate was higher (OR: 2.26; 95% CI: 1.43 to 3.58; Z = 3.48, P = 0.0005) in the experimental group compared to the control group. Symptom domain scores (MD: −24.86; 95% CI: −32.17 to −17.55; Z = 6.66, P < 0.00001), activity domain scores (MD: −16.52; 95% CI: −22.57 to −10.47; Z = 5.36, P < 0.00001) and impact domain scores (MD: −13.07; 95% CI: −17.23 to −8.92; Z = 6.16, P < 0.00001) of SGRQ in the experimental group improved more compared to the control group. There was no significant improvement in SGRQ total scores between two groups. The improvement of FEV1 was not significant between two groups, yet subgroup analysis showed that patients treated with AT adjunctive to other treatments improved more in FEV1 (MD: 0.41; 95% CI: 0.28 to 0.54; Z = 6.01, P < 0.00001) compared to those treated with other treatments alone. Conclusion AT may be effective in improving functional effects and quality of life in COPD patients. Besides, AT may also improve pulmonary function of patients with COPD. However, further high-quality RCTs are needed to confirm the efficacy and safety of AT for COPD patients.
Article
Full-text available
Introduction Meta-epidemiological studies examining the influence of methodological characteristics, such as allocation concealment and intention-to-treat analysis have been performed in a large number of healthcare areas. However, there are no studies investigating these characteristics in physical therapy interventions for patients with low back pain. The aim of this study is to investigate the influence of allocation concealment and the use of intention-to-treat analysis on estimates of treatment effects of physical therapy interventions in low back pain clinical trials. Methods and analysis Searches on PubMed, Embase, Cochrane Database of Systematic Reviews, Physiotherapy Evidence Database (PEDro) and CINAHL databases will be performed. We will search for systematic reviews that include a meta-analysis of randomised controlled trials that compared physical therapy interventions in patients with low back pain with placebo or no intervention, and have pain intensity or disability as the primary outcomes. Information about selection (allocation concealment) and attrition bias (intention-to-treat analysis) will be extracted from the PEDro database for each included trial. Information about bibliographic data, study characteristics, participants’ characteristics and study results will be extracted. A random-effects model will be used to provide separate estimates of treatment effects for trials with and without allocation concealment and with and without intention-to-treat analysis (eg, four estimates). A meta-regression will be performed to measure the association between methodological features and treatment effects from each trial. The dependent variable will be the treatment effect (the mean between-group differences) for the primary outcomes (pain or disability), while the independent variables will be the methodological features of interest (allocation concealment and intention-to-treat analysis). Other covariates will include sample size and sequence generation. Ethics and dissemination No ethical approval will be required for this study. The study findings will be published in a peer-reviewed journal and presented at international conferences. Registration number International Prospective Register of Systematic Reviews (CRD42016052347).
Article
Full-text available
Background This study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke. Methods The following 8 databases were systematically investigated from their inception to December 2015: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, National Institute of Informatics Scholarly and Academic Information Navigator, National Digital Science Library, Korean Traditional Knowledge Portal, and Korean Studies Information Service System. RCTs utilizing scalp acupuncture as an intervention for stroke were selected, and the quality of reports was assessed based on the Consolidated Standards of Reporting Trials 2010 statement (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture 2010 (STRICTA). For each study, the overall quality score (OQS) of 13 CONSORT items, a combined key methodological index score (MIS) of 5 CONSORT items, and the OQS of 17 STRICTA items were measured. Results The original reports of 63 RCTs were ultimately obtained, and the median CONSORT OQS was 7 (minimum 2, maximum 11). Particularly, the items ‘trial design’, ‘sample size’, ‘ancillary analyses’, and ‘harms’ had a positive rate of less than 10%. The median MIS was 1 (minimum 0, maximum 5), with ‘allocation concealment and implementation’ and ‘intent-to-treat analysis (ITT) analysis’ having a positive rate of less than 10%. The median STRICTA OQS was 11 (minimum 6, maximum 14), and only the items ‘sample size’ and ‘intent-to-treat analysis’ were reported, with a positive rate of less than 10%. The mean CONSORT OQS increased by approximately 0.81 for each 5-year period in which manuscripts were published (95% confidence interval: 0.43 to 1.19; p < 0.001). No variable was significantly associated with MIS in the ordinal regression model. Conclusion The quality of reports on RCTs investigating scalp acupuncture treatment for stroke was moderate to low. Furthermore, reporting of some items was either insufficient or inadequate in the majority of studies. In order to improve and standardize the quality of RCTs investigating scalp acupuncture for stroke, CONSORT and STRICTA guidelines should be utilized more frequently.
Article
Full-text available
Acupuncture is increasingly used worldwide. It is becoming more accepted by both patients and healthcare providers. However, the current understanding of its adverse events (AEs) is fragmented. We conducted this overview to collect all systematic reviews (SRs) on the AEs of acupuncture and related therapies. MEDLINE and EMBASE were searched from inception to December 2015. Methodological quality of included reviews was assessed with a validated instrument. Evidence was narratively reported. Seventeen SRs covering various types of acupuncture were included. Methodological quality of the reviews was overall mediocre. Four major categories of AEs were identified, which are organ or tissue injuries (13 reviews, median: 36 cases, median deaths: 4), infections (11 reviews, median: 17 cases, median deaths: 0.5), local AEs or reactions (12 reviews, median: 8.5 cases, no deaths were reported), and other complications such as dizziness or syncope (11 reviews, median: 21 cases, no deaths were reported). Minor and serious AEs can occur during the use of acupuncture and related modalities, contrary to the common impression that acupuncture is harmless. Serious AEs are rare, but need significant attention as mortality can be associated with them. Referrals should consider acupuncturists’ training credibility, and patient safety should be a core part of acupuncture education.
Article
Full-text available
Background This study aimed to evaluate the quality of reports about randomized controlled trials (RCTs) of scalp acupuncture (SA) for the treatment of vascular dementia (VD). MethodA systematic search of reports published through to December 2015 was performed in eight databases. The quality of RCTs that used SA as an intervention for VD was evaluated based on the 2010 Consolidated Standards for Reporting of Trials (CONSORT) and 2010 Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Thirteen items from the CONSORT guideline were scored to give an overall quality score (OQS, range 0–13), and a combined key methodological index score (MIS) (range 0–5) of five key methodological items was measured. The OQS of 17 items from the STRICTA guideline (range 0–17) was also measured. ResultsIn total, 26 reports were evaluated. The median OQS based on the CONSORT guideline was 8 (minimum 5, maximum 11), and “trial design,” “sample size,” “ancillary analyses,” and “harms” had a positive rate of less than 10%. The median MIS was 2 (minimum 0, maximum 5), with “allocation concealment and implementation,” “blinding,” and “intent-to-treat analysis” having a positive rate of less than 15%. The median OQS based on the STRICTA guideline was 12 (minimum 8, maximum 14), with “extent to which treatment was varied (1c),” “number of needle insertions per subject per session (2a),” and “setting and context of treatment (4b)” having a positive rate of less than 10%. Conclusions The overall quality of reports on RCTs of SA treatment for VD was moderate to low. The quality of methodological items was markedly lower than that of other items. The CONSORT and STRICTA guidelines should be used more frequently to standardize the quality of RCT reports of SA treatment for VD.
Article
Full-text available
Background Electroacupuncture (EA), as an extension technique of acupuncture based on traditional acupuncture combined with modern electrotherapy, is commonly used for stroke in clinical treatment and researches. However, there is still a lack of enough evidence to recommend the routine use of EA for stroke. This study is aimed at evaluating the quality of reporting of randomized controlled trials (RCTs) on EA for stroke. MethodsRCTs on EA for stroke were evaluated by using CONSORT guidelines and STRICTA guidelines. Microsoft Excel 2010 and the R software were used for descriptive statistics analyses. ResultsSeventy studies involving 5468 stroke patients were identified. The CONSORT scores ranged from 16.2 to 67.6% and STRICTA scores from 29.4 to 82.4%. The central items in CONSORT as eligibility criterion, sample size calculation, primary outcome, method of randomization sequence generation, allocation concealment, implementation of randomization, description of blinding, and detailed statistical methods were reported in 100, 6, 68, 37, 14, 10, 16, and 97% of trials, respectively. The reporting of items in STRICTA as acupuncture rationale was 1a (91%), 1b (86%) and 1c 0%; needling details 2a (33%), 2b (97%), 2c (29%), 2d (64%), 2e (100%), 2f (55%) and 2 g (66%); treatment regimen 3a (69%) and 3b (100%); other components of treatment 4a (86%) and 4b (13%); practitioner background item 5 (16%); control intervention(s) 6a (93%) and 6b (10%). Conclusions The quality of reporting of RCTs on EA for stroke was generally moderate. The reporting quality needs further improvement.
Article
Full-text available
Rationale: Acute exacerbations of chronic obstructive pulmonary disease (COPD) increase the risk of death and drive healthcare costs, but whether they accelerate loss of lung function remains controversial. Whether exacerbations in subjects with mild COPD or similar acute respiratory events in smokers without airflow obstruction affect lung function decline is unknown. Objectives: To determine the association between acute exacerbations of COPD (and acute respiratory events in smokers without COPD) and the change in lung function over 5 years of follow-up. Methods: We examined data on the first 2,000 subjects who returned for a second COPDGene visit 5 years after enrollment. Baseline data included demographics, smoking history, and computed tomography emphysema. We defined exacerbations (and acute respiratory events in those without established COPD) as acute respiratory symptoms requiring either antibiotics or systemic steroids, and severe events by the need for hospitalization. Throughout the 5-year follow-up period, we collected self-reported acute respiratory event data at 6-month intervals. We used linear mixed models to fit FEV1 decline based on reported exacerbations or acute respiratory events. Measurements and main results: In subjects with COPD, exacerbations were associated with excess FEV1 decline, with the greatest effect in Global Initiative for Chronic Obstructive Lung Disease stage 1, where each exacerbation was associated with an additional 23 ml/yr decline (95% confidence interval, 2-44; P = 0.03), and each severe exacerbation with an additional 87 ml/yr decline (95% confidence interval, 23-151; P = 0.008); statistically significant but smaller effects were observed in Global Initiative for Chronic Obstructive Lung Disease stage 2 and 3 subjects. In subjects without airflow obstruction, acute respiratory events were not associated with additional FEV1 decline. Conclusions: Exacerbations are associated with accelerated lung function loss in subjects with established COPD, particularly those with mild disease. Trials are needed to test existing and novel therapies in subjects with early/mild COPD to potentially reduce the risk of progressing to more advanced lung disease. Clinical trial registered with www.clinicaltrials.gov (NCT 00608764).
Article
Full-text available
Objectives To evaluate the completeness of reporting of randomised controlled trials (RCTs) of acupuncture for post-stroke rehabilitation in order to provide information to facilitate transparent and more complete reporting of acupuncture RCTs in this field. Methods Multiple databases were searched from their inception through September 2015. Quality of reporting for included papers was assessed against a subset of criteria adapted from the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Each item was scored 1 if it was reported, or 0 if it was not clearly stated. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess agreement between the two reviewers. Results A total of 87 RCTs were included in the full text. Based on CONSORT, good reporting was evident for items ‘‘Randomised’ in the title or abstract’, ‘Participants’, ‘Statistical methods’, ‘Recruitment’, ‘Baseline data’, and ‘Outcomes and estimation’, with positive rates >80%. However, the quality of reporting for the items ‘Trial design’, ‘Outcomes’, ‘Sample size’, ‘Allocation concealment’, ‘Implementation’, ‘Blinding’, ‘Flow chart’, ‘Intent-to-treat analysis’, and ‘Ancillary analyses’ was very poor with positive rates <10%. Based on STRICTA, the items ‘Number of needle insertions per subject per session’, ‘Responses sought’, and ‘Needle type’ had poor reporting with positive rates <50%. Substantial agreement was observed for most items and good agreement was observed for some items. Conclusions The reporting quality of RCTs in acupuncture for post-stroke rehabilitation is unsatisfactory and needs improvement.
Article
Full-text available
Background: We investigated whether there had been an improvement in the quality of reporting for randomised controlled trials of acupuncture and moxibustion published in Chinese journals. We compared the compliance rate for the quality of reporting following the publication of both the STRICTA and CONSORT recommendations in China. Methods: Four Chinese databases were searched for RCTs of acupuncture from January 1978 through to December 2012. The CONSORT and STRICTA checklists were used to assess the quality of reporting. Data were collected using a standardised form. All included RCTs were divided into three distinct time periods based on the time that CONSORT and STRICTA were introduced in China, respectively. Pearson's χ2 test and/or Fisher's exact test were used to assess differences in reporting among three groups. Principal findings: A total of 1978 RCTs were identified. Although the percentage of all the items has increased over time with the introduction of CONSORT and STRICTA in China, the actual compliance in several important methodological components, including sample size calculation (0% vs. 0% vs. 1.2%, for pre-CONSORT and pre-STRICTA, post-CONSORT but pre-STRICTA, and post-CONSORT and post-STRICTA, respectively), randomisation sequence generation (1.4% vs. 15% vs. 26.3%) and implementation (0% vs. 0% vs. 1.3%), allocation concealment (0% vs. 1.4% vs. 4.9%), and blinding (0% vs. 5.7% vs. 9.1%), remains low. Moreover, no RCTs have reported the setting and context of treatment and no descriptions of the participating acupuncturists have been provided thus far. Conclusions: Overall, the quality of the reporting of RCTs of acupuncture and moxibustion published in Chinese journals has improved since CONSORT and STRICTA were introduced in China, though the actual compliance rate of some important items were still low as of 2012. In the future, Chinese journals should enhance the adoption of the CONSORT and STRICTA statement to improve the reporting quality of the RCTs of acupuncture and moxibustion and to ensure the truth and reliability of the conclusions.
Article
Full-text available
The burden of chronic obstructive pulmonary disease (COPD) across many world regions is high. We aim to estimate COPD prevalence and number of disease cases for the years 1990 and 2010 across world regions based on the best available evidence in publicly accessible scientific databases. We conducted a systematic search of Medline, EMBASE and Global Health for original, population–based studies providing spirometry–based prevalence rates of COPD across the world from January 1990 to December 2014. Random effects meta–analysis was conducted on extracted crude prevalence rates of COPD, with overall summaries of the meta–estimates (and confidence intervals) reported separately for World Health Organization (WHO) regions, the World Bank's income categories and settings (urban and rural). We developed a meta–regression epidemiological model that we used to estimate the prevalence of COPD in people aged 30 years or more. Our search returned 37 472 publications. A total of 123 studies based on a spirometry–defined prevalence were retained for the review. From the meta–regression epidemiological model, we estimated about 227.3 million COPD cases in the year 1990 among people aged 30 years or more, corresponding to a global prevalence of 10.7% (95% confidence interval (CI) 7.3%–14.0%) in this age group. The number of COPD cases increased to 384 million in 2010, with a global prevalence of 11.7% (8.4%–15.0%). This increase of 68.9% was mainly driven by global demographic changes. Across WHO regions, the highest prevalence was estimated in the Americas (13.3% in 1990 and 15.2% in 2010), and the lowest in South East Asia (7.9% in 1990 and 9.7% in 2010). The percentage increase in COPD cases between 1990 and 2010 was the highest in the Eastern Mediterranean region (118.7%), followed by the African region (102.1%), while the European region recorded the lowest increase (22.5%). In 1990, we estimated about 120.9 million COPD cases among urban dwellers (prevalence of 13.2%) and 106.3 million cases among rural dwellers (prevalence of 8.8%). In 2010, there were more than 230 million COPD cases among urban dwellers (prevalence of 13.6%) and 153.7 million among rural dwellers (prevalence of 9.7%). The overall prevalence in men aged 30 years or more was 14.3% (95% CI 13.3%–15.3%) compared to 7.6% (95% CI 7.0%–8.2%) in women.
Article
Full-text available
To examine whether deviation from the standard intention to treat analysis has an influence on treatment effect estimates of randomised trials. Meta-epidemiological study. Medline, via PubMed, searched between 2006 and 2010; 43 systematic reviews of interventions and 310 randomised trials were included. From each year searched, random selection of 5% of intervention reviews with a meta-analysis that included at least one trial that deviated from the standard intention to treat approach. Basic characteristics of the systematic reviews and randomised trials were extracted. Information on the reporting of intention to treat analysis, outcome data, risk of bias items, post-randomisation exclusions, and funding were extracted from each trial. Trials were classified as: ITT (reporting the standard intention to treat approach), mITT (reporting a deviation from the standard approach), and no ITT (reporting no approach). Within each meta-analysis, treatment effects were compared between mITT and ITT trials, and between mITT and no ITT trials. The ratio of odds ratios was calculated (value <1 indicated larger treatment effects in mITT trials than in other trial categories). 50 meta-analyses and 322 comparisons of randomised trials (from 84 ITT trials, 118 mITT trials, and 108 no ITT trials; 12 trials contributed twice to the analysis) were examined. Compared with ITT trials, mITT trials showed a larger intervention effect (pooled ratio of odds ratios 0.83 (95% confidence interval 0.71 to 0.96), P=0.01; between meta-analyses variance τ(2)=0.13). Adjustments for sample size, type of centre, funding, items of risk of bias, post-randomisation exclusions, and variance of log odds ratio yielded consistent results (0.80 (0.69 to 0.94), P=0.005; τ(2)=0.08). After exclusion of five influential studies, results remained consistent (0.85 (0.75 to 0.98); τ(2)=0.08). The comparison between mITT trials and no ITT trials showed no statistical difference between the two groups (adjusted ratio of odds ratios 0.92 (0.70 to 1.23); τ(2)=0.57). Trials that deviated from the intention to treat analysis showed larger intervention effects than trials that reported the standard approach. Where an intention to treat analysis is impossible to perform, authors should clearly report who is included in the analysis and attempt to perform multiple imputations. © Abraha et al 2015.
Article
Full-text available
Background Results from clinical studies on acupuncture for stroke rehabilitation are contradictory. The reason for the inconsistent findings especially lie in the transparency and accuracy of randomized controlled trials (RCTs) reports. This study aims to analyze the quality of reporting and its correlates in RCTs on acupuncture for stroke rehabilitation. Methods Quality of reporting for included papers was assessed against a subset of criteria adapted from the CONSORT 2010 statement and STRICTA. An overall quality score (OQS) and a combined key methodological index score (MIS) was calculated for each trial. Then, factors associated with OQS and MIS were identified. Results A total of 15 RCTs were included in full text. The median OQS based on the CONSORT statement and STRICTA was 8 and 12, respectively. The significant predictors for CONSORT OQS was funding source, for STRICTA was year of publication. With regard to the MIS, no variable was associated with improved methodological quality. Conclusions Our study found that the overall quality of reporting on RCTs of acupuncture for stroke rehabilitation was general or good. But some items’ reporting was found where information was insufficient or inadequate in most studies which needed substantial improvement.
Article
Full-text available
This study aims to analyze the quality of reporting and its correlates in randomized controlled trials (RCTs) on acupuncture for cancer pain. Quality of reporting for included papers was assessed against a subset of criteria adapted from the CONSORT 2010 statement and STRICTA. An overall quality score (OQS) and a combined key methodologic index score (MIS) was calculated for each trial. Factors associated with OQS and MIS were then identified. A total of 32 RCTs were included in the full text. The median OQS based on the CONSORT Statement and STRICTA was 4.0 and 0, respectively. The significant predictors for CONSORT OQS were year of publication and nationality of authors, for STRICTA it was nationality of authors and for MIS it was publication language. The quality of reporting in RCTs on acupuncture for cancer pain was poor. This indicates that RCTs on acupuncture for cancer pain need substantial improvement.
Data
Full-text available
The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal ed-itors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 par-ticipants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treat-ment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical," to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, includ-ing uncontrolled outcome studies and case reports. It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.
Article
Full-text available
Acupuncture treatment has been widely used for many conditions, while results of the increasing numbers of randomized trials and systematic reviews remain controversial. Acupuncture is a complex intervention of both specific and non-specific factors associated with therapeutic benefit. Apart from needle insertion, issues such as needling sensation, psychological factors, acupoint specificity, acupuncture manipulation, and needle duration also have relevant influences on the therapeutic effects of acupuncture. Taking these factors into consideration would have considerable implications for the design and interpretation of clinical trials.
Article
Full-text available
Acupuncture practice is based on the theoretical, historical and philosophical principles, which are part of Chinese medicine. Traditional acupuncture practitioners assess their patients' conditions using Chinese medicine diagnostic techniques, which determine clinical care and treatment. Little is known about differences in the perceptions of research evidence among practitioners in the European Union (EU) and China, given the diversity of acupuncture practice. This study explored differences between practitioners of traditional acupuncture regarding perceived need for research evidence and prioritisation for future clinical trials, based on their practice within the EU and China. A convenience sample of acupuncturists in the EU (contacted by their professional organisation) and China (from geographically dispersed hospitals) were invited to participate in a survey, which was conducted during 2010/2011. Data collected included: practitioners' demographic details, country of training, practice setting, acupuncture techniques, perceived adverse event reporting, diagnostic methods, conditions commonly treated, conditions perceived as needing more evidence and practitioner perceptions of conditions which could demonstrate benefit if investigated in clinical trials. From 1126 survey responses, 1020 (559 EU, 461 China) could be included in the analysis for direct comparison. A response rate for the EU could not be calculated but for China was 98%. Pain was the most frequently reported commonly treated condition by EU acupuncturists and neurological conditions (mainly stroke) for Chinese practitioners. The top reported priorities for research were obstetrics/gynaecological conditions in the EU and neurological problems in China. The survey identified differences in practice and training between acupuncturists in China and the EU and between EU member states. These differences may inform prioritisation of health conditions for future trials. Innovative research methods are recommended to incorporate the complexity and plurality of acupuncture practice and theory. Creation of collaborative networks is crucial in overcoming these differences to facilitate international, multi-centre clinical trials.
Article
Full-text available
To evaluate the reports' qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Mild Cognitive Impairment (MIC). Nine databases including the Cochrane Central Register of Controlled Trials (CENTRAL,2010), PUBMED (1984-5/2010), EMbase (1984-5/2010), MEDLINE (1984-5/2010), CINAL (1984-5/2010), China National Knowledge Infrastructure (CNKI, 1980-5/2010), China Biomedicine Database disc (CBMdisc, 1980-5/2010), VIP (a full text issues database of China, 1989-5/2010) were searched systematically. Hand search for further references was conducted. Language was limited to Chinese and English. We identified 14 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). In regard to the items in the CONSORT statement, 13(92.86%) RCTs described baseline demographic and clinical characteristics in each group. 7 (50.0%) mentioned the method of generating the random sequence, only 2 (14.3%) RCTs had adequate allocation concealment. No RCTs used blinding. RCTs reported the sample size calculation. In regard to the items in STRICTA, 10 (71.43%) mentioned the depths of insertion, 6 (42.86%) reported acupuncture response, 11 (78.57%) mentioned the technique of acupuncture, 12 (85.71%) recorded the time, and only 3 (21.43%) RCTs reported the numbers of needles inserted. No RCTs reported the background of the acupuncture practitioners and professional title of practitioners. The reporting quality of RCTs of acupuncture for mild cognitive impairment was moderate to low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture in future.
Article
Objectives To investigate the reporting quality and risk of bias of randomized controlled trials (RCTs) of acupuncture for migraine, to facilitate and improve the quality of RCTs of acupuncture for migraine. Methods The Cochrane Library, PubMed and EMBASE were searched from inception to June 11, 2019 using a comprehensive search strategy. The reporting quality and risk of bias of included RCTs were independently evaluated by two investigators using STRICTA and RoB 2.0. Any disagreement was resolved by a third investigator. Results A total of 28 eligible RCTs were published in 24 academic journals from 1994 to 2018. Based on STRICTA, four sub-items including “details of other interventions’’ (1/28, 4 %), “setting and context of treatment” (9/28, 32 %), “the extent to which treatment was varied” (11/28, 39 %), and “number of needle insertions per subject per session” (13/28, 46 %), showed low reporting quality. A total of 32 different outcomes were reported in 28 RCTs, and based on RoB 2.0, nine (9/28, 32 %) RCTs were judged to be high RoB, three of which were owing to deviations from intended interventions; 11(11/28, 39 %) RCTs elicited some concerns; and eight (8/28, 29 %) RCTs were low RoB for their outcomes. Conclusions The reporting quality and risk of bias of RCTs of acupuncture for migraine remain suboptimal. Therefore, all stakeholders should make a contribution to improve the quality of RCTs of acupuncture for migraine using STRICTA and RoB 2.0, while not limiting this approach solely to studies on migraine, using STRICTA and RoB 2.0 tools.
Article
Background Chronic obstructive pulmonary disease (COPD) is highly prevalent around the world and has a large impact on its patients, leading to a poor health-related quality of life (HRQL) and exercise capacity. Even under optimal medications, there are still many patients with poor HRQL. Body acupuncture therapy (BAT) is a non-invasive and a popular therapy. Therefore, we aimed to comprehensively analyze the effects of BAT in COPD. Materials and methods Eight electronic databases were searched. We included randomized controlled trials (RCTs) that evaluated the effect of BAT, medication (M), and pulmonary rehabilitation (PR). The primary outcome was HRQL evaluated by St. George's respiratory questionnaire (SGRQ) or COPD assessment test (CAT). Results Of the 922 articles, 12 studies were included with attesting a total of 798 participants. The result obtained indicated a significant improvement that favored the BAT + M group over the M group in CAT scores (MD: −4.77; 95% CI: −6.53 to −3.01; p < 0.00001). Conclusions BAT is an effective adjunctive non-pharmacological treatment to improve HRQL in patients under medical treatment for COPD. We suggested that BAT should be considered as one of the methods of management in patients with COPD.
Article
Sample size estimates are critical to the planning and interpretation of clinical studies, whether they are descriptive or analytical. Too small a sample size will result in imprecise estimates in a descriptive study and failure to achieve ‘statistical significance’ in an analytic or comparative study. Here we discuss what both researchers and readers should understand about the reasons for sample size estimates, how they are done and how achieving or not achieving the desired sample size can affect the interpretation of the outcomes.
Article
The concept of clinical trial transparency has been promoted for more than 40 years. The act of clinical trial registration, report guidelines development, and data sharing has has been strongly pushed forward and become a common practice. The clinical trial process being the key procedure of trial operation and quality control, determines the accuracy of the results. However, the process report of clinical trials is insufficient. In this article, we summarize the importance of clinical trial process report and provide corresponding suggestions. We propose that medical journals, reporting guidelines developers and clinical trial registration platforms should work together to strengthen the process report of clinical trials and promote full transparency of clinical trials. © 2018, West China University of Medical Science. All rights reserved.
Article
Clinical trial transparency, include clinical trial registration, unbiased reporting results and sharing individual participant data (IPD), is one of the most important revolutionary concepts following clinical epidemiology and evidence-based medicine in the medical field. Sharing IPD is a medical ethics issue reflected a new sense of worth and constructing new rules of clinical trials. Our viewpoint is that from the essential purpose of clinical research, IPD is a social public property. Sharing IPD is a one of the best ways for respecting the contributions of the participants, and one of the keys for changing face of clinical trials. © 2018, West China University of Medical Science. All rights reserved.
Article
A randomized controlled trial (RCT) is a prospective, comparative, quantitative study/experiment performed under controlled conditions with random allocation of interventions to comparison groups. The RCT is the most rigorous and robust research method of determining whether a cause-effect relationship exists between an intervention and an outcome. High quality evidence can be generated by performing an RCT when evaluating the effectiveness and safety of an intervention. Furthermore, RCTs yield themselves well to systematic review and meta-analysis providing a solid base for synthesizing evidence generated by such studies. Evidence-based clinical practice improves patient outcomes, safety, and is generally cost-effective. Therefore, RCTs are becoming increasingly popular in all areas of clinical medicine including perinatology. However, designing and conducting an RCT, analyzing data, interpreting findings and disseminating results can be challenging as there are several practicalities to be considered. In this review, we provide a simple descriptive guidance on planning, conducting, analyzing and reporting RCTs. This article is protected by copyright. All rights reserved.
Article
Chronic obstructive pulmonary disease (COPD) kills more than 3 million people worldwide every year. Despite progress in the treatment of symptoms and prevention of acute exacerbations, few advances have been made to ameliorate disease progression or affect mortality. A better understanding of the complex disease mechanisms resulting in COPD is needed. Smoking cessation programmes, increasing physical activity, and early detection and treatment of comorbidities are further key components to reduce the burden of the disease. However, without a global political and economic effort to reduce tobacco use, to regulate environmental exposure, and to find alternatives to the massive use of biomass fuel, COPD will remain a major health-care problem for decades to come.
Article
Background The burden of chronic obstructive pulmonary disease (COPD) across many world regions is high. We aim to estimate COPD prevalence and number of disease cases for the years 1990 and 2010 across world regions based on the best available evidence in publicly accessible scientific databases. Methods We conducted a systematic search of Medline, EMBASE and Global Health for original, population–based studies providing spirometry–based prevalence rates of COPD across the world from January 1990 to December 2014. Random effects meta–analysis was conducted on extracted crude prevalence rates of COPD, with overall summaries of the meta–estimates (and confidence intervals) reported separately for World Health Organization (WHO) regions, the World Bank's income categories and settings (urban and rural). We developed a meta–regression epidemiological model that we used to estimate the prevalence of COPD in people aged 30 years or more. Findings Our search returned 37 472 publications. A total of 123 studies based on a spirometry–defined prevalence were retained for the review. From the meta–regression epidemiological model, we estimated about 227.3 million COPD cases in the year 1990 among people aged 30 years or more, corresponding to a global prevalence of 10.7% (95% confidence interval (CI) 7.3%–14.0%) in this age group. The number of COPD cases increased to 384 million in 2010, with a global prevalence of 11.7% (8.4%–15.0%). This increase of 68.9% was mainly driven by global demographic changes. Across WHO regions, the highest prevalence was estimated in the Americas (13.3% in 1990 and 15.2% in 2010), and the lowest in South East Asia (7.9% in 1990 and 9.7% in 2010). The percentage increase in COPD cases between 1990 and 2010 was the highest in the Eastern Mediterranean region (118.7%), followed by the African region (102.1%), while the European region recorded the lowest increase (22.5%). In 1990, we estimated about 120.9 million COPD cases among urban dwellers (prevalence of 13.2%) and 106.3 million cases among rural dwellers (prevalence of 8.8%). In 2010, there were more than 230 million COPD cases among urban dwellers (prevalence of 13.6%) and 153.7 million among rural dwellers (prevalence of 9.7%). The overall prevalence in men aged 30 years or more was 14.3% (95% CI 13.3%–15.3%) compared to 7.6% (95% CI 7.0%–8.2%) in women. Conclusions Our findings suggest a high and growing prevalence of COPD, both globally and regionally. There is a paucity of studies in Africa, South East Asia and the Eastern Mediterranean region. There is a need for governments, policy makers and international organizations to consider strengthening collaborations to address COPD globally.
Article
Investigators involved in clinical, epidemiological or translational research, have the drive to publish their results so that they can extrapolate their findings to the population. This begins with the preliminary step of deciding the topic to be studied, the subjects and the type of study design. In this context, the researcher must determine how many subjects would be required for the proposed study. Thus, the number of individuals to be included in the study, i.e., the sample size is an important consideration in the design of many clinical studies. The sample size determination should be based on the difference in the outcome between the two groups studied as in an analytical study, as well as on the accepted p value for statistical significance and the required statistical power to test a hypothesis. The accepted risk of type I error or alpha value, which by convention is set at the 0.05 level in biomedical research defines the cutoff point at which the p value obtained in the study is judged as significant or not. The power in clinical research is the likelihood of finding a statistically significant result when it exists and is typically set to >80%. This is necessary since the most rigorously executed studies may fail to answer the research question if the sample size is too small. Alternatively, a study with too large a sample size will be difficult and will result in waste of time and resources. Thus, the goal of sample size planning is to estimate an appropriate number of subjects for a given study design. This article describes the concepts in estimating the sample size.
Article
A no-touch control needle in which the needle tip cannot reach the skin has been designed, and has been validated for practitioner blinding in a previous study but not for participant blinding. To test whether the no-touch control needle can effectively blind subjects. An acupuncturist applied, in turn, a no-touch control, skin-touch placebo and penetrating needle in one forearm of 80 healthy subjects. After removing each needle, the subjects were asked to judge the type of needle and rate the sensation of skin penetration/penetration-like or skin pressure/pressure-like pain on a 100 mm visual analogue scale. The subjects correctly identified 67% of needles overall. 17 of the 80 no-touch control needles were judged as skin-touch, and one as penetrating. In addition, six skin-touch placebo needles, and no penetrating needles, were judged as no-touch. Half of the 80 skin-touch placebo needles and 65 of the 80 penetrating needles and two no-touch control needles elicited pain. Of 240 needles, the practitioner identified 120 correctly that did not fit the probability of 1/3 (χ(2)=30.00, p<0.01). The no-touch control needles may be used as a blind control for the acupuncture procedure, or to test the physiological effect of the skin-touch needles, but are not suitable for double-blind testing of the needle effect.
Article
Randomised controlled trials are the gold standard method for developing evidence-based medicine. Good trial design and an awareness of some potential pitfalls are likely to maximise the chances of a successful trial with a conclusion that adds meaningfully to the evidence base. This paper is aimed at people early in their research careers and focuses on some common, usually avoidable, pitfalls in trial design. The areas covered include: assessing the scientific idea; trial design; size and duration of the trial; analysis; and reporting and presentation.
Global initiative for chronic obstructive lung disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease
Global initiative for chronic obstructive lung disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (2021 REPORT) [EB/OL]; November 17, 2020. https://goldcopd.org/goldreports/.
Meta-analysis series 12: evaluation of allocation concealment
  • X T Zeng
  • K Shen
  • J Luo
Zeng XT, Shen K, Luo J. Meta-analysis series 12: evaluation of allocation concealment. Chin J Evid-Based Cardiovasc Med. 2013;5(03):219-221.