The Impact of STRICTA and CONSORT on Reporting of Randomised Control Trials of Acupuncture: A Systematic Methodological Evaluation

2018 ◽  
Vol 36 (6) ◽  
pp. 349-357 ◽  
Author(s):  
Simen Svenkerud ◽  
Hugh MacPherson

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.

2020 ◽  
Vol 40 (4) ◽  
pp. 394-404
Author(s):  
Janusz Witowski ◽  
Dorota Sikorska ◽  
András Rudolf ◽  
Izabela Miechowicz ◽  
Julian Kamhieh-Milz ◽  
...  

The concerns about reproducibility and validity of animal studies are partly related to poor experimental design and reporting. Here, we undertook a scoping review of the literature to determine the extent and quality of reporting of animal studies on peritoneal dialysis (PD). Online databases were searched to identify 567 relevant original articles published between 1979 and 2018. These were analyzed with respect to bibliographic parameters and general aspects of animal experimentation. A subgroup of 120 studies was analyzed in detail in terms of the impact on the reporting quality of the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines for animal studies. The number of animal studies on PD increased continuously over the years with a thematic shift toward long-term preservation of the peritoneum as a dialyzing organ. There were significant deficiencies in research design with the lack of sample size estimation, randomization, and blinding being the commonest shortcomings. The description of animal numbers, housing conditions, use of medication, and statistical analysis was incomplete. The introduction in 2010 of the ARRIVE guidelines produced very little improvement in the completeness of reporting regardless of journal impact factor. The animal studies on PD suffer from deficits in experimental protocols and transparent reporting. These drawbacks need to be corrected to ensure high-quality and much-needed animal research in PD.


2020 ◽  
Vol 99 (13) ◽  
pp. 1453-1460
Author(s):  
D. Qin ◽  
F. Hua ◽  
H. He ◽  
S. Liang ◽  
H. Worthington ◽  
...  

The objectives of this study were to assess the reporting quality and methodological quality of split-mouth trials (SMTs) published during the past 2 decades and to determine whether there has been an improvement in their quality over time. We searched the MEDLINE database via PubMed to identify SMTs published in 1998, 2008, and 2018. For each included SMT, we used the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 guideline, CONSORT for within-person trial (WPT) extension, and a new 3-item checklist to assess its trial reporting quality (TRQ), WPT-specific reporting quality (WRQ), and SMT-specific methodological quality (SMQ), respectively. Multivariable generalized linear models were performed to analyze the quality of SMTs over time, adjusting for potential confounding factors. A total of 119 SMTs were included. The mean overall score for the TRQ (score range, 0 to 32), WRQ (0 to 15), and SMQ (0 to 3) was 15.77 (SD 4.51), 6.06 (2.06), and 1.12 (0.70), respectively. The primary outcome was clearly defined in only 28 SMTs (23.5%), and only 27 (22.7%) presented a replicable sample size calculation. Only 45 SMTs (37.8%) provided the rationale for using a split-mouth design. The correlation between body sites was reported in only 5 studies (4.2%) for sample size calculation and 4 studies (3.4%) for statistical results. Only 2 studies (1.7%) performed an appropriate sample size calculation, and 46 (38.7%) chose appropriate statistical methods, both accounting for the correlation among treatment groups and the clustering/multiplicity of measurements within an individual. Results of regression analyses suggested that the TRQ of SMTs improved significantly with time ( P < 0.001), while there was no evidence of improvement in WRQ or SMQ. Both the reporting quality and methodological quality of SMTs still have much room for improvement. Concerted efforts are needed to improve the execution and reporting of SMTs.


BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036148
Author(s):  
Vivienne C Bachelet ◽  
Víctor A Carrasco ◽  
Fabiana Bravo-Córdova ◽  
Ruben A Díaz ◽  
Francisca J Lizana ◽  
...  

IntroductionQuality of reporting refers to how published articles communicate how the research was done and what was found. Gaps and imprecisions of reporting hamper the assessment of the methodological quality and internal and external validity. The CONsolidated Standards of Reporting Trials (CONSORT) are a set of evidence-based recommendations of the minimum elements to be included in the reporting of randomised controlled trials (RCTs) to ensure a complete and transparent account of what was done, how it was done and what was found. Few studies have been conducted on the impact of CONSORT on RCTs published in Latin American and Spanish journals. We aim to assess the reporting quality of RCTs of three clinical specialities published in Spanish and Latin American journals, as well as to assess changes over time and associations of quality with journal and country indicators.Methods and analysisWe will conduct a systematic survey of all RCTs published in Spanish-language journals in three clinical fields (dentistry, neurology and geriatrics) from 1990 to 2018. We will include RCTs from previous work that has identified all RCTs on these medical fields published in Spain and Latin America. We will update this work via handsearching of relevant journals. Assessment of quality of reporting will be conducted independently and in duplicate using the CONSORT 2010 Statement. We will also extract journal and country indicators. We will conduct descriptive statistics and secondary analyses considering the year, country, and journal of publication, among others.Ethics and disseminationThe Universidad de Santiago de Chile’s ethics committee approved the protocol. We will disseminate the results of this work in peer-reviewed scientific journals and conference proceedings. We expect to raise awareness among researchers, journal editors and funders on the importance of training in reporting guidelines and using them from the inception of RCT protocols.


2020 ◽  
Author(s):  
Kaiyan Hu ◽  
Ting Zhang ◽  
Weiyi Zhang ◽  
Qi Zhou ◽  
Mengyao Jiang New ◽  
...  

Abstract Background: Protocols of systematic reviews allow for planning and documentation of review methods and thus improve the transparency of the reviews process. However, pre-registration of a protocol is not enough, the author also need to follow it. PROSPERO is an open-access online database for the registration of non-Cochrane systematic reviews. The purpose of this study is to compare published non-Cochrane reviews with their pre-registered protocols on PROSPERO to determine what changes, if any, have been made, and how likely these changes are to impact the quality of systematic review. Methods: This is a retrospective comparative study. We searched for protocols on PROSPERO platform that were registered in 2018 and then selected the protocols that full text have been published as of January 1st 2019. Published full texts were identified through the protocol's final publication citation. Two authors independently compared and identified changes between protocols and systematic reviews and then evaluated the impact (improve, reduce, or unclear) of these changes on the reporting or methodology quality of reviews. Descriptive statistics of percentage (%) and frequency (n) were conducted. Results: We identified 39 pairs, all of which exhibited changes. “Search strategy”(92%, n=36), “data extraction”(90%, n=35), “data synthesis”(77%, n=30), “outcome”(64%, n=24), and “subgroup analysis”(64%, n=24) all showed significant changes. All changes to only one review were considered to improve the reporting or methodology quality, and the remaining 97% of reviews (n=38) contained changes that were considered to reduce the methodology or reporting quality or that had an unclear impact on systematic reviews. Conclusions: Changes between the non-Cochrane systematic reviews and their protocols recorded on PROSPERO were widespread. Some of the changes reduced the methodology or reporting quality of systematic reviews or had an unclear impact. Measures should be taken to further improve the transparency of the non-Cochrane systematic reviews. Adding a new item in updated “Preferred Reporting Items for Systematic reviews and Meta-Analyses” (PRISMA) and “Meta-analysis of Observational Studies in Epidemiology” (MOOSE) to guide reporting and explaining the changes, as well as advising peer reviewers (and editors) to check the reviews against the protocols are two suggested fundamental solutions.


2021 ◽  
pp. oemed-2020-107038
Author(s):  
Christina Tikka ◽  
Jos Verbeek ◽  
Sharea Ijaz ◽  
Jan L Hoving ◽  
Julitta Boschman ◽  
...  

ObjectivesTo assess the reporting quality of randomisation and allocation methods in occupational health and safety (OHS) trials in relation to Consolidated Standards of Reporting Trials (CONSORT) requirements of journals, risk of bias (RoB) and publication year.MethodsWe systematically searched for randomised controlled trials (RCTs) in PubMed between 2010 and May 2019 in 18 OHS journals. We measured reporting quality as percentage compliance with the CONSORT 2010 checklist (items 8–10) and RoB with the ROB V.2.0 tool (first domain). We tested the mean difference (MD) in % in reporting quality between CONSORT-requiring and non-requiring journals, trials with low, some concern and high RoB and publications before and after 2015.ResultsIn 135 articles reporting on 129 RCTs, average reporting quality was at 37.4% compliance (95% CI 31.9% to 43.0%), with 10% of articles reaching 100% compliance. Reporting quality was significantly better in CONSORT-requiring journals than non-requiring journals (MD 31.0% (95% CI 21.4% to 40.7%)), for studies at low RoB than high RoB (MD 33.1% (95% CI 16.1% to 50.2%)) and with RoB of some concern (MD 39.8% (95% CI 30.0% to 49.7%)). Reporting quality did not improve over time (MD −5.7% (95% CI −16.8% to 5.4%).ConclusionsArticles in CONSORT-requiring journals and of low RoB studies show better reporting quality. Low reporting quality is linked to unclear RoB judgements (some concern). Reporting quality did not improve over the last 10 years and CONSORT is insufficiently implemented. Concerted efforts by editors and authors are needed to improve CONSORT implementation.


2017 ◽  
Vol 16 (1) ◽  
pp. 198-203 ◽  
Author(s):  
Jamie Young ◽  
Bhasker Amatya ◽  
Mary P. Galea ◽  
Fary Khan

AbstractBackground and purposePain is a common symptom associated with multiple sclerosis (MS), and has lasting effects on an individual’s functional capacity and quality of life. A wide range of prevalence rates of pain (between 23% and 90%)have been reported in MS and this is mainly due to the methodological differences amongst the studies such as variability in patient sources, method of sampling and the definition of pain used. Chronic pain in MS, defined as pain lasting for greater than 3–6 months, can have a significant impact on their biopsychosocial health, including negative impact on activities of daily living, relationships and social participation. The long-term course of MS-related pain and its impact in an Australian cohort over a 7-year period has been investigated earlier. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period.MethodsThis was a prospective longitudinal study conducted at the Rehabilitation Department of Royal Melbourne Hospital (RMH), a tertiary referral hospital in Victoria and Australia. The source of participants was from the RMH MS database and contains detailed MS patient information including demographic data, diagnosis details (using McDonald’s criteria), pain characteristics. Structured face-face interviews and validated measures were used, which include the visual analogue scale (VAS); chronic pain grade (CPG); the assessment of quality of life (AQoL) and the carer strain index (CSI). The mean age of the participants (n = 70) was 55.3 years and majority (70%) were female.ResultsThe mean age of the participants (n = 70) was 55.3 years and majority (70%) were female. The findings show that over time (10 years), participants report having greater bilateral bodily pain and greater description of pain as ‘worse as it could be’. Pain types were similar to 7-years follow-up but remained higher than baseline. There was a significant deterioration in quality of life in those with more severe CPG over time. Almost half of the participants 31 (44%) required care either from a private carer, institution or from a family member. Although fear of taking medications and side effects were common barriers to treatment for pain, there was an increase in the use of pharmacological treatment over time and an increase in the use of healthcare services, mainly neurologists and general practitioners.ConclusionsThe pain measures reported by the participants were similar to those at the 7-year follow-up except there was a greater representation of bilateral pain locations (limb, trunk and facial pain) compared to baseline and 7-year follow-up. At 10-year follow-up, more participants used medications compared tc 7-year follow-up and there was an increase in the use of health professionals at the 10-year follow-up At the 10-year follow up QoL of the participants deteriorated significantly and more participants had progressed to higher CPGIII and CPGIV. This study demonstrates that chronic pain is a significant issue over time in MS, with clinical and health implications, impact on quality of life, disability and healthcare utilization.ImplicationsGreater awareness of chronic pain in pwMS, cognitive classifications and an interdisciplinary approach is required to improve long-term patient outcomes and well-being.Crown Copyright © 2017 Published by Elsevier B.V. on behalf of Scandinavian Association for the Study of Pain. All rights reserved.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Y. de Jong ◽  
E. M. van der Willik ◽  
J. Milders ◽  
C. G. N. Voorend ◽  
Rachael L. Morton ◽  
...  

Abstract Background Reviews of qualitative studies allow for deeper understanding of concepts and findings beyond the single qualitative studies. Concerns on study reporting quality led to the publication of the COREQ-guidelines for qualitative studies in 2007, followed by the ENTREQ-guidelines for qualitative reviews in 2012. The aim of this meta-review is to: 1) investigate the uptake of the COREQ- and ENTREQ- checklists in qualitative reviews; and 2) compare the quality of reporting of the primary qualitative studies included within these reviews prior- and post COREQ-publication. Methods Reviews were searched on 02-Sept-2020 and categorized as (1) COREQ- or (2) ENTREQ-using, (3) using both, or (4) non-COREQ/ENTREQ. Proportions of usage were calculated over time. COREQ-scores of the primary studies included in these reviews were compared prior- and post COREQ-publication using T-test with Bonferroni correction. Results 1.695 qualitative reviews were included (222 COREQ, 369 ENTREQ, 62 both COREQ/ENTREQ and 1.042 non-COREQ/ENTREQ), spanning 12 years (2007–2019) demonstrating an exponential publication rate. The uptake of the ENTREQ in reviews is higher than the COREQ (respectively 28% and 17%), and increases over time. COREQ-scores could be extracted from 139 reviews (including 2.775 appraisals). Reporting quality improved following the COREQ-publication with 13 of the 32 signalling questions showing improvement; the average total score increased from 15.15 to 17.74 (p-value < 0.001). Conclusion The number of qualitative reviews increased exponentially, but the uptake of the COREQ and ENTREQ was modest overall. Primary qualitative studies show a positive trend in reporting quality, which may have been facilitated by the publication of the COREQ.


Author(s):  
Pascale Guerre ◽  
Nermine Laaboub ◽  
Cyrille Colin ◽  
Jean-François Obadia ◽  
Christell Julien ◽  
...  

AbstractObjectivesCardiac surgery has seen substantial scientific progress over recent decades. Health economic evaluations have become important tools for decision makers to prioritize scarce health resources. The present study aimed to identify and critically appraise the reporting quality of health economic evaluations conducted in the field of cardiac surgery.MethodsA literature search was performed to identify health economic evaluations in cardiac surgery. The consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement was used to assess the quality of reporting of studies.ResultsA total 4,705 articles published between 1981 and 2016 were identified; sixty-nine studies fulfilled the inclusion criteria. There was a trend toward a greater number of publications and reporting quality over time. Six (8.7 percent) studies were conducted between 1981 and 1990, nine (13 percent) between 1991 and 2000, twenty-four (34.8 percent) between 2001 and 2010, and thirty (43.5 percent) after 2011. The mean CHEERS score of all articles was 16.7/24; for those published between 1980 and 1990 the mean (SD) score was 10.2 (±1.4), for those published between 1991 and 2000 it was 11.2 (±2.4), between 2001 and 2010 it was 15.3 (±4.8), and after 2011 it was 19.9 (±2.9). The quality of reporting was still insufficient for several studies after 2000, especially concerning items “characterizing heterogeneity,” “assumptions,” and “choice of model.”ConclusionsThe present study suggests that, even if the quantity and the quality of health economics evaluation in cardiac surgery has increased, there remains a need for improvement in several reporting criteria to ensure greater transparency.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Ran Tian ◽  
Xuan Zhang ◽  
Si-Yao Li ◽  
Qi-Ying Aixinjueluo ◽  
Wai Ching Lam ◽  
...  

Abstract Background Moxibustion is one of the major interventions of Chinese medicine (CM). The systematic reviews (SRs) are essential references for evaluating the efficacy and safety of moxibustion interventions. This study aimed to assess the reporting quality of these SRs, particularly whether necessary information related to moxibustion was adequately reported. Methods Seven databases (including four English and three Chinese databases) were systematically searched for SRs of moxibustion that were published up to 31 December 2019. The primary analysis was to assess their reporting quality based on 27-item of the Preferred Reporting Items for SRs and Meta-Analyses (PRISMA) and 14-item of moxibustion-related information designed according to CM theory and the STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM). Descriptive statistics were also used to analyze their baseline characteristics. Results A total of 97 SRs of moxibustion were identified from 2011 to 2019. For 27-item of PRISMA, except item 5, 8, 16 and 23, the remaining 23 items had the reporting compliances higher than 55%, of which 2 items (item 20 and 26) were fully reporting (100%). However, for moxibustion-related information, 69.1% (67/97) SRs did not provide the specific type of moxibustion, 39.2% (38/97) lacked details regarding the materials, procedure and technique used for moxibustion, 67.0% (65/97) did not report the selection criteria of acupoints for moxibustion, 28.9% (28/97) did not provide the number or duration of treatment sessions, 69.1% (67/97) did not provide any information about safety evaluation, and 94.8% (92/97) SRs did not report the treatment environment. For 51 (55.4%) of 92 SRs that included meta-analysis, it was impossible to assess whether meta-analysis had been properly conducted due to inadequate reporting of moxibustion interventions. Conclusion The reporting quality of SRs of moxibustion need further improvements in terms of adequate reporting of moxibustion interventions and of moxibustion-related rationales. Reporting guideline of “PRISMA extension for moxibustion interventions” should be developed thus to improve their quality.


Author(s):  
Daisuke Kato ◽  
Yuki Kataoka ◽  
Erfen Gustiawan Suwangto ◽  
Makoto Kaneko ◽  
Hideki Wakabayashi ◽  
...  

The objective of this study was to assess the impact of a 2010 community-based participatory research (CBPR) reporting guideline on the quality of reporting a CBPR on smoking cessation. We searched the MEDLINE, Embase, the Cochrane Central Register for Controlled Trials (CENTRAL), PsycINFO, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases and included articles published up to December 2019 (PROSPERO: CRD42019111668). We assessed reporting quality using the 13-item checklist. Of the 80 articles identified, 42 (53%) were published after 2010. The overall reporting quality before and after 2010 was poor and did not differ significantly (mean difference: 0.66, 95% confidence interval [CI]: −0.21 to 1.53). The total reporting scores of the studies did not differ significantly according to the effect size of the intervention (beta coefficient: −2.86, 95% CI: −5.77 to 0.04). This study demonstrates the need to improve the quality of reporting CBPRs. We recommend that journal editors endorse the CBPR reporting guideline to encourage its use by more researchers.


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