A systematic review of reporting quality for anaesthetic interventions in randomised controlled trials.
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SUBMITTER: Elliott L
PROVIDER: S-EPMC8246731 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:INTRODUCTION:There is significant variation in how anaesthesia is defined and reported in clinical research. This lack of standardisation complicates the interpretation of published evidence and planning of future clinical trials. This systematic review will assess the reporting of anaesthesia as an intervention in randomised controlled trials (RCT) against the Consolidated Standards of Reporting Trials for Non-Pharmacological Treatments (CONSORT-NPT) framework. METHODS AND ANALYSIS:Online archives of the top six journals ranked by impact factor for anaesthesia and the top three general medicine and general surgery journals will be systematically hand searched over a 42-month time period to identify RCTs describing the use of anaesthetic interventions for any invasive procedure. All modes of anaesthesia and anaesthesia techniques will be included. All study data, including the type of anaesthetic intervention described, will be extracted in keeping with the CONSORT-NPT checklist. Descriptive statistics will be used to summarise general study details including types/modes of anaesthetic interventions, and reporting standards of the trials. ETHICS AND DISSEMINATION:No ethical approval is required. The results will be used to inform a funding application to formally standardise general, local, regional anaesthesia and sedation for use in clinical research. The systematic review will be disseminated via peer-reviewed manuscript and conferences. PROSPERO REGISTRATION NUMBER:CRD42019141670.
| S-EPMC7045251 | biostudies-literature
Project description:BackgroundMany randomised controlled trials (RCTs) of herbal interventions have been conducted in the ASEAN Communities. Good quality reporting of RCTs is essential for assessing clinical significance. Given the importance ASEAN placed on herbal medicines, the reporting quality of RCTs of herbal interventions among the ASEAN Communities deserved a special attention.ObjectivesTo systematically review the quality of reporting of RCTs of herbal interventions conducted in the ASEAN Plus Six Countries.MethodsSearches were performed using PubMed, EMBASE, The Cochrane Library, and Allied and Complementary Medicine (AMED), from inception through October 2013. These were limited to studies specific to humans and RCTs. Herbal species search terms were based on those listed in the National List of Essential Medicines [NLEM (Thailand, 2011)]. Studies conducted in the ASEAN Plus Six Countries, published in English were included.ResultsSeventy-one articles were identified. Thirty (42.25%) RCTs were from ASEAN Countries, whereas 41 RCTs (57.75%) were from Plus Six Group. Adherence to the recommended CONSORT checklist items for reporting of RCTs of herbal interventions among ASEAN Plus Six Countries ranged from 0% to 97.18%. Less than a quarter of the RCTs (18.31%) reported information on standardisation of the herbal products. However, the scope of our interventions of interest was limited to those developed from 20 herbal species listed in the NLEM of Thailand.ConclusionsThe present study highlights the need to improve reporting quality of RCTs of herbal interventions across ASEAN Plus Six Communities.
| S-EPMC4310614 | biostudies-literature
Project description:Randomised controlled trials (RCTs) represent a gold standard for evaluating therapeutic interventions. However, poor reporting clarity can prevent readers from assessing potential bias that can arise from a lack of methodological rigour. The Consolidated Standards of Reporting Trials statement for non-pharmacological interventions 2008 (CONSORT NPT) was developed to aid reporting. RCTs in ophthalmic surgery pose particular challenges in study design and implementation. We aim to provide the first assessment of the compliance of RCTs in ophthalmic surgery to the CONSORT NPT statement.In August 2012, the Medline database was searched for RCTs in ophthalmic surgery reported between 1 January 2011 and 31 December 2011. Results were searched by two authors and relevant papers selected. Papers were scored against the 23-item CONSORT NPT checklist and compared against surrogate markers of paper quality. The CONSORT score was also compared between different RCT designs.In all, 186 papers were retrieved. Sixty-five RCTs, involving 5803 patients, met the inclusion criteria. The mean CONSORT score was 8.9 out of 23 (39%, range 3.0-14.7, SD 2.49). The least reported items related to the title and abstract (1.6%), reporting intervention adherence (3.1%), and interpretation of results (4.7%). No significant correlation was found between CONSORT score and journal impact factor (R=0.14, P=0.29), number of authors (R=0.01, P=0.93), or whether the RCT used paired-eye, one-eye, or two-eye designs in their randomisation (P=0.97).The reporting of RCTs in ophthalmic surgery is suboptimal. Further work is needed by trial groups, funding agencies, authors, and journals to improve reporting clarity.
| S-EPMC4274293 | biostudies-other
Project description:PurposeRandomised controlled trials (RCTs) are considered the gold standard for evaluating the efficacy of an intervention. However, previous research has shown that RCTs in several surgical specialities are poorly reported, making it difficult to ascertain if various biases have been appropriately minimised. This systematic review assesses the reporting quality of surgical head and neck cancer RCTs.MethodsA literature search of PubMed and Embase was performed. Papers were included if they reported RCTs which assessed a surgical technique used to treat or diagnose head and neck cancer published during or after 2011. The CONSORT 2010 checklist was used to evaluate the reporting quality of these trials.Results41 papers were included. The mean CONSORT score was 16.5/25 (66% adherence) and the scores ranged from 7.5 (30%) to 25. The most common omissions were full trial protocol (found in 14.6%), participant recruitment method (22%) and effect size with a precision estimate for all outcome measures (29.3%). The full design and implementation of the randomisation methods were reported in 6 (14.6%). Papers published in journals which endorsed CONSORT had significantly higher scores (p = 0.02) and the journal impact factor was significantly correlated with CONSORT score (p = 0.01).ConclusionWe have identified several pieces of information that are underreported in surgical head and neck cancer RCTs. These omissions make understanding and comparing the methodologies and conclusions of RCTs more difficult. The endorsement of CONSORT by journals improved adherence, suggesting that wider adoption of the checklist may improve reporting.
| S-EPMC8486722 | biostudies-literature
Project description:Objectives The aim of this study was to evaluate the quality of reporting of randomised controlled trials (RCTs) of artificial intelligence (AI) in healthcare against Consolidated Standards of Reporting Trials—AI (CONSORT-AI) guidelines. Design Systematic review. Data sources We searched PubMed and EMBASE databases for studies reported from January 2015 to December 2021. Eligibility criteria We included RCTs reported in English that used AI as the intervention. Protocols, conference abstracts, studies on robotics and studies related to medical education were excluded. Data extraction The included studies were graded using the CONSORT-AI checklist, comprising 43 items, by two independent graders. The results were tabulated and descriptive statistics were reported. Results We screened 1501 potential abstracts, of which 112 full-text articles were reviewed for eligibility. A total of 42 studies were included. The number of participants ranged from 22 to 2352. Only two items of the CONSORT-AI items were fully reported in all studies. Five items were not applicable in more than 85% of the studies. Nineteen per cent (8/42) of the studies did not report more than 50% (21/43) of the CONSORT-AI checklist items. Conclusions The quality of reporting of RCTs in AI is suboptimal. As reporting is variable in existing RCTs, caution should be exercised in interpreting the findings of some studies.
| S-EPMC9445816 | biostudies-literature
Project description:ObjectiveEvaluate the quality of exercise randomised controlled trial (RCT) reporting and conduct in clinical populations (ie, adults with or at risk of chronic conditions) and compare with matched pharmacological RCTs.DesignSystematic review.Data sourcesEmbase (Elsevier), PubMed (NLM) and CINAHL (EBSCO).Study selectionRCTs of exercise in clinical populations with matching pharmacological RCTs published in leading clinical, medical and specialist journals with impact factors ≥15.Review methodsOverall RCT quality was evaluated by two independent reviewers using three research reporting guidelines (ie, Consolidated Standards of Reporting Trials (CONSORT; pharmacological RCTs)/CONSORT for non-pharmacological treatments; exercise RCTs), CONSORT-Harms, Template for Intervention Description and Replication) and two risk of bias assessment (research conduct) tools (ie, Cochrane Risk of Bias, Jadad Scale). We compared research reporting and conduct quality within exercise RCTs with matched pharmacological RCTs, and examined factors associated with quality in exercise and pharmacological RCTs, separately.FindingsForty-eight exercise RCTs (11 658 patients; median sample n=138) and 48 matched pharmacological RCTs were evaluated (18 501 patients; median sample n=160). RCTs were conducted primarily in cardiovascular medicine (43%) or oncology (31%). Overall quality score (composite of all research reporting and conduct quality scores; primary endpoint) for exercise RCTs was 58% (median score 46 of 80; IQR: 39-51) compared with 77% (53 of 68; IQR: 47-58) in the matched pharmacological RCTs (p≤0.001). Individual quality scores for trial reporting and conduct were lower in exercise RCTs compared with matched pharmacological RCTs (p≤0.03). Factors associated with higher overall quality scores for exercise RCTs were journal impact factor (≥25), sample size (≥152) and publication year (≥2013).Conclusions and relevanceResearch reporting and conduct quality within exercise RCTs is inferior to matched pharmacological RCTs. Suboptimal RCT reporting and conduct impact the fidelity, interpretation, and reproducibility of exercise trials and, ultimately, implementation of exercise in clinical populations.Prospero registration numberCRD42018095033.
| S-EPMC8359527 | biostudies-literature
Project description:ObjectivesTo determine the incidence and characteristics of randomised controlled trials that report using the modified intention to treat approach, and how the approach is described.DesignSystematic review.Data sourcesPubMed, Embase, Cochrane central register of controlled trials, ISI Web of Knowledge, Ovid, HighWire Press, Science-Direct, Ingenta, Medscape, BioMed Central, Springer, and Wiley, from inception to December 2006.Main outcome measuresIncidence of trials in which use of modified intention to treat was reported, and how the approach was described (classified according to the type and number of deviations from the intention to treat approach).Results475 randomised controlled trials reported use of a modified intention to treat analysis. Of these, 76 (16%) were published in five highly cited general medical journals. The incidence of all trials that reported use of modified intention to treat published in journals indexed in Medline increased from 0.006% in 1982-6 to 0.5% in 2002-6 (P<0.001 for linear trend). When the description of the modified intention to treat was examined in each trial, 192 (40%) reported one type of deviation from the intention to treat approach, 261 (55%) reported two or more types, and 22 (5%) did not describe any type. In 266 (56%) of the trials the deviation was related to the treatment received, in 196 (41%) to a post baseline assessment, in 118 (25%) to a baseline assessment, in 108 (23%) to a target condition, and in 23 (5%) to follow-up. Post-randomisation exclusions occurred in 380 (80%) trials. The results reported by 270 of the 352 (77%) superiority trials favoured the drug under investigation. All of the 123 trials using equivalence or non-inferiority methods to investigate interventions reported results that favoured their assumptions.ConclusionsRandomised controlled trials that report using a modified intention to treat are increasingly being published in the medical literature. The descriptions of such an approach were ambiguous, and may cover any type of descriptions for exclusion, such as missing data and deviation from protocol. Explicit statements about post-randomisation exclusions should replace the ambiguous terminology of modified intention to treat.
| S-EPMC2885592 | biostudies-literature
Project description:To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran.Systematized review.We included RCTs conducted on diabetes mellitus in Iran. Animal studies, educational interventions, and non-randomized trials were excluded. We excluded duplicated publications reporting the same groups of participants and intervention. Two independent reviewers identify all eligible articles specifically designed data extraction form. We searched through international databases; Scopus, ProQuest, EBSCO, Science Direct, Web of Science, Cochrane Library, PubMed; and national databases (In Persian language) such as Magiran, Scientific Information Database (SID) and IranMedex from January 1995 to January of 2013 Two investigators assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statemen.t,. Discrepancies were resolved by third reviewer consulting.One hundred and eight five (185) studies were included and appraised. Half of them (55.7 %) were published in Iranian journals. Most (89.7 %) were parallel RCTs, and being performed on type2 diabetic patients (77.8 %). Less than half of the CONSORT items (43.2 %) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1 % mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8 % of trials report how blinding was applied.The findings of this study show that the quality of RCTs conducted in Iran in diabetes research seems suboptimal and the reporting is also incomplete however an increasing trend of improvement can be seen over time. Therefore, it is suggested Iranian researchers pay much more attention to design and methodological quality in conducting and reporting of diabetes RCTs.
| S-EPMC5015251 | biostudies-other
Project description:To systematically review the quality of reporting of pilot and feasibility of cluster randomised trials (CRTs). In particular, to assess (1) the number of pilot CRTs conducted between 1 January 2011 and 31 December 2014, (2) whether objectives and methods are appropriate and (3) reporting quality.We searched PubMed (2011-2014) for CRTs with 'pilot' or 'feasibility' in the title or abstract; that were assessing some element of feasibility and showing evidence the study was in preparation for a main effectiveness/efficacy trial. Quality assessment criteria were based on the Consolidated Standards of Reporting Trials (CONSORT) extensions for pilot trials and CRTs.Eighteen pilot CRTs were identified. Forty-four per cent did not have feasibility as their primary objective, and many (50%) performed formal hypothesis testing for effectiveness/efficacy despite being underpowered. Most (83%) included 'pilot' or 'feasibility' in the title, and discussed implications for progression from the pilot to the future definitive trial (89%), but fewer reported reasons for the randomised pilot trial (39%), sample size rationale (44%) or progression criteria (17%). Most defined the cluster (100%), and number of clusters randomised (94%), but few reported how the cluster design affected sample size (17%), whether consent was sought from clusters (11%), or who enrolled clusters (17%).That only 18 pilot CRTs were identified necessitates increased awareness of the importance of conducting and publishing pilot CRTs and improved reporting. Pilot CRTs should primarily be assessing feasibility, avoiding formal hypothesis testing for effectiveness/efficacy and reporting reasons for the pilot, sample size rationale and progression criteria, as well as enrolment of clusters, and how the cluster design affects design aspects. We recommend adherence to the CONSORT extensions for pilot trials and CRTs.
| S-EPMC5695336 | biostudies-literature
Project description:IntroductionTo date, there has been a lack of knowledge about the status, reporting completeness and methodological quality of pilot trials in the acupuncture field. Thus, this systematic review protocol aims to: (1) investigate publication trends and aspects of feasibility evaluated in acupuncture pilot trials; (2) identify the proportion of acupuncture pilot trials that lead to definitive trials and (3) assess the reporting completeness and methodological quality of pilot trials in acupuncture.Methods and analysisStudies of acupuncture pilot randomised controlled trials published from 2011 to 2021 will be retrieved in seven databases in January 2022, including PubMed, Web of Science, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database and Chinese Biomedical Literature Database. The methodological quality and reporting completeness of all included studies will be assessed using the risk of bias 2.0 tool (RoB 2) and the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials, respectively. For the primary analysis, publication trends, aspects of feasibility and the proportion of pilot trials that lead to definitive trials will be analysed. A quantitative analysis of the methodological quality and reporting completeness of the included trials will be implemented by calculating the percentage of items reported in each domain of RoB 2 and CONSORT. The secondary analysis will adopt a regression analysis to identify factors associated with the reporting completeness.Ethics and disseminationEthical approval is not required for this study. This study is planned to be submitted to a peer-reviewed academic journal.
| S-EPMC8647552 | biostudies-literature