Reporting quality of randomised controlled trial abstracts on age-related macular degeneration health care: a cross-sectional quantification of the adherence to CONSORT abstract reporting recommendations

Baulig, Christine; Krummenauer, Frank; Geis, Berit; Tulka, Sabrina; Knippschild, Stephanie

doi:10.1136/bmjopen-2018-021912

Cited by 21 publications

(31 citation statements)

References 29 publications

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“…Our findings are similar to other studies that have assessed the overall reporting quality and CONSORT statement checklist adherence in RCTs in a variety of fields [6, 25, 26]. As in other areas of health research, the reproducibility of clinical studies on diabetic retinopathy seems to be impaired by poor reporting.…”

Section: Discussionsupporting

confidence: 85%

Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist

Mozetic

Leonel

Pacheco

et al. 2019

Trials

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BackgroundA considerable amount of randomized controlled trials (RCTs) have been published on statins and/or fibrates for diabetic retinopathy, a clinical condition associated with high social and economic burden. Adherence to the CONSORT statement items is imperative to ensure transparency and reproducibility in clinical research. The aim of this study is to assess the reporting quality and the adherence to CONSORT of RCTs assessing statins and/or fibrates for diabetic retinopathy.MethodsWe conducted a critical appraisal study at Discipline of Evidence-based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). A sensitive literature search was performed to identify all relevant RCTs, with no time or language limits. Two authors independently evaluated the reporting quality of the selected RCTs using the CONSORT statement as a standard.ResultsThirteen reports of RCTs were included in this study. The adherence of the reports to CONSORT items ranged from 24% to 68%. The median score was 11 (interquartile range (IQR) 8 to 13). When analyzed separately, the methods sections of the reports had a median of three items (IQR 2 to 4) judged adherent to the methods items of CONSORT (items 3 to 12). The most underreported items were those related to trial design, title and abstract, allocation concealment, implementation of the randomization sequence, and blinding. Other important items, such as the one related to the description of the inclusion criteria, also had low adherence.ConclusionsThe overall adherence to the CONSORT checklist items was poor, especially in the items related to the methods section. RCT reports on statins and/or fibrates for diabetic retinopathy must be optimized to avoid reporting biases and to improve transparency and reproducibility.

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Section: Discussionsupporting

confidence: 85%

Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist

Mozetic

Leonel

Pacheco

et al. 2019

Trials

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“…The software program Excel 14 was used to compile data, and the data mask was generated on the basis of the CONSORT statement for abstracts. 12 At the start of the project, a tool for evaluating abstract quality was available from a preceding study, 8 which had to be slightly adapted and extended for the purposes of this investigation by its planners. All 16 CONSORT-A criteria were included in data compilation and analysis.…”

Section: Methodsmentioning

confidence: 99%

“…These problems are widespread in publications on various clinical indications. [7][8][9][10] In oral implantation, we found one publication that assessed the reporting quality in abstracts of RCTs. 11 This study determined a mean overall reporting quality score of 58.6% in RCTs by focusing on six leading implantology journals between 2008 and 2012.…”

Section: Background and Objectivementioning

confidence: 99%

Assessment of reporting quality in randomised controlled clinical trial abstracts of dental implantology published from 2014 to 2016

et al. 2021

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ObjectivesAccess to full texts of randomised controlled clinical trials (RCTs) is often limited, so brief summaries of studies play a pivotal role. In 2008, a checklist was provided to ensure the transparency and completeness of abstracts. The aim of this investigation was to estimate adherence to the reporting guidelines of the Consolidated Standards of Reporting Trials (CONSORT) criteria for abstracts (CONSORT-A) in RCT publications.Primary endpointAssessment according to the percentage of compliance with the 16 CONSORT-A criteria per study.Materials and methodsThis study is based on a full survey (212 RCT abstracts in dental implantology, PubMed search, publication period 2014–2016, 45 journals, median impact factor: 2.328). In addition to merely documenting ‘adherence’ to criteria, the authors also assessed the ‘complete implementation’ of the requested information where possible. The collection of data was performed independently by two dentists, and a final consensus was reached. The primary endpoint was evaluated by medians and quartiles. Additionally, a Poisson regression was conducted to detect influencing factors.ResultsA median of 50% (Q1–Q3: 44%–63%) was documented for the 16 criteria listed in the CONSORT-A statement. Nine of the 16 criteria were considered in fewer than 50% of the abstracts. ‘Correct implementation’ was achieved for a median of 43% (Q1–Q3: 31%–50%) of the criteria. An additional application of Poisson regression revealed that the number of words used had a locally significant impact on the number of reported CONSORT criteria for abstracts (incidence rate ratio 1.001, 95% CI 1.001 to 1.002).ConclusionTransparent and complete reporting in abstracts appears problematic. A limited word count seems to result in a reduction in necessary information. As current scientific knowledge is often not readily available in the form of publications, abstracts constitute the primary basis for decision making in clinical practice and research. This is why journals should refrain from limiting the number of words too strictly in order to facilitate comprehensive reporting in abstracts.

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“…Publications not affiliated to AMD, without randomisation, publications with an inappropriate study design and non-English publications were to be excluded from the analysis. Of 673 possible RCTs identified by this search, a total of 133 remained eligible for evaluation; for further description of this RCT publication pool and details on the underlying electronical search strategy, see Baulig et al 10. From this publicationpool a series of 97 RCT publications (see sample size calculation) was analysed.…”

Section: Methodsmentioning

confidence: 99%

Validity of sample sizes in publications of randomised controlled trials on the treatment of age-related macular degeneration: cross-sectional evaluation

et al. 2019

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ObjectiveThe aim of this cross-sectional study was to examine the completeness and accuracy of the reporting of sample size calculations in randomised controlled trial (RCT) publications on the treatment of age-related macular degeneration (AMD).MethodsA sample of 97 RCTs published between 2004 and 2014 was reviewed for the calculation of their sample size. It was examined whether a (complete) description of the sample size calculation was presented. Furthermore, the sample size was recalculated, whenever possible based on the published details, in order to verify the reported number of patients.Primary outcome measureThe primary endpoint of this cross-sectional investigation was a described sample size calculation that was reproducible, complete and correct (maximum tolerated deviation between reported and replicated sample size ±2 participants per trial arm).ResultsA total of 50 publications (52%) did not provide any information on the justification of the number of patients included. Only 17 publications (18%) provided all the necessary parameters for recalculation; 8 of 97 (8%, 95%-CI: 4% to 16%) publications achieved the primary endpoint. The median relative deviation between reported and recalculated sample sizes was 1%, with a range from −43% to +66%.ConclusionAlthough a transparent sample size legitimation is a crucial determinant of an RCT’s methodological validity, more than half of the RCT publications considered failed to report them. Furthermore, reported sample size legitimations were often incomplete or incorrect. In summary, clinical authors should pay more attention to the transparent reporting of sample size calculation, and clinical journal reviewers may opt to reproduce reported sample size calculations.SynopsisMore than half of the analysed RCT publications on the treatment of AMD did not report a transparent sample size calculation. Only 8% reported a complete and correct sample size calculation.

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Reporting quality of randomised controlled trial abstracts on age-related macular degeneration health care: a cross-sectional quantification of the adherence to CONSORT abstract reporting recommendations

Cited by 21 publications

References 29 publications

Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist

Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist

Assessment of reporting quality in randomised controlled clinical trial abstracts of dental implantology published from 2014 to 2016

Validity of sample sizes in publications of randomised controlled trials on the treatment of age-related macular degeneration: cross-sectional evaluation

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