Dataset Information

Adherence to the Standards for Reporting of Diagnostic Accuracy Studies (STARD): a survey of four journals in laboratory medicine.

ABSTRACT:

Background

The Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement has been updated in 2015. Many diagnostic test accuracy (DTA) studies have been published in medical laboratory journals, but their adherence to the updated STARD statement remains unknown.

Methods

We searched the PubMed database to verify studies published in 4 laboratory journals, including Clinical Chemistry, Clinical Chemistry and Laboratory Medicine, Clinica Chimica Acta, and Clinical Biochemistry, in 2019. DTA studies were identified and their adherence to the STARD statement was assessed.

Results

A total of 45 studies were included in this analysis. Overall, 18 out of 34 STARD items were reported. The items (adherence rate) of sample size estimation (4%), adverse events (9%), protocol (9%), registration (16%), missing value (22%), indeterminate results (18%), and cross-tabulation (22%) were the most frequently unreported items.

Conclusions

Adherence to the STARD statement in DTA articles published in laboratory medicine seems as yet unsatisfactory. Our study emphasizes the necessity to improve the reporting quality of DTA studies published in medical laboratory journals.

SUBMITTER: Zheng FF

PROVIDER: S-EPMC8263879 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Adherence to the Standards for Reporting of Diagnostic Accuracy Studies (STARD): a survey of four journals in laboratory medicine.

Zheng Fei-Fei FF Shen Wei-Hong WH Gong Fang F Hu Zhi-De ZD Lippi Giuseppe G Šimundić Ana-Maria AM Bossuyt Patrick M M PMM Plebani Mario M Zhang Kaiping K

Annals of translational medicine 20210601 11

<h4>Background</h4>The Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement has been updated in 2015. Many diagnostic test accuracy (DTA) studies have been published in medical laboratory journals, but their adherence to the updated STARD statement remains unknown.<h4>Methods</h4>We searched the PubMed database to verify studies published in 4 laboratory journals, including <i>Clinical Chemistry</i>, <i>Clinical Chemistry and Laboratory Medicine</i>, <i>Clinica Chimica Acta</ ...[more]

PMID: 34350233

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Project description:Importance:Incomplete reporting of diagnostic accuracy research impairs assessment of risk of bias and limits generalizability. Point-of-care ultrasound has become an important diagnostic tool for acute care physicians, but studies assessing its use are of varying methodological quality. Objective:To assess adherence to the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 guidelines in the literature on acute care point-of-care ultrasound. Evidence Review:MEDLINE was searched to identify diagnostic accuracy studies assessing point-of-care ultrasound published in critical care, emergency medicine, or anesthesia journals from 2016 to 2019. Studies were evaluated for adherence to the STARD 2015 guidelines, with the following variables analyzed: journal, country, STARD citation, STARD-adopting journal, impact factor, patient population, use of supplemental material, and body region. Data analysis was performed in November 2019. Findings:Seventy-four studies were included in this systematic review for assessment. Overall adherence to STARD was moderate, with 66% (mean [SD], 19.7 [2.9] of 30 items) of STARD items reported. Items pertaining to imaging specifications, patient population, and readers of the index test were frequently reported (>66% of studies). Items pertaining to blinding of readers to clinical data and to the index or reference standard, analysis of heterogeneity, indeterminate and missing data, and time intervals between index and reference test were either moderately (33%-66%) or infrequently (<33%) reported. Studies in STARD-adopting journals (mean [SD], 20.5 [2.9] items in adopting journals vs 18.6 [2.3] items in nonadopting journals; P = .002) and studies citing STARD (mean [SD], 21.3 [0.9] items in citing studies vs 19.5 [2.9] items in nonciting studies; P = .01) reported more items. Variation by country and journal of publication were identified. No differences in STARD adherence were identified by body region imaged (mean [SD], abdominal, 20.0 [2.5] items; head and neck, 17.8 [1.6] items; musculoskeletal, 19.2 [3.1] items; thoracic, 20.2 [2.8] items; and other or procedural, 19.8 [2.7] items; P = .29), study design (mean [SD], prospective, 19.7 [2.9] items; retrospective, 19.7 [1.8] items; P > .99), patient population (mean [SD], pediatric, 20.0 [3.1] items; adult, 20.2 [2.7] items; mixed, 17.9 [1.9] items; P = .09), use of supplementary materials (mean [SD], yes, 19.2 [3.0] items; no, 19.7 [2.8] items; P = .91), or journal impact factor (mean [SD], higher impact factor, 20.3 [3.1] items; lower impact factor, 19.1 [2.4] items; P = .08). Conclusions and Relevance:Overall, the literature on acute care point-of-care ultrasound showed moderate adherence to the STARD 2015 guidelines, with more complete reporting found in studies citing STARD and those published in STARD-adopting journals. This study has established a current baseline for reporting; however, future studies are required to understand barriers to complete reporting and to develop strategies to mitigate them.

Project description:BackgroundResearch has shown a modest adherence of diagnostic test accuracy (DTA) studies in glaucoma to the Standards for Reporting of Diagnostic Accuracy Studies (STARD). We have applied the updated 30-item STARD 2015 checklist to a set of studies included in a Cochrane DTA systematic review of imaging tools for diagnosing manifest glaucoma.MethodsThree pairs of reviewers, including one senior reviewer who assessed all studies, independently checked the adherence of each study to STARD 2015. Adherence was analyzed on an individual-item basis. Logistic regression was used to evaluate the effect of publication year and impact factor on adherence.ResultsWe included 106 DTA studies, published between 2003-2014 in journals with a median impact factor of 2.6. Overall adherence was 54.1% for 3,286 individual rating across 31 items, with a mean of 16.8 (SD: 3.1; range 8-23) items per study. Large variability in adherence to reporting standards was detected across individual STARD 2015 items, ranging from 0 to 100%. Nine items (1: identification as diagnostic accuracy study in title/abstract; 6: eligibility criteria; 10: index test (a) and reference standard (b) definition; 12: cut-off definitions for index test (a) and reference standard (b); 14: estimation of diagnostic accuracy measures; 21a: severity spectrum of diseased; 23: cross-tabulation of the index and reference standard results) were adequately reported in more than 90% of the studies. Conversely, 10 items (3: scientific and clinical background of the index test; 11: rationale for the reference standard; 13b: blinding of index test results; 17: analyses of variability; 18; sample size calculation; 19: study flow diagram; 20: baseline characteristics of participants; 28: registration number and registry; 29: availability of study protocol; 30: sources of funding) were adequately reported in less than 30% of the studies. Only four items showed a statistically significant improvement over time: missing data (16), baseline characteristics of participants (20), estimates of diagnostic accuracy (24) and sources of funding (30).ConclusionsAdherence to STARD 2015 among DTA studies in glaucoma research is incomplete, and only modestly increasing over time.

Project description:IntroductionStandards for Reporting of Diagnostic Accuracy Study (STARD) was developed to improve the completeness and transparency of reporting in studies investigating diagnostic test accuracy. However, its current form, STARD 2015 does not address the issues and challenges raised by artificial intelligence (AI)-centred interventions. As such, we propose an AI-specific version of the STARD checklist (STARD-AI), which focuses on the reporting of AI diagnostic test accuracy studies. This paper describes the methods that will be used to develop STARD-AI.Methods and analysisThe development of the STARD-AI checklist can be distilled into six stages. (1) A project organisation phase has been undertaken, during which a Project Team and a Steering Committee were established; (2) An item generation process has been completed following a literature review, a patient and public involvement and engagement exercise and an online scoping survey of international experts; (3) A three-round modified Delphi consensus methodology is underway, which will culminate in a teleconference consensus meeting of experts; (4) Thereafter, the Project Team will draft the initial STARD-AI checklist and the accompanying documents; (5) A piloting phase among expert users will be undertaken to identify items which are either unclear or missing. This process, consisting of surveys and semistructured interviews, will contribute towards the explanation and elaboration document and (6) On finalisation of the manuscripts, the group's efforts turn towards an organised dissemination and implementation strategy to maximise end-user adoption.Ethics and disseminationEthical approval has been granted by the Joint Research Compliance Office at Imperial College London (reference number: 19IC5679). A dissemination strategy will be aimed towards five groups of stakeholders: (1) academia, (2) policy, (3) guidelines and regulation, (4) industry and (5) public and non-specific stakeholders. We anticipate that dissemination will take place in Q3 of 2021.

Project description:ObjectivesTo investigate whether encouraging authors to follow the Standards for Reporting Diagnostic Accuracy (STARD) guidelines improves the quality of reporting of diagnostic accuracy studies.MethodsIn mid-2017, European Radiology started encouraging its authors to follow the STARD guidelines. Our MEDLINE search identified 114 diagnostic accuracy studies published in European Radiology in 2015 and 2019. The quality of reporting was evaluated by two independent reviewers using the revised STARD statement. Item 11 was excluded because a meaningful decision about adherence was not possible. Student's t test for independent samples was used to analyze differences in the mean number of reported STARD items between studies published in 2015 and in 2019. In addition, we calculated differences related to the study design, data collection, and citation rate.ResultsThe mean total number of reported STARD items for all 114 diagnostic accuracy studies analyzed was 15.9 ± 2.6 (54.8%) of 29 items (range 9.5-22.5). The quality of reporting of diagnostic accuracy studies was significantly better in 2019 (mean ± standard deviation (SD), 16.3 ± 2.7) than in 2015 (mean ± SD, 15.1 ± 2.3; p < 0.02). No significant differences in the reported STARD items were identified in relation to study design (p = 0.13), data collection (p = 0.87), and citation rate (p = 0.09).ConclusionThe quality of reporting of diagnostic accuracy studies according to the STARD statement was moderate with a slight improvement since European Radiology started to recommend its authors to follow the STARD guidelines.Key points• The quality of reporting of diagnostic accuracy studies was moderate with a mean total number of reported STARD items of 15.9 ± 2.6. • The adherence to STARD was significantly better in 2019 than in 2015 (16.3 ± 2.7 vs. 15.1 ± 2.3; p = 0.016). • No significant differences in the reported STARD items were identified in relation to study design (p = 0.13), data collection (p = 0.87), and citation rate (p = 0.09).

Dataset Information

Adherence to the Standards for Reporting of Diagnostic Accuracy Studies (STARD): a survey of four journals in laboratory medicine.

Background

Methods

Results

Conclusions

Publications

Adherence to the Standards for Reporting of Diagnostic Accuracy Studies (STARD): a survey of four journals in laboratory medicine.

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