eTable 1. Full MEDLINE Search Strategy
eTable 2. Modified STARD 2015 Checklist for Data Extraction
eTable 3. Complete List of Included Studies With STARD Adherence
eTable 4. Subgroup Analysis of STARD Adherence by Study Design
eTable 5. Subgroup Analysis of STARD Adherence by Country
eTable 6. Subgroup Analysis of STARD Adherence by Body System
eTable 7. Subgroup Analysis by STARD Adoption by Journal
eTable 8. Subgroup Analysis by STARD Citation in Article
eTable 9. Subgroup Analysis by Patient Population (Adult vs Pediatric vs Mixed)
eTable 10. Subgroup Analysis of the Five Most Common Journals
eTable 11. Subgroup Analysis by Use of Supplemental Materials
eTable 12. Subgroup Analysis by Impact Factor (Median Split)
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Prager R, Bowdridge J, Kareemi H, Wright C, McGrath TA, McInnes MDF. Adherence to the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 Guidelines in Acute Point-of-Care Ultrasound Research. JAMA Netw Open. 2020;3(5):e203871. doi:10.1001/jamanetworkopen.2020.3871
根据对诊断准确性报告规范 (Standards for Reporting of Diagnostic Accuracy, STARD) 2015 指南的依从性，紧急床旁即时超声文献报告的完整性如何？
这项对 74 项研究的系统评价发现，对 STARD 的总体依从性为中等，报告的 30 个项目中平均有 19.7 项依从指南 (66%)。引用 STARD 的研究以及在支持 STARD 的期刊上发表的研究，报告的项目数更高。
这些发现表明，床旁即时超声研究对 STARD 2015 指南的依从性为中等，这可能会限制检测个体研究中的偏倚的能力，并会妨碍将研究适当转化为临床实践。
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.
To assess adherence to the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 guidelines in the literature on acute care point-of-care ultrasound.
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.
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.
Point-of-care ultrasound (POCUS) has become an important part of the diagnostic arsenal for the contemporary acute care physician.1-6 In contrast to consultative ultrasound, where a scan is performed by a technologist and then later interpreted by a radiologist, POCUS can diagnose abnormal physiology and pathology at the bedside. With the increasing availability of ultrasound machines in hospitals, clinics, and the prehospital setting, the number of clinicians using POCUS and the potential indications for its use continue to grow.1-3,7-9 The diagnostic accuracy of consultative ultrasound has been well studied for numerous applications10-14; however, the test characteristics of POCUS remain an area of active research.6,9,15-17
Studies of diagnostic accuracy can be of heterogeneous methodological quality and have variable completeness of reporting.18 Incomplete reporting can limit the ability to detect bias, determine generalizability of study results, and reproduce research. Ultimately, this leads to the inability to appropriately translate research into clinical practice. Incomplete reporting can also prevent informative and unbiased systematic reviews and meta-analyses from being performed.19,20 As the body of literature surrounding POCUS continues to grow, any deficiencies in reporting must be identified with the aim of implementing knowledge translation strategies to correct them.
In 2003, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) group published a list of 25 essential items that should be reported in diagnostic accuracy research.21 The STARD group updated their reporting guideline in 2015 (hereafter referred to as STARD 2015), which now incorporates 30 essential items.22 These items have been deemed essential when interpreting primary diagnostic accuracy studies, and they allow readers to assess for bias and generalizability. To our knowledge, the current level of adherence to STARD 2015 is not known for the literature on acute care POCUS.
The objective of this study was to evaluate diagnostic accuracy studies published in the acute care medicine literature (emergency medicine, critical care, and anesthesia journals) for completeness of reporting, as defined by adherence to STARD 2015. This study will establish the current level of reporting and can serve as a call to action to improve completeness of reporting in deficient areas. As POCUS becomes further integrated into clinical practice, high-quality and completely reported research governing its use is essential.
Research ethics board approval for this type of research is not required at the University of Ottawa because no human participants were involved. The search, data extraction, and data analyses were performed according to a prespecified protocol available on the Open Science Framework.23 This systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.
The search was performed on June 13, 2019, with assistance from an experienced medical research librarian. MEDLINE was searched for diagnostic accuracy studies evaluating POCUS published in critical care, emergency medicine, and anesthesia journals (as designated by Thompson Reuters Journal Citations Reports 2018).24 A date range of 2016 to 2019 was applied to evaluate articles published after the introduction of the updated STARD 2015 criteria. The search was performed using a previously published search filter for diagnostic accuracy studies.25 The full search strategy is available in eTable 1 in the Supplement.
Studies were included if they met all of the following inclusion criteria: studies that examined the diagnostic accuracy of POCUS against a reference standard in human participants, studies that reported a measure of diagnostic accuracy (sensitivity, specificity, likelihood ratios, diagnostic odds ratio, or area under the receiver operating characteristic curve), and studies that were published in the English language. Point-of-care ultrasound was defined as ultrasound performed by nontechnologist, nonradiologist clinicians to distinguish it from consultative ultrasound. Studies were excluded if they evaluated predictive or prognostic tests or were reviews, meta-analyses, letters to the editor, or other commentaries.
Two reviewers (R.P. and J.B.) independently screened titles and abstracts to determine potential relevance. Any abstract that was deemed potentially relevant was automatically subject to full-text review. Full-text review was performed independently by 2 reviewers (R.P. and J.B.). Disagreements were resolved through consensus discussion with a third reviewer (T.A.M.).
Data were extracted independently by 2 reviewers (R.P., and one of J.B., H.K., or C.W.). Study characteristics extracted included study author, country of corresponding author’s institution, journal, journal impact factor in 2018, journal STARD endorsement included in the online instruction to authors (yes or no), year of publication, study design (prospective vs retrospective), patient population (pediatric vs adult vs mixed), use of supplementary material (yes or no), study citation of STARD (yes or no), and body region of POCUS scan (musculoskeletal vs head and neck vs thoracic vs abdominal vs skin and soft tissue vs procedural).
Adherence to the STARD 2015 checklist was extracted independently and in duplicate (R.P., and one of J.B., H.K., or C.W.). When assessing adherence to the STARD 2015 checklist, each reporting requirement was rated as yes, no, or not applicable, with all disagreements resolved by consensus between the 2 reviewers. Items rated as not applicable were treated as a yes during data analysis. Several examples of how an item could potentially be not applicable are provided in eTable 2 in the Supplement. In addition, items with potentially unique aspects to diagnostic imaging and POCUS were divided into multiple subitems. This was based on a previous STARD 2015 checklist from Hong et al26 specific to diagnostic imaging, with POCUS-specific modifications made after a consensus discussion between 2 investigators (R.P. and T.A.M.).26 Items with multiple subpoints were scored with a total of 1 point per question, with fractional points awarded for each subitem (eg, 8.1 for setting, 8.2 for location, and 8.3 for dates were scored with 0.33 points per subitem). eTable 2 in the Supplement includes the STARD 2015 checklist with a detailed scoring rubric.
If an item was reported anywhere in the article, it was scored as a yes, unless STARD guidelines specified that it must be reported in a particular section (eg, item 1 in the title or abstract). Information included in either the full text report or the supplementary material (including online-only material) was scored as a yes. To optimize interobserver agreement, a training session was done for all reviewers using 2 articles. Interrater reliability was calculated and a κ value was provided.
The overall adherence to STARD 2015 was calculated for each item, subitem, and study. Yes and not applicable were scored as 1 point, and no was scored as 0 points. The maximum number of points for a study was 30. An arbitrary distinction of frequently reported (>66%), moderately reported (33%-66%), and infrequently reported (<33%) was used on the basis of a previously published scoring system.26
The Shapiro-Wilks test was used to confirm normal distribution. One-way analysis of variance was used to evaluate adherence to STARD by association with country, journal, body region, and patient population. A Tukey honest significant difference test was used for pairwise comparisons. The top 12 countries with the most included studies (because of a 3-way tie for tenth), the top 5 journals (most included studies), and 5 prespecified body regions were selected for evaluation. The 2-sided Welch t test was used to evaluate adherence to STARD on the basis of study design, STARD-adopting journals, use of supplemental materials, impact factor (median split), and STARD citation.
All data were stored in Excel spreadsheet software version 2013 (Microsoft Corp), and data analysis was performed using R statistical software version 3.1.2 (R Project for Statistical Computing). The level of statistical significance was set at P < .05 for all analyses. Data analysis was performed in November 2019.
The literature search yielded 399 unique results. One hundred six results were selected for full-text review, and 74 studies were included for analysis after full-text screening. Details of the study selection process and reasons for exclusion during full-text assessment are provided in the Figure. Characteristics of the included studies are summarized in Table 1. According to the country of the corresponding author, one-half of the studies were from the US (22 studies [30%]) and Turkey (14 studies [20%]). Most of the journals had adopted STARD (41 journals [55%]), and their median impact factor was 1.65 (range, 1.12-9.66). Most of the studies were prospective (68 studies [92%]) and most involved adult patients (44 studies [62%]).
A summary of STARD 2015 adherence by item is presented in Table 2. Five of 74 studies cited STARD adherence in their methods. The mean (SD) number of STARD items reported for the 74 studies was 19.7 (2.9) of 30 items (66%), with a range from 13.8 to 25.8 items. The number of STARD items reported for each study is listed in eTable 3 in the Supplement. Interrater reliability was moderate (κ = 0.54).
Twenty-eight of the 30 items were frequently reported in whole, or in part (subitems), characterized by a reporting frequency of greater than 66%. Of note, the total number of frequently, moderately, and infrequently reported items is greater than 30 because some subitems are present in different categories. Some of the frequently reported items are of particular relevance to POCUS, including item 10.1 (a full description of the modality, equipment, and parameters of the ultrasound machine; reported by 74 studies [100%], 60 studies [81%], and 64 studies [86%], respectively), subitem 10.2b (the level of training of readers; reported by 63 studies [85%]), and subitem 10.3 (a clear description of the reference standard in sufficient detail to allow replication; reported by 71 studies [96%]).
Sixteen of the 30 items were moderately reported, in whole or in part (subitems), characterized by a reporting frequency of 33% to 66% (Table 2). Several items are particularly relevant to POCUS and are essential when assessing risk of bias. These include item 9 (whether participants formed a consecutive, convenience, or random sample; reported by 41 studies [55%]), and item 10.2c (whether images were interpreted independently or in consensus; reported by 32 studies [43%]). Notably, all subitems of item 13 were only moderately reported (whether readers of the index and reference tests were blinded to clinical data, and to each other).
Ten of the 30 items were infrequently reported, in whole or in part (subitems), characterized by a reporting frequency of less than 33% (Table 2). Some of these items are particularly relevant to POCUS and are essential when assessing risk of bias. These include item 15 (how indeterminate tests were handled; reported by 21 studies [28%]), subitem 17.2 (whether analyses of subgroups and heterogeneity were prespecified or exploratory; reported by 7 studies [9%]), and subitems 22.1 (the time interval between the index and reference test; reported by 23 studies [31%]) and 22.2 (whether any clinical interventions were performed between the index and reference test; reported by 19 studies [26%]).
Subgroup analyses of prespecified variables were performed and are summarized in Table 3. Additional details of the subgroup analyses are provided in eTables 4, 5, 6, 7, 8, 9, 10, 11, and 12 in the Supplement. The Shapiro-Wilks test confirmed the data are normally distributed (P = .41).
Studies published in STARD-adopting journals had a higher number of reported items compared with nonadopting journals (mean [SD], 20.5 [2.9] items vs 18.6 [2.3] items; P = .002). Studies that cited STARD had a higher number of reported items compared with nonciting studies (mean [SD], 21.3 [0.9] items vs 19.5 [2.9] items; P = .01). Variation by country and journal of publication were identified. A Tukey honestly significant difference test showed a difference based on country of corresponding author when France was compared with Turkey (mean [SD], 22.1 [2.4] items vs 17.6 [1.9] items; P = .04). In addition, studies published in Academic Emergency Medicine and The Journal of Emergency Medicine had a statistically significantly higher number of reported items compared with the American Journal of Emergency Medicine (mean [SD], 21.1 [2.2] items and 22.0 [1.9] items vs 18.1 [2.1] items; P = .002 and P = .02, respectively). There was no difference in the number of STARD items reported according to body region scanned (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).
The completeness of reporting of the acute care POCUS literature, defined as adherence to STARD 2015, was moderate with a mean (SD) of 19.7 (2.9) of 30 items (66%) being reported. The STARD reporting varied according to country of corresponding author, citation of STARD in the article, journal of publication, and whether the journal of publication endorsed STARD in the instructions to authors. Reporting did not vary on the basis of impact factor, study design, patient population, use of supplemental materials, or body region.
Items pertaining to the technical parameters of ultrasound (ie, machine model, details of scan, and probe specifications) and to the readers of POCUS were frequently reported; these are essential items to consider when evaluating the applicability of a study to clinical practice. For example, image quality can vary with machine make and model, which could limit reproducibility and generalizability of study results depending on equipment availability in a certain clinical setting. Point-of-care ultrasound is also highly operator dependent, and its accuracy varies with practitioner expertise.27,28 This makes it important to report operator expertise and any specific training received to learn a scan (eg, workshops) to allow other clinicians to assess the feasibility of integrating a new ultrasound scan into their own practice.
Although many items were frequently reported, the image interpretation practices (individual vs consensus reading), blinding to the reference standard and clinical information, and analysis of heterogeneity in the data were only moderately or infrequently reported (Table 2). Deficiencies in these areas of reporting are troublesome, because they can easily lead to bias and limit translation of research into clinical practice. Lack of blinding of the index test to the reference standard and failure to specify whether subgroup analyses are prespecified have both been shown to cause bias in diagnostic accuracy research and are included in the currently recommended risk of bias tool for assessing diagnostic accuracy studies.18
The observed deficiencies in reporting are not unique to this study and are similar to previous analyses of the diagnostic imaging literature.26,29 Hong et al26 investigated adherence to STARD 2015 for multiple imaging modalities. They found a lower number of STARD items reported compared with our sample (mean [SD],16.6 [2.21] of 30 items [55%]),26 and similar deficiencies in reporting on a per-item basis. In their subgroup of consultative ultrasound studies, the mean (SD) STARD adherence was 16.7 (2.05) of 30 items (55%)26; however, given potential confounders with study design and sample size, a direct comparison would be at high risk of bias. This suggests that any deficiencies in reporting may not be unique to POCUS but are more indicative of a global deficiency in the reporting of diagnostic imaging studies. A recent study by Thiessen et al29 assessed adherence of POCUS studies to the original STARD criteria (published in 2003) in 5 emergency medicine journals from 2005 to 2010. They found a mean of 15 of 25 (60%) STARD items reported.29 Several key differences in methods, including different scoring rubrics and their inclusion of studies not reporting diagnostic accuracy, limits direct comparison with our sample.
In the present study, blinding of the POCUS reader to clinical data was only moderately reported. Point-of-care ultrasound is performed and interpreted by clinicians at the bedside, making clinical information an important potential source of bias. For example, if the history and physical examination are suggestive of a fracture, a clinician performing POCUS may search with the ultrasound until a fracture is identified. This highlights a distinction between POCUS practice and research. In practice, POCUS is often thought of as an extension of the physical examination. During POCUS research, however, blinding to clinical information should be clearly reported. This helps readers evaluate the generalizability of the results and assess for inadvertent inclusion of clinical history and physical examination maneuvers in the POCUS accuracy estimates.
Several other infrequently reported STARD items include the time elapsed and any clinical interventions performed between the index test and reference standard. Point-of-care ultrasound is often used to diagnose acute and dynamic conditions (eg, heart failure or elevated intracranial pressure) that have the potential to rapidly improve or progress either spontaneously or through interventions. Delay in performing the reference standard has the potential to introduce false-positive or false-negative findings depending on the course of the acute illness. Certain procedures (eg, chest tube insertion for pneumothorax) also have the potential to entirely reverse the pathology identified by POCUS, potentially creating incorrect false-positive results.
Another notable finding was that there was a higher number of items reported in journals that endorse STARD in their instructions to authors; this is similar to previous evaluations and may be associated with STARD-adopting journals using the STARD 2015 checklist in their peer review process, or authors being prompted to adhere to STARD through the online instructions to authors.26 There was also a higher number of items reported in the 5 of 74 studies that cited STARD adherence in their methods. Adherence to reporting guidelines should be of interest to authors and journal editors alike, because it may be associated with higher citation rates; however, the literature30 is conflicting with a study by Dilauro et al31 showing that the association of STARD adherence with citation rate did not persist after controlling for journal impact factor. Despite this, only a small minority of the studies cited STARD adherence in their methods, suggesting either a lack of awareness regarding the STARD 2015 guidelines, lack of enforcement of reporting guidelines by journals, or other barriers to adherence.
Our literature search was only applied to journals listed in the categories of critical care, emergency medicine, and anesthesia as defined by the Thompson Reuters Journal Citations Reports 2018, and, therefore, our results may not be generalizable to POCUS research in other clinical settings. Additionally, although the study identified deficiencies in reporting, reasons for incomplete reporting were not assessed. Furthermore, because subgroups were prespecified, some categories have a small number of studies and post hoc recategorization was not performed to avoid introducing bias. Considering this, the study may have been underpowered to detect a difference in STARD adherence in some subgroups, including by journal impact factor (P = .08), which has previously been shown to vary between studies published in high–impact factor and low–impact factor journals.26 Furthermore, although a statistically significant difference between STARD-adopting journals compared with nonadopting journals was found, it is unclear how clinically important such a small difference would be to the reader of a study, because some STARD items have the potential to introduce more bias compared with others.
The role of POCUS in the diagnosis and management of acutely ill patients is continuing to expand. The ability to integrate POCUS into clinical practice relies on accurate estimates for the diagnostic accuracy of each scan. In this study, adherence of POCUS research to STARD 2015 was only moderate, which may limit the ability to detect bias in individual studies and prevent appropriate translation of research into clinical practice.
Accepted for Publication: February 28, 2020.
Published: May 1, 2020. doi:10.1001/jamanetworkopen.2020.3871
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Prager R et al. JAMA Network Open.
Corresponding Author: Matthew D. F. McInnes, MD, PhD, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, 1053 Carling Ave, Civic Campus, Room C159, Ottawa, ON K1Y 4E9, Canada (firstname.lastname@example.org).
Author Contributions: Drs McInnes and Prager had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Prager, McGrath, McInnes.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Prager, Wright, McInnes.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Prager, McGrath.
Administrative, technical, or material support: Prager.
Conflict of Interest Disclosures: None reported.
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