| Literature DB >> 32356885 |
Ross Prager1, Joshua Bowdridge1, Hashim Kareemi2, Chris Wright3, Trevor A McGrath4, Matthew D F McInnes4,5.
Abstract
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.Entities:
Year: 2020 PMID: 32356885 PMCID: PMC7195624 DOI: 10.1001/jamanetworkopen.2020.3871
Source DB: PubMed Journal: JAMA Netw Open ISSN: 2574-3805
Figure. Study Flowchart
Study Characteristics
| Characteristics | Studies, No. (%) (N = 74) |
|---|---|
| Standards for Reporting of Diagnostic Accuracy items reported, mean (SD) (n = 30 items total) | 19.7 (2.9) |
| Country of corresponding author | |
| US | 22 (30) |
| Turkey | 14 (20) |
| France | 6 (8) |
| Canada | 4 (5) |
| Australia | 3 (4) |
| China | 3 (4) |
| Italy | 3 (4) |
| Spain | 3 (4) |
| Others | 16 (22) |
| Publishing in Standards for Reporting of Diagnostic Accuracy–adopting journals | |
| Yes | 41 (55) |
| No | 33 (45) |
| Journal of publication | |
| 24 (32) | |
| 7 (9) | |
| 6 (8) | |
| 5 (7) | |
| 4 (5) | |
| Other | 28 (38) |
| Journal impact factor, median (range) | 1.65 (1.12-9.66) |
| Body region of scan | |
| Thoracic | 31 (42) |
| Abdominal | 16 (22) |
| Musculoskeletal | 16 (22) |
| Head and neck | 6 (8) |
| Other or procedural | 5 (7) |
| Study design | |
| Prospective | 68 (92) |
| Retrospective | 6 (8) |
| Patient population (n = 71) | |
| Adult | 44 (62) |
| Pediatric | 17 (24) |
| Mixed | 10 (14) |
| Use of supplemental material | |
| Yes | 8 (11) |
| No | 66 (89) |
Reporting Frequency of Standards for Reporting of Diagnostic Accuracy 2015 Items
| Article section, item No. | Item description | Studies reporting the item, No. (%) (N = 74) |
|---|---|---|
| Title or abstract | ||
| 1 | Identification as a study of diagnostic accuracy using at least 1 measure of accuracy (eg, sensitivity, specificity, predictive values, or area under the curve) | 74 (100) |
| Abstract | ||
| 2 | Structured summary of study design, methods, results, and conclusions | 73 (99) |
| Introduction | ||
| 3 | Scientific and clinical background, including the intended use and clinical role of the index test | 74 (100) |
| 4 | Study objectives and hypotheses | 74 (100) |
| Methods | ||
| 5 | Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study) | 72 (97) |
| 6 | Eligibility criteria | 72 (97) |
| 7 | On what basis potentially eligible participants were identified (eg, symptoms, results from previous tests, and inclusion in registry) | 72 (97) |
| 8 | Where and when potentially eligible participants were identified (setting, location, and dates) | |
| 8.1 | Setting | 71 (96) |
| 8.2 | Location | 31 (42) |
| 8.3 | Dates | 65 (89) |
| 9 | Whether participants formed a consecutive, random, or convenience series | 41 (55) |
| 10 | Index test, in sufficient detail to allow replication | |
| 10.1 | Details of imaging test provided in sufficient detail (multiple subitems) | |
| 10.1a | Modality (transabdominal, transesophageal, transthoracic, or transbronchial) | 74 (100) |
| 10.1b | Vendor | 65 (88) |
| 10.1c | Model | 60 (81) |
| 10.1d | Technical parameters: probe type, transducer frequency, gray scale, Doppler | 64 (86) |
| 10.1e | Ultrasound contrast (if applicable) | 74 (100) |
| 10.2 | Details of interpretation of the index test | |
| 10.2a | No. of readers | 56 (76) |
| 10.2b | Level of training of readers | 63 (85) |
| 10.2c | Images interpreted independently or in consensus | 32 (43) |
| 10.3 | Reference standard, in sufficient detail to allow replication | 71 (96) |
| 11 | Rationale for choosing the reference standard (if alternatives exist) | 56 (76) |
| 12 | ||
| 12.1 | Definition of and rationale for test positivity cutoffs or result categories of the index test, distinguishing prespecified from exploratory | |
| 12.1a | Definition of test positivity cutoffs or result categories of the index test reported | 63 (85) |
| 12.1b | Whether the test positivity cutoffs were prespecified vs exploratory | 35 (47) |
| 12.2 | Definition of and rationale for test positivity cutoffs or result categories of reference standard, distinguishing prespecified from exploratory | |
| 12.2a | Definition of and rationale for test positivity cutoffs or result categories of the reference standard reported | 46 (62) |
| 12.2b | Whether the test positivity cutoffs were prespecified vs exploratory | 22 (30) |
| 13 | ||
| 13.1 | Whether clinical information and reference standard results were available to the performers or readers of the index test | |
| 13.1a | Clinical information available to readers of the index test? | 28 (38) |
| 13.1b | Reference standard results available to readers of the index test? | 42 (57) |
| 13.2 | Whether clinical information and index test results were available to the assessors of the reference standard | |
| 13.2a | Clinical information available to assessors of the reference standard? | 27 (36) |
| 13.2b | Index test results available to assessors of the reference standard? | 41 (55) |
| 14 | Methods for estimating or comparing measures of diagnostic accuracy | 74 (100) |
| 15 | How indeterminate index test or reference standard results were handled | 21 (28) |
| 16 | How missing data on the index test and reference standard were handled | 25 (34) |
| 17 | Any analyses of variability in diagnostic accuracy, distinguishing prespecified from exploratory | |
| 17.1 | Analyses of variability | 33 (45) |
| 17.2 | Do they state which were prespecified vs exploratory? | 7 (9) |
| 18 | Intended sample size and how it was determined | |
| 18.1 | Intended sample size | 25 (34) |
| 18.2 | How sample size was determined | 24 (32) |
| Results | ||
| 19 | Flow of participants, using a diagram | 32 (43) |
| 20 | Baseline demographic and clinical characteristics of participants | 65 (88) |
| 21 | ||
| 21.1 | Distribution of severity of disease in those with the target condition | 63 (85) |
| 21.2 | Distribution of alternative diagnoses in those without the target condition | 40 (54) |
| 22 | Time interval and any clinical interventions between the index test and the reference standard | |
| 22.1 | Time interval | 23 (31) |
| 22.2 | Clinical interventions | 19 (26) |
| 23 | Cross-tabulation of the index test results (or their distribution) by the results of the reference standard | 45 (61) |
| 24 | Did the study provide estimates of diagnostic accuracy and their precision? | 68 (92) |
| 25 | Any adverse events from performing the index test or the reference standard | |
| 25.1 | Index test | 4 (5) |
| 25.2 | Reference standard | 9 (12) |
| Discussion | ||
| 26 | Study limitations, including sources of potential bias, statistical uncertainty, and generalizability | |
| 26.1 | Sources of potential bias | 70 (95) |
| 26.2 | Potential sources of statistical uncertainty reported? | 39 (53) |
| 26.3 | Generalizability | 61 (82) |
| 27 | Implications for practice, including the intended use and clinical role of the index test | 71 (96) |
| Other information | ||
| 28 | Registration No. and name of registry | 9 (12) |
| 29 | Where the full study protocol can be accessed | 9 (12) |
| 30 | Sources of funding and other support; role of funders | |
| 30.1 | Sources of funding and other support | 54 (73) |
| 30.2 | Role of funders | 52 (70) |
Frequently reported studies (>66%) do not have a footnote.
Moderately reported items (33%-66% of studies).
Infrequently reported items (<33% of studies).
Summary of Subgroup Analysis
| Subgroup | Summary of finding | STARD items, mean (SD), No. | |
|---|---|---|---|
| Country of corresponding author | Higher No. of STARD items when France was compared with Turkey | 22.1 (2.4) vs 17.6 (1.9) | .04 |
| STARD-adopting journal | Higher No. of items reported in STARD-adopting journals compared with nonadopting journals | 20.5 (2.9) vs 18.6 (2.3) | .002 |
| Citation of STARD in article | Higher No. of items reported in STARD citing studies compared with nonciting studies | 21.3 (0.9) vs 19.5 (2.9) | .01 |
| Journal of publication | Higher No. of STARD items in | 21.1 (2.2) vs 18.1 (2.1) | .002 |
| 22.0 (1.9) vs 18.1 (2.1) | .02 | ||
| Journal impact factor (median split) | No statistically significant difference between studies in higher impact factor compared with lower impact factor journals | 20.3 (3.1) vs 19.1 (2.4) | .08 |
| Supplementary material | No statistically significant difference between studies with supplemental materials compared with those without supplemental materials | 19.2 (3.0) vs 19.7 (2.8) | .91 |
| Patient population | No statistically significant difference between pediatric, adult, and mixed population studies | 20.0 (3.1) vs 20.2 (2.7) vs 17.9 (1.9) | . 09 |
| Study design | No statistically significant difference between prospective or retrospective studies | 19.7 (2.9) vs 19.7 (1.8) | >.99 |
| Body region | No statistically significant difference between body regions scanned (abdominal, head and neck, musculoskeletal, thoracic, and other or procedural) | 20.0 (2.5) vs 17.8 (1.6) vs 19.2 (3.1) vs 20.2 (2.8) vs 19.8 (2.7) | .29 |
Abbreviation: STARD, Standards for Reporting of Diagnostic Accuracy.
Analysis of variance with Tukey honest significant difference test.
Two-tailed t test.
Analysis of variance.