STAndards For The Reporting Of Diagnostic Accuracy Studies Research Articles

Introduction to diagnostic test accuracy studies.

Diagnostic accuracy studies are fundamental for the assessment of diagnostic tests. Researchers need to understand the implications of their chosen design, opting for comparative designs where possible. Researchers should analyse test accuracy studies using the appropriate methods, acknowledging the uncertainty of results and avoiding overstating conclusions and ignoring the clinical situation which should inform the trade-off between sensitivity and specificity. Test accuracy studies should be reported with transparency using the STAndards for the Reporting of Diagnostic accuracy studies (STARD) checklist.

Assessment of Adherence to the STARD Statement for the Quality of Reports on Diagnostic Studies Published on the Iranian Journal of Radiology

Background: Standards for the Reporting of diagnostic accuracy studies (STARD) statement was developed to improve the accuracy and completeness of reporting of studies of diagnostic accuracy. It allows readers evaluate the internal and external validity and enable readers to assess the potential for bias in the study and the generalizability of the results. Objectives: Up to date, few data exist about the quality of diagnostic accuracy studies in Iran. Therefore, we evaluated the extent of adherence to the STARD for the quality of reports on diagnostic accuracy studies in the Iranian journal of radiology. Methods: In this cross-sectional descriptive study, we searched Iranian journal of radiology and retrieved all diagnostic accuracy studies for recent 3 years and evaluated their adherence to STARD. We used STARD checklist (version January 2003) available at www.stard-statement.org Results: We identified about 14 potential diagnostic accuracy studies meeting our inclusion criteria. In this preliminary study 50% identified the article as diagnostic accuracy study in the title or abstract (MeSH heading sensitivity and specificity). 4% reported details of blinding. 3% had a flow diagram. 38% described the number, training and expertise of the persons reading the index tests and the reference standard. 25% reported definition of cutoffs and/or categories of the results of the index tests and the reference standard. Only 40% of the reports of diagnostic evaluations reported precision for the estimates of diagnostic accuracy. The occurrence of uninterpretable, indeterminate and intermediate test results were 30%. The report time interval from the index tests to the reference standard was 40%. Only 40% of articles reported on more than 50% of STARD items, while no articles reported on more than 85%. A flow chart was presented in 3 articles. Assessment of reporting on individual items of the STARD statement revealed wide variation, with some items described in 15% of articles and others in 100%. Mean STARD score (0 - 25 points available) was 14.8 (range, 5.5 19.5). Conclusions: These findings show non-adherence to the STARD. The authors, reviewers, and editors should pay more attention to reporting by checking STARD statement items and including a flow diagram to represent study design and patient flow.

Instruments to measure the quality of life in patients with oral mucositis undergoing oncological treatment: a systematic review of the literature

BackgroundOral mucositis (OM) is an inflammatory reaction of the oropharyngeal mucosa to cumulative chemotherapy (CT) and radiation therapy (RT), affecting one or more parts of the digestive tract along with the quality of life (QoL) of the patient. The goal of this study was to identify valid and reliable tools to evaluate QoL related to OM. MethodsA systematic review of the literature was conducted up to May 2016. Articles were selected by peers using the PubMed database through a search following the inclusion and exclusion criteria and STAndards for the Reporting of Diagnostic accuracy studies (STARD) checklist with a cut-off point ≥ 70%. ResultsWe identified four relevant articles that described instruments to assess the QoL related to OM in patients undergoing cancer treatment. ConclusionsThe evaluation of the QoL in patients with OM is a difficult scenario because of its multiple variables. The knowledge of this relationship is limited because general instruments of oral health or cancer therapy are commonly used for evaluation. However, valid instruments are already available for estimating the impact of OM on the QoL from the patient's perspective.

Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure.

Lung ultrasonography (LUS) is a bedside technique useful to diagnose neonatal respiratory problems, but, to our knowledge, no data are available about its use for monitoring lung function or eventually guiding surfactant therapy. To determine the diagnostic accuracy of a neonatal-adapted LUS score to evaluate oxygenation and predict need for surfactant administration. Prospective diagnostic accuracy study following STARD (Standards for the Reporting of Diagnostic Accuracy Studies) guidelines at a tertiary level academic neonatal intensive care unit in 2014. All neonates admitted to the neonatal intensive care unit with signs of respiratory distress were eligible, and 130 neonates were enrolled. The LUS score was calculated in the first hours of life under continuous positive airway pressure. The transcutaneous partial pressure of oxygen (Ptco2) to fraction of inspired oxygen (Fio2) ratio, alveolar-arterial gradient, oxygenation index, and arterial to alveolar ratio were calculated within 30 minutes from LUS, using transcutaneous blood gas monitoring. Surfactant was administered according to 2013 European guidelines. Correlation between LUS score and indices of oxygenation and prediction of surfactant administration. Among the 130 neonates in this study, the LUS score was significantly correlated with all indices of oxygenation, independent from gestational age (GA) (Ptco2 to Fio2 ratio: GA ≥ 34 weeks: ρ = -0.57; GA <34 weeks: ρ = -0.62; P < .001; alveolar-arterial gradient: GA ≥ 34 weeks: ρ = 0.62; GA <34 weeks: ρ = 0.59; P < .001; oxygenation index: GA ≥ 34 weeks: ρ = 0.63; GA <34 weeks: ρ = 0.69; P < .001; and arterial to alveolar ratio: GA ≥ 34 weeks: ρ = -0.60; GA <34 weeks: ρ = -0.56; P < .001). The LUS score predicted the need for surfactant better in preterm babies with a GA less than 34 weeks (area under the curve = 0.93; 95% CI, 0.86-0.99; P < .001) than in term and late-preterm neonates with a GA of 34 weeks or greater (area under the curve = 0.71; 95% CI, 0.54-0.90; P = .02); the areas under the curve for these 2 GA subgroups are significantly different (P = .02). In babies with a GA less than 34 weeks, a LUS score cutoff of 4 predicted surfactant administration with 100% sensitivity and 61% specificity, yielding a posttest probability of 72%. The LUS score is well correlated with oxygenation status in both term and preterm neonates, and it shows good reliability to predict surfactant administration in preterm babies with a GA less than 34 weeks under continuous positive airway pressure.

A systematic review of the PTSD Checklist's diagnostic accuracy studies using QUADAS.

Despite the popularity of the PTSD Checklist (PCL) as a clinical screening test, there has been no comprehensive quality review of studies evaluating its diagnostic accuracy. A systematic quality assessment of 22 diagnostic accuracy studies of the English-language PCL using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) assessment tool was conducted to examine (a) the quality of diagnostic accuracy studies of the PCL, and (b) whether quality has improved since the 2003 STAndards for the Reporting of Diagnostic accuracy studies (STARD) initiative regarding reporting guidelines for diagnostic accuracy studies. Three raters independently applied the QUADAS tool to each study, and a consensus among the 4 authors is reported. Findings indicated that although studies generally met standards in several quality areas, there is still room for improvement. Areas for improvement include establishing representativeness, adequately describing clinical and demographic characteristics of the sample, and presenting better descriptions of important aspects of test and reference standard execution. Only 2 studies met each of the 14 quality criteria. In addition, study quality has not appreciably improved since the publication of the STARD Statement in 2003. Recommendations for the improvement of diagnostic accuracy studies of the PCL are discussed.

Elevating the Quality of Disability and Rehabilitation Research

With the remarkable growth of disability- and rehabilitation- related research in the past decade, it is imperative that we support the highest-quality research possible. With cuts in research funding, rehabilitation research is now under a microscope like never before, and it is critical that we put our best foot forward. To ensure the quality of the disability and rehabilitation research that is published, the 28 rehabilitation journals simultaneously publishing this editorial (see Acknowledgements) have agreed to take a more aggressive stance on the use of reporting guidelines.* Research reports must contain sufficient information to allow readers to understand how a study was designed and conducted, including variable definitions, instruments and other measures, and analytical techniques.1 For review articles, whether systematic or narrative, readers should be informed of the rationale and details behind the literature search strategy. Too often, articles fail to include their standard for inclusion and their criteria for evaluating study quality.2 As noted by Doug Altman, co-originator of the Consolidated Standards of Reporting Trials (CONSORT) Statement and head of the Centre for Statistics in Medicine at Oxford University, “Good reporting is not an optional extra: it is an essential component of good research.”3

The Effect of Point‐of‐care Ultrasonography on Emergency Department Length of Stay and Computed Tomography Utilization in Children With Suspected Appendicitis

The role of clinician-performed ultrasonography (US) for suspected appendicitis is unclear. Published data conclude that US has high specificity to rule in the diagnosis of appendicitis, with variable sensitivity to rule it out. Newer data suggest that point-of-care (POC) US may have similar test characteristics. Our objective was to evaluate the effect of POC US in children with suspected appendicitis and its effect on emergency department (ED) length of stay (LOS) and computed tomography (CT) utilization. This was a prospective observational convenience sample of children with suspected appendicitis requiring imaging evaluation that adhered to the Standards for the Reporting of Diagnostic accuracy studies (STARD) criteria. Outcomes were determined by operative or pathology report in those who had appendicitis, and 3-week phone follow-up in those patients who were nonoperative. Differences in ED LOS were analyzed by one-way analysis of variance (ANOVA) between patients who received dispositions after POC US, radiology US, or CT. Test performance characteristics were calculated for all imaging modalities. Among 150 enrolled patients, 50 had appendicitis (33.3%). There were no missed cases of appendicitis in discharged patients at 3-week phone follow-up, nor negative laparotomies in those who went to the operating room. Those who had dispositions after POC US (n=25) had a significantly decreased mean ED LOS (154minutes, 95% confidence interval [CI]=115 to 193minutes) compared with those requiring radiology US (288minutes, 95% CI=257 to 319minutes) or CT scan (487minutes; 95% CI=434 to 540minutes). Baseline CT rate was 44.2% (95% CI=30.7% to 57.7%) prior to study start and decreased to 27.3% (95% CI=20.17% to 34.43%) during the study. CTs were avoided in four patients with conclusive POC US results and inconclusive radiology US results. The sensitivity, specificity, positive likelihood ratio (LR+), and negative likelihood ratio (LR-) forPOC US were60% (95% CI=46% to 72%), 94% (95% CI=88% to 97%), 10 (95% CI=4 to 23), and 0.4 (95% CI=0.3 to 0.6). For radiology US they were 63% (95% CI=48% to 75%), 99% (95% CI=94% to 99%), 94 (95% CI=6 to 1,500), and 0.4 (95% CI=0.3 to 0.6); and for CT they were 83% (95% CI=58% to 95%), 98% (95% CI=85% to 99%), 45 (95% CI=3 to 707), and 0.2 (95% CI=0.05 to 0.5). It may be feasible to reduce ED LOS and avoid CT scan when using POC US to evaluate children with suspected appendicitis. Test characteristics for POC US have high specificity to rule in appendicitis, similar to radiology US. Addition of POC US prior to sequential radiology imaging was safe, without missed cases of appendicitis or negative laparotomies.

Identification of ocular surface squamous neoplasia by in vivo staining with methylene blue

AimTo evaluate the diagnostic accuracy of methylene blue used as a non-invasive in vivo stain to detect ocular surface squamous neoplasia (OSSN).MethodsA test validation study was performed according to Standards...

2227 SERUM ISOFORM [−2]PROPSA DERIVATES (%P2PSA AND PHI) SIGNIFICANTLY IMPROVES THE PREDICTION OF PROSTATE CANCER AT INITIAL BIOPSY IN A TPSA RANGE 2-10 NG/ML. A MULTICENTRIC EUROPEAN STUDY

2227 SERUM ISOFORM [−2]PROPSA DERIVATES (%P2PSA AND PHI) SIGNIFICANTLY IMPROVES THE PREDICTION OF PROSTATE CANCER AT INITIAL BIOPSY IN A TPSA RANGE 2-10 NG/ML. A MULTICENTRIC EUROPEAN STUDY

A survey on the amount of adherence to STARD and CONSORT standards in the abstracts of diagnostic accuracy studies and randomized controlled trials published in International Continence Society abstract book 2011

Purpose : To assess reporting quality of Randomized Controlled Trials (RCTs) and Diagnostic Accuracy Studies (DASs) published in International Continence Society (ICS) abstract book 2011. Methods: Reports of RCTs and DASs published in ICS abstract book 2011 were identified. The proportion of adherence to each item in the Consolidated Standards of Reporting Trials (CONSORT) and STAndards for the Reporting of Diagnostic accuracy studies (STARD) checklists was evaluated for each article abstract by two independent reviewers masked to each other’s results giving one point to each item of the used checklists only if it was clearly defined in the abstract. Results: Out of 287 articles, 67 articles matched our inclusion criteria (37 RCTs and 30 DASs). The mean scores were 10.70 and 15.03 out of 17 and 25 respectively. The highest scored items were items 5 and 15 (INTERVENTION and CONCLUSION) in the CONSORT group (both being reported in 97.3% of articles). In the STARD group, items 2, 3, and 25 (INTRODUCTION, PARTICIPANTS/POPULATION and DISCUSSION) were fully reported. The lowest scored items were item 2 (AUTHORS) in the consort group and item 11 (TEST METHODS/BLINDING) in the diagnostic accuracy group reported in 0% and 13.3% of articles respectively. Conclusions: Our study revealed that the adherence level is moderate in both groups. In a high ranking society like ICS, we do believe that adopting these two tools would improve the reporting quality.

Systematic Review of Reliability and Diagnostic Validity of Joint Vibration Analysis for Diagnosis of Temporomandibular Disorders

To conduct a systematic review of papers reporting the reliability and diagnostic validity of the joint vibration analysis (JVA) for diagnosis of temporomandibular disorders (TMD). A search of Pubmed identified English-language publications of the reliability and diagnostic validity of the JVA. Guidelines were adapted from applied STAndards for the Reporting of Diagnostic accuracy studies (STARD) to evaluate the publications. Fifteen publications were included in this review, each of which presented methodological limitations. This literature is unable to provide evidence to support the reliability and diagnostic validity of the JVA for diagnosis of TMD.

Assessing Sensitivity and Specificity in New Diagnostic Tests: The Importance and Challenges of Study Populations

Assessing Sensitivity and Specificity in New Diagnostic Tests: The Importance and Challenges of Study Populations

Diagnostic Accuracy of Bedside Swallow Evaluation Versus Videofluoroscopy to Assess Dysphagia in Individuals With Tetraplegia

To assess the accuracy of bedside swallow evaluation (BSE) compared with videofluorosopic swallow study (VFSS) in diagnosing dysphagia in individuals with tetraplegia due to spinal cord injury (SCI). A prospective diagnostic accuracy study according to STAndards for the Reporting of Diagnostic accuracy studies (STARD) criteria. A county hospital with acute inpatient SCI unit. Thirty-nine subjects with SCI and tetraplegia were enrolled. All of the subjects underwent BSE, and 26 subjects completed the VFSS. Individuals with SCI underwent a BSE followed by a VFSS within 72 hours of the BSE. The subjects were diagnosed as having dysphagia if they had positive findings in either BSE or VFSS. Sensitivity, specificity, and positive and negative predictive values were calculated by using VFSS as the criterion standard. Fifteen subjects (38%) were diagnosed as having dysphagia based on the BSE results. Among the subjects who completed the VFSS, 11 were diagnosed with dysphagia (42%) and 4 were diagnosed with aspiration (10%). Of the 26 subjects who completed both BSE and VFSS, only 1 subject was diagnosed differently compared with BSE (3.8%). Different diet recommendations were made in 4 cases after VFSS versus BSE. Different liquid recommendations were made in 8 cases after VFSS versus BSE. Sensitivity of BSE was 100% (95% confidence interval [CI], 71.5%-100%), specificity was 93.3% (95% CI, 68.1%-99.8%). A positive predictive value of BSE was 91.7% (95% CI, 61.5%-100%), and the negative predictive value was 100% (95% CI, 76.8%-100%). Dysphagia is present in approximately 38% of individuals with acute tetraplegia. Because only one of the 21 subjects was diagnosed differently based on VFSS, we believe that BSE is an appropriate screening tool for dysphagia for individuals with cervical SCI. However, VFSS provided additional information on diet and liquid recommendations, so there appears to be an important clinical role for the VFSS.

Biomarkers for the differentiation of sepsis and SIRS: the need for the standardisation of diagnostic studies

Sepsis is a leading cause of death in the critically ill patient. It is a heterogeneous disease and it is frequently difficult to make an unequivocal and expeditious diagnosis. The current 'gold standard' in diagnosing sepsis is the blood culture but this is only available after a significant time delay. Mortality rates from sepsis remain high, however, the introduction of sepsis care bundles in its management has produced significant improvements in patient outcomes. Central to goal-directed resuscitation is the timely and accurate diagnosis of sepsis. The rapid diagnosis and commencement of the appropriate therapies has been shown to reduce the mortality. Biomarkers are already used in clinical practice to aid other more traditional diagnostic tests. In the absence of an adequate gold standard to diagnose sepsis, there has been considerable and growing interest in trying to identify suitable biomarkers. There is currently an unmet need in the medical literature to communicate the importance of the challenges relating to the rapid diagnosis and implementation of goal-directed therapy in sepsis and the underlying concepts that are directing these investigations. This article reviews the more novel biomarkers investigated to differentiate systemic inflammatory response syndrome from sepsis. The biomarkers described reflect the difficulties in making evidence-based recommendations particularly when interpreting studies where the methodology is of poor quality and the results are conflicting. We are reminded of our responsibilities to ensure high quality and standardised study design as articulated by the STAndards for the Reporting of Diagnostic accuracy studies (STARD) initiative.

Accuracy of Noninvasive Multiwave Pulse Oximetry Compared With Carboxyhemoglobin From Blood Gas Analysis in Unselected Emergency Department Patients

Accurate and timely diagnosis of carbon monoxide (CO) poisoning is difficult because of nonspecific symptoms. Multiwave pulse oximetry might facilitate the screening for occult poisoning by noninvasive measurement of carboxyhemoglobin (COHb), but its reliability is still unknown. We assess bias and precision of COHb oximetry compared with the criterion standard blood gas analysis. This was a prospective diagnostic accuracy study according to STARD (Standards for the Reporting of Diagnostic accuracy studies) criteria, performed at a tertiary care hospital emergency department. We included all patients for whom both invasive and noninvasive measurement within 60 minutes was available, regardless of their complaints, during a 1-year period. One thousand five hundred seventy-eight subjects were studied, of whom 17 (1.1%) received a diagnosis of CO poisoning. In accordance with this limited patient cohort, we found a bias of 2.99% COHb (1.50% for smokers, 4.33% for nonsmokers) and a precision of 3.27% COHb (2.90% for smokers, 2.98% for nonsmokers), limits of agreement from -3.55% to 9.53% COHb (-4.30% to 7.30% for smokers, -1.63% to 10.29% for nonsmokers). Upper limit of normal cutoff of 6.6% COHb had the highest sensitivity in screening for CO poisoning. Smoking status and COHb level had the most influence on the deviation between measurements. Multiwave pulse oximetry was found to measure COHb with an acceptable bias and precision. These results suggest it can be used to screen large numbers of patients for occult CO poisoning.

Quality reporting of endoscopic diagnostic studies in gastrointestinal journals: where do we stand on the use of the STARD and CONSORT statements?

Many papers have been published in the field of diagnostic endoscopy in the last few years. However, there are no reports on their quality. The aim of this study was to evaluate quality in recently published endoscopic articles. The study reviewed published articles on diagnostic endoscopy from 1998 to 2008. Quality was assessed and independently quantified by two observers using the STARD (STandards for the Reporting of Diagnostic accuracy studies) and CONSORT (Consolidated Standards for Reporting of Trials) statements. The interobserver proportion of agreement and kappa coefficient were estimated. A total of 120 articles comprising 10 randomized controlled trials and 110 diagnostic accuracy studies were evaluated. Most studies related to colonic polyp detection (30 %) or evaluation of Barrett's esophagus (29 %). Chromoscopy (45 %), fluorescence (21 %), and narrow-band imaging (14 %) were the technologies most often evaluated. The mean number of items (i. e. standard requirements) fulfilled by the randomized controlled trials was 15.7 +/- 2.2 out of 22 while for the diagnostic accuracy studies it was 12.2 +/- 3.6 out of 25. Reporting of study results was complete in 90 % of the randomized controlled trials, but only 65 % of the diagnostic accuracy studies presented a cross-table of results. The global proportion of agreement between observers was 97 % in randomized controlled trials and 95 % in diagnostic accuracy studies. Recent publications in diagnostic endoscopy achieve only medium quality according to the available statements. It seems that it would be useful for authors, reviewers, and editors to be familiar with and apply these statements. The development of a specific checklist for diagnostic endoscopy publications might be helpful toward achieving better quality reporting in the future.

Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 7: Systematic Reviews and Meta-Analyses of Diagnostic Accuracy Studies

Appropriate diagnosis is essential in providing proper and effective therapy. The field of diagnostic accuracy tests is dynamic with new tests being developed at a fast pace along with improvement in technology of existing tests on a continuous basis. Well-designed diagnostic test accuracy studies can help in making appropriate health care decisions, provided that they transparently and fully report their participants, tests, methods, and results. Exaggerated and biased results from poorly designed and reported diagnostic test studies can trigger their premature dissemination and lead physicians into making incorrect treatment decisions. Consequently, a diagnostic test is useful only to the extent that it distinguishes between conditions or disorders that might otherwise be confused. Since it is unlikely that clinicians, patients, and policy makers have the time, skills, and resources to find, appraise, and interpret the evidence and incorporate it into their health care decisions, systematic reviews and meta-analysis provide an accurate and reliable synthesis of vast quantities of data. A systematic review can identify what is known and what is unknown, giving guidance for future research. Systematic reviews have been considered as a vital link in the great chain of evidence that stretches from the laboratory to the bedside by helping to separate the insignificant, unsound, or redundant deadwood from the salient and critical studies that are worthy of reflection. A dangerous discrepancy exists between experts and evidence with all types of evidence. Historically, it has been reported that in only 15% of all cases can a pathoanatomical explanation be found for patients with chronic low back pain of more than 3 months resulting in the assumption that very little can be done in our present state of ignorance to treat these patients and improve their natural histories. On the other end of the spectrum, due to lack of sound diagnostic information, excessive health care is utilized with exploding costs. The validity of all diagnostic techniques has been described with variable accuracy and reliability. Lack of understanding of reference standards and their unavailability with interventional diagnostic techniques and misinterpretation secondary to interpretation bias may adversely influence the applicability of diagnostic interventions. This manuscript provides a review of the literature, a checklist, and a flow diagram describing the preferred way to present the abstract, introduction, methods, results, and discussion sections of the report of an analysis in a systematic review of diagnostic accuracy studies.

Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 5. Diagnostic Accuracy Studies

Diagnosis is a critical component of health care. The world of diagnostic tests is highly dynamic. New tests are developed at a fast pace and technology of existing tests is continuously being improved. However, clinicians, policy makers, and patients routinely face a range of questions regarding diagnostic tests. Well designed diagnostic test accuracy studies can help in making these decisions, provided that they transparently and fully report their participants, tests, methods, and results (as facilitated). For example, by the standards for the reporting of diagnostic accuracy studies (STARD) statement. Exaggerated and biased results from poorly designed and reported diagnostic test studies can trigger their premature dissemination and lead physicians into making incorrect treatment decisions. Thus, a diagnostic test is useful only to the extent that it distinguishes between conditions or disorders that might otherwise be confused. While almost any test can differentiate healthy persons from severely affected ones, appropriate diagnostic tests should differentiate mild and moderate forms of disease. Shortcomings in a study design and interpretation can affect estimates of diagnostic accuracy. Thus, quality diagnostic studies are essential in medicine in general and interventional pain management in particular. The STARD initiative was developed to improve the accuracy and completeness in the reporting of studies of diagnostic accuracy and provide guidance to assist in reducing the potential for bias in the study and to evaluate a study’s generalizability. In the practice of interventional pain management, in addition to diagnostic tests which include laboratory tests, imaging tests, and physical examination, diagnostic interventional techniques are crucial. Interventional techniques as a diagnostic tool in painful conditions is important due to multiple challenging clinical situations, which include the purely subjective nature of pain and underdetermined and uncertain pathophysiology in most painful spinal conditions. Precision diagnostic blocks are used to clarify these challenging clinical situations in order to determine the pathophysiology of clinical pain, the site of nociception, and the pathway of afferent neural signals. Part 5 of evidence-based medicine (EBM) in interventional pain management describes the various aspects of diagnostic accuracy studies. Key words: Evidence-based medicine, diagnostic studies, systematic reviews, randomized trials, interventional pain management, standards for the reporting of diagnostic accuracy studies (STARD)

Endorsement of the STARD Statement by Biomedical Journals: Survey of Instructions for Authors

The Standards for the Reporting of Diagnostic accuracy studies (STARD) statement was first published in 2003 (1)(2). In February 2006, the International Committee of Medical Journal Editors decided to encourage the use of the STARD statement by including it in their Uniform Requirements for Manuscripts Submitted to Biomedical journals (www.icmje.com). The STARD statement contains a checklist of 25 recommended items for the reporting of diagnostic accuracy studies and encourages the use of a flow diagram to represent the design of the study and the flow of patients through the study (1)(2). Early evaluation of the STARD statement showed that the quality of diagnostic research reports had improved slightly over time, without a more pronounced effect in adopting journals (i.e., journals mentioning STARD in their Instructions for Authors ) (3). We determined to what extent journals have adopted the STARD statement and incorporated the recommendations in their Instructions for Authors . We identified the top 50 journals that frequently publish diagnostic accuracy studies, including general and internal medical journals (26%) and specialty journals (74%) …

Reproducibility of the STARD checklist: an instrument to assess the quality of reporting of diagnostic accuracy studies

BackgroundIn January 2003, STAndards for the Reporting of Diagnostic accuracy studies (STARD) were published in a number of journals, to improve the quality of reporting in diagnostic accuracy studies. We designed a study to investigate the inter-assessment reproducibility, and intra- and inter-observer reproducibility of the items in the STARD statement.MethodsThirty-two diagnostic accuracy studies published in 2000 in medical journals with an impact factor of at least 4 were included. Two reviewers independently evaluated the quality of reporting of these studies using the 25 items of the STARD statement. A consensus evaluation was obtained by discussing and resolving disagreements between reviewers. Almost two years later, the same studies were evaluated by the same reviewers. For each item, percentages agreement and Cohen's kappa between first and second consensus assessments (inter-assessment) were calculated. Intraclass Correlation coefficients (ICC) were calculated to evaluate its reliability.ResultsThe overall inter-assessment agreement for all items of the STARD statement was 85% (Cohen's kappa 0.70) and varied from 63% to 100% for individual items. The largest differences between the two assessments were found for the reporting of the rationale of the reference standard (kappa 0.37), number of included participants that underwent tests (kappa 0.28), distribution of the severity of the disease (kappa 0.23), a cross tabulation of the results of the index test by the results of the reference standard (kappa 0.33) and how indeterminate results, missing data and outliers were handled (kappa 0.25). Within and between reviewers, also large differences were observed for these items. The inter-assessment reliability of the STARD checklist was satisfactory (ICC = 0.79 [95% CI: 0.62 to 0.89]).ConclusionAlthough the overall reproducibility of the quality of reporting on diagnostic accuracy studies using the STARD statement was found to be good, substantial disagreements were found for specific items. These disagreements were not so much caused by differences in interpretation of the items by the reviewers but rather by difficulties in assessing the reporting of these items due to lack of clarity within the articles. Including a flow diagram in all reports on diagnostic accuracy studies would be very helpful in reducing confusion between readers and among reviewers.