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Background: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors.Objective: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in the study and to evaluate its generalizability.Methods: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, methodologists and statisticians, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy.Results: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference standard, or both.Conclusions: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public. [ABSTRACT FROM AUTHOR]

Context: Magnetic resonance angiography (MRA) is a rapidly evolving technique that has been reported to be accurate for assessment of lower extremity arterial disease.Objective: To obtain the best available estimates of the diagnostic performance of MRA in patients with lower extremity arterial disease.Data Sources: Studies published from January 1985 through May 2000 in English, German, or French, identified from the MEDLINE, EMBASE, and Current Contents databases.Study Selection: Studies were included that allowed construction of 2 x 2 contingency tables for detection of stenosis greater than 50% or occlusion with MRA or arteriography in patients with claudication or critical ischemia.Data Extraction: Two observers graded the following elements of study quality: consecutively enrolled patients, prospective study design, clear cut-off levels, blinded assessment, and clear description of MRA technique. Summary receiver operating characteristic analysis was performed to examine the influence of year of publication, all methodological criteria, arterial tract, number of subdivisions within arterial tracts, and MRA technique on diagnostic performance.Data Synthesis: Of 3583 studies initially identified, 34 were included that evaluated MRA in 1090 patients (72% men; median age, 65 years). Magnetic resonance angiography was highly accurate for assessment of all lower extremity arteries. Three-dimensional gadolinium-enhanced (3-D Gd) MRA improved diagnostic performance compared with 2-D MRA (relative diagnostic odds ratio, 2.8 [95% confidence interval, 1.2-6.4]), adjusted for number of subdivisions within arterial tracts. The estimated points of equal sensitivity and specificity were 94% and 90% for 3-D Gd MRA and 2-D MRA, respectively.Conclusions: Magnetic resonance angiography is highly accurate for assessment of the entire lower extremity for arterial disease. Three-dimensional Gd-enhanced MRA improves diagnostic performance compared with 2-D MRA. [ABSTRACT FROM AUTHOR]

Serum progesterone measurement has been advocated as a diagnostic tool in the non-invasive diagnosis of ectopic pregnancy. To assess the accuracy of a single serum progesterone measurement in the diagnosis of ectopic pregnancy, a meta-analysis was performed incorporating 26 studies evaluating the performance of single serum progesterone measurement in the diagnosis of ectopic pregnancy. A distinction was made in the diagnosis of pregnancy failure of any type versus viable intrauterine pregnancy and the diagnosis of ectopic pregnancy versus non-ectopic pregnancy. The reported sensitivity and specificity differed between the studies. Since there was a clear negative correlation between sensitivity and specificity, summary receiver-operating characteristic (ROC) curves could be estimated. The ROC curve for the diagnosis of pregnancy failure versus viable intrauterine pregnancy showed a good discriminative capacity. Single serum progesterone measurement could not discriminate between ectopic pregnancy and non-ectopic pregnancy. It is concluded that serum progesterone measurement can identify patients at risk for ectopic pregnancy, who need further evaluation, but its discriminative capacity is insufficient to diagnose ectopic pregnancy with certainty. [ABSTRACT FROM AUTHOR]

Objectives: Diagnosis of patients suspected of mild dementia (MD) is a challenge and patient numbers continue to rise. A short test triaging patients in need of a neuropsychological assessment (NPA) is welcome. The Montreal cognitive assessment (MoCA) has high sensitivity at the original cutoff <26 for MD, but results in too many false-positive (FP) referrals in clinical practice (low specificity). A cutoff that finds all patients at high risk of MD without referring to many patients not (yet) in need of an NPA is needed. A difficulty is who is to be considered at risk, as definitions for disease (e.g. MD) do not always define health at the same time and thereby create subthreshold disorders., Design: In this study, we compared different selection strategies to efficiently identify patients in need of an NPA. Using the MoCA with a double threshold tackles the dilemma of increasing the specificity without decreasing the sensitivity and creates the opportunity to distinguish the clinical (MD) and subclinical (MCI) state and hence to get their appropriate policy., Setting/participants: Patients referred to old-age psychiatry suspected of cognitive impairment that could benefit from an NPA ( n = 693)., Results: The optimal strategy was a two-stage selection process using the MoCA with a double threshold as an add-on after initial assessment. By selecting who is likely to have dementia and should be assessed further (MoCA<21), who should be discharged (≥26), and who's course should be monitored actively as they are at increased risk (21<26)., Conclusion: By using two cutoffs, the clinical value of the MoCA improved for triaging. A double-threshold MoCA not only gave the best results; accuracy, PPV, NPV, and reducing FP referrals by 65%, still correctly triaging most MD patients. It also identified most MCIs whose intermediate state justifies active monitoring.

Background: Unintended pregnancies (UPs) are a global health problem as they contribute to adverse maternal and offspring outcomes, which underscores the need for prevention. As psychiatric vulnerability has previously been linked to sexual risk behavior, planning capacities and compliance with contraception methods, we aim to explore whether it is a risk factor for UPs., Methods: Electronic databases were searched in November 2020. All articles in English language with data on women with age ≥ 18 with a psychiatric diagnosis at time of conception and reported pregnancy intention were included, irrespective of obstetric outcome (fetal loss, livebirth, or abortion). Studies on women with intellectual disabilities were excluded. We used the National Institutes of Health tool for assessment of bias in individual studies and the Grading of Recommendations Assessment, Development and Evaluation method for assessment of quality of the primary outcome., Findings: Eleven studies reporting on psychiatric vulnerability and UPs were included. The participants of these studies were diagnosed with mood, anxiety, psychotic, substance use, conduct and eating disorders. The studies that have been conducted show that women with a psychiatric vulnerability (n = 2650) have an overall higher risk of UPs compared to women without a psychiatric vulnerability (n = 16,031) (OR 1.34, CI 1.08-1.67) and an overall weighed prevalence of UPs of 65% (CI 0.43-0.82) (n = 3881)., Interpretation: Studies conducted on psychiatric vulnerability and UPs are sparse and many (common) psychiatric vulnerabilities have not yet been studied in relation to UPs. The quality of the included studies was rated fair to poor due to difficulties with measuring the outcome pregnancy intention (use of various methods of assessment and use of retrospective study designs with risk of bias) and absence of a control group in most of the studies. The findings suggest an increased risk of UPs in women with psychiatric vulnerability. As UPs have important consequences for mother and child, discussing family planning in women with psychiatric vulnerabilities is of utmost importance., (© 2022. The Author(s).)

Objective: The aim of this study is to examine the impact of opening a medical psychiatric unit (MPU) on a variety of outcomes., Methods: In this non-equivalent groups design, there were two groups: 'pre-MPU' and 'actual MPU'. Staff assessed whether patients in the pre-MPU group were eligible for admission to a planned MPU, resulting in virtual admissions and discharges. The actual MPU group consisted of patients admitted after opening of the MPU., Results: The length of stay (LOS) in the hospital was one day longer for patients in the MPU group (8.68 vs. 9.89, p  = .004), but the LOS on the MPU was comparable in both groups (5.63 vs. 6.06, p  = .231). The LOS on the intensive care unit (ICU) was longer in the MPU group (0.10 vs. 0.40, p  < .001), even as the time patients were physically restraint (0.28 vs. 0.83, p  < .001). In the pre-MPU group, the odds were not significantly different for involuntary commitment (OR = 0.92; p  = .866) and death within six months after discharge (OR = 1.84; p  = .196)., Conclusions: Both physical restraint and ICU admission have a link with patient complexity, it therefore seemed that opening of the MPU resulted in the treatment of more complex patients with a comparable LOS on the MPU.KEY POINTSThe LOS on the MPU was not significantly different between the groups before and after opening of the MPU.Opening of the MPU resulted in the admission of patients that were admitted more days to the ICU and to more days of physically restraint.It can be considered that opening of the MPU resulted in an increased ability to treat complex patients.

Background and aims: To assess the preferences of Dutch psychiatric patients in three general hospital psychiatric settings for the dress of psychiatrists and patients preference to be addressed by psychiatrists. To assess the associations concerning different clothing styles and the attributes of the patient-doctor relationship. Methods: One hundred and seventy-three adults, in and outpatients (aged 18-89 years) attending the psychiatry departments of three general hospitals, were included during the period June 2015 to May 2016. In these hospitals, the psychiatrist staff has different clothing policies. Data were analyzed with SPSS21. Results: Divided over the three hospitals, 173 patients were included, 96 inpatients and 77 outpatients. The patients' opinions on the psychiatrists' dress differed significantly between the hospitals in line with the local hospital clothing policy ( p  = 0.002 for the male psychiatrists, p  = 0.000 for the female psychiatrists). The patients' ethnicity significantly influenced their preferences for dress and address, as a majority of the patients with a non-Dutch ethnic background expressed a preference for white coats, and address by surname (RR = 2.0, p  = 0.003 for male and RR = 2.1 p  = 0.002 for female psychiatrists). A significant difference in preference for being addressed by their first names by the psychiatrist was found between Dutch and non-native Dutch patients (RR = 2.6, p  = 0.005). According to patients, the male psychiatrist in trousers and a long sleeve shirt and female psychiatrist in casual clothing were most often associated as being the friendliest, a white coat as being the most competent, and wearing smart attire as being the most accessible. Conclusion: Patients' preferences are in line with current local clothing habits. Ethnicity, setting and country influence a patient's preferences. Casual clothing for psychiatrists is assessed as being the friendliest but as the least competent, and white coats are assessed as being the most competent but as being less friendly and less accessible.

Background: The mental status examination (MSE) is part of everyday psychiatric practice. However, it is unknown which items of the MSE are considered important and how the MSE is appreciated in the Netherlands.
AIM: To gain insight in the importance of the MSE, and to investigate which items are used in everyday practice.
METHOD: Dutch psychiatrists and residents filled in a questionnaire, using a 5-point Likert scale, where they rated frequency of use and importance of 24 different items of the Dutch MSE. They also reported which items, in their opinion, should be rated 'always', 'on indication only' or 'never'. Finally, the respondents were asked about their need of education and training in the MSE. The data were collected through an online questionnaire, which was distributed through email and the website of the Dutch psychiatric association.
RESULTS: A total of 402 respondents filled in the questionnaire, of which 60.4% were psychiatrists and 39.6% were residents. The MSE was seen as an essential part of the everyday psychiatric practice. The current format was appreciated strongly. In current practice, 10 items of the MSE were 'always' rated by more than 50% of the respondents. Ten items were rated very rarely, if ever. Respondents thought these items should only be rated on specific indication. There was a need for extra training in the MSE amongst residents and psychiatrists.
CONCLUSION: The Dutch MSE, consisting of 24 items, is strongly appreciated by psychiatrists and residents as an essential part of the psychiatric diagnostic process. In the everyday practice only a part of the items are used frequently.

Purpose: We selected and evaluated a comprehensive set of themes that encompass health-related quality of life (HRQOL) among HIV patients, which enables clinicians to tailor care to individual needs, follow changes over time and quantify returns on health care investments and interventions., Methods: HIV patients (N = 250) of two Dutch HIV clinics were invited to complete an online survey comprised of a set of (adaptations of) validated questionnaires measuring eight themes, including general health (SF-12), stigma (short stigma scale), social support (SSL12-I), self-esteem (SISE), sexuality problems, anxiety and depression (HADS), sleeping difficulties (SCL90-Sleep) and perceived side-effects., Results: Findings from 170 (response rate 68%) patients (Male = 159, 94.1%) showed that questionnaires had high internal consistency, and most themes significantly correlated (r's .21 to - .69, p < .05) in the expected directions. Exploring cut-off scores shows that a significant proportion of patients score outside of the desired range on single themes (between 16.0 and 73.1%), and many patients on multiple themes simultaneously (8.9% on 5 or more themes). Regression analysis showed that social support, self-esteem and sexuality problems were associated with general health (R = .48, R 2  = .23, F(4,145) = 10.57, p < .001); adding anxiety and depression, sleeping difficulties and perceived side-effects explained 51.2% of the variance in total (R = .72, ∆R 2  = .29, F(3, 142) = 27.82, p < .001)., Conclusions: We succeeded in developing a questionnaire that comprehensively assesses HRQOL. HRQOL of the majority of Dutch HIV patients could be improved. The themes strongly influenced each other, therefore insights into any of the themes could inform interventions to improve HRQOL, and increase attention to these themes in routine consultations between patients and health care professionals.

Objective: To study the course of the functional status and healthcare needs of patients on a Medical Psychiatric Unit (MPU)., Methods: In a single-centre observational prospective design the Health of the Nation Outcome Scales (HoNOS) and Camberwell Assessment of Needs Short Appraisal Schedule (CANSAS) instruments were administered at admission and discharge. Functional status and healthcare needs were assessed utilizing the HoNOS and CANSAS respectively. The total costs of healthcare claims related to the admission were calculated based on claims data., Results: In total 50 patients were included with a mean improvement of 4.6 on the HoNOS and an effect size of 0.6.The total number of unmet needs fell from 208 to 115. The median costs per decreased HoNOS point were €2.842 and €6.880 per unmet need., Discussion: Many patients improved, but due to a large standard deviation at baseline and a low Cronbach's alpha, only 4 patients showed a reliable improvement on functional status. That substantial remission was achieved was shown by the decrease in unmet needs of 93 (44.7%) for the whole group. These observations support the implementation of MPUs, although more research is warranted to ensure cost-effectiveness., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: Medical Psychiatry Units (MPUs), also known as Complexity Intervention Units (CIUs), provide care for complex patients suffering from both psychiatric and physical disorders. Because there is no consensus on the indications for admission to an MPU, daily practice and effectiveness research are hampered. This study therefore used a concept mapping approach to investigate which organizational and medical factors determine the decision to admit a patient to an MPU., Methods: The first step of the concept mapping approach was to create a list of factors determining MPU admission from literature. Secondly, clinical experts sorted and ranked these factors. The sorted and ranked data were then analyzed, and a draft conceptual framework was created. A final conceptual MPU admission framework was then drawn during an expert consensus meeting and recommendations for implementation were suggested., Results: Thirteen clinical experts defined 90 factors from literature, which were sorted and ranked by 40 experts from 21 Dutch hospitals. This concept mapping approach resulted in a five-cluster solution for an MPU admission framework based on: 1. Staff competencies and organizational pre-requisites; 2. Patient context; 3. Patient characteristics; 4. Medical needs and capabilities; and 5. Psychiatric symptoms and behavioral problems. Furthermore, three inclusion and two exclusion criteria were formulated to help the clinicians decide whether or not to admit patients to an MPU. These criteria can be implemented in daily practice., Conclusion: Implementing the five criteria derived from this conceptual framework will help make the admission decision for complex patients with psychiatric and physical disorders to an MPU more correct, consistent, and transparent., Competing Interests: The authors have declared that no competing interests exist.

Objective: To define generic quality indicators for general hospital psychiatry from the perspectives of patients, professionals (physicians, nurses, and managers), and payers (health insurance companies)., Methods: Quality variables were identified by reviewing the relevant literature. A working. group consisting of patients', professionals' and payers' representatives was mandated by their respective umbrella organizations. The working group prioritized the quality variables that were identified. Core values were defined and subsequently linked to preliminary quality indicators. These were tested for feasibility in ten hospitals in a four-week period. Stakeholder consultation took place by means of two invitational conferences and two written commentary rounds., Results: Forty-one quality variables were identified from the literature. After prioritization, seven core values were defined and translated to 22 preliminary indicators. Overall, the feasibility study showed high relevance scores and good implementability of the preliminary quality indicators. A final set of twenty-two quality indicators (17 structure, 3 process and 2 outcome indicators) was then established using a consensus-based approach., Conclusion: Consensus on a quality framework for general hospital psychiatry was built by incorporating the perspectives of relevant stakeholders. Results of the feasibility study suggest broad support and good implementability of the final quality indicators. Structural indicators were broadly defined, and process and outcome indicators are generic to facilitate quality measurement across settings. The quality indicator set can now be used to facilitate quality and outcome assessment, stimulate standardization of services, and help demonstrate (cost-) effectiveness., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.

Alterations of polyunsaturated fatty acids (PUFA) in schizophrenia have been reported, but there is substantial variation in the findings. We performed a systematic review and meta-analysis for docosapentaenoic acid (DPA), docosahexaenoic acid (DHA), linoleic acid (LA), and arachidonic acid (AA). We identified 18 studies which compared PUFA in the erythrocyte cell membrane between patients with schizophrenia and controls. A total of 642 patients (169 were antipsychotic-naïve) and 574 controls participated in these studies. We found suggestive evidence that the levels of DPA (C22:5n3) and DHA (C22:6n3) are decreased both in patients currently being treated with antipsychotic medication and antipsychotic-naïve patients. Our findings furthermore suggest that the levels of LA (C18:2n6) are decreased in the medicated subgroup, but not in the antipsychotic-naive group. Finally, we found decreased levels of AA (C20:4n6), most convincingly in antipsychotic-naive patients. Taken together, there is substantial evidence that decreased levels of DPA (C22:5n3), DHA (C22:6n3), and AA (C20:4n6) are associated with the schizophrenia syndrome, apart from a possible influence of antipsychotic medication. Given the large heterogeneity in results, these conclusions should be interpreted cautiously., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Aim: To assess health-related quality of life (HR-QoL) and academic functioning in adolescents and young adults 6 years after paediatric referral for chronic pain., Methods: In 99 children and adolescents with chronic pain (aged 8-17) referred to a paediatric outpatient clinic, pain and psychiatric disorders were assessed between 2000 and 2002. Participants were reassessed after minimal 5 years (aged 13-24). HR-QoL [Medical Outcomes Study 36-item Short-Form (SF-36)] was compared with Dutch population norms. Academic functioning (structured questionnaire) was compared with baseline., Results: Participant's ratings in most HR-QoL dimensions did not differ from population norms. Outcome was significantly decreased in Bodily Pain (p = 0.001 males, p < 0.000 females) and female General Health (p = 0.001). Poor general health perceptions (p = 0.002), poor global general health (p = 0.003) and a high somatic symptom level (p = 0.004) at baseline predicted poor HR-QoL outcome. School/work attendance was significantly better than at baseline (p = 0.002)., Conclusion: Six years after paediatric referral for chronic pain, HR-QoL was mostly comparable to that of peers, and academic functioning improved. Self-evaluated global health at referral may be an important predictor of HR-QoL outcome of children with chronic pain, rather than psychiatric comorbidity., (© 2012 The Author(s)/Acta Paediatrica © 2012 Foundation Acta Paediatrica.)

Little is known about how the biological stress response systems--the autonomic nervous system (ANS), the hypothalamic-pituitary-adrenal (HPA) axis, and the immune system--function during psychosis. Results of studies on the effect of stress on the immune and autonomic system in patients with schizophrenia are inconsistent. The present study investigates whether the stress response is impaired in medication-naive patients with a first episode of psychosis. Ten male patients with a first episode of psychosis and 15 controls were exposed to the stress of public speaking. Parameters of the ANS (heart rate and catecholamines), the HPA axis (plasma adrenocorticotropic hormone [ACTH] and cortisol), and the immune system (number and activity of natural killer [NK] cells) were measured. Peak responses were calculated to examine the relationship between stress-induced activation of the different systems. Subjective stress and anxiety before and during the task were assessed. Patients and controls displayed similar autonomic responses to acute stress. However, there was an impaired HPA axis response, slow onset and return of ACTH, and flattened cortisol response and a reduced increase in number NK cells and NK cell activity in patients with a first episode of psychosis. Furthermore, in patients, the relationship between the different stress response systems was weaker or absent compared with controls. These findings indicate that impairments in stress processing are associated with the endophenotype of psychosis and are not a result of illness progression or antipsychotic medication.

Objective: Psychiatric disorders are common in children with chronic pain, but their course and impact when children grow up are unknown. This study examines the 6-year clinical outcome of children referred for chronic pain with and without comorbid psychiatric disorders., Method: In 91 children and adolescents (aged 8 to 17 years) referred to a university outpatient clinic for chronic pain, child psychiatric disorders were assessed using the Diagnostic Interview Schedule for Children-parent version (DISC-P) between 2000 and 2002. Participants (aged 13 to 24 years) were reassessed on average 6-years later. Outcome measures were chronic pain and psychiatric disorders assessed with the Diagnostic Interview Schedule for Children-children version (DISC-C) or the Composite International Diagnostic Interview (CIDI) and Diagnostic Interview Schedule IV (DIS)., Results: After 6 years, 75% of the participants still experienced chronic pain and 15% were in complete remission of both chronic pain and psychiatric disorder. The prevalence of psychiatric disorders (both persistent and new onset disorders) at follow-up was 32%. Baseline psychiatric disorder was a predictor of psychiatric disorder at follow-up (OR = 2.6, 95% CI = 1.1-6.5, P = .04; adjusted OR = 2.8, 95% CI = 1.1-7.1, P = .03) but did not predict persistence of chronic pain., Conclusions: Children referred for chronic pain frequently continue to suffer from chronic pain and psychiatric disorders in adolescence and young adulthood. In this population, comorbid psychiatric disorder at study entry was a predictor of psychiatric disorder, but not of persistent chronic pain, in adolescence and young adulthood., (© Copyright 2012 Physicians Postgraduate Press, Inc.)

Background: In drug development, a 4-phase hierarchical model for the clinical evaluation of new pharmaceuticals is well known. Several comparable phased evaluation schemes have been proposed for medical tests., Purpose: To perform a systematic search of the literature, a synthesis, and a critical review of phased evaluation schemes for medical tests., Data Sources: Literature databases of Medline, Web of Science, and Embase., Study Selection and Data Extraction: Two authors separately evaluated potentially eligible papers and independently extracted data., Results: We identified 19 schemes, published between 1978 and 2007. Despite their variability, these models show substantial similarity. Common phases are evaluations of technical efficacy, diagnostic accuracy, diagnostic thinking efficacy, therapeutic efficacy, patient outcome, and societal aspects., Conclusions: The evaluation frameworks can be useful to distinguish between study types, but they cannot be seen as a necessary sequence of evaluations. The evaluation of tests is most likely not a linear but a cyclic and repetitive process.

Objective: To explore designs for evaluating the prognostic and predictive value of medical tests and their effect on patient outcome., Study Design: Theoretical analysis with examples from the medical literature., Results: For evaluating the prognostic value of a test, one can include the test at baseline in prognostic studies. To evaluate the value of test in predicting treatment outcome, the test results can be used as baseline information in randomized controlled trials of treatment. To compare the prognostic or predictive value of two or more tests, the test result combinations can be used as baseline information. To evaluate the effect on patient outcome, randomized controlled trials of test strategies are an option. Randomization can apply to all tested or be restricted to specific subgroups, such as those with discordant test results, to increase the efficiency of trials., Conclusion: The prognostic and predictive value of medical tests can and should be evaluated, to demonstrate the test's ability to guide clinical decision making and to improve patient outcome. Various randomized designs can be used to evaluate the effects on testing on patient outcome.

Objective: Our aim was to improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the generalizability of its results., Methods: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy., Results: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation and/or the reference standard., Conclusions: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve, to the advantage of clinicians, researchers, reviewers, journals and the public.

Diagnostic testing can be used to discriminate subjects with a target disorder from subjects without it. Several indicators of diagnostic performance have been proposed, such as sensitivity and specificity. Using paired indicators can be a disadvantage in comparing the performance of competing tests, especially if one test does not outperform the other on both indicators. Here we propose the use of the odds ratio as a single indicator of diagnostic performance. The diagnostic odds ratio is closely linked to existing indicators, it facilitates formal meta-analysis of studies on diagnostic test performance, and it is derived from logistic models, which allow for the inclusion of additional variables to correct for heterogeneity. A disadvantage is the impossibility of weighing the true positive and false positive rate separately. In this article the application of the diagnostic odds ratio in test evaluation is illustrated.

Objective: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the generalizability of its results., Methods: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy., Results: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard, or both., Conclusions: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in a study and to evaluate the generalisability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart, and this explanation and elaboration document should be useful resources to improve the reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in health care.

The objective of the 'Standards for Reporting of Diagnostic Accuracy' (STARD) initiative is to improve the reporting of studies of diagnostic accuracy, so as to allow readers to assess the potential for bias in a study and to evaluate the generalibility of its results. The group searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies. This was used to draw up a list of potential items. During a consensus meeting, a group of researchers, medical journal editors, and members of professional organisations reduced this list to a usable checklist. Wherever possible, evidence from the literature was used to justify the decisions made. The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which a list of 75 potential items was extracted. At the consensus meeting, participants shortened the list to a 25-item checklist. A generic flow diagram was drawn up to provide guidance on the method for including patients, the order in which tests were to be conducted and the number of patients to undergo the test being evaluated, the reference standard, or both. A scientific publication can only be assessed when the reporting is both correct and complete. Use of the checklist and flow diagram will improve the quality of reports produced, to the advantage of clinicians, researchers, reviewers, journal editors and other interested parties.

Whether or not patients are better off from undergoing a diagnostic test will depend on how test information is used to guide subsequent decisions on starting, stopping, or modifying treatment. Consequently, the practical value of a diagnostic test can only be assessed by taking into account subsequent health outcomes. In the appraisal of diagnostic test studies, it is essential to discriminate between studies that report on the accuracy of a diagnostic test and studies that report on health outcomes of strategies that incorporate diagnostic tests. In a study that reports on diagnostic accuracy, a cohort of patients is subjected to at least two diagnostic tests: the index test and the reference test, the latter usually being the best method available to detect the target condition. The accuracy of the index test can be expressed in terms of sensitivity, specificity, or likelihood ratios. Studies that compare two or more strategies that incorporate diagnostic tests as well as therapeutic interventions should be approached differently. Such studies do not require expression of test accuracy in terms of sensitivity and specificity. The merit of diagnostic tests evaluated in such studies can be expressed by comparing relevant outcomes of both strategies. The effectiveness of such strategies can be compared similarly as the effectiveness of treatment. However, due to the fact that the effect of a diagnostic test on health outcome is not as direct as the effect of treatment on health outcome, the design of outcome studies reporting on diagnostic tests requires special attention. It is important to establish a clear link between the result of the test under study and subsequent therapeutic management. Furthermore, trial efficiency can be improved by moving the point of randomization from the decision point, whether or not to test, to the point where a decision has to be made regarding what to do with the positive test results.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in the study and to evaluate the generalizability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the reporting the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding, and dissemination of the checklist. The document contains a clarification of the meaning, rationale, and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart, and this explanation and elaboration document should be useful resources to improve reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in health care.

Background: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors., Objective: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its generalisability., Methods: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy., Results: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both., Conclusions: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

It is indispensable for any meta-analysis that potential sources of heterogeneity are examined, before one considers pooling the results of primary studies into summary estimates with enhanced precision. In reviews of studies on the diagnostic accuracy of tests, variability beyond chance can be attributed to between-study differences in the selected cutpoint for positivity, in patient selection and clinical setting, in the type of test used, in the type of reference standard, or any combination of these factors. In addition, heterogeneity in study results can also be caused by flaws in study design. This paper critically examines some of the potential reasons for heterogeneity and the methods to explore them. Empirical support for the existence of different sources of variation is reviewed. Incorporation of sources of variability explicitly into systematic reviews on diagnostic accuracy is demonstrated with data from a recent review. Application of regression techniques in meta-analysis of diagnostic tests can provide relevant additional information. Results of such analyses will help understand problems with the transferability of diagnostic tests and to point out flaws in primary studies. As such, they can guide the design of future studies., (Copyright 2002 John Wiley & Sons, Ltd.)

Study Objective: We validate the Ottawa Ankle Rules and 2 Dutch ankle rules in distinguishing clinically significant fractures from insignificant fractures and other injuries in patients with a painful ankle presenting to the emergency department., Methods: This prospective comparison of 3 ankle rules was conducted in the ED of a 580-bed community teaching hospital in Amsterdam from January 1998 to April 1999. Participants included 647 consecutive patients aged 18 years or older presenting with a painful ankle after trauma. All physicians received extensive and pictorial training on how to correctly score the respective items of the rules. The physician on call recorded these items derived from history and physical examination on a standardized data sheet. All patients subsequently underwent standard radiographic assessment. A radiologist and a trauma surgeon evaluated the radiographs blinded from the results of the data sheet form and the treatment given. The diagnostic performance of the 3 rules was measured in terms of sensitivity, specificity, and the reduction of radiographs. Receiver operating characteristic (ROC) curves were constructed, and the area under the ROC curves was calculated and compared., Results: Seventy-four fractures were seen, of which 41 were clinically significant. The Ottawa Ankle Rules had a sensitivity of 98% for identifying clinically significant fractures; the local rules scored 88% and 59%, respectively. The potential savings in radiographs for the 3 decision rules were 24%, 54%, and 82%, respectively. The area under the ROC curve was better for both the local rules (0.84 and 0.83) compared with the Ottawa Ankle Rules (0.76)., Conclusion: Because the identification of all relevant fractures is more important than a reduction in radiographs, the higher sensitivity of the Ottawa Ankle Rules makes these most suitable for implementation in The Netherlands.

Background: Ankle decision rules help to determine which patients with ankle injuries should undergo radiography. However, these rules are limited by imperfect generalizability and sensitivity. The judgement of physicians, aided by structured data collection, is a potential alternative. We compared the diagnostic performance of 2 decision rules with the performance of physicians, aided by structured data collection, in ruling out fracture in patients with acute ankle injury., Methods: Consecutive patients with acute ankle injury who visited the emergency department of a teaching community hospital in Amsterdam were included in the study. After taking the patient's history and performing a physical examination, the surgical resident in each case completed a specially developed structured data form incorporating all of the variables in the Ottawa and Leiden ankle rules, as well as some additional variables. The form then asked whether the resident thought radiography was necessary. Each patient then underwent ankle and midfoot radiography. The films were independently interpreted by a radiologist and a trauma surgeon, who were both blinded to the information on the data form. Sensitivity, specificity and the percentage of patients for whom radiography was recommended were the main outcome measures., Results: Of 690 consecutive patients, 647 met the inclusion criteria. Fractures were observed in 74 (11%) of these patients. Sensitivity was 89% (95% confidence interval [CI] 80% to 95%) for the Ottawa ankle rules, 80% (95% CI 69% to 88%) for the Leiden ankle rule and 82% (95% CI 72% to 90%) for physicians' judgement. Specificity was 26% (95% CI 23% to 30%), 59% (95% CI 55% to 63%) and 68% (95% CI 64% to 71%) respectively. Radiography was recommended in 76% (95% CI 72% to 79%), 46% (95% CI 42% to 50%) and 38% (95% CI 34% to 42%) of cases respectively. The Ottawa rules missed 8 fractures, of which 1 was clinically significant, the Leiden rule missed 15 fractures, of which 5 were clinically significant, and the residents missed 13 fractures, of which 1 was clinically significant., Interpretation: Physicians' judgement, aided by structured data collection, was similar to existing international and local decision rules in terms of sensitivity in identifying cases requiring radiography and may outperform these prediction rules in terms of minimizing radiographic examinations for patients with ankle trauma.

We performed a study in 403 prospectively included patients with suspected pulmonary embolism to compare the accuracy of a combination of the SimpliRED D-dimer assay and an intuitive clinical probability estimate with either one alone. Based on a conjoint diagnostic refer, ence standard, including ventilation-perfusion lung scintigraphy and pulmonary angiography, the prevalence of pulmonary embolism was 31%. We demonstrated a high sensitivity (98%, 95% CI 95-100) and negative predictive value (94%, 95% CI 79-99) for the combination of the two tests. These figures were more favorable than for either test alone. The specificity of the combination was lower (11%, 95% CI 9-12) and consequently the proportion of patients in whom further diagnostic tests would have been avoided was only 8%. We conclude that the combined use of the SimpliRED test and the clinical probability estimate attains a higher sensitivity than either test alone. However, there remains a risk of false negatives and the exclusion efficiency is limited.

Objective: Evaluation of the diagnostic accuracy of ultrasound in the second trimester for the detection of spina bifida., Design: Systematic review and meta-analysis., Method: Medline and Embase were searched to identify prospective studies in a general pregnant population. Also, in the Cochrane Library, references of identified reports and recent reviews were checked for relevant studies. Retrieved abstracts were selected independently by 2 authors using predefined criteria. Assessment of quality and generalizability of the included studies and data extraction were performed by 3 authors independently. The data were tested for heterogeneity and pooled estimates of sensitivity and specificity were calculated for all studies., Results: 13 studies were included. Specificity was approximately 100% in all cases. Sensitivity varied from 40% to 100%. The summary point estimate for sensitivity was 71% with a 95% confidence interval of 59%-81%., Conclusion: Ultrasound in the second trimester is a specific investigation to detect spina bifida, which may detect seven out of ten defects. Used as a screening tool, it could contribute to a significant reduction in the number of children born with spina bifida.

We prospectively evaluated the diagnostic performance of a new soluble fibrin assay in 303 consecutive patients with suspected pulmonary embolism and examined potentially useful cut-off levels at which this disease can be safely excluded. In addition, the diagnostic accuracy was calculated in the subgroups of in- and outpatients. The ROC curve of the assay in the total study cohort had an area under the curve of 0.69. The cut-off level associated with a sensitivity and negative predictive value of 100% was 20 ng/ml, but the specificity was only 4%. The cut-off level with a sensitivity of 90% was 30 ng/ml, which corresponded with a specificity and negative predictive value of 27% and 86%. respectively. The diagnostic performance was comparable in the subgroups of in- and outpatients. We conclude that the soluble fibrin assay has a low diagnostic accuracy and seems unsuitable as a screening test for the exclusion of pulmonary embolism.

We prospectively evaluated the diagnostic accuracy of the Fibrinostika FbDP assay in 304 consecutive patients with suspected pulmonary embolism and examined potentially useful cut-off points at which the disease can be excluded. The prevalence of pulmonary embolism was 31%. The assay generated an area under the Receiver Operating Characteristic curve of 0.79 (95% CI 0.73-0.84). A cut-off point of 0.05 microg/ml yielded a sensitivity, specificity, negative predictive value and an exclusion efficiency of 100% (95% CI 96-100), 5% (95% CI 2-9), 100% (95% CI 69-100) and 3% (95% CI 2-6), respectively. A clinically useful cut-off point seems to be 0.11 microg/ml which corresponded with a sensitivity, specificity, negative predictive value and an exclusion efficiency of 96% (95% CI 90-99), 27% (95% CI 24-28), 93% (95% CI 84-98) and 20% (95% CI 16-25), respectively. We conclude that the assay has potential clinical utility for the exclusion of pulmonary embolism, but it cannot be used as a sole test.

Recent studies have suggested that both the subjective judgement of a physician and standardized clinical models can be helpful in the estimation of the probability of the disease in patients with suspected pulmonary embolism (PE). We performed a multi-center study in consecutive in- and outpatients with suspected PE to compare the potential diagnostic utility of these methods. Of the 517 study patients, 160 (31%) were classified as having PE. Of these patients, 14% had a low probability as estimated by the treating physician, while 25 to 36% were categorized as having a low clinical probability with the use of two previously described clinical models. The objectively confirmed prevalence of PE in these three low probability categories was 19%, 28% and 28%, respectively. The three methods yielded comparable predictive values for PE in the other probability categories. We conclude that a physician's clinical judgement alone and two standardized clinical models, although comparable, perform disappointingly in categorizing the pre-test probability in patients with suspected PE.

Study Objective: We evaluated the diagnostic accuracy of myoglobin determination for the early diagnosis of acute myocardial infarction (AMI)., Methods: Consecutive patients with chest pain were included in the study. Receiver operating characteristic (ROC) analysis was used to assess optimal timing of blood sampling and cutoff values., Results: A total of 309 patients were included, of whom 162 patients had a diagnosis of AMI. ROC analysis revealed that the diagnostic accuracy of myoglobin concentration as indicated by the area under the ROC curve (AUC) increased significantly from 3 (0.89+/-0.026) and 4 hours (0.93+/-0.019) to 5 hours after onset of symptoms (0. 96+/-0.014; P=.0040 and.035, respectively). At 5 hours (the earliest time point with maximal AUC), sensitivity was 87% and specificity was 97% using a myoglobin cutoff value of 90 microg/L. With a myoglobin cutoff value of 50 microg/L, sensitivity was 95% (95% confidence interval 90% to 98%), but specificity was 86% (95% confidence interval 80% to 93%)., Conclusion: Myoglobin has maximal diagnostic accuracy for the diagnosis of AMI at 5 hours after the onset of symptoms, using a cutoff value of 50 microg/L. In combination with the measurement of other biochemical markers, myoglobin determination could be particularly useful for triage of patients with AMI at an early stage.

Background: Our objective was to evaluate the diagnostic accuracy of abdominal symptoms in gallstones in studies using ultrasonography or oral cholecystography as the reference standard and to assess the extent to which variability in diagnostic accuracy is explained by patient selection and other characteristics of study design., Methods: A Medline search (1966-1998) was conducted in combination with reference checking for further relevant publications. Two independent assessors selected controlled studies that included patients > or =18 years of age. Articles were excluded if sensitivity and specificity could not be extracted or the included patients were at extraordinary risk for gallstones. Seven abdominal symptoms were evaluated. Modification of the diagnostic accuracy by clinical setting, extent of the disease, blinding, age, and sex was analysed by using logistic regression., Results: A total of 24 publications were included. The symptoms 'biliary colic', 'radiating pain', and 'analgesics used' were consistently related to gallstones. The setting of the study had a significant effect on the diagnostic accuracy of these symptoms. The unadjusted, pooled diagnostic odds ratios, however, were low (2.6 (95% confidence interval, 2.4-2.9), 2.8 (2.2-3.7), and 2 (1.6-2.5), respectively). The diagnostic odds ratio of biliary colic increased with the extent of gallstone disease (13.3 (4.2-42)., Conclusions: Although biliary colic was specific for gallstones, 80% of the referred patients with gallstones presented with other abdominal symptoms. There is no current evidence that justifies the use of single abdominal symptoms, other than biliary colic, in the diagnosis of symptomatic gallstones. Further research should focus on the prognosis of patients with non-specific abdominal symptoms and gallstones.

Objective: To evaluate the effect of verification bias on the accuracy of first-trimester nuchal translucency measurement for Down syndrome detection., Methods: We used MEDLINE and EMBASE to identify all papers relating the results of nuchal translucency measurement to fetal karyotype. The detected studies were scored for verification bias. Fifteen studies without and ten with verification bias were included., Results: Sensitivity and specificity were calculated for each study. For studies with verification bias, adjusted estimates of the sensitivity were calculated assuming a fetal loss rate for Down syndrome pregnancies of 48%. The sample size weighted sensitivity was 55% in studies without and 77% in those with verification bias, for specificities of 96% and 97%, respectively. After adjustment for verification bias, the sample size weighted sensitivity changed from 77% to 63%., Conclusion: Studies with verification bias reported higher sensitivities, but also slightly higher specificities of nuchal translucency measurement than studies without verification bias. The difference in sensitivity is greater than could be explained by verification bias. We postulate that the experience of the sonographist might be an explanation for the differences.