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PubMedDate not supplied

Proteomics: from basic research to diagnostic application. A review of requirements & needs.

For several years proteomics research has been expected to lead to the finding of new markers that will translate into clinical tests applicable to samples such as serum, plasma and urine: so-called in vitro diagnostics (IVDs). Attempts to implement technologies applied in proteomics, in particular protein arrays and surface-enhanced laser desorption ionization time-of-flight mass spectrometry (SELDI-TOF MS), as IVD instruments have initiated constructive discussions on opportunities and challenges inherent in such a translation process also with respect to the use of multi-marker profiling approaches and pattern signatures in IVD. Taking into account the role that IVD plays in health care, we describe IVD requirements and needs. Subject to stringent costs versus benefit analyses, IVD has to provide reliable information about a person's condition, prognosis or risk to suffer a disease, thus supporting decisions on treatment or prevention. It is mandatory to fulfill requirements in routine IVD, including disease prevention, diagnosis, prognosis, and treatment monitoring or follow up among others. To fulfill IVD requirements, it is essential to (1) provide diagnostic tests that allow for definite and reliable diagnosis tied to a decision on interventions (prevention, treatment, or nontreatment), (2) meet stringent performance characteristics for each analyte (in particular test accuracy, including both precision of the measurement and trueness of the measurement), and (3) provide adequate diagnostic accuracy, i.e., diagnostic sensitivity and diagnostic specificity, determined by the desired positive and negative predictive values which depend on disease frequency. The fulfillment of essential IVD requirements is mandatory in the regulated environment of modern diagnostics. Addressing IVD needs at an early stage can support a timely and effective transition of findings and developments into routine diagnosis. IVD needs reflect features that are useful in clinical practice. This helps to generate acceptance and assists the implementation process. On the basis of IVD requirements and needs, we outline potential implications for clinical proteomics focused on applied research activities.

Decision Making↗
PubMed2003

Comparison of diagnostic accuracy for cutaneous malignant melanoma between general dermatology, plastic surgery and pigmented lesion clinics.

BACKGROUND: Since the 1980s there have been dedicated pigmented lesion clinics (PLCs) in the U.K. Important considerations when comparing the efficacy of the PLC with other referral clinics include diagnostic accuracy. OBJECTIVES: To compare the false-negative rate of clinical diagnosis (FNR) in the PLC with that in the other clinics of primary referral of malignant melanoma (MM) in the same geographical area. We have previously shown that certain clinical features are risk factors for diagnostic failure of MM. A further aim of this study was to correct for any differences in frequency of these factors in the melanoma populations between clinics and to estimate the false-positive diagnostic rate (FPR) in the PLC. METHODS: To compare the FNR between clinics, the case notes of all patients presenting with histologically proven cutaneous MM in Leicestershire between 1987 and 1997 were examined retrospectively. A false-negative diagnosis was defined as documentation of another diagnosis and/or evidence in the case notes that the diagnosis was not considered to be MM. The FNR was estimated as the number of false-negative clinical diagnoses/number of true-positive histological diagnoses. To estimate the diagnostic FPR, which was defined as the number of false-positive clinical diagnoses of MM/total number of positive clinical diagnoses, in the PLC, the outcome of 500 consecutive patients attending the PLC was surveyed. RESULTS: The case notes of 731 patients were available, of whom approximately two-thirds initially attended the PLC, one-fifth the General Dermatology clinics (D) and the remainder were divided approximately equally (one-twentieth each) between Plastic Surgery clinics (P), other clinics (O) and the surgery of the general practitioner (GP). The last was regarded as the primary referral clinic if the lesion were excised there prior to any referral. The FNR was lowest for the PLC, at 10%, compared with 29% (D), 19% (P), 55% (O) and 54% (GP) (P < 0.0001). Lesions with risk factors for diagnostic failure were under-represented in the PLC (P < 0.0001), the mean frequencies of the risk factors being 20% (PLC), 25% (D), 22% (P), 31% (O) and 30% (GP). Differences were not large but still could partially explain the lower FNR of the PLC. However, when the FNR was estimated for lesions exhibiting each of these risk factors, the PLC was found to have the lowest rate in every case (PLC vs. all clinics combined, P = 0.04 to P < 0.0001). The mean FNR for the risk factors combined was 18% (PLC), 45% (D), 50% (P), 68% (O) and 71% (GP). Also on logistic multivariable analysis of the PLC vs. all the other clinics on FNR and the above factors, the higher FNR of the other clinics retained significance (odds ratio 5.9, P < 0.0001). In the 500 patients surveyed separately in the PLC, the MM pick-up rate on biopsy was 32% and the diagnostic FPR was 41%. CONCLUSIONS: The FNR of MM was lower in the PLC than in the other clinics, while the pick-up rate for MM on biopsy and the FPR were acceptably low.

Aged↗
PubMed2002

Limited value of routine microbiological diagnostics in patients hospitalized for community-acquired pneumonia.

Current guidelines recommend microbiological diagnostic procedures as a part of the management of patients hospitalized for community-acquired pneumonia (CAP), but the value of such efforts has been questioned. Patients hospitalized for CAP were studied retrospectively, focusing on the use of aetiological diagnostic methods and their clinical impact. Adult patients, without known human immunodeficiency virus infection, admitted to hospital for CAP during 12 months, were evaluated with regard to the importance of aetiological diagnosis for tailoring antibiotic therapy, antibiotic-associated diarrhoea, Clostridium difficile disease, length of hospital stay and mortality. Of the 605 studied patients, 482 (80%) were subjected to Mycoplasma pneumoniae and/or respiratory virus serology and/or cultures of blood and/or sputum. They had a better prognosis than patients not subjected to microbiological diagnostics (mortality within 3 months was 9% vs 24%, p = 0.001), apparently reflecting differences in general health (e.g. less dementia diagnosis) but not the outcome of diagnostics. A presumptive aetiology was obtained only in 132 of the 482 patients, Streptococcus pneumoniae and M. pneumoniae being the most common agents (in 49 and 36 patients, respectively). Establishing an aetiological diagnosis had no impact on the number of in-hospital changes of therapy, on the proportion of new regimens having a narrower antimicrobial spectrum than the initial one or on the outcome. Therapy was changed to a drug directed specifically against the identified pathogen in only 16 out of these 132 patients and again without any overall improvement in the outcome variables. In a setting with a low frequency of antibiotic-resistant respiratory tract pathogens current routine microbiological diagnostics were found to be of limited value for the clinical management of patients hospitalized for CAP. Improved diagnostics in CAP are urgently needed, as establishing an aetiological diagnosis carries a potential for optimizing the antibiotic therapy.

Adolescent↗
PubMedDate not supplied

DSM-IV diagnostic criteria for pathological gambling: reliability, validity, and classification accuracy.

The purpose of this study was to examine the reliability, validity, and classification accuracy of the DSM-IV diagnostic criteria for pathological gambling. Given the lack of a laboratory test to diagnose pathological gambling, two groups were recruited in order to test DSM-IV diagnostic classification accuracy, one which likely had the disorder and the other which likely did not have the disorder (121 men and women clients at a gambling treatment facility) (138 men and women selected at random from the Windsor, Ontario, community who had gambled in the past twelve months). The Gambling Behavior Interview was administered to both groups. The Gambling Behavior Interview was administered to both groups. The Gambling Behavior Interview includes items that measure the ten DSM-IV diagnostic criteria for pathological gambling as well as other gambling problem severity measures and scales that served as tests of convergent validity. The ten DSM-IV diagnostic criteria were found to exhibit satisfactory reliability, validity, and classification accuracy; however, lowering the cut score to four and using item weights yielded improved classification accuracy over the standard cut score of five. Some diagnostic criteria were found to have greater discriminatory power than other criteria. The results of this study suggest that the classification accuracy of DSM-IV diagnostic criteria can be improved upon with a lower cut score or using weighted criteria.

Adolescent↗
PubMed1999

Differences in diagnostic approach between family physicians and other specialists in patients with unintentional body weight loss.

BACKGROUND: Unintentional weight loss is a diagnostic dilemma with diverse diagnostic possibilities for physicians. OBJECTIVES: Our study focused on the evaluation of differences in diagnostic approach between family physicians and physicians in other specialties. METHODS: Outpatients who visited National Taiwan University Hospital from January 1996 to December 1996 with unintentional weight loss of 5% or more within 6 months were recruited by a computer search. All data were obtained from a structured medical record audit. RESULTS: There was no significant difference in the utilization of common diagnostic laboratory tests between the two groups. However, other specialists ordered more carcinoembryonic antigen tests (P < 0.01) and hepatitis B antigen tests (P < 0.05), but fewer upper gastrointestinal tract barium studies (P < 0.05) than family physicians. For patients without a definite final diagnosis, the diagnostic total costs for laboratory tests and imaging studies were lower for family physicians than other specialists (P < 0.01). For patients with biomedical disorders, the diagnostic cost was not significantly different between the two groups. For patients with psychological disorders, the costs for imaging studies were lower for family physicians than for other specialists (P < 0.05) but there was no significant difference in the total costs between these two groups. CONCLUSIONS: We conclude that the different approaches between the two groups are due to different training backgrounds and characteristics of practice. The patient-centred concepts of family physicians might be more cost-effective in dealing with undifferentiated problems.

Adolescent↗
PubMed2002

Asymmetric funnel plots and publication bias in meta-analyses of diagnostic accuracy.

BACKGROUND: Despite the great possibility of publication bias in studies of diagnostic test research, empirical studies about publication bias have mainly focused on studies of treatment effect. METHODS: A sample of 28 meta-analyses of diagnostic accuracy was selected from the Database of Abstracts of Reviews of Effectiveness (DARE). Methods used to deal with publication and related biases in these meta-analyses were examined. Asymmetry of funnel plot of estimated test accuracy against corresponding precision for each meta-analysis was assessed by three statistical methods: rank correlation method, regression analysis, and Trim and Fill method. RESULTS: In reviews of diagnostic accuracy, there was a general lack of consideration of appropriate literature searching to minimize publication bias, and the impact of possible publication bias has not been systematically assessed. The results of the three different statistical methods consistently showed that in a large proportion of the 28 meta-analyses evaluated, the smaller studies were associated with a greater diagnostic accuracy. Exploratory analyses found that the fewer the literature databases searched, the greater the funnel plot asymmetry in meta-analyses. Funnel plot asymmetry tended to be greater in meta-analyses that included smaller number of primary studies. Our data revealed no consistent relationship between funnel plot asymmetry and language restriction in reviews. CONCLUSIONS: Further research is required to explain why smaller studies tended to report greater test accuracy in a large proportion of meta-analyses of diagnostic tests. In systematic reviews of diagnostic studies, literature search should be sufficiently comprehensive and possible impact of publication bias should be assessed.

Diagnostic Techniques and Procedures↗
PubMedDate not supplied

The fallibility of diagnostic tests for sexually transmitted diseases: the impact of behavioral and epidemiologic studies.

OBJECTIVES: Analysis of sexually transmitted disease (STD) data to identify specific behaviors and risk factors often fails to take into account the misclassification of disease by a less than perfect diagnostic test. The authors consider here how a diagnostic test's performance profile can introduce misclassification and thereby bias measures of association. METHODS: The authors used hypothetical data relating to diagnostic tests for Chlamydia trachomatis infections and oral contraceptive use to determine odds ratio estimates given a range of sensitivity, specificity, prevalence of infection, and sample size. RESULTS: Lower specificity in a diagnostic test can result in an underestimation of a risk factor's association with an infection. This bias is particularly severe in low prevalence populations. Use of a diagnostic test with low specificity also will increase the sample size needed to demonstrate the association and, thus, the cost of such surveys. CONCLUSIONS: Diagnostics tests for sexually transmitted diseases have less than perfect sensitivity and specificity, which affects the validity of analyses of factors associated with sexually transmitted diseases. Analyses done using low prevalence populations and/or small sample sizes may underestimate the magnitude of effect in retrospective studies and clinical trials of behavioral interventions aimed at reducing sexually transmitted disease risk.

Chlamydia Infections↗
PubMed2006

Quality of reporting of orthopaedic diagnostic accuracy studies is suboptimal.

Complete and accurate reporting of diagnostic research are essential to assess the validity of its results. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy (STARD) steering committee has developed a checklist of 25 items. We asked whether the quality of reporting of diagnostic accuracy studies published in three major orthopaedic journals (Clinical Orthopaedics and Related Research, Journal of Bone and Joint Surgery British Volume, and Journal of Bone and Joint Surgery American Volume) would be similar across levels of study, journals, and years of publication, and would be similar to other subspecialty journals. We identified 37 articles from 2002-2004 diagnostic accuracy studies and applied the STARD checklist and scoring system. The scores ranged from 6.6 to 21.4 with a mean of 15 +/- 3.3. Only 38% of the articles (14 of 37) reported more than 2/3 of the items, and the majority failed to report nine specific items. The mean STARD scores were similar between the studies with different levels of evidence, across the three journals, and across the three years of publication. They were similar to scores for other subspecialty journals. The current standards of reporting of diagnostic accuracy studies in orthopaedic journals are suboptimal.

Diagnostic Techniques and Procedures↗
PubMed2006

Diagnosing major depressive disorder introduction: an examination of the DSM-IV diagnostic criteria.

During the past 3 decades, more research has been conducted on depression than any other psychiatric disorder. While there are numerous studies on depression in the areas of epidemiology, biopsychosocial correlates, genetics, course, and treatment, remarkably little research has focused on the criteria used to diagnose major depressive disorder. Nearly 10 years ago, we began the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, an integration of a comprehensive assessment protocol into a community-based psychiatry outpatient practice. As part of this clinical-research program, patients have been administered semistructured diagnostic interviews to assess the DSM-IV Axis I and Axis II disorders by well-trained interviewers. One of the goals of the MIDAS project has been to examine issues of nosology. While changes in the successive editions of the American Psychiatric Association's DSM have been increasingly grounded on empirical research, many of the sets of diagnostic criteria have not been subject to empirical scrutiny. During the next 12 months, we will be publishing a series of papers examining varying aspects of the diagnostic criteria for major depression. This series represents the type of methodical psychometric and conceptual analysis that should be conducted when developing or revising diagnostic criteria. We will examine whether the assumptions underlying the DSM's diagnostic rules have empirical support, and examine the impact of these rules on clinical practice. Our goal is not to develop a new definition of depression that would classify some individuals differently than how they are currently classified. That is, we are not seeking to develop a more valid definition of depression. However, our findings sometimes suggest changes that would simplify the criteria, improve their psychometric properties, and enhance their applicability in medical settings. Thus, the focus in the series is on clinical utility rather than validity.

Major Depressive Disorder↗
PubMed2026

Vitamin B12 Deficiency in Sickle Cell Disease: Method-Driven Estimates and Systematic Diagnostic Misclassification.

OBJECTIVES: To determine whether the reported 0%-70% prevalence of vitamin B12 deficiency in sickle cell disease (SCD) reflects true population variation or diagnostic misclassification. METHODS: We conducted a PRISMA 2020-compliant systematic review of observational studies (January 1, 2000-May 13, 2026; PROSPERO CRD420251087800) assessing B12 status in SCD. PubMed, AJOL, and Google Scholar were searched with citation tracking and dual screening. Diagnostic validity was assessed across biomarker strategy, analytical platform, thresholds, and confounder control using a proposed context-integrated framework to classify methodological robustness and discordance. RESULTS: Fourteen studies were included (57% high-income; 43% LMIC). The evidence base was dominated by limited diagnostic approaches: 71% used immunoassays, over one-third relied on circulating B12 alone, and functional biomarkers were inconsistently applied without systematic confounder adjustment. Prevalence estimates were strongly influenced by diagnostic methods rather than underlying population biology, ranging from 0% to 70% in single-marker studies (mostly 0%-7.1%, with outliers ~50%-70%) and 6.9%-53% in multi-marker studies. Discordance was substantial and greater in LMIC settings than HIC. CONCLUSION: Current diagnostic approaches in SCD appear method-dependent, generating heterogeneous prevalence estimates with uncertain clinical validity. These findings challenge existing estimates and have implications for clinical practice, research design, and diagnostic equity. TRIAL REGISTRATION: ClinicalTrials.gov identifier: CRD420251087800.

Humans↗
PubMed2005

The quality of reporting of diagnostic accuracy studies published in ophthalmic journals.

AIM: To evaluate the quality of reporting of all diagnostic studies published in five major ophthalmic journals in the year 2002 using the Standards for Reporting of Diagnostic Accuracy (STARD) initiative parameters. METHODS: Manual searching was used to identify diagnostic studies published in 2002 in five leading ophthalmic journals, the American Journal of Ophthalmology (AJO), Archives of Ophthalmology (Archives), British Journal of Ophthalmology (BJO), Investigative Ophthalmology and Visual Science (IOVS), and Ophthalmology. The STARD checklist of 25 items and flow chart was used to evaluate the quality of each publication. RESULTS: A total of 16 publications were included (AJO = 5, Archives = 1, BJO = 2, IOVS = 2, and Ophthalmology = 6). More than half of the studies (n = 9) were related to glaucoma diagnosis. Other specialties included retina (n = 4) cornea (n = 2), and neuro-ophthalmology (n = 1). The most common description of diagnostic accuracy was sensitivity and specificity values, published in 13 articles. The number of fully reported items in evaluated studies ranged from eight to 19. Seven studies reported more than 50% of the STARD items. CONCLUSIONS: The current standards of reporting of diagnostic accuracy tests are highly variable. The STARD initiative may be a useful tool for appraising the strengths and weaknesses of diagnostic accuracy studies.

Diagnostic Techniques, Ophthalmological↗
PubMed2006

The quality of reporting of diagnostic accuracy studies in glaucoma using the Heidelberg retina tomograph.

PURPOSE: Scanning laser tomography with the Heidelberg retina tomograph (HRT; Heidelberg Engineering, Heidelberg, Germany) has been proposed as a useful diagnostic test for glaucoma. This study was conducted to evaluate the quality of reporting of published studies using the HRT for diagnosing glaucoma. METHODS: A validated Medline and hand search of English-language articles reporting on measures of diagnostic accuracy of the HRT for glaucoma was performed. Two reviewers selected and appraised the papers independently. The Standards for Reporting of Diagnostic Accuracy (STARD) checklist was used to evaluate the quality of each publication. RESULTS: A total of 29 articles were included. Interobserver rating agreement was observed in 83% of items (kappa=0.76). The number of STARD items properly reported ranged from 5 to 18. Less than a third of studies (7/29) explicitly reported more than half of the STARD items. Descriptions of key aspects of the methodology were frequently missing. For example, the design of the study (prospective or retrospective) was reported in 6 of 29 studies, and details of participant sampling (e.g., consecutive or random selection) were described in 5 of 29 publications. The commonest description of diagnostic accuracy was sensitivity and specificity (25/29) followed by area under the ROC curve (13/29), with 9 of 29 publications reporting both. CONCLUSIONS: The quality of reporting of diagnostic accuracy tests for glaucoma with HRT is suboptimal. The STARD initiative may be a useful tool for appraising the strengths and weaknesses of diagnostic accuracy studies.

Databases, Factual↗
PubMed2004

Evaluation of diagnostic assessment units in oncology: a systematic review.

PURPOSE: This systematic review was undertaken to identify clinical and economic evaluations of diagnostic assessment units for cancer; summarize measures used to evaluate such programs; and discuss the strengths and weaknesses of these evaluations. METHODS: The review was conducted to identify randomized controlled trials, case control studies, and prospective or retrospective cohort studies examining the outcomes of diagnostic centers for patients with a presumptive diagnosis of breast, colorectal, lung, head and neck, or prostate cancer. Data on methodology and study results were tabulated. RESULTS: Twenty articles were eligible for review. Eleven studies examined outcomes associated with breast cancer assessment units: six with head and neck assessment units and three with colorectal assessment units. No studies were found that examined one-stop diagnostic assessment centers for lung cancer or prostate cancer. Seventeen studies were case series, one was a case-control study, and two were randomized controlled trials. No thorough economic analyses have been undertaken. There were no studies that based their assessment on measures suggested by a conceptual framework or validated model of diagnostic care. Few studies explicitly based their investigations on established quality indicators or clinical practice guideline recommendations. Diagnostic assessment centers appear to decrease the time to arrive at a diagnosis, which in turn appears to decrease patient anxiety and increase patient satisfaction. CONCLUSION: A comprehensive understanding of the benefit of diagnostic assessment centers can only be determined if such services are developed for a variety of disease sites and more rigorous evaluations are carried out to assess their benefit.

Diagnostic Services↗
PubMedDate not supplied

Diagnostic practices for attention deficit hyperactivity disorder: a national survey of primary care physicians.

BACKGROUND: The American Academy of Pediatrics (AAP) clinical practice guideline emphasizes the appropriate diagnosis of attention deficit hyperactivity disorder (ADHD) in school-aged children. Although previous studies have shown wide variation in diagnostic practices for ADHD, few recent studies have examined nationally representative samples. OBJECTIVE: To describe practice patterns of primary care physicians evaluating school-aged children for ADHD in the late 1990s and compare the patterns with subsequently published AAP guidelines. METHODS: We surveyed a national sample of 2000 primary care pediatricians and family physicians. Of the 1076 returned surveys, 861 (43%) met data quality criteria and were included in the analysis. We tabulated frequencies for each item and used a chi2 test to examine relationships between survey items and physician characteristics. RESULTS: Primary care physicians most commonly reported conducting 1-2 new evaluations for ADHD per month, the majority spending 15-45 minutes and at least 2 office visits to confirm a diagnosis of ADHD. Although 58% of physicians used formal diagnostic criteria, only 28% reported using criteria according to the Diagnostic and Statistical Manual of Mental Disorders. Eighty-three percent reported using any teacher or school information such as report cards and rating scales. Approximately 70% used ADHD-specific rating scales, and 60% used global behavior scales. A quarter of respondents obtained laboratory tests such as hematocrit, lead, and thyroid function profile. Most physicians reported routinely assessing for coexisting conditions, ranging from 74% for tic disorders to 91% for depression and conduct disorder. CONCLUSIONS: Before the publication of AAP guidelines, primary care physicians' evaluation practices for school-aged children with ADHD varied widely, especially with respect to use of Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria and inappropriate diagnostic tests.

Attention Deficit Disorder with Hyperactivity↗
PubMed2003

Critique of the Guide to the expression of uncertainty in measurement method of estimating and reporting uncertainty in diagnostic assays.

BACKGROUND: The Guide to the Expression of Uncertainty in Measurement (GUM) provides instructions for constructing uncertainty intervals for a measurement. This method is usually reserved for reference materials, but GUM has been recently proposed as a way to express uncertainty for commercial diagnostic assays. METHODS: Using the official GUM standard and published applications of GUM to commercial diagnostic assays, I undertook an analysis to evaluate whether applying GUM to commercial diagnostic assays is warranted. RESULTS: Certain important assays, such as troponin I, would not be candidates for GUM because troponin I is not a well-defined physical quantity. Unlike definitive methods, in which efforts are taken to detect and eliminate all systematic error sources, commercial assays often trade off features such as ease of use and cost with accuracy and allow systematic errors to be present as long as the overall accuracy meets the medical need goal. Laboratories are hindered in preparing GUM models because the knowledge required to specify some systematic errors is often available only to manufacturers. Some non-GUM methods to estimate uncertainty rely on observed data, which include both known and unknown sources of error. The occurrence of large, unknown errors for assays in routine use (e.g., outliers) is not unusual because diagnostic assays must be chemically specific in the presence of thousands of potentially interfering substances. There is no provision in GUM to deal with unexplained outliers, which may lead to uncertainty intervals that are not wide enough. Some clinicians assume that diagnostic assay results have little uncertainty. This situation may be made worse by including an uncertainty interval, which implies certification. CONCLUSIONS: Evaluations for accuracy (total analytical error) based on describing the distribution of result differences between commercial assays and reference methods indicate that some assays have a few results with large differences (e.g., outliers). This leads to a wide accuracy interval (total analytical error limits). It is unlikely that GUM would be able to predict these wide intervals, especially because there is little or no provision for outlier treatment in GUM. Presenting too narrow GUM uncertainty intervals to clinicians would be misleading. The modeling used by practitioners of the GUM method is potentially useful in improving quality, but commercial diagnostic assays are not ready for GUM uncertainty statements.

Clinical Laboratory Techniques↗
PubMed1998

Methodologic standards for diagnostic test research in pulmonary medicine.

STUDY OBJECTIVES: To determine conformance with methodologic standards in the evaluation of diagnostic tests. DATA SOURCES: MEDLINE database search (1992 to 1997) of nine prominent general medicine and six subspecialty journals for articles that report discriminative properties of diagnostic tests in pulmonary medicine. STUDY SELECTION: Articles were eligible if they reported discriminative properties of diagnostic tests in humans, diagnostic tests were intended for the detection of existing conditions, and the target disorder was relevant to pulmonary medicine. DATA EXTRACTION: Each study was critically reviewed independently by two observers. DATA SYNTHESIS: Of the 1,029 retrieved articles, 41 met study inclusion criteria. The median number of the 12 major standards for design fulfilled by study articles was 6 (range, 1 to 12, 25th to 75th percentile, 5.0 to 8.5) and only 2 articles fulfilled all 12 standards. Seven (17%) articles did not report any standard measures of diagnostic accuracy and 7 (17%) provided data only for sensitivity and specificity. Only 4 of 17 articles (24%) that compared different tests used standard statistical methods. CONCLUSION: These results indicate that greater methodologic rigor is needed for studies that evaluate diagnostic tests in pulmonary medicine. Existing deficiencies in methodology risk the introduction of invalid tests into clinical practice.

Area Under Curve↗
PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

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 regarding 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 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.

Algorithms↗
PubMed2026

Respiratory-onset peripartum cardiomyopathy: a systematic review of diagnostic pitfalls and clinical outcomes.

INTRODUCTION: Peripartum cardiomyopathy (PPCM) may initially present with prominent respiratory symptoms that resemble primary pulmonary disease, particularly in late pregnancy and the early postpartum period. In clinical practice, this presentation often triggers alternative diagnostic pathways, introducing delay at a time when rapid cardiac assessment is critical. Although respiratory-dominant presentations are repeatedly described across case-based and observational reports, they have not been systematically examined as a distinct diagnostic pathway within the PPCM literature. CONTENT: This PRISMA-guided systematic review synthesized evidence relating to respiratory-onset presentations of PPCM. Major databases and registers were searched comprehensively. Following screening of 589 records and full-text assessment of 145 reports, 49 studies met inclusion criteria. Twenty studies were qualitatively prioritized for narrative synthesis using ROBIS-informed methodological appraisal. Evidence was examined across diagnostic misclassification patterns, cardiopulmonary mechanisms, differential diagnoses, investigative strategies, and acute and longitudinal management considerations. SUMMARY: Respiratory-led presentations were commonly misattributed to asthma, pneumonia, pulmonary embolism, or perioperative causes, with diagnostic delay frequently reported. Across heterogeneous study designs, cardiogenic pulmonary edema with left-ventricular systolic dysfunction emerged as a recurring unifying mechanism. Early use of echocardiography, natriuretic peptides, and targeted imaging consistently aided differentiation from primary respiratory pathology. Severe clinical deterioration was often described in the context of delayed recognition. OUTLOOK: Respiratory-onset PPCM represents a high-risk diagnostic pathway rather than a discrete disease entity. Prospective registries, standardized diagnostic algorithms, and closer integration of obstetric and cardiopulmonary care are needed to refine early recognition and improve maternal outcomes.

Humans↗