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Assessment of the potential impact of a reminder system on the reduction of diagnostic errors: a quasi-experimental study.

BACKGROUND: Computerized decision support systems (DSS) have mainly focused on improving clinicians' diagnostic accuracy in unusual and challenging cases. However, since diagnostic omission errors may predominantly result from incomplete workup in routine clinical practice, the provision of appropriate patient- and context-specific reminders may result in greater impact on patient safety. In this experimental study, a mix of easy and difficult simulated cases were used to assess the impact of a novel diagnostic reminder system (ISABEL) on the quality of clinical decisions made by various grades of clinicians during acute assessment. METHODS: Subjects of different grades (consultants, registrars, senior house officers and medical students), assessed a balanced set of 24 simulated cases on a trial website. Subjects recorded their clinical decisions for the cases (differential diagnosis, test-ordering and treatment), before and after system consultation. A panel of two pediatric consultants independently provided gold standard responses for each case, against which subjects' quality of decisions was measured. The primary outcome measure was change in the count of diagnostic errors of omission (DEO). A more sensitive assessment of the system's impact was achieved using specific quality scores; additional consultation time resulting from DSS use was also calculated. RESULTS: 76 subjects (18 consultants, 24 registrars, 19 senior house officers and 15 students) completed a total of 751 case episodes. The mean count of DEO fell from 5.5 to 5.0 across all subjects (repeated measures ANOVA, p < 0.001); no significant interaction was seen with subject grade. Mean diagnostic quality score increased after system consultation (0.044; 95% confidence interval 0.032, 0.054). ISABEL reminded subjects to consider at least one clinically important diagnosis in 1 in 8 case episodes, and prompted them to order an important test in 1 in 10 case episodes. Median extra time taken for DSS consultation was 1 min (IQR: 30 sec to 2 min). CONCLUSION: The provision of patient- and context-specific reminders has the potential to reduce diagnostic omissions across all subject grades for a range of cases. This study suggests a promising role for the use of future reminder-based DSS in the reduction of diagnostic error.

Analysis of Variance↗

EMBASE search strategies for identifying methodologically sound diagnostic studies for use by clinicians and researchers.

BACKGROUND: Accurate diagnosis by clinicians is the cornerstone of decision making for recommending clinical interventions. The current best evidence from research concerning diagnostic tests changes unpredictably as science advances. Both clinicians and researchers need dependable access to published evidence concerning diagnostic accuracy. Bibliographic databases such as EMBASE provide the most widely available entrée to this literature. The objective of this study was to develop search strategies that optimize the retrieval of methodologically sound diagnostic studies from EMBASE for use by clinicians. METHODS: An analytic survey was conducted, comparing hand searches of 55 journals with retrievals from EMBASE for 4,843 candidate search terms and 6,574 combinations. All articles were rated using purpose and quality indicators, and clinically relevant diagnostic accuracy articles were categorized as 'pass' or 'fail' according to explicit criteria for scientific merit. Candidate search strategies were run in EMBASE, the retrievals being compared with the hand search data. The proposed search strategies were treated as "diagnostic tests" for sound studies and the manual review of the literature was treated as the "gold standard." The sensitivity, specificity, precision and accuracy of the search strategies were calculated. RESULTS: Of the 433 articles about diagnostic tests, 97 (22.4%) met basic criteria for scientific merit. Combinations of search terms reached peak sensitivities of 100% with specificity at 70.4%. Compared with best single terms, best multiple terms increased sensitivity for sound studies by 8.2% (absolute increase), but decreased specificity (absolute decrease 6%) when sensitivity was maximized. When terms were combined to maximize specificity, the single term "specificity.tw." (specificity of 98.2%) outperformed combinations of terms. CONCLUSION: Empirically derived search strategies combining indexing terms and textwords can achieve high sensitivity and specificity for retrieving sound diagnostic studies from EMBASE. These search filters will enhance the searching efforts of clinicians.

Abstracting and Indexing↗

Meta-analysis of diagnostic and screening test accuracy evaluations: methodologic primer.

OBJECTIVE: Interest in evidence-based diagnosis is growing rapidly as diagnostic and screening techniques proliferate. In this article we provide an overview of systematic reviews of diagnostic performance and discuss in detail statistical methods for the most common variant of the problem: meta-analysis of studies in which a pair of estimates of sensitivity and specificity is reported. The need to account for possible variations in threshold for test positivity across studies led to the formulation of the Summary ROC (SROC) curve method. We discuss graphical and model-based ways to estimate, summarize, and compare SROC curves, and we present an example from a meta-analysis of data on techniques for staging cervical cancer. We also present a brief survey of the methodologic literature for addressing heterogeneity, correlated data, multiple thresholds per study, and systematic reviews of ROC studies. We conclude with a discussion of the significant methodologic challenges that continue to face investigators in this area of diagnostic medicine research. CONCLUSION: Systematic reviews of diagnostic performance are a rigorous approach to examining and synthesizing evidence in the evaluation of diagnostic and screening tests. The information from such reviews is needed by clinicians, health policy makers, researchers in diagnostic medicine, developers of diagnostic techniques, and the general public. However, despite progress in study quality and reporting and in methodologic development, major challenges confront investigators undertaking these reviews.

Diagnostic Techniques and Procedures↗

Diagnostic imaging and differential diagnosis in 2 case reports.

STUDY DESIGN: Retrospective resident's case reports. BACKGROUND: In today's healthcare setting, it is important for physical therapists to recognize when diagnostic imaging is necessary--as well as know how to interpret the results of these tests--to assist in the clinical decision-making process. Two cases are presented that illustrate how a physical therapist, credentialed to request and review diagnostic imaging, effectively and efficiently utilized multiple forms of diagnostic imaging to assist in his differential diagnosis and clinical decision making. DIAGNOSIS: The first case report describes the differential diagnostic process for a 33-year-old active duty military paratrooper who had sustained trauma to his neck. His history was consistent with a C6 radiculopathy, which was confirmed by a neurological screening examination. Radiographs requested by the physical therapist revealed an anterolithesis of C5 on C6, with a possible fracture. An orthopedic surgeon was consulted and further diagnostic testing via magnetic resonance imaging revealed a large disc herniation at C5-6, with spinal cord compression, as well as a C5 vertebral body fracture with nearly perched facets at C5 on C6. The patient was subsequently referred to a neurosurgeon and underwent an emergency C5-6 fusion that afternoon. The second case report describes the differential diagnosis of a 20-year-old active-duty soldier referred for rehabilitation with a diagnosis of a distal fibula stress fracture. Previous treatment by the referring provider included 3 months of rest and anti-inflammatory medications. Physical examination of the patient revealed a marked decrease in ankle inversion with a firm end feel. This was not consistent with the diagnosis established by the referring provider. Subsequent radiographs requested by the physical therapist and a computed tomography scan requested by a podiatrist revealed synostosis of the middle facet of the talocalcaneal joint with an apparent fracture line. The patient subsequently underwent a subtalar arthrodesis. DISCUSSION: In these cases the physical therapist requested imaging needed for appropriate management, despite the patient having previously seen a primary care provider. In both examples, the physical therapist successfully identified abnormalities prior to a radiologist or other physician reviewing the results. This avoided delay in definitive management of the patients' problems. It is imperative that physical therapists understand when diagnostic imaging is necessary to assist in the differential diagnosis of patients. Likewise, it is important for physical therapists to be competent in interpreting the results of these tests. When not in a direct access physical therapy environment, a physical therapist should understand when diagnostic imaging tests are indicated. This facilitates working with the entire health care team to acquire necessary tests in an appropriate timeframe.

Adult↗

Factors associated with adequacy of diagnostic workup after abnormal breast cancer screening results.

BACKGROUND: Women with certain characteristics, such as those residing in rural areas, are less likely screened for breast cancer. To enhance detection of early breast cancer, it is imperative that all women who have abnormal screening results receive appropriate diagnostic procedures. This study reports differences in receipt of diagnostic services following abnormal screening results. METHODS: Screening and diagnostic data were collected as part of a breast and cervical cancer early detection program aimed at reaching women of lower socioeconomic status. Women with completed diagnostic information after having abnormal screening results were included. We based adequacy of diagnostic services on guidelines from the Society for Surgical Oncology, The Commission on Cancer of the American College of Surgeons, and the Centers for Disease Control and Prevention. Several factors were assessed for their association with adequacy of diagnostic follow-up: income, age, race, education, health insurance status, rural-urban residence, reported breast lump, family history of breast cancer, and clinical beast examination or mammogram results. RESULTS: Overall, 14.1% of the 351 abnormal findings were considered inadequately followed up based on the algorithm used. Eighty percent involved an abnormal finding on a clinical breast examination regardless of the mammogram results. Rural women, those with abnormal clinical breast examination findings but normal or equivocal findings on mammograms, and those who self-discovered a mass were less likely to receive adequate follow-up than were their counterparts in multivariate analysis. Rural women were less likely to receive a biopsy or fine-needle aspiration, although it was indicated. One facility accounted for most of the inadequate follow-up screenings among urban women. CONCLUSIONS: Women who have specific demographic and clinical characteristics were less likely to have received adequate diagnostic services. Breast cancers could have been missed initially as a result of inappropriate follow-up. Further investigation of the clinical scenarios using chart reviews is warranted.

Algorithms↗

A methodological review of how heterogeneity has been examined in systematic reviews of diagnostic test accuracy.

OBJECTIVES: To review how heterogeneity has been examined in systematic reviews of diagnostic test accuracy studies. DATA SOURCES: Centre for Reviews and Dissemination's Database of Abstracts of Reviews of Effects (DARE). REVIEW METHODS: Systematic reviews that evaluated a diagnostic or screening test by including studies that compared a test with a reference test were identified from DARE. Reviews for which structured abstracts had been written up to December 2002 were screened for inclusion. Data extraction was undertaken using standardised data extraction forms. RESULTS: A total of 189 systematic reviews met the inclusion criteria. The median number of studies included was 18. Meta-analyses have a higher number with a median of 22 studies compared with 11 for narrative reviews. Graphical plots to demonstrate the spread in study results were provided in 56% of meta-analyses; in 79% these were plots of sensitivity and specificity in the receiver operating characteristic (ROC) space. Statistical tests to identify heterogeneity were used in 32% of reviews: 41% of meta-analyses and 9% of reviews using narrative syntheses. The chi-squared test and Fisher's exact test to assess heterogeneity in individual aspects of test performance were the most common. In contrast, only 16% of meta-analyses used correlation coefficients to test for a threshold effect. A narrative synthesis was used in 30% of reviews. Of the meta-analyses, 52% carried out statistical pooling alone, 18% conducted only summary receiver operator characteristic (SROC) analyses and 30% used both methods of statistical synthesis. For those undertaking SROC analyses, the main differences between the models used were the weights chosen for the regression models, although in 42% of cases the use of, or choice of, weight was not provided. The proportion of reviews using statistical pooling alone has declined from 67% in 1995 to 42% in 2001, with a corresponding increase in the use of SROC methods, from 33% to 58%. However, two-thirds of those using SROC methods also carried out statistical pooling rather than presenting only SROC models. Reviews using SROC analyses also tended to present their results as some combination of sensitivity and specificity rather than using alternative, perhaps less clinically meaningful, means of data presentation such as diagnostic odds ratios. Three-quarters of meta-analyses attempted to investigate statistically possible sources of variation, using subgroup analysis or regression analysis. The impact of clinical or socio-demographic variables was investigated in 74% of these reviews and test- or threshold-related variables in 79%. At least one quality-related variable was investigated in 63% of reviews. Within this subset, the most commonly considered variables were the use of blinding, sample size, the reference test used and the avoidance of verification bias. CONCLUSIONS: The emphasis on pooling individual aspects of diagnostic test performance and the under-use of statistical tests and graphical approaches to identify heterogeneity perhaps reflect the uncertainty in the most appropriate methods to use and also greater familiarity with more traditional indices of test accuracy. This indicates the difficulty and complexity of carrying out such reviews. In these cases it is strongly suggested that meta-analyses are carried out with the involvement of a statistician familiar with the field. Further methodological work on the statistical methods available for combining diagnostic test accuracy studies is needed, as are sufficiently large, prospectively designed primary studies of diagnostic test accuracy comparing two or more tests for the same target disorder. Use of individual patient data meta-analysis in diagnostic test accuracy reviews should be explored to allow heterogeneity to be considered in more detail.

Diagnostic Tests, Routine↗

New simple early diagnostic methods using Omura's "Bi-Digital O-Ring Dysfunction Localization Method" and acupuncture organ representation points, and their applications to the "drug & food compatibility test" for individual organs and to auricular diagnosis of internal organs--part I.

By critically evaluating exceptions which may lead to false diagnoses, as well as by improving the currently-used applied kinesiology diagnostic method (="Dysfunction Localization Method"), the author was able to develop the "Thumb-Index Finger Bi-Digital O-Ring Diagnostic Method," using the Applied Kinesiology Dysfunction Localization Principle. By combining the author's "Bi-Digital O-Ring Dysfunction Localization Method" with clinically useful organ representation points in acupuncture medicine (where the presence of tenderness at the organ representation point is used for diagnosis as well as for the location of treatment), it has become possible to make early diagnoses of most of the internal organs, with an average diagnostic accuracy of over 85%, without knowing the patient's history or using any instruments. The method can detect dysfunctioning or diseased organs even before tenderness appears at the organ representation point, with an applied force of less than 1 gm/mm2 on the skin surface, while the detection of tenderness at the organ representation point often requires a minimum applied force of 80-100 gm/mm2. The method was applied to the "Drug and Food Compatibility Test" to determine the probable effects of a given food or drug on individual internal organs without going through time-consuming, expensive laboratory tests. It was also applied to auricular organ representation points and their evaluation, and has succeeded in increasing their diagnostic sensitivity. The method was also used for the evaluation of magnetic fields. Usually the North pole increased muscle strength and the South pole weakened it at most parts of the body. This simple, improved, economical diagnostic method may have invaluable implications in clinical diagnosis, treatment and drug research. Key Words: early diagnostic methods, "Thumb-Index Finger Bi-Digital O-Ring Diagnostic Method," applied kinesiology, cardio-vascular diseases, drugs, tenderness, pain, pain medicine, anti-hypertensive drugs, cardio-vascular drugs, aspirin, Bufferin, gastro-intestinal system, muscle strength, nutrition, magnetic field, sensory nerve, spinal cord, brain stem. Inderal.

Acupuncture Therapy↗

Diagnostic yield of flexible bronchoscopy in current clinical practice.

BACKGROUND: Flexible bronchoscopy is a procedure commonly performed for diagnostic and therapeutic purposes. The aim of this study was to assess the diagnostic yield and the safety of routine bronchoscopy techniques including transbronchial needle aspiration and transbronchial biopsy at a university hospital in Switzerland. METHODS: 616 consecutive bronchoscopies performed at the Pulmonary Medicine Department (University Hospital Basel) over a period of 6 months were analysed retrospectively using bronchoscopy reports and hospital charts. Diagnostic procedures included bronchial washings, bronchoalveolar lavage, bronchial brushings, transbronchial needle aspiration and transbronchial biopsies. RESULTS: 430 bronchoscopies had a diagnostic, 186 a therapeutic indication. The overall diagnostic yield was 57% (245/430). Bronchoscopy performed for suspected tumours confirmed malignancy in 43% of cases. Bronchoscopy in suspected infection and tuberculosis identified pathogenic organisms in 46% and 27% of cases, respectively. The diagnostic yield for central and peripheral TBNA was 37.8 and 43.6%, respectively. Complications were very rare (n = 10, 1.6%) and were only minor. CONCLUSION: This study demonstrates that routine bronchoscopy techniques including transbronchial needle aspiration and transbronchial biopsy are safe and have a high diagnostic yield.

Adolescent↗

Molecular diagnostics on lymphoid malignancies.

CONTEXT: Molecular diagnostics for lymphoid malignancies traditionally has focused on helping to provide a diagnosis on a tissue sample. The field has undergone substantial technical and conceptual evolution during the past 2 decades, and its role has expanded to new arenas, such as monitoring disease activities and detecting alterations in genes that are known to have a significant impact on disease outcome. OBJECTIVE: To review the advances in molecular diagnostics on lymphoid malignancies, including recent developments that may facilitate the development of mechanism-based diagnosis for individualized therapy. DESIGN: The development of molecular diagnostics in lymphoid malignancies is briefly reviewed with emphasis on the recent use of gene expression profiling for identifying important diagnostic and prognostic signatures. RESULTS: Genome-scale investigations are becoming technically feasible and have provided promising results in the identification of new disease entities and new, molecularly defined prognosticators. This development can potentially revolutionize diagnostic medicine in the near future. As new genes or genetic pathways that affect the clinical and biologic behavior of tumors are defined and can be readily assayed, molecular diagnostics will be expected to provide this relevant information. Ideally, therapy will be based on this information, delivering the most appropriate treatment with the least toxicity. CONCLUSIONS: Molecular diagnostics in the future will be moving toward a mechanism-based diagnosis for individualized therapy.

Humans↗

Association of symptoms of depression with diagnostic test charges among older adults.

BACKGROUND: Previous studies have documented greater use of health services by depressed persons and have postulated that health care costs could be reduced overall through better recognition and treatment of depression. OBJECTIVE: To determine whether a greater burden of medical illness contributes to excess charges for diagnostic tests among older adults with symptoms of depression. DESIGN: Prospective cohort study. SETTING: A primary care group practice at an academic institution. PATIENTS: 3767 patients 60 years of age and older who completed testing on the Centers for Epidemiologic Studies Depression Scale (CES-D) during routine office visits. MEASUREMENTS: Charges for all inpatient and ambulatory diagnostic testing for 2 years, including clinical pathology, diagnostic imaging, and special procedures; number of visits to the ambulatory care center or emergency department; and number of hospitalizations. The Ambulatory Care Group case-mix approach, which is based on ambulatory diagnoses, was used as a measure of health status and expected resource consumption. RESULTS: Patients with symptoms of depression (CES-D scores > or = 16) were significantly younger (66.6 compared with 68.1 years; P < 0.001), more likely to be white (50.5% compared with 33.9%; P = 0.001), and more likely to be female (75.8% compared with 67.6%; P = 0.001) than were those without these symptoms (CES-D scores < 16). They also had more nonpsychiatric comorbid conditions, had more visits to the ambulatory care center (9.2 compared with 7.8; P < 0.001), were more likely to use the emergency department (52.3% compared with 40%; P = 0.001), were more likely to be hospitalized (22.4% compared with 17%; P = 0.002), and had greater median total diagnostic test charges for a period of 1 year ($583 compared with $387; P < 0.001). The difference in charges, most of which were clinical pathology charges (54.2%), persisted into the second year. Ambulatory Care Group assignment was independently associated with diagnostic test charges. The CES-D summary score was not independently associated with diagnostic test charges when controlling for Ambulatory Care Group assignment. CONCLUSIONS: Patients with symptoms of depression accrue greater average diagnostic test charges. However, these data suggest that such patients also have a greater burden of comorbid nonpsychiatric illness. Efforts to improve outcome and decrease cost for patients who have late-life depression must target interventions to improve the care of psychiatric and medical illness concurrently.

Aged↗

[Evaluation of added value of diagnostic tests].

In the evaluation of diagnostic tests emphasis is placed on the evaluation of a particular diagnostic test in order to estimate it's sensitivity, specificity, or area under the 'receiver operating characteristic' curve (so called test research). This kind of test research is only useful in situations in which a diagnosis is set by one test (i.e. screening) and in the initial phases of test development for efficiency reasons. But, test research is not suitable to evaluate the clinical or added value of a test. The value of a diagnostic test can be evaluated on its value to discriminate between the presence and absence of a particular disease, to guide therapeutic decisions and to improve the prognosis of the patient. For evaluation of the added value of a diagnostic test within the diagnostic process, the study design should take into account the patient group in which the test will be applied in practice, the target disease of the test and the prior probability (prevalence) of the target disease in that population, the subsequent diagnostic stages and the reference test. In analysing the data it is calculated for each step of the diagnostic process how the test result changes the probability of presence or absence of the target disease.

Cost-Benefit Analysis↗

Genetics and molecular diagnostics in the clinical laboratory science curriculum.

OBJECTIVE: To determine the nature and extent of education in human genetics and molecular diagnostics in clinical laboratory science (CLS) programs throughout the U.S. DESIGN: A written survey was mailed to 263 CLS programs. Data were expressed as raw numbers and percentages of responses. SETTING: State University of New York, Upstate Medical University. PARTICIPANTS: There were 162 responses and 151 usable surveys. Most respondents (86.8%) were department chairs/CLS program directors; 13.2% were CLS faculty or educational coordinators. MAIN OUTCOME MEASURES: Questions were designed to determine frequency of CLS programs providing education in genetics, specific molecular methods and clinical applications, format of instruction, satisfaction levels with education provided, and perceptions on importance of teaching genetics, molecular diagnostics, and related hands-on experiences. RESULTS: Over 92% of CLS programs teach human genetics and molecular diagnostics in varied formats. Polymerase chain reaction was the most frequently taught molecular method; microorganism detection, the most commonly taught clinical application. More programs teach theory than provide hands-on experience in molecular diagnostics. Only 59 (39.1%) teach related ethical issues. Sixty-seven respondents (44.4%) were dissatisfied with the education they provide, due to lack of time to teach the material (n = 49; 73.1%), lack of knowledgeable faculty (n = 43; 64.2%), and expense of methods (n = 37; 55.2%). Most respondents felt it was important to include human genetics (n = 145; 96%) and molecular diagnostics (n = 149; 98.7%) in their curriculum, and related hands-on experiences in the student laboratory (n = 106; 70.2%) or clinical rotation (n = 135; 89.4%). Over 82% (n = 124) expected instruction of molecular diagnostics to increase in the next five years. CONCLUSION: Most CLS programs include human genetics and molecular diagnostics in their curriculum, and expect the education they provide to increase in the next 5 years. In order to meet this expectation, CLS programs may need to provide opportunities for faculty training, seek funding to cover the cost of methods, and consider innovative curriculum changes.

Curriculum↗

Retinoblastoma: a diagnostic model for India.

PURPOSE: Molecular genetic diagnostics for retinoblastoma are prerequisite for accurate risk prediction and effective management. Developing a retinoblastoma diagnostic model to establish a flow for laboratory tests is thus a necessity for tertiary ophthalmic institutions. An efficient diagnostic model could reduce the overall health care costs, redirect the resources to the high risk group and also avoid unnecessary worry for families. To the best of our knowledge there has hitherto been no comprehensive diagnostic model for retinoblastoma implemented in any institution in India. METHODS AND DISCUSSION: The diagnostic model demonstrates the logical and practical flow of various genetics tests like karyotyping, loss of heterozygosity analysis, molecular deletion, linkage analysis (familial cases), mutation screening of -CGA exons first and then non-CGA exons, methylation screening of RB1 and essential promoter regions screening in a laboratory. CONCLUSIONS: The diagnostic model proposed offers acomprehensive methodology to identify the causative two-hits for retinoblastomas that could be used while genetic counseling families. This model is applicable in tertiary hospitals in India and neighboring countries, which have the highest incidence of retinoblastoma and fertility rates in the world. We suggest that this diagnostic model could also be applied with modification for other cancers.

Child↗

Impact of the diagnostic methods on the therapeutic strategies.

Over the last 25 years the diagnostic approaches and therapeutic strategies of breast cancer have dramatically changed. The relationship between diagnosis and therapy has gradually become more complex due to the ever more sophisticated diagnostic tools (mammographic screening, digital mammography, magnetic resonance, SPECT scan and FDG-PET), which have improved resolution limits and accuracy, and also due to the different therapeutic planning applied to breast cancer in these years (conservative surgery, neo-adjuvant chemotherapy, axillary dissection or not). Thus, in this paper, we have briefly analyzed the many open questions in breast cancer management and the clinical challenges of present diagnostic tools in relation to pre-, peri- and postoperative phases, and to therapeutic strategies in general. The main goal of mammographic screening is to detect early invasive cancers and to treat them at the first useful moment. However, at which age should one begin screening, and what is the impact on overall survival, the cost-effectiveness, and, most of all, the best operative approach to suspect lesions? Can digital mammography give a better quality of imaging with respect to conventional mammography? Does unexpected multicentricity and/or multifocality, which is sometimes showed by magnetic resonance, have any clinical relevance? Is this technique really better than traditional methods for the identification of local recurrence? Is scintimammography able to improve the low diagnostic accuracy of mammography on non-palpable breast lesions? Moreover, at present, the need for axillary dissection and its therapeutic and staging value is deeply debated: however, clinical detection of axillary metastases is not a reliable diagnostic tool and there are no conventional radiologic techniques to be used: recently nuclear medicine imaging has provided various approaches, such as SPECT scan with different tracers, FDG-PET, or lymphoscintigraphy with gamma probe sentinel biopsy: there are not only methodologic but also phylosophic differences in using these techniques. Neo-adjuvant chemotherapy has allowed a dramatic reduction of primary breast cancer with a replanning of the surgical approach to large breast tumours but, at the same time, has posed new questions such as the adequacy of diagnostic pre- and perioperative revaluation. Finally, does postoperative follow-up take advantage of intensive diagnostic programs and are there therapeutic margins which would improve survival of patients with metastatic disease? This paper is an attempt to analyze the answers given in the literature. Nevertheless, at present, this matter is globally in progress and a scientific debate will provide, in the near future, a new promising scenario for breast cancer management.

Age Factors↗

Comparison of the use of standardized diagnostic criteria and intuitive clinical diagnosis in the diagnosis of common viral warts (verrucae vulgaris).

OBJECTIVE: To assess the diagnostic value of standardized diagnostic criteria compared with the clinical intuitive diagnosis for verrucae vulgaris. DESIGN: A blind comparison with cross-over of experienced dermatologists using either intuitive clinical diagnosis or else recording the presence of standardized diagnostic criteria in verrucae vulgaris. SETTING: Clinical outpatient department in a major teaching hospital. PATIENTS: Fifteen patients aged 6 to 60 years with 21 verrucae vulgaris and 24 control lesions. INTERVENTION: Dermatologists examined the lesions and recorded either the diagnosis by the usual clinical intuitive method or else whether standardized diagnostic criteria were present in the lesion of each patient. Each dermatologist did 1 only of the 2 methods for each lesion with the other doing the alternative method for the same lesion, neither of them having previously been aware of any of the diagnoses. MAIN OUTCOME MEASURE: The sensitivity, specificity, and positive predictive, negative predictive, and relative values for each diagnostic approach were compared. RESULTS: Use of intuitive clinical diagnosis resulted in 100% specificity, sensitivity, and positive predictive, negative predictive, and relative values for both the verrucae vulgaris and the control lesions. Recording the presence of the diagnostic criteria reduced to a varying extent all the parameters of diagnostic accuracy with site--fingers and hands, elbows, and knees--being the most efficacious of the criteria. CONCLUSIONS: These data indicate that care is required in relying too much on standardized criteria as the basis for clinical diagnosis, even for a lesion as simple as a wart. They also reinforce the value of clinical experience obtained from repeated exposure to multiple variants of a disease in the traditional bedside teaching model.

Adolescent↗

Diagnostic criteria for essential tremor: a population perspective.

BACKGROUND: Prevalence estimates vary 2750-fold among the 20 studies of essential tremor (ET). It is not clear how the choice of diagnostic criteria affects research results. OBJECTIVE: To determine the impact of alternative sets of diagnostic criteria on the diagnosis of ET. METHODS: As part of the Washington Heights-Inwood Genetic Study of ET (WHIGET), a population-based study of ET, 285 subjects who include 36 case subjects with probable or definite ET, 34 case subjects with possible ET, and 215 normal subjects were interviewed and examined. All diagnoses in WHIGET were assigned by 2 neurologists. Ten of the 20 published prevalence studies of ET provided diagnostic criteria for ET. Criteria differed in terms of requirements for the distribution, duration, and severity of tremor. These 10 sets of criteria were then each separately applied to the subjects in the WHIGET cohort to determine their impact on the diagnosis of ET. RESULTS: Depending on which diagnostic criteria were applied to the WHIGET cohort, the proportion of WHIGET case subjects with definite or probable ET who would have been diagnosed as having ET was as low as 14% and the proportion of WHIGET normal subjects who would have been diagnosed as having ET was as high as 51%. Diagnostic criteria that included a positive family history of ET or a lengthy duration of tremor would have classified many WHIGET case subjects with ET as normal, whereas criteria that did not specify a minimal tremor severity would have classified many WHIGET normal subjects as having ET. CONCLUSIONS: Alternative sets of diagnostic criteria for ET greatly impact on the diagnosis of ET. For population-based studies, information on tremor type and severity rather than family history should be included in diagnostic criteria.

Adolescent↗

A self-report scale to help make psychiatric diagnoses: the Psychiatric Diagnostic Screening Questionnaire.

BACKGROUND: The Psychiatric Diagnostic Screening Questionnaire (PDSQ) is a brief, psychometrically strong, self-report scale designed to screen for the most common DSM-IV Axis I disorders encountered in outpatient mental health settings. In the present report, we describe the diagnostic performance (sensitivity, specificity, and positive and negative predictive values) of the PDSQ in an outpatient setting. METHODS: Six hundred thirty psychiatric outpatients presenting for treatment were evaluated with the Structured Clinical Interview for DSM-IV after completing the PDSQ. Patients arrived approximately 20 minutes before the scheduled time of the appointment to complete the scale. Diagnostic raters were blind to responses on the scale. RESULTS: The PDSQ's subscales' diagnostic performance varied in a predictable manner according to the cutoff score-as the threshold for case identification increased, subscale sensitivity decreased and specificity increased. Mean subscale sensitivities of 80%, 85%, and 90% resulted in mean subscale specificities of 78%, 73%, and 66%, respectively, and negative predictive values of 95%, 96%, and 97%. Receiver operating curves were determined for each subscale and all areas under the curve were significant. CONCLUSIONS: The PDSQ is a diagnostic aid designed to be used in clinical practice to facilitate the efficiency of conducting initial diagnostic evaluations. From a clinical perspective, it is most important that a diagnostic aid have good sensitivity, so that most cases are detected, and high negative predictive value, so that most noncases on the measure are indeed noncases. Our results indicate that most of the PDSQ subscales were able to achieve this goal.

Adult↗

Diagnostic Accuracy of a CRISPR-Based Assay in Smear- and Culture-Negative Fungal Keratitis.

IMPORTANCE: Diagnosing fungal keratitis (FK) in patients with negative smear and culture results remains clinically challenging, highlighting the need for alternative diagnostic approaches. OBJECTIVE: To determine the diagnostic accuracy of the clustered regularly interspaced short palindromic repeats (CRISPR)-based Rapid Identification of Mycoses using CRISPR (RID-MyC) assay for detecting FK in patients with negative smear and culture results using in vivo confocal microscopy (IVCM) as the reference standard. DESIGN, SETTING, AND PARTICIPANTS: This prospective diagnostic accuracy study was conducted from December 2024 to March 2025 at Aravind Eye Hospital, a tertiary ophthalmology referral hospital in Coimbatore, India. Consecutive patients clinically suspected to have microbial keratitis with negative smear and culture results were eligible for inclusion. Data were analyzed from March 2025 to June 2025. INTERVENTIONS: All included participants underwent corneal scraping for RID-MyC assay and imaging by IVCM. MAIN OUTCOMES AND MEASURES: The primary outcomes were sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic concordance of the RID-MyC assay compared with IVCM results. RESULTS: Of 245 consecutive patients clinically suspected to have microbial keratitis, 82 were smear negative. After exclusions due to contraindications or positive subsequent cultures, 41 patients with smear- and culture-negative results were ultimately included in the final analysis. Of these 41 patients (mean [SD] age, 51.0 [14.6] years; 21 [51.2%] women), RID-MyC demonstrated sensitivity of 82.1% (95% CI, 63%-94%) and specificity of 76.9% (95% CI, 46%-95%). Positive predictive value was 88.5% (95% CI, 74%-95%) and negative predictive value was 66.7% (95% CI, 46%-82%). Concordance between RID-MyC and IVCM was observed in 33 cases (80.5%). Notably, prior antifungal treatment was most frequent (4 of 5 [80%]) among patients with positive IVCM but negative RID-MyC results. Conversely, all patients (3 of 3 [100%]) with negative IVCM but positive RID-MyC findings had smaller, peripheral, or paracentral lesions. CONCLUSIONS AND RELEVANCE: In this diagnostic study, in patients with smear- and culture-negative FK, the RID-MyC assay showed good diagnostic accuracy comparable with IVCM and was feasible in all cases, including those in whom imaging was not possible. With its rapid turnaround and minimal equipment needs, RID-MyC may serve as a practical adjunct to conventional diagnostics, particularly in high-burden, resource-limited settings where IVCM is unavailable or contraindicated.

Humans↗