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[Methodology of diagnostic validation studies. Errors in planning and analysis].

The evaluation of diagnostic tests play an important role in clinical research. Though detailed standards have been developed for treatment evaluation, widely accepted methodological standards in diagnostic test research are still lacking. Following recent methodological research German biostatisticians usually distinguish between 4 types of diagnostic validation studies (Phase I to IV). The diagnostic value of a test can be described by indexes like sensitivity, specificity and predictive values. Sensitivity and specificity are so-called nosological probabilities whereas predictive values describe the probabilities of the disease given a positive or negative test result, respectively. These posterior probabilities depend on the prevalence of the disease in question. The methodological problems that arise in the planning of diagnostic studies differ from those encountered in treatment evaluation. This contribution presents an annotated checklist of the most important faults and shortcomings in the planning and the analysis of diagnostic validation studies. Avoiding these deficiencies may help that the study results are accepted by biostatisticians, clinicians and cost units.

Diagnostic Techniques and Procedures↗

[The diagnostic concept of acute infection of the shoulder joint].

INTRODUCTION: It is generally accepted that septic conditions of the shoulder often lead to an earnest situation with joint damage. Because of the low incidence of shoulder infections there are only a few cases reported in the literature. Therefore, unlike joint infections of the knee no diagnostic and therapeutic standard procedure is documented for the shoulder. MATERIALS AND METHODS: In a retrospective study the results of 15 patients with a surgical revision at the BG-Clinic-Bergmannsheil-Bochum between 1 January 1989 and 31 August 1999 after an infection of the shoulder joint were analyzed. We registered the following parameters: etiology, intervall until the first clinical symptoms, clinical signs, diagnostic procedure, intraoperative site (Gächter classification), and operative treatment. The diagnostic procedure followed an algorithm, including CRP-determination, ultrasound of the shoulder, ultrasound-guided aspiration and a Gram stain. If the result was positive, surgical joint revision followed. The infection stage was classified intraoperatively according to the criteria of the Gächter classification. Eight patients were reexamined after an average follow-up of 4.8 years. RESULTS: Fourteen infections followed injection. All patients demonstrated increasing CRP levels and a painful limited range of motion. In all Gram stains we detected bacterial organisms. The diagnosis of an acute infection according to the criteria of this diagnostic algorithm was verified intraoperatively in all 15 joints. Two patients with delayed admission died postoperatively due to septic multiorgan failure despite maximal treatment under intensive care conditions. CONCLUSION: If there are suspicious clinical symptoms after a typical anamnesis, we recommend an immediate diagnostic algorithm, including CRP determination, ultrasound of the shoulder, ultrasound-guided joint puncture and a Gram stain. If there is acute joint infection, time-consuming diagnostic procedures must be avoided because of the risk of secondary reduced joint mobility or life-threatening complications.

Acute Disease↗

Influence of diagnostic classification on gender ratio in schizophrenia - a meta-analysis of youths hospitalized for psychosis.

BACKGROUND: The research literature on hospital admissions for psychoses in youths was reviewed in order to test whether there was a gender ratio discrepancy in diagnostic subgroups; the effect of the diagnostic criteria classification on this measure was also investigated. METHOD: A meta-analysis was conducted on 12 primary studies by assessing the male/female odds ratio (OR) in the schizophrenia and mood disorders with psychosis subgroups as well as the amount of variability between studies. Study inclusion criteria were: patients between the ages of 8 and 19, at least 15 patients with psychosis and a standardized diagnostic criteria classification system such as DSM, ICD or RDC. RESULTS: The male/female OR measured in this meta-analysis implies that a male subject with psychosis is 1.7 times as likely to obtain a diagnosis of schizophrenia; conversely, a female subject with psychosis is 2.1 times as likely to be assigned in the mood disorders with psychosis subgroup. Disparity in diagnostic criteria nomenclature (ICD-9 vs. DSM) could account for a statistically significant difference in male/female OR for the schizophrenia subgroup in a subset of 11 studies. CONCLUSIONS: Under the narrower definition of schizophrenia in studies using DSM diagnostic criteria classification, the shift towards a greater proportion of patients diagnosed with mood disorders with psychosis could be explained by the time criteria; the simultaneous emergence of the gender ratio difference is discussed. This study shows that subtle changes in diagnostic criteria in psychiatric illnesses can greatly influence observational data pertaining to youths.

Adolescent↗

Should we confirm our clinical diagnostic certainty by autopsies?

OBJECTIVE: To evaluate the frequency of diagnostic errors assessed by autopsies. DESIGN AND SETTING: Retrospective review of medical and pathological records in an 11-bed closed medical intensive care unit (ICU) at a 860-bed general hospital. PATIENTS AND INTERVENTIONS: Patients who died in the ICU between January 1998 and December 1999. Medical diagnoses were rated into three levels of clinical diagnostic certainty: complete certainty (group L1), minor diagnostic uncertainty (group L2), and major diagnostic uncertainty (group L3). The patients were divided into three error groups: group A, the autopsy confirmed the clinical diagnosis; group B, the autopsy demonstrated a new relevant diagnosis which would probably not have influenced the therapy and outcome; group C, the autopsy demonstrated a new relevant diagnosis which would probably have changed the therapy and outcome. RESULTS: The overall mortality was 20.3% (270/1331 patients). Autopsies were performed in 126 patients (46.9% of deaths), more often in younger patients (66.6+/-13.9 years vs 72.7+/-12.0 years, p<0.001), in patients with shorter ICU stay (4.7+/-5.6 days vs 6.7+/-8.7 days, p=0.054), and in patients in group L3 without chronic diseases (15/126 vs 1/144, p<0.001). Fatal but potentially treatable errors [group C, 12 patients (9.5%)] were found in 8.7%, 10.0%, and 10.5% of patients in groups L1, L2, and L3, respectively (NS between groups). An ICU length of stay shorter than 24 h was not related to the frequency of group C errors. CONCLUSIONS: Autopsies are performed more often in younger patients without chronic disease and in patients with a low clinical diagnostic certainty. No level of clinical diagnostic certainty could predict the pathological findings.

Adult↗

Personalized medicine and development of targeted therapies: The upcoming challenge for diagnostic molecular pathology. A review.

Due to continuous technical developments and new insights into the high complexity of many diseases, molecular pathology is a rapidly growing field gaining center stage in the clinical management of tumors as well as in the pharmaceutical development of new anti-cancer drugs. The application of novel compounds in clinical trials has revealed promising results; however, the current diagnostic procedures available for determining which patients will primarily benefit from rational tumor therapy are insufficient. To read a patient's tissue as "deeply" as possible, in the future, gaining information on the morphology and on genetic, proteomic, and epigenetic alterations will be the upcoming task of surgical pathologists experienced in molecular diagnostics to provide the clinicians with information relevant for an individualized medicine. Among the different high-throughput technologies, DNA microarrays are now the first array approach close to enter routine diagnostics. Technically advanced and well-established microarray platforms can nowadays be evaluated by distinct bioinformatic tools capable of identifying both novel genes associated with disease development and clusters of genes predicting clinical outcome of an individual tumor. The automatic, highly parallel analysis of proteins and complex proteins lysates for early detection of cancers such as breast, prostate and ovary as proteomic patterns in the serum also appears at the horizon. In addition, an improved analysis of tumor samples via antibody or reverse-phase protein arrays is likely to provide the pathologist in the future with information about activated oncogenic signaling pathways and other cell functions, such as drug response or the potential to metastasize. While expression microarrays and proteomic analysis rely on relatively unstable material incompatible with paraffin-embedded tissue samples, an investigation of DNA methylation using specialized high-throughput platforms has revealed the potential of being used in future diagnostics. Each of these approaches on its own might not suffice to extract all information required for an efficient individualized diagnostics. Therefore, a "multiplex approach" combining the different biological levels DNA, RNA, and protein, may be necessary to functionally classify malignant tumors. This appears to become a major challenge for diagnostic pathologists.

Drug Design↗

Diagnostic bias and toxic shock syndrome.

Diagnostic bias could have occurred in the tampon/toxic shock syndrome association if the original diagnostic judgments by physicians or the subsequent diagnostic selections by investigators were influenced by knowledge of the patient's gender, menstrual history, or catamenial product. To determine whether such diagnostic bias can occur, a set of descriptive vignettes was prepared for six cases (Series X) having diverse resemblances to toxic shock syndrome or Kawasaki's disease. For each vignette in Series X, a paired case in a complementary Series Y was described in identical text except for different information about gender, menstrual history, or tampon use. Either Series X or Series Y was sent to a randomly selected sample of internists, family practitioners, and infectious disease subspecialists. The physicians were asked to provide a diagnosis for each case, using their own nomenclature or choosing from a list of 22 diagnostic possibilities. Six weeks later, respondents were asked to provide diagnoses for the complementary series of cases. Regardless of medical specialty or type of series received first, the 368 responding physicians were more likely to diagnose toxic shock for menstruating tampon-users or menstruating women than for non-menstruating women or men. In the most striking difference, toxic shock was diagnosed in 85 percent of instances when the case was described in a menstruating tampon-user, but in 23 percent of instances when the same case was described in a man (odds ratio = 18.8). Since the current epidemiologic data may be seriously distorted by diagnostic bias, the results indicate the need for scientifically valid investigations of the toxic shock syndrome/tampon relationship.

Adolescent↗

Diagnostic delay in monogenic disease: A scoping review.

PURPOSE: Diagnostic delay in monogenic disease is reportedly common. We conducted a scoping review investigating variability in study design, results, and conclusions. METHODS: We searched the academic literature on January 17, 2023, for original peer reviewed journals and conference articles that quantified diagnostic delay in monogenic disease. We abstracted the reported diagnostic delay, relevant study design features, and definitions. RESULTS: Our search identified 259 articles quantifying diagnostic delay in 111 distinct monogenetic diseases. Median reported diagnostic delay for all studies collectively in monogenetic diseases was 5.0 years (IQR 2-10). There was major variation in the reported delay within individual monogenetic diseases. Shorter delay was associated with disorders of childhood metabolism, immunity, and development. The majority (67.6%) of articles that studied delay reported an improvement with calendar time. Study design and definitions of delay were highly heterogenous. Three gaps were identified: (1) no studies were conducted in the least developed countries, (2) delay has not been studied for the majority of known, or (3) most prevalent genetic diseases. CONCLUSION: Heterogenous study design and definitions of diagnostic delay inhibit comparison across studies. Future efforts should focus on standardizing delay measurements, while expanding the research to low-income countries.

Humans↗

Advances in the diagnostic management of arrhythmogenic right ventricular dysplasia-cardiomyopathy.

Latest advances in the diagnostic management of arrhythmogenic right ventricular dysplasia-cardiomyopathy (ARVD/C) confirm that ARVD/C is not a rare disease (one affected in 1000-1250 inhabitants) and is of familial origin in 50-80% of cases. Diagnostic criteria defined in 1994 lead to low rates in the diagnosis of ARVD/C. Progress was made in the definition of diagnostic markers. New criteria of localised right precordial QRS prolongation could be identified. The detection of epsilon potentials could be enhanced by highly amplified and modified recording techniques. Vectorcardiography, signal averaging per lead and electroanatomic voltage mapping might become more important in the future. Cardiac MRI does not represent the single diagnostic test to make the diagnosis of ARVD/C. It remains a promising noninvasive imaging technique with advantages in the evaluation of the right ventricle. After the characterisation of mutations in the plakophilin-2 gene, molecular genetics is going to become an important diagnostic tool. Up to now, unsolved problems exist in the differentiation of ARVD/C and other conditions with ventricular arrhythmias evolving from the right ventricle such as Brugada syndrome and right ventricular outflow tract tachycardia. These problems can be overcome by distinct ECG analysis and the use of imaging techniques. With the help of corrected and modified diagnostic criteria it seems to be possible to identify symptomatic and asymptomatic affected by ARVD/C with predominantly major criteria and only in a minority of cases minor criteria.

Arrhythmogenic Right Ventricular Dysplasia↗

Results of diagnostic accuracy studies are not always validated.

BACKGROUND AND OBJECTIVE: Internal validation of a diagnostic test estimates the degree of random error, using the original data of a diagnostic accuracy study. External validation requires a new study in an independent but similar population. Here we describe whether diagnostic research is validated, which technique is used, and to what extent the validation study results differ from the original. STUDY DESIGN AND SETTING: All original diagnostic accuracy studies published in 1993 in a predefined set of journals were selected. Validation of these studies was assessed in the original article and in articles published within a period of 10 years, through a literature search and contacting the authors. RESULTS: None of the original studies reported any form of validation. Validation studies published later could be identified for 7 of the 11 original studies. Test characteristics were difficult to compare. Despite what was generally believed, not every validation study showed results inferior to the original. We found more studies that evaluated the test in a different population than in a similar one. CONCLUSION: Not every diagnostic accuracy study is validated. Diagnostic tests are more often repeated in different populations.

Databases, Bibliographic↗

Social determinants of diagnostic labels in depression.

The role of diagnostic labels in medicine is usually that of labelling an illness as a means of communication. Control over labelling processes in medicine is ordinarily imposed via medical schools, textbooks, education or by diagnostic manuals. Diagnostic labels often change following new discoveries in underlying pathology such as 'consumption' being relabelled as 'TB' or 'cancer'. Sub-types of broad diagnostic labels also often emerge from such discoveries e.g. 'lung cancer' or 'throat cancer'. In mental health, underlying pathology is the subject of ongoing debate spanning ideas including the brain as a faulty organ, faulty genetics and environmental problems. With controversy over pathology comes controversy over labels and the idea that labels may be used not just for communication, but as devices of social and professional control, arising out of a social process. This study explores the codification of the diagnostic label 'depression' which emerged in the twentieth-century and has proliferated with numerous sub-types over the last 40 years. The aim is to examine its social determinants and context. Medline is used as a data source for professional label usage. A range of depression sub-type labels in professional use was identified. This exercise revealed many official and 'unofficial' terms in professional use. Citation rate plots by year were then generated for these depression sub-type labels. The rise and fall of different labels are examined in relation to social determinants and context, including publication of diagnostic manuals DSM and ICD, power shifts in psychiatry, the discovery of psychiatric drugs and the shift from inpatient to community care. Exploring the changing use of official and unofficial labels over time in this way provides a novel historical perspective on the concept of depression in the late twentieth-century.

Bibliometrics↗

Diagnostic potential of circulating TIMP-1 and MMP-2 as markers of liver fibrosis in patients with chronic hepatitis C.

BACKGROUND: Circulating levels of tissue inhibitor of metalloproteinase (TIMP)-1 and matrix metalloproteinase (MMP)-2 are investigated as parameters for the diagnosis of fibrosis in chronic liver disease. We evaluated their diagnostic potential in comparison to hepatic histology, serum hyaluronate and standard liver function tests. METHODS: Commercially available ELISA assays were used to study circulating values of TIMP-1 and MMP-2 (Bindazyme, Biotrak, Quantikine) in patients with chronic hepatitis C (CAH; n=59), hepatitis C virus-induced cirrhosis (n=19) and 30 healthy controls. Hepatic histology was evaluated using the Hepatitis-Activity-Index according to Ishak et al. [J. Hepatol., 22 (1995) 696-699], quantifying separately inflammatory activity and fibrosis. RESULTS: Normal ranges for TIMP-1 and MMP-2 values differed for the different assays. Nevertheless, the various assays showed similar diagnostic ability and linear correlation. MMP-2 values were similar in controls and in CAH patients with and without fibrosis, but increased significantly in cirrhosis. TIMP-1 values showed a steady increase from normal to CAH without fibrosis, hepatitis with fibrosis, and cirrhosis. The diagnostic potential of serum MMP-2 to detect fibrosis was low with a sensitivity of 7% in the two assays used and an overall diagnostic efficiency of 56% and 58%. The potential of circulating MMP-2 to detect cirrhosis was higher with sensitivities of 74% and 83% and specificities of 96% and 100%, resulting in a diagnostic efficiency of 92% in the different assays. Plasma TIMP-1 values detect fibrosis with a sensitivity of 52% and 67% and a specificity of 68% and 88% resulting in overall efficiency rates of 68% and 71%, respectively. TIMP-1 values detect cirrhosis with 100% sensitivity but only 56% and 75% specificity. The diagnostic potential of circulating TIMP-1 was similar to that of hyaluronate and better than that of enzymes or albumin values. CONCLUSION: Plasma values of TIMP-1 and MMP-2 are able to detect cirrhosis with high sensitivity. TIMP-1 values also detect fibrosis with comparable efficiency. Regular determinations of both TIMP-1 and MMP-2 in CAH patients may be used as indicators of increasing fibrosis and the development of cirrhosis.

Biomarkers↗

Verification bias in pediatric studies evaluating diagnostic tests.

Improperly designed evaluations of diagnostic tests may lead to inaccurate conclusions about a test's accuracy. One problem, verification bias, occurs if subjects are not equally likely to have the diagnosis verified by a gold-standard evaluation and if selection for further evaluation is dependent on the diagnostic test result. To determine whether verification bias is a problem in pediatric studies of diagnostic tests, we conducted a critical appraisal of all studies evaluating diagnostic tests published in three pediatric journals during a 3-year period. Thirty-six percent were subject to verification bias. The most prevalent cause was restriction of the patient sample to those whose diagnosis had been verified by a gold standard evaluation, when the decision to obtain the gold standard was influenced by the diagnostic test result. Verification bias may have serious effects on the estimated sensitivity and specificity of a test. Improved awareness of the potential for verification bias may help physicians improve their selection and interpretation of diagnostic tests and thereby improve the quality and efficiency of patient care.

Bias↗

Diagnostic yield of vitrectomy in eyes with suspected posterior segment infection or malignancy.

PURPOSE: To determine the yield of diagnostic pars plana vitrectomy in eyes with suspected posterior segment inflammation or malignancy when clinical examination and systemic laboratory testing did not yield a specific diagnosis. DESIGN: Non-comparative interventional case series PARTICIPANTS: Eighty-seven consecutive patients (90 eyes) who underwent diagnostic pars plana vitrectomy from 1989 through 1999. INTERVENTIONS: Vitreous samples were analyzed in a directed manner based on the preoperative clinical examination and systemic laboratory testing. MAIN OUTCOME MEASURES: Diagnosis from each test performed on the vitreous samples. RESULTS: Diagnostic vitrectomy was performed alone in 6 eyes (7%) and as part of a therapeutic procedure in the remaining 84 eyes. The diagnostic tests performed most frequently included cytopathology (83%), microbiologic culture and sensitivity (43%), polymerase chain reaction (PCR) (36%), and intraocular antibody levels for T. canis (14%). Of these, intraocular antibody testing and PCR had the highest positive yield, 46% and 39%, respectively. Overall, directed vitreous analysis identified a specific cause in 35 eyes (39%). Of the 65 cases in which an underlying infection was suspected preoperatively, the procedure yielded a specific diagnosis in 27 (42%). When intraocular malignancy was considered preoperatively (71 eyes), a diagnosis of intraocular lymphoma was obtained in seven (10%). This difference between these diagnostic yields was significant (P = 0.02, Fisher's exact test). CONCLUSIONS: Diagnostic vitrectomy with directed vitreous fluid analysis yields a specific cause and guides subsequent therapy in a high percentage of cases. This procedure is a valuable adjunct in cases that cannot be diagnosed by less invasive methods.

Adolescent↗

[Diagnostic approach to venous thromboembolic disease].

The diagnosis of pulmonary embolism (PE) and deep venous thrombosis (DVT) has long been based on purely clinical grounds. Pulmonary angiography and scintigraphy, as well as venography, reveal the poor diagnostic value of signs and symptoms of PE and DVT, which are now reduced to the role of triggers for these diagnostic tests. The development of simpler, but still imperfect, diagnostic tools (mainly, D-dimer plasma level, venous compression ultrasound, clinical probability of PE or DVT, spiral CT pulmonary angiography) has led to the development of diagnostic strategies, which use combinations of tests, not to provide diagnostic certainty for every patient (presence or absence of clots), but rather to select populations of patients who need treatment and others who can safely remain untreated. Such pragmatic approaches must be validated in appropriate outcome studies. The choice of a diagnostic strategy should depend not only on the strategy's cost-effectiveness in the population under study but also on the local facilities and expertise required for its use.

Cost-Benefit Analysis↗

Publications on diagnostic test evaluation in family medicine journals: an optimal search strategy.

Search strategies for articles reporting on diagnostic test evaluations have been subjected to less research than those in the domain of clinical trials. We set out to develop an optimal search strategy for publications on diagnostic test evaluations in general, that could be added to keywords describing the specific diagnostic test at issue. Nine Family Medicine journals were searched from 1992 through 1995 for primary publications on diagnostic test evaluation by hand searching and a Medline search strategy published earlier. Additionally, new search strategies have been developed with stepwise logistic regression, using Mesh terms and free text words related to diagnosis and test evaluation as independent variables. Hand searching identified 75 primary publications on diagnostic test evaluation from a total of 2467 primary publications. The previously published search strategy had a sensitivity of 73%, a specificity of 94%, and a positive predictive value of 29%. The most accurate new search strategy had a sensitivity of 80.0% (60/75; 95% CI: 71.0-89.1), a specificity of 97.3% (2327/2392; 95% CI; 96.6-97.9%), a positive predictive value of 48% (95% CI: 40-56) and diagnostic odds ratio of 149. All four new strategies used the Mesh term "sensitivity and specificity" (exploded with the Mesh terms "predictive value" and "ROC")and cumulatively added the text words "specificity," "false negative," "accuracy," and "screening." The search strategy using the Mesh term "sensitivity and specificity" (exploded) and the text words "specificity," "false negative," and "accuracy" has both higher sensitivity and specificity than the previously published strategy. The increase in specificity in three strategies reduces the absolute number of false-positive articles that have to be screened by 50-75%, compared to the number of false positives in the earlier strategy.

Diagnostic Tests, Routine↗

Effects of morphine analgesia on diagnostic accuracy in Emergency Department patients with abdominal pain: a prospective, randomized trial.

BACKGROUND: Because of concerns about masking important physical findings, there is controversy surrounding whether it is safe to provide analgesia to patients with undifferentiated abdominal pain. The purpose of this study was to address the effects of analgesia on the physical examination and diagnostic accuracy for patients with abdominal pain. STUDY DESIGN: The study was a prospective, double-blind clinical trial in which adult Emergency Department (ED) patients with undifferentiated abdominal pain were randomized to receive placebo (control group, n = 36) or morphine sulphate (MS group, n = 38). Diagnostic and physical examination assessments were recorded before and after a 60-minute period during which study medication was titrated. Diagnostic accuracy and physical examination changes were compared between groups using univariate statistical analyses. RESULTS: There were no differences between control and MS groups with respect to changes in physical or diagnostic accuracy. The overall likelihood of change in severity of tenderness was similar in MS (37.7%) as compared with control (35.3%) patients (risk ratio [RR] 1.07, 95% confidence interval [CI] 0.64-1.78). MS patients were no more likely than controls to have a change in pain location (34.0% versus 41.2%, RR 0.82, 95% CI 0.50-1.36). Diagnostic accuracy did not differ between MS and control groups (64.2% versus 66.7%, RR 0.96, 95% CI 0.73-1.27). There were no differences between groups with respect to likelihood of any change occurring in the diagnostic list (37.7% versus 31.4%, RR 1.20, 95% CI 0.71-2.05). Correlation with clinical course and final diagnosis revealed no instance of masking of physical examination findings. CONCLUSIONS: Results of this study support a practice of early provision of analgesia to patients with undifferentiated abdominal pain.

Abdominal Pain↗

The diagnostic interview for psychoses (DIP): development, reliability and applications.

BACKGROUND: We describe the development, reliability and applications of the Diagnostic Interview for Psychoses (DIP), a comprehensive interview schedule for psychotic disorders. METHOD: The DIP is intended for use by interviewers with a clinical background and was designed to occupy the middle ground between fully structured, lay-administered schedules, and semi-structured, psychiatrist-administered interviews. It encompasses four main domains: (a) demographic data; (b) social functioning and disability; (c) a diagnostic module comprising symptoms, signs and past history ratings; and (d) patterns of service utilization and patient-perceived need for services. It generates diagnoses according to several sets of criteria using the OPCRIT computerized diagnostic algorithm and can be administered either on-screen or in a hard-copy format. RESULTS: The DIP proved easy to use and was well accepted in the field. For the diagnostic module, inter-rater reliability was assessed on 20 cases rated by 24 clinicians: good reliability was demonstrated for both ICD-10 and DSM-III-R diagnoses. Seven cases were interviewed 2-11 weeks apart to determine test-retest reliability, with pairwise agreement of 0.8-1.0 for most items. Diagnostic validity was assessed in 10 cases, interviewed with the DIP and using the SCAN as 'gold standard': in nine cases clinical diagnoses were in agreement. CONCLUSIONS: The DIP is suitable for use in large-scale epidemiological studies of psychotic disorders, as well as in smaller studies where time is at a premium. While the diagnostic module stands on its own, the full DIP schedule, covering demography, social functioning and service utilization makes it a versatile multi-purpose tool.

Demography↗

Diffusion of diagnostic medical devices and policy implications for India.

OBJECTIVES: This study describes the diffusion of advanced diagnostic devices in India and assess implications for efficiency in resource use and equity. METHODS: Commodity-level import statistics, household survey data, and interviews with medical device sellers are used to assess the spread of diagnostic devices. Published qualitative evidence, case studies of diagnostic service providers, and cross-country analyses are used to identify the reasons underlying the spread of medical devices in India. Case studies of public and private providers and data from 150 hospitals in one Indian state are used to assess efficiency in resource use and the distributive impacts of diagnostic devices. RESULTS: High-end medical device inflows rose during the 1990s, with both supply- and demand-side factors influencing this trend. Although our results suggest that the overall quantity of advanced diagnostics in India is not excessive, there is some evidence of inefficiency in public facilities and possibly unethical practices in private diagnostic facilities. The unequal geographical distribution of magnetic resonance imaging facilities, coupled with inefficient use of medical devices in public facilities suggests inequality in access. CONCLUSIONS: The study points to major regulatory gaps and health system inefficiencies and suggests ways in which these gaps can be addressed.

Diagnostic Equipment↗