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At least 19 recordsLinked to original sources
PubMed1979

Quality assurance of clinical data: diagnostic standardization.

Diagnostic standardization requires substantial effort, including detailed specification of procedures in a written protocol and training of examiners in such procedures. Success is neither automatic nor assured. It is essential to monitor performance through replicate examinations and/or computation of examiner variance. When examiner variance exceeds permissible limits, consideration should be given to discarding the data.

Clinical Trials as Topic↗
PubMed1998

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↗
PubMed2004

[Investigation and analysis on diagnostic standard for TCM Syndrome Differentiation in 400 patients with climacteric syndrome].

OBJECTIVE: To explore the thinking and method of studying the diagnostic standard for TCM Syndrome Differentiation by means of clinical epidemiological investigation on climacteric syndrome. METHODS: Adopting DME (design measurement evaluation), the field investigation data of 400 patients with climacteric syndrome were statistically managed and analyzed using blind method. The distribution of syndromes, including information of four-diagnosis of various syndromes as well as the laboratory findings in patients were studied using factor analysis and model of structural equation. RESULTS: The Syndrome types of climacteric syndrome were identified as the Gan-Yang exuberance type, the Shen-Yang deficiency type, the Gan-Shen Yin-deficiency type and the Gan-stagnancy injuring Spirit type. CONCLUSION: Thinking of the diagnostic standard study for TCM Syndrome Differentiation is to identify the supposed diagnostic standard of a disease based on retrospective study, to formulate a new hypothetical standard of Syndrome by way of field investigation, category analysis, factor analysis, and critical theory, followed with identification of Syndrome distribution in the disease, its critical syndrome, typical syndrome, complicated syndrome, and criteria for Syndrome Differentiation.

Climacteric↗
PubMed1993

[A study with diagnostic standard of occult hyperprolactinemia (OHP) and the effect of bromocriptine administration].

It is well known that the transient excessive increase of serum prolactin level is harmful for the mechanism of ovulation or the steroidogenesis of the ovaries. The pathogenesis of latent or occult hyperprolactinemia (OHP) has been investigated recently. The present study was conducted to determine the diagnostic standard of OHP, and to elucidate the efficacy of bromocriptine administration for the treatment of OHP and other ovulatory disturbances. 110 cases of hypothalamic anovulations were selected from 385 cases of infertile patients by the LH-RH and TRH loading tests. Bromocriptine (5mg/day) was administered to all of the subjects for more than three months, and the efficacy of the bromocriptine administration was investigated. Follicular development was observed by transvaginal ultrasonography (mature follicular diameters > or = 20mm), and also luteal function was estimated by the duration of the luteal phase in the BBT charts (high phase > or = 12 days), the mid-luteal serum estradiol (> or = 200pg/ml) and progesterone (> or = 10ng/ml) levels. The subjects were divided into two groups: group A, bromocriptine effective patients (63 cases) and group B, bromocriptine non effective patients (47 cases). The results of the LH-RH and TRH loading tests were compared between these two groups. Serum prolactin levels at 30 min. after TRH loading (PRL30) in group B (61.5 +/- 28.3 vs. 38.0 +/- 19.3ng/ml, p < 0.01). At the cut-off points of 50, 60 and 70ng/ml over in the values of the PRL, the efficacies of the bromocriptine administration were 77.4, 78.9 and 88.5%, respectively. From these facts, it was thought suitable that the diagnostic standard of OHP was PRL30 > or = 70ng/ml, and values of PRL30 from 50 to 70ng/ml were borderline cases of OHP. The efficacy of the bromocriptine administration in the cases without OHP (n = 57) was also investigated. Serum LH levels at 30 min. after LH-RH loading (LH30) were compared between the cases of the bromocriptine effective (n = 22) and non effective (n = 35). As a result, the LH30 of the former was significantly higher than that of the latter (96.5 +/- 64.2 vs. 45.1 +/- 31.5mIU/ml, p < 0.005). In conclusion, the diagnostic standard of OHP was determined as PRL30 > or = 70ng/ml (borderline: 50 > 70ng/ml), and bromocriptine administration was effective not only in cases of OHP, but also in cases of hyperreactivities of LH (so-called endocrinological PCOD).

Anovulation↗
PubMedDate not supplied

Diagnosing major depression in the elderly: evidence for response bias in standardized diagnostic interviews?

Recent epidemiological and family genetic studies in different countries using standardized diagnostic interviews for mental disorders have rather consistently demonstrated considerably lower current (e.g. ECA Study: 0.9%) and lifetime (1.4%) prevalence estimates of Major Depression in the elderly (older than 65 years of age) as compared to younger age groups (e.g. 30-44 years: 1 year, 3.9%; lifetime, 7.5%). Some investigators have questioned the validity of these data and suggested alternative interpretations. One possibility is that the complex standardized symptoms and clinical probe questions, and the required judgmental process inherent in diagnostic interviews exceed the cognitive capacity of older adults. This may result in systematic response bias. This paper examines the degree to which the lower prevalence estimates of depression in the elderly are biased due to specific characteristics of the assessment strategy. Analyses of epidemiologic data from the Munich Follow-up Study (MFS), based on the Diagnostic Interview Schedule, demonstrate that (1) older respondents report lifetime depressive symptoms with the same frequency as younger respondents. The additional probe questions designed to identify the degree to which symptoms were caused by factors other than psychological revealed that (2) the elderly more often attribute such symptoms to physical illnesses or conditions. This results in (3) the exclusion of the reported symptoms as a basis for diagnosing depression. A laboratory study demonstrated that "working memory capacity" was a good predictor of this response behavior, indicating that the complexity of the formalized questions exceeds the cognitive capacity of the elderly. Attributing symptoms to a physical illness or condition might be a heuristic strategy to simplify complex recall and judgment processes; the resulting answer is plausible but incorrect. We recommend that the symptom and probe questions of standardized diagnostic interviews be simplified, especially for use with the elderly.

Adult↗
PubMed1976

The construction and use of diagnostic standards for primary radiographic caries.

The aim was to establish diagnostic standards for primary approximal radiographic caries diagnosis. These were described with reference to ranking of subjects, mean "intermediate" score per subject, which was based on the majority diagnosis recorded by three examiners, and by category of a certainty scale for individual tooth surface scores. The results recorded by two fourth year dental students and two hygienists, when reading 40 pairs of posterior bitewing radiographs of children between 13 and 15 years of age, showed an acceptable level of agreement for ranking of subjects. Agreement was less satisfactory, when comparing the mean scores of these four examiners with the "intermediate" score per subject and with a standard for individual surfaces. The proposed standards do not represent true scores, but serve as guidelines, as they depend on the diagnostic level of the examiners on whose scores the standards are based, and on the diagnostic criteria employed.

Adolescent↗
PubMed2002

[Study on diagnostic standards for fine needle aspiration cytological diagnosis of breast masses: a comparative analysis of cytology and histology of 951 cases].

OBJECTIVE: To study the basic morphological factors and the reliability and limitations of the diagnostic standards of fine needle aspiration cytology (FNAC) of breast masses which drafted. METHODS: A total of 4 309 fine needle aspiration biopsy cases of breast were performed and 951 cases of which were checked with their histological diagnosis. RESULTS: Of the 413 aspiration smear studies, relatively identical morphological features were found on the smears of lesions of the same nature. The sensitivity of diagnosis of malignant tumor in 732 cases, the specificity of diagnosis of benign lesion in 219 cases and the overall accuracy of diagnosis were 97.3%, 97.7%, and 97.4% respectively. The false negative rate, potential false positive rate and the overall misdiagnosis rate were 2.7%, 2.3% and 2.6% respectively, no false positive diagnosis case was found. CONCLUSIONS: (1) The differentiation and the arrangement pattern of the tubular epithelial cells and the amount of benign naked nuclear cells are the three essential factors in the analysis of morphological changes of FNAC of breast mass. (2) The examination of our diagnostic standards of FNAC of breast masses shows that the standards are very reliable but have certain limitations which need to be resolved by histopathological diagnosis.

Biopsy, Needle↗
PubMed1995

[Comparative study of diagnostic standards of eye-signs in blood stasis syndrome and of blood stasis syndrome].

By virtue of a diagnostic study of 781 cases on the basis of six standards, it was shown that for the effectiveness in diagnostic positive rate, sensitivity, specificity, false positive rate, false negative rate and comprehensive scoring, the International Diagnostic Standards for Blood Stasis Syndrome (BSS) and Chinese Diagnostic Standards for BSS were the best ones, BSS Eye-Signs and Japanese BSS Diagnostic Standards were the second, trial program of International Stasis Diagnostic Standards and Zhongshan's BSS tenderness points came the third. Each standard has its unique advantage and therefore, we should take the other's advantage to offset one's weakness. The causes of their weakness have been discussed and the rational recommendation for their application has been proposed.

Blood Viscosity↗
PubMed2005

Identification of methicillin-resistant Staphylococcus aureus (MRSA): Comparison of a new molecular genetic test kit (GenoType MRSA) with standard diagnostic methods.

Results obtained from 188 isolates of staphylococci using standard diagnostic methods for identifying MRSA were compared with those achieved with a newly available molecular genetic test kit, the GenoType, Version 1, MRSA (Hain Lifescience GmbH, Nehren, Germany). The GenoType MRSA detects the mecA gene and, in addition, a highly specific sequence for Staphylococcus aureus (S. aureus) by polymerase chain reaction (PCR) and reverse hybridization. There was a 100% overall correlation between the results of conventional and molecular genetic testing. 143 isolates were tested positive for MRSA, 10 isolates were identified as oxacillin-sensitive Staphylococcus aureus strains (MSSA), and 35 isolates were coagulase-negative staphylococci of various species. However, five of the 143 MRSA strains yielded ambiguous results with the first line standard tests and therefore required additional testing leading to delay of definitive diagnosis. As expected, mecA could not only be detected in MRSA strains, but also in coagulase-negative staphylococci. The reliable identification as S. aureus from the same isolate is therefore an essential prerequisite for MRSA diagnosis. The GenoType MRSA fulfills this requirement by parallel detection of a S. aureus-specific sequence and the mecA gene. Molecular genetic testing with the GenoType MRSA kit needs much less time than conventional microbiological methods. Therefore genetic testing provides not only a considerable advantage with respect to reliability but also to speed.

Bacterial Proteins↗
PubMed1989

The effects of ultrasonic scaling with oral hygiene education on the distribution of pathological pockets using CPITN diagnostic standards.

Thirty-three subjects aged 20-44 years, selected from Japanese company employees who had been given CPITN Codes of 3 or 4, received a treatment of ultrasonic scaling to investigate any changes in the distribution of pathological pockets after this treatment using CPITN diagnostic standards. A pathological pocket was defined as a pocket with a depth of 4 mm or deeper as described in the CPITN system. The results demonstrate that the number of teeth with pathological pockets was significantly reduced from 6.2 to 3.4 (45 per cent reduction) after scaling with an ultrasonic instrument requiring at most 30 minutes per subject. The reduction in pathological pockets was attributed to an improvement in shallow pockets rather than deep pockets. These results imply that as far as shallow pockets are concerned, one episode of scaling with ultrasonics is effective in reducing the extent of periodontal disease. Comparison between the number of sextants with shallow pockets before and after scaling further revealed that more improvements were observed in the subjects aged 20-29 years than in those aged 30-44 years. These results suggest that subjects aged 20-29 years with shallow pockets should be given first priority for scaling programmes in an adult population. The results also indicate that the CPITN diagnostic standards, in which the probe measures what is 'normal' and 'abnormal', is appropriate for the evaluation of periodontal status in an epidemiological study.

Adult↗
PubMed1992

Venography of the lower limbs. Pitfalls of the diagnostic standard. The ETTT Trial Investigators.

RATIONALE AND OBJECTIVES: Phlebography is considered the diagnostic standard for suspected deep venous thrombosis. The authors studied the inter-observer variability of phlebogram interpretation in the setting of a multicenter therapeutic trial of the thrombolytic agent alteplase. METHODS: The interpretation of 31 pairs of venograms (before and after thrombolytic therapy) was studied by comparing the quantitative Marder's scores which were computed by three experts and the qualitative assessment of phlebographic changes induced by thrombolysis by the panel of experts and by the investigators. RESULTS: Although the scores of the three experts correlated fairly well (r = .67-.82; P < .001), they differed significantly from each other (P < .0001). Substantial differences also were found between local (by investigators) qualitative evaluation of the venographic changes induced by the treatment and central evaluation by the panel of experts (coefficient of agreement kappa = 0.19), local assessment being significantly more optimistic (P = .002) than central judgment. CONCLUSION: Significant differences were observed between assessment of changes in venographic scores after thrombolytic treatment both among three expert radiologists, and between the panel of experts and the local investigators of the multicenter trial. This observation points to the need for an a priori definition of well-characterized decision criteria to allow a valid interpretation of the effects of the therapeutic intervention.

Adolescent↗
PubMed1977

The construction and use of diagnostic standards for radiographic caries incidence scores.

The aim was to construct and illustrate the use of diagnostic standards for recording of DFS incidence. Separate standards are presented for ranking of subjects; the mean "intermediate" DFS score per subject, which represented the majority decision of three dentists; and a certainty scale for individual tooth surfaces. The scores recorded for 40 sets of posterior bitewing radiographs of children between 13 and 15 years of age by two fourth year dental students and two dental hygienists were compared with the standards. Spearman's rank correlation coefficient reached the critical level of +0.70 in three of eight instances. Only one mean net DFS increment score differed significantly from the mean standard score (p less than 0.05). The level of agreement with the certainty scale for individual surfaces was low. Focusing attention on recording of DFS incidence gives a more severe test of examiners' diagnostic performance. The construction and use of control charts for monitoring the diagnostic level of examiners is suggested.

Adolescent↗
PubMed2002

Adrenal incidentaloma--experience of a standardized diagnostic programme in the Swedish prospective study.

OBJECTIVE: To report the 5-year experience of a diagnostic programme for adrenal incidentaloma with special emphasis to diagnose hormonally active and malignant lesions. DESIGN: A prospective study in which new cases of adrenal incidentalomas in Sweden have been evaluated by a standardized diagnostic protocol between January 1996 and July 2001. SETTING: Thirty-three different Swedish hospitals have contributed with cases. SUBJECTS: A total of 381 patients (217 females, 164 males) with adrenal incidentalomas were studied. INTERVENTIONS: Diagnostic procedures were undertaken according to a standardized programme. Operation was recommended if the incidentaloma had a size of more than 3-4 cm or if there was a suspicion of a hypersecreting tumour. MAIN OUTCOME MEASURES: The size of the incidentaloma, clinical characteristics of the patients and results of biochemical diagnostic tests were registered. RESULTS: The median age of the patients was 64 years (18-84 years), and the median size of the incidentalomas was 3 cm (1-20 cm). A total of 85(22%) patients were operated. Twenty of these patients were diagnosed with a benign hypersecreting tumour and 14 with a malignant tumour. Fourteen of 15 operated patients with diagnosed pheochromocytoma had elevated 24-h urinary noradrenaline and all of the patients operated because of a biochemical suspicion of aldosterone or cortisol hypersecretion (n = 6) were found to have adrenal adenomas. Of the 14 operated patients with malignant diseases, 10 were adrenal carcinomas (median size 10 cm; range 4-16 cm). In a multiple logistic regression model, incidentaloma size was significantly associated with the risk of a malignant tumour (P = 0.009), and there was a tendency of an association between age/male sex and the risk of a malignancy (both, P = 0.07). CONCLUSION: In this Swedish multicentre study of 381 cases with adrenal incidentalomas, 5% had benign hypersecreting tumours and nearly 4% had malignant tumours. The results of the biochemical diagnostic tests used had a high compatibility with the histological diagnosis found at operation in the patients with hypersecreting tumours. Tumour size, male gender and high age were predictive for the risk of a malignant tumour. A follow-up of the patients is warranted in order to establish whether there are undiscovered cases of malignant or hypersecreting tumours amongst the nonoperated patients.

Adenoma↗
PubMed1982

Diagnostic standards for occupational nasal allergy.

Based on studies of 70 outpatients having occupational nasal allergy as well as mass examinations of workers in two industries, diagnostic standards for this condition were evaluated. In practice, interviews concerning the causal relation, frequency, latent period and atopic disposition often provide suggestions, but sometimes give unreliable evidence for the basis by which to diagnose occupational nasal allergy. Both rhinoscopy and nasal smear test for eosinophilia are available, but these only distinguish allergy from non-allergy. Therefore, examinations, such as skin tests, nasal tests and determination of the IgE antibody level, using allergen extract of good quality, are necessary for a final diagnosis.

Air Pollutants, Occupational↗
PubMed2000

Towards global in vitro diagnostic standards, Part II.

The first global harmonized standards for in vitro diagnostic (IVD) products are nearing completion. Six of these standards are mandated for the IVD Directive. Part II of this two-part article continues with a report on the current status of these standards and reflects on the lessons learned so far from international standardization activity.

Clinical Laboratory Techniques↗