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OBJECTIVES: To comprehensively evaluate clinical predictors of spontaneous acute urinary retention (AUR) across pooled data of placebo-treated patients from clinical trials conducted in men with lower urinary tract symptoms and clinically diagnosed benign prostatic hyperplasia. METHODS: Data from the placebo-treatment groups of several prospective, randomized clinical trials conducted in the United States (n = 3040), Scandinavia, Canada, and worldwide (n = 2295) were combined in the analyses. More than 110 variables were considered individually and in combination as predictors of AUR using logistic regression analysis and classification and regression tree methods with a split-sample approach to cross-validation. RESULTS: The different methods of analysis identified consistent potential predictors of episodes of AUR. When prostate volume was included in the analyses, it was selected as the initial variable discriminating men with and without subsequent AUR. Omitting prostate volume because of its availability in only a subset of men, a logistic model including serum prostate-specific antigen (PSA), urinating more than every 2 hours, symptom problem index, maximum urinary flow rate, and hesitancy of urination had good predictive properties (area under the receiver-operating characteristic curve [AUC] = 0.742 +/- 0.047), as did a model with PSA (AUC = 0.716 +/- 0.045). A classification and regression decision tree with the same variables predicted AUR (AUC = 0.74, sensitivity = 72%, specificity = 67%) as well as did a tree with PSA alone (AUC = 0.70, sensitivity = 75%, specificity = 64%). CONCLUSIONS: Prostate volume and serum PSA are strong predictors of AUR in placebo-treated men with lower urinary tract symptoms and clinically diagnosed benign prostatic hyperplasia who were screened for prostate cancer. From more than 110 variables, logistic models and decision trees with PSA alone were comparable to expanded models that included PSA, urinary frequency and hesitancy, flow rate parameters, and symptom problem index, and to a scoring algorithm.
PURPOSE: The clinical investigator must understand that errors in measuring tumors can greatly affect such clinical-trial end points as tumor response. We performed a prospective, controlled study of tumor measurements that compared circumferential measurements made with a loop planimeter with linear measurements made with a standard caliper. METHODS: Using a cross-over design, 76 clinical oncology fellows/junior oncology faculty members attending a Methods in Clinical Cancer Research Workshop sponsored by the American Association for Cancer Research and the American Society of Clinical Oncology measured five pulmonary nodule phantoms that ranged in size from 1.76 to 13.21 cm(2) and five surface nodule phantoms with sizes ranging from 2.3 to 12.9 cm(2). To perform these measurements, they used both a loop planimeter and a caliper. Forty-two and 40 participants repeated measurements 3 days later on pulmonary and surface nodules. Accuracy, reproducibility, and time efficiency were evaluated. RESULTS: The linear caliper measurements overestimated pulmonary nodule and surface nodule size by a median of 37% and 23%, respectively. Circumferential loop planimeter measurements overestimated pulmonary nodule size and surface nodule size by a median of 8% and 17%, respectively. Interobserver reproducibility for the planimeter was greater than that for the caliper, as evidenced by thinner measurement interquartile ranges. Furthermore, intraobserver reproducibility was higher for the planimeter, with its variability being only 31.4% and 25.5% as large as that of the caliper when measuring the pulmonary and surface nodules, respectively. CONCLUSION: Circumferential measurements provide better accuracy, reproducibility, and speed in measuring both pulmonary and surface nodules than do perpendicular diameters.
AIM: The objective of this study was to compare the prevalence, severity and distribution of CDS in patients attending general dental clinics (GDC) and periodontal specialty clinics (PSC) and to correlate them to possible causal factors. MATERIAL AND METHODS: 2 groups of patients aged 20-60 years recruited from GDC (144) and PSC (151) were evaluated for CDS by means of a questionnaire and intraoral clinical examinations. Furthermore, gingival recession and plaque scores were recorded at the same visit. RESULTS: The results showed that patients referred to PSC had a significantly higher prevalence of CDS (60.3%) than those examined at GDC (42.4%) (p<0.001). Also, mean plaque scores of PSC patients (1.87 +/- 0.88) was found to be significantly higher than that of GDC (1.44 +/- 0.7) (p<0.01). The occurrence and extent of gingival recession associated with hypersensitive teeth was significantly higher in PSC than GDC patients (p<0.01), with a 5% incidence of severe recession (5 mm) in PSC only. The association of periodontal disease and periodontal treatment to the high prevalence of CDS and gingival recession in PSC patients would suggest their role in predisposition to hypersensitivity. The distribution of CDS in tooth types revealed that upper molars and lower anteriors of PSC patients were mainly affected, and followed by, to a lesser extent, lower right canine and right first molars of GDC patients. CONCLUSION: The prevalence of CDS among our periodontal patients appears somewhat lower than that reported in periodontal specialty clinics of earlier studies but still higher than those reported in other dental populations. This indicates that periodontal disease and its treatments may increase the occurrence of hypersensitivity.
The purposes of this commentary are 1) to summarize the problems and ambiguities that cause many clinical pathologists to discard the term "normal values"; 2) to describe and define two terms, 'normal values" and "clinical reference values", which are becoming important for clinical interpretation of laboratory data; 3) to describe a new method for estimating clinical reference ranges of blood chemistry laboratory tests performed on selected Tokai University Hospital patients; and 4) to provide a bibliography of articles that have focused attention on the conceptual problems in this field.
Since sorivudine incident has happened in Japan in 1993, an adverse drug-drug interaction has been of special meanings at each step of new drug development including the discovery step, NDA process, and on market. While it is known that several mechanisms are involved in the drug-drug interactions, the mechanisms related to drug metabolism are 1) inhibition of drug metabolizing enzymes, 2) induction of the enzymes, 3) drug absorption, 4) renal excretion, 5) hepatic transport, and 6) protein binding (displacement) interaction. In this report, proposals to avoid serious/lethal drug-drug interactions are presented with the examples. The proposals are: 1) To estimate the drug-drug interactions in consideration of the mechanisms reported so far, 2) To be especially careful for drugs with a small therapeutic index and severe/lethal toxicity, 3) To estimate the drug-drug interactions in consideration of physiological factors of patients, who receive drugs in combination, 4) Not to leave the mechanism unclear, when some data, which do not deny the critical drug-drug interactions, were obtained, and 5) To conduct the drug-drug interaction studies in humans in careful consideration of the safety.
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The UK National Institute for Clinical Excellence (NICE) is charged with the duty of providing informed guidance on clinical practice (clinical effectiveness and cost effectiveness) to patients and health professionals. The Appraisal Committee through its process of review of evidence advises NICE on the clinical effectiveness and cost effectiveness of new and existing technologies and their appropriate use within the National Health Service in England and Wales. The appraisal process takes into account both published and unpublished evidence as well as input from professional and patient and carer groups when coming to its decisions. The appraisal of a new technology often has to bridge the gap between the evidence required for licensing purposes and that needed to provide pragmatic advice to practising clinicians. The appraisal of zanamivir (Relenza) is an excellent working example of this difficult and important process.
PURPOSE: The American Society of Clinical Oncology (ASCO) Health Services Research Committee sought to assess whether more appropriate patterns of colony-stimulating factor (CSF) use occurred after the publication of ASCO evidence-based practice guidelines in 1994 and 1996 for patients with solid tumors or lymphoma. METHODS: In 1994 and 1997, questionnaires describing clinical scenarios were mailed to ASCO members who practiced medical oncology. Physicians were asked the extent to which they preferred to use a CSF for primary prophylaxis, secondary prophylaxis, or treatment of neutropenic complications. Multiple regression analyses were used to determine predictors of overall propensity to use CSFs and, when using a CSF, propensity to support longer schedules of CSF use. RESULTS: Decreased use of CSFs was shown in the following situations: (1) treatment for febrile neutropenia without localizing signs (39% in 1994 v 29% in 1997) or with a right lower lobe infiltrate (54% v 46%); (2) primary prophylaxis with paclitaxel for ovarian cancer (20% v 11%) or cyclophosphamide, doxorubicin, and vincristine chemotherapy for small-cell lung cancer (8.4% v 4.6%); and (3) secondary prophylaxis after afebrile neutropenia following chemotherapy for germ cell tumors (44.5% v 36.0%). One third fewer physicians supported the extended use of CSFs until an absolute neutrophil count >/= 10,000/mm(3) or a WBC count >/= 10,000/mm(3) was reached, both counts serving as criteria for stopping CSF therapy. However, we observed high rates of CSF use despite ASCO guideline recommendations against use in the following clinical situations: (1) primary prophylaxis in patients at low risk of febrile neutropenia (6% v 16%); (2) secondary prophylaxis late in the course of curative and palliative therapy (80% v 53%); and (3) treatment of afebrile and uncomplicated febrile neutropenia (30% v 60%). In 1994 and 1997, fee-for-service physicians were more likely than other physicians to prefer use of CSF support while maintaining treatment dose and schedule instead of using dose-reduction strategies, and, when using a CSF, they were more likely to support longer CSF treatment schedules (P <.05 for both scenarios). CONCLUSION: Decreased use and more appropriate use of CSFs in accordance with ASCO guideline recommendations occurred from 1994 to 1997, but there remain many opportunities to reduce CSF use with no clinical harm. Many oncologists continue to support the use of CSFs in scenarios and with scheduling criteria that the guidelines and evidence do not support. ASCO's evidence-based guidelines should be linked with formal continuous quality improvement initiatives to substantially improve the quality of supportive oncology care.
The purpose of this study was to answer the following questions: Do clinical signs in pregnant women with pelvic pain differ from signs in those without pelvic pain? Is there variation between the test signs found by four observers? Are the clinical signs correlated to pain and physical disability? Twenty pregnant women with pelvic pain and 20 pregnant women without pelvic pain were participating. Each woman reported her own pain sensation and physical disability and each woman was examined by 4 physiotherapists independently. Sixty-one clinical tests were applied. Only 8 tests showed predominantly positive signs in the pain group. These tests showed agreement between different observers judged by a kappa coefficient > 0.40. The number of positive clinical signs was well correlated to the reported pain and physical disability. The value of an extensive examination of posture, muscles and joints on pregnant women with pelvic pain is dubious.
A 1987 questionnaire sponsored by the Health and Welfare Ministry concerning the clinical subsets and severity of systemic lupus erythematosus (SLE) was distributed to 93 medial facilities. A clinical analysis of the outcome and treatments was accomplished on one thousand six hundred and fourteen SLE patients fulfilling ARA criteria. The outcome was evaluated into 6 categories, namely; complete remission, incomplete remission, no change, gradual worsening, rapid worsening and unknown. Treatments included (1) anti-inflammatory drugs, (2) initial dose of prednisolone (PSL) below 29 mg/day, (3) initial dose of PSL from 30 to 59 mg/day, (4) initial dose of PSL above 60 mg/day, (5) pulse therapy, (6) immunosuppressants, (7) plasmapheresis, and (8) hemodialysis. Statistical significances were determined with ridit analysis. The severity of the disease for 1,614 SLE patients was evaluated by the judgement of each medical facility independently, separating it into 3 grades. As a result, 16.8% was evaluated as severe, 54.6% was evaluated as moderate, and 28.6% was evaluated as mild. Clinical subsets were divided into 3 categories according to the outcome; (1) those with high complete remission rates (serositis, convulsion, oral ulcers, unconsciousness, hemolytic anemia and so on), (2) those with high incomplete remission rates (lupus nephritis, digital gangrene, hypertension, peripheral neuropathy, erythema, Raynaud's phenomenon and so on), and (3) those with high rates of no change or worsening (aseptic bone necrosis, pulmonary hypertension, pneumonitis, chronic renal failure and so on). SLE patients with persistent proteinuria below 3.4 g/day, pulmonary hypertension, or pneumonitis treated with large doses of PSL such as an initial dose of PSL above 60 mg/day and/or pulse therapy had a significantly higher remission rate than those treated with small dosages of PSL. Hereafter, the establishment of modes of treatments for increasing the remission rates of intractable clinical subsets in highly desired.
In 1978, clinical investigators decided to collaborate on clinical trials through a "cooperative group" mechanism in order to promote multidisciplinary treatment of cancer under the auspices of a Grant-in-Aid for Cancer Research from the Ministry and Health and Welfare. This cooperative study group was formally renamed in 1990 and became "The Japan Clinical Oncology Group (JCOG)," and its Statistical Center was housed in the National Cancer Center Hospital. This paper introduces various JCOG activities and the role of the Statistical Center.