Clinical performance and quality health care最新文献

{"title":"How do regulatory agencies ensure the release of a safe medical device?","authors":"B Haggar","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article describes the current regulatory activities of the Food and Drug Administration (FDA), in particular the FDA techniques for regulating medical-device approvals, medical-device reporting, and medical-device-company inspections. Also discussed are the FDA Modernization Act and the methods the FDA is using to implement the act.</p>","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 2","pages":"100-3"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21597907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementing preventive health measures: a pilot study.","authors":"P A Gross,&nbsp;P Cataruozolo,&nbsp;W Mitofsky,&nbsp;M Furnari,&nbsp;T Crupi,&nbsp;J H Skurnick,&nbsp;P DeMauro,&nbsp;G Statmore,&nbsp;M Moogan,&nbsp;J Berdy,&nbsp;C Sokol","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>Implementation of preventive services guidelines is performed inconsistently. In an attempt to reduce variation in guideline implementation, we developed a patient questionnaire based on the US Preventive Services Task Force Guide and the Health Plan Employer Data and Information Set 3.0 performance measures of the National Committee on Quality Assurance.</p><p><strong>Subjects: </strong>100 hospitalized patients of five primary-care physicians.</p><p><strong>Methods: </strong>In a pilot study, 100 hospitalized patients of five primary-care physicians were questioned about their compliance with evidence-based, preventive healthcare recommendations. Information was requested on blood pressure measurement, cholesterol screening, fecal occult blood testing, smoking-cessation counseling, Pap testing, mammography, postmenopausal hormonal replacement therapy counseling, prostate examination and prostate-specific antigen (PSA) testing, use of aspirin and beta-blockers following an acute myocardial infarction, testing of diabetics for hemoglobin A1c and retinal eye examinations, questioning of the elderly for auditory and visual problems, and receipt of influenza and pneumococcal vaccines. Information on variations from the recommended preventive service was fed back to their physicians. Six months after the initial survey, the patients were requestioned to determine if compliance had improved with the recommendations.</p><p><strong>Results: </strong>We found significant improvement in fecal occult blood testing, smoking cessation, Pap smear testing, mammography use, prostate examinations and PSA testing, hemoglobin A1c testing, seeing or hearing loss follow-up, and the administration of influenza and pneumococcal vaccines.</p><p><strong>Conclusions: </strong>Improving implementation of preventive services recommendations is a challenge. This pilot study suggests that involving the patient more in the process and informing the physician of the results may improve the process.</p>","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 2","pages":"52-5"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21598427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outpatient satisfaction: validation of a French-language questionnaire: data quality and identification of associated factors.","authors":"J Labarère,&nbsp;P François,&nbsp;D Bertrand,&nbsp;J C Peyrin,&nbsp;C Robert,&nbsp;M Fourny","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objectives: </strong>Following 1996 legislation requiring French hospitals to assess patient satisfaction, this study developed and validated a brief French-language multidimensional questionnaire designed to measure outpatient satisfaction with hospital visits and compared data quality for two patient-satisfaction survey methods.</p><p><strong>Design: </strong>Authors developed a 19-item questionnaire following a strict procedure (identification of dimensions to explore, formulation, and selection of items).</p><p><strong>Setting: </strong>Validation data were obtained from patients of six outpatient clinics in a teaching hospital.</p><p><strong>Participants: </strong>586 consenting eligible patients were randomized to receive the questionnaire 2 weeks after their visit with one of two survey methods: a mailed self-administered questionnaire or a telephone interview.</p><p><strong>Results: </strong>The response rate (79%) was not significantly different between the two survey methods. The risk of having one or more missing values was higher in the mail survey group (odds ratio, 1.65; 95% confidence interval, 1.03-2.63), but mail respondents were less likely to use the \"extremely positive\" response category. Principal component analysis identified four factors that accounted for 56% of the variance: interpersonal skills and information transfer, physical surroundings, convenience, and appointment delay. Patients' comments on open-ended questions validated the semantic content of the factorial construct. The internal consistency coefficient was greater than 0.70 for three of four subscales. Patient background characteristics accounted for less than 10% of the factorial score variance. Patient satisfaction was correlated with age, type of visit, and, to a lesser extent, gender and education level.</p><p><strong>Conclusion: </strong>This easily administered, multidimensional out-patient-satisfaction questionnaire provided encouraging preliminary psychometric characteristics.</p>","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 2","pages":"63-9"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21598430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dollars and sense: a practical guide to cost analysis for hospital epidemiology and infection control.","authors":"E A Chrischilles,&nbsp;D A Scholz","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This paper explains practical approaches for collecting inpatient cost data for cost-of-illness and cost-effectiveness analyses. The economic definition of cost of an item is the value of the resources that are consumed in its production. Cost analysis should collect the resources hypothesized to be affected by the illness or intervention. The dollar value of these resources can also be estimated. Diagnosis-related group (DRG) reimbursements are not helpful when all study patients have the same DRG or when no DRG exists (e.g., nosocomial infection). Hospital charges are not a good surrogate for costs. Hence, data needed include resources used, charges, and cost-to-charge ratios, so that cost can be estimated. Resources used can be obtained from hospital information systems. For some resource use (e.g., physician services, pharmacy, and intravenous fluids), charges or cost-to-charge ratios may not be available, and an external standard may be needed to estimate the dollar value. For many types of resources, hospital financial systems provide both charges and cost-to-charge ratios. This yields an estimate of average cost (total cost divided by patient days) when marginal cost (change in variable cost per day of patient stay) is a better estimate of the value of the resources consumed. However, cost-to-charge ratios remain the only practical way of estimating cost in many circumstances and are commonly used in economic studies. Cost-of-illness estimates vary among the various nonrandomized study designs used. \"Real-world\" randomized trials are potentially useful to obtain advantages of randomization but avoid the protocol-induced biases of traditional double-blind controlled trials.</p>","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 2","pages":"107-11"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21598431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The cost of burn care and implications for efficient care.","authors":"K Takayanagi,&nbsp;S Kawai,&nbsp;R Aoki","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>To clarify the social issues and problems associated with burn care in Japan, based on a cost analysis of acute burn care.</p><p><strong>Methods: </strong>A retrospective review was undertaken of 71 patients admitted with burns at Nippon Medical School between January 1 and December 31, 1997. A cost analysis was performed for three major burn patients with a burn surface area (BSA) of 70% to 80% and three minor burn patients with a BSA of 20% to 30%. A questionnaire was administered to both burn patients and medical providers in all 127 emergency centers to help improve long-term quality of life (QOL).</p><p><strong>Results: </strong>80% of burn patients were under age 70. In the major burn cases, the amount of reimbursement according to the government-regulated fee schedule was much less than the cost of treatment. The ratio of the cost of both medication and materials to total cost of treatment was higher for patients with major burns. Patients responding to the survey acknowledged being generally happy despite suffering from psychological and financial problems. A total of 413 medical providers from 63 institutions responded to the survey regarding improving long-term QOL.</p><p><strong>Conclusions: </strong>Acute burn care is a costly service. The goal of burn care should shift from saving lives to allowing for a productive return to society. Quality improvement, outcome measurement, and technology assessment combined with health economics research for burn care should be carried out in Japan.</p>","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 2","pages":"70-3"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21598432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emergence of highly antibiotic-resistant Pseudomonas aeruginosa in relation to duration of empirical antipseudomonal antibiotic treatment.","authors":"E Philippe,&nbsp;M Weiss,&nbsp;J M Shultz,&nbsp;F Yeomans,&nbsp;N J Ehrenkranz","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>This study examines antibiotic resistance in Pseudomonas aeruginosa in hospitalized patients in relation to prior empirical antibiotic therapy.</p><p><strong>Design: </strong>Two retrospective case analyses comparing patients who manifested P aeruginosa with differing patterns of antibiotic resistance.</p><p><strong>Setting and participants: </strong>Patients acquiring P aeruginosa in a community hospital.</p><p><strong>Measures: </strong>Patients were compared on duration of hospitalization and days and doses of antibiotics prior to recovery of P aeruginosa. Patients were grouped, based on susceptibility patterns of their P aeruginosa isolates classified as follows: (1) fully susceptible (susceptible to all classes of antipseudomonal antibiotics [SPA]), (2) multidrug-resistant (resistant to two classes of antipseudomonal antibiotics [MDRPA]), or (3) highly drug-resistant (resistant to > or = 6 classes of antipseudomonal antibiotics [HRPA]). To control for duration of hospitalization, antibiotic treatments of HRPA and SPA patients were compared during the first 21 days of care.</p><p><strong>Results: </strong>Prior to recovery of HRPA, six HRPA patients received greater amounts of antibiotics, both antipseudomonal and non-antipseudomonal, than did six SPA patients prior to recovery of SPA. For 14 patients with hospital-acquired SPA who later manifested MDRPA, duration and dosage of antipseudomonal antibiotics, but not all antibiotics, were significantly higher for the SPA-to-MDRPA interval than for the preceding admission-to-SPA interval. The median duration of antipseudomonal antibiotic treatment prior to the recovery of P aeruginosa was 0 days for SPA, 11 days for MDRPA, and 24 days for HRPA.</p><p><strong>Conclusion: </strong>Duration of empirical antipseudomonal antibiotic treatment influences selection of resistant strains of P aeruginosa; the longer the duration, the broader the pattern of resistance.</p>","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 2","pages":"83-7"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21597753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The indirect effect of managed care: a true story.","authors":"M D Nettleman","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 2","pages":"51"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21598426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors associated with changes in satisfaction with care.","authors":"B Newsome,&nbsp;S M Retchin,&nbsp;M Jurgensen,&nbsp;L Rossiter,&nbsp;W Glasheen,&nbsp;L Colley","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>Satisfaction with care is an important outcome for evaluating the effectiveness of medical care. Many factors can influence satisfaction, including disease state, healthcare utilization, and health-status changes. However, few studies have investigated the association between these factors and changes in satisfaction.</p><p><strong>Design: </strong>This study examined the influence of personal characteristics, type of health plan, disease states, and healthcare utilization on changes in satisfaction with care in a prospective cohort over a 12-month period through two surveys, baseline and follow-up.</p><p><strong>Participants: </strong>Enrollees in one of three different commercial health plans: point-of-service product, an unrestricted fee-for-service product, and a preferred-provider organization product.</p><p><strong>Measurements and main results: </strong>Two multivariate logistic regression models were constructed. The first model evaluated factors that predicted increased satisfaction with care between the two surveys. Compared with respondents who reported no change in health status, both those with improved health status (odds ratio [OR], 1.29, 95% confidence interval [CI95], 1.03-1.61) and those with declines in health (OR, 1.29, CI95, 1.03-1.61) were significantly more likely to report an increase in satisfaction with care. Those with a history of hospitalization were also more likely to report an increase in satisfaction with care (OR, 1.27, CI95, 1.01-1.59). The second multivariate logit model evaluated factors that predicted decreases in satisfaction with care from the baseline survey. Those with reported declines in health status were more likely to report decreases in satisfaction with medical care (OR, 1.43, CI95, 1.13-1.79). Neither age, gender, race, type of health plan, disease state, nor doctor's office visits were related to observed changes in satisfaction with medical care.</p><p><strong>Conclusion: </strong>Changes in satisfaction with care appear to be related to changes in health status. However, the relation between these two attributes is not intuitively apparent.</p>","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 2","pages":"56-62"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21598428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The psychological and physiological effects of an intensive-care unit environment on healthy individuals.","authors":"S Tanimoto,&nbsp;K Takayanagi,&nbsp;H Yokota,&nbsp;Y Yamamoto","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>The ideal inpatient environment would be one in which patient stress and anxiety are alleviated, but current inpatient hospital settings often do not seem to take this fact into consideration. To date, the effects of the actual hospital environment itself on patients is poorly understood. The purpose of the present study was to investigate the types of psychological and physiological changes that people undergo in response to being placed in an inpatient setting.</p><p><strong>Design and setting: </strong>Ten healthy volunteers were admitted to an intensive-care unit (ICU) for 4 days and 3 nights. The psychological and physiological changes before and after admission were examined. A qualitative assessment was also performed.</p><p><strong>Results: </strong>Most healthy individuals at times develop feelings of depression, which can be measured by the Profile of Mood States and the Zung Self-Rating Depression Scale (P < .05). In this study, participants' fatigue and confusion increased (P < .05) and vigor decreased (P < .01) as measured by the Profile of Mood States. There was also an increase in the General Health Questionnaire scores (P < .01). However, no significant physiological effects were apparent, as measured by peripheral lymphocyte counts, natural killer cells activity, and urinary 17-kerosteroid and 17-hydroxycorticosteroid levels. Subjects often engaged in introspection during hospitalization and often had a negative attitude towards the hospital environment.</p><p><strong>Conclusions: </strong>The findings of increased feelings of depression attributable solely to being in an ICU setting are inconsistent with the type of environment generally considered necessary to alleviate patient anxiety and tension in a critical-care-ward environment. The negative perception of this environment strongly suggests room for improvement. Efforts in this regard should focus on improving the five senses, particularly sight, sound, and taste within the ICU.</p>","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 2","pages":"77-82"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21598434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An anecdote of distance learning.","authors":"S Schwimmer","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Information Technology column in last quarter's issue provided an overview of continuing professional education options. The experience of a Society for Healthcare Epidemiology of America member as a student in one of the previously described distance-education degree programs is related in this column. The Medical College of Wisconsin, Milwaukee, distance learning Masters of Public Health program provided a means for advancing this member's education that otherwise would not have been practical.</p>","PeriodicalId":79831,"journal":{"name":"Clinical performance and quality health care","volume":"7 1","pages":"36-7"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21220001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}