Paying for patient care in treatment research--who is responsible?
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Biomedical Research↗
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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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Bioethical and legal considerations in increasing the supply of transplantable organs: from UAGA to "Baby Fae".
In the last 35 years, organ transplant technology has advanced greatly. The major problem associated with organ transplantation is organ availability, and not surgery-related mortality. This article examines current organ procurement procedures and technologies, legislative responses to the scarcity of transplantable organs, as well as the psychological barriers to organ donation. Issues of fairness in the allocation of scarce economic and social resources, the role of religion and ethics in organ donation and transplantation decision, and the impact of the media are also considered.
Animals↗
Health care technology and the inevitability of resource allocation and rationing decisions. Part II.
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Costs and Cost Analysis↗
[Residue analysis of substances with estrogenic effects].
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Chromatography, High Pressure Liquid↗
The cost-effectiveness of voluntary counseling and testing of hospital inpatients for HIV infection.
OBJECTIVE: To evaluate the cost-effectiveness of voluntary counseling and testing of US hospital inpatients for the human immunodeficiency virus (HIV). DATA SOURCES: Data for entry into the model were derived from a review of the literature, consultation with experts, and consensus of the authors. DATA EXTRACTION: We rated our confidence in these probabilities and costs by grading the data inputs using methods adapted from those of the US Preventive Services Task Force. DATA SYNTHESIS: Decision analysis models were developed to evaluate two outcomes: (1) cost per health care worker (HCW) HIV infection averted if measures are taken by the HCW to reduce his or her risk of acquiring HIV; and (2) cost per inpatient HIV infection detected. Sensitivity analyses were also conducted. Using baseline input values, testing to avert HCW infection may prevent 3.6 HIV infections per year at a total program cost of $2.7 billion, or a cost of $753 million per infection averted. At baseline assumptions (seroprevalence = 1%), testing to detect inpatient HIV infection would cost $16,104 per year per infection detected. Cost-effectiveness at baseline drops to $8353 per HIV infection detected if the seroprevalence is 10%. If testing is limited to hospitals with inpatient seroprevalences of at least 1%, approximately 5400 persons per year will be falsely labeled HIV-positive. CONCLUSIONS: This analysis provides no justification for testing inpatients to prevent HIV infection of HCWs. Screening inpatients to detect HIV infection may be justified at seroprevalences exceeding 1%, but issues of medical or social discrimination, false-positive results, informed consent, and logistics must be resolved first.
AIDS Serodiagnosis↗
The Advisory Committee on Human Radiation Experiments. Reflections on a Presidential Commission.
Like the National Commission and the President's Commission, the Advisory Committee on Human Radiation Experiments was formed to carry out specific ethical tasks. Yet the committee also had an "openness" mission, a charge to investigate allegations that the U.S. government secretly exposed Americans to environmental releases of radiation. Eighteen months later- and after sixteen public meetings, more than 200 interviews, and the review of about 400,000 documents-the committee delivered a 925-page report to the president.
Advisory Committees↗
Case management at work for SSA disability beneficiaries: process results of the Project NetWork return-to-work demonstration.
This article presents the results of the process analysis of the evaluation of the Project NetWork demonstration, a Federal demonstration undertaken by the Social Security Administration (SSA) in 1991 to test alternative methods of providing rehabilitation and employment services to SSA's Disability Insurance beneficiaries and Supplemental Security Income disabled and blind applicants and recipients. The major findings are: (1) from an operational standpoint, it is feasible to expand access to vocational rehabilitation (VR) services to a broad spectrum of SSA beneficiaries, and (2) roughly similar results are achieved, in terms of client intake and provision of services, when case management services are provided by SSA staff, contracted out to State VR agencies, or contracted with private VR providers. Later evaluation reports will trace demonstration impacts on earnings and disability benefits and report the overall benefits and costs of return-to-work services for this population.
Adolescent↗
[The "restraint" controversy in geriatric psychiatry. Focus study of factors influencing restraint measures].
The study examines the relationship between frequency and duration of restraints in psychogeriatric inpatients with their respective diagnosis, medication, reason for restraints, and age as a socio-demographic variable. Entered in the analysis were data from 590 inpatients from a total of 29 institutions within the Federal Republic of Germany psychogeriatric facilities; this was 24.7% of all psychogeriatrically treated inpatients on the survey day in the said 29 institutions. The data were analyzed via simple multifactorial analyses of variance followed by multiple classification analysis (SPSS for Windows). Neither age nor diagnosis showed any differential influence on frequency or duration of restraints. Among the reasons for restrains hetero-aggression led to fewer and shorter restraints; self-aggression led to fewer but longer restraints. Restless patients were restrained more often but for shorter intervals. The main psychopharmacological strategy, while having no influence on the frequency of restraints, showed a marked influence on their duration; patients treated with low potent neuroleptics had particularly short intervals of restraints, whereas patients free from psychopharmacological agents showed distinctly longer intervals of restraints than the mean of restrained patients.
Accidental Falls↗
Analysis of the cost of training residents in a community health center.
BACKGROUND: Currently one federal program funds community health centers (CHCs) to provide services in underserved communities, and a second supports development of primary care teaching programs. Teaching CHCs respond to both program's goals, but their development is hindered by restrictive regulations of the two programs and lack of information regarding cost. METHOD: Spreadsheet software was used to develop a model that allocates cost components of a CHC-based residency. Productivity and staffing data from a teaching CHC program were used to estimate the cost of training and its sensitivity to selected variables. Data from 1992 through 1994 were collected from the family practice residency sponsored by the Brown University School of Medicine, the Memorial Hospital of Rhode Island, and the Blackstone Valley Community Health Center. RESULTS: An educational supplement of $13.21 per visit would be required for the program to be cost-neutral relative to staff. The cost of outpatient training for a resident averaged $13,935 per year. Residents would "break even" if they saw patients at 19% above the average rate recommended by the residency review committee. If staff physicians instead of residents had provided the patient care, the CHC would have saved $6,171 per resident. Additional savings from improved physician recruiting and decreased turnover would increase the value of the program to the CHC. Cost was most sensitive to resident productivity, precepting arrangements, nursing staff support, and staff turnover. CONCLUSION: Developing graduate medical education programs in CHCs can be a cost-effective way of increasing the pool of appropriately trained primary care physicians and increasing health care access for underserved populations. If teaching CHCs are to expand, provisions will need to be made for adequate reimbursement of their costs.
Community Health Centers↗
Survival and prognostic factors in patients with ovarian cancer.
OBJECTIVE: To assess incidence during a 10-year study period and to identify and discuss clinical relevance for prognostic factors of survival within a cohort of Norwegian ovarian cancer patients. METHODS: Incidence and prognostic factors of survival within a population-based cohort of ovarian cancer patients from one health region in Norway were examined over the 10-year period 1987 through 1996. A total of 571 histologically verified cases of primary ovarian cancer originally registered either in the Cancer Registry of Norway or in the hospital's discharge registers were included in the study. Pearson chi(2) test was used in univariate analyses of cofactors by 5-year survival, and Kaplan-Meier survival curves were computed and tested statistically by the log rank test. A multivariable proportional hazard model (Cox) was applied to assess the prognostic significance of the different covariates. RESULTS: The incidence and crude 5-year survival remained stable over the 10-year study period. The standardized incidence rate for the time periods 1987-1991 and 1992-1996 was 11.9/100,000 and 12.5/100,000, respectively. The crude 5-year survival rate for the cohort was 39%, whereas median survival was 32 months. Cox multivariable regression analysis showed that the only independent significant prognostic factors were International Federation of Gynecology and Obstetrics stage (P <.001), size of residual tumor at the end of primary surgery (P <.001), and age at diagnosis (P <.01). Variables such as time period, histologic type and grade, treating hospital, comorbidity, or CA 125 were insignificant in predicting 5-year survival. CONCLUSION: The results underline the importance of improved surgical management of ovarian cancer, as residual tumor is the only prognostic factor achievable.
Adult↗
Prognostic factors in soft tissue sarcomas. A multivariate analysis of 109 cases.
Prognostic factors were evaluated in 109 soft tissue sarcomas of the extremities, walls of the trunk, head, and neck. All lesions were graded according to the systems proposed by the National Cancer Institute (NCI) and the French Federation of Cancer Centers (FNCLCC), and a correlation was found between tumor grade and prognosis. Univariate analysis selected the following variables as unfavorable prognostic factors: invasive tumor margins, extra-compartmental status, deep tumors, tumor diameters over 5 cm, inadequate excision, presence of necrosis, high mitotic count, histologically undifferentiated tumors, and blood vessel invasion. These variables were found to be interdependent. Multivariate analysis selected quality of surgery as the most important variable for predicting local recurrences. The factors selected with regard to overall and metastasis-free survival were tumor size, tumor margins, necrosis, and adequacy of excision. These results permitted classification of patients into four prognostic groups: two with good and two with bad prognosis. Five-year survival for the four groups was 100%, 83%, 53%, and 0%; 5-year metastatic rates were 0%, 12%, 67%, and 100%. Similar groups were obtained when the variables of tumor margins and size were combined with an adaptation of the NCI grading (low-grade tumors/high-grade tumors without necrosis/high-grade tumors with necrosis). Comparative analysis showed that patients with tumors of the same histologic grade or type were not necessarily classed in the same prognostic groups. A better clinicopathologic correlation was obtained using a combination of prognostic factors than with histologic grading or typing alone.
Adolescent↗
p53 and related proteins in epithelial ovarian cancer.
We conducted a retrospective immunohistochemical evaluation of the prognostic significance of the expression of p53 and the related proteins Bax, Bcl-2, growth arrest and DNA damage (Gadd45), murine double minute 2 (Mdm2) and p21(WAF1/CIP1) in chemonaive tumours taken from 66 patients with ovarian cancer. Ki-67 expression (a marker of cell proliferation) was also evaluated immunohistochemically, while apoptosis within malignant cells was determined with the terminal deoxynucleotidyltransferase-mediated dUTP nick-end labelling (TUNEL) assay. The expression of each of the following proteins was significantly associated in the tumours (P < 0.05 unless otherwise stated): Bax with Bcl-2 (P < 0.01); Bax with Mdm2; p21(WAF1/CIP1) with Gadd45 (P < 0.01); p21(WAF1/CIP1) with p53; p53 with Mdm2. Univariate analysis showed that expression of p53, Bax, bulk residual disease and International Federation of Gynecology and Obstetricians (FIGO) stage were all strongly correlated with response to chemotherapy (P < 0.01). Similarly, the FIGO stage and Ki-67 expression (P < 0.01), as well as pathological subtype and bulk residual disease (P < 0.05), were prognostic factors for disease progression. The FIGO stage and Ki-67 expression were significant prognostic factors for overall survival (P < 0.01), with Gadd45 expression and pathological subtype also significant (P < 0.05) in a univariate analysis. Multivariate analysis for response to chemotherapy showed that expression of p53, Bax and FIGO stage were all independent prognostic factors (P < 0.01). The FIGO stage was the most important independent prognostic factor for progression and survival on multivariate analysis (P < 0.01). However, Ki-67 expression was also an independent prognostic factor for disease progression (P < 0.05) and approached significance for survival (P = 0.055). Taken together, these data suggest that determination of Ki-67 expression could supplement established prognostic factors.
Adult↗
Determination of total, saturated, and monounsaturated fats in foodstuffs by hydrolytic extraction and gas chromatographic quantitation: collaborative study.
Using gas chromatography (GC), 10 collaborating laboratories measured total, saturated, and monounsaturated fats in 8 blind duplicate pairs of foodstuffs. The method involves a hydrolysis/ether extraction of fat followed by quantitative GC analysis versus an internal standard. Calculations were designed to comply with federal regulations as specified in the Nutrition Labeling and Education Act of 1990. The range of fat contents was about 1-50%. Collaborators received and analyzed (in triplicate) a pre-collaborative sample of known fat content as a practice sample. After satisfactory results were obtained, participants received the 16-sample set. The repeatability standard deviations (RSDr) for total fat ranged from 2.04 to 10.6%; the reproducibility standard deviations (RSDR) for total fat ranged from 3.74 to 15.8%. The hydrolytic extraction-GC method for determination of fat (total, saturated, and monounsaturated) in foodstuffs has been adopted first action by AOAC INTERNATIONAL.
Avena↗
NIH Consensus statement. Bioelectrical impedance analysis in body composition measurement. National Institutes of Health Technology Assessment Conference Statement. December 12-14, 1994.
OBJECTIVE: To provide physicians with a responsible assessment of bioelectrical impedance analysis (BIA) technology for body composition measurement. PARTICIPANTS: A non-Federal, nonadvocate, 13-member panel representing the fields of nutrition, pediatrics, surgery, public health, biomedical engineering, epidemiology, and biostatistics. In addition, 20 experts in nutrition, pediatrics, metabolism, biomedical engineering, physiology, and epidemiology presented data to the panel and a conference audience of 220. EVIDENCE: The literature was searched through Medline and an extensive bibliography of reference was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. ASSESSMENT PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after conference. CONCLUSIONS: BIA provides a reliable estimate of total body water under most conditions. It can be a useful technique for body composition analysis in healthy individuals and in those with a number of chronic conditions such as mild-to-moderate obesity, diabetes mellitus, and other medical conditions in which major disturbances of water distribution are not prominent. BIA values are affected by numerous variables including body position, hydration status, consumption of food and beverages, ambient air and skin temperature, recent physical activity, and conductance of the examining table. Reliable BIA requires standardization and control of these variables. A specific, well-defined procedure for performing routine BIA measurements is not practiced. Therefore, the panel recommends that a committee of appropriate scientific experts and instruments manufacturers be formed with the goal of setting instruments standards and procedural methods.
Adipose Tissue↗
Prediction of long-term survival by flow cytometric analysis of cellular DNA content in patients with advanced ovarian cancer.
The prognostic value of cellular DNA content in ovarian cancer (malignant common epithelial tumors) was investigated by flow cytometric analysis of paraffin-embedded tumor blocks from 128 previously untreated patients with International Federation of Gynecology and Obstetrics (FIGO) stage III and IV ovarian cancer entered in a prospective clinical trial of combination v sequential therapy with chlorambucil and cisplatin. Seventy-three percent of tumors were aneuploid and 27% were diploid. Multivariate analysis using a Cox model showed that cellular DNA content (P less than .001) and FIGO stage (P less than .02) were the only significant independent prognostic variables. The median survival was 13 months for patients with aneuploid tumors and 60 months for patients with diploid tumors (P less than .0001). Further analysis indicated that the good prognosis associated with diploid tumors was limited to patients with stage III disease, all patients with stage IV (spread beyond the peritoneal cavity or liver metastases) disease having a poor prognosis irrespective of ploidy. On pathological review, nine borderline ovarian tumors (of low malignant potential) were identified, and seven of these were diploid. These tumors have an unusually favorable prognosis, despite apparent dissemination within the peritoneal cavity, a paradox which is often difficult to explain using conventional histological criteria. Although the vast majority of tumors in this study (93%) were classified as invasive epithelial ovarian cancers, it is possible that some of the patients with stage III diploid tumors may have had malignancies that were predominantly of low malignant potential, thus accounting in part for the prognostic significance of DNA content. By incorporating flow cytometric DNA analysis with careful histopathological assessment, it may be possible to better identify patients with an inherently good prognosis. This assumes particular importance, as the relatively favorable prognosis of patients with stage III diploid ovarian tumors appears to be independent of the type of treatment.
Antineoplastic Combined Chemotherapy Protocols↗
What is the message of a meeting? Analysis and comparison of the 2458 abstracts of the EANM/WCNMB congress in Berlin and the SNM meeting in Toronto in 1998. European Association of Nuclear Medicine/World Federation of Nuclear Medicine and Biology, and the Society of Nuclear Medicine.
The abstracts of the joint congress of EANM/WCNMB in Berlin 1998 and of the 45th Annual Meeting of the Society of Nuclear Medicine in Toronto 1998 have been analysed and compared in terms of comprehensibility, composition, questions at issue, methods, patient/subject number, type of conclusion and duplication of information between the meetings. All 1362 and 1096 abstracts, respectively, were analysed from the abstract books with regard to ten "hard" and four "soft" variables. The dominant topics were new radiopharmaceuticals, methods of synthesis, examination methods, evaluation of examinations, investigation algorithms, technical devices and novel use of radiopharmaceuticals. In addition to these topics, there were numerous reports about established radiopharmaceuticals and techniques, often without a specific merit mentioned. There were also many abstracts with questions outside nuclear medicine, but using such techniques. Few papers reported negative findings or dealt with quality assurance, dosimetry, and cost-effectiveness. Many of the conclusions contained hyperbole. Some abstracts were very extensive and detailed. Sixty-seven contributions conveyed identical information at both meetings. Structured and/or paragraphed abstracts promote clarity and reduce the number of lines that need to be read in order to comprehend the background and aim of the abstract. Such contributions were more frequent at the EANM/WCNMB congress while the SNM meeting covered a wider field with a greater representation of radiophysics, instrumentation, and computer evaluations.
Abstracting and Indexing↗
Using the expected survival to explain differences between the results of randomized trials: a case in advanced ovarian cancer.
PURPOSE: A meta-analysis of randomized trials in advanced ovarian cancer showed a longer survival with cyclophosphamide, doxorubicin, and cisplatin (CAP) than with cyclophosphamide and cisplatin (CP; P =.009). In contrast, the results of the large International Collaborative Ovarian Neoplasm Study (ICON2) showed no survival difference between CAP and carboplatin (P =.98). In this article, we show how these discrepant results can be reconciled through the estimation of expected survival curves. MATERIALS AND METHODS: A proportional hazards model, fitted to the meta-analysis data, was used to construct the expected survival curve for each treatment arm of the ICON2 trial. Expected survival curves were compared with observed survival curves in the ICON2 trial at all time points using a nonparametric test. RESULTS: The prognostic model for survival obtained in the meta-analysis included extent of residual disease, age, histologic grade, and International Federation of Gynecology and Obstetrics stage. When this model was applied to the ICON2 data, there was no difference between the expected and observed curves in the CAP arm. In contrast, the observed survival curve for carboplatin was far superior to the expected survival curve for CP (P <.01). CONCLUSION: These analyses provide indirect evidence that better results are achieved with carboplatin alone at an optimally tolerated dose, compared with the CP combination at a cisplatin dose of 50 to 60 mg/m2. The expected survival may provide valuable insight when direct comparisons between randomized groups yield discrepant results across different studies.
Adult↗
Oregon's experiment.
Oregon's systematic design for universal access to health care, known as the Oregon Basic Health Services Act, has provoked heated debate over its rationale, plan and process. It is a novel attempt to address inequities in the distribution of health care for those below the federal poverty level. Its controversial nature compels more informed discussion to guide further analysis. Accordingly, this report is primarily descriptive, aiming to provide a clear synopsis of the Oregon project's history, complex methodology, and strengths and weaknesses.
Eligibility Determination↗