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PubMed1994

The National Institute on Aging and the National Cancer Institute SEER collaborative study on comorbidity and early diagnosis of cancer in the elderly.

BACKGROUND: An effect of comorbidity, or the coexistence of other diseases, on the stage of cancer at diagnosis and the appropriateness of therapy in older patients with cancer is hypothesized. The effect of comorbidity differs by cancer site and by type of comorbidity. Such variation could be due to the use of different populations or methods, or the natural history of the tumor being studied. METHODS: The National Institute on Aging (NIA) and the National Cancer Institute (NCI) have initiated a study using cancer patient populations in the NCI's SEER (Surveillance, Epidemiology and End Results) program. Five geographic locations participated in the NIA/NCI pilot study of comorbidity associated with seven cancer sites. Approximately 250 patients with each type of cancer, stratified by age (either 65-74 years of age or 75 years and older) had hospital records abstracted for comorbidity using a form derived from previously reported methods. RESULTS: After analyzing preliminary results for 1712 patients, it was ascertained that more and different chronic disease categories would be necessary, that it was not feasible to collect data on ability to perform certain physical functions from the medical records, and that the collection of data on current medications was possible. With these limitations, relationships of comorbid conditions with stage of cancer were analyzed. CONCLUSION: With the success of the pilot study, the full study is underway. In addition to the planned abstracting of approximately 7800 records, interviews assessing the behavior of illness in a sample of 1000 cancer patients will provide valuable information on the influence of comorbidity and age on stage at initial diagnosis and the treatment of older persons afflicted with cancer.

Aged↗
PubMed1991

Data monitoring committees for multicenter clinical trials sponsored by the National Institutes of Health. I. Roles and membership of data monitoring committees for trials sponsored by the National Eye Institute.

The operational aspects of data monitoring committees for multicenter clinical trials have received little attention in the published literature, in contrast to a wealth of publications concerning the statistical aspects of data monitoring. Occasional anecdotal reports suggest that the role of these committees is complex and that responsibilities and decisions extend beyond choice of a stopping rule. In an effort to gain a better appreciation of the domain of responsibilities shared by all or most of the data monitoring committees (DMCs) for the 20 multicenter studies (30 clinical trials) sponsored by the National Eye Institute, one of the National Institutes of Health, published information was studied and key members of the DMCs for these studies were surveyed. Information about the membership of these important groups also was sought in order to guide those with responsibility for appointing future DMCs. Three tasks--all directly associated with monitoring accumulating data for evidence of benefit or harm to trial patients--were reported unanimously to be the responsibility of the DMCs. In addition, many responsibilities concerned with study oversight rather than data monitoring were assigned to the DMC in 75% or more of the trials. The domain of responsibilities common to a majority of the DMCs suggests that these groups function in most NEI-sponsored multicenter trials as combined data monitoring and policy boards, even when not so designated. The median size of the 20 DMCs was 10 members, with six appointed and four ex officio members. Ophthalmologists accounted for 38% of all DMC positions and statisticians for 33%.

Clinical Trials as Topic↗
PubMed2006

The economic burden of angina in women with suspected ischemic heart disease: results from the National Institutes of Health--National Heart, Lung, and Blood Institute--sponsored Women's Ischemia Syndrome Evaluation.

BACKGROUND: Coronary angiography is one of the most frequently performed procedures in women; however, nonobstructive (ie, < 50% stenosis) coronary artery disease (CAD) is frequently reported. Few data exist regarding the type and intensity of resource consumption in women with chest pain after coronary angiography. METHODS AND RESULTS: A total of 883 women referred for coronary angiography were prospectively enrolled in the National Institutes of Health--National Heart, Lung, and Blood Institute--sponsored Women's Ischemia Syndrome Evaluation (WISE). Cardiovascular prognosis and cost data were collected. Direct (hospitalizations, office visits, procedures, and drug utilization) and indirect (out-of-pocket, lost productivity, and travel) costs were estimated through 5 years of follow-up. Among 883 women, 62%, 17%, 11%, and 10% had nonobstructive and 1-vessel, 2-vessel, and 3-vessel CAD, respectively. Five-year cardiovascular death or myocardial infarction rates ranged from 4% to 38% for women with nonobstructive to 3-vessel CAD (P < 0.0001). Five-year rates of hospitalization for chest pain occurred in 20% of women with nonobstructive CAD, increasing to 38% to 55% for women with 1-vessel to 3-vessel CAD (P < 0.0001). The volume of repeat catheterizations or angina hospitalizations was 1.8-fold higher in women with nonobstructive versus 1-vessel CAD after 1 year of follow-up (P < 0.0001). Drug treatment was highest for those with nonobstructive or 1-vessel CAD (P < 0.0001). The proportion of costs for anti-ischemic therapy was higher for women with nonobstructive CAD (15% versus 12% for 1-vessel to 3-vessel CAD; P = 0.001). For women with nonobstructive CAD, average lifetime cost estimates were $767,288 (95% CI, $708,480 to $826,097) and ranged from $1,001,493 to $1,051,302 for women with 1-vessel to 3-vessel CAD (P = 0.0003). CONCLUSIONS: Symptom-driven care is costly even for women with nonobstructive CAD. Our lifetime estimates for costs of cardiovascular care identify a significant subset of women who are unaccounted for within current estimates of the economic burden of coronary heart disease.

Aged↗
PubMed2002

Improving the health of future generations: the Canadian Institutes of Health Research Institute of Aboriginal Peoples' Health.

In the past and in the present, research studies and media reports have focused on pathology and dysfunction in aboriginal communities and have often failed to present a true and complete picture of the aboriginal experience. The Canadian Institutes of Health Research Institute of Aboriginal Peoples' Health is a national strategic research initiative led by both the aboriginal and research communities. This initiative aims to improve aboriginal health information, develop research capacity, better translate research into practice, and inform public health policy with the goal of improving the health of indigenous peoples.

Academies and Institutes↗
PubMed1998

Memorandum of understanding between the Food and Drug Administration and the National Institutes of Health's National Institute of Dental Research--FDA. Notice.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the National Institutes of Health's National Institute of Dental Research (NIDR) and three of FDA's line organizations: the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research. The purpose of the MOU is to facilitate interactions between NIDR and FDA regarding improvements in the quality and relevance of preclinical and clinical research, which is directed to the development of products for use in oral healthcare.

Dentistry↗
PubMed2003

The National Eye Institute of The National Institutes of Health: its history and impact on clinical eye care.

BACKGROUND: Research supported by the National Eye Institute (NEI) of the National Institutes of Health (NIH) has contributed to the visual well being of the world. Pertinent citations from the literature were compiled to produce a clinical database reviewing major studies of the NEI and their outcomes. METHODS: Using Internet search engines and library resources, clinical NEI studies were reviewed. Their purpose, description, outcome and clinical importance are summarized. RESULTS: The results of major clinical NEI research are presented and included are the current modalities of treatment for each disease studied. CONCLUSION: Each NEI study yielded results upon which current scientific guidelines for the treatment or prevention of ocular disease are based.

Biomedical Research↗
PubMed2006

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE; coverage of phase II and phase III clinical trials sponsored by the National Institutes of Health National Cancer Institute. Final rule.

The final rule allows the Department of Defense to waive normal requirements so that covered beneficiaries can participate in Phase II and Phase III clinical trials sponsored or approved by the National Institutes of Health National Cancer Institute (NIH NCI). This waiver authority is expected to promote beneficiary access to promising new treatments and contribute to the development of such treatments.

Clinical Trials, Phase II as Topic↗
PubMed1988

[The Central Scientific Research Roentgenoradiology Institute of the USSR Ministry of Public Health--70th anniversary (on the history of the Institute)].

The paper is devoted to the history of the organization of the Central Research Roentgenoradiology Institute, USSR Ministry of Health and its 70th anniversary. The great role of the Institute in the organization of Soviet and world roentgenoradiology is emphasized; the main stages of its investigations are described; qualified personnel has been trained over this period. The authors briefly describe the on-going investigations and prospects of their development.

Academies and Institutes↗
PubMed2000

Home-like versus conventional institutional settings for birth.

BACKGROUND: Many home-like birth centres have been established near conventional labour wards for the care of pregnant women who prefer and require little or no medical intervention during labour and birth. OBJECTIVES: The objective of this review was to assess the effects of care in a home-like birth environment compared to care in a conventional labour ward, on labour and birth outcomes. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register was searched. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing a home-like institutional birth environment to conventional hospital care for pregnant women at low risk of obstetric complications. DATA COLLECTION AND ANALYSIS: Trial quality was assessed. MAIN RESULTS: Five trials involving almost 8000 women were included. Substantial numbers of women allocated to home-like settings were transferred to standard care before or during labour, making interpretation of results difficult. Allocation to a home-like setting was associated with lower rates of intrapartum analgesia/anaesthesia (odds ratio 0.82, 95% confidence interval 0.72 to 0.93), fetal heart rate abnormalities (0.72, 95% confidence interval 0.63 to 0.81), augmented labour, and immobility during labour, as well as greater satisfaction with care, and increased likelihood of sore nipples and mastitis. There was a non-statistically significant trend towards higher perinatal mortality in the home-like setting (odds ratio 1.49, 95% confidence interval 0.79 to 2.78). REVIEWER'S CONCLUSIONS: There appear to be some benefits from home-like settings for childbirth, although increased support from caregivers may be more important. Caregivers and clients in home-like settings need to watch for signs of complications.

Birthing Centers↗
PubMed2002

The role of the institutional review board in quality improvement: a survey of quality officers, institutional review board chairs, and journal editors.

PURPOSE: There has been growing concern about whether and when quality improvement activities require Institutional Review Board (IRB) review and informed consent. We sought to determine whether quality officers, IRB chairs, and journal editors share similar views about the role of IRB review and informed consent in quality improvement. METHODS: A survey consisting of six quality improvement scenarios detailing the development, implementation, and evaluation of a clinical practice guideline for the management of patients with acute myocardial infarction was mailed to all medical directors of quality and IRB chairpersons at hospitals with at least 400 beds that are members of the Council of Teaching Hospitals of the Association of American Medical Colleges. The same survey was mailed to the editors of all U.S. medical journals that appear in Abridged Index Medicus. RESULTS: Quality officers were less likely than IRB chairs to believe that IRB review was required for all but one of the scenarios. When a clinical practice guideline developed by a national specialty society was implemented locally and its effects evaluated by chart review and telephone calls to patients, 47% (44/94) of IRB chairs, 66% (25/38) of journal editors, but only 20% (20/100) of quality officers believed the activity should be subjected to IRB review. Among those who thought that IRB review was required, there were similar but less striking differences in the perceived need for informed consent. Agreement between quality officers and IRB chairs within the same institution was poor, ranging from 44% to 52% for three of the six scenarios. CONCLUSION: In light of the pressing need to improve quality while protecting the rights of patients, efforts should be supported to clarify the role of the IRB in quality improvement activities.

Attitude of Health Personnel↗
PubMed1993

Clinical profile and problems of management of 108 cases of germ cell tumours of testis at Institute Rotary Cancer Hospital, All India Institute of Medical Sciences New Delhi 1985-1990.

A retrospective analysis of 108 cases of primary germ cell tumours of testis seen over a 6 year period at Institute Rotary Cancer Hospital of All India Institute of Medical Sciences, New Delhi is presented. There were 45 (42%) cases of seminoma and 63 (48%) of non-seminomatous germ cell tumours (NSGCT). The median age at presentation was 35 and 30 years respectively. Almost half (56) patients presented in advanced stage (stages IIc-IV). Tumours in undescended testis formed an important subgroup (14%). The standard approach of treatment was radiotherapy in stages I & II seminomas and chemotherapy in bulky seminomas and metastatic NSGCT. Chemotherapy protocols used were VAB-6 and PVB. Although a policy of surveillance has been practised for stage I NSGCT, it is debatable whether it is universally suitable for our patients. The results of treatment in low volume disease are comparable to that in the west but the management of bulky disease requires a more aggressive approach. Unfortunately only 74 out of 108 (68.5%) patients were able to complete the treatment prescribed. Most of the defaulters were from the chemotherapy group because of inability to afford the drugs. The probability of survival of those who completed treatment was 0.77 at 4 years. Since testicular tumours are largely curable, a more vigorous policy of detection, follow up and treatment needs to be pursued. Better screening of children with undescended testis will reduce cancer in this group. Failure to provide chemotherapy to all patients is particularly unfortunate for a curable disease like testis cancer.

Adult↗
PubMed2002

50 years of the Institute of Experimental Endocrinology of the Charité (Humboldt University, Berlin) -- the way from Aschheim's laboratory of the 2nd Department of Obstetrics & Gynaecology to a research institute.

The aim of this article is firstly to elucidate the historical roots which preceded the foundation of the first Institute of Experimental Endocrinology in Germany and secondly to illustrate the special development of this Institute with its ups and downs within the context of German history.

Berlin↗
PubMed2005

Implementing institutional change: an institutional case study of palliative sedation.

Palliative sedation is used in the rare patient who has intractable distress at the end of life. Implementation of palliative sedation, however, may meet resistance from various clinicians and other hospital staff. To ensure that our patients had access to this important treatment modality, we found it necessary to engage in a process of institutional change that resulted in acceptance of the use of palliative sedation in the non-ICU setting.* In this paper, we will review the processes we found to be successful in hopes that they will also be efficacious for others wishing to produce similar change within their institutions. We first will review the theoretical foundations described in organizational development and change management literature. Next we describe our implementation strategies (including education, multidisciplinary alliances, and the development and approval of a practice guideline). Finally, we discuss in detail the role of interpersonal interactions. Three clinical cases are used to demonstrate the change in attitudes, processes, and outcomes.

Aged↗
PubMed1999

Application of the National Institute on Aging (NIA)-Reagan Institute criteria for the neuropathological diagnosis of Alzheimer disease.

The Khachaturian criteria and the Consortium to Establish a Registry for Alzheimer Disease (CERAD) criteria for the neuropathological assessment of Alzheimer disease (AD) emphasize senile or neuritic plaques, age, and clinical history. A new scheme stressing topographic staging of neurofibrillary changes in addition to neuritic plaques has been proposed by the National Institute on Aging (NIA)-Reagan Institute Consensus Conference. This scheme assigns cases to high, intermediate, or low likelihood categories that the dementia is due to AD. We applied this method to 84 brains from subjects with clinical and neuropathological diagnoses of AD (n = 33), non-AD dementing illnesses (n = 34), including dementia with Lewy bodies (DLB) and progressive supranuclear palsy (PSP), and no neurological disease (n = 17). We also used Khachaturian and CERAD criteria. Neurofibrillary tangle and neuropil thread densities were assessed on 6-micrometer-thick modified Bielschowsky-stained paraffin sections from entorhinal-perirhinal cortex, CA1 of hippocampus, and neocortex including inferior temporal, visual association, and primary visual cortices. Each case was assigned a Braak and Braak stage. Using the NIA-Reagan criteria, we found excellent agreement between clinical history of AD dementia and brains assigned to the high likelihood category that dementia was due to AD. Among brains diagnosed neuropathologically with other degenerative diseases, NIA-Reagan criteria were more conservative than previous criteria, and these cases were likely to be categorized as intermediate or low likelihood that dementia was due to AD. All brains from nondemented subjects were assigned to the low (81%) or intermediate (19%) categories. In summary, we found good correlation between the NIA-Reagan criteria and clinical dementia, and there was generally good agreement between these criteria and existing neuropathological methods, Khachaturian and CERAD, in diagnosing AD. In studying several other neurodegenerative diseases, such as DLB, which shows neuropathological and clinical overlap with AD, the staging of neurofibrillary changes offered potential diagnostic refinement.

Aged↗
PubMed2007

Rejuvenating a foundering institutional review board: one institution's story.

This report recounts one institution's experience in the fundamental reorganization of its institutional review board (IRB). With an appropriate approach, organizational structure, and ethos, the goals of research participant safety, regulatory compliance, and efficiency are not in conflict but, rather, mutually reinforcing. These important goals were realized because all aspects of the IRB reorganization were guided by and measured against five related principles: (1) expertise, (2) service, (3) credibility, (4) efficiency, and (5) accountability. This medium-sized academic IRB was successfully reorganized to increase the scrutiny of protection of human subjects and to promote efficiency and investigator services. On average, the office returned expedited submissions to investigators with approvals or queries within two working days of submission. On submissions requiring full committee review, letters and faxes were issued to investigators within 48 hours of committee meetings. This turnaround time (combined with a nine-day premeeting submission requirement) meant that investigators who had submitted new studies for full committee review received an approval, request for modifications, queries for more information, or disapproval within 11 days from the reorganized IRB. In contrast, an Office of the Inspector General study noted that IRBs in academic medical centers typically report decisions within an average of 37 days. The reforms included mechanical and operational changes within office procedure, a robust educational program for committee members, and a revamped IRB office staff that decreased the total number of office employees from five to four but that increased educational levels and skills of the staff members.

Academic Medical Centers↗
PubMed2006

Advancing institutional anomie theory: a microlevel examination connecting culture, institutions, and deviance.

Institutional anomie theory (IAT) contends that crime can be explained by an examination of American society, particularly the exaggerated emphasis on economic success inherent in American culture, which has created a "cheating orientation" that permeates structural institutions, including academia. Consistent with its macrosocial perspective, previous tests of IAT have examined IAT variables at the structural level only. The current study tests the robustness of IAT by operationalizing IAT variables at the individual level and looking at a minor form of deviance, student cheating. The author also examines the role statistical modeling has in testing the theory at the microlevel. Undergraduates, 122 American born and 48 international, were surveyed about their cheating behaviors and adherence to economic goal orientations. Results related to the hypothesis that American students, relative to foreign-born students, will have an increased adherence to economic goal orientations that increase cheating behaviors are presented, as are suggestions for future studies.

Achievement↗
PubMed1999

Development of guidelines for treatment of children with phenylketonuria: report of a meeting at the National Institute of Child Health and Human Development held August 15, 1995, National Institutes of Health, Bethesda, Maryland.

OBJECTIVE: To convene a small group of experts in diagnosis and management of PKU to discuss the following issues: the Subject Review of PKU management being performed by the American Academy of Pediatrics (AAP) Committee on Genetics (COG), the published British guidelines on PKU management, and the feasibility, suitability, and mechanism of developing PKU management guidelines for the United States. METHODS: A 1-day meeting was held at the National Institutes of Health under the auspices of National Institute of Child Health and Human Development, convening experts in PKU diagnosis and management and members of the AAP/COG. RESULTS: The group reviewed the published reports of outcomes of treatment of PKU and the British guidelines that were developed based on those data. It also reviewed the results of surveys of directors of clinics that manage PKU, parents of children with PKU, and young adults with PKU. CONCLUSION: The group supported the efforts of the AAP/COG to perform this review of PKU management. The group concluded that significant issues need to be resolved to provide sufficient information to establish US guidelines for PKU management. The establishment of such guidelines is an important next step in PKU management in the United States.

Adult↗