[Current practice of gynecology and obstetrics in institutional medicine].
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Background. Undernutrition occurs in approximately 2 of every 5 nursing home residents, negatively influencing their health and quality of life. The purposes of this study were to collect data about institutional meal preparation and food service practices that promote or retard adequate nutritional intake and to evaluate residents' food and food service satisfaction. Methods. The FoodEx-LTC, a simple, 44-item, 5-subscale questionnaire that measures food and food service satisfaction, was administered to 61 residents. Serum albumin and body mass index gauged the nutritional status of each resident. SPSS for Windows, version 10, was used for analyses. Results. Overall, 89% of residents were satisfied or somewhat satisfied with the food service. Of those who ate in the dining room, 44% had to wait to go back to their rooms, presenting a quality of life issue. Fifty-two percent received food they hated, 56% often received the same food, and 59% received food always cooked the same way. Most residents (75%) felt comfortable refusing food they did not like, but 65% did not complain. Most (79%) wanted to choose what to eat, but only 54% believed that choosing when to eat was important. Conclusions. The FoodEx-LTC, used to monitor nutrition care in nursing homes, incorporates residents' views into service delivery and responds to the Health Care Finance Administration's Nutritional and Hydration Awareness Campaign, part of the federal Nursing Home Initiative. Using the FoodEx-LTC to identify residents' perspectives may promote resident satisfaction and dietary intake through adaptation of nursing home food and food service practices.
OBJECTIVE: To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. DESIGN: Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. DATA COLLECTION AND ABSTRACTION METHODS: Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. PRINCIPAL FINDINGS: Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites. (2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants. (3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document. (4) Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. CONCLUSIONS: Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.
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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.
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The purpose of this article was to describe the development and actual status of the financial independent dental hygienist in The Netherlands. In 15 years nearly 100 dental hygienists started in financial independent practice after a few years of experience. In a survey (response: 80%, N = 58) respondents reported that especially patients with advanced periodontal diseases were treated in their practice. A majority of the respondents also works for a dentist employer. Compensation by insurance companies makes the treatment by independent dental hygienists approachable for more patients and is therefore advisable.
Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.
BACKGROUND: An estimated 20% of allogeneic blood transfusions in the United States are associated with cardiac surgery. National consensus guidelines for allogeneic transfusion associated with coronary artery bypass graft (CABG) surgery have existed since the mid- to late 1980s. The appropriateness and uniformity of institutional transfusion practice was questioned in 1991. An assessment of current transfusion practice patterns was warranted. METHODS: The Multicenter Study of Perioperative Ischemia database consists of comprehensive information on the course of surgery in 2,417 randomly selected patients undergoing CABG surgery at 24 institutions. A subset of 713 patients expected to be at low risk for transfusion was examined. Allogeneic transfusion was evaluated across institutions. Institution as an independent risk factor for allogeneic transfusion was determined in a multivariable model. RESULTS: Significant variability in institutional transfusion practice was observed for allogeneic packed red blood cells (PRBCs) (27-92% of patients transfused) and hemostatic blood components (platelets, 0-36%; fresh frozen plasma, 0-36%; cryoprecipitate, 0-17% of patients transfused). For patients at institutions with liberal rather than conservative transfusion practice, the odds ratio for transfusion of PRBCs was 6.5 (95% confidence interval [CI], 3.8-10.8) and for hemostatic blood components it was 2 (95% CI, 1.2-3.4). Institution was an independent determinant of transfusion risk associated with CABG surgery. CONCLUSIONS: Institutions continue to vary significantly in their transfusion practices for CABG surgery. A more rational and conservative approach to transfusion practice at the institutional level is warranted.
OBJECTIVE: The purpose of this study was to determine the prevalence of hepatitis markers in inmates and staff of the Penitentiary of Neapolis on Crete and discuss the role of GPs in identifying and vaccinating susceptible subjects. METHOD: Forty-five prisoners and 20 house workers were invited to participate in the study. Hepatitis B (HBV) markers (HBsAg and anti-HBc) and hepatitis C antibodies (anti-HCV) were tested. Vaccination against hepatitis B was administered to all susceptible subjects. RESULTS: Hepatitis B carriage was found in 10 people, six of whom were prisoners. Fifteen of the subjects tested were found to be positive for anti-HBc, six of whom were house workers. Anti-HCV were found to be positive in seven prisoners and one worker. A vaccination programme against hepatitis B was introduced in 27 susceptible subjects (58.7% of unexposed subjects) and was completed in 22. CONCLUSION: Prisoners and staff at Neapolis Prison constitute a high-risk group for hepatitis B and C. Compliance rate in screening was high and GPs were successful in having a desirable response rate in the administration of vaccines.
BACKGROUND: The effectiveness of brachytherapy for the treatment of in-stent restenosis (ISR) has been established in a number of large randomized controlled trials. Efficacy of this therapy in general population is less well established. METHODS AND MATERIALS: We report our experience of 207 patients, 236 coronary lesions, treated with brachytherapy between November 2000 and November 2002. All commercially available brachytherapy devices, as well as one investigational device, were utilized. This cohort was followed over 9 months and clinical outcomes were obtained with subsequent analysis of patient and lesion-specific characteristics. RESULTS: Average treatment age was 62.5 years; 73% were male and the most frequent presentation was unstable angina (74%). All patients had successful delivery of radiation, with no in-hospital deaths. Novoste BetaCath device was used for 163 (65%) lesions, Cordis Checkmate for 56 (24%) lesions, Interventional Therapies device in 13 (8%) lesions, and Guidant Galileo in 4 lesions (3%). At a mean follow-up of 9.1 months, 78.7% were free of major adverse cardiac event (MACE). Twenty-one patients required repeat PTCA (10.1%), 19 had CABG (9.2%), 3 had MI (1.4%), and there was 1 death (0.5%). Unadjusted MACE rates for each device were 21% for Novoste, 28% for Checkmate, 8% for Interventional Therapies, and 50% for Galileo. Lesion length, minimal lumen diameter, renal failure, diabetes, and smoking did not predict treatment failure; only age was inversely correlated with MACE (P=.002). CONCLUSION: When applied across a spectrum of patients, lesions, and devices, brachytherapy retains its effectiveness with outcomes similar to those reported in randomized clinical trials.
BACKGROUND: Surgical practice is often perceived by students as a stressful and demanding lifestyle in which personal and family issues take low priority. For students to receive a more balanced view of surgical practice, we instituted a private practice preceptorship during the last week of our junior surgery clerkship in 2001. We hypothesized that a 4-day preceptorship with surgeons in private practice would improve student perception of surgery as a valid career choice without compromising student educational performance. METHODS: From January to December 2002, 107 junior medical students were assigned to a brief preceptorship with volunteer private practice surgeons during the surgery clerkship (group 1), while 28 students did not participate in the preceptorship (group 2). We assessed student satisfaction via questionnaire and compared student grade performance between groups. RESULTS: One hundred two questionnaires (95%) were returned. Overall, the preceptor experience was rated positively (9.0+/-0.1) based on a 10-point Likert scale. All students commented on the educational or enjoyment value of the preceptorship, with 44% specifically stating that the lifestyle in private surgical practice appeared pleasant. Interestingly, 9% of students volunteered that the experience had swayed them to consider surgery as a career. Twenty-four percent of questionnaires contained negative comments, mainly concerning not enough "hands-on" participation. Grades for the clerkship did not decrease in group 1 when compared with group 2 or with historic controls (n=113). CONCLUSIONS: A 4-day private practice preceptorship at the end of the junior surgery clerkship favorably alters student perceptions of a surgical career without diminishing student grade performance.
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PURPOSE: Policies on the use of dietary supplements in acute care facilities were studied. METHODS: A national online survey was conducted in 2004 to determine institutional policies and practices related to the use of dietary supplements. Directors of pharmacy in acute care settings were asked about the role of the pharmacy and therapeutics committee, the use of a nonformulary request process, the use of informed consent, requirements for written orders, mechanisms to identify dietary supplements, recording of supplement use in the pharmacy database, recording of supplement use in the medication administration record, prohibitions on dietary supplement use, storage of dietary supplements, reporting of adverse events, and the use of published references. RESULTS: Usable responses were received from 302 (25.4%) of 1189 pharmacy directors. Policies on dietary supplements were developed and implemented in 62% of facilities, with 38% of respondents indicating that no such policy existed. Policies most commonly required a written order by an authorized prescriber, documentation of use in the medication administration record, and a mechanism for identification of dietary supplements by a health care practitioner prior to use. Thirty percent of respondents with policies reported that they prohibited dietary supplement use, and 9% of those without policies prohibited use in practice. Most institutions allowed the use of a patient's own supply of supplements if ordered by an authorized prescriber. Supplements were most commonly stored at the nurses' station or in a patient drawer. The most commonly used reference was the Internet. Pharmacists had concerns about the consistency of dietary supplement formulations, the lack of FDA review of supplements, and the difficulty of identifying supplements and distinguishing reputable manufacturers. CONCLUSION: A survey of pharmacy directors in acute care facilities revealed that many had no formal policy regarding dietary supplements and had not implemented planning for such a policy.