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PubMed1995

Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients.

BACKGROUND: The process by which patients are informed and their consent is obtained in phase I trials has thus far been only marginally studied. Since 1986 we have followed an oral procedure, consisting of three consecutive conversations in which the investigator responsible for phase I studies, the research nurse and the patients' relatives and/or friends also participate, followed by the patients signing of a written consent form. It is required that six items of information considered essential by our staff be conveyed to patients by the responsible investigator. Meerwein's model, which defines three main dimensions of the informing process (the information itself, the emotional and interactive aspects), has been studied to ascertain whether it can be applied to evaluate the quality of the information proffered. METHODS: Thirty-two conversations were taped, transcribed and evaluated by one psychiatrist and one psychologist. A quantitative analysis of information was performed by calculating the number of patients to whom the essential items of information had been conveyed. The qualitative analysis was performed by rating on a five-point scoring system, from 1 (very bad) to 5 (excellent), the three dimensions of the informing process for each patient and by calculating for each dimension the mean score of the constituent items. RESULTS: Complete information about the characteristics of the phase I drug and the modalities of the treatment and follow up was given to almost 80% of the patients. All but one of the items of the information dimension scored 3.5 or higher, with the one related to the assessment by the doctor of the patient's understanding at the end of the consultation scoring less than 3 in 53% of the patients. All items of the emotional dimension scored higher than 3.5. Greater difficulty was encountered by the physician with the interactive dimension, the lowest mean scores being reported on the items related to the doctor's awareness of the indirectly expressed anxieties of the patients. In 71% of the consultations the three dimensions of information scored more than 3 and balanced one another, indicating a successful consultation by the Meerwein model. CONCLUSIONS: The informed consent procedure applied was satisfactory from a quantitative point of view, and the main items of information were acceptable to the patients. Meerweins's model proved to be applicable and useful for identifying pitfalls in communication. Greater attention should be paid to the indirect messages and implied criticisms of the patients to improve their participation in decision making. Physicians should become more skillful in providing adequate information and improve their methods of communication.

Adolescent↗
PubMed2000

Design, implementation, and evaluation at entry of a prospective cohort study of homosexual and bisexual HIV-1-negative men in Belo Horizonte, Brazil: Project Horizonte.

BACKGROUND AND OBJECTIVES: Project Horizonte, an open cohort of homosexual and bisexual HIV-1-negative men, is a component of the Minas Gerais AIDS Vaccine Program of the Federal University of Minas Gerais, Belo Horizonte, Brazil. Its objectives included the evaluation of seroincidence of HIV, to ascertain the role of counseling on behavior modification and to assess their willingness to participate in future HIV vaccine trials. METHODS: Various means of recruitment were used, including pamphlets, notices in community newspapers, radio, and television, at anonymous testing centers, and by word of mouth. RESULTS: From October 1994 to May 1999, 470 volunteers were enrolled. Their mean age was 26 years and over 70% of them had high school or college education. During the follow-up, they were seen every 6 months, when they received counseling and condoms, and when HIV testing was done. Eighteen seroconversions were observed, and the incidence rates estimates were 1.75 per 100 and 1.99 per 100 person-years, for 36 and 48 months of follow-up, respectively. During the entire period, 139 volunteers were lost to follow-up. Among them, 59 (42.4%) never returned after the initial visit and 51 (36.7) came only once after their initial visit. No losses were observed for those observed during follow-up for more than 3 years. At enrollment, 50% of participants said they would participate in a vaccine trial, and 30% said they might participate. CONCLUSIONS: The results obtained up to this moment confirm the feasibility of following this type of cohort for an extended period, estimating HIV incidence rate, and evaluating counseling for safe sexual practices in preparation for clinical trials with candidate HIV vaccines in Brazil.

Adult↗
PubMed1990

Medicare DRGs and post-hospital care for the elderly: does out of the hospital mean out of luck?

This article reports findings from a multistate study of the effects of medical cost containment policy, particularly the Medicare DRG (Diagnosis Related Groups) reimbursement policy, on community-based services for the elderly. The study findings reveal that since the implementation of DRGs, more older clients in poorer states of health are seeking posthospital care services. Greater client demand and illness acuity is leading to increases in service refusals to vulnerable clients and the creation of agency waiting lists. The majority of agency directors attribute the declining health status of clients to DRG reimbursement.

Aftercare↗
PubMed1998

Follow-up of sporadic cases of food-borne infection: comparison of a postal questionnaire with a personal visit.

The aim of the study was to evaluate the follow-up of sporadic cases of suspected food-borne illness by either a postal questionnaire or a personal visit by environmental health staff. This was achieved by comparing the practice in two authority areas within the West Pennine Health Authority in the north west of England. We included all identified cases of suspected food poisoning, campylobacteriosis, cryptosporidiosis, salmonellosis and dysentery occurring in the district between 1 July and 30 September 1996. The main outcome measures were: (1) the proportion of all cases which were successfully followed-up by each method; (2) the timeliness of follow-ups; (3) qualitative estimation by environmental health staff of the data obtained. Visiting by environmental health staff was successful in obtaining information from 76.3% (106/139) of cases, while the postal questionnaires elicited a 52% (50/96) response rate. We found that 70.5% of visits occurred within one week of notification. Although 69.8% (67/96) of questionnaires were issued within one week of notification, only 16% of replies to the questionnaire were received within this period. The information provided on the returned questionnaires was found by environmental health staff to be generally as useful as that obtained by visiting.

Adolescent↗
PubMed2001

Finding the meanings of college drinking: an analysis of fraternity drinking stories.

College drinking has traditionally been studied from a public health perspective that attempts to quantify behavior as a means toward description, explanation, and intervention. This article offers a critical and cultural approach to understanding the meanings and functions of high-risk drinking and the ways in which those meanings are reproduced within the culture. Data were collected via an ethnographic study of fraternity members at a large midwestern university to explore the communication of excessive drinking norms. Viewed from various narrative and structural theories, the study examines collected drinking stories as a source for analyzing the construction of meanings surrounding drunkenness for the fraternity subculture. Five themes emerged as functions of drunkenness for the culture. Implications for prevention are discussed.

Adult↗
PubMed1990

Revisiting the garden: medicine and management in the 1990s.

The importance of effective hospital-physician relationships is acknowledged by all. Yet few empirically based guidelines exist for strengthening such relationships. Based on an in-depth examination of ten sites' experience, this article suggests a number of approaches and ideas for forming more effective hospital-physician relationships in the 1990s. Among the issues addressed include the nature of hospital-physician collaboration and competition, embracing risk, forging new forms of partnership, creating value for purchasers, and grooming younger physicians for leadership roles.

Consumer Behavior↗
PubMed1983

Chronic low back pain: a medical-psychological report.

This paper begins with general discussion of chronic pain, in which the complex nature of this symptom is pointed out and the incorrect application of the widespread distinction between 'organic' and 'psychogenic' pain is criticized. A different classification which has proved clinically valuable is then briefly discussed. Subsequently, there is a discussion of the symptom of low back pain, a frequent disorder as demonstrated by the epidemiologic investigation reported. Then, reference is made to chronic low back pain which is often treated by surgical intervention such as operation for prolapsed intervertebral disc (PID). To conclude, a detailed report is presented of a study of 55 patients all of whom had been subjected at least once to a PID operation without success and who subsequently applied for partial percutaneous rhizotomy (PPR). Every patient was interviewed in depth and the results of these interviews are presented, classified by the main topics discussed. In addition, 6 months after PPR, a follow-up interview was conducted concerning the therapeutic results in the 31 patients who underwent this procedure.

Adult↗
PubMed2006

Reaching hard-to-reach migrants by letters: an HIV/AIDS awareness programme in Nepal.

We assessed the impact of an HIV/AIDS programme for Nepalese migrants to India that involved writing letters. The programme created opportunities for sending HIV/AIDS-related messages to the migrants in India, and encouraging them practicing safer sex. Initially, they received the messages only from the programme, but later from their colleagues, spouses or other family members. They discussed the messages in groups, disseminated them, and sought more knowledge in their destinations. These findings indicated that using letters could be an effective way to reach inaccessible migrants at their destinations, and help them to improve their HIV/AIDS-related knowledge, and safer sex practices.

Adolescent↗
PubMed1989

The Sickness Impact Profile as a measure of the health status of noncognitively impaired nursing home residents.

The Sickness Impact Profile (SIP) is a multidimensional, behaviorally based measure of the health status that has been successfully used in a wide range of applications. The characteristics of this measure have not been assessed with nursing home residents. The purpose of this study was to assess the feasibility, reliability (internal consistency), validity, and comprehensiveness of the SIP as a measure of the health status of a selected group of nursing home residents. One hundred sixty-eight veterans residing in community and VA nursing homes responded to a questionnaire consisting of the SIP, Index of Activities of Daily Living, Barthel Index, Life Satisfaction Index Z, and the Philadelphia Geriatric Center Morale Scale. In general, the respondents correctly interpreted instructions; reliability and validity were supported; and the SIP was found to provide a comprehensive assessment of physical function. Adding a measure of psychologic well-being to a study protocol involving this population may, however, provide additional useful information regarding this construct.

Activities of Daily Living↗