The impact of biopsychosocial factors on quality of life: women with primary biliary cirrhosis on waiting list and post liver transplantation.

OBJECTIVES: Primary biliary cirrhosis (PBC) is the second most common reason for liver transplants among women in the USA. While survival rates are high, there is evidence of persistent problems post-transplant. This study aimed to identify significant contributors to quality of life (QOL) for women with PBC on waiting list (WL) and post-transplant (PT) and compare QOL in each group with US population norms. DESIGN: A cross-sectional, two-group study design was used. METHODS: WL and PT participants were recruited through medical centres and on-line. QOL was measured by the Short Form-36 and an indicator of Social QOL created for this study. A biopsychosocial model incorporating demographic, biomedical, psychological, and sociological factors guided choice of variables affecting QOL. Analyses examined (1) all factors for differences between WL and PT groups, (2) association between factors and QOL outcomes within each group, (3) multivariate regression of QOL on factors in the model for the sample as a whole, and (4) comparison of QOL outcomes with national norms. RESULTS: One hundred women with PBC participated in the study, 25 on WL and 75 PT. Group comparisons showed improvement for PT participants in most biomedical and psychological variables and in QOL outcomes. QOL was related to many, but not all, of the variables in the model. In multivariate analysis, Fatigue, Depression, Coping, and Education - but not Transplant Status - were identified as indicators of QOL. Physical QOL improved significantly after 5 years PT, when it was no longer worse than national norms. Mental QOL remained worse than national norms despite distance in time from transplant. CONCLUSIONS: The model proved useful in identifying a range of factors that contributed to QOL for women with PBC before and after transplant. Recommendations were made for clinical practice to improve QOL through a combination of treatment and self-management.

Uncertainty and liver transplantation: women with primary biliary cirrhosis before and after transplant.

Uncertainty is a frequent feature of chronic illness and can have a particularly important impact in the case of organ transplantation. This study of 100 women with primary biliary cirrhosis who were either waiting for or had already had a liver transplant focused on both changes in uncertainty with transplant and the correlates of uncertainty both pre- and post-transplant. While those who were post-transplant had significantly lower uncertainty scores (measured by the Mishel Uncertainty in Illness Scale-Adult Version-MUIS-A) than those on the waiting list, uncertainty was still persistent and associated with a reduced quality of life. The most significant factors in relation to uncertainty were fatigue, depression, anxiety, and dissatisfaction with medical information received. It is important for both patients and transplant team members to recognize the impact of uncertainty on a patient's well-being, both before and after a transplant, and to address the underlying factors that continue to compromise quality of life even after a life-saving procedure.

Fatigue as a major predictor of quality of life in women with autoimmune liver disease: the case of primary biliary cirrhosis.

OBJECTIVES: Fatigue is a nearly universal symptom of many chronic diseases, yet it is often poorly understood and underappreciated as a factor in quality of life (QOL). Generally, clinicians have relied on subjective measures of fatigue, if they consider it at all. This study uses well-validated instruments to examine fatigue as a predictor of QOL in women with primary biliary cirrhosis (PBC), an autoimmune, chronic liver disease. METHODS: Eighty-one women with PBC completed a survey that included measures of fatigue (Fatigue Impact Scale) and QOL (SF-36) as well as demographic variables (age, education) and medical information (symptoms, stage of illness, time since diagnosis). QOL results for the sample were compared with those of a nationally normed U.S. population. Bivariate and multivariate analyses were conducted to identify contributors to variation in QOL. RESULTS: Compared with national norms, QOL for this PBC population was significantly impaired. When all variables with bivariate significance in relation to QOL were included in multivariate analyses, results showed fatigue to be the primary predictor of QOL, including all 8 QOL scales and the 2 summary scales. Regression results, dominated by fatigue, explain 25-59% of the variance in QOL. CONCLUSIONS: Fatigue has profound effects on every aspect of life for women with PBC-physical, social, emotional, and psychological. The results lead to recommendations for health care providers to assess fatigue in their patients with PBC and to take steps, where warranted, to mitigate its effects.

Seasonal patterns of fatal and nonfatal falls among older adults in the U.S.

INTRODUCTION: While many believe that older adults fall more often during the winter months, research on this is inconclusive. This study used nationally representative data from 2001 to 2002 to examine unintentional fatal fall rates among older men and women by season and climate, and nonfatal fall rates by season. METHODS: We studied fatal and nonfatal unintentional falls among U.S. adults aged > or =65 during December 2001-November 2002 by season. Fatal fall data were obtained from National Center for Health Statistics' annual mortality tapes; nonfatal fall data for injuries treated in emergency departments were obtained from the National Electronic Injury Surveillance System All Injury Program. Fatal falls were also analyzed by climate based on each state's average January 1, 2001 temperature (colder climates < or =32 degrees F (0 degrees C) and warmer climates >32 degrees F (0 degrees C)). RESULTS: From December 2001 through November 2002, neither fatal nor nonfatal fall injury rates showed any seasonal patterns. For fatal falls, the average rate was 9.1 percent higher in colder climates, regardless of season. CONCLUSION: Among older adults, fatal fall rates appear to be influenced more by climate than by season. Additional research is needed to clarify the mechanisms underlying these observations.

Fall-risk evaluation and management: challenges in adopting geriatric care practices.

One third of older adults fall each year, placing them at risk for serious injury, functional decline, and health care utilization. Despite the availability of effective preventive approaches, policy and clinical efforts at preventing falls among older adults have been limited. In this article we present the burden of falls, review evidence concerning the effectiveness of fall-prevention services, describe barriers for clinicians and for payers in promoting these services, and suggest strategies to encourage greater use of these services. The challenges are substantial, but strategies for incremental change are available while more broad-based changes in health care financing and clinical practice evolve to better manage the multiple chronic health conditions, including falls, experienced by older Americans.

Reputationally strong HIV prevention programs: lessons from the front line.

Although HIV prevention researchers have conducted numerous controlled outcome studies to evaluate the effectiveness of theory-based interventions aimed at reducing HIV risk behaviors, many HIV risk reduction interventions are conducted not by researchers but by staff in local health departments or community-based organizations (CBOs). Despite their widely recognized role in slowing the spread of HIV, very few attempts have been geared toward understanding the programmatic and organizational characteristics of their HIV prevention efforts. The Centers for Disease Control and Prevention's Characteristics of Reputationally Strong Programs project identified and profiled 18 innovative, community-based, HIV prevention programs viewed by community partners as successful. The aim was to determine common features of the programs that could be widely applied to improve HIV prevention research and programs. Results indicated that several common intervention characteristics and organizational characteristics, including agency support and staff commitment, played significant roles in the success of reputationally strong programs.

The role of an online community for people with a rare disease: content analysis of messages posted on a primary biliary cirrhosis mailinglist.

BACKGROUND: This study focuses on the role of an Internet-based group for people who have an autoimmune liver disease, primary biliary cirrhosis. Primary biliary cirrhosis is a relatively rare disease, affects primarily women in their 40's and older, and is not well understood. The PBCers Organization (PBC stands for primary biliary cirrhosis) provides electronic mailinglists (listservs) and informational resources for those with primary biliary cirrhosis. OBJECTIVES: (1) to identify the issues of greatest importance to those posting to the listserv, specifically the relative importance of biomedical, socioemotional, and organizational/systems messages; (2) to compare frequency and content of posts by people at different stages of disease; (3) to identify how people with primary biliary cirrhosis represent the psychosocial challenges and dilemmas (role and identity change, uncertainty, and stigma) identified in the social-scientific literature as key elements of the experience of chronic disease. METHODS: The paper is based on content analysis of messages posted during two months to the Daily Digest listserv for people who have primary biliary cirrhosis. To analyze the posts, we developed a coding system with three major categories--biomedical, socioemotional, and systems/organizations--and 12 codes in each category. RESULTS: A total of 275 people posted 710 messages. Of the 250 people for whom information on gender was available, 239 (95.6%) were women and 11 (4.4%) were men. Analysis of 710 messages posted to the listserv revealed a predominance of requests for and reports of biomedical information, such as health care providers (32.7%), medications (30.9%), tests and procedures (25.8%), and symptoms (25.7%), combined with very frequent expressions of emotional support. The most frequent single topics were peer support (included in 40.6% of all posts) and positive emotions (25.3%). Posters who reported fewer years since diagnosis were more likely to be seeking biomedical information than those who were further in time from their diagnosis (r= -.241, P<.001, n=313). Those in later stages posted an average of 3.87 messages, compared to an average of 2.64 for people in earlier stages (t= 1.786, P=.08, n=90), which is different from what we expected. No relation between years since diagnosis or age and number of messages was found. Contrary to our expectations, the topics reflecting issues of role change/identity (2.9%), stigma (0.7%), and thoughts about the future (3.9%), all identified in social-scientific literature as key concerns for people with chronic illness, appeared infrequently in this set of messages. CONCLUSIONS: Messages exchanged on this particular mailing list have a biomedical, rather than socioemotional or organizational, emphasis. The Internet offers a highly valued opportunity for those with rare diseases to connect with, learn from, and provide support to others having similar experiences. Research that compares those with primary biliary cirrhosis, who are involved in an Internet support group and those who are not, would be an important next step to better understanding the role of the Internet among patients with chronic liver disease and the implications of it in the course of their illness.

Theoretical issues in the synthesis of HIV prevention research.

The evidence base for science and health policy consists of many independent research studies. Combining evidence from multiple studies that differ in important ways presents challenges that have been addressed in other areas of scientific research and are now beginning to be addressed in HIV prevention research. Syntheses can enhance statistical power and produce summary evidence that is more generalizable than individual primary research.

The HIV/AIDS Prevention Research Synthesis Project: scope, methods, and study classification results.

In 1996, the Centers for Disease Control and Prevention (CDC), in collaboration with many partners, initiated the HIV/AIDS Prevention Research Synthesis (PRS) project to accumulate HIV prevention research studies and analyze their effectiveness in reducing sexual and drug-related risk behaviors for HIV transmission. The PRS team developed standardized guidelines and procedures for the systematic reviews, conducted systematic searches for pertinent studies, characterized the selected studies, analyzed effectiveness data, and established a cumulative database. As of June 1998, the database contained more than 5000 reports: 4068 were reports that met the PRS scope criteria for inclusion and 586 of those reports contained outcome data from an intervention study. Of the 586 reports that included outcome data, 276 have been reviewed: 223 (81%) included measures of PRS-specified behavioral or biologic HIV-related outcomes, and 124 of the 223 (56%) used PRS-defined rigorous study designs. The PRS database is a valuable resource for accessing and integrating the literature on HIV prevention research. CDC is committed to 1) updating the database; 2) producing systematic reviews, including meta-analyses, related to key research questions; and 3) disseminating findings to encourage and facilitate the use of science-based research in preventing HIV infection.

A profile of U.S.-based trials of behavioral and social interventions for HIV risk reduction.

We describe 99 (experimental and certain quasi-experimental) U.S.-based trials, reported or published since 1988, of behavioral and social interventions that measured prespecified behavioral and biologic outcomes and aimed to reduce risk for HIV infection. Studies identified through June 1998 by the HIV/AIDS Prevention Research Synthesis project were grouped into 4 risk behavior areas: drug-related (k [number of studies] = 48), heterosexual youth (k = 24), heterosexual adult (k = 17), and same-sex (k = 10). We compared the studies in the 4 areas by variables key to the development, evaluation, and transfer of interventions. Participants comprised injection drug users (43% of studies), drug users out of treatment (29%), African Americans (18%), clinic patients (18%), youth in schools (10%), and drug users in treatment (10%). Most studies were randomized (85%), provided another intervention to the control or comparison groups (71%), and evaluated behavioral interventions (92%). On average, interventions were conducted in 5 sessions (total, 8 hours) during 3 months. The theoretical basis of the intervention was not noted in 57% of the reports. At least one variable from each of the 3 outcome classifications was measured in 8% of the studies: behavioral, biologic, and psychosocial. Distinct profiles exist for the 4 risk areas. Addressing gaps in research and reporting would be helpful for analytical and program activities. This sizable portfolio of evaluated interventions contributes to effectiveness reviews and to considerations of transfer to program practice.

A protocol for the analytical aspects of a systematic review of HIV prevention research.

Quantitative analysis can reveal the consistency of intervention effects across studies, as well as the variation of effects according to study-level characteristics. After consulting with project experts in methods and content, and reviewing the literatures on research synthesis and on HIV prevention, we developed a systematic protocol of analytical methods for synthesis of behavioral and biologic outcome data from HIV intervention studies. This protocol included procedures for identifying eligible studies; defining, characterizing, and prioritizing outcomes; abstracting and calculating estimates of effect; adjusting for baseline distributions and intraclass correlation; transforming estimates to a common metric; summarizing effects; examining differences in effectiveness among groups of studies; and translating these results into terms useful to HIV prevention practitioners and researchers. We applied these procedures to transform outcome data reported in many different statistical formats into odds ratios that could be combined and compared across studies. We analyzed data on behaviors related to sexual risk for HIV infection (unprotected sex, condom use, and number of partners) as well as data on biologic outcomes (incidence of HIV and other sexually transmitted infections). This framework may be useful for meta-analyses of prevention research in other fields, particularly when primary research features diverse outcome measures and methods of analysis.

A meta-analysis of the effect of HIV prevention interventions on the sex behaviors of drug users in the United States.

We examined the effectiveness of 33 U.S.-based HIV intervention studies in reducing the sexual risk behaviors of drug users by reducing unprotected sex or increasing the use of male condoms. The studies, identified as of June 1998, through the HIV/AIDS Prevention Research Synthesis project, were published in 1988 or later, measured behavioral or biologic outcomes, used experimental designs or certain quasi-experimental designs, and reported sufficient data for calculating an effect size for sexual risk reduction. Of the 33 studies, 94% recruited injection drug users; 21% recruited crack users. The mean age of participants was 36 years. Almost all studies were randomized (94%), provided another HIV intervention to the comparison groups (91%), and evaluated behavioral interventions (91%). On average, interventions were conducted in 5 sessions (total, 10 hours) during 4.5 months. Interventions compared with no interventions were strong and significant (k = 3; odds ratio [OR], 0.60; 95% confidence interval [CI], 0.43-0.85). Interventions compared with other HIV interventions showed a modest additional benefit (k = 30; OR, 0.91; 95% CI, 0.81-1.03). When we extrapolated our result (an OR of 0.60) to a population with a 72% prevalence of risk behavior, the proportion of drug users who reduced their risk behaviors was 12.6% greater in the intervention groups than in the comparison groups. Our meta-analysis shows that interventions can lead to sexual risk reduction among drug users and justifies providing interventions to drug users. Developing interventions with stronger effects to further reduce sexual risk behaviors among drug users must remain a high priority.

Meta-analysis of the effects of behavioral HIV prevention interventions on the sexual risk behavior of sexually experienced adolescents in controlled studies in the United States.

To estimate the effect of behavioral and social interventions on sexual risk of HIV among sexually experienced adolescents in the United States and to assess factors associated with variation in outcomes, we selected studies from the HIV/AIDS Prevention Research Synthesis project database. Twenty studies published or reported during the years 1988 through 1998 met criteria: 16 presented sufficient data; of these, 15 evaluated behavioral interventions and 1 a social intervention. Summary odds ratios (ORs) and 95% confidence intervals (CIs), weighted by study precision, indicated significantly less sex without condoms (number of studies, k, 13; OR, 0.66; CI, 0.55-0.79) and lower behavioral risk (k, 2; OR, 0.66; CI, 0.50-0.88), but no difference in number of partners (k, 8; OR, 0.89; CI, 0.76-1.05) or STDs (k, 2; OR, 1.18; CI, 0.48-2.86). A composite sexual risk behavior variable (k, 16; 1 outcome per study; preferred order, sex without condoms, number of partners, risk index) was used for heterogeneity and publication bias tests and stratified analyses. Overall, these interventions had a significant protective effect on sexually experienced adolescents (k, 16; OR, 0.65; CI, 0.50 - 0.85), although there was a suggestion of publication bias. Study design and intervention variables did not explain outcome variation. An exploratory finding may merit investigation: interventions tested with single ethnic groups out-of-class (k, 5) had larger effects than in-class interventions with mixed ethnic groups (k, 11), whether the mixed groups were in- (k, 6) or out-of class (k, 5).

HIV prevention research for men who have sex with men: a systematic review and meta-analysis.

A systematic review of HIV prevention reports published or distributed in the United States as of June 1998 yielded 9 rigorous controlled trials reporting intervention effects on unprotected sex for men who have sex with men. A summary measure of these effects was favorable (odds ratio,.69), statistically significant (95% confidence interval, 0.56-0.86), and very homogeneous. This summary value indicates a 26% reduction in the proportion of men engaging in unprotected anal intercourse. The most clearly favorable effects were observed among interventions that promoted interpersonal skills, were delivered in community-level formats, or focused on younger populations or those at higher behavioral risk. These studies demonstrate that interventions can promote risk reduction among men who have sex with men. Yet given the epidemiology of HIV in the United States, the small number of rigorous controlled intervention trials for this population is striking. Many more rigorous evaluations of HIV prevention efforts with men who have sex with men are needed to ascertain with confidence the effects of specific intervention components, population characteristics, and methodologic features.

Review and meta-analysis of HIV prevention intervention research for heterosexual adult populations in the United States.

A meta-analysis was performed to examine the effects of 14 behavioral and social interventions for heterosexual adults on their adoption of safer sex behaviors or incidence of sexually transmitted diseases (STDs). The intervention studies were identified through a systematic search and review strategy. Data were extracted and combined by using well-defined methods and appropriate statistical techniques. For inclusion in this article, studies had to be based in the United States, written in English, first reported between 1988 and 1996, and aimed at reducing sex-related HIV risks. In addition to measuring behavioral or STD incidence outcomes, studies also had used experimental or quasi-experimental designs with control or comparison groups and reported sufficient outcome data to allow calculation of odds ratios. The meta-analytic results show statistically significant effects in reducing sex-related risks (10 studies; odds ratio [OR], 0.81; 95% confidence interval [CI], 0.69-0.95), particularly non-use of condoms (8; OR, 0.69; 95% CI, 0.53-0.90). The interventions also had significant effects in reducing STD infections (6 studies; OR, 0.74; 95% CI, 0.62-0.89). These analyses indicate that science-based prevention interventions have positive effects among populations at risk through heterosexual transmission and that these positive effects are found with biologic and self-reported behavioral measures.