Marcia G. Ory

Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium.

Treatment fidelity refers to the methodological strategies used to monitor and enhance the reliability and validity of behavioral interventions. This article describes a multisite effort by the Treatment Fidelity Workgroup of the National Institutes of Health Behavior Change Consortium (BCC) to identify treatment fidelity concepts and strategies in health behavior intervention research. The work group reviewed treatment fidelity practices in the research literature, identified techniques used within the BCC, and developed recommendations for incorporating these practices more consistently. The recommendations cover study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. Funding agencies, reviewers, and journal editors are encouraged to make treatment fidelity a standard part of the conduct and evaluation of health behavior intervention research.

The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques

OBJECTIVE To determine if short-term exercise reduces falls and fall-related injuries in the elderly. DESIGN A preplanned meta-analysis of the seven Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT)--independent, randomized, controlled clinical trials that assessed intervention efficacy in reducing falls and frailty in elderly patients. All included an exercise component for 10 to 36 weeks. Fall and injury follow-up was obtained for up to 2 to 4 years. SETTING Two nursing home and five community-dwelling (three health maintenance organizations) sites. Six were group and center based; one was conducted at home. PARTICIPANTS Numbers of participants ranged from 100 to 1323 per study. Subjects were mostly ambulatory and cognitively intact, with minimum ages of 60 to 75 years, although some studies required additional deficits, such as functionally dependent in two or more activities of daily living, balance deficits or lower extremity weakness, or high risk of falling. INTERVENTIONS Exercise components varied across studies in character, duration, frequency, and intensity. Training was performed in one area or more of endurance, flexibility, balance platform, Tai Chi (dynamic balance), and resistance. Several treatment arms included additional nonexercise components, such as behavioral components, medication changes, education, functional activity, or nutritional supplements. MAIN OUTCOME MEASURES Time to each fall (fall-related injury) by self-report and/or medical records. RESULTS Using the Andersen-Gill extension of the Cox model that allows multiple fall outcomes per patient, the adjusted fall incidence ratio for treatment arms including general exercise was 0.90 (95% confidence limits [CL], 0.81, 0.99) and for those including balance was 0.83 (95% CL, 0.70, 0.98). No exercise component was significant for injurious falls, but power was low to detect this outcome. CONCLUSIONS Treatments including exercise for elderly adults reduce the risk of falls.

Measuring multiple dimensions of religion and spirituality for health research: Conceptual background and findings from the 1998 general social survey

Progress in studying the relationship between religion and health has been hampered by the absence of an adequate measure of religiousness and spirituality. This article reports on the conceptual and empirical development of an instrument to measure religiousness and spirituality, intended explicitly for studies of health. It is multidimensional to allow investigation of multiple possible mechanisms of effect, brief enough to be included in clinical or epidemiological surveys, inclusive of both traditional religiousness and noninstitutionally based spirituality, and appropriate for diverse Judeo-Christian populations. The measure may be particularly useful for studies of health in elderly populations in which religious involvement is higher. The measure was tested in the nationally representative 1998 General Social Survey (N = 1,445). Nine dimensions have indices with moderate-to-good internal consistency, and there are three single-item domains. Analysis by age and sex shows that elderly respondents report higher levels of religiousness in virtually every domain of the measure.

Development of the common data base for the FICSIT trials

The eight FICSIT (Frailty and Injuries: Cooperative Studies of Intervention Techniques) sites test different intervention strategies in selected target groups of older adults. To compare the relative potential of these interventions to reduce frailty and fall‐related injuries, all sites share certain descriptive (risk‐adjustment) measures and outcome measures. This article describes the shared measures, which are referred to as the FICSIT Common Data Base (CDB). The description is divided into four sections according to the four FICSIT committees responsible for the CDB: (1) psychosocial health and demographic measures; (2) physical health measures; (3) fall‐related measures; and (4) cost and cost‐effectiveness measures. Because the structure of the FICSIT trial is unusual, the CDB should expedite secondary analyses of various research questions dealing with frailty and falls.

Effect of Multicomponent Interventions on Caregiver Burden and Depression: The REACH Multisite Initiative at 6-Month Follow-Up

Meta-analysis was used to examine pooled parameter estimates of 9 active compared with 6 control conditions of the Resources for Enhancing Alzheimers Caregiver Health (REACH) project at 6 months on caregiver burden and depressive symptoms. Associations of caregiver characteristics and outcomes were examined. For burden, active interventions were superior to control conditions (p = .022). Also, active interventions were superior to control conditions for women versus men and for caregivers with lower education versus those with higher education. For depressive symptoms, a statistically significant association of group assignment was found for Miamis family therapy and computer technology intervention (p = .034). Also, active interventions were superior to control conditions for Hispanics, nonspouses, and caregivers with lower education. Results suggest interventions should be multicomponent and tailored.

Positive Aspects of Caregiving Contributions of the REACH Project to the Development of New Measures for Alzheimer’s Caregiving

The aim of this study was to assess a newly developed measure for the positive aspects of caregiving using a sample of dementia caregivers. The measure was developed and administered to 1,229 participants in a national collaborative Alzheimer’s disease caregiver study and evaluated for validity and reliability using standard psychometric analyses. Factor analysis identified two components in this nine-item measure: Self-Affirmation and Outlook on Life. Cronbach’s alphas for the components were .86 and .80, respectively. For the entire scale, Cronbach’s alpha was .89. The Positive Aspects of Caregiving measure, tested with a large, diverse, and well-characterized sample shows promise as a valid and reliable instrument. With additional implementation and testing, the measure has the potential to substantially increase our understanding of basic caregiving research and the outcomes of intervention efforts.

Sexual functioning and practices in a multi‐ethnic study of midlife women: Baseline results from swan

This study examined the sexual practices and function of midlife women by ethnicity (African American, Caucasian, Chinese, Hispanic, Japanese) and menopausal status. Sexual behavior was compared in 3,262 women in the baseline cohort of SWAN. Participants were 42 to 52 years old, premenopausal or early perimenopausal, and not hysterectomized or using hormones. Analysis used multivariate proportional odds regression. In our sample, 79% had engaged in sex with a partner in the last 6 months, and a third considered sex to be very important. Common reasons for no sex (n = 676) were lack of partner (67%), lack of interest (33%), and fatigue (16%). Compared with Caucasians, Japanese and Chinese women were less likely, and African Americans more likely, to report sex as very important (p < 0.005). Significant ethnic differences were found for frequency of all practices. Perimenopause status was associated only with higher frequencies of masturbation and pain during intercourse.

Correlates of sexual function among multi-ethnic middle-aged women: results from the Study of Women's Health Across the Nation (SWAN)

Objective:To examine sexual function in a cohort of Baby Boomer women of diverse racial/ethnic backgrounds; to compare differences between pre-and early perimenopausal women; and to identify sociodemographic, health-related, and psychosocial (including psychological, behavioral, and relationship) factors related to sexual function. Design:Six domains of sexual function were studied in 3,167 women in the baseline cohort of the Study of Womens Health Across the Nation (SWAN). Participants were 42 to 52 years old, pre-or early perimenopausal, and not using hormones. The study sample included non-Hispanic white, African American, Hispanic, Chinese, and Japanese women. Results:Early perimenopausal women reported greater pain with intercourse than premenopausal women (P = 0.01), but the two groups did not differ in frequency of sexual intercourse, desire, arousal, or physical or emotional satisfaction. Variables having the greatest association across all outcomes were relationship factors, the perceived importance of sex, attitudes toward aging, and vaginal dryness. Despite controlling for a wide range of variables, we still found ethnic differences for arousal (P < 0.0001), pain (P = 0.03), desire (P < 0.0001), and frequency of sexual intercourse (P = 0.0003). African American women reported higher frequency of sexual intercourse than white women; Hispanic women reported lower physical pleasure and arousal. Chinese women reported more pain and less desire and arousal than the white women, as did the Japanese women, although the only significant difference was for arousal. Conclusions:Relationship variables, attitudes toward sex and aging, vaginal dryness, and cultural background have a greater impact on most aspects of sexual function than the transition to early perimenopause.

The Resources for Enhancing Alzheimer's Caregiver Health (REACH): project design and baseline characteristics.

The Resources for Enhancing Alzheimers Cargiver Health (REACH) project was designed to test promising interventions for enhancing family caregiving for persons with dementia. The purpose of this article is to describe the research design, interventions, and outcome measures used in REACH and to characterize the sample recruited for the study. Nine interventions and 2 control conditions were implemented at 6 sites; 1,222 dyads were randomly assigned to an intervention or a control condition. The caregiver sample was 18.6% male with an average age of 62.3 years (56% Caucasian, 24% Black, and 19% Hispanic). Caregivers reported high levels of depressive symptoms and moderate burden. Care recipients were older, with a mean age of 79, and were moderately to severely impaired with mean Mini-Mental State Exam scores of 13/30.

Frailty and injuries in later life: the FICSIT trials.

Physical frailty and fall‐related injuries present two of the biggest threats to older peoples functioning and quality of life. The Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT) trials represent a set of eight different clinical trials concerning physical frailty and injuries in later life. This report documents the history and organization of the trials and provides an overview of the measures being collected at multiple sites and the analytic strategies to be used for multi‐site investigations.