Ethical review issues in collaborative research between us and low-middle income country partners: a case example.

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct of human behavior research and research capacity building in the host country.

Tobacco use in six economically disadvantaged communities in the Dominican Republic.

The Dominican Republic is a tobacco-growing country, and tobacco control efforts there have been virtually nonexistent. This study provides a first systematic surveillance of tobacco use in six economically disadvantaged Dominican Republic communities (two small urban, two peri-urban, two rural; half were tobacco growing). Approximately 175 households were randomly selected in each community (total N = 1,048), and an adult household member reported on household demographics and resources (e.g., electricity), tobacco use and health conditions of household members, and household policies on tobacco use. Poverty and unemployment were high in all communities, and significant gaps in access to basic resources such as electricity, running water, telephones/cell phones, and secondary education were present. Exposure to tobacco smoke was high, with 38.4% of households reporting at least one tobacco user, and 75.5% allowing smoking in the home. Overall, 22.5% reported using tobacco, with commercial cigarettes (58.0%) or self-rolled cigarettes (20.1%) the most commonly used types. Considerable variability in prevalence and type of use was found across communities. Overall, tobacco use was higher in males, illiterate groups, those aged 45 or older, rural dwellers, and tobacco-growing communities. Based on reported health conditions, tobacco attributable risks, and World Health Organization mortality data, it is estimated that at least 2,254 lives could potentially be saved each year in the Dominican Republic with tobacco cessation. Although it is expected that the reported prevalence of tobacco use and health conditions represent underestimates, these figures provide a starting point for understanding tobacco use and its prevalence in the Dominican Republic.

Recruitment of physician offices for an office-based adolescent smoking cessation study.

Physician office settings play an important role in tobacco cessation intervention. However, few tobacco cessation trials are conducted at these sites, in part because of the many challenges associated with recruiting community physician offices into research. The present study identified and implemented strategies for recruiting physician offices into a randomized clinical trial of tobacco screening and cessation interventions with adolescent patients. A total of 30 community physicians participated in focus groups to elicit their perceptions of facilitators of and barriers to initial engagement of physician practices and the subsequent enrollment of the practices in long-term research projects. Physicians identified facilitators such as (a) the involvement of office staff in the recruitment process and (b) on-site presentations of the study's background and aims. Some of the barriers identified were time commitment concerns and the lack of incentives in exchange for participation. These focus group findings were then integrated with theory-based and empirically driven recruitment strategies for a 12-month randomized tobacco intervention trial with adolescent patients. Of 185 office practices approached to participate (screened from a pool of 273 practices), 103 agreed to on-site presentations of the study. Subsequently, almost all of the practices (101) that received the presentation agreed to enroll in the study. Conclusions are that (a) recruitment is a multicomponent process, (b) the processes of communication, engagement, and enrollment must be carefully planned and implemented to achieve maximal results, and (c) the development of effective strategies for recruiting health care provider practices presents an important infrastructure for testing adolescent smoking cessation interventions.

Attitudes toward giving smoking cessation advice among nursing staff at a long-term residential care facility.

The objective of this study was to provide a first assessment of (a) long-term care staffs' prevalence of and attitudes toward giving smoking cessation advice to residents and (b) predictors of advice giving. Results of a survey (N = 115) found that 54.8% of licensed nurses and 34.6% of nursing assistants reported ever advising. Advising was associated with job classification and believing that residents' problem lists should include smoking. Not advising was associated with believing advice is the physicians' responsibility. Staff somewhat endorsed risks of smoking and benefits of cessation for residents, smoking as a right and pleasure, and that some residents cannot make decisions about smoking. Staff moderately endorsed safety concerns: 36% wanted policy changes. Lack of institutional support and perceived residents' cessation disinterest were key barriers. The findings suggest that staff may be missing intervention opportunities and that institutional support of advising cessation may facilitate maintenance and improvement of nursing home residents' health.

Quitlines in North America: evidence base and applications.

Quitlines provide a model for the translation of research findings to public health application. Quitlines are currently in operation in more than half of US states, in Canada, and in multiple countries globally. Overall, when implemented correctly, quitlines have been shown to be efficacious and effective. Multiple quitline models are in use, but there is no evidence on the relative effectiveness of one over the other. Differences have been demonstrated for the efficacy of quitlines for specific applications, with the strongest evidence base for application as a primary intervention or as follow-up for hospitalized patients and particularly for cardiac patients. The evidence base for both reactive and proactive services is reviewed, and future directions to continue to advance the field are discussed.

Improving the future of youth smoking cessation.

OBJECTIVES: To provide recommendations that will build a better foundation for research on youth smoking cessation. METHODS: The Youth Tobacco Collaborative Cessation panel evaluated youth tobacco cessation literature and convened meetings to reach consensus. RESULTS: Methodological issues include design, recruitment and retention, follow-up, measurement, and youth vernacular. Research gaps include youth characteristics, theoretical approaches, delivery settings, and type of provider. Thirteen key research components for reporting are addressed. CONCLUSIONS: Given the dearth of studies on youth smoking cessation, scientifically rigorous studies need to be conducted with attention to methodological issues, research gaps, and reporting of key research components.

Measures of abstinence in clinical trials: issues and recommendations.

A workgroup formed by the Society for Research on Nicotine and Tobacco reviewed the literature on abstinence measures used in trials of smoking cessation interventions. We recommend that trials report multiple measures of abstinence. However, at a minimum we recommend that trial: (a) report prolonged abstinence (i.e., sustained abstinence after an initial period in which smoking is not counted as a failure) as the preferred measure, plus point prevalence as a secondary measure; (b) use 7 consecutive days of smoking or smoking on > or = 1 day of 2 consecutive weeks to define treatment failure; (c) include non-cigarette tobacco use, but not nicotine medications in definitions of failure; and (d) report results from survival analysis to describe outcomes more fully. Trials of smokers willing to set a quit date should tie all follow-ups to the quit date and report 6- and/or 12-month abstinence rates. For these trials, we recommend an initial 2-week grace period for prolonged abstinence definitions; however, the period may vary, depending on the presumed mechanism of the treatment. Trials of smokers who may not be currently trying to quit should tie follow-up to the initiation of the intervention and should report a prolonged abstinence measure of > or = 6-month duration and point prevalence rates at 6- and 12-month follow-ups. The grace period for these trials will depend on the time necessary for treatment dissemination, which will vary depending on the treatment, setting, and population. Trials that use short-term follow-ups (< or = 3 months) to demonstrate possible efficacy should report a prolonged abstinence measure of > or = 4 weeks. We again recommend a 2-week grace period; however, that period can vary.

Benchmarking implementation of a computerized system for long-term care.

The purpose of this study was to apply a benchmarking methodology to identify the most effective approaches used by long-term care facilities in implementing new computerized resident assessment instrument/minimum data set (RAI/MDS) systems and to develop implementation protocols based on these "best practices." Site visits were conducted with 3 long-term care facilities, selected on the basis of a national search. Facility directors, directors of nursing, information system managers, and frontline staff at each facility were targeted, and questionnaires were developed for each to assess factors viewed as important to successful implementation. A convergence was found in recommended action steps reported across sites to facilitate introduction and implementation of new RAI/MDS software. An example of how benchmarking results were used to develop an implementation plan is provided. Benchmarking provided a useful methodology for identifying best practices to guide implementation planing for adoption of a new computerized RAI/MDS system in the current trial. The benchmarking steps described are replicable and can be used to guide implementation of other new systems in the nursing home setting.

Smoking history, knowledge, and attitudes among older residents of a long-term care facility.

In the absence of empirical literature from the resident perspective, this study provided a first assessment of smoking history, knowledge of the risks of smoking, the risks of environmental tobacco exposure, and the benefits of quitting among older (age 50+) nursing home unit residents, as well as readiness to quit, barriers to quitting, frequency of cessation advice by healthcare givers, and quit-attempt history of residents who smoke. Subjects were 25 smokers and 70 non-smokers housed on long-term nursing home units in a county hospital. Results indicated that smoking status for the majority of residents was similar to when they were admitted, although smokers smoked fewer cigarettes (M = 11.6, SD = 9.2) than prior to admission (M = 18.6, SD = 11.8). Smokers were less likely than non-smokers to agree that smoking is harmful to their health. Both smokers and non-smokers were not well informed of the dangers of passive smoke exposure. The majority of smokers were in precontemplation (no interest in quitting within the next 6 months). Fewer than half of residents who smoked reported receiving cessation advice from physicians (40%) or nurses (36%), and no in-house cessation programs were available. These results suggest gaps in knowledge and resources for smoking cessation in this setting and an opportunity for intervention. This study begins to build an evidence base from the residents' perspective that can be used by healthcare providers, administrators, and policy makers in addressing smoking in the nursing home.