Measuring hot flashes: summary of a National Institutes of Health workshop.

The etiology and mechanism of hot flashes remain incompletely understood. Future studies of hormonal and neurologic systems may provide promising leads to improve our understanding of the basic phenomenon and perhaps also shed light on the placebo effect. However, this is likely a complex undertaking. Critical to this effort is the ability to reliably identify when a hot flash has occurred. The leading objective measure in use today--sternal skin conductance monitoring--has some limitations in ambulatory settings. However, a more severe limitation is the inability of sternal skin conductance to provide any information on duration, intensity, and interference with activities. Ultimately, researchers desire a convenient and cost-effective sensor for monitoring hot flashes without cumbersome electrodes that might become compromised if a subject experiences extensive sweating or takes a shower and one that can capture data continuously for relatively long periods of observation. However, researchers also need well-characterized methods for collecting self-reported data. If the primary concern is helping women with hot flashes find relief, then subjective measures collected through diaries or interviews cannot be dismissed. Given the importance of this information, it would make sense to undertake methodologic research to ensure that the best possible systems are used to collect valid and reliable information. The factors that we want to measure with respect to hot flashes are likely to change over time as more is learned about the underlying phenomenon. This will probably be an evolutionary process, one involving decisions about what biological factors will be most useful for the task at hand, what technologies might be available or easily adaptable, which measures should be bundled together to maximize the precision of data collected with the available technology, and the analysis of the data to generate new hypotheses and perhaps the need for new measurement tools. Investigators face several challenges when considering the design of studies of hot flashes. Substantial placebo effects and small sample sizes have produced studies with equivocal findings. The placebo effect, while remarkable in its dimensions in some studies of hot flash interventions, is not understood. Distinguishing placebo effects from the natural dissipation of symptoms over time would be extremely helpful. Similarly, the ability to induce a placebo effect to reduce the discomfort and annoyance associated with hot flashes might be helpful. The use of neuroimaging technology offers potential for greater understanding of the placebo effect. The group concluded that better measures of hot flashes require improved knowledge in several areas: The physical processes underlying hot flashes, which will identify additional factors to measure and the factors that influence the perception and reporting of hot flashes. Improved sternal skin conductance systems, with additional tools to be developed when other factors of hot flashes are identified. The performance characteristics of questionnaires and diaries to collect self-reported data on hot flash frequency. Improved and validated instruments for collecting data on intensity and interference with daily activities. The mechanism(s) of action of placebo, which may also help distinguish natural attrition of symptoms from placebo effect. Animal models to elucidate triggers and mechanisms of hot flashes and to screen potential treatments. Investigators interested in studying hot flashes face complex issues. The incomplete understanding of the basic physiology underlying hot flashes clearly calls for further work in this area. Some mechanistic studies cannot be conducted with human subjects; thus, animal models are needed. Animal models could be particularly helpful for understanding the neurobiology of hot flashes and perhaps placebo effects. Bringing scientists together from different fields would appear to be a promising approach to moving this area forward. Scientific advances are being made increasingly at the interfaces of traditional disciplines, and approaches to science are becoming more integrative. Finding appropriate collaborators from other disciplines is not necessarily easy, and meeting a collaborator from another discipline is only the first step in building a multidisciplinary research team. Effective teams begin with compelling reasons for their existence, but further incentives must be developed to ensure full realization of their potential. The success of team science depends on individuals who are comfortable with boundary-crossing activities. Working as part of a team that is seeking solutions to complex problems requires a willingness to work in an interdisciplinary environment, to collaborate with different types of organizations, and to recognize the importance of a variety of roles in the project. It is likely that a multidisciplinary approach to hot flash research would be helpful given the number of physiologic, clinical, and behavioral factors involved. For example, psychologists and sociologists could contribute to identifying factors that may influence the placebo effect, such as pill color; developing and validating questionnaire items and diary formats; ascertaining the effect of mode of data collection on the quality of the resulting data; and determining the best ways to provide information to subjects. However, if they were part of a multidisciplinary team that included basic scientists, clinicians, and bioengineers, different questions might be asked, and better tools might be developed to collect both subjective and objective data on hot flashes. The increasing emphasis on collaborative science is also embraced at the NIH level. Since May 2002, the NIH has been engaged in a series of activities collectively known as the "NIH Roadmap," whose goal, in keeping with the NIH mission of uncovering new knowledge about the prevention, detection, diagnosis, and treatment of disease and disability, is to accelerate both the pace of discovery in these key areas and the translation of therapies from bench to bedside. The timing of this workshop to assess measures of hot flashes appears auspicious for several reasons. First, the issue of refining and validating self-reported measures of symptoms through the use of biomarkers and multidisciplinary research teams is consonant with an NIH Roadmap initiative. Second, the new National Institute for Biomedical Imaging and Bioengineering at the NIH offers impetus for linking biomedical, social, and behavioral scientists with bioengineers to assess and improve existing technology or develop new technologies to collect data on physiological markers specific to hot flashes. Third, people are already purchasing and using CAM modalities or are resuming hormone therapy for relief of hot flashes, and they and their clinicians are eager for and deserve more information on the safety and efficacy of these remedies.

Interview Mode and Measurement of Sexual Behaviors: Methodological Issues.

Studies of sexual and other sensitive behaviors are often fraught with a variety of reporting biases. When IAQs are used to collect data, respondents may underreport certain sensitive behaviors and overreport normative behaviors. SAQs can also pose problems: requiring that respondents be literate and able to follow skip patterns. In recent years, the development of computerized technologies--audio-CASI and T-ACASI--have begun to overcome some of the limitations of IAQs and SAQs. By providing a more private mode for data collection and standardized delivery of all questions, as well as automated skip patterns and range checks, audio-CASI and T-ACASI have been tested in a number of studies and found to be an effective way of reducing response bias, and thus, contributing to a better understanding of the prevalence and patterns of sexual and other sensitive behaviors.

Measuring AIDS-Related Behaviors in Older Populations: Methodological Issues.

Because of a dearth of research on reporting biases in the measurement of HIV-related sexual and drug use behaviors in older populations, it is frequently assumed that methodological findings of research conducted with younger populations will generalize to older respondents. In this study, estimates of the effect of the experimental manipulation of interview mode (interviewer administered vs. self-administered) were derived separately for three age strata: 12 to 49, 50 to 64, and 65+. Results of these analyses indicate that there were a number of noteworthy reversals in which interviewer-administered questioning in the older age strata produced higher esti-mates of the prevalence of substance use or alcohol-related problem behaviors. These results suggest that caution should be exercised in making generalizations from studies of reporting bias for HIV-related behaviors to older populations.

Automating Telephone Surveys: Using T-ACASI to Obtain Data on Sensitive Topics.

This paper describes a new interview data collection system that uses a personal computer equipped with a telephone interface card. This system, telephone audio computer-assisted self-interviewing or T-ACASI, offers the economy of telephone interviews while providing the privacy of self-administered questionnaires. We describe T-ACASI design considerations and operational characteristics. In addition, we present data from recent studies indicating that the T-ACASI system is stable, robust, and suitable for administering relatively long and complex questionnaires on sensitive topics, including drug use and sexual behaviors associated with HIV and other STDs.

NAAT-identified and self-reported gonorrhea and chlamydial infections: different at-risk population subgroups?

BACKGROUND: Information on the characteristics and behaviors of persons at high risk for gonorrhea and chlamydial infection has typically been derived from studies of sexually transmitted disease (STD) clinic populations. The Baltimore STD and Behavior Survey (BSBS) used urine-based nucleic acid amplification testing (NAAT) to assess the prevalence and behavioral correlates of gonorrhea and chlamydial infection in a population-based cross-sectional survey of adults in Baltimore, Maryland. GOAL: The goal of this study was to examine the demographic characteristics and behavioral markers of gonorrhea and chlamydial infection as reported by adults with a self-reported history of gonorrhea and chlamydial infection and to compare these to the characteristics and behaviors of individuals with current NAAT-identified gonorrhea and/or chlamydial infection. STUDY DESIGN: A probability sample of adults aged 18 to 35 years residing in Baltimore was evaluated with collection of urine specimens and administration of a health and behavior survey. Data and specimens were collected between January 1997 and September 1998. RESULTS: Respondents with NAAT-detected gonorrhea and/or chlamydial infection (7.9%) did not report a history of high-risk behaviors or more recent occurrences of those behaviors, and the majority were asymptomatic. However, adults in our study who self-reported a history of infection (26.0%) were more likely than those with no history of infection to report multiple partners, paid sex, partners with prior STDs, and STD symptoms-a pattern consistent with findings described in previous clinic-based reports. CONCLUSION: The risk profile generated from studies of clinic populations, with a focus on symptomatic disease, may not characterize the broader population with current, untreated, largely asymptomatic infection.

Untreated gonococcal and chlamydial infection in a probability sample of adults.

CONTEXT: The prevalence and distribution of gonococcal and chlamydial infections in the general population are poorly understood. Development of nucleic acid amplification tests, such as the ligase chain reaction assay, provides new opportunities to estimate the prevalence of untreated infections in the population. OBJECTIVE: To estimate the overall prevalence of untreated gonococcal and chlamydial infections and to describe patterns of infection within specific demographic subgroups of the young adult population in Baltimore, Md. DESIGN AND SETTING: Cross-sectional behavioral survey based on a probability sample of Baltimore households with collection of urine specimens between January 1997 and September 1998. PARTICIPANTS: A total of 728 adults aged 18 to 35 years completed the interview portion of the study, and 579 of these respondents also provided a urine specimen adequate for testing. MAIN OUTCOME MEASURE: Prevalence of untreated infection, as measured by the percentage of specimens testing positive for gonococcal and chlamydial infection by ligase chain reaction, weighted to reflect variations in probabilities of sample selection from the population. Alternate estimates of the prevalence of recent treated infection were derived from clinically diagnosed cases reported to the Baltimore City Health Department and by diagnoses reported by participants in the survey. RESULTS: An estimated 5.3% (SE, 1.4%) of the population aged 18 to 35 years has an untreated gonococcal infection, and 3.0% (SE, 0.8%) is estimated to have an untreated chlamydial infection. While 7.9% (SE, 1.6%) of the population is estimated to have either an untreated gonococcal or chlamydial infection, estimated prevalence is substantially higher among black women (15.0%; SE, 3.7%). Few participants with untreated infections reported dysuria or discharge during the 6 months preceding testing. The estimated number of untreated gonococcal infections in the population (9241; SE, 2441) substantially exceeds both the number of such infections diagnosed among Baltimore adults aged 18 to 35 years and reported to the Baltimore City Health Department during 1998 (4566), and the estimated number of diagnoses derived using participants' reports for the 12 months prior to the survey (4708 [SE, 1918] to 5231 [SE, 2092]). The estimated number of untreated chlamydial infections (5231; SE, 1395) is also greater than the number of cases reported to the health department in 1998 (3664) but is slightly less than the estimated number of diagnoses derived using participants' reports of chlamydial infections diagnosed during the 12 months prior to the survey (5580 [SE, 1918] to 6975 [SE, 2441]). CONCLUSION: In 1997-1998, the estimated number of undiagnosed gonococcal and chlamydial infections prevalent in the population of Baltimore adults aged 18 to 35 years approached or exceeded the number of infections that were diagnosed and treated annually.