Claudia Squire

Measuring Health Literacy: A Pilot Study of a New Skills-Based Instrument

Although a number of instruments have been used to measure health literacy, a key limitation of the leading instruments is that they only measure reading ability or print literacy and, to a limited extent, numeracy. Consequently, the present study aimed to develop a new instrument to measure an individuals health literacy using a more comprehensive and skills-based approach. First, we identified a set of skills to demonstrate and tasks to perform. Next, we selected real-world health-related stimuli to enable measurement of these skills, and then we developed survey items. After a series of cognitive interviews, the survey items were revised, developed into a 38-item instrument, and pilot tested using a Web-based panel. Based on the psychometric properties, we removed items that did not perform as well, resulting in a 25-item instrument named the Health Literacy Skills Instrument. Based on confirmatory factor analysis, the items were grouped into five subscales representing prose, document, quantitative, oral, and Internet-based information seeking skills. Construct validity was supported by correlations with the short form of the Test of Functional Health Literacy in Adults and self-reported skills. The overall instrument demonstrated good internal consistency, with a Cronbachs alpha of 0.86. Additional analyses are planned, with the goal of creating a short form of the instrument.

Development and validation of an instrument to measure resources and support for chronic illness self-management: a model using diabetes.

PURPOSEnFew comprehensive and practical instruments exist to measure the receipt of self-management support for chronic illness. An instrument was developed to measure resources and support for self-management (RSSM) for the survey component of the evaluation of the Robert Wood Johnson Foundations Diabetes Initiative. It includes items to measure an ecological range of RSSM. This article describes the development and validation of the instrument, focusing on individuals reported access to RSSM from providers and from nonclinical, social, and community sources.nnnMETHODSnCross-sectional analyses of the second wave of a survey of participants in the Diabetes Initiative (68% response rate, n = 957) were used.nnnRESULTSnConfirmatory factor analyses supported grouping the 17 items into 5 subscales, measuring key aspects of RSSM: individualized assessment, collaborative goal setting, enhancing skills, ongoing follow-up and support, and community resources (comparative fit index = 0.97, Tucker-Lewis fit index = 0.99, and root means square error of approximation = 0.06). The overall scale and 5 subscales were internally consistent (Cronbach alpha >or= .70) and were significantly, positively related to diabetes self-management behaviors, supporting their construct validity.nnnCONCLUSIONSnThis instrument shows promise for measuring RSSM. Although it was developed for diabetes programs, its ecological orientation and link to the broad framework of chronic care suggest broader application.

Parents' views on sexual debut among pre-teen children in Washington, DC.

Objective: Present US parents perceptions about factors leading to early intercourse and strategies for overcoming them. Methods: Conducted analysis of eight focus groups with 78 male and female African‐American and Hispanic caregivers of fifth‐graders and sixth‐graders (ages 10–12). Results: Participants gave the following primary reasons for early sexual activity: lack of structured activities, adult supervision, and communication; and influence of peers, society, and media. They suggested strategies targeting these reasons, and the need for parents, schools, and the community to work together. Conclusion: Incorporating parents perspectives would help tailor interventions to the needs of the target population and increase parental support.

Women's Knowledge, Views, and Experiences Regarding Alcohol Use and Pregnancy: Opportunities to Improve Health Messages

Background Women continue to drink alcohol during pregnancy despite Surgeon Generals Advisory statements and educational efforts about the dangers. Purpose This focus group research study examined womens knowledge and beliefs about alcohol consumption and its risks during pregnancy along with related perceptions of social influences and information sources in order to inform future messaging. Methods The study included 20 focus groups of 149 reproductive-age women segmented by age, pregnancy status, and race/ethnicity. Results and Discussion Women acknowledged the risks and consequences of drinking alcohol during pregnancy, but many held common misconceptions. Some women continued to drink during pregnancy or expressed intent to continue drinking until pregnancy confirmation. Findings indicated that womens partners, families, and friends influence womens decisions to drink or abstain from alcohol. In addition, health care providers and the Internet act as important sources of health information for women but sometimes do not adequately educate them about the risks of alcohol use and pregnancy. Translation to Health Education Practice Considerations for messaging and educational materials related to alcohol use and pregnancy include providing clear and consistent messaging (especially from health professionals), focusing on social support strategies, and utilizing electronic media.

Communicating risk of hereditary breast and ovarian cancer with an interactive decision support tool

OBJECTIVEnWomen with hereditary breast and ovarian cancer syndrome (HBOC) face a higher risk of earlier, more aggressive cancer. Because of HBOCs rarity, screening is recommended only for women with strong cancer family histories. However, most patients do not have accurate history available and struggle to understand genetic concepts.nnnMETHODSnCancer in the Family, an online clinical decision support tool, calculated womens HBOC risk and promoted shared patient-provider decisions about screening. A pilot evaluation (n=9 providers, n=48 patients) assessed the tools impact on knowledge, attitudes, and screening decisions. Patients used the tool before wellness exams and completed three surveys. Providers accessed the tool during exams, completed exam checklists, and completed four surveys.nnnRESULTSnPatients entered complete family histories (67%), calculated personal risk (96%), and shared risk printouts with providers (65%). HBOC knowledge increased dramatically for patients and providers, and many patients (75%) perceived tool results as valid. The tool prompted patient-provider discussions about HBOC risk and cancer family history (88%).nnnCONCLUSIONSnThe tool was effective in increasing knowledge, collecting family history, and sparking patient-provider discussions about HBOC screening.nnnPRACTICE IMPLICATIONSnInteractive tools can effectively communicate personalized risk and promote shared decisions, but they are not a substitute for patient-provider discussions.

Effects of comparative claims in prescription drug direct-to-consumer advertising on consumer perceptions and recall

Although pharmaceutical companies cannot make comparative claims in direct-to-consumer (DTC) ads for prescription drugs without substantial evidence, the U.S. Food and Drug Administration permits some comparisons based on labeled attributes of the drug, such as dosing. Researchers have examined comparative advertising for packaged goods; however, scant research has examined comparative DTC advertising. We conducted two studies to determine if comparative claims in DTC ads influence consumers perceptions and recall of drug information. In Experiment 1, participants with osteoarthritis (n=1934) viewed a fictitious print or video DTC ad that had no comparative claim or made an efficacy comparison to a named or unnamed competitor. Participants who viewed print (but not video) ads with named competitors had greater efficacy and lower risk perceptions than participants who viewed unnamed competitor and noncomparative ads. In Experiment 2, participants with high cholesterol or high body mass index (n=5317) viewed a fictitious print or video DTC ad that had no comparative claim or made a comparison to a named or unnamed competitor. We varied the type of comparison (of indication, dosing, or mechanism of action) and whether the comparison was accompanied by a visual depiction. Participants who viewed print and video ads with named competitors had greater efficacy perceptions than participants who viewed unnamed competitor and noncomparative ads. Unlike Experiment 1, named competitors in print ads resulted in higher risk perceptions than unnamed competitors. In video ads, participants who saw an indication comparison had greater benefit recall than participants who saw dosing or mechanism of action comparisons. In addition, visual depictions of the comparison decreased risk recall for video ads. Overall, the results suggest that comparative claims in DTC ads could mislead consumers about a drugs efficacy and risk; therefore, caution should be used when presenting comparative claims in DTC ads.

An Empirical Examination of the FDAAA-Mandated Toll-Free Statement for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements

This research investigates how the inclusion of the “toll-free statement” (a message about a toll-free number by which consumers can report drug side effects to the U. S. Food and Drug Administration) in direct-to-consumer (DTC) television advertisements for prescription drugs affects consumers’ comprehension of product risks and benefits, as well as their comprehension and memory of the toll-free statement. Participants viewed one of nine mock television advertisements across which elements of the toll-free statement varied. Presenting the statement in both text and audio resulted in better processing of the statement than text-only presentations. When the statement was shown in text alone, presenting it during the entire advertisement or after the statement of risks resulted in better processing than a placement before the risk information. The placement, duration, and prominence of the statement did not affect risk or benefit comprehension. These findings suggest that the toll-free statement can be added to DTC television advertisements without significantly affecting risk and benefit comprehension and that certain presentations are preferable for communicating the statement. The appropriate inclusion of the toll-free statement in DTC television advertisements may increase the visibility of the adverse event reporting system, without cost to the understanding of benefits or risks.

Who Said It Better? A Test of Wording Differences in the MedWatch “Toll-Free Statement” for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements

Background: A toll-free statement alerting consumers how to report side effects to the US Food and Drug Administration (FDA) is required for both prescription drug labeling and direct-to-consumer (DTC) print ads. Because of different regulatory requirements between these materials (the Toll-free Number for Reporting Adverse Events on Labeling for Human Drug Products Rule [TFNR] versus the FDA Amendments Act [FDAAA], respectively), the wording of this statement differs. We studied how statement wording for reporting side effects to FDA in DTC television ads affects comprehension of product risks and benefits, comprehension of and memory for the toll-free statement, and perceived statement clarity. Methods: Participants viewed 1 of 8 mock prescription drug television ads that varied the wording and placement of the toll-free statement, and then responded to a questionnaire. Results: The FDAAA statement was more noticeable, clear, and more participants were able to recall and recognize its correct purpose. Comprehension of product risk and benefit information did not differ based on statement wording. Conclusions: Findings suggest that the FDAAA toll-free statement wording is superior to that of the TFNR.

Communicating efficacy information based on composite scores in direct-to-consumer prescription drug advertising

OBJECTIVEnDrug efficacy can be measured by composite scores, which consist of two or more symptoms or other clinical components of a disease. We evaluated how individuals interpret composite scores in direct-to-consumer (DTC) prescription drug advertising.nnnMETHODSnWe conducted an experimental study of seasonal allergy sufferers (n=1967) who viewed a fictitious print DTC ad that varied by the type of information featured (general indication, list of symptoms, or definition of composite scores) and the presence or absence of an educational intervention about composite scores. We measured composite score recognition and comprehension, and perceived drug efficacy and risk.nnnRESULTSnAds that featured either (1) the composite score definition alone or (2) the list of symptoms or general indication information along with the educational intervention improved composite score comprehension. Ads that included the composite score definition or the educational intervention led to lower confidence in the drugs benefits. The composite score definition improved composite score recognition and lowered drug risk perceptions.nnnCONCLUSIONnAdding composite score information to DTC print ads may improve individuals comprehension of composite scores and affect their perceptions of the drug.nnnPRACTICE IMPLICATIONSnProviding composite score information may lead to more informed patient-provider prescription drug decisions.

Serious and actionable risks, plus disclosure: Investigating an alternative approach for presenting risk information in prescription drug television advertisements

Background: Broadcast direct‐to‐consumer (DTC) prescription drug ads that present product claims are required to also present the products major risks. Debate exists regarding how much information should be included in these major risk statements. Some argue that such statements expose people to unnecessary amounts of information, while others argue that they leave out important information. Objectives: Examine the impact of type of risk statement (unedited versus serious and actionable risks only) and a disclosure indicating that not all risks are presented on consumers ability to remember the important risks and benefits of a drug following exposure to a DTC television advertisement (ad). Risk and benefit perceptions, ad‐prompted actions, recognition of the disclosure statement, and evaluations of both the disclosure and risk statement were also examined. Methods: A web‐based experiment was conducted in which US adults who self‐reported as having depression (N = 500), insomnia (N = 500), or high cholesterol (N = 500) were randomly assigned to view one of four versions of the television ad, and then complete a questionnaire. Results: The type of risk statement had a significant effect on risk recall and recognition, benefit recognition, perceived risk severity (depression condition only), and perceived benefit magnitude (high cholesterol condition only). Disclosure recognition (using bias‐corrected scores) ranged from 63% to 70% across the three illness samples. Conclusions: The revised risk statement improved overall processing of the television ad, as evidenced by improved risk recall and recognition and improved benefit recognition. Further, the presence of the disclosure did not adversely affect consumers processing of drug risk and benefit information. Therefore, limiting the risks presented in DTC television ads and including a disclosure alerting consumers that not all risks are presented may be an effective strategy for communicating product risks.