Determining an Appropriate Sample Size for Qualitative Interviews to Achieve True and Near Code Saturation: Secondary Analysis of Data.

BACKGROUND: In-depth interviews are a common method of qualitative data collection, providing rich data on individuals' perceptions and behaviors that would be challenging to collect with quantitative methods. Researchers typically need to decide on sample size a priori. Although studies have assessed when saturation has been achieved, there is no agreement on the minimum number of interviews needed to achieve saturation. To date, most research on saturation has been based on in-person data collection. During the COVID-19 pandemic, web-based data collection became increasingly common, as traditional in-person data collection was possible. Researchers continue to use web-based data collection methods post the COVID-19 emergency, making it important to assess whether findings around saturation differ for in-person versus web-based interviews. OBJECTIVE: We aimed to identify the number of web-based interviews needed to achieve true code saturation or near code saturation. METHODS: The analyses for this study were based on data from 5 Food and Drug Administration-funded studies conducted through web-based platforms with patients with underlying medical conditions or with health care providers who provide primary or specialty care to patients. We extracted code- and interview-specific data and examined the data summaries to determine when true saturation or near saturation was reached. RESULTS: The sample size used in the 5 studies ranged from 30 to 70 interviews. True saturation was reached after 91% to 100% (n=30-67) of planned interviews, whereas near saturation was reached after 33% to 60% (n=15-23) of planned interviews. Studies that relied heavily on deductive coding and studies that had a more structured interview guide reached both true saturation and near saturation sooner. We also examined the types of codes applied after near saturation had been reached. In 4 of the 5 studies, most of these codes represented previously established core concepts or themes. Codes representing newly identified concepts, other or miscellaneous responses (eg, "in general"), uncertainty or confusion (eg, "don't know"), or categorization for analysis (eg, correct as compared with incorrect) were less commonly applied after near saturation had been reached. CONCLUSIONS: This study provides support that near saturation may be a sufficient measure to target and that conducting additional interviews after that point may result in diminishing returns. Factors to consider in determining how many interviews to conduct include the structure and type of questions included in the interview guide, the coding structure, and the population under study. Studies with less structured interview guides, studies that rely heavily on inductive coding and analytic techniques, and studies that include populations that may be less knowledgeable about the topics discussed may require a larger sample size to reach an acceptable level of saturation. Our findings also build on previous studies looking at saturation for in-person data collection conducted at a small number of sites.

Physicians' use of and preferences for FDA-approved prescribing information.

BACKGROUND: The Prescribing Information (PI) is the US Food and Drug Administration (FDA)'s primary tool for communicating a summary of the essential scientific information needed for the safe and effective use of a prescription drug to healthcare providers.[1] One challenge with this type of communication is balancing the need to be thorough with the need to be concise. OBJECTIVES: This study aimed to explore physicians' preferences for and understanding of specific content and formatting in the PI. This study also explored physicians' use of and perceptions of the PI. METHODS: Seventy semi-structured qualitative interviews were conducted with primary care physicians (n = 35) and physicians from a wide range of specialties (n = 35) using web conferencing technology. Using fictitious PI examples, the guide assessed physicians' interpretation of language and preferences for how certain information is organized and communicated in select sections of the PI. The interview guide also included questions about the resources physicians use to find information about prescription drugs, when and how physicians access the PI, and their perceptions of the PI. RESULTS: The findings suggest that of the content and formatting items surveyed, physicians had the greatest preference for: (1) uniformly specifying the age group for which the drug is indicated in the INDICATIONS AND USAGE section, even for medical conditions that are highly associated with only one particular age group (e.g., adult patients), and (2) uniformly including administration information in relation to food (e.g., "with or without food") in the DOSAGE AND ADMINISTRATION section for drugs with oral dosing. The findings also suggest that including a long list of interacting drug examples in the DRUG INTERACTIONS section may be misinterpreted to be a comprehensive list. CONCLUSION: This qualitative research suggests physicians may prefer more clarity in some sections of the PI.

FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone.

BACKGROUND: The opioid crisis highlights the need to increase access to naloxone, possibly through regulatory approval for over-the-counter sales. To address industry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model drug facts label for such sales to assess whether consumers understood the key statements for safe and effective use. METHODS: In this label-comprehension study, we conducted individual structured interviews with 710 adults and adolescents, including 430 adults who use opioids and their family and friends. Eight primary end points were developed to assess user comprehension of each of the key steps in the label. Each of these end points included a prespecified target threshold ranging from 80 to 90% that was evaluated through a comparison of the lower boundary of the 95% exact confidence interval. RESULTS: The results for performance on six primary end points met or exceeded thresholds, including the steps "Check for a suspected overdose" (threshold, 85%; point estimate [PE], 95.8%; 95% confidence interval [CI], 94.0 to 97.1) and "Give the first dose" (threshold, 85%; PE, 98.2%; 95% CI, 96.9 to 99.0). The lower boundaries for four other primary end points ranged from 88.8 to 94.0%. One exception was comprehension of "Call 911 immediately," but this instruction closely approximated the target of 90% (PE, 90.3%; 95% CI, 87.9 to 92.4). Another exception was comprehension of the composite step of "Check, give, and call 911 immediately" (threshold, 85%; PE, 81.1%; 95% CI, 78.0 to 83.9). CONCLUSIONS: Consumers met thresholds for sufficient understanding of six of eight components of the instructions in the drug facts label for naloxone use and came close on two others. Overall, the FDA found that the model label was adequate for use in the development of a naloxone product intended for over-the-counter sales.

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 product's 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.

Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.

In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed.

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

OBJECTIVE: Drug 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. METHODS: We 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. RESULTS: Ads 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 drug's benefits. The composite score definition improved composite score recognition and lowered drug risk perceptions. CONCLUSION: Adding composite score information to DTC print ads may improve individuals' comprehension of composite scores and affect their perceptions of the drug. PRACTICE IMPLICATIONS: Providing composite score information may lead to more informed patient-provider prescription drug decisions.

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.

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

We investigated how inclusion of a "toll-free statement" for reporting side effects to FDA in prescription drug direct-to-consumer (DTC) television ads affects comprehension of product risks and benefits, and comprehension of and memory for the toll-free statement itself. Participants viewed one of nine mock prescription drug television ads that varied elements of the toll-free statement, and then responded to a questionnaire. Presenting the statement in both text and audio resulted in better processing of the statement compared to only text. When shown in text alone, presenting the statement during the entire advertisement or after the statement of risks resulted in better processing of the statement compared to placement before the presentation of risk information. The placement, duration, or prominence of the statement did not affect comprehension of product risk and benefit information. Our findings suggest that the toll-free statement can be added to DTC television ads without significantly affecting comprehension of product risk and benefit information, and that select presentations are preferable for communicating the toll-free statement. The appropriate inclusion of the toll-free statement in DTC television ads may increase the visibility of the adverse event reporting system, without any apparent cost to the understanding of benefits and risks.

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 drug's efficacy and risk; therefore, caution should be used when presenting comparative claims in DTC ads.

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

OBJECTIVE: Women with hereditary breast and ovarian cancer syndrome (HBOC) face a higher risk of earlier, more aggressive cancer. Because of HBOC's 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. METHODS: Cancer in the Family, an online clinical decision support tool, calculated women's HBOC risk and promoted shared patient-provider decisions about screening. A pilot evaluation (n=9 providers, n=48 patients) assessed the tool's 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. RESULTS: Patients 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%). CONCLUSIONS: The tool was effective in increasing knowledge, collecting family history, and sparking patient-provider discussions about HBOC screening. PRACTICE IMPLICATIONS: Interactive tools can effectively communicate personalized risk and promote shared decisions, but they are not a substitute for patient-provider discussions.

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 women's 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 women's partners, families, and friends influence women's 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. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

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 individual's 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 Cronbach's alpha of 0.86. Additional analyses are planned, with the goal of creating a short form of the instrument.

Patterns of prescribing antiepileptic drugs for bipolar disorder.

Off-label use of medications is the subject of great debate. Prescribing is influenced by a number of factors, including peer recommendations, pharmaceutical industry marketing, and evidence-based drug effectiveness reports. Understanding prescribing patterns for a particular drug class can inform efforts to provide fair and balanced information to prescribers. This study investigated four dimensions of psychiatrists' prescribing practices for antiepileptic drugs (AEDs) for bipolar disorder: 1) psychiatrists' current use of AEDs, 2) their actual and preferred sources of information on AEDs, 3) their knowledge about the Neurontin lawsuit, and 4) their reactions to sample marketing campaign materials, including key messages from an evidence-based report on the topic. Qualitative methods, including telephone and in-person focus groups and in-depth interviews, were used to explore these dimensions. We found that psychiatrists prescribe AEDs for off-label use, but that they are not using gabapentin as a primary treatment for bipolar disorder. The psychiatrists also reported that they obtained their information about AEDs from professional journals, colleagues, and pharmaceutical representatives. The psychiatrists were asked to review a set of four key messages derived from an evidence-based report on the use of AEDs to treat bipolar disorder. They had misconceptions about the efficacy of the draft messages as they were written, stating that they were oversimplified and erroneous. The messages were revised based on the participants' feedback. However, the core findings from the evidence-based report remained unchanged. Recommendations for developing and disseminating messages and materials for a future corrective marketing campaign to provide fair and balanced information to physicians about gabapentin and other AEDs are discussed.

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

PURPOSE: Few 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 Foundation's 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. METHODS: Cross-sectional analyses of the second wave of a survey of participants in the Diabetes Initiative (68% response rate, n = 957) were used. RESULTS: Confirmatory 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. CONCLUSIONS: This 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.

Voluntary disenrollment from Medicare advantage plans: valuable signals of market performance.

OBJECTIVE: To examine 2000-2005 trends in the reasons Medicare beneficiaries gave for disenrolling from their Medicare Advantage (MA) plans. STUDY DESIGN: We used data from 6 consecutive years of Consumer Assessment of Health Plans surveys, which asked about 33 possible reasons for disenrollment, including problems with plan information, out-of-pocket costs, plan benefits, and coverage. Respondents numbered more than 50,000 beneficiaries each year from a variety of MA plan types providing full Medicare benefits in place of traditional fee-for-service Medicare. The survey also collected demographic and health status information. METHODS: We classified reasons for disenrollment into 2 key groups: (1) reasons related to plan information and (2) reasons related to cost/benefits problems. We examined whether disparities existed between vulnerable and less vulnerable populations that might reflect different experiences by these groups over time. RESULTS: Disparities between vulnerable and less vulnerable groups were present but generally diminished over time as competition intensified, with noticeable differences between African American and Hispanic subpopulations regarding problems with plan information. CONCLUSIONS: The premise of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 was that more plans would increase competition, resulting in higher-quality healthcare services. However, an increased number of plan choices complicates the health plan decision-making process for beneficiaries. With further expansion of plans and choices following implementation of Part D, efforts must continue to direct informational materials to all beneficiaries, particularly those in vulnerable subgroups. More help in interpreting the information may be required to maximize consumer benefits.

Voluntary disenrollment from Medicare managed care: market factors and disabled beneficiaries.

Disenrollment rates from Medicare managed care plans have been reported to the public as an indicator of health plan quality. Previous studies have shown that voluntary disenrollment rates differ among vulnerable subgroups, and that these rates can reflect patient care experiences. We hypothesized that disabled beneficiaries may be affected differently than other beneficiaries by competitive market factors, due to higher expected expenditures and impaired mobility. Findings suggest that disabled beneficiaries are more likely to experience multiple problems with managed care.