Preliminary engagement of a patient advisory board of African American community members with type 2 diabetes in a peer-led medication adherence intervention.

BACKGROUND: The Peers Supporting Health Literacy, Self-efficacy, Self-Advocacy, and Adherence (Peers LEAD) program is a culturally tailored educational-behavioral 8-week intervention that addressed psychosocial and sociocultural barriers to diabetes medication adherence in African Americans. A brief 3-week version of the Peers LEAD intervention used a community engagement approach to examine the feasibility and acceptability of the intervention amongst patient stakeholders. MAIN BODY: African Americans who were adherent to their diabetes medicines were paired with those who were non-adherent to their medicines. Together, they participated in the group and phone-based medication adherence intervention. Input from this brief intervention was important for the design of the remainder weeks of the 8-week program. The intervention targeted negative beliefs about diabetes, use of diabetes medicines, and offering culturally tailored peer support to improve medication adherence in African Americans. To receive input in the development and implementation of the program, we worked with community advisors and a peer ambassador board of African Americans who were adherent to their diabetes medicines. The peer ambassador board and community advisors reviewed intervention materials to ensure they were understandable and appropriate for the community. As well, they provided feedback on the process for intervention delivery. CONCLUSION: The active engagement of the peer ambassador board and community advisors led to a revised intervention process and materials for a medication adherence program for African Americans with type 2 diabetes.

A Case Study of Engaging Hard-to-Reach Participants in the Research Process: Community Advisors on Research Design and Strategies (CARDS)®.

Lack of diversity among study participants in clinical research limits progress in eliminating health disparities. The engagement of lay stakeholders, such as patient or community advisory boards (CABs), has the potential to increase recruitment and retention of underrepresented groups by providing a structure for gathering feedback on research plans and materials from this target population. However, many CABs intentionally recruit prominent stakeholders who are connected to or comfortable with research and academia and thus may not accurately represent the perspectives of underrepresented groups who have been labeled hard-to-reach, including racial minorities and low-income or low-literacy populations. We developed a partnership between the University of Wisconsin-Madison School of Nursing and two community centers to deliberately engage hard-to-reach people in two lay advisory groups, the Community Advisors on Research Design and Strategies (CARDS)®. Community center staff recruited the CARDS from center programs, including parenting and childcare programs, women's support groups, food pantries, and senior meal programs. The CARDS model differs from other CABs in its participants, processes, and outcomes. Since 2010, the CARDS have met monthly with nurses and other researchers, helping them understand how research processes and the language, tone, appearance, and organization of research materials can discourage people from enrolling in clinical studies. We have successfully used the CARDS model to bring hard-to-reach populations into the research process and have sustained their participation. The model represents a promising strategy for increasing the diversity of participants in clinical research. © 2016 Wiley Periodicals, Inc.

Placebo effects and the common cold: a randomized controlled trial.

PURPOSE: We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open-label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODS: We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTS: Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were -0.16 days (95% CI, -0.90 to 0.58 days) for illness duration and -22 severity points (95% CI, -70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, -0.28 to 1.12 days) and 22 severity points (95% CI, -19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statistically significant. Among the 120 participants who at intake rated echinacea's effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, -4.47 to -0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not significantly different (-97.0, 95% CI, -249.8 to 55.8 points). In this subgroup, neither duration nor severity differed significantly between the group blinded to echinacea and the open-label echinacea group. CONCLUSIONS: Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These findings support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions.

Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21).

BACKGROUND: The Wisconsin Upper Respiratory Symptom Survey (WURSS) is an illness-specific health-related quality-of-life questionnaire outcomes instrument. OBJECTIVES: Research questions were: 1) How well does the WURSS-21 assess the symptoms and functional impairments associated with common cold? 2) How well can this instrument measure change over time (responsiveness)? 3) What is the minimal important difference (MID) that can be detected by the WURSS-21? 4) What are the descriptive statistics for area under the time severity curve (AUC)? 5) What sample sizes would trials require to detect MID or AUC criteria? 6) What does factor analysis tell us about the underlying dimensional structure of the common cold? 7) How reliable are items, domains, and summary scores represented in WURSS? 8) For each of these considerations, how well does the WURSS-21 compare to the WURSS-44, Jackson, and SF-8? STUDY DESIGN AND SETTING: People with Jackson-defined colds were recruited from the community in and around Madison, Wisconsin. Participants were enrolled within 48 hours of first cold symptom and monitored for up to 14 days of illness. Half the sample filled out the WURSS-21 in the morning and the WURSS-44 in the evening, with the other half reversing the daily order. External comparators were the SF-8, a 24-hour recall general health measure yielding separate physical and mental health scores, and the eight-item Jackson cold index, which assesses symptoms, but not functional impairment or quality of life. RESULTS: In all, 230 participants were monitored for 2,457 person-days. Participants were aged 14 to 83 years (mean 34.1, SD 13.6), majority female (66.5%), mostly white (86.0%), and represented substantive education and income diversity. WURSS-21 items demonstrated similar performance when embedded within the WURSS-44 or in the stand-alone WURSS-21. Minimal important difference (MID) and Guyatt's responsiveness index were 10.3, 0.71 for the WURSS-21 and 18.5, 0.75 for the WURSS-44. Factorial analysis suggested an eight dimension structure for the WURSS-44 and a three dimension structure for the WURSS-21, with composite reliability coefficients ranging from 0.87 to 0.97, and Cronbach's alpha ranging from 0.76 to 0.96. Both WURSS versions correlated significantly with the Jackson scale (W-21 R=0.85; W-44 R=0.88), with the SF-8 physical health (W-21 R=-0.79; W-44 R=-0.80) and SF-8 mental health (W-21 R=-0.55; W-44 R=-0.60). CONCLUSION: The WURSS-44 and WURSS-21 perform well as illness-specific quality-of-life evaluative outcome instruments. Construct validity is supported by the data presented here. While the WURSS-44 covers more symptoms, the WURSS-21 exhibits similar performance in terms of reliability, responsiveness, importance-to-patients, and convergence with other measures.

Rationale and methods for a trial assessing placebo, echinacea, and doctor-patient interaction in the common cold.

BACKGROUND: Clinical medicine and healthcare policy are increasingly guided by randomized controlled trials, which in turn are dependent on the validity of placebo control. It is important to understand the effects of placebo control on outcome measurement, especially for assessment of symptoms and functional impairments where subjectivity, expectancy, and motivation may significantly impact outcome evaluation. This paper describes the rationale and methodology of a trial designed to evaluate placebo effects related to taking pills and to compare these with effects attributable to standard or enhanced (patient-oriented) doctor-patient interaction. DESIGN: This trial uses two-way factorial allocation to randomize people with new onset common cold in two directions: pill related and doctor related. In one direction, participants are randomized to (1) no pills, (2) blinded placebo, (3) blinded echinacea, or (4) unblinded open-label echinacea. In the other direction, participants are randomized to: (1) no doctor-patient interaction, (2) standard doctor-patient interaction, and (3) enhanced doctor-patient interaction. Enhanced interaction includes education, empathy, empowerment, positive prognosis, and connectedness. Area under the time severity curve is the primary outcome, with the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) the measure of severity. A priori power studies called for a sample size of N = 720 trial finishers to detect 15% to 20% between-group differences in this outcome. Secondary outcomes include general health-related quality of life, perceived stress, interpersonal support, optimism, patient satisfaction, and positive and negative affectivity. Two biomarkers are also assessed: interleukin-8 (inflammatory cytokine) and neutrophil count from nasal wash. IMPORTANCE: This paper describes the rationale and methodology of a trial assessing placebo effects related to pills and to doctor-patient interaction. This is one of very few similar studies and is the first in the common cold. Data collected will also provide an excellent opportunity to investigate relationships among demographic (age, sex, education, income) and psychosocial (perceived stress, interpersonal support, optimism, affectivity) indicators in relation to common cold outcomes.