Developing a patient-centered outcome measure for complementary and alternative medicine therapies II: Refining content validity through cognitive interviews

BACKGROUND: Available measures of patient-reported outcomes for complementary and alternative medicine (CAM) inadequately capture the range of patient-reported treatment effects. The Self-Assessment of Change questionnaire was developed to measure multi-dimensional shifts in well-being for CAM users. With content derived from patient narratives, items were subsequently focused through interviews on a new cohort of participants. Here we present the development of the final version in which the content and format is refined through cognitive interviews. METHODS: We conducted cognitive interviews across five iterations of questionnaire refinement with a culturally diverse sample of 28 CAM users. In each iteration, participant critiques were used to revise the questionnaire, which was then re-tested in subsequent rounds of cognitive interviews. Following all five iterations, transcripts of cognitive interviews were systematically coded and analyzed to examine participants' understanding of the format and content of the final questionnaire. Based on this data, we established summary descriptions and selected exemplar quotations for each word pair on the final questionnaire. RESULTS: The final version of the Self-Assessment of Change questionnaire (SAC) includes 16 word pairs, nine of which remained unchanged from the original draft. Participants consistently said that these stable word pairs represented opposite ends of the same domain of experience and the meanings of these terms were stable across the participant pool. Five pairs underwent revision and two word pairs were added. Four word pairs were eliminated for redundancy or because participants did not agree on the meaning of the terms. Cognitive interviews indicate that participants understood the format of the questionnaire and considered each word pair to represent opposite poles of a shared domain of experience. CONCLUSIONS: We have placed lay language and direct experience at the center of questionnaire revision and refinement. In so doing, we provide an innovative model for the development of truly patient-centered outcome measures. Although this instrument was designed and tested in a CAM-specific population, it may be useful in assessing multi-dimensional shifts in well-being across a broader patient population

Acupuncture for chronic neck pain: a pilot for a randomised controlled trial

Background: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. Methods: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture ( up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. Results: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). Conclusion: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

Background: There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods: The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results: Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion: The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design

Disparities in healthy food zoning, farmers’ market availability, and fruit and vegetable consumption among North Carolina residents

Background Context and purpose of the study. To examine (1) associations between county-level zoning to support farmers’ market placement and county-level farmers’ market availability, rural/urban designation, percent African American residents, and percent of residents living below poverty and (2) individual-level associations between zoning to support farmers’ markets; fruit and vegetable consumption and body mass index (BMI) among a random sample of residents of six North Carolina (NC) counties. Methods Zoning ordinances were scored to indicate supportiveness for healthy food outlets. Number of farmers’ markets (per capita) was obtained from the NC-Community Transformation Grant Project Fruit and Vegetable Outlet Inventory (2013). County-level census data on rural/urban status, percent African American, and percent poverty were obtained. For data on farmers’ market shopping, fruit and vegetable consumption, and BMI, trained interviewers conducted a random digit dial telephone survey of residents of six NC counties (3 urban and 3 rural). Pearson correlation coefficients and multilevel linear regression models were used to examine county-level and individual-level associations between zoning supportiveness, farmers’ market availability, and fruit and vegetable consumption and BMI. Results At the county-level, healthier food zoning was greater in more urban areas and areas with less poverty. At the individual-level, self-reported fruit and vegetable consumption was associated with healthier food zoning. Conclusions Disparities in zoning to promote healthy eating should be further examined, and future studies should assess whether amending zoning ordinances will lead to greater availability of healthy foods and changes in dietary behavior and health outcomes.ECU Open Access Publishing Support Fun

Reproductive and hormonal factors and mortality among women with colorectal cancer in the NIH-AARP Diet and Health Study

BACKGROUND: Although use of menopausal hormone therapy (MHT) and some reproductive factors have been associated with colorectal cancer (CRC) risk, relations between these factors and survival after CRC diagnosis are unclear. METHODS: Among 2053 post-menopausal women diagnosed with incident CRC in the NIH-AARP Diet and Health Study, we calculated hazard ratios (HRs) and 95% confidence intervals (CIs) using multivariable Cox proportional hazards regression to test associations between oral contraceptive (OC) use, menarche age, age at first birth, parity, menopausal age, and MHT use with all-cause and CRC-specific mortality. RESULTS: There were 759 deaths (332 CRC-related deaths) over a median follow-up of 7.7 years. We observed no statistically significant associations between OC use, menarche age, age at first birth, parity, menopausal age, and mortality. Compared with never MHT use, former use was not associated with mortality, but we found an inverse association among baseline current users, for both all-cause (HR=0.79, 95% CI 0.66–0.94) and CRC mortality (0.76, 0.59–0.99). CONCLUSION: Future studies should further focus on the mechanisms by which exogenous oestrogen exposure might affect tumour progression and CRC survival

Knowledge, Attitudes and Beliefs That May Influence Infant Feeding Practices in American Indian Mothers

The promotion of healthy infant feeding is increasingly recognized as an important obesity prevention strategy. This is relevant for American Indian (AI) populations, who exhibit high levels of obesity and low compliance with infant feeding guidelines. The literature examining the knowledge, attitudes and beliefs (KAB) surrounding infant feeding within the AI population is sparse and focuses primarily on breastfeeding, with limited information on the introduction of solid foods and related practices that may be important in an obesity prevention context. This research presents descriptive findings from a baseline KAB questionnaire on infant feeding and related behaviors, administered to mothers (n=438) from five Northwest AI tribes that participated in the Prevention of Toddler Overweight and Teeth Health Study (PTOTS). Enrollment occurred during pregnancy or up to 6 months postpartum. The KAB questionnaire focused on themes of Breastfeeding/Formula Feeding and Introducing Solid Foods, with supplemental questions on Physical Activity. Knowledge questions were multiple-choice or true/false. Attitudes and beliefs were assessed on Likert scales. Descriptive statistics included frequencies and percents, and means and standard deviations. Most women knew basic breastfeeding recommendations and facts, but fewer recognized the broader health benefits of breastfeeding (e.g., reducing diabetes risk), or knew when to introduce solid foods. Women believed breastfeeding to be healthy and perceived their social networks to agree. Attitudes and beliefs about formula feeding and social support were more ambivalent. This work suggests opportunities to increase the perceived value of breastfeeding to include broader health benefits, increase knowledge about solid foods, and strengthen social support