Development and validation of a psoriasis treatment acceptability measure through group concept mapping.

BACKGROUND: Psoriasis is a common autoimmune dermatologic condition which has a pronounced negative impact on patient quality of life and disease burden. Currently, there are a number of treatments available for psoriasis, with differences in efficacy, mechanism of action, mode of administration, adverse effects, and tolerability. However, a reliable, validated patient-reported instrument to address patient expectations and of psoriasis treatment has not been developed. This project was undertaken with the aim of developing a fit-for-purpose self-reported instrument to inform patient expectations and preferences of psoriasis treatments. METHODS: Two studies, both utilizing qualitative and quantitative methods, were conducted in patients within the entire spectrum of psoriasis severity. In Study 1, a group concept mapping (GCM) exercise was conducted with dermatologists and moderate-to-severe psoriasis patients to identify concepts important in the treatment of psoriasis. In Study 2, a preliminary Treatment Acceptability Questionnaire (TAQ) was developed using GCM-derived concepts from Studies 1 and 2, followed by cognitive debriefing (CD) telephone interviews of the preliminary TAQ. In Study 2, another GCM exercise was conducted with mild and newly diagnosed psoriasis patients. Psychometric analyses were performed on the TAQ to evaluate validity and reliability. RESULTS: The Study 1 GCM exercise generated 43 concepts from moderate-to-severe psoriasis patients (n = 20) and dermatologists (n = 10). In Study 2, 37 GCM concepts were generated from mild and newly diagnosed psoriasis patients (n = 20). From the 2 GCM exercises, 28 concepts were selected to form the preliminary TAQ; CD interviews indicated strong understanding and relevance of TAQ items among patients with disease ranging from mild to severe. The final TAQ consisted of 20 items; psychometric analysis demonstrated strong validity and reliability of the TAQ. CONCLUSIONS: The TAQ is a novel psychometrically validated patient-reported instrument to inform healthcare providers of patients' expectations of and preferences for treatment of their psoriasis and can help in shared decision making between patients and physicians.

Group Medical Visits for Addressing Weight and Blood Pressure in an Underserved Population.

The effect of group medical visits (GMV) compared to individual medical visits (IMV), on weight and blood pressure in a large primary care practice serving a predominantly underserved population, was assessed. The records of 304 patients attending a weight-loss program were analyzed using mixed-effects regression models. Patients in GMV lost an average of 11.63 lbs, whereas patients in IMV lost an average of 3.99 lbs (p < 0.001). A total of 55% of patients lost ≥7% in GMV compared to 11% of patients in IMV (p ≤ 0.001). Individuals who lost >5% of their baseline weight had a higher reduction in overall blood pressure. For systolic and diastolic blood pressure, the differences between baseline and three months for GMV and IMV were −7.4 vs. 4.1 mm of Hg (p = 0.002) and −4.6 vs. 4.2 mm of Hg (p = 0.003), respectively. Results from this study demonstrate that GMV may be a potentially useful modality for addressing weight and blood pressure in an underserved population.

Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting.

PURPOSE: Psychometric evaluation of the Nocturia Impact (NI) Diary was conducted to support its use as a trial endpoint. METHODS: As part of a randomized, controlled Phase 2 clinical trial investigating a novel drug candidate for nocturnal polyuria, adult nocturia patients completed the NI Diary and a voiding diary for three nights preceding their clinic visit at Baseline and Weeks 1, 4, 8, and 12 (end of treatment). Exit interviews were conducted to obtain patient impressions of the NI Diary. RESULTS: A total of N = 302 participants were included. Confirmatory factor analysis (CFA) indicated that the 11-item measure is unidimensional with values of CFI, TLI, and RMSEA meeting relevant thresholds. Good internal consistency (Cronbach's α 0.941) and test-retest reliability (intra-class correlation coefficients 0.730-0.880). Convergent validity with two reference measures was demonstrated with strong correlations of 0.573-0.730 were shown. Significant differences (P = 0.0018, standardized effect size = 0.372) between groups defined by number of night-time voids supported known-groups validity. Exit interviews in 66 patients indicated all participants experienced improvement in at least 1 NI Diary item and that a 1-point improvement on the item response scale and 1-void reduction per night (associated with an average best cut point on ROC analysis of - 11.6) constituted meaningful improvement. Anchor and distribution-based analyses identified a meaningful change threshold of - 15 to - 18 points on the NI Diary. CONCLUSION: The NI Diary is a reliable and valid patient-reported psychometric instrument which is fit-for-purpose to evaluate the impact of nocturia on patient quality of life in the clinical trial setting. Trial registration number and registration date NCT03201419; June 28, 2017.

A Study Comparing Patient and Clinician Perspectives of Treatments for Multiple Sclerosis via Group Concept Mapping.

BACKGROUND: Clinicians treating multiple sclerosis (MS) should consider patient preferences when making treatment decisions. An online mixed-methods approach to elicit patient-centered concepts, group concept mapping (GCM), was used to generate statements reflecting the patient experience in relapsing-remitting MS and identify the most important patient-centered outcomes from patient and clinician perspectives. PATIENTS AND METHODS: Twenty patients and 12 MS specialists in the United States provided statements describing what an ideal treatment would do to improve symptoms and daily functioning. Statements were sorted by participants into meaningful domains and rated on importance on an 11-point scale. RESULTS: Sixty-four unique statements supporting 6 domains of clustered concepts were generated. Patient and clinician ratings of importance were highly correlated (r=0.82); however, patients rated the domains of Activities of Daily Living, Prevent & Cure, and Address Symptoms as highest in importance, whereas clinicians rated Prevent & Cure, Safe & Effective, and Activities of Daily Living as highest in importance. Statements rated above the domain mean by both patients and clinicians included "Improve cognitive function" and "Improve motor function" in the Activities of Daily Living domain and "Help with memory issues" and "Help preserve cognition" in the Address Symptoms domain. The statement "Improve short term memory" was 1 of 3 statements rated above the domain mean by patients but below the domain mean by clinicians. CONCLUSION: High levels of agreement of concept importance were found between patients and MS specialists, although certain domains and statements were rated more highly by one group. Overall, concepts such as cognitive function, physical and emotional functioning, and activities of daily living were perceived as having great importance for treatment outcomes versus symptom-focused outcomes like gait or tingling sensations. This comprehensive concept model for the MS patient experience can be used for further development of patient-centered outcome measures in MS treatment.

Outcomes from a Whole-Systems Ayurvedic Medicine and Yoga Therapy Treatment for Obesity Pilot Study.

OBJECTIVES: To determine the feasibility and acceptability of an Ayurveda/Yoga intervention for weight loss, using dual-diagnosis inclusion criteria, dual-paradigm outcomes, and a semistandardized protocol with tailoring according to the Ayurvedic constitution/imbalance profile of each participant. DESIGN: Seventeen participants enrolled in a weekly intervention for 3 months. Outcome measurements were performed at baseline, postintervention, and 3 and 6 months follow-up. SETTING: The intervention was conducted through the University of Arizona, Department of Family and Community Medicine from April through December 2012. SUBJECTS: Participants included 2 men and 15 women recruited from the community of Tucson, AZ using flyers and hospital message boards. Seventeen enrolled and 12 participants provided complete follow-up data. INTERVENTION: Participants met with an Ayurvedic practitioner twice monthly (six times) and followed semistandardized dietary guidelines with individual tailoring to address relevant psychophysiological imbalances obstructing weight loss and a standardized protocol of therapeutic yoga classes three times weekly with recommended home practice of two to four additional sessions. OUTCOME MEASURES: Primary outcome was weight loss. Other biomedical outcomes included body mass index, body fat percentage, waist and hip circumference, waist to hip ratio, and blood pressure. Unique instruments were designed to collect data on outcomes associated with the Ayurvedic medical paradigm, including dietary changes by food qualities, mood/affect, relationships, and changes in Ayurvedic imbalance profiles. RESULTS: Participants lost an average of 3.5 kg during the 3-month intervention. Weight loss at 3 and 6 months postintervention increased to an average of 5.6 kg and 5.9 kg, respectively. Participants who lost 3% of their body weight during the 12 week intervention, lost on average an additional 3% during the follow-up period. Psychosocial outcomes also improved. No additional services were provided to participants during the follow-up period. CONCLUSIONS: A whole-systems Ayurvedic medicine and Yoga therapy approach provides a feasible promising noninvasive low-cost alternative to traditional weight loss interventions with potential added benefits associated with sustainable holistic lifestyle modification and positive psychosocial changes.

A Survey of Licensed Massage Therapists' Perceptions of Skin Cancer Prevention and Detection Activities.

BACKGROUND: Skin cancer is the most common cancer in the US. Training massage therapists (MTs) in skin cancer prevention and detection creates opportunity for reducing skin cancer burden. Little is known about MTs' perceptions of skin cancer prevention and detection, their discussions of these topics with clients, or their referral recommendations for suspicious skin lesions. PURPOSE: We surveyed MTs' perceptions of their role in engaging in conversations about skin cancer prevention, viewing the skin for suspicious lesions, and referring clients with such lesions to health care providers. SETTING PARTICIPANTS RESEARCH DESIGN: We administered an online survey from 2015-2017 of licensed MTs practicing in the US and at least age 21 years (n = 102); quantitative and qualitative data were analyzed in 2017. MAIN OUTCOME MEASURES: The main variables assessed were MTs perceptions of (a) appropriateness for asking clients about skin cancer history, skin cancer prevention, suspicious lesion referral and follow-up; and (b) comfort with recognizing and discussing suspicious lesions, recommending a client see a doctor for suspicious lesion, and discussing skin cancer prevention. RESULTS: Quantitative data revealed that most MTs were amenable to discussing skin cancer prevention during appointments; few were engaging in these conversations. MTs were more comfortable discussing suspicious lesions and recommending that a client see a doctor than they were sharing knowledge about skin cancer and sun safety. Categories based on qualitative content analysis were: sharing information for the client's benefit, and concerns about remaining within scope of practice. CONCLUSIONS: MTs have boundaries for skin cancer risk-reduction content to include in a client discussion and remain in their scope of practice. These findings will help support a future educational intervention for MTs to learn about and incorporate skin cancer risk-reduction messages and activities into their practice.

Impact of Healthy Vending Machine Options in a Large Community Health Organization.

PURPOSE: To determine whether increasing the proportion of healthier options in vending machines decreases the amount of calories, fat, sugar, and sodium vended, while maintaining total sales revenue. DESIGN: This study evaluated the impact of altering nutritious options to vending machines throughout the Banner Health organization by comparing vended items' sales and nutrition information over 6 months compared to the same 6 months of the previous year. SETTING: Twenty-three locations including corporate and patient-care centers. INTERVENTION: Changing vending machine composition toward more nutritious options. MEASURES: Comparisons of monthly aggregates of sales, units vended, calories, fat, sodium, and sugar vended by site. ANALYSIS: A pre-post analysis using paired t tests comparing 6 months before implementation to the equivalent 6 months postimplementation. RESULTS: Significant average monthly decreases were seen for calories (16.7%, P = .002), fat (27.4%, P ≤ .0001), sodium (25.9%, P ≤ .0001), and sugar (11.8%, P = .045) vended from 2014 to 2015. Changes in revenue and units vended did not change from 2014 to 2015 ( P = .58 and P = .45, respectively). CONCLUSION: Increasing the proportion of healthier options in vending machines from 20% to 80% significantly lowered the amount of calories, sodium, fat, and sugar vended, while not reducing units vended or having a negative financial impact.

Implementation of tobacco cessation brief intervention in complementary and alternative medicine practice: qualitative evaluation.

BACKGROUND: This article presents findings from qualitative interviews conducted as part of a research study that trained Acupuncture, Massage, and Chiropractic practitioners' in Arizona, US, to implement evidence-based tobacco cessation brief interventions (BI) in their routine practice. The qualitative phase of the overall study aimed to assess: the impact of tailored training in evidence-based tobacco cessation BI on complementary and alternative medicine (CAM) practitioners' knowledge and willingness to implement BIs in their routine practice; and their patients' responses to cessation intervention in CAM context. METHODS: To evaluate the implementation of skills learned from a tailored training program, we conducted semi-structured qualitative interviews with 54 CAM practitioners in Southern Arizona and 38 of their patients. Interview questions focused on reactions to the implementation of tobacco cessation BIs in CAM practice. RESULTS: After participating in a tailored BI training, CAM practitioners reported increased confidence, knowledge, and motivation to address tobacco in their routine practice. Patients were open to being approached by CAM practitioners about tobacco use and viewed BIs as an expected part of wellness care. CONCLUSIONS: Tailored training motivated CAM practitioners in this study to implement evidence-based tobacco cessation BIs in their routine practice. Results suggest that CAM practitioners can be a valuable point of contact and should be included in tobacco cessation efforts.

Integrative tobacco cessation: A survey assessing past quit strategies and future interest.

PURPOSE: Tobacco cessation remains a public health priority. Unassisted quits are most common despite evidence for a combination of guideline-recommended strategies. This paper reports findings from a pilot study designed to assess past quit strategies and tobacco users' receptiveness to using an integrative clinic that offers both conventional and alternative treatments for future cessation attempts. METHODS: Participants were recruited from a pool of individuals reporting for jury duty. Paper-pencil surveys assessed smoking, past cessation behaviors, and interest in use of the integrative clinic which offers both conventional and alternative treatments. Current and former smokers (n=304) returned surveys. RESULTS: Using multivariate logistic regression, past physiological quit strategies, past behavioral quit strategies, and use of multiple quit strategies increased agreement with interest in future use of an integrative clinic option. Additionally, there is support for the notion that if such a clinic were offered, smokers may be inclined to use this resource for a future quit attempt. CONCLUSIONS: An integrative clinic option for tobacco cessation may encourage smokers to try to quit, especially for those who have used varied cessation strategies in the past. Motivating smokers to use a combined approach for tobacco cessation is a potential future direction for tobacco cessation treatment. Developing and testing an integrative approach may support this effort.

Printed Educational Materials' Impact on Tobacco Cessation Brief Interventions in CAM Practice: Patient and Practitioner Experiences.

Printed educational materials (PEMs) have long demonstrated their usefulness as economical and effective media for health communication. In this article, we evaluate the impact of targeted tobacco cessation PEMS for use along with a brief intervention training designed for three types of complementary and alternative medicine (CAM) practitioners: chiropractic, acupuncture, and massage. We describe how PEMs in CAM practitioners' offices were perceived and used by practitioners and by patients. Semistructured qualitative interviews were conducted with 53 practitioners and 38 of their patients. This analysis specifically focused on developing and distributing project-related posters and pamphlets in CAM practice. Our findings indicate that materials (1) legitimated tobacco-related expertise among CAM practitioners and tobacco-related conversations as part of routine CAM practice, (2) increased practitioners' willingness to approach the topic of tobacco with patients, (3) created an effective way to communicate tobacco-related information and broaden the reach of brief intervention initiatives, and (4) were given to patients who were not willing to engage in direct discussion of tobacco use with practitioners.

Tobacco Cessation Training for Complementary and Alternative Medicine Practitioners: Results of a Practice-Based Trial.

INTRODUCTION: Brief behavioral intervention (BI) is a tobacco-cessation best practice well established among conventional healthcare practitioners. Complementary and alternative medicine (CAM) practitioners treat significant numbers of tobacco users, but do not systematically receive BI training. The CAM Reach study developed and evaluated a tobacco cessation BI training program/practice system intervention adapted specifically for CAM practitioners, and evaluated in real-world CAM practices. STUDY DESIGN: Single-arm intervention. Data were collected in 2010-2014 and analyzed in 2015. SETTING/PARTICIPANTS: Private practices of 30 chiropractors, 27 acupuncturists, 42 massage therapists (N=99), in metropolitan Tucson, Arizona. INTERVENTION: Eight-hour tobacco cessation BI continuing education workshop, in-office BI skills practice/assessment, and system intervention. Training tailored to the CAM practice setting addressed tobacco cessation best practices from the U.S. Public Health Service Guidelines. MAIN OUTCOME MEASURES: Seventeen items (assessing practitioner behavior, motivation, and self-efficacy with tobacco cessation) comprising three factors, Tobacco Cessation Activity, Tobacco Cessation Motivation, and Non-CAM Tobacco Cessation Comfort, were assessed at baseline and 3, 6, 9, and 12 months post-training by practitioner self-report. Research staff visited practices at approximately the same intervals to directly observe changes in clinical practice systems. RESULTS: At 3 months, there were significant increases in practitioners' tobacco cessation activities, motivation and confidence in helping patients quit tobacco, and comfort with providing information and referrals for guideline-based tobacco cessation aids (p<0.0001). Practitioners significantly increased rates of discussing cessation medications with patients (AOR=3.76, 95% CI=1.84, 7.68), and routinely asking about tobacco use in clinical practice (AOR=2.62, 95% CI=1.11, 6.20). Increases occurred across all three practitioner types and were sustained at 12 months-despite heterogeneity in professional training, practice patterns/organization, and practice business models. CONCLUSIONS: Results suggest CAM practitioners are willing and able to offer BIs, and are an important, yet overlooked channel for promoting tobacco cessation and use of evidence-based cessation aids.

Online Tobacco Cessation Training and Competency Assessment for Complementary and Alternative Medicine (CAM) Practitioners: Protocol for the CAM Reach Web Study.

BACKGROUND: Complementary and alternative medicine (CAM) practitioners, such as chiropractors, acupuncturists, and massage therapists, are a growing presence in the US health care landscape and already provide health and wellness care to significant numbers of patients who use tobacco. For decades, conventional biomedical practitioners have received training to provide evidence-based tobacco cessation brief interventions (BIs) and referrals to cessation services as part of routine clinical care, whereas CAM practitioners have been largely overlooked for BI training. Web-based training has clear potential to meet large-scale training dissemination needs. However, despite the exploding use of Web-based training for health professionals, Web-based evaluation of clinical skills competency remains underdeveloped. OBJECTIVE: In pursuit of a long-term goal of helping CAM practitioners integrate evidence-based practices from US Public Health Service Tobacco Dependence Treatment Guideline into routine clinical care, this pilot protocol aims to develop and test a Web-based tobacco cessation training program tailored for CAM practitioners. METHODS: In preparation for a larger trial to examine the effect of training on CAM practitioner clinical practice behaviors around tobacco cessation, this developmental study will (1) adapt an existing in-person tobacco cessation BI training program that is specifically tailored for CAM therapists for delivery via the Internet; (2) develop a novel, Web-based tool to assess CAM practitioner competence in tobacco cessation BI skills, and conduct a pilot validation study comparing the competency assessment tool to live video role plays with a standardized patient; (3) pilot test the Web-based training with 120 CAM practitioners (40 acupuncturists, 40 chiropractors, 40 massage therapists) for usability, accessibility, acceptability, and effects on practitioner knowledge, self-efficacy, and competency with tobacco cessation; and (4) conduct qualitative and quantitative formative research on factors influencing practitioner tobacco cessation clinical behaviors (eg, practice environment, peer social influence, and insurance reimbursement). RESULTS: Web-training and competency assessment tool development and study enrollment and training activities are complete (N=203 practitioners enrolled). Training completion rates were lower than expected (36.9%, 75/203), necessitating over enrollment to ensure a sufficient number of training completers. Follow-up data collection is in progress. Data analysis will begin immediately after data collection is complete. CONCLUSIONS: To realize CAM practitioners' potential to promote tobacco cessation and use of evidence-based treatments, there is a need to know more about the facilitative and inhibitory factors influencing CAM practitioner tobacco intervention behaviors (eg, social influence and insurance reimbursement). Given marked differences between conventional and CAM practitioners, extant knowledge about factors influencing conventional practitioner adoption of tobacco cessation behaviors cannot be confidently extrapolated to CAM practitioners. The potential impact of this study is to expand tobacco cessation and health promotion infrastructure in a new group of health practitioners who can help combat the continuing epidemic of tobacco use.

Considerations for practice-based research: a cross-sectional survey of chiropractic, acupuncture and massage practices.

BACKGROUND: Complementary and alternative medicine (CAM) use has steadily increased globally over the past two decades and is increasingly playing a role in the healthcare system in the United States. CAM practice-based effectiveness research requires an understanding of the settings in which CAM practitioners provide services. This paper describes and quantifies practice environment characteristics for a cross-sectional sample of doctors of chiropractic (DCs), licensed acupuncturists (LAcs), and licensed massage therapists (LMTs) in the United States. METHODS: Using a cross-sectional telephone survey of DCs (n = 32), LAcs (n = 70), and LMTs (n = 184) in the Tucson, AZ metropolitan area, we collected data about each location where practitioners work, as well as measures on practitioner and practice characteristics including: patient volume, number of locations where practitioners worked, CAM practitioner types working at each location, and business models of practice. RESULTS: The majority of practitioners reported having one practice location (93.8% of DCs, 80% of LAcs and 59.8% of LMTs) where they treat patients. Patient volume/week was related to practitioner type; DCs saw 83.13 (SD = 49.29) patients/week, LAcs saw 22.29 (SD = 16.88) patients/week, and LMTs saw 14.21 (SD =10.25) patients per week. Practitioners completed surveys for N = 388 practice locations. Many CAM practices were found to be multidisciplinary and/or have more than one practitioner: 9/35 (25.7%) chiropractic practices, 24/87 (27.6%) acupuncture practices, and 141/266 (53.0%) massage practices. Practice business models across CAM practitioner types were heterogeneous, e.g. sole proprietor, employee, partner, and independent contractor. CONCLUSIONS: CAM practices vary across and within disciplines in ways that can significantly impact design and implementation of practice-based research. CAM research and intervention programs need to be mindful of the heterogeneity of CAM practices in order to create appropriate interventions, study designs, and implementation plans.

Tobacco brief intervention training for chiropractic, acupuncture, and massage practitioners: protocol for the CAM reach study.

BACKGROUND: Tobacco use remains the leading cause of morbidity and mortality in the US. Effective tobacco cessation aids are widely available, yet underutilized. Tobacco cessation brief interventions (BIs) increase quit rates. However, BI training has focused on conventional medical providers, overlooking other health practitioners with regular contact with tobacco users. The 2007 National Health Interview Survey found that approximately 20% of those who use provider-based complementary and alternative medicine (CAM) are tobacco users. Thus, CAM practitioners potentially represent a large, untapped community resource for promoting tobacco cessation and use of effective cessation aids. Existing BI training is not well suited for CAM practitioners' background and practice patterns, because it assumes a conventional biomedical foundation of knowledge and philosophical approaches to health, healing and the patient-practitioner relationship. There is a pressing need to develop and test the effectiveness of BI training that is both grounded in Public Health Service (PHS) Guidelines for tobacco dependence treatment and that is relevant and appropriate for CAM practitioners. METHODS/DESIGN: The CAM Reach (CAMR) intervention is a tobacco cessation BI training and office system intervention tailored specifically for chiropractors, acupuncturists and massage therapists. The CAMR study utilizes a single group one-way crossover design to examine the CAMR intervention's impact on CAM practitioners' tobacco-related practice behaviors. Primary outcomes included CAM practitioners' self-reported conduct of tobacco use screening and BIs. Secondary outcomes include tobacco using patients' readiness to quit, quit attempts, use of guideline-based treatments, and quit rates and also non-tobacco-using patients' actions to help someone else quit. DISCUSSION: CAM practitioners provide care to significant numbers of tobacco users. Their practice patterns and philosophical approaches to health and healing are well suited for providing BIs. The CAMR study is examining the impact of the CAMR intervention on practitioners' tobacco-related practice behaviors, CAM patient behaviors, and documenting factors important to the conduct of practice-based research in real-world CAM practices.

A Pilot Feasibility Study of Whole-systems Ayurvedic Medicine and Yoga Therapy for Weight Loss.

OBJECTIVE: To develop and test the feasibility of a whole-systems lifestyle intervention for obesity treatment based on the practices of Ayurvedic medicine/ Yoga therapy. DESIGN: A pre-post weight loss intervention pilot study using conventional and Ayurvedic diagnosis inclusion criteria, tailored treatment within a standardized treatment algorithm, and standardized data collection instruments for collecting Ayurvedic outcomes. PARTICIPANTS: A convenience sample of overweight/obese adult community members from Tucson, Arizona interested in a "holistic weight loss program" and meeting predetermined inclusion/exclusion criteria. INTERVENTION: A comprehensive diet, activity, and lifestyle modification program based on principles of Ayurvedic medicine/yoga therapy with significant self-monitoring of lifestyle behaviors. The 3-month program was designed to change eating and activity patterns and to improve self-efficacy, quality of life, well-being, vitality, and self-awareness around food choices, stress management, and barriers to weight loss. PRIMARY OUTCOME MEASURES: Changes in body weight, body mass index; body fat percentage, fat/lean mass, waist/hip circumference and ratio, and blood pressure. SECONDARY OUTCOME MEASURES: Diet and exercise self-efficacy scales; perceived stress scale; visual analog scales (VAS) of energy, appetite, stress, quality of life, well-being, and program satisfaction at all time points. RESULTS: Twenty-two adults attended an in-person Ayurvedic screening; 17 initiated the intervention, and 12 completed the 3-month intervention. Twelve completed follow-up at 6 months and 11 completed follow-up at 9 months. Mean weight loss at 3 months was 3.54 kg (SD 4.76); 6 months: 4.63 kg, (SD 6.23) and 9 months: 5.9 kg (SD 8.52). Self-report of program satisfaction was more than 90% at all time points. CONCLUSIONS: An Ayurveda-/yoga-based lifestyle modification program is an acceptable and feasible approach to weight management. Data collection, including self-monitoring and conventional and Ayurvedic outcomes, did not unduly burden participants, with attrition similar to that of other weight loss studies.

Use of provider-based complementary and alternative medicine by adult smokers in the United States: Comparison from the 2002 and 2007 NHIS survey.

PURPOSE: To provide a snapshot of provider-based complementary and alternative medicine (pbCAM) use among adult smokers and assess the opportunity for these providers to deliver tobacco cessation interventions. DESIGN: Cross-sectional analysis of data from the 2002 and 2007 National Health Interview Surveys. SETTING: Nationally representative sample. SUBJECTS: A total of 54,437 (31,044 from 2002; 23,393 from 2007) adults 18 years and older. MEASURES: The analysis focuses on 10 types of pbCAM, including acupuncture, Ayurveda, biofeedback, chelation therapy, chiropractic care, energy therapy, folk medicine, hypnosis, massage, and naturopathy. ANALYSIS: The proportions of current smokers using any pbCAM as well as specific types of pbCAM in 2002 and 2007 are compared using SAS SURVEYLOGISTIC. RESULTS: Between 2002 and 2007, the percentage of recent users of any pbCAM therapy increased from 12.5% to 15.4% (p = .001). The largest increases occurred in massage, chiropractic, and acupuncture. Despite a decrease in the national average of current smokers (22.0% to 19.4%; p = .001), proportions of smokers within specific pbCAM disciplines remained consistent. CONCLUSION: Complementary and alternative medicine (CAM) practitioners, particularly those in chiropractic, acupuncture, and massage, represent new cohorts in the health care community to promote tobacco cessation. There is an opportunity to provide brief tobacco intervention training to CAM practitioners and engage them in public health efforts to reduce the burden of tobacco use in the United States.

Acute electroencephalographic effects from repeated olfactory administration of homeopathic remedies in individuals with self-reported chemical sensitivity.

BACKGROUND: Homeopaths report that individuals with heightened self-reported environmental chemical intolerance (CI) exhibit increased reactivity to homeopathic remedies. Persons high in CI sensitize their electroencephalographic (EEG) alpha responses to repeated intermittent chemical exposures. PRIMARY STUDY OBJECTIVE: The present feasibility study explored interactions between CI and one of two specific homeopathic remedies over time (Sulphur or Pulsatilla nigricans [Pulsatilla]). DESIGN: This study used a two-arm, double-blind, placebo-controlled repeated measures design. Intervention Participants underwent a series of three once-weekly sessions during which they repeatedly sniffed one remedy (6c, 12c, 30c; one potency per week) matched to their Homeopathic Constitutional Type Questionnaire (CTQ) type and two solvent controls (distilled water and a waterethanol [95%] solution). Within sessions, remedies and control solvents were administered via 2-second sniffs (eight sniffs of each of four different succussion levels per potency, in randomized order). PARTICIPANTS: Participants were college student volunteers (N = 96, ages 18-30, both sexes), screened for good health and relatively elevated Sulphur or Pulsatilla symptom pattern scores on the Homeopathic Constitutional Type Questionnaire (CTQ). Participants also completed a validated trait CI scale. PRIMARY OUTCOME MEASURES: Average 19-lead relative EEG alpha power (alpha 1 8-10 Hz; alpha 2 10-12 Hz). RESULTS: Trait CI interacted significantly with time factors for each remedy (both over visit weeks and over sniff cycles during sessions). The patterns were nonlinear and differed between the two remedies. Individuals high in CI showed greater variability over time in remedy EEG alpha effects than did those low in CI. CONCLUSION: The data suggest that CI, with an underlying susceptibility to time-dependent sensitization and oscillatory responses, could contribute to nonlinear dose-response patterns and inconsistent reproducibility of homeopathic clinical care and research.

Nonlinear dynamical systems effects of homeopathic remedies on multiscale entropy and correlation dimension of slow wave sleep EEG in young adults with histories of coffee-induced insomnia.

BACKGROUND: Investigators of homeopathy have proposed that nonlinear dynamical systems (NDS) and complex systems science offer conceptual and analytic tools for evaluating homeopathic remedy effects. Previous animal studies demonstrate that homeopathic medicines alter delta electroencephalographic (EEG) slow wave sleep. The present study extended findings of remedy-related sleep stage alterations in human subjects by testing the feasibility of using two different NDS analytic approaches to assess remedy effects on human slow wave sleep EEG. METHODS: Subjects (N=54) were young adult male and female college students with a history of coffee-related insomnia who participated in a larger 4-week study of the polysomnographic effects of homeopathic medicines on home-based all-night sleep recordings. Subjects took one bedtime dose of a homeopathic remedy (Coffea cruda or Nux vomica 30c). We computed multiscale entropy (MSE) and the correlation dimension (Mekler-D2) for stages 3 and 4 slow wave sleep EEG sampled in artifact-free 2-min segments during the first two rapid-eye-movement (REM) cycles for remedy and post-remedy nights, controlling for placebo and post-placebo night effects. RESULTS: MSE results indicate significant, remedy-specific directional effects, especially later in the night (REM cycle 2) (CC: remedy night increases and post-remedy night decreases in MSE at multiple sites for both stages 3 and 4 in both REM cycles; NV: remedy night decreases and post-remedy night increases, mainly in stage 3 REM cycle 2 MSE). D2 analyses yielded more sporadic and inconsistent findings. CONCLUSIONS: Homeopathic medicines Coffea cruda and Nux vomica in 30c potencies alter short-term nonlinear dynamic parameters of slow wave sleep EEG in healthy young adults. MSE may provide a more sensitive NDS analytic method than D2 for evaluating homeopathic remedy effects on human sleep EEG patterns.

Multiweek resting EEG cordance change patterns from repeated olfactory activation with two constitutionally salient homeopathic remedies in healthy young adults.

OBJECTIVES: Electroencephalography (EEG) offers psychophysiologic tools to improve sensitivity for detecting objective effects in complementary and alternative medicine. This current investigation extended prior clinical research studies to evaluate effects of one of two different homeopathic remedies on resting EEG cordance after an olfactory activation protocol on healthy young adults with remedy-relevant, self-perceived characteristics. METHODS: Ninety-seven (7) young adults (N=97, mean age 19 years, 55% women) with good self-rated global health and screened for homeopathic constitutional types consistent with one of two remedies (either Sulphur or Pulsatilla) underwent three weekly laboratory sessions. At each visit, subjects had 5-minute resting, eyes-closed EEG recordings before and after a placebo-controlled olfactory activation task with their constitutionally relevant verum remedy. One remedy potency (6c, 12c, or 30c) used per week, was presented in a randomized order over the 3 sessions. Prefrontal resting EEG cordance values at Fp1 and Fp2 were computed from artifact-free 2-minute EEG samples from the presniffing and postsniffing rest periods. Cordance derives from an algorithm that incorporates absolute and relative EEG values. RESULTS: The data showed significant two-way oscillatory interactions of remedy by time for ß, α, θ, and δ cordance, controlling for gender and chemical sensitivity. CONCLUSIONS: EEG cordance provided a minimally invasive technique for assessing objective nonlinear physiologic effects of two different homeopathic remedies salient to the individuals who received them. Time factors modulated the direction of effects. Given previous evidence of correlations between cordance and single-photon emission computed tomography, these findings encourage additional neuroimaging research on nonlinear psychophysiologic effects of specific homeopathic remedies.

State-space grid analysis: applications for clinical whole systems complementary and alternative medicine research.

This paper presents state space grids (SSGs) as a mathematically less intensive methodology for process-oriented research beyond traditional qualitative and quantitative approaches in whole systems of complementary and alternative medicine (WS-CAM). SSGs, originally applied in developmental psychology research, offer a logical, flexible, and accessible tool for capturing emergent changes in the temporal dynamics of patient behaviors, manifestations of resilience, and outcomes. The SSG method generates a two-dimensional visualization and quantification of the inter-relationships between variables on a moment-to-moment basis. SSGs can describe dyadic interactive behavior in real time and, followed longitudinally, allow evaluation of how change occurs over extended time periods. Practice theories of WS-CAM encompass the holistic health concept of whole-person outcomes, including nonlinear pathways to complex, multidimensional changes. Understanding how the patient as a living system arrives at these outcomes requires studying the process of healing, e.g., sudden abrupt worsening and/or improvements, 'healing crises', and 'unstuckness', from which the multiple inter-personal and intra-personal outcomes emerge. SSGs can document the indirect, emergent dynamic effects of interventions, transitional phases, and the mutual interaction of patient and environment that underlie the healing process. Two WS-CAM research exemplars are provided to demonstrate the feasibility of using SSGs in both dyadic and within-patient contexts, and to illustrate the possibilities for clinically relevant, process-focused hypotheses. This type of research has the potential to help clinicians select, modify and optimize treatment plans earlier in the course of care and produce more successful outcomes for more patients.