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1.  Modes of Hoping: Understanding hope and expectation in the context of a clinical trial of complementary and alternative medicine for chronic pain 
Explore (New York, N.Y.)  2014;10(4):225-232.
This article explores the role of hope in participants’ assessments of their expectations, experiences and treatment outcomes. Data analysis focused on semi-structured, open-ended interviews with 44 participants, interviewed 3-5 times each over the course of a study evaluating Traditional Chinese Medicine (TCM) for Temporomandibular Disorders (TMD, a form of chronic orofacial pain). Transcripts were coded and analyzed using qualitative and ethnographic methods. A “Modes of Hoping”1 framework informed our analysis. Five modes of hoping emerged from participant narratives: Realistic Hope; Wishful Hope; Utopian Hope; Technoscience Hope; and Transcendent Hope. Using this framework, hope is demonstrated as exerting a profound influence over how participants assess and report their expectations. This suggests that researchers interested in measuring expectations and understanding their role in treatment outcomes should consider hope as exercising a multifaceted and dynamic influence on participants’ reporting of expectations and their experience and evaluation of treatment.
PMCID: PMC4104425  PMID: 25037665
Hope; Expectation; TCM; TMD; qualitative
2.  Considerations for practice-based research: a cross-sectional survey of chiropractic, acupuncture and massage practices 
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.
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.
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.
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.
PMCID: PMC4429345  PMID: 25933801
Complementary and alternative medicine; Practitioners; Chiropractors; Acupuncturists; Massage therapists; Practice-based research; Practice patterns; Cross-sectional survey
3.  Intervention development for integration of conventional tobacco cessation interventions into routine CAM practice 
Practitioners of complementary and alternative medicine (CAM) therapies are an important and growing presence in health care systems worldwide. A central question is whether evidence-based behavior change interventions routinely employed in conventional health care could also be integrated into CAM practice to address public health priorities. Essential for successful integration are intervention approaches deemed acceptable and consistent with practice patterns and treatment approaches of different types of CAM practitioners – that is, they have context validity. Intervention development to ensure context validity was integral to Project CAM Reach (CAMR), a project examining the public health potential of tobacco cessation training for chiropractors, acupuncturists and massage therapists (CAM practitioners). This paper describes formative research conducted to achieve this goal.
Intervention development, undertaken in three CAM disciplines (chiropractic, acupuncture, massage therapy), consisted of six iterative steps: 1) exploratory key informant interviews; 2) local CAM practitioner community survey; 3) existing tobacco cessation curriculum demonstration with CAM practitioners; 4) adapting/tailoring of existing curriculum; 5) external review of adaptations; 6) delivery of tailored curriculum to CAM practitioners with follow-up curriculum evaluation.
CAM practitioners identified barriers and facilitators to addressing tobacco use with patients/clients and saw the relevance and acceptability of the intervention content. The intervention development process was attentive to their real world intervention concerns. Extensive intervention tailoring to the context of each CAM discipline was found unnecessary. Participants and advisors from all CAM disciplines embraced training content, deeming it to have broad relevance and application across the three CAM disciplines. All findings informed the final intervention.
The participatory and iterative formative research process yielded an intervention with context validity in real-world CAM practices as it: 1) is patient/client-centered, emphasizing the practitioner’s role in a healing relationship; 2) is responsive to the different contexts of CAM practitioners’ work and patient/client relationships; 3) integrates relevant best practices from US Public Health Service Clinical Practice Guidelines on treating tobacco dependence; and 4) is suited to the range of healing philosophies, scopes of practice and practice patterns found in participating CAM practitioners. The full CAMR study to evaluate the impact of the CAMR intervention on CAM practitioners’ clinical behavior is underway.
PMCID: PMC4391469  PMID: 25887742
Context validity; Intervention protocol; Curriculum development; Training; Interprofessional education; Tobacco cessation; Chiropractic; Acupuncture; Massage therapist; Community based participatory research
4.  A qualitative study of changes in expectations over time among patients with chronic low back pain seeking four CAM therapies 
The relationship between patient expectations about a treatment and the treatment outcomes, particularly for Complementary and Alternative Medicine (CAM) therapies, is not well understood. Using qualitative data from a larger study to develop a valid expectancy questionnaire for use with participants starting new CAM therapies, we examined how participants’ expectations of treatment changed over the course of a therapy.
We conducted semi-structured qualitative interviews with 64 participants initiating one of four CAM therapies (yoga, chiropractic, acupuncture, massage) for chronic low back pain. Participants just starting treatment were interviewed up to three times over a period of 3 months. Interviews were transcribed verbatim and analyzed using a qualitative mixed methods approach incorporating immersion/crystallization and matrix analysis for a decontexualization and recontextualization approach to understand changes in thematic emphasis over time.
Pre-treatment expectations consisted of conjecture about whether or not the CAM therapy could relieve pain and improve participation in meaningful activities. Expectations tended to shift over the course of treatment to be more inclusive of broader lifestyle factors, the need for long-term pain management strategies and attention to long-term quality of life and wellness. Although a shift toward greater acceptance of chronic pain and the need for strategies to keep pain from flaring was observed across participants regardless of therapy, participants varied in their assessments of whether increased awareness of the need for ongoing self-care and maintenance strategies was considered a “positive outcome”. Regardless of how participants evaluated the outcome of treatment, participants from all four therapies reported increased awareness, acceptance of the chronic nature of pain, and attention to the need to take responsibility for their own health.
The shift in treatment expectations to greater acceptance of pain and the need for continued self-care suggests that future research should explore how CAM practitioners can capitalize on these shifts to encourage feelings of empowerment rather than disappointment surrounding realizations of the need for continued engagement with self-care.
PMCID: PMC4322442  PMID: 25652396
Chronic low back pain; Acupuncture; Chiropractic; Yoga; Massage; CAM; Expectations; Self-care; Pain management
5.  Tobacco brief intervention training for chiropractic, acupuncture, and massage practitioners: protocol for the CAM reach study 
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.
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.
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.
PMCID: PMC4320589  PMID: 25524595
Tobacco cessation; Brief intervention; Training; Communication; Acupuncture; Chiropractic; Massage therapy; System intervention; Longitudinal study; Qualitative study
8.  New perspectives on patient expectations of treatment outcomes: results from qualitative interviews with patients seeking complementary and alternative medicine treatments for chronic low back pain 
Positive patient expectations are often believed to be associated with greater benefits from complementary and alternative medicine (CAM) treatments. However, clinical studies of CAM treatments for chronic pain have not consistently supported this assumption, possibly because of differences in definitions and measures of expectations. The goal of this qualitative paper is to provide new perspectives on the outcome expectations of patients prior to receiving CAM therapies for chronic low back pain.
We conducted semi-structured interviews with 64 individuals receiving massage, chiropractic, acupuncture or yoga for chronic low back pain. Interviews were recorded and transcribed. Transcripts were analyzed by a team of experienced qualitative researchers using an immersion/crystallization approach to coding and analysis.
Overall, participants’ expectations of treatment outcomes tended to cluster in four key domains: pain relief, improved function (including an increase in ability to engage in meaningful activities), improved physical fitness, and improved overall well-being (including mental well-being). Typically, patients had modest expectations for outcomes from treatment. Furthermore, outcome expectations were complex on several levels. First, the concept of expectations overlapped with several related concepts; in particular, hopes. Participants sometimes used expectations and hopes interchangeably and at other times made clear distinctions between these two terms depending on context. A related finding was that participants were cautious about stating that they expected positive outcomes. Finally, participants articulated strong interrelationships among the four key domains and often discussed how changes in one domain might affect other domains.
Overall, these findings contribute to a growing body of literature exploring the role of expectations in patient outcomes. This paper provides important guidance that may help refine the way treatment expectations are studied in the future. In particular, participants’ statements indicate that standardized measures of patient expectations should include items that capture hesitancy to articulate overly optimistic outcomes as well as interrelationships among different outcomes.
PMCID: PMC4129105  PMID: 25077732
9.  The TOTS Community Intervention to Prevent Overweight in American Indian Toddlers: A Feasibility and Efficacy Study 
Journal of community health  2010;35(6):667-675.
Excess weight gain in American Indian/Alaskan native (AI/AN) children is a public health concern. This study tested 1) the feasibility of delivering community-wide interventions, alone or in combination with family-based interventions, to promote breastfeeding and reduce the consumption of sugar-sweetened beverages; and 2) whether these interventions decrease Body Mass Index (BMI)-Z scores in children 18–24 months of age.
Three AI/AN tribes were randomly assigned to two active interventions; a community-wide intervention alone (tribe A; n=63 families) or community-wide intervention containing a family component (tribes B and C; n=142 families). Tribal staff and the research team designed community-tailored interventions and trained community health workers to deliver the family intervention through home visits. Feasibility and acceptability of the intervention and BMI-Z scores at 18–24 months were compared between tribe A and tribes B&C combined using a separate sample pretest, posttest design.
Eighty-six percent of enrolled families completed the study. Breastfeeding initiation and 6-month duration increased 14 and 15%, respectively, in all tribes compared to national rates for American Indians. Breastfeeding at 12 months was comparable to national data. Parents expressed confidence in their ability to curtail family consumption of sugar-sweetened beverages. Compared to a pretest sample of children of a similar age two years before the study begun, BMI-Z scores increased in all tribes. However, the increase was less in tribes B &C compared to tribe A (−0.75, p=0.016).
Family, plus community-wide interventions to increase breastfeeding and curtail sugar-sweetened beverages attenuate BMI rise in AI/AN toddlers more than community-wide interventions alone.
PMCID: PMC4058573  PMID: 20508978
Obesity prevention; infants; toddlers; breastfeeding; sugar-sweetened beverages
10.  Dental Caries in American Indian Toddlers after a Community-Based Beverage Intervention 
Ethnicity & disease  2010;20(4):444-450.
The Toddler Overweight and Tooth decay prevention Study (TOTS) was an overweight and early childhood caries (ECC) project in the Pacific Northwest USA. It targeted American Indian (AI) toddlers from birth, to effect changes in breastfeeding and sweetened beverage consumption.
The intervention cohort was children born in three communities during 12 months; expectant mothers were identified through prenatal visits, and recruited by tribal coordinators. The local comparison cohorts were children in those communities who were 18–30 months at study start. A control longitudinal cohort consisted of annual samples of children aged 18–30 months in a fourth community, supplying secular trends.
Outcome measures
d1–2mfs was used to identify incident caries in intervention, comparison, and control cohorts after 18-to-30 months of follow-up in 2006.
No missing or filled teeth were found. For d1t, all three intervention cohorts showed statistically significant downward intervention effects, decreases of between 0.300 and 0.631 in terms of the fraction of affected mouths. The results for d2t were similar but of smaller magnitudes, decreases of between 0.342 and 0.449; these results met the 0.05 level for significance in two of three cases. In light of an estimated secular increase in dental caries in the control site, all three intervention cohorts showed improvements in both d1t and d2t.
Simple interventions targeting sweetened beverage availability (in combination with related measures) reduced high tooth decay trends, and were both feasible and acceptable to the AI communities we studied.
PMCID: PMC4058337  PMID: 21305835
Caries; American Indian; child; community intervention; soft drinks; sugared beverages
11.  Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document 
Trials  2014;15:169.
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.
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.
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.
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.
PMCID: PMC4045891  PMID: 24885146
Comparative effectiveness research; Effectiveness guidance document; Chinese medicine research
12.  Intervention in Overweight Children Improves BMI and Physical Activity 
Childhood obesity is a growing epidemic in family medicine with few clinical treatment options. We implemented and evaluated a group office-visit intervention by family physicians emphasizing nutrition and physical activity within a resiliency psychosocial model, for overweight children and their parents.
The intervention lasted for 3 months, with half of the children crossing over to intervention after 6 months on study. Participants included 35 children who met eligibility criteria of being in third through fifth grades and having a body mass index above the 85th percentile. The 3-month twelve-session intervention, “Choices”, included topics on nutrition, physical activity, and resiliency. The sessions were developed for delivery by a family physician, and a nutritionist, who all received training in positive psychology and resilience skills. Main outcome measures were body mass index (BMI) z-scores for age-and-gender, and weight-for-age-and-gender z-scores, as well as qualitative interviews to understand individual and family processes.
The intervention resulted in a significant effect on one primary outcome, BMI z-score (-0.138 per 9 months (p =0.017) and a trend toward significance on the other, weight for age z-score (-0.87 per 9 months (p=0.09). The net shift of activity from the low METS to the high METS had an intervention effect of 2.84 METS (p = 0.037). Families reported lasting changes in behaviors and attitudes.
The innovative approach used in this study demonstrated modest efficacy in reducing BMI z-score, changing physical activity levels, and possibly shifting family dynamics.
PMCID: PMC4010584  PMID: 23471926
intervention for overweight children; sedentary behavior in children; resiliency
13.  Hibiscus sabdariffa L. in the treatment of hypertension and hyperlipidemia: a comprehensive review of animal and human studies 
Fitoterapia  2013;85:84-94.
The effectiveness of Hibiscus sabdariffa L. (HS) in the treatment of risk factors associated with cardiovascular disease is assessed in this review by taking a comprehensive approach to interpreting the randomized clinical trial (RCT) results in the context of the available ethnomedical, phytochemical, pharmacological, and safety and toxicity information. HS decoctions and infusions of calyxes, and on occasion leaves, are used in at least 10 countries worldwide in the treatment of hypertension and hyperlipidemia with no reported adverse events or side effects. HS extracts have a low degree of toxicity with a LD50 ranging from 2,000 to over 5,000 mg/kg/day. There is no evidence of hepatic or renal toxicity as the result of HS extract consumption, except for possible adverse hepatic effects at high doses. There is evidence that HS acts as a diuretic, however in most cases the extract did not significantly influence electrolyte levels. Animal studies have consistently shown that consumption of HS extract reduces blood pressure in a dose dependent manner. In RCTs, the daily consumption of a tea or extract produced from HS calyxes significantly lowered systolic blood pressure (SBP) and diastolic blood pressure (DBP) in adults with pre to moderate essential hypertension and type 2 diabetes. In addition, HS tea was as effective at lowering blood pressure as the commonly used blood pressure medication Captropril, but less effective than Lisinopril. Total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglycerides were lowered in the majority of normolipidemic, hypolipidemic, and diabetic animal models, whereas high-density lipoprotein cholesterol (HDL-C) was generally not affected by the consumption of HS extract. Over half of the RCTs showed that daily consumption of HS tea or extracts had favorable influence on lipid profiles including reduced total cholesterol, LDL-C, triglycerides, as well as increased HDL-C. Anthocyanins found in abundance in HS calyxes are generally considered the phytochemicals responsible for the antihypertensive and hypocholesterolemic effects, however evidence has also been provided for the role of polyphenols and hibiscus acid. A number of potential mechanisms have been proposed to explain the hypotensive and anticholesterol effects, but the most common explanation is the antioxidant effects of the anthocyanins inhibition of LDL-C oxidation, which impedes atherosclerosis, an important cardiovascular risk factor. This comprehensive body of evidence suggests that extracts of HS are promising as a treatment of hypertension and hyperlipidemia, however more high quality animal and human studies informed by actual therapeutic practices are needed to provide recommendations for use that have the potential for widespread public health benefit.
PMCID: PMC3593772  PMID: 23333908
Hibiscus sabdariffa L.; Roselle; hypertension; cholesterol; randomized clinical trials; ethnopharmacology
14.  Adherence to, and Satisfaction with, the Self-Acupressure Intervention in the LIFE Weight-Loss Maintenance Study 
Medical Acupuncture  2013;25(1):43-47.
The LIFE study was a randomized controlled trial assessing the impact of a self-acupressure intervention, Tapas Acupressure Technique® (TAT®), on weight-loss maintenance. The primary analysis showed no significant difference between TAT and social support (SS) for weight-loss maintenance, while exploratory post hoc tests suggested that, among participants with highest initial weight-loss, those in the TAT condition regained less weight than those in the SS condition.
The aim of the current study was to assess adherence to, and satisfaction with, the experimental self-acupressure intervention in the LIFE weight loss maintenance trial.
This was a secondary analysis of adherence and satisfaction patterns in a large randomized controlled trial.
The study was conducted at a prominent health maintenance organization in the Pacific Northwest.
This study involved 142 obese participants who had lost >10 pounds in a conventional weight-loss program and who were randomized to the experimental acupressure intervention.
The experimental intervention (n=142) arm consisted of instruction and application of a self-acupressure intervention, the Tapas Acupressure Technique® (TAT®).
Outcome Measures
The outcome sought was self-reported satisfaction and frequency of TAT practice
Sixty-six percent of TAT participants attended at least 6 of 8 intervention sessions. More than 80% of participants reported practicing TAT at home, on average, at least 2 days per week. Sixty two percent reported practicing <10 minutes per session, while 27% reported practicing 10–20 minutes per session. Higher satisfaction scores were significantly correlated with less weight regain (p=0.001). Frequency of TAT practice was not significantly associated with changes in weight, stress, insomnia, depression, or quality of life.
These data suggest moderate acceptance of, and adherence to, the TAT intervention. Further research is required to identify and achieve optimal home-practice levels of self-acupressure techniques.
PMCID: PMC3584503  PMID: 24761167
Acupressure; Tapas Acupressure Technique; Weight Loss Maintenance; Energy Psychology
15.  Cognitive interviews guide design of a new CAM patient expectations questionnaire 
No consistent relationship exists between pre-treatment expectations and therapeutic benefit from various complementary and alternative medicine (CAM) therapies in clinical trials. However, many different expectancy measures have been used in those studies, with no validated questionnaires clearly focused on CAM and pain. We undertook cognitive interviews as part of a process to develop and validate such a questionnaire.
We reviewed questions about expectations of benefits of acupuncture, chiropractic, massage, or yoga for pain. Components of the questions – verbs, nouns, response options, terms and phrases describing back pain – were identified. Using seven different cognitive interview scripts, we conducted 39 interviews to evaluate how individuals with chronic low back pain understood these individual components in the context of expectancy questions for a therapy they had not yet received. Chosen items were those with the greatest agreement and least confusion among participants, and were closest to the meanings intended by the investigators.
The questionnaire drafted for psychometric evaluation had 18 items covering various domains of expectancy. “Back pain” was the most consistently interpreted descriptor for this condition. The most understandable response options were 0-10 scales, a structure used throughout the questionnaire, with 0 always indicating no change, and 10 anchored with an absolute descriptor such as “complete relief”. The use of words to describe midpoints was found to be confusing. The word “expect” held different and shifting meanings for participants. Thus paired items comparing “hope” and “realistically expect” were chosen to evaluate 5 different aspects of treatment expectations (back pain; back dysfunction and global effects; impact of back pain on specific areas of life; sleep, mood, and energy; coping). “Impact of back pain” on various areas of life was found to be a consistently meaningful concept, and more global than “interference”.
Cognitive interviews identified wordings with considerable agreement among both participants and investigators. Some items widely used in clinical studies had different meanings to participants than investigators, or were confusing to participants. The final 18-item questionnaire is undergoing psychometric evaluation with goals of streamlining as well as identifying best items for use when questionnaire length is constrained.
PMCID: PMC3906834  PMID: 24460709
Cognitive interviews; Questionnaires; Expectations; Low back pain; Acupuncture; Chiropractic; Massage therapy; Yoga
16.  Comparative Effectiveness of Traditional Chinese Medicine (TCM) and Psychosocial Care in the Treatment of TMD-associated Chronic Facial Pain 
This dual-site study sought to identify the appropriate role for TCM (acupuncture and herbs) in conjunction with a validated psychosocial self-care intervention (SC) for treating chronic TMD-associated pain. Participants with RDC-TMD-confirmed TMD (n=168) entered a stepped-care protocol that began with a basic TMD class. At weeks 2 and 10, patients receiving SC whose worst facial pain was above predetermined levels were reallocated by minimization to SC or TCM with experienced practitioners. Characteristic facial pain (CFP: mean of worst pain, average pain when having pain, current pain; each VAS 0-10) was the primary outcome. Social activity interference (VAS 0-10) was a secondary outcome. Patients were monitored for safety.
TCM provided significantly greater short-term (8-week) relief than SC (CFP reduction difference, −0.60 [SDE 0.26], p=0.020), and greater reduction in interference with social activities (−0.81 [SDE 0.33], p=0.016). In two of five treatment trajectory groups, more than 2/3 of participants demonstrated clinically meaningful responses (> 30% improvement) in pain interference over 16 weeks. This study provides evidence that TMD patients referred for TCM in a community-based model will receive safe treatment that is likely to provide some short-term pain relief and improved quality of life. Similar designs may also apply to evaluations of other kinds of chronic pain. ( number NCT00856167)
This short-term comparative effectiveness study of chronic facial pain suggests that Traditional Chinese Medicine is safe and frequently efficacious alone or subsequent to standard psychosocial interventions. TCM is widely available throughout North America and may provide clinicians and patients with a reasonable addition or alternative to other forms of therapy.
PMCID: PMC3490702  PMID: 23059454
17.  A Community-Based Intervention to Prevent Obesity Beginning at Birth among American Indian Children: Study Design and Rationale for the PTOTS study 
The journal of primary prevention  2012;33(4):161-174.
Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that American Indian (AI) children have higher rates of overweight and obesity than children of other races/ethnicities. The Prevention of Toddler Obesity and Teeth Health Study (PTOTS) is a community-partnered randomized controlled trial designed to prevent obesity beginning at birth in AI children. PTOTS was developed to test the effectiveness of a multi-component intervention designed to: promote breastfeeding, reduce sugar-sweetened beverage consumption, appropriately time the introduction of healthy solid foods, and counsel parents to reduce sedentary lifestyles in their children. A birth cohort of 577 children from five AI tribes is randomized by tribe to either the intervention (three tribes) or the comparison condition (two tribes). The strengths and weaknesses of PTOTS include a focus on a critical growth phase, placement in the community, and intervention at many levels, using a variety of approaches.
PMCID: PMC3490127  PMID: 23001689
Primary Obesity Prevention; Infants; Toddlers; American Indians
18.  Complementary and alternative medicine (CAM) providers’ views of chronic low back pain patients’ expectations of CAM therapies: a qualitative study 
Some researchers think that patients with higher expectations for CAM therapies experience better outcomes and that enthusiastic providers can enhance treatment outcomes. This is in contrast to evidence suggesting conventional medical providers often reorient patient expectations to better match what providers believe to be realistic. However, there is a paucity of research on CAM providers’ views of their patients’ expectations regarding CAM therapy and the role of these expectations in patient outcomes.
To better understand how CAM providers view and respond to their patients’ expectations of a particular therapy, we conducted 32 semi-structured, qualitative interviews with acupuncturists, chiropractors, massage therapists and yoga instructors identified through convenience sampling. Interviews were recorded, transcribed and analyzed thematically using Atlas ti version 6.1.
CAM providers reported that they attempt to ensure that their patients’ expectations are realistic. Providers indicated they manage their patients’ expectations in a number of domains— roles and responsibilities of providers and patients, treatment outcomes, timeframe for improvement, and treatment experience. Providers reported that patients’ expectations change over time and that they need to continually manage these expectations to enhance patient engagement and satisfaction with treatment.
Providers of four types of CAM therapies viewed patients’ expectations as an important component of their experiences with CAM therapy and indicated that they try to align patient expectations with reality. These findings suggest that CAM providers are similar in this respect to conventional medical providers.
PMCID: PMC3533863  PMID: 23186539
Expectations; Providers; Qualitative research; Chiropractic; Massage; Acupuncture; Yoga; Complementary medicine; Alternative medicine
19.  Effectiveness guidance document (EGD) for acupuncture research - a consensus document for conducting trials 
There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making.
Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved.
Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.
The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.
PMCID: PMC3495216  PMID: 22953730
Comparative effectiveness research; Effectiveness guidance document; Acupuncture
20.  Reductions in Pain Medication Use Associated with Traditional Chinese Medicine for Chronic Pain 
The Permanente Journal  2012;16(3):18-23.
Context: Participants in a randomized trial of traditional Chinese medicine (TCM) for temporomandibular joint dysfunction (TMD) had a linear decline in pain over 16 TCM visits.
Objective: To investigate whether reductions in pain among participants receiving TCM can be explained by increased use of pain medications, or whether use of pain medications also declined in this group.
Design: One hundred sixty-eight participants with TMD were treated with TCM or enhanced self-care according to a stepped-care design. Those for whom self-care failed were sequentially randomized to further self-care or TCM. This report includes 111 participants during their first 16 TCM visits. The initial 8 visits occurred more than once a week; participants and practitioners determined the frequency of subsequent visits.
Outcome measures: Average pain (visual analog scale, range 0–10) and morphine and aspirin dose equivalents.
Results: The sample was 87% women and the average age was 44 ± 13 years. Average pain of narcotics users (n = 21) improved by 2.73 units over 16 visits (p < 0.001). Overall narcotics use trended downward until visit 11 (−3.27 doses/week, p = 0.156), and then trended upward until week 16 (+4.29 doses/week, p = 0.264). Among those using narcotics, use of nonsteroidal anti-inflammatory drugs (NSAIDs) declined linearly over visits 1–16 (−1.94 doses/week, p = 0.002).
Among the top quartile of NSAID-only users (n = 22), average pain decreased linearly over 16 visits (−1.52 units, p = 0.036). Overall NSAID doses/week declined between visits 1 and 7 (−9.95 doses/week, p < 0.001) and then remained stable through 16 visits. NSAID use also declined among the third quartile (n = 23) and remained low and stable among the lower half (sorted by total intake) of NSAID users.
Conclusions: Among the heaviest NSAID users, we observed a short-term reduction in NSAID use that was sustained as TCM visits became less frequent. There was no indication that pain reduction during TCM treatment was influenced by drug use.
PMCID: PMC3442756  PMID: 23012594
21.  Randomized trial of tapas acupressure technique for weight loss maintenance 
Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance.
Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®), or a control intervention comprised of social-support group meetings (SS) led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation.
Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd) = 11), mean BMI at randomization was 34 (sd = 5), and mean initial weight loss was 9.8 kg (sd = 5). In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85) weight regain for TAT and 2.96 kg (se 0.96) weight regain for SS, p < 0.097) Tests of between- arm differences for secondary outcomes were also not significant. A secondary analysis showed a significant interaction between treatment and initial weight loss (p < .036), with exploratory post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT.
The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research.
Trial Registration NCT00526565
PMCID: PMC3375195  PMID: 22417316
Obesity; Weight-loss maintenance; Energy medicine; Acupressure
22.  Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format 
Patients receiving complementary and alternative medicine (CAM) therapies often report shifts in well-being that go beyond resolution of the original presenting symptoms. We undertook a research program to develop and evaluate a patient-centered outcome measure to assess the multidimensional impacts of CAM therapies, utilizing a novel mixed methods approach that relied upon techniques from the fields of anthropology and psychometrics. This tool would have broad applicability, both for CAM practitioners to measure shifts in patients' states following treatments, and conventional clinical trial researchers needing validated outcome measures. The US Food and Drug Administration has highlighted the importance of valid and reliable measurement of patient-reported outcomes in the evaluation of conventional medical products. Here we describe Phase I of our research program, the iterative process of content identification, item development and refinement, and response format selection. Cognitive interviews and psychometric evaluation are reported separately.
From a database of patient interviews (n = 177) from six diverse CAM studies, 150 interviews were identified for secondary analysis in which individuals spontaneously discussed unexpected changes associated with CAM. Using ATLAS.ti, we identified common themes and language to inform questionnaire item content and wording. Respondents' language was often richly textured, but item development required a stripping down of language to extract essential meaning and minimize potential comprehension barriers across populations. Through an evocative card sort interview process, we identified those items most widely applicable and covering standard psychometric domains. We developed, pilot-tested, and refined the format, yielding a questionnaire for cognitive interviews and psychometric evaluation.
The resulting questionnaire contained 18 items, in visual analog scale format, in which each line was anchored by the positive and negative extremes relevant to the experiential domain. Because of frequent informant allusions to response set shifts from before to after CAM therapies, we chose a retrospective pretest format. Items cover physical, emotional, cognitive, social, spiritual, and whole person domains.
This paper reports the success of a novel approach to the development of outcome instruments, in which items are extracted from patients' words instead of being distilled from pre-existing theory. The resulting instrument, focused on measuring shifts in patients' perceptions of health and well-being along pre-specified axes, is undergoing continued testing, and is available for use by cooperating investigators.
PMCID: PMC3293761  PMID: 22206345
Complementary and alternative medicine (CAM); patient-reported outcomes (PROs); patient-centered care; non-specific outcomes; questionnaire development; retrospective pre-test; well-being
23.  Developing a patient-centered outcome measure for complementary and alternative medicine therapies II: Refining content validity through cognitive interviews 
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.
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.
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.
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.
PMCID: PMC3439682  PMID: 22206409
Complementary and alternative medicine (CAM); patient-reported outcomes (PROs); cognitive interviewing; patient-centered care; non-specific outcomes; questionnaire development; retrospective pre-test; well-being
24.  Acupuncture and chiropractic care for chronic pain in an integrated health plan: a mixed methods study 
Substantial recent research examines the efficacy of many types of complementary and alternative (CAM) therapies. However, outcomes associated with the "real-world" use of CAM has been largely overlooked, despite calls for CAM therapies to be studied in the manner in which they are practiced. Americans seek CAM treatments far more often for chronic musculoskeletal pain (CMP) than for any other condition. Among CAM treatments for CMP, acupuncture and chiropractic (A/C) care are among those with the highest acceptance by physician groups and the best evidence to support their use. Further, recent alarming increases in delivery of opioid treatment and surgical interventions for chronic pain--despite their high costs, potential adverse effects, and modest efficacy--suggests the need to evaluate real world outcomes associated with promising non-pharmacological/non-surgical CAM treatments for CMP, which are often well accepted by patients and increasingly used in the community.
This multi-phase, mixed methods study will: (1) conduct a retrospective study using information from electronic medical records (EMRs) of a large HMO to identify unique clusters of patients with CMP (e.g., those with differing demographics, histories of pain condition, use of allopathic and CAM health services, and comorbidity profiles) that may be associated with different propensities for A/C utilization and/or differential outcomes associated with such care; (2) use qualitative interviews to explore allopathic providers' recommendations for A/C and patients' decisions to pursue and retain CAM care; and (3) prospectively evaluate health services/costs and broader clinical and functional outcomes associated with the receipt of A/C relative to carefully matched comparison participants receiving traditional CMP services. Sensitivity analyses will compare methods relying solely on EMR-derived data versus analyses supplementing EMR data with conventionally collected patient and clinician data.
Successful completion of these aggregate aims will provide an evaluation of outcomes associated with the real-world use of A/C services. The trio of retrospective, qualitative, and prospective study will also provide a clearer understanding of the decision-making processes behind the use of A/C for CMP and a transportable methodology that can be applied to other health care settings, CAM treatments, and clinical populations.
Trial registration NCT01345409
PMCID: PMC3256110  PMID: 22118061
25.  Association between dietary fats and age-related macular degeneration (AMD) in the Carotenoids in Age-Related Eye Disease Study (CAREDS), an ancillary study of the Women’s Health Initiative123 
Archives of ophthalmology  2009;127(11):1483-1493.
Evaluating relationships of amount and type of dietary fat to intermediate AMD.
Women, ages 50–79, from the Women’s Health Initiative-Observational Study, with high and low lutein intakes, were recruited into the Carotenoids in Age-Related Eye Disease Study (CAREDS). Fat intake in 1994–1998 was estimated using food frequency questionnaires. AMD was assessed in 2001–2004 from stereoscopic fundus photographs.
Intakes of omega-6 and omega-3 polyunsaturated fats (ω-6 and ω-3 PUFA), which were highly correlated (r=0.8), were associated with higher prevalence of intermediate AMD. Significant age-interactions were noted for associations with total fat, monounsaturated and saturated fat (p= 0.01–0.02). In women <75 years (n=1,325), diets high in total fat (% energy) were associated with increased prevalence of AMD (OR (95% CI) for quintile five vs. one = 1.73 (1.02–2.7; p-trend=0.10); the association was reversed in older women. Monounsaturated fat (MUFA) intakes in quintiles three through five vs. one were associated with lower prevalence of AMD in the whole population.
Overall associations of dietary fat to AMD differed by type of fat and, often, by age in this cohort. These findings contribute insights about sources of inconsistencies of fat to AMD in epidemiological studies.
PMCID: PMC3144752  PMID: 19901214
total fat; saturated fats; omega-6 polyunsaturated fats; monounsaturated fats; omega-3 polyunsaturated fats; age-related macular degeneration

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