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author:("gherkin, Dan")
1.  Effectiveness guidance document (EGD) for acupuncture research - a consensus document for conducting trials 
Background
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.
Methods
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.
Results
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.
Conclusion
The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.
doi:10.1186/1472-6882-12-148
PMCID: PMC3495216  PMID: 22953730
Comparative effectiveness research; Effectiveness guidance document; Acupuncture
2.  A Framework for Making Patient-Centered Care Front and Center 
The Permanente Journal  2012;16(3):49-53.
The concept of patient-centered care has received increased attention in recent years and is now considered an essential aspiration of high-quality health care systems. Because of technologic advances as well as changes in the organization and financing of care delivery, contemporary health care has evolved tremendously since the concept of patient-centeredness was introduced in the late 1980s. Historically, those advocating patient-centered care have focused on the relationship between the patient and the physician or care team. Although that relationship is still integral, changes to the health care system suggest that a broader range of factors may affect the patient-centeredness of health care experiences. A multidimensional conceptualization of patient-centered care and examples from our health care system illustrate how clinical, structural, and interpersonal attributes can collectively influence the patient's experience. The proposed framework is designed to enable any health system to identify ways in which care could be more patient-centered and move toward a goal of making it a “systems property.”
PMCID: PMC3442762  PMID: 23012599
3.  Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year 
Background
Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC) in primary care patients with inadequately controlled type 2 diabetes.
Methods
Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c) values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight). Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure) were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment.
Results
Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001), diet (P = 0.001), physical activity (P = 0.02), mood (P = 0.001), self-efficacy (P = 0.0001) and motivation to change lifestyle (P = 0.003). Improvements in glucose testing, mood, self-efficacy and motivation to change lifestyle persisted at 12-months (all P < 0.005). For clinical outcomes, mean HbA1c decreased by −0.90 % (P = 0.02) in the ANC cohort at 6-months, a −0.51 % mean difference compared to usual care (P = 0.07). Reductions at 12-months were not statistically significant (−0.34 % in the ANC cohort, P = 0.14; -0.37 % difference compared to the usual care cohort, P = 0.12).
Conclusions
Improvements were noted in self-monitoring of glucose, diet, self-efficacy, motivation and mood following initiation of ANC for patients with inadequately controlled type 2 diabetes. Study participants also experienced reductions in blood glucose that exceeded those for similar patients who did not receive ANC. Randomized clinical trials will be necessary to determine if ANC was responsible for these benefits.
doi:10.1186/1472-6882-12-44
PMCID: PMC3403984  PMID: 22512949
4.  Survey of CAM interest, self-care, and satisfaction with health care for type 2 diabetes at group health cooperative 
Background
Very little research has explored the factors that influence interest in complementary and alternative medicine (CAM) treatments. We surveyed persons with sub-optimally controlled type 2 diabetes to evaluate potential relationships between interest in complementary and alternative medicine (CAM) treatments, current self-care practices, motivation to improve self-care practices and satisfaction with current health care for diabetes.
Methods
321 patients from a large integrated healthcare system with type 2 diabetes, who were not using insulin and had hemoglobin A1c values between 7.5-9.5%, were telephoned between 2009-2010 and asked about their self-care behaviors, motivation to change, satisfaction with current health care and interest in trying naturopathic (ND) care for their diabetes. Responses from patients most interested in trying ND care were compared with those from patients with less interest.
Results
219 (68.5%) patients completed the survey. Nearly half (48%) stated they would be very likely to try ND care for their diabetes if covered by their insurance. Interest in trying ND care was not related to patient demographics, health history, clinical status, or self-care behaviors. Patients with greater interest in trying ND care rated their current healthcare as less effective for controlling their blood sugar (mean response 5.9 +/- 1.9 vs. 6.6 +/- 1.5, p = 0.003), and were more determined to succeed in self-care (p = 0.007). Current CAM use for diabetes was also greater in ND interested patients.
Conclusions
Patients with sub-optimally controlled type 2 diabetes expressed a high level of interest in trying ND care. Those patients with the greatest interest were less satisfied with their diabetes care, more motivated to engage in self-care, and more likely to use other CAM therapies for their diabetes.
doi:10.1186/1472-6882-11-121
PMCID: PMC3280939  PMID: 22132687
5.  Unanticipated Benefits of CAM Therapies for Back Pain: An Exploration of Patient Experiences 
Abstract
Objectives
The goal of this research was to provide insight into the full range of meaningful outcomes experienced by patients who participate in clinical trials of complementary and alternative medicine (CAM) therapies.
Design
Data for this study were assembled from five randomized trials evaluating six different CAM treatments for back pain. A conventional qualitative content analysis was conducted on responses to open-ended questions asked at the end of telephone interviews assessing treatment outcomes.
Subjects
A total of 884 study participants who received CAM therapies completed post-treatment interviews. Of these, 327 provided qualitative data used in the analyses.
Results
Our analysis identified a range of positive outcomes that participants in CAM trials considered important but were not captured by standard quantitative outcome measures. Positive outcome themes included increased options and hope, increased ability to relax, positive changes in emotional states, increased body awareness, changes in thinking that increased the ability to cope with back pain, increased sense of well-being, improvement in physical conditions unrelated to back pain, increased energy, increased patient activation, and dramatic improvements in health or well-being. The first five of these themes were mentioned for all of the CAM treatments, while others tended to be more treatment specific. A small fraction of these effects were considered life transforming.
Conclusions
Our findings suggest that standard measures used to assess the outcomes of CAM treatments fail to capture the full range of outcomes that are important to patients. In order to capture the full impact of CAM therapies, future trials should include a broader range of outcomes measures.
doi:10.1089/acm.2009.0188
PMCID: PMC3110102  PMID: 20180688
6.  Dr Cherkin Responds 
Western Journal of Medicine  1989;151(1):83-84.
PMCID: PMC1026978

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