A crisis confronts the Complementary and Integrative Health (CIH) teaching institutions in the US. Research infrastructure is needed to build and sustain productive research programs and retain their own research faculty. In most health professions, this infrastructure is largely built through research grants. In CIH, most educational institutions are funded through student tuition, which has historically also had to be the source for building their research programs. Only a limited number of these institutions have emerged as National Institute of Health (NIH) grant-funded programs. As a result, the American chiropractic institutions have seen a retrenchment in the number of active research programs. In addition, although research training programs e.g., NIH's K awards are available for CIH researchers, these programs generally result in these researchers leaving their institutions and depriving future CIH practitioners of the benefit of being trained in a culture of research. One proposed solution is to leverage the substantial research infrastructure and long history of collaboration available at the RAND Corporation (https://www.rand.org) This article presents the proposed five components of the RAND Center for Collaborative CIH Research and the steps required to bring it to being: 1) the CIH Research Network - an online resource and collaborative site for CIH researchers; 2) the CIH Research Advisory Board - the governing body for the Center selected by its members; 3) the RAND CIH Interest Group - a group of RAND researchers with an interest in and who could provide support to CIH research; 4) CIH Researcher Training - access to existing RAND research training as well as the potential for the Center to provide a research training home for those with training grants; and 5) CIH RAND Partnership for Research - a mentorship program to support successful CIH research. By necessity the first step in the Center's creation would be a meeting between the heads of interested CIH institutions to work out the details and to obtain buy-in. The future success of CIH-directed research on CIH will require a pooling of talent and resources across institutions; something that the American chiropractic institutions have not yet been able to achieve. This article discusses one possible solution.

This article is based on an extensive review of integrative medicine (IM) and integrative health care (IHC). Since there is no general agreement of what constitutes IM/IHC, several major problems were identified that make the review of work in this field problematic. In applying the systematic review methodology, we found that many of those captured articles that used the term integrative medicine were in actuality referring to adjunctive, complementary, or supplemental medicine. The objective of this study was to apply a sensitivity analysis to demonstrate how the results of a systematic review of IM and IHC will differ according to what inclusion criteria is used based on the definition of IM/IHC. By analyzing 4 different scenarios, the authors show that, due to unclear usage of these terms, results vary dramatically, exposing an inconsistent literature base for this field.

Abstract Background An international panel of experts was convened to examine the challenges faced in conducting economic analyses of Complementary, Alternative and Integrative Medicine (CAIM). Methods A one and a half-day panel of experts was convened in early 2011 to discuss what was needed to bring about robust economic analysis of CAIM. The goals of the expert panel were to review the current state of the science of economic evaluations in health, and to discuss the issues involved in applying these methods to CAIM, recognizing its unique characteristics. The panel proceedings were audiotaped and a thematic analysis was conducted independently by two researchers. The results were then discussed and differences resolved. This manuscript summarizes the discussions held by the panel members on each theme. Results The panel identified seven major themes regarding economic evaluation that are particularly salient to determining the economics of CAIM: standardization (in order to compare CAIM with conventional therapies, the same basic economic evaluation methods and framework must be used); identifying the question being asked, the audience targeted for the results and whose perspective is being used (e.g., the patient perspective is especially relevant to CAIM because of the high level of self-referral and out-of-pocket payment); the analytic methods to be used (e.g., the importance of treatment description and fidelity); the outcomes to be measured (e.g., it is important to consider a broad range of outcomes, particularly for CAIM therapies, which often treat the whole person rather than a specific symptom or disease); costs (e.g., again because of treating the whole person, the impact of CAIM on overall healthcare costs, rather than only disease-specific costs, should be measured); implementation (e.g., highlighting studies where CAIM allows cost savings may help offset its image as an “add on” cost); and generalizability (e.g., proper reporting can enable study results to be useful beyond the study sample). Conclusions The business case for CAIM depends on economic analysis and standard methods for conducting such economic evaluations exist. The challenge for CAIM lies in appropriately applying these methods. The deliberations of this panel provide a list of factors to be considered in meeting that challenge.

A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED), BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the "gray literature." Available studies published in English language were included. Three independent reviewers rated each article and assessed the methodological quality of studies using the Scottish Intercollegiate Guidelines Network (SIGN 50). Our search yielded 11,891 total citations but 6 clinical studies, including 4 randomized, met our inclusion criteria. There are no available systematic reviews/meta-analyses published that met our inclusion criteria. The methodological quality of the included studies was assessed independently using quality checklists of the SIGN 50. Only a small number of RCTs and CCTs with a limited number of patients and lack of adequate control groups assessing integrative health care research are available. These studies provide limited evidence of effective integrative health care on some modalities. However, integrative health care regimen appears to be generally safe.

Objective

This paper describes a process for ensuring and documenting Health Insurance Portability and Accountability Act (HIPAA) compliance in clinical practice-based research.

Methods

The Center of Excellence for Research in Complementary and Alternative Medicine was funded by National Center for Complementary and Integrative Health to develop the methods for researching the appropriateness of care in complementary and integrative health, which previously was known as complementary and alternative medicine. We recruited 125 participating chiropractic clinics for enrolling patients and gathering their data via the online surveys. Chiropractic clinics completed the following: (1) obtained the files of patients who provided prior consent (the prospective sample), (2) obtained the files of the patients selected randomly using specified randomization procedures (the retrospective sample), and (3) transferred all patient data to the RAND Corporation via an encrypted file.

Results

Most of the doctors of chiropractic from clinical practices had no concerns about obtaining and transferring the files of patients who provided informed consent. However, some doctors were uneasy about allowing the researchers to access the randomly selected files of patients who had not provided prior authorization. This led us to develop a set of forms to provide clinics about HIPAA compliance.

Conclusion

For this study, we provided clinics with information about the rules under HIPAA, demonstrated how the study complied with those rules, explained the logic behind the necessity for collecting files from both the prospective and retrospective samples, and, if requested, provided clinics with a confidentiality agreement signed by the study principal investigator and an organizational contracts representative. The process we developed may assist other complementary and integrative health researchers and practitioners in future studies.

Background

In 2014, the National Institutes of Health Pain Consortium Research Task Force recommended that patients with chronic low back pain (CLBP) be stratified by its impact on their lives. They proposed the Impact Stratification Score (ISS) to help guide therapy and facilitate study comparability. The ISS has been evaluated as a continuous measure, but not for use as a stratification or classification scheme.

Objectives

Identify the characteristics of successful schemes to inform the use of the ISS for stratification or classification.

Study design

Scoping review of the peer-reviewed literature.

Methods

Search of PubMed, CINAHL, and APA PsycInfo to identify patient self-report-based classification schemes applicable to CLBP. Data were captured on the methods used for each scheme's development, the domains covered, their scoring criteria and what the classification has successfully measured. The study was reviewed and approved by the RAND Human Subjects Protection Committee (2019-0651-AM02).

Results

The search identified 87 published articles about the development and testing of 5 classification schemes: 1) The Subgroups for Targeted Treatment (STarT) Back Screening Tool, 2) Multiaxial Assessment of Pain, 3) Graded Chronic Pain Scale, 4) Back Pain Classification Scale, and 5) Chronic Pain Risk Score. All have been shown to be predictive of future outcomes and the STarT Back has been found useful in identifying effective classification-specific treatment. Each scheme had a different classification scoring structure, was developed using different methods, and 3 included domains not found in the ISS.

Limitations

Expanding the search to other databases may have identified more classification schemes. Our minimum number of publications inclusion criterion eliminated dozens of cluster analyses, some of which may have eventually been replicated.

Conclusions

The methods used to develop these successful classification schemes, especially those that use straightforward scoring schemes, should be considered for use in the development of a scheme based on the ISS.

Objective

The purpose of this study was to compare the crowdsourcing platform Amazon Mechanical Turk (MTurk) with in-person recruitment and web-based surveys as a method to (1) recruit study participants and (2) obtain low-cost data quickly from chiropractic patients with chronic low back pain in the United States.

Methods

In this 2-arm quasi-experimental study, we used in-person clinical sampling and web-based surveys from a separate study (RAND sample, n = 1677, data collected October 2016 to January 2017) compared with MTurk (n = 310, data collected November 2016) as a sampling and data collection tool. We gathered patient-reported health outcomes and other characteristics of adults with chronic low back pain receiving chiropractic care. Parametric and nonparametric tests were run. We assessed statistical and practical differences based on P values and effect sizes, respectively.

Results

Compared with the RAND sample, the MTurk sample was statistically significantly younger (mean age 35.4 years, SD 9.7 vs 48.9, SD 14.8), made less money (24% vs 17% reported less than $30,000 annual income), and reported worst mental health than the RAND sample. Other differences were that the MTurk sample had more men (37% vs 29%), fewer White patients (87% vs 92%), more Hispanic patients (9% vs 5%), fewer people with a college degree (59% vs 68%), and patients were more likely to be working full time (62% vs 58%). The MTurk sample was more likely to have chronic low back pain (78% vs 66%) that differed in pain frequency and duration. The MTurk sample had less disability and better global health scores. In terms of efficiency, the surveys cost $2.50 per participant in incentives for the MTurk sample. Survey development took 2 weeks and data collection took 1 month.

Conclusion

Our results suggest that there may be differences between crowdsourcing and a clinic-based sample. These differences range from small to medium on demographics and self-reported health. The low incentive costs and rapid data collection of MTurk makes it an economically viable method of collecting data from chiropractic patients with low back pain. Further research is needed to explore the utility of MTurk for recruiting clinical samples, such as comparisons to nationally representative samples.

OBJECTIVE: To expand the appropriateness of care methodology to include patient preferences and resource utilization, and the impact of care appropriateness on patient outcomes. DATA SOURCES/STUDY SETTING: Primary data from expert panels, focus groups, chiropractors, chiropractic patients with chronic low back pain (CLBP) and chronic cervical pain (CCP), and from internet “workers” via crowdsourcing. Study setting is a cluster sample of 125 chiropractic clinics from six US regions. STUDY DESIGN: This multicomponent methods study includes analysis of longitudinal data on patient outcomes, preferences, CLBP and CCP symptoms and healthcare utilization. DATA COLLECTION/EXTRACTION METHODS: Data were collected bi-weekly for 3 months via online surveys that included both new and legacy measures, including PROMIS and CAHPS. PRINCIPLE FINDINGS: Appropriateness panels generated ratings for 1800 CLBP and 744 CCP indications which will be applied to patient charts. Data from 2025 patients are being analyzed. CONCLUSIONS: Patient-centered care is a significant policy initiative but translating it into policy that has been clinician and research-expert based, poses significant methodological issues. Nonetheless, we make the case that patient preferences, self-reported outcomes, and financial burden should be considered in the evaluation of the appropriateness of healthcare.

Study design

A prospective observational study.

Objective

The aim of this study was to evaluate group-level and individual-level change in health-related quality of life among persons with chronic low back pain or neck pain receiving chiropractic care in the United States.

Summary of background data

Chiropractors treat chronic low back and neck pain, but there is limited evidence of the effectiveness of their treatment METHODS.: A 3-month longitudinal study of 2024 patients with chronic low back pain or neck pain receiving care from 125 chiropractic clinics at six locations throughout the United States was conducted. Ninety-one percent of the sample completed the baseline and 3-month follow-up survey (n = 1835). Average age was 49, 74% females, and most of the sample had a college degree, were non-Hispanic White, worked full-time, and had an annual income of $60,000 or more. Group-level (within-group t tests) and individual-level (coefficient of repeatability) changes on the Patient-Reported Outcomes Measurement Information System (PROMIS-29) v2.0 profile measure was evaluated: six multi-item scales (physical functioning, pain, fatigue, sleep disturbance, social health, emotional distress) and physical and mental health summary scores.

Results

Within-group t tests indicated significant group-level change (P < 0.05) for all scores except for emotional distress, and these changes represented small improvements in health (absolute value of effect sizes ranged from 0.08 for physical functioning to 0.20 for pain). From 13% (physical functioning) to 30% (PROMIS-29 v2.0 Mental Health Summary Score) got better from baseline to 3 months later according to the coefficient of repeatability.

Conclusion

Chiropractic care was associated with significant group-level improvement in health-related quality of life over time, especially in pain. But only a minority of the individuals in the sample got significantly better ("responders"). This study suggests some benefits of chiropractic on functioning and well-being of patients with low back pain or neck pain.

Level of evidence

3.