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Objective: The purpose of this article is to discuss a literature review-a recent systematic review of nonmusculoskeletal disorders-that demonstrates the potential for faulty conclusions and misguided policy implications, and to offer an alternate interpretation of the data using present models and criteria., Methods: We participated in a chiropractic meeting (Global Summit) that aimed to perform a systematic review of the literature on the efficacy and effectiveness of mobilization or spinal manipulative therapy (SMT) for the primary, secondary, and tertiary prevention and treatment of nonmusculoskeletal disorders. After considering an early draft of the resulting manuscript, we identified points of concern and therefore declined authorship. The present article was developed to describe those concerns about the review and its conclusions., Results: Three main concerns were identified: the inherent limitations of a systematic review of 6 articles on the topic of SMT for nonmusculoskeletal disorders, the lack of biological plausibility of collapsing 5 different disorders into a single category, and considerations for best practices when using evidence in policy-making. We propose that the following conclusion is more consistent with a review of the 6 articles. The small cadre of high- or moderate-quality randomized controlled trials reviewed in this study found either no or equivocal effects from SMT as a stand-alone treatment for infantile colic, childhood asthma, hypertension, primary dysmenorrhea, or migraine, and found no or low-quality evidence available to support other nonmusculoskeletal conditions. Therefore, further research is needed to determine if SMT may have an effect in these and other nonmusculoskeletal conditions. Until the results of such research are available, the benefits of SMT for specific or general nonmusculoskeletal disorders should not be promoted as having strong supportive evidence. Further, a lack of evidence cannot be interpreted as counterevidence, nor used as evidence of falsification or verification., Conclusion: Based on the available evidence, some statements generated from the Summit were extrapolated beyond the data, have the potential to misrepresent the literature, and should be used with caution. Given that none of the trials included in the literature review were definitively negative, the current evidence suggests that more research on nonmusculoskeletal conditions is warranted before any definitive conclusions can be made. Governments, insurers, payers, regulators, educators, and clinicians should avoid using systematic reviews in decisions where the research is insufficient to determine the clinical appropriateness of specific care., (Copyright © 2021. Published by Elsevier Inc.)

Background: Musculoskeletal disorders are the second leading cause of disability worldwide., Objective: Examine experiences of chiropractic patients in the United States with chronic low back or neck pain., Method: Observational study of 1853 chronic low back pain and neck pain patients (74% female) who completed an online questionnaire at the 3-month follow-up that included Consumer Assessment of Healthcare Providers and Systems (CAHPS) items assessing their experiences with care., Results: We found similar reports of communication for the chiropractic sample and patients in the 2016 CAHPS National Database, but 85% in the database versus 79% in the chiropractic sample gave the most positive response to the time spent with provider item. More patients in the CAHPS database rated their provider at the top of the scale (8 percentage points). More chiropractic patients reported always getting answers to questions the same day (16 percentage points) and always being seen within 15 minutes of their appointment time (29 percentage points)., Conclusions: The positive experiences of patients with chronic back and neck pain are supportive of their use of chiropractic care., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2019.)

Objectives: To develop computerized adaptive testing (CAT) and short forms of self-report oral health measures that are predictive of both the children's oral health status index (COHSI) and the children's oral health referral recommendation (COHRR) scales, for children and adolescents, ages 8-17., Material and Methods: Using final item calibration parameters (discrimination and difficulty parameters) from the item response theory analysis, we performed post hoc CAT simulation. Items most frequently administered in the simulation were incorporated for possible inclusion in final oral health assessment toolkits, to select the best performing eight items for COHSI and COHRR., Results: Two previously identified unidimensional sets of self-report items consisting of 19 items for the COHSI and 22 items for the COHRR were administered through CAT resulting in eight-item short forms for both the COHSI and COHRR. Correlations between the simulated CAT scores and the full item bank representing the latent trait are r = .94 for COHSI and r = .96 for COHRR, respectively, which demonstrated high reliability of the CAT and short form., Conclusions: Using established rigorous measurement development standards, the CAT and corresponding eight-item short form items for COHSI and COHRR were developed to assess the oral health status of children and adolescents, ages 8-17. These measures demonstrated good psychometric properties and can have clinical utility in oral health screening and evaluation and clinical referral recommendations., (©2019 The Authors. Clinical and Experimental Dental Research published by John Wiley & Sons Ltd.)

Objectives: The purpose of this study was to describe coping strategies (eg, mechanisms, including self-treatment) that a person uses to reduce pain and its impact on functioning as reported by patients with chronic low back pain who were seen by doctors of chiropractic and how these coping strategies vary by patient characteristics., Methods: Data were collected from a national sample of US chiropractic patients recruited from chiropractic practices in 6 states from major geographical regions of the United States using a multistage stratified sampling strategy. Reports of coping behaviors used to manage pain during the past 6 months were used to create counts across 6 domains: cognitive, self-care, environmental, medical care, social activities, and work. Exploratory analyses examined counts in domains and frequencies of individual items by levels of patient characteristics., Results: A total of 1677 respondents with chronic low back pain reported using an average of 9 coping behaviors in the prior 6 months. Use of more types of behaviors were reported among those with more severe back pain, who rated their health as fair or poor and who had daily occurrences of pain. Exercise was more frequent among the healthy and those with less pain. Female respondents tended to report using more coping behaviors than men, and Hispanics more than non-Hispanics., Conclusion: Persons with chronic back pain were proactive in their coping strategies and frequently used self-care coping strategies like those provided by chiropractors in patient education. In alignment with patients' beliefs that their condition was chronic and lifelong, many patients attempted a wide range of coping strategies to relieve their pain., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: The purpose of this article is to describe how we designed patient survey instruments to ensure that patient data about preferences and experience could be included in appropriateness decisions. These actions were part of a project that examined the appropriateness of spinal manipulation and mobilization for chronic low back pain and chronic neck pain., Methods: We conducted focus groups, cognitive interviews, a literature review of measures in prior chiropractic and complementary and integrative health research, and a pilot study to develop questionnaires of patient preferences, experiences, values, and beliefs., Results: Questionnaires were administered online to 2024 individuals from 125 chiropractic clinics. The survey included 3 long questionnaires and 5 shorter ones. All were administered online. The baseline items had 2 questionnaires that respondents could complete in different sittings. Respondents completed shorter biweekly follow-ups every 2 weeks and a final questionnaire at 3 months. The 2 initial questionnaires had 81 and 140 items, the 5 biweekly follow-up questionnaires had 37 items each, and the endline questionnaire contained 121 items. Participants generally responded positively to the survey items, and 91% of the patients who completed a baseline questionnaire completed the endpoint survey 3 months later. We used "legacy" measures, and we also adapted measures and developed new measures for this study. Preliminary assessment of reliability and validity for a newly developed scale about coping behaviors indicates that the items work well together in a scale., Conclusions: This article documents the challenges and the efforts involved in designing data collection tools to facilitate the inclusion of patient data into appropriateness decisions., (Copyright © 2019. Published by Elsevier Inc.)

Background: Mobilization and manipulation therapies are widely used by patients with chronic nonspecific neck pain; however, questions remain around efficacy, dosing, and safety, as well as how these approaches compare to other therapies., Objectives: Based on published trials, to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic nonspecific neck pain., Study Design: A systematic literature review and meta-analysis., Methods: We identified studies published between January 2000 and September 2017, by searching multiple electronic databases, examining reference lists, and communicating with experts. We selected randomized controlled trials comparing manipulation and/or mobilization therapies to sham, no treatment, each other, and other active therapies, or when combined as multimodal therapeutic approaches. We assessed risk of bias by using the Scottish Intercollegiate Guidelines Network criteria. When possible, we pooled data using random-effects meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation was applied to determine the confidence in effect estimates. This project was funded by the National Center for Complementary and Integrative Health under award number U19AT007912 and ultimately used to inform an appropriateness panel., Results: A total of 47 randomized trials (47 unique trials in 53 publications) were included in the systematic review. These studies were rated as having low risk of bias and included a total of 4,460 patients with nonspecific chronic neck pain who were being treated by a practitioner using various types of manipulation and/or mobilization interventions. A total of 37 trials were categorized as unimodal approaches and involved thrust or nonthrust compared with sham, no treatment, or other active comparators. Of these, only 6 trials with similar intervention styles, comparators, and outcome measures/timepoints were pooled for meta-analysis at 1, 3, and 6 months, showing a small effect in favor of thrust plus exercise compared to an exercise regimen alone for a reduction in pain and disability. Multimodal approaches appeared to be effective at reducing pain and improving function from the 10 studies evaluated. Health-related quality of life was seldom reported. Some 22/47 studies did not report or mention adverse events. Of the 25 that did, either no or minor events occurred., Limitations: The current evidence is heterogeneous, and sample sizes are generally small., Conclusions: Studies published since January 2000 provide low-moderate quality evidence that various types of manipulation and/or mobilization will reduce pain and improve function for chronic nonspecific neck pain compared to other interventions. It appears that multimodal approaches, in which multiple treatment approaches are integrated, might have the greatest potential impact. The studies comparing to no treatment or sham were mostly testing the effect of a single dose, which may or may not be helpful to inform practice. According to the published trials reviewed, manipulation and mobilization appear safe. However, given the low rate of serious adverse events, other types of studies with much larger sample sizes would be required to fully describe the safety of manipulation and/or mobilization for nonspecific chronic neck pain., Key Words: Chronic neck pain, nonspecific, chiropractic, manipulation, mobilization, systematic review, meta-analysis, appropriateness.

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., (Copyright © 2018. Published by Elsevier Inc.)

Objectives: The purpose of this article is to report on the Center of Excellence for Research on Complementary and Alternative Medicine at RAND Corporation. The overall project examined the appropriateness of chiropractic spinal manipulation and mobilization for chronic low back pain and chronic cervical pain using the RAND and University of California Los Angeles Appropriateness Method, including patient preferences and costs, to acknowledge the importance of patient-centered care in clinical decision-making., Methods: This article is a narrative summary of the overall project and its inter-related components (ie, 4 Research Project Grants and 2 centers), including the Data Collection Core, whose activities and learning will be the subject of a following series of methods articles., Results: The project team faced many challenges in accomplishing data collection goals. The processes we developed to overcome barriers may be of use to other researchers and for practitioners who may want to participate in such studies in complementary and integrative health, which previously was known as complementary and alternative medicine., Conclusion: For this large, complex, successful project, we gathered online survey data, collected charts, and abstracted chart data from thousands of chiropractic patients. The present article delineates the challenges and lessons that were learned during this project so that others may gain from the authors' experience. This information may be of use to future research that collects data from independent practitioners and their patients because it provides what is needed to be successful in such studies and may encourage participation., (Copyright © 2018. Published by Elsevier Inc.)

Objectives: Chronic low back pain (CLBP) and chronic neck pain (CNP) are the most common types of chronic pain, and chiropractic spinal manipulation is a common nonpharmacologic treatment. This study presents the characteristics of a large United States sample of chiropractic patients with CLBP and CNP., Methods: Data were collected from chiropractic patients using multistage systematic stratified sampling with 4 sampling levels: regions and states, sites (ie, metropolitan areas), providers and clinics, and patients. The sites and regions were San Diego, California; Tampa, Florida; Minneapolis, Minnesota; Seneca Falls and Upstate New York; Portland, Oregon; and Dallas, Texas. Data were collected from patients through an iPad-based prescreening questionnaire in the clinic and emailed links to full screening and baseline online questionnaires. The goal was 20 providers or clinics and 7 patients with CLBP and 7 with CNP from each clinic., Results: We had 6342 patients at 125 clinics complete the prescreening questionnaire, 3333 patients start the full screening questionnaire, and 2024 eligible patients completed the baseline questionnaire: 518 with CLBP only, 347 with CNP only, and 1159 with both. In general, most of this sample were highly-educated, non-Hispanic, white females with at least partial insurance coverage for chiropractic care who have been in pain and using chiropractic care for years. Over 90% reported high satisfaction with their care, few used narcotics, and avoiding surgery was the most important reason they chose chiropractic care., Conclusions: Given the prevalence of CLBP and CNP, the need to find effective nonpharmacologic alternatives for chronic pain, and the satisfaction these patients found with their care, further study of these patients is worthwhile., (Copyright © 2018. Published by Elsevier Inc.)

Background Context: Mobilization and manipulation therapies are widely used to benefit patients with chronic low back pain. However, questions remain about their efficacy, dosing, safety, and how these approaches compare with other therapies., Purpose: The present study aims to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic low back pain., Study Design/setting: This is a systematic literature review and meta-analysis., Outcome Measures: The present study measures self-reported pain, function, health-related quality of life, and adverse events., Methods: We identified studies by searching multiple electronic databases from January 2000 to March 2017, examining reference lists, and communicating with experts. We selected randomized controlled trials comparing manipulation or mobilization therapies with sham, no treatment, other active therapies, and multimodal therapeutic approaches. We assessed risk of bias using Scottish Intercollegiate Guidelines Network criteria. Where possible, we pooled data using random-effects meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was applied to determine the confidence in effect estimates. This project is funded by the National Center for Complementary and Integrative Health under Award Number U19AT007912., Results: Fifty-one trials were included in the systematic review. Nine trials (1,176 patients) provided sufficient data and were judged similar enough to be pooled for meta-analysis. The standardized mean difference for a reduction of pain was SMD=-0.28, 95% confidence interval (CI) -0.47 to -0.09, p=.004; I 2 =57% after treatment; within seven trials (923 patients), the reduction in disability was SMD=-0.33, 95% CI -0.63 to -0.03, p=.03; I 2 =78% for manipulation or mobilization compared with other active therapies. Subgroup analyses showed that manipulation significantly reduced pain and disability, compared with other active comparators including exercise and physical therapy (SMD=-0.43, 95% CI -0.86 to 0.00; p=.05, I 2 =79%; SMD=-0.86, 95% CI -1.27 to -0.45; p<.0001, I 2 =46%). Mobilization interventions, compared with other active comparators including exercise regimens, significantly reduced pain (SMD=-0.20, 95% CI -0.35 to -0.04; p=.01; I 2 =0%) but not disability (SMD=-0.10, 95% CI -0.28 to 0.07; p=.25; I 2 =21%). Studies comparing manipulation or mobilization with sham or no treatment were too few or too heterogeneous to allow for pooling as were studies examining relationships between dose and outcomes. Few studies assessed health-related quality of life. Twenty-six of 51 trials were multimodal studies and narratively described., Conclusion: There is moderate-quality evidence that manipulation and mobilization are likely to reduce pain and improve function for patients with chronic low back pain; manipulation appears to produce a larger effect than mobilization. Both therapies appear safe. Multimodal programs may be a promising option., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The present paper examines the experience of establishing a center for evidence-based complementary and alternative medicine (EBCAM) practice. It examines both the difficulties and the challenges of doing research to establish EBCAM. The paper also examines the political context of the demand for evidence- based practice (EBP) for CAM., Implementation: A center for EBCAM was funded for 3 years within the Southern California Evidence-Based Practice Center by the National Center for CAM and administered by the Agency for Health Research Quality. This experience provides the basis for this paper., Results: While the experience of creating an EBM Center for CAM has shown that much work can be accomplished by applying standard methods of EBP medicine, it also highlights the weaknesses of such an agenda. Many standard research methods are simply not applicable to CAM, and even where they are, effectiveness is a much more important means of assessing CAM than simply efficacy. Researchers however, must be conscious of the political motivations behind much of the demand for EBCAM. Where such demands are coming from allopathic medicine, they clearly form a continuing part of medical opposition to CAM and may be intended to perpetuate the dominance of the biomedical paradigm in healthcare. The challenge for CAM is to recognize the limitations of EBP but not to throw the 'baby out with the bathwater'. There is much in EBP that clearly should be emulated by the CAM community but only where it is appropriate.