Incorporating Complementary and Integrative Health Providers in the Public Health Pandemic Response: Lessons from COVID-19 and Recommendations for the Future from a Multidisciplinary Expert Panel.

Complementary and integrative health (CIH) providers, such as chiropractors and naturopathic doctors, have been an underutilized public health asset in the response to the COVID-19 pandemic. This article seeks to inform how they can be better integrated into future responses to public health emergencies. The authors convened an expert panel of ten CIH and public health practitioners and researchers for a daylong discussion of how the CIH workforce could be better mobilized during future crises. In this article, the authors summarize the key barriers identified in the discussion and make recommendations on how they can be overcome.

Barriers to the Engagement of Complementary and Integrative Health Providers in Public Health Responses to COVID-19: Recommendations From a Multidisciplinary Expert Panel.

OBJECTIVE: The purpose of this project was to explore barriers to the involvement of complementary and integrative health (CIH) providers in the public health response to COVID-19 and potential solutions for future involvement in public health crises. METHODS: An expert panel of 10 people, which included doctors of chiropractic, naturopathic doctors, public health practitioners, and researchers from the United States, was convened for a day-long online panel discussion. Facilitators asked panelists how CIH practitioners could contribute and be mobilized. We summarized themes and recommendations from the discussion. RESULTS: Despite their skills and resources, few CIH providers participated in public health efforts like testing and contact tracing during the COVID-19 pandemic. Panelists described that CIH professionals may not have participated in those efforts due to the CIH providers possibly not having sufficient public health training and limited contact with public health professionals, as well as policy and financial challenges during the pandemic. Panelists proposed solutions to these barriers, including more public health training, stronger formal relationships between CIH and public health organizations, and improved financial support for both CIH care and public health efforts. CONCLUSION: Through an expert panel discussion, we identified barriers that hindered the involvement of CIH providers in the public health response to the COVID-19 pandemic. During future pandemics in the United States, public health planners should recognize CIH providers as part of the existing labor resource, with clinical expertise and community-level connections that can be called upon in a crisis. During future events, CIH professional leaders should be more proactive in seeking out a supportive role and sharing their knowledge, skills, and expertise.

Manipulation and Mobilization for Treating Chronic Nonspecific Neck Pain: A Systematic Review and Meta-Analysis for an Appropriateness Panel.

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.

Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis.

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; I2=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; I2=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, I2=79%; SMD=-0.86, 95% CI -1.27 to -0.45; p<.0001, I2=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; I2=0%) but not disability (SMD=-0.10, 95% CI -0.28 to 0.07; p=.25; I2=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.

Systematic Review of Nondrug, Nonsurgical Treatment of Shoulder Conditions.

OBJECTIVE: The purpose of this review was to evaluate the effectiveness of conservative nondrug, nonsurgical interventions, either alone or in combination, for conditions of the shoulder. METHODS: The review was conducted from March 2016 to November 2016 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), and was registered with PROSPERO. Eligibility criteria included randomized controlled trials (RCTs), systematic reviews, or meta-analyses studying adult patients with a shoulder diagnosis. Interventions qualified if they did not involve prescription medication or surgical procedures, although these could be used in the comparison group or groups. At least 2 independent reviewers assessed the quality of each study using the Scottish Intercollegiate Guidelines Network checklists. Shoulder conditions addressed were shoulder impingement syndrome (SIS), rotator cuff-associated disorders (RCs), adhesive capsulitis (AC), and nonspecific shoulder pain. RESULTS: Twenty-five systematic reviews and 44 RCTs met inclusion criteria. Low- to moderate-quality evidence supported the use of manual therapies for all 4 shoulder conditions. Exercise, particularly combined with physical therapy protocols, was beneficial for SIS and AC. For SIS, moderate evidence supported several passive modalities. For RC, physical therapy protocols were found beneficial but not superior to surgery in the long term. Moderate evidence supported extracorporeal shockwave therapy for calcific tendinitis RC. Low-level laser was the only modality for which there was moderate evidence supporting its use for all 4 conditions. CONCLUSION: The findings of this literature review may help inform practitioners who use conservative methods (eg, doctors of chiropractic, physical therapists, and other manual therapists) regarding the levels of evidence for modalities used for common shoulder conditions.

Rapid Evidence Assessment of the Literature (REAL(©)): streamlining the systematic review process and creating utility for evidence-based health care.

BACKGROUND: Systematic reviews (SRs) are widely recognized as the best means of synthesizing clinical research. However, traditional approaches can be costly and time-consuming and can be subject to selection and judgment bias. It can also be difficult to interpret the results of a SR in a meaningful way in order to make research recommendations, clinical or policy decisions, or practice guidelines. Samueli Institute has developed the Rapid Evidence Assessment of the Literature (REAL) SR process to address these issues. REAL provides up-to-date, rigorous, high quality SR information on health care practices, products, or programs in a streamlined, efficient and reliable manner. This process is a component of the Scientific Evaluation and Review of Claims in Health Care (SEaRCH™) program developed by Samueli Institute, which aims at answering the question of "What works?" in health care. METHODS/DESIGN: The REAL process (1) tailors a standardized search strategy to a specific and relevant research question developed with various stakeholders to survey the available literature; (2) evaluates the quantity and quality of the literature using structured tools and rulebooks to ensure objectivity, reliability and reproducibility of reviewer ratings in an independent fashion and; (3) obtains formalized, balanced input from trained subject matter experts on the implications of the evidence for future research and current practice. RESULTS: Online tools and quality assurance processes are utilized for each step of the review to ensure a rapid, rigorous, reliable, transparent and reproducible SR process. CONCLUSIONS: The REAL is a rapid SR process developed to streamline and aid in the rigorous and reliable evaluation and review of claims in health care in order to make evidence-based, informed decisions, and has been used by a variety of organizations aiming to gain insight into "what works" in health care. Using the REAL system allows for the facilitation of recommendations on appropriate next steps in policy, funding, and research and for making clinical and field decisions in a timely, transparent, and cost-effective manner.

Are there efficacious treatments for treating the fatigue-sleep disturbance-depression symptom cluster in breast cancer patients? A Rapid Evidence Assessment of the Literature (REAL(©)).

PURPOSE: While fatigue, sleep disturbance, and depression often co-occur in breast cancer patients, treatment efficacy for this symptom cluster is unknown. A systematic review was conducted to determine whether there are specific interventions (ie, medical, pharmacological, behavioral, psychological, and complementary medicine approaches) that are effective in mitigating the fatigue-sleep disturbance-depression symptom cluster in breast cancer patients, using the Rapid Evidence Assessment of the Literature (REAL(©)) process. METHODS: Peer-reviewed literature was searched across multiple databases; from database inception - October 2011, using keywords pre-identified to capture randomized controlled trials (RCT) relevant to the research question. Methodological bias was assessed using the Scottish Intercollegiate Guidelines Network (SIGN) 50 checklist. Confidence in the estimate of effect and assessment of safety were also evaluated across the categories of included interventions via the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology. RESULTS: The initial search yielded 531 citations, of which 41 met the inclusion criteria. Of these, twelve RCTs reported on all three symptoms, and eight of these were able to be included in the GRADE analysis. The remaining 29 RCTs reported on two symptoms. Studies were of mixed quality and many were underpowered. Overall, results suggest that there is: 1) promising evidence for the effectiveness of various treatment types in mitigating sleep disturbance in breast cancer patients; 2) mixed evidence for fatigue; 3) little evidence for treating depression; and 4) no clear evidence that treatment of one symptom results in effective treatment for other symptoms. CONCLUSION: More high-quality studies are needed to determine the impact of varied treatments in mitigating the fatigue-sleep disturbance-depression symptom cluster in breast cancer patients. Furthermore, we encourage future studies to examine the psychometric and clinical validity of the hypothesized relationship between the symptoms in the fatigue-sleep disturbance-depression symptom cluster.

Tyrosine for Mitigating Stress and Enhancing Performance in Healthy Adult Humans, a Rapid Evidence Assessment of the Literature.

BACKGROUND: Tyrosine, a precursor of catecholamine neurotransmitters, may help alleviate physical/cognitive performance decrements in humans under conditions of high physical/psychological stress. OBJECTIVE: Determine whether supplemental tyrosine mitigates stress-induced decrements in cognitive and/or physical performance in healthy individuals using Samueli Institute's Rapid Evidence Assessment of the Literature methodology. METHODS: Key databases (PubMed/MEDLINE, CINAHL, Embase, PsycInfo, and Agricola) were searched for randomized controlled trials from inception to October 2012. Scottish Intercollegiate Guidelines 50 criteria and Grading of Recommendation Assessment, Development, and Evaluation framework were used to assess the quality of individual studies and the overall literature pool, respectively. Controlled clinical trials were included later in the overall methodology. RESULTS: 10 randomized controlled trials and 4 controlled clinical trials met our inclusion criteria. On the basis of the available evidence, no recommendation could be made for the effect of tyrosine on physical performance under stressful physical conditions. However, a weak recommendation in favor of tyrosine was made for cognitive stress as all studies showed a positive effect. CONCLUSIONS: This review indicates that the available evidence is insufficient to make confident recommendations on the effectiveness of tyrosine for mitigating stress effects on physical/cognitive performance. However, tyrosine may benefit cognitive performance and is worthy of further study.

Variations in the implementation and characteristics of chiropractic services in VA.

BACKGROUND: In 2004, the US Department of Veterans Affairs expanded its delivery of chiropractic care by establishing onsite chiropractic clinics at select facilities across the country. Systematic information regarding the planning and implementation of these clinics and describing their features and performance is lacking. OBJECTIVES: To document the planning, implementation, key features and performance of VA chiropractic clinics, and to identify variations and their underlying causes and key consequences as well as their implications for policy, practice, and research on the introduction of new clinical services into integrated health care delivery systems. RESEARCH DESIGN, METHODS, AND SUBJECTS: Comparative case study of 7 clinics involving site visit-based and telephone-based interviews with 118 key stakeholders, including VA clinicians, clinical leaders and administrative staff, and selected external stakeholders, as well as reviews of key documents and administrative data on clinic performance and service delivery. Interviews were recorded, transcribed, and analyzed using a mixed inductive (exploratory) and deductive approach. RESULTS AND CONCLUSIONS: Interview data revealed considerable variations in clinic planning and implementation processes and clinic features, as well as perceptions of clinic performance and quality. Administrative data showed high variation in patterns of clinic patient care volume over time. A facility's initial willingness to establish a chiropractic clinic, along with a higher degree of perceived evidence-based and collegial attributes of the facility chiropractor, emerged as key factors associated with higher and more consistent delivery of chiropractic services and higher perceived quality of those services.

The effect of omega-3 fatty acids on biomarkers of inflammation: a rapid evidence assessment of the literature.

INTRODUCTION: Previous studies of omega-3 fatty acids report improved outcomes where inflammation is a key factor. The objective of this systematic review is to evaluate effects of omega-3s on inflammatory biomarkers. METHODS: Randomized clinical studies that measured the influence of omega-3 fatty acids on inflammatory biomarkers were identified using a comprehensive search. Eligible studies were rated with the American Dietetic Association Evidence Analysis Manual and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) process to examine study quality and risk/benefit. RESULTS: 112 studies were included. Over 65% reported statistically significant effects. The majority were scored as low risk of bias (high quality) and scored strong (cardiac populations and critically ill) to weak (Alzheimer's Disease, hypertriglyceridemia/diabetes, and obesity) on the risk/benefit ratio evidence for modulation of inflammatory biomarkers. There was inadequate data to determine a GRADE for inflammatory biomarker studies for some conditions (healthy individuals, rheumatoid arthritis, metabolic syndrome, renal disease, pregnancy, or children). CONCLUSION: Clinical literature on the effects of omega-3 fatty acids on inflammatory biomarkers contains mostly small sample sizes, is neutral to high quality, and report mixed effects. Larger studies examining dose and delivery are needed.

How to assess the external validity and model validity of therapeutic trials: a conceptual approach to systematic review methodology.

Background. Evidence rankings do not consider equally internal (IV), external (EV), and model validity (MV) for clinical studies including complementary and alternative medicine/integrative medicine (CAM/IM) research. This paper describe this model and offers an EV assessment tool (EVAT©) for weighing studies according to EV and MV in addition to IV. Methods. An abbreviated systematic review methodology was employed to search, assemble, and evaluate the literature that has been published on EV/MV criteria. Standard databases were searched for keywords relating to EV, MV, and bias-scoring from inception to Jan 2013. Tools identified and concepts described were pooled to assemble a robust tool for evaluating these quality criteria. Results. This study assembled a streamlined, objective tool to incorporate for the evaluation of quality of EV/MV research that is more sensitive to CAM/IM research. Conclusion. Improved reporting on EV can help produce and provide information that will help guide policy makers, public health researchers, and other scientists in their selection, development, and improvement in their research-tested intervention. Overall, clinical studies with high EV have the potential to provide the most useful information about "real-world" consequences of health interventions. It is hoped that this novel tool which considers IV, EV, and MV on equal footing will better guide clinical decision making.

A systematic review of biopsychosocial training programs for the self-management of emotional stress: potential applications for the military.

Combat-exposed troops and their family members are at risk for stress reactions and related disorders. Multimodal biopsychosocial training programs incorporating complementary and alternative self-management techniques have the potential to reduce stress-related symptoms and dysfunction. Such training can preempt or attenuate the posttraumatic stress response and may be effectively incorporated into the training cycle for deploying and redeploying troops and their families. A large systematic review was conducted to survey the literature on multimodal training programs for the self-management of emotional stress. This report is an overview of the randomized controlled trials (RCTs) identified in this systematic review. Select programs such as mindfulness-Based Stress Reduction, Cognitive Behavioral Stress Management, Autogenic Training, Relaxation Response Training, and other meditation and mind-body skills practices are highlighted, and the feasibility of their implementation within military settings is addressed.

Challenges of systematic reviewing integrative health care.

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.

Mixed-Methods Research in a Complex Multisite VA Health Services Study: Variations in the Implementation and Characteristics of Chiropractic Services in VA.

Maximizing the quality and benefits of newly established chiropractic services represents an important policy and practice goal for the US Department of Veterans Affairs' healthcare system. Understanding the implementation process and characteristics of new chiropractic clinics and the determinants and consequences of these processes and characteristics is a critical first step in guiding quality improvement. This paper reports insights and lessons learned regarding the successful application of mixed methods research approaches-insights derived from a study of chiropractic clinic implementation and characteristics, Variations in the Implementation and Characteristics of Chiropractic Services in VA (VICCS). Challenges and solutions are presented in areas ranging from selection and recruitment of sites and participants to the collection and analysis of varied data sources. The VICCS study illustrates the importance of several factors in successful mixed-methods approaches, including (1) the importance of a formal, fully developed logic model to identify and link data sources, variables, and outcomes of interest to the study's analysis plan and its data collection instruments and codebook and (2) ensuring that data collection methods, including mixed-methods, match study aims. Overall, successful application of a mixed-methods approach requires careful planning, frequent trade-offs, and complex coding and analysis.

Systematic review of integrative health care research: randomized control trials, clinical controlled trials, and meta-analysis.

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.

Integrative health care under review: an emerging field.

OBJECTIVE: The purpose of this study was to review the research literature for the emerging field of Integrative Medicine/Integrative Health Care (IM) using the methods of systematic review. METHODS: We conducted an electronic literature search using PubMed, Allied and Complementary Medicine, 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. RESULTS: Our initial search yielded 11 591 citations. Of these, only 660 were judged to be relevant to the purpose of our search. Most articles deal with implementing and implemented programs. They focus on practice models, strategies for integrative health, the business case, and descriptive studies. This is followed in terms of numbers by conceptual/philosophical writings. These in turn are followed by research articles including randomized controlled trials, program evaluations, and cost-effectiveness studies. The literature reflects an emerging field in that it is focused more on how to create IM than on researching outcomes. However, the lack of definition and clarity about the term integrative medicine (also known as integrative health care) and the absence of taxonomy for models of IM make it very difficult to efficiently conduct systematic reviews of this field at the moment. CONCLUSION: Our review revealed that most articles focused on describing practice models and conceptual/philosophical models, whereas there are fewer randomized controlled trials and observation studies. The lack of consensus on a clear definition and taxonomy for integrative health care represents a major methodological barrier on conducting systematic literature reviews and meta-analysis in this emerging field.

Methodological complexities associated with systematic review of healing relationships.

BACKGROUND/CONTEXT: There is growing recognition within the field of medicine that healing and healing relationships are important and that developing evidence-based medicine approaches to healing should be an important aspect of this emerging field, including the use of systematic reviews. Health care leaders charged with developing healing initiatives in hospitals often are frustrated in their attempts to find rigorous reviews of the literature to support their programs. OBJECTIVE: The objective of this project was to conduct a systematic review that asked, "What is the return on investment to hospitals that implement programs aimed at enhancing healing relationships?" METHODS: A comprehensive literature search using several electronic databases was conducted to locate studies that evaluated hospital-based programs involving "healing relationships." All studies found were evaluated as to their relevance to the study and screened for methodological quality. RESULTS: Research investigators found broad heterogeneity across the 80 included studies with regard to stated aims, target populations, outcomes measured, measurement tools employed, and evaluation methods used. Only 10 articles were categorized as being methodologically strong. CONCLUSIONS: Results of the systematic review highlighted challenges in synthesizing knowledge about healing that included absence of widely accepted definitions and language around "healing", locating literature published across many different disciplines, and absence of standards for conducting rigorous program evaluations in hospitals. A less formal qualitative review of included studies also revealed themes in the literature that provide clues about the professional, social, cultural, and historical influences that have helped to shape the evidence base to date.

Patient-based outcome assessment instruments in acupuncture research.

BACKGROUND: Outcome assessment can support the therapeutic process by providing a way to track symptoms and functionality over time, providing insights to clinicians and patients, as well as offering a common language to discuss patient behavior/functioning. OBJECTIVES: In this article, we examine the patient-based outcome assessment (PBOA) instruments that have been used to determine outcomes in acupuncture clinical research and highlight measures that are feasible, practical, economical, reliable, valid, and responsive to clinical change. The aims of this review were to assess and identify the commonly available PBOA measures, describe a framework for identifying appropriate sets of measures, and address the challenges associated with these measures and acupuncture. Instruments were evaluated in terms of feasibility, practicality, economy, reliability, validity, and responsiveness to clinical change. METHODS: This study was a systematic review. A total of 582 abstracts were reviewed using PubMed (from inception through April 2009). RESULTS: A total of 582 citations were identified. After screening of title/abstract, 212 articles were excluded. From the remaining 370 citations, 258 manuscripts identified explicit PBOA; 112 abstracts did not include any PBOA. The five most common PBOA instruments identified were the Visual Analog Scale, Symptom Diary, Numerical Pain Rating Scales, SF-36, and depression scales such as the Beck Depression Inventory. CONCLUSIONS: The way a questionnaire or scale is administered can have an effect on the outcome. Also, developing and validating outcome measures can be costly and difficult. Therefore, reviewing the literature on existing measures before creating or modifying PBOA instruments can significantly reduce the burden of developing a new measure.