Raheleh Khorsan

Measures in Chiropractic Research: Choosing Patient-Based Outcome Assessments

OBJECTIVE Outcome assessment normally used in research can support the therapeutic process by tracking patient symptoms and function and offering a common language to clinicians and researchers. This studys objectives were to (1) identify patient-based outcomes assessments used in published chiropractic studies, (2) describe a framework for identifying appropriate sets of measures, and (3) address the challenges associated with these measures relevant to chiropractic. METHODS This literature review identified and evaluated the most commonly used to outcome measures in chiropractic research. Instruments were evaluated in terms of feasibility, practicality, economy, reliability, validity, and responsiveness to clinical change. A search of PubMed and Index to Chiropractic Literature (from inception to June 2006) was performed. RESULTS A total of 1166 citations were identified. Of these, 629 were selected as relevant. The most common patient-based outcomes assessments instruments identified were the Oswestry Pain/Disability Index, Visual Analog Scale, and Short Form 36. CONCLUSIONS The integration of outcome measures is consistent with current national initiatives to enhance health care quality through performance measurement and can also be used to further the field of chiropractic health care research. Outcome measures are both a research tool and a means by which providers can consistently measure health care quality. Based upon this review, there is a wide range of outcome measures available for use in chiropractic care. Those most commonly cited in the literature are the numeric rating scale, Visual Analog Scale, Oswestry Pain/Disability Index, Roland-Morris Low Back Pain and Disability Questionnaire, and Short Form 36.

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.

Herbal treatments of asthma: a systematic review.

Background: Asthma is a condition, often chronic, characterized by respiratory symptoms, variable airflow limitation and/or airway hyper-reactivity with symptoms causally related to family history, environmental influences, exposure to viruses and allergens as examples. The high economic burden associated with asthma is associated primarily with health care costs, missed work or school days. This systematic review was conducted to determine the study quality of articles investigating ayurvedic/collateral herbs, the effectiveness/efficacy and safety profile, as reported in the studies. Methods: Literature searches were conducted using PubMed, EMBASE, Mantis, Ovid, Annotated Bibliography of Indian Medicine, and Cochrane library to identify published trials on herbal medicines for asthma of which Ayruvedic herbals are a subset. Randomized Controlled Trials (RCTs) and Quasi-Experimental Designs (QEDs) were included in this systematic review. The classic Jadad Scale, Singh RCT Scale with additional domains than Jadad, Safety Scoring Scale for clinical trials and the Singh QED Scale based on expanded features of QEDs were used to assess study quality. Herbs included in Traditional Chinese Medicine were excluded from this review. Forty-two articles were retrieved and 37 studies were ultimately reviewed utilizing 3 independent evaluators/1 arbitrator. Results: Articles reviewed indicated benefit from most of the herbs used either as a primary or adjunctive treatment for Asthma. Study quality was mixed and therefore caution in interpretation of findings of usefulness of these herbals must be suggested. Limited safety information was mixed and generally was related to GI symptoms, though one herbal investigated reported more serious side effects. Conclusions: Herbs may be useful in treatment of asthma. There is insufficient evidence to make recommendations for or against the use of these herbals. Established effectiveness must be balanced with study quality and safety profile for the herb.

Manipulative therapy for pregnancy and related conditions: a systematic review.

Objective: The objective of this review is to evaluate the evidence on the effects of Spinal Manipulative Therapy (SMT) on back pain and other related symptoms during pregnancy. Data Sources: A literature search was conducted using Pubmed, Manual, Alternative and Natural Therapy Index System, Cumulated Index to Nursing and Allied Health, Index to Chiropractic Literature, the Cochrane Library, and Google Scholar. In addition hand searches and reference tracking were also performed, and the citation list was assessed for comprehensiveness by content experts. Methods of Study Selection: This review was limited to peer-reviewed manuscripts published in English from 1966 until September 2008. The initial search strategy yielded 140 citations of which 12 studies were reviewed for quality. Tabulation, Integration, and Results: The methodological quality of the included studies was assessed independently using quality checklists of the Scottish Intercollegiate Guidelines Network and Council on Chiropractic Guidelines and Practice Parameters. The review indicates that the use of SMT during pregnancy to reduce back pain and other related symptoms is supported by limited evidence. Conclusion: Overall, this body of evidence is best described as emergent. However, since effective treatments for pregnancy-related back pain are limited, clinicians may want to consider SMT as a treatment option, if no contraindications are present. Target Audience: Obstetricians & Gynecologists, Family Physicians Learning Objectives: After completion of this article, the reader should be able to describe the concepts of spinal manipulative therapy and types of symptoms for which it might be considered in pregnancy, explain the quality of available research on the use of spinal manipulative therapy, and plan to discuss this therapy with interested pregnant patients.

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.

External Validity and Model Validity: A Conceptual Approach for 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 health care (CAM/IHC) 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/IHC 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.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.

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

BackgroundSystematic 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/designThe 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.ResultsOnline tools and quality assurance processes are utilized for each step of the review to ensure a rapid, rigorous, reliable, transparent and reproducible SR process.ConclusionsThe 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.

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 (Alzheimers 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.

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.