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Reliability of Ayurvedic Diagnosis for Knee Osteoarthritis Patients: A Nested Diagnostic Study Within a Randomized Controlled Trial.

ABSTRACT: Background: Ayurveda is a traditional Indian system of medicine. The customized Ayurvedic approach consists of a combination of several diagnostic procedures and subsequent individualized therapeutic interventions. Evaluation of inter-rater reliability (IRR) of Ayurvedic diagnoses has rarely been performed. The aim of this study was to evaluate IRR of Ayurvedic diagnosis for patients with knee osteoarthritis. Methods: A diagnostic reliability study of 30 patients and 4 Ayurvedic experts was nested in a randomized controlled trial. Patients were diagnosed in a sequential order by all experts utilizing a semistructured patient history form. A nominal group technique as consensus procedure was performed to reach agreement on the items to be diagnosed. An IRR analysis using Fleiss' and Cohen's kappa statistics was performed to determine a chance-corrected measure of agreement among raters. Results: One hundred and twenty different ratings and 30 consensus ratings were performed and analyzed. While high percentages of agreement for main diagnostic entities and the final Ayurveda diagnosis (95% consensus agreement on main diagnosis) could be observed, this was not reflected in the corresponding kappa values, which largely yielded fair-to-poor inter-rater agreement kappas for central diagnostic aspects such as prakriti and agni (? values between 0 and 0.4). Notably, agreement on disease-related entities was better than that on constitutional entities. Conclusions: This is the first diagnostic study embedded in a clinical trial on patients with knee osteoarthritis utilizing a multimodality whole systems approach. Results showed a contrast between the high agreement of the consented final diagnosis and disagreement on certain diagnostic details. Future diagnostic studies should have larger sample sizes and a methodology more tailored to the specificities of traditional whole systems of medicine. Equal emphasis will need to be placed on all core diagnostic components of Ayurveda, both constitutional and disease specific, using detailed structured history taking forms.

SUBMITTER: Kessler CS

PROVIDER: S-EPMC6748397 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Reliability of Ayurvedic Diagnosis for Knee Osteoarthritis Patients: A Nested Diagnostic Study Within a Randomized Controlled Trial.

Kessler Christian S CS Morandi Antonio A Kumar Abhimanyu A Dhiman Kartar S KS Gupta Shivenarain S Icke Katja K Bühner Carina C Stapelfeldt Elmar E Wischnewsky Manfred M Kronpaß Ludwig L Murthy Vijayendra V Michalsen Andreas A Witt Claudia M CM

Journal of alternative and complementary medicine (New York, N.Y.) 20190117 9

Background: Ayurveda is a traditional Indian system of medicine. The customized Ayurvedic approach consists of a combination of several diagnostic procedures and subsequent individualized therapeutic interventions. Evaluation of inter-rater reliability (IRR) of Ayurvedic diagnoses has rarely been performed. The aim of this study was to evaluate IRR of Ayurvedic diagnosis for patients with knee osteoarthritis. Methods: A diagnostic reliability study of 30 patients and ...[more]

PMID: 30653338

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Project description:Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis.In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ?40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum.This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism.NCT01225133.

Project description:BackgroundThe delivery of physiotherapy via telehealth could provide more equitable access to services for patients. Videoconference-based telehealth has been shown to be an effective and acceptable mode of service delivery for exercise-based interventions for chronic knee pain; however, specific training in telehealth is required for physiotherapists to effectively and consistently deliver care using telehealth. The development and evaluation of training programs to upskill health care professionals in the management of osteoarthritis (OA) has also been identified as an important priority to improve OA care delivery.ObjectiveThis study aims to explore physiotherapists' experiences with and perceptions of an e-learning program about best practice knee OA management (focused on a structured program of education, exercise, and physical activity) that includes telehealth delivery via videoconferencing.MethodsWe conducted a qualitative study using individual semistructured telephone interviews, nested within the Physiotherapy Exercise and Physical Activity for Knee Osteoarthritis randomized controlled trial, referred to as the PEAK trial. A total of 15 Australian physiotherapists from metropolitan and regional private practices were interviewed following the completion of an e-learning program. The PEAK trial e-learning program involved self-directed learning modules, a mock video consultation with a researcher (simulated patient), and 4 audited practice video consultations with pilot patients with chronic knee pain. Interviews were audio recorded and transcribed verbatim. Data were thematically analyzed.ResultsA total of five themes (with associated subthemes) were identified: the experience of self-directed e-learning (physiotherapists were more familiar with in-person learning; however, they valued the comprehensive, self-paced web-based modules. Unwieldy technological features could be frustrating); practice makes perfect (physiotherapists benefited from the mock consultation with the researcher and practice sessions with pilot patients alongside individualized performance feedback, resulting in confidence and preparedness to implement new skills); the telehealth journey (although inexperienced with telehealth before training, physiotherapists were confident and able to deliver remote care following training; however, they still experienced some technological challenges); the whole package (the combination of self-directed learning modules, mock consultation, and practice consultations with pilot patients was felt to be an effective learning approach, and patient information booklets supported the training package); and impact on broader clinical practice (training consolidated and refined existing OA management skills and enabled a switch to telehealth when the COVID-19 pandemic affected in-person clinical care).ConclusionsFindings provide evidence for the perceived effectiveness and acceptability of an e-learning program to train physiotherapists (in the context of a clinical trial) on best practice knee OA management, including telehealth delivery via videoconferencing. The implementation of e-learning programs to upskill physiotherapists in telehealth appears to be warranted, given the increasing adoption of telehealth service models for the delivery of clinical care.

Project description:Traditional Chinese medication (TCM) has analgesic and anti-inflammatory effects in patients with knee osteoarthritis (OA). We conducted the first systematic review of the best quantitative and qualitative evidence currently available in order to evaluate the effectiveness of TCM in relieving pain in knee OA. A comprehensive literature search was conducted using three English and four Chinese biomedical databases from their inception through March 1, 2015. We included randomized controlled trials of TCM for knee OA with intervention durations of at least two weeks. The effects of TCM on pain and other clinical symptoms were measured with the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total effectiveness rate, which was used to assess overall pain, physical performance and wellness, was also measured. Two researchers independently extracted data on study design, population characteristics, duration, intervention, outcomes, risk of bias, and primary results. We performed a random-effects meta-analysis when appropriate. We also explored factors that could explain the heterogeneity by conducting subgroup and meta-regression analyses. Twenty-three studies, totaling 2362 subjects, met the eligibility criteria. Treatments were formulated with an average of 8 Chinese herbs and were prescribed based on the traditional Chinese diagnostic method of syndrome differentiation. The mean treatment duration was seven weeks, with oral administration occurring one to three times a day. Compared with non-steroidal anti-inflammatory drugs and intra-articular hyaluronate injections, 18 of the studies showed significantly improved VAS pain scores (Mean Difference [MD] [Formula: see text] 0.56; 95% confidence interval [CI], 0.18 to 0.94; [Formula: see text]), six of the studies showed significantly improved WOMAC pain subscale scores (MD [Formula: see text] 2.23; 95% CI, 0.56 to 3.91; [Formula: see text]), and 16 of the trials showed significantly improved total effectiveness rates (risk ratio [Formula: see text] 1.12; 95% CI, 1.05 to 1.19; [Formula: see text] 0.0003). In addition, TCM showed a lower risk of adverse events than standard western treatments. This evidence suggests that TCM is safe and effective for improving pain, function, and wellness in treatments of knee OA. However, there is inherent clinical heterogeneity (diverse TCM formulations, controls, and treatment regimens) among the included trials. Despite these limitations, the potential analgesic effects of TCM warrant further methodologically rigorous research to determine the clinical implications of TCM on pain management in knee OA.

Project description:BackgroundEvidence-based models are needed to deliver exercise-related services for knee osteoarthritis efficiently and according to patient needs.ObjectiveTo examine a stepped exercise program for patients with knee osteoarthritis (STEP-KOA).DesignRandomized controlled trial. (ClinicalTrials.gov: NCT02653768).Setting2 U.S. Department of Veterans Affairs sites.Participants345 patients (mean age, 60 years; 15% female; 67% people of color) with symptomatic knee osteoarthritis.InterventionParticipants were randomly assigned in a 2:1 ratio to STEP-KOA or an arthritis education (AE) control group, respectively. The STEP-KOA intervention began with 3 months of an internet-based exercise program (step 1). Participants who did not meet response criteria for improvement in pain and function after step 1 progressed to step 2, which involved 3 months of biweekly physical activity coaching calls. Participants who did not meet response criteria after step 2 went on to in-person physical therapy visits (step 3). The AE group received educational materials via mail every 2 weeks.MeasurementsPrimary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scores for the STEP-KOA and AE groups at 9 months were compared by using linear mixed models.ResultsIn the STEP-KOA group, 65% of participants (150 of 230) progressed to step 2 and 35% (81 of 230) to step 3. The estimated baseline WOMAC score for the full sample was 47.5 (95% CI, 45.7 to 49.2). At 9-month follow-up, the estimated mean WOMAC score was 6.8 points (CI, -10.5 to -3.2 points) lower in the STEP-KOA than the AE group, indicating greater improvement.LimitationParticipants were mostly male veterans, and follow-up was limited.ConclusionVeterans in STEP-KOA reported modest improvements in knee osteoarthritis symptoms compared with the control group. The STEP-KOA strategy may be efficient for delivering exercise therapies for knee osteoarthritis.Primary funding sourceDepartment of Veterans Affairs, Health Services Research and Development Service.

Dataset Information

Reliability of Ayurvedic Diagnosis for Knee Osteoarthritis Patients: A Nested Diagnostic Study Within a Randomized Controlled Trial.

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Reliability of Ayurvedic Diagnosis for Knee Osteoarthritis Patients: A Nested Diagnostic Study Within a Randomized Controlled Trial.

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