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Background: Cancer patients often suffer from high levels of distress. Mobile health (mHealth) applications might be an innovative way to deliver mindfulness and relaxation interventions for cancer patients. However, data about the implementation of apps in health care are lacking. Adherence to mHealth interventions is an important indicator for a successful implementation and might be needed to maximize treatment effects. However, the decrease in distress might reduce the motivation of patients to engage in such self-care tools in the long run. Therefore, the aim of this analysis was to investigate the association between the course of distress over time and the adherence to a relaxation self-care app in cancer patients. Methods: We developed an app for cancer patients (CanRelax) and 83 patients who participated in the prospective observational study used the app at least once. The evaluation was guided by the RE-AIM framework, and this analysis focused on the implementation of the app. Patients were grouped into five subgroups according to their course of distress over 10 weeks (Distress Thermometer). These subgroups of patients were compared with each other to identify different user groups. Findings: About half of the patients were adherent over 10 weeks. However, a decrease in distress was associated with lower adherence to the app intervention, whereas patients with moderate distress or an increase in distress showed more adherence. Conclusion: Adherence to an app intervention might be also driven by patients' distress level. A decrease in distress might reduce patients' motivation to continue with a self-care intervention. The interplay between adherence and treatment outcomes should be explored in upcoming mHealth trials to get a better understanding for the implementation of such interventions. Encouraging patients to continue self-care interventions is a major challenge in integrative medicine if they are delivered digitally. The Clinical Trial Registration number: DRKS00010481. [ABSTRACT FROM AUTHOR]

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 (κ 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. [ABSTRACT FROM AUTHOR]

Objectives: To report the results of health economic analyses comparing two treatment approaches for chronic low back pain (CLBP). Design: Observational prospective cohort study comparing effectiveness and cost-effectiveness of CLBP care provided at an integrative care clinic with that provided in other clinics within the same hospital. CLBP-related medical utilization, function, quality of life, and days of work incapacity were self-reported at baseline, 3, 6, and 12 months. Settings/Location: Osher Clinical Center (OCC) based at a tertiary academic hospital (Brigham and Women's Hospital [BWH]) and other clinics at BWH. Subjects: CLBP patients seeking care at OCC or non-OCC BWH clinics. Interventions: Integrative or conventional care for CLBP as prescribed by the treating clinician(s). Outcome measures: Quality-adjusted life years (QALYs) were estimated per treatment approach based on the SF-12. Cost per QALY gained was evaluated using an incremental cost-effectiveness ratio (ICER). ICERs based on CLBP-specific effectiveness measures (Roland Disability Questionnaire [RDQ] and bothersomeness of pain [BOP]) were exploratory outcomes. Results: Total adjusted annual CLBP-related costs per patient were greater in the OCC versus non-OCC group ($11,526.73 vs. $6,810.63). Between group differences in QALYs were small and ICER estimate of cost per QALY gained was high ($436,676). However, unadjusted mean direct costs per patient decreased over time in the OCC group. Savings in direct costs of $391 (95% confidence interval: −1,078 to 1,861) were observed in the OCC group for the 6- to 12-month period, driven primarily by reduced medication usage. ICERs based on adjusted RDQ and BOP group differences showed cost of $2,073 and $4,203 for a one-point reduction per respective scale. Conclusions: When adjusted for baseline differences, self-reported costs were higher in the OCC group with only small effects on QALYs. However, trends toward decreased direct expenditures and medication usage over time warrant further investigation. Future studies evaluating potential benefits of integrative care models for the management of CLBP should employ randomized designs, longer observational periods, and explore multiple metrics of cost-effectiveness. [ABSTRACT FROM AUTHOR]

Background: Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. Methods: Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. Results: A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. Conclusions: In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone. [ABSTRACT FROM AUTHOR]