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Objective: To evaluate whether tuina is more effective and cost-effective in reducing pain compared to no intervention in patients with chronic neck pain. Design: Single-center randomized two-armed controlled trial. Setting: University outpatient clinic specialized in Integrative Medicine. Subjects: Outpatients with chronic neck pain were randomly allocated to tuina or no intervention. Intervention: Six tuina treatments within 3 weeks. Outcome measures: The primary outcome was the mean neck pain intensity during the previous 7 days on a visual analogue scale after 4 weeks (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain). Secondary outcomes included Neck Pain and Disability Scale (NPDS), Neck Disability Index (NDI), health-related quality of life (12-item quality-of-life questionnaire [SF-12]), medication intake, and cost-effectiveness after 4 and 12 weeks. Statistical analysis included analysis of covariance adjusted for baseline values and a full economic analysis from a societal perspective. Results: Altogether, 92 outpatients were included (46 in both groups, 87% female, mean age 45.4 [standard deviation ±9.7], and mean VAS 57.7± 11.5). Tuina treatment led to a clinically meaningful reduction in neck pain intensity (group differences, 4 weeks: -22.8 mm [95% confidence interval, -31.7 to -13.8]; p<0.001 and 12 weeks: -17.9 mm [-27.1 to -8.8], p < 0.001). No serious adverse events were observed. Total costs as well as quality-adjusted life years (QALYs) did not differ significantly between the groups. When taking group differences into account independently from their statistical significance, costs per QALY gained (incremental cost-effectiveness ratio) would range within a cost-effective area from €7,566 (for costs €10.28 per session) to €39,414 (cost €35 per session). Conclusion: An additional treatment with six tuina sessions over 3 weeks was effective, safe and relatively cost-effective for patients with chronic neck pain. A future trial should compare tuina to other best care options. [ABSTRACT FROM AUTHOR]

Background Chronic low back pain (LBP) and neck pain (NP) are highly prevalent conditions resulting in high economic costs. Treatment guidelines recommend relaxation techniques, such as progressive muscle relaxation, as adjuvant therapies. Self-care interventions could have the potential to reduce costs in the health care system, but their effectiveness, especially in a usual care setting, is unclear. The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone. Methods/design Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic (>12 weeks) LBP or NP and an average pain intensity of ≥ 4 on a numeric rating scale (NRS) in the 7 days before recruitment. The participants will be randomized into an intervention and a usual care group. The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization: autogenic training, mindfulness meditation, or guided imagery. Instructions and exercises will be provided using a smartphone app, baseline information will be collected using paper and pencil. Follow-up information (daily, weekly, and after 3 and 6 months) will be collected using electronic diaries and questionnaires included in the app. The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS (0 = no pain, 10 = worst possible pain). The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements, the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months, pain acceptance, 'LBP- and NP-related' stress, sick leave days, pain medication intake, adherence, suspected adverse reaction, and serious adverse events. Discussion The designed studies reflect a usual self-care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals. [ABSTRACT FROM AUTHOR]

Background: Many oncology physicians are confronted with the topic of complementary and integrative medicine (CIM) by cancer patients. This study examined whether a blended learning (e-learning and a workshop) to train oncology physicians in providing advice on CIM therapies to their cancer patients, in addition to distributing an information leaflet about reputable CIM websites, had different effects on physician-reported outcomes in regard to consultations compared with only distributing the leaflet. Methods: In a multicenter, cluster-randomized trial, 48 oncology physicians were randomly allocated to an intervention group (CIM consultation and an information leaflet) or a control group (information leaflet only). After the training, the oncology physicians conducted 297 consultations with their cancer patients. Measurements were assessed at oncology physician, physician–patient-interaction (measured by external reviewers), and patient levels. This analysis focused on the physician outcomes of stress reaction and perceived consultation skill competency. In addition, qualitative interviews were conducted with a subsample of oncology physicians who experienced both, the intervention and control condition. Results: The oncology physicians in the intervention group showed a lower stress reaction in all measured dimensions after CIM consultations than those in the control group. There was no significant difference between oncology physicians in the intervention and control groups regarding the perceived consultation skill competency (overburden: intervention 1.4 [95% CI: 0.7;2.1]; control 2.1 [95% CI: 1.4;2.7], tension: 1.3 [95% CI: 0.7;2.0] vs. 1.9 [95% CI: 1.3;2.5], and discomfort with consultation situations: 1.0 [95% CI: 0.4;1.7]; vs. 1.7 [95% CI: 1.2;2.3]). The qualitative data showed that only providing the leaflet seemed impersonal to oncology physicians, while the training made them feel well prepared to conduct a full conversation about CIM and provide the information leaflet. Conclusions: In our exploratory study providing structured CIM consultations showed positive effects on the perceived stress of oncology physicians, and the training was subjectively experienced as an approach that improved physician preparation for advising cancer patients about CIM, however no effects regarding perceived consultation skill competency were found. Trial registration: The trial registration number of the KOKON-KTO study is DRKS00012704 in the German Clinical Trials Register (Date of registration: 28.08.2017). [ABSTRACT FROM AUTHOR]

Background: Chronic health conditions have a big impact on disability, morbidity, and mortality worldwide. Smartphone health applications (apps) can improve the health of patients with chronic conditions and enhance the quality and efficiency of healthcare. The number of randomized controlled trials (RCTs) of smartphone health apps is increasing, but a collection of the available evidence into a single database is still missing. The purpose of this study is to describe Smartphone-RCCT, which is an in-progress database of RCTs of smartphone apps for chronic conditions.Methods: For a study to be included in the database, the following criteria had to be met: (a) RCT published in a peer-reviewed journal; (b) population: adult study participants with one or several chronic conditions that represent the main health problem addressed by the study intervention; (c) intervention: smartphone health app used by the patient; (d) comparator: any control condition; (e) outcomes: any patient-reported health outcome (studies exclusively measuring the patients' knowledge about the chronic conditions or their satisfaction with the smartphone app were excluded); (f) sample size: at least 15 participants per study arm. We searched in electronic databases and other resources to identify relevant studies. Two reviewers selected the studies and extracted data independently. Annual updates are planned.Results: The proposed database is called Smartphone-RCCT, an open-access repository collecting bibliographic references and important characteristics of RCTs of smartphone apps for chronic conditions. The database is available for free in Open Science Framework (OSF): https://osf.io/nxerf/ . To date, it includes 70 trials. Their references can be exported to standard reference management software and the extracted data is available in a Microsoft Excel file.Conclusions: Smartphone-RCCT is the first systematic open-access database collecting peer-reviewed publications of RCTs of smartphone apps for patients with chronic conditions. The database accelerates the delivery of evidence-based information in a dynamic research field. It represents an essential resource for different stakeholders, such as professionals working in evidence synthesis, meta-epidemiological studies, or planning an RCT. [ABSTRACT FROM AUTHOR]

BACKGROUND: Many patients with cancer do not disclose complementary medicine use but want their physician's advice on this matter. This study evaluated whether using blended learning (e‐learning plus a workshop) to train oncology physicians in providing advice on complementary and integrative medicine (CIM) therapies to their patients with cancer, in addition to distributing an information leaflet on reputable CIM websites, had different effects on patient‐reported outcomes for the consultation than only distributing the leaflet. METHODS: In this multicenter, cluster‐randomized trial, patients from private practices/hospital departments, recruited by 48 oncology physicians randomly allocated to an intervention group (CIM consultation plus information leaflet) or a control group (information leaflet), received CIM information. Patient‐reported outcomes included satisfaction (Patient Satisfaction With Information on Cancer Treatment), readiness to make a decision (Preparation for Decision Making), and physician‐patient communication (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire and Communication 26 [EORTC QLQ‐COMU26]) for the consultation. Qualitative interviews were conducted with a physician subsample. RESULTS: A total of 291 patients (128 in the intervention group and 169 in the control group) advised by 41 physicians participated. Patients in the intervention group rated physician‐patient communication higher on all EORTC QLQ‐COMU26 scales (mean total score, 84.3 [95% CI, 79.5‐89.2] vs 73.6 [95% CI, 69.3‐78.0]; P =.002), were more satisfied with the advice (mean, 4.2 [95% CI, 4.0‐4.4] vs 3.7 [95% CI, 3.5‐3.8]; P <.001), and were readier to make a decision (mean, 63.5 [95% CI, 57.4‐69.6] vs 53.2 [95% CI, 47.8‐58.7]; P =.016) than the control group. Physicians who reported patients in both settings seemed satisfied with the advice given. CONCLUSIONS: This study evaluated a novel education intervention for training oncology physicians in providing CIM advice in routine care. Providing structured CIM consultations had positive effects on patient satisfaction, readiness to make decisions, and physician‐patient communication. This is the first study to implement and evaluate an evidence‐based complementary and integrative medicine (CIM) consultation in routine cancer treatment. Advising patients with cancer according to a structured, evidence‐based consultation manual has positive effects on patient satisfaction, preparation for decision‐making, and physician‐patient communication in comparison with only distributing an information leaflet about CIM. [ABSTRACT FROM AUTHOR]

Traditional medical practice has suffered from male bias, which can lead to sub-optimal treatment options for female patients and increase the incidence of severe side-effects in this population. Mobile health applications, mHealth apps, represent one essential component of the shift towards consumer-centered self-administered individualized health. To prevent sex-specific bias it is important that trials consider sex and gender when developing mHealth apps. We evaluated the inclusion and reporting of sex and gender at all levels in mHealth randomized controlled trials (RCTs). To this end, we conducted a secondary analysis of a large study database addressing the effectiveness of app interventions on clinical outcomes in patients with chronic medical conditions. We followed the 5 steps described in the framework by Arksey and O'Malley and the guidelines of the PRISMA-ScR. Of the 72 app-based RCTs which reported information about sex overall, 62 included individuals of both sexes. The concept of gender was not addressed in any of the studies. The consideration of sex aspects in the design, execution and reporting of mHealth RCTs was minimal or absent. To adequately address the health and preventative needs of the mHealth user population, sex and gender should be systematically included in the research, development and evaluation of mHealth applications. [ABSTRACT FROM AUTHOR]

Objective: Since recent studies suggested a role of the striatum and prefrontal cortex for multiple sclerosis (MS)-related fatigue, we investigated resting-state functional connectivity alterations of striatal subdivisions and the dorsolateral prefrontal cortex (dlPFC). Methods: Resting-state functional magnetic resonance imaging was acquired in 77 relapsing–remitting MS patients (38 fatigued (F-MS), 39 non-fatigued (NF-MS)) and 41 matched healthy controls (HC). Fatigue severity was assessed using the fatigue severity scale. Seed-based connectivity analyses were performed using subregions of the striatum and the dlPFC as regions of interest applying non-parametric permutation testing. Results: Compared to HC and NF-MS patients, F-MS patients showed reduced caudate nucleus and ventral striatum functional connectivity with the sensorimotor cortex (SMC) and frontal, parietal, and temporal cortex regions. Fatigue severity correlated negatively with functional connectivity of the caudate nucleus and ventral striatum with the SMC and positively with functional connectivity of the dlPFC with the rostral inferior parietal gyrus and SMC. Conclusion: MS-related fatigue is associated with reduced functional connectivity between the striatum and sensorimotor as well as attention and reward networks, in which the ventral striatum might be a key integration hub. Together with increased connectivity between the dlPFC and sensory cortical areas, these connectivity alterations shed light on the mechanisms of MS-related fatigue. [ABSTRACT FROM AUTHOR]

Background: Many cancer patients are interested in complementary and integrative medicine during and after regular cancer treatment. Given the high number of users it is important that physicians and patients engage in a dialog about useful complementary and integrative medicine therapies during cancer treatment. In a prospective, multi-center, cluster-randomized evaluation study we will develop, implement and evaluate a training program for oncology physicians advising their patients on complementary and integrative medicine. The main objective of the study is to evaluate whether training physicians in a blended-learning approach (e-learning + skills-training workshop) in providing advice to their cancer patients on complementary and integrative medicine, in addition to handing out an information leaflet about reputable websites, has different effects on the outcomes of patients, physicians, and their interaction level, compared to only giving out the information leaflet.Methods/design: Forty-eight oncology physicians will be included into a cluster-randomized trial to either participate or not in the blended-learning training. Physicians will then advise 10 cancer patients each, resulting in 480 patients participating in the trial. The blended learning consists of nine units of up to 45 min of e-learning and 18 units of up to 45 min of on-site skills-training workshop focusing. Outcomes will be measured on the physician, patient, and physician-patient-interaction level.Discussion: A blended-learning program for oncology physicians to advise their cancer patients in a systematic way and a reasonable time frame on complementary and integrative medicine will be evaluated in depth in a large cluster-randomized trial.Trial Registration: German Clinical Trials Register, ID: DRKS00012704 . Registered on 28 August 2017. [ABSTRACT FROM AUTHOR]