Effectiveness of rehabilitation for working-age patients after a total hip arthroplasty: a comparison of usual care between the Netherlands and Germany.

BACKGROUND: Postoperative rehabilitation after primary total hip arthroplasty (p-THA) differs between the Netherlands and Germany. Aim is to compare clinical effectiveness and to get a first impression of cost effectiveness of Dutch versus German usual care after p-THA. METHODS: A transnational prospective controlled observational trial. Clinical effectiveness was assessed with self-reported questionnaires and functional tests. Measurements were taken preoperatively and 4 weeks, 12 weeks, and 6 months postoperatively. For cost effectiveness, long-term economic aspects were assessed from a societal perspective. RESULTS: 124 working-age patients finished the measurements. German usual care leads to a significantly larger proportion (65.6% versus 47.5%) of satisfied patients 12 weeks postoperatively and significantly better self-reported function and Five Times Sit-to-Stand Test (FTSST) results. German usual care is generally 45% more expensive than Dutch usual care, and 20% more expensive for working-age patients. A scenario analysis assumed that German patients work the same number of hours as the Dutch, and that productivity costs are the same. This analysis revealed German care is still more expensive but the difference decreased to 8%. CONCLUSIONS: German rehabilitation is clinically advantageous yet more expensive, although comparisons are less straightforward as the socioeconomic context differs between the two countries. TRIAL REGISTRATION: The study is registered in the German Registry of Clinical Trials (DRKS00011345, 18/11/2016).

Rationale and Design of the Future Optimal Research and Care Evaluation in Patients with Acute Coronary Syndrome (FORCE-ACS) Registry: Towards "Personalized Medicine" in Daily Clinical Practice.

Diagnostic and treatment strategies for acute coronary syndrome have improved dramatically over the past few decades, but mortality and recurrent myocardial infarction rates remain high. An aging population with increasing co-morbidities heralds new clinical challenges. Therefore, in order to evaluate and improve current treatment strategies, detailed information on clinical presentation, treatment and follow-up in real-world patients is needed. The Future Optimal Research and Care Evaluation in patients with Acute Coronary Syndrome (FORCE-ACS) registry (ClinicalTrials.gov Identifier: NCT03823547) is a multi-center, prospective real-world registry of patients admitted with (suspected) acute coronary syndrome. Both non-interventional and interventional cardiac centers in different regions of the Netherlands are currently participating. Patients are treated according to local protocols, enabling the evaluation of different diagnostic and treatment strategies used in daily practice. Data collection is performed using electronic medical records and quality-of-life questionnaires, which are sent 1, 12, 24 and 36 months after initial admission. Major end points are all-cause mortality, myocardial infarction, stent thrombosis, stroke, revascularization and all bleeding requiring medical attention. Invasive therapy, antithrombotic therapy including patient-tailored strategies, such as the use of risk scores, pharmacogenetic guided antiplatelet therapy and patient reported outcome measures are monitored. The FORCE-ACS registry provides insight into numerous aspects of the (quality of) care for acute coronary syndrome patients.

Effectiveness of a Home-Based Rehabilitation Program After Total Hip Arthroplasty Driven by a Tablet App and Remote Coaching: Nonrandomized Controlled Trial Combining a Single-Arm Intervention Cohort With Historical Controls.

BACKGROUND: Recent technological developments such as wearable sensors and tablets with a mobile internet connection hold promise for providing electronic health home-based programs with remote coaching for patients following total hip arthroplasty. It can be hypothesized that such a home-based rehabilitation program can offer an effective alternative to usual care. OBJECTIVE: The aim of this study was to determine the effectiveness of a home-based rehabilitation program driven by a tablet app and remote coaching for patients following total hip arthroplasty. METHODS: Existing data of two studies were combined, in which patients of a single-arm intervention study were matched with historical controls of an observational study. Patients aged 18-65 years who had undergone total hip arthroplasty as a treatment for primary or secondary osteoarthritis were included. The intervention consisted of a 12-week home-based rehabilitation program with video instructions on a tablet and remote coaching (intervention group). Patients were asked to do strengthening and walking exercises at least 5 days a week. Data of the intervention group were compared with those of patients who received usual care (control group). Effectiveness was measured at four moments (preoperatively, and 4 weeks, 12 weeks, and 6 months postoperatively) by means of functional tests (Timed Up & Go test and the Five Times Sit-to Stand Test) and self-reported questionnaires (Hip disability and Osteoarthritis Outcome Score [HOOS] and Short Form 36 [SF-36]). Each patient of the intervention group was matched with two patients of the control group. Patient characteristics were summarized with descriptive statistics. The 1:2 matching situation was analyzed with a conditional logistic regression. Effect sizes were calculated by Cohen d. RESULTS: Overall, 15 patients of the intervention group were included in this study, and 15 and 12 subjects from the control group were matched to the intervention group, respectively. The intervention group performed functional tests significantly faster at 12 weeks and 6 months postoperatively. The intervention group also scored significantly higher on the subscales "function in sport and recreational activities" and "hip-related quality of life" of HOOS, and on the subscale "physical role limitations" of SF-36 at 12 weeks and 6 months postoperatively. Large effect sizes were found on functional tests at 12 weeks and at 6 months (Cohen d=0.5-1.2), endorsed by effect sizes on the self-reported outcomes. CONCLUSIONS: Our results clearly demonstrate larger effects in the intervention group compared to the historical controls. These results imply that a home-based rehabilitation program delivered by means of internet technology after total hip arthroplasty can be more effective than usual care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03846063; https://clinicaltrials.gov/ct2/show/NCT03846063 and German Registry of Clinical Trials DRKS00011345; https://tinyurl.com/yd32gmdo.

Investigation of the immunostimulatory properties of oxihumate.

A unique process has been developed to convert bituminous coal by controlled wet oxidation followed by base treatment to a water-soluble humate called oxihumate. The effects of oxihumate on the proliferative response of lymphocytes has been studied in vitro and ex vivo. Oxihumate increased the proliferative response of phytohaemagglutinin-stimulated human lymphocytes, from a concentration of 20 microg/ml and upwards. This response was even more striking in the case of lymphocytes from HIV-infected patients and was not limited to the in vitro setting since similar effects were observed ex vivo following administration of a non-toxic dosage of 4 g oxihumate per day to HIV-positive individuals for two weeks. Mechanistic studies revealed that stimulation of the proliferative response of lymphocytes by oxihumate is associated with an increased production of IL-2, as well as expression of the IL-2 receptor in the setting of decreased production of IL-10. Oxihumate therefore holds promise for the treatment of immunocompromized patients.