Home-based exergaming to treat gait and balance disorders in patients with Parkinson's disease: A phase II randomized controlled trial.

BACKGROUND: Exergaming has been proposed to improve gait and balance disorders in Parkinson's disease (PD) patients. We aimed to assess the efficacy of a home-based, tailored, exergaming training system designed for PD patients with dopa-resistant gait and/or balance disorders in a controlled randomized trial. METHODS: We recruited PD patients with dopa-resistant gait and/or balance disorders. Patients were randomly assigned (1:1 ratio) to receive 18 training sessions at home by playing a tailored exergame with full-body movements using a motion capture system (Active group), or by playing the same game with the computer's keyboard (Control group). The primary endpoint was the between-group difference in the Stand-Walk-Sit Test (SWST) duration change after training. Secondary outcomes included parkinsonian clinical scales, gait recordings, and safety. RESULTS: Fifty PD patients were enrolled and randomized. After training, no significant difference in SWST change was found between groups (mean change SWST duration [SD] -3.71 [18.06] s after Active versus -0.71 [3.41] s after Control training, p = 0.61). Some 32% of patients in the Active and 8% in the Control group were considered responders to the training program (e.g., SWST duration change ≥2 s, p = 0.03). The clinical severity of gait and balance disorders also significantly decreased after Active training, with a between-group difference in favor of the Active training (p = 0.0082). Home-based training induced no serious adverse events. CONCLUSIONS: Home-based training using a tailored exergame can be performed safely by PD patients and could improve gait and balance disorders. Future research is needed to investigate the potential of exergaming.

Management of patients with rheumatoid arthritis by telemedicine: connected monitoring. A randomized controlled trial.

OBJECTIVES: Rheumatoid arthritis (RA) is a prevalent and disabling disease that is the source of significant direct and indirect costs. The current recommended therapeutic strategy is based on the rapid introduction of therapy with conventional Disease-Modifying Anti-Rheumatic Drugs (DMARDs) combined with regular disease monitoring by the rheumatologist. The onerous nature of such intense monitoring has motivated the development of new, less demanding strategies such as telemedicine. This study aimed to estimate the cost-effectiveness of the connected monitoring of RA patients initiating a new DMARD therapy versus conventional monitoring. METHODS: An economic evaluation based on a randomized controlled trial of 89 patients was conducted. The patients in the intervention group (n=45) were monitored using a connected monitoring interface on a smartphone, while patients in the control group (n=44) were conventionally monitored. Health outcomes were measured as the gain in quality-adjusted life-years (QALYs), assessed using the EuroQol-5D questionnaire. Resource use and health outcomes were collected alongside the trial and at the six-month follow-up using application data and the related clinical case manager time, visits, hospitalisations, and transport records. These outcomes were valued using externally collected data on unit costs and QALY weights. RESULTS: Compared to conventionally monitored patients, patients receiving connected monitoring had a slightly greater but not significant gain in the average QALY of 0.07. The economic analysis found that connected monitoring resulted in a significant cost reduction of 72€ (2927€ vs. 2999€, P<0.01). The incremental cost-utility ratio of the intervention was equal to -1,029€ per QALY (95% CI: -32,033; +24,625) with a 97.8% chance of being cost-effective at a threshold of 30,000€ per QALY gained. CONCLUSION: Implementing EULAR recommendations for RA patients initiating a DMARD treatment using connected monitoring is more efficient and less expensive than conventional care. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03005925).

Out-of-pocket payments, vertical equity and unmet medical needs in France: A national multicenter prospective study on lymphedema.

Out-of-pocket payments might threaten the vertical equity of financing and generate unmet medical needs. The main objective was to assess the vertical equity of outpatient out-of-pocket payments for lymphedema patients in France. Twenty-seven centres, among which 11 secondary care hospitals and 16 primary care practices participated in this prospective national multicenter study. We measured the lymphedema-specific outpatient out-of-pocket payments over 6 months. The vertical equity of out-of-pocket payments was examined using concentration curves, the Gini coefficient for income, the Kakwani index, and the Reynolds-Smolensky index. We included 231 lymphedema patients aged 7 years or more, living in metropolitan France, and being able to use Internet and email. After voluntary health insurance reimbursement, the mean out-of-pocket payment was equal to 101.4 Euros per month, mainly due to transport (32%) and medical devices (26%). Concentration curves indicated regressivity of out-of-pocket payments. Total out-of-pocket payments represented 10.1% of the income by consumption unit for the poorest quintile and 3.5% for the wealthiest (p<0.05). The Kakwani index for out-of-pocket payments was equal to -0.18. Regarding outpatient health care, French lymphedema patients face significant and regressive out-of-pocket payments, associated with an increased risk of unmet medical needs. Such results shed light on significant socioeconomic inequalities and bring into question the current financing arrangements of outpatient health care in France. Trial registration: ClinicalTrials.gov ID: NCT02988479.

LIMPRINT: Health-Related Quality of Life in Adult Patients with Chronic Edema.

Background: Chronic edema is a condition posing a high burden on patients. The primary aim of the study was to assess the health-related quality of life (QoL) of adult patients living with chronic edema. Methods and Results: As part of an international, multicenter, prospective study, we prospectively assessed the health-related QoL of adult patients living with a chronic edema using a disease-specific tool and a generic one. In total, 1094 patients were included, aged 57 years on average. The average EQ-5D and LYMQOL visual analogue scale (VAS) scores were equal to 63.6 (SD = 20.2) and 6.3 (SD = 2.0), respectively. After adjustment, the EQ-5D VAS was explained by LYMQOL VAS (ß = 7.85; p < 0.001), age (ß = -0.08; p = 0.02), obesity (ß = -1.89; p = 0.001), and male gender (ß = 3.32; p = 0.002). As for the LYMQOL VAS, it was independently associated with EQ-5D VAS (ß = 0.07; p < 0.001), LYMQOL function (ß = -0.21; p < 0.001), and LYMQOL mood (ß = -0.49; p < 0.001). Conclusion: This study confirms that patients living with a chronic edema experience a poor disease-specific and generic health-related QoL.

LIMPRINT: Estimation of the Prevalence of Lymphoedema/Chronic Oedema in Acute Hospital in In-Patients.

Background: To estimate the prevalence of lymphedema/chronic edema (CO) and wounds in acute hospital inpatients in five different countries. Methods and Results: A point-prevalence study was carried out during working day periods in six general hospitals in four countries (Denmark, France, United Kingdom, and Australia) and one hospital oncology inpatient unit in one other country (Ireland). The study used validated clinical tools for the assessment and collection of data. Data were collected by expert clinicians through interviews and physical examination of the patients present in the wards. A total of 1905 patients could be included and investigated among the 3041 total bed occupancy in the seven hospitals. Lymphedema/CO was present in 723 of them (38%). Main risk factors associated with CO were age, morbid obesity, and heart failure, as well as chair bound immobility and neurological deficiency. History of cellulitis was frequent in patients with CO and wounds (24.8%) and CO alone (14.1%) compared to the 1.5% prevalence in patients without CO. Conclusion: Lymphedema/CO is very frequent in patients hospitalized in hospital acute wards. It is strongly associated with obesity, venous insufficiency, and heart failure. Our results strongly suggest a hidden health care burden and cost linked to CO independently of chronic wounds.