Abdominal massage to prevent ileus after colorectal surgery. A single-center, prospective, randomized clinical trial: the MATRAC Trial.

BACKGROUND: There is scarce literature on the effect of mechanical abdominal massage on the duration of ileus after colectomy, particularly in the era of enhanced recovery after surgery (ERAS). The aim of this study was to determine whether abdominal massage after colorectal surgery with anastomosis and no stoma helps toward a faster return of intestinal transit. METHODS: This study was a superiority trial and designed as a prospective open-label, single-center, randomized controlled clinical trial with two parallel groups. Patients scheduled to undergo intestinal resection and follow an ERAS protocol were randomly assigned to either the standard ERAS group or the ERAS plus massage group. The primary endpoint was the return of intestinal transit, defined as the first passage of flatus following the operation. Secondary endpoints included time of the first bowel motion, maximal pain, 30 day complications, complications due to massage, anxiety score given by the Hospital Anxiety and Depression (HAD) questionnaire, and quality of life assessed by the EQ-5D-3L questionnaire. RESULTS: Between July 2020 and June 2021, 36 patients were randomly assigned to the ERAS group or the ERAS plus massage group (n = 19). Patients characteristics were comparable. There was no significant difference in time to passage of the first flatus between the ERAS group and the ERAS plus abdominal massage group (1065 versus 1389 min, p = 0.274). No statistically significant intergroup difference was noted for the secondary endpoints. CONCLUSION: Our study, despite its limitations, failed to demonstrate any advantage of abdominal massage to prevent or even reduce symptoms of postoperative ileus after colorectal surgery. TRIAL REGISTRATION NUMBER: 38RC20.021.

Sociological determinants of adherence to continuous positive airway pressure in the management of sleep apnoea syndrome: protocol for a transdisciplinary, prospective observational study.

INTRODUCTION: Obstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that has a negative impact on quality of life. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS. However, CPAP termination rates remain very high, and adherence to therapy is a major issue. To date, studies targeting predictive factors of CPAP adherence by OSAS patients mainly include clinical data. The social, socioeconomic, psychological, and home environment aspects have been far less studied and largely underestimated. This study aims to obtain solid quantitative results examining the relationship between the determinants of refusal, non-adherence, or termination of CPAP treatment, and in particular the pivotal role played by health literacy. METHODS AND ANALYSIS: This is a prospective, multicentre, observational study recruiting patients attending the sleep clinic of the Grenoble Alpes University Hospital, France. Consecutive adults (>18 years) recently diagnosed with OSAS and prescribed CPAP treatment with telemonitoring will be enrolled in the present study. They will benefit from home visits by a CPAP technician or nurse at CPAP initiation. Patients will then be followed up for 6 months through the telemonitoring platform of a home-care provider. The primary objective is to evaluate the impact of health literacy (health literacy, measured by the European Health Literacy Survey questionnaire (HLS-EU-16) on the refusal, non-adherence or termination of CPAP treatment in newly diagnosed OSAS patients, during the first 6 months after diagnosis. The target sample size is 250 participants. ETHICS AND DISSEMINATION: The study protocol, patient information, and the non-opposition form were approved by the French national ethics committee (CPP 2021-92, January 2022). All patients are required to have signed a written informed consent form permitting their anonymised personal and medical data to be used for clinical research purposes. We will publish the results in a peer-reviewed medical journal and on our institutional websites. TRIAL REGISTRATION NUMBER: NCT05385302.

Oral anticoagulant safety in family practice: prognostic accuracy of Bleeding Risk Scores (from the CACAO study).

BACKGROUND: To assess bleeding risk of patients treated by oral anticoagulants, several scores have been constructed to assist physicians in the evaluation of the benefit risk. Most of these scores lack a strong enough level of evidence for use in family practice. OBJECTIVE: To assess the predictive prognostic accuracy of 13 scores designed to assess the risk of major or clinically relevant non-major (CRNM) bleeding events in a French ambulatory cohort receiving Vitamin-K antagonists (VKA) or direct oral anticoagulants (DOACs) in a family practice setting. METHODS: CACAO (Comparison of Accidents and their Circumstances with Oral Anticoagulants) was a multicentre prospective cohort of ambulatory patients prescribed oral anticoagulants. We selected patients from the cohort who had received an oral anticoagulant because of non-valvular atrial fibrillation (NVAF) and/or venous thromboembolism (VTE) to be followed during one year by their GP. The following scores were calculated: mOBRI, Shireman, Kuijer, HEMORR2HAGES, ATRIA, HAS-BLED, RIETE, VTE-BLEED, ACCP score, Rutherford, ABH-Score, GARFIEL-AF, and Outcomes Registry for Better InformedTreatment of Atrial Fibrillation (ORBIT). Prognostic accuracy was assessed by using receiver operating characteristic curves and c-statistics. RESULTS: During 1 year, 3,082 patients were followed. All of the scores demonstrated only poor to moderate ability to predict major bleeding or CRNM in NVAF patients on DOACs (c-statistic: 0.41-0.66 and 0.45-0.58), respectively. The results were only slightly better for patients prescribed VKA (0.47-0.66 and 0.5-0.55, respectively) in this indication. The results were also unsatisfactory in patients treated for VTE. CONCLUSION: None of the scores demonstrated satisfactory discriminatory ability when used in family practice. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02376777.

Oncological outcomes and hospitalization cost of hyperthermic intraperitoneal chemotherapy (HIPEC) open and closed abdomen techniques: Results from two French expert centers.

BACKGROUND: Hyperthermic intraperitoneal chemotherapy (HIPEC) associated with CC0 excision is performed using either an open (OPEN_HIPEC) or closed abdominal technique (CLOSED_HIPEC). However, little data is available on the costs of this treatment, as there is no code for HIPEC in the French Classification of Medical Acts. Oncological outcomes and the mean cost of hospitalization were compared. METHODS: Between 2017 and 2021, 144 patients with peritoneal carcinomatosis (all etiologies) were included (OPEN_HIPEC, n = 70; CLOSED_HIPEC, n = 74) in this retrospective two-center study. Morbi-mortality, overall survival (OS), recurrence-free-survival (RFS) and mean cost of hospitalization were compared. RESULTS: The median OS and RFS were 71.3 months [63-71.5] and 26.8 months [20-35.3] respectively, and were similar for both techniques; and after stratification by histology. Multivariate analysis adjusted on PCI score of OS identified mitomycin as a protective factor (HR = 0.31 [0.10-0.90], p = 0.032) and ASA score>2 (HR = 2.32 [1.32- 4.06], p = 0.003) and number of resection (HR = 1.21 [1.06-1.39], p = 0.006) as a risk factors of RFS. Complication rates at day 30 were similar between OPEN and CLOSED_HIPEC, 31 (44.3 %) vs 42 (56.8 %); p = 0.135. OPEN_HIPEC had more severe complications (11 (35.5 %) vs 6 (14.3 %); p = 0.034). The mean cost of hospitalization was estimated as €15,627 for OPEN_HIPEC and €14,211 for CLOSED_HIPEC for a mean length-of-stay of 12.7 and 16.7 days respectively. The mean amount received by the hospital per hospitalization was estimated at €16,399 and €15,536 respectively. CONCLUSIONS: OS and RFS were similar for open and closed HIPEC. Severe complications at day 30 were more frequent in OPEN_HIPEC group. The amount received by hospital for both HIPEC techniques is sufficient.

Early prediction of in-hospital mortality utilizing multivariate predictive modelling of electronic medical records and socio-determinants of health of the first day of hospitalization.

BACKGROUND: In France an average of 4% of hospitalized patients die during their hospital stay. To aid medical decision making and the attribution of resources, within a few days of admission the identification of patients at high risk of dying in hospital is essential. METHODS: We used de-identified routine patient data available in the first 2 days of hospitalization in a French University Hospital (between 2016 and 2018) to build models predicting in-hospital mortality (at ≥ 2 and ≤ 30 days after admission). We tested nine different machine learning algorithms with repeated 10-fold cross-validation. Models were trained with 283 variables including age, sex, socio-determinants of health, laboratory test results, procedures (Classification of Medical Acts), medications (Anatomical Therapeutic Chemical code), hospital department/unit and home address (urban, rural etc.). The models were evaluated using various performance metrics. The dataset contained 123,729 admissions, of which the outcome for 3542 was all-cause in-hospital mortality and 120,187 admissions (no death reported within 30 days) were controls. RESULTS: The support vector machine, logistic regression and Xgboost algorithms demonstrated high discrimination with a balanced accuracy of 0.81 (95%CI 0.80-0.82), 0.82 (95%CI 0.80-0.83) and 0.83 (95%CI 0.80-0.83) and AUC of 0.90 (95%CI 0.88-0.91), 0.90 (95%CI 0.89-0.91) and 0.90 (95%CI 0.89-0.91) respectively. The most predictive variables for in-hospital mortality in all three models were older age (greater risk), and admission with a confirmed appointment (reduced risk). CONCLUSION: We propose three highly discriminating machine-learning models that could improve clinical and organizational decision making for adult patients at hospital admission.

Evidence-Based Pharmaceutical Care in Community Pharmacies: A Survey of 595 French Pharmacists.

We assessed the use of evidence-based practice (EBP) among pharmacists working in community pharmacies in France and the factors linked to this practice. During 3 months in 2018, an online survey was sent to over 7000 active pharmacists and posted on pharmacists' social media sites. In total, 595 pharmacists completed the questionnaire. The responders were on average younger than the general population of community pharmacists. The 40-item questionnaire described four fictional clinical cases reflecting typical situations (conventional medicine and complementary and alternative medicine) encountered daily by community pharmacists. Multiple-choice responses were proposed and scored according to whether they reflected EBP. A high total score indicated behaviour in line with EBP. We observed 344/595 participants with a positive EBP score (57.8% [53.7-61.8%]). Univariate and multivariate analyses were used to evaluate factors that might explain adherence to EPB (the pharmacy's characteristics, the pharmacist's status, the mode of continuing education and sources of information). The majority relied on pharmaceutical industry and other biased and/or non-evidence-based sources, particularly concerning information on homeopathic products. The consultation of independent reviews, health agency recommendations and peer-reviewed scientific journals was associated with evidence-based decisions. In contrast, reliance on pharmaceutical industry documents, personal experience and informal handbooks was linked to lower EBP scores. The level of EBP use by French community pharmacists needs to be improved to ensure that good-quality, science-based advice is given to customers.

Creating an Optimal Approach for Diagnosing Sleep Apnea.

Sleep apnea is nowadays recognized as a treatable chronic disease and awareness of it has increased, leading to an upsurge in demand for diagnostic testing. Conventionally, diagnosis depends on overnight polysomnography in a sleep clinic, which is highly human-resource intensive and ignores the night-to-night variability in classical sleep apnea markers, such as the apnea-hypopnea index. In this review, the authors summarize the main improvements that could be made in the sleep apnea diagnosis strategy; how technological innovations and multi-night home testing could be used to simplify, increase access, and reduce costs of diagnostic testing while avoiding misclassification of severity.

Impact of Body Mass Index on Postoperative Pain and Opioid Administration After Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC).

PURPOSE: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new surgical technique, developed for the treatment of peritoneal carcinomatosis (PC). In this retrospective observational study we assessed the impact of body mass index (BMI) on postoperative pain and opioid consumption. METHODS: We analyzed pain scores after 100 PIPAC procedures using either oxaliplatin or doxorubicin-cisplatin performed in 49 patients with PC between July 2016 and September 2020. The patients were divided into 3 groups (BMI <18.5, 18.5 ≥ BMI < 25, BMI≥25). Pain was self-rated on a visual analogue scale (VAS) from 0 to 10. RESULTS: Univariate logistic regression analysis identified oxaliplatin and PCI score to be associated with moderate to severe pain (VAS 4-10 at 8 am D1) after adjustment on BMI (OR [95% CI]; 3.26[1.00 - 10.65] p=0.050) and (OR [95% CI]; 1.09[1.01 - 1.17] p=0.019). The level of pain appeared significantly different between the treatment groups (median 2.5[0; 5] vs 0[0; 2.5] p=0.0017) irrespective of BMI (p =0.705 and p=0.118). Multivariate logistic regression analysis identified moderate to severe pain and synchronous PC to be associated with greater use of opioids (OR [95% CI]: 3.91 [1.24 - 12.32]) and (OR [95% CI]: 5.16 [1.71 - 15.58]; respectively. Opioids were administered after 45 procedures (45%) and was comparable between the treatment groups. Opioid administration and length-of-stay were similar among BMI bands. CONCLUSION: BMI is not related to postoperative pain or opioid use, howevermoderate to severe pain and synchronous PC are factors associated with requiring opioids.

Oncological Outcomes After Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in the Treatment of Peritoneal Carcinomatosis.

BACKGROUND: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new surgical technique for the treatment of initially unresectable peritoneal carcinomatosis (PC). Our objective was to assess its oncological outcomes. METHODS: Between July 2016 and September 2020, data from 100 PIPAC procedures with oxaliplatin or doxorubicin-cisplatin in 49 patients with PC (all etiologies) were analyzed. We studied the evolution of the peritoneal cancer index (PCI), the need for radical surgery (R0), and overall survival (OS). RESULTS: The patients' median age was 65 (59; 71) years, and 55.1% were women. Median PIPAC procedures per patient were 2 (1-3), and 28 (57.1%) underwent more than one PIPAC procedure. Median PCI at the first PIPAC was 19 (15-22). PCI decreased for 37%, remained stable for 29.6%, and increased for 33.4% patients. Four (8.3%) underwent radical R0 surgery after PIPAC. After a median follow-up of 16.1 months (1.5-90.1), the median overall survival from PC diagnosis was 29.1 months (14.8-34.3), with a median gastric and colorectal PC survival of 11.3 (7.2-34.3) and 29.1 months (16.1-31) respectively. Overall survival after the first PIPAC session was 11.6 months (6-17.3), with median survival after gastric and colorectal PCs being 6 (2.9-15.5) and 13.3 months (5-17.6), respectively. Stratification of patients according to the number of lines of systemic chemotherapy, PIPAC procedures, and the chronology of PC onset did not result in a significant difference in survival. CONCLUSION: The OS was in line with the literature. PIPAC could delay oncological progression and improve survival. These encouraging results justify the ongoing and future evaluations of PIPAC by prospective randomized trials.

Association between Enhanced Recovery After Surgery (ERAS) protocol, risk factors and 3-year survival after colorectal surgery for cancer in the elderly.

INTRODUCTION: As life expectancy is currently growing, more elderly and fragile patients need colorectal resection for cancer. We sought to assess the link between enhanced rehabilitation after surgery (ERAS), risk factors and overall survival at 3 years, in patients aged 65 and over. METHODS: Between 2005 and 2017, all patients undergoing colorectal resection for cancer were included. Overall survival at 3 years was compared for patients treated in following ERAS guidelines compared to conventional treatment (pre-ERAS). RESULTS: 661 patients were included (ERAS, n = 325; pre-ERAS, n = 336). The 3-year overall survival rate was significantly better regardless of age for ERAS vs pre-ERAS patients (73.1% vs 64.4%; p = 0.016). With overall survival rates of 83.2% vs 73.8%, 65.4% vs 62.8% and 59.6% vs 40% for the age bands 65-74, 75-84 and ≥ 85 years. The analysis of survival at 3 years by a multivariate Cox model identified ERAS as a protective factor with a reduction in the risk of death of 30% (HR = 0.70 [0.50-0.94], p = 0017) independently of other identified risk factors: age bands, ASA score > 2, smoking, atrial fibrillation and abdominal surgery. This result is confirmed by an analysis of the propensity score (HR = 0.67 [0.47-0.97], p = 0.032). CONCLUSIONS: Our study shows that ERAS is associated with better 3-year survival in patients undergoing colorectal resection for cancer, independent of risk factors. The practice of ERAS is effective and should be offered to patients aged 65 and over.

Hospitalization cost of Pressurized Intraperitoneal Aerosol chemotherapy (PIPAC).

INTRODUCTION: Pressurized Intraperitoneal Aerosol chemotherapy (PIPAC) is a new surgical technique for the treatment of unresectable peritoneal carcinomatosis. Very little data is available on the costs of this treatment in France as there is currently no code for PIPAC in the French Common Classification of Medical Acts (CCAM). Our objective was to estimate the mean cost of hospitalization for PIPAC in two French public teaching hospitals. METHODS: The mean cost of hospitalization was estimated from the mean fixed-rate remuneration paid to the hospital and the mean additional costs of treatment paid by the hospital. At discharge a patient's hospitalization is classified into a diagnosis related group, which determines the fixed-rate remuneration paid to the hospital (obtained from the national hospitals database - PMSI). Costs of medical devices and drug treatments specific to PIPAC, not covered by the fixed-rate remuneration, were obtained from the hospital pharmacies. RESULTS: Between July 2016 and November 2021, 205 PIPAC procedures were performed on 79 patients (mean procedures per patient = 2.6). Mean operating room occupancy was 165 min. The mean fixed-rate remuneration received by the hospitals per PIPAC hospitalization was €4031. The actual mean cost per hospitalization was €6562 for a mean length-of-stay of 3.3 days. Thus, each PIPAC hospitalization cost the hospital €2531 on average. CONCLUSION: The current reimbursement of PIPAC treatment by the national health system is insufficient and represents only 61% of the real cost. The creation of a new fixed-rate remuneration for PIPAC taking into account this cost differential is necessary.

Why People Forgo Healthcare in France: A National Survey of 164 092 Individuals to Inform Healthcare Policy-Makers.

BACKGROUND: Even in countries having nearly universal healthcare provision some individuals forgo or postpone healthcare to which they are entitled. Socioeconomic and geographic inequalities can make access to healthcare difficult for some people, such that they fail to seek it, particularly if they deem the type of care as non-essential. The need to pay at the point of care, the complexity and cost of top-up health insurance, and delays or only partial reimbursement can discourage take-up of care. This can affect the general health of the population. METHODS: To estimate the rate of forgoing healthcare in the general French population, between 2015 and 2018 we conducted a nationwide cross-sectional survey of individuals visiting French primary healthcare insurance agencies (Caisse Primaire d'Assurance Maladie, CPAM). We asked whether the person had foregone or postponed healthcare in the last 12 months, if so the types of healthcare forgone or put-off, and reasons. Individuals were stratified by the type of complementary (top-up) health insurance they had. RESULTS: Out of 164 092 individuals who responded, 158 032 were included in the analysis. Respondents had either private complementary (top-up) insurance (60%), top-up insurance subsidized by the state (29%), or no top-up health insurance (11%). Forgoers (n=40 115; 25.4%) most often lived alone (with or without children), were unemployed, and/ or female. Dental care (54%) and consultations with ophthalmologists, gynaecologists and dermatologists (41%) were most commonly forgone. The reasons were: inability to advance payment and/or to pay the uninsured part (69%), time constraints and difficulty in obtaining appointments (26%). CONCLUSION: We present a snapshot of forgoing healthcare in a developed country, highlighting the need for continuing review by policy-makers of payment regimens, insurance cover, availability and accessibility. While initiatives have already emerged from the results, further reforms are needed to address the problem of people forgoing preventative or perceived non-urgent healthcare, particularly for disadvantaged subgroups.

The Incident Feedback Committee (IFC): A Useful Tool to Investigate Errors in Clinical Research.

In clinical practice, an objective of safety management is to identify preventable causes of adverse events to avoid the incidents from recurring. Likewise, in the field of clinical research adequate methods to investigate incidents that impair the quality of a clinical trial are needed. Understanding the causes of errors and undesirable incidents can help guarantee participant safety, improve the practices of research coordinators, investigators, and clinical research assistants and help to minimize research costs. Here, we present the main features of our Incident Feedback Committees (IFC) in clinical research, with outcomes over 5 years. METHODS: The IFC has adapted the ALARM and ORION post-event methods with investigations focused on 'the incidents' occurring during research studies. It sought the root causes contributing to these incidents and proposed corrective actions. RESULTS: Since our IFC was set up in 2015 it has examined 52 incidents from nine studies. The most frequent causes mainly concerned the working environment (54%). Most incidents had two or more causes. Some corrective actions were planned for ongoing or future studies. CONCLUSION: IFCs provide a useful and much-appreciated method of analysing incidents in the performance of clinical research. A multicentre study is needed to evaluate the effect of IFCs on the quality of an establishment's clinical research, at the individual level (patient safety) and also at the system level (changes in the organization of tasks).

Assessment of postoperative pain after pressurized intraperitoneal aerosol chemotherapy (PIPAC) in the treatment of peritoneal metastasis.

PURPOSE: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new surgical technique, for the treatment of initially unresectable peritoneal metastasis (PM). Our objective was to assess postoperative pain and morbidity. METHODS: Between July 2016 and September 2020, data from 100 consecutive PIPAC procedures with oxaliplatin (PIPAC Ox) or doxorubicin-cisplatin (PIPAC C/D) in 49 patients with PM (all etiologies) were analyzed. Pain was self-assessed using a visual analog scale (VAS) of 0-10. RESULTS: The median PIPAC procedures per patient were 2 [1-3]. Patients indicated greatest pain at 4 pm on the day of the procedure (D0) and on postoperative D1 at 8 am and 4 pm. Postprocedural moderate-to-severe pain (VAS 4-10) was more frequent with PIPAC Ox than with PIPAC C/D, respectively 14 (36.8%) vs 7 (13.5%); p = 0.010. Hospitalization was longer for patients with moderate-to-severe pain than for others (median 4 days [3-7] vs 3 days [2-4], p = 0.004). Multivariate analysis identified oxaliplatin as a factor associated with greater pain (OR [95% CI], 2.95 [1.10-7.89]. Opiate administration was similar after PIPAC Ox and PIPAC C/D procedures, p = 0.477. CONCLUSION: PIPAC was well-tolerated, and pain was well-controlled in the majority of patients. Pain was greatest at 4 pm on D0 and 8 am and 4 pm on D1. PIPAC Ox is associated with greater pain than PIPAC C/D, independently of opiate treatment. Moderate-to-severe pain was associated with longer hospital stays.

Effect of implementation of enhanced recovery after surgery (ERAS) protocol and risk factors on 3-year survival after colorectal surgery for cancer-a retrospective cohort of 1001 patients.

PURPOSE: Several recent studies have shown that the enhanced recovery after surgery (ERAS) protocol reduces morbidity and mortality and shortens the length of stay compared to conventional recovery strategy (pre-ERAS). The aim of this study was to evaluate the effect of the implementation of this protocol on 3-year overall survival and postoperative outcome in patients undergoing colorectal resection for cancer. METHODS: This was a retrospective, single-center, comparative, and non-randomized study. Between January, 2005, and December, 2017, 1001 patients were included (ERAS, n = 497; pre-ERAS, n = 504). RESULTS: The 3-year overall survival rate was significantly better for ERAS than for pre-ERAS patients (76.1 vs 69.2%; p = 0.017). The length of hospital stay (median 10 days vs 15; p = ≤ 0.001) and the 90-day readmission rate (15 vs 20%; p = 0.037) were significantly lower in the ERAS group. Three-year recurrence-free survival (p = 0.398) and 90-day complications (p = 0.560) were similar in the two groups. Analysis of 3-year survival by a multivariate Cox model identified ERAS as a protective factor with a 30% reduction in the risk of death: (HR = 0.70 [0.55-0.90]). CONCLUSION: The implementation of the ERAS protocol was associated with an improvement in 3-year survival, a reduction of the length of hospital stay and the rate of readmission. ERAS is associated with better 3-year survival, independent of other commonly considered parameters. An ASA score > 2, smoking, a history of cancer, and atrial fibrillation are deleterious risk factors linked to earlier mortality.

Evaluation of the benefit of thermal spa therapy in plaque psoriasis: the PSOTHERMES randomized clinical trial.

Spa therapy is considered an add-on treatment for psoriasis, but without any objective evaluation in the absence of randomized trials. This multicenter, open-label, randomized trial compared immediate spa therapy versus a control group having usual treatments until study assessments at 4.5 months. Spa therapy was proposed in five French spa resorts with standardized programs. Inclusion criteria were adults with plaque psoriasis, Dermatology Life Quality Index (DLQI) > 10, and stable medical treatment in the last 6 months. The main objective was DLQI ≤ 10 at 4.5 months after inclusion. VQ-Dermato and EQ5D-3L also assessed quality of life (QoL), Perceived Stress Scale (PSS) stress, and visual analogue scales (VAS) pain and pruritus. Between January 2015 and November 2018, 128 patients were randomized to either immediate spa therapy (64) (within 34 days, median) or usual treatments (61) until assessment at 4.5 months. Most were first-time spa users (71.2%). Mean DLQI and Psoriasis Area and Severity Index at inclusion were 16.7 and 10.5, respectively. Immediate spa therapy patients achieved the primary objective for 66.1% [95% CI 52.6% > 77.9%] vs 41.4% [95% CI 28.6% > 55.1%] control group patients (p = 0.007). VQ-Dermato scores and pruritus VAS significantly improved. Outcomes at 12-month follow-up of the immediate spa therapy group showed persistent improvement of DLQI, VQ-Dermato, and pruritus. This randomized controlled trial demonstrated that a cure of spa therapy improves QoL and alleviates certain symptoms of psoriasis, in short and long terms. This justifies its integration in the therapeutic strategies for psoriasis. Trial registration number: ClinicalTrials.gov Identifier: NCT02098213.

A program centered on smart electrically assisted bicycle outings for rehabilitation after breast cancer: A pilot study.

The benefits of physical activity during cancer care and rehabilitation are well established, however introducing and maintaining healthy behaviors in the long-term remains challenging. Technological advances in electrically assisted bicycles and on-board sensors led us to propose an original rehabilitation program combining smart electric bicycle outings with health education. This was a pilot study with physical activity questionnaires and endurance tests to evaluate physical activity following a 6-week program comprising 2 bicycle outings per week in groups of 5 (supervised or not) with briefing and debriefing supplemented by health education sessions. Fourteen post-breast cancer patients participated (median age 52 [IQR 46-55]). A gain of at least 2 International Physical Activity Questionnaire points and over 600 MET.min/week was achieved by 9/10 (90%; 95%CI[55.5-99.7]) women. The feasibility of the program was clearly demonstrated, with excellent patient adherence (11/12 planned 2 h outings per patient). The electric bicycle program strengthened the womens' physiological capacities through personalized levels of electrical assistance made possible by the fine settings of the motorization. This enabled the whole group to achieve the outing objectives together despite very variable levels of deconditioning. The pleasure shared in the group activity and personal empowerment gained should promote long-term maintenance of physical activity.