[Feasibility study: The medical imaging as a tool for therapeutic education in radiotherapy]. / Étude de faisabilité : l'utilisation de l'imagerie médicale en éducation thérapeutique en radiothérapie.

PURPOSE: Assess the feasibility of a randomized controlled trial (RCT) exploring the use of medical imaging as a therapeutic education (TPE) intervention in external radiation therapy. MATERIALS AND METHODS: Experimental feasibility trial of "RCT" type carried out in a single-center, between November 2019 and March 2020, following adult patients treated by thoracic radiotherapy. In addition to the information usually given, the experimental group benefited from an intervention consisting in the visualization of their own medical images using the open-source software "Stone of Orthanc". RESULTS: Forty-nine patients were recruited with a refusal rate of 8.16% (4/49). 20 patients were withdrawn from the study for health reasons (COVID), 10 for medical reasons. All the remaining 15 participants completed the process. Although not significant, the experimental group showed a median gain in the perception of knowledge compared to the control group (+ 1.9 (1.6 - 2.2)) vs (+ 1.4 (1.4 - 1.8)), as well as a decrease in scores related to anxiety (- 3.0 (-4.5 - (-2.0)) vs - 1.0 (-5.0 - 0.0)) and emotional distress ((- 5.0 (- 7.5 - (- 3.5)) vs (- 2.0 (- 5.0 - (- 1.0)) A significant reduction (p=0.043) is observed for the depression score ((- 2.0 (-3.0 - (-1.5)) vs (0.0 (0.0 - 0.0)). CONCLUSION: This study demonstrates the feasibility of the project, with promising preliminary results. Some adaptations in order to conduct a larger-scale RCT are highlighted.

Assessment of diagnostic accuracy of lung function indices and FeNO for a positive methacholine challenge.

Demonstration of bronchial hyperresponsiveness is a key feature in asthma diagnosis. Methacholine challenge has proved to be a highly sensitive test to diagnose asthma in patients with chronic respiratory symptoms and preserved baseline lung function (FEV1 > 70% pred.) but is time consuming and may sometimes reveal unpleasant to the patient. We conducted a retrospective study on 270 patients recruited from the University Asthma Clinic of Liege. We have compared the values of several lung function indices and fractional exhaled nitric oxide (FeNO) in predicting a provocative methacholine concentration ≤16 mg/ml on a discovery cohort of 129 patients (57 already on ICS) and on a validation cohort of 141 patients (66 already on ICS). In the discovery study (n = 129), 85 patients (66%) had a positive methacholine challenge with PC20M ≤ 16 mg/ml. Those patients had lower baseline % predicted FEV1 (92% vs. 100%; p < 0.01), lower FEV1/FVC ratio (79% vs. 82%; p < 0.05), higher RV/TLC ratio (114% vs. 100%; p < 0,0001), lower SGaw (specific conductance) (0.76 vs. 0.95; p < 0,001) and higher FeNO (29 ppb vs. 19 ppb; p < 0,01). When performing ROC curve the RV/TLC ratio provided the greatest AUC (0.74, p < 0.001), sGAW had intermediate AUC of 0.69 (p < 0.001) while FeNO, FEV1 and FEV1/FVC ratio were modestly predictive (AUC of 0.65 (p < 0.05), 0,67 (p < 0.001) and 0,63 (p < 0.001). These results were confirmed in the validation study (n = 141). Based on a logistic regression analysis, significant variables associated with positive methacholine challenge were FeNO and RV/TLC (% Pred). A combined application of FeNO and RV/TLC (% Pred) for predicting the PC20M had a specificity of 85%, a sensitivity of 59% and an AUC of 0.79. In the validation study, three variables (RV/TLC, FeNO and FEV1) were independently associated with positive methacholine challenge and the combination of these three variables yielded a specificity of 77%, a sensitivity of 39% and an AUC of 0.77. The RV/TLC ratio combined to FeNO may be of interest to predict significant methacholine bronchial hyperresponsiveness.

Bio-optimized Curcuma longa extract is efficient on knee osteoarthritis pain: a double-blind multicenter randomized placebo controlled three-arm study.

OBJECTIVES: Comparison of two doses of bio-optimized Curcuma longa extract (BCL) in the management of symptomatic knee osteoarthritis (OA). METHODS: A prospective, randomized, 3-month, double-blind, multicenter, three-group, placebo-controlled trial assessing Patient Global Assessment of Disease Activity (PGADA) and serum sColl2-1, a biomarker of cartilage degradation, as co-primary endpoints. Pain on visual analog scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), and paracetamol/non-steroidal anti-inflammatory drug (NSAID) consumption were used as secondary endpoints. RESULTS: One hundred fifty patients with knee OA were followed for 90 days. Low and high doses of BCL showed a greater decrease of PGADA than placebo. Analysis of sColl2-1 showed in the placebo and BCL low-dose groups, but not in the BCL high-dose group, a transient but non-significant increase of sColl2-1 between T0 and T1. Thereafter, in all groups, sColl2-1 decreased between T1 and T3 (all p < 0.01), but no difference between the groups was found. Pain reduction at day 90 in the low- and high-dose BCL groups (- 29.5 mm and - 36.5 mm) was higher than that in the placebo (- 8 mm; p = 0.018). The global KOOS significantly decreased overtime, but changes were comparable across treatment arms. The ratio of patients with adverse events (AE) related to the product was similar in the placebo and treatment groups, but the number of AE linked to the product was higher in the high-dose BCL group compared to the placebo (p = 0.012). CONCLUSIONS: BCL appeared safe and well-tolerated with no evidence of severe adverse effects. Efficacy analysis suggested positive trends for measurements of PGADA and serum levels of an OA biomarker and showed a rapid and significant decrease of pain in knee OA (Trial registration: ISRCTN, ISRCTN12345678. Registered 21 September 2016-retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02909621?term=osteoarthritis+curcumin&rank=5-Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA) NCT02909621).

[Alcohol consumption : from epidemiology to prevention]. / La consommation d'alcool : de l'épidémiologie à la prévention.

The epidemiological data about alcohol consumption show that the current preventive measures have their limits. Worryingly, the morbidity and mortality associated remain significant in the world. Two main types of preventive approaches, based on individual affect exist: the negative approach based on fear and threat and the so-called Social Norm Approach (SNA). The last original and more positive approach has been used across the Atlantic for thirty years and shows to be efficient. It aims to reduce an individual's consumption of addictive substance by confronting his own social norm (what he thinks people drink, quantities generally overestimated) to the real norm of consumption by a reference social group. A cross-border project is currently evaluating the feasibility of this approach in the Euregio Meuse-Rhin.

Les données épidémiologiques de la consommation d'alcool les plus récentes montrent que les mesures préventives actuelles connaissent leurs limites. De façon inquiétante, la morbidité et la mortalité qui lui sont associées restent importantes dans le monde. Deux grands types d'approches préventives ciblant directement les affects des individus existent : l'approche négative basée sur la peur et la menace et l'approche dite par la norme sociale (SNA pour Social Norm Approach). Cette dernière approche originale et plus positive de la santé est utilisée depuis une trentaine d'années outre-Atlantique et montre une certaine efficacité. Elle vise à réduire la consommation d'une substance addictive par un individu en confrontant sa norme sociale (ce qu'il pense que les gens boivent, quantités généralement surestimées) à la norme réelle de consommation du groupe social de référence. Un projet transfrontalier évalue actuellement la faisabilité de ce genre d'approche dans l'Eurégio Meuse-Rhin.

[Exploratory population study of overweight and obese subjects' perceptions: Searching for improved management practices]. / L'exploration des perceptions relatives à l'excès de poids pour mieux comprendre les difficultés dans la prise en charge de l'obésité : une étude populationnelle exploratoire.

BACKGROUND: Overweight and obesity are major public health problems of growing concern. Few studies have investigated the representations and perceptions of subjects with overweight and obesity, especially in the general population, as compared to people in a medical weight loss process. The objective of this study was to fill this gap by enabling participants to express their feelings and experience about their overweight, and to assess the extent of the body mass index (BMI) as a determinant of these perceptions. METHODS: A total of 4155 persons participated in an exploratory study conducted in Wallonia (Belgium). Data were collected by means of a web-based questionnaire. This study investigated the following parameters: sociodemographic and anthropometric factors, perceived health, quality of life, diet perception, enrolment in a weight loss process and weight loss target. The influence of BMI was considered, on one hand, looking at how the above variables evolve according to BMI category, secondly, as a mediation factor in the relationship between socioeconomic level and these same variables. RESULTS: A large majority (87.5%) of subjects were overweight (32.2%) or obese (obese class I 29.9%, class II 14.8%, class III 10.6%). Perceived health was found to deteriorate with the BMI (P<0.0001); obese class III had a 5.9-fold risk to present bad perceived health compared to subjects with normal weight. The physical and psychological quality of life reported by the subjects decreased significantly with the BMI (P<0.0001) particularly for the physical quality of life. The percentage of poor diet perception (frustration, weight gain, aggressiveness, inefficacy and impossibility) as well as the weight loss targeted by the subjects increased with the BMI. Between overweight subjects and obese class III subjects, weight loss target increased from 13% to 34% of the initial weight. The majority of subjects judged that diet represents "aggressiveness", "weight gain" and "impossibility". A partial mediation role of BMI was identified in the relationship between social status and the variables of interest. CONCLUSIONS: This study focused on a sample of people from the general population. It confirmed previous results of others studies. All results gave a feeling of resignation and powerlessness which can seize obese individuals (especially when BMI increases). As a consequence, there is a need for more adapted weight management to achieve a genuine therapeutic alliance.

Pre-Operative Ability of Clinical Scores to Predict Obstructive Sleep Apnea (OSA) Severity in Susceptible Surgical Patients.

BACKGROUND: Severe obstructive sleep apnea (OSA) is an independent risk factor for perioperative complications. Clinical scores such as Snoring, Tiredness, Observed apnea, high blood Pressure, Body Mass Index (BMI) higher than 35 kg m-2, Age older than 50 years, Neck circumference larger than 40 cm, and male gender (STOP-Bang), perioperative sleep apnea prediction (P-SAP), and OSA50 have been proposed for detecting OSA. We recently proposed a new score based on morphological metrics only, the DES-OSA score. This study compared the DES-OSA score to the three other ones with regard to their ability to detect OSA. Obese patients are particularly at risk of OSA. METHODS: Following informed consent and institutional review board (IRB) approval, 1584 consecutive adults were. Should the STOP-Bang be indicative of increased risk of severe OSA, the patient was referred to complementary polysomnography (PSG). Eventual already existing recent PSG data were also collected. The abilities of the four scores to predict OSA severity were compared using sensitivity, specificity, Cohen's kappa coefficient (CKC), and area under ROC curve (AUROC) analysis. RESULTS: PSG was performed in 150 patients. For detecting severe OSA, OSA50 had the highest sensitivity [value (95 % CI) 0.98 (0.90-1)]. STOP-Bang was significantly less sensitive than P-SAP and OSA50. In that respect, DES-OSA was significantly more specific than the three other ones [0.75 (0.65-0.83)]. The AUROC of DES-OSA was significantly the largest [0.9 (0.84-0.95)]. The highest CKC at detecting severe OSA was 0.62 (0.49-0.74) for DES-OSA. Similar results were obtained for moderate to severe OSA prediction. CONCLUSIONS: DES-OSA, which is the only exclusively morphological score available, appears to surpass the three other scores in their ability to predict moderate to severe and severe OSA, at least in our setting and in our screened population. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov NCT02051829.

One-year prevalence of migraine using a validated extended French version of the ID Migraine™: A Belgian population-based study.

BACKGROUND: Country-specific prevalence data on migraine and comorbidities are vital to assess the public health burden of migraine and the corresponding resources required for proper management. Considering the absence of reliable statistics, this study aimed to estimate the one-year prevalence of migraine in Wallonia (Belgium) in relation to socio-demographic factors and several health indicators. METHODS: Among the 1071 people aged 20-69 years who participated in the NESCaV survey, 751 (70.1%) were screened for one-year migraine attacks using the "ef-ID Migraine", a validated, extended French version of the self-administered ID Migraine™ questionnaire. Socio-demographic and health data were collected with a self-administered questionnaire and a physical examination. RESULTS: The overall one-year prevalence of migraine was 25.8%; 40.8% of migraineurs reported visual symptoms compatible with an aura. The prevalence was higher in women than in men (33.9% vs. 17.9%, P<0.0001) and declined markedly after the age of 50 (P=0.005). Importantly, migraine was associated with the subjective feeling of poorer health (P=0.0004). No other socio-demographic factor or health indicator studied was significantly correlated with migraine. CONCLUSIONS: High prevalence of migraine and strong association with feeling of poor health should incite health authorities to institute more active public health and management policies with regards to the migraine problem.

Oleuropein or rutin consumption decreases the spontaneous development of osteoarthritis in the Hartley guinea pig.

OBJECTIVE: To assess the potential protective effects of three polyphenols oleuropein, rutin and curcumin, on joint ageing and osteoarthritis (OA) development. DESIGN: Sixty 4-week-old Dunkin-Hartley guinea pigs were randomized into four groups and received daily during 31 weeks either standard guinea pig diet (control group) or a standard guinea pig diet enriched with oleuropein (0.025%), rutin (0.5%) or rutin/curcumin (0.5%/0.25%) association. Biomarkers of OA (Coll2-1, Coll2-1NO2, Fib3-1, Fib3-2, ARGS), as well as inflammation prostaglandin E2 (PGE2) were quantified in the serum. Histological assessments of knee cartilage and synovial membrane were performed at week 4 (five young reference guinea pigs) and week 35. RESULTS: At week 35, guinea pigs in the control group spontaneously developed significant cartilage lesions with mild synovial inflammation. The histological scores of cartilage lesions and synovitis were well correlated with the increased level of serum biomarkers. Histologically, all treatments significantly reduced the cartilage degradation score (P < 0.01), but only oleuropein significantly decreased the synovial histological score (P < 0.05) and serum PGE2 levels (P < 0.01) compared to the control group. Coll2-1 was decreased by rutin and the combination of rutin/curcumin, Fib3-1 and Fib3-2 were only decreased by the rutin/curcumin mixture, while Coll2-1NO2 was significantly decreased by all treatments (P < 0.05). CONCLUSION: Oleuropein and rutin ± curcumin significantly slowed down the progression of spontaneous OA lesions in guinea pigs. While no additive effect was seen in the curcumin + rutin group, the differential effects of oleuropein and rutin on inflammatory and cartilage catabolic markers suggest an interesting combination for future studies in OA protection.

Preoperative adherence to continuous positive airway pressure among obstructive sleep apnea patients.

BACKGROUND: Obstructive Sleep Apnea (OSA) increases the perioperative risk of complications. Chronic use of Continuous Positive Airway Pressure (CPAP) by patients decreases the importance of comorbidities caused by the OSA. However, many patients do not adhere to the treatment. Given the postoperative complications, it is important for the anesthesiologist to identify non-adherent patients. This prospective study was designed to identify factors that would predict patient adherence. METHODS: Ninety patients who were treated by CPAP for more than one year were recruited. Among them, and based on objective criteria such as length of use of CPAP during the night, 75 were considered as being adherent to CPAP, while the other 15 were not. Sixty-two potential causes of non-adherence were investigated (some have not been tested before), and further divided into five categories. Those categories included cultural, intellectual, or economic factors, OSA comorbidities, patient belief about health, ENT-related problems, and pathophysiological features estimating the degree of improvement afforded by CPAP introduction. RESULTS: Multivariate binary logistic regression analysis identified one criterion of non-adherence to treatment, namely the feeling of breathlessness, and three criteria of adherence, namely awareness of the risk of complications, awareness of treatment efficacy, and feeling of being less tired with CPAP therapy. CONCLUSIONS: These four new criteria should preoperatively be sought, in order to detect non-adherent patients more efficiently.

Simulation-based study comparing multiple imputation methods for non-monotone missing ordinal data in longitudinal settings.

The application of multiple imputation (MI) techniques as a preliminary step to handle missing values in data analysis is well established. The MI method can be classified into two broad classes, the joint modeling and the fully conditional specification approaches. Their relative performance for the longitudinal ordinal data setting under the missing at random (MAR) assumption is not well documented. This article intends to fill this gap by conducting a large simulation study on the estimation of the parameters of a longitudinal proportional odds model. The two MI methods are also illustrated in quality of life data from a cancer clinical trial.

Longitudinal quality of life data: a comparison of continuous and ordinal approaches.

PURPOSE: In cancer clinical trials, health-related quality of life (HRQoL) is a major outcome measure. It is generally assessed at specified time intervals by filling out a questionnaire with ordered response categories. Despite recent advances in the statistical methodology for handling ordinal longitudinal outcome data, most users keep treating HRQoL scales as continuous rather than ordinal variables regardless of the number of categories. The purpose of this study was to compare the results of analyzing HRQoL longitudinal data under both approaches, continuous and ordinal. METHODS: The EORTC QLQ-C30 scores of two EORTC randomized brain cancer clinical trials (26951 and 26981) were analyzed using the two approaches. In the 26951 trial, a total of 368 patients were randomly assigned to receive either radiotherapy (RT) or the same RT plus procarbazine, CCNU, and vincristine. In the 26981 trial, 573 patients were randomly allocated to RT or RT plus temozolomide. Comparison of the two treatment arms was done using methods for longitudinal quantitative and longitudinal ordinal data. Both statistical methods were adapted to account for missing data and compared in terms of statistical significance of the results (p values) but also with respect to data interpretation. RESULTS: Three scales, i.e., appetite loss, insomnia, and drowsiness, presenting four response categories ("Not at all", "A little", "Quite a bite", and "Very much") were analyzed in each trial. Both statistical methods (continuous and ordinal) showed statistically significant differences between the two treatments, not only globally but also at the same assessment time points. The magnitude of the p values, however, varied at some time points and was less pronounced in the ordinal approach. CONCLUSIONS: The analysis of the two clinical trials showed that treating the HRQoL scales by a quantitative or an ordinal method did not make much difference as far as statistical significance was concerned. The interpretation of results, however, was easier under the ordinal approach. Treatment effects may be more meaningful when expressed in terms of odds ratios than as mean values, particularly when the number categories is small.

On the potential increase of the oxidative stress status in patients with abdominal aortic aneurysm.

BACKGROUND: Abdominal aortic aneurysm (AAA) is a major cause of preventable deaths in older patients. Oxidative stress has been suggested to play a key role in the pathogenesis of AAA. However, only few studies have been conducted to evaluate the blood oxidative stress status of AAA patients. METHODS AND RESULTS: Twenty seven AAA patients (mean age of 70 years) divided into two groups according to AAA size (≤ 50 or > 50 mm) were compared with an age-matched group of 18 healthy subjects. Antioxidants (vitamins C and E, ß-carotene, glutathione, thiols, and ubiquinone), trace elements (selenium, copper, zinc, and copper/zinc ratio) and markers of oxidative damage to lipids (lipid peroxides, antibodies against oxidized patients, and isoprostanes) were measured in each subject. The comparison of the three groups by ordinal logistic regression showed a significant decrease of the plasma levels of vitamin C (P = 0.011), α-tocopherol (P = 0.016) but not when corrected for cholesterol values, ß-carotene (P = 0.0096), ubiquinone (P = 0.014), zinc (P = 0.0035), and of selenium (P = 0.0038), as AAA size increased. By contrast, specific markers of lipid peroxidation such as the Cu/Zn ratio (P = 0.046) and to a lesser extent isoprostanes (P = 0.052) increased. CONCLUSION: The present study emphasizes the potential role of the oxidative stress in AAA disease and suggests that an antioxidant therapy could be of interest to delay AAA progression.

Determinants of sickness absence duration after an occupational back injury in the Belgian population.

BACKGROUND: This study aimed at assessing factors associated to the duration of sickness absence after a back injury in the Belgian working population, with a special emphasis on cultural factors. METHODS: The data were retrieved from the Belgian Fund for Work Accidents database over a 3-year period (2001-2003). The population source involved all Belgian workers under a job contract in the private sector registered as compensated cases for an accident that occurred at the workplace (n = 558,276). From that database, all back injury cases involving a complete data set and registered during the first 6 months of each year (n = 11,262) were selected and eight factors (gender, age, seniority in the current job, job category, accident regional location, enterprise size, sector of activity, and accident circumstances) were analyzed in relation to the outcome variable, sick leave duration recorded as ordered time intervals between 0 and 183-366 days. RESULTS: Sick leave duration was strongly associated in a multivariate model to age (≥40 years: OR = 2.18), blue-collar job (1.55), work in building industry (1.32), and enterprise size (>100: 0.85), and to a less extent to seniority (>10y: 0.88), and circumstance of accident (falls: 1.26). Injuries occurring in the French-speaking part of the country were associated to a longer sick leave (1.07; P = 0.034). CONCLUSIONS: This study shows that besides well-known risk factors, subtle cultural language-linked factors and/or regional differences in economic climate may significantly influence the length of disability period after a back injury.

Induction of long-lasting changes of visual cortex excitability by five daily sessions of repetitive transcranial magnetic stimulation (rTMS) in healthy volunteers and migraine patients.

We have shown that in healthy volunteers (HV) one session of 1 Hz repetitive transcranial magnetic stimulation (rTMS) over the visual cortex induces dishabituation of visual evoked potentials (VEPs) on average for 30 min, while in migraineurs one session of 10 Hz rTMS replaces the abnormal VEP potentiation by a normal habituation for 9 min. In the present study, we investigated whether repeated rTMS sessions (1 Hz in eight HV; 10 Hz in eight migraineurs) on 5 consecutive days can modify VEPs for longer periods. In all eight HV, the 1 Hz rTMS-induced dishabituation increased in duration over consecutive sessions and persisted between several hours (n=4) and several weeks (n=4) after the fifth session. In six out eight migraineurs, the normalization of VEP habituation by 10 Hz rTMS lasted longer after each daily stimulation but did not exceed several hours after the last session, except in two patients, where it persisted for 2 days and 1 week. Daily rTMS can thus induce long-lasting changes in cortical excitability and VEP habituation pattern. Whether this effect may be useful in preventative migraine therapy remains to be determined.