Real-life pilot study on the impact of the telemedicine platform EasyMICI-MaMICI® on quality of life and quality of care in patients with inflammatory bowel disease.

BACKGROUND: Telemedicine has shown promising results in the follow up of patients with inflammatory bowel disease. This study compared quality of life and disease activity in patients with inflammatory bowel disease monitored using a telemedicine platform versus standard care. METHODS: In this prospective multicenter study, patients with active inflammatory bowel disease were randomized to EasyMICI-MaMICI® telemedicine platform or standard care. The main objective was to assess the efficacy of the software platform, as measured by quality of life and quality of care. Secondary outcomes were changes in the use of healthcare resources, and patient satisfaction in the MaMICI group. RESULTS: Fifty-four patients were enrolled (November 2017-June 2018); 59.3% had Crohn's disease and 40.7% ulcerative colitis. Forty-two patients received biologics at inclusion. After 12 months, a significant improvement in quality of life was observed with MaMICI versus standard care, with mean (standard deviation) changes from baseline of 14.8 (11.8) vs 6.3 (9.7) in the SIBDQ scores and 18.5 (18.7) vs 2.4 (8.3) in the EuroQol 5 D-3L questionnaire scores (both p ≤ .02). Disease activity was similar in both treatment groups. Use of MaMICI slightly reduced healthcare utilization versus controls (mean gastroenterologist consultations 2.2 vs 4.1; p = .1308). Overall satisfaction with MaMICI was high (mean score 7/10), and 46.2% of remaining patients in the MaMICI group continued to use the platform until 12 months. CONCLUSION: Significant improvement in quality of life and overall satisfaction with this telemedicine platform, indicates that further evaluation of EasyMICI-MaMICI in larger numbers of patients with inflammatory bowel disease is warranted.

Creating conditions for the success of the French industrial advanced therapy sector.

Although the European Union merely followed the initiatives of the United States and Japan by introducing special regimes for orphan medicinal products, it has introduced a special status for a new category of biological medicinal products, advanced therapy medicinal products (ATMPs), adopting specific associated regulations. European Regulation (which constitutes the highest legal instrument in the hierarchy of European law texts) [EC] No. 1394/2007, published in 2007, uses this term to define somatic cell therapy medicinal products, tissue-engineered products, and gene therapy medicinal products, possibly combined with medical devices. The stated objective was two-fold: both to promote their industrialization and market access, while guaranteeing a high level of health protection for patients. Since publication of the regulation, few marketing authorizations have been granted in Europe, and these have not been accompanied by commercial success. However, certain recent studies show that this is a growing sector and that France remains the leading European nation in terms of clinical trials. This round table brought together a panel of representatives of French public and private protagonists from the advanced therapy sector. The discussions focused on the conditions to ensure the success of translational research and, more generally, the French advanced therapy sector. These enabled a number of obstacles to be identified, which once lifted, by means of recommendations, would facilitate the development and success of this sector.

Treatment of A3.2 and A2 traumatic thoracolumbar spine compression fractures using vertebral body stenting: a 63-patient series.

BACKGROUND: Percutaneous treatments for spinal injury are underused by neuroradiologists and spine surgeons, mainly owing to a lack of data on indications. OBJECTIVE: To assess the safety and efficacy of vertebral body stenting (VBS) for post-traumatic A3.2 and A2 fractures (Magerl classification) and determine the factors that influence the improvements. METHODS: We retrospectively reviewed patients who underwent VBS to treat a single traumatic thoracolumbar fracture from 2010 to 2019. Kyphosis, loss of vertebral body height (VBH), and clinical and functional outcomes (including the Visual Analog Scale pain score and Oswestry Disability Index) were assessed. We examined the overall effects of VBH in all patients by constructing a linear statistical model and evaluated whether the efficacy was dependent on the characteristics of the patients or fractures. RESULTS: We included 63 patients comprising 44 A3.2 and 19 A2 fractures. No patient had worsening neurological symptoms or wound infection. The average rates of change were 67.1% (95% CI 59.1% to 75%) for kyphosis and 88.5% (95% CI 85.6% to 91.3%) for VBH (both p<0.0001). After 1 year, the VBS treatment was more effective for kyphosis in younger patients and at the L1 level, and for VBH in younger patients and cases of Magerl A3.2 fracture. CONCLUSIONS: This large reported series on VBS validates this surgical treatment. All patients had improved kyphosis and restored VBH. We recommend using VBS rather than open surgery for A3.2 and A2 fractures at the thoracolumbar junction and in young patients.

Treating traumatic thoracolumbar spine fractures using minimally invasive percutaneous stabilization plus balloon kyphoplasty: a 102-patient series.

BACKGROUND: There is no consensus on the treatment for spinal injuries resulting in thoracolumbar fractures without neurological impairment. Many trauma centers are opting for open surgery rather than a neurointerventional approach combining posterior percutaneous short fixation (PPSF) plus balloon kyphoplasty (BK). OBJECTIVE: To assess the safety and efficacy of PPSF+BK and to estimate the expected improvement by clarifying the factors that influence improvement. METHODS: We retrospectively reviewed patients who underwent PPSF+BK for the treatment of single traumatic thoracolumbar fractures from 2007 to 2019. Kyphosis, loss of vertebral body height (VBH), clinical and functional outcomes including visual analog scale and Oswestry disability index were assessed. We examined the overall effects in all patients by constructing a linear statistical model, and then examined whether efficacy was dependent on the characteristics of the patients or the fractures. RESULTS: A total of 102 patients were included. No patient experienced neurological worsening or wound infections. The average rates of change were 74.4% (95% CI 72.6% to 76.1%) for kyphosis and 85.5% (95% CI 84.4% to 86.6%) for VBH (both p<0.0001). The kyphosis treatment was more effective on Magerl A3 and B2 fractures than on those classified as A2.3, as well as for fractures with slight posterior wall protrusion on the spinal canal. A higher postoperative visual analog scale score was predictive of poorer outcome at 1 year. CONCLUSIONS: This is the largest series reported to date and confirms and validates this surgical treatment. All patients exhibited improved kyphosis and restoration of VBH. We advise opting for this technique rather than open surgery.

Influence of a temporary stabilization device on respiratory status in patients with severe trauma with a femoral shaft fracture treated by damage control strategy.

BACKGROUND: There are few studies on the safety and respiratory consequences of the use of a skeletal traction (ST) device in the management of femoral shaft fractures with damage control orthopaedics (DCO) strategy, particularly in cases of prolonged use. The aim of this study was to assess the influence of ST compared with an external fixator (EF) on respiratory complications and mechanical ventilation requirements in patients with severe trauma with a femoral shaft fracture managed by DCO strategy. METHODS: We retrospectively reviewed all patients with severe trauma patients with a unilateral femoral shaft fracture admitted to our institution from 2010 to 2015. Patients who did not undergo definitive osteosynthesis during the first 24 h were included and divided into two groups: DCO-ST group and DCO-EF group. In addition to trauma severity, global management of respiratory complications, the incidence of acute respiratory distress syndrome (ARDS) and mechanical ventilation requirements and outcome were compared. RESULTS: Fifty-five patients were managed with DCO strategy (mean Injury Severity Score, 28.4); there were 31 in the DCO-ST group and 24 in the DCO-EF group. No significant difference in terms of the main characteristics, initial severity and associated injuries was observed between the two groups. In contrast, ARDS was found more frequently in the DCO-ST group (81% versus 54%; P = 0.035). Number of ventilation days also tended to be higher in the DCO-ST group (9 days [IQR 3-15 days] versus 7 [IQR 2-16 days]; P = 0.24). No difference was found for mortality and hospitalization duration between the DCO-ST and DCO-EF groups. CONCLUSION: The prolonged use of an ST device in the present cohort was associated with a higher incidence of impaired respiratory function. Therefore, our findings suggest that EF is preferable to ST in the DCO setting for femoral shaft fracture, especially in trauma patients at high risk of developing delayed respiratory failure.

Angioleiomyoma in the ankle mimicking tarsal tunnel syndrome: a case report and review of the literature.

We present the case of a 64-year-old woman with a subcutaneous vascular leiomyoma in the tarsal tunnel in the ankle. The patient presented with pain of several years' duration in the medial aspect of the ankle in the retromalleolar region corresponding to the tarsal tunnel and associated with a subcutaneous mass. We report the clinical manifestation, the imaging and histopathologic features, and a review of the literature. Vascular leiomyomas are part of the differential diagnosis of painful subcutaneous masses in the lower extremity.

Evidence of Authorship on Messages in Facilitated Communication: A Case Report Using Accelerometry.

Facilitated communication (FC) belongs to augmentative and alternative methods of communication. Currently, FC is very rarely and unofficially used with people suffering from verbal/communicative disorders or neurodevelopmental disorders such as intellectual deficiency or autism spectrum disorder (ASD). FC consists of physical support exerted by a facilitator at the hand/wrist/forearm/elbow of a patient/participant, aimed at helping him/her to point at pictures/words, and sometimes to type letters/words on a keyboard. Given most of (but not all) validation studies using control procedures failed to confirm that ASD participants themselves were authoring the messages via FC, this method has been massively disputed and rejected. However, firm and definitive conclusions for/against the validity of FC requires more robust demonstrations, particularly when considering the motor participation of both protagonists. We present here a case report investigating the motor contribution of both protagonists during a typing process using the non-invasive technique of accelerometry. A 17-year-old boy diagnosed with congenital deafness, ASD, and developmental delay, and his facilitator, were equipped with small accelerometers fixed on their index finger, aimed at transforming index acceleration along the three spatial axes into electric signals. Typing on a PC keyboard was performed under three support conditions: hand support, forearm support, elbow support, plus a solo-typing condition. Accelerometric signals and video data were recorded during four FC sessions. We measured and compared the typing speed, the number/percentage of acceleration peaks produced by the participant or by the facilitator first, and those of "signal under detection threshold" in the facilitator, the time offset between acceleration peaks of both protagonists, and the difference of the amount of acceleration between them, across the different support conditions. Results indicate that in the hand support, most of the time, acceleration motions of the participant's index finger preceded those of the facilitator's index finger. Then, the more distal the physical support (i.e., farer from the participant's hand), the slower the speed of typing, the higher the percentage of "signal under detection threshold" in the facilitator, the bigger the motor contribution from the participant. Altogether, in all the support conditions, the participant's authorship or, at least, co-authorship on the messages seems warranted. Finally, accelerometry seems relevant to objectivize authorship or co-authorship in FC and delineate various forms of FC.

Motivation to pursue anti-TNFα treatment in patients with Crohn's disease - the SPACE motivation study.

BACKGROUND: Crohn's disease (CD) is a chronic disorder requiring long-term treatment. However, up to 20% of patients interrupt temporarily or permanently anti-TNFα. Primary aim was to identify internal and external factors influencing patient's motivation to pursue anti-TNFα in active CD. METHODS: This was a French, multicentre, prospective study enrolling CD patients on anti-TNFα therapy since more than 3 months. Patients completed the Satisfaction of Patients with Crohn's Disease questionnaire (SPACE-Q) and other patient-reported-outcome tools at inclusion visit, and after 6 and 12 months. RESULTS: A total of 274 patients were included: 146 (53.3%) received adalimumab, while 128 (46.7%) infliximab. Most patients (78%) were still treated with anti-TNFα 12 months after enrolment. Patients' perception of necessity (p = 0.01) and concerns (p<0.0001) regarding medication, evaluated through the Belief about Medicines Questionnaire (BMQ), and expectation confirmation towards treatment convenience (p = 0.02), towards efficacy (p = 0.04), and treatment satisfaction (p = 0.03) according to SPACE-Q, correlated with motivation to pursue treatment. Patients with higher treatment satisfaction (p = 0.0004), stronger belief in treatment necessity (p<0.0001) and fewer concerns (p = 0.0002) were more likely to be very motivated. CONCLUSION: Treatment satisfaction, treatment necessity, and concerns are correlated to motivation to pursue anti-TNFα. Specific questions focused on these patients' perceptions could help physicians to identify patients at risk of non-adherence and prevent therapy interruption.

Femoral neck shortening after internal fixation of Garden I fractures increases the risk of femoral head collapse.

BACKGROUND: Arthroplasty has not been proven superior over internal fixation for the treatment of non-displaced femoral neck fractures. However, internal fixation has been followed by high rates of revision for mechanical complications and of femoral neck impaction within the first postoperative year. The objective of this study was to determine whether femoral neck impaction was associated with avascular necrosis (AVN). HYPOTHESIS: Fracture healing with femoral neck shortening by impaction after internal fixation of a femoral neck fracture is associated with AVN. MATERIAL AND METHODS: A single-centre retrospective study in patients with Garden I fractures managed by screw fixation was performed to compare outcomes in the groups with and without femoral neck impaction. Follow-up radiographs were assessed for evidence of the femoral neck impaction during fracture healing. The occurrence of AVN was the primary evaluation criterion. The secondary evaluation criteria were risk factors for impaction and complications. RESULTS: Of the 75 included patients, 9 (12%) experienced AVN. Impaction was significantly associated with AVN (p=0.02; relative risk, 4.38). Significant risk factors for impaction were a higher body mass index (p=0.0003) and valgus-impacted fracture reduction between the radiographs at baseline and immediately after surgery (p=0.0001). DISCUSSION: Femoral neck impaction was a significant risk factor for AVN after screw fixation of Garden I fractures. Valgus-impacted fracture reduction must receive careful attention during fixation. We suggest static internal fixation if the impaction is reduced on a traction table and advise caution when using parallel screws. The diagnostic and therapeutic strategy proposed here deserves to be evaluated in a prospective study. LEVEL OF EVIDENCE: III, retrospective comparative study.

Antitumor effect of in vivo somatostatin receptor subtype 2 gene transfer in primary and metastatic pancreatic cancer models.

Our previous studies conducted in pancreatic cancer models established in nude mice and hamsters revealed that cloned somatostatin receptor subtype 2 (sst2) gene expression induced both antioncogenic and local antitumor bystander effects in vivo. In the present study, in vivo gene transfer of sst2 was investigated in two transplantable models of primary and metastatic pancreatic carcinoma developed in hamsters. LacZ reporter or mouse sst2 genes were expressed by means of two different delivery agents: an adenoviral vector and a synthetic polycationic carrier [linear polyethylenimine (PEI)]. sst2 was injected into either exponentially growing pancreatic primary tumors or hepatic metastases, and then transgene expression and tumor progression were investigated 5-6 days after gene transfer. Molecular mechanisms involved in the inhibition of tumor growth were also analyzed. Both adenovirus- and PEI-mediated in vivo gene transfer in primary pancreatic tumors induced an increase of beta-galactosidase activity and expression of sst2 transgene nRNA (100% and 86% of tumors for adenovirus and PEI vector, respectively). Adenoviral vector-based sst2 gene transfer resulted in significant reduction of pancreatic tumor growth (P < 0.05). Using PEI vector, both pancreatic primary tumor growth and metastatic tumor growth were also significantly slackened as compared with both LacZ-treated and untreated control groups (P < 0.02). Moreover, the proliferative index decreased significantly (P < 0.005), whereas apoptosis increased (P < 0.005) in tumors transferred with sst2 gene. The increase of apoptosis correlated with an activation of the caspase-3 and poly(ADP-ribose) polymerase pathways. We concluded that in both primary and metastatic pancreatic cancer models, the synthetic gene delivery system can achieve in vivo sst2 gene transfer and results in a significant antitumor effect characterized by an increase of apoptosis and an inhibition of cell proliferation. This new strategy of gene therapy allows the restoration of expression of an antioncogenic molecule and could be promising for the treatment of advanced pancreatic cancer.

Implementation of the French national consensus for the management of ulcerative colitis into clinical practice.

BACKGROUND: Recently, treatment algorithms were developed in France additionally to ECCO recommendations that should be used as reference for ulcerative colitis (UC) management. Nevertheless, their implementation in clinical practice remains challenging. AIMS: To evaluate the prevalence of the use of these UC management algorithms in 127 patients followed by private gastroenterologists. METHODS: Charts of all UC patients seen during the year 2015 (n=127) by 10 gastroenterologists were reviewed. The gastroenterologist's management was then compared to the corresponding algorithm situation and, in case of disagreement, analysed by an expert committee. RESULTS: 94.5% of patients corresponded to a clinical situation described in algorithms. Gastroenterologist's management was adequate to the corresponding algorithm situation in 74.2% of cases. Among the 31 cases of disagreement, the gastroenterologist's decision differed from the algorithm position in 21 cases, and in 76.2% of cases the expert committee would have made the same decision. In the remaining 10 cases, the decision differed from the corresponding algorithm for reasons independent from the gastroenterologist (patient's choice etc.). CONCLUSIONS: French national algorithms for UC management allowed coverage of 95% of clinical cases in real world. In three quarters of cases, these algorithms were strictly followed by private gastroenterologists. Dissemination of these algorithms could optimize and strengthen the practitioner's choice.

Management of inflammatory bowel disease in France: a nationwide survey among private gastroenterologists.

BACKGROUND: Data on the current management of inflammatory bowel disease are scarce. METHODS: This was a nationwide survey among 65 private gastroenterologists treating patients with inflammatory bowel disease in France in 2012. RESULTS: A total of 375 inflammatory bowel disease patients were analysed: 48% had ulcerative colitis. One third of inflammatory bowel disease patients had a history of hospitalisation, and 40% of Crohn's disease patients had prior surgery. Two thirds of inflammatory bowel disease patients had active disease. Significantly fewer ulcerative colitis patients were treated with anti-tumour necrosis factor therapy than Crohn's disease patients (18.9% vs. 38.9%; p<0.0001). Among patients treated with anti-tumour necrosis factor, only 4.5% were receiving concomitant immunomodulators. Half of inflammatory bowel disease patients had undergone a colonoscopy within the past year. For colorectal cancer screening, random biopsies and chromoendoscopy were performed in 75% and 40% of cases, respectively. An endoscopic score was used for only 10% of inflammatory bowel disease patients. About one third of inflammatory bowel disease patients had imaging studies within the past year (magnetic resonance enterography in 65%). An abdominal computed tomography scan was prescribed for 12% of inflammatory bowel disease patients. CONCLUSIONS: Many patients still have active disease in the biologics era, and the number of patients receiving combination therapy is low in private practice. Chromoendoscopy and endoscopy scores are not often used.

Measuring patients' satisfaction with their anti-TNF treatment in severe Crohn's disease: scoring and psychometric validation of the Satisfaction for PAtients in Crohn's diseasE Questionnaire (SPACE-Q(©)).

BACKGROUND: Severe Crohn's disease management includes anti-tumor necrosis factor (anti-TNF) drugs that differ from early-stage treatments regarding efficacy, safety, and convenience. This study aimed to finalize and psychometrically validate the Satisfaction for PAtients in Crohn's diseasE Questionnaire (SPACE-Q(©)), developed to measure satisfaction with anti-TNF treatment in patients with severe Crohn's disease. METHODS: A total of 279 patients with severe Crohn's disease receiving anti-TNF therapy completed the SPACE-Q 62-item pilot version at inclusion and 12 and 13 weeks after first anti-TNF injection. The final SPACE-Q scoring was defined using multitrait and regression analyses and clinical relevance considerations. Psychometric validation included clinical validity against Harvey-Bradshaw score, concurrent validity against Treatment Satisfaction Questionnaire for Medication (TSQM), internal consistency reliability, test-retest reliability, and responsiveness against the patient global impression of change (PGIC). RESULTS: Quality of completion was good (55%-67% of patients completed all items). Four items were removed from the questionnaire. Eleven scores were defined within the final 58-item SPACE-Q: disease control; symptoms, anal symptoms, and quality of life transition scales; tolerability; convenience; expectation confirmation toward efficacy, side effects, and convenience; satisfaction with treatment; and motivation. Scores met standards for concurrent validity (correlation between SPACE-Q satisfaction with treatment and TSQM satisfaction scores =0.59), internal consistency reliability (Cronbach's α=0.67-0.93), test-retest reliability (intraclass correlations =0.62-0.91), and responsiveness (improvement in treatment experience assessed by the SPACE-Q for patients reporting improvement on the PGIC). Significantly different mean scores were observed between groups of patients with different Harvey-Bradshaw disease severity scores. CONCLUSION: The SPACE-Q is a valid, reliable, and responsive instrument to measure satisfaction with anti-TNF treatment in patients with severe Crohn's disease and for use in future studies.

5-Aminosalicylates and renal function monitoring in inflammatory bowel disease: a nationwide survey.

BACKGROUND AND AIM: 5-Aminosalicylates (ASA) are widely used in inflammatory bowel disease (IBD). Nephrotoxicity has been described in some IBD patients treated with 5-ASA. Whether physicians managing these patients are monitoring renal function in daily practice is unknown. The aims of this paper were to investigate how private gastroenterologists monitor renal function and manage renal failure in IBD patients treated with oral 5-ASA therapy. METHODS: This was a web-based cross sectional national survey which was conducted among private gastroenterologists. RESULTS: A total of 249 practitioners completed the survey. Eighty two percent (n=205) of responders declared that they always monitor renal function. The respondents monitored twice a year Glomerular Filtration Rate (eGFR) using Modification of Diet in Renal Disease (MDRD) [90% (n=225)] and Creatinine Clearance (CCr) using a 24-hour urine collection [51% (n=126)]. Blood electrolytes, 24-hour urinary protein rate and dipsticks are performed by 41%, 39% and 22% of practitioners, respectively. Before oral 5-ASA initiation, 59% (n=148) of respondents screen for renal failure. In case of elevated serum creatinine, a nephrologist's opinion is asked by 80% (n=200) of responders and by 76% (n=189) of respondents before treatment initiation. CONCLUSIONS: Most gastroenterologists are monitoring renal function once or twice a year in IBD patients on 5-ASA. Less than two thirds of them screen for renal failure before treatment initiation. MDRD is mainly used, but a wide range of parameters is evaluated.

Pitfall in total hip arthroplasty: intraoperative migration of the trial femoral head through the iliopsoas muscle.

Total hip arthroplasty is actually one of the most orthopaedic procedures realised to treat a lot of conditions in hip pathology. Complications associated with this operation are well established and reported in the medical literature. Only few cases of intraoperative dislocation of the trial femoral head had been reported; we present a case of intraoperative intrapelvic dislocation of the trial femoral head through the iliopsoas muscle during total hip replacement with a standard posterolateral approach of Moore.

Assessing patients' satisfaction with anti-TNFα treatment in Crohn's disease: qualitative steps of the development of a new questionnaire.

PURPOSE: To develop a self-administered questionnaire assessing patients' satisfaction with treatments in Crohn's disease for use in clinical research and epidemiological studies. PATIENTS AND METHODS: Semi-directive interviews (16) were conducted with patients with severe Crohn's disease treated with anti-tumor necrosis factor alpha (anti-TNFα). Transcripts were analyzed and concepts related to satisfaction with treatment were extracted and organized into a model. Items were generated using patients' words. The resulting test version was tested for relevance and comprehension with 7 patients and revised accordingly; the new version was tested with 5 other patients and revised to provide the pilot version. A clinician advisory board was involved at each milestone of the development. RESULTS: The test questionnaire assessed treatment satisfaction through 67 items, organized into 5 sections: treatment efficacy, side-effects, convenience and constraints, overall impact, and satisfaction. Conceptual content of the questionnaire includes comparison with prior state and with expectations, satisfaction, acceptability, and intentions. The questionnaire was generally well accepted and understood by patients; few modifications were made in the structure and item formulation. After the second round of comprehension tests, the pilot version contained 62 items; the questionnaire was named Satisfaction of PAtients in Crohn's diseasE (SPACE(©)). CONCLUSION: The questionnaire is a unique tool to assess treatment satisfaction in patients with Crohn's disease. A scoring and validation study is currently being performed to finalize and establish its scoring, as well as its psychometric properties.