If only they knew! A non-inferiority randomized controlled trial comparing deceptive and open-label placebo in healthy individuals.

BACKGROUND: Placebo use is widespread in clinical practice. However, they are most often administered deceptively rather than openly. It is often suggested that open-label placebos (OLP) are less effective than deceptive placebos (DP). This study aimed to compare the use of DP and OLP treatments to reduce pain in healthy volunteers. METHODS: We conducted a non-inferiority, parallel, randomized, controlled trial, which also included a nested cross-over no-treatment condition. This study was conducted at a university clinic in France. RESULTS: We included 60 subjects and the main result shows that the OLP was not inferior to the DP by a margin of 10 mm. The mean difference between both groups regarding intensity of pain was 0.7 mm with a 95% compatibility interval (95% CI) of ]-∞; 5.4], and 97.5% CI of ]-∞; 6.3]. Secondary outcomes require cautious interpretation of the effect of placebo versus no treatment due to a time-treatment interaction. CONCLUSION: The study indicates that OLP may perform just as well as DP and could provide support for the use of OLP as an ethical alternative to DP when they are to be used in a clinical setting. If only patients knew about the placebo nature of some treatments they are receiving, unnecessary lies could be avoided while maintaining similar placebo effects. SIGNIFICANCE: This study is the first to show non-inferiority of placebos administered honestly, also called OLP, compared to DP in reducing pain. This suggests that OLP could be as effective as their deceptive counterparts while having the ethical advantage of not being required to lie. If deception is not a necessary condition for efficacy, OLP should be preferred over DP.

[How can the transition of adolescents from a children's to an adult CF center be improved? Analysis of adolescents' and parents' needs during the post-transfer period]. / Comment améliorer la transition au sein des CRCM : analyse des besoins des patients et de leurs parents lors de l'arrivée en service adulte.

INTRODUCTION: In 2018, 55.4% of the 7180 French cystic fibrosis (CF) patients were adults. Our study was aimed at identifying young adult patients' needs and those of their parents when the young adults arrived in an adult CF center. METHODOLOGY: Semi-structured interviews, conducted between July 2018 and December 2019and involving all the concerned teenagers and their parents, took place at least 6 months after their transfer. The interview guide dwelt on the aspects having had an impact on their experience of the transition. The interviews were recorded, transcribed and analyzed exhaustively. The results were classified by categorizing the contents according to respondent profile. RESULTS: Thirty-eight young adult patients and 16 parents were interviewed. As regards the young adults, analysis of their needs underlined the importance of their continuing to develop their skills in adaptation, communication and self-care. As regards their parents, they needed support in view of defining their role in their children's new care pathway. CONCLUSION: During and also following the transfer, therapeutic education for the parents as well as the young adults requires reinforcement.

Smoothing the transition of adolescents with CF from pediatric to adult care: Pre-transfer needs.

INTRODUCTION: In France, the cystic fibrosis (CF) care pathway is performed in 45 CF centers, the life expectancy of patients has steadily increased, but to date there are no national recommendations for the transition from pediatric to adult care. The transition to an adult CF center still raises questions about the relevance of its organizational arrangements. The "SAFETIM need" study aimed to identify the organizational needs both of patients and of parents before the transfer to an adult CF center. METHODS: This was a prospective, observational, multicenter study conducted between July 2017 and December 2018, involving the three CF centers of a regional network in southeastern France. Each adolescent registered with the center and his or her parents were interviewed individually, on the same day, during the 6 months leading up to transfer. They participated in semi-structured interviews during one of their routine consultations at the CF center. The interview manual, based on literature reviews and targeting national recommendations, was tested and validated by the national CF therapeutic education group (GETheM). All interviews were transcribed and checked by two different people, and analyzed by two researchers individually. The results were classified by topic according to content categorization. RESULTS: Overall, 43 adolescents and 41 parents were interviewed, respectively, who were followed up by CF centers: 14% (n=6) in a mixed CF center (pediatric and adult); 19% (n=8) and 67% (n=29), respectively, in two different pediatric CF centers. Adolescents were between 16 and 19 years old. For adolescents, the average interview time was 5.11min. (standard deviation [SD]: 3.8min; minimum: 2.53min; maximum: 17.14min). For parents, the average interview time was 7.99min (SD: 3.56min, minimum: 3.43min; maximum: 22.50min). DISCUSSION: Our study enquired only about the preparation and organization of the transfer. We identified three areas of actions matching the needs of adolescents and parents before transfer. The first one is to anticipate team change to prepare follow-up in their future CF center: acquire new skills, consider the future CF center according to the adolescent's curriculum, be involved in the transition process. The second area is to accompany the upcoming change. The care team could help by providing information and support during the start of teenagers' transition toward autonomy. And parents were aware that the CF center change will reverse roles. They must provide their own knowledge and manage the ambivalence of this as well as letting go. The third one is to announce the transition process and functioning of the future adult CF center, because the transition would require time to find their place (patients and parents) with the new team. CONCLUSION: The "SAFETIM needs" pre-transfer study results show that we can identify the main criteria to be developed and strengthened, to promote a smooth, high-quality transition from pediatric to adult CF care for patients in France. For most patients, the transition cannot be prepared at the last minute. Caregivers need to develop specific skills in adolescent and young adult care and follow-up. Each team must consider the transition as a normal part of the patient care cycle. While it must be structured, some flexibility must be allowed so as to give everyone the chance to be prepared and to personalize the care.

Use of a smart electrically assisted bicycle (VELIS) in the health field -Proof of concept.

Physical activity (PA) is highly recommended in the management of most chronic diseases. For these patients, the smart electric bicycle can be effective to improve adherence to this behavior. The E-bike used in this study (called VELIS) has an innovative onboard technology that allows for subject monitoring and the engine power is designed to adapt to the user's abilities. A prerequisite for the use of the VELIS with patients is to initially carry out a pilot study on healthy subjects. The objective was to evaluate the impact of the customizable settings on physiological parameters and to ensure this prototype's efficiency and safety of use. Twelve healthy participants with various profiles (physical condition, used to cycling or not) were included. They have completed four times a 14 km itinerary with various settings of the VELIS. We recorded GPS data, heart rate and perceived exertion. Based on exercise intensity, we confirm that riding an E-bike should be considered as a physical activity. Safety of the participants is ensured by the engine brake. Recordings show that it took between 1 and 3 min for the novice to become familiar with the VELIS and to get optimal assistance. The main finding of this pilot study confirms that VELIS is an easy to use and secure tool to make PA approachable, whatever the level of training in healthy subjects.

[Quality criteria for the transition to adult care in French CF centers - results from the SAFETIM APP study?] / Critères de qualité pour la transition dans la mucoviscidose en France (suivi des adolescents, des familles et des équipes, pour une transition idéale en mucoviscidose ­ analyse des pratiques professionnelles).

INTRODUCTION: SAFETIM-APP compiled an inventory of professional practice in the 45 French cystic fibrosis reference centres (CFRC), between February 2015 and December 2016, related to the transition of adolescents with cystic fibrosis to adult centres. METHOD: This multicentre cross-sectional study addressed the modalities of the transition in CFRCs and proposed a list of items that could be used to establish quality criteria. Quantitative analysis of the criteria and a qualitative analysis of the transition procedure were carried out. RESULTS: A total of 77% of the CFRCs that were contacted took part. Transition lasted 3 to 5 years and began at around 15 years of age. Nine criteria were described as fundamental, including: collaboration between teams, taking adolescence into account, having a time for adolescents to speak with the physician alone, defining a program including therapeutic education, involving the family, accompanying the parents. Seven additional criteria were noted to be important, including: re-announcing the diagnosis, identifying a common thread (caregiver) accompanying the family, scheduling adult follow-up from paediatrics onwards, visiting the adult department, organizing a formal departure/reception time, initiating the process early enough, identifying indicators to evaluate practices. CONCLUSION: The transition processes in place in CFRCs can be improved by implementing the use of these quality criteria systematically.

Can a plantar pressure-based tongue-placed electrotactile biofeedback improve postural control under altered vestibular and neck proprioceptive conditions?

We investigated the effects of a plantar pressure-based tongue-placed electrotactile biofeedback on postural control during quiet standing under normal and altered vestibular and neck proprioceptive conditions. To achieve this goal, 14 young healthy adults were asked to stand upright as immobile as possible with their eyes closed in two Neutral and Extended head postures and two conditions of No-biofeedback and Biofeedback. The underlying principle of the biofeedback consisted of providing supplementary information related to foot sole pressure distribution through a wireless embedded tongue-placed tactile output device. Center of foot pressure (CoP) displacements were recorded using a plantar pressure data acquisition system. Results showed that (1) the Extended head posture yielded increased CoP displacements relative to the Neutral head posture in the No-biofeedback condition, with a greater effect along the anteroposterior than mediolateral axis, whereas (2) no significant difference between the two Neutral and Extended head postures was observed in the Biofeedback condition. The present findings suggested that the availability of the plantar pressure-based tongue-placed electrotactile biofeedback allowed the subjects to suppress the destabilizing effect induced by the disruption of vestibular and neck proprioceptive inputs associated with the head extended posture. These results are discussed according to the sensory re-weighting hypothesis, whereby the CNS would dynamically and selectively adjust the relative contributions of sensory inputs (i.e. the sensory weights) to maintain upright stance depending on the sensory contexts and the neuromuscular constraints acting on the subject.

[Cervicocephalic relocation test: a study of performance stability]. / Test de repositionnement céphalique: étude de la stabilité de performance.

OBJECTIVE: The purpose of the present experiment was to determine the reliability of the cervicocephalic relocation test (CRT). METHODOLOGY: Thirteen young healthy adults were recruited to undergo a CRT test-retest. The test-retest reliability was determined by repeatedly measuring CR to a neutral position after active movement, with trials approximately 1 hour apart. Each CRT involved 20 CRs to a natural head position, 10 repositioning after right head rotation, and 10 repositioning after left head rotation (with the order of rotation sides randomized). The performance score for each subject for each CRT was the mean of the errors made during the 20 relocations (in degrees). STUDY RESULTS: The mean rate of error of the first and second trials was 3.2+/-1.1 degrees and 2.9+/-0.9 degrees, respectively. The intra class correlation coefficient was 0.81, and the standard error of measurement 0.90 degrees. CONCLUSION: CRT testing supports evidence of reliable cervicocephalic performance stability in healthy young adults. CRT shows promise as a relevant tool of assessment in head and neck proprioception.

Pressure sensor-based tongue-placed electrotactile biofeedback for balance improvement--biomedical application to prevent pressure sores formation and falls.

We introduce the innovative technologies, based on the concept of "sensory substitution", we are developing in the fields of biomedical engineering and human disability. Precisely, our goal is to design, develop and validate practical assistive biomedical and/or technical devices and/or rehabilitating procedures for persons with disabilities, using artificial tongue-placed tactile biofeedback systems. Proposed applications are dealing with: (1) pressure sores prevention in case of spinal cord injuries (persons with paraplegia, or tetraplegia); and (2) balance control improvement to prevent fall in older and/or disabled adults. This paper describes the architecture and the functioning principle of these biofeedback systems and presents preliminary results of two feasibility studies performed on young healthy adults.