"Cooperation between physicians and physios fosters trust you know": a qualitative study exploring patients' experience with first-contact physiotherapy for low back pain in French primary care.

BACKGROUND: Physiotherapists working in collaboration with family physicians in French multidisciplinary primary healthcare clinics are now able to manage acute low back pain patients as first-contact practitioners in advanced practice roles. This includes medical act delegation such as making a medical diagnosis and prescribing medication. The aim of this study is to explore patients' experience and perceptions when attending a first-contact physiotherapist (FCP) in an advanced practice collaborative primary care model for acute low back pain (LBP). METHODS: A qualitative study using semi-structured interviews was conducted. Patients that consulted a FCP for acute LBP care in new collaborative model were included. Interviews were transcribed verbatim and inductive thematic analysis was performed to generate themes related to patients' experience and perceptions. RESULTS: Ten patients were interviewed (3 women, 7 men; mean age 36.5 ± 9.63 years). All LBP participants experienced important level of pain and disability. Four overarching themes related to patients' experience with the new FCP model were formalized: 1) "Going to see a physiotherapist who specializes in painful movements, well that makes sense to me", 2) "Physiotherapist offered to give me exercises to do at home to relieve the back pain", 3) "I went there feeling confident", 4) "The physiotherapist can do more than just send you to see more appropriate people". Participants highlighted the need to receive timely and high-quality care and were receptive with being autonomously managed by a FCP. Overall, patients' experiences with FCP model of care were positive. Participants were highly confident in the FCP's ability to perform delegated medical tasks including making a medical diagnosis and prescribing oral medication such as analgesic drugs. Patients felt that a greater expansion of FCPs' scope of practice was needed to improve the model. CONCLUSION: Findings from this study can inform the implementation of FCP in countries where patients are not typically granted FCP by underlining that patients are favourable towards the advance practice model as such models support timely and high-quality care. Further research is needed to better determine the future advance practice physiotherapists' scope of practice in French primary and secondary care settings.

Using contextual factors to elicit placebo and nocebo effects: An online survey of healthcare providers' practice.

Contextual factor use by healthcare professionals has been studied mainly among nurses and physiotherapists. Preliminary results show that healthcare professionals use contextual factors without specifically labelling them as such. The main objective of this study was to evaluate knowledge and explore voluntary contextual factor use among various healthcare professions. The results aim to facilitate hypothesis-generation, to better position further research to explain and characterise contextual factor use. We conducted a web-based questionnaire cross-sectional observational study on a non-probabilistic convenience sample. Face and content validity were tested through cognitive interviews. Data were analysed descriptively. The target population was the main healthcare profession, or final year students, defined by the French public health law. The countries of distribution of the questionnaire were the French-speaking European countries. Among our 1236 participants, use of contextual factors was widespread. Those relating to the therapeutic relationship (e.g., communication) and patient characteristics (e.g., past experiences) were reportedly the most used. Meanwhile, contextual factors related to the healthcare providers' characteristics and their own beliefs were reported as less used. Despite high variability, respondents suggested contextual effects contribute to approximately half of the overall effect in healthcare and were perceived as more effective on children and elderly adults. Conceptual variations that exist in the literature are also present in the way healthcare providers consider contextual effects. Interestingly, there seems to be common ground between how physiotherapists, nurses and physicians use different contextual factors. Finally, in the present study we also observed that while there are similarities across usage, there is lack of both an epistemological and ethical consensus among healthcare providers with respect to contextual factors.

'It's not my greengrocer, it's someone from the medical profession': A qualitative study regarding acceptability of deceptive and open-label placebo prescribing in France.

OBJECTIVES: To explore participants' views regarding clinical use of deceptive placebo (DP) and open-label placebo (OLP) treatments. DESIGN: Qualitative thematic analysis. METHODS: We conducted eight semi-structured interviews with healthy participants in an experimental trial comparing the efficacy of OLP and DP (Clinical trials n°NCT03934138). Interviewees' opinions were solicited following administration of placebos during the trial. Interviews were analysed using data-driven analysis. RESULTS: We identified three themes. First, participants considered trust central in judging a placebo treatment to be acceptable. They expressed the importance of an implicit trust both in their health care professionals' (HCPs') competency as well as in the profession at large. A second theme was the perception of how placebo treatments might solve health problems. Acceptability of both types of placebo treatments was dependent on the perception patients had about the treatment solving their problem and/or doubts regarding the effectiveness of placebos The third theme encompassed perceived risks associated with placebo prescribing. Some comments viewed placebos positively as facilitating reduced medication intake. However, participants also identified the potential of placebos to generate adverse side effects. CONCLUSIONS: Treatment acceptability by patients is a pre-requisite, alongside effectiveness, to harness OLPs in clinical care. Our study identified the importance of trust in HCPs prescribing placebos, the clinical effectiveness of placebos and the potential risks of these interventions in assessing their acceptability. Future research is needed to explore the contexts in which placebos might be used, and how best to communicate information about placebo interventions.

Can an Open-Label Placebo Be as Effective as a Deceptive Placebo? Methodological Considerations of a Study Protocol.

Background: Placebo has been studied for many years and is ever-present in healthcare. In clinical practice, its use is limited by ethical issues raised by the deception entailed by its administration. Objective: To investigate whether, when given detailed information about pain and underlying placebo mechanisms, subjects will have a response similar to that of those subjected to a procedure in which they receive a conventional placebo treatment. Methods: The study is designed as a non-inferiority randomized, parallel with a nested crossover trial. In addition, 126 subjects without any known pathology will be included. They will be randomized into two groups. Each subject will undergo three Cold Pressor Tests (CPT): calibration, condition of interest (deceptive placebo or educated placebo), and control. Our main judgment criterion will be the comparison in pain intensity experienced on the visual analog scale between the two CPTs with placebo conditions. Results: This study will allow us to rule on the non-inferiority of an "educated" placebo compared to a deceptive placebo in the context of an acute painful stimulation. It is another step towards the understanding of open-label placebo and its use in clinical practice. Conclusions: This study has been approved by the ethics committee in France (2017-A01643-50) and registered on ClinicalTrials.gov (NCT03934138).

The I-CAM-FR: A French Translation and Cross-Cultural Adaptation of the I-CAM-Q.

Background: The use of complementary and alternative medicine (CAM) is growing every year. The extent of its use is still not clear, and it is difficult to undertake comparative studies due to the variety of data collection tools used. Therefore, a standardized International Complementary and Alternative Medicine Questionnaire (I-CAM-Q) has been recommended to determine data about its usage. The purpose of the present study is to present a controlled translation of the questionnaire into French which is also properly adapted to a French audience. Methods: The English-written questionnaire, the I-CAM-Q, was submitted to three independent translators. Each translator produced a separate French translation (FT.1.1, FT.1.2, FT.1.3) that was then synthesized into a unique new version (FT.2.0). Version FT.2.0 was then submitted to three new translators, who translated them back to three distinct English versions (BT.1.1, BT.1.2, BT.1.3). These versions were once again synthesized in a unique questionnaire (BT.2.0). The version BT.2.0 was then submitted to an expert committee that compared it to the original I-CAM-Q in order to review the process and adapt FT.2.0 according to differences between the I-CAM-Q and BT.2.0. This led to a revised French version, PT.0.0. Version PT.0.0 was then tested with the use of cognitive interviews. These interviews allowed a final adjustment of the translations to produce a definitive version in French: the I-CAM-FR. Results: Four French translations and four versions in English of the I-CAM-Q questionnaire were produced. This allowed us to present a consolidated French translation to an expert committee. Their adjustments were taken into account before testing the final French-translated questionnaire on a group of people (n = 10) representing a diverse sample of the French population. The expert committee then suggested changes according to the errors due to the translation process sought out by the pre-tests, and recommendations based on the errors that were not due to the translation process. Conclusions: Through a rigorous methodology, we produced a French translation and a cross-cultural adaptation of the I-CAM-Q questionnaire. This work has led to the creation of an equivalent questionnaire available for use in France, the I-CAM-FR.