Development of a patient decision aid for COVID-19 vaccination with the Comirnaty vaccine.

BACKGROUND: SARS-CoV-2 has been responsible for a pandemic since the beginning of 2020. Vaccine arrival brings a concrete solution to fight the virus. However, vaccine hesitancy is high. In France, the first available vaccine was Comirnaty from Pfizer-BioNTech. Shared decision-making, based on tools such as patient decision aids (PtDAs), can help patients make an informed choice about vaccination with Comirnaty. OBJECTIVE: The French College of Teachers in General Practice (CNGE) aimed to create a PtDA for people who have to decide whether they will receive the Comirnaty vaccine. METHODS: Development of the PtDA was performed according to the International Patient Decision Aids Standards (IPDAS). The initial design was based on a literature review and semistructured interviews with 17 patients to explore and clarify patients' expectations. A first draft of the PtDA was then alpha tested by a patient expert group and a physician expert group. The PtDA was finally beta tested in 14 prevaccine consultations. A steering group was consulted throughout the work. Patient support, community groups and the French National Authority for Health (HAS) were involved in the development process. RESULTS: A literature review identified one randomized trial on Comirnaty efficacy and safety. The first part of the PtDA allows patients to identify their own risk factors. The second part of the PtDA provides information on vaccination: benefits and risks, unknown data, and technical explanations about the mRNA vaccine. CONCLUSIONS: We developed a PtDA to be used in primary care settings for shared decision-making regarding vaccination with Comirnaty.

Correction to: Efficacy of phloroglucinol for the treatment of pain of gynaecologic or obstetrical origin: a systematic review of literature of randomised controlled trials.

The correct presentation of the Author names are shown in this paper.

Efficacy of acetylleucine in vertigo and dizziness: a systematic review of randomised controlled trials.

PURPOSE: To assess the efficacy of acetylleucine to improve or stop an attack of vertigo and dizziness (vertigo/dizziness). METHODS: Systematic review by 2 independent reviewers. Consultation of the Medline, Cochrane and ClinicalTrials.gov databases until September 2018. Keywords used: Acetylleucine, Tanganil®, Acetyl-DL-leucine, Acetyl-leucine. Trial selection: randomised controlled trials (RCTs) comparing acetylleucine against placebo. RESULTS: Up until 2018, no RCTs have been published on the efficacy of acetylleucine in vertigo/dizziness. CONCLUSION: There is no solid evidence of the efficacy of acetylleucine in vertigo/dizziness. Given its frequent prescription and the cost generated for the French social security system, high-quality randomised trials should be carried out to assess its efficacy.

Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo.

AIM: Phloroglucinol is a musculotropic anti-spasmodic drug. It is frequently prescribed in many European countries with a considerable cost for health services. The purpose of this study was to review the existing randomised controlled trials (RCT) comparing the efficacy of phloroglucinol treating abdominal pain versus placebo. METHODS: A literature search was carried out up to May 2017 to select RCT comparing the effect of phloroglucinol versus placebo with intensity of abdominal pain as an endpoint. Studies concerning obstetric or gynaecologic-related pain were not included. RESULTS: Three RCT were included and then analysed for risk of bias and meta-analysed. Only one RCT found that phloroglucinol was superior to placebo, although with a high risk of bias. The meta-analysis found a risk ratio of 1.10 (95% CI 0.95, 1.27) with no statistical significance. DISCUSSION: There is insufficient data to justify the wide-spread prescription of phloroglucinol for alleviating abdominal pain.

Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial.

BACKGROUND: The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial aimed to determine whether a pragmatic education intervention in general practice could improve the quality of life of patients with chronic heart failure (CHF) compared with routine care. RESULTS: This cluster randomised controlled clinical trial included 241 patients with CHF attending 54 general practitioners (GPs) in France and involved 19 months of follow-up. The GPs in the Intervention Group were trained during a 2-day interactive workshop to provide a patient education programme. The mean age of the patients was 74 years (±10.5), 62 % were men and their mean left-ventricular ejection fraction was 49.3 % (± 14.3). At the end of the follow-up period, the mean Minnesota Living with Heart Failure Questionnaire scores in the Intervention and Control Groups were 33.4 (± 22.1) versus 27.2 (± 23.3; P = 0.74, intra-cluster coefficient [ICC] = 0.11). At the end of the follow-up period, the 36-Item Short Form Health Survey (mental health and physical health) scores in the Intervention and Control Groups were 58 (± 22.1) versus 58.7 (± 23.9; P = 0.58, ICC = 0.01) and 52.8 (± 23.8) versus 51.6 (± 25.5; P = 0.57, ICC = 0.01), respectively. CONCLUSIONS: Patient education delivered by GPs to elderly patients with stable heart failure in the ETIC programme did not achieve an improvement in their quality of life compared with routine care. Further research on improving the quality of life and clinical outcomes of elderly patients with CHF in primary care is necessary. TRIAL REGISTRATION: The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial is a cluster randomised controlled trial registered with ClinicalTrials.gov ( REGISTRATION NUMBER: NCT01065142 ) and the French Drug Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé; REGISTRATION NUMBER: 2009-A01142-55).

Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial.

BACKGROUND: Chronic heart failure, is increasing due to the aging population and improvements in heart disease detection and management. The prevalence is estimated at ~10% of the French general practice patient population over 59 years old. The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner (GP) education in primary care. METHODS: A randomised, cluster controlled trial, stratified over 4 areas of the Auvergne region in France comparing intervention and control groups. The inclusion criteria are: patients older than 50 years with New York Heart Association (NYHA) stage I, II, or III heart failure, with reduced ejection fraction or with preserved ejection fraction. Heart failure should be confirmed by the patient's cardiologist according to the European Society of Cardiology guidelines criteria. The exclusion criteria include: severe cognitive disorders, living in an institution, participating in another clinical trial, having NYHA stage IV heart failure, or a lack of French language skills. The complex intervention consists of training at the GP practice with an interactive 2-day workshop to provide a patient's education programme. GPs are trained to perform case management, lifestyle counselling and motivational interviewing, to educate patients on the main topics including clinical alarm signs, physical activity, diet and cardiovascular risk factors. The patients' education sessions are scheduled at 1, 4, 7, 10, 13 and 19 months following the start of the trial. The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires: the Minnesota Living with Heart Failure Questionnaire and SF-36. To detect a difference in the mean quality of life at 19 months, we anticipate studying a minimum of 400 patients from 80 GPs. DISCUSSION: This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a 2-day GP workshop and patients' education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure. This complex intervention tool could be used during initial and further medical training. TRIAL REGISTRATION: ETIC is a cluster-randomised, controlled trial registered on ClinicalTrials.gov [ NCT01065142 , 2010, Feb 8] and the French drug agency [Agence Nationale de Sécurité du Médicament et des produits de santé; registration number: 2009-A01142-55, on March 5th, 2010].

Randomised, double-blind, placebo-controlled trial of glycopyrronium in children and adolescents with severe sialorrhoea and neurodisabilities: protocol of the SALIVA trial.

INTRODUCTION: Severe sialorrhoea is a common, distressing problem in children/adolescents with neurodisabilities, which has adverse health and social consequences. The SALIVA trial is designed to evaluate the efficacy and safety of a paediatric-specific oral solution of glycopyrronium along with its impact on quality-of-life (QoL), which has been lacking from previous trials of sialorrhoea treatments. METHODS AND ANALYSIS: A double-blind, placebo-controlled, randomised phase IV trial is ongoing in several centres across France. Eighty children aged 3-17 years with severe sialorrhoea (≥6 on the modified Teachers Drooling Scale) related to chronic neurological disorders in whom non-pharmacological standard of care has already been implemented or has failed, will be recruited. Patients will be randomised 1:1 to receive a 2 mg/5 mL solution of glycopyrronium bromide (Sialanar 320 µg/mL glycopyrronium) or placebo three times daily during a 3-month blinded period. After Day 84, participants will be invited into a 6-month, open-label study extension period, where they will all receive glycopyrronium. The primary endpoint of the double-blind period will be the change from baseline to Day 84 in the Drooling Impact Scale (DIS), a validated measure to assess sialorrhoea. A series of secondary efficacy endpoints involving change in total DIS, specific DIS items and response (DIS improvement ≥13.6 points) will be analysed in a prespecified hierarchy. QoL data will be collected from parents, caregivers and patients where possible using specific DIS questions and DISABKIDS questionnaires. Safety endpoints, including adverse events, will be assessed throughout the trial periods. ETHICS AND DISSEMINATION: In total, 87 children have been recruited and recruitment is now complete. Final results are expected by the end of 2023. Findings will be presented at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: EudraCT 2020-005534-15.

Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial.

BACKGROUND: Medical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon®, 4 × 10 mL/day) and omeprazole (20 mg/day) on GERD symptoms in general practice. METHODS: A 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14. RESULTS: 278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon® and 2.0 (± 2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups. CONCLUSION: Gaviscon® was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care. TRIAL REGISTRATION: ISRCTN62203233.

Home blood pressure monitoring and adherence in patients with hypertension on primary prevention treatment: a survey of 1026 patients in general medicine in the Auvergne region.

BACKGROUND: Home blood pressure monitoring (HBPM) could improve blood pressure control through therapeutic adherence. The main objective of this study was to determine the link between HBPM used by hypertensive patients treated in primary care and their medication adherence. METHODS: Cross-sectional comparative study conducted in the Auvergne region from June to November 2016. Patients were recruited by general practitioners (GPs) selected at random. Adherence was evaluated according to the Girerd score. RESULTS: From a sample of eighty-two GPs including 1026 patients, 45% of patients reported owning an HBPM device. Among these, 18% knew the rule of 3 (3 measurements in the morning and 3 in the evening for 3 days) recommended by the French State Health Authority. There was no difference in adherence between patients using HBPM and those who did not. Patients with HBPM using the rule of 3 reported better adherence than patients without the device (p = 0.06), and those who did not perform self-measurements according to the rule of 3 (p = 0.01). Patients who used HBPM according to the rule of 3 were older (p = 0.006) and less smokers (p = 0.001) than the others. Their GPs were more often GP teachers (p < 0.001) who practiced in rural areas (p = 0.001). CONCLUSION: The statistical link between medication adherence and HBPM for patients who apply the rule of 3, emphasizes the importance of the GP educating the patient on the proper use of HBPM.

Impact of a phone call with a medical student/general practitioner team on morbidity of chronic patients during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial.

OBJECTIVES: The first COVID-19 lockdown led to a significantly reduced access to healthcare, which may have increased decompensations in frail patients with chronic diseases, especially older patients living with a chronic cardiovascular disease (CVD) or a mental health disorder (MHD). The objective of COVIQuest was to evaluate whether a general practitioner (GP)-initiated phone call to patients with CVD and MHD during the COVID-19 lockdown could reduce the number of hospitalisation(s) over a 1-month period. DESIGN: This is a cluster randomised controlled trial. Clusters were GPs from eight French regions. PARTICIPANTS: Patients ≥70 years old with chronic CVD (COVIQuest_CV subtrial) or ≥18 years old with MHD (COVIQuest_MH subtrial). INTERVENTIONS: A standardised GP-initiated phone call aiming to evaluate patients' need for urgent healthcare, with a control group benefiting from usual care (ie, the contact with the GP was by the patient's initiative). MAIN OUTCOME MEASURES: Hospital admission within 1 month after the phone call. RESULTS: In the COVIQuest_CV subtrial, 131 GPs and 1834 patients were included in the intervention group and 136 GPs and 1510 patients were allocated to the control group. Overall, 65 (3.54%) patients were hospitalised in the intervention group vs 69 (4.57%) in the control group (OR 0.82, 95% CI 0.56 to 1.20; risk difference -0.77, 95% CI -2.28 to 0.74). In the COVIQuest_MH subtrial, 136 GPs and 832 patients were included in the intervention group and 131 GPs and 548 patients were allocated to the control group. Overall, 27 (3.25%) patients were hospitalised in the intervention group vs 12 (2.19%) in the control group (OR 1.52, 95% CI 0.82 to 2.81; risk difference 1.38, 95% CI 0.06 to 2.70). CONCLUSION: A GP-initiated phone call may have been associated with more hospitalisations within 1 month for patients with MHD, but results lack robustness and significance depending on the statistical approach used. TRIAL REGISTRATION NUMBER: NCT04359875.

Accuracy of patient-reported height loss and risk factors for height loss among postmenopausal women.

BACKGROUND: Since loss of height may indicate vertebral fracture, the accuracy of the information on height is relevant for clinical practice. We undertook this study to compare reported and measured loss of height among post-menopausal women in a primary care setting. We also analyzed the determinants of this height loss. METHODS: In an observational study conducted between December 2007 and May 2008, we asked 1779 randomly selected general practitioners to recruit the first five female patients who were more than 60 years of age, regardless of the reason for the consultation. Using a questionnaire, physicians collected data on demographic and clinical variables, history of osteoporosis and current anti-osteoporotic treatment. We used three assessments of height: tallest height in early adulthood recalled by the patient, estimated current height reported by the patient at the visit and current measured height. We defined loss of height as the difference between the patient's tallest recalled height and her current measured height. RESULTS: A total of 8610 patients were included in the analysis; the mean age was 70.9 (standard deviation [SD] 7.2) years. The mean loss of height was 4.5 cm. The mean current reported height was 2.1 (SD 2.5) cm lower than the tallest recalled height and 2.4 (SD 2.6) cm lower than the measured current height. The best predictors of a loss of height of 3 cm or more were age (odds ratio [OR] 1.09, 95% confidence interval [CI] 1.08-1.10), previous vertebral fracture (OR 1.49, 95% CI 1.16-1.91), previous nonvertebral fracture (OR 1.26, 95% CI 1.06-1.51), thoracic kyphosis (OR 2.07, 95% CI 1.69-2.55), scoliosis (OR 1.35, 95% CI 1.12-1.63), back pain (OR 1.22, 95% CI 1.07-1.39) and osteoporosis (OR 1.39, 95% CI 1.20-1.60). INTERPRETATION: Our study showed that the patients' estimated current height was not correct, with a mean difference of -2.5 cm from the current measured height. The mean height loss was 4.5 cm. Previous vertebral fracture and thoracic kyphosis were strong determinants of the height loss.

Validity of the Good Practice Guidelines: The example of type 2 diabetes.

AIMS: To assess the methodological quality of the systematic reviews of the literature for Good Practice Guidelines (GPGs) for treatment of type 2 diabetes (T2D). METHODS: The GPGs on treatment of T2D from May 2012 onwards were searched on PubMed, the Guidelines International Network, the National Guidelines Clearing House and the Infobanque des guides de pratique clinique. Quality of the GPGs was assessed by means of grading of levels of evidence, strength of recommendations, statements pertaining to systematic reviews, description of their methods, search for Randomized Controlled Trials meta-analyses, and citations from three meta-analyses which contested the strategy of intensive glycemic control and metformin as first-line treatment. RESULTS: Fiflty-two GPGs were included; half of them had and applied a system of grading and strength of recommendation and 58% stated they had carried out a systematic review. Only one GPG cited the three meta-analyses. Three quarters of the GPGs failed to detail their bibliographic research methods. CONCLUSION: The GPGs for treatment of T2D were of poor quality and their methodological rigor was insufficient. Even though the meta-analyses had a higher level of evidence, they were seldom cited.

Quality of evidence of the efficacy of therapeutic interventions on patient-important outcomes in Cochrane's systematic reviews' abstracts: A survey.

OBJECTIVE: The objective of this study was to evaluate the proportion of therapeutics that have proven their efficacy on patient-important outcomes with a high quality of evidence among Cochrane systematic reviews (SRs). METHODS: We surveyed a random sample of 400 SRs' abstracts published between September 2012 and December 2015, which compared therapeutic interventions with at least a placebo or no intervention control. The primary endpoint was the proportion of SRs with a statistically significant efficacy on a patient-important outcome and with a high quality of evidence. RESULTS: Among the 400 abstracts surveyed, 32 (8%) found efficacy on a patient-important outcome with a high quality of evidence. Half of the 400 SRs (50.2%) evaluated a pharmacological intervention and 12% of these found efficacy of the intervention on a patient-important outcome with a reported high quality of evidence. CONCLUSION: Based on an analysis of 400 abstracts of SRs from the Cochrane Collaboration, we found that there is a low number of therapeutic interventions which have proven their efficacy on patient-important outcomes with a high quality of evidence.

The development of self-efficacy beliefs during general practice vocational training: an exploratory study.

INTRODUCTION: Retention of general practitioners (GPs) is crucial to ensure appropriate primary care. However, some recently qualified GPs feel unprepared for practice, which may lead them to leave the profession or restrict their scope of practice. The development of self-efficacy beliefs during vocational training may be an important factor in this phenomenon. METHODS: Five focus groups with a total of 28 GP trainees and recent graduates were conducted in Belgium and France. Initial analysis using the immersion-crystallisation method was followed by analysis using Bandura's self-efficacy framework. RESULTS: Participants described beginning their training with low self-efficacy beliefs. Most participants described how they overcame stressful situations. Some, however, seemed to be developing avoidance strategies. Successfully resolving patient problems, sharing experiences with peers and receiving positive feedback from supervisors, colleagues and patients were conducive to the development of positive self-efficacy beliefs. DISCUSSION: Although low self-efficacy beliefs are natural at the beginning of training, participants seemed to develop in two ways, either overcoming their fears or avoiding them. Identifying the pattern of trainees' responses to allow tailoring of interventions should be investigated by those who run training programs. Interventions could include reassurance, peer interaction and an appropriate degree of autonomy.

What does it mean to be a family physician?: Exploratory study with family medicine residents from 3 countries.

OBJECTIVE: To explore the conceptions that family medicine residents from 3 countries have of the roles and responsibilities of family physicians in order to gain a better understanding of challenges that might transcend the specific contexts of different health care systems. DESIGN: Qualitative study using focus groups. SETTING: Resident training programs in France, Belgium, and Canada. PARTICIPANTS: A total of 57 residents in the last year of training. METHOD: Ten focus groups were conducted in 3 countries: 2 in France, 3 in Belgium, and 5 in Canada. All focus groups were held in different cities, with residents registered in different universities in France and Canada and with residents from the same university in Belgium. The study was informed by Abbott's conceptual framework on the system of professions. Each 90-minute focus group was moderated by the same researchers. The transcripts were analyzed according to the immersion-crystallization method. MAIN FINDINGS: Respondents shared common conceptions of the family physician's role: continuity of care and patient advocacy were seen as the foundations of the discipline. Respondents also shared a sense of discomfort about how accessible they were expected to be for patients and about the scope of family practice. They saw family medicine as flexible and reported that they strove for balance between their professional and personal life goals. All respondents strongly believed that their profession was undervalued by the medical schools where they trained. CONCLUSION: This exploratory study suggests that there are more similarities than differences in the understanding that future family physicians from different countries have of their discipline and of their careers. We observed a tension between a desire to develop a "new general practice" and the more traditional vision of the discipline. The culture in academic settings appears to contribute to the persistent low appeal of being a primary care physician.

[Improving care for depressed patients: what is added by GP's meetings?]. / Amélioration de la prise en charge des patients déprimés. L'apport de tables rondes de médecins généralistes.

PURPOSE: To show what French GP's have to say about their management of depressed patients, and how to improve it. METHODS: GP's forum discussions, as peer groups, controlled by an independent moderator and recorded by another, both Gp's. Reports have been synthesised through a list of items, until saturation. RESULTS: 83 reports have been analysed. The most important difficulties were about diagnosis of depression (patient's denial, multiplicity of complaints, polypathology), about treatment (bad acceptability of antidepressants, difficulties to access to a psychotherapy) and about care organisation (exchange between GP's and psychiatrists are difficult and unusual). DISCUSSION: Questions about quality of GP's care to depressed patients come from populations which differ from GP's patients. CONCLUSION: The specificity of primary care exercise should be taken into account to elaborate recommendations and to evaluate quality of care.

The effect of an information leaflet upon knowledge and awareness of COPD in potential sufferers. A randomized controlled study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is markedly under-diagnosed, which may be related to the under-reporting of symptoms and poor awareness of the disease. We hypothesized that written information on COPD may help increase awareness of the disease in people at risk of developing it. OBJECTIVES: To evaluate the impact of an information leaflet sent by postal mail on the level of knowledge of COPD in subjects with or at risk of COPD. METHODS: A total of 860 subjects with or at risk of COPD were selected by using a phone questionnaire. All subjects who reported a known diagnosis of COPD, a chronic cough and sputum production, or a smoking history of at least 15 pack-years were eligible for selection. Their knowledge of COPD was assessed during a telephone interview (baseline). They were randomized into 2 groups, with only 1 group receiving the information leaflet, and were then contacted 3 months later for a second interview. The changes in the knowledge of COPD from baseline were compared between subjects who reported receiving and reading the leaflet (true sensitized group) and subjects to whom the leaflet was not sent (control group). RESULTS: At the follow-up interview, the proportion of patients who spontaneously mentioned 'respiratory difficulties', when asked about the meaning of COPD, significantly increased in the true sensitized group (+11.9%) compared with the control group (+2.6%, p < 0.05). In addition, the frequency of patients who cited lung function test as the primary diagnostic tool for COPD increased by +14.4% in the true sensitized group versus+2.0% in the control group (p < 0.05). However, there was no short-term leaflet-dependent improvement in smoking behaviour or utilization of health-care resources. CONCLUSIONS: This study shows that an information leaflet sent by postal mail to subjects with or at risk of COPD can significantly improve their knowledge of COPD; however, it has no significant impact on their behaviour.

[Prevalence and prevention of venous thromboembolic events in general practice. Multicenter, prospective cohort study]. / Prévalence et prévention des événements thromboemboliques veineux en médecine générale. Etude multicentrique, prospective de cohorte.

OBJECTIVE: To determine the incidence of clinical venous thromboembolic events in home-care patients presenting an acute condition resulting in a significant and transitory reduction in mobility. To describe the measures implemented to prevent thromboembolic risks. METHOD: Prospective, multicenter, observational cohort study conducted among 2,895 general practitioners randomly drawn, who included the first 6 eligible patients: outpatients aged 40 years and over in which a reduction in mobility longer than 48 hours was expected due to acute medical condition. The primary endpoint was the incidence of deep venous thrombosis and symptomatic pulmonary embolism at 3 weeks. RESULTS: 16,532 patients whose average age was 71 years were included between October 2002 and June 2003. The most common acute conditions resulting in a reduction in mobility were infections, acute rheumatologic diseases and falls without fracture. The incidences of deep venous thrombosis and symptomatic pulmonary embolism were respectively 1% (95% CI = 0.84-1.14) and 0.20% (95% CI = 0.13-0.27). Cancer and personal or family history of venous thromboembolic disease were independent risk factors for thromboembolic events. A thromboprophylaxis was initiated in 35% of patients. The main decisive factor for prescription was the personal history of venous thromboembolic disease. DISCUSSION: The risk of symptomatic venous thromboembolic disease in outpatients whose mobility is reduced for medical reasons is close to that described in hospitalized patients.

Kinesiophobia and physical therapy-related pain in musculoskeletal pain: A national multicenter cohort study on patients and their general physicians.

INTRODUCTION: Physical therapy (PT) represents a major approach in musculoskeletal (MSK) pain. This study aimed to assess kinesiophobia, its impact and management, in patients with MSK pain treated by PT. METHODS: A national multicenter, prospective study was conducted in France in patients with MSK pain referred to PT. Kinesiophobia was scored with the Tampa Scale of Kinesiophobia (TSK). Pain, satisfaction, analgesic intake and acceptability were assessed at the initial visit, at the 5th PT session, and at the end of PT. RESULTS: A total of 700 consecutive outpatients with MSK pain, 54.5% female, referred to PT were recruited by 186 GPs: 501 had significant levels of kinesiophobia (TSK score>40). Patients with kinesiophobia were significantly older, with less physical activity, more pain and less acceptability. Patients from GPs presenting with kinesiophobia had both higher pain and kinesiophobia levels. After 5 PT sessions, global satisfaction was significantly higher in patients without kinesiophobia. A significant increase of PT satisfaction was observed in patients who had been given preventive analgesics before PT sessions, in 25.6% of patients. Independent predictors for specific management of PT-induced pain were: patient's kinesiophobia (OR=2.02 [1.07-3.82]), current analgesics treatment (OR=2.05 [1.16-3.63]), GP with postgraduate course on pain (OR=2.65 [1.29-5.43]), GP's independent practice (OR=1.88 [1.01-3.48]). CONCLUSION: Kinesiophobia is frequent in patients with MSK pain, is associated to GPs' kinesiophobia and decreases satisfaction of physical therapy. Preventive analgesic treatment before PT sessions improves patients' satisfaction and should be proposed to improve MSK pain management.