Identification of Responders to Balneotherapy among Adults over 60 Years of Age with Chronic Low Back Pain: A Pilot Study with Trajectory Model Analysis.

Balneotherapy may be a relevant treatment for chronic low back pain (LBP) in individuals > 60 years old. This pilot study aimed to determine the effectiveness of balneotherapy for chronic LBP in people > 60 years old and to determine profiles of responders with trajectory model analysis. This was a pilot prospective open cohort study, with repeated measurements using validated questionnaires; participants were their own controls. The primary endpoint was the proportion of participants with a change in pain intensity between the start of treatment and 3 months after treatment assessed with a numeric scale (NS) from 0 to 100 mm, with an effect size (ES) > 0.5. The assessments involved questionnaires that were self-administered on days (D) 1 and 21 and at months 3 and 6. The secondary objective was to determine the profile of responders to balneotherapy. We included 78 patients (69.2% women), mean age 68.3 ± 5.3 years. The mean pain score on the NS was 48.8 ± 19.9 at D1 and 39.1 ± 20.5 at 3 months (p < 0.001). The ES was 0.47 [95% confidence interval [CI] 0.25 to 0.69] for the whole sample; 36% (28/78) had an ES > 0.5; 23% (18/78) had a moderate ES (0 to 0.5); and 41% (32/78) had an ES of zero (14/78) or < 0 (18/78), corresponding to increased pain intensity. The pain trajectory model showed that the change in pain between D1 and D21 for trajectory A (larger reduction in pain intensity) was -50% [95% CI -60 to -27], and for trajectory B (smaller reduction in pain intensity), it was -13% [-33 to 0] (p < 0.001). Between Day 1 and month 3, the change for trajectory A was -33% [-54; 0] and for trajectory B was -13% [-40 to 0] (p = 0.14). Finally, between D1 and month 6, the change for trajectory A was -50% [-60 to 0] and for trajectory B was -6% [-33 to 17] (p = 0.007). The patients in trajectory A reported performing more physical activity than those in trajectory B (p = 0.04). They were also less disabled, with a mean Oswestry Disability Index of 40.4 versus 45.7 for those in trajectory A and B, respectively, (p = 0.03) and had a higher total Arthritis Self-Efficacy Scale score. This real-life study of the effectiveness of balneotherapy on chronic LBP identified distinct pain trajectories and predictive variables for responders. These criteria could be used in decision-making regarding the prescription of balneotherapy, to ensure personalized management of chronic LBP.

Trends of influenza vaccination coverage in pregnant women: a ten-year analysis from a French healthcare database.

Pregnant women have a high risk of severe influenza, associated with obstetrical complications. The World Health Organization (WHO) has recommended influenza vaccination for all pregnant women since 2012. The vaccination coverage remains low worldwide, and in Europe, due to a lack of proposition from the health care providers, and a high refusal rate from the women. The primary aim of this study was to estimate the influenza vaccination coverage (IVC) in a population of pregnant women in France, and to analyse its evolution from 2009 to 2018. The secondary objective was to describe the vaccinated population and to find determinants associated with the vaccination. This retrospective cohort study is based on the EGB French health care database, a representative sample of the French population containing data from the health insurance system. All pregnant women who delivered medically or spontaneously over the 2009-2018 period were included. In the 2009-2018 period, only 1.2% pregnant women were vaccinated against influenza (n = 875/72,207; 95% CI 1.14-1.30). The IVC slightly increased after the 2012 WHO recommendation, from 0.33 to 1.79% (p < 0.001) but remained extremely low (4.1% in 2018). Women younger than 25 years old had a low coverage (0.6%) whereas women over 35 years old were more likely to get the influenza vaccine (1.7%; OR: 2.82, 95% CI 2.14-3.71). The vaccination behavior was not influenced by multifetal pregnancy or parity, but socio-economically deprived women were less likely to be vaccinated (OR: 0.81, 95% CI: 0.67-0.98). Women with pre-existing medical conditions had an overall higher vaccination rate (2.5%; OR: 2.32, 95% CI: 1.94-2.77). The vaccine was mainly prescribed by family physicians (58%). Influenza vaccination in pregnant women in France remains very low, particularly in younger, healthy women, and measures such as information campaigns towards pregnant women and studies of the knowledge, attitudes, and practices of the health care professionals need to be undertaken to improve the coverage.

Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial.

Importance: Multidisciplinary prehabilitation before total knee replacement (TKR) for osteoarthritis may improve outcomes in the postoperative period. Objective: To compare multidisciplinary prehabilitation with usual care before TKR for osteoarthritis in terms of functional independence and activity limitations after surgery. Design, Setting, and Participants: This prospective, open-label randomized clinical trial recruited participants 50 to 85 years of age with knee osteoarthritis according to the American College of Rheumatology criteria for whom a TKR was scheduled at 3 French tertiary care centers. Recruitment started on October 4, 2012, with follow-up completed on November 29, 2017. Statistical analyses were conducted from March 29, 2018, to March 6, 2019. Interventions: Four supervised sessions of multidisciplinary rehabilitation and education (2 sessions per week, at least 2 months before TKR, delivered to groups of 4-6 participants at each investigating center; session duration was 90 minutes and included 30 minutes of education followed by 60 minutes of exercise therapy) or usual care (information booklet and standard advice by the orthopedic surgeon) before TKR. Main Outcomes and Measures: The short-term primary end point was the proportion of participants achieving functional independence a mean (SD) of 4 (1) days after surgery defined as level 3 on the 4 functional tests. The midterm primary end point was activity limitations within 6 months after TKR assessed by the area under the receiver operating characteristic curve of the self-administered Western Ontario Questionnaire and McMaster Universities Osteoarthritis Index function subscale. Results: A total of 262 patients (mean [SD] age, 68.6 [8.0] years; 178 women [68%]) were randomized (131 to each group). A mean (SD) of 4 (1) days after surgery, 34 of 101 (34%) in the experimental group vs 26 of 95 (27%) in the control group achieved functional independence (risk ratio, 1.4; 97.5% CI, 0.9-2.1; P = .15). At 6 months, the mean (SD) area under the curve for the Western Ontario Questionnaire and McMaster Universities Osteoarthritis Index function subscale was 38.1 (16.5) mm2 in the experimental group vs 40.6 (17.8) mm2 in the control group (absolute difference, -2.8 mm2; 97.5% CI, -7.8 to 2.3; P = .31 after multiple imputation). No differences were found in secondary outcomes. Conclusions and Relevance: This randomized clinical trial found no evidence that multidisciplinary prehabilitation before TKR for osteoarthritis improves short-term functional independence or reduces midterm activity limitations after surgery. Trial registration: ClinicalTrials.gov Identifier: NCT01671917.

Saline nasal irrigation for acute upper respiratory tract infections in infants and children: A systematic review and meta-analysis.

PURPOSE: Acute upper respiratory tract infections are the most common infections in infants and children. Saline nasal irrigation (SNI) is widely prescribed and recommended. We conducted a systematic review to assess the efficacy and safety of SNI in infants and children with acute rhinopharyngitis. METHODS: We searched CENTRAL, Medline, Embase and clinicalTrials.gov. Two authors selected randomized control trials (RCTs), including infants ≥3 months and children ≤12 years, comparing the use of isotonic saline solutions, whatever their mode of administration, with one therapeutic abstention, or a therapy deemed less important for nasal lavage. Trial quality was assessed independently by two authors, who, with a third author, extracted and analysed data. Statistical analysis was conducted using Comprehensive Meta-Analysis software. The standard difference in means (SMD) between groups and its 95% confidence interval were estimated. RESULTS: Four RCTs (569 participants) were included. The analysis showed a benefit of SNI for certain clinical rhinological symptoms (SMD = -0.29 [-0.45; -0.13]) but no significant improvement of respiratory symptoms (SMD = -0.19 [-0.70; 1.08]) or health status (SMD = -0.30 [-0.68; 0.07]). Its use appeared to limit the prescription of other treatments, whether local or systemic, and particularly antibiotics. Long-term use led to a decrease in the incidence of acute rhinosinusitis and its complications. SNI appeared to be a safe treatment. CONCLUSIONS: SNI is beneficial for rhinological symptoms but not respiratory symptoms. Further research is needed to address the full benefits/risks of this treatment.

Mixed qualitative and quantitative approach for validating an information booklet before total hip arthroplasty.

OBJECTIVE: Providing patients with validated information before total hip arthroplasty may help lessen discrepancies between patients' expectations and the surgical result. This study sought to validate an information booklet for candidates for hip arthroplasty by using a mixed qualitative and quantitative approach based on a panel of patients and a sample of healthcare professionals. METHODS: We developed a booklet in accordance with the standard methods and then conducted focus groups to collect the opinions of a sample of multidisciplinary experts involved in the care of patients with hip osteoarthritis. The number of focus groups and experts was determined according to the data saturation principle. A panel of patients awaiting hip arthroplasty or those in the immediate post-operative period assessed the booklet with self-reporting questionnaires (knowledge, beliefs, and expectations) and semi-structured interviews. RESULTS: All experts and both patient groups validated the booklet in terms of content and presentation. Semi-structured interviews were uninformative, especially for post-operative patients. Reading the booklet significantly (P<0.001) improved the knowledge scores in both groups, with no intergroup differences, but did not affect beliefs in either patient group. Only pre-operative patients significantly changed their expectations. CONCLUSION: Our mixed qualitative and quantitative approach allowed us to validate a booklet for patients awaiting hip arthroplasty, taking into account the opinions of both patients and healthcare professionals.

Motivators for and barriers to physical activity in people with knee osteoarthritis: A qualitative study.

OBJECTIVES: We aimed to explore the motivators for and barriers to regular physical activity in people with knee osteoarthritis. METHODS: We performed a cross-sectional, monocentric qualitative study based on 20 semi-structured individual interviews and two focus groups. People with knee osteoarthritis according to American College of Rheumatology criteria were recruited from spa therapy resorts (Royat, France). Data were collected by interviews, which were then transcribed and coded. The analysis was performed according to the researcher triangulation method. RESULTS: Among the 27 participants (17 women), the mean age was 67years (SD 7.8) and mean body mass index 29.2kg/m2 (SD 8.2). The motivators for physical activity were physical (well-being, decreased pain, self-perception), personal (lifestyle, psychological well-being), societal (relationships, others' views), and environmental (living). The motivators differed by gender, with the concept of performance predominant for men and others' views for women. The barriers were psychological (fear of pain, lack of motivation) and physical (knee pain, asthenia) and were also potentially related to life events (depression, hospitalization). CONCLUSIONS: The study population had an overall positive idea of the value of physical activity for knee osteoarthritis. The participants expressed beliefs and knowledge generally in line with current recommendations. Compliance with these recommendations remains moderate. An educational support for progressive adapted physical activity and identification of barriers and motivators could help improve adherence.

Intensive spa and exercise therapy program for returning to work for low back pain patients: a randomized controlled trial.

We aimed to determine whether a 5-day intensive inpatient spa and exercise therapy and educational program is more effective than usual care in improving the rate of returning to work at 1 year for patients with subacute and chronic low back pain (LBP) on sick leave for 4 to 24 weeks. We conducted a 12-month randomized controlled trial. LBP patients were assigned to 5-day spa (2 hr/day), exercise (30 min/day) and education (45 min/day) or to usual care. The primary outcome was the percentage of patients returning to work at 1 year after randomization. Secondary outcomes were pain, disability and health-related quality of life at 1 year and number of sick leave days from 6 to 12 months. The projected recruitment was not achieved. Only 88/700 (12.6%) patients planned were enrolled: 45 in the spa therapy group and 43 in the usual care group. At 1 year, returning to work was 56.3% versus 41.9% (OR 1.69 [95% CI 0.60-4.73], p = 0.32) respectively. There was no significant difference for any of the secondary outcomes. However, our study lacked power.

Randomized blinded trial of standardized written patient information before total knee arthroplasty.

BACKGROUND: The effect of patient education before total knee arthroplasty (TKA) is controversial. No consensus exists about the optimal content of educational interventions. In a previous study, we developed and validated an educational booklet on the peri-TKA management of knee osteoarthritis. PURPOSES: Our primary purpose was to evaluate the impact of the educational booklet on knowledge among patients awaiting TKA. PATIENTS AND METHODS: This randomized controlled single-blind trial evaluated standard information by the surgeon with or without delivery of the educational booklet 4-6 weeks before primary noncomplex TKA in patients aged 55-75 years with incapacitating knee osteoarthritis. Patients were enrolled at a French surgical center between June 2011 and January 2012. A patient knowledge score was determined at baseline, on the day before TKA, and 3-6 weeks after TKA, using a self-administered questionnaire developed for our previous study. The assessor was blinded to group assignment. RESULTS: Of 44 eligible patients, 42 were randomized, 22 to the intervention and 20 to the control group, all of whom were included in the analysis. The groups were comparable at baseline. The intervention was associated with significantly better patient knowledge scores. CONCLUSIONS: An educational booklet improves knowledge among patients awaiting TKA. A study assessing the impact of the booklet combined with a exercise program would be helpful. LEVEL OF EVIDENCE: Level I, randomized controlled double-blind trial; see S1 CONSORT Checklist. TRIAL REGISTRATION: clinicaltrials.gov #NCT01747759.

Cannabis and Young Users-A Brief Intervention to Reduce Their Consumption (CANABIC): A Cluster Randomized Controlled Trial in Primary Care.

PURPOSE: Brief intervention to reduce cannabis is a promising technique that could be adapted for use in primary care, but it has not been well studied in this setting. We tested the efficacy of a brief intervention conducted by general practitioners among cannabis users aged 15 to 25 years. METHODS: We performed a cluster randomized controlled trial with 77 general practitioners in France. The intervention consisted of an interview designed according to the FRAMES (feedback, responsibility, advice, menu, empathy, self-efficacy) model, while the control condition consisted of routine care. RESULTS: The general practitioners screened and followed up 261 young cannabis users. After 1 year, there was no significant difference between the intervention and control groups in the median number of joints smoked per month among all users (17.5 vs 17.5; P = .13), but there was a difference in favor of the intervention among nondaily users (3 vs 10; P = .01). After 6 months, the intervention was associated with a more favorable change from baseline in the number of joints smoked (-33.3% vs 0%, P = .01) and, among users younger than age of 18, smoking of fewer joints per month (12.5 vs 20, P = .04). CONCLUSIONS: Our findings suggest that a brief intervention conducted by general practitioners with French young cannabis users does not affect use overall. They do, however, strongly support use of brief intervention for younger users and for moderate users.

French women's representations and experiences of the post-treatment management of breast cancer and their perception of the general practitioner's role in follow-up care: A qualitative study.

BACKGROUND: In France, the Cancer Plan II 2009-2013 was launched to improve post-cancer management and promote greater involvement of general practitioners (GPs) in follow-up care. OBJECTIVES: We investigated how women experienced the post-treatment management of breast cancer and perceived the role of the GP in follow-up care. DESIGN: We conducted a qualitative study based on semi-structured interviews with women with breast cancer in remission. The interviews were transcribed and analysed in accordance with the principles of thematic analysis. SETTING AND PARTICIPANTS: We interviewed 21 patients aged between 30 and 86. Eighteen breast cancer survivors were recruited from GP practices and five from a patients' association. RESULTS: Four themes emerged from the thematic analysis: that breast cancer is a life-changing event; how patients managed the effects of treatment; how patients viewed the future; and patients' expectations of their GP. DISCUSSION AND CONCLUSION: French survivors of breast cancer perceived the physical changes caused by their illness to impact their womanhood, leading to difficulties with sexual relations, a diminished sense of self and fears for the future. They felt abandoned at the end of treatment and desired support. They appreciated the ease of contacting their GP but considered follow-up care outside their remit. They agreed to be followed up by their GP, provided that they co-operated closely with a cancer specialist. This is in accordance with the French Cancer Plan II 2009-2013, which recommends greater involvement of GPs in a monitoring protocol shared with cancer specialists.

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).

[Quality of life of women GPs in Auvergne]. / Qualité de vie des femmes médecins généralistes en Auvergne.

BACKGROUND: The medical profession is feminising. In parallel, the importance of quality of life (QOL) must be addressed. Family practice needs personal investment and availability. This profession can have repercussions on womens' QOL. The objective of the study was to compare female GPs QOL to other women with the comparable socioprofessional status. The secondary objective was to study the influence of factors, such as workplace and work methods. METHOD: Comparative cross-sectional study. A self-assessed questionnaire, sent by post to 394 female general practitioners in Auvergne, each was asked to recruit one woman (non-GP), with similar age and socioprofessional status. RESULTS: A total of 148 female GPs (37.6%) and 122 non-GPs responded. The global score of QOL was lower in the GP group, noticeably showing a poorer QOL in the relational and material areas. The professional QOL was similar between the 2 groups. The study did not find a significant difference concerning the QOL in its physical and psychological dimensions. The main negative factors influencing the QOL were: age; isolation of the occupation; living alone; and liberal occupation. Working in a rural area did not influence the QOL. CONCLUSION: The profession of GPs remains demanding, and the female GP feels a poorer QOL. Nevertheless, they seem to like their job and they feel fulfilled. The uneasiness comes essentially from the lack of free time, and from low financial income. Working in association seems to be a first step to improve the QOL of female GPs.