Project rebuild the evidence base (REB): A method to interpret randomised clinical trials and their meta-analysis to present solid benefit-risk assessments to patients.

Evidence-based medicine is the cornerstone of shared-decision making in healthcare today. The public deserves clear, transparent and trust-worthy information on drug efficacy. Yet today, many drugs are prescribed and used without solid evidence of efficacy. Clinical trials and randomised clinical trials (RCTs) are the best method to evaluate drug efficacy and side effects. In a shared medical decision-making approach, general practitioners need drug assessment based on patient-important outcomes. The aim of project rebuild the evidence base (REB) is to bridge the gap between the data needed in clinical practice and the data available from clinical research. The drugs will be assessed on clinical patient important outcomes and for a population. Using the Cochrane tools, we propose to analyse for each population and outcome: 1) a meta-analysis based on RCTs with a low risk of bias overall; 2) an evaluation of results of confirmatory RCTs; 3) a statistical analysis of heterrogeneity between RCTs and 4) an analysis of publication bias. Depending on the results of these analyses, the evidence will be categorized in 4 different levels: firm evidence, evidence (to be confirmed), signal or absence of evidence. Project REB proposes a method for reading and interpreting RCTs and their meta-analysis to produce quality data for general practitioners to focus on risk-benefit assessment in the interest of patients. If this data does not exist, it could enable clinical research to better its aim.

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.

[Comparative study in primary care of the stability of INR in patients treated with warfarin or fluindione for atrial fibrillation. The FLOWER study (FLuindione Or WarfarinE - Result INR)]. / Étude comparative en soins primaires du taux d'INR dans la cible thérapeutique chez des patients traités par warfarine ou fluindione pour une fibrillation atriale. L'étude FLOWER (FLuindione Or WarfarinE ­ Result INR).

INTRODUCTION: The aim of our study was to compare the time spent within the target INR or Time in Therapeutic Range (TTR) of patients treated with fluindione to that of patients treated with warfarin for non-valvular atrial fibrillation (NVAF) and followed in general practice, with the hypothesis of a better TTR with warfarin, which is the VKA most commonly prescribed in France. METHOD: Liberal nurses and general practitioners working in the Auvergne region recruited patients treated with fluindione or warfarin for NVAF. Patients' INRs (International Normalized Ratios) were recorded by medical analysis laboratories for 6 months. The primary endpoint was TTR, the secondary endpoint the number of hemorrhagic and/or thromboembolic events. RESULTS: Of the 342 participants with a mean age of 75.3 ± 9.8 years, 239 (70%) were treated with fluindione and 103 (30%) with warfarin. The mean number of INRs achieved per patient was 9.2 ± 4.0 in the fluindione group and 9.3 ± 4.0 in the warfarin group (p=0.73). The median TTR of fluindione was 81.9% [63.5; 94.1] and that of warfarin was 81.3% [65.6; 92.6] (p=0.98). Twenty-eight of 263 patients reported hemorrhage (10.6%) and 4 reported thromboembolic events (0.8%), with no significant difference between the groups. CONCLUSION: The TTRs of patients treated for NVAF with fluindione versus warfarin do not differ significantly over an observation period of 6 consecutive months in a patient population comparable to that of the publications in this field. However, these TTRs are significantly higher than those reported in the literature, with no difference between the two treatments. The TTRs of patients treated for VANF with fluindione versus warfarin do not differ significantly over a 6-month observation period in a patient population comparable to that of the publications in this indication.

"I Can't Go Far": Perceptions and Experiences of Heart Failure Patients Regarding Physical Activity: A Qualitative Study Using Semistructured Face-to-Face Interviews.

BACKGROUND: Participation in regular physical activity (RPA) is beneficial to the quality of life and life expectancy of patients with chronic heart failure (CHF). However, it is inadequate in many patients. AIMS: To determine the factors that influence the practice of RPA in patients with CHF managed in general practice. METHOD: This was a qualitative study using semistructured, individual face-to-face interviews. Patients with CHF (New York Heart Association Stages 1-3) capable of participating in RPA were enrolled by their general practitioner. A longitudinal and transversal inductive thematic analysis was performed by two researchers. RESULTS: Five themes emerged from the 19 interviews that were conducted. Poor knowledge of the disease and the benefits of participating in RPA, as well as the lack of motivation or enjoyment, in particular due to the absence of previous participation, were considered significant obstacles. Fear associated with CHF or other comorbidities was also an obstacle. Attendance at a rehabilitation center, family and social circles, and having a pet all appeared to be beneficial. Family and friends were important for motivating the patient to participate in an activity but could also be an obstacle when they were overprotective. CONCLUSION: This study helps highlight the difficulties for patients with CHF associated with participation in RPA. Despite the obstacles, there are enabling factors on which the general practitioner may rely to motivate their patients.

Benefits and adverse effects of sacubitril/valsartan in patients with chronic heart failure: A systematic review and meta-analysis.

This review aims to assess the benefits and adverse effects of sacubitril/valsartan in heart failure, with a focus on important patient outcomes. A systematic review was conducted of double-blind randomized controlled trials (RCTs) comparing sacubitril/valsartan versus a reference drug, in heart failure patients with reduced (HFrEF) and preserved (HFpEF) ejection fraction, published in French or English. Searches were undertaken of Medline, Cochrane Central, and Embase. The primary outcomes were all-cause mortality and adverse events. From 2 082 articles analyzed, 5 were included. For all-cause mortality, the absolute numbers for HFrEF (2 RCTs, 4627 patients) were 16% on sacubitril/valsartan and 18% on enalapril, with a risk ratio (RR) of 0.85 [CI = 0.78, 0.93], and 13% vs 14% in with HFpEF (2 RCTs, 5097 patients), with no statistical difference. Under the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the evidence for HFrEF patients was of moderate quality. For HFrEF patients, an increased risk of symptomatic hypotension and angioedema (low quality of evidence) was shown. There was no statistical difference for the risk of hyperkalemia or worsening renal function. There was a protective RR (0.50 [0.34, 0.75]) for worsening renal function for patients with HFpEF, with a high quality of evidence despite similar absolute numbers (1.4% vs. 2.8%). To keep in mind for shared decision-making, sacubitril/valsartan reduces all-cause mortality in HFrEF patients but for HFpEF further data are needed. Take into consideration the small number of studies to date to assess the risks.

Effect of Home Exercise Training in Patients with Nonspecific Low-Back Pain: A Systematic Review and Meta-Analysis.

BACKGROUND: Exercise therapy is recommended to treat non-specific low back pain (LBP). Home-based exercises are promising way to mitigate the lack of availability of exercise centers. In this paper, we conducted a systemic review and meta-analysis on the effects of home-based exercise on pain and functional limitation in LBP. METHOD: PubMed, Cochrane, Embase and ScienceDirect were searched until April 20th, 2021. In order to be selected, studies needed to report the pain and functional limitation of patients before and after home-based exercise or after exercise both in a center and at-home. Random-effect meta-analyses and meta-regressions were conducted. RESULTS: We included 33 studies and 9588 patients. We found that pain intensity decreased in the exclusive home exercise group (Effect size = -0.89. 95% CI -0.99 to -0.80) and in the group which conducted exercise both at-home and at another setting (-0.73. -0.86 to -0.59). Similarly, functional limitation also decreased in both groups (-0.75. -0.91 to -0.60, and -0.70, -0.92 to -0.48, respectively). Relaxation and postural exercise seemed to be ineffective in decreasing pain intensity, whereas trunk, pelvic or leg stretching decreased pain intensity. Yoga improved functional limitation. Supervised training was the most effective method to improve pain intensity. Insufficient data precluded robust conclusions around the duration and frequency of the sessions and program. CONCLUSION: Home-based exercise training improved pain intensity and functional limitation parameters in LBP.

Benefits and adverse effects of ACE inhibitors in patients with heart failure with reduced ejection fraction: a systematic review and meta-analysis.

PURPOSE: Angiotensin-converting enzyme (ACE) inhibitors are part of first-line treatment for reduced ejection fraction heart failure (HFrEF). The aim was to assess the benefits and adverse effects of ACE inhibitors in HFrEF with a focus on important patient outcomes. METHODS: A systematic review of double-blind randomized clinical trials (RCTs) and comparison of ACE inhibitors versus placebo, in HFrEF patients published in French or English. Searches were undertaken of Medline, Cochrane Central, and Embase. The primary outcomes were all-cause mortality and adverse events. RESULTS: From 636 articles analysed, 11 were included (13,882 patients). For all-cause mortality (5 RCTs, 9277 patients), the number needed to treat (NNT) to avoid one death at 6 months was 50 (33-107). The NNT to prevent one death at 12 months (6 RCTs, 13,016 patients) was 63 (35-314). Under the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the evidence was of moderate quality. The number needed to harm was 12 (10-15) for cough, 20 (14-31) for hypotension, 23 (17-36) for dizziness, 31 (23-47) for hyperkalaemia, and 49 (30-121) for increased creatinine levels. The quality of evidence was moderate for these criteria except for cough (low quality of evidence). CONCLUSION: This review focuses on clinical elements necessary in a shared decision-making process. In practice, general practitioners will be able to use these data to discuss ACE inhibitor treatment with HFrEF patients. This study was registered in the PROSPERO registry under the reference number CRD42018096930.