ESCAPE ancillary blood pressure measurement study 2: changes in end-digit preference after 2 years of a cluster randomized trial.

OBJECTIVE: The aim of the ESCAPE AMPA 2 trial was to describe the evolution of end-digit preference (EDP) practices in primary care after 2 years of trial. METHODS: A descriptive analysis of the EDP in the intervention group (IG) and in the electronic control group (ECG) of the ESCAPE trial and a comparative analysis of EDP changes in blood pressure (BP) measures of both groups were carried out between baseline and 2 years. In the ESCAPE trial, physicians in the IG were new users of electronic devices provided in the trial to measure their patients' BP and physicians in the ECG were former users of electronic devices. Hierarchical mixed-effects models were used for statistical analysis in a pragmatic cluster randomized-controlled trial. RESULTS: After 2 years, the proportion of BP measures ending with a 0 or a 5 was significantly higher in the ECG than in the IG (50.4 vs. 33.4%, P<0.0001). There was no significant change in EDP tendency between baseline and the end of the trial in the ECG (65.6-56.7%, P=0.39) and in the IG (29.6-38.2%, P=0.07), with a between-groups P value of 0.11. Over 2 years, there was no significant change in systematic EDP in the ECG (18.8-20.0%, P=0.29) and in the IG (4.8-10.6%, P=0.01), with a between-groups P value of 0.17. CONCLUSION: EDP is not eliminated by electronic devices and tends to increase with time for new users.

Effects of a multifaceted intervention on cardiovascular risk factors in high-risk hypertensive patients: the ESCAPE trial, a pragmatic cluster randomized trial in general practice.

BACKGROUND: Several observational studies on hypertensive patients have shown a gap between therapeutic targets recommended in guidelines and those achieved in daily practice. The ESCAPE trial aimed to determine whether a multifaceted intervention focused on general practitioners (GPs), could increase significantly the proportion of hypertensive patients at high risk in primary prevention who achieved all their recommended therapeutic targets. METHODS: A pragmatic, cluster randomized trial involving 257 GPs randomized by region. The GPs in the intervention group had a one-day training session and were given an electronic blood pressure measurement device and a short recommendation leaflet. Along with usual follow-up, they focused one consultation on hypertension and other cardiovascular risk factors every six months for two years. They also received feedback at baseline and at one year on their patients' clinical and biological parameters. Main outcome measures were change in the proportion of patients achieving all their therapeutic targets and each individual therapeutic target at two years, and quality of life. RESULTS: 1,832 high-risk hypertensive patients were included. After two years, the proportion of patients achieving all their therapeutic targets increased significantly in both groups, but significantly more in the intervention group: OR (odds-ratio) 1.89, (95% confidence interval (CI) 1.09 to 3.27, P = 0.02). Significantly more patients achieved their blood pressure targets in the intervention group than in the usual care group: OR 2.03 (95% CI 1.44 to 2.88, P < 0.0001). Systolic and diastolic blood pressures decreased significantly more in the intervention group than in the usual care group, by 4.8 mmHg and 1.9 mmHg, respectively (P < 0.0001 for both). There were no significant difference changes in physical and mental quality of life between groups. CONCLUSION: An easy-to-perform, multifaceted intervention targeting only GPs increased significantly the proportion of high-risk hypertensive patients in primary prevention achieving their recommended therapeutic targets. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov, number NCT00348855.

ESCAPE-ancillary blood pressure measurement study: end-digit preference in blood pressure measurement within a cluster-randomized trial.

BACKGROUND: In a cluster-randomized trial including 1832 hypertensive patients, all 126 general practitioners (GPs) in the intervention group (IG) used an oscillometric device that was provided for blood pressure (BP) measurements. Of the 131 GPs of the control group (CG), 24.6% used an oscillometric device (OCG), and 75.4% used a manual device (MCG). At baseline, patients in the IG and CG were comparable for all clinical and biological characteristics, except BP, which was higher in the IG (146/84 vs. 139/81 mmHg; P<0.001). The purpose of this ancillary study was to assess whether these differences in BP values were related to the end-digit preference (EDP), selection bias, or both. METHODS: Analysis was carried out and comparison was made of 3629 BP measurements by 257 GPs. Statistical analysis used hierarchical mixed-effect models with random physician effect and fixed-effect covariables. RESULTS: The frequencies of 0 end digit were 16.7% in the IG, 32.4% in the OCG and 68.8% in the MCG for systolic BP (SBP; P<0.001 for all comparisons), and respectively 17.7, 38.1, and 74.1% for diastolic BP (DBP; P=0.017 for all comparisons). SBP was higher in the IG than in OCG (+3.65 mmHg, P=0.017). The same trend was observed for DBP, though not significant (+1.50 mmHg, P=0.20). The EDP in the CG led to a mean underevaluation of 2.4 mmHg (P<0.0005) of SBP and DBP. CONCLUSION: The observed differences in BP between the groups are partly explained by the impact of EDP. Compared with the manual, oscillometric measurement may reduce EDP.

Management of osteoporosis and associated quality of life in post menopausal women.

BACKGROUND: The study aimed to describe the characteristics of women treated for recently-diagnosed osteoporosis, to identify variables associated with different treatment regimens and to assess impact on quality of life. METHODS: This is an observational, cross-sectional pharmacoepidemiological study performed in France. A random sample of 684 general practitioners, gynaecologists and rheumatologists included the first three post-menopausal osteoporotic women consulting in the previous six months on the basis of densitometry or fracture. Data on osteoporosis, fracture risk factors, treatments and comorbidities was collected with a physician questionnaire. Data on quality of life was collected using the SF-12. RESULTS: Data were analysed for 1,306 patients, of whom 1,117 (85.5%) had been evaluated by densitometry within the previous six months and 554 (42.4%) had experienced a fracture, most frequently of the spine or wrist within the previous six months. Osteoporotic fracture risk factors were reported in 1,028 women (78.7%). 746 women (57.1%) were currently receiving treatment, most frequently weekly or monthly bisphosphonates. Five variables were associated with prescription choice: age (p < 0.0001), physician speciality (p < 0.0001), previous fracture history (p = 0.0002), ongoing treatment at the time of consultation (p = 0.0091) and paraclinical investigations performed in the previous six months (p = 0.0060). SF-12 scores were lower in women complaining of pain, with recent fractures and with spine or hip fractures and in women consulting rheumatologists. CONCLUSIONS: A high proportion of women diagnosed with osteoporosis had been evaluated by densitometry, in agreement with national guidelines. Treatment choice varied between physician groups.

Compliance and treatment satisfaction of post menopausal women treated for osteoporosis. Compliance with osteoporosis treatment.

BACKGROUND: Adherence to anti-osteoporosis treatments is poor, exposing treated women to increased fracture risk. Determinants of poor adherence are poorly understood. The study aims to determine physician- and patient- rated treatment compliance with osteoporosis treatments and to evaluate factors influencing compliance. METHODS: This was an observational, cross-sectional pharmacoepidemiological study with a randomly-selected sample of 420 GPs, 154 rheumatologists and 110 gynaecologists practicing in France. Investigators included post-menopausal women with a diagnosis of osteoporosis and a treatment initiated in the previous six months. Investigators completed a questionnaire on clinical features, treatments and medical history, and on patient compliance. Patients completed a questionnaire on sociodemographic features, lifestyle, attitudes and knowledge about osteoporosis, treatment compliance, treatment satisfaction and quality of life. Treatment compliance was evaluated with the Morisky Medication-taking Adherence Scale. Variables collected in the questionnaires were evaluated for association with compliance using multivariate logistic regression analysis. RESULTS: 785 women were evaluated. Physicians considered 95.4% of the sample to be compliant, but only 65.5% of women considered themselves compliant. The correlation between patient and physician perceptions of compliance was low (κ: 0.11 [95% CI: 0.06 to 0.16]). Patient-rated compliance was highest for monthly bisphosphonates (79.7%) and lowest for hormone substitution therapy (50.0%). Six variables were associated with compliance: treatment administration frequency, perceptions of long-term treatment acceptability, perceptions of health consequences of osteoporosis, perceptions of knowledge about osteoporosis, exercise and mental quality of life. CONCLUSION: Compliance to anti-osteoporosis treatments is poor. Reduction of dosing regimen frequency and patient education may be useful ways of improving compliance.

Control of asthma in children: still unacceptable? A French cross-sectional study.

BACKGROUND: The goal of asthma management focuses on adequate control of asthma, although little is known about the optimal level of asthma control to be reached. The ELIOS study was conducted in France to address this lack of information. METHODS: Cross-sectional study of asthmatic children (4-15 years) visiting their medical practitioner. The primary objective was to assess the level of asthma control with a 3-level composite score based on French (ANAES) guidelines criteria (optimal, acceptable, and unacceptable). RESULTS: Asthma control was assessed in 3431 children and classified as optimal (26%), acceptable (41.3%), and unacceptable (32.7%). When PEFR was studied, asthma control was optimal in 23.0%, acceptable in 35.8% and unacceptable in 41.2% (p<0.001) of children. Unacceptable asthma control was significantly associated with higher BMI (p=0.002), more recent diagnosis of asthma (p=0.008), passive exposure to parental tobacco smoke (p<0.001), number of associated allergic diseases (p<0.001), frequent respiratory tract infections (p<0.001) and low socioeconomic status (p<0.001). Multivariate analysis identified presence of respiratory tract infections (p<0.0001), passive exposure to parental tobacco smoke (p=0.009) and low socioeconomic status (p=0.042) as variables associated with unacceptable asthma control. CONCLUSIONS: There is room for improvement in France as only 25% of asthmatic children are optimally controlled. Public health strategies should increase awareness among physicians and parents about the importance of using asthma control tools, eliminating exposure to tobacco smoke and treating associated allergic diseases.

[Difficulties in the assessment of dyspnea and respiratory function in general practice]. / Difficultés de l'évaluation de la dyspnée et de la fonction respiratoire en médecine générale.

BACKGROUND: Dyspnea is one of the principal signs of chronic respiratory diseases. OBJECTIVE AND METHODS: To determine the appropriate questions and tests for recognizing dyspnea, 295 general practitioners questioned 1991 patients with or at risk of COPD in this cross-sectional study. After a brief training session, the physicians were asked to assess respiratory function with a small electronic spirometer. RESULTS: A questionnaire with a six-point semi-quantitative scale of dyspnea detected more dyspneic patients (78.1%) than the single question "Are you usually short of breath?" (68.6%), which in turn detected this symptom more often than simply listening for spontaneous complaints (33.7%). Even when dyspnea was reported only for substantial exertion, it was associated with impairment of all domains of quality of life. Only half the spirometry results met the minimal criteria of validity and reproducibility. DISCUSSION AND CONCLUSIONS: These results underline the importance of a specific, systematic assessment of dyspnea in patients at risk, and the need for sufficient training and practice before the use of electronic spirometers in general practice.

Diagnostic indicators of restless legs syndrome in primary care consultations: the DESYR study.

The objective of this study is to determine whether spontaneous complaints about sleep or the legs could be used as potential indicators of restless legs syndrome (RLS) in primary care. A total of 351 general practitioners participated in the study. In a first historical patient identification phase, all patients with spontaneous complaints of sleep or leg symptoms over the previous year were identified. A control group without such complaints was identified. In a second prospective data collection phase, those who consulted a participating physician were interviewed to assess consensus diagnostic criteria of RLS. Severity was assessed with the International Restless Legs Syndrome Study Group severity rating scale. Of 1,405,823 patients consulting during the historical phase, a leg complaint was reported in 61,685 and a sleep complaint in 40,568. A total of 1,432 consulted during the prospective phase. A diagnosis of RLS was assigned to 42.6% of patients with leg complaints, 35.5% of those with sleep complaints, 54.9% of those with both complaints, and 12.9% of those with no complaints. Median RLS severity scores were 18.8 to 20.4. A total of 63.7% of patients were prescribed a venotonic, 43.7% a hypnotic, and 41.5% an anxiolytic. Complaints of sleep or leg symptoms are frequently associated with a diagnosis of RLS, and their presence should alert the physician to the possibility of a differential diagnosis of RLS.

Assessing chronic pain in general practice: are guidelines relevant? A cluster randomized controlled trial.

OBJECTIVES: To evaluate the impact of using pain assessment scales on the management of musculoskeletal chronic pain. METHODS: Cluster-randomized controlled multicentre trial in French general practice settings. Practices were randomized by region before patient recruitment. The inclusion concerned patients suffering from musculoskeletal chronic pain. General practitioners assigned to the scale group used two validated assessment instruments; those assigned to the control group cared for their patients according to their usual practice. The primary end-point was the level of relief obtained and the secondary changes in prescription of painkilling modalities. RESULTS: A total of 155 general practitioners included 772 successive patients suffering from musculoskeletal chronic pain. The control group reported a mean level of relief of 50.7% compared with one of 41.1% in the scale group (p<0.0001). In the intervention group, physicians decreased significantly their prescription of level two painkillers. CONCLUSIONS: In general practice, the use of pain assessment scales is not associated with greater pain relief. The lesser level of pain relief obtained in the scale group does provide evidence that using pain assessment scales does not enhance the relief of chronic pain in patients in primary care. Guidelines which recommend the systematic use of scales for the assessment and monitoring of chronic pain are not tailored to either the context or the patients encountered in the primary care setting.

A pragmatic trial of acamprosate in the treatment of alcohol dependence in primary care.

AIMS: To assess the effectiveness of pharmacotherapy with acamprosate in alcohol-dependent patients treated in a naturalistic setting in primary care in France. METHODS: The ARES (Acamprosate et Repercussions Economiques et Sociales; Acamprosate and Economic and Social Repercussions) study was performed by 149 general practitioners interested in treating alcohol use disorders in France who included patients fulfilling DSM-IV criteria for alcohol dependence. The only exclusion criteria concerned contra-indications to acamprosate, co-medication with naltrexone and multiple substance abuse. Eligible patients were randomized to one of two treatment arms, either standard care alone or standard care with acamprosate, using an open-label design and followed up quarterly for a period of 1 year. The primary outcome variable was the change from baseline on the Alcohol-Related Problems Questionnaire. Secondary efficacy variables were abstinence, Clinical Global Impression, quality of life measured with the SF-36 and incidence of adverse events. An intent-to-treat population was used for outcome analysis. RESULTS: 422 patients were included, of whom 348 (82%) completed the protocol as planned. At the end of the study, patients randomized to the acamprosate group had significantly better outcomes in terms of total ARPQ score, change from baseline (-2.61 vs -3.44) and number of subjects with no alcohol-related problem. On average, patients treated with acamprosate had one less alcohol-related problem than did the controls. The number needed to treat in order to save one additional patient from alcohol-related problems compared to standard care was 7.14. Statistically significant differences in favour of the acamprosate group were observed for all secondary efficacy outcome measures including quality of life. CONCLUSIONS: Adjunctive therapy with acamprosate in primary care is associated with significantly better functional outcome. Pragmatic trials in alcohol dependence are both feasible and informative.