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This paper describes a participatory ergonomics program aimed at early return to regular work of workers suffering from subacute occupational back pain and assesses the perceptions of the participants on the implementation of ergonomic solutions in the workplace. The participatory ergonomics program was used in the rehabilitation of workers suffering from subacute back pain for more than 6 weeks, a program that was associated with an increased rate of return to work. The perceptions of the participatory ergonomics participants were assessed 6 months after completion of the ergonomic intervention through a questionnaire sent to employer representatives, union representatives and injured workers of participating workplaces. About half of the ergonomic solutions were implemented according to the perception of the participants, with a substantial agreement between respondents. [C] 2001 Elsevier Science Ltd. All rights reserved. Keywords: Back pain; Participatory ergonomics; Rehabilitation

Background To evaluate the real-life impact of ezetimibe on cardiovascular (CV) morbidity and mortality in France. Objective To estimate the number of non-fatal and fatal CV events that could be prevented and corresponding number of patients needed to treat (NNT) with ezetimibe to prevent one CV event over 5 years. Methods Non-interventional 48-month follow-up cohort conducted in hypercholesterolemic patients starting on ezetimibe <3 months at study entry, either as monotherapy or combined with statins. Prediction modeling using discrete event simulation with calibrated Framingham CV risk equations was applied to data from pivotal clinical trials on ezetimibe and real-life data derived from the cohort. Results A total of 3215 patients in the cohort accumulated 9314 person-years of follow-up for an average of 2.9 years. Mean age was 61.5 (standard deviation [SD] = 10.7), 54.6% were males, and 27.0% had a history of CV disease. Baseline LDL-cholesterol averaged 4.1 mmol/L (159 mg/dL; SD = 1.0) and HDL-C 1.6 mmol/L (62 mg/dL; SD = 0.5). LDL-C decreased in the first 12 months in ezetimibe-LLT (lipid-lowering therapy) initiators, switchers (monotherapy), and combination therapy with a statin by respectively 21.3%, 6.4%, and 29.1%. The corresponding predicted rate reductions of CV events (non-fatal and fatal) compared to no treatment or to a statin (combination therapy) were respectively 8, 2, and 12 per 1000 patients treated over 5 years, with a global NNT of 143 patients over 5 years. Conclusion These results, accounting for observed CV event rates, risk factors evolution over time and adherence to treatment in real life, were consistent with those from clinical trials. [ABSTRACT FROM AUTHOR]

EZE cohort was a 48-month prospective, nationwide study conducted between 2008 and 2013 in Franceat the request of the French Haute Autorité de Santé. Its objective was to assess the real life use and impact of the drug on lipid lowering. Over 700 physicians (94% general practitioners and 4% cardiologists recruited and described 3,395 eligible adult patients who had initiated ezetimibe treatment for no longer than three months, of which 3,215 (94.7%) were entered in the analyses. Patients were naturalistically followed up to 4 years without any visits formally planned. Blood lipids were reported by physicians every twelve months and lipid lowering medicines utilization every six months with patient’s telephone interviews between each physician’s visit. 9 314 person-years of follow-up were accumulated. At inclusion, patients were 61.5 year-old on average (standard deviation (SD): 10.7) and 54.6% were males. Classified by CV risk categories were for primary prevention 29.3% low, 32.4% moderate and 11.4% high, and 26.9% secondary prevention. Type of ezetimibe exposure at inclusion was 33.1% monotherapy, 13.2% ezetimibe added to a statin, and 53.7% fixed association ezetimibe – simvastatin. Exposure to ezetimibe has been very stable during follow-up of the cohort with treatment interruption rate of 12.5 per 100 person-years of followup. LDL-C was 4.1mmol/L (SD: 1.1) at baseline and decreased by 23.8% (SD: 28.8) in the first 12 months, reaching –27.3% (SD: 28.3) at 48 months. Adjusting for baseline clinical characteristics and risk factors, interruption of lipid lowering treatment at least once during the follow-up was associated with a lower probability for the LDL-C to progress to the lower tertile (OR: 0.38, 95% confidence interval: 0.31 – 0.45). In this population with incident exposure to ezetimibe LDL-C decreased by one quarter in the first year and remained stable over the four-year follow-up. [ABSTRACT FROM AUTHOR]

Background While gout is considered as a risk factor for vascular diseases, the relation of allopurinol with the risk of cardiovascular events is controversial. In some studies, drug use was associated with an increased vascular risk, while other studies described a protective effect. Objectives We conducted a case-control study to examine the relation between allopurinol use and risk of myocardial infarction (MI). Methods Cases (n=2277) were successive patients with a first-ever non-fatal MI referred to 63 cardiology centres throughout France between March 15, 2007 and November 30, 2010. They were matched to 4849 controls selected in a large (12,313) general practice patient referent population. Controls had no past history of coronary heart disease and were matched to MI cases on age, gender, number of visits to a doctor in the preceding year, date of consultation (MI) and past history of high blood pressure. Data about medication use during the two preceding years, and past medical history and life habits (smoking, physical activity, etc.) were obtained from patient's standardized interview and GP records. Odds ratios (OR) and their 95% confidence interval were computed using conditional logistic regression, adjusting for classical vascular risk factors (body mass index, smoking, diabetes, physical activity). Results MI cases and controls had a mean age of 59 years, 76% were men and 56% reported a history of high blood pressure. High body mass index, low physical activity, smoking and diabetes were more prevalent in cases than in controls. Overall, during the two preceding years, 3.8% of controls and 3.1% of MI cases had used allopurinol, and 1.1 of both cases and controls had used another hypouricemiant. Use of allopurinol was associated with a non-significant decreased risk of MI (adjusted OR (95%CI): 0.75 (0.56 - 1.01). Conclusions This study showed that allopurinol use is not a risk factor for first-ever non-fatal MI and might rather be associated with a decreased risk of MI. [ABSTRACT FROM AUTHOR]

Background Despite demonstrated positive effects in a number of clinical trials, the evidence is lacking as to the impact of statins on the risk of first myocardial infarction (MI) in real life settings. Objectives To assess the impact of real life statin utilization on the risk of first non-fatal MI Methods Case-control methodology using the pharmacoepidemiological information system PGRx. Data on comorbidities, risk factors and medications were obtained from medical records and patient telephone interviews. General practices (n=371) and cardiology centres (n=60) across France were employed in the study. Cases were patients with the first MI ≤ 1 month before the date of recruitment (n=2238). Controls were patients seen by a general practitioner (GP) with no restriction as to the reasons of consultation (n=2238), matched to MI cases on gender, age, frequency of visits to a doctor, date of recruitment and personal history of non-cardiovascular chronic disease. Statin exposure was defined as any utilisation in the two-year prior to date of MI in cases or recruitment date in controls. Adjusted odds ratios (OR) of the risk of first MI was estimated by multiple conditional logistic regression models. Comparative effectiveness and propensity to use of individual statin molecules were assessed. Results The use of statins was associated with a lower MI risk (adjusted OR 0.67 [95% CI 0.56 - 0.79] for current use (within 2 months before the index date) and 0.73 [0.62 0.86] for any use within 24 months). Among individual statins, rosuvastatin was associated with the lowest MI risk (adjusted OR 0.49 [0.35 - 0.68] for any use in 24 months preceding the index date) followed by simvastatin (0.62 [0.46 - 0.84]). Conclusions In this first major population-based observational study we reproduced the results observed in recent meta-analyses accounting for real life compliance and population variability. The results could be of interest and applicable to other industrialised countries as the observed risk reduction was constant across MI risk levels. [ABSTRACT FROM AUTHOR]

Background: The concept of the "efficacy-effectiveness gap" (EEG) has started to challenge confidence in decisions made for drugs when based on randomized controlled trials alone. Launched by the Innovative Medicines Initiative, the GetReal project aims to improve understanding of how to reconcile evidence to support efficacy and effectiveness and at proposing operational solutions.Objectives: The objectives of the present narrative review were 1) to understand the historical background in which the concept of the EEG has emerged and 2) to describe the conceptualization of EEG.Methods: A focused literature review was conducted across the gray literature and articles published in English reporting insights on the EEG concept. The identification of different "paradigms" was performed by simple inductive analysis of the documents' content.Results: The literature on the EEG falls into three major paradigms, in which EEG is related to 1) real-life characteristics of the health care system; 2) the method used to measure the drug's effect; and 3) a complex interaction between the drug's biological effect and contextual factors.Conclusions: The third paradigm provides an opportunity to look beyond any dichotomy between "standardized" versus "real-life" characteristics of the health care system and study designs. Namely, future research will determine whether the identification of these contextual factors can help to best design randomized controlled trials that provide better estimates of drugs' effectiveness. [ABSTRACT FROM AUTHOR]

Abstract: Background: Evidence on the real effectiveness of statins on acute coronary syndrome (ACS) incidence is scarce. We assessed the effectiveness of real-life statins on the risk of first non-fatal ACS in a low-cardiovascular-risk country. Methods: Systematic case–control study was conducted in 60 cardiology centres and 371 general practices from across France. A total of 2238 cases with first ACS within 1month from recruitment and 2238 controls without history of ACS were included; controls were matched to ACS cases on sex, age, frequency of visits to GPs, date of recruitment and personal history of chronic diseases. Statin exposure and risk factors were documented through patient telephone interviews and validated against medical records. The index date was the date of ACS for cases. Adjusted odds ratios (OR) of first ACS and statin use were estimated by multiple conditional logistic regression models controlled for risk factors and propensity score for statin exposure. Results: Statin use was associated with lower ACS risk, with an adjusted matched OR of 0.67; 95% confidence interval (CI): 0.56 to 0.79 for current use (within 2months) and 0.73; 95% CI: 0.62 to 0.86 for any use within 24months [atorvastatin: 0.83 (0.63–1.10), fluvastatin: 0.75 (0.43–1.30), pravastatin: 0.98 (0.72–1.34), rosuvastatin: 0.49 (0.35–0.68) and simvastatin: 0.62 (0.46–0.84)]. The preventive effect of statins on non-fatal ACS reached its maximum after one to four years of use. Conclusion: A similar magnitude of effect for statin use was observed in real life, as compared to randomised clinical trials in France. [Copyright &y& Elsevier]

Interest in focal therapy for prostate cancer has recently been renewed owing to downward stage migration, improved biopsy and imaging techniques, and the prevalence of either unifocal cancer or a dominant cancer with secondary tumors of minimal malignant potential. Several techniques have potential for focal ablation of prostate cancer. Cryotherapy has been used for some time as primary therapy for complete ablation of the prostate or local recurrence after radiotherapy. Enthusiasm for cryotherapy as the primary therapy has been tempered by the uncertainty about complete ablation of the cancer, the frequent persistence of measurable prostate-specific antigen levels after the procedure, and a high rate of erectile dysfunction. Studies have reported “focal ablation” of prostate cancer with cryotherapy, targeting 1 side of the gland to eliminate a cancer confined to that side with less risk of urinary or sexual complications. Whether cryotherapy has sufficient power to eradicate focal cancer and can be targeted with sufficient accuracy to avoid damage to surrounding structures remains to be demonstrated in prospective clinical trials. High-intensity focused ultrasound (HIFU) has been used widely in Europe for complete ablation of the prostate, especially in elderly men who are unwilling or unable to undergo radical therapy. For low- or intermediate-risk cancer, the short- and intermediate-term oncologic results have been acceptable but need confirmation in prospective multicenter trials presently underway. Whole gland therapy with transrectal ultrasound guidance has been associated with a high risk of acute urinary symptoms, often requiring transurethral resection before or after HIFU. Adverse effects on erectile function seem likely after a therapy that depends on heat to eradicate the cancer, but erectile function after HIFU has not been adequately documented with patient-reported questionnaires. HIFU holds promise for focal ablation of prostate cancer. As with cryotherapy, focal HIFU should reduce the adverse sexual, urinary, and bowel effects of whole gland ablation. New techniques are being developed to allow HIFU treatment under real-time guidance using magnetic resonance imaging, which could improve the precision and reduce the adverse effects further. Another promising technique, currently in clinical trials, is vascular-targeted photodynamic therapy, which has been used for whole gland ablation of locally recurrent cancer after radiotherapy and, more recently, for focal ablation of previously untreated cancer. In combination with a new, systemically administered photodynamic agent, laser light is delivered through fibers introduced into the prostate under ultrasound guidance. This technique does not heat the prostate but destroys the endothelial cells and cancer by activating the photodynamic agent. Damage to surrounding structures appears to be limited and can be controlled by the duration and intensity of the light. We have reviewed the principles of focal therapy and these new therapeutic modalities. [Copyright &y& Elsevier]

The dramatic increase during the past decade in prostate-specific antigen (PSA) testing and prostate biopsies has resulted in the detection of large numbers of small lesions, an increase in the incidence of prostate cancer, and an increasing incidence-to-mortality ratio. Currently, the risk of being diagnosed with prostate cancer is increasingly greater than the risk of dying of it. The currently available treatments for prostate cancer are not well suited to treating small or indolent tumors. Radical treatment, whether surgery or radiotherapy, can eradicate cancer effectively, but these techniques, as well as hormonal manipulations, can have adverse effects on patients'' health and quality of life. Watchful waiting, or “active surveillance,” has the advantage of avoiding the deleterious effects on quality of life, but it confronts patients with the emotional burden of living with an untreated cancer that could progress and metastasize. For active surveillance, no established, objective criteria are available for progression that would signal the optimal time for therapeutic intervention. PSA levels in patients with low-risk, small-volume cancers are more indicative of the size of the benign prostate or the presence of inflammation than of changes in the volume or growth of the cancer, and PSA levels inherently fluctuate, creating a low signal-to-noise ratio until the cancer is very large. Little risk exists in waiting to confirm a sustained increase in the PSA level before proceeding with a diagnostic biopsy. This policy would decrease the number of unnecessary biopsies, but still diagnose men within a safe timeframe. In studies controlled for age and comorbidity, the survival rate for patients with low-risk prostate cancer mirrors that expected in the general population. This holds true across cohorts of patients, whatever the treatment used. Because no strong medical or scientific evidence supports any particular ablative technique for low-risk prostate cancer, no standard of care has been universally accepted. Therefore, practice patterns are heterogeneous and depend more on the availability of treatments than on the features of the disease itself. [Copyright &y& Elsevier]