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1.
J Womens Health (Larchmt) ; 31(10): 1472-1480, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35834620

ABSTRACT

Objective: We assessed whether general practitioner (GP) delivery of a vaginal self-sampling kit was non-inferior to home-mailed delivery on cervical cancer screening (CCS) participation. Methods: Two hundred and ten French GPs from Indre-et-Loire French department were randomized into two groups, and their unscreened women patients aged 30-65 were included in February-March 2015. In the GP delivery group (n = 105 GPs; 1,806 women), women were sent a reminder letter inviting them to collect a vaginal self-sampling kit at their regular GP's practice. In the home-mailed delivery group (n = 105 GPs; 1,806 women), women were sent a reminder letter with a vaginal self-sampling kit directly at home. The primary outcome was participation in complete CCS within 9 months. A cost-effectiveness analysis was also performed. Results: At 9 months, 14.9% (95% CI: 12.9-16.9) and 27.9% (95% CI: 25.7-30.0) of women in the GP and home-mailed delivery groups participated in complete CCS. The absolute between-group difference was -13.0 percentage points (95% CI: -15.9 to -10.0) in favor of the home-mailed delivery group, crossing the non-inferiority pre-defined non-inferiority margin of 5%. The home-mailed delivery strategy cost 50.81€ more per additional woman screened. Conclusions: The GP delivery was inferior to home-mailed delivery in increasing participation in CCS. Home-mailed delivery of a vaginal self-sampling kit is a cost-effective way to increase CCS in that the additional cost of this strategy seems acceptable. This study is registered at www.Clinicaltrials.gov NCT02255084.


Subject(s)
General Practitioners , Papillomavirus Infections , Uterine Cervical Neoplasms , Female , Humans , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/prevention & control , Early Detection of Cancer , Cost-Benefit Analysis , Papillomaviridae , Papillomavirus Infections/diagnosis , Specimen Handling , Mass Screening , Vaginal Smears
2.
BMC Womens Health ; 21(1): 221, 2021 05 26.
Article in English | MEDLINE | ID: mdl-34039341

ABSTRACT

BACKGROUND: The purpose of this study was to compare cervical cancer screening by pap smear (PS) versus preliminary HPV testing based on self-collected samples (SC-HPV). METHODS: Interventional study among underprivileged women from 25 to 65 years old in four French cities. The control group (CG) was referred for a PS. The experimental group (EG) conducted a SC-HPV test followed by a PS in case of positivity. Differences on screening completion and cytological abnormalities were analysed by logistic and Cox regression. RESULTS: 383 women were assigned to the EG and 304 to the CG. The screening completion proportion was 39.5% in the CG compared to 71.3% in the EG (HR = 2.48 (CI 95% [1.99-3.08]; p < 0.001). The proportion of cytological abnormalities was 2.0% in the CG and 2.3% in the EG (OR = 1.20 (CI 95% [0.42-3.40]; p = 0.7). The proportion of participants lost to follow-up was 60.5% in the CG and 63.2% in the EG HPV positive (p = 0.18). CONCLUSION: Providing an SC-HPV-test increased the participation of underprivileged women in CCS. Nevertheless, the significant number of lost to follow-up in both groups can undermine the initial benefits of the strategy for HPV positive women. Registration: Clinicaltrials.gov: NCT03118258.


Subject(s)
Papillomavirus Infections , Uterine Cervical Neoplasms , Adult , Aged , Early Detection of Cancer , Female , France , Humans , Mass Screening , Middle Aged , Papanicolaou Test , Papillomaviridae , Papillomavirus Infections/diagnosis , Uterine Cervical Neoplasms/diagnosis , Vaginal Smears
3.
Joint Bone Spine ; 82(1): 52-5, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25241339

ABSTRACT

INTRODUCTION: Despite reliable diagnostic methods and effective drugs, the prevention and management of osteoporosis seems insufficient in France. We evaluated bone mineral density (BMD) assessment and prescription of anti-osteoporotic drugs after forearm fracture in women. METHODS: We used a health insurance database for outpatients from private clinics in a French population of more than 500,000 inhabitants. Medical expenses were analyzed for women 50 years of age or older who had a forearm fracture between August 1, 2010 and June 30, 2012. RESULTS: We identified 250 forearm fractures in women during the study period. In total, 12 women (4.8%) underwent BMD assessment before the fracture and were not taken into account in the analysis. For the 238 others, 24 (10.1%) had undergone BMD assessment at a median of 4 months after the fracture. A total of 32 women (13.4%) received an anti-osteoporotic drug at the time of the fracture and 14 of 206 untreated women (6.8%) received an anti-osteoporotic drug at a median of 3.8 months after the fracture. Receipt of an anti-osteoporotic drug was more frequent for women with than without BMD assessment after the fracture (8/19 [40.1%] versus 6/187 [3.2%]; P<0.005). CONCLUSION: This work, performed in a large sample, suggests that only 10% of women 50 years of age or older in France undergo BMD assessment after a forearm fracture and that BMD assessment is associated with anti-osteoporotic drug prescription.


Subject(s)
Bone Density Conservation Agents/therapeutic use , Bone Density , Forearm Injuries/drug therapy , Osteoporotic Fractures/drug therapy , Aged , Aged, 80 and over , Databases, Factual , Female , Forearm Injuries/etiology , France , Humans , Insurance, Health , Middle Aged , Osteoporosis/complications , Osteoporosis/diagnosis , Osteoporosis/drug therapy , Osteoporotic Fractures/diagnosis , Osteoporotic Fractures/etiology
4.
Am J Med ; 127(10): 972-8, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24929021

ABSTRACT

BACKGROUND: Patients with nonvalvular atrial fibrillation are often denied oral anticoagulation due to falls risk. The latter is variably defined, and existing studies have not compared the associated risk of bleeding with other cardiovascular events. There are no data about outcomes in individuals with nonvalvular atrial fibrillation with a prior history of (actual) falls, rather than being "at risk of falls." Our objective was to evaluate the risk of cardiovascular outcomes associated with prior history of falls in patients with atrial fibrillation in a contemporary "real world" cohort. METHODS: Patients with nonvalvular atrial fibrillation in a 4-hospital institution between 2000 and 2010 were included. Stroke/thromboembolism event rates were calculated according to prior history of falls. Risk factors were investigated by Cox regression. RESULTS: Among 7156 atrial fibrillation patients, prior history of falls/trauma was uncommon (n = 76; 1.1%). Compared with patients without history of falls, those patients were older and less likely to be on oral anticoagulation; they also had higher risk scores for stroke/thromboembolism but not for bleeding. Compared with no prior history of falls, rates of stroke/thromboembolism (P = .01) and all-cause mortality (P < .0001) were significantly higher in patients with previous falls. In multivariable analyses, prior history of falls was independently associated with stroke/thromboembolism (hazard ratio [HR] 5.19; 95% confidence interval [CI], 2.1-12.6; P < .0001), major bleeding (HR 3.32 [1.23-8.91]; P = .02), and all-cause mortality (HR 3.69; 95% CI, 1.52-8.95; P = .04), but not hemorrhagic stroke (HR 4.20; 95% CI, 0.58-30.48; P = .16) in patients on oral anticoagulation. CONCLUSION: In this large "real world" atrial fibrillation cohort, prior history of falls was uncommon but independently increased risk of stroke/thromboembolism, bleeding, and mortality, but not hemorrhagic stroke in the presence of anticoagulation. Prior history of (actual) falls may be a more clinically useful risk prognosticator than "being at risk of falls."


Subject(s)
Accidental Falls/statistics & numerical data , Atrial Fibrillation/drug therapy , Hemorrhage/etiology , Stroke/etiology , Thromboembolism/etiology , Warfarin/therapeutic use , Accidental Falls/prevention & control , Age Distribution , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Cause of Death , Contraindications , Female , Follow-Up Studies , France/epidemiology , Hemorrhage/prevention & control , Humans , Male , Multivariate Analysis , Proportional Hazards Models , Risk Assessment/methods , Sex Distribution , Stroke/prevention & control , Thromboembolism/prevention & control , Warfarin/adverse effects
5.
Chest ; 146(3): 719-726, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24722973

ABSTRACT

BACKGROUND: The efficacy and safety of anticoagulation with use of vitamin K antagonists (VKAs) is highly dependent on the quality of anticoagulation control as reflected by the average time in a therapeutic range of 2.0 to 3.0. A clinical dilemma is trying to predict which anticoagulation-naive patients with atrial fibrillation (AF) would do well on a VKA (with a time in therapeutic range > 70%) and which are less likely to do well on a VKA but could be managed with novel oral anticoagulants. METHODS: The cohort comprised 8,120 patients, among whom 4,637 patients were receiving VKA. We investigated whether the SAMe-TT2R2 (sex female, age < 60 years, medical history [more than two comorbidities], treatment [interacting drugs, eg, amiodarone for rhythm control], tobacco use [doubled], race [doubled]) score could discriminate among patients with AF who were likely to have a labile international normalized ratio (INR) during follow-up as well as stroke/thromboembolism (TE), clinically relevant bleeding (defined as severe bleeding and as Bleeding Academic Research Consortium [BARC]-defined major bleeding), and death while being treated with a VKA. RESULTS: During a mean follow-up of 1,016 ± 1,108 days, there was a significant increase in risk of severe bleeding events (risk ratio [RR], 1.38; 95% CI, 1.12-2.68; P = .002) and a significant increase in risk of major BARC bleeding (RR, 1.77; 95% CI, 1.29-2.44; P = .0005) in patients with AF with a high SAMe-TT2R2 score (> 2). Increasing SAMe-TT2R2 score was associated with an increasing risk of labile INR (P = .004), stroke/TE (P = .007), severe bleeding (P < .0001), major BARC bleeding (P < .0001), and death (P = .002) at follow-up. Among the patients taking VKAs, the SAMe-TT2R2 score was predictive of labile INR (C statistic approximately 0.58) as well as of stroke/TE, severe bleeding, major BARC bleeding, and death (C statistic, 0.54-0.57 for events), reflecting the suboptimal time in therapeutic range in such patients. This was not the case for patients who were not taking VKAs. CONCLUSIONS: We demonstrate that the SAMe-TT2R2 score was predictive for an increasing risk of stroke/TE, severe bleeding, major BARC bleeding, and death, reflecting poor anticoagulation control (and labile INRs) among patients with AF given VKAs.


Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Cerebral Hemorrhage/epidemiology , International Normalized Ratio/methods , Risk Assessment/methods , Stroke/epidemiology , Vitamin K/antagonists & inhibitors , Adult , Age Factors , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Cerebral Hemorrhage/mortality , Cohort Studies , Comorbidity , Drug Interactions , Female , Follow-Up Studies , Humans , Male , Middle Aged , Predictive Value of Tests , Racial Groups , Sex Factors , Stroke/mortality , Survival Rate , Tobacco Use , Treatment Outcome , Vitamin K/adverse effects
6.
Thromb Haemost ; 103(4): 833-40, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20135077

ABSTRACT

In patients with atrial fibrillation (AF) and an intermediate risk of stroke (CHADS2 score =1), available evidence from clinical trials is inconclusive and the present guidelines for the management of AF indicate that the choice between oral anticoagulant and aspirin in these patients is open. Our goal was to evaluate whether, in patients with AF and only one moderate risk factor for thromboembolism, treatment with an oral anticoagulant is appreciably more beneficial than treatment with an antiplatelet agent. Among 6,517 unselected patients with AF, 1,012 of them (15.5%) had a CHADS2 score of 1 and were liable to treatment with an antiplatelet agent or an anticoagulant. An oral anticoagulant was prescribed for 606 patients (59.9%) and an antiplatelet agent or no antithrombotic treatment for 406 (40.1%). During follow-up (median=793 days, interquartile range=1,332 days), 105 deaths (10.4%) and 19 strokes (1.9%) were recorded. The administration of an anticoagulant was associated with a lower rate of events (relative risk=0.42, 95% confidence interval 0.29-0.60, p<0.0001) than when no anticoagulant was prescribed. Results remained similar after adjustment for age and other confounding factors. In contrast, prescription of an antiplatelet agent was not associated with a lower risk of events. Factors independently associated with an increased risk of events were older age (p<0.0001), concomitant heart failure (p=0.0002), diabetes (p=0.0025), lack of prescription of an anticoagulant (p<0.0001) and permanent AF (p=0.04). Thus, prescription of an anticoagulant is independently associated with a decreased risk of death or stroke among patients with AF and a CHADS2 score =1.


Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Fibrinolytic Agents/therapeutic use , Health Status Indicators , Platelet Aggregation Inhibitors/therapeutic use , Stroke/prevention & control , Administration, Oral , Age Factors , Aged , Aged, 80 and over , Anticoagulants/administration & dosage , Atrial Fibrillation/complications , Atrial Fibrillation/mortality , Chi-Square Distribution , Diabetes Complications/etiology , Disease-Free Survival , Drug Prescriptions , Drug Therapy, Combination , Female , Fibrinolytic Agents/administration & dosage , Heart Failure/complications , Humans , Incidence , Logistic Models , Male , Middle Aged , Platelet Aggregation Inhibitors/administration & dosage , Retrospective Studies , Risk Assessment , Risk Factors , Stroke/etiology , Stroke/mortality , Time Factors , Treatment Outcome
7.
Pediatr Radiol ; 36(10): 1037-42, 2006 Oct.
Article in English | MEDLINE | ID: mdl-16865391

ABSTRACT

BACKGROUND: A vestibular aqueduct midpoint width greater than 1.50 mm is currently considered to be pathognomonic for a large vestibular aqueduct syndrome. OBJECTIVE: To analyse the diameter of the vestibular aqueduct in children as a function of age and consequently to determine if a fixed measure could serve as a pertinent diagnostic criterion. MATERIALS AND METHODS: This was a retrospective study of 200 high-resolution CT scans of the ear in 100 patients aged 0-16 years and from various paediatric medical departments. On each CT scan, the lateral semicircular canal diameter, the vestibular aqueduct midpoint width between the external aperture and common crus, and the vestibular aqueduct external aperture diameter were measured. Spearman's rank test and the Mann-Whitney correlation test were used for an integrated statistical analysis. RESULTS: There was no statistically significant variability in vestibular aqueduct diameter as a function of age or sex of patients. CONCLUSION: A CT scan threshold value, fixed and independent of age and sex, is thus legitimate for the diagnosis of vestibular aqueduct dilatation.


Subject(s)
Vestibular Aqueduct/abnormalities , Vestibular Aqueduct/diagnostic imaging , Adolescent , Child , Child, Preschool , Endolymphatic Duct/abnormalities , Endolymphatic Duct/diagnostic imaging , Endolymphatic Sac/abnormalities , Endolymphatic Sac/diagnostic imaging , Female , Humans , Infant , Infant, Newborn , Male , Reference Values , Retrospective Studies , Statistics, Nonparametric , Tomography, X-Ray Computed
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