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The Health Technology Assessment (HTA) of esthetic procedures was performed by the French National Authority for Health (HAS), at the request of the French Ministry of Health (MoH), and under a new regulatory framework enabling the government to ban esthetic procedures considered harmful or potentially harmful to patients and consumers by HAS. Objectives: Describe HAS’ seven year experience with the safety assessment of four esthetic procedures.
This is an HAS review of its methods used in four HTAs for the following evaluated techniques: lipolysis; cryolipolysis; esthetic mesotherapy; and, ultraviolet (UV) radiation in tanning devices. The review aimed to describe how these assessments have been undertaken and information sources used, from 2010 to 2017, to appreciate the safety profile of these procedures.
A systematic literature review (SRL) and analysis was performed for all four HTAs. Since findings did not allow for thorough appreciation of safety, additional sources of information were consulted to address evidence gaps. Sources may have included any combination of the following: i) National and international health care authority data and alerts ii) Legal and ethical frameworks iii) Public consultation iv) Expert opinion v) Patient-consumer association opinion vi) Economic analysis
An adaptation of the HTA methodology was necessary to meet the specific requirements of these assessments. Despite sources accumulated and consulted within the seven year period, quantitative data were found insufficient to fully appreciate the safety profile for any one of the studied esthetic procedures. National regulatory reinforcement on the reporting of adverse events, with implementation of a centralized online tool, is expected to generate and capture reliable data on the frequency and severity of adverse events associated with esthetic procedures. Recent European Union (EU) regulatory requirements on the safety and performance of medical devices include equipment used for esthetic procedures, indicating agreement and alignment on national and EU-level monitoring efforts.
To establish whether continuous subglottic suctioning (CSS) could be cost-effective.
Cost-benefit analysis, based on a hypothetical replacement of conventional ventilation (CV) with CSS.
A surgical intensive care unit (SICU) of a tertiary care university hospital in France.
All consecutive patients receiving ventilation in the SICU in 2006.
Efficacy data for CSS were obtained from the literature and applied to the SICU of our hospital. Costs for CV and CSS were provided by the hospital pharmacy; costs for ventilator-associated pneumonia (VAP) were obtained from the literature. The cost per averted VAP episode was calculated, and a sensitivity analysis was performed on VAP incidence and on the number of tubes required for each patient.
At our SICU in 2006, 416 patients received mechanical ventilation for 3,487 ventilation-days, and 32 VAP episodes were observed (7.9 episodes per 100 ventilated patients; incidence density, 9.2 episodes per 10,000 ventilation-days). Based on the hypothesis of a 29% reduction in the risk of VAP with CSS than CV, 9 VAP episodes could have been averted. The additional cost of CSS for 2006 was estimated to be €10,585.34. The cost per averted VAP episode was €1,176.15. Assuming a VAP cost of €4,387, a total of 3 averted VAP episodes would neutralize the additional cost. For a low VAP incidence of 6.6%, the cost per averted VAP would be €1,323. If each patient required 2 tubes during ventilation, the cost would be €1,383.69 per averted VAP episode.
Replacement of CV with CSS was cost-effective even when assuming the most pessimistic scenario of VAP incidence and costs.
To evaluate the knowledge of healthcare students after four curricula on infection control and to identify sources of information.
Four healthcare schools at Rouen University (Rouen, France).
Medical students, nursing students, assistant radiologist students, and physiotherapist students taking public health courses.
To measure students' knowledge of infection control and their sources of information, 6 multiple-choice questions were asked about 3 specific areas: standard precautions, hand hygiene, and nosocomial infection. Each questionnaire section had 10 possible points, for an overall perfect score of 30. The sources of information for these 3 areas were also recorded: self-learning, practice training in wards, formal training in wards, and teaching during the curriculum. A logistic regression analysis was performed to identify factors associated with acceptable level of knowledge.
Three hundred fifty students (107 medical students, 78 nursing students, 71 physiotherapist students, and 94 assistant radiologist students) were included in the study. The mean overall score (±SD) was 21.5 ± 2.84. Nursing students had a better mean overall score (23.2 ± 2.35) than did physiotherapist students (21.9 ± 2.36), medical students (21.1 ± 2.35), and assistant radiologist students (20.5 ± 3.04; P < .001). The mean scores (±SD) for the component sections of the questionnaire were 8.5 ±1.4 for standard precautions, 7.4 ± 1.26 for hand hygiene, and 5.7 ± 1.55 for nosocomial infections (P < .001). The main source of information was material taught during the curriculum. Results of multivariate analysis indicate that the probability of attaining acceptable knowledge in each area was smaller for medical students and assistant radiologist students than for nursing students.
The overall score for infection control indicated that instruction was effective; however, knowledge levels were different by area (the best scores were results of tests of standard precautions) and curriculum (nursing students achieved the best overall score). Ward training for daily infection control practice (ie, bedside instructions training and course work) could be improved for healthcare students.
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