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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.

PRECIS-2 : making trials matter : providing an empirical basis for the selection of pragmatic design choices in clinical trials

Loudon, Kirstine January 2015 (has links)
Aim PRECIS (PRagmatic Explanatory Continuum Indicator Summaries 2009) is a tool with a simple wheel format that trialists can use when designing their trials to improve the applicability of results but users highlighted problems. The aim of the study was to produce an improved and validated version of PRECIS, called PRECIS-2 and test this tool out with trial teams designing primary care trials. Methods Brainstorming and a 2-round Delphi survey of authors who cited PRECIS plus user-testing of candidate PRECIS-2 models was followed by validity and reliability testing of the most promising PRECIS-2 candidate using a sample of 15 trials rated by 19 different trialists. The validated PRECIS-2 tool was then used to consider the risk of bias (internal validity) and estimates of treatment effect of a matched set of explanatory (ideal conditions) and pragmatic (real world) trials. The PRECIS-2 website was also created with a database of pragmatic trials and a toolkit for trial groups. This was tested out at the Pragmatic Clinical Trials Unit (PCTU) in London with trial teams designing primary care trials. Results Forty-two people responded to the Delphi and highlighted scoring, domain choice, and tool format as issues. An expert panel of 14 in Toronto provided the basis for a PRECIS-2 model that was then user tested by 19 other methodologists and trialists. After 13 iterations, a PRECIS-2 model with 9 domains (i.e. Eligibility, Recruitment, Setting, Organisation, Flexibility Delivery, Flexibility Adherence, Follow up, Primary Outcome, Primary Analysis) was tested for validity and reliability. Inter-rater reliability was generally good, with eight of nine domains having an ICC over 0.65. Discriminant validity was reasonable for all domains, though with wide confidence intervals. Matching trials taking pragmatic (‘real world’) and explanatory (‘ideal world’) approaches was challenging but we found no indication that a pragmatic approach compromises internal validity. We were unable to extract sufficient information for a planned analysis of estimates of treatment effect. At the PCTU, the tool highlighted differences in opinion with trial team members and demonstrated convergence of opinion following discussion. There was acknowledgment that scoring of PRECIS-2 domains assisted trials teams in considering the intended audience and creation of trials relevant to practice. Useful feedback was obtained to improve the PRECIS-2 tool software for users. Conclusions PRECIS was improved by the addition of scoring and additional domains after consultation with over 80 international trialists. We have a validated PRECIS-2, in the visually appealing wheel format with 9 spokes, which is being made available through an increasingly accessed website. Work at the PCTU improved the usability of the PRECIS-2 website and demonstrated that the tool increases transparency in trial design and assists trialists in considering applicability of trial results. More matching work on the impact of design approaches on effect size is needed, and further data to support the risk of bias results would be valuable.

Optimising the quality and effectiveness of risk : benefit appraisal methodologies utilised in randomised control trials

Brindley, David January 2015 (has links)
No description available.

Outcome reporting bias in randomised trials : implications for systematic reviews

Chan, An-Wen January 2003 (has links)
Background Selective reporting of outcomes within a published study based on their nature or direction can result in systematic differences between reported and unreported data. Direct evidence of outcome reporting bias is limited to case reports. Objective To study empirically the nature of outcome reporting bias in randomised controlled trials (RCTs). Methods Three cohorts of RCTs were identified: PubMed-indexed RCTs published in December 2000; trial protocols approved by a Danish ethics committee from 1994-95; and trial protocols funded by a government agency in Canada from 1990-98. Data on reported and unreported outcomes were recorded from all trial publications and a survey of authors. An outcome was considered incompletely reported if insufficient data were presented for meta-analysis. Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial, and then pooled using a random effects meta-analysis. Protocols and publications were also reviewed for discrepancies in primary outcome reporting. Results 519 trials with 10,557 outcomes, 102 trials with 3613 outcomes, and 48 trials with 1390 outcomes were identified for the PubMed, ethics committee, and funding agency cohorts respectively. 22%-35% of outcomes per parallel group study were, on average, incompletely reported for meta-analysis. Fully reported outcomes had a two- to three-fold higher odds of being statistically significant compared to incompletely reported outcomes. The most common reasons given for omitting outcomes included a lack of clinical importance, lack of statistical significance, and space constraints. Major discrepancies between primary outcomes in protocols and publications were found in one half of trials. Discussion and conclusions The reporting of trial outcomes is frequently inadequate for meta-analysis; is biased to favour statistical significance; and is inconsistent with pre-specified protocol outcomes. Unacknowledged modifications to outcomes specified in trial protocols constitute scientific misconduct. Meta-analyses may therefore produce inflated and unreliable estimates of treatment effect.

Marqueurs non-invasifs de stéatose et fibrose hépatique / Non-invasive markers of steatosis and liver fibrosis.

Perazzo Pedroso Barbosa, Hugo 14 March 2014 (has links)
Les méthodes non invasives d'évaluation des lésions tissulaires hépatiques les plus utilisées et les mieux validées sont l'élastométrie et le FibroTest. La stéatopathie non-alcoolique (NAFLD) est devenue la forme la plus fréquente de maladie hépatique. Différentes études suggèrent que la NAFLD est associée à un risque accru de mortalité, en particulier d'origine cardiovasculaire. Les objectifs de cette thèse étaient 1) de mieux définir certaines limites des méthodes non invasives d'évaluation de la fibrose hépatique; 2) d'évaluer la valeur pronostique du FibroTest et d'un biomarqueur de stéatose, le SteatoTest chez les patients ayant un diabète et/ou une dyslipidémie. Le travail réalisé a permis de montrer une variabilité interobservateur notable de l'élastométrie entre deux opérateurs expérimentés dans l'hépatite chronique virale C. La stéatose du foie, estimée par le SteatoTest, a été identifiée comme un facteur indépendant associé à la surestimation de la fibrose du foie par l'élastométrie chez les sujets ayant un diabète de type 2. Nous avons également mis en évidence une variabilité du test APRI et l'impact de l'activité nécrotico-inflammatoire sur ce test dont la formule comprend l'aspartate transaminase exprimée en multiple de la normale dans l'hépatite chronique virale C. Chez des patients à haut risque de NAFLD, nous avons pu démontrer la valeur pronostique à 10 ans du FibroTest et du SteatoTest, pour prédire la mortalité globale indépendamment des facteurs métaboliques. Le FibroTest était également prédictif de la mortalité d'origine hépatique et de l'incidence des complications cardiovasculaires et le SteatoTest de la mortalité d'origine cardiovasculaire / Several non-invasive methods have been proposed to replace liver biopsy. Transient elastography and FibroTest are the most widely used and best validated non-invasive methods to assess liver fibrosis. Subjects with metabolic disorders such as type-2 diabetes or dyslipidemia, have a high risk of non-alcoholic fatty liver disease (NAFLD). Evidence was previously provided to indicate that NAFLD is associated with an increased risk of cardiovascular disease and overall mortality. The aims of this thesis were. 1) to evaluate the main limitations of non-invasive methods to assess liver fibrosis. 2) to evaluate the prognostic value of liver biomarkers, such as FibroTest and SteatoTest, in patients with type-2 diabetes and/or dyslipidemia. We demonstrated a marked interobserver variability of transient elastography between two experienced operators in chronic hepatitis C. Hepatic steatosis, estimated by SteatoTest, was identified as an independent factor associated with an overestimation of liver fibrosis by transient elastography in patients with type-2 diabetes. We could also show the variability of the APRI test, based on the expression of aspartate aminotransferase relative to the upper limit of normal and the risk of overestimating fibrosis stage by this test due to necro-inflammatory activity in chronic hepatitis C. We reported that FibroTest and SteatoTest had a 10-year prognostic value for prediction of overall mortality independently of metabolic factors in patients at high risk of NAFLD. FibroTest was also predictive of liver-related death and incidence of cardiovascular events. In addition, SteatoTest had a prognostic value for cardiovascular-related death.

Economic evaluation of factorial randomised controlled trials

Dakin, Helen A. January 2015 (has links)
Factorial randomised controlled trials (RCTs) evaluate two or more interventions simultaneously, enabling assessment of interactions between treatments. This thesis presents literature reviews, methodological reviews, simulation studies and applied case studies that explore methods for assessing cost-effectiveness based on factorial RCTs. My systematic review suggests that factorial RCTs account for around 3% of trial-based economic evaluations, although there is currently no guidance or methodological work indicating the most appropriate methods. Around 40% of published studies assumed no interaction between treatments and many were poorly-reported. Various mechanisms are likely to produce large interactions within economic endpoints such as costs, quality-adjusted life-years (QALYs) and net benefits. Failing to take account of interactions can introduce bias and prevent efficient allocation of healthcare resources. I developed the opportunity cost of ignoring interactions as a measure of the implications of this bias. However, allowing for small, chance interactions is inefficient, potentially leading to over-investment in research if trial-based evaluations are used to inform decisions about subsequent research. Nonetheless, analyses on simulated trial data suggest that the opportunity cost of adopting a treatment that will not maximise health gains from the healthcare budget is minimised by including all interactions regardless of magnitude or statistical significance. Different approaches for conducting economic evaluations of factorial RCTs (including regression techniques, extrapolation using patient-level simulation, and considering different components of net benefit separately) are evaluated within three applied studies, including both full and partial factorials with 2x2 and 2x2x2 designs. I demonstrate that within both trial-based and model-based economic evaluation, efficient allocation of healthcare resources requires consideration of interactions between treatments, and joint decisions about interacting treatments based on incremental cost-effectiveness evaluated “inside-the-table” on a natural scale. I make recommendations for the design, analysis and reporting of factorial trial-based economic evaluations based on the results of this thesis.

Apport potentiel de la spectroscopie Raman dans le traitement chirurgical des carcinomes cutanés (CBC) / Potential contribution of Raman spectroscopy in the surgical treatment of skin carcinomas (BCC)

Mainreck, Nathalie 24 January 2017 (has links)
Le carcinome basocellulaire (CBC) est un cancer cutané très fréquent représentant un problème de santé publique majeur. Il métastase rarement mais peut devenir très invasif localement s’il n’est pas pris en charge rapidement. Actuellement, le diagnostic de certitude du CBC est obtenu par examen anatomopathologique de coupes fines ; ce qui présente pour inconvénient d’être invasif et de donner une réponse différée. De plus, la chirurgie du CBC ne bénéficie pas d’outil permettant de définir en temps réel la largeur optimale des marges de sécurité ; celles-ci devant être minimales pour éviter les séquelles esthétiques mais suffisantes pour empêcher toute récidive. L’objectif de ces travaux de thèse est d’évaluer l’apport potentiel de la spectroscopie Raman dans la prise en charge du CBC. Cette technologie applicable in vivo grâce au développement de sondes adaptées, permet une exploration tissulaire à un niveau moléculaire relativement rapide. Au total, 32 patients ont été inclus dans cette étude. A partir des spectres enregistrés in vivo, un modèle de discrimination CBC / peau saine a été développé, à partir duquel les marges d’excision latérales ont pu être évaluées. Les marges profondes ont également été étudiées après enregistrement de spectres sur les pièces fraichement excisées. Des marqueurs Raman de discrimination ont été identifiés aux différentes échelles in vivo, ex vivo et in vitro; ils constituent des bio-indicateurs potentiels pour orienter la prise de décision chirurgicale. Enfin, la contribution des fonds spectraux, habituellement écartés des analyses Raman, a été considérée et leur intérêt dans le cadre de ce projet a été discuté. / Basal cell carcinoma (BCC) is the most common skin cancer and a major problem for healthcare services worldwide. BCC rarely metastasizes but can become highly damaging for surrounding tissue in case of late diagnosis. Actually, the gold standard for BCC diagnosis relies on histopathological assessment of thin sections, but it is an invasive method which provides a delayed response. Moreover, it will be helpful during surgery of BCC to assess in real-time the optimal size of the security margins, which has to be small enough to minimize aesthetic sequelae but sufficient to avoid recurrence. The aim of this work is to evaluate the potential contribution of Raman spectroscopy in the management of BCC. This technology can be applied in vivo thanks to the development of appropriate probes and allows a relatively rapid tissue exploration at a molecular level. A total of 32 patients were included in this study. From in vivo recorded spectra, a model of discrimination BCC / healthy skin was implemented, from which the width of excision margins was evaluated. Deep margins were also studied after recording spectra on freshly excised pieces. Discriminant Raman markers were identified at different levels in vivo, ex vivo and in vitro; they are potential bio-indicators to help the surgeon to define ideal excision margins. In addition, the contribution of spectral backgrounds, usually removed from Raman analysis, was considered and their interest in this project was discussed

Couplage "complexe récepteur de l'élastine / récepteur de l'insuline" : la désialylation des glycanes comme facteur d'insulino résistance / Elastin complex receptor / Insulin receptor : the glycan desialylation as an insulin-resistance factor

Guillot, Alexandre 30 January 2017 (has links)
Longtemps considérée comme un simple support mécanique, la matrice extracellulaire (MEC) est un élément majeur dans le maintien de l’homéostasie. Ainsi l’élastine, principal constituant de la MEC des gros vaisseaux élastiques, est dégradée au cours du vieillissement, produisant ainsi des peptides d’élastine bioactifs (PE). Plusieurs études ont démontré l'implication des PE en physiopathologies tels que l’invasion tumorale, l’athérosclérose ou l’insulino-résistance (IRes). Ces effets s’expliquent par l’activation du complexe récepteur de l’élastine (CRE), composé par : une sous-unité extracellulaire liant les PE (EBP, elastin binding protein), la cathepsine A (dont le rôle reste inconnu), et la neuraminidase 1 (induisant la signalisation intracellulaire). L'IRes décrite, pourrait être associée à l’activité de désialylation de la neuraminidase-1 sur les chaines de N-glycosylation (Ng-c) du récepteur de l’insuline (RI). Sur la base de cette hypothèse, notre objectif a donc été de confirmer ce mécanisme et ses conséquences in silico (sur le RI), in vitro (pré-adipocytes 3T3-L1) et in vivo (aorte de souris). Nous montrons ainsi in vitro que les PE provoquent un dysfonctionnement de l’autophosphorylation du RI se répercutant sur plusieurs processus cellulaires comme l’entrée du glucose ou encore la différenciation adipocytaire. In silico, nous montrons pour la première fois le rôle des acides sialiques sur le comportement des Ng-c d'une part et sur le RI d'autre part. Enfin, in vivo, cette interaction CRE / IR engendre une hypertension artérielle par une diminution de la vasorelaxation des cellules endothéliales. / Often considered as a simple mechanical support, the extracellular matrix (ECM) is a major element of homeostasis regulation. Thus, elastin, the main constituent of large elastic vessels, is degraded during aging, producing bioactive elastin-derived-peptides (EDP). Several studies have demonstrated the EDP effects in physiopathologies such as tumor invasion, atherosclerosis, or insulin resistance (IRes) development. Those effects are explained by the activation of the elastin receptor complex (CRE), composed of: an extracellular subunit binding EDP (EBP, elastin binding protein), cathepsin A (its role is still unknown) and the sialidase neuraminidase-1 (Neu-1, involved in signaling pathway induction). Interestingly, the lab suggested that IRes may be induced by the desialylation of the N-glycan chains (Ng-c) on the insulin receptor (IR). The aim of this study was to confirm this hypothesis by demonstrating the consequence of desialylation on the IR in silico, on a 3T3-L1 pre-adipocyte cell in vitro, and on vascular complications in vivo. We show that EDP induce in vitro an impairment of IR autophosphorylation, affecting glucose uptake and adipocyte differentiation. In silico approach demonstrates the role of sialic acids on the behavior of Ng-c in the one hand and in other hand of IR. Finally, the IRes induced by ERC-IR interaction increase the vascular complication such as arterial hypertension by endothelial cell impairment. To conclude, Ng-c alteration would likely be responsible for structural changes in the IR at the origin of insulin resistance.

Diagnostic pré-symptomatique rapide du sepsis par spectroscopie vibrationnelle / Rapid pre-symptomatic diagnosis of sepsis by vibrational spectroscopy

Lovergne, Lila 25 January 2018 (has links)
Le sepsis est une dérégulation de la réponse de l’hôte à une infection, associé à un dysfonctionnement des organes engageant le pronostic vital du patient. Plus de 30 millions de cas et 5 millions de décès sont estimés par an dans le monde. Le diagnostic du sepsis est basé sur des signes cliniques non spécifiques et la longue procédure d’identification des pathogènes responsables de l’infection. L’objectif de cette étude est de développer et d’évaluer le potentiel de la spectroscopie vibrationnelle appliquée au sérum pour améliorer le diagnostic du sepsis. Les défis inhérents à la nature de l’échantillon et à la technique de même que certains paramètres pré-analytiques ont été évalués pour assurer la qualité des données. Les variations de contenu en eau des échantillons après séchage pouvant affecter la discrimination des données, ont été corrigées en testant différentes méthodes. Enfin, des sérums de patients septicémiques (n=380) collectés avant chirurgie et jusqu’à 3 jours avant et le jour du diagnostic ont été analysés. Les échantillons du groupe contrôle (n=353) collectés suivant la même cinétique, provenant de patients ayant un profil similaire en termes d’âge, de sexe, de procédure chirurgicale subie mais n’ayant pas développé de sepsis et des échantillons (n=180) de patients atteints d’un syndrome de réponse inflammatoire systémique collectés avant chirurgie et le jour du diagnostic ont également été analysés. Les données acquises ont été exploitées par méthodes chimiométriques pour discriminer des zones spectrales reflétant des différences de composition moléculaire avec des sensibilités et spécificités supérieures à 70% malgré l’influence de l’eau résiduelle. / Sepsis is a dysregulated host response to an infection that causes life-threatening organ dysfunction. Each year, over 30 million cases and 5 million deaths are estimated worldwide. Diagnosis of sepsis is based on non-specific clinical signs and time consuming positive identification of the causative pathogen. The objective of this study is to develop and evaluate the potential of vibrational spectroscopy applied to human serum to improve diagnosis of sepsis. Challenges of serum spectroscopy inherent to the sample nature and preparation as well as to the technique have been assessed to determine the most suitable methodological approach. Then, some aspects of the pre-analytical phase have been addressed in order to standardise protocols in sample handling and preparation for spectral acquisitions to ensure quality and reproducibility of spectral data collected. Different methods have been tested to correct water content variations in dried serum, which can impact on data discrimination. Finally, based upon the developed methodology, patient serum samples (n=380) collected before surgery, up to 3 days before sepsis diagnosis, and on the day of sepsis diagnosis have been analysed. Control serum samples (n=353) from age/ sex/ procedure-matched patients who did not go on to develop sepsis have been also analysed over similar timeframes post-surgery as well as samples (n=180) from patients with systemic inflammatory response syndrome. Spectral data acquired have been interrogated by chemometric methods to identify spectral zones reflecting differences in molecular composition allowing discrimination with over 70% of sensitivities and specificities despite water interferences.

Description d'un mécanisme, à l'origine de l'induction de la réponse SOS par les aminosides chez Escherichia coli, favorisant l'émergence de la résistance aux fluoroquinolones. / A mechanism for aminoglycosides-mediated SOS induction in Escherichia coli that cross-selects for fluoroquinolone resistance

Babosan, Anamaria 25 May 2018 (has links)
L’émergence des déterminants de résistances plasmidiques aux quinolones (PMQR), auxquels appartient le gène qnrD, participent de manière significative à la sélection des résistances de haut-niveau aux permet les réparations de l’ADN lors des stress soumis aux bactéries, et d’autre part, que les aminosides, une autre classe d’antibiotiques que les fluoroquinolones, induisaient la réponse SOS chez Escherichia coli. En effet, nous avons montré que les petits plasmides-qnrD chez E. coli, induisent la formation de monoxyde de nitrogène et l’inhibition de la voie de détoxification Hmp-dépendante. Ces processus génèrent des lésions à l’ADN qui s’ajoutent à celles occasionnées par les aminosides concourant à activer la réponse SOS chez E. coli. L’ensemble de nos résultats montrent que l’émergence de la résistance aux fluoroquinolones peut être occasionnée par l’exposition d’E. coli à une autre classe d’antibiotiques, ici les aminosides. / The emerging plasmid-mediated quinolones resistance (PMQR) determinants significantly participate in the selection of high-level of resistance to the major antibiotics fluoroquinolones, leading to numerous clinical failures. In this study, we reported for the first time that PMQR expression could be triggered by the fluoroquinolones but also by another major class of antibiotics, the aminoglycosides. We were able to show that this unique cross selection of antibiotic resistance was the consequence of the PMQR determinant qnrD being SOS-regulated in a RecA-LexA dependent manner. We demonstrated that sub inhibitory concentration of aminoglycoside induced nitric oxide formation associated with the repression of the Hmp-mediated detoxification pathway, resulting in the induction of the SOS response and thus up-regulation of the PMQR. Overall, our findings revealed an unexpected antibiotic resistance cross-selection with low aminoglycosides concentrations promoting emergence of fluoroquinolones resistance.

Evaluation de l'activité antibactérienne d'éléments en alliages de cuivre dans des établissements de santé. / Evaluation of antibacterial properties of copper alloys surfaces in long-term geriatric care facilities.

Colin, Marius 29 March 2019 (has links)
En France, les infections associées aux soins concernent environ un patient hospitalisé sur vingt. Les pathogènes en cause se transmettent d’unepersonne à l’autre par contact direct entre les personnes mais aussi par les surfaces de contact sur lesquelles certains microorganismes peuventpersister jusqu’à plusieurs mois. Le cuivre étant un puissant antimicrobien naturel, des éléments en alliages de cuivre ont été conçu. Ce travailde thèse vise à étudier la capacité de ces éléments à réduire les contaminations bactériennes lors d’une utilisation prolongée en établissementsde santé. Pour cela, cinq EHPAD et une MARPA (Marne, France) ont été équipées à 50% de poignées de portes et rampes de maintien en alliagesde cuivre. Plus de 1300 prélèvements bactériologiques ont été effectués sur la surface des éléments en établissements entre 1,5 et 3,5 ans aprèsleur installation. Les bactéries récoltées ont été cultivées sur différents milieux gélosés et les unités formant colonie ont pu être dénombrées. Ledénombrement a révélé que les niveaux de contamination sont significativement plus faibles sur les poignées et rampes en cuivre que sur leséléments standards. L’identification des souches bactériennes récoltées a ensuite été effectuée par spectrométrie de masse MALDI-TOF. Cetteanalyse a montré que les genres prédominants sur les surfaces de contact sont Staphylococcus et Micrococcus, et que les genres Staphylococcus,Streptococcus et Roseomonas sont significativement moins fréquents sur les éléments en cuivre. L’espèce pathogène. S. aureus a été observémoins fréquemment sur les éléments en cuivre que sur les éléments standard. Les éléments en alliage de cuivre sont donc efficaces pour éviterdes contaminations bactériennes de surfaces en milieux de santé. De plus, les propriétés antibactériennes des éléments en alliages de cuivresont conservées plusieurs années après leur mise en service, soulignant l’intérêt de leur utilisation en milieu de santé. / In France, healthcare-associated infections concern one on twenty patients during hospitalization. Pathogenic microorganisms spread from oneperson to another by direct contact between people, but also through touch surfaces where the can persist up to several months. Copper is anatural and powerful antimicrobial metal. Thus, copper alloyed elements and surfaces have been designed and manufactured. This thesis workaims to investigate on the ability of copper elements to reduce bacterial contaminations during an extended period of use in healthcare facilities.Five long-term care facilities were 50% outfitted with copper alloyed door handles and handrails. Over 1300 samplings were performed between1.5 and 3.5 years after copper elements installation. Sampled bacteria were cultivated on a range of agar plates and colony forming units werecounted. It revealed that contamination levels were lower on copper door handles and handrails than on controls. Identifications of sampledbacterial strains were then performed by MALDI-TOF mass spectrometry. This analysis showed that Staphylococcus and Micrococcus largelyprevailed on touch surfaces and that Staphylococcus, Streptococcus and Roseomonas are significantly less frequent on copper elements surfaces.Pathogenic species S. aureus was less frequently observed on copper elements than on controls. This study suggests that copper alloyedelements are effective to limit bacterial contaminations of surfaces in healthcare facilities. Moreover, these elements still display significativeantibacterial properties after several years of use. Thus, copper alloyed elements represent a very promising solution to control bacterialcontamination of touch surfaces in healthcare facilities.

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