Publications by authors named "Isabella Locatelli"

44 Publications

Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS).

JMIR Res Protoc 2021 Mar 19;10(3):e25966. Epub 2021 Mar 19.

School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.

Background: Despite effective treatments, more than 30% of patients with diabetes will present with diabetic kidney disease (DKD) at some point. Patients with DKD are among the most complex as their care is multifactorial and involves different groups of health care providers. Suboptimal adherence to polypharmacy is frequent and contributes to poor outcomes. As self-management is one of the keys to clinical success, structured medication adherence programs are crucial. The PANDIA-IRIS (patients diabétiques et insuffisants rénaux: un programme interdisciplinaire de soutien à l'adhésion thérapeutique) study is based on a routine medication adherence program led by pharmacists.

Objective: The aim of this study is to define the impact of the duration of this medication adherence program on long-term adherence and clinical outcomes in patients with DKD.

Methods: This monocentric adherence program consists of short, repeated motivational interviews focused on patients' medication behaviors combined with the use of electronic monitors containing patients' medications. When patients open the electronic monitor cap to take their medication, the date and hour at each opening are registered. In total, 73 patients are randomized as 1:1 in 2 parallel groups; the adherence program will last 6 months in the first group versus 12 months in the second group. After the intervention phases, patients continue using their electronic monitors for a total of 24 months but without receiving feedback. Electronic monitors and pill counts are used to assess medication adherence. Persistence and implementation will be described using Kaplan-Meier curves and generalized estimating equation multimodeling, respectively. Longitudinal adherence will be presented as the product of persistence and implementation and modelized by generalized estimating equation multimodeling. The evolution of the ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified-Release Controlled Evaluation) and UKPDS (United Kingdom Prospective Diabetes Study) clinical scores based on medication adherence will be analyzed with generalized estimating equation multimodeling. Patients' satisfaction with this study will be assessed through qualitative interviews, which will be transcribed verbatim, coded, and analyzed for the main themes.

Results: This study was approved by the local ethics committee (Vaud, Switzerland) in November 2015. Since then, 2 amendments to the protocol have been approved in June 2017 and October 2019. Patients' recruitment began in April 2016 and ended in October 2020. This study was introduced to all consecutive eligible patients (n=275). Among them, 73 accepted to participate (26.5%) and 202 (73.5%) refused. Data collection is ongoing and data analysis is planned for 2022.

Conclusions: The PANDIA-IRIS study will provide crucial information about the impact of the medication adherence program on the adherence and clinical outcomes of patients with DKD. Monitoring medication adherence during the postintervention phase is innovative and will shed light on the duration of the intervention on medication adherence.

Trial Registration: Clinicaltrials.gov NCT04190251_PANDIA IRIS; https://clinicaltrials.gov/ct2/show/NCT04190251.

International Registered Report Identifier (irrid): DERR1-10.2196/25966.
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http://dx.doi.org/10.2196/25966DOI Listing
March 2021

Estimating the basic reproduction number for COVID-19 in Western Europe.

PLoS One 2021 17;16(3):e0248731. Epub 2021 Mar 17.

Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.

Objective: To estimate the basic reproduction number (R0) for COVID-19 in Western Europe.

Methods: Data (official statistics) on the cumulative incidence of COVID-19 at the start of the outbreak (before any confinement rules were declared) were retrieved in the 15 largest countries in Western Europe, allowing us to estimate the exponential growth rate of the disease. The rate was then combined with estimates of the distribution of the generation interval as reconstructed from the literature.

Results: Despite the possible unreliability of some official statistics about COVID-19, the spread of the disease appears to be remarkably similar in most European countries, allowing us to estimate an average R0 in Western Europe of 2.2 (95% CI: 1.9-2.6).

Conclusions: The value of R0 for COVID-19 in Western Europe appears to be significantly lower than that in China. The proportion of immune persons in the European population required to stop the outbreak could thus be closer to 50% than to 70%.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248731PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7968714PMC
March 2021

Alcohol consumption and neurocognitive deficits in people with well-treated HIV in Switzerland.

PLoS One 2021 2;16(3):e0246579. Epub 2021 Mar 2.

Infectious Diseases Service, Lausanne University Hospital, Lausanne, Switzerland.

Background: Hazardous alcohol consumption and HIV infection increase the risk of neurocognitive impairment (NCI). We examined the association between alcohol consumption and specific neurocognitive domain function in people with HIV (PWH) taking modern antiretroviral therapy.

Methods: The Neurocognitive Assessment in the Metabolic and Aging Cohort (NAMACO) study is a prospective, longitudinal, multicentre and multilingual (French, German and Italian) study of patients aged ≥45 years old enrolled in the Swiss HIV Cohort Study (SHCS). Baseline data from 981 study participants were examined. Five neurocognitive domains were evaluated: motor skills, speed of information processing, attention/working memory, executive function and verbal episodic memory. NCI was examined as binary (presence/absence) and continuous (mean z-score) outcomes against Alcohol Use Disorders Identification Test for Consumption (AUDIT-C) scores using logistic and linear regression models, respectively.

Results: Most participants (96.2%) had undetectable viral loads and 64% were aged >50 years old. Hazardous alcohol consumption was observed in 49.4% of participants and binge drinking in 4.2%. While alcohol consumption frequency and quantity were not associated with NCI, the practice of binge drinking was significantly associated with impaired motor skills and overall neurocognitive function in both binary (odds ratio, OR ≥2.0, P <0.05) and continuous (mean z-score difference -0.2 to -0.4, P ≤0.01) outcomes. A significant U-shaped distribution of AUDIT-C score was also observed for motor skills and overall neurocognitive function.

Conclusions: In this cohort of PWH with well-controlled HIV infection, NCI was associated with the practice of binge drinking rather than alcohol consumption frequency or quantity. Longitudinal analysis of alcohol consumption and NCI in this population is currently underway.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0246579PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7924787PMC
March 2021

The association between depressive symptoms and neurocognitive impairment in people with well-treated HIV in Switzerland.

Int J STD AIDS 2021 Feb 25:956462420987434. Epub 2021 Feb 25.

Infectious Diseases Service, 30635Lausanne University Hospital, Lausanne, Switzerland.

Background: Depression may contribute to neurocognitive impairment (NCI) in people with HIV (PWH). Attributing NCI to depression rather than to HIV is complicated as depression may be both a causal factor and an effect of NCI. This study aimed to determine the association between depressive symptoms and NCI among PWH with well-controlled infection.

Methods: The Neurocognitive Assessment in the Metabolic and Ageing Cohort study is an ongoing, prospective, longitudinal study of PWH aged ≥45 years old nested within the Swiss HIV Cohort Study. Neurocognitive Assessment in the Metabolic and Ageing Cohort study participants underwent neurocognitive assessment and grading of depressive symptoms using the Centre for Epidemiological Studies Depression Scale. Neurocognitive impairment categories were defined using Frascati criteria. Participants with NCI related to neurological or psychiatric confounders other than depression were excluded. The cross-sectional association between the Centre for Epidemiological Studies Depression score and neurocognitive impairment was examined taking Centre for Epidemiological Studies Depression score as a continuous variable and then as a binary variable using two score thresholds, 16 and 27.

Results: Excluding 79 participants with confounding factors, 902 participants were studied: 81% were men; 96% had plasma viral loads <50 copies/ml; 35% had neurocognitive impairment; 28% had Centre for Epidemiological Studies Depression scores ≥16. Higher Centre for Epidemiological Studies Depression scores were associated with female sex ( = 0.0003), non-Caucasian origin ( = 0.011) and current/past intravenous drug use ( = 0.002). Whilst neurocognitive impairment was associated with higher Centre for Epidemiological Studies Depression scores, the Centre for Epidemiological Studies Depression score was a poor predictor of having neurocognitive impairment (area under the ROC curve 0.604). Applying a Centre for Epidemiological Studies Depression score threshold of 16 predicted the presence of neurocognitive impairment with a sensitivity of 38.3% (specificity 77.2%), increasing the threshold to 27 lowered sensitivity to 15.4% (specificity 93.6%).

Conclusion: In this large cohort of PWH in Switzerland, we did not observe a Centre for Epidemiological Studies Depression score threshold that was sensitive in predicting neurocognitive impairment. As neurocognitive impairment was however associated with higher Centre for Epidemiological Studies Depression scores, the data support the screening for and treatment of depression among PWH diagnosed with neurocognitive impairment.
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http://dx.doi.org/10.1177/0956462420987434DOI Listing
February 2021

Longitudinal analysis of safety and medication adherence of patients in the Fingolimod patient support program: a real-world observational study.

Sci Rep 2021 Feb 18;11(1):4107. Epub 2021 Feb 18.

Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.

The Fingolimod Patient Support Program (F-PSP) is an interprofessional specialty pharmacy service designed to ensure responsible use of fingolimod by promoting patient safety and medication adherence. This study aims to evaluate the safety and medication adherence of patients who joined the F-PSP between 2013 and 2016. Sociodemographic and medical characteristics, patient safety data (patient-reported symptoms, discontinuations due to adverse events (AEs), repeated first-dose monitoring), and medication adherence (implementation, persistence, reasons for discontinuation, influence of covariates, barriers and facilitators) were described. Sixty-seven patients joined the F-PSP. Patients reported a high frequency of symptoms. Due to AEs, 7 patients discontinued fingolimod, 3 took therapeutic breaks, and 1 reduced the regimen temporarily. Three patients repeated the first-dose monitoring. Patients had a high medication adherence over the 18-month analysis period: implementation decreased from 98.8 to 93.7%, and fingolimod persistence was 83.2% at 18 months. The patients' level of education, professional situation, and living with child(ren) influenced implementation. Patients reported more facilitators of medication adherence than barriers. The F-PSP seems valuable for supporting individual patients (ensuring responsible use of fingolimod and inviting patients for shared-decision making) and public health (indirectly gathering real-world evidence).
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http://dx.doi.org/10.1038/s41598-021-83220-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892872PMC
February 2021

Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT).

BMJ Open 2020 11 19;10(11):e040117. Epub 2020 Nov 19.

Service of Obstetrics, Department Woman Mother Child, University Hospital of Lausanne, Lausanne, Vaud, Switzerland.

Introduction: Few studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.

Methods And Analysis: The study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.

Ethics And Dissemination: Ethical approval has been obtained by the competent ethics committee (Commission cantonale d'éthique de la recherche sur l'être humain, CER-VD 2017-00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.

Trial Registration Numbers: ClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-040117DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7678377PMC
November 2020

Correlation of clinical decision-making with probability of disease: A web-based study among general practitioners.

PLoS One 2020 29;15(10):e0241210. Epub 2020 Oct 29.

Center for Primary Care and Public Health (Unisanté), Lausanne, Switzerland.

Background: Medical decision-making relies partly on the probability of disease. Current recommendations for the management of common diseases are based increasingly on scores that use arbitrary probability thresholds.

Objective: To assess decision-making in pharyngitis and appendicitis using a set of clinical vignettes, and the extent to which management is congruent with the true probability of having the disease.

Design: We developed twenty-four clinical vignettes with clinical presentations corresponding to specific probabilities of having disease defined by McIsaac (pharyngitis) or Alvarado (appendicitis) scores. Each participant answered four randomly selected web-based vignettes.

Participants: General practitioners (GP) working in primary care structures in Switzerland and the USA.

Main Measures: A comparison between the GP's management decision according to the true probability of having the disease and to the GP's estimated probability, investigating the GP's ability to estimate probability of disease.

Key Results: The mean age of the GPs was 48 years (SD 12) and 66% were men. The correlation between the GP's clinical management decision based on the vignette and the recommendations was stronger for appendicitis than pharyngitis (kw = 0.74, 95% CI 0.70-0.78 vs. kw = 0.66, 95% CI 0.62-0.71). On the other hand, the association between the clinical management decision and the probability of disease estimated by GPs was more congruent with recommendations for pharyngitis than appendicitis (kw = 0.70, 95% CI 0.66-0.73 vs. 0.61, 95% CI 0.56-0.66). Only a minority of GPs correctly estimated the probability of disease (29% for appendicitis and 39% for pharyngitis).

Conclusions: Despite the fact that general practitioners often misestimate the probability of disease, their management decisions are usually in line with recommendations. This means that they use other approaches, perhaps more subjective, to make decisions, such as clinical judgment or reasoning that integrate factors other than just the risk of the disease.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0241210PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595298PMC
December 2020

Gender awareness among medical students in a Swiss University.

BMC Med Educ 2020 Jun 3;20(1):156. Epub 2020 Jun 3.

Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.

Background: Gender is an important social determinant, that influences healthcare. The lack of awareness on how gender influences health might lead to gender bias and can contribute to substandard patient care. Our objectives were to assess gender sensitivity and the presence of gender stereotypes among swiss medical students.

Methods: A validated scale (N-GAMS - Nijmegen Gender Awareness in Medicine Scale), with 3 subscores assessing gender sensitivity (GS) and gender stereotypes toward patients (GRIP) and doctors (GRID) (ranging from 1 to 5), was translated into French and was distributed to all medical students registered at the University of Lausanne, Switzerland in April-May 2017. Reliability of the three subscales was assessed calculating the alpha Cronbach coefficient. Mean subscales were calculated for male and female students and compared using two sample t-tests. A linear model was built with each subscale as a dependent variable and students' sex and age as covariables.

Results: In total, 396 students answered the N-GAMS questionnaire, their mean age was 22 years old, 62.6% of them were women. GS and GRID sub-scores were not significantly different between female and male students (GS 3.62 for women, 3.70 for men, p = 0.27, GRID 2.10 for women, 2.13 for men, p = 0.76). A statistically significant difference was found in the GRIP subscale, with a mean score of 1.83 for women and 2.07 for men (p < 0.001), which suggests a more gender stereotyped opinion toward patients among male students. A trend was observed with age, gender sensibility increased (p < 0.001) and stereotypes decreased (GRIP p = 0.04, GRID p = 0.02) with students getting older.

Conclusion: Medical students' gender sensitivity seems to improve throughout the medical curriculum, and women students have less stereotypes towards patients than men do. The implementation of a gender-sensitive teaching in the medical curriculum could improve students' knowledge, limit gender bias and improve patients' care.
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http://dx.doi.org/10.1186/s12909-020-02037-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7268694PMC
June 2020

Patient adherence to rivaroxaban in deep vein thrombosis, a cohort study in Switzerland: quantitative results.

Int J Clin Pharm 2019 Dec 28;41(6):1625-1633. Epub 2019 Nov 28.

Angiology Division, Heart and Vessel Department, Lausanne University Hospital, Lausanne, Switzerland.

Background Direct oral anticoagulants (DOACs) have the advantage of being administered orally at a fixed dose without laboratory monitoring, in contrast to the frequent international normalized ratio measurements used to adjust for vitamin K antagonists dosing. Rivaroxaban, has a short half-life. The anticoagulation effect rapidly decreases if medication adherence is suboptimal. Objective The purpose of this quantitative study (called RIVA) is to longitudinally describe adherence to rivaroxaban (implementation and persistence) in patients with deep vein thrombosis (DVT). Setting The community pharmacy of the Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland in collaboration with the angiology division of the Lausanne University Hospital (CHUV). Methods This is an observational study. Patients received rivaroxaban for 3 or 6 months: 15 mg twice a day during the first 3 weeks and then 20 mg once a day until the end of the treatment. Adherence was measured using electronic monitoring. Implementation and adherence were modelled using a generalized estimating equation model. Persistence was represented using a Kaplan-Meier survival curve. Main outcome measure Medication adherence (implementation and persistence). Results Thirty-one consecutive patients were included (68% male, mean age: 47 years old). The collected adherence data consisted of 57 inter-visit phases, 2899 electronic monitoring openings and a median follow-up of 92 days (IQR: 87; 100). Implementation to rivaroxaban was initially high [96.3 (92.8; 98.1)] but decreased during the first 3 weeks, until it reached 89.3 (76.0; 95.6). After the switch from twice a day 15 mg to a once a day 20 mg regimen, implementation increased again and remained stable [95.4 (92.2; 97.3)] for 90 days. Four patients who experienced adverse events discontinued the treatment before the end of the study and were considered non-persistent (clinically appropriate discontinuation). Conclusion Adherence to rivaroxaban in deep vein trombosis is high in persistent patients. Discontinuation is related to rivaroxaban adverse effects/toxicity. Implementation should be reinforced during the twice a day-phase, and this first 3-week experience should help patients and healthcare professionals choose the best timing for the once a day phase.
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http://dx.doi.org/10.1007/s11096-019-00928-xDOI Listing
December 2019

Procalcitonin and lung ultrasonography point-of-care testing to decide on antibiotic prescription in patients with lower respiratory tract infection in primary care: protocol of a pragmatic cluster randomized trial.

BMC Pulm Med 2019 Aug 6;19(1):143. Epub 2019 Aug 6.

Infectious Diseases Service, University Hospital of Lausanne, Lausanne, Switzerland.

Background: A minority of patients presenting with lower respiratory tract infection (LRTI) to their general practitioner (GP) have community-acquired pneumonia (CAP) and require antibiotic therapy. Identifying them is challenging, because of overlapping symptomatology and low diagnostic performance of chest X-ray. Procalcitonin (PCT) can be safely used to decide on antibiotic prescription in patients with LRTI. Lung ultrasound (LUS) is effective in detecting lung consolidation in pneumonia and might compensate for the lack of specificity of PCT. We hypothesize that combining PCT and LUS, available as point-of care tests (POCT), might reduce antibiotic prescription in LRTIs without impacting patient safety in the primary care setting.

Methods: This is a three-arm pragmatic cluster randomized controlled clinical trial. GPs are randomized either to PCT and LUS-guided antibiotic therapy or to PCT only-guided therapy or to usual care. Consecutive adult patients with an acute cough due to a respiratory infection will be screened and included if they present a clinical pneumonia as defined by European guidelines. Exclusion criteria are previous antibiotics for the current episode, working diagnosis of sinusitis, severe underlying lung disease, severe immunosuppression, hospital admission, pregnancy, inability to provide informed consent and unavailability of the GP. Patients will fill in a 28 day-symptom diary and will be contacted by phone on days 7 and 28. The primary outcome is the proportion of patients prescribed any antibiotic up to day 28. Secondary outcomes include clinical failure by day 7 (death, admission to hospital, absence of amelioration or worsening of relevant symptoms) and by day 28, duration of restricted daily activities, episode duration as defined by symptom score, number of medical visits, number of days with side effects due to antibiotics and a composite outcome combining death, admission to hospital and complications due to LRTI by day 28. An evaluation of the cost-effectiveness and of processes in the clinic using a mixed qualitative and quantitative approach will also be conducted.

Discussion: Our intervention targets only patients with clinically suspected CAP who have a higher pretest probability of definite pneumonia. The intervention will not substitute clinical assessment but completes it by introducing new easy-to-perform tests.

Trial Registration: The study was registered on the 19th of June 2017 on the clinicaltrials.gov registry using reference number; NCT03191071 .
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http://dx.doi.org/10.1186/s12890-019-0898-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6683414PMC
August 2019

Cross-Sectional and Cumulative Longitudinal Central Nervous System Penetration Effectiveness Scores Are Not Associated With Neurocognitive Impairment in a Well Treated Aging Human Immunodeficiency Virus-Positive Population in Switzerland.

Open Forum Infect Dis 2019 Jul 8;6(7):ofz277. Epub 2019 Jul 8.

Infectious Diseases Service, Lausanne University Hospital, Switzerland.

Background: Neurocognitive impairment (NCI) in people with human immunodeficiency virus (PWH) remains a concern despite potent antiretroviral therapy (ART). Higher central nervous system (CNS) penetration effectiveness (CPE) scores have been associated with better CNS human immunodeficiency virus (HIV) replication control, but the association between CPE and NCI remains controversial.

Methods: The Neurocognitive Assessment in the Metabolic and Aging Cohort (NAMACO) study is a subgroup of the Swiss HIV Cohort Study (SHCS) that invited patients aged ≥45 years enrolled in the SHCS and followed-up at NAMACO-affiliated centers in Switzerland to participate between May 2013 and November 2016. In total, 981 patients were enrolled, all of whom underwent standardized neurocognitive assessment. Neurocognitive impairment, if present, was characterized using Frascati criteria. The CPE scores of NAMACO study participants with undetectable plasma HIV-ribonucleic acid at enrollment (909 patients) were analyzed. Cross-sectional CPE scores (at neurocognitive assessment) were examined as potential predictors of NCI in multivariate logistic regression models. The analysis was then repeated taking CPE as a cumulative score (summarizing CPE scores from ART initiation to the time of neurocognitive assessment).

Results: Most patients were male (80%) and Caucasian (92%). Neurocognitive impairment was present in 40%: 27% with HIV-associated NCI (mostly asymptomatic neurocognitive impairment), and 13% with NCI related to other factors. None of the CPE scores, neither cross-sectional nor cumulative, was statistically significantly associated with NCI.

Conclusions: In this large cohort of aviremic PWH, we observed no association between NCI, whether HIV-associated or related to other factors, and CPE score, whether cross-sectional or cumulative.
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http://dx.doi.org/10.1093/ofid/ofz277DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612860PMC
July 2019

Study to determine clinical decision thresholds in small animal veterinary practice.

Vet Rec 2019 08 3;185(6):170. Epub 2019 Jun 3.

Department of Ambulatory Care and Community Medicine, Universite de Lausanne, Lausanne, Switzerland.

This study aimed to determine clinical decision thresholds for six common conditions in small animal veterinary practice. Participants were provided with an online survey. Five questions described scenarios of canine patients with suspected panosteitis, hypothyroidism, urinary tract infection (UTI), mechanical gastrointestinal obstruction (GIO) and idiopathic epilepsy, and one question described a feline patient with suspected chronic kidney disease. A range of probabilities was applied to each scenario. Test and treatment threshold levels were computed for each scenario from 297 usable responses. The test and treatment thresholds were determined for UTI (test=12.8 per cent; 95 per centCI=1.1 to 20.7; treatment=82.0per cent; 95 per centCI=66.3 to 100) and GIO (test=3.2 per cent; 95 per cent CI=0 to 10.4; treatment=87.3 per cent; 95 per centCI=82.6 to 93.5). All other scenarios did not provide data that allowed interpretable test and treatment thresholds. This pilot study has used a new approach in determining clinical thresholds in small animal medicine. Thresholds were successfully determined for two common conditions-canine mechanical GIO and canine UTI. Future research should broaden investigation of methods to determine group clinical threshold levels among veterinarians, which may be used as the basis for clinical decision rules.
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http://dx.doi.org/10.1136/vr.104596DOI Listing
August 2019

Retrospective study on the usefulness of pulse oximetry for the identification of young children with severe illnesses and severe pneumonia in a rural outpatient clinic of Papua New Guinea.

PLoS One 2019 15;14(4):e0213937. Epub 2019 Apr 15.

Department of Ambulatory Care and Community Medicine, University of Lausanne, Lausanne, Switzerland.

Objective: This secondary analysis of data of a randomized controlled trial (RCT) retrospectively investigated the performance of pulse oximetry in identifying children with severe illnesses, with and without respiratory signs/symptoms, in a cohort of children followed for morbid episodes in an intervention trial assessing the efficacy of Intermittent Preventive Treatment for malaria in infants (IPTi) in Papua New Guinea (PNG) from June 2006 to May 2010.

Setting: The IPTi study was conducted in a paediatric population visiting two health centres on the north coast of PNG in the Mugil area of the Sumkar District.

Participants: A total of 669 children visited the clinic and a total of 1921 illness episodes were recorded. Inclusion criteria were: age between 3 and 27 months, full clinical record (signs/symptoms) and pulse oximetry used systematically to assess sick children at all visits. Children were excluded if they visited the clinic in the previous 14 days.

Outcomes: The outcome measures were severe illness, severe pneumonia, pneumonia, defined by the Integrated Management of Childhood Illness (IMCI) definitions, and hospitalization.

Results: Out of 1921 illness episodes, 1663 fulfilled the inclusion criteria. A total of 139 severe illnesses were identified, of which 93 were severe pneumonia. The ROC curves of pulse oximetry (continuous variable) showed an AUC of 0.63, 0.68 and 0.65 for prediction of severe illness, severe pneumonia and hospitalization, respectively. Pulse oximetry allowed better discrimination between severe and non-severe illness, severe and non-severe pneumonia, admitted and non-admitted patients, in children ≤12-months of age relative to older patients. For the threshold of peripheral arterial oxygen saturation ≤ 94% measured by pulse oximetry (SpO2), unadjusted odds ratios for severe illness, severe pneumonia and hospitalization were 6.1 (95% Confidence Interval (CI) 3.9-9.8), 8.5 (4.9-14.6) and 5.9 (3.4-10.3), respectively.

Conclusion: Pulse oximetry was helpful in identifying children with severe illness in outpatient facilities in PNG. A SpO2 of 94% seems the most discriminative threshold. Considering its affordability and ease of use, pulse oximetry could be a valuable additional tool assisting the decision to admit for treatment.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0213937PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464326PMC
December 2019

Home visits made by general practitioners in the canton of Vaud between 2006 and 2015.

Swiss Med Wkly 2019 Mar 24;149:w20037. Epub 2019 Mar 24.

Department of Family Medicine / Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland.

Aim Of The Study: Although physicians’ home visits are highly valued by patients, and are among the measures that contribute to maintaining elderly patients at home, their number is decreasing worldwide. We aimed to describe the trends in home visits made by general practitioners (GPs) in the canton of Vaud in Switzerland between 2006 and 2015, and to explore their associated characteristics.

Methods: We retrospectively analysed billing data from family physicians (internists, generalists and practicing physicians) transmitted to the cantonal trust centre between 2006 and 2015. We explored physician and patient characteristics, first over the entire 10-year study period and then averaged by year. To explore factors associated with the number of home visits, we fitted a mixed effect negative binomial regression of the annual number of home visits per physician.

Results: Over ten years, 631 physicians billed a total of 451,634 home visits, of which 19.8% (n = 89,966) were emergency visits, and 9.7% (n = 43,915) were over the weekend. Home visits represented 2.5% of all consultations. Although the average annual number of physicians doing home visits remained stable at around 400, the mean annual number of visits per physician decreased from 125 in 2006 to 75 in 2015, resulting in a 40% decline in the absolute number of visits. Male physicians undertook more home visits than their female counterparts did, although the difference diminished over time. Visits to elderly patients (65+) represented 84.2% of the home visits.

Conclusions: Although most physicians in the canton of Vaud continue to visit patients at home, the overall number of home visits is declining. Most home visits consist of routine visits to elderly patients. Physicians’ gender, age and specialty are associated with the number of home visits. In the rapidly evolving context of an ageing population and the development of home care, physicians’ role in home care provision should be revised, taking into account patient expectations and current health system constraints.
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http://dx.doi.org/10.4414/smw.2019.20037DOI Listing
March 2019

A Novel Approach to Better Characterize Medication Adherence in Oral Anticancer Treatments.

Front Pharmacol 2018 29;9:1567. Epub 2019 Jan 29.

Department of Ambulatory Care and Primary Medicine, University of Lausanne, Lausanne, Switzerland.

This study aims to describe a 12-month medication adherence with oral anticancer medications (OAMs) in a routine care medication adherence program, and to better characterize non-persistence. In this observational, one-centered, longitudinal study, medication adherence was monitored electronically while patients were taking part in a medication adherence program for 12 months or until treatment stop. Patients were >18 years and starting or taking one of the following OAMs: letrozole, exemestane, imatinib, sunitinib, capecitabine, or temozolomide. Non-persistence was defined as any premature treatment interruption due to patient's unilateral decision or to a medical decision because of adverse effects. The Kaplan Meier survival function estimate was used to characterize persistence, and Generalized Estimating Equations (GEE) were adopted to fit implementation. Statistical analyses were performed using the R software package. Forty-three outpatients with various tumor entities were enrolled. Reasons for quitting the medication adherence program and/or OAM medication were characterized as OAM discontinuation due to adverse effects or toxicity ( = 5), planned OAM completion time ( = 10), OAM failure (cancer relapse) ( = 5) and non-compliance to the adherence program ( = 3). In persistent patients, the implementation rates were high (from 98% at baseline to 97% at 12 months). The probability of being persistent at 12 months was estimated at 85%. A better characterization of both persistence and implementation to OAMs in real life settings is crucial for understanding and optimizing medication adherence to OAMs. The complex identification of non-persistence underlines the need to carefully and prospectively assess OAM interruption or treatment switch reasons. The GEE analysis for describing implementation to OAMs will allow researchers and professionals to take advantage of the richness of longitudinal real-time data, to avoid reducing such data through thresholds and to put them into perspective with OAM blood levels.
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http://dx.doi.org/10.3389/fphar.2018.01567DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6361826PMC
January 2019

Sex/gender bias in the management of chest pain in ambulatory care.

Womens Health (Lond) 2018 Jan-Dec;14:1745506518805641

1 Department of Ambulatory Care and Community Medicine, University of Lausanne, Lausanne, Switzerland.

Objective: Cardiovascular diseases (CVD) are the main cause of death worldwide and despite a higher prevalence in men, mortality from CVD is higher among women. Few studies have assessed sex differences in chest pain management in ambulatory care. The objective of this post hoc analysis of data from a prospective cohort study was to assess sex differences in the management of chest pain in ambulatory care.

Setting: We used data from the Thoracic Pain in Community cohort study that was realized in 58 primary care practices and one university ambulatory clinic in Switzerland.

Participants: In total, 672 consecutive patients aged over 16 years attending a primary care practice or ambulatory care clinic with a complaint of chest pain were included between February and June 2001. Their mean age was 55.2 years and 52.5% were women.

Main Outcome Measures: The main outcome was the proportion of patients referred to a cardiologist at 12 months follow-up. A panel of primary care physicians assessed the final diagnosis retained for chest pain at 12 months.

Results: The prevalence of chest pain of cardiovascular origin (n = 108, 16.1%) was similar for men and women (17.5% vs 14.8%, respectively, p = 0.4). Men with chest pain were 2.5 times more likely to be referred to a cardiologist than women (16.6% vs 7.4%, odds ratio: 2.49, 95% confidence interval: 1.52-4.09). After adjustment for the patients' age and cardiovascular disease risk factors, the estimates did not significantly change (odds ratio: 2.30, 95% confidence interval: 1.30-3.78).

Conclusion: Although the same proportion of women and men present with a chest pain of cardiovascular origin in ambulatory care, there is a strong sex bias in their management. These data suggest that effort must be made to assure equity between men and women in medical care.
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http://dx.doi.org/10.1177/1745506518805641DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6300868PMC
January 2019

Diagnosis and treatment of community-acquired pneumonia in patients with acute cough: a quantitative study of decision thresholds in primary care.

Br J Gen Pract 2018 Nov;68(676):e765-e774

Department of Epidemiology and Biostatistics, College of Public Health, the University of Georgia (UGA), Athens, Georgia, US.

Background: Test and treatment thresholds have not yet been described for decision-making regarding the likelihood of pneumonia in patients with acute cough.

Aim: To determine decision thresholds in the management of patients with acute cough.

Design And Setting: Set among primary care physicians attending meetings in the US and Switzerland, using data from a prospective cohort of primary care patients.

Method: Clinical vignettes were used to study the clinical decisions of physicians regarding eight patients with cough that varied by six signs and symptoms. The probability of community-acquired pneumonia (CAP) was determined for each vignette based on a multivariate model. A previously published approach based on logistic regression was used to determine test and treatment thresholds.

Results: In total, 256 physicians made 764 clinical decisions. Initial physician estimates systematically overestimated the likelihood of CAP; 75% estimating a higher probability than that predicted by the multivariate model. Given the probability of CAP from a multivariate model, 16.7% (125 of 749) changed their decision from 'treat' to 'test' or 'test' to 'rule out', whereas only 3.5% (26/749) changed their decision from 'rule out' to 'test' or 'test' to 'treat'. Test and treatment thresholds were 9.5% (95% confidence interval (CI) = 8.7 to 10.5) and 43.1% (95% CI = 40.1 to 46.4) and were updated to 12.7% (95% CI = 11.7 to 13.8) and 51.3% (95% CI = 48.3 to 54.9) once the true probability of CAP was given. Test thresholds were consistent between subgroups. Treatment thresholds were higher if radiography was available, for Swiss physicians, and for non-primary care physicians.

Conclusion: Test and treatment thresholds for CAP in patients with acute cough were 9.5% and 43.1%, respectively. Physicians tended to overestimate the likelihood of CAP, and providing information from a clinical decision rule (CDR) changed about 1 in 6 clinical decisions.
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http://dx.doi.org/10.3399/bjgp18X699545DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6193794PMC
November 2018

Performance of a brief geriatric evaluation compared to a comprehensive geriatric assessment for detection of geriatric syndromes in family medicine: a prospective diagnostic study.

BMC Geriatr 2018 03 13;18(1):72. Epub 2018 Mar 13.

University Institute of Family Medicine, Department of Ambulatory Care and Community Medicine (DACCM), University of Lausanne, Rue du Bugnon 44, 1011, Lausanne, Switzerland.

Background: Geriatric syndromes are rarely detected in family medicine. Within the AGE program (active geriatric evaluation), a brief assessment tool (BAT) designed for family physicians (FP) was developed and its diagnostic performance estimated by comparison to a comprehensive geriatric assessment.

Methods: This prospective diagnostic study was conducted in four primary care sites in Switzerland. Participants were aged at least 70 years and attending a routine appointment with their physician, without previous documented geriatric assessment. Participants were assessed by their family physicians using the BAT, and by a geriatriciant who performed a comprehensive geriatric assessment within the following two-month period (reference standard). Both the BAT and the full assessment targeted eight geriatric syndromes: cognitive impairment, mood impairment, urinary incontinence, visual impairment, hearing loss, undernutrition, osteoporosis and gait and balance impairment. Diagnostic accuracy of the BAT was estimated in terms of sensitivity, specificity, and predictive values; secondary outcomes were measures of feasibility, in terms of added consultation time and comprehensiveness in applying the BAT items.

Results: Prevalence of the geriatric syndromes in participants (N=85, 46 (54.1%) women, mean age 78 years (SD 6))ranged from 30.0% (malnutrition and cognitive impairment) to 71.0% (visual impairment), with a median number of 3 syndromes (IQR 2 to 4) per participant. Sensitivity of the BAT ranged from 25.0% for undernutrition (95%CI 9.8% - 46.7%) to 82.1% for hearing impairment (95%CI 66.5% - 92.5%), while specificity ranged from 45.8% for visual impairment (95%CI 25.6-67.2) to 87.7% for undernutrition (76.3% to 94.9%). Finally, most negative predictive values (NPV) were between 73.5% and 84.1%, excluding visual impairment with a NPV of 50.0%. Family physicians reported BAT use as per instructions for 76.7% of the syndromes assessed.

Conclusions: Although the BAT does not replace a comprehensive geriatric assessment, it is a useful and appropriate tool for the FP to screen elderly patients for most geriatric syndromes.

Trial Registration: The study was registered on ClinicalTrials.gov on February 20, 2013 ( NCT01816087 ).
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http://dx.doi.org/10.1186/s12877-018-0761-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5850979PMC
March 2018

Does This Patient Have Acute Mountain Sickness?: The Rational Clinical Examination Systematic Review.

JAMA 2017 11;318(18):1810-1819

Service of Internal Medicine, Lausanne University Hospital, Lausanne, Switzerland.

Importance: Acute mountain sickness (AMS) affects more than 25% of individuals ascending to 3500 m (11 500 ft) and more than 50% of those above 6000 m (19 700 ft). AMS may progress from nonspecific symptoms to life-threatening high-altitude cerebral edema in less than 1% of patients. It is not clear how to best diagnose AMS.

Objective: To systematically review studies assessing the accuracy of AMS diagnostic instruments, including the visual analog scale (VAS) score, which quantifies the overall feeling of sickness at altitude (VAS[O]; various thresholds), Acute Mountain Sickness-Cerebral score (AMS-C; ≥0.7 indicates AMS), and the clinical functional score (CFS; ≥2 indicates AMS) compared with the Lake Louise Questionnaire Score (LLQS; score of ≥5).

Data Extraction And Synthesis: Searches of MEDLINE and EMBASE from inception to May 2017 identified 1245 publications of which 91 were suitable for prevalence analysis (66 944 participants) and 14 compared at least 2 instruments (1858 participants) using a score of 5 or greater on the LLQS as a reference standard. To determine the prevalence of AMS for establishing the pretest probability of AMS, a random-effects meta-regression was performed based on the reported prevalence of AMS as a function of altitude.

Main Outcomes And Measures: AMS prevalence, likelihood ratios (LRs), sensitivity, and specificity of screening instruments.

Results: The final analysis included 91 articles (comprising 66 944 study participants). Altitude predicted AMS and accounted for 28% of heterogeneity between studies. For each 1000-m (3300-ft) increase in altitude above 2500 m (8200 ft), AMS prevalence increased 13% (95% CI, 9.5%-17%). Testing characteristics were similar for VAS(O), AMS-C, and CFS vs a score of 5 or greater on the LLQS (positive LRs: range, 3.2-8.2; P = .22 for comparisons; specificity range, 67%-92%; negative LRs: range, 0.30-0.36; P = .50 for comparisons; sensitivity range, 67%-82%). The CFS asks a single question: "overall if you had any symptoms, how did they affect your activity (ordinal scale 0-3)?" For CFS, moderate to severe reduction in daily activities had a positive LR of 3.2 (95% CI, 1.4-7.2) and specificity of 67% (95% CI, 37%-97%); no reduction to mild reduction in activities had a negative LR of 0.30 (95% CI, 0.22-0.39) and sensitivity of 82% (95% CI, 77%-87%).

Conclusions And Relevance: The prevalence of acute mountain sickness increases with higher altitudes. The visual analog scale for the overall feeling of sickness at altitude, Acute Mountain Sickness-Cerebral, and clinical functional score perform similarly to the Lake Louise Questionnaire Score using a score of 5 or greater as a reference standard. In clinical and travel settings, the clinical functional score is the simplest instrument to use. Clinicians evaluating high-altitude travelers who report moderate to severe limitations in activities of daily living (clinical functional score ≥2) should use the Lake Louise Questionnaire Score to assess the severity of acute mountain sickness.
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http://dx.doi.org/10.1001/jama.2017.16192DOI Listing
November 2017

Clinical and laboratory predictors of death in African children with features of severe malaria: a systematic review and meta-analysis.

BMC Med 2017 08 3;15(1):147. Epub 2017 Aug 3.

Department of Ambulatory Care and Community Medicine, University of Lausanne, Lausanne, Switzerland.

Background: The criteria for defining severe malaria have evolved over the last 20 years. We aimed to assess the strength of association of death with features currently characterizing severe malaria through a systematic review and meta-analysis.

Method: Electronic databases (Medline, Embase, Cochrane Database of Systematic Reviews, Thomson Reuters Web of Knowledge) were searched to identify publications including African children with severe malaria. PRISMA guidelines were followed. Selection was based on design (epidemiological, clinical and treatment studies), setting (Africa), participants (children < 15 years old with severe malaria), outcome (survival/death rate), and prognostic indicators (clinical and laboratory features). Quality assessment was performed following the criteria of the 2011 Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). Odds ratios (ORs) were calculated for each study and prognostic indicator, and, when a test was assessed in at least two studies, pooled estimates of ORs were computed using fixed- or random-effects meta-analysis.

Results: A total of 601 articles were identified and screened and 30 publications were retained. Features with the highest pooled ORs were renal failure (5.96, 95% CI 2.93-12.11), coma score (4.83, 95% CI 3.11-7.5), hypoglycemia (4.59, 95% CI 2.68-7.89), shock (4.31, 95% CI 2.15-8.64), and deep breathing (3.8, 95% CI 3.29-4.39). Only half of the criteria had an OR > 2. Features with the lowest pooled ORs were impaired consciousness (0.58, 95% CI 0.25-1.37), severe anemia (0.76, 95% CI 0.5- 1.13), and prostration (1.12, 95% CI 0.45-2.82).

Conclusion: The findings of this meta-analysis show that the strength of association between the criteria defining severe malaria and death is quite variable for each clinical and/or laboratory feature (OR ranging from 0.58 to 5.96). This ranking allowed the identification of features weakly associated with death, such as impaired consciousness and prostration, which could assist to improve case definition, and thus optimize antimalarial treatment.
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http://dx.doi.org/10.1186/s12916-017-0906-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5541406PMC
August 2017

A prospective study assessing agreement and reliability of a geriatric evaluation.

BMC Geriatr 2017 07 19;17(1):153. Epub 2017 Jul 19.

Institute of family medicine, Department of ambulatory care and community medicine, University of Lausanne, Lausanne, Switzerland.

Background: The present study takes place within a geriatric program, aiming at improving the diagnosis and management of geriatric syndromes in primary care. Within this program it was of prime importance to be able to rely on a robust and reproducible geriatric consultation to use as a gold standard for evaluating a primary care brief assessment tool. The specific objective of the present study was thus assessing the agreement and reliability of a comprehensive geriatric consultation.

Method: The study was conducted at the outpatient clinic of the Service of Geriatric Medicine, University of Lausanne, Switzerland. All community-dwelling older persons aged 70 years and above were eligible. Patients were excluded if they hadn't a primary care physician, they were unable to speak French, or they were already assessed by a geriatrician within the last 12 months. A set of 9 geriatricians evaluated 20 patients. Each patient was assessed twice within a 2-month delay. Geriatric consultations were based on a structured evaluation process, leading to rating the following geriatric conditions: functional, cognitive, visual, and hearing impairment, mood disorders, risk of fall, osteoporosis, malnutrition, and urinary incontinence. Reliability and agreement estimates on each of these items were obtained using a three-way Intraclass Correlation and a three-way Observed Disagreement index. The latter allowed a decomposition of overall disagreement into disagreements due to each source of error variability (visit, rater and random).

Results: Agreement ranged between 0.62 and 0.85. For most domains, geriatrician-related error variability explained an important proportion of disagreement. Reliability ranged between 0 and 0.8. It was poor/moderate for visual impairment, malnutrition and risk of fall, and good/excellent for functional/cognitive/hearing impairment, osteoporosis, incontinence and mood disorders.

Conclusions: Six out of nine items of the geriatric consultation described in this study (functional/cognitive/hearing impairment, osteoporosis, incontinence and mood disorders) present a good to excellent reliability and can safely be used as a reference (gold standard) to evaluate the diagnostic performance of a primary care brief assessment tool. More objective/significant measures are needed to improve reliability of malnutrition, visual impairment, and risk of fall assessment before they can serve as a safe gold standard of a primary care tool.
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http://dx.doi.org/10.1186/s12877-017-0546-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5517926PMC
July 2017

Determining clinical decision thresholds for HIV-positive patients suspected of having tuberculosis.

Evid Based Med 2017 Aug 17;22(4):132-138. Epub 2017 Jul 17.

Department of Epidemiology and Biostatics, University of Georgia, Athens, Georgia, USA.

Clinical decision thresholds may aid the evaluation of diagnostic tests but have rarely been determined for tuberculosis (TB). We presented clinicians with six web-based clinical scenarios, describing patients with HIV and possible TB at various sites and with a range of clinical stability. The probability of disease was varied randomly and clinicians asked to make treatment decisions; threshold curves and therapeutic thresholds were calculated. Test and treatment thresholds were calculated using Bayes theorem and the diagnostic accuracy of Xpert MTB/RIF. We received 165 replies to our survey. Therapeutic thresholds vary depending on the clinical stability and site of suspected disease. For inpatients, it ranges from 3.4% in unstable to 79.6% in stable patients. For TB meningitis, it ranges from 0% in unstable to 51.4% in stable patients and for pulmonary TB in outpatients it ranges from 29.1% in unstable to 74.5% in the stable patients. Test and treatment thresholds vary in a similar way with test thresholds ranging from 0 in unstable patients with suspected meningitis to 8.2% for stable inpatients. Treatment thresholds vary from 0 for unstable patients with suspected meningitis to 97% for stable inpatients. Therapeutic thresholds for TB can be determined by presenting clinicians with patient scenarios with random probabilities of disease and can be used to calculate test and treatment thresholds using Bayes theorem. Thresholds are lower when patients are more clinically unstable and when the implications of inappropriately withholding therapy are more serious. These results can be used to improve use and evaluation of diagnostic tests.
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http://dx.doi.org/10.1136/ebmed-2017-110718DOI Listing
August 2017

Clinical decision making : from theory to practice… and backward.

Rev Med Suisse 2017 Mai 10;13(562):986-989

Centre de médecine générale, PMU, 1011 Lausanne.

Being able to analyze all the successive steps of decision making from the first contact with the patient to the final diagnosis is complex because it refers sometimes to intuitive elements proper to each clinician. However, understanding how they integrate probabilities of diseases into their clinical practice and manage diagnostic uncertainties is crucial. This allows a more rational practice of medicine and identifying factors related to the patient, physician or context that may modify the clinical decision making. Furthermore, the use of tools such as clinical scores has taken an important place with the evidence based medicine. Given the fact that they are partly theoretical, it is necessary to assess whether these recommendations are in line with clinical practice.
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May 2018

The Presence of Human Immunodeficiency Virus-Associated Neurocognitive Disorders Is Associated With a Lower Adherence to Combined Antiretroviral Treatment.

Open Forum Infect Dis 2017 6;4(2):ofx070. Epub 2017 Apr 6.

Community Pharmacy, School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Switzerland.

Background: Human immunodeficiency virus (HIV)-associated neurocognitive disorders (HAND) are defined according to their diagnostic degrees as follows: asymptomatic neurocognitive impairment, mild neurocognitive disorder, and HIV-associated dementia. Because high adherence to combined antiretroviral therapy (cART) is required to maintain viral suppression among HIV-infected patients, it is important to investigate the impact of HAND on medication adherence. Our study hypothesis was that patients with HAND had a lower medication adherence than patients who did not have HAND.

Methods: This was an observational, exploratory, 2-center pilot study of patients who had a state-of-the-art neurocognitive assessment performed between January 2011 and June 2015 while also being followed at their respective adherence clinics. Adherence was measured with electronic monitors. Patients' sociodemographic characteristics, HIV viral load, and CD4 counts were retrieved from the Swiss HIV Cohort Study database. At each time , adherence was computed as the proportion of patients taking medication as prescribed at that time.

Results: We included 59 patients, with a median (Q1, Q3) age of 53 years (47-58) and 39 (66%) were male participants. Twenty-two patients (35%) had no neurocognitive deficits, 16 (27%) patients had HAND, and 21 (35%) patients had non-HAND (mostly depression). Implementation over 3 years showed a significant decline (50%) in medication adherence among patients diagnosed with HAND in comparison with patients who had a normal neuropsychological status or a non-HIV-related cognitive deficit (implementation stayed 90% during follow-up).

Conclusions: Our findings support the hypothesis that HAND is associated with reduced cART adherence.
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http://dx.doi.org/10.1093/ofid/ofx070DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5450901PMC
April 2017

Association of disclosure of HIV status with medication adherence.

Patient Educ Couns 2016 08 17;99(8):1413-20. Epub 2016 Mar 17.

Community pharmacy, School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva, Switzerland; Community pharmacy, Department of Ambulatory Care & Community Medicine, University of Lausanne, Lausanne, Switzerland. Electronic address:

Objective: Disclosure may affect adherence to antiretroviral treatment. In a medication adherence program, this cross-sectional study describes disclosure, perceived reaction after disclosure, living situations, and the relationship of disclosure with antiretroviral adherence.

Methods: A combination of a questionnaire to measure disclosure and longitudinal electronic monitoring of medication adherence was used.

Results: A total of 103 out of 159 eligible patients gave informed consent. The characteristics differed between participants and nonparticipants (race, education, sexual orientation, medication adherence). Thirteen participants did not disclose their HIV status. Seventy-three (81%) participants judged the reaction after disclosure positive. Among the 62 participants cohabiting, 52% disclosed to all co-residents. Adherence was high (median 100%). HIV disclosure was negatively associated with adherence, when disclosing to the mother (OR=2.46, p-value=0.086) and to siblings (OR=2.89, p-value=0.029). Living alone was associated to a lower adherence than cohabitation (Rate Ratio=1.42, p-value=0.007).

Conclusion: HIV disclosure and adherence are sensitive issues, which may explain the reason for refusal. Nonparticipants may be those with the most difficulties disclosing.

Practice Implications: An unbiased collection of sensitive information, as HIV disclosure, is a difficult task. A cohort design, with research data collected systematically by a trusted healthcare provider, may better describe the association between adherence and disclosure.
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http://dx.doi.org/10.1016/j.pec.2016.03.012DOI Listing
August 2016

Assessing interrater agreement on binary measurements via intraclass odds ratio.

Biom J 2016 Jul 14;58(4):962-73. Epub 2016 Mar 14.

Division of Biostatistics, Institute for Social and Preventive Medicine, University Hospital Lausanne, Route de la Corniche 10, CH-1010 Lausanne, Switzerland.

Interrater agreement on binary measurements is usually assessed via Scott's π or Cohen's κ, which are known to be difficult to interpret. One reason for this difficulty is that these coefficients can be defined as a correlation between two exchangeable measurements made on the same subject, that is as an "intraclass correlation", a concept originally defined for continuous measurements. To measure an association between two binary variables, it is however more common to calculate an odds ratio rather than a correlation. For assessing interrater agreement on binary measurements, we suggest thus to calculate the odds ratio between two exchangeable measurements made on the same subject, yielding the concept of "intraclass odds ratio". Since it is interpretable as a ratio of probabilities of (strict) concordance and discordance (between two raters rating two subjects), an intraclass odds ratio might be easier to understand for researchers and clinicians than an intraclass correlation. It might thus be a valuable descriptive measure (summary index) to evaluate the agreement among a set of raters, without having to refer to arbitrary benchmark values. To facilitate its use, an explicit formula to calculate a confidence interval for the intraclass odds ratio is also provided.
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http://dx.doi.org/10.1002/bimj.201500109DOI Listing
July 2016

Associations Between Cardiovascular Risk Factors, Inflammation, and Progression of Carotid Atherosclerosis Among Smokers.

Nicotine Tob Res 2016 06 16;18(6):1533-8. Epub 2015 Nov 16.

Department of General Internal Medicine, Inselspital, University of Bern, Bern, Switzerland

Introduction: The high risk of cardiovascular events in smokers requires adequate control of other cardiovascular risk factors (CVRFs) to curtail atherosclerosis progression. However, it is unclear which CVRFs have the most influence on atherosclerosis progression in smokers.

Methods: In 260 smokers aged 40-70 included in a smoking cessation trial, we analyzed the association between traditional CVRFs, high-sensitivity C-reactive protein (hs-CRP), smoking cessation and 3-year progression of carotid intima-media thickness (CIMT, assessed by repeated ultrasound measurements) in a longitudinal multivariate model.

Results: Participants (mean age 52 years, 47% women) had a mean smoking duration of 32 years with a median daily consumption of 20 cigarettes. Baseline CIMT was 1185 μm (95% confidence interval [CI]: 1082-1287) and increased by 93 μm (95% CI: 25-161) and 108 μm (95% CI: 33-183) after 1 and 3 years, respectively. Age, male sex, daily cigarette consumption, systolic blood pressure (SBP), but neither low-density lipoprotein cholesterol nor hs-CRP, were independently associated with baseline CIMT (all P ≤ .05). Baseline SBP, but neither low-density lipoprotein cholesterol nor hs-CRP, was associated with 3-year atherosclerosis progression (P = .01 at 3 years). The higher the SBP at baseline, the steeper was the CIMT increase over 3-year follow-up. We found an increase of 26 μm per each 10-mmHg raise in SBP at 1 year and an increase of 39 μm per each 10 mmHg raise in SBP at 3 years. Due to insufficient statistical power, we could not exclude an effect of smoking abstinence on CIMT progression.

Conclusion: Control of blood pressure may be an important factor to limit atherosclerosis progression in smokers, besides support for smoking cessation.

Implications: Among 260 smokers aged 40-70 years with a mean smoking duration of 32 years, baseline SBP was associated with atherosclerosis progression over 3 years, as measured by CIMT (P = .01 at 3 years), independently of smoking variables and other CVRFs. The higher the SBP at baseline, the steeper was the CIMT increase over 3-year follow-up. Our findings emphasize the importance of focusing not only on smoking cessation among smokers, but to simultaneously control other CVRFs, particularly blood pressure, in order to prevent future cardiovascular disease.
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http://dx.doi.org/10.1093/ntr/ntv255DOI Listing
June 2016

A novel approach to the determination of clinical decision thresholds.

Evid Based Med 2015 Apr 3;20(2):41-7. Epub 2015 Mar 3.

Department of Ambulatory Care and Community Medicine, University of Lausanne, Lausanne, Switzerland.

Our objective was to determine the test and treatment thresholds for common acute primary care conditions. We presented 200 clinicians with a series of web-based clinical vignettes, describing patients with possible influenza, acute coronary syndrome (ACS), pneumonia, deep vein thrombosis (DVT) and urinary tract infection (UTI). We randomly varied the probability of disease and asked whether the clinician wanted to rule out disease, order tests or rule in disease. By randomly varying the probability, we obtained clinical decisions across a broad range of disease probabilities that we used to create threshold curves. For influenza, the test (4.5% vs 32%, p<0.001) and treatment (55% vs 68%, p=0.11) thresholds were lower for US compared with Swiss physicians. US physicians had somewhat higher test (3.8% vs 0.7%, p=0.107) and treatment (76% vs 58%, p=0.005) thresholds for ACS than Swiss physicians. For both groups, the range between test and treatment thresholds was greater for ACS than for influenza (which is sensible, given the consequences of incorrect diagnosis). For pneumonia, US physicians had a trend towards higher test thresholds and lower treatment thresholds (48% vs 64%, p=0.076) than Swiss physicians. The DVT and UTI scenarios did not provide easily interpretable data, perhaps due to poor wording of the vignettes. We have developed a novel approach for determining decision thresholds. We found important differences in thresholds for US and Swiss physicians that may be a function of differences in healthcare systems. Our results can also guide development of clinical decision rules and guidelines.
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http://dx.doi.org/10.1136/ebmed-2014-110140DOI Listing
April 2015

Patients satisfaction in an academic walk-in centre: a new model of residents training achieved by family doctors.

BMC Res Notes 2014 Dec 4;7:874. Epub 2014 Dec 4.

Policlinique Médicale Universitaire, Rue du Bugnon 44, CH-1011 Lausanne, Switzerland.

Background: Walk-in centres may improve access to healthcare for some patients, due to their convenient location and extensive opening hours, with no need for an appointment. Herein, we describe and assess a new model of walk-in centre, characterised by care provided by residents and supervision achieved by experienced family doctors. The main aim of the study was to assess patients' satisfaction about the care they received from residents and their supervision by family doctors. The secondary aim was to describe walk-in patients' demographic characteristics and to identify potential associations with satisfaction.

Methods: The study was conducted in the walk-in centre of Lausanne. Patients who consulted between 11th and 31st April were automatically included and received a questionnaire in French. We used a five-point Likert scale, ranging from "not at all satisfied" to "very satisfied", converted from values of 1 to 5. We focused on the satisfaction regarding residents' care and supervision by a family doctor. The former was divided in three categories: "Skills", "Treatment" and "Behaviour". A mean satisfaction score was calculated for each category and a multivariable logistic model was applied in order to identify associations with patients' demographics.

Results: The overall response rate was 47% [184/395]. Walk-in patients were more likely to be women (62%), young (median age 31), with a high education level (40% of University degree or equivalent). Patients were "very satisfied" with residents' care, with a median satisfaction score between 4.5 and 5, for each category. Over 90% of patients were "satisfied" or "very satisfied" that a family doctor was involved in the consultation. Age showed the greatest association with satisfaction.

Conclusion: Patients were highly satisfied with care provided by residents and with the involvement of a family doctor in the consultation. Older age showed the greatest positive association with satisfaction with a positive impact. The high level satisfaction reported by walk-in patients supports this new model of walk-in centre.
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http://dx.doi.org/10.1186/1756-0500-7-874DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4295283PMC
December 2014

Leptin and smoking cessation: secondary analyses of a randomized controlled trial assessing physical activity as an aid for smoking cessation.

BMC Public Health 2014 Sep 3;14:911. Epub 2014 Sep 3.

Department of Epidemiology and Biostatistics, University of California San Francisco, 1450 3rd Street, San Francisco, CA, USA.

Background: Smokers have a lower body weight compared to non-smokers. Smoking cessation is associated with weight gain in most cases. A hormonal mechanism of action might be implicated in weight variations related to smoking, and leptin might be implicated. We made secondary analyses of an RCT, with a hypothesis-free exploratory approach to study the dynamic of leptin following smoking cessation.

Methods: We measured serum leptin levels among 271 sedentary smokers willing to quit who participated in a randomized controlled trial assessing a 9-week moderate-intensity physical activity intervention as an aid for smoking cessation. We adjusted leptin for body fat levels. We performed linear regressions to test for an association between leptin levels and the study group over time.

Results: One year after smoking cessation, the mean serum leptin change was +3.23 mg/l (SD 4.89) in the control group and +1.25 mg/l (SD 4.86) in the intervention group (p of the difference < 0.05). When adjusted for body fat levels, leptin was higher in the control group than in the intervention group (p of the difference < 0.01). The mean weight gain was +2.91 (SD 6.66) Kg in the intervention and +3.33 (SD 4.47) Kg in the control groups, respectively (p not significant).

Conclusions: Serum leptin levels significantly increased after smoking cessation, in spite of substantial weight gain. The leptin dynamic might be different in chronic tobacco users who quit smoking, and physical activity might impact the dynamic of leptin in such a situation. Clinical trial registration number: NCT00521391.
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http://dx.doi.org/10.1186/1471-2458-14-911DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4165916PMC
September 2014