Direct and indirect impact of the COVID-19 pandemic on the survival of kidney transplant recipients: A national observational study in France.

During the pandemic period, health care systems were substantially reorganized for managing COVID-19 cases. Corresponding consequences on persons with chronic diseases remain insufficiently documented. This observational cohort study investigated the direct and indirect impact of the pandemic period on the survival of kidney transplant recipients (KTR). Using the French National Health Data System, incident persons with end-stage kidney disease between 2015 and 2020, and who received a kidney transplant during this period were included and followed up from their transplantation date to December 31, 2021. The survival of KTR during the prepandemic and pandemic periods was investigated using Cox models with time-dependent covariates. There were 10 637 KTR included in the study, with 324 and 430 deaths observed during the prepandemic and pandemic periods, respectively. The adjusted risk of death during the pandemic period was similar to that observed during the prepandemic period (hazard ratio [HR] [95% confidence interval]: 0.92 [0.77-1.11]), COVID-19-related hospitalization was associated with an increased risk of death (HR: 10.62 [8.46-13.33]), and a third vaccine dose was associated with a lower risk of death (HR: 0.42 [0.30-0.57]). The pandemic period was not associated with an indirect higher risk of death in KTR with no COVID-19-related hospitalization.

Real-world economic burden of hepatitis C and impact of direct-acting antivirals in France: A nationwide claims data analysis.

BACKGROUND AND AIMS: The economic impact of managing patients with hepatitis C virus (HCV) infection remains unknown. This study aimed to assess the economic burden of chronic HCV infection from a national health insurance perspective and the impact of direct-acting antivirals (DAAs) using nationwide real-world data. METHODS: Patients with chronic HCV infection were identified from the French Health Insurance Claims Databases (SNDS) and matched for age and sex to the general population. Health resource utilization and reimbursements were summarized according to healthcare expenditure items from 2012 to 2021. The economic burden attributable to chronic HCV infection was evaluated over a 10-year period. Finally, the impact of DAAs was estimated using economic data derived from the SNDS. RESULTS: A total of 145 187 patients with chronic HCV infection were identified. Among the patients eligible for DAA therapy, 81.5% had received DAA by the end of 2021. Over a 10-year period, managing patients with chronic HCV infection resulted in an additional cost of €9.71 billion (95% confidence interval [CI]: €9.66-€9.78 billion) or €9191 (95% CI: €9134-€9252) per patient per year compared to the general population. After DAA therapy, patients with chronic HCV infection had a higher economic burden than the general population, with an additional cost of €5781 (95% CI: €5540-€6028) per patient at the fifth-year post-DAA therapy. CONCLUSIONS: A significant economic burden persists among patients with HCV infection after DAA treatment. The high proportion of patients not treated with DAA therapy supports reinforcing policies for universal access.

Performance of algorithms for identifying patients with chronic hepatitis B or C infection in the french health insurance claims databases using the ANRS CO22 HEPATHER cohort.

The validity of algorithms for identifying patients with chronic hepatitis B or C virus (HBV or HCV) infection in claims databases has been little explored. The performance of 15 algorithms was evaluated. Data from HBV- or HCV-infected patients enrolled between August 2012 and December 2015 in French hepatology centres (ANRS CO22 HEPATHER cohort) were individually linked to the French national health insurance system (SNDS). The SNDS covers 99% of the French population and contains healthcare reimbursement data. Performance metrics were calculated by comparing the viral status established by clinicians with those obtained with the algorithms identifying chronic HBV- and HCV-infected patients. A total of 14 751 patients (29% with chronic HBV and 63% with chronic HCV infection) followed-up until December 2018 were selected. Despite good specificity, the algorithms relying on ICD-10 codes performed poorly. By contrast, the multi-criteria algorithms combining ICD-10 codes, antiviral dispensing, laboratory diagnostic tests (HBV DNA or HCV RNA detection and quantification, HCV genotyping), examinations for the assessment of liver fibrosis and long-term disease registrations were the most effective (sensitivity 0.92, 95% CI, 0.91-0.93 and specificity 0.96, 95% CI, 0.95-0.96 for identifying chronic HBV-infected patients; sensitivity 0.94, 95% CI, 0.94-0.94 and specificity 0.85, 95% CI, 0.84-0.86 for identifying chronic HCV-infected patients). In conclusion, the multi-criteria algorithms perform well in identifying patients with chronic hepatitis B or C infection and can be used to estimate the magnitude of the public health burden associated with hepatitis B and C in France.

Impact of direct-acting antiviral treatment for hepatitis C on cardiovascular diseases and extrahepatic cancers.

PURPOSE: The impact of direct-acting antivirals (DAAs) on extrahepatic complications in chronic hepatitis C (CHC) patients remains poorly described. We estimated the association of DAAs with cardiovascular events and extrahepatic cancers. METHODS: The prospective ANRS CO22 HEPATHER cohort was enriched with individual data until December 2018 from the French Health Insurance Database (SNDS). CHC patients were enrolled between August 2012 and December 2015 in 32 French hepatology centers. A total of 8148 CHC adults were selected. Cardiovascular events (stroke, acute coronary syndrome, pulmonary embolism, heart failure, arrhythmias and conduction disorders [ACD], peripheral arterial disease [PAD]) and extrahepatic solid cancers were derived from the SNDS. Associations between DAAs and extrahepatic events were estimated using marginal structural models, with adjustments for clinical confounders. RESULTS: Analyses of 12 905 person-years of no DAA exposure and 22 326 person-years following DAA exposure showed a decreased risk of PAD after DAA exposure (hazard ratio [HR], 0.54; 95% CI, 0.33-0.89), a beneficial effect of DAAs on overall cardiovascular outcomes in patients with advanced fibrosis (aHR, 0.58; 95% CI, 0.42-0.79), and an increased risk of ACD (hazard ratio [HR], 1.46; 95% CI, 1.04-2.04), predominant after the first year following DAA initiation. There was no association between DAAs and extrahepatic cancer risk (HR, 1.23; 95% CI, 0.50-3.03). CONCLUSIONS: DAAs were not associated with extrahepatic cancer development or reduction. They were associated with a decreased risk of PAD and an increased risk of ACD, supporting long-term cardiac monitoring after DAA therapy.

Comparing SF-36 Scores Collected Through Web-Based Questionnaire Self-completions and Telephone Interviews: An Ancillary Study of the SENTIPAT Multicenter Randomized Controlled Trial.

BACKGROUND: The 36-Item Short Form Health Survey (SF-36) is a popular questionnaire for measuring the self-perception of quality of life in a given population of interest. Processing the answers of a participant comprises the calculation of 10 scores corresponding to 8 scales measuring several aspects of perceived health and 2 summary components (physical and mental). Surprisingly, no study has compared score values issued from a telephone interview versus those from an internet-based questionnaire self-completion. OBJECTIVE: This study aims to compare the SF-36 score values issued from a telephone interview versus those from an internet-based questionnaire self-completion. METHODS: Patients with an internet connection and returning home after hospital discharge were enrolled in the SENTIPAT multicenter randomized trial on the day of discharge. They were randomized to either self-completing a set of questionnaires using a dedicated website (internet group) or providing answers to the same questionnaires administered during a telephone interview (telephone group). This ancillary study of the trial compared SF-36 data related to the posthospitalization period in these 2 groups. To anticipate the potential unbalanced characteristics of the responders in the 2 groups, the impact of the mode of administration of the questionnaire on score differences was investigated using a matched sample of individuals originating from the internet and telephone groups (1:1 ratio), in which the matching procedure was based on a propensity score approach. SF-36 scores observed in the internet and telephone groups were compared using the Wilcoxon-Mann-Whitney test, and the score differences between the 2 groups were also examined according to Cohen effect size. RESULTS: Overall, 29.2% (245/840) and 75% (630/840) of SF-36 questionnaires were completed in the internet and telephone groups, respectively (P<.001). Globally, the score differences between groups before matching were similar to those observed in the matched sample. Mean scores observed in the telephone group were all above the corresponding values observed in the internet group. After matching, score differences in 6 out of the 8 SF-36 scales were statistically significant, with a mean difference greater than 5 for 4 scales and an associated mild effect size ranging from 0.22 to 0.29, and with a mean difference near this threshold for 2 other scales (4.57 and 4.56) and a low corresponding effect size (0.18 and 0.16, respectively). CONCLUSIONS: The telephone mode of administration of SF-36 involved an interviewer effect, increasing SF-36 scores. Questionnaire self-completion via the internet should be preferred, and surveys combining various administration methods should be avoided. TRIAL REGISTRATION: ClinicalTrials.gov NCT01769261; https://www.clinicaltrials.gov/ct2/show/record/NCT01769261.

Comparing interferon-free with interferon-based regimens in HCV patients: Rogers phenomenon and Simpson's paradox.

Comparisons of time-to-event clinical outcomes between patients with or without a sustained virological response (SVR) after treatment of chronic hepatitis C infection have been repeatedly reported in emphasizing the potential clinical impact of treatment. Combining recently published data from different therapeutic eras with simple examples, we show that comparisons of incidence rates by SVR status between patients treated with interferon-based and interferon-free regimens are flawed through confounding by prognosis. The relevant analysis for evaluating and comparing the clinical impact of these regimens should be a comparison between randomized treatment groups, irrespective of the SVR status.

Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial.

STUDY OBJECTIVE: This study compares the effectiveness and cost-effectiveness of nurse-driven targeted HIV screening alongside physician-directed diagnostic testing (intervention strategy) with diagnostic testing alone (control strategy) in 8 emergency departments. METHODS: In this cluster-randomized, 2-period, crossover trial, 18- to 64-year-old patients presenting for reasons other than potential exposure to HIV were included. The strategy applied first was randomly assigned. During both periods, diagnostic testing was prescribed by physicians following usual care. During the intervention periods, patients were asked to complete a self-administered questionnaire. According to their answers, the triage nurse suggested performing a rapid test to patients belonging to a high-risk group. The primary outcome was the proportion of new diagnoses among included patients, which further refers to effectiveness. A secondary outcome was the intervention's incremental cost (health care system perspective) per additional diagnosis. RESULTS: During the intervention periods, 74,161 patients were included, 16,468 completed the questionnaire, 4,341 belonged to high-risk groups, and 2,818 were tested by nurses, yielding 13 new diagnoses. Combined with 9 diagnoses confirmed through 97 diagnostic tests, 22 new diagnoses were established. During the control periods, 74,166 patients were included, 92 were tested, and 6 received a new diagnosis. The proportion of new diagnoses among included patients was higher during the intervention than in the control periods (3.0 per 10,000 versus 0.8 per 10,000; difference 2.2 per 10,000, 95% CI 1.3 to 3.6; relative risk 3.7, 95% CI 1.4 to 9.8). The incremental cost was €1,324 per additional new diagnosis. CONCLUSION: The combined strategy of targeted screening and diagnostic testing was effective.

Comparing Inpatient Satisfaction Collected via a Web-Based Questionnaire Self-Completion and Through a Telephone Interview: An Ancillary Study of the SENTIPAT Randomized Controlled Trial.

BACKGROUND: Assessing the satisfaction of patients about the health care they have received is relatively common nowadays. In France, the satisfaction questionnaire, I-Satis, is deployed in each institution admitting inpatients. Internet self-completion and telephone interview are the two modes of administration for collecting inpatient satisfaction that have never been compared in a multicenter randomized experiment involving a substantial number of patients. OBJECTIVE: The objective of this study was to compare two modes of survey administration for collecting inpatient satisfaction: Internet self-completion and telephone interview. METHODS: In the multicenter SENTIPAT (acronym for the concept of sentinel patients, ie, patients who would voluntarily report their health evolution on a dedicated website) randomized controlled trial, patients who were discharged from the hospital to home and had an Internet connection at home were enrolled between February 2013 and September 2014. They were randomized to either self-complete a set of questionnaires using a dedicated website or to provide answers to the same questionnaires administered during a telephone interview. As recommended by French authorities, the analysis of I-Satis satisfaction questionnaire involved all inpatients with a length of stay (LOS), including at least two nights. Participation rates, questionnaire consistency (measured using Cronbach alpha coefficient), and satisfaction scores were compared in the two groups. RESULTS: A total of 1680 eligible patients were randomized to the Internet group (n=840) or the telephone group (n=840). The analysis of I-Satis concerned 392 and 389 patients fulfilling the minimum LOS required in the Internet and telephone group, respectively. There were 39.3% (154/392) and 88.4% (344/389) responders in the Internet and telephone group, respectively (P<.001), with similar baseline variables. Internal consistency of the global satisfaction score was higher (P=.03) in the Internet group (Cronbach alpha estimate=.89; 95% CI 0.86-0.91) than in the telephone group (Cronbach alpha estimate=.84; 95% CI 0.79-0.87). The mean global satisfaction score was lower (P=.03) in the Internet group (68.9; 95% CI 66.4-71.4) than in the telephone group (72.1; 95% CI 70.4-74.6), with a corresponding effect size of the difference at -0.253. CONCLUSIONS: The lower response rate issued from Internet administration should be balanced with a likely improved quality in satisfaction estimates, when compared with telephone administration, for which an interviewer effect cannot be excluded. TRIAL REGISTRATION: Clinicaltrials.gov NCT01769261 ; http://clinicaltrials.gov/ct2/show/NCT01769261 (Archived by WebCite at http://www.webcitation.org/6ZDF5lA41).

The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial.

BACKGROUND: In 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings. Despite these recommendations, non-targeted screening has not been implemented and only physician-directed diagnostic testing is currently performed. A survey conducted in 2010 in 29 French Emergency Departments (EDs) showed that non-targeted nurse-driven screening was feasible though only a few new HIV diagnoses were identified, predominantly among high-risk groups. A strategy targeting high-risk groups combined with current practice could be shown to be feasible, more efficient and cost-effective than current practice alone. METHODS/DESIGN: DICI-VIH (acronym for nurse-driven targeted HIV screening) is a multicentre, cluster-randomized, two-period crossover trial. The primary objective is to compare the effectiveness of 2 strategies for diagnosing HIV among adult patients visiting EDs: nurse-driven targeted HIV screening combined with current practice (physician-directed diagnostic testing) versus current practice alone. Main secondary objectives are to compare access to specialist consultation and how early HIV diagnosis occurs in the course of the disease between the 2 groups, and to evaluate the implementation, acceptability and cost-effectiveness of nurse-driven targeted screening. The 2 strategies take place during 2 randomly assigned periods in 8 EDs of metropolitan Paris, where 42 % of France's new HIV patients are diagnosed every year. All patients aged 18 to 64, not presenting secondary to HIV exposure are included. During the intervention period, patients are invited to fill a 7-item questionnaire (country of birth, sexual partners and injection drug use) in order to select individuals who are offered a rapid test. If the rapid test is reactive, a follow-up visit with an infectious disease specialist is scheduled within 72 h. Assuming an 80 % statistical power and a 5 % type 1 error, with 1.04 and 3.38 new diagnoses per 10,000 patients in the control and targeted groups respectively, a sample size of 140,000 patients was estimated corresponding to 8,750 patients per ED and per period. Inclusions started in June 2014. Results are expected by mid-2016. DISCUSSION: The DICI-VIH study is the first large randomized controlled trial designed to assess nurse-driven targeted HIV screening. This study can provide valuable information on HIV screening in health care settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02127424 (29 April 2014).

Homeless Patients in the ICU: An Observational Propensity-Matched Cohort Study.

OBJECTIVE: To describe epidemiology and outcome of critically ill homeless patients, as compared with those of nonhomeless patients. DESIGN: Homeless and nonhomeless admissions were matched on the basis of a 1:4 ratio, using a propensity score-based procedure involving age, sex, date, and main diagnosis at ICU admission. SETTING: A 18-bed closed medical ICU of a French tertiary care university hospital. PATIENTS: All consecutive admissions from July 2000 to December 2012. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: There were 421 homeless and 9,353 nonhomeless admissions. Considering homeless admissions, 50% patients had no health insurance, 56% had no financial resource, 91% were socially isolated, and 69% lived in street. In a multivariable analysis of homeless admissions including age, sex, and Simplified Acute Physiology Score II, living in street was significantly associated with hospital mortality (odds ratio=2.94; 95% CI, 1.30-7.10; p=0.012). As compared with nonhomeless, homeless admissions more frequently concerned men (89% vs 57%; p<0.0001) and younger patients (49 yr [43-57] vs 62 yr [46-76]; p<0.0001), whereas Simplified Acute Physiology Score II (37 [24-50] vs 37 [25-52]; p=0.99) and distribution of the number of organ supports (p=0.49) were similar. ICU mortality concerned 19.1% and 18% of matched homeless and nonhomeless admissions, respectively. The corresponding figures for hospital mortality were 20.8% and 20.6%. In multivariable analysis, homeless status was associated with neither ICU (odds ratio=1.27 [0.92-1.73]; p=0.14) nor hospital mortality (odds ratio=1.07 [0.77-1.49]; p=0.68), while it was independently associated with longer ICU (means ratio=1.16 [1.01-1.34]; p=0.035) and hospital (means ratio=1.30 [1.12-1.49]; p=0.0002) stay of survivors. CONCLUSIONS: Critically ill homeless patients benefit from the same level of care and have globally the same prognosis than housed patients but experience longer lengths of stay. Most precarious patients living in street have a higher mortality rate. The study perspective is not ICU centered but also concerns the global organization of healthcare since homeless patients are referred by numerous sources and discharged to different wards.

Comparing Patients' Opinions on the Hospital Discharge Process Collected With a Self-Reported Questionnaire Completed Via the Internet or Through a Telephone Survey: An Ancillary Study of the SENTIPAT Randomized Controlled Trial.

BACKGROUND: Hospital discharge, a critical stage in the hospital-to-home transition of patient care, is a complex process with potential dysfunctions having an impact on patients' health on their return home. No study has yet reported the feasibility and usefulness of an information system that would directly collect and transmit, via the Internet, volunteer patients' opinions on their satisfaction concerning the organization of hospital discharge. OBJECTIVE: Our primary objective was to compare patients' opinions on the discharge process collected with 2 different methods: self-questionnaire completed on a dedicated website versus a telephone interview. The secondary goal was to estimate patient satisfaction. METHODS: We created a questionnaire to examine hospital discharge according to 3 dimensions: discharge logistics organization, preplanned posthospital continuity-of-care organization, and patients' impressions at the time of discharge. A satisfaction score (between 0 and 1) for each of those dimensions and an associated total score were calculated. Taking advantage of the randomized SENTIPAT trial that questioned patients recruited at hospital discharge about the evolution of their health after returning home and randomly assigned them to complete a self-questionnaire directly online or during a telephone interview, we conducted an ancillary study comparing satisfaction with the organization of hospital discharge for these 2 patient groups. The questionnaire was proposed to 1141 patients included in the trial who were hospitalized for ≥2 days, among whom 867 eligible patients had access to the Internet at home and were randomized to the Internet or telephone group. RESULTS: Of the 1141 patients included, 755 (66.17%) completed the questionnaire. The response rates for the Internet (39.1%, 168/430) and telephone groups (87.2%, 381/437) differed significantly (P<.001), but their total satisfaction scores did not (P=.08) nor did the satisfaction subscores (P=.58 for discharge logistics organization, P=.12 for preplanned posthospital continuity-of-care organization, and P=.35 for patients' impressions at the time of discharge). The total satisfaction score (median 0.83, IQR 0.72-0.92) indicated the patients' high satisfaction. CONCLUSIONS: The direct transmission of personal health data via the Internet requires patients' active participation and those planning surveys in the domain explored in this study should anticipate a lower response rate than that issued from a similar survey conducted by telephone interviews. Nevertheless, collecting patients' opinions on their hospital discharge via the Internet proved operational; study results indicate that conducting such surveys via the Internet yields similar estimates to those obtained via a telephone survey. The results support the establishment of a permanent dedicated website that could also be used to obtain users' opinions on other aspects of their hospital stay and follow-up. TRIAL REGISTRATION: Clinicaltrials.gov NCT01769261; http://clinicaltrials.gov/ct2/show/NCT01769261 (Archived by WebCite at http://www.webcitation.org/6ZDF5bdQb).

A systematic review of adult admissions to ICUs related to adverse drug events.

Adverse drug events (ADE) may lead to hospital admission, and in some cases admission to an ICU is mandatory. We conducted a systematic review dealing with the incidence of ADE requiring ICU admission in adult patients, the reference population being all ICU admissions. Medline, Embase and Web of Science databases were screened from January 1982 to July 2014, using appropriate key words. Only original articles in English reporting the incidence of ADE requiring ICU admission in adult patients among total ICU admissions were included. Article eligibility was assessed by two independent reviewers, a third being involved in cases of disagreement. All reported characteristics (type of ICU, characteristics of patients, incidence of ADE, severity and preventability, drugs involved, causality) in the selected articles were collected for the review. The quality of studies was independently assessed by two reviewers with a specific score that we developed. A meta-analysis was conducted. Inclusion criteria were fulfilled by 11 studies out of the 4,311 identified in the initial literature search. The median (interquartile) quality score was 0.61 (0.44; 0.69). The reported incidences of ADE requiring ICU admission in adult patients ranged from 0.37 to 27.4%, with an associated mortality rate ranging from 2 to 28.1% and a mean length of stay ranging from 2.3 to 6.4 days. Preventable events accounted for 17.5 to 85.7% of the events. Costs and mechanisms at the root of ADE were investigated in only two and five studies, respectively. The forest plot examining the incidence of ADE requiring ICU admission in adult patients was associated with high heterogeneity (I (2) statistic > 98%), and the shape of the corresponding funnel plot was asymmetric. Heterogeneity across studies concerned many features, including studied populations, events considered, causality assessment methods, definitions of preventability and severity. Despite the heterogeneity of the reports, our review indicates that ICU admission due to ADE is a significant issue that should deserve further interest. The review led us to propose a list of items devoted to the reporting of future studies on ADE requiring ICU admissions.

Determination of French influenza outbreaks periods between 1985 and 2011 through a web-based Delphi method.

BACKGROUND: Assessing the accuracy of influenza epidemic periods determined by statistical models is important to improve the performance of algorithms used in real-time syndromic surveillance systems. This is a difficult problem to address in the absence of a reliable gold standard. The objective of this study is to establish an expert-based determination of the start and the end of influenza epidemics in France. METHODS: A three-round international web-based Delphi survey was proposed to 288 eligible influenza experts. Fifty-seven (20%) experts completed the three-rounds of the study. The experts were invited to indicate the starting and the ending week of influenza epidemics, on 32 time-series graphs of influenza seasons drawn using data from the French Sentinelles Network (Influenza-like illness incidence rates) and virological data from the WHO-FluNet. Twenty-six of 32 time-series graphs proposed corresponded to each of the French influenza seasons observed between 1985 and 2011. Six influenza seasons were proposed twice at each round to measure variation among expert responses. RESULTS: We obtained consensual results for 88% (23/26) of the epidemic periods. In two or three rounds (depending on the season) answers gathered around modes, and the internal control demonstrated a good reproducibility of the answers. Virological data did not appear to have a significant impact on the answers or the level of consensus, except for a season with a major mismatch between virological and incidence data timings. CONCLUSIONS: Thanks to this international web-based Delphi survey, we obtained reproducible, stable and consensual results for the majority of the French influenza epidemic curves analysed. The detailed curves together with the estimates from the Delphi study could be a helpful tool for assessing the performance of statistical outbreak detection methods, in order to optimize them.

Hospital admissions and mortality for acute exacerbations of COPD during the COVID-19 pandemic: A nationwide study in France.

Background: A global reduction in hospital admissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) was observed during the first months of the COVID-19 pandemic. Large-scale studies covering the entire pandemic period are lacking. We investigated hospitalizations for AECOPD and the associated in-hospital mortality at the national level in France during the first 2 years of the pandemic. Methods: We used the French National Hospital Database to analyse the time trends in (1) monthly incidences of hospitalizations for AECOPD, considering intensive care unit (ICU) admission and COVID-19 diagnoses, and (2) the related in-hospital mortality, from January 2016 to November 2021. Pandemic years were compared with the pre-pandemic years using Poisson regressions. Results: The database included 565,890 hospitalizations for AECOPD during the study period. The median age at admission was 74 years (interquartile range 65-83), and 37% of the stays concerned women. We found: (1) a dramatic and sustainable decline in hospitalizations for AECOPD over the pandemic period (from 8,899 to 6,032 monthly admissions, relative risk (RR) 0.65, 95% confidence interval (CI) 0.65-0.66), and (2) a concomitant increase in in-hospital mortality for AECOPD stays (from 6.2 to 7.6% per month, RR 1.24, 95% CI 1.21-1.27). The proportion of stays yielding ICU admission was similar in the pre-pandemic and pandemic years, 21.5 and 21.3%, respectively. In-hospital mortality increased to a greater extent for stays without ICU admission (RR 1.39, 95% CI 1.35-1.43) than for those with ICU admission (RR 1.09, 95% CI 1.05-1.13). Since January 2020, only 1.5% of stays were associated with a diagnosis of COVID-19, and their mortality rate was nearly three-times higher than those without COVID-19 (RR 2.66, 95% CI 2.41-2.93). Conclusion: The decline in admissions for AECOPD during the pandemic could be attributed to a decrease in the incidence of exacerbations for COPD patients and/or to a possible shift from hospital to community care. The rise in in-hospital mortality is partially explained by COVID-19, and could be related to restricted access to ICUs for some patients and/or to greater proportions of severe cases among the patients hospitalized during the pandemic.

Variability of the chronic obstructive pulmonary disease key epidemiological data in Europe: systematic review.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is predicted to become a major cause of death worldwide. Studies on the variability in the estimates of key epidemiological parameters of COPD may contribute to better assessment of the burden of this disease and to helpful guidance for future research and public policies. In the present study, we examined differences in the main epidemiological characteristics of COPD derived from studies across countries of the European Union, focusing on prevalence, severity, frequency of exacerbations and mortality, as well as on differences between the studies' methods. METHODS: This systematic review was based on a search for the relevant literature in the Science Citation Index database via the Web of Science and on COPD mortality rates issued from national statistics. Analysis was finally based on 65 articles and Eurostat COPD mortality data for 21 European countries. RESULTS: Epidemiological characteristics of COPD varied widely from country to country. For example, prevalence estimates ranged between 2.1% and 26.1%, depending on the country, the age group and the methods used. Likewise, COPD mortality rates ranged from 7.2 to 36.1 per 10(5) inhabitants. The methods used to estimate these epidemiological parameters were highly variable in terms of the definition of COPD, severity scales, methods of investigation and target populations. Nevertheless, to a large extent, several recent international guidelines or research initiatives, such as GOLD, BOLD or PLATINO, have boosted a substantial standardization of methodology in data collection and have resulted in the availability of more comparable epidemiological estimates across countries. On the basis of such standardization, severity estimates as well as prevalence estimates present much less variation across countries. The contribution of these recent guidelines and initiatives is outlined, as are the problems remaining in arriving at more accurate COPD epidemiological estimates across European countries. CONCLUSIONS: The accuracy of COPD epidemiological parameters is important for guiding decision making with regard to preventive measures, interventions and patient management in various health care systems. Therefore, the recent initiatives for standardizing data collection should be enhanced to result in COPD epidemiological estimates of improved quality. Moreover, establishing international guidelines for reporting research on COPD may also constitute a major contribution.

Smoking cessation using preference-based tools among socially disadvantaged smokers: study protocol for a pragmatic, multicentre randomised controlled trial.

INTRODUCTION: Many smoking cessation aids such as nicotine replacement treatments and e-cigarettes have been proven effective in aiding smoking cessation attempts. Encouraging smokers with low socioeconomic position (SEP) to choose their smoking aid tool based on their preferences, and giving that tool free of charge, might increase the odds of smoking cessation. This trial examines the effectiveness of the 'STOP' (Sevrage Tabagique à l'aide d'Outils dédiés selon la Préférence: Smoking cessation using preference-based tools), a preference-based smoking cessation intervention for smokers with low SEP. METHODS AND ANALYSIS: The STOP study is a randomised, multicentre, controlled trial (RCT). Smokers with low SEP and wishing to quit will be randomised to either the intervention or the control group (standard care). Participants in the intervention group will be asked to choose between different types of nicotine substitutes (patches, inhalers, gum, tablets, etc) and/or an electronic cigarette which will be delivered free of charge to aid their smoking cessation attempt.The primary outcome will be smoking abstinence at 6 months after inclusion, defined as self-reported 7-day point prevalence of tobacco abstinence. Secondary outcomes include the total number of days of abstinence at 6 months after inclusion, 7-day point prevalence tobacco abstinence at 1 and 3 months after inclusion and number of relapses.The study will also include an economic evaluation, and a process evaluation using a mixed methods approach. ETHICS AND DISSEMINATION: The study was approved by the 'Île de France II' Institutional Review Board on 8 September 2020 (CPP Île de France II; Ref No: 20.01.31.65528 RIPH2 HPS), and results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04654585.

Anatomy of the epidemiological literature on the 2003 SARS outbreaks in Hong Kong and Toronto: a time-stratified review.

BACKGROUND: Outbreaks of emerging infectious diseases, especially those of a global nature, require rapid epidemiological analysis and information dissemination. The final products of those activities usually comprise internal memoranda and briefs within public health authorities and original research published in peer-reviewed journals. Using the 2003 severe acute respiratory syndrome (SARS) epidemic as an example, we conducted a comprehensive time-stratified review of the published literature to describe the different types of epidemiological outputs. METHODS AND FINDINGS: We identified and analyzed all published articles on the epidemiology of the SARS outbreak in Hong Kong or Toronto. The analysis was stratified by study design, research domain, data collection, and analytical technique. We compared the SARS-case and matched-control non-SARS articles published according to the timeline of submission, acceptance, and publication. The impact factors of the publishing journals were examined according to the time of publication of SARS articles, and the numbers of citations received by SARS-case and matched-control articles submitted during and after the epidemic were compared. Descriptive, analytical, theoretical, and experimental epidemiology concerned, respectively, 54%, 30%, 11%, and 6% of the studies. Only 22% of the studies were submitted, 8% accepted, and 7% published during the epidemic. The submission-to-acceptance and acceptance-to-publication intervals of the SARS articles submitted during the epidemic period were significantly shorter than the corresponding intervals of matched-control non-SARS articles published in the same journal issues (p<0.001 and p<0.01, respectively). The differences of median submission-to-acceptance intervals and median acceptance-to-publication intervals between SARS articles and their corresponding control articles were 106.5 d (95% confidence interval [CI] 55.0-140.1) and 63.5 d (95% CI 18.0-94.1), respectively. The median numbers of citations of the SARS articles submitted during the epidemic and over the 2 y thereafter were 17 (interquartile range [IQR] 8.0-52.0) and 8 (IQR 3.2-21.8), respectively, significantly higher than the median numbers of control article citations (15, IQR 8.5-16.5, p<0.05, and 7, IQR 3.0-12.0, p<0.01, respectively). CONCLUSIONS: A majority of the epidemiological articles on SARS were submitted after the epidemic had ended, although the corresponding studies had relevance to public health authorities during the epidemic. To minimize the lag between research and the exigency of public health practice in the future, researchers should consider adopting common, predefined protocols and ready-to-use instruments to improve timeliness, and thus, relevance, in addition to standardizing comparability across studies. To facilitate information dissemination, journal managers should reengineer their fast-track channels, which should be adapted to the purpose of an emerging outbreak, taking into account the requirement of high standards of quality for scientific journals and competition with other online resources.

Comparison of routine and on-demand prescription of chest radiographs in mechanically ventilated adults: a multicentre, cluster-randomised, two-period crossover study.

BACKGROUND: Present guidelines recommend routine daily chest radiographs for mechanically ventilated patients in intensive care units. However, some units use an on-demand strategy, in which chest radiographs are done only if warranted by the patient's clinical status. By comparison between routine and on-demand strategies, we aimed to establish which strategy was more efficient and effective for optimum patient care. METHODS: In a cluster-randomised, open-label crossover study, we randomly assigned 21 intensive care units at 18 hospitals in France to use a routine or an on-demand strategy for prescription of chest radiographs during the first of two treatment periods. Units used the alternative strategy in the second period. Each treatment period lasted for the time taken for enrolment and study of 20 consecutive patients per intensive care unit; patients were monitored until discharge from the unit or for up to 30 days' mechanical ventilation, whichever was first. Units enrolled 967 patients, but 118 were excluded because they had been receiving mechanical ventilation for less than 2 days. The primary outcome measure was the mean number of chest radiographs per patient-day of mechanical ventilation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00893672. FINDINGS: 11 intensive care units were randomly allocated to use a routine strategy to order chest radiographs in the first treatment period, and 10 units to use an on-demand strategy. Overall, 424 patients had 4607 routine chest radiographs (mean per patient-day of mechanical ventilation 1.09, 95% CI 1.05-1.14), and 425 had 3148 on-demand chest radiographs (mean 0.75, 0.67-0.83), which corresponded to a reduction of 32% (95% CI 25-38) with the on-demand strategy (p<0.0001). INTERPRETATION: Our results strongly support adoption of an on-demand strategy in preference to a routine strategy to decrease use of chest radiographs in mechanically ventilated patients without a reduction in patients' quality of care or safety. FUNDING: Assistance Publique-Hôpitaux de Paris (Direction Régionale de la Recherche Clinique Ile de France).

Factors associated with excessively lengthy treatment of tuberculosis in the eastern Paris region of France in 2004.

BACKGROUND: Few data are available on prescriber adherence to tuberculosis (TB) treatment guidelines. In particular, excessively long treatment carries a risk of avoidable adverse effects and represents a waste of healthcare resources. We examined factors potentially associated with excessively long treatment. METHODS: We reviewed the medical records of patients diagnosed with TB in 2004 in the eastern Paris region. Sociodemographic and clinical factors associated with excessively long treatment were identified by logistic regression analyses. Based on contemporary guidelines, excessively long treatment was defined as more than 6 months of a four-drug regimen for thoracic TB with full sensitive strains, and more than 12 months for patients with extrathoracic TB. RESULTS: Analyses concerned 478 patients with a median age of 36.0 +/- 13.5 years, of whom 48% were living in precarious conditions (i.e. poor living conditions and/or no health insurance), 80% were born abroad, and 17% were HIV-seropositive. TB was restricted to the chest in 279 patients (isolated pulmonary, pleuropulmonary, and isolated pleural TB in 245, 13, and 21 patients, respectively), exclusively extrathoracic in 115 patients, and mixed in the remaining 84 patients. Treatment was prescribed by a chest specialist in 211 cases (44.1%) and 295 patients (61.7%) were managed in a single institution. The treatment duration complied with contemporary guidelines in 316 cases (66.1%) and was excessively long in 162 cases (33.9%). The median duration of excessively long treatment was 313 days (IQR: 272-412). In multivariate analysis, isolated thoracic TB, previous TB, HIV infection, a prescriber other than a chest specialist, and management in more than one healthcare center during treatment were independently associated with excessively lengthy treatment. CONCLUSION: One-third of TB patients received excessively long treatment, reflecting inadequate awareness of management guidelines or unwillingness to implement them.

Biased and unbiased estimation of the average length of stay in intensive care units in the Covid-19 pandemic.

BACKGROUND: The average length of stay (LOS) in the intensive care unit (ICU_ALOS) is a helpful parameter summarizing critical bed occupancy. During the outbreak of a novel virus, estimating early a reliable ICU_ALOS estimate of infected patients is critical to accurately parameterize models examining mitigation and preparedness scenarios. METHODS: Two estimation methods of ICU_ALOS were compared: the average LOS of already discharged patients at the date of estimation (DPE), and a standard parametric method used for analyzing time-to-event data which fits a given distribution to observed data and includes the censored stays of patients still treated in the ICU at the date of estimation (CPE). Methods were compared on a series of all COVID-19 consecutive cases (n = 59) admitted in an ICU devoted to such patients. At the last follow-up date, 99 days after the first admission, all patients but one had been discharged. A simulation study investigated the generalizability of the methods' patterns. CPE and DPE estimates were also compared to COVID-19 estimates reported to date. RESULTS: LOS ≥ 30 days concerned 14 out of the 59 patients (24%), including 8 of the 21 deaths observed. Two months after the first admission, 38 (64%) patients had been discharged, with corresponding DPE and CPE estimates of ICU_ALOS (95% CI) at 13.0 days (10.4-15.6) and 23.1 days (18.1-29.7), respectively. Series' true ICU_ALOS was greater than 21 days, well above reported estimates to date. CONCLUSIONS: Discharges of short stays are more likely observed earlier during the course of an outbreak. Cautious unbiased ICU_ALOS estimates suggest parameterizing a higher burden of ICU bed occupancy than that adopted to date in COVID-19 forecasting models. FUNDING: Support by the National Natural Science Foundation of China (81900097 to Dr. Zhou) and the Emergency Response Project of Hubei Science and Technology Department (2020FCA023 to Pr. Zhao).