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Research paper
Cost effectiveness of full coverage of the medical management of smoking cessation in France
  1. Karine Chevreul1,2,3,
  2. Benjamin Cadier2,
  3. Isabelle Durand-Zaleski1,2,3,
  4. Elis Chan2,
  5. Daniel Thomas4
  1. 1Department of Public Health, AP-HP, Henri Mondor-Albert Chenevier Hospitals, Créteil, France
  2. 2URC Eco Ile-de-France, AP-HP, Paris, France
  3. 3LIC E4393, Université Paris-Est, IFR10, Cretéil, France
  4. 4Institut de Cardiologie, Hôpital Pitié-Salpêtrière, AP-HP, Université Paris-VI, Paris, France
  1. Correspondence to Dr Karine Chevreul, URC Eco Ile-de-France (AP-HP), Hotel Dieu, 1, Place du Parvis Notre Dame, Paris 75004, France; karine.chevreul{at}urc-eco.fr

Abstract

Objective To estimate the incremental cost effectiveness of full coverage of the medical management of smoking cessation from the perspective of statutory health insurance (SHI) in France.

Design and population Cost-effectiveness analysis based on a Markov state-transition decision analytic model was used to compare full SHI coverage of smoking cessation and actual coverage based on an annual €50 lump sum per insured person among current French smokers aged 15–75 years. We used a scenario approach to take into account the many different behaviours of smokers and the likely variability of SHI policy choices in terms of participation rate and number and frequency of attempts covered.

Interventions Drug treatments for smoking cessation combined with six medical consultations including individual counselling.

Main outcomes measures The cost effectiveness of full coverage was expressed by the incremental cost-effectiveness ratio (ICER) in 2009 euros per life-year gained (LYG) at the lifetime horizon.

Results The cost effectiveness per LYG for smokers ranged from €1786 to €2012, with an average value of €1911. The minimum value was very close to the maximum value with a difference of only €226. The cost-effectiveness ratio was only minimally sensitive to the participation rate, the number of attempts covered and the cessation rate.

Conclusions Compared to other health measures in primary and secondary prevention of cardiovascular disease already covered by SHI, full coverage of smoking cessation is the most cost-effective approach.

  • Cessation
  • Economics
  • Public policy

https://doi.org/10.1136/tobaccocontrol-2012-050520

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    Introduction

    The consequences of smoking in terms of morbidity and health costs are significant and avoidable. According to the French Monitoring Centre for Drugs and Drug Addiction (Observatoire français des drogues et des toxicomanies; OFDT), deaths due to smoking account for 10–12% of annual mortality in France. The economic burden of smoking represents approximately 12% of hospital costs and 7% of expenses for office visits to self-employed physicians.1 In light of these figures, actions to reduce the prevalence of smoking are needed.

    In France, interventions against tobacco use have increased since the 1991 Evin Law. The law's ban on smoking in public places, regulation of tobacco advertising and a significant increase in the pack price have helped to reduce smoking prevalence.2 Since 1998, at the impetus of the government, some hospital cardiology and thoracic medicine departments have set up out-patient clinics to help people quit smoking. However, these clinics are small in number and care mostly for smokers using hospital services because of existing health problems. Thus, smokers who want to quit are primarily treated by general practitioners (GPs), cardiologists or thoracic specialists. The statutory health insurance system (SHI), which provides equity in access to healthcare by covering almost 100% of the population for an average of 75% of healthcare expenditure, has implemented measures to reduce smoking prevalence. However, these measures have been insufficient. Since February 2007, the French SHI has offered a fixed annual coverage of €50 per insured person for expenditures related to smoking cessation drugs, which means that most of the cost of these drugs and 30% of the cost of the consultations for medical counselling sessions in doctors’ practices or hospital-based tobacco cessation clinics is paid by the patient. After 3 years of operation, the prevalence of smoking increased from 27% in 2007 to 29% in 2010,2 ,3 suggesting that this partial coverage of smoking cessation has had no significant impact on the population-level cessation rate. We assume that this is in part because partial coverage does not remove the economic barrier to access to medical support.4 Today, the small investment made by the SHI seems insufficient to control the use of tobacco.

    In this context one could question the usefulness of full coverage (100%) of smoking cessation expenditure. However, full coverage coupled with increased therapeutic monitoring would finance additional attempts to quit smoking, thereby presumably increasing the number of quitters.5–7 This is the finding of a report on treatment strategies for smoking cessation by the French Health Products Safety Agency (Agence française de sécurité sanitaire des produits de santé; AFSSAPS)8 and also the conclusion of many international guidelines.9–12 Moreover, these policies have already been implemented successfully in the UK and Québec, among other jurisdictions.13 ,14

    However, there are few French studies assessing the potential benefit of and resources needed for full coverage of the medical management of smoking cessation to improve the health of the population. For this reason we undertook a study to calculate the cost effectiveness of full coverage of the medical management of smoking cessation from the point of view of the SHI.

    Method

    We performed a cost-effectiveness analysis of full coverage of the medical management of smoking cessation compared to the current €50 coverage by the French SHI.

    Strategies: intervention and comparator

    The proposed intervention was the full coverage of a medical management programme of smoking cessation based on the current practice in hospital smoking cessation out-patient clinics, which is considered the standard for good practice. The intervention would fully cover drug treatments combined with medical consultations that include medical counselling delivered by self-employed doctors or existing hospital smoking cessation clinics. There would be six consultations spread over time (from 12 to 24 weeks), depending on the prescribed treatment.15 The drug treatments to be used were oral nicotine replacement therapy (NRT), transdermal patches (patches), varenicline (Champix) and bupropion (Zyban). The utilisation rate for each therapy was based on the sales of treatments in 2009 in France16: 48.65% for oral NRT, 35.85% for patches, 14.39% for varenicline and 1.12% for bupropion. There would be 100% financial support for consultations and drugs paid by the SHI.

    The comparator was the existing €50 coverage under the SHI for medical treatment for smoking cessation. It includes a fixed annual lump sum of €50 per insured person that partially covers one of two smoking cessation drug therapies (NRT or patches) in addition to the consultation required to obtain the prescription. No follow-up consultations or adjustments to drug therapies are included.

    The target population was French smokers (defined as ≥1 cigarette/day) aged 15–75 years. Our fictive cohort was representative of the age and gender distribution of the target population.17 ,18

    Cost and health benefits were modelled over the lifetime of the cohort. Costs were from the perspective of the SHI, and the base year of analysis was 2009. Our analysis did not take into account any cost offsets. We sought to identify only the expenditures by the SHI without regard for the potential cost savings due to reduced treatment of tobacco-attributable diseases, such as coronary disease or lung cancer.

    To estimate the cost effectiveness of full coverage, we chose the incremental cost-effectiveness ratio (ICER), which measures the cost per life-year gained (LYG) due to the intervention. The ratio denominator is a gain in health expressed in years of life gained, and the ratio numerator is the cost associated with the health gain. The results were expressed in euros per LYG at the lifetime horizon.

    Model

    Model method

    We used a Markov model in order to predict the effectiveness of the interventions beyond the limited time horizon of clinical trials.19 The transition probabilities from one state to another were time-dependent, and thus we conducted a cohort analysis. The most appropriate cycle for our model was the year. Mortality data and cost data were available and readily calculable on an annual basis. The model was performed in Microsoft Office Excel 2007.

    Model structure

    Our model consisted of three mutually exclusive states: smoker, former and dead.20 In the first cycle all individuals are in the smoker state. At the end of each cycle a smoker is found in one of three states: remain a smoker (PSS), become a former smoker (PSF) or dead (PSD). From cycle two until the end of the model, former smokers have three possibilities: they remain former (PFF), relapse and become a smoker again (PFS) or they die, passing into the dead state (PFD). Finally, the dead state is an absorbing state (PDD). The model stops when all individuals in the cohort are found in this state (figure 1).

    Figure 1
    Figure 1

    Schematic diagram of Markov model estimating the effectiveness of smoking cessation strategies.

    Death rate

    There are no specific annual mortality data for French smokers (PSD) and former smokers (PFD). To estimate smoking-related mortality, we selected the Doll cohort,21 composed of 34 439 British male doctors aged 35–64 years and followed over a period of 40 years between 1950 and 1990. We chose this cohort because it included only observed values and, more importantly, had a longer temporal horizon than others, such as CPS-II.22 The Doll cohort is stratified by age, and death rates of smokers and former smokers are given for each 5-year increment up to 100 years.

    In order to obtain an annual figure, we converted the 5-year death rate, taking into account acceleration in the death rate. Moreover, because the background death rates in France and the UK are different, we applied a mortality ratio between the two countries.23

    We had to estimate tobacco-related mortality for female smokers and former smokers because the Doll cohort is exclusively male. We used a female/male mortality ratio for both smokers and former smokers that was calculated using lung cancer mortality (mortality from lung cancer was respectively six and eight deaths per 100 000 men and women aged 35–44 years) as a proxy for tobacco-related mortality.24 Despite the fact that this ratio was calculated only for women aged 35–44 years, we hypothesised that the majority would follow this behaviour because over 68% of female smokers are aged less than 45 years.

    Similarly, the Doll cohort does not include mortality data before the age of 35 years. Because Doll showed that ex-smokers who quit before the age of 35 years had the same life expectancy as non-smokers,23 we used the annual death rate of the general population for smokers and former smokers aged less than 35 years.

    Effectiveness of strategies

    To compare the effectiveness between full coverage and €50 coverage, we built a life table for both cohorts based on the number of smokers and former smokers.

    Effectiveness of full coverage

    Because no evaluations are available for the effectiveness of hospital smoking cessation clinics’ current standard practice and because the population consulting such clinics is not representative of the population of smokers who want to quit, we estimated the effectiveness of full coverage based on the results of a meta-analysis of randomised controlled trials of smoking cessation drugs25 and a meta-analysis of individual counselling.26 First, we corrected the ORs to approximate the relative risk ratios27 and applied the French spontaneous cessation rate of 2.6%.28 Then we calculated an overall drug cessation rate, weighting by their utilisation rates for the year 2009.16 This was adjusted to account for the impact of individual counselling.26 The results are set forth in table 1. Based on these assumptions, the definitive cessation rate for the full coverage strategy was 7.04%. Because available data did not allow disentangling of the relapse rate, which is included in the definitive smoking cessation rate used, no relapse rate was directly introduced in the model. If we were to take the 1-year cessation rate of 14.6% for the UK National Health Service (NHS) full coverage programme29 and apply a lifetime relapse rate of 50%, our estimates would remain highly conservative.

    View this table:
    Table 1

    Cessation rate for full coverage

    Effectiveness of €50 coverage

    There has been no assessment of the smoking cessation rate since implementation of the €50 coverage policy. However, given that tobacco sales did not decrease over the 2007–2009 period, we assumed that the policy had no significant impact on the annual smoking cessation rate, and thus we used the spontaneous annual smoking cessation rate, which is estimated at 2.6%.28 As previously noted, the available data did not allow disentangling of the relapse rate, which is included in the definitive smoking cessation rate used, and thus no relapse rate was directly introduced in the model.

    Costs of strategies

    The cost of each strategy took into account both the costs related to coverage of medical consultations and those related to drugs for smoking cessation.

    Costs for full coverage

    The total consultation cost was calculated based on the tariff of €22 for a general practice consultation in 200930 (table 2).

    View this table:
    Table 2

    Cost of full coverage

    To obtain the average cost of a complete smoking cessation treatment regimen, the cost of each drug regimen was weighted by its utilisation rate in 2009. The price of patches was based on a 2008 survey of 30 pharmacies located in five areas of Paris.31 The costs of the other drugs were based on the results of a 2009 survey of seven pharmacies in Créteil, a town in the Paris suburbs. These costs were very close to the prices cited on non-government drug price websites. With the exception of bupropion, which has a treatment duration of 8 weeks, the costs of these drugs were calculated on the basis of the average duration of a drug smoking cessation regimen, which is 12 weeks.15 Assuming full coverage, the intervention cost was €332.97 per smoker for the first cycle (table 2).

    Costs for €50 coverage

    The €50 coverage of smoking cessation is comprised of a fixed annual lump sum of €50 for drugs in addition to 70% coverage (minus a €1 deductible) of a single doctor visit. The total cost of the €50 coverage in 2009 was €64.40 per smoker following this strategy.

    Scenario approach

    Although we could fix some of the previous parameters, we could not, however, know in advance how many attempts the SHI would decide to fully cover. Moreover, we could not be certain in advance of the smokers’ participation rate and the time frequency of their quit attempts. Consequently, we chose to use a scenario approach to take into account the likely variability of SHI policy choices and the many different behaviours in the population of smokers.

    Participation rate

    The participation rate is defined as the number of smokers who decide to follow the strategy among the total population of smokers. We based our assumption for the scenarios on smokers’ declarations of their intention to quit2 in order to test the impact of the participation rate on the ICER value. Thus, for the base case scenario of the full coverage strategy we applied a participation rate of 7.3, that is 10% of the 73% of smokers who are motivated to quit,2 which is equivalent to the participation rate that was reported in the UK. Then we tested the participation rates of one-third, two-thirds and 100% of this population. For the sensitivity analysis, we used the average of the participation rates in the UK (7%)32 and Québec (13.7%).14 Participation was applied to the model by age group.33 For the €50 coverage strategy, the participation rate in 2008 was estimated at 3.75% based on data provided by the SHI.

    Number and frequency of attempts covered

    Based on the fact that 75% of smokers have tried to quit four times,17 we tested two, four and six as the number of attempts covered to quit smoking in the model. A smoker who relapses needs time to try to quit again. We made the assumption that he or she would try again every 2 years.

    Table 4 sets out the 12 scenarios we considered, based on our assumptions with respect to the cessation rate, the participation rate and the frequency and number of attempts to quit.

    Inflation, discounting and uncertainty

    The annual inflation rate was calculated using the healthcare price indexes.34 From 2004 to 2008, the annual inflation rate was 0.23% for GP visits and 2.19% for drugs. For the discount rate, we applied the standard rate of 3%.35

    To account for the uncertainties in the values and future events of the model, we performed a Monte Carlo simulation (1000 iterations) using Statscorer software. The parameters were varied as follows: the permanent cessation rate was calculated with the 95% CI of the OR of quitting25 (table 3). In addition, because the time between two consecutive attempts to quit smoking varies greatly among smokers, we tested annual and 4-year intervals between attempts covered. Because the inflation of health goods varies and because the healthcare price indexes for consultations were higher between 2000 and 2004, we decided to use the inflation rate of this time period last in the sensitivity analysis. This produced annual inflation rates for GP visits of +1.32%.34 We also assumed that the price of smoking cessation drugs would be regulated if fully covered by the SHI. Thus, we used the specific index of nominal prices of SHI-covered drugs of −5.38%,34 and we applied a reduction of up to 40% of the cost of the drugs.36 Finally, discount rates of 0% and 6% based on the WHO standard rate were used in the sensitivity analysis.35

    View this table:
    Table 3

    Sensitivity analysis

    Results

    The cost effectiveness per LYG for smokers representative of French smokers ranged from €1786 to €2012, with an average value of €1911. The minimum value was close to the maximum value with a difference of only €226. The cost-effectiveness ratio was only minimally sensitive to the participation rate and the number of attempts covered, even when the number of the yearly attempts covered was unlimited. Table 4 summarises the cost, the life expectancy and the ICER per LYG estimated by our model for all scenarios.

    View this table:
    Table 4

    ICER per LYG among studied scenarios

    Variation in parameters results in final ICER values ranging from €736 to €4849 (see histogram in figure 2) and an average value of €1689 (SD is €357). The distribution of the ICER value is normal with a slight right skewness and a 95% CI from €1666 to €1711. The cumulative distribution (see curves in figure 2) reveals that the cost-effectiveness ratio has a median value of €1646 and an IQR of €1432 to €1893. The ICER remains under €2338 in 95% of cases and under €2725 in 99% of cases. These results demonstrate the robustness of our model because the random variation of key parameters had a moderate impact on the final ICER values.

    Figure 2
    Figure 2

    Probabilistic sensitivity analysis (Monte Carlo simulation): frequency and cumulative frequency of incremental cost-effectiveness ratio values. ICER, incremental cost-effectiveness ratio; LYG, life-year gained.

    The x-axis shows the ICER values.

    The left hand y-axis corresponds to the frequency histograms of the 1000 randomly calculated ICER values. For example, 0.55% (ie, the highest histogram) corresponds to a value of €1642.

    The right hand y-axis corresponds to the cumulative frequency of the 1000 randomly calculated ICER values. To determine the median value of the 1000 randomly cumulated ICERs, one therefore draws a line parallel to the x-axis that passes through the value 50% and projects its intersection with the curve on the x-axis, which shows €1646 per LYG.

    Discussion

    With an average value of €1911, the cost-effectiveness ratio for SHI full coverage compared to €50 coverage is very low, particularly in light of the fact that it does not take into account any cost offsets. Indeed, the results are well below the median cost of US$19 000 (€21 468 in 2009€) for a medical intervention per LYG found in an analysis of more than 310 studies of cost efficiency.37 While France has not established a cost-effectiveness threshold, full coverage of smoking cessation retains its dominance when compared to other established thresholds, including the UK's quality-adjusted life year (QALY) threshold of £20 000 to £30 000 (€22 500 to €33 800 in 2009€)38 or the WHO's threshold, in which interventions are considered very cost-effective if they are less than the gross domestic product (GDP) per capita (€34 300 in France in 2009).39

    Of particular interest is the consistency of our results, even when uncertain parameters such as the participation rate, the cessation rate and the number of attempts were varied, given the unpredictability of the behaviour of smokers when quitting. Moreover, even with a conservative approach with assumptions of minimal participation (7%) and a low cessation rate (5.64%), the value of the cost-effectiveness ratio remains very low (€2667).

    When we conducted a similar study with a ‘do nothing’ comparator, our result of €2003 was quite similar to those found in several studies measuring the ICER of public coverage of smoking cessation from a lifetime perspective. Indeed, a multi-country study estimated an ICER range of €2543 to €3971 (€2920 to €4560 in 2009€) for drug management of a French male smoker aged 45 years, depending upon the NRT used.40 The Bertram study of public coverage in Australia is one of the few finding much higher ICER values, with cost-effectiveness ratios ranging from $A7900 to $A17 000 (€4974 to €10 703 in 2009€) depending on the drug used.20 However, this gap can be partly explained by the 8.6% natural cessation rate and the higher initial cost of treatment of $A490 (€309 in 2009€).

    A cost-effectiveness study of a Norwegian smoking cessation programme for patients admitted for coronary heart disease found a lower ICER per LYG of €280 and €110 (€303 and €119 in 2009€) in the low- and high-risk groups, respectively.41 However, this study took place in a secondary prevention environment, demonstrating that this type of intervention is even more cost-effective in this context. It is important to note that this smoking cessation programme was delivered solely by cardiac nurses, with no doctors involved, and the cost of drugs was not included in the analysis.

    The recent results of the evaluation of the UK NHS Stop Smoking Services reveal that 70 000 lives have been saved,42 for a total cost of £434 million (€487 million in 2009€) over 10 years.43 The price per death avoided is £6200 (€6961 in 2009€). If we assume an additional life expectancy of 6 months, 1 year or 3 years per death avoided,23 the incremental cost per life-year saved would be, respectively, £12 400 (€13 922 in 2009€), £6200 (€6961 in 2009€) or £2065 (€2318 in 2009€) from a 10-year perspective.

    With respect to the data, we were faced with three limitations. First, the Doll cohort is exclusively male, and thus an estimate based on the actual lung cancer death rate ratio between men and women was applied.24 While this approach may be simplistic, it is justified given that the health consequences are the same for men and women44 and that the smoking habits of women have become closer to those of men since 1980 in terms of consumption and prevalence.45 Second, the nature of the Doll cohort involves temporal and spatial data limits. As regards the temporal limits, we applied the observed results in the UK over the period 1910–1994 to the French population of smokers for the period 1940–2010. To validate the legitimacy of these data, consumption habits (type of tobacco, duration and amount of consumption) at that time and in the UK should be comparable to the consumption habits of current French smokers. A study found that current tobacco consumption in France and the UK is comparable,45 although in the past (around 1950) consumption in the UK was slightly higher than in France. In addition, the types of cigarettes sold in France and UK have always been the same.45 Therefore, all things being equal, the negative consequences on health from tobacco were more significant in our model than in reality. To address the spatial limit we used a mortality ratio to adjust the UK mortality to the French mortality. These assumptions ensure that our mortality data are not underestimated and that our approach remains conservative. Finally, we assumed that prior to the age of 35 years, smoking would not impact on mortality. For younger smokers this assumption may lead to underestimation of the death rate by not taking into account those who have smoked for more than 15 years for whom mortality is increased.46 However, the consequences of this assumption are very small for the final result because the death rate between ages 15 and 35 is low (less than 1.3/1000 per year).

    If we compare our results to other health actions in the field of primary and secondary prevention of cardiovascular disease already covered by the SHI, full coverage of smoking cessation is clearly the most cost-effective measure. For example, statins showed a cost-effectiveness ratio of €2506 (€2579 in 2009€) in the primary prevention of cardiovascular disease for French patients with diabetes in 200847 and of €15 000 for patients aged 30–69 years using cholesterol-lowering or antihypertensive treatment in the Netherlands in 2009.48 Aldosterone had a cost-effectiveness ratio of €15 382 (€17 333 in 2009€) in the secondary prevention of myocardial infarction in the French population in 2003.49 Aspirin use for the primary prevention of complications in patients with type II diabetes had a cost-effectiveness ratio estimated at US$5428 (€4098 in 2009€) in the USA in 2010.50

    The dominance of full coverage of smoking cessation in terms of cost effectiveness would be potentially even greater if the SHI were to adopt this approach because the cessation drugs would then fall under the rules for SHI-covered drugs and thus would benefit from statutory tariffs that are strongly negotiated by the French pricing committee. One could expect a 20% to 40% reduction in drug cost, leading to even lower ICER values (on average €1789 to €1563).

    Notwithstanding its demonstrated cost effectiveness, the success of a full coverage programme is dependant on the involvement of all policy actors and health authorities. Access to drug therapies and coverage of medical consultations must be accompanied by a significant level of counselling of patients, as proposed by the Russell standard,51 which has already been implemented in the UK.

    One could challenge the need for public coverage of smoking cessation programmes on the grounds that unassisted cessation is as successful or even more so, as some have suggested.52 However, this assertion has been largely based on raw numbers rather than the success rates of assisted (19.7%) versus unassisted (7.3%) cessation, and ignores the heterogeneity of the smoking population in terms of level of dependency (physiological need) and income level (financial need).53 Indeed, lower dependence has been generally found to be predictive of making a quit attempt, suggesting a lower need for assistance.54 However, a comprehensive policy that encourages all smokers to quit has the virtue of helping people with higher levels of dependency to undertake a quit attempt. Moreover, highly dependent smokers are usually more socially disadvantaged and therefore more likely to fail.55 In light of our results showing that full public coverage of smoking cessation is highly cost-effective, the economic and social policy question of whether to make medically-supported cessation affordable to this population is more likely to be positively answered.

    In the French context, the initial results of the most recent French health barometer (2010) show that the prevalence of smoking increased between 2005 and 2010, underscoring the importance of taking effective health action. In light of the economic arguments presented above, one could argue that full coverage of smoking cessation by the SHI should be a priority for policymakers, consistent with Article 14 of the WHO Framework Convention on Tobacco Control, which states that financial access to tobacco cessation treatment including drugs should be facilitated.56 Indeed, just as it would be unthinkable today not to cover a person with diabetes who has an unhealthy lifestyle, we should consider smokers who want to stop in the same light and offer them access to full medical assistance to help them quit.

    What this paper adds

    • Several jurisdictions, including the UK and the province of Québec, which have adopted full coverage of smoking cessation treatment have seen the prevalence of smoking decrease.

    • France has partially covered certain smoking cessation treatments since February 2007, but the prevalence of smoking has nonetheless continued to increase, raising the question of whether full coverage could reverse this trend.

    • Using a Markov model, our study is the first to estimate the incremental cost-effectiveness ratio (ICER) of full versus partial coverage of medically managed smoking cessation programmes in France for the full spectrum of treatments, including nicotine replacement therapy (NRT), bupropion and varenicline.

    • Our results show that full coverage, with an average ICER value of €1911 (2009€) for 1 year of life gained, would clearly be more cost-effective than partial coverage.

    • In the context of primary and secondary prevention of cardiovascular disease, full coverage of smoking cessation would be more cost-effective than other preventative measures already covered by statutory health insurance.

    Acknowledgments

    We thank Karen Berg Brigham for her helpful review of the manuscript. We are grateful to the National Institute for Prevention and Health Education (INPES) for providing unpublished data from the ITC France Survey, Wave 1.

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    Footnotes

    • Contributors KC substantially contributed to the design of the study and the analysis and interpretation of the data as well as the drafting of the manuscript. BC substantially contributed to the refinement of the methodology and the statistical analysis and interpretation as well as the drafting of the manuscript. IDZ substantially contributed to the analysis and interpretation of the data as well as the critical revisions of the manuscript. EC substantially contributed to the design and acquisition and analysis of the data as well as the drafting of an early version of this study, which formed the basis of his medical thesis. DT was responsible for the conception of the study and substantially contributed to the critical revisions of the manuscript. All authors gave final approval of the version to be published.

    • Funding Assistance Publique-Hôpitaux de Paris (AP-HP) funded this study.

    • Competing interests None.

    • Provenance and peer review Not commissioned; externally peer reviewed.