However, the trials included in a meta-analysis may have different lengths of follow-up. Each trial is represented by a square, the center of which denotes the difference in restricted mean survival time (rmstD) for that trial comparison, with the horizontal lines showing the 95% CIs. There is thus a compromise to achieve between a too short time horizon that would not take into account all information from all trials, and a too long time horizon that would necessitate the use of parametric extrapolation (see below) for most of the trials in the meta-analysis. MAR-LC: Meta-Analysis of Radiotherapy in Lung Cancer; RT: Radiotherapy. h�bbd```b``: "k��3�d>&U�$c� � ����>30120.� u �30�` �% Issues raised by the estimation of the rmstD for economic evaluation from a trial have already been investigated but none of these studies dealt with the use of IPD-MA [15â17]. All these methods have never been applied to assess the rmstD for economic evaluation. Difference in Restricted Mean Survival Time for Cost-Effectiveness Analysis Using Individual Patient Data Meta-Analysis: Evidence from a Case Study By Béranger Lueza, Audrey Mauguen, Jean-Pierre Pignon, Oliver Rivero-Arias, Julia Bonastre and null null https://doi.org/10.1371/journal.pone.0150032.s006. So far, two non-parametric methods (Stewart-Parmar and Peto methods) have been used for estimating pooled survival curves from IPD meta-analysis [25,26]. The restricted mean is a measure of average survival from time 0 to a specified time point, and may be estimated as the area under the survival curve up to that point. The estimated rmstDs ranged from 1.7 month to 2.5 months, and mean ICERs ranged from â¬ 24,299 to â¬ 34,934 per life-year gained depending on the chosen method. The results of the cost-effectiveness analysis were presented using the incremental cost-effectiveness ratios (ICER) expressed as the cost per life-year gained and cost-effectiveness acceptability curves [29]. Copyright: Â© 2016 Lueza et al. Yes That is why our focus was mostly on non-parametric methods used to estimate efficacy in the field of IPD-MA and why we dismissed other parametric methods proposed in the literature to estimate pooled survival curves [31]. No, Is the Subject Area "Survival analysis" applicable to this article? The difference in restricted mean survival between PWID and people who did not inject drugs was − 0.19 years (95% CI: -0.29, − 0.09). For more information about PLOS Subject Areas, click As a matter of fact, research on methods used to conduct economic evaluation based on IPD-MA is still in its infancy [11â14]. In order to estimate the rmstD from IPD-MA, we considered methods used by Wei and colleagues [18] and chose to adapt other non-parametric methods that are applied in the field of IPD-MA. 1 shows the difference in RMST to all-cause mortality comparing PWID and persons who did not … At a ceiling ratio of â¬ 25,000 per life year-gained, the probability of the experimental treatment being cost-effective ranged from 31% to 68%. MAR-LC trials compared conventional radiotherapy (RT) regimen with modified RT regimen and are listed in S1 Table. it is the mean up to some point t ∗. 3-5 It is equivalent to the area under the Kaplan-Meier curve from the beginning of the study through that point. We applied Stewart and Parmar methodology [25] to estimate the pooled survival curve for the experimental arm using the pooled hazard ratio and the naive Kaplan-Meier survival curve in the control group. We chose the exponential model because log-likelihood ratio tests and log-cumulative hazard plots in each of the MAR-LC trials were in favour of this model. Through this case study, we showed that different survival analysis methods used to estimate the difference in restricted mean survival time (rmstD) from IPD-MA may lead to different cost-effectiveness results. Methods were classified into two approaches. Then, parametric models can be used to estimate the difference in mean survival time beyond the trialsâ follow-up. No, Is the Subject Area "Radiation therapy" applicable to this article? restricted mean time of each health state also was quan-tiﬁed as a percentage of the 36-month period. Second, we considered an actuarial method developed by Richard Peto [26] which is often used in oncology [1,2,19]. Some economic studies have already used IPD-MA [8â10]. https://doi.org/10.1371/journal.pone.0150032, Editor: Robert K. Hills, Cardiff University, UNITED KINGDOM, Received: November 9, 2015; Accepted: February 8, 2016; Published: March 9, 2016. Mean costs, differences in the restricted mean survival time (rmstD) and ICERs were associated with 95% non-parametric bootstrap percentile confidence intervals (CI). Gustave Roussy, Ligue Nationale Contre le Cancer meta-analysis plateform, Villejuif, France, Affiliations Is the Subject Area "Metaanalysis" applicable to this article? Similarly, the Kaplan-Meier based methods and the Pooled Exponential method generated wider confidence intervals for the rmstD than the Peto-year and Peto-quintiles methods. No, Is the Subject Area "Cost-effectiveness analysis" applicable to this article? In each trial, the rmstD can be estimated using different survival analysis methods. here. We adjusted for sex, age, and time-varying risk factors. The Greenwood plug-in estimator is used for the asymptotic variance. CESP, INSERM U1018, UniversitÃ© Paris-Sud, UniversitÃ© Paris-Saclay, Villejuif, France, Details on the methods are provided in Table 1 and in the S1 Supporting Information. In the Peto-month method, survival probabilities are estimated every month which is quite similar to estimations at each event. University of Oxford, National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, United Kingdom, h��o�@���{ߪ���K����6i�èʤ�)D)҉����(eSA]�Sp�g��sL@�� V �p��@�k�d��Q����Jh$��K9��7�vU�r�Z��ޔr��L��+{=��oge� o���ZL�y����e�Xf�U��.m�u�� Contributed reagents/materials/analysis tools: BL AM JPP ORA JB. We especially thank Dr CÃ©cile Le PÃ©choux for her help discussing clinical assumptions. This would allow estimating the difference in mean survival time with lifetime extrapolation. Citation: Lueza B, Mauguen A, Pignon J-P, Rivero-Arias O, Bonastre J, MAR-LC Collaborative Group (2016) Difference in Restricted Mean Survival Time for Cost-Effectiveness Analysis Using Individual Patient Data Meta-Analysis: Evidence from a Case Study. These methods were developed for summary data and are not applicable to IPD meta-analysis. Yes 291 0 obj <>stream https://doi.org/10.1371/journal.pone.0150032.g001, https://doi.org/10.1371/journal.pone.0150032.t002. [18] showed that this method led to similar results as the non-parametric Pooled Kaplan-Meier method. RT-induced toxicity costs were estimated using the presence of acute severe esophageal toxicity. The mean survival time will in general depend on what value is chosen for the maximum survival time. Belani (Penn State Hershey Cancer Institute), J. Beresford (Peter MacCallum Cancer Centre), J. Bishop (Victorian Comprehensive Cancer Centre), J.A. Gustave Roussy, Service de biostatistique et dâÃ©pidÃ©miologie, Villejuif, France, With a ceiling ratio of â¬ 25,000 per life-year gained, the probability of modified RT being cost-effective ranged from 31% with Peto-quintiles to 68% with the Pooled Exponential method (Fig 2). The average incremental cost-effectiveness ratio (ICER) and acceptability curves were sensitive to the method used to estimate the rmstD. This study illustrates how different survival analysis methods can be used to estimate the rmstD for economic evaluation using individual patient data (IPD) meta-analysis. Radiotherapy and acute esophagitis unit costs were computed as the mean lump sum per corresponding diagnosis-related group in the French prospective payment scheme. In economic evaluation, a commonly used outcome measure for the treatment effect is the between-arm difference in restricted mean survival time (rmstD). In this case-study, we illustrate how different survival analysis methods can be used to estimate the rmstD for economic evaluation using IPD-MA. We thank the members of the MAR-LC Collaborative Group who agreed to share their data. Parmar (MRC Clinical Trials Unit), R. Paulus (Radiation Therapy Oncology Group), J.P. Pignon (Gustave Roussy), M.I. ODS Graphics must be enabled for graphs to be produced. We estimated HRs and differences in restricted mean survival times, the mean difference in time alive and AF free. Yes Apply the difference in restricted mean survival time (rmstD) in a NMA and compare the results with those obtained in a NMA with hazard ratio. With this approach, the pooled difference in restricted mean survival time (rmstD) is obtained aggregating the rmstDs estimated in each trial using an inverse variance weighted average. The Naive Kaplan-Meier method considers the IPD from the different RCTs as if they originated from a unique RCT. Discover a faster, simpler path to publishing in a high-quality journal. The RMST and RMTL options estimate the restricted mean survival time and the restricted mean time lost, respectively. We had access to the patient-level data from the Meta-Analysis of Radiotherapy in Lung Cancer (MAR-LC) collaborative group [19] which was previously used in a Dutch economic evaluation [20]. However, all the survival analysis methods we studied in this paper can provide an estimation of the difference in mean survival time with lifetime extrapolation. The costs were estimated in the French context from a payerâs perspective and expressed in 2012 euros. In a recent paper, Wei and colleagues used the same two-stage approach as our second approach in which the rmstDs are estimated in each trial and are then aggregated [18]. In this method, stratification by trial, treatment effect heterogeneity and non-proportionality of hazards can be handled. https://doi.org/10.1371/journal.pone.0150032.g002. Several regression-based methods exist to estimate an adjusted difference in RMSTs, but they digress from the model-free method of taking the area under the survival function. With the second approach, the rmstD is based on the aggregation of the rmstDs estimated in each trial. The funding sources had no role in study design, data collection, data analysis, data interpretation, or manuscript writing. * E-mail: beranger.lueza@gustaveroussy.fr, Affiliations There is currently a debate about when and how to extrapolate survival curves up to a lifetime horizon for economic evaluations [15â17]. ENDPOINT. A challenge in individual patient data … This study illustrates how different survival analysis methods can be used to estimate the rmstD for economic evaluation using individual patient data (IPD) meta-analysis. In this case study, we focused on the rmstD using the follow-up of the trials of the MAR-LC. The mean total cost per patient was â¬ 25,331 (95% CI: â¬ 23,630ââ¬ 27,115) for conventional RT and â¬ 29,659 (95% CI: â¬ 27,845ââ¬ 31,507) for modified RT, corresponding to a mean incremental cost of â¬ 4,328 (95% CI: â¬ 1,830ââ¬ 6,804). the difference in RMST, the ratio of RMST and the ratio of the restricted mean time lost (RMTL)) are computed. Survival curves for the two arms in MAR-LC estimated using Naive Kaplan-Meier and Stewart-Parmar, Peto-month, Peto-year and Peto-quintiles are respectively shown in S1âS4 Figs. The treatment effect in a RCT can be defined as the difference in RMST between the randomized arms at time t ∗. Restricted mean survival time (RMST) evaluates the mean event‐free survival time up to a prespecified time point. Three kinds of between-group contrast metrics (i.e., the difference in RMST, the ratio of RMST and the ratio of the restricted mean time lost (RMTL)) are computed. For the second approach, with the Pooled Kaplan-Meier method, difference in mean survival time could be estimated for each trial using Kaplan-Meier curves with extrapolated parametric [33] or non-parametric [34] tails. In each trial, the mean cost per patient for RT and medical transportation were estimated from the number of RT fractions received. Then, one could use a pooled hazard ratio to derive the survival function in the experimental arm. The RMST approach is applied to five completed CVOTs and is compared with the corresponding hazard ratios. of the restricted mean, in a ‘‘QTWIST’’ analysis. It is estimated as the between-arm difference in the restricted mean survival time (rmstD) and corresponds to the area between the two survival curves for the experimental arm and the control arm restricted to a certain time horizon [7]. Mandrekar (Mayo Clinic), A. Mauguen (Gustave Roussy), F. Mornex (Centre Hospitalier Lyon Sud), M. Nankivell (MRC Clinical Trials Unit), G. Nelson (Mayo Clinic), M.K. Economic evaluations based on IPD-MA raise methodological concerns because of data clustering (patients within trials) which must be considered in the analysis. Panel A of Fig. However, the choice of the extrapolation model is critical and the sensitivity of the results should be tested [17]. We considered methods either used in the field of meta-analysis or in economic evaluation but never applied to assess the rmstD for economic evaluation using IPD meta-analysis. e0150032. With the first approach, the rmstD is estimated directly as the area between the two pooled survival curves. Modified RT was associated with longer overall survival (pooled hazard ratio = 0.88, 95% CI: [0.80â0.97], p = 0.009). Conversely, a common outcome measure in economic evaluation is the difference in the restricted mean survival time (rmstD) [6,7]. RMST focusses on the difference in the mean, average or expected time to event but the proportional hazards assumption 'averages' the relative event rates throughout follow-up and uses this overall 'average' as a summary measure of the treatment effect. Yes Conceived and designed the experiments: BL AM JPP ORA JB. We coded the methods using R version 3.1.3 (R Foundation, Vienna, Austria) and SAS version 9.3 (SAS Institute, Cary, NC). Restricted mean survival time (RMST) can provide additional insight to the survival distribution and is not subject to underestimation by definition. In each bootstrap replicate, modified RT was both more effectiveâirrespective of the survival analysis method usedâand more expensive than conventional RT. We decided to apply these methods together with the Naive Kaplan-Meier method. The acceptability curve represents the proportion of the replicates where modified RT is cost-effective for a range of different willingness-to-pay. They compared three methods of estimation of the trial-specific rmstD: the âIntegrated difference of survival functionsâ method, which is equivalent to the Pooled Kaplan-Meier method, a pseudo values method and a flexible parametric survival model. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. broad scope, and wide readership â a perfect fit for your research every time. Performs two-sample comparisons using the restricted mean survival time (RMST) as a summary measure of the survival time distribution. Table 1. Cox models indicated that nonobese participants had a decreased rate of AF … Stewart-Parmar and Peto methods are based on the aggregation of the hazard ratios across RCTs using the inverse variance weighted average. The overall proportional hazard assumption was verified in the meta-analysis (p = 0.91) as well as in individual trials according to Wei and colleaguesâ approach [18]. Performs two-sample comparisons using the restricted mean survival time (RMST) as a summary measure of the survival time distribution. For each replicate, the mean incremental cost, the rmstD (for each survival analysis method) and thus the ICER were estimated. Except for the NaÃ¯ve Kaplan-Meier method, all survival analysis methods were not available in standard statistical softwares. The difference summarizes the association between group assignment and survival. Modified RT included hyperfractionated RT which consists in increasing the number of fractions per day with a decreased dose per fraction, and/or accelerated RT, in which the overall treatment time is reduced. No, PLOS is a nonprofit 501(c)(3) corporation, #C2354500, based in San Francisco, California, US, https://doi.org/10.1371/journal.pone.0150032. This case study showed that the choice of survival analysis method to estimate the difference in restricted mean survival time from an IPD meta-analysis is likely to exert an impact on cost-effectiveness results. These methods lead to the most optimistic acceptability curves. The selection of the parametric model was based upon the log-likelihood ratio test and log-cumulative hazard plots [17]. By contrast, economic evaluation uses an absolute outcome measure such as the number of life-years gained associated with the experimental treatment [6]. The cost of disease progression was assessed using the post-progression survival time. The MAR-LC comprised 2,000 distinct patients with a non-metastatic non-small cell lung cancer treated with radiotherapy and who had been enrolled in ten distinct phase III RCTs [19]. strmst2 performs k-sample comparisons using the restricted mean survival time (RMST) as a summary measure of the survival time distribution. Cost-effectiveness acceptability curves were derived from the 1,000 ICERs based on the bootstrap replicates to illustrate the uncertainty surrounding the cost-effectiveness of the experimental arm radiotherapy. Yes Data Availability: Data were used with permission obtained from the MAR-LC Collaborative Group investigators, who agreed to share their data with us by signing an amendment to the original protocol. Second, unlike the actuarial Peto method, it does not rely on any time interval definition. The restricted mean survival time at time t ∗ is defined as, E [ m i n (t, t ∗)] i.e. It is a two-stage method which is based on the estimation of the treatment effect, firstly, in each RCT and secondly, the aggregation of estimates [22â24]. The method used in meta-analysis to pool treatment effects across RCTs is the inverse variance weighted average, also called fixed effect model [21]. Modified RT is considered cost-effective if the ICER is less than the willingness-to-pay for one life year. No, Is the Subject Area "Non-small cell lung cancer" applicable to this article? The diamonds represent overall rmstDs, with the center denoting the rmstD and the extremities the 95% CI. 0r�n��`����:&��{��)g�fQ�B��b�3��F9���%��Î�^[m�u+dz�{c�P'(���'��ˑ�u���%�j�6&��� ���p�q��H>^�IZt��A��[А- [�m,�#���#GD��B�-�V�V����Y�i���mu؏�v� �E���R'��ߋ��6ZN�;n�m�T���$S��_r;M���Q�N���9����s�!p3c��v�M�(��Ǹ�0 �S��"o��EF��� �#( (Ѐ2pHO TA�V{B�`BH>H��S�/���o��pO�rE��74 �,��}��������J� ��H9z�8�T��\ �C�����R�;{f��;����%H�4�1�� |J�� It performs an ANCOVA-type covariate adjustment as well as unadjusted analyses for … Competing interests: The authors have declared that no competing interests exist. We did not consider the non-parametric pseudo-values method, but Wei et al. This pooled treatment effect is a relative outcome measure often expressed for survival data as a pooled hazard ratio. In the meta-analysis literature, methods used to estimate pooled survival curves from published data have already been proposed and compared. This second approach is an extension of the inverse variance weighted average method that is classically used in meta-analysis to pool treatment effects across RCTs. The individual patient data meta-analysis (IPD-MA) has become the gold standard for obtaining the best evidence for treatment effects (e.g. Our aim was to study if/how the choice of a method … Funding: This work was supported by ITMO Cancer and IReSP (French Public Health Research Institute) as part of the French âPlan Cancer 2009â2013â, by the French âProgramme Hospitalier de Recherche Cliniqueâ, and by the French âLigue Nationale Contre le Cancerâ. In our case-study, as recommended by Royston et al and Wei et al, we adopted the time horizon of the meta-analysis MAR-LC (5 years); all trials had a follow-up of at least 5 years. We are particularly grateful to Janneke Grutters, Manuela Joore, Bram Ramaekers and Dr Dirk de Ruysscher (Maastricht University, Netherlands) who initiated the cost-effectiveness project based on the MAR-LC database. Furthermore, without PH, the estimated HR is not a simple average of HRs over time, and is even more difficult to interpret. This method does not assume proportional hazards, but neither stratification by trial nor heterogeneity of treatment effect can be taken into account to estimate the pooled survival curves. Analyzed the data: BL AM. The Pooled Kaplan-Meier and Pooled Exponential methods deal with stratification by trial and treatment effect heterogeneity. Dahlberg (Dana-Farber Cancer Institute), D. De Ruysscher (University Hospital Leuven and University Hospital Maastricht), S. Dische (Mount Vernon Hospital), P. Fournel (Institut de CancÃ©rologie de la Loire), R. Koch (University of Dresden), C. Le PÃ©choux (Gustave Roussy), S.J. For the first approach, the rmstD can be estimated based on the follow-up of the trials using pooled survival curves. 1,2 In this article, we discuss the advantages of an alternative analytical procedure based on the restricted mean survival time (RMST) 1,2 via 3 examples. The difference in restricted mean survival times (RMSTs) up to a pre-specified time point is an alternative measure that offers a clinically meaningful interpretation. The difference in restricted mean survival times (RMSTD) is an appealing measure of treatment effect for randomized controlled trials (RCTs) with time-to-event outcomes. We used IPD from the Meta-Analysis of Radiotherapy in Lung Cancer concerning 2,000 patients with locally advanced non-small cell lung cancer, included in ten trials. The non-parametric bootstrap was performed using 1,000 replicates and was stratified by trial to take into account data clustering. It can also account for a potential difference in the treatment effect between trials (between-trial heterogeneity). Our future prospects include a simulation study in order to be able to generalize the results found in this case study. Even though, there was no treatment effect heterogeneity between MAR-LC trials and survival hazards were proportional, we noted a difference in mean ICERs generated by the methods. Estimations were done every 355 deaths: at 0.45 year, 0.81 year, 1.25 year, 2.02 years, 5 years and an extra point estimation for patients who died after 5 years. %PDF-1.6 %���� When different lengths of follow-up is an issue (e.g. By contrast, the Peto-year and the Peto-quintiles methods yield different results because they are based on larger time intervals which provide less uncertainty in the rmstD estimation, possibly at the cost of being biased as they provide notably lower estimations for the rmstD as compared to the other studied methods. W. Sause ( Intermountain medical center ), H. Choy ( the University Alabama-Birmingham... Considered cost-effective if the ICER is less than the willingness-to-pay for one life year cost-effectiveness! Be estimated based on the follow-up of the restricted mean survival time equal. Fit for your research every time in economic evaluation is the area under the Kaplan Meier method exhibits advantages... Study design, data analysis, data collection, data collection, analysis. Many advantages AM JPP ORA JB of acute severe esophageal toxicity influences cost-effectiveness results chosen! From published data have already used IPD-MA [ 8â10 ] and was stratified by trial, the rmstD economic... The literature for medical transportation were estimated above the six other methods ( Fig )... ’ ’ analysis acceptability curve of the restricted mean survival time ( RMST as. Between ICERs ( Table 2 we focused on the methods are provided Table! 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Icer is less than the Peto-year and Peto-quintiles methods not consider the Kaplan-Meier method and the extremities the 95 CI... Experimental arm incremental cost, the rmstD than the willingness-to-pay for one life year a perfect fit for research., in the STRATA statement to compute the RMST can be handled Fig 2 ) tools BL. Trials '' applicable to this article already been proposed and compared from a payerâs and. In standard statistical softwares hazard plots [ 17 ] replicate, the rmstD is estimated directly as the difference mean! Methods and the restricted mean survival time with print ( km, print.rmean=TRUE ) `` Radiation therapy '' to! Bootstrap replicate, the treatment effect is defined as the mean up to a prespecified time point ( Vernon... Table 2 ), respectively time point point t ∗ curves were sensitive to method! Tested [ 17 ] considers the IPD from the literature for medical [.

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