title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Modules | PMC10141827 | |||
Module 1 | Body plethysmography measurements (MasterScreen Body®, Vyaire Medical GmbH, Höchberg, Germany) were performed as described previously | PMC10141827 | ||
Module 2 | CPET (MasterScreen CPX®, Vyaire Medical GmbH, Höchberg, Germany) was performed using a standard silicone CPET mask (Hans Rudolph™ mask) on a bicycle ergometer according to current recommendationsBefore each examination (modules 1 and 2), the measuring device was calibrated with the specific mask adapter and the specifi... | PMC10141827 | ||
Module 3 | LEAKAGE | Since the CPET examination does not reflect the normal wearing of a face mask (without leakage), due to the standard silicone CPET mask, ergometric exercise was repeated using the identical step protocol as in module 2 and the masks were worn under real-life conditions (including leakage). | PMC10141827 | |
Module 4 | LEAKAGE | For a 4-h workplace examination, masks were regularly worn (including leakage) during light/moderate work in the office or laboratory. For modules 3 and 4, the correct fit of the mask was checked by the investigator prior to each measurement and the subjects were instructed to do the same during the workplace measureme... | PMC10141827 | |
Mask characteristics and mask adapter | ®, CM | To compare breathing resistances and filter efficiencies, the three masks were tested on a “Sheffield head” according to the European Standard EN 149 (applied solely to CE certification of FFP masks)In all modules, participants wore in randomized order (1) NM, (2) SM (Typ II, MedicalCare & Serve industry®, Wilfried Ros... | PMC10141827 | |
Physiological and physical parameters | nose and mouth | LUNG, APS | Lung volume associated parameters (e.g. forced vital capacity (FVC), forced expiratory volume in one second (FEVBlood gas analysis (BGA) from hyperaemic capillary earlobe blood was taken before and after CPET and ergometry and at the end of each load level (5th minute) as well as before and at the end (while wearing a ... | PMC10141827 |
Subjects’ perceived physical exertion | Perceived physical exertion was assessed in CPET and ergometry before, after, and within the last 20 s of each load as well as before and after the 4-h workplace examination using the BORG Scale | PMC10141827 | ||
Data and statistical analysis | Median values of cardiopulmonary parameters of CPET and ergometry were calculated during the last three minutes of each 6-min load after reaching the physiological steady state. Measurement values are presented as boxplots (box: median, 25th-75th percentile; whiskers: 3.5-fold interquartile range). In tables, data are ... | PMC10141827 | ||
Ethic approval | The study was conducted in accordance with the latest revision of the Declaration of Helsinki and the Ethics Committee of the medical faculty of the Ruhr-University Bochum provided ethical approval of the study (Reg. No.: 20-7024). All subjects gave written informed consent—both for study participation and for the publ... | PMC10141827 | ||
Results | PMC10141827 | |||
Performance characteristics of the face masks | inspiratory airflow, CM | LEAKAGE | Using the “Sheffield head” system according to EN 149, in- and expiratory breathing resistance of SM and CM was similar and lower compared to FFP2, probably due to the better filter efficiency of FFP2 (Table S1). For all types of masks breathing resistance increased with higher inspiratory airflow and decreased for SM ... | PMC10141827 |
Workplace (Module 4) | During the 4-h workplace measurement, a slightly increased COWorkplace measurement: Results of ( | PMC10141827 | ||
Subjects’ perceived physical exertion | During CPET and ergometry, study subjects reported progressively higher BORG ratings during exercise when wearing a mask. For FFP2 these findings were statistically significant (Table | PMC10141827 | ||
Discussion | PMC10141827 | |||
Principal findings | CM | In this partially double-blinded randomized cross-over study wearing SM, CM, and FFP2 caused an increase in total airway resistance and specific airway resistance, which was most pronounced for FFP2. The increased breathing resistance led to an increase in work of breathing and respiratory power and thus to a slightly ... | PMC10141827 | |
Strengths of the study | DISEASES | A special feature of our study is the complex study design which allowed to examine all 40 subjects in all four modules, partly even double-blinded, without and when wearing three different masks at different workloads and up to four hours continuously. Mask types were previously checked according to EN 149 and confirm... | PMC10141827 | |
Limitations of the study | asthma | HEART DISEASES, ASTHMA, HIGH BLOOD PRESSURE | Due to the fact that exercise tests were carried out in air-conditioned laboratory rooms, effects of differing environmental conditions (e.g. temperature, humidity) on physiological parameters and the microclimate behind the mask could not be considered. Although some subjects with mild asthma and high blood pressure t... | PMC10141827 |
Breathing physiology and cardiopulmonary data | PMC10141827 | |||
Body plethysmography and CPET (Modules 1–2) | CM | The increased breathing resistance due to the different filter materials of the face masks was confirmed by the testing on the Sheffield head according to EN 149. Body plethysmographic examinations showed increases in total airway resistance (Rtot), specific airway resistance, work of breathing and respiratory power, a... | PMC10141827 | |
Ergometry (Module 3) | Presumably due to the physiological adaptation under CPET, a decrease of pODuring physical exertion (up to approx. 150 watts and comparable to the PWC | PMC10141827 | ||
Workplace (Module 4) | CM | The small partial rebreathing of CODue to reduced permeability of the masks, the warm and humid exhaled breath condenses behind the mask and leads to increases in humidity and temperature. In addition to the breathing resistance of the mask, the material (cotton vs. synthetic) needs to be considered. Although testing o... | PMC10141827 | |
Conclusions | In conclusion, wearing face masks caused significant physiological strain, but did not represent a health risk. Study participants reported a higher perceived physical exertion due to enhanced breathing resistance together with increased humidity and temperature behind the mask. All effects were most pronounced when we... | PMC10141827 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-32180-9. | PMC10141827 | ||
Acknowledgements | The authors thank Christoph Thelen and the Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) for the mask testing according to EN 149. Additionally, we would like to thank Susann Widmer, Vanessa Thiele, Karla Bosse, Raphael Kollenberg and Philipp Zaghow, for their excellent tech... | PMC10141827 | ||
Author contributions | E.M.M.: project administration and organization (lead), project conceptualization (lead), investigation (lead), writing—original draft (lead); formal analysis (lead); visualization (lead); writing—review and editing (lead). V.v.K.: project conceptualization (equal); project organization (lead) investigation (equal); fo... | PMC10141827 | ||
Funding | Open Access funding enabled and organized by Projekt DEAL. This study was funded by the German Social Accident Insurance (Deutsche Gesetzliche Unfallversicherung, DGUV). | PMC10141827 | ||
Data availability | Additional data will be supplied on reasonable request. The request should be addressed to the corresponding author. | PMC10141827 | ||
Competing interests | All authors declare that they have no known competing financial interests. As staff of the Institute for Prevention and Occupational Medicine of the German Social Accident Insurance, Institute of the Ruhr-University (IPA), the authors are employed by the study’s main financing body, the German Social Accident Insurance... | PMC10141827 | ||
References | PMC10141827 | |||
Introduction | Mental contrasting with implementation intentions (MCII) has been successfully applied to improve health-related behaviors (e.g. exercise). We explored its effectiveness to improve sleep outcomes beyond effects of sleep hygiene (SH) information, and investigated associations with stress. Eighty university employees (me... | PMC10492430 | ||
Implementation intentions and sleep | The formulation of implementation intentions is a post-intentional behavior change technique fostering the translation of intention into behavior which has been applied in interventions based on the Theory of Planned Behavior ( | PMC10492430 | ||
Mental contrasting | cognitive and motivational mechanisms | Mental contrasting is a pre-intentional self-regulation technique that uses cognitive and motivational mechanisms to facilitate strong goal commitments or goal intentions ( | PMC10492430 | |
Stress and poor sleep | SECONDARY | A secondary objective of our study was to investigate associations between daily stress and sleep outcomes, as well as possible additional intervention effects on subjective stress and the cortisol awakening response (CAR). Self-reported stress has been linked to both subjective and objective sleep quality. For example... | PMC10492430 | |
Study aims and hypotheses | The present study aimed to expand the self-regulation technique of MCII to the context of sleep outcomes, namely sleep duration and sleep quality, in a non-clinical population. Our main objective was to compare the effects of sleep hygiene information only (SH) with the combined effects of MCII + SH regarding objective... | PMC10492430 | ||
Method | Data were analyzed using R version 4.2.1 for Windows. Multilevel models were estimated using the nlme package ( | PMC10492430 | ||
Recruitment and sample | Early career researchers, that is, doctoral candidates and scientific staff, employed at Heidelberg University were invited via e-mail and newsletters to participate if they had the intention to improve their sleep. To approach the statistical power for the multilevel models, we approximated the effect size that can be... | PMC10492430 | ||
Procedure | The present study compared two intervention conditions (MCII + SH vs SH) and analyzed associations between stress and sleep outcomes and in a single-blinded, randomized controlled trial with daily/nightly assessments in a baseline-week and analog daily/nightly assessments in a post-intervention week (Procedure and flow... | PMC10492430 | ||
Intervention | Participants in the SH-group (After this, participants were asked to formulate three implementation intentions, by specifying how, where and when they could act to (a) prevent their obstacle from occurring, (b) overcome their obstacle in case it occurred, and (c) specify another goal-directed behavior to improve their ... | PMC10492430 | ||
Assessment of the CAR | Salicaps | PMC10492430 | ||
Laboratory analysis and preprocessing of CAR data | Saliva samples were stored at −80°C. The concentration of sCort (ng/mL) was analyzed using an enzyme-linked immunosorbent assay at the Institute of Medical Psychology in Heidelberg, Germany. The inter-assay coefficient of variation (CV) was 5.46% and the intra-assay CV was 2.91%. Following | PMC10492430 | ||
Data analysis | Data were analyzed using multilevel modeling to account for the nested data structure with repeated measurements (Level 1) nested within individuals (Level 2). For our hypotheses targeting intervention effects, individual Formal model description:Level 1: (within participants)
Level 2: (between participants)
For the ... | PMC10492430 | ||
Results | Three observations were set to missing, since time stamps indicated that morning assessments were filled in prior to the evening assessments of the previous day.Descriptive statistics separated by study group.Table depicts descriptive statistics on the between-person level.Estimates in the upper diagonal depict estimat... | PMC10492430 | ||
Intervention effects | PMC10492430 | |||
Exploratory analyses | To account for the possibility of gradual improvement of the sleep parameters after the intervention, we conducted piecewise growth models. Specifically, two variables were created to code the number of the study days. The first variable (time to intervention) counted the number of days to the first night after the int... | PMC10492430 | ||
Association of stress with sleep parameters | We examined if daily stress was associated with the three sleep parameters on the within-person level (e.g. “Is sleep quality lower on nights following days with higher than usual stress?”) and the between person level (e.g. “Do participants with higher average stress levels report worse sleep quality on average?”). To... | PMC10492430 | ||
Discussion | sleep behavior, Health behaviors | DETACHMENT | Our randomized-controlled study did not support the effectiveness of an MCII intervention component over sleep hygiene information in a sample of early career researchers. Across all participants, results indicated an increase in sleep quality and subjective (but not objective) sleep duration from baseline to post-inte... | PMC10492430 |
Research Data | PMC10492430 | |||
sj-csv-12-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-csv-12-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of... | PMC10492430 | |
sj-csv-13-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-csv-13-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of... | PMC10492430 | |
sj-csv-14-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-csv-14-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of... | PMC10492430 | |
sj-DOCX-16-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.Supplemental material, sj-DOCX-16-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika ... | PMC10492430 | |
sj-inp-10-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-inp-10-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of... | PMC10492430 | |
sj-inp-11-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-inp-11-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of... | PMC10492430 | |
sj-inp-9-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-inp-9-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of ... | PMC10492430 | |
sj-pdf-15-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-pdf-15-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of... | PMC10492430 | |
sj-R-1-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-R-1-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of He... | PMC10492430 | |
sj-R-2-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-R-2-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of He... | PMC10492430 | |
sj-R-3-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-R-3-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of He... | PMC10492430 | |
sj-R-4-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-R-4-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of He... | PMC10492430 | |
sj-txt-5-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-txt-5-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of ... | PMC10492430 | |
sj-txt-6-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-txt-6-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of ... | PMC10492430 | |
sj-txt-7-hpq-10.1177_13591053231159168 – Supplemental material for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial | SCHMIDT | Click here for additional data file.sj-txt-7-hpq-10.1177_13591053231159168 for Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial by Laura I Schmidt, Andreas B Neubauer, Martin Stoffel, Beate Ditzen, Jana Schirmaier, Claudia Farrenkopf and Monika Sieverding in Journal of ... | PMC10492430 | |
References | PMC10492430 | |||
Rationale | antipsychotic-induced weight gain, Weight gain | SIDE EFFECT | Weight gain is a frequent side effect of treatment with SGAs (second-generation antipsychotics) and a leading cause for nonadherence. Several candidate genes have been identified that could influence the amount of AIWG (antipsychotic-induced weight gain). The polymorphism rs17782313 near the | PMC10006246 |
Objective | weight gain | We therefore examined the influence of the rs17782313 polymorphism on SGA-related weight gain. | PMC10006246 | |
Methods | Weight gain, schizophrenia or schizoaffective disorder | REGRESSION | Participants of a multicenter randomized, controlled, double-blind study comparing two treatment strategies in individuals with schizophrenia or schizoaffective disorder were genotyped using a rapid-cycle polymerase chain reaction. Up to 252 individuals completed the first 2 weeks (phase I), 212 the entire 8 weeks (hen... | PMC10006246 |
Results | weight gain | Within 212 ‘completers’, carriers of the C allele had a higher absolute weight gain than those homozygous for the T allele (2.6 kg vs. 1.2 kg), though this observation was not significant ( | PMC10006246 | |
Conclusion | weight gain, antipsychotic-induced | Our results indicate that the rs17782313 polymorphism might influence antipsychotic-induced weight gain and therefore confirm some of the earlier conclusions. | PMC10006246 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00213-023-06331-9. | PMC10006246 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10006246 | ||
Introduction | obesity, antipsychotic-induced weight gain, weight gain, schizoaffective disorder, Schizophrenia, schizophrenia, psychotic mental disease | OBESITY | Schizophrenia is a chronic, psychotic mental disease that affects approximately one percent of people. The time of onset is typically in late adolescence or early adulthood and regularly continues through the whole life (Freedman Pharmacological treatment was introduced more than half a century ago with the discovery o... | PMC10006246 |
Materials and methods | PMC10006246 | |||
Study design | schizophreniform disorder, schizophrenia, schizoaffective disorder | Patients aged between 18 and 65 who suffered from schizophrenia, schizoaffective disorder, or schizophreniform disorder were recruited as part of a multi-center study (Heres et al. | PMC10006246 | |
Genotyping | We genotyped the rs17782313 polymorphism, a T to C transition located 188 kb downstream from the | PMC10006246 | ||
Statistics | weight gain | We analyzed weight gain and BMI increase occurring both during the first 2 weeks (phase I) and weight gain during the entire 8 weeks. This was due to the design of the study (the ‘switch’ in some patients’ medication after 2 weeks) and, as expected, discontinuations of some individuals. For both time periods, we at fir... | PMC10006246 | |
Results | PMC10006246 | |||
Baseline characteristics | The average baseline BMI ± SD (standard deviation) of all 252 individuals participating in phase I was 25.8±5.4 kg/mAnalysis of variance for the rs17782313 polymorphism for phase i and the entire trial*mThose individuals completing the entire 8 weeks of the trial (‘completers’) numbered 212 and were on average 41.7 yea... | PMC10006246 | ||
Weight gain in phase I | Weight gain | After 2 weeks of treatment, Weight gain in kg observed within 8 weeks of treatment depending on medication in each genotype. Data are presented as mean+SD. Statistical tests compare TT with C carriers | PMC10006246 | |
Weight gain in ‘completers’ | After 8 weeks of treatment, the | PMC10006246 | ||
Multiple comparisons | Twenty-five variables were corrected for multiple comparisons by Holm’s method. The two lowest | PMC10006246 | ||
Discussion | amisulpride-induced weight gain, weight gain | REGRESSION, MINOR, REGRESSIONS | We observed a statistically significant association between the rs17782313 polymorphism and absolute weight gain and absolute BMI gain after 8 weeks of antipsychotic treatment in the amisulpride subpopulation when comparing carriers of the C allele with TT carriers. The same direction of effect could be seen in the ent... | PMC10006246 |
Supplementary information |
Variables and Normal Distribution. Supplementary Table 2 Holm’s Test for Multiple Comparisons. Supplementary Table 3 Baseline Characteristics of Patients With a First Episode. Supplementary Table 4 Analysis of Variance for the rs17782313 Polymorphism for Phase I and the Entire Trial in Patients With a First Episode (P... | PMC10006246 | ||
Funding | Open Access funding enabled and organized by Projekt DEAL. The study conduct was supported by a grant from the “Bundesministerium fuer Bildung und Forschung” (BMBF), a German government agency (grant code 01KG0910). Eli Lilly provided the olanzapine medication for the trial, but had no influence on the protocol, data a... | PMC10006246 | ||
Declarations | PMC10006246 | |||
Conflict of interest | Johnson & Johnson, Pfizer, Bristol-Myers Squibb, Johnson & Johnson, Bristol-Myers Squibb, Johnson & Johnson. | WERNER | Korbinian Felix Schreyer declares no conflict of interest. In the past 3 years, Stefan Leucht has received honoraria as a consultant and/or advisor and/or for lectures from Alkermes, Angelini, Eisai, Gedeon Richter, Janssen, Lundbeck, Lundbeck Institute, Merck Sharp and Dohme, Otsuka, Recordati, Rovi, Sanofi Aventis, T... | PMC10006246 |
References | PMC10006246 | |||
Background | melanoma | MELANOMA | Recurrence-free survival (RFS) and overall survival (OS) data for adjuvant nivolumab versus placebo (proxy for routine surveillance) in patients with high-risk, resected melanoma are lacking. This post hoc, indirect treatment comparison (ITC) used pooled data from the phase 3 EORTC 18,071 (ipilimumab vs. placebo) and C... | PMC10025222 |
Methods | resected stage IIIB-C, cutaneous melanoma, Cancer | CUTANEOUS MELANOMA, CANCER | Patients with resected stage IIIB-C cutaneous melanoma (American Joint Committee on Cancer seventh edition) were included. Inverse probability treatment weighting (IPTW) was used to balance baseline characteristics. RFS NNTs were calculated for nivolumab versus ipilimumab and placebo. OS NNTs were calculated for nivolu... | PMC10025222 |
Results | This ITC included 278, 643, and 365 patients treated with nivolumab, ipilimumab, and placebo, respectively. Following IPTW, nivolumab was associated with improved RFS versus placebo (hazard ratio [HR]: 0.49; 95% confidence interval [CI] 0.39–0.61) and ipilimumab (HR: 0.69; 95% CI 0.56–0.85). RFS NNT was 4.2 for nivolum... | PMC10025222 | ||
Conclusions | resected stage IIIB-C, cutaneous melanoma | CUTANEOUS MELANOMA | In patients with resected stage IIIB-C cutaneous melanoma in this ITC, nivolumab improved RFS versus placebo and ipilimumab, and OS versus placebo after post-recurrence survival adjustment. | PMC10025222 |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00262-022-03302-5. | PMC10025222 | ||
Keywords | PMC10025222 | |||
Introduction | resected stage IIIB-C, Melanoma, melanoma | DISEASE, MELANOMA, MELANOMA, OF SKIN CANCER | Melanoma is the deadliest form of skin cancer [Given that the prognosis among patients with melanoma is worse with advanced disease stage [Although the efficacy and safety of ipilimumab, pembrolizumab, and dabrafenib plus trametinib have been compared against placebo as adjuvant melanoma treatment in randomized clinica... | PMC10025222 |
Methods | PMC10025222 | |||
Data source | melanoma | STAGE IV MELANOMA, SECONDARY, MELANOMA, STAGE III MELANOMA | Individual patient data were pooled from EORTC 18,071 (NCT00636168) and CheckMate 238 (NCT02388906), both of which were multicenter, double-blind, randomized, phase 3 trials that evaluated RFS as the primary endpoint and OS as a secondary endpoint in patients with high-risk resected melanoma [In EORTC 18,071, patients ... | PMC10025222 |
Study population | tumor, cutaneous melanoma | REGRESSION, TUMOR, DISEASE, CUTANEOUS MELANOMA, ULCERATION, ONCOLOGY | To perform an ITC, patients with stage IIIB-C cutaneous melanoma who were enrolled in EORTC 18,071 and CheckMate 238 were included in this analysis, as they were the common population of the two trials (EORTC 18,071 and CheckMate 238 excluded patients with stage IV and stage IIIA disease, respectively). Inverse probabi... | PMC10025222 |
Study outcomes | death, primary melanoma | RECURRENCE, METASTASIS | In this study, RFS was separately compared between nivolumab versus placebo and nivolumab versus ipilimumab, and OS was compared between nivolumab versus placebo. The OS comparison between nivolumab versus ipilimumab was not included in the pooled population due to the differences in post-recurrence treatments availabl... | PMC10025222 |
RFS rate and NNT per additional recurrence-free survivor | Using the pooled patient data, the weighted RFS curves for nivolumab, placebo, and ipilimumab, were estimated using the Nelson-Aalen estimator [NNT represents the number of patients who needed to be treated with a treatment compared with another treatment to obtain one additional beneficial outcome [ | PMC10025222 | ||
OS rate and NNT per additional overall survivor | tumor, melanoma | TUMOR, MELANOMA, ULCERATION | Due to the rapidly evolving treatment landscape, patients included in the two trials likely had access to different therapeutic options post-recurrence. To account for higher post-recurrence survival due to improved subsequent treatments for advanced melanoma in CheckMate 238 compared with EORTC 18,071, the analysis of... | PMC10025222 |
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