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Methods | Across three double-blind, placebo-controlled, within-subject experiments, cocaine (0, 125, 250 mg/70 kg; | PMC10006272 | ||
Results | Data were well modeled by the demand curve function, with significantly higher intensity (purchasing at low prices) for active drug doses compared to placebo for all experiments. Unit-price analyses revealed more persistent consumption across prices (lower | PMC10006272 | ||
Conclusions | Orderly demand curve data revealed differences across drug and placebo conditions, and relations to real-world measures of drug spending, and subjective effects. Unit-price analyses enabled parsimonious comparisons across doses. Results lend credence to the validity of the Blinded-Dose Purchase Task, which allows for control of drug expectancies. | PMC10006272 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00213-023-06334-6. | PMC10006272 | ||
Keywords | PMC10006272 | |||
Introduction | substance-related | Behavioral economics offers a broad framework for understanding how the behavior of an organism is maintained by reinforcers (Hursh, In a standard laboratory preparation, demand curves are generated with fixed-ratio (FR) schedules to model the price of a commodity, often a drug (e.g., Johnson & Bickel, Simulated purchase tasks have shown relevance for treatment outcomes, dependence levels, substance-related correlates, and individual differences in smoking risk (MacKillop & Murphy, Although hypothetical drug purchase tasks allow for more cost- and time-effective methods, and appear to correspond well with real scenarios, most drug purchase task scenarios involve choices about hypothetical drug doses. These tasks require participants to “imagine a standard/average/typical drug dose” which introduces variability across participants given diverse drug expectancy effects and experiences (the expectation of drug effects, variability in potency with typical drugs purchased). Even when the drug dose is defined (Bruner & Johnson, | PMC10006272 | |
Methods | PMC10006272 | |||
Compliance with ethical standards | Johns Hopkins University Institutional Review Board approved these studies, and these studies were performed in accordance with the 1964 Declaration of Helsinki. Participants provided their written informed consent. | PMC10006272 | ||
Participants | Secondary data were drawn from three separate experimental laboratory decision-making protocols involving double-blind drug administration of either cocaine hydrochloride (Demographic characteristics across cocaine, methamphetamine, and alcohol studiesVariables reported as mean (± | PMC10006272 | ||
Cocaine administration study participants | Participation criteria have been reported in detail previously (Johnson et al., | PMC10006272 | ||
Methamphetamine administration study participants | Participation criteria have been reported in detail previously (Berry et al., | PMC10006272 | ||
Alcohol administration study participants | Participation criteria have been reported in detail previously (Johnson et al., | PMC10006272 | ||
General laboratory procedures | Each of these studies consisted of double-blind, randomized, within-subject, placebo-controlled sessions involving nontreatment-seeking individuals. Study duration consisted of three experimental laboratory sessions for the cocaine and methamphetamine groups (placebo and two active doses) and two experimental laboratory sessions for the alcohol group (placebo and one active dose) with no less than 24 h between sessions. Participants were phoned at least 24 h before each scheduled laboratory session and reminded to abstain from using any drugs including alcohol for the day before sessions but they should otherwise maintain their normal routine (e.g., sleep, caffeine consumption). Participants were also asked to refrain from eating or drinking overnight. Scheduled sessions began at 7:00 a.m. and were rescheduled if participants showed nonzero breath alcohol concentration (BrAC) levels. Participants who were regular tobacco smokers were allowed to smoke a cigarette at the start of each day’s session. Participants were then served a standardized low-fat breakfast (2 toast slices or 1 bagel; a single serving of jelly or butter; 355 ml of either apple or grape juice) which was finished by 8:00 a.m. | PMC10006272 | ||
Drug administration procedures | For each study, the drugs were prepared in an onsite pharmacy. Subjective drug effects were assessed throughout the session (see primary sources for each study’s time course and additional session timing details). The Blinded-Dose Purchase Task (described in more detail below) was administered at the end of the session so participants could experience the full time course of the drug prior to evaluating how many doses of the experienced drug they would purchase (approximately 2 h and 15 min following cocaine/placebo administration; approximately 7 h and 15 min following methamphetamine/placebo administration; and approximately 5 h and 15 min following completion of alcohol/placebo administration). | PMC10006272 | ||
Cocaine | During three drug administration sessions, participants orally ingested, with water, a size 00 opaque capsule containing either 0 (placebo), 125 mg/70 kg, or 250 mg/70 kg of cocaine hydrochloride. Across sessions, the capsules appeared identical and were each filled completely with a combination of cellulose and/or cocaine hydrochloride. Drug administration was double-blind. Administration order was randomized across participants. | PMC10006272 | ||
Methamphetamine | During three drug administration sessions, participants orally ingested, with water, a size 00 opaque capsule containing either 0 (placebo), 20 mg, or 40 mg of d-methamphetamine hydrochloride (Mylan, Inc.) and cellulose. Across sessions, the capsules appeared identical. Each participant received each condition once across her or his three sessions (i.e., dose conditions were compared within subject). Administration was double-blind, and dose order was counterbalanced. | PMC10006272 | ||
Alcohol | Placebo- and alcohol-containing solutions were prepared in an onsite pharmacy. A weight-based administration procedure was used to determine the volume of a 1 g/kg alcohol dose (USP 95% ethanol; Letco Medical, Decatur, AL) or water to be mixed in grapefruit juice. Total solution volume was determined per bodyweight so that alcohol (or added water) was 8% of solution by volume. This was divided equally across three cups. Participants experienced placebo and alcohol sessions in a pseudo-random order. Each cup was fitted with a lid and a straw with a 95% alcohol-soaked elastic hairband wrapped around it to obscure olfactory discrimination of alcohol and placebo sessions. Drinks were served promptly after being refrigerated at ~4 °C. Participants were instructed to drink 1 cup at a regular pace over the course of a 20-min interval, resulting in a 1-h administration period for all three cups. | PMC10006272 | ||
Assessments | PMC10006272 | |||
Substance use patterns and subjective drug effects | Information about individual patterns of substance use was obtained during the in-person screening and the following three variables were selected for analysis for insight into real-world use and spending behavior: (1) the average amount of money participants spent on the substance (or drug class) per week in the last month; (2) the number of days participants used the substance in the last month; and (3) the estimated number of times participants used the substance per week in the last month. To assess within-session subjective drug effects for each blinded dose, at regular post-administration intervals, participants were asked to rate on a 5-point scale, among other characteristics of the dose consumed (see Berry et al., | PMC10006272 | ||
The Blinded-Dose Purchase Task | At the end of each session, participants in the cocaine and methamphetamine groups completed a blinded purchasing task for hypothetical capsules of that morning’s randomized dose (oral placebo, 125 mg/70 kg, or 250 mg/70 kg for cocaine hydrochloride; oral placebo, 20 mg, or 40 mg for d-methamphetamine hydrochloride). The alcohol group completed the Blinded-Dose Purchase Task for drinks associated with either the placebo or 1.0 g/kg dose of ethyl alcohol. In these tasks, participants indicated how many units of that day’s dose they would purchase to consume over the next month across the following 10 escalating price points: $0.01, $0.03, $0.30, $1, $3, $10, $30, $100, $300, and $1000. Price points were presented on separate pages, and were selected primarily to assess the range of purchasing across numerous prices as in previous studies. Participants read the following scenario prior to beginning the purchase task:Imagine that you have finished the study and will spend the next month in your usual home environment. Also imagine that you have the chance to buy today’s drug dose for your own personal use within the next month. Please consider what you have received today to be a single dose. You can buy as many doses as you like, but you cannot sell, trade, or give them away, and you cannot save them for more than a month. Other than the fact that the doses are for your own use within the next month, there is no limit to the number of doses you can buy. Please do not buy more than you will use...Participants then responded to the following question for each of the price points: If today’s drug dose costs [X] each, how many drug doses would you buy to use in the next month? | PMC10006272 | ||
Data analysis | Orderliness of dose purchasing task data was evaluated according to previously published criteria (Bruner & Johnson, To conform to distributional assumptions of parametric statistical tests, we performed natural-log (ln) transformations on | PMC10006272 | ||
Results | PMC10006272 | |||
Modeling drug purchasing behavior | Simulated purchasing of each day’s dose varied as an inverse function of increases in price across the three studies (see Fig. Left panel: Blinded-Dose Purchase Task demand curves for active and placebo doses across the cocaine (top), methamphetamine (middle), and alcohol (bottom) studies. Error bars represent standard error of the mean. Consumption data plotted as a function of price per dose (rather than unit price; see text for additional comparisons based on unit price). Right panel: demand intensity (left Equation Lastly, purchasing data for the alcohol study were also well described by Eq. | PMC10006272 | ||
Subjective drug effects | There was a significant main effect of dose on peak drug “liking” in the cocaine study (In the methamphetamine study, peak drug “liking” also significantly differed as a function of dose (Finally, in the alcohol study, there were significantly lower ratings of peak “liking” for the placebo than for the 1.0 g/kg active dose ( | PMC10006272 | ||
Bivariate associations between behavioral economic demand measures, substance use patterns, and subjective drug effects | Correlations describing the degree to which purchase task indices were associated with reported substance use patterns and peak subjective drug effects can be found in Table Bivariate associations between behavioral economic indices, substance use patterns, and peak subjective effectsDrug doses are reported as mg/70 kg for cocaine, mg for methamphetamine, and g/kg for alcohol*In the methamphetamine study, the amount of money spent on stimulants each week was significantly associated with intensity across the 20 mg (Finally, in the alcohol study, significant associations emerged between intensity and money spent on alcohol each week ( | PMC10006272 | ||
Discussion | Martínez-Loredo | Across all substance administration studies, the Blinded-Dose Purchase Task yielded orderly demand data that showed significantly greater demand in the active dose conditions compared to the placebo conditions using a double-blind, placebo-controlled within-subject design. Demand was significantly correlated with substance use and monetary patterns of drug spending, as well as some subjective effects of the drugs. These relations differed by drug and dose administered. These data highlight the potential of the Blinded-Dose Purchase Task for assessing drug demand while controlling for drug expectancy effects.The results underscore the viability of this task as an addition to laboratory drug administration studies. The task takes approximately 3–5 min to administer, offering a simple and straightforward assessment that provides additional information on drug reinforcement beyond what is typically provided by a typical abuse liability study that only assesses subjective effects. The present findings significantly extend results from purely hypothetical purchase tasks, and represent an important preliminary step in extending the literature. Specifically, the present studies and analyses build on a noteworthy study in which stimulant-naïve individuals completed a blinded purchase task following a single dose of D-amphetamine or placebo (MacKillop et al., Contrary to previous work, in the present study, we used the novel Blinded-Dose Purchase Task to assess reinforcing value of the dose effects of cocaine and methamphetamine and a single dose of alcohol, The demand metrics evaluated appear to track real-world drug spending and drug use behavior, further highlighting the viability of the present task. In the cocaine administration study in which individuals who met Higher peak ratings in the 250 mg/70 kg cocaine dose condition were generally associated with less persistent consumption. Specifically, participants who reported higher peak subjective ratings also tended to report lower intensity and marginally lower In the methamphetamine administration study, in which individuals who recreationally used stimulants participated, money spent on stimulants each week was significantly and positively associated with demand metrics further validating this task. Specifically, money spent on stimulants each week was significantly and positively associated with intensity and Simulated methamphetamine purchasing did not appear to show indications of dose effects for the 20 mg or 40 mg doses for either intensity or rate of change of elasticity (Unit-price analyses indicated somewhat higher intensity and significantly lower Similar to the cocaine study, peak subjective effects for methamphetamine at the 20 and 40 mg doses were inversely associated with money spent on stimulants per week and the number of days stimulants were used in the last month, potentially representing tolerance with increased purchasing with decreased “liking” or “good” effects. These results highlight the importance of multidimensional evaluations of drug reinforcement when administering substances. More research is needed in this regard to understand drug administration in the context of dose effects of hypothetical purchasing and relations to subjective effects, as well as other informative demand metrics that may illuminate clinically relevant drug purchasing behaviors (e.g., understanding drug purchasing in the context of commonly co-used drugs, cross-price elasticity; Bergeria et al., In the alcohol administration study, in which individuals who reported at least occasionally drinking 4–5 drinks per episode participated, significant positive associations emerged between intensity and money spent on alcohol per week and weekly alcohol use as well as between Data from the present studies generally align with purely hypothetical tasks in which the doses are not administered, highlighting the versatility and viability of purchase tasks. However, more research is needed to understand potential differences of purchase task metrics across different drugs, doses, and populations. Far less research exists regarding methamphetamine or cocaine purchase tasks relative to alcohol purchase tasks, making conclusions as to the most critical and predictive demand metrics and how these might differ across drugs/drug classes difficult (see Martínez-Loredo et al., As with any study, these findings should be considered in the context of study limitations. These studies and analyses should be considered preliminary, but represent an important first step in evaluating forced sampling methods in cocaine, methamphetamine, and alcohol purchase tasks. An important future direction will be to directly compare purchasing results of forced sampling methodology as used in the present study, with results obtained from purely hypothetical purchase tasks with cocaine, methamphetamine, and alcohol purchasing. Currently, purely hypothetical purchase tasks are much more common in the literature (although see Bergeria et al., Furthermore, the sample size was limited and a portion of the findings are correlational in nature. Increased statistical power upon replication would allow for greater flexibility in analyses and increased credence to the present findings. Multi-level modeling which can incorporate multiple variables of interest into a single analysis (e.g., Kaplan et al., | PMC10006272 | |
Acknowledgements | SWEENEY, BRADLEY | We thank Crystal Barnhouser, Grant Glatfelter, Curtis Bradley, and Katherine Buckheit for protocol assistance; Leticia Nanda, Annie Umbricht, Eric Strain, Andrew Tompkins, and Denis Antoine for medical oversight; and Lauren Nieder for help with manuscript preparation. We also thank Mary M. Sweeney, Evan S. Herrmann, Robert S. LeComte, and Natalie R. Bruner. | PMC10006272 | |
Author contribution | All authors contributed in a significant way to the manuscript and all authors have read and approved the final manuscript. | PMC10006272 | ||
Funding | ABUSE | We gratefully acknowledge that this research was supported in part by the National Institute on Drug Abuse (NIDA) grants R21DA032717 (MWJ), R01DA032363 (MWJ), and R01DA035277 (MWJ). Support for MSB, GPN, and PSJ was provided by the National Institute on Drug Abuse Grant T32DA007209. MSB gratefully acknowledges that her time was also supported in part by NIDA grant K01DA052673. | PMC10006272 | |
Declarations | PMC10006272 | |||
Conflict of interest | The authors declare no competing interests. | PMC10006272 | ||
References | PMC10006272 | |||
Background | mantle cell lymphoma | DISEASE, MANTLE CELL LYMPHOMA | Despite high response rates to initial therapy, most patients with mantle cell lymphoma (MCL) experience relapsed or refractory (R/R) disease. Here, we report the efficacy, safety, and pharmacokinetics of the Phase 2, single-arm M20-075 study (NCT04477486) of ibrutinib and venetoclax combination therapy in Japanese patients with R/R MCL. | PMC10808627 |
Methods | toxicity | DISEASE, MINIMAL RESIDUAL DISEASE | Patients received 560 mg ibrutinib and 400 mg venetoclax (after a 5-week ramp-up from 20 mg) once daily for up to 104 weeks. Primary endpoint was complete response (CR) rate by independent review committee (IRC). Secondary endpoints included overall response rate (ORR), duration of response (DOR), undetectable minimal residual disease (uMRD) rate, progression-free survival (PFS), overall survival (OS), safety including dose-limiting toxicity (DLT) assessment in the first six patients, and pharmacokinetic parameters. Full analysis set (FAS) comprised all treated patients. Per protocol set (PPS) excluded treated patients with non-evaluable disease at baseline by IRC. | PMC10808627 |
Results | Thirteen patients were treated (FAS | PMC10808627 | ||
Conclusion | Ibrutinib plus venetoclax exhibited high response rates and a well-tolerated safety profile in Japanese patients with R/R MCL. | PMC10808627 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s10147-023-02443-6. | PMC10808627 | ||
Keywords | PMC10808627 | |||
Introduction | malignant lymphoma, Mantle cell lymphoma | MALIGNANT LYMPHOMA, MANTLE CELL LYMPHOMA | Mantle cell lymphoma (MCL) represents approximately 3% of all malignant lymphoma cases in Japan and occurs more commonly in elderly men [Prior preclinical investigations in MCL models have reported synergistic anti-tumor activity with ibrutinib and venetoclax combination [ | PMC10808627 |
Patients and methods | PMC10808627 | |||
Study design and patients | DISEASE PROGRESSION, DISEASE | M20-075 is an open-label, single-arm, Phase 2 study (NCT04477486). There were 12 sites that participated in the study, of which eight sites enrolled patients. The full eligibility criteria are described in the Supplementary Materials. Briefly, patients aged 20 years or older with pathologically confirmed MCL with at least one measurable disease were enrolled. Patients must have been previously treated with one to five prior lines of therapy including at least one prior rituximab/anti-CD20–containing regimen. Failure to achieve at least a partial response (PR) with, or documented disease progression after, the most recent treatment regimen was required. No prior therapy with ibrutinib or other BTKis was allowed. The full analysis set (FAS) comprised patients who received ≥ 1 dose of study drug. The per protocol set (PPS) excluded FAS patients who were determined to have non-evaluable disease at baseline based on assessment by independent review committee (IRC). The study was approved by institutional review boards and/or independent ethics committees. The study was conducted in accordance with the International Council for Harmonisation guidelines and the Declaration of Helsinki. All patients provided written consent. | PMC10808627 | |
Treatment and assessments | toxicity, DLTs, non-hematologic | DISEASE PROGRESSION | Patients were administered 560 mg ibrutinib once daily as a fixed dose from initial administration with concurrent venetoclax (starting with a ramp-up period to mitigate the risk of TLS). Venetoclax ramp-up consisted of four dose increases every 7 days: patients received a starting dose of 20 mg, then proceeded to 50 mg, 100 mg, 200 mg, and 400 mg venetoclax. DLTs were assessed in the first six patients during the venetoclax ramp-up period for a minimum of 5 weeks and at least 1 week of venetoclax dosing at 400 mg. Further detail pertaining to definition and criteria of DLTs (non-hematologic and hematologic) are described in the supplement. The supplement includes details on ibrutinib and venetoclax dose interruptions and reductions. Patients could continue ibrutinib plus venetoclax for a maximum of 104 weeks followed by ibrutinib monotherapy until disease progression, unacceptable toxicity, or withdrawal of consent. Patients who were high-risk for TLS (at least one lesion > 10 cm or at least one lesion > 5 cm and circulating lymphocytes) and/or baseline creatine clearance < 60 mL/min were followed closely with prophylactic measures including adequate hydration, anti-hyperuricemic agents, labs, and hospitalization [ | PMC10808627 |
Endpoints | Clinical response was assessed according to the positron emission tomography criteria of the Lugano classification [ | PMC10808627 | ||
Pharmacokinetics | BLOOD | Blood samples were collected on Week 6 Day 1 for the evaluation of venetoclax and ibrutinib PK. Samples were collected pre-dose (0 h) and at 1, 2, 4, 6 and 8 h post-dose. Pharmacokinetic parameters, including peak plasma concentration (C | PMC10808627 | |
Statistical analyses | The FAS was used for all efficacy endpoints (except endpoints based on assessment by IRC), safety, PK, and baseline analysis. The PPS was used for endpoints based on assessment by IRC and used as appropriate for investigator assessment endpoints. The estimate and 95% confidence interval (CI) for the CR rate, ORR, and uMRD rate were based on exact binomial distribution. The CR rate was compared to a historical control threshold of 12.5% observed with ibrutinib monotherapy in Japanese patients with R/R MCL using the exact binomial test at a 1-sided overall significance level of 0.025 [ | PMC10808627 | ||
Results | PMC10808627 | |||
Efficacy outcomes | With a median follow-up of 9.6 months, the ORR was 83% (10 of 12 patients in the PPS; 95% CI 51.6–97.9; Fig. Response rates by IRC (per protocol set). Overall response and duration of treatment. Progression-free survival (full analysis set). Overall survival (full analysis set) | PMC10808627 | ||
Pharmacokinetic outcomes | Pharmacokinetic data were available from 11 patients. Two patients discontinued treatment prior to the PK sampling day (Week 6 Day 1), and no PK data were available for those patients. Steady-state plasma concentration versus time profiles for venetoclax and ibrutinib are provided in the data supplement (Supplemental Fig. | PMC10808627 | ||
Discussion | chronic lymphocytic leukemia | CHRONIC LYMPHOCYTIC LEUKEMIA | The primary efficacy outcome of CR rate (83%) in this study shows statistically significant superiority of venetoclax and ibrutinib compared to ibrutinib monotherapy (historical CR rate of 12.5%) in Japanese patients with R/R MCL [Prior studies have demonstrated the efficacy of ibrutinib and venetoclax as single-agent monotherapy [Venetoclax exposures in combination with ibrutinib in this patient cohort was approximately 2.5-fold higher compared to exposures observed in Japanese patients with chronic lymphocytic leukemia receiving venetoclax monotherapy [Due to its potent anti-apoptotic effect, treatment with venetoclax carries risk of TLS [Despite the limitations of this study, including the small sample size and lack of a control group, the combination of ibrutinib and venetoclax demonstrated a clinically meaningful benefit in Japanese patients with R/R MCL. High CR rates and a tolerable safety profile with ibrutinib plus venetoclax were observed in elderly patients, representing a real-world population. The findings of this Phase 2 study reinforce the continued evaluation of the combination of ibrutinib and venetoclax, including the ongoing Phase 3 SYMPATICO study, for the treatment of R/R MCL. | PMC10808627 |
Acknowledgements | AbbVie and authors thank all the trial investigators and the patients who participated in this clinical trial. Medical writing assistance was provided by Daniel Roybal, PhD, of Bio Connections, LLC and funded by AbbVie Inc. | PMC10808627 | ||
Author contributions | Conception and design: Koji Izutsu, Hideyuki Honda, Sumiko Okubo. Provision of study materials or patients: Hideki Goto, Koji Izutsu, Satoshi Ito, Masahiro Kizaki, Masaki Yamaguchi, Noriko Fukuhara, Koji Kato, Toko Saito. Collection and assembly of data: Sumiko Okubo, Tomomi Soshin, Jiewei Zeng, Mohamed Badawi, Jeremy Ross. Data analysis and interpretation: All authors. Manuscript writing: All authors. Final approval of manuscript: All authors. | PMC10808627 | ||
Funding | AbbVie. | PMC10808627 | ||
Declarations | PMC10808627 | |||
Conflict of interest | Venetoclax is being developed in collaboration between AbbVie and Genentech. Ibrutinib is being developed in collaboration between AbbVie and Janssen Research & Development, LLC. The study sponsor funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data, and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Daniel Roybal, PhD, of Bio Connections, LLC, funded by AbbVie. | PMC10808627 | ||
Disclosures | Jiewei, Symbio | ONCOLOGY | Hideki Goto reports lecture fees earned from Kyowa Kirin. Satoshi Ito reports research funding from AbbVie, Amgen, Insight, Novartis, and Zenyaku-Kogyo. Masahiro Kizaki has nothing to declare. Masaki Yamaguchi has nothing to declare. Noriko Fukuhara reports research funding from AbbVie, Bayer, Celgene, Chordia Therapeutics, Chugai, Genmab, Incyte, Kyowa-Kirin, LOXO Oncology, and Takeda. Koji Kato reports research funding from AbbVie, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Janssen, Kyowa Kirin, Novartis, and Takeda. Toko Saito has nothing to declare. Yasuhito Terui reports lecture fees earned from AbbVie, Celgene, Chugai, Eisai, Janssen, Ono, and Symbio and a certain contribution from Eisai. Sumiko Okubo reports employment with and research funding from AbbVie and may hold stock options or other ownership in AbbVie. Tomomi Soshin reports her and her husband’s employment with AbbVie and may hold stock options or other ownership in AbbVie. Jiewei Zeng reports employment with AbbVie and may hold stock options or other ownership in AbbVie. Hideyuki Honda reports employment with AbbVie and may hold stock options or other ownership in AbbVie. Mohamed Badawi reports employment with and research funding from AbbVie and may hold stock options or other ownership in AbbVie. Jeremy A. Ross reports employment with and research funding from AbbVie and may hold stock options or other ownership in AbbVie. Koji Izutsu reports advisory board and honoraria fees from AbbVie. | PMC10808627 |
References | PMC10808627 | |||
Background | SEQUELAE | Edited by: Gilson Dorneles, Hospital Moinhos de Vento, BrazilReviewed by: Bruna Marmett, Hospital Moinhos de Vento, Brazil; Abdel-Hameed Al-Mistarehi, Johns Hopkins Medicine, United StatesThis article was submitted to Digital Public Health, a section of the journal Frontiers in Public HealthNumerous recommendations from pulmonary scientific societies indicate the need to implement rehabilitation programs for patients after COVID-19. The aim of this study was to propose an innovative comprehensive intervention based on a hospital-based pulmonary rehabilitation program for individuals with post-acute sequelae of COVID-19. | PMC9939639 | |
Methods | infection | INFECTION | It was decided to evaluate two forms of hospital rehabilitation: traditional and one provided through virtual reality. Preliminary results are based on a group of 32 patients (20 female and 12 male), of average age 57.8 (4.92) years in the period of 3–6 months after the initial infection. Primary outcomes included analysis of lung function, exercise performance and stress level. A 3-week, high-intensity, five-times per week pulmonary rehabilitation program was designed to compare the effectiveness of a traditional form with a VR-led, novel form of therapy. | PMC9939639 |
Results | dyspnoea | The analysis of the results showed a statistically significant improvement in both groups with regard to exercise performance expressed as 6MWT distance. Moreover, a statistically significant decrease in dyspnoea levels following the 6MWT was also noted in intergroup comparison, but the between-group comparison revealed non-statistically significant changes with low effect size. Regarding lung function, the analysis showed essentially normal lung function at baseline and a non-statistically significant improvement after the completion of the rehabilitation program. The analysis of the stress level showed a statistically significant improvement in both groups within the inter-group comparison, yet the between-group comparison of deltas values showed a non-significant difference with low effect size. | PMC9939639 | |
Conclusion | SEQUELAE | A 3-weeks inpatients pulmonary rehabilitation program led to improvement of the exercise performance of people with post-acute sequelae of COVID-19, but not lung function. Furthermore, the program was shown to reduce patients' stress levels. A comparison of the traditional form of rehabilitation to the novel form using VR, shows similar effectiveness in terms of exercise performance and stress levels. | PMC9939639 | |
Introduction | chronic respiratory diseases, SARS-CoV-2 infection, fatigue, shortness of breath | VIRUS, SEQUELAE, SARS-COV-2 INFECTION, CHRONIC RESPIRATORY DISEASE | Over recent years, SARS-CoV-2 infection has been confirmed in millions of people around the world. The virus spreads mainly through the respiratory tract (especially from droplets arising from coughing, sneezing, and talking) and through contaminated surfaces and biological substances (In the initial phase of the epidemic, very few people were diagnosed. Those who were hospitalized had health-threatening “severe” symptoms. In addition to the hospitalized patients with “severe” COVID-19, millions of people have most probably been infected with SARS-CoV-2 without formal COVID-19 testing and/or medical treatment in the hospital (The benefits of respiratory rehabilitation are well-known and existing programmes can be used as one of the referral paths for the rehabilitation of COVID-19 survivors with symptoms and/or impairment of physical functions. Many systematic literature reviews show the beneficial effect of pulmonary rehabilitation in patients with chronic respiratory diseases on exercise capacity (The use of virtual reality (VR) in pulmonary rehabilitation programs has been reported for several years in the research literature. VR presents engaging scenarios that can shift attention, distracting the patient from negative sensations (e.g., fatigue and shortness of breath) during physical activity (The aim of this study was to propose an innovative comprehensive intervention based on a pulmonary rehabilitation programme for patients with post-acute sequelae of COVID-19. Moreover, this project evaluates the use of VR in the rehabilitation processes. This study aims to address the following hypotheses:1. Participation in the 3-week pulmonary rehabilitation programme will improve the pulmonary function and exercise capacity of individuals with post-acute sequelae of COVID-19.2. Participation in the 3-week pulmonary rehabilitation programme will improve the stress level of individuals post-acute sequelae of COVID-19. | PMC9939639 |
Materials and methods | PMC9939639 | |||
Participants | lung cancer, pneumonia, heart disease, cognitive impairment | PNEUMONIA, HEART DISEASE, POLAND, COVID-19 INFECTION, LUNG CANCER, INSULIN-DEPENDENT DIABETES MELLITUS | The study was conducted among patients with PASC who participated in inpatient pulmonary rehabilitation at the Specialist Hospital in Glucholazy (Poland). These preliminary results included 32 randomly selected patients aged 41–67 years old who met the inclusion criteria and gave written consent to participate in the study. The patients were randomized to two groups: experimental (VR group) which participated in the pulmonary rehabilitation program incorporated with VR-based features, and the control group (control group) participating in the same therapeutic elements but in a traditional manner. Randomization was performed using the Research Randomizer (ratio 1:1), a web-based service that offers instant random assignment. Sealed envelopes were used for group assignment. The inclusion criteria were: women and men aged 40–80 years and a confirmation from a primary care physician of having had COVID-19 infection. The exclusion criteria were: no consent to participate, active pneumonia diagnosed by x-ray, documented heart disease (stable or unstable), status after coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, insulin-dependent diabetes mellitus, inability to exercise independently or musculoskeletal/neurological conditions that would prevent completion of the course, lung cancer, cognitive impairment, or Mini-Mental State Examination < 24. This study implemented a randomized control trial study design, approved by Bioethical commission Opole Medical Chamber in Opole (Approval Number: No. 343, 25 November 2021), registered in ClinicalTrials.gov (NCT05244135), and carried out in accordance with the Declaration of Helsinki guidelines ( | PMC9939639 |
Intervention | dyspnea, COPD | COPD | A 3-week, five-times-week high-intensity pulmonary rehabilitation program was designed to compare the effectiveness of a traditional form with a VR-led, novel form of therapy. Such programs have been shown to produce clinically significant improvements in exercise capacity, dyspnea, quality of life and lung function in patients with COPD (Qualification criteria for pulmonary rehabilitation model.Cycle ergometer training was conducted at the training heart rate—which was a percentage of the achieved heart rate in the 6-minute walk test. The limits of the initial training heart rate on the cycle ergometer, varied depending on the model (model A-−90% of peak 6-minute walk heart rate, model B-−80%, model C-−70%, and model D-−20–30% increase in heart rate during exercise compared to resting heart rate). Initial work rate and increment were also adapted to the rehabilitation model:Model A−50W, 70W, 90W, 110W, 130W, 150WModel B−50W, 60W, 70W, 80W, 90W, 100WModel C−30W, 40W, 50W, 60W, 70W, 80WModel D−30WMoreover, the Virtual Park software features an automatic system of changes in training heart rate: after reaching the target heart rate in the previous training session, the work rate on the last phase was increased by 5W; if the heart rate was not reached, the final work rate was reduced by 5W. Prior to training, the therapist recorded heart rate (HR) and pulse oximeter saturation (SpOWith regard to relaxation training, patients in the control group participated in Schulz autogenic training while patients in the VR group were given guided relaxation in a virtual setting using the goggles. The time components were the same in both groups. | PMC9939639 |
Exercise training in VR | The VR group conducted endurance training using the “Virtual Park” software developed by STIIMA-CNR. The scenery depicted a sunny island where the participants conducted a bicycle ride enriched with realistic elements and sound effects to simulate real-life situations. The software was linked to the ergometer so the dynamics of the image changed with the cadence of pedaling. The training station consisted of a COSMED cycle ergometer, VR goggles, and physiological sensors—an HR band and pulse oximeter (Exercise training on cycle ergometer with VR. | PMC9939639 | ||
Relaxation in virtual reality | A VR TierOne device (StolgrafVR station for relaxation. | PMC9939639 | ||
Measurement | infection | INFECTION | At baseline, participants completed a self-administered sociodemographic questionnaire. Questions included gender, marital status, place of residence, education, comorbidities, and history of hospitalization for SARS-CoV2 infection. | PMC9939639 |
Functional capacity | The functional capacity assessment included exercise performance (6-minute walk test: 6MWT), spirometry [forced expiratory volume for 1 second (FEV | PMC9939639 | ||
Stress level | The Perceived Stress Scale (PSS-10) is a widely used psychological instrument for measuring the perception of stress (These examinations were performed before the start of rehabilitation and after its completion. | PMC9939639 | ||
Statistical analysis | POLAND | Analyses were performed using Statistica 13 software (StatSoft, Cracow, Poland) and JASP software (JASP Team, Amsterdam, Netherlands) ( | PMC9939639 | |
Results | REGRESSION | The main groups characteristic is presented in Groups characteristic.The analysis of the results showed a statistically significant improvement in both groups with regard to exercise performance expressed as 6MWT distance (CG: Results of the 6-minute walk test.Regarding lung function, the analysis showed essentially normal lung function at baseline and a non-statistically significant improvement after the completion of the rehabilitation program.The analysis of the stress level showed a statistically significant improvement in both groups (CG: Results of the analyzed outcomes.Bold highlights statistical significance p < 0.05.FEV1, forced expiratory volume for 1 s; FVC, forced vital capacity; FEV1%VC, forced expiratory volume in one second % of vital capacity; TLC, total lung capacity; % pred, predicted values from Viljanen (Data is presented as mean (SD) or median [IRQ]. Differences in pre-post rehabilitation values were analyzed by paired t-student test or Wilcoxon test, depending on the distribution of the variables. Evaluation of between-group differences was assessed using the Mann-Whitney U-test.Stepwise multiple regression was used to examine how stress level could explain a statistically significant amount of variance in functional capacity (Stress level (PSS-10) a predictor for functional capacity outcomes (stepwise regression results).The following covariates were considered but not included: TLC pre, FVC pre, FEV | PMC9939639 | |
Discussion | cough, desaturation, fatigue, shortness of breath | CRITICAL ILLNESS, COVID-19 INFECTION | In COVID-19 survivors, physical impairment can persist for weeks after COVID-19, such as shortness of breath, desaturation, cough, weakness, and fatigue. Even in the early stages of the pandemic, expert opinions suggested the need for rehabilitation, based on the fact that exercise is feasible and useful in survivors of critical illness (Our study contributes to the growing literature on the benefits of rehabilitation for patients admitted to inpatient rehabilitation after COVID-19 infection. Previous European studies have shown improvements after inpatient rehabilitation programs in physical fitness, ADL ability, and pulmonary measurements. A study by Piquet et al. evaluated the effectiveness of inpatient rehabilitation for 100 post-acute care COVID-19 patients (Although this study provides evidence for the effectiveness of hospital-based rehabilitation programs, we recognize that some limitations should be considered. First, the lack of inclusion of data from the full spirometry (including FEF 25–75%) study in the analysis may bias the results. Second, future studies could be enriched with a wider range of diagnostic tools, including more objective ways to measure stress levels (e.g., cortisol levels). Third, a follow-up assessment could provide additional valuable information on efficacy comparisons with traditional therapies. Finally, the subgroup analysis omitted inclusion of the time of symptom onset, which may impact the validity of the results. It is acknowledged that an increase in symptom duration is positively correlated with the magnitude of the immune response and, as such, may influence the recovery of patients. However, we would like to emphasize that the results obtained are preliminary reports, and the project is still in the implementation phase. | PMC9939639 |
Conclusions | dyspnea | VIRUS, SEQUELAE | From a clinical perspective, this study's results suggest that VR rehabilitation may be an effective intervention for improving exercise performance and reducing dyspnea levels in patients with post-acute sequelae of COVID-19, although VR was not shown to be more effective than standard rehabilitative practices. This is important as in this patient's cohort are a new population and not much is known about the long-term effects of the virus on lung function, exercise performance and dyspnea levels. The study's findings suggest that VR rehabilitation can help improve exercise performance and reduce dyspnea levels, which can improve patients' quality of life and ability to perform daily activities. Moreover, the results contribute to the understanding of the long-term effects of COVID-19 on the lung and the effectiveness of rehabilitation interventions in patients with post-acute sequelae of COVID-19. Furthermore, the finding that baseline stress level was a significant predictor of changes in end-exercise dyspnea highlights the importance of addressing stress in rehabilitation patients with post-acute sequelae of COVID-19, which is important for the overall wellbeing. | PMC9939639 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC9939639 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Bioethical Commission Opole Medical Chamber in Opole (Approval Number: 343, 25 November 2021). The patients/participants provided their written informed consent to participate in this study. | PMC9939639 | ||
Author contributions | SR: conceptualization, project administration, and funding acquisition. SR, JS, and RC: methodology. SR and RC: formal analysis. KB, AR, and JS: investigation. SR, AR, and RC: writing—original draft preparation. RC: supervision. All authors: writing—review and editing, meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE), read and approved the final manuscript, and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.The authors thank the team of physiotherapists for supporting the study. | PMC9939639 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9939639 | ||
Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC9939639 | ||
References | PMC9939639 | |||
Abstract | PMC10315777 | |||
Background | cancer, GCA, Gastric cardia adenocarcinoma | CANCER, GCA | Gastric cardia adenocarcinoma (GCA) is a highly fatal form of cancer in humans. The aim of this study was to extract clinicopathological data of postoperative patients with GCA from the Surveillance, Epidemiology, and End Results database, analyze prognostic risk factors, and build a nomogram. | PMC10315777 |
Methods | GCA | In this study, the clinical information of 1448 patients with GCA who underwent radical surgery and were diagnosed between 2010 and 2015 was extracted from the SEER database. The patients were then randomly divided into training ( | PMC10315777 | |
Results | REGRESSION | The results of the multivariate Cox regression analysis showed that age, grade, race, marital status, T stage, and log odds of positive lymph nodes (LODDS) were independently associated with cancer‐specific survival in the training cohort. Both the C‐index and AUC values depicted in the nomogram were greater than 0.71. The calibration curve revealed that the nomogram's CSS prediction was consistent with the actual outcomes. The decision curve analysis suggested moderately positive net benefits. Based on the nomogram risk score, significant differences in survival between the high‐ and low‐risk groups were observed. | PMC10315777 | |
Conclusions | GCA | Race, age, marital status, differentiation grade, T stage, and LODDS are independent predictors of CSS in patients with GCA after radical surgery. Our predictive nomogram constructed based on these variables demonstrated good predictive ability.The nomogram for postoperative patients with GCA we constructed has good predictive power and can help clinicians accurately assess patient prognosis and identify high‐risk patients to develop more personalized treatment plans.
Lei Wang and Jingjing Ge contributed equally as first authors. | PMC10315777 | |
INTRODUCTION | tumor, death, GCA, malignant tumor, Gastric cardia adenocarcinoma | MALIGNANT TUMOR, TUMOR, GCA, PRIMARY TUMOR | Gastric cardia adenocarcinoma (GCA) is a commonly diagnosed malignant tumor of the digestive tract.The TNM staging system is currently the primary method used to evaluate patient prognosis and guide clinical treatment approaches.The Surveillance, Epidemiology, and End Results (SEER) database covers over 28% of the population of the United States and includes information on patient demographics, stage of diagnosis, treatment process, tumor morphology, primary tumor site, vital status follow‐up, and causes of death, thus providing an effective tool for tumor epidemiological research. | PMC10315777 |
METHODS | PMC10315777 | |||
Patient selection | tumors, adenocarcinoma, cardia | TUMORS, GCA, ADENOCARCINOMA, TUMOR METASTASIS | The specific operational process for extracting information from the SEER database is outlined below: (1) Register for a personal account on the SEER database official website and install the SEER*Stat software; (2) Extract clinical data of patients based on the inclusion and exclusion criteria determined in this study; (3) Export the extracted data as a spreadsheet and proceed to the next step of organizing and analyzing the data.The data for patients with GCA between 2010 and 2015 were downloaded from the SEER*Stat 8.4.0 software using a private ID (13914‐Nov2021), based on the 2021 release of the SEER database. According to the SEER codes, patients with adenocarcinoma (ICD‐O‐3 codes: 8140–8145,8147, 8210, 8211, 8214, 8220, 8221, 8230, 8231, 8255, 8260–8263, 8310, 8480, 8481, 8490, 8510, 8560, 8562, 8570–8576) and tumors located in the cardia (site code: C16.0) were included. All patients underwent radical surgery (surgery encode 30–80); however, those with stage IV GCA were excluded due to the controversial nature of their operation. In addition, patients with missing information on relevant variables were excluded from this study. The detailed screening process and selection criteria are shown in Figure Flowchart for the selection of the patients.In addition to the above data, the data of patients with GCA after surgery at the First Affiliated Hospital of Zhengzhou University between 2012 and 2018 were collected for validation. Patients underwent thorough preoperative assessments, including physical exams, medical history recording, hematological testing, and imaging. Furthermore, tumor metastasis was evaluated using various imaging techniques. The study was approved by the hospital ethics committee, and patient records were kept confidential in accordance with ethical standards. | PMC10315777 |
Variable collection | tumor, death, adenocarcinoma, N0, Cancer | TUMOR, SIGNET RING CELL CARCINOMA, ADENOCARCINOMA, CANCER | According to the instructions provided by the National Cancer Institute, the code data extracted from the SEER database was translated. The external validation cohort data was obtained through the hospital medical record system. The variables collected in this study were mainly divided into three categories: patient‐related variables, disease‐related variables, and follow‐up information. (1) Patient‐related variables: race, sex, age at diagnosis, and marital status. (2) Disease‐related variables: histological type, differentiation grade, 7th edition AJCC clinical stage (TNM), tumor size, examined lymph nodes (ELN), positive lymph nodes (PLN), and LODDS, which is calculated as LODDS = log[(PLN + 0.5)/(ELN‐PLN + 0.5)]. (3) Follow‐up information: survival status, cause of death, and survival time.Each variable was categorized as follows: marital status, unmarried or married; sex, male or female; histological type, adenocarcinoma or signet ring cell carcinoma; differentiation grade, G1–2 (well to moderately differentiated) or G3–4 (poorly differentiated and undifferentiated); and the 7th edition AJCC clinical stage, which divided T stage into T1, T2, T3, and T4 and N stage into N0, N1, N2, and N3. The X‐tile software was used to determine the optimal cutoff values for the three continuous variables of age, tumor size, and LODDS. Age was classified as <65, 65–71, and >71 years; tumor size was classified as <2.6, 2.6–4.8, and <4.8 cm; LODDS was classified as LODDS1 (< −1.20), LODDS2 (−1.20 to −0.60), and LODDS3 (< −0.60). | PMC10315777 |
Statistical analysis | REGRESSION | SPSS (26.0) and R (4.2.2) software were used for statistical analysis and graph plotting. The X‐tile software determined the optimal cutoff value, and continuous variables were transformed into categorical variables accordingly. Categorical variables were compared between groups using the Fisher's exact test or chi‐square test. Univariate Cox analysis was conducted for each variable, and variables with statistical significance (Based on the multivariate Cox regression analysis, a nomogram was constructed to predict patient CSS using the rms and survival packages in R software. The model's reliability was validated by internal and external validation cohorts. The model's discrimination was evaluated using the concordance index (C‐index), with a C‐index greater than 0.71 indicating excellent discrimination. The calibration curve measured the degree of closeness between the predicted and actual risk, with a closer curve indicating better predictive results. The time‐dependent receiver operating characteristic curve (ROC curve) evaluated the model's accuracy, with an area under the curve (AUC) greater than 0.71 indicating good predictive ability. Decision curve analysis (DCA) evaluated the model's clinical utility and quantified the net benefits at different threshold probabilities. Patients were divided into high‐risk and low‐risk groups based on the median risk score from the column chart. Kaplan–Meier analysis was used to plot the survival curves of high‐risk and low‐risk groups for predicting CSS, and the log‐rank test was used for survival analysis. | PMC10315777 | |
RESULTS | PMC10315777 | |||
Patient characteristics | GCA | Data of 1448 patients with GCA who underwent curative surgery were extracted from the SEER database, and these patients were randomly assigned to a training set (1013 patients) and an internal validation set (435 patients) at a ratio of 7:3. In the training cohort, the median follow‐up time was 41 months, with 3‐year and 5‐year CSS rates of 57.7% and 47.3%, respectively. In the internal validation cohort, the median follow‐up time was 37 months, with 3‐year and 5‐year CSS rates of 55.5% and 43.9%, respectively. In the training cohort, there were 818 male (80.8%) and 195 female (19.2%) patients. Of the total sample, 86.2% (Retrospective clinical data of 218 patients with GCA who underwent curative surgery at a Chinese hospital were collected, and these patients were assigned to an external validation cohort according to the same inclusion and exclusion criteria, and the nomogram model was validated with external data. In the external validation cohort, the median follow‐up time was 31 months, with 3‐year and 5‐year CSS rates of 69.0% and 58.6%, respectively. There were 174 male (79.8%) and 44 female (20.2%) patients in the external validation cohort. In this cohort, 136 patients aged <65 years (62.4%), 57 aged between 65 and 71 years (26.1%), and 25 aged >71 years (11.5%). The basic information is presented in Table Clinicopathological characteristics of the postoperative patients with stage I–III GCA. | PMC10315777 | |
Independent prognostic factors | tumor | REGRESSION, TUMOR | The univariate Cox regression analysis showed that race, age, marital status, grade, T stage, N stage, tumor size, and LODDS score were related to CSS. To avoid overfitting, LASSO regression was performed using those eight variables. All eight variables were included in the model, as their coefficients were non‐zero (Figure LASSO coefficients of eight features (A) and the selection of tuning parameter (λ) for the LASSO model (B).Univariate and multivariate cox regression analyses of the prognostic factors for CSS.The bold font represents | PMC10315777 |
Establishment of the nomogram | REGRESSION | Based on the results of the multivariate Cox regression analysis, a nomogram was established and is presented in Figure Nomogram predicting CSS of the postoperative patients with GCA.Calibration curves of the nomogram for predicting 3‐year CSS (A) and 5‐year CSS (B) in the training set; the calibration curves of the nomogram for predicting 3‐year CSS (C) and 5‐year CSS (D) in the internal validation set; and the calibration curves of the nomogram for predicting 3‐year CSS (E) and 5‐year CSS (F) in the external validation set.Time‐dependent ROC curves were used to test the predictive power of the 3‐year CSS and 5‐year CSS in the training se (A and D); the internal validation set (B and E); and the external validation set (C and F), respectively.DCA of the nomogram and TNM stage 3‐year CSS and 5‐year CSS of the training (A and D), internal (B and E), and external cohorts (C and F), respectively. | PMC10315777 | |
Risk stratification based on the nomogram | The risk score was calculated using the nomogram, and patients were categorized into low‐risk and high‐risk groups based on the median value as the cutoff point. The Kaplan–Meier plot (Figure Kaplan–Meier curves for the patients in the low‐ and high‐risk groups based on the risk scores. (A) training cohort; (B) internal validation set; and (C) external validation set.Effect of chemotherapy on the survival in the total population (A), low‐risk group (B), and high‐risk group (C). | PMC10315777 | ||
DISCUSSION | cancer | CANCER, GCA | Currently, mainstream studies consider the EGJ to be a region that is separate from both the esophagus and the stomach.Our study aimed to construct a nomogram that accurately predicts the prognosis of postoperative patients with GCA at stages I–III based on a multivariate analysis. The C‐index and AUC values were both greater than 0.71, indicating favorable discrimination of the nomogram. Compared to the TNM staging system alone, the nomogram model had a higher accuracy, as shown by the AUC value. The DCA curve was used to analyze the clinical benefits of the model, and the results suggested that the nomogram had a high net clinical benefit. Further statistical analyses showed that the nomogram model had more advantages than the TNM staging system. The use of our nomogram model aligns with the current principles of personalized treatment. Finally, the applicability of the model was verified using an external population.Although chemotherapy is widely used in the treatment of GCA, our study found that it did not have a positive therapeutic effect on patients in this study.In the multifactor analysis, race, age, marital status, histological grade, T stage, and LODDS were determined to be independent prognostic factors. It has been widely reported that older age is a poor prognostic factor in cancer patients.Zhu et al. observed that White patients had the highest risk of GCA compared with that in the other ethnic groups, which is consistent with our findings.Compared with the study by Guo et al., | PMC10315777 |
CONCLUSIONS | GCA | In conclusion, we utilized clinical data from the SEER database to identify factors associated with survival in postoperative patients with GCA at stages I–III. Subsequently, we developed a nomogram that accurately predicted CSS in patients with GCA who underwent radical surgery. Our findings indicate that the nomogram outperforms TNM staging in terms of predictive power and may provide greater clinical benefits for patients with GCA after radical surgery. | PMC10315777 | |
AUTHOR CONTRIBUTIONS | PMC10315777 | |||
CONFLICT OF INTEREST STATEMENT | The authors have no conflict of interest to declare. | PMC10315777 | ||
ETHICS APPROVAL STATEMENT | The First Affiliated Hospital of Zhengzhou University's Medical Ethics Committee examined and approved this study involving human participants (2023‐KY‐0019‐001). | PMC10315777 | ||
PATIENT CONSENT STATEMENT | As this was a retrospective study, no written informed consent was required. | PMC10315777 |
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