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Quality of life and health status in older adults (≥65 years) up to five years following colorectal cancer treatment: Findings from the ColoREctal Wellbeing (CREW) cohort study

PLoS One. 2022 Jul 14;17(7):e0270033. doi: 10.1371/journal.pone.0270033. eCollection 2022.

ABSTRACT

OBJECTIVE: Colorectal cancer (CRC) is common in older adults, with more than 70% of diagnoses in people aged ≥65 years. Despite this, there is a knowledge gap regarding longer-term outcomes in this population. Here, we identify those older people most at risk of poor quality of life (QoL) and health status in the five years following CRC treatment.

MATERIALS AND METHODS: CREW is a UK longitudinal cohort study investigating factors associated with health and wellbeing recovery following curative-intent CRC surgery. Participants completed self-report questionnaires pre-surgery, then at least annually up to five years. Longitudinal analyses explored the prevalence and pre-surgery risk factors of poor QoL (QLACS-GSS) and health status (EQ-5D: presence/absence of problems in five domains) in older (≥65 years) participants over five years.

RESULTS: 501 participants aged ≥65years completed questionnaires pre-surgery; 45% completed questionnaires five years later. Oldest-old participants (≥80 years) reported poorer QoL (18% higher QLACS-GSS) and 2-4 times higher odds of having problems with mobility or usual activities, compared with the youngest-old (65-69 years) over follow-up. Baseline higher self-efficacy was significantly associated with better QoL (10-30% lower QLACS-GSS scores compared to those with low self-efficacy) and lower odds of problems in all EQ-5D domains. Adequate social support was significantly associated with better QoL (8% lower QLACS-GSS) and lower odds of problems with usual activities (OR = 0.62) and anxiety/depression (OR = 0.56).

CONCLUSION: There are important differences in QoL and health status outcomes for the oldest-old during CRC recovery. CREW reveals pre-surgery risk factors that are amenable to intervention including self-efficacy and social support.

PMID:35834525 | DOI:10.1371/journal.pone.0270033

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Birth weight reference for Japanese twins and risk factors for infant mortality: A population-based study

PLoS One. 2022 Jul 14;17(7):e0271440. doi: 10.1371/journal.pone.0271440. eCollection 2022.

ABSTRACT

There is no standard birth weight curve for twins in Japan other than a prototype curve based on 1988-1991. Twins have a high perinatal mortality rate than singletons; therefore, we developed a new standard curve for twin birth weight using data from the 1995-2016 Vital Statistics and compared it with previous reports. We used 469,064 cases for analysis, excluding stillbirths and cases with missing values, and created a standard curve using LMS (statistical methods to vary the distribution by using skewness, median, and coefficient of variation) method. In comparison with previous reports, the mean birth weight decreased by 100-200 g. The groups with the lowest neonatal death rates (NDRs) and infant death rates (IDRs) were those with a birth weight of 1,500-2,499 g (NDR: 0.3%, IDR: 0.6%) and those born at 34-36 weeks (NDR: 0.2%, IDR: 0.4%). Compared to these, the IDR was significantly higher in the 2,500-3,999 g group and the 37-39 weeks group (incidence rate ratio (IRR): 1.1 in the 2,500-3,999 g group, IRR: 1.3 in the 37w0d-39w6d group). In particular, the risks of neonatal mortality and infant mortality were higher in infants born at a birth weight above 3,500 g. Infants born at a birth weight above 3,500 g may include recipients of twin-to-twin transfusion syndrome. The most common causes of infant mortality are accidental death and sudden infant death syndrome (SIDS). We considered the possibility that infants treated as healthy newborns and whose mothers were discharged from the hospital without adequate twin care guidance may be more likely to experience unintentional accidents and SIDS at home. The present study suggested that creating a new twin birth weight standard curve and guidance on managing twins at home for full-term and normal birth weight infants may lead to a reduction in infant deaths.

PMID:35834520 | DOI:10.1371/journal.pone.0271440

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Burnout and Associated Psychological Problems Among Teachers and the Impact of the Wellness4Teachers Supportive Text Messaging Program: Protocol for a Cross-sectional and Program Evaluation Study

JMIR Res Protoc. 2022 Jul 14;11(7):e37934. doi: 10.2196/37934.

ABSTRACT

BACKGROUND: Stress, burnout, anxiety, and depression continue to be a problem among teachers worldwide. It is not presently known what the prevalence and correlates for these psychological problems are among teachers in Alberta and Nova Scotia. It is also not known if a supportive text message program (Wellness4Teachers) would be effective in reducing stress, burnout, anxiety, or depression symptoms among teachers.

OBJECTIVE: The goal of this study is to evaluate the prevalence and correlates of stress, burnout, symptoms of anxiety, depression, and low resilience among elementary and high school teachers in Alberta and Nova Scotia, Canada. It also aims to determine if daily supportive text messages can help reduce the prevalence of these psychological problems in teachers.

METHODS: This is a cross-sessional mixed methods study with data to be collected from subscribers of Wellness4Teachers using a web-based survey at baseline (onset of text messaging), 6 weeks, the program’s midpoint (3 months), and end point (6 months). Teachers can subscribe to the Wellness4Teachers program by texting the keyword “TeachWell” to the program phone number. Outcome measures will be assessed using standardized rating scales and key informant interviews. Data will be analyzed with descriptive and inferential statistics using SPSS and thematic analysis using NVivo.

RESULTS: The results of this study are expected 24 months after program launch. It is expected that the prevalence of stress, burnout, anxiety, depression, and low resilience among teachers in Alberta and Nova Scotia would be comparable to those reported in other jurisdictions. It is also expected that factors such as gender, number of years teaching, grade of teaching, and school type (elementary vs high school) will have an association with burnout and other psychological disorders among teachers. Furthermore, it is expected that Wellness4Teachers will reduce the prevalence and severity of psychological problems in teachers, and subscriber satisfaction will be high.

CONCLUSIONS: The Wellness4Teachers project will provide key information regarding prevalence and correlates of common mental health conditions in teachers in Alberta and Nova Scotia, as well as the impact of daily supportive text messages on these mental health parameters. Information from this study will be useful for informing policy and decision-making concerning psychological interventions for schoolteachers.

PMID:35834305 | DOI:10.2196/37934

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Effects of an mHealth Intervention for Pulmonary Tuberculosis Self-management Based on the Integrated Theory of Health Behavior Change: Randomized Controlled Trial

JMIR Public Health Surveill. 2022 Jul 14;8(7):e34277. doi: 10.2196/34277.

ABSTRACT

BACKGROUND: Improving the health self-management level of patients with tuberculosis (TB) is significant for reducing drug resistance, improving the cure rate, and controlling the prevalence of TB. Mobile health (mHealth) interventions based on behavioral science theories may be promising to achieve this goal.

OBJECTIVE: This study aims to explore and conduct an mHealth intervention based on the Integrated Theory of Health Behavior Change (ITHBC) in patients with pulmonary TB to increase their ability of self-care management.

METHODS: A prospective randomized controlled study was conducted from May to November 2020. A total of 114 patients who were admitted consecutively to the TB clinic of Harbin Chest Hospital, China from May 2020 to August 2020 were recruited by convenience sampling. Patients were divided into the control group and intervention group, and all received a 3-month intervention. Patients in the intervention group and the control group received routine medical and nursing care in the TB clinic, including the supervision of their medications. In addition, pharmacist-assisted mHealth (WeChat) intervention based on the ITHBC theory about TB management was provided to the intervention group. The primary outcome was self-management behavior, while the secondary outcomes were TB awareness, self-efficacy, social support, and degree of satisfaction with health education. The outcomes were measured using web-based self-designed and standard questionnaires administered at baseline and at the end point of the study. Intergroup data were assessed using the Mann-Whitney U test, whereas intragroup data were assessed with the Wilcoxon test (for paired samples).

RESULTS: A total of 112 patients (59 in intervention group and 53 in control group) completed the study. After the intervention, a statistically significant increase was noted in the scores of each item of self-care management behaviors compared with the scores at the baseline (P<.001) in the intervention group. The scores of all self-care management behaviors of the control group were lower than those of all self-care management behaviors in the intervention group (all P<.05), except for the item “cover your mouth and nose when coughing or sneezing” (P=.23) and item “wash hands properly” (P=.60), which had no statistically significant difference from those in the intervention group. Compared with those at baseline, TB knowledge awareness, self-efficacy, social support, and degree of satisfaction with health education in the intervention group increased significantly (P<.001), and the intervention group had significantly higher scores than the control group (P<.001).

CONCLUSIONS: mHealth intervention for TB self-management based on ITHBC could deepen the understanding of patients with TB about their disease and improve their objective initiative and self-care management behaviors, which were beneficial for promoting compliance behavior and quality of prevention and control for pulmonary TB.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2200055557; https://tinyurl.com/4ray3xnw.

PMID:35834302 | DOI:10.2196/34277

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Practical notes on popular statistical tests in renal physiology

Am J Physiol Renal Physiol. 2022 Jul 14. doi: 10.1152/ajprenal.00427.2021. Online ahead of print.

ABSTRACT

Competent statistical analysis is essential to maintain rigor and reproducibility in physiological research. Unfortunately, the benefits offered by statistics are often negated by misuse or inadequate reporting of statistical methods. To address the need for improved quality of statistical analysis in papers, the American Physiological Society released Guidelines for reporting statistics in journals published by the society. The Guidelines reinforce high standards for the presentation of statistical data in physiology, but focus on the conceptual challenges and, thus, may be of limited use to an unprepared reader. Experimental scientists working in the renal field may benefit from putting the existing guidelines in a practical context. This paper discusses the application of widespread hypothesis tests in a confirmatory study. We simulated pharmacological experiments assessing intracellular calcium in cultured renal cells and kidney function at the systemic level to review best practices for data analysis, graphical presentation, and reporting. Such experiments are ubiquitously used in renal physiology and could be easily translated to other practical applications to fit the reader’s specific needs. We provide step-by-step guidelines for using the most common types of t-tests and ANOVA and discuss typical mistakes associated with them. We also briefly consider normality tests, exclusion criteria, and identification of technical and experimental replicates. This manuscript is supposed to help the reader analyze, illustrate and report the findings correctly, and hopefully serve as a gauge for a level of design complexity when it might be time to consult a biostatistician.

PMID:35834273 | DOI:10.1152/ajprenal.00427.2021

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Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge: A Cohort Study and Randomized Comparative Effectiveness Trial

JAMA Netw Open. 2022 Jul 1;5(7):e2220957. doi: 10.1001/jamanetworkopen.2022.20957.

ABSTRACT

IMPORTANCE: The effectiveness of monoclonal antibodies (mAbs), casirivimab-imdevimab and sotrovimab, is unknown in patients with mild to moderate COVID-19 caused by the SARS-CoV-2 Delta variant.

OBJECTIVE: To evaluate the effectiveness of mAb against the Delta variant compared with no mAb treatment and to ascertain the comparative effectiveness of casirivimab-imdevimab and sotrovimab.

DESIGN, SETTING, AND PARTICIPANTS: This study comprised 2 parallel studies: (1) a propensity score-matched cohort study of mAb treatment vs no mAb treatment and (2) a randomized comparative effectiveness trial of casirivimab-imdevimab and sotrovimab. The cohort consisted of patients who received mAb treatment at the University of Pittsburgh Medical Center outpatient infusion centers and emergency departments from July 14 to September 29, 2021. Participants were patients with a positive SARS-CoV-2 test result who were eligible to receive mAbs according to emergency use authorization criteria.

EXPOSURE: For the trial, patients were randomized to either intravenous casirivimab-imdevimab or sotrovimab according to a system therapeutic interchange policy.

MAIN OUTCOMES AND MEASURES: For the cohort study, risk ratio (RR) estimates for the primary outcome of hospitalization or death by 28 days were compared between mAb treatment and no mAb treatment using propensity score-matched models. For the comparative effectiveness trial, the primary outcome was hospital-free days (days alive and free of hospitalization) within 28 days after mAb treatment, where patients who died were assigned -1 day in a bayesian cumulative logistic model adjusted for treatment location, age, sex, and time. Inferiority was defined as a 99% posterior probability of an odds ratio (OR) less than 1. Equivalence was defined as a 95% posterior probability that the OR was within a given bound.

RESULTS: A total of 3069 patients (1023 received mAb treatment: mean [SD] age, 53.2 [16.4] years; 569 women [56%]; 2046 had no mAb treatment: mean [SD] age, 52.8 [19.5] years; 1157 women [57%]) were included in the prospective cohort study, and 3558 patients (mean [SD] age, 54 [18] years; 1919 women [54%]) were included in the randomized comparative effectiveness trial. In propensity score-matched models, mAb treatment was associated with reduced risk of hospitalization or death (RR, 0.40; 95% CI, 0.28-0.57) compared with no treatment. Both casirivimab-imdevimab (RR, 0.31; 95% CI, 0.20-0.50) and sotrovimab (RR, 0.60; 95% CI, 0.37-1.00) were associated with reduced hospitalization or death compared with no mAb treatment. In the clinical trial, 2454 patients were randomized to receive casirivimab-imdevimab and 1104 patients were randomized to receive sotrovimab. The median (IQR) hospital-free days were 28 (28-28) for both mAb treatments, the 28-day mortality rate was less than 1% (n = 12) for casirivimab-imdevimab and less than 1% (n = 7) for sotrovimab, and the hospitalization rate by day 28 was 12% (n = 291) for casirivimab-imdevimab and 13% (n = 140) for sotrovimab. Compared with patients who received casirivimab-imdevimab, those who received sotrovimab had a median adjusted OR for hospital-free days of 0.88 (95% credible interval, 0.70-1.11). This OR yielded 86% probability of inferiority for sotrovimab vs casirivimab-imdevimab and 79% probability of equivalence.

CONCLUSIONS AND RELEVANCE: In this propensity score-matched cohort study and randomized comparative effectiveness trial, the effectiveness of casirivimab-imdevimab and sotrovimab against the Delta variant was similar, although the prespecified criteria for statistical inferiority or equivalence were not met. Both mAb treatments were associated with a reduced risk of hospitalization or death in nonhospitalized patients with mild to moderate COVID-19 caused by the Delta variant.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04790786.

PMID:35834252 | DOI:10.1001/jamanetworkopen.2022.20957

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Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial

JAMA Netw Open. 2022 Jul 1;5(7):e2221699. doi: 10.1001/jamanetworkopen.2022.21699.

ABSTRACT

IMPORTANCE: Ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution seems to be efficacious and safe in treating acute otitis externa (AOE) compared with ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solution alone.

OBJECTIVE: To evaluate the superiority of ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution compared with ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solution alone in treating AOE.

DESIGN, SETTING, AND PARTICIPANTS: A phase 3 randomized, double-blind, active-controlled clinical trial was conducted between August 1, 2017, and September 14, 2018, at 36 centers in the US. The study population comprised 493 patients aged 6 months or older with AOE of less than 21 days’ duration with otorrhea, moderate or severe otalgia, and edema, as well as a Brighton grading of II or III (tympanic membrane obscure but without systemic illness). Statistical analysis was performed from November 14, 2018, to February 14, 2019.

INTERVENTIONS: Participants were randomly assigned to receive ciprofloxacin plus fluocinolone, ciprofloxacin, or fluocinolone twice daily for 7 days and were evaluated on day 1 (visit 1; baseline), days 3 to 4 (visit 2; conducted via telephone), days 8 to 10 (visit 3; end of treatment), and days 15 to 17 (visit 4; test of cure).

MAIN OUTCOMES AND MEASURES: The primary outcome was therapeutic cure (clinical and microbiological) at the end of the treatment period. The principal secondary end point was the time to end of ear pain. Efficacy analyses were conducted in the microbiological intent-to-treat population, clinical intent-to-treat population, and microbiological intent-to-treat population with Pseudomonas aeruginosa and Staphylococcus aureus.

RESULTS: A total of 493 patients (254 female patients [51.5%]; mean [SD] age, 38.2 [23.1] years) were randomized (197 to receive ciprofloxacin plus fluocinolone, 196 to receive ciprofloxacin, and 100 to receive fluocinolone). Therapeutic cure in the modified intent-to-treat population with ciprofloxacin plus fluocinolone (63 of 103 [61.2%]) was statistically comparable to that of ciprofloxacin (49 of 91 [53.8%]; difference in response rate, 7.3%; 95% CI, -6.6% to 21.2%; P = .30) and fluocinolone (20 of 45 [44.4%]; difference in response rate, 16.7%; 95% CI, -0.6% to 34.0%; P = .06) at visit 3 and significantly superior to ciprofloxacin at visit 4 (90 of 103 [87.4%] vs 69 of 91 [75.8%]; difference in response rate, 11.6%; 95% CI, 0.7%-22.4%; P = .04). A statistically faster resolution of otalgia was achieved among patients treated with ciprofloxacin plus fluocinolone (median, 5.0 days [range, 4.2-6.3 days]) vs ciprofloxacin (median, 5.9 days [range, 4.3-7.3 days]; 95% CI, 4.3-7.3 days; P = .002) or fluocinolone (median, 7.7 days [range, 6.7-9.0 days]; 95% CI, 6.7-9.0 days; P < .001). Ciprofloxacin plus fluocinolone demonstrated statistical superiority in sustained microbiological response vs ciprofloxacin (94 of 103 [91.3%] vs 74 of 91 [81.3%]; difference in response rate, 9.9%; 95% CI, 0.3%-19.6%; P = .04) and fluocinolone (34 of 45 [75.6%]; difference in response rate, 15.7%; 95% CI, 2.0%-29.4%; P = .01) and in the microbiological outcome vs fluocinolone by visit 3 (99 of 103 [96.1%] vs 37 of 45 [82.2%]; difference in response rate, 13.9%; 95% CI, 2.1%-25.7%; P = .01) and ciprofloxacin by visit 4 (97 of 103 [94.2%] vs 77 of 91 [84.6%]; difference in response rate, 9.6%; 95% CI, 0.9%-18.2%; P = .02). Fifteen adverse events related to study medications were registered, all of which were mild or moderate.

CONCLUSIONS AND RELEVANCE: Ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution was efficacious and safe in treating AOE but did not demonstrate superiority vs ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solutions alone in the main study end point of therapeutic cure.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03196973.

PMID:35834251 | DOI:10.1001/jamanetworkopen.2022.21699

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Exposure to other people’s gambling and gambling behaviors in Australian secondary school students

Psychol Addict Behav. 2022 Jul 14. doi: 10.1037/adb0000854. Online ahead of print.

ABSTRACT

OBJECTIVE: This study explored associations between exposure to other people’s gambling and the prevalence of gambling in the last month, engagement in hard gambling activities (defined as those which occur more frequently, with a quicker determination of outcomes, and/or high payout ratios), and the prevalence of at risk and problem gambling, among a large sample of Australian adolescent school students.

METHOD: In 2017, 6,377 students from Victoria and Queensland answered gambling questions as part of the cross-sectional triennial Australian Secondary Students’ Alcohol and Drug Survey. Students reported on gambling behaviors (gambling in the last month, types of gambling activities), were assessed for problem gambling using the Diagnostic Statistical Manual IV adapted for Juveniles (DSM-IV-[MR]-J), and reported whether people they knew (parents, siblings, other relatives, best friend, or someone else) had gambled in the last month. Logistic regressions explored the relationship between other people’s gambling and student gambling behaviors in the last month.

RESULTS: Approximately, one in five students reported that someone from their household gambled in the last month. Overall, 6% of students reported they had gambled, and 4% gambled on a hard gambling activity, in the previous month; 10% were classified as potentially at risk or problem gamblers. Having a parent, sibling, best friend, another relative, or someone else who gambled in the last month were each significantly associated with the three gambling outcomes.

CONCLUSIONS: There is a need to address the modeling of gambling behaviors by young people’s friends, family, and others, in order to reduce gambling behaviors and problem gambling among Australian adolescents. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:35834199 | DOI:10.1037/adb0000854

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Efficacy of Preoperative mFOLFIRINOX vs mFOLFIRINOX Plus Hypofractionated Radiotherapy for Borderline Resectable Adenocarcinoma of the Pancreas: The A021501 Phase 2 Randomized Clinical Trial

JAMA Oncol. 2022 Jul 14. doi: 10.1001/jamaoncol.2022.2319. Online ahead of print.

ABSTRACT

IMPORTANCE: National guidelines endorse treatment with neoadjuvant therapy for borderline resectable pancreatic ductal adenocarcinoma (PDAC), but the optimal strategy remains unclear.

OBJECTIVE: To compare treatment with neoadjuvant modified FOLFIRINOX (mFOLFIRINOX) with or without hypofractionated radiation therapy with historical data and establish standards for therapy in borderline resectable PDAC.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, multicenter, randomized phase 2 clinical trial conducted from February 2017 to January 2019 among member institutions of National Clinical Trials Network cooperative groups used standardized quality control measures and included 126 patients, of whom 70 (55.6%) were registered to arm 1 (systemic therapy; 54 randomized, 16 following closure of arm 2 at interim analysis) and 56 (44.4%) to arm 2 (systemic therapy and sequential hypofractionated radiotherapy; all randomized before closure). Data were analyzed by the Alliance Statistics and Data Management Center during September 2021.

INTERVENTIONS: Arm 1: 8 treatment cycles of mFOLFIRINOX (oxaliplatin, 85 mg/m2; irinotecan, 180 mg/m2; leucovorin, 400 mg/m2; and infusional fluorouracil, 2400 mg/m2) over 46 hours, administered every 2 weeks. Arm 2: 7 treatment cycles of mFOLFIRINOX followed by stereotactic body radiotherapy (33-40 Gy in 5 fractions) or hypofractionated image-guided radiotherapy (25 Gy in 5 fractions). Patients without disease progression underwent pancreatectomy, which was followed by 4 cycles of treatment with postoperative FOLFOX6 (oxaliplatin, 85 mg/m2; leucovorin, 400 mg/m2; bolus fluorouracil, 400 mg/m2; and infusional fluorouracil, 2400 mg/m2 over 46 hours).

MAIN OUTCOMES AND MEASURES: Each treatment arm’s 18-month overall survival (OS) rate was compared with a historical control rate of 50%. A planned interim analysis mandated closure of either arm for which 11 or fewer of the first 30 accrued patients underwent margin-negative (R0) resection.

RESULTS: Of 126 patients, 62 (49%) were women, and the median (range) age was 64 (37-83) years. Among the first 30 evaluable patients enrolled to each arm, 17 patients in arm 1 (57%) and 10 patients in arm 2 (33%) had undergone R0 resection, leading to closure of arm 2 but continuation to full enrollment in arm 1. The 18-month OS rate of evaluable patients was 66.7% (95% CI, 56.1%-79.4%) in arm 1 and 47.3% (95% CI 35.8%-62.5%) in arm 2. The median OS of evaluable patients in arm 1 and arm 2 was 29.8 (95% CI, 21.1-36.6) months and 17.1 (95% CI, 12.8-24.4) months, respectively.

CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that treatment with neoadjuvant mFOLFIRINOX alone was associated with favorable OS in patients with borderline resectable PDAC compared with mFOLFIRINOX treatment plus hypofractionated radiotherapy; thus, mFOLFIRINOX represents a reference regimen in this setting.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02839343.

PMID:35834226 | DOI:10.1001/jamaoncol.2022.2319

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The Economic Benefit of Remission for Patients with Rheumatoid Arthritis

Rheumatol Ther. 2022 Jul 14. doi: 10.1007/s40744-022-00473-6. Online ahead of print.

ABSTRACT

INTRODUCTION: In patients with rheumatoid arthritis (RA), attaining remission or low disease activity (LDA), as recommended by the treat-to-target approach, has shown to yield improvement in symptoms and quality of life. However, limited evidence from real-world settings is available to support the premise that better disease control is associated with lower healthcare costs. This study fills in evidence gaps regarding the cost of care by RA disease activity (DA) states and by therapy.

METHODS: This retrospective cohort study linked medical and prescription claims from Optum Clinformatics Data Mart to electronic health record data from Illumination Health over 1/1/2010-3/31/2020. Mean annual costs for payers and patients were examined, stratifying on DA state and baseline use of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologics, and targeted synthetic (ts)DMARDs. Subgroup analysis examining within-person change in costs pre- and post-initiation of new therapy was also performed. Descriptive statistics, means, and boot-strapped confidence intervals were analyzed by DA state and by RA therapy. Furthermore, multivariate negative binomial regression analysis adjusting for key baseline characteristics was conducted.

RESULTS: Of 2339 eligible patients, 19% were in remission, 40% in LDA, 29% in moderate DA (MDA), and 12% in high DA (HDA) at baseline. Mean annual costs during follow-up were substantially less for patients in remission ($40,072) versus those in MDA ($56,536) and HDA ($59,217). For patients in remission, csDMARD use was associated with the lowest mean annual cost ($25,575), tsDMARD was highest ($75,512), and tumor necrosis factor inhibitor (TNFi) ($69,846) and non-TNFi ($57,507) were intermediate. Among new TNFi (n = 137) and non-TNFi initiators (n = 107), 31% and 26% attained LDA/remission, respectively, and the time to achieve remission/LDA was numerically shorter in TNFi vs. non-TNFi initiators. For those on biologics, mean annual within-person medical and inpatient costs were lower after achieving LDA/remission, although pharmacy costs were higher.

CONCLUSIONS: Cost of care increased with increasing DA state, with patients in remission having the lowest costs. Optimizing DA has the potential for substantial savings in healthcare costs, although may be partially offset by the high cost of targeted RA therapies.

PMID:35834162 | DOI:10.1007/s40744-022-00473-6