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Nevin Manimala Statistics

Beyond 5-year survival. A report from the Cooperative Osteosarcoma Study Group (COSS)

Cancer Med. 2024 Jan;13(1):e6893. doi: 10.1002/cam4.6893.

ABSTRACT

PURPOSE: Prognostic factors have been well described for osteosarcoma, but analyses evaluating the further course of long-term survivors are lacking. We used the large database of the Cooperative Osteosarcoma Study Group (COSS) to perform such an analysis.

PATIENTS AND METHODS: The COSS database 1980-04/2019 was searched for 5-year survivors of primary high-grade central osteosarcoma of the extremities or trunk. Identified patients were analyzed for their further survival outcomes, assessing potentially prognostic and predictive factors already evident at initial disease presentation and treatment as well as their disease course during the first 5 years of follow-up.

RESULTS: Two thousand and nine former eligible patients were identified (median age at initial diagnosis 15.1 (2.5-63.0) years; male vs. female 1149 (57.2%) vs. 860 (42.8%); extremities vs. trunk 1927 (95.9%) vs. 82 (4.1%); extremity primaries <1/3 vs. ≥1/3 of the involved bone 997 (67.8%) vs. 474 (32.2%) (456 unknown); localized vs. primary metastatic 1881 (93.6%) vs. 128 (6.4%); osteosarcoma as a secondary malignancy 41/2009 (2.0%)). Therapy starting by chemotherapy versus primary surgery 1860 (92.6%) versus 149 (7.4%); definitive tumor surgery by limb salvage versus ablative 1347 (67.0%) versus 659 (1 no surgery, 2 unknown); tumor response to preoperative chemotherapy documented for 1765 (94.9%) patients receiving neoadjuvant chemotherapy, good (<10% viable tumor) versus poor 1130 (64.0%) versus 635 (36.0%), local radiotherapy documented for 19 (0.9%) tumors. Recurrence during preceding 5 years no versus yes 1681 (83.7%) versus 328 (16.3%). Median follow-up starting 5 years after initial diagnosis 6.1 (0.002-32.2) years; 1815 survivors and 194 deaths. Overall survival after another 5/10/15/20 years 91.7%/88.9%/85.8%/83.4% for all patients; 97.5%/95.2%/92.4%/89.9% if in remission years 1-5 versus 62.7%/57.3%/53.0%/51.2% if recurrence year 1-5 (p < 0.001). Significant predictors of survival for all patients age at diagnosis (p = 0.038), tumor site (p = 0.030), having experienced the osteosarcoma as secondary malignancy (p < 0.001), tumor response to preoperative chemotherapy (p = 0.002). Multivariate Cox regression testing possible for 1759 (87.6%) patients with complete dataset: Having had a recurrence in years 1-5 (p < 0.001), older age at diagnosis (p = 0.009), and osteosarcoma as secondary malignancy (p = 0.013) retained significance.

DISCUSSION: Highly important predictors of death such as the extent of tumor response to chemotherapy no longer remain valid after 5-year survival. The individual history of malignancies and their outcomes seems to gain pivotal importance.

CONCLUSION: This benchmark analysis clearly defined risk factors for the further course of 5-year survivors from osteosarcoma. It argues for large disease-oriented databases as well as for very long follow-up periods. Novel findings will most likely require innovative statistical models to analyze such cohorts.

PMID:39102672 | DOI:10.1002/cam4.6893

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Nevin Manimala Statistics

Help-Seeking Behaviors in a Community Experiencing Multiple, Concurrent Natural Disasters. Lessons from a Greater Houston Community

Issues Ment Health Nurs. 2024 Aug 5:1-8. doi: 10.1080/01612840.2024.2373257. Online ahead of print.

ABSTRACT

Previous disaster research exploring mental health consequences has been conducted after a single disaster. Community mental health nurses offer critical support in the aftermath of a disaster through complex assessments, psychosocial education and treatment. This research examines help-seeking behaviors in a Greater Houston community struggling with two simultaneous disasters, a historic winter freeze amidst the COVID-19 pandemic. Three Mental Health Crisis clinics, staffed by an interdisciplinary team, offered walk-in crisis services. The study characterizes adults who accessed services and describes those who accepted follow-up, subsidized behavioral health therapy or case management, including populations experiencing health disparities. Statistical analysis included descriptive and inferential statistics. Those who recognized the need for behavioral health care and accessed episodic care differed from those who accepted follow-up care. The population that was more likely to accept follow up care largely consisted of females, individuals without a previously existing mental health condition, those who reported trauma exposure, and young adults of Hispanic/Latino origin. Nurses can leverage female support to inspire male adults to seek care and advocate for increased resources and training to support culturally relevant care. Nurses and the interdisciplinary team need to assess for trauma exposure, as it influences care decisions.

PMID:39102666 | DOI:10.1080/01612840.2024.2373257

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Short and Long-term Effects of Cognitive Behavioral Therapy on Sleep Problems and Psychotic Symptoms in Patients with Psychotic Disorders: A Meta-Analysis Study

Braz J Psychiatry. 2024 Aug 5. doi: 10.47626/1516-4446-2024-3623. Online ahead of print.

ABSTRACT

OBJECTIVE: Sleep problems are common in patients with psychotic disorders, especially schizophrenia. Although pharmacological methods are at the forefront of treatment, this method has some drawbacks. Cognitive behavioral therapy for insomnia (CBT-I) is an option for the treatment of individuals with insomnia. In recent years, there has been an increasing interest in its use in patients with psychotic disorders. This meta-analysis aims to evaluate the effectiveness of CBT-I on sleep problems in patients with psychotic disorders.

METHODS: A systematic search was conducted using PubMed, Scopus, and EBSCO (MEDLINE) databases to identify relevant studies. The study included RCTs and uncontrolled studies that focused on participants diagnosed with schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorders, or unipolar depression with psychotic features, who had sleep problems for at least one month, and who were receiving treatment. The initial search yielded 246 studies, and eight studies were selected for the meta-analysis after screening and applying inclusion and exclusion criteria.The statistical analysis was conducted using the R software.

RESULTS: CBT-I significantly ameliorates insomnia and sleep quality in patients with psychotic disorders during short and long-term periods. In addition to this, CBT-I leads to a significant improvement in psychotic symptoms in the short-term period and contributes significantly to the improvement in mental well-being in both short and long-term periods.

CONCLUSIONS: CBT-I is an effective and valuable method for sleep problems in patients with psychotic disorders and its use is recommended to be widespread.

PMID:39102660 | DOI:10.47626/1516-4446-2024-3623

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Does outcome expectancy predict outcomes in online depression prevention? Secondary analysis of randomised-controlled trials

Health Expect. 2024 Feb;27(1):e13951. doi: 10.1111/hex.13951.

ABSTRACT

BACKGROUND: Evidence shows that online interventions could prevent depression. However, to improve the effectiveness of preventive online interventions in individuals with subthreshold depression, it is worthwhile to study factors influencing intervention outcomes. Outcome expectancy has been shown to predict treatment outcomes in psychotherapy for depression. However, little is known about whether this also applies to depression prevention. The aim of this study was to investigate the role of participants’ outcome expectancy in an online depression prevention intervention.

METHODS: A secondary data analysis was conducted using data from two randomised-controlled trials (N = 304). Multilevel modelling was used to explore the effect of outcome expectancy on depressive symptoms and close-to-symptom-free status postintervention (6-7 weeks) and at follow-up (3-6 months). In a subsample (n = 102), Cox regression was applied to assess the effect on depression onset within 12 months. Explorative analyses included baseline characteristics as possible moderators. Outcome expectancy did not predict posttreatment outcomes or the onset of depression.

RESULTS: Small effects were observed at follow-up for depressive symptoms (β = -.39, 95% confidence interval [CI]: [-0.75, -0.03], p = .032, padjusted = .130) and close-to-symptom-free status (relative risk = 1.06, 95% CI: [1.01, 1.11], p = .013, padjusted = 0.064), but statistical significance was not maintained when controlling for multiple testing. Moderator analyses indicated that expectancy could be more influential for females and individuals with higher initial symptom severity.

CONCLUSION: More thoroughly designed, predictive studies targeting outcome expectancy are necessary to assess the full impact of the construct for effective depression prevention.

PATIENT OR PUBLIC CONTRIBUTION: This secondary analysis did not involve patients, service users, care-givers, people with lived experience or members of the public. However, the findings incorporate the expectations of participants using the preventive online intervention, and these exploratory findings may inform the future involvement of participants in the design of indicated depression prevention interventions for adults.

CLINICAL TRIAL REGISTRATION: Original studies: DRKS00004709, DRKS00005973; secondary analysis: osf.io/9xj6a.

PMID:39102655 | DOI:10.1111/hex.13951

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Improving Access to Hereditary Testing in Pancreatic Ductal Carcinoma

JCO Precis Oncol. 2024 Aug;8:e2400167. doi: 10.1200/PO.24.00167.

ABSTRACT

PURPOSE: Approximately 5%-10% of patients with pancreatic ductal adenocarcinoma (PDAC) have an inherited basis, yet uptake of genetic testing remains low and subject to disparities. This study compared two genetic testing pathways available to patients referred to a provincial cancer center, BC Cancer: a traditional hereditary cancer clinic-initiated testing (HCT) pathway and a new oncology clinic-initiated testing (OCT) pathway.

METHODS: Study subjects were patients with confirmed PDAC referred for genetic testing through the HCT or OCT pathway between June 1, 2020, and February 1, 2022. Charts were retrospectively reviewed for patient characteristics and testing outcomes.

RESULTS: The study population was 397 patients (HCT, n = 279 and OCT, n = 118). OCT patients were more likely to have non-European ethnicity compared with HCT patients (41.9% v 25.6%, P = .004), to have earlier-stage disease (P = .012), and to have better Eastern Cooperative Oncology Group performance status than the HCT group (P = .001). A total of 306 patients completed testing (77%). OCT patients had higher test completion rates than HCT patients (odds ratio, 3.74 [95% CI, 1.66 to 9.62]). Median time for results was shorter in OCT than in HCT (53 days [IQR, 44-76] v 107 days [IQR, 63.8-158.3]). Pancreatic cancer susceptibility pathogenic gene variants were identified in 8.5% (26/306).

CONCLUSION: The real-world observations in our study show that oncology clinic-initiated hereditary testing is more effective and faster than testing through hereditary cancer clinic referrals and reaches a more ethnically diverse population. This has important implications for publicly funded environments with limited resources for genetic counseling.

PMID:39102633 | DOI:10.1200/PO.24.00167

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Bevacizumab Erlotinib Switch Maintenance in Chemo-Responsive Advanced Gallbladder and Cholangiocarcinoma (BEER BTC): A Multicenter, Open-Label, Randomized, Phase II Trial

J Clin Oncol. 2024 Aug 5:JCO2302420. doi: 10.1200/JCO.23.02420. Online ahead of print.

ABSTRACT

PURPOSE: Patients with chemotherapy-responsive advanced biliary tract cancers (BTCs) are usually observed after 6 months of gemcitabine-based therapy. There is limited prospective evidence for maintenance strategies after chemotherapy.

METHODS: This investigator-initiated, open-label, randomized, integrated phase II-III study enrolled adult patients with advanced BTC from two cancer centers in India. Patients with histologically confirmed advanced biliary tract adenocarcinoma who had at least disease stabilization after 6 months of gemcitabine-based chemotherapy were randomly assigned (1:1) to either active surveillance or switch maintenance, which was a combination of bevacizumab 5 mg/kg intravenous once every 21 days plus erlotinib 100 mg once daily. Both arms were continued until disease progression, unacceptable toxicity, or patient decision to withdraw. The primary end point of the phase II component of the trial was investigator-evaluated progression-free survival. This trial is registered with Clinical Trials Registry of India (CTRI/2019/05/019323I).

RESULTS: From May 2021 to November 2022, 98 patients were randomly assigned to active surveillance (n = 49) or bevacizumab-erlotinib (n = 49). A majority of patients had gallbladder cancer (80%). The median follow-up was 13.4 months. The median progression-free survival was 3.1 months (95% CI, 2.47 to 3.64) in the active surveillance group versus 5.3 months (95% CI, 3.53 to 7.04) in the bevacizumab-erlotinib group (hazard ratio, 0.51 [95% CI, 0.33 to 0·74]; P = .0013). The most common grade 3 class-specific adverse events associated with bevacizumab-erlotinib were acneiform rash 1 (2%) and oral stomatitis 1 (2%) with erlotinib and bleeding 1 (2%) with bevacizumab.

CONCLUSION: The combination of bevacizumab and erlotinib as switch maintenance improves progression-free survival with an acceptable safety profile compared with active surveillance in patients with advanced BTCs in this phase II study. The trial moves on to the phase III component to evaluate improvement in overall survival.

PMID:39102628 | DOI:10.1200/JCO.23.02420

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Unlocking the benefits of montessori-based reading activities in nursing home: A multiple baseline study on groups of individuals with severe dementia

Dementia (London). 2024 Aug 5:14713012241270805. doi: 10.1177/14713012241270805. Online ahead of print.

ABSTRACT

OBJECTIVE: Group activities are commonly offered to residents of nursing homes, and increasingly with a person-centred care approach. The aim of this study is to compare the impacts of a Montessori-based reading activity with a more traditional reading activity.

METHOD: A multiple baseline design was used, with 3 groups of 5 older adults with moderate to severe dementia. All sessions were videorecorded and analysed by independent judges, blinded to our hypotheses and conditions. Impacts of the type of activity (storytelling or Montessori-based reading) on verbal interactions, engagement level, affect and behavioural aspects were estimated with both visual analyses and statistical analyses using the between-case standardised mean differences method.

RESULTS: Significant differences were found in favour of the Montessori-based activities with regard to the number of verbal interactions, constructive and passive engagement and positive affect expressed, with moderate to large effect size (from 0.46 to 1.66).

CONCLUSION: The Montessori-based reading group activity really seems to be preferable to a more traditional storytelling activity, with multiple benefits for residents. Depending on the preserved abilities and interests of the participants, it can also be aimed at people with severe dementia.

PMID:39102610 | DOI:10.1177/14713012241270805

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Trauma Activation Fees Vary Widely Across US Trauma Centers

Health Aff (Millwood). 2024 Aug;43(8):1180-1189. doi: 10.1377/hlthaff.2023.00933.

ABSTRACT

Trauma activation fees are intended to help trauma centers cover the costs of providing lifesaving care at all times, but they have fallen under greater scrutiny because of a lack of regulation and wide variability in charges. We leveraged the federal Hospital Price Transparency rule to systematically describe trauma activation fees as captured in the Turquoise Health database for all Level I-III trauma centers nationally and across payer types. As of April 18, 2023, a total of 38 percent of US trauma centers published trauma activation fees. These fees varied widely by payer type. The minimum fee charged was $40 (for a Medicaid contract); the maximum fees charged were $28,356 (self-pay) and $28,893 (commercial payers). Trauma centers that were larger, metropolitan, located in the West, and associated with proprietary (investor-owned, for-profit) hospitals had higher trauma activation fees. Proprietary hospitals posted fees that were 60 percent higher than those published by public, nonfederal hospitals. Unmerited variation in trauma activation fees may suggest that the current funding strategy is equitable neither for trauma centers nor for the severely injured patients who rely on them for lifesaving care.

PMID:39102607 | DOI:10.1377/hlthaff.2023.00933

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Biosimilar Uptake In The US: Patient And Prescriber Factors

Health Aff (Millwood). 2024 Aug;43(8):1159-1164. doi: 10.1377/hlthaff.2023.01215.

ABSTRACT

Among 196,766 commercially insured and Medicare Advantage patients who newly initiated biologic drugs with available biosimilar versions, biosimilar initiation increased from 1 percent in 2013 to 34 percent in 2022. Patients were less likely to initiate biosimilars if they were younger than age eighteen or the drug was prescribed by a specialist or administered in a hospital outpatient facility.

PMID:39102605 | DOI:10.1377/hlthaff.2023.01215

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Most State Medicaid Programs Cover Routine Eye Exams For Adults, But Coverage Of Other Routine Vision Services Varies

Health Aff (Millwood). 2024 Aug;43(8):1073-1081. doi: 10.1377/hlthaff.2023.00873.

ABSTRACT

More than twelve million US adults ages forty and older are affected by vision impairment, and projections suggest that this number will double by 2050. Although most vision impairment can be eliminated with corrective lenses, many adults lack access to routine eye care. In this study, we analyzed detailed state-by-state Medicaid policies for 2022 and documented variability in coverage for adult vision services. Most fee-for-service Medicaid programs covered routine eye exams, although many did not cover glasses (twenty states) or low vision aids (thirty-five states), and about two-thirds of states with routine coverage required enrollee cost sharing. Managed care plans generally provided consistent or enhanced coverage relative to fee-for-service programs, although coverage sometimes varied between plans within a state. We estimated that about 6.5 million and 14.6 million adult enrollees resided in states without comprehensive coverage for routine eye exams and glasses, respectively. These findings reveal important gaps and opportunities for states to increase access to routine vision care.

PMID:39102604 | DOI:10.1377/hlthaff.2023.00873