Smoking cessation services and shared decision-making practices among lung cancer screening facilities: A cross-sectional study.

BACKGROUND: Little is known about how screening facilities are meeting the requirements for the reimbursement of lung cancer screening from the Centers for Medicare & Medicaid Services (CMS), including 1) the collection and submission of data to the CMS-approved registry (American College of Radiology [ACR] Lung Cancer Screening Registry), 2) the verification of a counseling and shared decision-making (SDM) visit having occurred as part of the written order for lung cancer screening with low-dose computed tomography, and 3) the offering of smoking cessation interventions. METHODS: The authors identified facilities in a southwestern state that were listed by either the ACR Lung Cancer Screening Registry or the GO2 Foundation Centers of Excellence. To select facilities, they used 2 purposive sampling approaches: maximum variation sampling and snowball sampling. They surveyed facilities from February to November 2019. RESULTS: There were 87 facilities contacted, and a total of 63 facilities representing 32 counties across Texas completed the survey. Nearly all facilities used Lung-RADS to classify nodules (92%; n = 58) and submitted data to a CMS-approved registry (92%; n = 57). Most facilities verified that the counseling and SDM visit had occurred (86%; n = 54). Although slightly more than half of the facilities reported always providing self-help cessation materials (68%; n = 42), similar or higher proportions of facilities reported that they never referred smokers to onsite cessation services (68%; n = 42) or quitlines (77%; n = 47), provided cessation counseling (81%; n = 50), or recommended medications (85%; n = 52). CONCLUSIONS: In general, screening facilities are meeting CMS requirements for screening, but they are struggling to offer smoking cessation interventions other than providing self-help materials.

The utility of erythrocyte sedimentation rate, C-reactive protein, and procalcitonin in detecting infections in patients with systemic lupus erythematosus: A systematic review.

OBJECTIVES: We conducted a systematic review with metanalysis to investigate the utility of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and procalcitonin (PCT) in diagnosing infections in hospitalized patients with SLE. METHODS: We searched Medline, Embase, Web of Science, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials (CENTRAL) with a search strategy developed by a medical librarian. We included retrospective, cross-sectional, case-control, and prospective studies in our analysis. We used the Quality Assessment of Diagnostic Studies (QUADAS-2) to assess for bias and applicability. We obtained mean differences, sensitivities, and specificities in our analysis. RESULTS: We included 26 studies in our analysis. Most studies had an unclear or high risk of bias and our results were widely heterogenous. For the diagnosis of infections, the CRP had a pooled sensitivity of 0.75 (95%CI 0.57-0.94) and specificity of 0.72 (0.59-0.85), PCT had a pooled sensitivity of 0.68 (95% CI 0.0.59-0.77) and specificity of 0.75 (0.59-0.90), and for ESR pooled estimates were not calculated but sensitivity ranged from 50 to 69.8 and specificity from 38.5 to 55.6. Modifying cut-offs improved sensitivities and specificities. The ESR, CRP, and PCT mean differences were all greater in infection groups versus non-infection (10.1, 95% CI 3.2-17.0; 46.8, 95% CI 36.5-57.0; 0.53, 95% CI 0.26-0.80; respectively). DISCUSSION: Poor sensitivities and specificities were observed for the evaluated biomarkers with substantial heterogeneity in the cut-offs used to determine infection. Although mean biomarker values were increased in the infection group compared with the non-infection, our findings do not support the widespread use of ESR, CRP, or PCT in diagnosing infection in hospitalized patients with SLE due to increased heterogeneity and risk of bias. Further investigation is needed.

All-cause mortality in cancer patients treated for sepsis in intensive care units: a systematic review and meta-analysis.

PURPOSE: Sepsis is a common complication in patients with cancer, but studies evaluating the outcomes of critically ill cancer patients with sepsis on a global scale are limited. We aimed to summarize the existing evidence on mortality rates in this patient population. METHODS: Prospective and retrospective observational studies evaluating critically ill adult cancer patients with sepsis, severe sepsis, and/or septic shock were included. Studies published from January 2010 to September 2021 that reported at least one mortality outcome were retrieved from MEDLINE (Ovid), Embase (Ovid), and Cochrane databases. Study selection, bias assessment, and data collection were performed independently by two reviewers, and any discrepancies were resolved by a third reviewer. The risk of bias was assessed using the Newcastle-Ottawa scale. We calculated pooled intensive care unit (ICU), hospital, and 28/30-day mortality rates. The heterogeneity of the data was tested using the chi-square test, with a P value < 0.10 indicating significant heterogeneity. RESULTS: A total of 5464 citations were reviewed, of which 10 studies met the inclusion criteria; these studies included 6605 patients. All studies had a Newcastle-Ottawa scale score of 7 or higher. The mean patient age ranged from 51.4 to 64.9 years. The pooled ICU, hospital, and 28/30 day mortality rates were 48% (95% CI, 43- 53%; I2 = 80.6%), 62% (95% CI, 58-67%; I2 = 0%), and 50% (95% CI, 38- 62%; I2 = 98%), respectively. Substantial between-study heterogeneity was observed. CONCLUSION: Critically ill cancer patients with sepsis had poor survival, with a hospital mortality rate of about two-thirds. The substantial observed heterogeneity among studies could be attributed to variability in the criteria used to define sepsis as well as variability in treatment, the severity of illness, and care across settings. Our results are a call to action to identify strategies that improve outcomes for cancer patients with sepsis.

Preferred Strategies for Delivering Health Information to Patients With Musculoskeletal Disorders: A Qualitative Study.

BACKGROUND: Patients' information needs may differ from what their care providers may perceive to be the patients' needs. This discordance needs to be recognized and addressed. OBJECTIVE: We conducted a qualitative study to explore the perceptions of patients with selected musculoskeletal disorders and those of rheumatologists, on their preferred strategies for delivery of disease management information. METHODS: Fifty-two patients diagnosed with either rheumatoid arthritis, knee osteoarthritis, or osteoporosis took part in 6 focus groups and 18 individual semistructured interviews. In addition, 11 rheumatologists participated in 2 focus groups and 4 semistructured individual interviews. Data were explored by thematic content analysis. Perceived preferences were identified and compared between patients and rheumatologists regarding (a) media, (b) setting, (c) messengers, and (d) key message content. RESULTS: Patients' preferred media for disease management information were electronic (television and videos delivered as digital optical discs or the Internet), group instruction, and printed material. Patients preferred the information to be delivered in the setting of their homes, doctor's offices, or clinic waiting areas by the rheumatologists and patients with disease experience, addressing healthy lifestyle changes, medication adherence, and consequences of noncompliance. For rheumatologists, the perceived preference for information delivery was through printed material (brochures, booklets, and pamphlets) delivered in waiting areas by nurses and physicians, addressing nature of the disease, complications, and treatment adverse effects. CONCLUSIONS: Provider perspectives on strategies for education may differ from those of patients. Our findings highlight the need for considering different stakeholder perspectives in designing educational tools and decision support materials for patients with chronic diseases. TAKEHOME MESSAGE: Rheumatologists' preferences on strategies for education (mode of delivery, delivery setting, messengers, and topics) differ from those of patients. For example, patients want to learn about lifestyle changes and consequences of compliance versus noncompliance, whereas rheumatologists considered more important for patients to understand their disease, treatment adverse effects, and consequences of noncompliance.

Clinical management among individuals with variant of uncertain significance in hereditary cancer: A systematic review and meta-analysis.

Improper medical use of variant of uncertain significance (VUS) remains a concern in hereditary cancer genetic testing. The goal of this study was to assess the association between pathogenic and likely pathogenic (P/LP), VUS, and benign and likely benign (B/LB) genetic test results and cancer-related surgical and screening management. Systematic searches of Medline, Embase, EBSCO CINAHL Plus, and PsycINFO were conducted from 1946 to August 26, 2020. Eligible studies included individuals with cancer genetic test result and surgical or screening management outcomes. We reviewed 885 abstracts and 22 studies that reported relevant surgical and screening outcomes were included. Meta-analysis revealed significantly higher surgical rates among individuals with P/LP than among those with VUS for therapeutic mastectomy with contralateral prophylactic mastectomy (OR = 7.35, 95% CI, 4.14-13.64), prophylactic mastectomy (OR = 3.05, 95% CI, 1.5-6.19), and oophorectomy (OR = 6.46, 95% CI, 3.64-11.44). There were no significant differences in therapeutic mastectomy, or breast conservation or lumpectomy rates between individuals with P/LP and VUS, or in any outcomes between patients with VUS and B/LB. Studies evaluating screening outcomes were limited, and results were conflicting. Comprehensive analysis do not indicate that a significant number of individuals with VUS results undergo inappropriate clinical management.

Clinical Practice Guidelines and Consensus Statements About Pain Management in Critically Ill End-of-Life Patients: A Systematic Review.

OBJECTIVES: To identify and synthesize available recommendations from scientific societies and experts on pain management at the end-of-life in the ICU. DATA SOURCES: We conducted a systematic review of PubMed, EMBASE, the Cochrane Database of Systematic Reviews, and Biblioteca Virtual en Salud from their inception until March 28, 2019. STUDY SELECTION: We included all clinical practice guidelines, consensus statements, and benchmarks for quality. DATA EXTRACTION: Study selection, methodological quality, and data extraction were performed independently by two investigators. A quality assessment was performed by four investigators using the Appraisal of Guidelines for Research and Evaluation II instrument. The recommendations were then synthesized and categorized. DATA SYNTHESIS: Ten publications were included. The Appraisal of Guidelines for Research and Evaluation II statement showed low scores in various quality domains, especially in the applicability and rigor of development. Most documents were in agreement on five topics: 1) using a quantitative tool for pain assessment; 2) administering narcotics for pain relief and benzodiazepines for anxiety relief; 3) against prescribing neuromuscular blockers during withdrawal of life support to assess pain; 4) endorsing the use of high doses of opioids and sedatives for pain control, regardless of the risk that they will hasten death; and 5) using quality indicators to improve pain management during end-of-life in the ICU. CONCLUSIONS: In spite of the lack of high-quality evidence, recommendations for pain management at the end-of-life in the ICU are homogeneous and are justified by ethical principles and agreement among experts. Considering the growing demand for the involvement of palliative care teams in the management of the dying patients in the ICU, there is a need to clearly define their early involvement and to further develop comprehensive evidence-based pain management strategies. Based on the study findings, we propose a management algorithm to improve the overall care of dying critically ill patients.

Financial Burdens of Cancer Treatment: A Systematic Review of Risk Factors and Outcomes.

BACKGROUND: Patients with cancer experience financial toxicity from the costs of treatment, as well as material and psychologic stress related to this burden. A synthesized understanding of predictors and outcomes of the financial burdens associated with cancer care is needed to underpin strategic responses in oncology care. This study systematically reviewed risk factors and outcomes associated with financial burdens related to cancer treatment. METHODS: MEDLINE, Embase, PubMed, PsychINFO, and the Cochrane Library were searched from study inception through June 2018, and reference lists were scanned from studies of patient-level predictors and outcomes of financial burdens in US patients with cancer (aged ≥18 years). Two reviewers conducted screening, abstraction, and quality assessment. Variables associated with financial burdens were synthesized. When possible, pooled estimates of associations were calculated using random-effects models. RESULTS: A total of 74 observational studies of financial burdens in 598,751 patients with cancer were identified, among which 49% of patients reported material or psychologic financial burdens (95% CI, 41%-56%). Socioeconomic predictors of worse financial burdens with treatment were lack of health insurance, lower income, unemployment, and younger age at cancer diagnosis. Compared with patients with health insurance, those who were uninsured demonstrated twice the odds of financial burdens (pooled odds ratio [OR], 2.09; 95% CI, 1.33-3.30). Financial burdens were most severe early in cancer treatment, did not differ by disease site, and were associated with worse health-related quality of life (HRQoL) and nearly twice the odds of cancer medication nonadherence (pooled OR, 1.70; 95% CI, 1.13-2.56). Only a single study demonstrated an association with increased mortality. Studies assessing the comparative effectiveness of interventions to mitigate financial burdens in patients with cancer were lacking. CONCLUSIONS: Evidence showed that financial burdens are common, disproportionately impacting younger and socioeconomically disadvantaged patients with cancer, across disease sites, and are associated with worse treatment adherence and HRQoL. Available evidence helped identify vulnerable patients needing oncology provider engagement and response, but evidence is critically needed on the effectiveness of interventions designed to mitigate financial burden and impact.

Anesthetic technique and cancer outcomes: a meta-analysis of total intravenous versus volatile anesthesia.

PURPOSE: Cancer-related mortality, a leading cause of death worldwide, is often the result of metastatic disease recurrence. Anesthetic techniques have varying effects on innate and cellular immunity, activation of adrenergic-inflammatory pathways, and activation of cancer-promoting cellular signaling pathways; these effects may translate into an influence of anesthetic technique on long-term cancer outcomes. To further analyze the effects of propofol (intravenous) and volatile (inhalational gas) anesthesia on cancer recurrence and survival, we undertook a systematic review with meta-analysis. SOURCE: Databases were searched up to 14 November 2018. Comparative studies examining the effect of inhalational volatile anesthesia and propofol-based total intravenous anesthesia (TIVA) on cancer outcomes were included. The Newcastle Ottawa Scale (NOS) was used to assess methodological quality and bias. Reported hazard ratios (HRs) were pooled and 95% confidence intervals (CIs) calculated. PRINCIPAL FINDINGS: Ten studies were included; six studies examined the effect of anesthetic agent type on recurrence-free survival following breast, esophageal, and non-small cell lung cancer (n = 7,866). The use of TIVA was associated with improved recurrence-free survival in all cancer types (pooled HR, 0.78; 95% CI, 0.65 to 0.94; P < 0.01). Eight studies (n = 18,778) explored the effect of anesthetic agent type on overall survival, with TIVA use associated with improved overall survival (pooled HR, 0.76; 95% CI, 0.63 to 0.92; P < 0.01). CONCLUSION: This meta-analysis suggests that propofol-TIVA use may be associated with improved recurrence-free survival and overall survival in patients having cancer surgery. This is especially evident where major cancer surgery was undertaken. Nevertheless, given the inherent limitations of studies included in this meta-analysis these findings necessitate prospective randomized trials to guide clinical practice. TRIAL REGISTRATION: PROSPERO (CRD42018081478); registered 8 October, 2018.

RéSUMé: OBJECTIF: La mortalité liée au cancer, une cause majeure de décès dans le monde entier, est bien souvent le résultat de la récurrence de la maladie métastatique. Les techniques anesthésiques ont des effets variés sur l'immunité naturelle et cellulaire, l'activation des voies adrénergiques inflammatoires, et l'activation des voies de signalisation cellulaire promouvant le cancer; ces effets pourraient se traduire dans une influence de la technique anesthésique sur les pronostics de cancer à long terme. Afin d'approfondir l'analyse des effets de l'anesthésie au propofol (voie intraveineuse) et par inhalation (gaz) sur la récurrence du cancer et la survie, nous avons entrepris une revue systématique avec méta-analyse. SOURCE: Nous avons réalisé des recherches dans les bases de données jusqu'au 14 novembre 2018. Les études comparatives examinant l'effet d'une anesthésie par inhalation et d'une anesthésie intraveineuse totale (TIVA) avec propofol sur les pronostics de cancer ont été incluses dans notre revue. L'échelle de Newcastle-Ottawa (NOS) a été utilisée pour évaluer la qualité méthodologique et le biais. Les rapports de risque (RR) rapportés ont été pondérés et les intervalles de confiance (IC) à 95 % calculés. CONSTATATIONS PRINCIPALES: Dix études ont été incluses; six études ont examiné l'effet du type d'agent anesthésique sur la survie sans récurrence après un cancer du sein, de l'œsophage et du cancer pulmonaire non à petites cellules (n = 7866). L'utilisation d'une TIVA était associée à une amélioration de la survie sans récurrence, tous types de cancer confondus (RR pondéré, 0,78; IC 95 %, 0,65 à 0,94; P < 0,01). Huit études (n = 18 778) ont exploré l'effet du type d'agent anesthésique sur la survie globale, l'utilisation d'une TIVA étant alors associée à une amélioration de la survie globale (RR pondéré, 0,76; IC 95 %, 0,63 à 0,92; P < 0,01). CONCLUSION: Cette méta-analyse suggère que l'administration d'une TIVA à base de propofol pourrait être associée à une amélioration de la survie sans récurrence et de la survie globale chez les patients subissant une chirurgie oncologique. Cette observation est particulièrement frappante dans les cas de chirurgie oncologique majeure. Toutefois, étant donné les lacunes inhérentes des études incluses dans cette méta-analyse, ces résultats nécessitent la réalisation d'études randomisées prospectives afin d'éclairer la pratique clinique. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42018081478); enregistrée le 8 octobre 2018.

Correction to: Anesthetic technique and cancer outcomes: a meta-analysis of total intravenous versus volatile anesthesia.

There was an isolated error relating to the Oh et al. study (1) within our recurrence-free survival analysis. When the reported estimates for Oh et al. are corrected, the pooled hazard ratio (HR) is now 0.87; 95% confidence interval (CI), 0.66 to 1.15; P=0.32.

Use of Immune Checkpoint Inhibitors in the Treatment of Patients With Cancer and Preexisting Autoimmune Disease: A Systematic Review.

Background: Cancer immunotherapy with checkpoint inhibitors (CPIs) is associated with frequent immune-related adverse events (irAEs) and is often not recommended for patients with concomitant autoimmune disease. Purpose: To summarize the evidence on adverse events associated with CPIs in patients with cancer and preexisting autoimmune disease. Data Sources: MEDLINE, EMBASE, Web of Science, PubMed ePubs, and the Cochrane Central Register of Controlled Trials through September 2017 with no language restrictions. Study Selection: Original case reports, case series, and observational studies describing patients with cancer and autoimmune disease who were receiving CPIs. Data Extraction: 2 reviewers independently extracted data and assessed the quality of reporting. Data Synthesis: 123 patients in 49 publications were identified; 92 (75%) had exacerbation of preexisting autoimmune disease, irAEs, or both. No differences in adverse events were observed in patients with active versus inactive disease. Patients receiving immunosuppressive therapy at initiation of CPI therapy seemed to have fewer adverse events than those not receiving treatment. Most flares and irAEs were managed with corticosteroids; 16% required other immunosuppressive therapies. Adverse events improved in more than half of patients without discontinuation of CPI therapy. Three patients died of adverse events. Limitations: The quality and quantity of data were limited. Case reports typically describe unique manifestations and are not generalizable to the population at large. Because there were no prospective observational studies, incidence could not be determined. Conclusion: Flares and irAEs in patients with autoimmune disease who are receiving CPIs can often be managed without discontinuing therapy, although some events may be severe and fatal. Prospective longitudinal studies are needed to establish incidence of adverse events and evaluate risk-benefit ratios and patient preferences in this population. Primary Funding Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Direct-Acting Antiviral Agents for Patients With Hepatitis C Virus Genotype 1 Infection Are Cost-Saving.

BACKGROUND & AIMS: Direct-acting antivirals (DAAs) are effective in treatment of hepatitis C virus (HCV) genotype 1 infection, but their cost and value have been debated. We performed a systematic review of published cost-effectiveness analyses of DAAs, synthesized their results with updated drug prices, and calculated the maximum price at which DAA therapy for HCV genotype 1 infection is cost-effective (increased quality-adjusted life-years [QALYs] and increased cost that the society is willing to pay) and cost-saving (increased QALYs and decreased costs). METHODS: We conducted a systematic review of the PubMed, Medline, EMBASE, Cochrane library, EconLit, Database of Abstracts of Reviews of Effects, National Health Service Economic Evaluation Database, Health Technology Assessment, and Tufts University databases for cost-effectiveness analyses published from 2011 through 2015. Our analysis included cost effectiveness of DAAs versus previous standard-of-care regimens (peginterferon and ribavirin, boceprevir and telaprevir), or no treatment, performed for patients with HCV genotype 1 infection. We excluded studies that were not written in English or those that did not report QALYs. Reported incremental cost-effectiveness ratios (ICERs) and treatment costs for each comparison were extracted; the threshold price was estimated for each analysis in which regimens were found to be cost-effective (ICER ≤$100,000/QALY) or cost-saving (ICER <$0), those that decreased costs and increased QALYs. RESULTS: We identified 24 cost-effectiveness studies that reported 170 ICERs for combinations of 11 drugs, from 11 countries. Of those, 81 ICERs were determined for first-generation DAAs (boceprevir and telaprevir) and 89 ICERs were determined for second-generation DAAs (drugs approved after the first-generation DAAs) as a primary intervention. The median threshold prices at which first-generation and second-generation DAAs became cost-effective were estimated as $120,100 (interquartile range, $90,700-$176,800) and $227,200 (interquartile range, $142,800-$355,800), respectively. At the discounted price of $60,000, a total of 71% of the analyses found second-generation DAAs to be cost-saving and 22% to be cost-effective. CONCLUSIONS: In a systematic review, we found treatment of HCV genotype 1 infection with second-generation DAAs to be cost-effective when they cost less than and $227,200; these drugs produced cost savings at current discounts.

Online Educational Tool to Promote Bone Health in Cancer Survivors.

Osteoporosis burden is significant in cancer survivors. Websites providing health information abound, but their development, quality, and source of information remain unclear. Our aim was to use a systematic and transparent approach to create an educational website on bone health, and to evaluate its potential to improve knowledge, self-management, and awareness in prostate cancer (PCa) and breast cancer (BCa) survivors. Guided by the Health Belief Model, we created a website using international standards and evaluated it in 10 PCa and 10 BCa survivors with self-administered questionnaire before, after, and 1 month after navigating the website. The mean scores on the knowledge questionnaire at baseline, postintervention and 1 month were, respectively, 5.1 (±2.0), 6.9 (±2.5), and 6.7 (±2.4), p < .008, in PCa and 3.4 (±2.7), 7.6 (±3.0), and 6.5 (±3.8), p  = .016, in BCa survivors. Acceptability ratings ranged from 60% to 100%. Participants found the website useful, helpful, and able to raise bone health awareness. Our website improved bone health knowledge in both PCa and BCa survivors. A systematic and transparent approach to the development of online educational websites could result in a tool capable of meeting the educational needs of targeted consumers. Cancer survivors could benefit from proven online educational tools.

Use of medication reminders in patients with rheumatoid arthritis.

Patients with rheumatoid arthritis (RA) often have difficulties adhering to their medical treatment plans. We determined the characteristics of patients with RA who used reminders and the association between reminders and adherence. A total of 201 patients with RA were asked the frequency of reminders use such as pill containers, calendars, or diaries. Patients completed self-reported adherence questionnaires, and their disease activity and functional ability were measured. Sixty-eight patients (34 %) reported using a reminder. Factors associated with reminder use were older age (yes-mean age 54 vs no-mean age 49, p = 0.004), race (Whites-54 % vs Blacks-30 % vs Hispanics-26 %, p = 0.003), and sex (males-50 % vs females 28 %, p = 0.005). Working patients were less likely to use reminders (employed-21 % vs unemployed-43 %, p = 0.006). Use of calendars was associated with adherence while away from home (ρ = 0.16, p = 0.03), when busy (ρ = 0.16, p = 0.03), and use of any reminder was associated with adherence when running out of pills (ρ = 0.15, p = 0.04). The use of calendar reminders was associated with fewer tender joints (ρ = -0.17, p = 0.02). Few patients with RA used reminders, and whites, males and patients of increasing age were most likely to use reminders. Our findings show that reminders can assist patients with RA in taking medications, particularly when they are most prone to forgetting, such as when they are away from home or busy. Providers should encourage using reminders as a low-cost aid to enhance adherence.

Patient Voices in Rheumatic Immune-related Adverse Events.

Patients with cancer considering immune checkpoint inhibitor (ICI) therapy often look for health information and peer support through online communities. The authors used social media content analysis to obtain the perspectives of patients receiving ICI treatment about immune-related adverse events (irAEs), with particular focus on rheumatological symptoms. The most reported rheumatic symptom was joint pain. Other commonly reported symptoms included muscle pain, joint stiffness, arthritis, myositis, bone pain, back pain, and tendon/ligament pain. A few users reported development of rheumatic diseases. The authors' analyses allowed for cataloging and assessment of patient and caregiver experiences with ICI therapy and rheumatic irAEs.

A systematic review and meta-analysis of observational studies and uncontrolled trials reporting on the use of checkpoint blockers in patients with cancer and pre-existing autoimmune disease.

BACKGROUND: Cancer patients with autoimmune disease have been excluded from randomized trials of immune checkpoint blockers (ICBs). We conducted a systematic review of observational studies and uncontrolled trials including cancer patients with pre-existing autoimmune disease who received ICBs. METHODS: We searched 5 electronic databases through November 2023. Study selection, data collection, and quality assessment were performed independently by 2 investigators. We performed a meta-analysis to pool incidence of immune-related adverse events (irAEs), including de novo events and flares of existing autoimmune disease, hospitalizations due to irAEs, as well as deaths. RESULTS: A total of 95 studies were included (23,897 patients with cancer and preexisting autoimmune disease). The most common cancer evaluated was lung cancer (30.7 %) followed by skin cancer (15.7 %). Patients with autoimmune disease were more likely to report irAEs compared to patients without autoimmune disease (relative risk 1.3, 95 % CI 1.0 to 1.6). The pooled occurrence rate of any irAEs (flares or de novo) was 61 % (95 % CI 54 % to 68 %); that of flares was 36 % (95 % CI 30 % to 43 %), and that of de novo irAEs was 23 % (95 % CI 16 % to 30 %). Flares were mild (grade <3) in half of cases and more commonly reported in patients with psoriasis/psoriatic arthritis (39 %), inflammatory bowel disease (37 %), and rheumatoid arthritis (36 %). 32 % of the patients with irAEs required hospitalization and treatment of irAEs included corticosteroids in 72 % of the cases. The irAEs mortality rate was 0.07 %. There were no statistically significant differences in cancer response to ICBs between patients with and without autoimmune disease. CONCLUSIONS: Although more patients with pre-existing autoimmune disease had irAEs, these were mild and managed with corticosteroids in most cases, with no impact on cancer response. These results suggest that ICBs can be used in these patients, but careful monitoring is required, as over a third of the patients will experience a flare of their autoimmune disease and/or require hospitalization. These findings provide a crucial foundation for oncologists to refine their monitoring and management strategies, ensuring that the benefits of ICB therapy are maximized while minimizing its risks.

Patient outcomes in longitudinal observational studies (POLOS) of rheumatoid arthritis: Determining the OMERACT core domain set.

OBJECTIVE: To define and select rheumatoid arthritis (RA)-specific core domain set for Longitudinal Observational Studies (LOS) within the Outcome Measures in Rheumatology (OMERACT) framework. METHODS: A three-round online Delphi exercise, including patient research partners (PRPs) and other community partners in healthcare, was conducted. Domains scored 7-9 (i.e., critically important to include) by ≥ 70 % of participants in both groups were included. Items were consolidated in a subsequent dedicated meeting. RESULTS: Nineteen domains scored ≥ 70 % consensus in both groups. The focus group refined these into a list of twelve domains. CONCLUSION: The achieved consensus will inform the next steps of developing the core domain set for LOS in RA.

Generating a list of potentially important contextual factors covering randomized trials, cohorts, and measurement property studies: An OMERACT initiative.

OBJECTIVES: To generate candidates for contextual factors (CFs) for each CF type (i.e., Effect Modifying Contextual Factors (EM-CFs), Outcome Influencing Contextual Factors (OI-CFs), and Measurement Affecting Contextual Factors (MA-CFs)) considered important within rheumatology. METHODS: We surveyed OMERACT working groups and conducted a Special Interest Group (SIG) session at the OMERACT 2023 meeting, where the results were reviewed, and additional CFs suggested. RESULTS: The working groups suggested 44, 49, and 21 generic EM-CFs, OI-CFs, and MA-CFs, respectively. SIG participants added 49, 44, and 55 factors, respectively. CONCLUSION: Candidate CFs were identified, next step is a consensus-based set of endorsed (important) CFs.

Rasburicase in tumor lysis syndrome of the adult: a systematic review and meta-analysis.

BACKGROUND: The use of rasburicase has been evaluated extensively in children, but not in adults. We review the current literature to evaluate its effect on adults. STUDY DESIGN: Systematic review and meta-analysis. SETTING & POPULATION: Adults receiving rasburicase for tumor lysis syndrome (TLS). SELECTION CRITERIA FOR STUDIES: Electronic databases, regulatory documents, and websites were searched up to August 7, 2012. Reference lists of published articles were examined for additional relevant references. Any controlled trial or observational studies (controlled before and after) were included. Studies considering children only or mixing data for children and adults were excluded. INTERVENTION: Rasburicase for TLS. OUTCOMES: The primary outcome was TLS development. Secondary outcomes included percentage of patients improving, total adverse events, acute kidney failure, deaths, and serum uric acid and creatinine levels. RESULTS: 21 studies (24 publications) reported data for 1,261 adult patients, 768 receiving rasburicase for either the treatment or prophylaxis of TLS; these comprised 4 controlled trials and 17 observational studies. No statistically significant differences in clinical TLS development were observed in the controlled trials between the rasburicase and control groups. For the observational studies, 7.4% of patients developed clinical TLS after rasburicase (95% CI, 1.7%-16.7%), 93.4% of patients achieved normalized serum uric acid levels after rasburicase treatment (95% CI, 91.7%-94.6%), 4.4% developed acute kidney injury (95% CI, 3.0%-6.0%), and 2.6% died (95% CI, 0.95%-5.0%). The mean reduction in serum uric acid levels ranged from 5.3-12.8 mg/dL, and for serum creatinine levels, from 0.10-2.1 mg/dL. LIMITATIONS: Controlled trials differed in outcomes reported; meta-analysis was not performed. CONCLUSIONS: Rasburicase is effective in reducing serum uric acid levels in adults with TLS but at a significant cost, and evidence currently is lacking in adults to report whether rasburicase use improves clinical outcomes compared with other alternatives. Until new evidence is available, use of rasburicase may be limited to adult patients with a high risk of TLS.