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Nevin Manimala Statistics

Translation and Validation of the Comprehensive Score of Financial Toxicity for Cancer Patients Into Arabic

J Nurs Meas. 2021 Sep 13:JNM-D-20-00140. doi: 10.1891/JNM-D-20-00140. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: We aimed to translate the Comprehensive Score of Financial Toxicity (COST) questionnaire into Arabic and to evaluate its reliability and validity.

METHODS: We applied the four-step translation method and conducted a pilot validation study over 179 medical oncology patients. Reliability was tested using the Cronbach alpha coefficient and test-retest stability. Validity was tested using the correlation with Functional assessment of Cancer Therapy-General score (FACT-G), factorial analysis and the content validity index.

RESULTS: Questionnaire showed high internal consistency and test retest reliability; Cronbach alpha coefficient was 0.77 and Pearson stability coefficient was 0.8. Convergent validity evaluation showed a statistically significant moderate correlation with the FACT-G (r = .42, p = .047). Content validly index was 0.93.

CONCLUSIONS: The Arabic version of COST questionnaire, was a valid and reliable tool that could be used in clinical practice by healthcare providers to evaluate financial toxicity in Arab speaking cancer patients.

PMID:34518422 | DOI:10.1891/JNM-D-20-00140

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Septic arthritis in the end-stage renal disease population

J Investig Med. 2021 Sep 13:jim-2021-001869. doi: 10.1136/jim-2021-001869. Online ahead of print.

ABSTRACT

Septic arthritis is important to consider in any patient who presents with joint pain because it is a medical emergency with an 11% fatality rate. Diagnosis and treatment may improve prognosis; however, many patients do not regain full joint function. In patients with end-stage renal disease (ESRD), immune dysfunction due to uremia and chronic vascular access leads to increased risk of infection. We examined the incidence, risk factors and sequelae of septic arthritis in a cohort of hemodialysis patients. The US Renal Data System was queried for diagnoses of septic arthritis and selected sequelae using International Statistical Classification of Diseases and Related Health Problems-9 and Current Procedural Terminology-4 codes in patients who initiated hemodialysis between 2005 and 2010. Multivariable logistic regression was used to determine potential risk factors for septic arthritis and its sequelae. 7009 cases of septic arthritis were identified, an incidence of 514.8 per 100,000 persons per year. Of these patients, 2179 were diagnosed with a documented organism within 30 days prior to or 14 days after the septic arthritis diagnosis, with methicillin-resistant Staphylococcus aureus infections (57.4%) being the most common. Significant risk factors for septic arthritis included history of joint disease, immune compromise (diabetes, HIV, cirrhosis), bacteremia and urinary tract infection. One of the four sequelae examined (joint replacement, amputation, osteomyelitis, Clostridioides difficile infection) occurred in 25% of septic arthritis cases. The high incidence of septic arthritis and the potential for serious sequelae in patients with ESRD suggest that physicians treating individuals with ESRD and joint pain/inflammation should maintain a high clinical suspicion for septic arthritis.

PMID:34518317 | DOI:10.1136/jim-2021-001869

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Factors Affecting Cancer Prevention Behaviors and Cancer Screening in First-Degree Relatives of Breast and Colorectal Cancer Patients in Korea: A Cross-Sectional Study

Res Theory Nurs Pract. 2021 Sep 13:RTNP-D-20-00113. doi: 10.1891/RTNP-D-20-00113. Online ahead of print.

ABSTRACT

BACKGROUND: First-degree relatives (FDRs) of cancer patients have a high risk of cancer due to a similar lifestyle and genetic predisposition. However, previous studies rarely examined the level of cancer prevention behaviors and screening and affecting factors in cancer patients’ FDRs.

PURPOSE: This study aimed to describe the levels of cancer knowledge, attitudes toward cancer, cancer worry, perceived cancer risk, and cancer prevention behaviors and cancer screening in FDRs of breast and colorectal cancer patients. Moreover, it sought to identify factors affecting cancer prevention behavior and cancer screening.

METHODS: A cross-sectional, descriptive correlational design was used. The study enrolled 138 FDRs of breast and colorectal cancer patients. Participants completed self-administered questionnaires at a tertiary hospital in Seoul, Korea. Descriptive statistics, frequencies, chi-square test, independent t test, one-way analysis of variance (ANOVA), Pearson’s correlation, multiple regression, and logistic regression were performed for data analysis.

RESULTS: The levels of perceived cancer risk, cancer knowledge, attitude toward cancer, and cancer prevention behaviors were moderate, while the level of cancer worry was high. Ninety-two participants reported having undergone cancer screenings, but the types of screening were not associated with their family history. Age, gender, and attitude toward cancer affected cancer prevention behaviors. The cancer screening rate was higher in older participants, in women, and in patients’ FDRs with a longer cancer diagnosis.

IMPLICATIONS FOR PRACTICE: Attitude was the modifiable factor for cancer prevention behaviors. Nurse-led educational and counseling interventions should be developed to improve attitude toward cancer among FDRs of cancer patients.

PMID:34518358 | DOI:10.1891/RTNP-D-20-00113

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Implementation and 1-year follow-up of the cardiovascular ICU standardised handover

BMJ Open Qual. 2021 Sep;10(3):e001063. doi: 10.1136/bmjoq-2020-001063.

ABSTRACT

BACKGROUND: Miscommunication during clinical handover can lead to partial information transfer and healthcare provider dissatisfaction. We hypothesised that a quality improvement project to standardise the cardiovascular intensive care unit (CVICU) handover could improve healthcare provider satisfaction and reduce information omission.

METHODS: After institutional review board approval, the operating room (OR) to CVICU handover was audited prior, post and 1 year after standardisation implementation. The medical information transferred, healthcare provider participation and satisfaction, and patient outcome data were collected. Additionally, surveys were sent to the OR and CVICU staff by email.

RESULTS: There were 68 handover processes observed. The odds of greater satisfaction with handover for providers were 18 times higher with the process post implementation (p<0.0001) and 26 times higher 1 year after implementation (p<0.0001). There was statistically significant difference between intensive care unit resident presence (45% vs 76% vs 91%, p=0.004), surgical faculty presence (10% vs 36% vs 45%, p=0.034) and surgical fellow presence (15% vs 64% vs 62%, p=0.001) between the three time periods. More information related to the surgeon (5% vs 52% vs 27%, p=0.002), the medical history (65% vs 96% vs 91%, p=0.014) and the cardiopulmonary bypass (47% vs 88% vs 76%, p=0.017) was conveyed. The duration of mechanical ventilation was shorter after implementation (2.2±2.6 days vs 1.2±1.9 days vs 0.5±1.2 days, p=0.026).

CONCLUSIONS: One year after the OR to CVICU standardised handover implementation, the healthcare provider satisfaction remained increased, more team members participated and the information transfer increased. Although some clinical outcomes improved, further studies are recommended to prove causality.

PMID:34518301 | DOI:10.1136/bmjoq-2020-001063

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A Phase 1 Study of an MPS1 Inhibitor (BAY 1217389) in Combination with Paclitaxel using a novel Randomized Continual Reassessment Method for Dose Escalation

Clin Cancer Res. 2021 Sep 13:clincanres.4185.2020. doi: 10.1158/1078-0432.CCR-20-4185. Online ahead of print.

ABSTRACT

PURPOSE: MPS1 kinase inhibitor, BAY 1217389 (BAY) synergizes with paclitaxel. This phase 1 study assessed the combination of BAY with paclitaxel using a novel randomized continuous reassessment method (rCRM) to improve dose determination.

EXPERIMENTAL DESIGN: Patients with solid tumors were randomized to receive oral BAY (BID 2‑days‑on/5‑days‑off) with weekly paclitaxel (90 mg/m2) or paclitaxel monotherapy in cycle 1. Dose escalation was guided by CRM modeling. Primary objectives were to assess safety, establish the maximum tolerated dose (MTD) of BAY and to evaluate the pharmacokinetic profiles for both compounds. Simulations were performed to determine the contribution of the rCRM for dose determination.

RESULTS: In total, 75 patients were enrolled. The main dose limiting toxicities were hematologic toxicities (55.6%). The MTD of BAY was established at 64 mg BID with paclitaxel. Inclusion of a control arm enabled the definitive attribution of grade {greater than or equal to}3 neutropenia to higher BAY exposure (AUC0-12 (P< .001)). After determining the MTD, we included nineteen breast cancer patients at this dose for dose expansion. Other common toxicities were nausea (45.3%), fatigue (41.3%) and diarrhea (40.0%). Overall confirmed responses were seen in 31.6% of evaluable patients. Simulations showed that rCRM outperforms traditional designs in determining the true MTD.

CONCLUSIONS: The combination of BAY with paclitaxel was associated with considerable toxicity without a therapeutic window. However, the use of the rCRM design enabled us to determine the exposure-toxicity relation for BAY. Therefore we propose that the rCRM could improve dose determination in phase I trials that combine agents with overlapping toxicities.

PMID:34518310 | DOI:10.1158/1078-0432.CCR-20-4185

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The Clinical Application of Urine Soluble CD163 in ANCA-Associated Vasculitis

J Am Soc Nephrol. 2021 Sep 13:ASN.2021030382. doi: 10.1681/ASN.2021030382. Online ahead of print.

ABSTRACT

Background Up to 70% of patients with ANCA-associated vasculitis (AAV) develop glomerulonephritis, with 26% progressing to ESKD. Diagnostic-grade and noninvasive tools to detect active renal inflammation are needed. Urinary soluble CD163 (sCD163) is a promising biomarker of active renal vasculitis, but a diagnostic-grade assay, assessment of its utility in prospective diagnosis of renal vasculitis flares, and evaluation of its utility in proteinuric states are needed. Methods We assessed a diagnostic-grade urinary sCD163 assay in (1) a real-world cohort of 405 patients with AAV and 121 healthy and 488 non-AAV disease controls; (2) a prospective multicenter study of 84 patients with potential renal vasculitis flare; (3) a longitudinal multicenter cohort of 65 patients with podocytopathy; and (4) a cohort of 29 patients with AAV (with or without proteinuria) and 10 controls. Results We established a diagnostic reference range, with a cutoff of 250 ng/mmol for active renal vasculitis (area under the curve [AUC], 0.978). Using this cutoff, urinary sCD163 was elevated in renal vasculitis flare (AUC, 0.95) but remained low in flare mimics, such as nonvasculitic acute kidney injury. Urinary sCD163’s specificity declined in AAV patients with nephrotic-range proteinuria and in primary podocytopathy, with 62% of nephrotic patients displaying a “positive” urinary sCD163. In AAV patients with significant proteinuria, urinary sCD163 normalization to total urine protein rather than creatinine provided the greatest clinical utility for diagnosing active renal vasculitis. Conclusions Urinary sCD163 is elevated in renal vasculitis flare and remains low in flare mimics. Nonspecific protein leakage in nephrotic syndrome elevates urinary sCD163 in the absence of glomerular macrophage infiltration, resulting in false-positive results; this can be corrected with urine protein normalization.

PMID:34518279 | DOI:10.1681/ASN.2021030382

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Clinical outcomes in patients with metastatic renal cell carcinoma and brain metastasis treated with ipilimumab and nivolumab

J Immunother Cancer. 2021 Sep;9(9):e003281. doi: 10.1136/jitc-2021-003281.

ABSTRACT

The combination of ipilimumab plus nivolumab (I+N) has greatly improved outcomes in patients with intermediate or poor-risk untreated metastatic renal cell carcinoma (mRCC). However, little is known about the outcomes of patients with brain metastasis (BrM) treated with I+N. A search was performed to retrospectively identify all patients with mRCC treated with I+N in the Duke Cancer Institute and the Cleveland Clinic Taussig Cancer Center, followed by a chart review. Patients were included if they had BrM at the time of I+N initiation. Cohort characteristics are summarized with descriptive statistics. Kaplan-Meier method was used to estimate overall survival (OS) and global, intracranial, and extracranial progression-free survival (PFS) for the cohort and log rank test was used to compare OS and PFS between patient groups. Radiographic response was categorized by RECIST. Fisher’s exact test was used to correlate patient factors with radiographic response. From October 2017 to December 2020, 19 patients with BrM received I+N for mRCC with a median follow-up time of 27.1 months (range 15.0-35.6). By International Metastatic RCC Database Consortium (IMDC) risk criteria, 16% had favorable, 58% had intermediate, and 26% had poor-risk disease. 68% were systemic therapy naïve, and 77% of patients had clear cell histology. 95% had received local CNS directed therapy with surgery, radiotherapy, or both. The objective response rate was 44% (0% complete response) with three of six patients treated in the second line or greater setting experiencing a partial response. The median PFS was 7.6 months (95% CI 5.6 to 14.9). The median extracranial PFS was 8.5 months (95% CI 5.6 to 19.7), and median intracranial PFS was 14.7 months (95% CI 7.2 to not reached). No variables assessed were significantly associated with radiographic response (gender, IMDC risk, presence of bone metastasis, line of therapy, or presence of immune related adverse events). In our retrospective cohort of patients with mRCC with BrM, I+N, in combination with CNS-directed local therapy, appears to have clinical efficacy as previously described with responses seen beyond the first-line setting. Further investigation is warranted in this population given exclusion from prior clinical trials.

PMID:34518292 | DOI:10.1136/jitc-2021-003281

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Consumer understanding of terms used in imaging reports requested for low back pain: a cross-sectional survey

BMJ Open. 2021 Sep 13;11(9):e049938. doi: 10.1136/bmjopen-2021-049938.

ABSTRACT

OBJECTIVES: To investigate (1) self-reported societal comprehension of common and usually non-serious terms found in lumbar spine imaging reports and (2) its relationship to perceived seriousness, likely persistence of low back pain (LBP), fear of movement, back beliefs and history and intensity of LBP.

DESIGN: Cross-sectional online survey of the general public.

SETTING: Five English-speaking countries: UK, USA, Canada, New Zealand and Australia.

PARTICIPANTS: Adults (age >18 years) with or without a history of LBP recruited in April 2019 with quotas for country, age and gender.

PRIMARY AND SECONDARY OUTCOME MEASURES: Self-reported understanding of 14 terms (annular fissure, disc bulge, disc degeneration, disc extrusion, disc height loss, disc protrusion, disc signal loss, facet joint degeneration, high intensity zone, mild canal stenosis, Modic changes, nerve root contact, spondylolisthesis and spondylosis) commonly found in lumbar spine imaging reports. For each term, we also elicited worry about its seriousness, and whether its presence would indicate pain persistence and prompt fear of movement.

RESULTS: From 774 responses, we included 677 (87.5%) with complete and valid responses. 577 (85%) participants had a current or past history of LBP of whom 251 (44%) had received lumbar spine imaging. Self-reported understanding of all terms was poor. At best, 235 (35%) reported understanding the term ‘disc degeneration’, while only 71 (10.5%) reported understanding the term ‘Modic changes’. For all terms, a moderate to large proportion of participants (range 59%-71%), considered they indicated a serious back problem, that pain might persist (range 52%-71%) and they would be fearful of movement (range 42%-57%).

CONCLUSION: Common and usually non-serious terms in lumbar spine imaging reports are poorly understood by the general population and may contribute to the burden of LBP.

TRIAL REGISTRATION NUMBER: ACTRN12619000545167.

PMID:34518265 | DOI:10.1136/bmjopen-2021-049938

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Which resources help young people to prevent and overcome mental distress in deprived urban areas in Latin America? A protocol for a prospective cohort study

BMJ Open. 2021 Sep 13;11(9):e052339. doi: 10.1136/bmjopen-2021-052339.

ABSTRACT

INTRODUCTION: Improving the mental health of young people is a global public health priority. In Latin America, young people living in deprived urban areas face various risk factors for mental distress. However, most either do not develop mental distress in the form of depression and anxiety, or recover within a year without treatment from mental health services. This research programme seeks to identify the personal and social resources that help young people to prevent and recover from mental distress.

METHODS AND ANALYSIS: A cross-sectional study will compare personal and social resources used by 1020 young people (aged 15-16 and 20-24 years) with symptoms of depression and/or anxiety and 1020 without. A longitudinal cohort study will follow-up young people with mental distress after 6 months and 1 year and compare resource use in those who do and do not recover. An experience sampling method study will intensively assess activities, experiences and mental distress in subgroups over short time periods. Finally, we will develop case studies highlighting existing initiatives that effectively support young people to prevent and recover from mental distress. The analysis will assess differences between young people with and without distress at baseline using t-tests and χ2 tests. Within the groups with mental distress, multivariate logistic regression analyses using a random effects model will assess the relationship between predictor variables and recovery.

ETHICS AND DISSEMINATION: Ethics approvals are received from Ethics Committee in Biomedical Research, Faculty of Medicine, University of Buenos Aires; Faculty of Medicine-Research and Ethics Committee of the Pontificia Universidad Javeriana, Bogotá; Institutional Ethics Committee of Research of the Universidad Peruana Cayetano Heredia and Queen Mary Ethics of Research Committee. Dissemination will include arts-based methods and target different audiences such as national stakeholders, researchers from different disciplines and the general public.

TRIAL REGISTRATION NUMBER: ISRCTN72241383.

PMID:34518275 | DOI:10.1136/bmjopen-2021-052339

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Health status of individuals referred to first-line intervention for hip and knee osteoarthritis compared with the general population: an observational register-based study

BMJ Open. 2021 Sep 13;11(9):e049476. doi: 10.1136/bmjopen-2021-049476.

ABSTRACT

OBJECTIVES: To describe the prevalence of comorbidities in a population referred to standardised first-line intervention (patient education and exercise) for hip and knee osteoarthritis (OA), in comparison with the general population. Furthermore, we aimed to evaluate if eventual differences were associated with socioeconomic inequalities.

DESIGN: Register-based study.

SETTING: Primary healthcare, Sweden.

PARTICIPANTS: Individuals with hip and/or knee OA included in the Better Management for Patients with Osteoarthritis Register between 2008 and 2016 and and an age-matched, sex-matched and residence-matched reference cohort (1:3) from the general Swedish population.

OUTCOME MEASURES: Comorbidities were identified with the RxRisk Index, the Elixhauser Comorbidity Index and the Charlson Comorbidity Index, and presented with descriptive statistics as (1) individual diseases, (2) disease categories and (3) scores for each index. The prevalence of comorbidities in the two populations was tested using logistic regression, with separate analyses for age groups and the most affected joint. We then adjusted the analyses for socioeconomic status.

RESULTS: In this OA population, 85% had ≥1 comorbidity compared with 78% of the reference cohort (OR; 1.62 (95% CI 1.59 to 1.66)). Cardiovascular/blood diseases were the most common comorbidities in both populations (OA, 59%; reference, 54%), with OR; 1.22 (95% CI 1.20 to 1.24) for the OA population. Younger individuals with OA were more comorbid than their matched references overall, and population differences decreased with age (eg, ≥3 comorbidities, aged ≤45 years OR; 1.74 (95% CI 1.52 to 1.98), ≥81 years OR; 0.95 (95% CI 0.87 to 1.04)). Individuals with knee OA were more comorbid than those with hip OA overall. Adjustment for socioeconomic status did not change the estimates.

CONCLUSION: Comorbidities were more common among individuals with hip and knee OA than among matched references from the general population. The differences could not be explained by socioeconomic status.

TRIAL REGISTRATION NUMBER: NCT03438630.

PMID:34518262 | DOI:10.1136/bmjopen-2021-049476