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Active surveillance of chemotherapy-related symptom burden in ambulatory cancer patients via the implementation of electronic patient-reported outcomes and sensor-enabled vital signs capture: protocol for a decentralised feasibility pilot study

Por: Offodile · A. C. · DiBrito · S. R. · Finder · J. P. · Shete · S. · Jain · S. · Delgado · D. A. · Miller · C. J. · Davidson · E. · Overman · M. J. · Peterson · S. K.
Introduction

Remote patient monitoring (RPM) has emerged as a potential avenue for optimising the management of symptoms in patients undergoing chemotherapy. However, RPM is a complex, multilevel intervention with technology, workflow, contextual and patient experience components. The purpose of this pilot study is to determine the feasibility of RPM protocol implementation with respect to decentralised recruitment, patient retention, adherence to reporting recommendations, RPM platform usability and patient experience in ambulatory cancer patients at high risk for chemotherapy-related symptoms.

Methods and analysis

This protocol describes a single-arm decentralised feasibility pilot study of technology-enhanced outpatient symptom management system in patients with gastrointestinal and thoracic cancer receiving chemotherapy and cancer care at a single site (MD Anderson Cancer Center, Houston Texas). An anticipated total of 25 patients will be recruited prior to the initiation of chemotherapy and provided with a set of validated questionnaires at enrollment and after our 1-month feasibility pilot trial period. Our intervention entails the self-reporting of symptoms and vital signs via a HIPAA-compliant, secure tablet interface that also enables (1) the provision of self-care materials to patients, (2) generation of threshold alerts to a dedicated call-centre and (3) videoconferencing. Vital sign information (heart rate, blood pressure, pulse, oxygen saturation, weight and temperature) will be captured via Bluetooth-enabled biometric monitoring devices which are integrated with the tablet interface. Protocolised triage and management of symptoms will occur in response to the alerts. Feasibility and acceptability metrics will characterise our recruitment process, protocol adherence, patient retention and usability of the RPM platform. We will also document the perceived effectiveness of our intervention by patients.

Ethics and dissemination

This study has been granted approval by the institutional review board of MD Anderson Cancer Center. We anticipate dissemination of our pilot and subsequent effectiveness trial results via presentations at national conferences and peer-reviewed publications in the relevant medical journals. Our results will also be made available to cancer survivors, their caregivers and hospital administration.

Trial registration number

NCI202107464.

Associations of statin use with 30-day adverse outcomes among 4 801 406 US Veterans with and without SARS-CoV-2: an observational cohort study

Por: Wander · P. L. · Lowy · E. · Beste · L. A. · Tulloch-Palomino · L. · Korpak · A. · Peterson · A. C. · Kahn · S. E. · Danaei · G. · Boyko · E. J.
Objective

To estimate associations of statin use with hospitalisation, intensive care unit (ICU) admission and mortality at 30 days among individuals with and without a positive test for SARS-CoV-2.

Design

Retrospective cohort study.

Setting

US Veterans Health Administration (VHA).

Participants

All veterans receiving VHA healthcare with ≥1 positive nasal swab for SARS-CoV-2 between 1 March 2020 and 10 March 2021 (cases; n=231 154) and a comparator group of controls comprising all veterans who did not have a positive nasal swab for SARS-CoV-2 but who did have ≥1 clinical lab test performed during the same time period (n=4 570 252).

Main outcomes

Associations of: (1) any statin use, (2) use of specific statins or (3) low-intensity/moderate-intensity versus high-intensity statin use at the time of positive nasal swab for SARS-CoV-2 (cases) or result of clinical lab test (controls) assessed from pharmacy records with hospitalisation, ICU admission and death at 30 days. We also examined whether associations differed between individuals with and without a positive test for SARS-CoV-2.

Results

Among individuals who tested positive for SARS-CoV-2, statin use was associated with lower odds of death at 30 days (OR 0.81 (95% CI 0.77 to 0.85)) but not with hospitalisation or ICU admission. Associations were similar comparing use of each specific statin to no statin. Compared with low-/moderate intensity statin use, high-intensity statin use was not associated with lower odds of ICU admission or death. Over the same period, associations of statin use with 30-day outcomes were significantly stronger among individuals without a positive test for SARS-CoV-2: hospitalisation OR 0.79 (95% CI 0.77 to 0.80), ICU admission OR 0.86 (95% CI 0.81 to 0.90) and death 0.60 (95% CI 0.58 to 0.62; p for interaction all

Conclusions

Associations of statin use with lower adverse 30-day outcomes are weaker among individuals who tested positive for SARS-CoV-2 compared with individuals without a positive test, indicating that statins do not exert SARS-CoV-2 specific effects.

Assessing tobacco smoke exposure in pregnancy from self-report, urinary cotinine and NNAL: a validation study using the New Hampshire Birth Cohort Study

Por: Peacock · J. L. · Palys · T. J. · Halchenko · Y. · Sayarath · V. · Takigawa · C. A. · Murphy · S. E. · Peterson · L. A. · Baker · E. R. · Karagas · M. R.
Objectives

Accurate assessment of tobacco smoke exposure is key to evaluate its effects. We sought to validate and establish cut-offs for self-reported smoking and secondhand smoke (SHS) exposure during pregnancy using urinary cotinine and 4-(methylnitrosamino)-1-(-3-pyridyl)-1-butanol (NNAL) in a large contemporary prospective study from the USA, with lower smoking prevalence than has previously been evaluated.

Design

Prospective birth cohort.

Setting

Pregnancy clinics in New Hampshire and Vermont, USA.

Participants

1396 women enrolled in the New Hampshire Birth Cohort Study with self-reported smoking, urinary cotinine, NNAL and pregnancy outcomes.

Primary and secondary outcome measures

Cut-offs for urinary cotinine and NNAL concentrations were estimated from logistic regression models using Youden’s method to predict SHS and active smoking. Cotinine and NNAL were each used as the exposure in separate multifactorial models for pregnancy outcomes.

Results

Self-reported maternal smoking was: 72% non-smokers, 5.7% ex-smokers, 6.4% SHS exposure, 6.2% currently smoked, 10% unreported. Cotinine and NNAL levels were low and highly intercorrelated (r=0.91). Geometric mean cotinine, NNAL were 0.99 ng/mL, 0.05 pmol/mL, respectively. Cotinine cut-offs for SHS, current smoking were 1.2 ng/mL and 1.8 ng/mL (area under curve (AUC) 95% CI: 0.52 (0.47 to 0.57), 0.90 (0.85 to 0.94)). NNAL cut-off for current smoking was 0.09 pmol/mL (AUC=0.82 (95% CI 0.77 to 0.87)). Using cotinine and NNAL cut-offs combined gave similar AUC to cotinine alone, 0.87 (95% CI 0.82 to 0.91). Cotinine and NNAL gave almost identical effect estimates when modelling pregnancy outcomes.

Conclusions

In this population, we observed high concordance between self-complete questionnaire smoking data and urinary cotinine and NNAL. With respect to biomarkers, either cotinine or NNAL can be used as a measure of tobacco smoke exposure overall but only cotinine can be used to detect SHS.

Role of gender in perspectives of discrimination, stigma, and attitudes relative to cervical cancer in rural Sénégal

by Natalia Ongtengco, Hamidou Thiam, Zola Collins, Elly Lou De Jesus, Caryn E. Peterson, Tianxiu Wang, Ellen Hendrix, Youssoupha Ndiaye, Babacar Gueye, Omar Gassama, Abdoul Aziz Kasse, Adama Faye, Jennifer S. Smith, Marian Fitzgibbon, Jon Andrew Dykens

Cervical cancer is the leading cause of female cancer deaths in Sénégal which is ranked 17th in incidence globally, however, the screening rate there is very low. Nuanced gendered perceptions and health behaviors of both women and men play a significant role in women’s health. Our study analyzed gender differences on perceptions of gender roles, discrimination, cancer attitudes, cancer stigma, and influences in healthcare decision making within our study population to inform ongoing cervical cancer prevention work in the rural region of Kédougou, Sénégal. We conducted a cross-sectional survey of 158 participants, 101 women and 57 men (ages 30–59) across nine non-probability-sampled communities from October 2018 through February 2019. Bivariate analysis was conducted to assess gender differences across all variables. We also conducted analyses to determine whether there were significant differences in beliefs and attitudes, by screening behavior and by education. We found significant gender differences regarding the perception of a woman’s role (P
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