Association of e-Cigarette Use and Postpartum Depression: Pregnancy Risk Assessment Monitoring System 2016-2019.

Background: Postpartum depression (PPD) is a prevalent public health concern. Combustible cigarette use is associated with increased risk of PPD. While electronic cigarette (e-cigarette) use during pregnancy is linked to increased risk of depressive symptoms during pregnancy, the relationship between e-cigarette use and PPD is not well understood. We sought to examine the association of e-cigarette use with PPD. Materials and Methods: Using Pregnancy Risk Assessment Monitoring System 2016-2019 data, unadjusted and adjusted logistic regression analyses for PPD were conducted via three analyses where e-cigarette use (any vs. none) was retrospectively self-reported (1) in past 2-year, (2) prepregnancy (i.e., 3 months before pregnancy), and (3) during pregnancy (i.e., last 3 months of pregnancy). We conducted an additional past 2-year e-cigarette use analysis excluding those who used combustible cigarette and/or hookah. Covariates included age, race, ethnicity, combustible cigarette, and/or hookah use, prenatal care during the last trimester, health insurance coverage during pregnancy, physical abuse during pregnancy, income, and survey type. Results: Only unadjusted odds ratios from past 2-year e-cigarette use (1.63, 95% confidence interval [CI]: 1.42-1.87) and past 2-year e-cigarette use excluding individuals with cigarette and/or hookah use (1.78, 95% CI: 1.30-2.38) were statistically associated with PPD. No adjusted analyses were statistically significant. Conclusion: Any e-cigarette use, as compared to no use, does not appear to be an independent risk factor of PPD, though it may be a useful clinical marker of increased risk of PPD. Future studies are warranted to advance our knowledge of impact of e-cigarette use on PPD.

US-Mexico Border Stress and Daily Substance Use among Latino Youth: a Cross-Sectional Study.

Background: Historically marginalized youth are at risk for daily substance use. Daily use may be associated with social and environmental factors. Methods: In March 2018, we surveyed primarily Latino adolescents ages 14-18 who lived on the US-Mexico border and assessed associations between daily substance use, neighborhood stress, border community and immigration stress, and family support. Results: Of 443 surveyed adolescents, 41 (9%) reported daily use. Those who used daily were more likely to be older, identify as male, and reported lower social support and higher neighborhood and border community stress compared to those who did not use daily. Perceived neighborhood stress (OR = 1.95, 95% CI 1.37-2.80) and border community and immigration stress (OR = 1.55, 95% CI 1.12-2.02) were associated with increased odds of daily substance use. Discussion: Latino adolescents who live near the US-Mexico border experience unique socioenvironmental stress which is associated with daily substance use.

Anxiety, depression, and concentration in cancer survivors: National Health and Nutrition Examination Survey results.

PURPOSE: We report on prevalence of anxiety, depression, and concentration difficulties and their associations in survivors of cancer in a nationally representative sample up to 25 years after diagnosis. METHODS: Using the National Health and Nutrition Examination Survey (NHANES) data from 2015 to 2018, participants between the ages of 18 and 79 self-reported on cancer history, symptoms of anxiety, depression, and difficulties with concentration. RESULTS: Of 10,337 participants, 691 (6.7%) reported a previous diagnosis of cancer; the median time since diagnosis was 8 years. Prevalence was similar between those with and without cancer for anxiety (45.8% versus 46.9%) and depression (19.7% versus 20.0%). Concentration difficulties were more common (11.3% versus 9.0%) for those with a history of cancer compared to those without (adjusted OR = 1.38, 95% CI: 1.00-1.90). Prevalence of mental health symptoms was not related to time since diagnosis. Anxiety and depression were highly correlated (r = 0.81, 95% CI: 0.74-0.86) and moderately correlated with difficulty with concentration (r = 0.52, 95%CI: 0.40-0.64 and r = 0.64, 95% CI: 0.53-0.74 respectively). CONCLUSIONS: Difficulty with concentration was more commonly reported by participants with than without a cancer history. Report of anxiety and depression was no different between participants with and without a history of cancer. Anxiety, depression, and difficulties with concentration were strongly related. Further research is needed to explore if there is a causal association, and if so, the direction of these correlations, so that interventions may be appropriately targeted.

Healthcare System Distrust and Non-Prescription Antibiotic Use: A Cross-Sectional Survey of Adult Antibiotic Users.

Antibiotic resistance is a major public health concern driven by antibiotic overuse. Antibiotic stewardship programs are often limited to clinical settings and do little to address non-prescription antibiotic use in community settings. This study investigates the association between non-prescription antibiotic use and healthcare system distrust in the United States and Mexico. An online survey was deployed in the United States and Mexico with enhanced sampling through in-person recruiting in the border region. Non-prescription antibiotic use was defined as having bought or borrowed non-prescription oral or injectable antibiotics within the last 3 years. The survey included a previously validated 10-item scale to measure healthcare system distrust. Logistic regression was used to model the use of non-prescription antibiotics by the level of healthcare system distrust, adjusted for demographic characteristics and antibiotic knowledge. In total, 568 survey participants were included in the analysis, 48.6% of whom had used non-prescription oral or injectable antibiotics in the last 3 years. In the fully adjusted regression model, the odds of using non-prescription antibiotics were 3.2 (95% CI: 1.8, 6.1) times higher for those in the highest distrust quartile versus the lowest. These findings underscore the importance of community-based antibiotic stewardship and suggest that these programs are particularly critical for communities with high levels of healthcare system distrust.

The Association Between Duration of School Garden Exposure and Self-Reported Learning and School Connectedness.

When students feel connected to their school, they experience positive health and academic outcomes. In contrast, school disengagement is a predictor of dropout, delinquency, and substance use. School garden programming has the potential to help children achieve academic outcomes and feel connected to their school. Unfortunately, most school garden research has been conducted with white, affluent study participants. We describe the results of a secondary analysis utilizing data from an evaluation of a university-supported community school garden program (CSGP). Using a cross-sectional survey study design, we examined the impact of school garden programming in Title I schools on primarily Latino/a (Hispanic) elementary student self-reported learning and feelings of school connectedness by comparing students with ≤1 year exposure to those with >1 year. Social cognitive theory formed the conceptual basis for the analysis. Duration of school garden exposure did not have a significant association with self-reported learning or feelings of school connectedness. Regardless of past exposure, fifth-grade students, females, and those who identify as Latino/a (Hispanic) felt that school garden programming improved their learning. Latino/a (Hispanic) students who participate in school garden programming may also feel a greater sense of connection to their teachers and peers at school. Qualitative results demonstrated that most students enjoyed spending time in the garden and indicated that participating in the program helped them learn new things and feel connected to their school. If individuals who may be disadvantaged because of systemic racism, such as Latino/a (Hispanic) students, can benefit from school garden programming, such interventions should be further investigated and prioritized.

Firefighter occupational factors and the risk of preterm birth: results from a survey of women firefighters in the USA.

OBJECTIVES: Previous research has suggested that women firefighters may have a greater risk of adverse reproductive outcomes compared with non-firefighting women. In this study, we investigated the association between firefighter occupational factors and risk of preterm birth. METHODS: This cross-sectional analysis of US firefighters surveyed in 2017 compared preterm birth among firefighters to non-firefighters using age-at-pregnancy-standardised prevalence ratios. Generalised estimating equations estimated relative risks and 95% CIs between firefighter occupational factors (career or volunteer, wildland status, shift schedule, fire responses, work restriction) and preterm birth risk. We adjusted for age-at-pregnancy, education, gravidity, BMI, and smoking and considered effect modification by age-at-pregnancy and career versus volunteer status. RESULTS: Among 934 women who reported 1356 live births, 12% were preterm (n=161). Preterm birth prevalence among firefighters was 1.41 times greater than non-firefighters (95% CI 1.18 to 1.68). Among wildland and combination wildland/structural firefighters, volunteers had 2.82 times the risk of preterm birth (95% CI 1.19 to 6.67) compared with career firefighters. Firefighters who started restricting their work in the 2nd trimester had a nonsignificant 0.67 times lower risk of preterm birth than those who started in the 3rd trimester or did not restrict work at all (95% CI 0.43 to 1.03). CONCLUSIONS: Firefighters may have greater risk of preterm birth than non-firefighters, which could be influenced by roles in the fire service and work restrictions taken.

Self-Reported Symptoms at Last Febrile Illness as a Predictor of Treatment-Seeking in Western Kenya: A Cross-Sectional Study.

Timely treatment-seeking behavior can reduce morbidity and mortality due to infectious diseases. Patterns of treatment-seeking behavior can differ by access to health care, and perceptions of disease severity and symptoms. We evaluated the association between self-reported symptoms at last illness and the level of treatment-seeking behaviors. We analyzed cross-sectional data from 1,037 participants from the lowlands and highlands of Western Kenya from 2015 using logistic regression models. There was considerable heterogeneity in the symptoms and treatment-seeking behaviors reported among individuals who were febrile at their last illness. A greater number of self-reported categories of symptoms tended to be associated with a higher likelihood of treatment-seeking in both sites. Participants were significantly more likely to seek treatment if they reported fever, aches, and digestive symptoms at last illness than just fever and aches or fever alone, but the frequency of treatment-seeking for fever in combination with aches and respiratory symptoms did not follow a consistent pattern. Among those who sought treatment, most used a formal source, but the patterns were inconsistent across sites and by the number of symptoms categories. Understanding the drivers of treatment-seeking behavior after febrile illness is important to control and treat infectious diseases in Kenya.

A randomised controlled trial evaluating two cognitive rehabilitation approaches for cancer survivors with perceived cognitive impairment.

PURPOSE: Up to 70% of survivors report cognitive symptoms after chemotherapy. We compared two cognitive rehabilitation programs to a control group in cancer survivors. METHODS: Study population were adult cancer survivors with cognitive symptoms 6-60 months after adjuvant chemotherapy. Participants randomised to: Attention Process Training (APT), Compensatory Strategy Training (CST), or control group. Active interventions comprised 6-week, 2-h/week small group sessions. ASSESSMENTS: pre- and post-intervention, 6- and 12-months later. Primary outcome was change in cognitive symptoms (FACT-COG-PCI subscale) between baseline and post-intervention. Secondary endpoints included objective neuropsychological performance, Functional Impact Assessment (FIA), patient-reported outcome measures, and associations. Analyses were on an intention-to-treat basis. Analysis of covariance mixed models were used for continuous outcomes. RESULTS: Sixty-five participants were randomised (APT n = 21; CST n = 24; controls n = 20): 94% breast cancer, median age 54. Median time since chemotherapy 20.7 months. FACT-COG-PCI, clinical neuropsychological T-scores, and FIA improved in all groups over time, but no significant differences between arms. On mean neuropsychological T-scores 19/65 (29%) were impaired at baseline; post-intervention impairment controls 31.3%, CST 16.7%, APT 20.0%. On FIA at baseline, nine were impaired; this decreased to three post-intervention (one/group). FACT-COG-PCI was weakly associated with neuropsychological tests (rho = 0.24, p = 0.051) at baseline, and had no association with FIA. Neuropsychological total mean T-score was moderately positively associated with FIA (rho = 0.37, p = 0.003). CONCLUSION: There were no significant differences between intervention groups and controls using linear mixed models adjusted for baseline scores. IMPLICATIONS FOR CANCER SURVIVORS: Cognitive symptoms and neuropsychological test scores improve over time.

Comorbidities and perceived health status in persons with history of cancer in the USA.

PURPOSE: Comorbidities can further challenge prognosis and general wellbeing of cancer patients. This study aimed to assess the association between comorbidities and perceived health status (PHS) of US persons with cancer. METHODS: This cross-sectional study used 2019 Medical Expenditure Panel Survey (MEPS) data and included individuals who were alive throughout the year, aged 18 to 84 years, and had diagnosis for cancer. Using adjusted logistic regression models, we estimated the association of comorbidities (no, few [1/2], and more [3 or more] comorbidities) with PHS. Analyses accounted for the complex design of MEPS. RESULTS: The dataset included 28,512 participants, 1739 of which were eligible for the study. Of these, 11.16% (95% CI 9.64, 12.59%); 41.73% (95% CI 39.21, 43.96%); and 47.10% (95% CI 44.86, 49.73%) reported having no, few, and more comorbidities, respectively. While breast (N = 356), prostate (N = 276), and melanoma (N = 273) were the most common cancers, hypertension (88.3%), hypercholesterolemia (49.5%), and arthritis (48%) were the most prevalent comorbidities. Adjusted logistic regression showed that, compared with those with no comorbidities, persons with few and more comorbidities had 1.58 (95% CI = 0.79, 3.15) and 2.27 (95% CI = 1.19, 4.32) times greater odds of poor PHS. Younger or male patients, those with less formal education, low-income, pain, functional limitation, or poor perception of mental health were more likely to regard their health as poor. CONCLUSION: About 88% of persons with history of cancer in the USA aged 18-84 years reported at least one comorbidity. Having more comorbidities, along with several other variables, was associated with poor PHS. Comorbidities management must be given special consideration to improve the prognosis and general wellbeing of persons with cancer.

Perceived Normalization of Drug Trafficking and Adolescent Substance Use on the US-Mexico Border.

Background: Historically marginalized youth are at risk for daily substance use. Daily use may be associated with social and environmental factors. Methods: In March 2018, we surveyed primarily Latino adolescents ages 14-18 who lived on the US-Mexico border and assessed associations between daily substance use, neighborhood stress, border community and immigration stress, and family support. Results: Of 443 surveyed adolescents, 41 (9%) reported daily use. Those who used daily were more likely to be older, identify as male, and reported lower social support and higher neighborhood and border community stress compared to those who did not use daily. Perceived neighborhood stress (OR = 1.95, 95% CI 1.37-2.80) and border community and immigration stress (OR = 1.55, 95% CI 1.12-2.02) were associated with increased odds of daily substance use. Discussion: Latino adolescents who live near the US-Mexico border experience unique socioenvironmental stress which is associated with daily substance use.

The Effect of Physical Activity on Sleep Quality among Older Stroke Survivors: Secondary Analysis from a Randomized Controlled Trial.

Poor sleep quality constitutes one of the most common difficulties faced by stroke survivors. Physical activity has been shown to improve sleep quality among healthy adults. The study objective was to examine the effect of physical activity on sleep outcomes in community-dwelling stroke survivors previously enrolled in a randomized clinical trial (RCT). Secondary analysis of data collected in the RCT was used to examine the effects of physical activity (PA) on sleep outcomes using the Pittsburgh Sleep Quality Index (PSQI), compared to usual care (controls). Unadjusted and adjusted mixed effects models were used to model changes in sleep quality between groups. At baseline, poor sleep quality (PSQI > 5) was reported by about half of the participants (PA group = 48.5%, n = 47/97; controls = 56.3%, n = 27/48). Results from the unadjusted and adjusted models for sleep quality were similar and showed no statistically significant differences between groups (p > 0.05). In the unadjusted model, the difference between groups (change from baseline to 24 weeks) showed that the PA group had better sleep quality than the controls (difference= -1.02 points, 95% CI -2.12, 0.07, p = 0.07). In the model adjusted for age, social support, and marital status, the difference between groups (change from baseline to 24 weeks) showed that the PA group had better sleep quality than the controls (difference= -1.07 points, 95% CI -2.19, 0.05, p = 0.06). PA did not significantly improve sleep quality in older community-dwelling stroke survivors. Further research is needed to confirm or refute these findings.

mHealth-Supported Gender- and Culturally Sensitive Weight Loss Intervention for Hispanic Men With Overweight and Obesity: Single-Arm Pilot Study.

BACKGROUND: Hispanic men have disproportionate rates of overweight and obesity compared with other racial and ethnic subpopulations. However, few weight loss interventions have been developed specifically for this high-risk group. Furthermore, the use of mobile health (mHealth) technologies to support lifestyle behavior changes in weight loss interventions for Hispanic men is largely untested. OBJECTIVE: This single-arm pilot study examined the feasibility and acceptability of integrating mHealth technology into a 12-week gender- and culturally sensitive weight loss intervention (GCSWLI) for Hispanic men with overweight and obesity. METHODS: A total of 18 Hispanic men (mean age 38, SD 10.9 years; mean BMI 34.3, SD 5.5 kg/m²; 10/18, 56% Spanish monolingual) received a GCSWLI, including weekly in-person individual sessions, a daily calorie goal, and prescription of ≥225 minutes of moderate-intensity physical activity per week. mHealth technology support included tailored SMS text messaging, behavior self-monitoring support using Fitbit Charge 2, and weight tracking using a Fitbit Aria Wi-Fi Smart Scale. Changes in weight from baseline to 12 weeks were estimated using a paired 2-tailed t test. Descriptive analyses characterized the use of Fitbit and smart scales. Semistructured interviews were conducted immediately after intervention to assess the participants' weight loss experiences and perspectives on mHealth technologies. RESULTS: Of 18 participants, 16 (89%) completed the 12-week assessments; the overall attrition rate was 11.1%. The mean weight loss at week 12 was -4.7 kg (95% CI 7.1 to -2.4 kg; P<.001). Participants wore the Fitbit 71.58% (962/1344) of the intervention days and logged their body weight using the smart scale (410/1344, 30.51% of the intervention days). Participants identified barriers to the use of the technology, such as lack of technological literacy and unreliable internet access for the smart scale. CONCLUSIONS: Although clinically significant weight loss was achieved by integrating mHealth technology into the GCSWLI, adherence to the prescribed use of technology was modest. Addressing barriers to the use of such technologies identified in our work may help to refine an mHealth intervention approach for Hispanic men. TRIAL REGISTRATION: ClinicalTrials.gov NCT02783521; https://clinicaltrials.gov/ct2/show/NCT02783521.

Persisting gastrointestinal symptoms and post-infectious irritable bowel syndrome following SARS-CoV-2 infection: results from the Arizona CoVHORT.

In this study, we aimed to examine the association between gastrointestinal (GI) symptom presence during severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the prevalence of GI symptoms and the development of post-infectious irritable bowel syndrome (PI-IBS). We used data from a prospective cohort and logistic regression to examine the association between GI symptom status during confirmed SARS-CoV-2 infection and prevalence of persistent GI symptoms at ≥45 days. We also report the incidence of PI-IBS following SARS-CoV-2 infection. Of the 1475 participants in this study, 33.8% (n = 499) had GI symptoms during acute infection. Cases with acute GI symptoms had an odds of persisting GI symptoms 4 times higher than cases without acute GI symptoms (odds ratio (OR) 4.29, 95% confidence interval (CI) 2.45-7.53); symptoms lasted on average 8 months following infection. Of those with persisting GI symptoms, 67% sought care for their symptoms and incident PI-IBS occurred in 3.0% (n = 15) of participants. Those with acute GI symptoms after SARS-CoV-2 infection are likely to have similar persistent symptoms 45 days and greater. These data indicate that attention to a potential increase in related healthcare needs is warranted.

Laparoscopically Confirmed Endometriosis and Risk of Incident Stroke: A Prospective Cohort Study.

BACKGROUND: Prior research suggests that women with endometriosis are at greater risk of coronary heart disease. Therefore, our objective was to prospectively investigate the association between laparoscopically confirmed endometriosis and risk of incident stroke during 28 years of follow-up. METHODS: Participants in the NHSII cohort study (Nurses' Health Study II) were followed from 1989 when they were between the ages of 25 to 42 until 2017 for development of incident stroke (ischemic and hemorrhagic). Cox proportional hazard models were used to calculate hazard ratios and 95% CI, with adjustment for potential confounding variables (alcohol intake, body mass index at age 18, current body mass index, age at menarche, menstrual cycle pattern in adolescence, current menstrual cycle pattern, parity, oral contraceptive use history, smoking history, diet quality, physical activity, NSAID use, aspirin use, race/ethnicity, and income). We estimated the proportion of the total association mediated by history of hypertension, hypercholesterolemia, hysterectomy/oophorectomy, and hormone therapy. We also tested for effect modification by age (<50, ≥50 years), infertility history, body mass index (<25, ≥25 kg/m2), and menopausal status. RESULTS: We documented 893 incident cases of stroke during 2 770 152 person-years of follow-up. Women with laparoscopically confirmed endometriosis had a 34% greater risk of stroke in multivariable-adjusted models (hazard ratio, 1.34 [95% CI, 1.10-1.62]), compared to those without a history of endometriosis. Of the total association of endometriosis with risk of stroke, the largest proportion was attributed to hysterectomy/oophorectomy (39% mediated [95% CI, 14%-71%]) and hormone therapy (16% mediated [95% CI, 5%-40%]). We observed no differences in the relationship between endometriosis and stroke by age, infertility history, body mass index, or menopausal status. CONCLUSIONS: We observed that women with endometriosis were at elevated risk of stroke. Women and their health care providers should be aware of endometriosis history, maximize primary cardiovascular prevention, and discuss signs and symptoms of cardiovascular disease.

Detangling Seasonal Relationships of Fecal Contamination Sources and Correlates with Indicators in Michigan Watersheds.

Despite the widely acknowledged public health impacts of surface water fecal contamination, there is limited understanding of seasonal effects on (i) fate and transport processes and (ii) the mechanisms by which they contribute to water quality impairment. Quantifying relationships between land use, chemical parameters, and fecal bacterial concentrations in watersheds can help guide the monitoring and control of microbial water quality and explain seasonal differences. The goals of this study were to (i) identify seasonal differences in Escherichia coli and Bacteroides thetaiotaomicron concentrations, (ii) evaluate environmental drivers influencing microbial contamination during baseflow, snowmelt, and summer rain seasons, and (iii) relate seasonal changes in B. thetaiotaomicron to anticipated gastrointestinal infection risks. Water chemistry data collected during three hydroclimatic seasons from 64 Michigan watersheds were analyzed using seasonal linear regression models with candidate variables including crop and land use proportions, prior precipitation, chemical parameters, and variables related to both wastewater treatment and septic usage. Adaptive least absolute shrinkage and selection operator (LASSO) linear regression with bootstrapping was used to select explanatory variables and estimate coefficients. Regardless of season, wastewater treatment plant and septic system usage were consistently selected in all primary models for B. thetaiotaomicron and E. coli. Chemistry and precipitation-related variable selection depended upon season and organism. These results suggest a link between human pollution (e.g., septic systems) and microbial water quality that is dependent on flow regime. IMPORTANCE In this study, a data set of 64 Michigan watersheds was utilized to gain insights into fecal contamination sources, drivers, and chemical correlates across seasons for general E. coli and human-specific fecal indicators. Results reaffirmed a link between human-specific sources (e.g., septic systems) and microbial water quality. While the importance of human sources of fecal contamination and fate and transport variables (e.g., precipitation) remain important across seasons, this study provides evidence that fate and transport mechanisms vary with seasonal hydrologic condition and microorganism source. This study contributes to a body of research that informs prioritization of fecal contamination source control and surveillance strategy development to reduce the public health burden of surface water fecal contamination.

Managing missing items in the Fagerström Test for Nicotine Dependence: a simulation study.

BACKGROUND: The Fagerström Test for Nicotine Dependence (FTND) is frequently used to assess the level of smokers' nicotine dependence; however, it is unclear how to manage missing items. The aim of this study was to investigate different methods for managing missing items in the FTND. METHODS: We performed a simulation study using data from the Arizona Smokers' Helpline. We randomly sampled with replacement from the complete data to simulate 1000 datasets for each parameter combination of sample size, proportion of missing data, and type of missing data (missing at random and missing not at random). Then for six methods for managing missing items on the FTND (two involving no imputation and four involving single imputation), we assessed the accuracy (via bias) and precision (via bias of standard error) of the total FTND score itself and of the regression coefficient for the total FTND score regressed on a covariate. RESULTS: When using the total FTND score as a descriptive statistic or in analysis for both types of missing data and for all levels of missing data, proration performed the best in terms of accuracy and precision. Proration's accuracy decreased with the amount of missing data; for example, at 9% missing data proration's maximum bias for the mean FTND was only - 0.3%, but at 35% missing data its maximum bias for the mean FTND increased to - 6%. CONCLUSIONS: For managing missing items on the FTND, we recommend proration, because it was found to be accurate and precise, and it is easy to implement. However, because proration becomes less accurate with more missing data, if more than ~ 10% of data are missing, we recommend performing a sensitivity analysis with a different method of managing missing data.

Missing data in palliative care research: estimands and estimators.

There are several methodological challenges when conducting randomised controlled trials in palliative care. These include worsening function and high mortality, leading to treatment discontinuation, some of which will be unrelated to the intervention being evaluated.Recently, a new framework for handling postrandomisation events, such as attrition, has been released. This framework aims to align trial objectives, design, conduct and analysis by clarifying what and how to estimate treatment effects in the presence of data affected by postrandomisation events.The purpose of this paper is to introduce palliative care researchers to this framework and how it can guide trial design, and efficacy and safety analysis in a palliative care context where individual withdrawal from the trial is common.In this paper, we describe the estimand framework and the background for it. We also consider postrandomisation events that are frequently encountered in palliative care trials and how these might affect objectives of interest. We then construct efficacy and safety estimands for a trial in palliative care. Better trial design and alignment of objectives with analysis can improve our understanding of what treatments do and do not work in palliative care.

Screening for cognitive symptoms among cancer patients during chemotherapy: Sensitivity and specificity of a single item self-report cognitive change score.

OBJECTIVES: Cognitive symptoms are commonly reported among cancer patients and survivors, yet guidance on when self-reported cognitive symptoms warrant follow-up is lacking. We sought to establish cut-off scores for identifying patients with perceived low cognitive functioning on widely used self-report measures of cognition and a novel single item Cognitive Change Score. METHODS: Adult patients diagnosed with invasive cancer who had completed at least one cycle of chemotherapy completed a questionnaire containing the EORTC-Cognitive Function (CF) subscale, Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) Perceived Cognitive Impairment (PCI) and our Cognitive Change Score (CCS). We used receiver operating characteristic analyses to establish the discriminative ability of these measures against the Patient's Assessment of Own Functioning Inventory (PAOFI) as our reference standard. We chose cut-off scores on each measure that maximised both sensitivity and specificity for identifying patients with self-reported low CF. RESULTS: We recruited 294 participants (55.8% women, mean age 56.6 years) with mixed cancer diagnoses (25.5 months since diagnosis). On the CCS, 77.6% reported some cognitive change since starting chemotherapy. On the PAOFI 36% had low CF. The following cut-off scores identified cases of low CF: ≥28.5 on the CCS (75.5% sensitivity, 67.6% specificity); ≤75.0 on the European Organisation for Research and Treatment of Cancer, QLQ-C30 Cognitive Functioning scale (90.9% sensitivity, 57.1% specificity); ≤55.1 on the FACT-COG PCI-18 (84.8% sensitivity, 76.2% specificity), and ≤59.5 on the FACT-COG PCI-20 (78.8% sensitivity, 84.1% specificity). CONCLUSIONS: We found a single item question asking about cognitive change has acceptable discrimination between patients with self-reported normal and low CF when compared to other more comprehensive self-report measures of cognitive symptoms. Further validation work is required.

The relationship between sleep and weight change among women diagnosed with breast cancer participating in the Women's Health Initiative.

PURPOSE: Short and long sleep duration and poor sleep quality are risk factors for weight gain and cancer mortality. The purpose of this study is to investigate the relationship between sleep and weight change among postmenopausal breast cancer survivors. METHODS: Women participating in the Women's Health Initiative who were diagnosed with incident breast cancer between year one and year three were included. Self-reported sleep duration was categorized as ≤ 5 h (short), 6 h, 7-8 h (optimal), and ≥ 9 h (long). Self-reported sleep quality was categorized as poor, average, and above average. Post-diagnosis weight change was the difference of weight closest to, but preceding diagnosis, and year 3 weight. We used linear regression to evaluate sleep duration and sleep quality associations with post-diagnosis weight change adjusted for potential confounders. RESULTS: Among 1156 participants, 63% were weight stable after diagnosis; average weight gain post cancer diagnosis was 3.2 kg. Six percent of women reported sleeping ≤ 5 h, 26% reported 6 h, 64% reported 7-8 h, and 4% reported ≥ 9 h. There were no differences in adjusted estimates of weight change among participants with short duration (0.37 kg; 95% CI - 0.88, 1.63), or long duration (- 0.56 kg; 95% CI - 2.03, 0.90) compared to optimal duration, nor was there a difference among poor quality (- 0.51 kg; 95% CI - 1.42, 0.41) compared to above average quality. CONCLUSION: Among postmenopausal breast cancer survivors, sleep duration and quality were not associated with weight change after breast cancer diagnosis. Future studies should consider capturing change in adiposity and to expand beyond self-reported sleep.

Elucidating symptoms of COVID-19 illness in the Arizona CoVHORT: a longitudinal cohort study.

OBJECTIVE: To elucidate the symptoms of laboratory-confirmed COVID-19 cases as compared with laboratory-confirmed negative individuals and to the untested general population among all participants who reported symptoms within a large prospective cohort study. SETTING AND DESIGN: This work was conducted within the framework of the Arizona CoVHORT, a longitudinal prospective cohort study conducted among Arizona residents. PARTICIPANTS: Eligible participants were any individual living in Arizona and were recruited from across Arizona via COVID-19 case investigations, participation in testing studies and a postcard mailing effort. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was a comparison of the type and frequency of symptoms between COVID-19-positive cases, tested but negative individuals and the general untested population who reported experiencing symptoms consistent with COVID-19. RESULTS: Of the 1335 laboratory-confirmed COVID-19 cases, 180 (13.5%) reported having no symptoms. Of those that did report symptoms, the most commonly reported were fatigue (82.2%), headache (74.6%), aches, pains or sore muscles (66.3%), loss of taste or smell (62.8) and cough (61.9%). In adjusted logistic regression models, COVID-19-positive participants were more likely than negative participants to experience loss of taste and smell (OR 12.1; 95% CI 9.6 to 15.2), bone or nerve pain (OR 3.0; 95% CI 2.2 to 4.1), headache (OR 2.6; 95% CI 2.2 to 3.2), nausea (OR 2.4; 95% CI 1.9 to 3.1) or diarrhoea (OR 2.1; 95% CI 1.7 to 2.6). Fatigue (82.9) and headache (74.9) had the highest sensitivities among symptoms, while loss of taste or smell (87.2) and bone or nerve pain (92.9) had the high specificities among significant symptoms associated with COVID-19. CONCLUSION: When comparing confirmed COVID-19 cases with either confirmed negative or untested participants, the pattern of symptoms that discriminates SARS-CoV-2 infection from those arising from other potential circulating pathogens may differ from general reports of symptoms among cases alone.