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With the proliferation of cancer research based on large databases, misalignment of research questions and data set capabilities is inevitable. Nationally maintained databases are appealing to cancer researchers because of the ease of access to large amounts of patient data available for analysis and risk estimation. Data sets that are commonly used in cancer research include the National Cancer Database, the SEER (Surveillance, Epidemiology, and End Results) program of the National Cancer Institute, the SEER-Medicare database, the American College of Surgeons National Surgical Quality Improvement Program, and the Healthcare Cost and Utilization Project databases, among others. Each data set has pros and cons with respect to variable availability and the ability to analyze cancer-specific outcomes. It is critical for researchers to understand the strengths and limitations of each database. Changing variable definitions, the length of postoperative data collection, and the availability of patient-reported outcomes or social determinants of health data are examples of factors that researchers must consider when selecting a data set for research purposes. For the current review, the authors summarized the advantages and disadvantages of various national data sets for cohort studies in cancer populations.

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This editorial monograph explores the advances and pitfalls of the common forms of purposeful sampling. Purposeful sampling is a common research design in qualitative research.

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BACKGROUND: Research on smoking as a risk factor for death due to COVID-19 remains inconclusive, with different studies demonstrating either an increased or decreased risk of COVID-19 death among smokers. To investigate this controversy, this study uses data from the Netherlands to assess the relationship between smoking and death due to COVID-19. METHODS: In this population-based quasi-cohort study, we linked pseudonymized individual data on smoking status from the 2016 and 2020 'Health Monitor Adults and Elderly' in the Netherlands (n = 914 494) to data from the cause-of-death registry (n = 2962). Death due to COVID-19 in 2020 or 2021 was taken as the main outcome. Poisson regression modelling was used to calculate relative risks (RRs) and 95% CIs of death due to COVID-19 for current and former smokers compared with never smokers while adjusting for relevant confounders (age, sex, educational level, body mass index and perceived health). RESULTS: Former smokers had a higher risk of death due to COVID-19 compared with never smokers across unadjusted (RR, 2.22; 95% CI, 2.04-2.42), age-sex-adjusted (RR, 1.38; 95% CI, 1.22-1.55) and fully adjusted (RR, 1.30; 95% CI, 1.16-1.45) models. Current smokers had a slightly higher risk of death due to COVID-19 compared with never smokers after adjusting for age and sex (RR, 1.21; 95% CI, 1.00-1.48) and after full adjustment (RR, 1.08; 95% CI, 0.90-1.29), although the results were statistically non-significant. CONCLUSIONS: People with a history of smoking appear to have a higher risk of death due to COVID-19. Further research is needed to investigate which underlying mechanisms may explain this.

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BACKGROUND: While considerable research has been conducted on household food insecurity (HFI), little research has examined the effects of food donation programs on users' living conditions. The Pathways study was established to investigate the long-term effects of food donation programs on food insecurity as well as other critical outcomes, such as diet, health, and social support. Herein, we describe the design of the Pathways Study and the participants' characteristics at baseline. METHODS: The Pathways study is a prospective cohort study of 1001 food-aid users in Quebec (Canada). We recruited newly registered users of food donation programs from 106 community-based food-aid organizations that partnered with the study. Baseline data were collected through face-to-face interviews from September 2018 to January 2020, with planned follow-up interviews at 12 and 24 months after enrollment. Household food insecurity, diet, food competencies, food shopping behaviors, perceived food environment, health status, social support and isolation, sociodemographic characteristics, housing conditions, negative life events, and the impacts of COVID-19 were assessed with validated questionnaires. RESULTS: The cohort included 1001 participants living in rural (n = 181), semi-urban (n = 250), and urban areas (n = 570). Overall, household food insecurity was reported as severe among 46.2% and moderate in 36.9% of participants. Severe household food insecurity was more prevalent in rural (51.4%) and urban (47.8%) areas compared to semi-urban (39%) areas. Overall, 76.1% of participants reported an annual income below C$20,000. Half (52%) had low education levels (high school or lower), 22.0% lived in single-parent households, and 52.1% lived alone. Most (62.9%) experienced at least one major financial crisis in the preceding year. CONCLUSIONS: Results show that newly registered users of food donation programs often have low-income and severe food insecurity, with major differences across geographical locations. The Pathways study is the first study designed to follow, over a 2-year period, a cohort of newly registered users of food donation programs and to quantify their trajectories of service use. Findings from the Pathways study might help adapt the community response to the strategies used by food-insecure households to feed themselves.

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•Researchers must overcome multiple barriers in recruiting and retaining research participants living in conditions of vulnerability.•A comprehensive recruitment strategy that combines various elements tailored to vulnerable populations is required.•Most studies describing recruitment and retention of participants from vulnerable populations pertain to clinical settings.•This study describes strategies and challenges in recruiting participants through community organizations.•This paper provides recommendations on recruiting and retaining people living in conditions of extreme vulnerability.

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Monitoring of cognitive abilities in large-scale survey research is receiving increasing attention. Conventional cognitive testing, however, is often impractical on a population level highlighting the need for alternative means of cognitive assessment. We evaluated whether response times (RTs) to online survey items could be useful to infer cognitive abilities. We analyzed >5 million survey item RTs from >6000 individuals administered over 6.5 years in an internet panel together with cognitive tests (numerical reasoning, verbal reasoning, task switching/inhibitory control). We derived measures of mean RT and intraindividual RT variability from a multilevel location-scale model as well as an expanded version that separated intraindividual RT variability into systematic RT adjustments (variation of RTs with item time intensities) and residual intraindividual RT variability (residual error in RTs). RT measures from the location-scale model showed weak associations with cognitive test scores. However, RT measures from the expanded model explained 22−26% of the variance in cognitive scores and had prospective associations with cognitive assessments over lag-periods of at least 6.5 years (mean RTs), 4.5 years (systematic RT adjustments) and 1 year (residual RT variability). Our findings suggest that RTs in online surveys may be useful for gaining information about cognitive abilities in large-scale survey research.

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Pyrethroid insecticides are used, for example, in agriculture, indoor environments, and mosquito control programs, resulting in human exposure. Urinary 3-phenoxybenzoic acid (3-PBA) is a nonspecific biomarker for exposure to many pyrethroids. This systematic review identified human biomonitoring studies with 3-PBA that characterize environmental pyrethroid exposures in children and adolescents, pregnant women, and adults or occupational pyrethroid exposures relative to the National Health and Nutrition Examination Survey (NHANES) populations in the United States (US). PubMed, Embase, and SciFinder were searched for "3-phenoxybenzoic acid ", CAS No. 3739-38-6, and urine or urinary or urine level. Duplicate studies and studies meeting the exclusion criteria were removed from the search results based on predetermined exclusion criteria. This screening process identified 57 papers. Twenty-one, thirteen, twenty-two, and eleven manuscripts reported urinary 3-PBA levels in children, pregnant women, environmentally exposed adults, and occupationally exposed adults, respectively. Median 3-PBA levels ranged from 0.2 to 4.7 µg/g creatinine in children (1999-2016), 0.23-1.55 µg/g creatinine in pregnant women (1997-2014), and 0.11-3.34 µg/g creatinine in environmentally exposed adults (1999-2017). 3-PBA levels in occupationally exposed adults were significantly higher than in environmentally exposed populations, ranging from 0.43 to 14 µg/g creatinine (2004-2017). 3-PBA levels in children and adults from the general North American population increased significantly with the sampling year. A decrease in 3-PBA levels was noted in the adult cohorts from PR China and Japan. 3-PBA levels in most studies appeared to be comparable to levels in the NHANES populations; however, some smaller studies had high pyrethroid exposures. Factors contributing to higher 3-PBA levels in the general population included primarily dietary exposures and residential and agricultural pyrethroid applications. These findings demonstrate that pyrethroid exposures are near-ubiquitous worldwide and, in some regions, appear to increase over time. Thus, exposures to pyrethroid insecticides represent a continuing public health concern.

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OBJECTIVES/HYPOTHESIS: A subset of patients will undergo revision endoscopic sinus surgery (ESS) with a different otolaryngologist than the one who performed their primary surgery. The purpose of this study is to report the incidence of and clinicodemographic factors associated with a change in surgeon for revision ESS. STUDY DESIGN: Retrospective cohort study. METHODS: Adult patients who underwent at least two outpatient ESS procedures between 2009 and 2014 using the State Ambulatory Surgery Database for Florida were included in the study. Change in surgeon was defined by a change in a unique provider identifier for the revision procedure. Multivariable regression analysis was used to determine characteristics associated with a change in surgeon. RESULTS: A total of 2,963 patients were included. For the revision procedure, 47.7% of patients changed their surgeon. On multivariable logistic regression, a medium- (odds ratio [OR]: 0.64; 95% confidence interval [CI]: 0.53-0.77) or high-volume (OR: 0.50; 95% CI: 0.42-0.61) surgeon performing the index surgery and advanced age (≥65 years) (OR: 0.79; 95% CI: 0.63-0.99) were associated with decreased odds of surgeon change for revision ESS. Longer time elapsed between index and revision surgery (OR: 1.15; 95% CI: 1.13-1.17) was associated with increased odds of surgeon change. CONCLUSIONS: Nearly half of patients who undergo revision ESS select a surgeon other than the one who performed their primary procedure. Surgeon volume, age, and time between surgeries affect the likelihood of a change in surgeon for revision ESS. These findings may provide introductory insights into patient preferences and decision making in the surgical management of recalcitrant chronic rhinosinusitis. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E1049-E1053, 2021.

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BACKGROUND: In a community sample of slow-to-talk toddlers, we aimed to (a) quantify how well maternal responsive behaviors at age 2 years predict language ability at age 4 and (b) examine whether maternal responsive behaviors more accurately predict low language status at age 4 than does expressive vocabulary measured at age 2 years. DESIGN OR METHODS: Prospective community-based longitudinal study. At child age 18 months, 1,138 parents completed a 100-word expressive vocabulary checklist within a population survey; 251 (22.1%) children scored ≤20th percentile and were eligible for the current study. Potential predictors at 2 years were (a) responsive language behaviors derived from videotaped parent-child free-play samples and (b) late-talker status. Outcomes were (a) Clinical Evaluation of Language Fundamentals-Preschool Second Edition receptive and expressive language standard score at 4 years and (b) low language status (standard score > 1.25 standard deviations below the mean on expressive or receptive language). RESULTS: Two hundred eight (82.9% of 251) participants were retained to age 4. In adjusted linear regression analyses, maternal expansions predicted higher receptive (p < 0.001, partial R2  = 6.5%) and expressive (p < 0.001, partial R2  = 7.7%), whereas labels predicted lower receptive (p = 0.01, partial R2  = 2.8%) and expressive (p = 0.007, partial R2  = 3.5%) language scores at 4. The logistic regression model containing only responsive behaviors achieved "fair" predictive ability of low language status at age 4 (area under curve [AUC] = 0.79), slightly better than the model containing only late-talker status (AUC = 0.74). This improved to "good" predictive ability with inclusion of other known risk factors (AUC = 0.82). CONCLUSION: A combination of short measures of different dimensions, such as parent responsive behaviors, in addition to a child's earlier language skills increases the ability to predict language outcomes at age 4 to a precision that is approaching clinical value. Research to further enhance predictive values should be a priority, enabling health professionals to identify which slow-to-talk toddlers most likely will or will not experience later poorer language.

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Objective Tympanostomy tube (TT) insertion is the most common ambulatory surgery performed on children. American Academy of Otolaryngology-Head and Neck Surgery Founda-tion (AAO-HNSF) Clinical Practice Guidelines (CPGs) recommend hearing testing for all pediatric TT candidates. The aim of this study was to assess audiometric testing in this population. Study Design Retrospective population-based cohort study. Setting All hospitals in the Canadian province of Ontario. Subjects and Methods All patients 12 years of age and younger who underwent at least 1 TT procedure between January 1993 and June 2016. The primary outcomes were the percentage of patients who underwent a hearing test within 1 year before and/or 1 year after surgery. Results A total of 316,599 bilateral TT procedures were performed during the study period (1993 to 2016). Presurgical hearing tests increased from 55.7% to 74.9%, and postsurgical hearing tests increased from 42.2% to 68.9%. Younger surgeons demonstrated a greater adherence to the CPGs (relative risk [RR], 1.22; 95% CI, 1.08-1.38; P = .001). Remarkably, there was not a spike in preoperative hearing tests following the introduction of the CPGs in 2013 (RR, 1.12; 95% CI, 0.85-1.47; P = .432). Presurgical hearing testing ranged from 26.1% to 83.5% across health regions. Conclusion In this cohort of children who underwent TT placement, the trends of preoperative and postoperative audiometric testing are increasing but are still lower than recommended by the CPGs, despite a tripling of practicing audiologists. This study describes the current state of testing in Ontario and highlights issues of access to audiology services, possible parent preferences, and the importance of ongoing continuing medical education for all health care practitioners.

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BACKGROUND: There is increasing availability of data derived from diagnoses made routinely in mental health care, and interest in using these for research. Such data will be subject to both diagnostic (clinical) error and administrative error, and so it is necessary to evaluate its accuracy against a reference-standard. Our aim was to review studies where this had been done to guide the use of other available data. METHODS: We searched PubMed and EMBASE for studies comparing routinely collected mental health diagnosis data to a reference standard. We produced diagnostic category-specific positive predictive values (PPV) and Cohen's kappa for each study. RESULTS: We found 39 eligible studies. Studies were heterogeneous in design, with a wide range of outcomes. Administrative error was small compared to diagnostic error. PPV was related to base rate of the respective condition, with overall median of 76 %. Kappa results on average showed a moderate agreement between source data and reference standard for most diagnostic categories (median kappa = 0.45-0.55); anxiety disorders and schizoaffective disorder showed poorer agreement. There was no significant benefit in accuracy for diagnoses made in inpatients. CONCLUSIONS: The current evidence partly answered our questions. There was wide variation in the quality of source data, with a risk of publication bias. For some diagnoses, especially psychotic categories, administrative data were generally predictive of true diagnosis. For others, such as anxiety disorders, the data were less satisfactory. We discuss the implications of our findings, and the need for researchers to validate routine diagnostic data.

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PURPOSE: Policy is increasingly focused on implementing a recovery-orientation within mental health services, yet the subjective experience of individuals receiving a pro-recovery intervention is under-studied. The aim of this study was to explore the service user experience of receiving a complex, pro-recovery intervention (REFOCUS), which aimed to encourage the use of recovery-supporting tools and support recovery-promoting relationships. METHODS: Interviews (n = 24) and two focus groups (n = 13) were conducted as part of a process evaluation and included a purposive sample of service users who received the complex, pro-recovery intervention within the REFOCUS randomised controlled trial (ISRCTN02507940). Thematic analysis was used to analyse the data. RESULTS: Participants reported that the intervention supported the development of an open and collaborative relationship with staff, with new conversations around values, strengths and goals. This was experienced as hope-inspiring and empowering. However, others described how the recovery tools were used without context, meaning participants were unclear of their purpose and did not see their benefit. During the interviews, some individuals struggled to report any new tasks or conversations occurring during the intervention. CONCLUSION: Recovery-supporting tools can support the development of a recovery-promoting relationship, which can contribute to positive outcomes for individuals. The tools should be used in a collaborative and flexible manner. Information exchanged around values, strengths and goals should be used in care-planning. As some service users struggled to report their experience of the intervention, alternative evaluation approaches need to be considered if the service user experience is to be fully captured.

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OBJECTIVE: The goal of this study was to identify distinct frailty trajectories (clusters of individuals following a similar progression of frailty over time) in an ageing population and to determine social and behavioural factors associated with frailty trajectories. DESIGN: Population-based cohort study. SETTING: Olmsted County, Minnesota. PARTICIPANTS: Olmsted County, Minnesota residents aged 60-89 in 2005. PRIMARY OUTCOME MEASURE: Changes in frailty over an 8-year period from 2005 to 2012, measured by constructing a yearly frailty index. Frailty trajectories by decade of age were determined using k-means cluster modelling for longitudinal data. RESULTS: After adjustment for age and sex, all social and behavioural factors (education, marital status, living arrangements, smoking status and alcohol use) were significantly associated with frailty trajectories in those aged 60-69 and 70-79 years. After further adjustment for baseline frailty, the likelihood of being in the high frailty trajectory was greatest among those reporting concerns from relatives/friends about alcohol consumption (OR (95% CI) 2.26 (1.19 to 4.29)) and those with less than a high school education (OR (95% CI) 1.98 (1.32 to 2.96)) in the 60-69 year olds. In the 70-79 year olds, the largest associations were observed among those with concerns from oneself about alcohol consumption (OR (95% CI) 1.92 (1.23 to 3.00)), those with less than a high school education (OR (95% CI) 1.57 (1.12 to 2.22)), and those living with family (vs spouse; OR (95% CI) 1.76 (1.05 to 2.94)). No factors remained associated with frailty trajectories in the 80-89 year olds after adjustment for baseline frailty. CONCLUSIONS: Social and behavioural factors are associated with frailty, with stronger associations observed in younger ages. Recognition of social and behavioural factors associated with increasing frailty may inform interventions for individuals at risk of worsening frailty, specifically when targeted at younger individuals.

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OBJECTIVES: To identify distinct frailty trajectories (clusters of individuals following a similar progression of frailty over time) in an aging population and to estimate associations between frailty trajectories and emergency department visits, hospitalizations, and all-cause mortality. DESIGN: Population-based cohort study. SETTING: Olmsted County, Minnesota. PARTICIPANTS: Olmsted County, Minnesota residents aged 60-89 in 2005. MEASUREMENTS: Longitudinal changes in frailty between 2005 and 2012 were measured by constructing a yearly Rockwood frailty index incorporating body mass index, 17 comorbidities, and 14 activities of daily living. The frailty index measures variation in health status as the proportion of deficits present of the 32 considered (range 0-1). RESULTS: Of the 16,443 Olmsted County residents aged 60-89 in 2005, 12,270 (74.6%) had at least 3 years of frailty index measures and were retained for analysis. The median baseline frailty index increased with age (0.11 for 60-69, 0.14 for 70-79, 0.19 for 80-89). Three distinct frailty trajectories were identified in individuals aged 60-69 at baseline and two trajectories in those aged 70-79 and 80-89. Within each decade of age, increasing frailty trajectories were associated with greater risks of emergency department visits, hospitalization, and all-cause mortality, even after adjustment for baseline frailty index. CONCLUSION: The number of frailty trajectories differed according to age. Within each age group, those in the highest frailty trajectory had greater healthcare use and worse survival. Frailty trajectories may offer a way to target aging individuals at high risk of hospitalization or death for therapeutic or preventive interventions.

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The Kavli HUMAN Project (KHP) will provide groundbreaking insights into how biological, medical, and social factors interact and impact the risks for cognitive decline from birth through older age. It will richly measure the effect of cognitive decline on the ability to perform key activities of daily living. In addition, due to its family focus, the KHP will measure the impact on family members, including the amount of time that family members spend providing care to older adults with dementia. It will also clarify the division of caregiving duties among family members and the effects on caregivers' work, family life, and balance thereof. At the same time, for care that the family cannot provide, it will clarify the extent to which cognitive decline impacts healthcare utilization and end-of-life decision making.

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BACKGROUND: Growing numbers of older women receive adjuvant breast cancer therapies, but little is known about the long-term effects of current therapies upon health-related quality of life outside of clinical trials. METHODS: A population-based cohort of postmenopausal women with incident breast cancer aged sixty-five and older was identified from Medicare claims from four states and followed over five years. General health-related quality of life (HRQOL) was assessed using the Medical Outcomes Study SF-12 Health Survey, and breast cancer-related HRQOL was assessed using the breast cancer subscale of the functional assessment of cancer therapy (FACT-B BCS). The association of HRQOL with sociodemographic variables, comorbidity, and breast cancer variables (stage, treatments, and treatment sequelae) was examined in longitudinal models. RESULTS: Among the 3083 older breast cancer survivors, general HRQOL as measured by SF-12 mental and physical component scores was similar to norms for non-cancer populations, and remained stable throughout follow-up. Breast cancer treatments, including surgery and radiation, adjuvant hormonal therapy, and cytotoxic chemotherapy were not associated with worsened general health scores. A similar pattern was seen for breast cancer-related HRQOL scores, except that chemotherapy was associated with slightly worse scores. Lymphedema occurred in 17% of the cohort, and was strongly associated with all measures of HRQOL. Reductions in general HRQOL with lymphedema development were larger than those with an age increase of 10 years. CONCLUSIONS: There is little association of breast cancer treatment with HRQOL in older breast cancer patients followed for up to five years, but the development of lymphedema is associated with substantial reductions in HRQOL.

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OBJECTIVE: A new meningococcal serogroup B (Men B) vaccine has been licensed in the European Union (EU) and Australia. This study aimed to assess community and parental attitudes to introduction of new Men B vaccines and identify facilitators and barriers to vaccine implementation. METHODS: Cross-sectional survey including face-to-face interviews with adolescents, parents and adults from randomly selected households in South Australia in 2012. Survey data were weighted to the age, gender and geographical area profile of the population. RESULTS: 3055 interviews were conducted with individuals aged 15-97 years, including 966 parents. Participation rate was 66.4%. 82.5% (95% CI 79.7-85.4) of parents (797/966) wanted their child to receive the Men B vaccine, with 12.2% (9.7-14.7) (118/966) unsure. Main parental concerns included potential side effects (41.3% (26.7-46.0)) and adequate vaccine testing (11.7% (9.4-14.1)). Potential for an extra injection at an immunisation visit resulted in 15.7% (12.8-18.5) of parents (n=152/966) less likely to have their child immunised. Potential redness/swelling at the injection site or mild/moderate fever resulted in only 8.5% (6.3-10.7) and 10.8% (8.5-13.2) of parents, respectively, less likely to have their child immunised. Children being up to date with vaccinations and recommendation from family physician were the strongest independent predictors of parents agreeing their children should be immunised with Men B vaccine (OR=6.58; p=0.006 and OR=4.15; p<0.001, respectively). Only 16.4% (14.9-17.9) of adults (501/3055) stated that they would not want to receive a Men B vaccine, with family physician recommendation the strongest independent predictor of acceptance (OR=3.81; p<0.001). CONCLUSIONS: There is strong community support for introduction of Men B vaccines, with parental willingness to have children immunised, impacted more by number of injections than potential for adverse events such as local reactions or fever.

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