Introduction Immunocompromised individuals have suboptimal COVID-19 vaccine responses and may continue physically distancing to avoid COVID-19. The EAGLE Study aimed to quantify physical distancing behaviours and associations with health-related quality of life (HRQoL) and related measures in immunocompromised adults. Methods EAGLE was a cross-sectional, observational online survey study of US and UK immunocompromised adults, children and those children’s caregivers, with adult analyses reported here. Multichannel enrolment and self-reported data collection occurred from December 2022 to June 2023. Immunocompromising diagnosis confirmation using medical records was requested from a randomly selected subset. Physical distancing (in past 4 weeks) was measured using the Physical Distancing Scale for COVID-19 Avoidance (PDS-C19). HRQoL and related measures were the 12-item Short Form Health Survey version 2 (SF-12v2) (includes Short-Form 6-Dimensions), Quality of Life Disease Impact Scale-7-item (QDIS-7), Direct Measure of Loneliness, EQ-5D-5L, Hospital Anxiety and Depression Scale and Work Productivity and Activity Impairment plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP). Associations between PDS-C19 and HRQoL and related measures were assessed using Pearson correlation, linear regression (potential confounders-adjusted) and preliminary structural equation modelling (SEM). Results 2320 immunocompromised adults fully completed the survey. Confirmation of diagnosis was requested from 27% and confirmed for 90% of responders. 68% of participants reported moderate to high physical distancing. Physical distancing had low correlations with SF-12v2-measured HRQoL domains (range |r|=0.18 to 0.39) and medium correlations with QDIS-7 (r=0.78) and WPAI+CIQ:SHP-measured activity impairment (r=0.68) and presenteeism (r=0.51). In SEM, direct PDS-C19 relationships explained most activity correlations: QDIS, β=0.46 (SE=0.02); activity impairment, β=0.40 (0.02); presenteeism, β=0.29 (0.04). Unstandardised PDS-C19 confounder-adjusted linear regression coefficients were similar to those of SEM. Conclusions Over 3 years after COVID-19 emergence, a disproportionate number of immunocompromised adults reported substantially physically distancing to avoid COVID-19. Higher physical distancing intensities were associated with greater HRQoL impairments, suggesting such challenges coexist as ongoing concerns for immunocompromised adults.

Many immunocompromised individuals continue to practice physical distancing behaviors to avoid severe COVID-19 outcomes. To measure the intensity of these physical distancing behaviors, we aimed to develop and validate a standardized metric across age groups: the Physical Distancing Scale for COVID-19 Avoidance (PDS-C19©). PDS-C19 development involved content scoping, initial draft PDS-C19 design phase, and exploratory testing (via asynchronous online forums). Psychometric properties (structural validity, reliability, and construct validity) of the PDS-C19 were evaluated using a random sample of immunocompromised and non-immunocompromised participants (n = 1059) of the EAGLE Study, including adults and children aged 0.5–17 years from the US and UK. Adult caregivers of children aged ≤ 12 years completed a proxy version of the PDS-C19 on their behalf, in addition to providing self-reported responses. Findings from the two asynchronous forums (n = 23 and n = 22) indicated that the items identified in the scoping phase were relevant and well-understood. As part of the structural validity analysis, item-response distributions, inter-item correlations, and exploratory factor analyses supported a nine-item unidimensional intensity scale. Confirmatory factor analyses reduced the PDS-C19 to seven items (two items were dropped due to high residual correlations or differential item functioning by age). Internal consistency was high (ω = 0.97); convergent validity was good, with high correlations (rmax=0.74) with clinical outcome assessments of the ability to participate in activities and with worry. The PDS-C19 had good known-groups validity, with scores distinguishable by types of activities, level of worry, and number of close contacts. The PDS-C19 had acceptable structural and construct validity and high internal consistency, demonstrating its value as a measure of physical distancing to avoid COVID-19 in immunocompromised and non-immunocompromised individuals. Even though COVID-19 restrictions have been lifted, some people with weak immune systems still stay away from people and places to avoid getting COVID-19. This is called physical distancing. Physical distancing can make people’s lives less enjoyable and less productive. The aim of this study was to develop a survey to find out how much people are distancing. We first tested the survey on 24 people who were very vulnerable to COVID-19, including people with weak immune systems. We then gave the survey to 1059 people of all ages, both with and without weak immune systems. Caregivers completed the survey on behalf of young children. We used mathematical methods to test how well the survey worked. Based on these tests, we made improvements to the survey. The improved final survey worked well to show how much people of all ages, and with and without weak immune systems, physically distanced to avoid COVID-19.

Background:Comprehensive health-related quality of life (QOL) assessment under severe respondent burden constraints requires improved single-item scales for frequently surveyed domains. This article documents how new single-item-per-domain (SIPD) QOL General (QGEN-8) measures were constructed for domains common to SF-36 and results from the first psychometric tests comparing scores for the new measure in relation to those for the SF-36 profile and summary components.Research Design:Online NORC surveys of adults, ages 19-93 (mean=52 y) representing the US population in 2020 (N=1648) included QGEN-8 and SF-36 items measuring physical (PF), social (SF), role physical (RP) and role emotional (RE) functioning and feelings of bodily pain (BP), vitality (VT), and mental health (MH). QGEN-8 items were constructed with response categories increasing score ranges for functioning (PF, SF, RP, RE) and directly measuring first-order factors for feelings (BP, VT, and MH). Analyses compared ceiling effects, convergent-discriminant correlations, classic and confirmatory factor analysis (CFA) testing for higher-order physical and mental components, and validity in discriminating across groups differing in comorbid condition severity.Results:QGEN-8 reduced response times by 75% and lowered ceiling effect percentages (-2.2% to -27.8%, median=-14%) in comparison with SF-36. Their common measurement model was supported by: (1) substantial convergent correlations (r=0.576-0.778, median r=0.721) between methods for all domains; (2) lower discriminant correlations between different domains; (3) patterns of factor loadings equivalent to previous studies and adequate CFA model fit; (4) high correlations between methods for physical (r=0.813) and mental (r=0.761) component scores; and (5) equivalent average declines across groups reporting worse comorbid conditions.Conclusions:Overall, results support the use of QGEN-8 to reduce respondent burden and ceiling effects while maintaining convergent and discriminant validity sufficient to estimate group-level SF-36 physical (PCS) and mental (MCS) summary scores. To facilitate its use, QGEN-8 has been made available in multiple languages from the non-profit Mapi Research Trust at https://eprovide.mapi-trust.org.

When measuring disease-specific quality of life (QOL), scores from different instruments can almost never be compared, so clinical and research questions involving more than one disease cannot be answered. To overcome that limitation, the Quality of Life Disease Impact Scale (QDIS-7) uses standardized content and only one metric. We tested whether QDIS-7 scores are comparable across diseases. In an online survey, 2,627 adults who had sought care for headache, low-back pain, asthma, or diabetes, responded to the QDIS-7 and to a previously-validated disease-specific QOL instrument ("legacy scale") that measured QOL in their specific disease. Using the slopes of four independent regressions of legacy-scale scores on QDIS-7 scores, we tested the hypothesis that QDIS-7 scores can be compared across those four different medical conditions. The four regression-line slopes were nearly identical: 0.12 to 0.14 legacy-scale standard deviations per 1-point difference in QDIS-7 score. Thus, each 10-point difference in QDIS-7 scores was equal to slightly more than one standard-deviation difference in legacy-scale scores, for all four groups. The equivalence of the four slopes supports the use of the QDIS-7 to compare disease-specific QOL across different medical conditions. Thus, QDIS-7 users can answer clinical and research questions that are otherwise impossible to address.

BACKGROUND:Comprehensive health-related quality of life (QOL) assessment under severe respondent burden constraints requires improved single-item scales for frequently surveyed domains. This article documents how new single-item-per-domain (SIPD) QOL General (QGEN-8) measures were constructed for domains common to SF-36 and results from the first psychometric tests comparing scores for the new measure in relation to those for the SF-36 profile and summary components. RESEARCH DESIGN:Online NORC surveys of adults, ages 19-93 (mean=52 y) representing the US population in 2020 (N=1648) included QGEN-8 and SF-36 items measuring physical (PF), social (SF), role physical (RP) and role emotional (RE) functioning and feelings of bodily pain (BP), vitality (VT), and mental health (MH). QGEN-8 items were constructed with response categories increasing score ranges for functioning (PF, SF, RP, RE) and directly measuring first-order factors for feelings (BP, VT, and MH). Analyses compared ceiling effects, convergent-discriminant correlations, classic and confirmatory factor analysis (CFA) testing for higher-order physical and mental components, and validity in discriminating across groups differing in comorbid condition severity. RESULTS:QGEN-8 reduced response times by 75% and lowered ceiling effect percentages (-2.2% to -27.8%, median=-14%) in comparison with SF-36. Their common measurement model was supported by: (1) substantial convergent correlations (r=0.576-0.778, median r=0.721) between methods for all domains; (2) lower discriminant correlations between different domains; (3) patterns of factor loadings equivalent to previous studies and adequate CFA model fit; (4) high correlations between methods for physical (r=0.813) and mental (r=0.761) component scores; and (5) equivalent average declines across groups reporting worse comorbid conditions. CONCLUSIONS:Overall, results support the use of QGEN-8 to reduce respondent burden and ceiling effects while maintaining convergent and discriminant validity sufficient to estimate group-level SF-36 physical (PCS) and mental (MCS) summary scores. To facilitate its use, QGEN-8 has been made available in multiple languages from the non-profit Mapi Research Trust at https://eprovide.mapi-trust.org .

Practical considerations precluding health-related quality of life (HRQOL) monitoring in population and clinical research have spawned development of improved items for more brief surveys of frequently measured HRQOL outcomes. The aim of this study was to validate the use of the Quality of Life General (QGEN-8), a shorter 8-item alternative to the longer 36-item short form (SF)-36 Health Survey for measuring the same eight HRQOL domains across groups of adults with varying severity of acute respiratory symptoms, such as cough and sore throat. National Opinion Research Center (NORC) representative probability (N = 1,648) and supplemental opt-in (N = 5,915) U.S. adult samples were surveyed cross-sectionally online in 2020. Parallel analyses compared QGEN-8 and SF-36 estimates of group means for each of eight matching profile domains and summary physical and mental scores across groups differing in severity of acute symptoms and chronic respiratory conditions using analysis of covariance (ANCOVAs) controlling for socio-demographics and presence of chronic respiratory conditions. In support of discriminant validity, ANCOVA estimates of QGEN-8 means with SF-36 estimates revealed the same patterns of declining HRQOL with the presence and increasing severity of symptoms and chronic condition severity. QGEN-8® shows satisfactory validity and warrants further testing in cross-sectional and longitudinal population and clinical survey research as a more practical method for estimating group differences in SF-36 profile and summary component HRQOL scores. Upper respiratory tract infections (URTI) with symptoms such as cough and sore throat are highly prevalent and negatively impact on health-related quality of life (HRQOL). Existing instruments that comprehensively measure HRQOL are lengthy, potentially increasing respondent burden and restricting their use in clinical studies and research. The aim of this study was to evaluate whether eight newly constructed survey items, the QGEN-8®, measure the same HRQOL outcomes as the 36-item SF-36 Health Survey well enough to serve as a more practical alternative for purposes of detecting the physical and mental HRQOL effects on differing severity of acute URTI symptoms, specifically cough and sore throat. The results showed that the QGEN-8® was psychometrically sound and able to differentiate between different levels of URTI symptoms, even in cases where respondents had chronic respiratory conditions. This indicates that the briefer QGEN-8® with 75

Background: Immunocompromised individuals are known to respond inadequately to SARS-CoV-2 vaccines, placing them athigh risk of severe or fatal COVID-19. Thus, immunocompromised individuals and their caregivers may still practice varying degrees of social or physical distancing to avoid COVID-19. However, the association between physical distancing to avoidCOVID-19 and quality of life has not been comprehensively evaluated in any study.Objective: We aim to measure physical distancing behaviors among immunocompromised individuals and the associationbetween those behaviors and person-centric outcomes, including health-related quality of life (HRQoL) measures, health stateutilities, anxiety and depression, and work and school productivity impairment.Methods: A patient-informed protocol was developed to conduct the EAGLE Study, a large cross-sectional, observationalstudy, and this paper describes that protocol. EAGLE is designed to measure distancing behaviors and outcomes inimmunocompromised individuals, including children (aged >= 6 mo) and their caregivers, and nonimmunocompromised adults inthe United States and United Kingdom who report no receipt of passive immunization against COVID-19. We previously developeda novel self- and observer-reported instrument, the Physical Distancing Scale for COVID-19 Avoidance (PDS-C19), to measurephysical distancing behavior levels cross-sectionally and retrospectively. Using an interim or a randomly selected subset of thestudy population, the PDS-C19 psychometric properties will be assessed, including structural validity, internal consistency,known-group validity, and convergent validity. Associations (correlations) will be assessed between the PDS-C19 and validatedHRQoL-related measures and utilities. Structural equation modeling and regression will be used to assess these associations,adjusting for potential confounders. Participant recruitment and data collection took place from December 2022 to June 2023using direct-to-patient channels, including panels, clinician referral, patient advocacy groups, and social media, withimmunocompromising diagnosis confirmation collected and assessed for a randomly selected 25% of immunocompromisedparticipants. The planned total sample size is 3718 participants and participant-caregiver pairs. Results will be reported byimmunocompromised status, immunocompromising condition category, country, age group, and other subgroups.Results: All data analyses and reporting were planned to be completed by December 2023. Results are planned to be submittedfor publication in peer-reviewed journals in 2024-2025.Conclusions: This study will quantify immunocompromised individuals'physical distancing behaviors to avoid COVID-19and their association with HRQoL as well as health state utilities.International Registered Report Identifier (IRRID): RR1-10.2196/52643

Background: When studying health-related quality of life (QOL), disease-specific instruments have the advantage of measuring the unique effects of particular medical conditions. Almost every disease-specific QOL instrument uses its own metric, and measures QOL in its own content areas. The unfortunate result is that scores from different disease-specific QOL instruments cannot be compared. In contrast, the seven-item Quality of Life Disease Impact Scale (QDIS-7) has response choices on only one scale (one metric) and its content is standardized. Thus, the QDIS-7 should allow disease-specific QOL to be compared across different diseases. We therefore tested whether, unlike scores from the traditional mutually-incompatible metrics, those from the single-metric QDIS-7 are comparable across diseases. Methods: Responses to the QDIS-7 questions (regarding global QOL, physical functioning, role functioning, social functioning, vitality, mental health, and health outlook) were used to compute a single score, based on an item-response model. When the QDIS-7 was completed by respondents with different diseases, the content of the question-items was the same, and the only difference was the name of the disease to which the respondents explicitly attributed any impact on their QOL. In an online survey, 2,627 adults who had sought care for headache, low-back pain, asthma, or diabetes, each responded to the QDIS-7 and to a previously-validated disease-specific QOL instrument ("legacy scale") that was developed to measure QOL in their specific disease. We examined the slopes from four regressions of legacy-scale scores on QDIS-7 scores. Similarity of those slopes would support the hypothesis that the QDIS-7 enables quantitative comparisons of disease-specific QOL across those four different medical conditions. Results: For all four groups, the regression-line slopes were nearly the same: 0.12 to 0.14 legacy-scale standard deviations per 1-point difference in QDIS-7 score. Thus, each 10-point difference in QDIS-7 scores is equal to slightly more than one standard-deviation difference in legacy-scale scores, for all four groups. Conclusions: The relationships of score differences on the legacy measures to score differences on the QDIS-7 (i.e., the slopes) were similar across the four groups, which is consistent with the idea that the QDIS-7 enables comparisons of disease-specific QOL across different medical conditions. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement Funding for parts of this study came from the Ministry of Education, Culture, Sports, Science and Technology of Japan, through the Japan Society for the Promotion of Science. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: On August 21, 2020, the plan for this study (201611-3) was approved by the Institutional Review Board of the the Institute for Health Outcomes and Process Evaluation Research (iHope: ). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All reasonable requests for access to the data produced in the present study should be directed to the corresponding author.

Background Immunocompromised individuals are known to respond inadequately to SARS-CoV-2 vaccines, placing them at high risk of severe or fatal COVID-19. Thus, immunocompromised individuals and their caregivers may still practice varying degrees of social or physical distancing to avoid COVID-19. However, the association between physical distancing to avoid COVID-19 and quality of life has not been comprehensively evaluated in any study. Objective We aim to measure physical distancing behaviors among immunocompromised individuals and the association between those behaviors and person-centric outcomes, including health-related quality of life (HRQoL) measures, health state utilities, anxiety and depression, and work and school productivity impairment. Methods A patient-informed protocol was developed to conduct the EAGLE Study, a large cross-sectional, observational study, and this paper describes that protocol. EAGLE is designed to measure distancing behaviors and outcomes in immunocompromised individuals, including children (aged ≥6 mo) and their caregivers, and nonimmunocompromised adults in the United States and United Kingdom who report no receipt of passive immunization against COVID-19. We previously developed a novel self- and observer-reported instrument, the Physical Distancing Scale for COVID-19 Avoidance (PDS-C19), to measure physical distancing behavior levels cross-sectionally and retrospectively. Using an interim or a randomly selected subset of the study population, the PDS-C19 psychometric properties will be assessed, including structural validity, internal consistency, known-group validity, and convergent validity. Associations (correlations) will be assessed between the PDS-C19 and validated HRQoL-related measures and utilities. Structural equation modeling and regression will be used to assess these associations, adjusting for potential confounders. Participant recruitment and data collection took place from December 2022 to June 2023 using direct-to-patient channels, including panels, clinician referral, patient advocacy groups, and social media, with immunocompromising diagnosis confirmation collected and assessed for a randomly selected 25% of immunocompromised participants. The planned total sample size is 3718 participants and participant-caregiver pairs. Results will be reported by immunocompromised status, immunocompromising condition category, country, age group, and other subgroups. Results All data analyses and reporting were planned to be completed by December 2023. Results are planned to be submitted for publication in peer-reviewed journals in 2024-2025. Conclusions This study will quantify immunocompromised individuals’ physical distancing behaviors to avoid COVID-19 and their association with HRQoL as well as health state utilities. International Registered Report Identifier (IRRID) RR1-10.2196/52643

Introduction Hyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical adverse outcomes and to enable treatment with disease-modifying therapies including renin–angiotensin–aldosterone system inhibitors. However, the experiences of patients undergoing treatment of HK are not clearly understood. Optimising treatment decisions and improving long-term patient management requires a better understanding of patients’ quality of life (QOL). Thus, the aims of this research are: (1) to describe treatment patterns and the impact of treatment on a patient’s QOL, (2) to study the relationships between treatment patterns and the impact of treatment on a patient’s QOL and (3) to study the relationships between the control of serum potassium (S-K) and the impact of treatment on a patient’s QOL, in patients with HK.Methods and analysis This is a prospective cohort study with 6 months of follow-up in 30–40 outpatient nephrology and cardiology clinics in Japan. The participants will be 350 patients with CKD or CHF who received their first potassium binders (PB) prescription to treat HK within the previous 6 months. Medical records will be used to obtain information on S-K, on treatment of HK with PBs and with diet, and on the patients’ characteristics. To assess the impact of treatment on a patient’s QOL, questionnaires will be used to obtain generic health-related QOL, CKD-specific and CHF-specific QOL, and PB-specific QOL. Multivariable regression models will be used to quantify how treatment patterns and S-K control are related to the impact of treatment on a patient’s QOL.Ethics and dissemination Institutional review boards at all participating facilities review the study protocol. Patient consent will be obtained. The results will be published in international journals.Trial registration number NCT05297409.

Purpose Upper respiratory tract infections (URTI) and related symptoms are widespread and a common reason for visiting primary care with cough and sore throat being most prevalent. Despite their impact on daily activities, no studies have explored the impact on health-related quality of life (HRQOL) in representative general populations. We aimed to understand the short-term impact of the two most prevalent URTI symptoms on HRQOL. Methods Online 2020 surveys including acute (≤ 4 weeks) respiratory symptoms (sore throat and cough) and SF-36 ® health survey (all with 4-week recall) were analysed using analysis of covariance (ANCOVA) in comparison with adult US population norms. Linear T-score transformation of SF-6D utility (ranging from 0 to 1) enabled direct comparisons with SF-36. Results In total, 7563 US adults responded (average age: 52 years; range: 18–100 years). Sore throat and cough lasting at least several days were experienced by 14% and 22% participants, respectively. Chronic respiratory conditions were reported by 22% of the sample. A clear and consistent pattern of group HRQOL means declining significantly ( p < 0.001) for acute cough and sore throat symptom presence and severity. Declines were observed on SF-36 physical (PCS) and mental component (MCS) and health utility (SF-6D) scores controlling for covariates. Those reporting respiratory symptoms ‘most days’ declined ≥ 0.5 standard deviation (minimal important difference [MID]) worse with averages at the 19th and 34th centiles for cough on the PCS and MCS, and 21st to 26th centile for sore throat. Conclusion Declines in HRQOL with acute cough and sore throat symptoms consistently exceeded MID standards and should not be ignored as self-limiting without intervention. Future studies on early self-care for symptom relief and its implications on HRQOL and health economics would be valuable to understand the benefits on healthcare burden and need for updating treatment guidelines.

Journal of the American Academy of Orthopaedic Surgeons 31(20):p 1047, October 15, 2023. | DOI: 10.5435/JAAOS-D-23-00570

BACKGROUND:To prepare for a longitudinal study of the effects of potassium-lowering treatment on quality of life (QOL), we quantified the validity of a new disease-specific instrument for measuring QOL, using data from patients who had hyperkalemia (HK) due to chronic kidney disease (CKD) or chronic heart failure, and were also being treated with potassium binders (PBs).METHODS:In this cross-sectional study, the participants were 98 patients at five outpatient clinics in Japan. The outcome measures were the Medical Outcomes Study 36-item short-form (SF-36), a widely used generic measure of QOL, and the Quality of Life Disease-specific Impact Scale (QDIS-7), a recently-developed disease-specific measure of QOL. Internal-consistency reliability was quantified, and factor analysis was done to confirm hypothesized QOL dimensions. Validation tests used two external criteria: CKD stage, and PB formulation. PB formulation was used because different formulations are associated with different degrees of patients' burden. Using a previously-described method, we computed the relative validity (RV) of the two measures.RESULTS:Two factor scoring of the SF-36 and one factor scoring of the QDIS-7, as standardized from previous studies, were confirmed. The RVs showed that the QDIS-7 was much more valid than the SF-36, for discriminating between groups defined clinically (by CKD stage), and also between groups defined by PB formulation. Reliability was satisfactory: 0.73-0.95 for the SF-36 and 0.86 for the QDIS-7.CONCLUSIONS:The QDIS-7 with CKD or PB attributions was more valid than the SF-36 for measuring the effects of CKD and of PB formulation on QOL.

Abstract Background Interpretation of health-related quality of life (QOL) outcomes requires improved methods to control for the effects of multiple chronic conditions (MCC). This study systematically compared legacy and improved method effects of aggregating MCC on the accuracy of predictions of QOL outcomes. Methods Online surveys administered generic physical (PCS) and mental (MCS) QOL outcome measures, the Charlson Comorbidity Index (CCI), an expanded chronic condition checklist (CCC), and individualized QOL Disease-specific Impact Scale (QDIS) ratings in a developmental sample (N = 5490) of US adults. Controlling for sociodemographic variables, regression models compared 12- and 35-condition checklists, mortality vs. population QOL-weighting, and population vs. individualized QOL weighting methods. Analyses were cross-validated in an independent sample (N = 1220) representing the adult general population. Models compared estimates of variance explained (adjusted R2) and model fit (AIC) for generic PCS and MCS across aggregation methods at baseline and nine-month follow-up. Results In comparison with sociodemographic-only regression models (MCS R2 = 0.08, PCS = 0.09) and Charlson CCI models (MCS R2 = 0.12, PCS = 0.16), increased variance was accounted for using the 35-item CCC (MCS R2 = 0.22, PCS = 0.31), population MCS/PCS QOL weighting (R2 = 0.31–0.38, respectively) and individualized QDIS weighting (R2 = 0.33 & 0.42). Model R2 and fit were replicated upon cross-validation. Conclusions Physical and mental outcomes were more accurately predicted using an expanded MCC checklist, population QOL rather than mortality CCI weighting, and individualized rather than population QOL weighting for each reported condition. The 3-min combination of CCC and QDIS ratings (QDIS-MCC) warrant further testing for purposes of predicting and interpreting QOL outcomes affected by MCC.

Acute sore throat is the most prevalent symptom of upper respiratory tract infection (URTI) often accompanied by cough, affecting adult population and are common reasons for visiting primary care. The aim of this study was to assess the impact of symptom severity on HRQOL over the short-term. Adult and elderly participants were drawn from National Opinion Research Center (NORC) AmeriSpeak® panel and supplemental samples. Participants completed the survey online, fielded from April-July 2020. Data collected included acute respiratory symptoms and the SF-36 (4-week recall period) which was converted to adult US population norms. Data were analyzed using analysis of covariance. A total of 7,507 US adults completed the survey with an average age of 52 years (range: 18 to 100 years). Sore throat and cough lasting at least several days was experienced by 14% and 22% participants, respectively. Comorbidities were reported by 80% of the sample. A clear and consistent pattern was observed with HRQOL declining in line with increasing symptom severity. These results were observed on both, SF-36 physical (PCS) and mental component scores (MCS) as well as across all eight SF-36 domains, when covariates including co-morbidities were also controlled for. Those participants reporting cough symptoms on “most days”, scores corresponded to the 19th and 34th centiles on the PCS and MCS for the US adult population, and 21st to 26th centile for sore throat. These findings highlight that sore throat and cough severity significantly worsen HRQOL in the short-term. Thus, these symptoms should’nt be ignored as self-limiting but should drive early symptom management to avoid burden on HRQOL.

Practical considerations preclude HRQOL monitoring in population surveys and clinical research. A COS based on one-item HRQOL general(QGEN) measures is known to yield unbiased estimates of SF-36 & summary QOL measures with 75% reduced respondent burden. Whether it captures the HRQOL effects of common respiratory symptoms is unknown. We tested 2 approaches to COS measures:an 8-item QGEN and SF-36 for convergent validity & accuracy in discriminating groups differing in sore throat and cough severity. National Opinion Research Center (NORC) representative (N=1,570) & supplemental (N=4,828) U.S. adult samples were surveyed online in 2020. To compare symptom severity groups, two COS modules measuring the same 8 generic HRQOL domains and summary physical and mental scores were fielded. Data including gender, age, ethnicity, employment and comorbidities were analyzed using product-moment correlations and analysis of covariance. In support of convergent validity, high product-moment correlations were observed between QGEN item and SF-36 multi-item COS method estimates for all 8 common domains (0.578-0.767, median=0.702) and two summary HRQOL measures (0.841-0.847). Comparisons of means across severity groups for both methods revealed a clear and consistent pattern of declining HRQOL with worse symptom severity on controlling for covariates. QGEN-8 and SF-36 have satisfactory validity in relation to each other and for capturing the worsening of physical and mental HRQOL for groups with more frequent cough and sore throat. QGEN-8 warrants further testing as an alternative for estimating HRQOL outcomes in clinical studies requiring limited respondent burden.

It is clear that the field of cancer and health care in general very much need more cost effective ways to obtain new and better data about patient functioning, well-being and other generic health outcomes. The methods must be practical and they must satisfy the most crucial psychometric standards. The trade-off between practical considerations and psychometric standards has led to a rethinking of measurement strategy. An important feature of health is its dimensionality. Health has distinct components, that must be measured and interpreted separately, to fully understand health at a point in time, as well as changes in health over time. Interestingly, almost completely orthogonal to the physical functioning axis is the mental health axis, which includes psychological distress, psychological well-being, and life satisfaction. In most populations individuals at all levels of the physical functioning axis are observed at all levels of the mental health axis.

Objective To develop a tool for estimating the 10-year risk of death from other causes in men with localized prostate cancer. Subjects and methods We identified 2,425 patients from the Surveillance Epidemiology and End Results—Medicare Health Outcomes Survey database, age <80, newly diagnosed with clinical stage T1-T3a prostate cancer from 1/1/1998-12/31/2009, with follow-up through 2/28/2013. We developed a Fine and Gray competing-risks model for 10-year other cause mortality considering age, patient-reported comorbid medical conditions, component scores and items of the SF-36 Health Survey, activities of daily living, and sociodemographic characteristics. Model discrimination and calibration were compared to predictions from Social Security life table mortality risk estimates. Results Over a median follow-up of 7.7 years, 76 men died of prostate-specific causes and 465 died of other causes. The strongest predictors of 10-year other cause mortality risk included increasing age at diagnosis, higher approximated Charlson Comorbidity Index score, worse patient-reported general health (fair or poor vs. excellent-good), smoking at diagnosis, and marital status (all other vs. married) (all p<0.05). Model discrimination improved over Social Security life tables (c-index of 0.70 vs. 0.59, respectively). Predictions were more accurate than predictions from the Social Security life tables, which overestimated risk in our population. Conclusions We provide a tool for estimating the 10-year risk of dying from other causes when making decisions about treating prostate cancer using pre-treatment patient-reported characteristics.