Background PATHFINDER was a prospective cohort study of multicancer early detection (MCED) testing in an outpatient ambulatory population. The aim of this study is to report the patient-reported outcomes (PROs) collected as secondary and exploratory measures in the PATHFINDER study. Methods PATHFINDER is a prospective, multicentre, cohort study that enrolled existing healthy ambulatory outpatients at seven health networks in the USA, including hospitals, academic medical centres, and integrated health systems. Enrolled adults were aged 50 years or older without clinical suspicion of cancer, with or without additional cancer risk factors (smoking history, genetic predisposition, or previous cancer diagnosis). The primary objective was time to diagnostic resolution after an MCED cancer signal detected (CSD) result and extent of testing pursued. The objectives of the 12-month PATHFINDER study reported here were assessment of patient-reported outcomes and perceptions with MCED testing (the effect of the MCED test result disclosure, general anxiety symptoms, health-related quality of life, and satisfaction with the MCED test). PRO instruments used included an adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) for distress, uncertainty, and positive experience at MCED test result disclosure; PRO Measurement Information System (PROMIS) Anxiety short-form for anxiety symptoms; and Short Form 12-Item Health Survey (SF-12v2) for health-related quality of life. Intentions towards adherence to guideline recommended screening was also assessed as an exploratory objective. This study is registered at ClinicalTrials.gov, NCT04241796, and is complete. Findings Between Dec 12, 2019, and Dec 4, 2020, 6662 participants were recruited and 6621 eligible participants had analysable MCED test results (n=92 CSD and n=6529 no CSD [NCSD]). The majority of participants were women (4204 [63·5%] of 6621) and White (6071 [91·7%] of 6621). For participants who completed the MICRA at results disclosure, the mean total MICRA score was 28·4 (SD 14·9) for the 50 patients with a CSD result and 8·8 (7·2) for those with an NCSD result (n=5864 completed the full questionnaire). Mean general anxiety scores increased in true-positive and false-positive groups at results disclosure. The PROMIS anxiety true-positive group baseline score of 46·2 (SD 6·5; n=35) increased to 48·4 (7·3; n=19) and the scores in the false-positive group increased from 47·3 (7·3; n=52) to 49·7 (7·7; n=30). Mean scores in both groups returned towards baseline by end of study (true positive 46·8, SD 8·0; n=28; false positive 46·9, 8·1; n=41). Mean SF-12v2 mental component summary and scale scores were within the average general population range at all timepoints. A high proportion of participants (5749 [97·1%] of 5920) responded they were “satisfied”, “very satisfied”, or “extremely satisfied” with the MCED test, with this proportion highest in those with NCSD (5698 [97·2%] of 5861), followed by those with a true-positive MCED result (23 [92·0%] of 25) and those with a false-positive result (28 [82·4%] of 34). Most participants indicated they were likely or very likely to adhere to health-care providers' future cancer screening recommendations at end of study (5182 [95·6%] of 5418). Interpretation The negative patient-reported effects associated with a CSD result from MCED testing were small and returned to baseline within 12 months for participants with or without a cancer diagnosis. PATHFINDER results indicate potential clinical benefit of early cancer detection and minimal patient distress associated with MCED testing. Funding GRAIL.

To refine the 23-item chronic Hepatitis B quality of life instrument (CHBQOL) using the modified Delphi method and Rasch model analysis, this study conducted a secondary data analysis on 578 chronic Hepatitis B (CHB) patients. The preliminary evaluation of the item's importance of the original CHBQOL and the final review of the short form of CHBQOL (CHBQOL-SF) were collected by the Delphi method. A bi-factor model was estimated and Rasch analysis with partial credit model was performed on each domain of the CHBQOL. Six items were suggested to remove based on the Delphi results. The fit of the bi-factor model was acceptable (RMSEA = 0.040; CFI = 0.983; TLI = 0.965). Disordered thresholds were initially found on three out of five items in Somatic symptoms, and four out of six items in Social stigma. Uniform differential item functioning was observed for three items for age group, two items for gender, and one item each for different ALT levels and HBV-DNA levels. Finally, the 10-item CHBQOL-SF retained the four-dimensional structure of the original instrument. The 10 items fit the Rasch model well and response options were set reasonably. The 10-item CHBQOL-SF would offer a brief and easily administrative CHB-specific patient-reported outcome measure for use in clinical practice and population studies.

PURPOSE:Limited evidence evaluates parents' perceptions of their child's clinical genome-scale sequencing (GS) results, particularly among individuals from medically underserved groups. Five Clinical Sequencing Evidence-Generating Research consortium studies performed GS in children with suspected genetic conditions with high proportions of individuals from underserved groups to address this evidence gap. METHODS:Parents completed surveys of perceived understanding, personal utility, and test-related distress after GS result disclosure. We assessed outcomes' associations with child- and parent-related factors: child age; type of GS finding; and parent health literacy, numeracy, and education. RESULTS:A total of 1763 parents completed surveys; 83% met "underserved" criteria based on race, ethnicity, and risk factors for barriers to access. We observed high perceived understanding and personal utility and low test-related distress. Outcomes were associated with the type of GS finding; parents of children with a pathogenic or likely pathogenic finding endorsed higher personal utility and more test-related distress than those whose children had a variant of uncertain significance or normal finding. Personal utility was higher in parents who met the criteria for "underserved." CONCLUSION:Our findings shed light on correlates of parents' cognitive and emotional responses to their child's GS findings and emphasize the need for tailored support in disclosure discussions.

10608 Background: Cancer is one of the most feared diseases. Multi-cancer early detection (MCED) tests have the potential to expand the number of cancers that are detected at earlier stages, which could result in better clinical outcomes. However, behavioral impacts based on MCED test results could affect the utility and value of these tests. Methods: Two independent data sources evaluated the impact of MCED test results on behavioral intentions and perceptions: a survey of the general population and PRO in an MCED clinical trial. A web-based, 30-minute survey of the US general population was used to ascertain attitudes toward a hypothetical MCED test. Eligible respondents were adults aged 40-80 years without a cancer diagnosis in the previous 5 years. The survey assessed the perceived value of negative results (ie, no cancer signal detected [NCSD]) and the projected impact on post-test behaviors. The prospective PATHFINDER study (NCT04241796) of adults aged ≥50 years who underwent MCED cancer screening included PRO assessments. Post-test assessments included: "I am feeling relieved about my test result" from the adapted MICRA and “How likely are you to follow your healthcare provider’s cancer screening recommendations.” The consistency of sentiment after an NCSD MCED result from the online survey and clinical study was assessed. Results: Of the 1073 online survey respondents, 53% were female, 77% White, 14% Black/African American, and 13% Hispanic. Mean age was 58 years. The most common anticipated emotional impacts were relief (84%), happiness (72%), and confidence (69%). Respondents (66-70%) reported they would expect less worry, fear, stress, and anxiety after an NCSD MCED result. The majority (73%) reported they would maintain or improve health behaviors after an NCSD result. NCSD results were projected to lead to an increase in health-related behaviors, including adherence to recommended cancer screening (98%; 68% increase, 30% maintain current level) and regular doctor visits (46%). Of the 6529 PATHFINDER study participants who received NCSD results, 64% were female, 92% White. Mean age was 63 years. 80% of participants (n = 4685/5865) with NCSD felt relief "sometimes" or "often" after their MCED test result. Over 95% of participants (n = 5637/5863) with NCSD indicated they were "likely" or "very likely" to adhere to cancer screening recommendations in the future. Conclusions: Results from a general population survey and a prospective clinical study indicate that an NCSD result may be associated with positive cancer screening intentions and other preventive healthcare behaviors. An NCSD result may also positively impact psychological and emotional health. While these findings suggest that an NCSD result may provide additional value beyond traditional clinical benefits associated with cancer screening, future research is needed to delineate the behavioral impact following MCED screening. Clinical trial information: NCT04241796 .

BACKGROUND:No previously validated patient-reported experience measures exist for use among patients undergoing home dialysis. We tested the Home Dialysis Care Experience survey, a newly developed 26-item experience measure, among patients from 30 dialysis facilities in the United States. METHODS:Using mail and telephone survey modalities, we approached 1372 patients treated with peritoneal dialysis or home hemodialysis for participation. Using the results from completed surveys, we evaluated item calibration by assessing item floor and ceiling effects. We tested three sets of composite scores and used factor analysis to assess model fit for each. We evaluated associations of composite scores with global ratings and separately with patient and dialysis facility characteristics. Finally, we measured test-retest reliability in patients who completed the survey at two separate time points. RESULTS:Overall, 495 eligible patients completed at least one survey (response rate 36%). Of these, 49 completed the survey in Spanish and 61 completed a second survey within 30 days. We did not detect significant floor or ceiling effects, except for one item that demonstrated >90% responses at the top response option. Analyses supported one 12-item composite scale with high internal consistency reliability: Quality of Home Dialysis Care and Operations (Cronbach alpha=0.85). This scale strongly correlated with overall staff rating ( r =0.73) and overall center rating ( r =0.70). Patient demographic and dialysis facility characteristics were not consistently associated with composite scale scores or overall staff or center ratings. Intraclass correlation coefficients in the test-retest population were 0.74 for the Quality scale, 0.88 for overall staff rating, and 0.90 for overall center rating. CONCLUSIONS:The Home Dialysis Care Experience survey is a 26-item measure that includes one composite scale and two global rating scores and is an informative tool to evaluate patient experience of care for home dialysis.

Objectives (1) Assess caregiver-reported development in infants born with cleft lip ± alveolus (CL ± A) and cleft lip and palate (CLP); (2) determine factors associated with increased developmental risk; and (3) determine consistency of developmental risk before and after surgery for cleft lip. Design Prospective, longitudinal assessment of development. Time (T) 1, prior to lip closure; T2, 2 months post lip closure. Setting Three US craniofacial teams and online parent support groups. Participants 123 total caregivers (96% mothers); 100 at T1, 92 at T2, and 69 at both T1 and T2. Measure Ages and Stages Questionnaire-3 (ASQ-3): Communication, Gross Motor, Fine Motor, Problem Solving, Personal Social Domains. Results At T1 47%; at T2 42% passed all 5 Domains; 36% of infants pass all 5 Domains at both T1 and T2. Infants with CLP were at greatest risk on Communication [ B = 1.449 (CI = .149-20.079), p = .038; Odds Ratio (OR) = 4.3 (CI = .923-19.650)] and Gross Motor Domains [ B = 1.753 (CI = .316-20.605), p = .034; OR = 5.8 (CI = 1.162-28.671)]. Male infants were at greatest risk on Fine Motor [ B = 1.542 (CI = .495-20.005), p = .009; OR = 4.7 (CI = 1.278-17.101)] and Problem Solving Domains [ B = 1.200 (CI = .118-19.708), p = .044; OR = 3.3 (CI = .896-12.285)]. Conclusions Based on caregiver report, infants with CL ± A and CLP meet referral criteria at a high rate. Infants with CLP and male infants were at greatest risk. Regular developmental screening is recommended.

Introduction: There is an increased demand for well-validated PROMs in otology. This study will systematically assess the methodological quality of all published patient-reported outcome measures (PROMS) for patients with multiple ear complaints and to identify the best suitable PROM for use by clinicians treating patients with multiple ear complaints. Methods: An extensive systematic mapping review on all otology questionnaires was performed to identify questionnaires measuring multiple ear complaints. The ‘Consensus‐based standards for the selection of health measurement Instruments’ (COSMIN) checklists were used to evaluate the quality of the questionnaire by two researchers. The worst item score per aspect of the methodological assessment counted. Results: Twelve multiple complaint questionnaires were included in the study for quality assessment. Ten questionnaires were disease specific (COMQ-12, CES, ZCMEI-21, MD-POSI, PAN-QOL, ETDQ-7, MDOQ, GYSSCDQ, COMOT-15 and DEU-MDDS). Two questionnaires were ear domain specific (OQUA and COQOL). The majority of multiple complaint questionnaires lacked good design with concept elicitation and patient involvement. Conclusion: For the majority of questionnaires, the quality assessment was inadequate as only a few authors consulted with patients affected by the complaints in the development. Modifications of earlier versions of PROMS or combinations of multiple questionnaires lead to ongoing (cross-cultural) validation of these questionnaires albeit the mediocre design and validation. The two domain specific questionnaires are the COQOL and OQUA, both with adequate quality but different focus. COOQL to quantify the quality of life and OQUA to measure and evaluate severity and impact of ear complaints.

Objective To evaluate the sensitivity to change of daily ratings of the comfort (COMF) and behavioral/emotional health (BEH) domains of the Infants with Clefts Observation Outcomes Instrument (iCOO) at 3 time points, and to assess the association of post-surgical interventions on iCOO ratings. Design The COMF and BEH domains were completed by caregivers before (T0), immediately after (T1), and 2-months after (T2) cleft lip (CL) surgery. Analyses included descriptive statistics, correlations, t-tests, and generalized estimating equations. Participants Caregivers ( N = 140) of infants with CL with/without cleft palate. Main Outcome Measures The COMF and BEH domain scores of the iCOO: Scale (SCALE), a summary of observable signs; and Global Impression (IMPR), a single item measuring caregivers’ overall impression. Results Daily COMF and BEH SCALE and IMPR scores changed significantly during T1 ( P's < 0.001) but not T0 or T2. Day 1 and 7 T0 scores were significantly higher than Day 1 and 7 T1 scores ( P's <0.001 to <0.012) but similar at T2 ( P's > 0.05). After CL surgery, the combined use of immobilizers and nasal stents and the use of multiple feeding methods with treatment for gastroesophageal reflux were associated with lower daily scores in COMF and BEH SCALE and IMPR ( P's: 0.040 to <0.001). Conclusions COMF and BEH iCOO scores were sensitive to daily changes in infant well-being following CL surgery. Future studies should further investigate impact of post-surgical treatments on infant well-being.

Abstract Background The involvement of quality of life as the UNAIDS fourth 90 target to monitor the global HIV response highlighted the development of patient-reported outcome (PRO) measures to help address the holistic needs of people living with HIV/AIDS (PLWHA) beyond viral suppression. This study developed and tested preliminary measurement properties of a new patient-reported outcome (PROHIV-OLD) measure designed specifically to capture influences of HIV on patients aged 50 and older in China. Methods Ninety-three older people living with HIV/AIDS (PLWHA) were interviewed to solicit items and two rounds of patient cognitive interviews were conducted to modify the content and wording of the initial items. A validation study was then conducted to refine the initial instrument and evaluate measurement properties. Patients were recruited between February 2021 and November 2021, and followed six months later after the first investigation. Classical test theory (CTT) and item response theory (IRT) were used to select items using the baseline data. The follow-up data were used to evaluate the measurement properties of the final instrument. Results A total of 600 patients were recruited at the baseline. Of the 485 patients who completed the follow-up investigation, 483 were included in the validation sample. The final scale of PROHIV-OLD contained 25 items describing five dimensions (physical symptoms, mental status, illness perception, family relationship, and treatment). All the PROHIV-OLD dimensions had satisfactory reliability with Cronbach’s alpha coefficient, McDonald’s ω, and composite reliability of each dimension being all higher than 0.85. Most dimensions met the test-retest reliability standard except for the physical symptoms dimension (ICC = 0.64). Confirmatory factor analysis supported the structural validity of the final scale, and the model fit index satisfied the criterion. The correlations between dimensions of PROHIV-OLD and MOS-HIV met hypotheses in general. Significant differences on scores of the PROHIV-OLD were found between demographic and clinical subgroups, supporting known-groups validity. Conclusions The PROHIV-OLD was found to have good feasibility, reliability and validity for evaluating health outcome of Chinese older PLWHA. Other measurement properties such as responsiveness and interpretability will be further examined.

BackgroundCancer stage at diagnosis is an important prognostic indicator for patient outcomes, with detection at later stages associated with increased mortality and morbidity. The impact of cancer stage on patient-reported outcomes is poorly understood. This research aimed to understand symptom burden and health related quality of life (HRQoL) impact by cancer stage for ten cancer types: 1) ovarian, 2) lung, 3) pancreatic, 4) esophageal, 5) stomach, 6) head and neck, 7) colorectal, 8) anal, 9) cervical, and 10) liver and bile duct.MethodsTen narrative literature reviews were performed to identify and collate published literature on patient burden at different stages of disease progression. Literature searches were conducted using an AI-assisted platform to identify relevant articles published in the last five (2017-2022) or ten years (2012-2022) where articles were limited. Conference abstracts were searched for the last two years (2020-2022). The geographic scope was limited to the United States, Canada, Europe, and global studies, and only journal articles written in English were included.ResultsA total of 26 studies with results stratified by cancer stage at diagnosis (and before treatment) were selected for the cancer types of lung, pancreatic, esophageal, stomach, head and neck, colorectal, anal, and cervical cancers. Two cancer types, ovarian cancer, and liver and bile duct cancer did not return any search results with outcomes stratified by disease stage. A general trend was observed for worse patient-reported outcomes in patients with cancer diagnosed at an advanced stage of disease compared with diagnosis at an earlier stage. Advanced disease stage was associated with greater symptom impact including general physical impairments such as pain, fatigue, and interference with functioning, as well as disease/region-specific symptom burden. Poorer HRQoL was also associated with advanced disease with commonly reported symptoms including anxiety and depression.ConclusionsOverall, the general trend for greater symptom burden and poorer HRQoL seen in late stage versus early-stage disease across the included cancer types supports the importance for early diagnosis and treatment to improve patient survival and decrease negative impacts on disease burden and HRQoL.

Purpose: This study implemented the individualized Youth Quality of Life Instrument-Research Version (YQOL-R) to estimate the quality of life (QoL) among Chinese adolescents with three different Body Mass Index (BMI) levels. The study aims to explore and provide a reference for developing individualized QoL (IQoL) measurements in China.Methods: The sample consisted of 822 aged 11-18 from nine schools. The data collection included all participants' primary characters (age, sex, annual household income, parental education, and recruitment community) and their self-report QoL. Precisely, based on the generic measurement of YQOL-R, we developed IQoL measurements by asking adolescents' perceived five most important things to them (IQOL(importance)) and the aspects they most want to change (IQOL(change)) from 19 facets, respectively. The one-way analysis of variance (ANOVA) was applied to compare total and subscale scores of IQOL(importance), IQOL(change), and YQOL-R among adolescents with three different weight status. Also, the data analysis used multivariable linear regression modeling to test the effects on scores of IQOL(importance) and IQOL(change).Results: Overall, the obese adolescents identified "Having good physical health" as the most important (54.03%) and most like-to-change (42.65%); in contrast, the normal-weight group ranked "Being myself" as the top facet of IQOL(importance) (52.42%) and "Having good friends" as the top facet of IQOL(change) (43.12%). The obese adolescents' reported IQOL(importance) scores are significantly lower than those of the normal-weight group (P=0.039). However, there is no significant difference in IQOL(change) score among the three weight-status groups. The multivariable linear regression models indicated that adolescents who are girls (P=0.035), have higher educated fathers (P=0.049), and are overweight/obese (P=0.041) self-reported worse IQOL(importance) score; yet, the girls (P=0.023) and older adolescents (P=0.004) answered lower IQOL(change) scores. In addition, adolescents who had higher educated mothers (P=0.047; 0.023) and responded with higher total YQOL-R scores (P<0.001; <0.001) reported higher IQOL(importance) and IQOL(change) scores.Conclusion: In the current study, although the self-reported YQOL-R scores from different weight status did not present a significant difference, the obese group reported a statistical trend towards lower IQOL(importance) scores than the normal-weight and overweight adolescents. These findings emphasize that IQOL(importance) and IQOL(change) could capture adolescents' perspectives with different weight statuses about their lives, which are unique as complementary health outcomes accompanying YQOL-R in health surveys and interventions among Chinese adolescents.

Abstract Background/Objective: The goal of the Patient-Centered Outcomes Research Partnership was to prepare health care professionals and researchers to conduct patient-centered outcomes and comparative effectiveness research (CER). Substantial evidence gaps, heterogeneous health care systems, and decision-making challenges in the USA underscore the need for evidence-based strategies. Methods: We engaged five community-based health care organizations that serve diverse and underrepresented patient populations from Hawai’i to Minnesota. Each partner nominated two in-house scholars to participate in the 2-year program. The program focused on seven competencies pertinent to patient-centered outcomes and CER. It combined in-person and experiential learning with asynchronous, online education, and created adaptive, pragmatic learning opportunities and a Summer Institute. Metrics included the Clinical Research Appraisal Inventory (CRAI), a tool designed to assess research self-efficacy and clinical research skills across 10 domains. Results: We trained 31 scholars in 3 cohorts. Mean scores in nine domains of the CRAI improved; greater improvement was observed from the beginning to the midpoint than from the midpoint to conclusion of the program. Across all three cohorts, mean scores on 52 items (100%) increased (p ≤ 0.01), and 91% of scholars reported the program improved their skills moderately/significantly. Satisfaction with the program was high (91%). Conclusions: Investigators that conduct patient-centered outcomes and CER must know how to collaborate with regional health care systems to identify priorities; pose questions; design, conduct, and disseminate observational and experimental research; and transform knowledge into practical clinical applications. Training programs such as ours can facilitate such collaborations.

Caregiver and observer-reported measures are frequently used as outcomes for research on infants and young children who are unable to report on their own health. Our team developed the Infant with Clefts Observation Outcomes Instrument (iCOO) for infants with cleft lip with or without cleft palate. This exploratory study compared test-retest and interrater reliabilities to inform whether differences in caregiver perspective might affect the iCOO.This study is a secondary analysis comparing caregiver interrater agreement to test-retest reliability. Twenty-five pairs of caregivers completed the iCOO before surgery, 1 week later for test-retest reliability, 2 days after surgery, and 2 months after surgery. Reliability was assessed using intraclass correlations (ICCs) and t-tests were used to compare ratings between caregivers.Infants had cleft lip (28%) or cleft lip and palate (72%). Primary caregivers were predominantly mothers (92%) and secondary caregivers were predominantly fathers (80%). Test-retest reliability met psychometric standards for most items on the iCOO (81%-86% of items). Caregiver agreement on the iCOO items was lower than test-retest reliability (33%-46% of items met psychometric standards). Caregivers did not systematically differ in whether they rated infants as healthier or less healthy than the other caregiver (5%-16% of items had statistically significant differences).Caregivers used the measure consistently, but had different experiences and perceptions of their infant's health and functioning. Future studies are needed to explore mechanisms for the differences in test-retest and interrater reliability. Whenever possible, the same caregiver should provide ratings of the infant, including on the iCOO.

OBJECTIVE Our goal was to compare data collected from 3- and 7-day Infant with Clefts Observation Outcomes (iCOO) diaries. DESIGN Secondary data analysis of an observational longitudinal cohort study. Caregivers completed the daily iCOO for 7 days before cleft lip surgery (T0) and for 7 days after cleft lip repair (T1). We compared 3- and 7-day diaries collected at T0 and 3- and 7-day diaries collected at T1. SETTING United States. PARTICIPANTS Primary caregivers of infants with cleft lip with and without cleft palate (N  =  131) planning lip repair and enrolled in original iCOO study. MAIN OUTCOMES MEASURE(S) Mean differences and Pearson correlation coefficients. RESULTS Correlation coefficients were high for global impressions (>0.90) and scaled scores (0.80-0.98). Mean differences were small across iCOO domains at T0. T1 comparisons reflected the same pattern. CONCLUSIONS Three-day diary data is comparable to 7-day diaries for measuring caregiver observations using iCOO across T0 and T1.

Key Points Question What is the efficacy of a diabetes prevention program among Latino youths with prediabetes and obesity compared with usual care? Findings In this randomized clinical trial with 117 Latino youths, both lifestyle intervention and usual care led to significant improvements in glucose tolerance. However, lifestyle intervention significantly improved quality of life compared with usual care. Meaning These findings suggest that increasing access to diabetes prevention services among high-risk youths may lead to reductions in type 2 diabetes rates in underserved populations.

A multi-cancer early detection (MCED) test using methylation patterns in plasma cell-free DNA to detect a cancer signal and predict site of origin was evaluated in the prospective PATHFINDER study. Because MCED testing has the potential to cause anxiety and distress, participant-reported outcomes were assessed. Adults ≥50 y with or without additional cancer risk factors (a cancer diagnosis >3 years prior, smoking history, genetic predisposition) underwent the MCED blood test to screen for cancer. When a cancer signal was detected, the diagnostic workup was directed by the physician. Participants completed the Patient Reported Outcomes Measurement Information System (PROMIS) anxiety short form (higher scores = increased anxiety) pre-MCED test, post return of MCED test results (RoR), diagnostic resolution, and at end of study (EOS; 12 months). An adapted Multidimensional Impact of Cancer Risk Assessment (MICRA, higher scores = worsening) was completed post RoR. A three-item satisfaction questionnaire was completed post RoR for those with a signal not detected or at diagnostic resolution for signal detected. Participants with a cancer signal detected had increased anxiety following RoR which decreased by EOS (Table). MICRA scores were low, though participants with cancer signal detected had greater distress and uncertainty and worse experience vs those with no signal detected (Table). Of the 89.4% of participants who completed the satisfaction questionnaire, most were satisfied with the test (n=5749/5920; 48.5% extremely satisfied, 33.3% very satisfied, 15.3% satisfied) regardless of the MCED test result or cancer status upon diagnostic resolution.Table: 908PScale (score range) completion rate n/N, %Signal detected mean (SD)No signal detected mean (SD)PROMIS anxiety (0-100), Pre test 6434/6621, 97.2%n=88 47.0 (7.1)n=6346 47.6 (7.5)Δ Post test at RoR 5789/6621, 87.4%3.6 (7.2)0.7 (6.4)Δ Diagnostic resolution 58/91, 63.7%2.5 (6.3)—True Positive4.7 (6.1)—False Positive0.8 (6.1)—Δ End of study 5310/6621, 80.2%0.6 (7.2)0.7 (7.1)True positive1.2 (6.4)—False positive0.1 (7.8)—MICRA, Total score (0-95) 5914/6621, 89.3%n=50 28.4 (14.9)n=5864 8.8 (7.2)Distress (0-30)7.6 (6.9)0.6 (1.8)Uncertainty (0-45)11.3 (7.4)3.2 (4.2)Positive experience (0-20, higher score = worse experience)9.6 (4.6)5.0 (5.5) Open table in a new tab While anxiety was elevated following a positive MCED test result, it was more pronounced for participants diagnosed with cancer, and did approach baseline by EOS for both true and false positive participants. High rates of satisfaction were reported with MCED testing irrespective of test result.

Background: The purpose of these analyses was to determine whether overall costs were reduced in cystic fibrosis (CF) patients experiencing pulmonary exacerbation (PEx) who received shorter versus longer durations of treatment. Methods: Among people with CF experiencing PEx, we calculated 30-day inpatient, outpatient, emergency room, and medication costs and summed these to derive total costs in 2020 USD. Using the Kaplan-Meier sample average (KMSA) method, we calculated adjusted costs and differences in costs within two pairs of randomized groups: early robust responders (ERR) randomized to receive treatment for 10 days (ERR-10 days) or 14 days (ERR-14 days), and non-early robust responders (NERR) randomized to receive treatment for 14 days (NERR-14 days) or 21 days (NERR-21 days). Results: Patients in the shorter treatment duration groups had shorter lengths of stay per hospitalization (mean I standard deviation (SD) for ERR-10 days: 7.9 +/- 3.0 days per hospitalization compared to 10.1 +/- 4.2 days in ERR-14 days; for NERR-14 days: 8.7 +/- 4.9 days per hospitalization compared to 9.6 +/- 6.5 days in NERR-21 days). We found statistically significantly lower adjusted mean costs (95% confidence interval) among those who were randomized to receive shorter treatment durations (ERR-10 days: $60,800 ($59,150 - $62,430) vs $74,420 ($72,610 - $76,450) in ERR-14 days; NERR-14 days: $66,690 ($65,960-$67,400) versus $74,830 ($73,980-$75,650) in NERR-21 days). Conclusions: Tied with earlier evidence that shorter treatment duration was not associated with worse clinical outcomes, our analyses indicate that treating with shorter antimicrobial durations can reduce costs without diminishing clinical outcomes. (C) 2022 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.