Acceptability and usefulness of the EORTC 'Write In three Symptoms/Problems' (WISP): a brief open-ended instrument for symptom assessment in cancer patients.

BACKGROUND: The use of open-ended questions supplementing static questionnaires with closed questions may facilitate the recognition of symptoms and toxicities. The open-ended 'Write In three Symptoms/Problems (WISP)' instrument permits patients to report additional symptoms/problems not covered by selected EORTC questionnaires. We evaluated the acceptability and usefulness of WISP with cancer patients receiving active and palliative care/treatment in Austria, Chile, France, Jordan, the Netherlands, Norway, Spain and the United Kingdom. METHODS: We conducted a literature search on validated instruments for cancer patients including open-ended questions and analyzing their responses. WISP was translated into eight languages and pilot tested. WISP translations were pre-tested together with EORTC QLQ-C30, QLQ-C15-PAL and relevant modules, followed by patient interviews to evaluate their understanding about WISP. Proportions were used to summarize patient responses obtained from interviews and WISP. RESULTS: From the seven instruments identified in the literature, only the free text collected from the PRO-CTAE has been analyzed previously. In our study, 161 cancer patients participated in the pre-testing and interviews (50% in active treatment). Qualitative interviews showed high acceptability of WISP. Among the 295 symptoms/problems reported using WISP, skin problems, sore mouth and bleeding were more prevalent in patients in active treatment, whereas numbness/tingling, dry mouth and existential problems were more prevalent in patients in palliative care/treatment. CONCLUSIONS: The EORTC WISP instrument was found to be acceptable and useful for symptom assessment in cancer patients. WISP improves the identification of symptoms/problems not assessed by cancer-generic questionnaires and therefore, we recommend its use alongside the EORTC questionnaires.

Danish value sets for the EORTC QLU-C10D utility instrument.

PURPOSE: In this study, we developed Danish utility weights for the European Organisation for Research and Treatment of Cancer (EORTC) QLU-C10D, a cancer-specific utility instrument based on the EORTC QLQ-C30. METHODS: Following a standardized methodology, 1001 adult participants from the Danish general population were quota-sampled and completed a cross-sectional web-based survey and discrete choice experiment (DCE). In the DCE, participants considered 16 choice sets constructed from the key 10 dimensions of the QLU-C10D and chose their preferred health state for each one. Utility weights were calculated using conditional logistic regression with correction for non-monotonicity. RESULTS: The sample (n = 1001) was representative of the Danish general population with regard to age and gender. The domains with the largest utility decrements, i.e., the domains with the biggest impact on health utility, were physical functioning (- 0.224), pain (- 0.160), and role functioning (- 0.136). The smallest utility decrements were observed for the domains lack of appetite (- 0.024), sleep disorders (- 0.057), and fatigue (- 0.064). Non-monotonicity of severity levels was observed for the domains sleep disturbances, lack of appetite, and bowel problems. Deviations from monotonicity were not statistically significant. CONCLUSION: The EORTC QLU-C10D is a relatively new multi-attribute utility instrument and is a promising cancer-specific health technology assessment candidate measure. The country-specific Danish utility weights from this study can be used for cost-utility analyses in Danish patients and for comparison with other country-specific utility data.

Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit-risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change. This Policy Review presents international stakeholder views on the need for SISAQOL-IMI, the agreed on and prioritised set of PRO objectives, and a roadmap to ensure that international consensus recommendations are achieved.

Content comparison of the EORTC CAT Core, SF-36, FACT-G, and PROMIS role and social functioning measures based on the International Classification of Functioning, Disability and Health.

OBJECTIVES: In line with the World Health Organizations' health definition, patient-reported outcome (PRO) measures frequently cover aspects of social health. Our study aimed to evaluate the role functioning (RF) and social functioning (SF) contents assessed by PRO measures commonly used in cancer patients. METHODS: We analysed the item content of the SF and RF domains of the EORTC CAT Core, the EORTC QLQ-C30, the SF-36, and the FACT-G as well as the PROMIS item bank covering the Ability to Participate in Social Roles and Activities. Following an established methodology we linked item content to the International Classification of Functioning, Disability and Health (ICF) framework. RESULTS: The content of 85 items was assigned to three ICF components ('Activities and Participation', 'Body Functions', and 'Environmental Factors'). The EORTC CAT Core RF items were mostly related to the first-level ICF categories 'Domestic life' and 'Community, social and civic life', while its SF item bank focused on 'Interpersonal interactions and relationships'. These three categories were also covered by the PROMIS social participation item bank. The FACT-G Social/Family scale focused on environmental factors ('Support and Relationships' and 'Attitudes') while the SF-36 Role-physical/emotional scales had a stronger focus on 'General tasks and demands' and 'Major life areas'. CONCLUSIONS: Our results highlight conceptual overlap and differences among PRO measures for the assessment of social health in cancer. This information may help to select the most appropriate measure for a specific setting or study purpose and to better understand the possibilities of linking scores across different PRO measures.

Patient-reported outcome measures for emotional functioning in cancer patients: Content comparison of the EORTC CAT Core, FACT-G, HADS, SF-36, PRO-CTCAE, and PROMIS instruments.

BACKGROUND: Cancer and its treatment can have substantial impact on patients' emotional functioning. Several patient-reported outcome measures (PROMs) assessing emotional functioning are available, but differences in content limit the comparability of results. To better understand conceptual (dis)similarities, we conducted a content comparison of commonly used PROMs. METHODS: We included emotional functioning items, scales, and item banks from the EORTC CAT Core, EORTC QLQ-C30, FACT-G, Hospital anxiety and depression scale (HADS), SF-36, PRO-CTCAE, and PROMIS (item banks for anxiety, depression, and anger). Item content was linked to the International Classification of Functioning, Disability, and Health (ICF) and a hierarchical framework established for PROMIS. Single items could be coded with more than one ICF category but were solely assigned to one facet within the PROMIS framework. RESULTS: The measures comprise 132 unique items covering the ICF components 'Body functions' (136/153 codings, 88.9%) and 'Activities and participation' (15/153, 9.8%). Most ICF codings (112/153, 73.2%) referred to the third-level category 'b1528 Emotional functions, other specified'. According to the PROMIS framework 48.5% of the items assessed depression (64/132 items), followed by anxiety (41/132, 31.1%) and anger (26/132, 19.7%). The EORTC measures covered depression, anxiety, and anger in a single measure, while the PROMIS inventory provides separate item banks for these concepts. The FACT-G, SF-36, PRO-CTCAE and HADS covered depression and anxiety, but not anger. CONCLUSION: Our results provide an in-depth conceptual understanding of selected PROMs and important qualitative information going beyond psychometric evidence. Such information supports the identification of PROMs for which scores can be meaningfully linked with quantitative methods.

The European Organisation for Research and Treatment of Cancer Quality of Life Utility-Core 10 Dimensions: Development and Investigation of General Population Utility Norms for Canada, France, Germany, Italy, Poland, and the United Kingdom.

OBJECTIVES: The European Organisation for Research and Treatment of Cancer Quality of Life Utility-Core 10 Dimensions (EORTC QLU-C10D) is a cancer-specific preference-based measure, providing health utilities for use in economic evaluations derived from the widely used health-related quality of life measure, EORTC QLQ-C30. Several EORTC QLU-C10D country-specific value sets are available. This article aimed to provide EORTC QLU-C10D general population utility norms for Canada, France, Germany, Italy, Poland, and the United Kingdom, to aid interpretability of obtained utilities in these countries. METHODS: Data were collected in aforementioned countries via a quota-sampled, cross-sectional online survey (n = 100/age-sex group; N = approximately 1000/country). Participants were asked to complete the EORTC QLQ-C30 and provide sociodemographic data. Country-specific utility norms were calculated using the respective country tariff on the country's EORTC QLQ-C30 data after weighting to achieve population representativeness for age and sex. Norm values are provided as means (SDs) by country, age, and sex groups. Tukey's multiple comparison test investigated mean differences among countries. The impact of country, age, and sex on utility values was investigated with a multiple linear regression model. RESULTS: Country-specific mean utilities range from 0.724 (United Kingdom) to 0.843 (Italy). Country-, sex-, and age-specific mean utilities range from 0.664 for 30- to 39-year-old male Canadians to 0.899 for > 70-year-old male Italians. Utilities were lower in females in 4 of 6 countries, and the impact of age differed among countries. Independent of the impact of age and sex, between-country differences were found (P ≤ .05). CONCLUSION: Results showed a varying impact of age and sex on EORTC QLU-C10D utilities and significant between-country differences. Using national utility norms and utility decrements is recommended.

Can virtual care reduce treatment burden in pediatric leukemia? A retrospective cost analysis.

We conducted a retrospective analysis to determine the potential reduction in treatment burden through the expansion of virtual care among children with leukemia (n = 152). Patients living in urban areas traveled median distances of 1555 km compared with 7536 km for patients living in rural areas (p < .05). For the latter group, a median reduction in travel distance of 3560 km (interquartile range [IQR], 2136-5787 km), travel time of 51 h (IQR, 26-78 h), and CO2 emissions of 623 kg (IQR, 374-1013 kg) was estimated, if every second visit was replaced by video consultations.

Disagreement between mothers' and fathers' rating of health-related quality of life in children with cancer.

PURPOSE: Serial assessment of health condition based on self-report made by children and their proxies has consistently shown a lack of congruence. The study explored the discrepancies between mother's, father's, and children's reports on health-related quality of life (HRQOL) during the first two months of pediatric cancer treatment. METHODS: In this cohort study, children and parents completed the generic and cancer-specific Pediatric Quality-of-Life Inventory (PedsQL) questionnaires at initial diagnosis and in the subsequent months. Evaluation of discrepancies included intraclass correlations between mother-child and father-child dyads at different domain levels. RESULTS: Thirty-six children with a diagnosis of cancer between May 2020 and November 2021 and their parents were included in this study. At diagnosis, mother-child dyads showed better agreement on more domains of the PedsQL Generic Core Scale than father-child dyads; moderate agreement persisted for both parents at subsequent time points on the physical domain. The disease-specific PedsQL Cancer Module revealed moderate and better agreement for mother-child dyads during active cancer therapy. In particular, agreement of mother-child dyads was pronounced for domains such as worry (0.77 [95% CI 0.52-0.89, P < 0.001]), whereas fathers tended to overestimate the child's symptom burden for most of the remaining domains of the PedsQL Cancer Module. CONCLUSION: This cohort study shows that both parent proxy reports can provide valid information on child's HRQOL, but that fathers tend to overestimate, particularly for non-observable domains. Proxy reports derived from mothers more closely agreed with children's HRQOL and might be more weighted, if there is uncertainty between parents.

Relevance of spirituality and perceived social support to mental health of people with pre-existing mental health disorders during the COVID-19 pandemic: a longitudinal investigation.

BACKGROUND: The COVID-19 pandemic and related measures have negatively impacted mental health worldwide. The main objective of the present longitudinal study was to investigate mental health in people living in Tyrol (Austria) and South Tyrol (Italy) during the COVID-19 pandemic and to report the prevalence of psychological distress among individuals with versus those without pre-existing mental health disorders (MHD) in the long-term (summer 2020-winter 2022). Here, we specifically focus on the relevance of spirituality and perceived social support in this regard. METHODS: 161 individuals who had been diagnosed with MHD and 446 reference subjects participated in this online survey. Electronic data capture was conducted using the Computer-based Health Evaluation System and included both sociodemographic and clinical aspects as well as standardized questionnaires on psychological distress, spirituality, and the perception of social support. RESULTS: The prevalence of psychological distress was significantly higher in individuals with MHD (36.6% vs. 12.3%) and remained unchanged among both groups over time. At baseline, the perception of social support was significantly higher in healthy control subjects, whereas the two groups were comparable in regards of the subjective relevance of faith. Reference subjects indicated significantly higher spiritual well-being in terms of the sense of meaning in life and peacefulness, which mediated in large part the between-group difference of psychological distress at follow-up. Notably, both faith and the perception of social support did not prove to be relevant in this context. CONCLUSIONS: These findings point to a consistently high prevalence of psychological distress among people suffering from MHD and underscore the prominent role of meaning in life and peacefulness as a protective factor in times of crisis. Therapeutic strategies that specifically target spirituality may have a beneficial impact on mental health.

Usability of Electronic Patient-Reported Outcome Measures for Older Patients With Cancer: Secondary Analysis of Data from an Observational Single Center Study.

BACKGROUND: Patient-reported outcomes are considered the gold standard for assessing subjective health status in oncology patients. Electronic assessment of patient-reported outcomes (ePRO) has become increasingly popular in recent years in both clinical trials and practice. However, there is limited evidence on how well older patients with cancer can complete ePRO assessments. OBJECTIVE: We aimed to investigate how well adult patients with cancer of different age ranges could complete ePRO assessments at home and in a treatment facility and to identify factors associated with the ability to complete questionnaires electronically. METHODS: This retrospective longitudinal single-center study involved survivors of cancer who participated in inpatient rehabilitation. Patients completed ePRO assessments before rehabilitation at home (T1) and after rehabilitation at the facility (T2). We analyzed the rate of patients who could complete the ePRO assessment at T1 and T2, the proportion of patients who required assistance, and the time it took patients to complete standardized questionnaires. Multivariate logistic regression analyses were conducted to identify predictors of ePRO completion rate and the need for assistance. RESULTS: Between 2017 and 2022, a total of 5571 patients were included in this study. Patients had a mean age of 60.3 (SD 12.2) years (range 18 to 93 years), and 1135 (20.3%) of them were classified as geriatric patients (>70 years). While more than 90% (5060/5571) of all patients completed the ePRO assessment, fewer patients in the age group of >70 years (924/1135, 81.4% at T1 vs 963/1135, 84.8% at T2) completed the assessment. Approximately 19% (1056/5571) of patients reported a need for assistance with the ePRO assessment at home, compared to 6.8% (304/4483) at the institution. Patients older than 70 years had a significantly higher need for assistance than those in younger age groups. Moreover, a gender difference was observed, with older women reporting a higher need for assistance than men (71-80 years: women requiring assistance 215/482, 44.6% vs men 96/350, 27.4%; P<.001 and >80 years: women 102/141, 72.3% vs men 57/112, 50.9%; P<.001). On average, patients needed 4.9 (SD 3.20) minutes to remotely complete a 30-item questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) and patients in the older age groups took significantly longer compared to younger age groups. Lower age and higher physical functioning were the clearest predictors for both the ePRO completion rate and the need for assistance in the multivariate regression analysis. CONCLUSIONS: This study's results indicate that ePRO assessment is feasible in older individuals with cancer, but older patients may require assistance (eg, from relatives) to complete home-based assessments. It may be more feasible to conduct assessments in-house in this population. Additionally, it is crucial to carefully consider which resources are necessary and available to support patients in using ePRO devices.

Adherence to Patient-Reported Symptom Monitoring and Subsequent Clinical Interventions for Patients With Multiple Myeloma in Outpatient Care: Longitudinal Observational Study.

BACKGROUND: The use of software to monitor patient-reported outcome measures (PROMs) can improve outcomes for patients with cancer receiving anticancer therapy; however, evidence from applications used in routine clinical practice is lacking. OBJECTIVE: We aimed to investigate adherence to and patient perceptions of a weekly, web-based PROM symptom monitoring program in routine clinical practice for patients with Multiple Myeloma. Moreover, we aimed to capture how clinical alerts prompted by the system influenced clinical care. METHODS: We conducted a single-center longitudinal observational study to evaluate patient adherence to and perceptions of the PROM monitoring software in routine practice. Patients with Multiple Myeloma remotely completed weekly treatment-specific PROMs to monitor key symptoms via a dedicated web-based platform. Alarming symptoms triggered clinical alerts in the application for the treatment team, which could initiate clinical interventions. The primary outcomes were the web-based assessment completion rate and patients' perceptions of the monitoring program, as assessed by an evaluation questionnaire. Moreover, clinical alerts prompted by the system and consequential clinical interventions were analyzed. RESULTS: Between July 2021 and June 2022, a total of 55 patients were approached for participation; 39 patients participated (24, 61% male, mean age 63.2, SD 9.2 years). The median assessment completion rate out of all weekly scheduled assessments was 70.3% (IQR 41.2%-89.6%). Most patients (77%) felt that the health care team was better informed about their health status due to the web-based assessments. Clinical alerts were triggered for 1758 of 14,639 (12%) reported symptoms. For 548 of 1758 (31.2%) alerts, the symptom had been registered before and no further action was required; for 348 of 1758 (19.9%) alerts, telephone consultation and self-management advice sufficed. Higher-level interventions were seldom needed in response to alerts: referral to a doctor or specialist (88/1758, 5% alerts), medication changes (22/1758, 1.3%), scheduling additional diagnostics (9/1758, 0.5%), or unplanned emergency visits (7/1758, 0.4%). Most patients (55%) reported the calls in response to alerts gave them "quite a bit" or "very much" of an added feeling of security during therapy. CONCLUSIONS: Our study shows that high adherence to regular and tailored PROM monitoring can be achieved in routine clinical care. The findings provide valuable insight into how the PROM monitoring program and the clinical alerts and resulting interventions shaped clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT05036863; https://clinicaltrials.gov/study/NCT05036863.

Phenotyping of Acute and Persistent Coronavirus Disease 2019 Features in the Outpatient Setting: Exploratory Analysis of an International Cross-sectional Online Survey.

BACKGROUND: Long COVID, defined as the presence of coronavirus disease 2019 (COVID-19) symptoms ≥28 days after clinical onset, is an emerging challenge to healthcare systems. The objective of the current study was to explore recovery phenotypes in nonhospitalized individuals with COVID-19. METHODS: A dual cohort, online survey study was conducted between September 2020 and July 2021 in the neighboring European regions Tyrol (TY; Austria, n = 1157) and South Tyrol (STY; Italy, n = 893). Data were collected on demographics, comorbid conditions, COVID-19 symptoms, and recovery in adult outpatients. Phenotypes of acute COVID-19, postacute sequelae, and risk of protracted recovery were explored using semi-supervised clustering and multiparameter least absolute shrinkage and selection operator (LASSO) modeling. RESULTS: Participants in the study cohorts were predominantly working age (median age [interquartile range], 43 [31-53] years] for TY and 45 [35-55] years] for STY) and female (65.1% in TY and 68.3% in STY). Nearly half (47.6% in TY and 49.3% in STY) reported symptom persistence beyond 28 days. Two acute COVID-19 phenotypes were discerned: the nonspecific infection phenotype and the multiorgan phenotype (MOP). Acute MOP symptoms encompassing multiple neurological, cardiopulmonary, gastrointestinal, and dermatological symptoms were linked to elevated risk of protracted recovery. The major subset of individuals with long COVID (49.3% in TY; 55.6% in STY) displayed no persistent hyposmia or hypogeusia but high counts of postacute MOP symptoms and poor self-reported physical recovery. CONCLUSIONS: The results of our 2-cohort analysis delineated phenotypic diversity of acute and postacute COVID-19 manifestations in home-isolated patients, which must be considered in predicting protracted convalescence and allocating medical resources.

Randomized Trial of a Supportive Psychotherapy for Parents of Adolescents and Young Adults With Hematologic Malignancies.

BACKGROUND: Cancer regularly disrupts health and developmental trajectories in adolescents and young adults (AYAs). Parents have been shown to have a substantial impact on the health and cancer survivorship activities of AYA patients in the form of symptom management. However, no randomized controlled trial has evaluated a coping support intervention (CSI) program for parents of AYAs with cancer aged 18 to 40 years. PATIENTS AND METHODS: From November 30, 2012, to August 29, 2016, parents of AYAs with hematologic malignancies were randomized in a phase III controlled trial (1:1 ratio, stratified sampling) to either the research-based CSI AYA-Parents group (CSI group; n=82) or the standard care (SC) group (n=70). CSI consisted of 5 sessions to achieve the enhancement of parental adaptive coping as the primary outcome (per the adaptive coping scale of the 28-item Brief COPE, a validated multidimensional self-assessment-questionnaire recommended for clinical cancer research). Measures of adaptive coping, depression, and mental health were collected at pre-CSI (measurement date T1), at the end of the intervention sessions (measurement date T2), and at follow-up (3 months). We calculated mean change scores in outcomes and estimated intervention effect sizes (Cohen's d) for changes from T1 to T2/T3, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect. All statistical tests were 2-sided. RESULTS: In the intention-to-treat analysis, the CSI group significantly improved their adaptive coping compared with the SC group (95% CI, 0.30-2.54; P=.013; d=0.405), whereas adaptive coping in the SC group deteriorated. The CSI group also experienced a significant decrease in depressive symptoms and improved mental health with clinical significance (95% CI, -1.98 to -0.30; P=.008; d=0.433, and 95% CI, -0.19 to 3.97; P=.074; d=0.292, respectively). Sensitivity analyses confirmed the robustness of the main intention-to-treat analysis. CONCLUSIONS: CSI improved effectively adaptive coping and depression in parents of AYAs with hematologic malignancies. It may represent a novel family-based approach in AYA oncology care.

Driving fitness in clinically stable outpatients with chronic schizophrenia.

INTRODUCTION: Driving motorized vehicles is an integral part of individual mobility and a key parameter for employment and social integration. This naturalistic, cross-sectional study investigated the associations between driving fitness, residual symptomatology, olanzapine equivalent, and extrapyramidal symptoms (EPS) in long term stable outpatients with schizophrenia. METHODS: Beside sociodemographic data, and driving habits, residual symptoms, and EPS were assessed using the Positive and Negative Syndrome Scale (PANSS), and the Modified Simpson Angus Scale (MSAS). PANSS symptoms were analyzed using the Wallwork/Fortgang five-factor model. MSAS cut-off scores ≥3 were defined as positive for EPS. Driving skills were assessed using the Vienna Test System and an expert evaluation. RESULTS: 50 patients were included into the study. Mean PANSS total scores indicated mild residual symptomatology and EPS were not present in 48% of study participants. 44% passed the driving fitness assessment and were considered as competent to drive, 20% were judged to be partially competent and 36% to be incompetent to drive. With the exception of disorganization (r = -0·287, p = 0·048) residual symptoms of schizophrenia did not correlate with driving fitness. However, moderate negative correlations were detected between driving fitness and the severity of EPS (r = -0·554, p = 0·000), age (r = -0·413, p = 0·003) as well as olanzapine equivalent doses (r = -0·432, p = 0·002). These results were not corrected for multiple comparison. DISCUSSION: The present findings indicate that up to two thirds of clinically stable outpatients with chronic schizophrenia may be (partially) competent to drive. Both the presence of EPS as well as the dosage of antipsychotic medication seem to be of particular relevance in this regard.

Usability evaluation of the Computer-Based Health Evaluation System (CHES) eDiary for patients with faecal incontinence: a pilot study.

BACKGROUND: Faecal incontinence (FI) is prevalent in 15-20% of elderly individuals and is frequently monitored in clinical trials and practice. Bowel diaries are the most common way to document FI, but, in clinical practice, are mainly used as paper-based versions. Electronic diaries (eDiaries) offer many potential benefits over paper-based diaries. The aim of this study was to develop and test an eDiary to document FI. METHODS: We migrated a paper FI diary to an eDiary app based on the Computer-based Health Evaluation System (CHES). To assess usability, we conducted functionality and usability tests at two time points in a sample of patients with FI. In the first assessment, the eDiary functionalities were tested, patients completed the System Usability Scale (SUS, range 0-100) and compared the paper diary with the eDiary. We set a threshold for minimum acceptable average usability at 70 points. Patients were then instructed to use the eDiary for 2 days at home and contacted to report on their usage and completed the SUS a second time. RESULTS: We recruited a sample of N = 14 patients to use the eDiary. All patients were able to use all functionalities of the eDiary and only a few patients with lower technological literacy or access to devices (n = 3) needed initial assistance. The mean usability rating given at the first time point was high with 88 points (SD 18, 95% CI 78.2-96.8) and most patients (n = 10) reported they would prefer the eDiary over the paper-based version. Nine patients (n = 9) participated in the follow-up assessment and the mean SUS rating at the second time point was 97 points (SD 7, 95% CI 92.8-100). CONCLUSION: The eDiary showed excellent usability scores for the assessment of FI at both assessments. Generally, patients preferred the eDiary over the paper-based version. We recommend the eDiary for usage with patients who own and use a smartphone and discuss potential solutions for patients with lower technological literacy or access.

The Attitude towards Polypills Questionnaire (APPQ): a phase I-III development and validation study in patients with cerebrovascular disease.

BACKGROUND AND PURPOSE: The polypill approach has been proposed to reduce patients' pill burden, increase medication adherence and lower stroke incidence. However, little is known about patients' attitudes towards polypills for cerebrovascular medication. METHODS: Based on the European Organization for Research and Treatment of Cancer Quality of Life Group questionnaire development guidelines, a questionnaire to measure patients' attitudes towards polypills for the secondary prevention of stroke (phase I-III) was developed. In phase I, issues were generated via literature review and interviews with patients and healthcare professionals. The issues were operationalized into items in phase II. In phase III the questionnaire was validated in a large single-centre sample, and test-retest and internal validity were evaluated. RESULTS: In phase I, 34 relevant issues were identified through literature search and interviews. Pre-testing the questionnaire indicated high applicability and comprehensibility. The final Attitudes towards Polypills Questionnaire was tested in N = 260 patients and showed a two-factor structure. The factors were labelled 'concerns' and 'benefits'. The scales showed acceptable and good internal validity (concerns, Cronbach's α = 0.85; benefits, α = 0.93), but the scales' test-retest validity was ambiguous. On a 0 to 3 rating scale, concerns were rated lower than benefits (mean 1.07, SD 0.69 vs. mean 1.87, SD 0.89). CONCLUSIONS: The Attitudes towards Polypills Questionnaire showed high comprehensibility and content validity to assess German language patients' attitudes towards a polypill medication. Our data and questionnaire may aid the implementation of polypill treatments in clinical practice and can be used in the design of future clinical trials on polypill therapy. Further validation of the questionnaire is advised.

Implementation of daily patient-reported outcome measurements to support children with cancer.

BACKGROUND: Several stakeholders, including patients and health care providers, suggest symptom self-reporting measurements for a more patient-directed cancer control approach. However, services tailored to measure daily reporting and implementing it in clinical care are lacking. This study aimed to evaluate the feasibility and value of daily patient-reported outcome measures (PROMs) by children receiving chemotherapy for cancer. METHODS: Health status was recorded daily with a web-based child-friendly patient portal (ePROtect). Following aspects of feasibility and usability were assessed: (a) the completion rate and time, (b) user feedback on usability and satisfaction, and (c) the performed interventions if moderate to severe symptom deterioration was noted. RESULTS: Twelve children (median age: 7.2 years) were included. A total number of 891 daily reports were collected during the study period; the median percentage of ePROtect completion days was 85.3% (interquartile range [IQR] 64.2-100.0) and 55.9% (IQR 51.9-76.9) for inpatient and outpatient stay, respectively. Mean time to complete the questionnaire was 47.6 seconds. Severe symptoms were reported in 14.7% of measurement time points, which led to prompt health care interventions in 57 cases, including extension of supportive care (n = 37) and pre-emptive inpatient admissions (n = 5). Over 80% of the patients (10/12) and their proxies (16/18) provided feedback with high rating for satisfaction (>90%) and usefulness (>80%) of ePROtect. CONCLUSION: Our study shows that daily symptom monitoring is feasible for all children with newly diagnosed cancer aged 5-18 years. Monitoring offers the opportunity to identify symptoms early and trigger appropriate clinical action.

Estimating seroprevalence of SARS-CoV-2 antibodies using three self-reported symptoms: development of a prediction model based on data from Ischgl, Austria.

We report the development of a regression model to predict the prevalence of severe acute respiratory syndrome coronavirus (SARS-CoV-2) antibodies on a population level based on self-reported symptoms. We assessed participant-reported symptoms in the past 12 weeks, as well as the presence of SARS-CoV-2 antibodies during a study conducted in April 2020 in Ischgl, Austria. We conducted multivariate binary logistic regression to predict seroprevalence in the sample. Participants (n = 451) were on average 47.4 years old (s.d. 16.8) and 52.5% female. SARS-CoV-2 antibodies were found in n = 197 (43.7%) participants. In the multivariate analysis, three significant predictors were included and the odds ratios (OR) for the most predictive categories were cough (OR 3.34, CI 1.70-6.58), gustatory/olfactory alterations (OR 13.78, CI 5.90-32.17) and limb pain (OR 2.55, CI 1.20-6.50). The area under the receiver operating characteristic curve was 0.773 (95% CI 0.727-0.820). Our regression model may be used to estimate the seroprevalence on a population level and a web application is being developed to facilitate the use of the model.

Investigating the response scale of the EORTC QLQ-C30 in German cancer patients and a population survey.

BACKGROUND: The European Organization for research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) scales are scored on a 4-point response scale, ranging from not at all to very much. Previous studies have shown that the German translation of the response option quite a bit as mäßig violates interval scale assumptions, and that ziemlich is a more appropriate translation. The present studies investigated differences between the two questionnaire versions. METHODS: The first study employed a balanced cross-over design and included 450 patients with different types of cancer from three German-speaking countries. The second study was a representative survey in Germany including 2033 respondents. The main analyses included compared the ziemlich and mäßig version of the questionnaire using analyses of covariance adjusted for sex, age, and health burden. RESULTS: In accordance with our hypothesis, the adjusted summary score was lower in the mäßig than in the ziemlich version; Study 1: - 4.5 (95% CI - 7.8 to - 1.3), p = 0.006, Study 2: - 3.1 (95% CI - 4.6 to - 1.5), p < 0.001. In both studies, this effect was pronounced in respondents with a higher health burden; Study 1: - 6.8 (95% CI - 12.2 to - 1.4), p = 0.013; Study 2: - 4.5 (95% CI - 7.3 to - 1.7), p = 0.002. CONCLUSIONS: We found subtle but consistent differences between the two questionnaire versions. We recommend to use the optimized response option for the EORTC QLQ-C30 as well as for all other German modules. TRIAL REGISTRATION: The study was retrospectively registered on the German Registry for Clinical Studies (reference number DRKS00012759, 04th August 2017, https://www.drks.de/DRKS00012759 ).

Evaluation by electronic patient-reported outcomes of cancer survivors' needs and the efficacy of inpatient cancer rehabilitation in different tumor entities.

OBJECTIVE: We investigated cancer survivors' health-related quality of life (HRQOL), specific deficiencies related to underlying disease or treatment, and benefits of rehabilitation in a large variety of cancer entities. PATIENTS AND METHODS: Electronic patient-reported outcomes were performed as clinical routine procedures. Cancer survivors underwent a 3-week multidisciplinary inpatient rehabilitation. Twenty-one different cancer entities were analyzed separately before (T0) and by the end (T1) of rehabilitation. HRQOL, symptoms, and functions were assessed with EORTC-QLQ-C30 questionnaire, psychological distress with Hospital Anxiety and Depression Scale (HADS). RESULTS: Four thousand four hundred one of 5912 rehabilitants were evaluable, having completed both questionnaires at T0 and T1. All function mean scores and HRQOL were lower than in Austrian normal population, while levels of anxiety, depression, and all symptom scores were higher. HRQOL was particularly low in lung, liver, and bladder cancer patients. Maximum anxiety levels were observed in patients with breast and thyroid cancer patients, the highest levels of depression in liver and brain cancer patients. Fatigue was severe in patients with lung, liver, esophageal, bladder cancer, and myeloma patients. Mean scores were also high for pain and insomnia. In the group of all rehabilitants, a highly significant improvement of global HRQOL, anxiety, depression, and all function and symptom scores was observed at T1 (p < 0.001). We noted significant improvement of HRQOL, anxiety, depression, fatigue, emotional, social, role, and physical functions in each cancer entity with medium to large effect sizes. Other recorded symptoms were reduced in the majority of cancers. CONCLUSION: Rehabilitation effectively improves psychological distress and HRQOL as a part of treatment for various cancers.