Patient-reported outcomes in randomized controlled trials evaluating BRAF inhibitors in patients with cutaneous melanoma: a systematic scoping review of quality of reporting and trial results.

The objective of this study was to provide an overview of the current practice of patient-reported outcome (PRO) assessments in trials investigating treatment with BRAF inhibitors in patients with advanced melanomas. In addition, we extracted information on symptomatic adverse events (AEs) reported by clinicians to inform future PRO measurement strategies. For our systematic scoping review, we investigated randomized controlled trials (RCTs) evaluating treatment with BRAF inhibitors that had a primary, secondary or exploratory PRO endpoint and were indexed on PubMed.

An international study of clinical, demographic, and competence-related determinants of communication with professionals.

Purpose: This study aims to identify a combination of clinical, demographic, and patient competence determinants of patients' communication with doctors and nurses in an international sample of cancer patients.

Methods: For our cross-sectional study, cancer patients assessed their communication with their doctors or nurses at the start of their treatment. Patients completed EORTC communication questionnaire QLQ-COMU26 to assess ten areas of communication with their doctor or nurses plus another item to assess how competent they felt when communicating with professionals.

Machine learning models including patient-reported outcome data in oncology: a systematic literature review and analysis of their reporting quality.

Purpose: To critically examine the current state of machine learning (ML) models including patient-reported outcome measure (PROM) scores in cancer research, by investigating the reporting quality of currently available studies and proposing areas of improvement for future use of ML in the field.

Methods: PubMed and Web of Science were systematically searched for publications of studies on patients with cancer applying ML models with PROM scores as either predictors or outcomes. The reporting quality of applied ML models was assessed utilizing an adapted version of the MI-CLAIM (Minimum Information about CLinical Artificial Intelligence Modelling) checklist.

Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review.

Background: There are different modes and ways to assess patient-reported outcomes (PROs) in clinical trials. However, there is little systematic information on how often different modes of assessment (MOA) are used in cancer clinical trials and how exactly assessments are conducted. The goal of this scoping review is to gain an understanding of the MOA and data management of PROs in cancer randomised controlled trials (RCTs) and the reporting quality thereof.

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.

Information about missing patient-reported outcome data in breast cancer trials is frequently not documented: a scoping review.

Objectives: This review addresses the common problem of missing patient-reported outcome (PRO) data in clinical trials by assessing the current practice of their statistical handling as reported in publications of randomized controlled trials (RCTs) in patients with breast cancer.

Study Design And Setting: We searched PubMed to identify RCTs evaluating biomedical treatments in breast cancer patients with at least one PRO endpoint published between January 2019 and February 2022. Two reviewers independently assessed the eligibility of the publications for this scoping review and extracted prespecified information on missing PRO data and related statistical practices.

PRO Hair Safe Study: The Patient's Perspective on the Effects of Scalp Cooling on Hair Preservation.

Purpose: Alopecia has been reported a distressing side-effect of chemotherapy for breast cancer patients (BCP) that is highly relevant for quality of life during treatment. For the prevention of chemotherapy-induced alopecia, scalp cooling (SC) has been reported to be an effective and safe intervention. However, data on the patient's perspective on effectiveness and applicability of SC in a clinical routine setting are scarce.

Assessing the quality of patient-reported outcome measurements for gynecological cancers: a systematic review.

To provide perspective on patient-reported outcome measurement (PROM) instruments to adopt in patients diagnosed with gynecological cancers. A systematic search was conducted to identify PROMs developed for or applied in gynecological cancer populations. PROMs identified in more than one study subsequently underwent assessment according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria.

Does the toxicity of endocrine therapy persist into long-term survivorship?: Patient-reported outcome results from a follow-up study beyond a 10-year-survival.

Background: Endocrine treatment (ET) is a highly effective breast cancer treatment but can distinctly impair breast cancer patients' quality of life (QOL). In a patient-reported outcome (PROs) study conducted by the authors in 2011, patients reported higher ET-induced symptom levels than known from the registration trials, and was underestimated. Based on these study results, we investigated the long-term sequelae of ET reported by breast cancer survivors (BCS) in a follow-up study conducted 5-10 years after an earlier assessment.

Developing an e-learning course on the use of PRO measures in oncological practice: health care professionals' preferences for learning content and methods.

Purpose: Implementation of patient-reported outcome measures (PROMs) in clinical routine requires knowledge and competences regarding their use. In order to facilitate implementation, an e-learning course for health care professionals (HCPs) on the utilisation of European Organisation for Research and Treatment of Cancer (EORTC) PROMs in oncological clinical practice is being developed. This study aimed to explore future users' educational needs regarding content and learning methods.

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.

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.

Development of an EORTC questionnaire measuring instrumental activities of daily living (IADL) in patients with brain tumours: phase I-III.

Purpose: Being able to function independently in society is an important aspect of quality of life. This ability goes beyond self-care, requires higher order cognitive functioning, and is typically measured with instrumental activities of daily living (IADL) questionnaires. Cognitive deficits are frequently observed in brain tumour patients, however, IADL is almost never assessed because no valid and reliable IADL measure is available for this patient group.

Validation and reference values of the EORTC QLQ-CML24 questionnaire to assess health-related quality of life in patients with chronic myeloid leukemia.

Health-related quality of life (HRQOL) assessment is important to facilitate decisions in the current treatment landscape of chronic myeloid leukemia (CML). Therefore, the availability of a validated HRQOL questionnaire, specifically developed for CML patients treated with tyrosine kinase inhibitors (TKIs), may enhance quality of research in this area. We performed an international study including 782 CML patients to assess the validity of the EORTC QLQ-CML 24 questionnaire, and to generate HRQOL reference values to facilitate interpretation of results in future studies.

Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial.

Background: In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings.

How to implement routine electronic patient-reported outcome monitoring in oncology rehabilitation.

Background: Implemenation of patient-reported outcomes (PRO) like quality of life can add the patient's perspective to traditional clinical outcomes of cancer rehabilitation in a structured and standardized way.

Aim: To present useful steps for a successful implementation of routine electronic patient-reported outcomes (ePRO) monitoring. The presented steps are exemplified by describing the procedure applied in an Austrian inpatient cancer rehabilitation centre.

Normative data for the EORTC QLQ-C30 from the Austrian general population.

Background: The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a widely used cancer-specific questionnaire assessing 15 domains of health-related quality of life (HRQoL). Our aim was to facilitate the interpretation of scores on this questionnaire by providing Austrian normative data based on a general population sample.

Methods: The calculation of normative data was based on the EORTC QLQ-C30 data collected from an Austrian general population sample that was part of an international online panel study on the development of European normative data.

Complementing clinical cancer registry data with patient reported outcomes: A feasibility study on routine electronic patient-reported outcome assessment for the Austrian Myelome Registry.

Objectives: Routinely assessed patient-reported outcomes (PROs), such as quality of life (QOL), are important to supplement clinical cancer data but requires rigorous implementation. This study aims at depicting the implementation procedure and evaluating the feasibility of routine electronic PRO monitoring (ePRO) for collecting data supplementing the Austrian Myeloma Registry (AMR).

Methods: Integration of ePRO monitoring into clinical routine was planned according to the Replicating Effective Programs framework.

International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26.

Background: Given the high cure-rate for testicular cancer (TC) and the patients' young age, comprehensive evaluation of health-related quality of life (HRQOL) is an important consideration in this patient population. The EORTC QLQ-TC26 questionnaire module has been developed to supplement the EORTC QLQ-C30 in assessing TC-specific HRQOL in clinical trials and routine clinical practice. This international, multicentre phase IV validation study evaluated the psychometric properties of the new module.

Implementation of an electronic routine outcome monitoring at an inpatient unit for psychosomatic medicine.

Background: Patient-reported outcomes (PROs) can be part of an electronic routine outcome monitoring (eROM). eROM can improve patient involvement, treatment outcomes and simplify scientific data assessment. Available studies on eROM focus on its evaluation only and lack a detailed description of the prior implementation procedure.