Patient-Reported Outcome Measures in Liver and Gastrointestinal Cancer Randomized Controlled Trials.

OBJECTIVE: For many years, outcomes such as mortality and morbidity were the standard for evaluating oncological treatment effectiveness. With the introduction of patient-reported outcome measures (PROMs), the focus shifted from a mere extension of a patient's life or release from disease to the improvement of a multilayered concept of health, decisively affecting life satisfaction. In this study, we deal with the topic of PROMs in liver and gastrointestinal randomized controlled trials. RESULTS: The final database included 43 papers reporting results of randomized controlled trials (RCTs) for liver or gastrointestinal cancer interventions where one of the primary or secondary outcomes was a health-related quality of life measure. The most often used PROM was the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30) for both liver cancer and gastrointestinal cancer (in 62% of gastrointestinal cancer studies and 57% of liver cancer studies). For the gastrointestinal cancer group, the QLQ-STO22, a cancer-specific extension of the QLQ-C30, was the second most commonly used PROM. In liver cancer, the generic PROM Short Form 36 and the EORTC QLQ-HCC18, a cancer-specific extension of the QLQ-C30, were the second most commonly used PROMs. CONCLUSION: We found that RCTs often do not include comprehensive quality-of-life measures. When quality of life is part of an RCT, it is often only a secondary outcome. For a holistic view of the patient, a stronger integration and weighting of patient-reported outcomes in RCTs would be desirable.

Identification of Relevant Attributes for Liver Cancer Therapies (IRALCT): a maximum-difference-scaling analysis.

The Identification of Relevant Attributes for Liver Cancer Therapies (IRALCT) project is intended to provide new insights into the relevant utility attributes regarding therapy choices for malignant primary and secondary liver tumors from the perspective of those who are involved in the decision-making process. It addresses the potential value of taking patients' expectations and preferences into account during the decision-making and, when possible, adapting therapies according to these preferences. Specifically, it is intended to identify the relevant clinical attributes that influence the patients', medical laymen's, and medical professionals' decisions and compare the three groups' preferences. We conducted maximum difference (MaxDiff) scaling among 261 participants (75 physicians, 97 patients with hepatic malignancies, and 89 medical laymen) to rank the importance of 14 attributes previously identified through a literature review. We evaluated the MaxDiff data using count analysis and hierarchical Bayes estimation (HB). Physicians, patients, and medical laymen assessed the same 7 attributes as the most important: probability (certainty) of a complete removal of the tumor, probability of reoccurrence of the disease, pathological evidence of tumor removal, possible complications during the medical intervention, welfare after the medical intervention, duration and intensity of the pain, and degree of difficulty of the medical intervention. The cumulative relative importance of these 7 attributes was 88.3%. Our results show that the physicians', patients', and medical laymen's preferences were very similar and stable.Trial registration DRKS-ID of the study: DRKS00013304, Date of Registration in DRKS: 2017/11/16.

Health Technology Assessments in Radiology in Germany: Lack of Demand, Lack of Supply. / Health-Technology-Assessments in der Radiologie in Deutschland: Fehlende Nachfrage, fehlendes Angebot.

BACKGROUND: Health technology assessments (HTAs) are an interdisciplinary method to support sustainable, evidence-based healthcare decisions. They systematically assess medical products, procedures, and technologies with respect to medical, economic, legal, social, and ethical aspects. METHOD: This review analyzes the current use of HTAs in radiology in Germany and discusses challenges associated with HTAs. In particular, incentive structures of various players in the healthcare field involved in HTA implementation are considered for both the inpatient and outpatient sectors. Taking into account that the Joint Federal Committee (G-BA) has different authority between sectors ("ban reservation" for inpatients and "authorization right" for outpatients), we focus on the repercussions on reimbursement for new diagnosis or treatment methods by statutory health insurance companies. RESULTS: The G-BA's authority implicitly creates a paradox in terms of incentives to implement and finance HTAs: in the outpatient sector HTAs are considered necessary to evaluate new medical services while players may not have sufficient incentive to implement and finance HTAs in the inpatient sector. CONCLUSION: Characteristics of HTAs differ widely with respect to the items to be assessed. Therefore, an HTA for drug effectiveness is not easily transferable to radiological procedures. Within radiology, each method must be assessed individually (e. g. according to tumor stage). Despite these challenges, systematic compilation and critical assessment (regarding both cost and medical effectiveness) of available evidence should be a basic component of evidence-based radiology. As companies in healthcare fail to invest in studies that advance evidence-based radiology and considering the lack of incentive for such investments, public funding institutions need to accept the challenge to support studies that assess the benefit of radiological procedures. KEY POINTS: · HTAs should be a basic component of evidence-based radiology.. · G-BA's authority implicitly creates a paradox in terms of inventives to implement and finance HTAs.. · University hospitals and public funding institutions need to support studies that assess the benefit of radiological procedures.. CITATION FORMAT: · Winkelmann C, Neumann T, Zeidler J et al. Health Technology Assessments in Radiology in Germany: Lack of Demand, Lack of Supply. Fortschr Röntgenstr 2019; 191: 635 - 642.