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Objective: To identify and describe the breast cancer–specific health-related quality of life (HRQoL) instruments with evidence of validation in the breast cancer population for potential use in patients treated for breast cancer (excluding surgery). Methods: We conducted a systematic literature review using PubMed, Embase, and PsycINFO databases to identify articles that contain psychometric properties of HRQoL instruments used in patients with breast cancer. Relevant literature from January 1, 2009, to August 19, 2019, was searched. Articles published in English that reported psychometric properties (reliability, validity) of HRQoL instruments were identified.Results: The database search yielded 613 unique records; 131 full-text articles were reviewed; 80 articles presented psychometric data for instruments used in breast cancer. This article focuses on the 33 that described psychometric properties of breast cancer–specific HRQoL instruments. Twelve breast cancer–specific HRQoL instruments were identified and reviewed: EORTC QLQ-C30, EORTC QLQ-BR23, FACT-B, FBSI, NFBSI-16, YW-BCI36, BCSS, QuEST-Br, QLICP-BR, INA-BCHRQoL, and two newly developed unnamed measures, one by Deshpande and colleagues (for use in India) and one by Vanlemmens and colleagues (for use among young women and their partners). The articles that described the EORTC QLQ-C30, QLQ-BR23, and FACT-B centered on validating translations, providing additional support for content validity, and demonstrating acceptability of electronic patient-reported outcome administration. Psychometric properties of the measures were acceptable. Several new measures have been developed in Asia with an emphasis on development on cultural relevance/sensitivity. Others focused on specific populations (i.e., young women with breast cancer). Conclusions: Historically, there have been limited options for validated measures to assess HRQoL of patients with breast cancer. A number of new measures have been developed and validated, offering promising options for assessing HRQoL in this patient population. This review supports the reliability and validity of the EORTC QLQ-C30 and FACT-B; new translations and electronic versions of these measures further support their use for this population.

Healthcare decisions are more effective when the patient voice is included in clinical research, and the Food and Drug Administration encourages the patient’s voice in drug development and regulatory decision-making. Clinical trials should not only demonstrate the effect of a drug on clinical outcomes but should also demonstrate that these outcomes are important or meaningful to patients. Several qualitative and quantitative methods are available to collect patient experience data (e.g., traditional patient-reported outcome [PRO] measures, interviews with clinical trial participants). We aimed to understand if in-depth exit interviews were more effective assessments of the patient experience in recent type 1 diabetes (T1D) clinical trials than existing diabetes-specific PROs. In-depth qualitative interviews were conducted with 41 adults with T1D who had completed or withdrew from a phase 3 study of sotagliflozin, a dual inhibitor of SGLT1 and SGLT2. A targeted literature review was conducted to identify diabetes-specific PROs used in randomized controlled clinical trials of novel T1D medications reported over the past 5 years. Included trials had to investigate a pharmaceutical intervention for adults with T1D and report a diabetes-specific PRO. The concepts assessed in the PRO measures were mapped against those elicited during the 41 exit interviews. A total of 336 publications were identified in the literature search of which 26 were eligible for analysis. Eight diabetes-specific PROs were identified and reviewed from which 54 concepts related to the patient experience were identified. The patient exit interviews included 42/54 (78%) of the patient experience-related concepts identified across all 8 PROs from the literature review. Of the 8 PRO instruments, the Diabetes Quality of Life Measure (DQOL) covered the most concepts (18/54, 33%), followed closely by the Audit of the Diabetes-Dependent Quality of Life (ADDQoL; 16/54, 30%). Some of the most prominent concepts from both approaches were related to impact on life and family; fear of complications; and impact on physical activity, lifestyle and social perceptions. There were several concepts identified in the exit interviews that were not covered in any of the 8 PRO instruments (related to keeping blood sugars within a desired range, ability to manage changes in insulin use). Overall, the exit interviews appeared to provide a more comprehensive picture of patient experience domains. Although existing diabetes PRO measures cover a range of concepts and may adequately assess changes in certain outcomes, data from patient exit interviews provide more comprehensive insights into the patient experience. Exit interview data may provide a more detailed understanding of the disease burden and impact of treatment on improvements in well-being, daily functioning, and treatment satisfaction.

Objectives: Conservative Management (CM) has emerged as the predominant treatment for localized prostate cancer patients (LPC) with low-risk disease and/or limited life expectancy. However, many non-disease related factors are associated with overtreatment among elderly adults. We examined the associations of multimorbidity and patient-reported experiences of care to use of CM among elderly Medicare Fee-for-Service (FFS) beneficiaries with LPC. Methods: We used linked Surveillance, Epidemiology and End Results (SEER) cancer Registry, Medicare Claims, and the Medicare Consumer Assessment of Healthcare Providers and Systems (MCAHPS Ò ) (SEER-CAHPS) patient experience survey files. Our study sample comprised of elderly (Age $ 66 years) FFS Medicare Beneficiaries who were diagnosed with incident LPC between 2003-2013 and completed a MCAHPS survey within one year post-diagnosis (n=496). We used multivariable logistic regression to determine the associations of pre-existing multimorbidity ($ 3 chronic conditions) and MCAHPS patient reported experiences (i.e., physician communication, timeliness of care, and ease of getting care) to use of CM (no curative treatment 12 months of diagnosis). Results: Timeliness of care ("getting care quickly") mean scores were significantly higher among CM use (M = 75.0, SD = 19.1) versus curative treatment (M = 68.7, SD = 22.7) groups (p = 0.002). In adjusted analyses, LPC patients with multimorbidity were significantly less likely to use CM (adjusted odd ratio (AOR) = 0.42 (0.27-0.66), P,0.001); conversely, those with higher scores on "getting care quickly" were significantly more likely to use CM (AOR=1.21 (1.09, 1.35), P, 0.001). Conclusions: Timeliness of care was significantly and positively associated, and multimorbidity, significantly and inversely associated with CM use. Identifying and addressing barriers to timely care for elderly patients with LPC, and the reasons for lower CM use among those with multimorbidity, could help increase adoption of CM and reduce the adverse effects of overtreatment on health outcomes and costs.

were carried out by drug/technology sponsors (Group-1) or independent evaluators (Group-2). These were then bucketed into one of the following based on the key reporting measure used: 1) absolute difference, 2) per patient utilizing the drug/technology, 3) per disease-prevalent plan population, and 4) per overall plan population. ReSultS: Of the 255 studies analyzed, a third in both Group-1 (n= 193) and Group-2 (n= 62) showed an incremental budget impact, while the remaining showed savings. When reporting an increased budget, as many as 60% of Group-1 chose the largest base (per plan population) versus only 22% of Group-2. In contrast, 15% were reported only in absolute terms by Group-1 versus 61% of Group-2. When reporting savings however, there was little difference between the groups -51% and 46% respectively reported absolute savings. ConCluSionS: The choice of reporting measures was inconsistent, and appeared to be biased by the nature of the evaluators. Within Group-1, the measures were chosen to amplify (in case of savings) or understate (in case of incremental budget) the magnitude of the impact. There is good basis to put in place guidelines to standardize reporting measures, to both remove evaluator bias, and to allow decision-makers to more easily compare different evaluations.