Content validation of the Well-being of Older People measure (WOOP).

BACKGROUND: Valid measures of the well-being of older people are important for the evaluation of health and social care services. The nine-item Well-being of Older People measure (WOOP) was based on a novel framework derived from a recent Q-methodology study, and was developed to capture a comprehensive set of well-being domains relevant to older people, as identified by themselves. This study introduces the WOOP and describes the qualitative assessment of its feasibility and content validity. METHODS: Between December 2017 and January 2018, a sampling agency retrieved data from 269 adults aged 65 years and older in the Netherlands. Using an online survey, participants were asked to complete the WOOP and to indicate the importance of each item to their well-being. Open-ended questions were used to collect information about participants' own definition of well-being, their interpretation of the items of the WOOP, and their assessment of the descriptions and response options provided with each item. Data were analysed using inductive content analysis with the software package ATLAS.ti. RESULTS: The WOOP closely resembled respondents' own description of what well-being means to them. The majority of the respondents reported no important well-being aspects to be missing from the WOOP, and indicated all WOOP items to be at least 'reasonably important' to their well-being. Many linked the WOOP items to well-being aspects as intended, and only a few had suggestions for improving the items' descriptions and response options. CONCLUSIONS: Given these results, all nine items were retained, and no items were added to the measure. Based on respondents' feedback, minor changes were made to the wording of some descriptions and response options of items. Concluding, the feasibility and content validity of the WOOP seem satisfactory. Further validation of this new measure is required, in different health and social care settings and among subgroups of older people with potentially different views on what constitutes well-being.

Does the ICECAP-O cover the physical, mental and social functioning of older people in the UK?

PURPOSE: The ICEpop CAPability measure for Older people (ICECAP-O) is intended for use in economic evaluations of care services for older people. Although studies support the validity of the ICECAP-O, it does not directly ask older people about their health. This raises questions about its ability to capture health indirectly. Previous studies found mixed results in this aspect, especially for physical health. This study further investigates whether the ICECAP-O indirectly includes health. METHODS: Using a cross-sectional design, a sampling agency retrieved data from 516 people aged 70 and older from the UK through an online questionnaire. The overlap in underlying constructs of the ICECAP-O and EQ-5D-5L was assessed using exploratory factor analysis. Spearman correlations and variance analysis were conducted by relating the ICECAP-O to measures of physical, mental and social functioning. RESULTS: The ICECAP-O and EQ-5D-5L items loaded on two factors. Their overlap was limited, as four out of five EQ-5D-5L items loaded on the first factor, while four out of five ICECAP-O items loaded on the second. The ICECAP-O correlated highly with (mental and social functioning) health measures, and was able to differentiate between individuals with different scores on these measures. However, the correlation with the Barthel Index, a measure of physical functioning, was moderate. CONCLUSIONS: The ICECAP-O may not fully cover all aspects of health. Therefore, a complementary health measure should be used in addition to the ICECAP-O to capture the full benefits of care interventions for older people in economic evaluations.

Valid Outcome Measures in Care for Older People: Comparing the ASCOT and the ICECAP-O.

BACKGROUND: Limited health care budgets and population aging result in a need to compare care services on their benefits and costs. Because services for older people often aim to improve multiple life aspects, valid measures are needed to examine their benefits on individuals' health and well-being simultaneously. Two measures may meet this end: the Adult Social Care Outcomes Toolkit (ASCOT) and the ICEpop CAPability measure for Older people (ICECAP-O). OBJECTIVES: To compare the validity of both measures, the ASCOT and the ICECAP-O. METHODS: A sampling agency gathered cross-sectional data in May 2015. Using exploratory factor analysis, the underlying factor structure of the ASCOT and the ICECAP-O was examined for the first time. Convergent and discriminant validity in relation to health measures (five-level EuroQol five-dimensional questionnaire, EuroQol Visual Analogue Scale, Barthel Index, and Geriatric Depression Scale-15) and well-being measures (Older People's Quality of Life Questionnaire-13, Satisfaction with Life Scale, and Cantril's Ladder) were tested using Spearman rank correlations and variance analysis. RESULTS: The ASCOT and the ICECAP-O tapped into a shared factor, whereas both measures also loaded on two separate factors. The ASCOT and the ICECAP-O correlated highly with the health and well-being measures, but the correlation with the physical health measure Barthel Index was moderate. Both measures discriminated between subgroups of respondents. CONCLUSIONS: The ASCOT and the ICECAP-O seem promising measures to evaluate well-being among older people, whereby the ASCOT seems more specific to social care-related outcomes. The performance of both measures in other respondent groups and countries, and their relation to physical health, need to be further examined before their use in economic evaluations can be recommended.

Real-world palbociclib effectiveness in patients with metastatic breast cancer: Focus on neutropenia-related treatment modification strategies and clinical outcomes.

INTRODUCTION: In addition to clinical trials, real-world data is needed to verify the effectiveness of the CDK 4/6 inhibitor palbociclib. The primary aim was to examine real-world variation in treatment modification strategies for neutropenia and its relation to progression-free survival (PFS). The secondary aim was to assess if there is a gap between real-world and clinical trial outcomes. MATERIALS AND METHODS: In this multicenter, retrospective observational cohort study 229 patients were analyzed who started palbociclib and fulvestrant as second- or later-line therapy for HR-positive, HER2-negative metastatic breast cancer in the Santeon hospital group in the Netherlands between September 2016 and December 2019. Data were manually retrieved from patients' electronic medical records. PFS was examined using the Kaplan-Meier method to compare neutropenia-related treatment modification strategies within the first three months after neutropenia grade 3 - 4 occurred, as well as patients' eligibility to have participated in the PALOMA-3 clinical trial or not. RESULTS: Even though treatment modification strategies differed from those in PALOMA-3 (dose interruptions: 26 vs 54%, cycle delays: 54 vs 36%, and dose reductions: 39 vs 34%), these did not influence PFS. Patients who were PALOMA-3 ineligible experienced a shorter median PFS than those who were eligible (10.2 vs. 14.1 months; HR 1.52; 95% CI 1.12 - 2.07). An overall longer median PFS was found compared to PALOMA-3 (11.6 vs. 9.5 months; HR 0.70; 95% CI 0.54 - 0.90). CONCLUSION: This study suggests no impact of neutropenia-related treatment modifications on PFS and confirms inferior outcomes outside clinical trial eligibility.

Estimating an anchored utility tariff for the well-being of older people measure (WOOP) for the Netherlands.

OBJECTIVE: Health economic evaluations using common health-related quality of life measures may fall short in adequately incorporating all relevant benefits of health and social care interventions targeted at older people. The Well-being of Older People measure (WOOP) is a broader well-being measure that comprises nine well-being domains. The objective of this study was to estimate a utility tariff for the WOOP, to facilitate its application in cost-utility analyses. METHODS: A discrete choice experiment (DCE) with duration approach was set up and fielded among 2,012 individuals from the Netherlands aged 65 years and above. Matched pairwise choice tasks, colour-coding and level overlap were used to reduce the cognitive burden of the DCE. The choice tasks were created using a Bayesian heterogeneous D-efficient design. The estimation procedure accommodated for nonlinear time preferences via an exponential discounting function. RESULTS: The estimation results showed that 'physical health', 'mental health', and 'making ends meet' were the most important well-being domains for older people, followed by 'independence' and 'living situation'. Of somewhat lesser importance were domains like 'social life', 'receiving support' and 'feeling useful'. The generated utility tariffs can be used to translate well-being states described with the WOOP to a utility score between -0.616 and 1. CONCLUSIONS: This study established a tariff for the WOOP, which will facilitate its use in economic evaluations of health and social care interventions targeted at older people, first of all in the Netherlands.

Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series.

INTRODUCTION: Within the value-based healthcare framework, outcome data can be used to inform patients about (treatment) options, and empower them to make shared decisions with their health care professional. To facilitate shared decision-making (SDM) supported by outcome data, a multicomponent intervention has been designed, including patient decision aids on the organisation of post-treatment surveillance (breast cancer); discharge location (stroke) and treatment modality (advanced kidney disease), and training on SDM for health care professionals. The SHared decision-making supported by OUTcome information (SHOUT) study will examine the effectiveness of the intervention and its implementation in clinical practice. METHODS AND ANALYSIS: Multiple interrupted time series will be used to stepwise implement the intervention. Patients diagnosed with either breast cancer (N=630), stroke (N=630) or advanced kidney disease (N=473) will be included. Measurements will be performed at baseline, three (stroke), six and twelve (breast cancer and advanced kidney disease) months. Trends on outcomes will be measured over a period of 20 months. The primary outcome will be patients' perceived level of involvement in decision-making. Secondary outcomes regarding effectiveness will include patient-reported SDM, decisional conflict, role in decision-making, knowledge, quality of life, preferred and chosen care, satisfaction with the intervention, healthcare utilisation and health outcomes. Outcomes regarding implementation will include the implementation rate and a questionnaire on the health care professionals' perspective on the implementation process. ETHICS AND DISSEMINATION: The Medical research Ethics Committees United in Nieuwegein, the Netherlands, has confirmed that the Medical Research Involving Human Subjects Act does not apply to this study. Bureau Onderzoek & Innovatie of Santeon, the Netherlands, approved this study. The results will contribute to insight in and knowledge on the use of outcome data for SDM, and can stimulate sustainable implementation of SDM. TRIAL REGISTRATION NUMBER: NL8374, NL8375 and NL8376.

Well-being of Older People (WOOP): Quantitative validation of a new outcome measure for use in economic evaluations.

There is a need for comprehensive measures to evaluate the benefits of health and social care services for older people. The newly developed Well-being of Older People measure (WOOP) aims to capture all aspects that older people find important to their well-being. This study explores the validity and test-retest reliability of the WOOP. Between December 2017 and January 2018, an online survey was used to retrieve data from 1113 people aged 65 years and older in the Netherlands. Regression analyses on Cantril's Ladder scores were conducted to explore the relative importance of the items of the WOOP. Dimensionality was checked using exploratory factor analysis. Convergent and discriminant validity were investigated by relating the WOOP to several measures of health and well-being. Test-retest reliability was examined using data from 269 respondents that participated in a second online survey, distributed one week after the first. The items of the WOOP were significantly associated with Cantril's Ladder scores. When regressed simultaneously this was still true for all but the 'social contacts' item and one level of the 'acceptance and resilience' item. The dimensionality analysis revealed three factors, of which two included items of the WOOP and the EQ-5D-5L and the third only items of the WOOP. The WOOP correlated moderately to highly with physical health, and (very) highly with (mental) health and well-being measures. The test-retest reliability in terms of ICC was high, whereas the kappa for the items was fair to good, except for two items. Overall, the WOOP seems to capture aspects relevant to the well-being of older people adequately, and the results of first validity and reliability tests were satisfactory. Before the WOOP can be used in economic evaluations, further validation in a variety of health and social care settings is recommended, and utility weights need to be determined.

Views of older people in the Netherlands on wellbeing: A Q-methodology study.

Population ageing and restricted budgets result in the need for an efficient allocation of scarce resources in care services for older people. As these services tend to address more than only health, diverse wellbeing measures have been developed to assess their benefits in economic evaluations. These measures are grounded in research on wellbeing of older people and its determinants. Little is known about possible heterogeneity in this context and the extent to which wellbeing measures cover the aspects of wellbeing that are most important to older people with different views on wellbeing. We conducted a Q-methodology study between December 2016 and October 2017 to investigate the variety in views among people aged 65 and older in the Netherlands on what is important to their wellbeing. A purposive sample of 53 respondents ranked 34 opinion statements according to importance to their wellbeing and explained their ranking during a follow-up interview. Data were analysed using by-person factor analysis to identify common patterns in the rankings of the statements. Five distinct views were extracted in which different aspects were considered important: (I) health, financial security and a life partner; (II) family, support and physical functioning (III); autonomy, mental health and helping others; (IV) social contacts, support, mental health and religion; and (V) a life partner, social contacts, living environment and adaptation. This heterogeneity in views of older people on what constitutes wellbeing supports the use of person-centered approaches in care services for older people. Arguably, (evaluations of) policies and services for older people should take this plurality into consideration.