Purpose: Although the use of Patient-Reported Outcomes Measurement Information System (PROMIS) measures is widely advocated, little is known on their use in patients with inflammatory arthritis. We... Show morePurpose: Although the use of Patient-Reported Outcomes Measurement Information System (PROMIS) measures is widely advocated, little is known on their use in patients with inflammatory arthritis. We systematically describe the use and outcomes of PROMIS measures in clinical studies involving people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). Methods: A systematic review was conducted according to the PRISMA guidelines. Through a systematic search of nine electronic databases, clinical studies including patients with RA or axSpA and reporting the use of PROMIS measure were selected. Study characteristics, details of PROMIS measures and their outcomes, if available, were extracted. Results: In total, 29 studies described in 40 articles met the inclusion criteria, of which 25 studies included RA patients, three studies included axSpA patients and one study included both RA and axSpA patients. The use of two general PROMIS measures (PROMIS Global Health, PROMIS-29) and 13 different domain-specific PROMIS measures was reported, of which the PROMIS Pain Interference (n = 17), Physical Function (n = 14), Fatigue (n = 13), and Depression (n = 12) measures were most frequently used. Twenty-one studies reported their results in terms of T-scores. Most T-scores were worse than the general population mean, indicating impairments of health status. Eight studies did not report actual data but rather measurement properties of the PROMIS measures. Conclusion: There was considerable variety regarding the different PROMIS measures used, with the PROMIS Pain interference, Physical function, Fatigue, and Depression measures being the most frequently used. In order to facilitate the comparisons across studies, more standardization of the selection of PROMIS measures is needed. Show less
BackgroundCheckpoint inhibitors have been shown to substantially improve the survival of patients with advanced melanoma. With this growing group of survivors treated with immunotherapies,... Show moreBackgroundCheckpoint inhibitors have been shown to substantially improve the survival of patients with advanced melanoma. With this growing group of survivors treated with immunotherapies, assessing their health-state utilities is essential and can be used for the calculation of quality-adjusted life years and for cost-effectiveness analyses. Therefore, we evaluated the health-state utilities in long-term advanced melanoma survivors.MethodsHealth-state utilities were evaluated in a cohort of advanced melanoma survivors 24-36 months (N = 37) and 36-plus months (N = 47) post-ipilimumab monotherapy. In addition, the health-state utilities of the 24-36 months survivor group were assessed longitudinally, and utilities of the combined survival groups (N = 84) were compared with a matched control population (N = 168). The EQ-5D was used to generate health-state utility values, and quality-of-life questionnaires were used to establish correlations and influencing factors of utility scores.ResultsHealth-state utility scores were similar between the 24-36 months'- and the 36-plus months' survival group (0.81 vs 0.86; p = .22). In survivors, lower utility scores were associated with symptoms of depression (beta = - .82, p = .022) and fatigue burden (beta = - .29, p = .007). Utility scores did not significantly change after 24-36 months of survival, and the utilities of survivors were comparable to the matched control population (0.84 vs 0.87; p = .07).DiscussionOur results show that long-term advanced melanoma survivors treated with ipilimumab monotherapy experience relatively stable and high health-state utility scores. Show less
Haspels, H.N.; Vries, M. de; Akker-van Marle, M.E. van den 2022
Purpose Financial resources for health care are limited, so assessment of intervention effectiveness in terms of health in relation to its costs is important. Measuring health outcomes in cost... Show morePurpose Financial resources for health care are limited, so assessment of intervention effectiveness in terms of health in relation to its costs is important. Measuring health outcomes in cost-effectiveness analyses is usually done by health-related quality of life measures, like the EQ-5D. However, over the past decade, innovations on the conceptual level of health have evolved and novel approaches are rising such as the capability approach, subjective wellbeing, and Positive Health. This study assesses the psychometric properties of the subjective wellbeing-5 dimension (SWB-5D) outcome measure. Methods A quantitative, cross-sectional study design was used to determine the concurrent and construct (convergent and known group) validity for the SWB-5D. Concurrent and convergent validity were estimated as correlations between the SWB-5D and the Dutch version of the EQ-5D, ICECAP-A, and PH-17. Assessment of known-groups validity was based on the variables illness, education, and the overall happiness (Cantril Ladder) and overall health scale (EQ-5D VAS). Results A representative sample of 1016 respondents of the Dutch population completed an online questionnaire. The SWB-5D showed reasonable concurrent validity and showed good convergent and known-group validity. The SWB-5D had a lower ceiling effect compared to the EQ-5D and ICECAP-A. Conclusion Compared to traditional health measurement approaches, novel approaches are more focused on the mental and social pillars of health. The SWB-5D shows psychometric feasibility of comprehensive measurement of health, as indicated by a range of validity measures in a large representative sample of the Dutch population. Show less
Caramanna, I.; Klein, M.; Bent, M. van den; Idbaih, A.; Wick, W.; Taphoorn, M.J.B.; ... ; EORTC Brain Tumor Grp 2022
Purpose: The rate of missing data on patient-reported health-related quality of life (HRQOL) in brain tumor clinical trials is particularly high over time. One solution to this issue is the use of... Show morePurpose: The rate of missing data on patient-reported health-related quality of life (HRQOL) in brain tumor clinical trials is particularly high over time. One solution to this issue is the use of proxy (i.e., partner, relative, informal caregiver) ratings in lieu of patient-reported outcomes (PROs). In this study we investigated patient-proxy agreement on HRQOL outcomes in high-grade glioma (HGG) patients. Methods: Generic and disease-specific HRQOL were assessed using the EORTC QLQ-C30 and QLQ-BN20 in a sample of 501 patient-proxy dyads participating in EORTC trials 26101 and 26091. Patients were classified as impaired or intact, based on their neurocognitive performance. The level of patient-proxy agreement was measured using Lin's concordance correlation coefficient (CCC) and the Bland-Altman limit of agreement. The Wilcoxon signed-rank test was used to evaluate differences between patients' and proxies' HRQOL. Results: Patient-proxy agreement in all HGG patients (N = 501) ranged from 0.082 to 0.460. Only 18.8% of all patients were neurocognitively intact. Lin's CCC ranged from 0.088 to 0.455 in cognitively impaired patients and their proxies and from 0.027 to 0.538 in cognitively intact patients and their proxies. Conclusion: While patient-proxy agreement on health-related quality of life outcomes is somewhat higher in cognitively intact patients, agreement in high-grade glioma patients is low in general. In light of these findings, we suggest to cautiously consider the use of proxy's evaluation in lieu of patient-reported outcomes, regardless of patient's neurocognitive status. Show less
PURPOSE\nMETHODS\nRESULTS\nCONCLUSIONS\nTreatment outcome for common psychiatric disorders, such as mood and anxiety disorders, is usually assessed by self-report measures regarding psychopathology... Show morePURPOSE\nMETHODS\nRESULTS\nCONCLUSIONS\nTreatment outcome for common psychiatric disorders, such as mood and anxiety disorders, is usually assessed by self-report measures regarding psychopathology [e.g., via Brief Symptom Inventory (BSI)]. However, health-related quality of life [as measured by the 36-item Short-Form Health Survey (SF-36)] may be a useful supplementary outcome domain for routine outcome monitoring (ROM). To date, the assessment of both outcomes has become fairly commonplace with severe mental illness, but this is not yet the case for common psychiatric disorders. The present study examined among outpatients with common psychiatric disorders whether aggregate assessments of change across treatment regarding psychopathology and health-related quality of life yield similar results and effect sizes.\nWe compared treatment outcome on the BSI and the SF-36 in a sample of 13,423 outpatients. The concordance of both instruments was assessed at various time points during treatment.\nScores on both instruments were associated, but not so strongly to suggest they measure the same underlying construct. The SF-36 scales presented a varied picture of treatment outcome: understandably, patients changed more on the mental component scales than on physical component scales. Outcome according to the BSI was quite similar to outcome according to scales of the SF-36 that showed the largest change.\nAlthough (mental health) scores on both instruments are associated, adding the SF-36 in addition to the BSI in treatment evaluation research produces valuable information as the SF-36 measures a broader concept and contains physical/functional component scales, resulting in a more complete clinical picture of individual patients. Show less
Purpose Both the International Consortium for Health Outcomes Measurement and the National Institutes of Health recommend the use of Patient-Reported Outcomes Measurement Information System (PROMIS... Show morePurpose Both the International Consortium for Health Outcomes Measurement and the National Institutes of Health recommend the use of Patient-Reported Outcomes Measurement Information System (PROMIS (R)) measures in clinical care and research for stroke patients. This study aimed to systematically review the literature on the measurement properties and interpretability of PROMIS measures in stroke patients. Methods Nine databases were searched from January 1st, 2007 till April 12th, 2021 for studies concerning the measurement properties and interpretability of PROMIS measures in stroke patients. The findings of these studies were analyzed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline for systematic reviews of Patient-Reported Outcome Measures (PROMs). Results Ten studies were included. The PROMIS Global Health was studied the most: its two subscales had sufficient structural validity in one study of very good quality, sufficient construct validity with > 75% of hypotheses tested confirmed (high GRADE rating), sufficient internal consistency, i.e. alpha >= 0.70 in two studies (high GRADE rating), sufficient reliability, i.e. ICC >= 0.70 in one study of doubtful quality, and indeterminate responsiveness in one study of inadequate quality. For other PROMIS measures, the measurement properties and interpretability were limitedly studied. Conclusion The PROMIS Global Health showed sufficient structural and construct validity and internal consistency in stroke patients. There is a need for further research on content validity, structural validity, and measurement invariance of PROMIS measures in stroke patients. Show less
Background Health-related quality of life (HRQoL) is an important outcome measure when considering medical treatment; however, the impact of polypharmacy on trajectories of HRQoL over time is... Show moreBackground Health-related quality of life (HRQoL) is an important outcome measure when considering medical treatment; however, the impact of polypharmacy on trajectories of HRQoL over time is unknown. This study aimed to investigate the association between polypharmacy status and trajectories of HRQoL in older adults. Methods A longitudinal cohort study of 2181 community-dwelling adults, 65 years and older, who participated in the 2013 to 2017 waves of the Household Income and Labour Dynamics in Australia (HILDA) Survey. Polypharmacy was defined as the regular use of >= 5 prescription medications. Polypharmacy status was categorised into no polypharmacy, in 2013 only (baseline only polypharmacy), in 2017 only (incident polypharmacy) or at both time points (persistent polypharmacy). HRQoL was assessed through the SF-36 questionnaire generating two summary scores: physical component summary (PCS) and mental component summary (MCS). Linear mixed-effects models stratified according to polypharmacy status and change in comorbidities were used to assess trajectories of HRQoL. Results Older adults with persistent polypharmacy had lowest scores for HRQoL measures from 2013 to 2017. After adjusting for all covariates, those with incident polypharmacy had the steepest annual decline in both the PCS and MCS: - 0.86 in PCS and - 0.76 in MCS for those with decreasing or stable comorbidities, and - 1.20 in PCS and - 0.75 in MCS for those with increasing comorbidities. Conclusions Polypharmacy was associated with poorer HRQoL, even after adjusting for confounders. Incident polypharmacy was found to be associated with a clinically important decline in HRQoL and this should be considered when prescribing additional medication to older adults. Show less
Purpose Treatment outcome for common psychiatric disorders, such as mood and anxiety disorders, is usually assessed by self-report measures regarding psychopathology [e.g., via Brief Symptom... Show morePurpose Treatment outcome for common psychiatric disorders, such as mood and anxiety disorders, is usually assessed by self-report measures regarding psychopathology [e.g., via Brief Symptom Inventory (BSI)]. However, health-related quality of life [as measured by the 36-item Short-Form Health Survey (SF-36)] may be a useful supplementary outcome domain for routine outcome monitoring (ROM). To date, the assessment of both outcomes has become fairly commonplace with severe mental illness, but this is not yet the case for common psychiatric disorders. The present study examined among outpatients with common psychiatric disorders whether aggregate assessments of change across treatment regarding psychopathology and health-related quality of life yield similar results and effect sizes. Methods We compared treatment outcome on the BSI and the SF-36 in a sample of 13,423 outpatients. The concordance of both instruments was assessed at various time points during treatment. Results Scores on both instruments were associated, but not so strongly to suggest they measure the same underlying construct. The SF-36 scales presented a varied picture of treatment outcome: understandably, patients changed more on the mental component scales than on physical component scales. Outcome according to the BSI was quite similar to outcome according to scales of the SF-36 that showed the largest change. Conclusions Although (mental health) scores on both instruments are associated, adding the SF-36 in addition to the BSI in treatment evaluation research produces valuable information as the SF-36 measures a broader concept and contains physical/functional component scales, resulting in a more complete clinical picture of individual patients. Show less
Previous studies of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) interview version suggested a second-order model, with a general disability factor and six factors... Show morePrevious studies of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) interview version suggested a second-order model, with a general disability factor and six factors on a lower level. The goal of this study is to investigate if we can find support for a similar higher-order factor structure of the 36-item self-report version of the WHODAS 2.0 in a Dutch psychiatric outpatient sample. We aim to give special attention to the differences between the non-working group sample and the working group sample. Additionally, we intend to provide preliminary norms for clinical interpretation of the WHODAS 2.0 scores in psychiatric settings.\nPatients seeking specialized ambulatory treatment, primarily for depressive or anxiety symptoms, completed the WHODAS 2.0 as part of the initial interview. The total sample consisted of 770 patients with a mean age of 37.5 years (SD = 13.3) of whom 280 were males and 490 were females. Several factorial compositions (i.e., one unidimensional model and two second-order models) were modeled using confirmatory factor analysis (CFA). Descriptive statistics, model-fit statistics, reliability of the (sub)scales, and preliminary norms for interpreting test scores are reported. For the non-working group, the second-order model with a general disability factor and six factors on a lower level, provided an adequate fit. Whereas, for the working group, the second-order model with a general disability factor and seven factors on a lower level seemed more appropriate. The WHODAS 2.0 36-item self-report form showed adequate levels of reliability. Percentile ranks and normalized T-scores are provided to aid clinical evaluations. Our results lend support for a factorial structure of the WHODAS 2.0 36-item self-report version that is comparable to the interview version. While we conjecture that a seven-factor solution might give a better reflection of item content and item variance, further research is needed to assess the clinical relevance of such a model. At this point, we recommend using the second-order structure with six factors that matches past findings of the interview form. Show less
Purpose The ICEpop CAPability measure for Adults (ICECAP-A) assesses five capabilities that are important to one’s well-being. The instrument might be an important addition to generic health... Show morePurpose The ICEpop CAPability measure for Adults (ICECAP-A) assesses five capabilities that are important to one’s well-being. The instrument might be an important addition to generic health questionnaires when valuating quality of life extending beyond health. This study aimed to conduct a psychometric assessment of the Dutch translation of the ICECAP-A.Methods Construct validity of the instrument was assessed in two days. First, by measuring correlations with the EQ-5D-5L questionnaire and a measure of self-efficacy and, econd, by investigating the ability to distinguish between groups known to differ on the construct the ICECAP-A means to capture. Additionally, test–retest reliability was evaluated.Results In total, 1002 participants representative of the general Dutch population completed an online survey. For test–retest reliability, 252 participants completed the same questionnaire 2 weeks later. The ICECAP-A indicated moderate to strong correlations with the EQ-5D-5L and a strong correlation with self-efficacy. Furthermore, it was capable of differentiating known groups. Moreover, results indicated adequate test–retest reliability with an intraclass correlation coefficient of 0.79.Conclusion In summary, results suggest adequate test–retest reliability and construct validity and indicate that the ICECAP-A might be of added value, especially when considering areas outside of the traditional health intervention model. Show less
Helmrich, I.R.A.R.; Klaveren, D. van; Dijkland, S.A.; Lingsma, H.F.; Polinder, S.; Wilson, L.; ... ; CENTER TBI Collaborators 2021
Background Traumatic brain injury (TBI) is a leading cause of impairments affecting Health-Related Quality of Life (HRQoL). We aimed to identify predictors of and develop prognostic models for... Show moreBackground Traumatic brain injury (TBI) is a leading cause of impairments affecting Health-Related Quality of Life (HRQoL). We aimed to identify predictors of and develop prognostic models for HRQoL following TBI. Methods We used data from the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) Core study, including patients with a clinical diagnosis of TBI and an indication for computed tomography presenting within 24 h of injury. The primary outcome measures were the SF-36v2 physical (PCS) and mental (MCS) health component summary scores and the Quality of Life after Traumatic Brain Injury (QOLIBRI) total score 6 months post injury. We considered 16 patient and injury characteristics in linear regression analyses. Model performance was expressed as proportion of variance explained (R-2) and corrected for optimism with bootstrap procedures. Results 2666 Adult patients completed the HRQoL questionnaires. Most were mild TBI patients (74%). The strongest predictors for PCS were Glasgow Coma Scale, major extracranial injury, and pre-injury health status, while MCS and QOLIBRI were mainly related to pre-injury mental health problems, level of education, and type of employment. R-2 of the full models was 19% for PCS, 9% for MCS, and 13% for the QOLIBRI. In a subset of patients following predominantly mild TBI (N = 436), including 2 week HRQoL assessment improved model performance substantially (R-2 PCS 15% to 37%, MCS 12% to 36%, and QOLIBRI 10% to 48%). Conclusion Medical and injury-related characteristics are of greatest importance for the prediction of PCS, whereas patient-related characteristics are more important for the prediction of MCS and the QOLIBRI following TBI. Show less
Purpose The aims of this study were to investigate (1) the extent to which response shift occurs among patients with coronary artery disease (CAD) after coronary revascularization, (2) whether the... Show morePurpose The aims of this study were to investigate (1) the extent to which response shift occurs among patients with coronary artery disease (CAD) after coronary revascularization, (2) whether the assessment of changes in health-related quality of life (HRQoL), controlled for response shift, yield more valid estimates of changes in HRQoL, as indicated by stronger associations with criterion measures of change, than without controlling for response shift, and (3) if occurrences of response shift are related to patient characteristics. Methods Patients with CAD completed the SF-36 and the Seattle Angina Questionnaire (SAQ7) at baseline and 3 months after coronary revascularization. Sociodemographic, clinical and psychosocial variables were measured with the patient version of the New York Heart Association-class, Subjective Significance Questionnaire, Reconstruction of Life Events Questionnaire (RE-LIFE), and HEXACO personality inventory. Oort's Structural Equation Modeling (SEM) approach was used to investigate response shift. Results 191 patient completed questionnaires at baseline and at 3 months after treatment. The SF-36 showed recalibration and reprioritization response shift and the SAQ7 reconceptualization response shift. Controlling for these response shift effects did not result in more valid estimates of change. One significant association was found between reprioritization response shift and complete integration of having CAD into their life story, as indicated by the RE-LIFE. Conclusion Results indicate response shift in HRQoL following coronary revascularization. While we did not find an impact of response shift on the estimates of change, the SEM approach provides a more comprehensive insight into the different types of change in HRQoL following coronary revascularization. Show less
Purpose Previous studies of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) interview version suggested a second-order model, with a general disability factor and six... Show morePurpose Previous studies of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) interview version suggested a second-order model, with a general disability factor and six factors on a lower level. The goal of this study is to investigate if we can find support for a similar higher-order factor structure of the 36-item self-report version of the WHODAS 2.0 in a Dutch psychiatric outpatient sample. We aim to give special attention to the differences between the non-working group sample and the working group sample. Additionally, we intend to provide preliminary norms for clinical interpretation of the WHODAS 2.0 scores in psychiatric settings. Methods Patients seeking specialized ambulatory treatment, primarily for depressive or anxiety symptoms, completed the WHODAS 2.0 as part of the initial interview. The total sample consisted of 770 patients with a mean age of 37.5 years (SD = 13.3) of whom 280 were males and 490 were females. Several factorial compositions (i.e., one unidimensional model and two second-order models) were modeled using confirmatory factor analysis (CFA). Descriptive statistics, model-fit statistics, reliability of the (sub)scales, and preliminary norms for interpreting test scores are reported. Results For the non-working group, the second-order model with a general disability factor and six factors on a lower level, provided an adequate fit. Whereas, for the working group, the second-order model with a general disability factor and seven factors on a lower level seemed more appropriate. The WHODAS 2.0 36-item self-report form showed adequate levels of reliability. Percentile ranks and normalized T-scores are provided to aid clinical evaluations. Conclusion Our results lend support for a factorial structure of the WHODAS 2.0 36-item self-report version that is comparable to the interview version. While we conjecture that a seven-factor solution might give a better reflection of item content and item variance, further research is needed to assess the clinical relevance of such a model. At this point, we recommend using the second-order structure with six factors that matches past findings of the interview form. Show less
Sawatzky, R.; Kwon, J.Y.; Barclay, R.; Chauhan, C.; Frank, L.; Hout, W.B. van den; ... ; Response Shift Syn 2021
Purpose Results of patient-reported outcome measures (PROMs) are increasingly used to inform healthcare decision-making. Research has shown that response shift can impact PROM results. As part of... Show morePurpose Results of patient-reported outcome measures (PROMs) are increasingly used to inform healthcare decision-making. Research has shown that response shift can impact PROM results. As part of an international collaboration, our goal is to provide a framework regarding the implications of response shift at the level of patient care (micro), healthcare institute (meso), and healthcare policy (macro). Methods Empirical evidence of response shift that can influence patients' self-reported health and preferences provided the foundation for development of the framework. Measurement validity theory, hermeneutic philosophy, and micro-, meso-, and macro-level healthcare decision-making informed our theoretical analysis. Results At the micro-level, patients' self-reported health needs to be interpreted via dialogue with the clinician to avoid misinterpretation of PROM data due to response shift. It is also important to consider the potential impact of response shift on study results, when these are used to support decisions. At the meso-level, individual-level data should be examined for response shift before aggregating PROM data for decision-making related to quality improvement, performance monitoring, and accreditation. At the macro-level, critical reflection on the conceptualization of health is required to know whether response shift needs to be controlled for when PROM data are used to inform healthcare coverage. Conclusion Given empirical evidence of response shift, there is a critical need for guidelines and knowledge translation to avoid potential misinterpretations of PROM results and consequential biases in decision-making. Our framework with guiding questions provides a structure for developing strategies to address potential impacts of response shift at micro-, meso-, and macro-levels. Show less
Rationale The impact of prophylactic implantable cardioverter-defibrillator (ICD) implantation on the psychological well-being of patients on dialysis is unknown.Objective We aimed to identify the... Show moreRationale The impact of prophylactic implantable cardioverter-defibrillator (ICD) implantation on the psychological well-being of patients on dialysis is unknown.Objective We aimed to identify the effect of primary ICD implantation on quality of life (QoL), mood and dispositional optimism in patients undergoing dialysis.Methods and results We performed a prespecified subanalysis of the randomized controlled ICD2 trial. In total, 177 patients on chronic dialysis, with an age of 55-81 years, and a left ventricular ejection fraction of >= 35%, were included in the per-protocol analysis. Eighty patients received an ICD for primary prevention, and 91 patients received standard care. The Short Form-36 (SF-36), Geriatric Depression Scale-15 (GDS-15), Revised Life Orientation Test (LOT-R) questionnaires were administered prior to ICD implantation (T0), and at 1-year follow-up (T1) to assess QoL, depression and optimism, respectively. The patients were predominantly male (76.0%), with a median age of 67 years. Hemodialysis was the predominant mode of dialysis (70.2%). The GDS-15 score difference (T1 - T0) was 0.5 (2.1) in the ICD group compared with 0.3 (2.2) in the control group (mean difference - 0.3; 95% CI - 1.1 to 0.6; P = 0.58). The LOT-R score difference was - 0.2 (4.1) in the ICD group compared with - 1.5 (4.0) in the control group (mean difference - 1.1 (0.8); 95% CI - 2.6 to 0.4; P = 0.17). The mean difference scores of all subscales of the SF-36 were not significantly different between randomization groups.Conclusions In our population of patients on dialysis, ICD implantation did not affect QoL, mood or dispositional optimism significantly during 1-year follow-up. Show less
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... Show morePurpose 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. Therefore, this measure is currently being developed. Methods This international multicentre study followed European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group module development guidelines. Three out of four phases are completed: phases (I) generation of items, (II) construction of the item list, and (III) pre-testing. This paper reports the item selection procedures and preliminary psychometric properties of the questionnaire. Brain tumour patients (gliomas and brain metastases), their informal caregivers, and health care professionals (HCPs) were included. Results Phase I (n = 44 patient-proxy dyads and 26 HCPs) generated 59 relevant and important activities. In phase II, the activities were converted into items. In phase III (n = 85 dyads), the 59 items were pre-tested. Item selection procedures resulted in 32 items. Exploratory factor analysis revealed a preliminary dimensional structure consisting of five scales with acceptable to excellent internal consistency (alpha = 0.73-0.94) and two single items. For three scales, patients with cognitive impairments had significantly more IADL problems than patients without impairments. Conclusion A phase IV validation study is needed to confirm the psychometric properties of the EORTC IADL-BN32 questionnaire in a larger international sample. Show less
Larsen, M.; Goemans, A.; Baste, V.; Wilderjans, T.F.; Lehmann, S. 2020
