General population normative data from seven European countries for the K10 and K6 scales for psychological distress.

The 10-item Kessler Psychological Distress scale (K10) and its 6-item short-form version (K6) measure psychological distress, particularly anxiety or depressive symptoms. While these questionnaire scales are widely used in various settings and populations, general population normative data are rarely available. To facilitate the interpretation of K10 and K6 scores, we provide normative general population data from seven European countries. We used an online survey to collect K10 data from general population samples in Austria, Italy, Germany, France, the Netherlands, Poland and Spain. We calculated the age- and sex-specific normative values separately for each country. For more specific estimates of K10 and K6 scores for individuals or groups, we also established a multivariable regression model based on socio-demographic and health data. In total, N = 7,087 adults participated in our study (51.6% women; mean age, 49.6 years). The mean K10 score in the total sample was 8.5 points (standard deviation, 7.3) on 0-40 points metric, with mean scores in individual countries ranging from 6.9 (the Netherlands) to 9.9 (Spain). Women showed higher scores than men and younger participants scored higher than older participants. Our study is the first to present normative K10 and K6 data from several European countries using a consistent sampling approach. These reference values will facilitate the interpretation of K10 and K6 scores in clinical research and practice and also highlight the variation in psychological distress levels across countries and groups according to their socio-demographic and health characteristics.

The current use of the EORTC QLQ-NMIBC24 and QLQ-BLM30 questionnaires for the assessment of health-related quality of life in bladder cancer patients: a systematic review.

PURPOSE: Investigating the use of the EORTC bladder cancer (BC) modules by evaluating: (a) study contexts/designs; (b) languages/countries in which the modules were administered; (c) their acceptance by patients/investigators; and (d) their psychometric properties. METHODS: A systematic review was performed with studies from 1998 until 20/10/2021 in five databases. Articles/conference abstracts using the EORTC-QLQBLM30 (muscle invasive BC) and the EORTC-QLQNMIBC24 (previously referred to as QLQ-BLS24; non-muscle invasive BC) were included. Two authors independently screened titles/abstracts/full-texts and performed data extraction. RESULTS: A total of 76 eligible studies were identified. Most studies included the BLM30 (n = 53), were in a urological surgery context (n = 41) and were cross-sectional (n = 35) or prospective (n = 30) in design. The BC modules were administered in 14 languages across 19 countries. Missing data were low-moderate for all non-sex related questions (< 1% to 15%). Sex-related questions had higher rates of missing data (ranging from 6.9% to 84%). Most investigators did not use all scales of the questionnaires. One validation study for the original BLS24 led to the development of the NMIBC24, which adopted a new scale structure for which good structural validity was confirmed (n = 3). Good reliability and validity was shown for the NMIBC24 module, except for malaise and bloating/flatulence scales. Psychometric evidence for BLM30 is lacking. CONCLUSION: These results provide insight into how the EORTC BC quality of life modules could be further improved. Current work is ongoing to update the modules and to determine if the two modules can be combined into a single questionnaire that works well in both the NMIBC and MIBC settings.

Patient-reported outcome measures for physical function in cancer patients: content comparison of the EORTC CAT Core, EORTC QLQ-C30, SF-36, FACT-G, and PROMIS measures using the International Classification of Functioning, Disability and Health.

BACKGROUND: Patient-reported physical function (PF) is a key endpoint in cancer clinical trials. Using complex statistical methods, common metrics have been developed to compare scores from different patient-reported outcome (PRO) measures, but such methods do not account for possible differences in questionnaire content. Therefore, the aim of our study was a content comparison of frequently used PRO measures for PF in cancer patients. METHODS: Relying on the framework of the International Classification of Functioning, Disability and Health (ICF) we categorized the item content of the physical domains of the following measures: EORTC CAT Core, EORTC QLQ-C30, SF-36, PROMIS Cancer Item Bank for Physical Function, PROMIS Short Form for Physical Function 20a, and the FACT-G. Item content was linked to ICF categories by two independent reviewers. RESULTS: The 118 items investigated were assigned to 3 components ('d - Activities and Participation', 'b - Body Functions', and 'e - Environmental Factors') and 11 first-level ICF categories. All PF items of the EORTC measures but one were assigned to the first-level ICF categories 'd4 - Mobility' and 'd5 - Self-care', all within the component 'd - Activities and Participation'. The SF-36 additionally included item content related to 'd9 - Community, social and civic life' and the PROMIS Short Form for Physical Function 20a also included content related to 'd6 - domestic life'. The PROMIS Cancer Item Bank (v1.1) covered, in addition, two first-level categories within the component 'b - Body Functions'. The FACT-G Physical Well-being scale was found to be the most diverse scale with item content partly not covered by the ICF framework. DISCUSSION: Our results provide information about conceptual differences between common PRO measures for the assessment of PF in cancer patients. Our results complement quantitative information on psychometric characteristics of these measures and provide a better understanding of the possibilities of establishing common metrics.

EORTC QLU-C10D value sets for Austria, Italy, and Poland.

OBJECTIVE: To develop Austrian, Italian, and Polish general population value sets for the EORTC QLU-C10D, a cancer-specific utility instrument based on the EORTC QLQ-C30, and to descriptively compare their index scores for distinct health states. METHODS: The QLU-C10D descriptive system comprises 10 health attributes and each can take on 4 levels. A standardised and pre-tested methodology has been applied for valuations including a web-based discrete choice experiment (DCE). It was administered in 1000 general population respondents per country recruited via online panels, aiming at representativeness for core socio-demographic variables. RESULTS: In all three countries, the attributes with the largest impact on utility were physical functioning, pain, and role functioning. Cancer-specific dimensions with the largest impact were nausea and fatigue or bowel problems. Utility values of the worst health state (i.e. severe problems on all 10 dimension) were -0.111 (Austria), 0.025 (Italy), and 0.048 (Poland). Country-specific utilities differed for a selection of health states across the continuum. Austrian utilities were systematically lower for moderately and severely impaired health states. CONCLUSION: QLU-C10D cancer-specific utilities can now be calculated in three more countries. Differences between countries indicate that careful consideration is required when using non-country-specific value sets in economic evaluations.

Establishing the European Norm for the health-related quality of life domains of the computer-adaptive test EORTC CAT Core.

OBJECTIVE: The computer-adaptive test (CAT) of the European Organisation for Research and Treatment of Cancer (EORTC), the EORTC CAT Core, assesses the same 15 domains as the EORTC QLQ-C30 health-related quality of life questionnaire but with increased precision, efficiency, measurement range and flexibility. CAT parameters for estimating scores have been established based on clinical data from cancer patients. This study aimed at establishing the European Norm for each CAT domain based on general population data. METHODS: We collected representative general population data across 11 European Union (EU) countries, Russia, Turkey, Canada and the United States (n ≥ 1000/country; stratified by sex and age). We selected item subsets from each CAT domain for data collection (totalling 86 items). Differential item functioning (DIF) analyses were conducted to investigate cross-cultural measurement invariance. For each domain, means and standard deviations from the EU countries (weighted by country population, sex and age) were used to establish a T-metric with a European general population mean = 50 (standard deviation = 10). RESULTS: A total of 15,386 respondents completed the online survey (n = 11,343 from EU countries). EORTC CAT Core norm scores for all 15 countries were calculated. DIF had negligible impact on scoring. Domain-specific T-scores differed significantly across countries with small to medium effect sizes. CONCLUSION: This study establishes the official European Norm for the EORTC CAT Core. The European CAT Norm can be used globally and allows for meaningful interpretation of scores. Furthermore, CAT scores can be compared with sex- and age-adjusted norm scores at a national level within each of the 15 countries.

General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States.

OBJECTIVE: The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life questionnaire is one of the most widely used cancer-specific health-related quality of life questionnaires worldwide. General population norm data can facilitate the interpretation of QLQ-C30 data obtained from cancer patients. This study aimed at systematically collecting norm data from the general population to develop European QLQ-C30 norm scores and to generate comparable norm data for individual countries in Europe and North America. METHODS: We collected QLQ-C30 data from the general population across 11 European Union (EU) countries, Russia, Turkey, Canada and United States (n ≥ 1000/country). Representative samples were stratified by sex and age groups (18-39, 40-49, 50-59, 60-69 and ≥ 70 years). After applying weights based on the United Nations population distribution statistics, we calculated QLQ-C30 domain scores to generate a 'European QLQ-C30 Norm' based on the EU countries. Further, we calculated QLQ-C30 norm scores for all 15 individual countries. RESULTS: A total of 15,386 respondents completed the online survey. For the EU sample, most QLQ-C30 domains showed differences by sex/age, with men scoring somewhat better health than women, while age effects varied across domains. Substantially larger differences were seen in inter-country comparisons, with Austrian and Dutch respondents reporting consistently better health compared with British and Polish respondents. CONCLUSIONS: This study is the first to systematically collect EORTC QLQ-C30 general population norm data across Europe and North America applying a consistent data collection method across 15 countries. These new norm data facilitate valid intra-country as well as inter-country comparisons and QLQ-C30 score interpretation.

What makes patients aware of their artificial knee joint?

BACKGROUND: Joint awareness was recently introduced as a new concept for outcome assessment after total knee arthroplasty (TKA). Findings from qualitative and psychometric studies suggest that joint awareness is a distinct concept especially relevant to patients with good surgical outcome and patients at late follow-up time points. The aim of this study was to improve the understanding of the concept of joint awareness by identifying situations in which patients are aware of their artificial knee joint and to investigate what bodily sensations and psychological factors raise a patient's awareness of her/his knee. In addition, we evaluated the relative importance of patient-reported outcome parameters that are commonly assessed in orthopaedics. METHODS: Qualitative interviews were conducted with patients being at least 12 months after TKA. The interviews focused on when, where and for what reasons patients were aware of their artificial knee joint. To evaluate the relative importance of 'joint awareness' after TKA among nine commonly assessed outcome parameters (e.g. pain or stiffness), we collected importance ratings ('0' indicating no importance at all and '10' indicating high importance). RESULTS: We conducted interviews with 40 TKA patients (mean age 69.0 years; 65.0% female). Joint awareness was found to be frequently triggered by kneeling on the floor (30%), climbing stairs (25%), and starting up after resting (25%). Patients reported joint awareness to be related to activities of daily living (68%), specific movements (60%), or meteoropathy (18%). Sensations causing joint awareness included pain (45%) or stiffness (15%). Psychological factors raising a patient's awareness of his/her knee comprised for example feelings of insecurity (15%), and fears related to revision surgeries, inflammations or recurring pain (8%). Patients' importance ratings of outcome parameters were generally high and did not allow differentiating clearly among them. CONCLUSIONS: We have identified a wide range of situations, activities, movements and psychological factors contributing to patients' awareness of their artificial knee joints. This improves the understanding of the concept of joint awareness and of a patient's perception of his/her artificial knee joint. The diversity of sensations and factors raising patient's awareness of their joint encourages taking a broader perspective on outcome after TKA.

International validation of the European Organisation for Research and Treatment of Cancer QLQ-BRECON23 quality-of-life questionnaire for women undergoing breast reconstruction.

BACKGROUND: The aim was to carry out phase 4 international field-testing of the European Organisation for Research and Treatment of Cancer (EORTC) breast reconstruction (BRECON) module. The primary objective was finalization of its scale structure. Secondary objectives were evaluation of its reliability, validity, responsiveness, acceptability and interpretability in patients with breast cancer undergoing mastectomy and reconstruction. METHODS: The EORTC module development guidelines were followed. Patients were recruited from 28 centres in seven countries. A prospective cohort completed the QLQ-BRECON15 before mastectomy and the QLQ-BRECON24 at 4-8 months after reconstruction. The cross-sectional cohort completed the QLQ-BRECON24 at 1-5 years after reconstruction, and repeated this 2-8 weeks later (test-retest reliability). All participants completed debriefing questionnaires. RESULTS: A total of 438 patients were recruited, 234 in the prospective cohort and 204 in the cross-sectional cohort. A total of 414 reconstructions were immediate, with a comparable number of implants (176) and donor-site flaps (166). Control groups comprised patients who underwent two-stage implant procedures (72, 75 per cent) or delayed reconstruction (24, 25 per cent). Psychometric scale validity was supported by moderate to high item-own scale and item-total correlations (over 0·5). Questionnaire validity was confirmed by good scale-to-sample targeting, and computable scale scores exceeding 50 per cent, except nipple cosmesis (over 40 per cent). In known-group comparisons, QLQ-BRECON24 scales and items differentiated between patient groups defined by clinical criteria, such as type and timing of reconstruction, postmastectomy radiotherapy and surgical complications, with moderate effect sizes. Prospectively, sexuality and surgical side-effects scales showed significant responsiveness over time (P < 0·001). Scale reliability was supported by high Cronbach's α coefficients (over 0·7) and test-retest (intraclass correlation more than 0·8). One item (finding a well fitting bra) was excluded based on high floor/ceiling effects, poor test-retest and weak correlations in factor analysis (below 0·3), thus generating the QLQ-BRECON23 questionnaire. CONCLUSION: The QLQ-BRECON23 is an internationally validated tool to be used alongside the EORTC QLQ-C30 (cancer) and QLQ-BR23 (breast cancer) questionnaires for evaluating quality of life and satisfaction after breast reconstruction.

Can we use gonadotropin plasma concentration as surrogate marker for BMI-related incomplete estrogen suppression in breast cancer patients receiving anastrozole?

BACKGROUND: BMI has been suggested to impact on estrogenic activity in patients receiving anastrozole resulting in a reduced treatment efficacy in obese women. Current evidence in this regard is controversially discussed. Since estradiol is inversely correlated with gonadotropins it can be assumed that an impact of BMI is also reflected by gonadotropin plasma concentrations. We aim at investigating the impact of BMI on the hormonal state of breast cancer (BC) patients receiving anastrozole indicated by LH, FSH and SHBG as well as estradiol. METHODS: We determined gonadotropin-, estradiol- and anastrozole- serum concentrations from postmenopausal, early stage breast cancer patients receiving upfront anastrozole within routine after care. Gonadotropin plasma concentrations were derived from the routine laboratory examination report. A liquid chromatography tandem mass spectrometry method was used for the measurement of anastrozole serum concentrations. BMI was assessed within the routine after-care check-up. RESULTS: The overall sample comprised 135 BC patients with a mean age of 65.3 years. BMI was significantly correlated with LH, FSH and SHBG. This association was neither influenced by age nor by anastrozole serum concentrations according to the regression model. Despite aromatase inhibition 12% of patients had detectable estrogen levels in routine quantification. CONCLUSION: Obese women have an altered hormonal situation compared to normally weight women under the same dose of anastrozole. Our study findings are a further indicator for the relevance of BMI in regard of anastrozole metabolism and possible estrogenic activity indicated by gonadotropin plasma level.

Cancer patients' understanding of longitudinal EORTC QLQ-C30 scores presented as bar charts.

OBJECTIVE: To investigate cancer patients' understanding of graphical presentations of longitudinal EORTC QLQ-C30 scores. METHODS: We conducted semi-structured interviews with brain tumour patients participating in routine patient-reported outcome (PRO) monitoring. We assessed understanding of longitudinal quality of life (QOL) profiles, presented as bar charts objectively and with self-ratings. In addition, patients' opinions on congruency of the QOL scores with their self-perceived health status were evaluated. RESULTS: We recruited 40 brain tumour patients (57.5% female; mean age 52.7, SD 13.7). In total, 90% of patients rated the graphs as easy to understand. Accordingly, almost all questions on assessing understanding objectively were answered correctly by at least 80% of the patients. More than 95% indicated that the displayed QOL scores matched their personal perception of symptom burden and functional health in the observed period. CONCLUSION: Patients are able to understand their QOL results when presented graphically and are able to interpret important changes. Displayed QOL scores obtained with the EORTC QLQ-C30 are consistent with the patients' personal perception of physical and emotional functioning, pain and fatigue. PRACTICE IMPLICATIONS: Knowledge about patients' understanding of graphically displayed QOL results contributes to creation of optimal evidence-based feedback on the patients' present QOL and its trajectory.

Patients' and health professionals' understanding of and preferences for graphical presentation styles for individual-level EORTC QLQ-C30 scores.

PURPOSE: To investigate patients' and health professionals' understanding of and preferences for different graphical presentation styles for individual-level EORTC QLQ-C30 scores. METHODS: We recruited cancer patients (any treatment and diagnosis) in four European countries and health professionals in the Netherlands. Using a questionnaire, we assessed objective and self-rated understanding of QLQ-C30 scores and preferences for five presentation styles (bar and line charts, with or without color coding, and a heat map). RESULTS: In total, 548 patients and 227 health professionals participated. Eighty-three percent of patients and 85 % of professionals self-rated the graphs as very or quite easy to understand; this did not differ between graphical presentation styles. The mean percentage of correct answers to questions objectively assessing understanding was 59 % in patients, 78 % in medical specialists, and 74 % in other health professionals. Objective understanding did not differ between graphical formats in patients. For non-colored charts, 49.8 % of patients did not have a preference. Colored bar charts (39 %) were preferred over heat maps (20 %) and colored line charts (12 %). Medical specialists preferred heat maps (46 %) followed by non-colored bar charts (19 %), whereas these charts were equally valued by other health professionals (both 32 %). CONCLUSION: The substantial discrepancy between participants' high self-rated and relatively low objective understanding of graphical presentation of PRO results highlights the need to provide sufficient guidance when presenting such results. It may be appropriate to adapt the presentation of PRO results to individual preferences. This could be facilitated when PROs are administered and presented to patients and health professionals electronically.

Evaluation of electronic patient-reported outcome assessment with cancer patients in the hospital and at home.

BACKGROUND: Patient-reported outcomes (PRO) provide a more comprehensive picture of patients' quality of life than do mere physicians' ratings. Electronic data collection of PRO offers several advantages and allows assessments at patients' homes as well. This study reports on patients' personal internet use, their attitudes towards electronic and web-based PRO assessment (clinic-ePRO and home-ePRO) and the feasibility of these two assessment modes. METHODS: At the Medical University of Innsbruck and Kufstein County Hospital, cancer patients who participated in clinic-ePRO/home-ePRO were asked to complete a comprehensive evaluation form on their personal internet usage, attitudes towards and the feasibility of routine clinic-ePRO/home-ePRO with the Computer-based Health Evaluation System (CHES) software. RESULTS: In total, 113 patients completed the evaluation form for clinic-ePRO (Ø 45 years, SD 14) and 45 patients for home-ePRO (Ø 58 years, SD 10; 33.1 per cent inclusion rate for this sample). Most patients expressed willingness to complete routine clinic-ePRO assessments in the future (94.7 per cent of clinic-ePRO patients and 84.4 per cent of home-ePRO patients) and to discuss their data with attending physicians (82.2 per cent, home-ePRO patients only). Overall, patients preferred the software over paper-pencil questionnaires (67.2 per cent of clinic-ePRO patients and 60 per cent of home-ePRO patients) and experienced it as easy to use. Only a few minor suggestions for improvement were made (e.g. adjustable font sizes). CONCLUSIONS: The use of clinic-ePRO/home-ePRO was in general shown to be feasible and well accepted. However, to be more inclusive in the implementation of clinic-ePRO/home-ePRO, educational programs concerning their particular benefit in oncology practice potentially could enhance patients' attitudes towards, and consequently their acceptance of and compliance with electronic PRO assessments.

Comparative responsiveness of outcome measures for total knee arthroplasty.

OBJECTIVE: The aim of this study was to compare the responsiveness of various patient-reported outcome measures (PROMs) and clinician-reported outcomes following total knee arthroplasty (TKA) over a 2-year period. METHODS: Data were collected in a prospective cohort study of primary TKA. Patients who had completed Forgotten Joint Score-12 (FJS-12), Western Ontario and McMaster Universities (WOMAC) osteoarthritis (OA) index, EQ-5D, Knee Society Score and range of movement (ROM) assessment were included. Five time points were assessed: pre-operative, 2 months, 6 months, 1 year and 2 years post-operative. RESULTS: Data from 98 TKAs were available for analysis. Largest effect sizes (ES) for change from pre-operative to 2-month follow-up were observed for the Knee Society Score (KSS) Knee score (1.70) and WOMAC Total (-1.50). For the period from 6 months to 1 year the largest ES for change were shown by the FJS-12 (0.99) and the KSS Function Score (0.88). The EQ-5D showed the strongest ceiling effect at 1-year follow-up with 84.4% of patients scoring the maximum score. ES for the time from 1- to 2-year follow-up were largest for the FJS-12 (0.50). All other outcome measures showed ES equal or below 0.30. CONCLUSION: Outcome measures differ considerably in responsiveness, especially beyond one year post-operatively. Joint-specific outcome measures are more responsive than clinician-reported or generic health outcome tools. The FJS-12 was the most responsive of the tools assessed; suggesting that joint awareness may be a more discerning measure of patient outcome than traditional PROMs.

Quality of life during chemotherapy in lung cancer patients: results across different treatment lines.

BACKGROUND: Most lung cancer patients are diagnosed at an advanced disease stage and predominantly receive palliative treatment, which increasingly consists of several chemotherapy lines. We report on patients' quality of life (QOL) to gain knowledge on QOL during and across multiple lines of chemotherapy. This includes patients with (neo)adjuvant therapy up to 3rd or above line palliative chemotherapy. METHODS: Lung cancer patients receiving outpatient chemotherapy at the Kufstein County Hospital completed an electronic version of the EORTC QLQ-C30. Linear mixed models were used for statistical analysis. RESULTS: One hundred and eighty seven patients were included in the study. Surprisingly, irrespective of the chemotherapy line patients reported stable QOL scores during treatment. None of the calculated monthly change rates attained clinical significance, referring to established guidelines that classify a small clinical meaningful change as 5 to 10 points. According to treatment line, 3rd or above line palliative chemotherapy was associated with the worst QOL scores, whereas patients undergoing (neo)adjuvant or 1st line palliative chemotherapy reported fairly comparable QOL. CONCLUSION: The essential finding of our study is that all QOL aspects of the EORTC QLQ-C30 questionnaire remained unchanged during each chemotherapy line in an unselected population of lung cancer patients. Between treatment lines pronounced differences were found, indicating that later palliative chemotherapy lines are associated with higher QOL impairments. These changes in QOL may not primarily be related to the treatment, but rather refer to impairments due to disease progression and may be partly due to a consequence of the prior therapies.

Chemotherapy line-associated differences in quality of life in patients with advanced cancer.

PURPOSE: The aim of this study was to investigate quality of life (QOL) differences between patients receiving first, second, or third-line palliative chemotherapy (CT).Furthermore, QOL was also compared to a sex- and age-matched sample of healthy controls. METHODS: Patients with different metastatic cancers receiving palliative CT were approached to complete the EORTC QLQ-C30 questionnaire by means of touch-screen computers before the start of CT, after 3 cycles and at the end of cytostatic treatment. RESULTS: One hundred four patients were recruited for QOL assessment (56.9% of patients in first, 22.5% second and 20.6% third- or above-line palliative CT). Compared to healthy controls, they suffered from substantial QOL impairments in all EORTC QLQ-C30 sub-domains. In regard to CT lines, patients with first-line CT reached better scores in emotional and social functioning than second-line patients and less financial difficulties than third-line patients. Despite the high level of impairment in the patient sample, electronic data collection proved to be feasible and well accepted. CONCLUSIONS: The results indicate that patients receiving third- or above-line palliative CT are confronted with stronger QOL impairments than first- and second-line patients. Supported by its feasibility and acceptance of by patients, electronic QOL data capture is an attractive method to screen for symptoms and track their course within clinical routine.

Impact of GvHD on quality of life in long-term survivors of haematopoietic transplantation.

Allogenic haematopoietic stem cell transplantation (HCT) has become an effective therapy in patients with various haematological malignancies. GvHD is known to be a major complication in this patient group and is assumed to have a major impact on patients' quality of life (QOL). Patients after BMT or transplantation of mobilized PBSCs were considered for enrolment in the study 6 months after transplantation. QOL and symptom burden were assessed using the EORTC QLQ-C30 and the QLQ-HDC29. Data from age- and sex-matched healthy controls were collected for comparison. In all, 100 patients (55.0% women; mean age 46.3 years) after allogeneic HCT were included in the study. In this patient group, we found a clinically relevant impact of GvHD on role functioning, global QOL, fatigue, dyspnoea, gastrointestinal side effects, worries/anxiety and skin problems. In comparison to healthy controls, various aspects of QOL were severely impaired. Our study revealed severe impairments of QOL in survivors of HCT, in particular in those suffering from GvHD. Taking into account, that the prevalence of GvHD might be higher in patients after PBSCT compared with patients after BMT, PBSCT is expected to lead to more severe impairments of QOL than BMT.

Six independent domains are defined by geriatric assessment in elderly cancer patients.

BACKGROUND: Geriatric assessment (GA) must be integrated into treatment concepts for elderly cancer patients. Aim of this study was to assess the coverage of a large battery of GA instruments by determining the number of independent domains measured. METHODS: Thirteen different GA scores were applied in 78 elderly tumor patients (mean age 72.9 years). Data were analyzed by exploratory factor analysis and substantiated by non-parametric correlation analyses. RESULTS: Factor analysis yielded a six-factor solution explaining 77.1% of the total variance. The six domains identified may be described as general functioning in everyday life, health-related quality of life, co-morbidities, social support, cognition, and nutritional status. This factor structure was reasonably well confirmed by correlation analyses. Notably, WHO Performance Status, Karnofsky Index, VES-13 and PPT generally revealed high correlations with functional capacities, but only low correlations with comorbidities, social support, cognitive functioning or nutritional status. CONCLUSIONS: From the six domains described a basis for efficient application of GA instruments in elderly cancer patients is worked out. The classical instruments WHO and KI as well as the screening scores VES-13 and PPT, while capturing physical functioning well, fail to cover several other important GA domains.

A new approach to combining clinical relevance and statistical significance for evaluation of quality of life changes in the individual patient.

OBJECTIVE: Empirical investigation of formerly proposed criteria for relevant changes of health-related quality of life (QOL) regarding their use for monitoring changes in the individual patient. Suggestion of a new criterion trying to overcome the drawbacks of former criteria. STUDY DESIGN AND SETTING: QOL data were collected longitudinally in 160 cancer patients receiving chemotherapy at an oncological outpatient unit, giving rise to a total of 975 QOL assessments. QOL was measured using the European Organization on Research and Treatment of Cancer Quality of Life Core Questionnaire. Several formerly suggested criteria of relevant change (distribution based, anchor based) were compared in terms of both prevalence and statistical significance of the resulting relevant changes. RESULTS: When considering criteria of relevant change suggested in the literature, high proportions (average: 42.3-48.3%) of reputedly relevant changes were found. The majority of these changes (average: 55.8-62.2%) were statistically insignificant. Combination of an increased threshold for clinical relevance with the concept of statistical significance resulted in a more meaningful change criterion. CONCLUSION: Formerly recommended thresholds of relevant change in QOL appear to be unduly low when focusing on the individual patient. A modified criterion is therefore suggested for this case. However, more research is needed for validation and refinement of the proposed criterion.

Equating EORTC QLQ-C30 and FACT-G scores and its use in oncological research.

OBJECTIVE: To investigate the equivalence of the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) and the Functional Assessment for Cancer Therapy-General (FACT-G) on the basis of corresponding subscales, and where appropriate to derive a scheme for converting QLQ-C30 scores into FACT-G scores and vice versa for use in oncological research. METHOD: A calibration sample of 737 cancer patients (mean age 51.4+/-7.6 (SD), 63% female, 25% with current chemotherapy) who filled in both quality of life (QOL) questionnaires was used. Both classical test theory and the Rasch measurement model were applied. RESULTS: Three of the four subscales common to both QOL instruments (physical, emotional, functional) proved suitable for equating (acceptable inter-correlations of corresponding subscales physical (r=0.77), emotional domain (r=0.60) role/functional (r=0.63) relative to their internal consistency, sufficient unidimensionality of pooled subscales, satisfactory fit to the Rasch model). Conversion tables for these subscales were generated. CONCLUSIONS: The conversion tables developed in this study (physical, emotional and functional/role domain) appear promising for the comparison between EORTC QLQ-C30 and FACT-G scores of patient samples.

An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer.

This study defines the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QOL) questionnaire designed to measure the QOL of patients with ovarian cancer. The ovarian cancer module (EORTC QLQ-OV28) was developed to supplement the EORTC QLQ-C30. The core questionnaire and the QLQ-OV28 were prospectively administered to 368 ovarian cancer patients after they had been treated with radical or debulking surgery followed by chemotherapy. The QLQ-OV28 module assesses abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning. Questionnaires were well accepted by patients, baseline compliance rates were 86%, 72% provided a second assessment, less than 3% of the items had missing data. Multi-trait scaling analyses confirmed the hypothesised scales. All hypothesised scales exhibited good psychometric properties. These results support the clinical and psychometric validity of the EORTC QLQ-OV28 module as a supplement to the EORTC QLQ-C30.