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Introduction: Minimal important differences (MIDs) are useful for interpreting changes or differences in health-related quality of life scores in terms of clinical importance. There are currently no MID guidelines for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) specific to ovarian cancer. This study aims to estimate MIDs for interpreting group-level change of EORTC QLQ-C30 scores in ovarian cancer., Methods: Data were derived from four EORTC published trials. Clinical anchors for each EORTC QLQ-C30 scale were selected using correlation strength and clinical plausibility. MIDs for within-group change and between-group differences in change over time were estimated via mean change method and linear regression respectively. For each EORTC QLQ-C30 scale, MID estimates from multiple anchors were summarized via weighted-correlation. Distribution-based MIDs were also examined as supportive evidence., Results: Anchor-based MIDs were determined for deterioration in 7 of the 14 EORTC QLQ-C30 scales assessed, and in 11 scales for improvement. Anchor-based MIDs for within-group change ranged from 4 to 19 (improvement) and - 9 to -4 (deterioration). Between-group MIDs ranged from 3 to 13 (improvement) and - 11 to -4 (deterioration). Generally, absolute anchor-based MIDs for most scales ranged from 4 to 10 points., Conclusions: Our findings will aid interpretation of EORTC QLQ-C30 scores in ovarian cancer and inform sample size calculations in future ovarian cancer trials with endpoints that are based on EORTC QLQ-C30 scales., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Many advanced cancers are managed as chronic diseases, yet there are currently no international guidelines for the support of patients living with chronic cancer. It is important to understand whether care and service arrangements meet the needs of this rapidly growing patient group. This study aimed to develop and validate a questionnaire to capture patients' experiences of living with chronic cancer and their views of clinical and support services., Methods: The research was carried out between 1 July 2010 and 21 February 2013. A conceptual framework and initial item bank were derived from prior interviews with 56 patients with chronic cancer. Items were reviewed by 4 oncologists and 1 clinical nurse specialist and during 2 focus groups with 9 patients. Pilot questionnaires were completed by 416 patients across 5 cancer units. Item selection and scale reliability was explored using descriptive data, exploratory factor analysis, internal consistency analyses, multitrait scaling analyses and known-groups comparisons., Results: The final Chronic Cancer Experiences Questionnaire (CCEQ) includes 75 items. 62 items contribute to 14 subscales with internal consistency between α 0·68-0·88 and minimal scaling errors. Known-groups comparisons confirmed subscale utility in distinguishing between patient groups. Subscales were labelled: managing appointments, coordination of care, general practitioner involvement, clinical trials, information and questions, making treatment decisions, symptom non-reporting, key worker, limitations, sustaining normality, financial advice, worries and anxieties, sharing feelings with others, and accessing support. 13 items assessing symptom experiences were retained as single items., Conclusions: The CCEQ has the potential to be used as a clinical instrument to assess patient experiences of chronic cancer or to screen for patient needs. It may also be used as an outcome measure for evaluating programmes and models of care and may identify areas for service development that could ultimately improve the care and support received by patients with chronic cancer., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Introduction: Health-related quality of life (HRQOL) is increasingly recognised as an important end-point in cancer clinical trials. The concept of minimally important difference (MID) enables interpreting differences and changes in HRQOL scores in terms of clinical meaningfulness. We aimed to estimate MIDs for interpreting group-level change of European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) scores in patients with malignant melanoma., Methods: Data were pooled from three published melanoma phase III trials. Anchors relying on clinician's ratings, e.g. performance status, were selected using correlation strength and clinical plausibility of associating the anchor/EORTC QLQ-C30 scale pair. HRQOL change was evaluated between time periods that were common to all trials: start of treatment to end of treatment and end of treatment to end of follow-up. Three change status groups were formed: deteriorated by one anchor category, improved by one anchor category and no change. Patients with greater anchor change were excluded. The mean change method and linear regression were used to estimate MIDs for change in HRQOL scores within the group and between the groups of patients, respectively., Results: MIDs varied according to QLQ-C30 scale, direction (improvement versus deterioration), anchor and period. MIDs for within-group change ranged from 4 to 18 points (improvement) and -16 to -4 points (deterioration), and MIDs for between-group change ranged from 3 to 16 points and from -16 to -3 points. MIDs for most of QLQ-C30 scales ranged from 5 to 10 points in absolute values., Conclusions: These results are useful for interpreting changes in EORTC QLQ-C30 scores over time and for performing more accurate sample size calculations in adjuvant melanoma settings., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Context: Clinical studies have over the past decade paid increasing attention to health-related quality of life data. Multiple questionnaires are often administered resulting in overlapping questions increasing patient burden., Objectives: To examine the correlations between the commonly used European Organization for Research and Treatment of Cancer Quality of Life Questionnnaire-C30 (QLQ-C30) and the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) on six coinciding items to determine consistency between overlapping items., Methods: Data were prospectively collected from patients attending two cancer centers in the U.K. Participants completed the QLQ-C30 version 3.0 every four weeks and the PRO-CTCAE at least once a week for 12 weeks. Data were collected via the Internet or an interactive voice response. For the six coinciding items in QLQ-C30 and PRO-CTCAE: pain, nausea, vomiting, constipation, diarrhea, and fatigue, comparisons were made between all possible related responses by aligning the four responses in the QLQ-C30 with two condensed versions of the five responses in the PRO-CTCAE. Consistency and reliability was determined with the intraclass correlation coefficient (ICC) and Cronbach's α., Results: About 247 patients completed 785 QLQ-C30 and 2501 PRO-CTCAE questionnaires. Moderate (ICC >0.5) to good (ICC >0.75) reliability and Cronbach's α >0.7 were found on all coinciding questions except for questions concerning the severity of nausea and vomiting as a result of relatively few patients responding to these questions. Items on frequency showed better correlations than the severity and interference items., Conclusion: The good reliability and consistency between the QLQ-C30 and PRO-CTCAE support future attempts to minimize patient burden by shortening health-related quality of life questionnaires., (Copyright © 2018 American Academy of Hospice and Palliative Medicine. All rights reserved.)

Introduction: As patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30). We will mainly focus on MID estimation for group-level comparisons. Responder thresholds for individual-level change will also be estimated., Methods and Analysis: Data will be derived from published phase II and III EORTC trials that used the QLQ-C30 instrument, covering several cancer sites. We will use individual patient data to estimate MIDs for different cancer sites separately. Focus is on anchor-based methods. Anchors will be selected per disease site from available data. A disease-oriented and methodological panel will provide independent guidance on anchor selection. We aim to construct multiple clinical anchors per QLQ-C30 scale and also to compare with several anchor-based methods. The effects of covariates, for example, gender, age, disease stage and so on, will also be investigated. We will examine how our estimated MIDs compare with previously published guidelines, hence further contributing to robust MID guidelines for the EORTC QLQ-C30., Ethics and Dissemination: All patient data originate from completed clinical trials with mandatory written informed consent, approved by local ethical committees. Our findings will be presented at scientific conferences, disseminated via peer-reviewed publications and also compiled in a MID 'blue book' which will be made available online on the EORTC Quality of Life Group website as a free guideline document., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Purpose: We evaluated the psychometric properties of the Korean version of the European Organization for Research and Treatment of Cancer high-dose chemotherapy specific quality of life questionnaire module (EORTC QLQ-HDC29) when implemented with Korean patients by conducting a multicenter, longitudinal study in three Korean hospitals., Methods: A total of 226 patients who scheduled to receive the HDC followed by hematopoietic stem cell transplantation (HSCT) were enrolled. The patients were asked to complete three questionnaires [the EORTC Core Questionnaire (QLQ-C30), QLQ-HDC29, and the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation] at four points in time: before HSCT and 100, 180, and 365 days after HSCT. Standard validity and reliability analyses were performed., Results: Internal consistency of the QLQ-HDC29 was generally acceptable, as tested by Cronbach's α, except for the scales body image and the inpatient issues. Cronbach's α values for the Korean version of the QLQ-HDC29 were almost in accordance with results of the original version, except for the scales body image (lower to the original QLQ-HDC29, α = 0.73) and impact on family (higher to the original QLQ-HDC29, α = 0.52). Known-group comparison analyses showed significantly higher symptom burdens in patients with poor performance status or graft versus host disease (similar to the original QLQ-HDC29). The QLQ-HDC29 indicated good convergent and discriminant validity and showed responsiveness to changes in line with a clinical course over time after HSCT., Conclusions: The QLQ-HDC29 is generally reliable and adequate to assess QoL in Korean patients undergoing HDC followed by HSCT.

Purpose: To assess the feasibility of using a discrete choice experiment (DCE) to value health states within the QLU-C10D, a utility instrument derived from the QLQ-C30, and to assess clarity, difficulty, and respondent preference between two presentation formats., Methods: We ran a DCE valuation task in an online panel (N = 430). Respondents answered 16 choice pairs; in half of these, differences between dimensions were highlighted, and in the remainder, common dimensions were described in text and differing attributes were tabulated. To simplify the cognitive task, only four of the QLU-C10D's ten dimensions differed per choice set. We assessed difficulty and clarity of the valuation task with Likert-type scales, and respondents were asked which format they preferred. We analysed the DCE data by format with a conditional logit model and used Chi-squared tests to compare other responses by format. Semi-structured telephone interviews (N = 8) explored respondents' cognitive approaches to the valuation task., Results: Four hundred and forty-nine individuals were recruited, 430 completed at least one choice set, and 422/449 (94 %) completed all 16 choice sets. Interviews revealed that respondents found ten domains difficult but manageable, many adopting simplifying heuristics. Results for clarity and difficulty were identical between formats, but the "highlight" format was preferred by 68 % of respondents. Conditional logit parameter estimates were monotonic within domains, suggesting respondents were able to complete the DCE sensibly, yielding valid results., Conclusion: A DCE valuation task in which only four of the QLU-C10D's ten dimensions differed in any choice set is feasible for deriving utility weights for the QLU-C10D.

Purpose: To derive a health state classification system (HSCS) from the cancer-specific quality of life questionnaire, the EORTC QLQ-C30, as the basis for a multi-attribute utility instrument., Methods: The conceptual model for the HSCS was based on the established domain structure of the QLQ-C30. Several criteria were considered to select a subset of dimensions and items for the HSCS. Expert opinion and patient input informed a priori selection of key dimensions. Psychometric criteria were assessed via secondary analysis of a pooled dataset comprising HRQOL and clinical data from 2616 patients from eight countries and a range of primary cancer sites, disease stages, and treatments. We used confirmatory factor analysis (CFA) to assess the conceptual model's robustness and generalisability. We assessed item floor effects (>75 % observations at lowest score), disordered item response thresholds, coverage of the latent variable and differential item function using Rasch analysis. We calculated effect sizes for known group comparisons based on disease stage and responsiveness to change. Seventy-nine cancer patients assessed the relative importance of items within dimensions., Results: CFA supported the conceptual model and its generalisability across primary cancer sites. After considering all criteria, 12 items were selected representing 10 dimensions: physical functioning (mobility), role functioning, social functioning, emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems., Conclusions: The HSCS created from QLQ-C30 items is known as the EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The next phase of the QLU-C10D's development involves valuation studies, currently planned or being conducted across the globe.

Objective: To further evaluate the higher order measurement structure of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), with the aim of generating a summary score., Study Design and Setting: Using pretreatment QLQ-C30 data (N = 3,282), we conducted confirmatory factor analyses to test seven previously evaluated higher order models. We compared the summary score(s) derived from the best performing higher order model with the original QLQ-C30 scale scores, using tumor stage, performance status, and change over time (N = 244) as grouping variables., Results: Although all models showed acceptable fit, we continued in the interest of parsimony with known-groups validity and responsiveness analyses using a summary score derived from the single higher order factor model. The validity and responsiveness of this QLQ-C30 summary score was equal to, and in many cases superior to the original, underlying QLQ-C30 scale scores., Conclusion: Our results provide empirical support for a measurement model for the QLQ-C30 yielding a single summary score. The availability of this summary score can avoid problems with potential type I errors that arise because of multiple testing when making comparisons based on the 15 outcomes generated by this questionnaire and may reduce sample size requirements for health-related quality of life studies using the QLQ-C30 questionnaire when an overall summary score is a relevant primary outcome., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Aim: The surgical management of locally recurrent rectal cancer (LRRC) has become widely accepted to afford cure and improve quality of life in this subset of patients. Thus far, traditional surgical and oncological markers have been used to highlight the success of surgical intervention. The use of patient-reported outcomes, specifically health-related quality of life (HRQoL), is sparse in these patients. This may be in part due to the lack of well-designed, validated instruments. This study identifies HRQoL issues relevant to patients undergoing surgery for LRRC, with the aim of developing a conceptual framework of HRQoL specific to LRRC to enable measurement of patient-reported outcomes in this cohort of patients., Method: Qualitative focus groups were undertaken at two institutions to identify relevant HRQoL themes. The principles of thematic content analysis were used to analysis data. NViVo10 was used to analyse data., Results: Twenty-one patients participated in six consecutive focus groups. Two patterns of themes emerged related to HRQoL and healthcare service delivery and utilization. Identified themes related to HRQoL included symptoms, sexual function, psychological impact, role and social functioning and future perspective. Under healthcare service and delivery and utilization the subdomain of disease management, treatment expectations and healthcare professionals were identified., Conclusion: This is the first qualitative study undertaken exclusively in patients with LRRC to ascertain relevant HRQoL outcomes. The impact of LRRC on patients is wide-ranging and extends beyond traditional HRQoL outcomes. The study operationalizes the identified outcomes into a conceptual framework, which will provide the basis for the development of a LRRC-specific patient-reported outcome measure., (Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.)

There is increasing interest in the use of patient-reported outcomes (PROs) in routine practice in cancer care to measure symptoms and health related quality of life (HRQOL). PROs are designed to capture the patient's perspective of their care and treatment, and complement the traditional clinical outcomes of survival and toxicity assessment. Integrating routine collection and feedback of PROs has been found to improve care for patients on both an individual level, through improved communication and management of symptoms, and at an organizational level, by enabling aggregation of data to compare performance. This article reviews the benefits and challenges of introducing patient-reported assessments into routine clinical practice. Methods for choosing a questionnaire; collection and presentation of results; timing and frequency of administration as well as clinician training methods to aid the ability of clinicians to integrate the use of PROs into their own practice are described. Electronic PRO capture and integration with electronic health records seems to provide the most effective method for seamless integration into existing patient care pathways. Case studies from our own practice illustrate the issues raised. Electronic methods enabling immediate collection, scoring and interpretation of the data, as well as real-time data capture, email alert systems and individualized, online self-management advice may enable severe symptoms to be managed in a more timely manner. Evaluation methods are described to establish the effectiveness of the PRO intervention. Engaging stakeholders throughout the process of initial consultation and development, during delivery and evaluation is key to success. Future work needs to focus on the effectiveness of PROs in longer-term follow-up of patients in routine care and the relationship between the PRO severity grading and clinician severity grading using the Common Terminology Criteria of Adverse Events (CTCAE)., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: The aim of this paper is to provide new insights into the psychometrics of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire, originally developed for longer-term survivors 5+years post-diagnosis. Specifically, to examine the classic psychometric properties of QLACS in a sample of shorter-term survivors, and to undertake Rasch analysis to explore the extent to which the Generic and Cancer-Specific summary scales (and separately-analysed Benefits of cancer domain) are unidimensional, with linear measurement properties and no differential item functioning (DIF)., Methods: Patients with potentially curable breast, colorectal or prostate cancer completed QLACS 15 months post-diagnosis (N=407). Score distributions, floor and ceiling effects, internal reliability, and feasibility (completion time and missing data) were examined. Rasch analysis included examination of item fit, DIF and unidimensionality., Results: The QLACS domains and summary scales had very similar score distributions and classic psychometric properties (no ceiling effects, majority no floor effects, acceptable reliability) to those found in development work with longer-term survivors. Median completion time was 10 min and total missing data 2.3%. The Generic summary scale contained several misfitting items and exhibited multidimensionality. The Cancer-Specific summary scale and Benefits domain showed fit to the Rasch model and demonstrated unidimensionality and no DIF, with just one or no item modifications respectively., Conclusion: QLACS demonstrates similarly good classic psychometric properties among shorter-term as among longer-term survivors, and has good feasibility. The Cancer-Specific summary scale and Benefits domain showed an impressive degree of fit to the Rasch model, although the validity of computing the Generic summary score was not supported., (Copyright © 2014. Published by Elsevier Inc.)

Objective: To provide new insights into the psychometrics of the revised Illness Perception Questionnaire (IPQ-R) in cancer patients. To undertake, for the first time using data from breast, colorectal and prostate cancer patients, a confirmatory factor analysis (CFA) to assess the validity of the IPQ-R's core seven-factor structure. Also, for the first time in any illness group, to undertake Rasch analysis to explore the extent to which the IPQ-R factors form unidimensional scales, with linear measurement properties and no Differential Item Functioning (DIF)., Methods: Patients with potentially curable breast, colorectal or prostate cancer, within 6months post-diagnosis, completed the IPQ-R online (N=531). CFA was conducted, including multi-sample analysis, and for each IPQ-R factor fit to the Rasch model was assessed by examining, amongst other things, item fit, DIF and unidimensionality., Results: The CFA showed a moderate fit of the data to the IPQ-R model, and stability across diagnosis, although fit was significantly improved following the removal of selected items. All seven factors achieved fit to the Rasch model, and exhibited unidimensionality and minimal DIF, although in most cases this was after some item rescoring and/or deletion. In both analyses, IPQ-R items 12, 18 and 24 were indicated as misfitting and removed., Conclusion: Given the rigorous standard of Rasch measurement, and the generic nature of the IPQ-R, it stood up well to the demands of the Rasch model in this study. Importantly, the results show that with some relatively minor, pragmatic modifications the IPQ-R could possess Rasch-standard measurement in cancer patients., (© 2013.)

Purpose: The Social Difficulties Inventory (SDI-21) assesses everyday problems experienced by cancer patients, including difficulties with self-care, work and relationships. Early development and psychometric evaluation studies have validated the SDI-21 for computer administration. However, several recent studies have administered the SDI-21 on paper. We sought to test the score equivalence of electronic and paper versions of the SDI-21., Methods: A randomised two-arm crossover trial in a sample of cancer patients with varied diagnoses. Patients completed electronic (via the internet) and paper versions of the SDI-21, with half randomly assigned to complete the electronic version first (n = 51) and half the paper version first (n = 60). Patients were asked to complete both versions at home, within 2 weeks. Analyses were performed for the SDI-21 summary score and three subscales., Results: Score distributions and internal reliabilities for the paper and electronic versions were highly similar. There were no significant differences between mean summary or subscale scores for the two administration modes. All mean score differences (all <0.25 of a scale point) were well below the SDI-21's established minimally important differences, and all 95 % confidence intervals were narrow and included zero. Intraclass correlations between paper and electronic scores were uniformly high and significant (all ≥0.85) and above the standard acceptable level of reliability., Conclusions: Paper and electronic versions of the SDI-21 can be considered equivalent and used interchangeably. This is important because, despite the growth of electronic formats, paper versions are currently still necessary to ensure inclusive use of the SDI-21 with representative samples.

Objectives: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is developing a computer-adaptive test (CAT) version of the EORTC Quality of Life Questionnaire (QLQ-C30). We evaluated the measurement properties of the CAT versions of physical functioning (PF) and fatigue (FA) and compared these with the corresponding QLQ-C30 scales., Study Design and Setting: Based on international samples of more than 1,000 cancer patients, we simulated CAT administration of varying numbers of items and compared the resulting scores with those based on all items in the respective item pools. Furthermore, the relative validity (RV) of CATs was compared with that of the QLQ-C30 scales using known groups validity., Results: For both dimensions, CATs of all lengths resulted in unbiased score estimates. CATs consisting of five or more items had reliability>0.90, correlated ≥ 0.97 with the full scale, and had root mean square error <0.25. The average RVs for these CATs ranged 1.02-1.33, indicating possible savings in sample size requirements of 3-42% using CAT., Conclusion: The CAT versions of PF and FA exhibited high levels of measurement precision and efficiency. The potential savings in sample size requirements using CATs compared with those using the original QLQ-C30 scales were typically 20% or more., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Aims and Background: Patient-reported outcomes (PROs) include areas of health-related quality of life but also broader concepts such as patient satisfaction with care. The aim of this review is to give an account of all instruments with potential use in patients with a history of treatment for breast cancer (including surgery, chemotherapy and/or radiotherapy) with evidence of validation in the breast cancer population., Methods: All instruments included in this review were identified as PRO measures measuring breast-related quality of life and/or satisfaction that had undergone development and validation with breast oncology patients. We specifically looked for PRO measures examining patient satisfaction and/or quality of life after breast cancer treatment. Following an evaluation of 323 papers, we identified 15 instruments that were able to satisfy our inclusion criteria., Results: These instruments are the EORTC QOL-C30 and QLQ-BR23 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module), the FACT-B (Functional Assessment of Cancer Therapy-Breast Cancer), the SLDS-BC (Satisfaction with Life Domains Scale for Breast Cancer), the BIBCQ (Body Image after Breast Cancer Questionnaire), the HIBS (Hopwood Body Image Scale), the PBIS (Polivy Body Image Scale), the MBROS (Michigan Breast Reconstruction Outcomes Study) Satisfaction and Body Image Questionnaires, the BREAST-Q, the BCTOS (Breast Cancer Treatment Outcome Scale), the BCQ, the FACT-ES (Functional Assessment of Cancer Therapy-Endocrine System), the MAS (Mastectomy Attitude Scale), and the Breast Cancer Prevention Trial Symptom Checklist (BCPT)., Conclusions: Suggestions for future directions include (1) to use and utilize validated instruments tailored to clinical practice; (2) to develop a comprehensive measurement of surgical outcome requiring the combination of objective and subjective measures; (3) to aim for a compromise between these two competing considerations in the form of a scale incorporating both generalizability in cancer-related QOL and specificity in breast cancer issues.

Aim: To use published literature and experts' opinion to investigate the clinical meaning and magnitude of changes in the Quality of Life (QOL) of groups of patients measured with the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)., Methods: An innovative method combining systematic review of published studies, expert opinions and meta-analysis was used to estimate large, medium, and small mean changes over time for QLQ-C30 scores., Results: Nine hundred and eleven papers were identified, leading to 118 relevant papers. One thousand two hundred and thirty two mean changes in QOL over time were combined in the meta-analysis, with timescales ranging from four days to five years. Guidelines were produced for trivial, small, and medium size classes, for each subscale and for improving and declining scores separately. Estimates for improvements were smaller than respective estimates for declines., Conclusions: These guidelines can be used to aid sample size calculations and interpretation of mean changes over time from groups of patients. Observed mean changes in the QLQ-C30 scores are generally small in most clinical situations, possibly due to response shift. Careful consideration is needed when planning studies where QOL changes over time are of primary interest; the timing of follow up, sample attrition, direction of QOL changes, and subscales of primary interest are key considerations., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Purpose: The current study reviewed and adapted existing health-related quality of life (HRQoL) instruments for use in routine clinical practice delivering outpatient chemotherapy for colorectal, breast and gynaecological cancers., Methods: 564 (288 gynaecological, 208 breast and 68 colorectal) outpatient consultations of 141 patients were audio-recorded and analysed to identify discussed issues. Issues were ranked from most to least commonly discussed within each disease group. Existing HRQoL instruments were evaluated against these lists and best fitting items entered into cancer-specific item banks. Item banks were evaluated during semi-structured interviews by twenty-one oncologists (13 consultants and 8 specialist registrars), four clinical nurse specialists and thirty patients, from breast, gynaecological and colorectal cancer practices. Pilot questionnaires were completed by 448 (145 breast, 148 gynaecological and 155 colorectal) patients attending outpatient clinics. Item selection and scale reliability was explored using descriptive data and psychometric methods alongside qualitative patient and clinician ratings., Results: Each questionnaire includes five physical and three psychosocial function scales each with good internal consistency reliability (α > 0.70) plus disease-specific individual-symptom items identified as useful in clinical practice., Conclusions: Three cancer-specific health-related quality of life measures were developed for use in routine clinical practice. Initial analyses suggest good clinical utility and acceptable psychometric properties for the new instruments.

Objective: The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is one of the most commonly used measures in cancer care but in its current form cannot be used in economic evaluation because it does not incorporate preferences. We address this gap by estimating a preference-based measure for cancer from the EORTC QLQ-C30., Methods: Factor analysis, Rasch analysis, and other psychometric analyses were undertaken on a clinical trial dataset of 655 patients with multiple myeloma to derive a health state classification system amenable to valuation. Second a valuation study was conducted of 350 members of the UK general population using time trade-off. Mean and individual-level multivariate regression models were fitted to derive preference weights for the classification system., Results: The health state classification system has eight dimensions (physical functioning, role functioning, social functioning, emotional functioning, pain, fatigue and sleep disturbance, nausea, constipation, and diarrhea) with four or five levels each. Regression models have few inconsistencies (0 to 2) in estimated preference weights and small mean absolute error ranges (0.046 to 0.054)., Conclusions: It is feasible to derive a preference-based measure from the EORTC QLQ-C30 for use in economic evaluation. Future research will extend this to other countries and replicate across other patient groups., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Purpose: Computerized adaptive test (CAT) methods, based on item response theory (IRT), enable a patient-reported outcome instrument to be adapted to the individual patient while maintaining direct comparability of scores. The EORTC Quality of Life Group is developing a CAT version of the widely used EORTC QLQ-C30. We present the development and psychometric validation of the item pool for the first of the scales, physical functioning (PF)., Methods: Initial developments (including literature search and patient and expert evaluations) resulted in 56 candidate items. Responses to these items were collected from 1,176 patients with cancer from Denmark, France, Germany, Italy, Taiwan, and the United Kingdom. The items were evaluated with regard to psychometric properties., Results: Evaluations showed that 31 of the items could be included in a unidimensional IRT model with acceptable fit and good content coverage, although the pool may lack items at the upper extreme (good PF). There were several findings of significant differential item functioning (DIF). However, the DIF findings appeared to have little impact on the PF estimation., Conclusions: We have established an item pool for CAT measurement of PF and believe that this CAT instrument will clearly improve the EORTC measurement of PF.

Purpose: The SD-16 is a 16-item instrument assessing social distress in cancer patients. In addition to work underlining the scale's reliability, validity and clinical utility, recent research has also determined minimally important differences (MID) for the instrument. The aim of this study was to assess whether item locations remained stable over time, in order to support the longitudinal use of the instrument., Methods: Data were collated from cancer patients (N = 123) who had completed the SD-16 at four time points (baseline, 6 months, 1 and 2 years). The Partial Credit Model (Rasch analysis) was applied to the data and item fit evaluated against published criteria. Measurement invariance of item location and person measures over time was assessed using analysis of variance., Results: Good item fit was found with the exception of one item ("work"), which demonstrated misfit at two time points. No statistically significant differences were found for item locations. As anticipated, there were changes over time in patients' scores, particularly in the first 6 months., Conclusions: The instrument can be used longitudinally to accurately assess changes in cancer patients' social distress.

Purpose: In the United Kingdom, cross-cultural adaptation of questionnaires would allow for inclusivity in assessment in cancer clinics for non-English speakers. The aim was to translate the Social Difficulties Inventory (SDI-21) into Urdu, Punjabi and Hindi and undertake preliminary evaluation of translated versions., Methods: The study comprised three stages: (1) translation/back translation and evaluation of cultural equivalence of the SDI-21, (2) south Asian (SA) patient evaluation of SDI-21 translations and (3) evaluation using Rasch analysis comparing English and Urdu SDI-21 from data pooled from this and three other studies., Results: Forward/backward translation resulted in minor amendments particularly in forward translation of SDI-21(Hindi). The majority of the 55 patients interviewed found the SDI-21 acceptable and clear, resulting in no amendments (all versions). Rasch analysis demonstrated good fit. Differential item functioning (DIF) was found for one item, in the comparison of white English (WE)- and SA Urdu-speaking groups. Detailed DIF analysis comparing self-completion and read-aloud administration by language group demonstrated this DIF only held for the comparison between SA English speakers (self-completion) and SA Urdu (read out)., Conclusions: Translated versions are culturally and linguistically acceptable. The SDI-21 (Urdu) performs similarly to the English version when self-completed.

Unlabelled: PURPOSE; To use published literature to estimate large, medium, and small differences in quality of life (QOL) data from the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)., Methods: An innovative method combining systematic review of published studies, expert opinions, and meta-analysis was used to estimate large, medium, and small differences for QLQ-C30 scores. Published mean data were identified from the literature. Differences (contrasts) between groups (eg, between treatment groups, age groups, and performance status groups) were reviewed by 34 experts in QOL measurement and cancer treatment. The experts, blinded to actual QOL results, were asked to predict these differences. A large difference was defined as one representing unequivocal clinical relevance. A medium difference was defined as likely to be clinically relevant but to a lesser extent. A small difference was one believed to be subtle but nevertheless clinically relevant. A trivial difference was used to describe circumstances unlikely to have any clinical relevance. Actual QOL results were combined using meta-analytic techniques to estimate differences corresponding to small, medium, or large effects., Results: Nine hundred eleven articles were identified, leading to 152 relevant articles (2,217 contrasts) being reviewed by at least two experts. Resulting estimates from the meta-analysis varied depending on the subscale. Thus, the recommended minimum to detect medium differences ranges from 9 (cognitive functioning) to 19 points (role functioning)., Conclusion: Guidelines for the size of effects are provided for the QLQ-C30 subscales. These guidelines can be used for sample size calculations for clinical trials and can also be used to aid interpretation of differences in QLQ-C30 scores.

Aim: The EORTC Quality of Life (QOL) Group has developed an instrument to evaluate the information received by cancer patients. This study assessed the psychometric characteristics of the EORTC INFO module in a large international/multi-cultural sample of cancer patients., Methods: The provisional 26-item information module (EORTC INFO26) was administered with the EORTC QLQ-C30 and the information scales of the inpatient satisfaction module EORTC IN-PATSAT32 on two occasions during the patients' treatment and follow-up period. Questionnaire-hypothesised scale structure, reliability, validity and responsiveness to changes were evaluated through standard psychometric analyses. Patient acceptability was assessed with a debriefing questionnaire., Results: The study comprised 509 patients from 8 countries (7 European countries and Taiwan) with different cancers and disease stages. Multi-trait scaling analysis led to the deletion of one item but confirmed the hypothesised 4 multi-item scales (information about disease, medical tests, treatment and other services) and eight single items. Internal consistency for all scales was good (α>0.70), as was test-retest reliability (intraclass correlations>0.70). All items can be combined to generate a single score (α>0.90). Convergent validity was supported by significant correlations with related areas of IN-PATSAT32 (r>0.40). Low correlations with EORTC QLQ-C30 scales confirmed divergent validity (r<0.30) The EORTC INFO-25 module discriminated among groups based on gender, age, education, levels of anxiety and depression, information wishes and satisfaction. Only one scale captured changes over time., Conclusions: The EORTC QLQ-INFO 25 is a reliable and valid self-reported instrument. The module can be used in cross-cultural observational and intervention studies., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Background: Health-related quality of life (HRQOL) questionnaires should ideally be adapted to the individual patient and at the same time scores should be directly comparable across patients. This is achievable using a computerised adaptive test (CAT). Basing the CAT on an existing instrument enables measurement within an established HRQOL framework and allows backward-compatibility with studies using the original instrument. Because of these advantages the EORTC Quality of Life Group (QLG) has initiated a project to develop a CAT version of the widely used EORTC QLQ-C30., Methods: We present the EORTC QLG's strategy for developing a CAT. For each dimension of the EORTC QLQ-C30 our approach includes literature search and conceptualisation, formulation of new items, expert and patient evaluations, field-testing, and psychometric analyses of the items. The strategy is illustrated with the initial results of the development of CAT for physical functioning (PF)., Results: We identified 975 PF items in the literature. Of these, 407 items were deemed relevant, i.e. measured one of the PF aspects measured by the QLQ-C30. Based on these items we developed 86 new items. Review by the EORTC CAT-project group reduced this to 66 items. Based on expert and patient evaluations several items were revised and the list was further reduced to 51 items., Conclusions: Based on the findings for PF, we believe that our approach will generate item pools that are relevant and appropriate for cancer patients. These will form the basis for a backward-compatible CAT assessing the HRQOL dimensions of the EORTC QLQ-C30., (Copyright (c) 2010 Elsevier Ltd. All rights reserved.)

Background: The General Health Questionnaire (GHQ) - 12 was designed as a short questionnaire to assess psychiatric morbidity. Despite the fact that studies have suggested a number of competing multidimensional factor structures, it continues to be largely used as a unidimensional instrument. This may have an impact on the identification of psychiatric morbidity in target populations. The aim of this study was to explore the dimensionality of the GHQ-12 and to evaluate a number of alternative models for the instrument., Methods: The data were drawn from a large heterogeneous sample of cancer patients. The Partial Credit Model (Rasch) was applied to the 12-item GHQ. Item misfit (infit mean square >or= 1.3) was identified, misfitting items removed and unidimensionality and differential item functioning (age, gender, and treatment aims) were assessed. The factor structures of the various alternative models proposed in the literature were explored and optimum model fit evaluated using Confirmatory Factor Analysis., Results: The Rasch analysis of the 12-item GHQ identified six misfitting items. Removal of these items produced a six-item instrument which was not unidimensional. The Rasch analysis of an 8-item GHQ demonstrated two unidimensional structures corresponding to Anxiety/Depression and Social Dysfunction. No significant differential item functioning was observed by age, gender and treatment aims for the six- and eight-item GHQ. Two models competed for best fit from the confirmatory factor analysis, namely the GHQ-8 and Hankin's (2008) unidimensional model, however, the GHQ-8 produced the best overall fit statistics., Conclusions: The results are consistent with the evidence that the GHQ-12 is a multi-dimensional instrument. Use of the summated scores for the GHQ-12 could potentially lead to an incorrect assessment of patients' psychiatric morbidity. Further evaluation of the GHQ-12 with different target populations is warranted.

Objectives: To adapt the Components of Primary Care Index (CPCI) to be applicable to oncology outpatients and to assess the reliability and validity of the adapted instrument (renamed the Medical Care Questionnaire [MCQ])., Methods: The development and validation of the MCQ took place in four phases. Phase 1 reviewed the literature and examined existing measures. In Phase 2, the selected instrument (CPCI) was reviewed by a panel of experts using a stepwise consensus procedure. In Phase 3, the adapted 21-item MCQ was administered to 200 outpatients attending oncology appointments. The instrument was refined to 15 items and in Phase 4, it was completed by 477 oncology outpatients. The psychometric properties of the new instrument were assessed using exploratory factor analysis (EFA), confirmatory factor analysis, multitrait scaling analysis, and by comparing MCQ scores between known groups., Results: EFA of the 15-item MCQ suggested three subscales with acceptable to good reliability: "Communication"alpha = 0.69; "Coordination"alpha = 0.84; and "Preferences"alpha = 0.75. Comparing known groups showed that patients who saw fewer doctors during their clinic visits reported stronger "Preferences" to see their usual doctor and rated "Communication" with their doctors as better than patients who saw more doctors during their clinic visits., Conclusion: The MCQ demonstrates good psychometric properties in the target population. It is a brief and simple-to-use instrument, which provides a valid perspective on patients' experiences of communicating with doctors and their perceptions of the continuity and coordination of their cancer care.

Aim: To review reporting standard, presentation and interpretation for quality of life (QOL) outcomes in randomised controlled trials (RCTs) using the European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC QLQ-C30)., Methods: Cancer RCTs reporting EORTC QLQ-C30 data were identified and reviewed against a reporting quality checklist. Interpretation/presentation methods for QOL data were also recorded., Results: Eighty-two papers were reviewed. Seventy percent met criteria for high quality reporting; 94% reported mean scores; 84% presented results in tables/graphs; 80% reported p-values or statistical significance. Clinical significance was addressed in 38%. Where clinical significance was not addressed, reliance was usually on statistical significance to interpret the results., Discussion: EORTC QLQ-C30 results are generally reported well, although it was common to rely on statistical significance alone for interpreting results. Whilst interpretation in terms of clinical significance has improved in recent years, there is still a lack of robust clinical interpretation of QOL results even in papers reported to a high standard.

Guidelines for psychosocial support have been developed, but there are no standard approaches in routine oncology practice to identify patients experiencing social difficulties. We have designed and evaluated a Social Difficulties Inventory (SDI) to identify patients requiring further assessment and, where appropriate, referral to support services. The purpose of this study was to develop a clinically meaningful SDI scoring system with guidance for oncology staff. Out of 189 patients, 183 completed the SDI and were interviewed by a social work researcher who scored the SDI independently. Comparison of patient/interviewer assessment was good (intraclass correlation 0.61, 95% confidence interval: 0.51, 0.70). Using top 10% of interviewer social distress (SD) scores to indicate 'SD case', the best 'cut-point' was a patient score of > or =10 (sensitivity=0.80; specificity=0.76; 56 out of 183 'cases'). Out of 127 patients, 72 with SD score <10 had individual SDI item rated at a higher level. Following interview, 32 patients were referred to specialist services, 46 given information and 112 had no action taken. An interpretation algorithm developed includes SD score, individual SDI item rating, and an additional general question, illustrated using four case scenarios. In conclusion, general guidance for interpreting the SDI has been developed to enhance health-care professional/patient consultations with a view to identifying patients who may benefit from support, advice or intervention.

Psychological distress is a common problem among cancer patients. Despite the large number of instruments that have been developed to assess distress, their utility remains disappointing. This study aimed to use Rasch models to develop an item-bank which would provide the basis for better means of assessing psychological distress in cancer patients.An item bank was developed from eight psychological distress questionnaires using Rasch analysis to link common items. Items from the questionnaires were added iteratively with common items as anchor points and misfitting items (infit mean square >1.3) removed, and unidimensionality assessed.A total of 4914 patients completed the questionnaires providing an initial pool of 83 items. Twenty items were removed resulting in a final pool of 63 items. Good fit was demonstrated and no additional factor structure was evident from the residuals. However, there was little overlap between item locations and person measures, since items mainly targeted higher levels of distress. The Rasch analysis allowed items to be pooled and generated a unidimensional instrument for measuring psychological distress in cancer patients. Additional items are required to more accurately assess patients across the whole continuum of psychological distress., (Copyright (c) 2006 John Wiley & Sons, Ltd.)

Aim: To test the reliability, validity and sensitivity of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-MY24 questionnaire, designed to assess the quality of life of myeloma patients with the QLQ-C30., Methods: The study was carried out through the EORTC Quality of Life Group using clinical trials in seven countries. All trials used the QLQ-C30 and QLQ-MY24 at baseline and a follow-up timepoint., Results: Two hundred and forty patients participated. The questionnaires were acceptable to patients. The hypothesised scale structure (disease symptoms, side-effects, body image and future perspective) was confirmed by multi-trait scaling, internal consistency and correlation analysis. Most scales demonstrated sensitivity to change and discriminated between clinically different patients. The social support scale (4 items) was removed due to observed ceiling effects., Conclusion: The final questionnaire contains 20 items, QLQ-MY20, and is a reliable and valid instrument recommended for use with the QLQ-C30 in myeloma patients.

Background: Although the Functional Assessment of Cancer Therapy--General questionnaire (FACT-G) has been validated few studies have explored the factor structure of the instrument, in particular using non-sample dependent measurement techniques, such as Rasch Models. Furthermore, few studies have explored the relationship between item fit to the Rasch Model and clinical utility. The aim of this study was to investigate the dimensionality and measurement properties of the FACT-G with Rasch Models and Factor analysis., Methods: A factor analysis and Rasch analysis (Partial Credit Model) was carried out on the FACT-G completed by a heterogeneous sample of cancer patients (n = 465). For the Rasch analysis item fit (infit mean squares > or = 1.30), dimensionality and item invariance were assessed. The impact of removing misfitting items on the clinical utility of the subscales and FACT-G total scale was also assessed., Results: The factor analysis demonstrated a four factor structure of the FACT-G which broadly corresponded to the four subscales of the instrument. Internal consistency for these four scales was very good (Cronbach's alpha 0.72 - 0.85). The Rasch analysis demonstrated that each of the subscales and the FACT-G total scale had misfitting items (infit means square > or = 1.30). All these scales with the exception of the Social & Family Well-being Scale (SFWB) were unidimensional. When misfitting items were removed, the effect sizes and the clinical utility of the instrument were maintained for the subscales and the total FACT-G scores., Conclusion: The results of the traditional factor analysis and Rasch analysis of the FACT-G broadly agreed. Caution should be exercised when utilising the Social & Family Well-being scale and further work is required to determine whether this scale is best represented by two factors. Additionally, removing misfitting items from scales should be performed alongside an assessment of the impact on clinical utility.

Information disclosure is a key factor in the support for cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed a questionnaire to evaluate the level of information received by cancer patients at different stages of their disease and treatment: the EORTC QLQ-INFO26. It can be used in clinical practice and research, including clinical trials. The questionnaire was developed following EORTC Quality of Life Group guidelines. The paper presents the data on 133 patients from eight countries. The resulting EORTC QLQ-INFO26 questionnaire includes four sub-scales on information regarding their cancer, medical tests, treatment and other services and several single items., (Copyright 2006 John Wiley & Sons, Ltd.)

High-dose chemotherapy followed by haematopoietic stem cell transplantation can be associated with high physical and emotional distress levels and reduced quality of life. Systematic prospective measurement of impact of therapy on patient quality of life can aid treatment choices and provide better patient information. We describe the development of a high-dose chemotherapy questionnaire module to supplement the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30). Phases 1-3 of module development were conducted in United Kingdom, Germany, Austria and Norway, according to EORTC QOL Group guidelines. Forty-eight quality of life (QOL) issues were generated from the literature searches and interviews with health care professionals (n=24) and patients (n=92). This produced a 50 item provisional module. Further testing in 169 patients resulted in the QLQ-HDC29 module, containing 29 items, conceptualised into six multi-item scales and eight single items. The EORTC QLQ-C30, supplemented by QLQ-HDC29 will provide a comprehensive QOL measure for the international clinical trials of high-dose chemotherapy.

The Hospital Anxiety and Depression Scale (HADS) has been used extensively in cancer patients to identify psychological distress. Reports of the factor structure and screening performance of the instrument vary. Rasch models allow an assessment of the structure of a questionnaire by identifying item fit. Removal of misfitting items may improve both the dimensionality and efficacy of screening questionnaires. A Rasch analysis of the HADS-T and subscales was used to explore the factor structure, dimensionality and screening efficacy. A total of 1855 patients completed a touchscreen version of the HADS, including 381 patients who had received a psychiatric interview (SCAN/PSE). These data were analysed using Rasch models, and the screening efficacy at identifying cases of psychological distress and anxiety and depression evaluated. The results demonstrated that the structure of the HADS-T and subscales was unidimensional. Three items from the HADS-T, and one from each of the subscales demonstrated misfit. Screening efficacy for the HADS-T and subscales was modest. However, removal of misfitting items had little impact on screening, demonstrating that items could potentially be omitted, if required. The item range covered a narrow spectrum of psychological distress, predominantly higher levels of distress. Additional items have to be added if screening for moderate to mild distress is to be improved for cancer patients., (Copyright 2005 John Wiley & Sons, Ltd.)

The aim of the study is to investigate associations between deprivation and self-reported social difficulties and psychological distress in cancer patients. A total of 304 men and 305 women (age range 18-88 years) with a range of cancer diagnoses and living in a socially diverse region (Carstairs and Morris index) completed the Hospital Anxiety and Depression Scale and the Social Difficulties Inventory. Univariate analyses of variance revealed statistically significant differences in reported social difficulties between groups (F (67, 576)=2.4, P<0.0001) with stage of disease (F (5, 576)=7.6, P<0.0001), age (F (2, 576)=4.8, P=0.009) and to a lesser extent deprivation (F (1, 576)=4.0, P=0.048) making significant contributions. Significantly more social difficulties were reported by less affluent patients with locally recurrent disease or 'survivors'. No other interactions were found. Significant differences in levels of reported psychological distress were found between groups (F (67, 575)=1.723, P=0.001) for stage of disease, sex and deprivation but no interactions observed. In conclusion, deprivation is associated with reported psychological distress and, to a lesser extent, social difficulties. Patients at particular risk cannot be identified with confidence by socio-demographic and clinical means supporting the recommendation from National Institute for Clinical Excellence for provision of psychosocial assessment for individual cancer patients.

Information disclosure is one of the key areas of support that patients may receive. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has a group working on the development of a questionnaire that evaluates information received by cancer patients at different stages of their disease--EORTC QLQ-INFO30. This instrument is being developed by professionals from most European regions. The questionnaire aims to evaluate the information received by cancer patients on different areas of the disease, diagnosis, treatment and care. Besides, the instrument also assesses qualitative aspects of the information they have received. The present paper presents the first two phases of the module development process that include literature review, interviews with patients and professionals, and formulation of the items. All these steps have been carried out in different countries and have been approved by the EORTC QLG.

Purpose: To examine the effects on process of care and patient well-being, of the regular collection and use of health-related quality-of-life (HRQL) data in oncology practice., Patients and Methods: In a prospective study with repeated measures involving 28 oncologists, 286 cancer patients were randomly assigned to either the intervention group (regular completion of European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire version 3.0, and Hospital Anxiety and Depression Scale on touch-screen computers in clinic and feedback of results to physicians); attention-control group (completion of questionnaires, but no feedback); or control group (no HRQL measurement in clinic before encounters). Primary outcomes were patient HRQL over time, measured by the Functional Assessment of Cancer Therapy-General questionnaire, physician-patient communication, and clinical management, measured by content analysis of tape-recorded encounters. Analysis employed mixed-effects modeling and multiple regression., Results: Patients in the intervention and attention-control groups had better HRQL than the control group (P =.006 and P =.01, respectively), but the intervention and attention-control groups were not significantly different (P =.80). A positive effect on emotional well-being was associated with feedback of data (P =.008), but not with instrument completion (P =.12). A larger proportion of intervention patients showed clinically meaningful improvement in HRQL. More frequent discussion of chronic nonspecific symptoms (P =.03) was found in the intervention group, without prolonging encounters. There was no detectable effect on patient management (P =.60). In the intervention patients, HRQL improvement was associated with explicit use of HRQL data (P =.016), discussion of pain, and role function (P =.046)., Conclusion: Routine assessment of cancer patients' HRQL had an impact on physician-patient communication and resulted in benefits for some patients, who had better HRQL and emotional functioning.

Purpose: To investigate the applicability of a standard quality of life (QL) questionnaire to individual cancer patients and to explore the potential for impact of QL information on the process of care by comparing at group level the QL results with the medical records., Patients and Methods: One hundred fourteen consecutive patients at the oncology clinics at St James's Hospital, Leeds, United Kingdom, completed the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 on a touch-screen computer over a 6-month period. The QL results were compared with the corresponding medical records at individual and group level., Results: For individual patients, the serial measurement of QL allowed recognition of patterns over time corresponding to disease course. At group level, a higher proportion of patients reported problems on EORTC QLQ-C30 than were mentioned in the medical records (McNemar paired test, P <.01). Most often clinicians mentioned pain (22% to 39%), and at the initial visit role (66%), and social issues (77%). For the rest of the symptoms and functions, the problems were recorded in between 1% and 25% of the notes, but 20% to 76% of the patients reported QL impairment. Problems that were not recorded in the medical notes tended to be of low severity, with a significant trend observed for pain, fatigue, nausea/vomiting, dyspnea, loss of appetite, and physical function scale (chi(2) test, 11.55 to 34.42, df = 1, P <.001)., Conclusion: The QL data on individual patients was consistent with the clinical records, thus providing evidence for the validity of these measures in assessment of the individual. The QL profiles had more information on symptoms and particularly on functional issues, such as emotional distress and physical performance.

A multiple myeloma-specific quality-of-life questionnaire module has been designed in collaboration with the EORTC Quality-of-Life Study Group to be used in clinical trials with the EORTC QLQ-C30, a general cancer questionnaire. Strict methodology was employed to ensure thorough and appropriate development of the module. An extensive literature review was performed to identify health-related quality-of-life issues relevant to patients with multiple myeloma. Semi-structured interviews were then carried out in several European countries with health-care providers experienced in the treatment of patients with multiple myeloma, and with a group of patients with multiple myeloma, to identify the issues which were most important to patients. A questionnaire was devised from the list of issues, using a 1-week time-frame and response categories consistent with the EORTC QLQ-C30. The provisional questionnaire and the EORTC QLQ-C30 were administered to patients with multiple myeloma in each participating country with further semi-structured interviews to refine the content and design of the questionnaire. A review of the results obtained in each stage of development resulted in a 24-item myeloma-specific module, the EORTC QLQ-MY24, which assesses disease-specific symptoms and their impact on everyday life, treatment side-effects, social support, and future perspective. The module is currently undergoing further international field-testing to assess its psychometric properties.