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Purpose: Complications following upper gastrointestinal (UGI) surgery are common. Symptom-monitoring following discharge is not standardized. An electronic patient-reported outcome (ePRO) system providing feedback to patients and clinicians could support patients and improve outcomes. Little is known about patients' experiences of using such systems. This qualitative sub-study explored patients' perspectives of the benefits of using a novel ePRO system, developed as part of the mixed methods eRAPID pilot study, to support recovery following discharge after UGI surgery., Methods: Patients completed the online ePRO symptom-report system post-discharge. Weekly interviews explored patients' experiences of using ePRO, the acceptability of feedback generated and its value for supporting their recovery. Interviews were audio-recorded and targeted transcriptions were thematically analysed., Results: Thirty-five interviews with 16 participants (11 men, mean age 63 years) were analysed. Two main themes were identified: (1) reassurance and (2) empowerment. Feelings of isolation were common; many patients felt uninformed regarding their expectations of recovery and whether their symptoms warranted clinical investigation. Participants were reassured by tailored feedback advising them to contact their care team, alleviating their anxiety. Patients reported feeling empowered by the ePRO system and in control of their symptoms and recovery., Conclusion: Patients recovering at home following major cancer surgery regarded electronic symptom-monitoring and feedback as acceptable and beneficial. Patients perceived that the system enhanced information provision and provided a direct link to their care team. Patients felt that the system provided reassurance at a time of uncertainty and isolation, enabling them to feel in control of their symptoms and recovery., (© 2020. The Author(s).)

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.

In 2014, the European Medicines Agency (EMA) released for comment a draft reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. A twelve-member International Society for Quality of Life Research (ISOQOL) taskforce was convened to coordinate the ISOQOL response. Twenty-one ISOQOL members provided detailed comments and suggestions on the paper: 81 % from academia and 19 % from industry. Taskforce members consolidated and further refined these comments and shared the recommendations with the wider ISOQOL membership. A final response was submitted to the EMA in November 2014. The impending publication of the EMA reflection paper presents a valuable opportunity for ISOQOL to comment on the current direction of EMA PRO guidance and strategy. The EMA paper, although focused on cancer, could serve as a model for using PROs in other conditions, as it provides a useful update surrounding some of the design issues common to all trial research including PRO endpoints. However, we believe there are a number of additional areas in need of greater consideration. The purpose of this commentary is therefore to highlight the strengths of this timely and potentially useful document, but also to outline areas that may warrant further discussion.

Purpose: Patient-reported outcomes should ideally be adapted to the individual patient while maintaining comparability of scores across patients. This is achievable using computerized adaptive testing (CAT). The aim here was to develop an item bank for CAT measurement of the pain domain as measured by the EORTC QLQ-C30 questionnaire., Methods: The development process consisted of four steps: (1) literature search, (2) formulation of new items and expert evaluations, (3) pretesting and (4) field-testing and psychometric analyses for the final selection of items., Results: In step 1, we identified 337 pain items from the literature. Twenty-nine new items fitting the QLQ-C30 item style were formulated in step 2 that were reduced to 26 items by expert evaluations. Based on interviews with 31 patients from Denmark, France and the UK, the list was further reduced to 21 items in step 3. In phase 4, responses were obtained from 1103 cancer patients from five countries. Psychometric evaluations showed that 16 items could be retained in a unidimensional item bank. Evaluations indicated that use of the CAT measure may reduce sample size requirements with 15-25% compared to using the QLQ-C30 pain scale., Conclusions: We have established an item bank of 16 items suitable for CAT measurement of pain. While being backward compatible with the QLQ-C30, the new item bank will significantly improve measurement precision of pain. We recommend initiating CAT measurement by screening for pain using the two original QLQ-C30 pain items. The EORTC pain CAT is currently available for "experimental" purposes.

Introduction: Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters., Methods: Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations., Results: The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation., Conclusion: Adult learning programs teaching clinicians how to use and act on PROs in clinical practice are a key steps in supporting patient engagement and participation in shared decision-making. Researchers and clinicians from different clinical areas should collaborate to share ideas, develop guidelines and promote good practice in patient-centred care.

Background: In the UK, demonstration of patient and public involvement (PPI) is now a funding requirement. Despite advice being available to researchers regarding PPI, levels of engagement are variable. Patient involvement has been at the core of the Leeds Psychosocial Oncology and Clinical Practice Research Group since 2007 when a local Research Advisory Group (RAG) was established. In addition, we work with experienced patient advocates from national groups., Methods: The RAG is led by designated researchers who manage and communicate with members. The RAG is invited to twice yearly meetings with the full research team when study findings are disseminated and advice sought. The meetings are also an opportunity to socialise and thank members. Effective partnerships and engagement require good communication, building relationships over time and tailoring involvement to individuals' skills and experience., Results: Patients have been involved in design, planning new projects and assisting with grant proposals; development, pilot testing of interview strategies and question generation, project steering groups and management teams, development of self-management advice for online patient portals; implementation, extensive beta testing of new questionnaire builder software to enable collection of online patient-reported outcomes (PRO) and study websites, cognitive interviews to develop PRO items; dissemination, co-authorship of papers and presentations, attendance/representation of the group at conferences., Conclusion: The involvement of patient advocates is integral to ensuring PRO development remains patient-centred. Having a co-operative, well-established local PPI group and nationally active patient collaborators has had a rewarding and significant impact on our research programmes.

Purpose: The EORTC Quality of Life Questionnaire is a widely used cancer-specific quality of life instrument comprising a core set of 30 items (QLQ-C30) supplemented by cancer site-specific modules. The purpose of this paper was to examine the extent to which the conventional multi-item domain structure of the QLQ-C30 holds across patients with seven different primary cancer sites., Methods: Multi-group confirmatory factor analysis was used to test whether a measurement model of the QLQ-C30 was invariant across cancer sites. Configural (same patterns of factor loadings), metric (equivalence of factor loadings) and scalar (equivalence of thresholds) invariance amongst the cancer site groups were assessed (N = 1,906) by comparing the fit of a model with these parameters freely estimated to a model where estimates were constrained to be equal for the corresponding items in each group., Results: All groups exhibited good model fit except for the prostate group, which was excluded. Only 1 of 576 parameters was found to differ between primary sites: specifically, the first threshold of Item 1 in the breast cancer group exhibited non-invariance. In a post hoc analysis, several instances of non-invariance by treatment status (baseline, on-treatment, off-treatment) were observed., Conclusions: Given only one instance of non-invariance between cancer sites, there is a reason to be confident in the validity of conclusions drawn when comparing QLQ-C30 domain scores between different sites and when interpreting the scores of heterogeneous samples, although future research should assess the potential impact of confounding variables such as treatment and gender.

Purpose: An essential aspect of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) is the integration of patient perspectives and experiences with clinical data to evaluate interventions. Thus, PCOR and CER require capturing patient-reported outcome (PRO) data appropriately to inform research, healthcare delivery, and policy. This initiative's goal was to identify minimum standards for the design and selection of a PRO measure for use in PCOR and CER., Methods: We performed a literature review to find existing guidelines for the selection of PRO measures. We also conducted an online survey of the International Society for Quality of Life Research (ISOQOL) membership to solicit input on PRO standards. A standard was designated as "recommended" when >50 % respondents endorsed it as "required as a minimum standard.", Results: The literature review identified 387 articles. Survey response rate was 120 of 506 ISOQOL members. The respondents had an average of 15 years experience in PRO research, and 89 % felt competent or very competent providing feedback. Final recommendations for PRO measure standards included: documentation of the conceptual and measurement model; evidence for reliability, validity (content validity, construct validity, responsiveness); interpretability of scores; quality translation, and acceptable patient and investigator burden., Conclusion: The development of these minimum measurement standards is intended to promote the appropriate use of PRO measures to inform PCOR and CER, which in turn can improve the effectiveness and efficiency of healthcare delivery. A next step is to expand these minimum standards to identify best practices for selecting decision-relevant PRO measures.

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.

Purpose: We conducted a secondary qualitative analysis of consultations between oncologists and their patients to explore how patient-reported outcome measures (PROMs) data were referred to in the process of (1) eliciting and exploring patients' concerns; (2) making decisions about supportive treatment and (3) making decisions about chemotherapy and other systemic treatments., Methods: We purposively sampled audio recordings of 18 consultations from the intervention arm and 4 from the attention control arm of a previous UK randomised controlled trial of the feedback of PROMs data to doctors (Velikova et al. in J Clin Oncol 22(4):714-724 [1]). We used a combination of content and conversation analysis to examine how opportunities for discussion of health-related quality of life issues are opened up or closed down within the consultation and explore why this may or may not lead to changes in patient management., Findings: Explicit reference to the PROMs data provided an opportunity for the patient to clarify and further elaborate on the side effects of chemotherapy. High scores on the PROMs data were not explored further if the patient indicated they were not a problem or were not related to the cancer or chemotherapy. Symptomatic treatment was more often offered for problems like nausea, constipation, pain and depression but much less so for fatigue. Doctors discussed fatigue by providing a cause for the fatigue (e.g. the chemotherapy), presenting this as 'something to be expected', minimising its impact or moving on to another topic. Chemotherapy regimens were not changed on the basis of the PROMs data alone, but PROMs data were sometimes used to legitimise changes., Conclusions: Explicit mention of PROMs data in the consultation may strengthen opportunities for patients to elaborate on their problems, but doctors may not always know how to do this. Our findings have informed the development of a training package to enable doctors to optimise their use of PROMs data within the consultation.

Purpose: To investigate the statistical fit of alternative higher order models for summarizing the health-related quality of life profile generated by the EORTC QLQ-C30 questionnaire., Methods: A 50% random sample was drawn from a dataset of more than 9,000 pre-treatment QLQ-C30 v 3.0 questionnaires completed by cancer patients from 48 countries, differing in primary tumor site and disease stage. Building on a "standard" 14-dimensional QLQ-C30 model, confirmatory factor analysis was used to compare 6 higher order models, including a 1-dimensional (1D) model, a 2D "symptom burden and function" model, two 2D "mental/physical" models, and two models with a "formative" (or "causal") formulation of "symptom burden," and "function.", Results: All of the models considered had at least an "adequate" fit to the data: the less restricted the model, the better the fit. The RMSEA fit indices for the various models ranged from 0.042 to 0.061, CFI's 0.90-0.96, and TLI's from 0.96 to 0.98. All chi-square tests were significant. One of the Physical/Mental models had fit indices superior to the other models considered., Conclusions: The Physical/Mental health model had the best fit of the higher order models considered, and enjoys empirical and theoretical support in comparable instruments and applications.

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.

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.

Background: Social difficulties may add to the psychological burden experienced by cancer patients. Therefore identifying social difficulties in routine oncology practice may help prevent or alleviate distress. The Social Difficulties Inventory (SDI) is a short questionnaire developed for assessing social difficulties in cancer patients. Although well-validated, not enough is known about the clinical meaning and utility of the instrument or whether the items can be meaningfully summed to form a summary index of "Social Distress"., Purpose: To determine, using Rasch analysis, whether the SDI could be used as a summary index of social distress specifically examining three fundamental criteria: item fit, unidimensionality and item invariance., Methods: The Partial Credit Model was applied to a heterogeneous sample of cancer patients (n = 609) who had completed the SDI., Results: Five items were identified as misfitting (infit mean square > or = 1.3 and standardised t-statistic > or = 2) and excluded from the subsequent analysis. The remaining items formed a unidimensional interval scale with no additional factors identified in a principal components analysis of the residuals. No differential item functioning was observed for age, gender, diagnosis, extent of disease or social deprivation. The 16-item SDI can be summed to produce an overall index of social distress, facilitating routine identification of social difficulties. Subsequent work is needed to evaluate whether the instrument is able to identify patients with high levels of social distress requiring intervention.