Prevalence and characteristics of distress in a sample of large hospital's workers in Rome in a period between two peaks of the covid-19 pandemic.

AIM: The aim of this study has been to measure the distress of workers at a large hospital in Rome, immediately after the lockdown with relaxed national restrictions except the indication to wear masks FP2 and to maintain the interpersonal distance of at least one meter. METHOD: A web-based anonymous survey has been conducted. Of the 324 responders (23-69 years; 78.09% females), 41.05% was nurse, 31.17% medical doctor, 7.72% employee with administrative function, 3.09% psychologist, 1.54% biologist, 13.58% grouped in the "other" category. 60.49% worked in a no-covid-19 ward, 20.37% in the covid-19 ward, 13.58% in outpatient clinics, and 5.56% outside the hospital. 45.06% have been exposed to covid-19 and 7.72% tested positive for covid-19. 66.67% were satisfied with the safety measures taken by the hospital. Post-traumatic stress disorder (PTSD) symptoms, as measured by IES-R, and peritraumatic distress, measured by CPDI, were frequently reported (41.05% and 43.21%, respectively). PTSD resulted independently associated with peritraumatic distress (Adjusted Odds Ratio, AOR 49.83), perception of being avoided by family and/or friends due to work performed (AOR= 4.05), low hope for the future (AOR= 2.25) and female gender (AOR= 2.90). Age and profession were considered confounding variables. RESULTS: These results showed that even in times of reduced restrictions, the prevalence of peritraumatic distress and PTSD is high, regardless of work and professional specialization, length of service, more or less direct contact with covid-19 patients. CONCLUSIONS: Since the biological damage resulting from a PTSD is known, it is important to activate screening programs followed by specific interventions to reduce long-term risks to mental health.

COVID-19 pandemic distress among a sample of Italian psycho-oncologists: risk of isolation and loneliness.

PURPOSE: To measure the prevalence and characteristics of distress and hope for the future among psycho-oncologists, who faced the coronavirus disease 2019 (COVID-19) emergency along with other healthcare workers. METHODS: A web-based study was conducted among members of the Italian Society of Psycho-Oncology between May 29 and June 5, 2020. RESULTS: A total of 237 members, aged 28-72 years, completed the COVID-19 Peritraumatic Distress Index (CPDI), Impact of Event Scale-Revised (IES-R), and HOPE questionnaires; 86.92% were female, 58.65% worked in hospitals, 21.10% were exposed to COVID-19, 11.39% experienced peritraumatic distress, and 3.38% had posttraumatic stress disorder symptoms. Peritraumatic distress was associated with living alone (adjusted odds ratio [AOR] 3.05; 95% confidence interval [CI] 1.41-8.13), using sleep remedies (AOR 3.79; 95% CI 1.41-10.21), and the perception of being avoided by family or friends because of work (AOR 2.69; 95% CI 1.02-7.11); high HOPE-Agency scores were associated with the absence of peritraumatic stress (AOR 0.40; 95% CI 0.16-0.96) after adjustment for age and sex. CONCLUSIONS: Psycho-oncologists showed greater resilience than other healthcare workers as they are trained to help others, but also to review their own values and behavior in light of stressful events. Of interest is the association between peritraumatic distress and social isolation, real or perceived. Healthcare institutions should pay attention to the mental well-being of their employees by promoting distress screening using simple tools such as the CPDI and implementing support interventions. Psycho-oncology associations should introduce policies aimed at developing a sense of social connectedness by providing an interactive system of orientation and scientific reference.

Psychometric validation of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Sexual Health (EORTC QLQ-SH22).

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire. METHODS: The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures. RESULTS: The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender-specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale, .80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from .70 to .93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status. CONCLUSION: The study supports the reliability, the content and construct validity of the QLQ-SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice.

Italian validation of CoViD-19 Peritraumatic Distress Index and preliminary data in a sample of general population.

INTRODUCTION: Peritraumatic distress is an important predictor of post-traumatic stress disorder and although several questionnaires are available for its measurement, none of these are specific to CoViD-19. The new CoViD-19 Peritraumatic Distress Index (CPDI), developed in China, is characterized as a rapid compilation tool (10 minutes), easily understandable and appreciated by people. AIM: The objectives of this study were: (1) the validation of the Italian version of the CPDI, and (2) the measurement of the prevalence of peritraumatic distress in this phase 1 CoViD-19. METHOD: CPDI has been translated using a standard forward-backward-translation procedure and offered online to 329 people (191 females and 137 males, aged 46.49 ± 13.58 years). The CPDI showed an internal-consistency of Cronbach's α =0.916. Content validity was judged satisfactory by two psychologists experienced in stress and trauma. The construct validity is given by the high correlation with the dimensions of Intrusion, Avoidance and Hyperarousal as measured by the Impact of Event Scale-Revised (r=0.63, r=0.57, r=0.71, respectively). RESULTS: Our results are comparable to the Chinese ones. A third of people experienced symptoms of mild/moderate and severe peritraumatic distress. Females have higher scores, compared to males. Older people are more resilient, compared to younger, and those who have been in quarantine report less distress than those didn't, as evidenced by the results of the multivariate logistic regression model. High distress was associated with use of psychotropic drugs (AOR=4.28; 95% CI=1.55-11.85), sleeping remedies (AOR=4.05; 95% CI=2.07-7.94), be worried about dying in case of contagion CoViD-19 (AOR=3.33; 95% CI=1.83-6.06), female gender (AOR=2.95; 95% CI=1.58-5.53) and have a religious belief (AOR=1.97; 95% CI=1.05-3.70). To be aged 51-71 years, to have been in quarantine and to have received psychological support were variables associated with lower distress scores. CONCLUSIONS: The psychometric properties of the Italian version are satisfactory and confirm that CPDI is a tool fast, non-intrusive, administered online, and therefore 'safe' in a phase with a high risk of contagion. It allows, like a psychic thermoscan, to quickly detect the needs of the population and propose equally rapid interventions.

International validation of the EORTC CAT Core: a new adaptive instrument for measuring core quality of life domains in cancer.

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed computerised adaptive tests (CATs) for the 14 functional and symptom domains of the EORTC QLQ-C30 quality of life questionnaire. This is expected to optimise measurement precision, relevance to patients and flexibility. Here, we present the first international validation of the EORTC CAT Core. METHODS: A heterogeneous sample of 699 cancer patients scheduled for chemotherapy and/or radiotherapy was recruited across seven European countries. The EORTC CAT Core and all QLQ-C30 items were administered to participants before and after initiating treatment. Correlations between CAT and QLQ-C30 scores and floor/ceiling effects were calculated. Using several grouping variables, relative validity (cross-sectional known groups difference), responsiveness (changes over time) and relative sample size requirements of the CAT compared to the QLQ-C30 were estimated. RESULTS: Correlations of the CAT and QLQ-C30 ranged from 0.81 to 0.93 across domains. The mean relative reduction in floor and ceiling effects using the CAT was 42% (range 3-99%). Analyses of known groups validity and responsiveness indicated that, across domains, mean sample size requirements for the CAT were 72% and 70%, respectively, of those using the QLQ-C30. CONCLUSIONS: The EORTC CAT Core measures the same domains as the QLQ-C30 with reduced floor/ceiling effects. The CAT generally facilitated the use of smaller samples (about 30% smaller on average) without loss of power compared to the QLQ-C30. Based on this study, the EORTC QLG will release the EORTC CAT Core for general use.

Associations between sex, age and spiritual well-being scores on the EORTC QLQ-SWB32 for patients receiving palliative care for cancer: A further analysis of data from an international validation study.

OBJECTIVE: The EORTC QOL Group has recently completed the cross-cultural development and validation of a standalone measure of spiritual well-being (SWB) for cancer patients receiving palliative care: the EORTC QLQ-SWB32. The measure includes four scales: Relationships with Others, Relationship with Self, Relationship with Someone or Something Greater, and Existential, plus a Global-SWB item. This paper reports on further research investigating relationships between sex, age and SWB for patients receiving palliative care for cancer-adjusting for other socio-demographic, clinical and function variables, including WHO performance status and EORTC QLQ-C15-PAL emotional and physical function scores. METHODS: Cross-sectional data from the validation study were used, and chi-square, independent t tests, Mann-Whitney U tests and multiple regression analyses applied. RESULTS: The study included 451 participants with advanced and incurable cancer, from 14 countries. Adjusted analyses found better scores for female participants than males on three of the four EORTC QLQ-SWB32 subscales; Relationship with others, Relationship with Someone or Something Greater and Existential plus Global-SWB. Older age was positively associated with better Relationship with Self. CONCLUSION: The findings from our participants suggest that it might be beneficial if healthcare providers seeking to address patients' spiritual needs pay particular attention to male patients, younger patients and those with poor emotional functioning.

The EORTC CAT Core-The computer adaptive version of the EORTC QLQ-C30 questionnaire.

BACKGROUND: To optimise measurement precision, relevance to patients and flexibility, patient-reported outcome measures (PROMs) should ideally be adapted to the individual patient/study while retaining direct comparability of scores across patients/studies. This is achievable using item banks and computerised adaptive tests (CATs). The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) is one of the most widely used PROMs in cancer research and clinical practice. Here we provide an overview of the research program to develop CAT versions of the QLQ-C30's 14 functional and symptom domains. METHODS: The EORTC Quality of Life Group's strategy for developing CAT item banks consists of: literature search to identify potential candidate items; formulation of new items compatible with the QLQ-C30 item style; expert evaluations and patient interviews; field-testing and psychometric analyses, including factor analysis, item response theory calibration and simulation of measurement properties. In addition, software for setting up, running and scoring CAT has been developed. RESULTS: Across eight rounds of data collections, 9782 patients were recruited from 12 countries for the field-testing. The four phases of development resulted in a total of 260 unique items across the 14 domains. Each item bank consists of 7-34 items. Psychometric evaluations indicated higher measurement precision and increased statistical power of the CAT measures compared to the QLQ-C30 scales. Using CAT, sample size requirements may be reduced by approximately 20-35% on average without loss of power. CONCLUSIONS: The EORTC CAT Core represents a more precise, powerful and flexible measurement system than the QLQ-C30. It is currently being validated in a large independent, international sample of cancer patients.

Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire.

BACKROUND: The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used. METHODS: We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors. RESULTS: We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment. CONCLUSIONS: Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.

Phase 1-3 of the cross-cultural development of an EORTC questionnaire for the assessment of sexual health in cancer patients: the EORTC SHQ-22.

To develop and pretest an European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire (EORTC SHQ-22) for the assessment of physical, psychological, and social aspects of sexual health (SH) in male and female cancer patients and survivors. Questionnaire construction started with creating a list of relevant SH issues based on a comprehensive literature review. Issues were subsequently evaluated for relevance and prioritization by 78 healthcare professionals (HCP) and 107 patients from 12 countries during in-depth interviews (phase 1). Extracted issues were operationalized into items (phase 2). Phase 3 focused on pretesting the preliminary questionnaire in a cross-cultural patient sample (n = 171) using debriefing interviews. Psychometric properties were preliminary determined using a principal component analysis and Cronbach's alpha. We derived 53 relevant SH issues from the literature. Based on HCP and patient interviews, 22 of these 53 issues were selected and operationalized into items. Testing the preliminary 22-item short questionnaire resulted in a change of wording in five items and two communication-related items; no items were removed. Preliminary psychometric analysis revealed a two-factor solution and 11 single items; both scales showed good reliability indicated by a Cronbach's alpha of 0.87 (sexual satisfaction) and 0.82 (sexual pain). Cross-cultural pretesting of the preliminary EORTC SH questionnaire has indicated excellent applicability, patient acceptance, and comprehensiveness as well as good psychometric properties. The final development phase, that is psychometric validation (phase four) including large-scale, cross-cultural field testing of the EORTC SHQ-22, has commenced.

La comunicación entre el paciente oncológico y los profesionales. El cuestionario de comunicación de la EORTC / The communication between cancer patients and professionals. The EORTC communication questionnaire

Este trabajo pretende introducir el área de la comunicación entre el paciente oncológico y los profesionales, y destacar el impacto que tiene en el paciente. Además, se presenta el cuestionario de comunicación de la EORTC. La comunicación entre el paciente y los profesionales es uno de los elementos claves del soporte que se ofrece a dichos pacientes. En dicha comunicación participan un rango importante de profesionales. Hay una necesidad de realizar más investigación sobre la comunicación. Se presentan dos modelos principales de atención al paciente: el Paternalista y el de Atención Centrada en el Paciente con cáncer. Este último lleva asociada la Comunicación Centrada en el Paciente - CCP. Se revisa la relación entre comunicación y otros PRO: Calidad de Vida, información, y Satisfacción con los Cuidados. Existen diferencias culturales en comunicación que pueden estar relacionadas con el modelo de atención al paciente. El Grupo de Calidad de Vida de la Organización Europea para la Investigación y Tratamiento del Cáncer-EORTC está desarrollando una escala de comunicación entre el paciente oncológico y los profesionales. La mayoría del contenido de dicho cuestionario se centra en las conductas de los profesionales. Los aspectos culturales tienen un papel fundamental en el desarrollo del instrumento. El cuestionario se basa en el modelo de Comunicación Centrada en el Paciente - CCP. Se presenta el cuestionario EORTC QLQ-COMU26, que consta de seis escalas y cuatro ítems individuales. Se describen las tres primeras fases que se han dado en su creación. En la actualidad su funcionamiento psicométrico se está valorando en un estudio internacional (AU)

The aims of the present work are to introduce to the field of communication between the cancer patient and the professionals, to remark the positive influence communication may have on the patient, and to present the EORTC communication questionnaire. Communication between patient and professional is a key element in the support that is offered to cancer patients. It is important to consider different professionals communicate with cancer patients. There is a need of research in communication between patients and professionals. Two main models of patient care are presented: Paternalistic and Patient-Centered Cancer Care. Patient-Centered Care includes Patient- Centered Communication - PCC. The relation between communication and other PROs - Quality of Life, Information and Satisfaction with Care - is presented. There are cross-cultural differences in communication that could be related to the model of patient care. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is developing a questionnaire to assess communication between cancer patient and the professionals. This Communication questionnaire mainly assesses professionals’ behaviors. Cultural aspects have a key role in the development of the EORTC questionnaire. This instrument is based on the Patient- Centered Communication - PCC model. The EORTC QLQ-COMU26 is presented. It includes six scales and four individual items. The three phases of the questionnaire development process are described. At the present moment the EORTC QLQ-COMU26 is being field-tested in a larger international study (phase IV), to ensure it is an appropriate and psychometrically valid instrument (AU)

The factor structure and use of the Demoralization Scale (DS-IT) in Italian cancer patients.

OBJECTIVE: Demoralization is a commonly observed syndrome in cancer patients, deserving to be carefully assessed in cross-cultural contexts. AIMS: To examine the factor structure and concurrent and divergent validity of the Italian version of the Demoralization Scale (DS-IT) in cancer patients. METHODS: The sample included 194 Italian cancer outpatients who were assessed by using the DS-IT and the Diagnostic Criteria of Psychosomatic Research-Demoralization module to examine demoralization. The Patient Health Questionnaire-9 (PHQ-9) to explore depression and the Mini-Mental Adjustment-to-Cancer-Hopelessness/Helplessness scale (Mini-MAC-HH) to explore maladaptive coping were also administered. RESULTS: Four factors were extracted by exploratory factor analysis on the DS-IT (disheartenment, α = .87; sense of failure, α = .77; dysphoria, α = .73; loss of meaning/purpose, α = .72; total = 0.91), accounting for 57.1% of the variance. The DS-IT factors shared between 17% and 36% of the variance. Patients reporting a diagnosis of demoralization on the Diagnostic Criteria of Psychosomatic Research-Demoralization module (23.7%) had higher scores on DS-IT loss of meaning/purpose, sense of failure, dysphoria, and DS-IT total. About half of those who were highly demoralized were not depressed and among those who had moderate or moderately severe demoralization, about 80% were not depressed on the PHQ-9. The DS-IT was significantly associated with PHQ-9 and Mini-MAC-HH. CONCLUSIONS: The study presents further evidence that demoralization is a significant clinical condition and that the DS-IT demonstrates satisfactory levels of validity and reliability to support its use in patients in the ambulatory cancer setting.

Differences in health-related quality of life between European and Asian patients with hepatocellular carcinoma.

AIM: The aim of this study is to explore the possible effects of clinical and cultural characteristics of hepatocellular carcinoma on patients' health-related quality of life (HRQoL). METHODS: Patients with hepatocellular carcinoma from Asian and European countries completed the EORTC QLQ-C30 and the EORTC QLQ-HCC18. Comparisons were made using Student's t-test and Wilcoxon rank-sum test with method of false discovery to correct multiple comparisons. Multiway analysis of variance and model selection were used to assess the effects of clinical characteristics and geographic areas. RESULTS: Two hundred and twenty-seven patients with hepatocellular carcinoma completed questionnaires. After adjusting for demographic and clinical characteristics, Asian patients still had significantly better HRQoL scores in emotional functioning, insomnia, (QLQ-C30) and in sexual interest (QLQ-HCC18). We also found an interaction in physical functioning (QLQ-C30) and fatigue (QLQ-HCC18) between geographic region and marital status, married European had worse HRQoL scores than Asian singles. CONCLUSIONS: Both clinical characteristics and geographic areas affected the HRQoL in with hepatocellular carcinoma. Cultural differences and clinical differences in the pattern of disease due to active surveillance of Asian countries may explain the results.

Dignity and Psychosocial-Related Variables in Advanced and Nonadvanced Cancer Patients by Using the Patient Dignity Inventory-Italian Version.

CONTEXT: The Patient Dignity Inventory (PDI) is a valid and reliable instrument to measure dignity, as a state of physical, mental, social, and spiritual well-being in palliative care patients and an essential dimension for a comprehensive patient-centered approach. OBJECTIVES: We examined the factor structure and correlation of the Italian version of the PDI (PDI-IT) with psychosocial variables among advanced and nonadvanced cancer outpatients in two Italian centers. METHODS: In a sample of 194 patients, principal component analysis, reliability analysis (Cronbach's coefficient alpha), and correlation analysis of the PDI-IT were performed. Concurrent validity was evaluated with respect to the Italian versions of Patient Health Questionnaire-9 (PHQ-9), as a measure of depression, the Mini-Mental Adjustment to Cancer-Hopelessness Scale, as a measure of dysfunctional coping, and the Demoralization Scale (DS-IT), as a measure of demoralization. RESULTS: Three factors were extracted by exploratory factor analysis, which accounted for 64.38% of the variance, namely existential distress (Cronbach's α = 0.95), psychological distress (Cronbach's α = 0.88), and physical distress (Cronbach's α = 0.81), with a Cronbach's α coefficient for the PDI-IT total score of 0.96. PDI-IT factors were significantly intercorrelated and shared between 42% and 53% of the variance. Higher scores on all the PDI-IT factors and PDI-IT total were found among patients who were clinically depressed (PHQ-9) and among those who were demoralized on the DS-IT. Significant correlations were also found between all PDI-IT and the DS-IT, PHQ-9, and the Mini-Mental Adjustment to Cancer-Hopelessness Scale. CONCLUSIONS: The study confirmed that the PDI-IT is a valid instrument to be applied in oncology and measuring three factors, namely existential, psychological, and physical distress, as core dimensions of dignity, to be monitored and treated in clinical settings.

Patients' perception of chemotherapy side effects: Expectations, doctor-patient communication and impact on quality of life - An Italian survey.

Chemotherapy side effects (CSE) have a strong impact on patients' quality of life (QOL). To assess patient perceptions of CSE, their impact on QOL and doctor-patient communication regarding these aspects, a survey was conducted among Italian cancer patients. Patients at least 18 years of age, who received chemotherapy, were administered a dedicated questionnaire to assess their point of view on five domains: expectations about CSE and impact on QOL; doctor-patient communication about CSE; treatments to reduce the impact of CSE; sexual life; family relationships/activities and employment. A total of 761 patients participated. CSE had a considerable impact on patient QOL. Nausea/vomiting was the most feared adverse effect before initiating chemotherapy and the one most commonly experienced during treatment. Patients generally reported good doctor-patient communication regarding information about CSE. In almost all cases, the oncologists prescribed an antiemetic treatment, but the incidence of nausea/vomiting was high. Cancer and CSE severely affected sexual life, daily activities and employment. CSE had a strong negative impact on QOL. Good doctor-patient communication is essential. Improving antiemetic strategies may improve QOL. Doctors' ability to inform patients about delicate issues, such as the impact of CSE on sexual life, needs to be improved.

EORTC QLQ-COMU26: a questionnaire for the assessment of communication between patients and professionals. Phase III of the module development in ten countries.

PURPOSE: Communication between patients and professionals is one major aspect of the support offered to cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed a cancer-specific instrument for the measurement of different issues related to the communication between cancer patients and their health care professionals. METHODS: Questionnaire development followed the EORTC QLG Module Development Guidelines. A provisional questionnaire was pre-tested (phase III) in a multicenter study within ten countries from five cultural areas (Northern and South Europe, UK, Poland and Taiwan). Patients from seven subgroups (before, during and after treatment, for localized and advanced disease each, plus palliative patients) were recruited. Structured interviews were conducted. Qualitative and quantitative analyses have been performed. RESULTS: One hundred forty patients were interviewed. Nine items were deleted and one shortened. Patients' comments had a key role in item selection. No item was deleted due to just quantitative criteria. Consistency was observed in patients' answers across cultural areas. The revised version of the module EORTC QLQ-COMU26 has 26 items, organized in 6 scales and 4 individual items. CONCLUSIONS: The EORTC COMU26 questionnaire can be used in daily clinical practice and research, in various patient groups from different cultures. The next step will be an international field test with a large heterogeneous group of cancer patients.

Development of an item bank for the EORTC Role Functioning Computer Adaptive Test (EORTC RF-CAT).

BACKGROUND: Role functioning (RF) as a core construct of health-related quality of life (HRQOL) comprises aspects of occupational and social roles relevant for patients in all treatment phases as well as for survivors. The objective of the current study was to improve its assessment by developing a computer-adaptive test (CAT) for RF. This was part of a larger project whose objective is to develop a CAT version of the EORTC QLQ-C30 which is one of the most widely used HRQOL instruments in oncology. METHODS: In accordance with EORTC guidelines, the development of the RF-CAT comprised four phases. Phase I involved the conceptualization of RF. In Phase II, a provisional list of items was defined and revised by experts in the field. In phase III, feedback was obtained from cancer patients in various countries. Phase IV comprised field testing in an international sample, calibration of the item bank, and evaluation of the psychometric performance of the RF-CAT. RESULTS: Phases I-III yielded a list of 12 items eligible for phase IV field-testing. The field-testing sample included 1,023 patients from Austria, Denmark, Italy, and the UK. Psychometric evaluation and item response theory analyses yielded 10 items with good psychometric properties. The resulting item bank exhibits excellent reliability (mean reliability = 0.85, median = 0.95). Using the RF-CAT may allow sample size savings from 11 % up to 50 % compared to using the QLQ-C30 RF scale. CONCLUSIONS: The RF-CAT item bank improves the precision and efficiency with which RF can be assessed, promoting its integration into oncology research and clinical practice.

An emotional functioning item bank of 24 items for computerized adaptive testing (CAT) was established.

OBJECTIVE: To improve measurement precision, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is developing an item bank for computerized adaptive testing (CAT) of emotional functioning (EF). The item bank will be within the conceptual framework of the widely used EORTC Quality of Life questionnaire (QLQ-C30). STUDY DESIGN AND SETTING: On the basis of literature search and evaluations by international samples of experts and cancer patients, 38 candidate items were developed. The psychometric properties of the items were evaluated in a large international sample of cancer patients. This included evaluations of dimensionality, item response theory (IRT) model fit, differential item functioning (DIF), and of measurement precision/statistical power. RESULTS: Responses were obtained from 1,023 cancer patients from four countries. The evaluations showed that 24 items could be included in a unidimensional IRT model. DIF did not seem to have any significant impact on the estimation of EF. Evaluations indicated that the CAT measure may reduce sample size requirements by up to 50% compared to the QLQ-C30 EF scale without reducing power. CONCLUSION: On the basis of thorough psychometric evaluations, we have established an EF item bank of 24 items. This will allow for more precise and flexible measurement of EF, while maintaining backward compatibility with the QLQ-C30 EF scale.

Development of an item bank for computerized adaptive test (CAT) measurement of pain.

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.