Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation

Kirsch, Monika; Mitchell, Sandra A.; Dobbels, Fabienne; Stüssi, Georg; Basch, Ethan; Geest, Sabina De

doi:10.1016/j.ejon.2014.07.007

Cited by 29 publications

(28 citation statements)

References 33 publications

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“…First, our study was conducted in an English-speaking U.S.-residing patient population. Ongoing research is evaluating linguistic adaptations of PRO-CTCAE, and the measurement properties of both the English and other language versions in settings outside the U.S. 31 Linguistic validation of a Spanish language translation of PRO-CTCAE is being reported elsewhere. 18 Second, we assessed reliability in a subset of 49 items; thus, future studies to examine the test-retest reliability of the remaining PRO-CTCAE items are warranted.…”

Section: Discussionmentioning

confidence: 99%

Validity and Reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

et al. 2015

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Importance Symptomatic adverse events (AEs) in cancer trials are currently reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective, the NCI developed a patient-reported outcomes version of the CTCAE (PRO-CTCAE) to capture symptomatic AEs directly from patients. Objective To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. Design Participants completed PRO-CTCAE items on tablet computers in clinic waiting rooms at two visits 1-6 weeks apart. A subset completed PRO-CTCAE items during an additional visit one business day after the first visit. Setting Nine U.S. cancer centers and community oncology practices. Participants 975 adult cancer patients undergoing outpatient chemotherapy and/or radiation enrolled between January 2011 and February 2012. Eligibility required participants to read English and be without clinically significant cognitive impairment. Main Outcome(s) and Measure(s) Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). Results 940/975 (96%) and 852/940 (91%) participants completed PRO-CTCAE items at each visit. 938/940 (99.8%) participants (53% female, median age 59, 32% high school education or less, 17% ECOG PS 2-4) reported having at least one symptom. All PRO-CTCAE items had at least one correlation in the expected direction with a QLQ-C30 scale (111/124 P<.05). Stronger correlations were seen between PRO-CTCAE items and conceptually-related QLQ-C30 domains. Scores for 94/124 PRO-CTCAE items were higher in the ECOG PS 2-4 versus 0-1 group (58/124 P<.05). Overall, 119/124 items met at least one construct validity criterion. Test-retest reliability was acceptable for 36/49 pre-specified items (median intra-class correlation coefficient .76; range .53-.96). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes reached statistical significance for 27 pre-specified items (median r=.43, range .10-.56; all P≤.006). Conclusions and Relevance Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous U.S. sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are underway to inform further development of PRO-CTCAE and its inclusion in cancer trials.

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Section: Discussionmentioning

confidence: 99%

Validity and Reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

et al. 2015

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“…The severity of the symptoms was graded during the patients' visit. 17 Common terminology criteria for adverse events (CTCAE; Version 4.0) were used to classify and grade late effects, grade 1 being mild, asymptomatic or symptomatic not needing any intervention, and grade 3 and 4, severe and life-threatening, respectively. 18 For grading fatigue, Version 3.0 of the CTCAE was used as follows: grade 1, mild fatigue over baseline; grade 2, moderate or causing difficulty performing some activity of daily living (ADL); grade 3, severe fatigue interfering with ADL; grade 4, disabling.…”

Section: Methodsmentioning

confidence: 99%

Inability to work and need for disability pension among long-term survivors of hematopoietic stem cell transplantation

Thewis

Gerull

Holbro

et al. 2017

Bone Marrow Transplant

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Return to work is critical goal following HSCT. However, late effects may impede return to normal activity after HSCT. In the case of inability to work, patients may need a work disability pension to ensure a reasonable livelihood. This study evaluated inability to work and need for disability pension among long-term survivors and analyzed possible determinants of need for social support. This retrospective, single-center study included all HSCT patients surviving ⩾5 years seen at the outpatient clinic between January 2013 and August 2015. There were 203 patients, median age at HSCT 35 years, and 50 years at time of study; median time between HSCT and study control was 12 years; 178 had allo-HSCT, 187 had a malignant disease. At time of study, 156 (77%) were working full or part-time, 47 (23%) were not working. In total, 76 (37%) survivors were receiving a work disability pension compared to 3.17% of the Swiss working population. Patients with a disability pension were significantly older at HSCT, were more often living alone, had more active physical and mental late effects, and higher score of fatigue compared to patients without. These findings underline the importance of screening for employment and the social consequences of non-employment in long-term survivors after HSCT.

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“…Details of that study's methods have been published elsewhere (Kirsch et al, 2015;NCT01275535). In brief, data were collected from November 2011 to October 2012 from a convenience sample of 376 patients attending the University Hospitals Basel and Zurich outpatient clinics following HSCT.…”

Section: Design Sample and Settingmentioning

confidence: 99%

“…Evidence suggests that patients' positive perceptions of their disease and side effects accompany a clearer understanding of their illness and enhanced self-management (Zivkovic et al, 2012). This sub-study of the PROVIVO study was the first to administer the German version of the BIPQ in long-term survivors (Kirsch et al, 2015). …”

Section: Introductionmentioning

confidence: 99%

Perception of late effects among long-term survivors after haematopoietic stem cell transplantation: Descriptive analysis and validation of the Brief Illness Perception Questionnaire. A sub-study of the PROVIVO study

Valenta

Geest

Fierz

et al. 2017

European Journal of Oncology Nursing

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a b s t r a c tPurpose: To give a first description of the perception of late effects among long-term survivors after Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) and to validate the German Brief Illness Perception Questionnaire (BIPQ). Methods: This is a secondary analysis of data from the cross-sectional, mixed-method PROVIVO study, which included 376 survivors from two Swiss HSCT-centres. First, we analysed the sample characteristics and the distribution for each BIPQ item. Secondly, we tested three validity types following the American Educational Research Association (AERA)Standards: content validity indices (CVIs) were assessed based on an expert survey (n ¼ 9). A confirmatory factor analysis (CFA) explored the internal structure, and correlations tested the validity in relations to other variables including data from the Hospital Anxiety and Depression Scale (HADS), the number and burden of late effects and clinical variables. Results: In total, 319 HSCT recipients returned completed BIPQs. For this sample, the most feared threat for post-transplant life was long lasting late effects (median ¼ 8/10). The expert-survey revealed an overall acceptable CVI (0.82), three itemseon personal control, treatment control and causal representationeyielded low CVIs (<.78). The CFA confirmed that the BIPQ fits the underlying construct, the Common-Sense Model (CSM) (c 2 (df) ¼ 956.321, p ¼ 0.00). The HADS-scores correlated strongly with the item emotional representation (r ¼ 0.648; r ¼ 0.656). Conclusion: According to its overall content validity, the German BIPQ is a promising instrument to gain deeper insights into patients' perceptions of HSCT late effects. However, as three items revealed potential problems, improvements and adaptions in translation are therefore required. Following these revisions, validity evidence should be re-examined through an in-depth patient survey.

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Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation

Cited by 29 publications

References 33 publications

Validity and Reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Validity and Reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Inability to work and need for disability pension among long-term survivors of hematopoietic stem cell transplantation

Perception of late effects among long-term survivors after haematopoietic stem cell transplantation: Descriptive analysis and validation of the Brief Illness Perception Questionnaire. A sub-study of the PROVIVO study

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