Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial

Poirier, A.-L.; Kwiatkowski, Fabrice; Commer, Jean-Marie; d’Aillières, Bénédicte; Berger, Virginie; Mercier, Mariette; Bonnetain, Franck

doi:10.1186/1745-6215-13-39

Cited by 5 publications

(4 citation statements)

References 47 publications

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“… a Quality of Life at the End of Life: QUAL-E [25] b Edmonton Symptom Assessment: ESAS [26] c Support Team Assessment Schedule: STAS [27] d EORTC Quality of Life of Palliative Cancer Patients: EORTC QLQ-C15-PAL [28] e McGill Quality of Life Questionnaire-Revised: MQOL-R [29] f M. D. Anderson Symptom Inventory: MDASI [30]…”

Section: Results: Findings and Challenges From The French Translationmentioning

confidence: 99%

Challenges in a six-phase process of questionnaire adaptation: findings from the French translation of the Integrated Palliative care Outcome Scale

Sterie

Bernard

2019

BMC Palliat Care

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Background The Integrated Palliative care Outcome Scale (IPOS) was developed for evaluating essential outcomes for palliative care patients. Our objectives here are to describe the process of a six-phase cross-cultural adaptation of IPOS to French (IPOS-Fr), highlight the difficulties encountered and strategies to solve them, and discuss the implications that adaptation may have on the validity and reliability of a questionnaire. Methods The adaptation of IPOS consisted of six phases: (i) literature review and interviews with target population; (ii) forward translation to French; (iii) backward translation to English; (iv) Expert Review; (v) cognitive interviews with target population; (vi) final review. Results Translation, cognitive interviews, and exchanges with Expert Review members allowed to make changes adapted to the target language regarding item 5 (“vomiting”) and 8 (“sore or dry mouth”), and to identify and address, in the original version of IPOS, syntactic inconsistencies in language used in items 11 to 15 and methodological problems with items 11 (“anxiety about treatment and illness”), 15 (“share … as much as you wanted”) and 17 (“problems addressed”). The adaptation also indicated that patients might have difficulties in interpreting items 8 (“sore or dry mouth”), 10 (“poor mobility”), 11 (“anxiety”), 12 (projected feelings of family and friends), and 14 (“feeling at peace”), thus indicating the need of monitoring during the psychometric validation. Conclusions Following this process, IPOS-Fr has proved content and face validity. In our case, the adaptation allowed adjustments to be made to the questionnaire and, when this was not possible, highlighted potential biases and inconsistencies during the validation. The result relied on an intertwined and iterative process of seeking and reaching semantic, conceptual, and normative equivalence. We are now assessing the psychometrical properties of IPOS-Fr.

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Section: Results: Findings and Challenges From The French Translationmentioning

confidence: 99%

Challenges in a six-phase process of questionnaire adaptation: findings from the French translation of the Integrated Palliative care Outcome Scale

Sterie

Bernard

2019

BMC Palliat Care

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“… ➢ For patients at the end-of-life stage: the Quality of Life at End of Life (QUAL-E) questionnaire will be administered by a clinical research assistant and completed based on the patient’s responses. This questionnaire has been validated in the English-language version [ 22 ], and a cross-cultural validation into the French language has been completed [ 23 ]. The French-language version comprises 25 questions (compared with 24 in the English version) plus one global question, covering five domains: …”

Section: Methodsmentioning

confidence: 99%

Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial

Pazart

Cretin²,

Grodard

et al. 2014

Trials

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BackgroundMalnutrition is a common complication in patients at the palliative stage of cancer. During the curative phase of cancer, optimal enteral or parenteral nutrition intake can reduce morbidity and mortality, and improve quality of life. When the main goal of treatment becomes palliative, introduction of artificial nutrition is controversial. Although scientific societies do not recommend the introduction of artificial nutrition in all cases of malnutrition, especially in hypophagic patients if their life expectancy is shorter than 2 months, considerable differences in the use of parenteral nutrition in nonsurgical oncology practice are noted around the world. One explanation is a paucity of well-conducted randomized controlled trials in these situations, and consequently, the risk/benefit ratio of parenteral nutrition and its impact on quality of life in palliative care remains uncertain.Methods/designThe ALIM-K study is a French national multicenter randomized controlled trial designed to evaluate the effectiveness of parenteral nutrition, versus an exclusive oral-feeding supply, on the quality of life of malnourished patients who have a functional digestive tube and who are at the palliative phase of advanced cancer with a life expectancy of more than 2 months.DiscussionThis article presents the methodologic options chosen for our study, and in particular, the choice of the Zelen method of randomization, the definition of the main end point (quality of life), the choice of comparator (oral feeding), and the inclusion criteria (life expectancy of more than 2 months), which are all critical points in building a randomized controlled trial in the setting of palliative care.Trial registrationThis study was registered with the clinical trials database ClinicalTrials.gov on May 27, 2014, under the number NCT02151214.

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“…The first step is the cultural adaptation, and the second is the psychometric validation. The Protocol of the study has been extensively described elsewhere [23]. This paper describes the first step: the cultural adaptation of the two questionnaires: MVQOLI and QUAL-E in a French-language version.…”

Section: Designmentioning

confidence: 99%

Report on the First Stages in the Translation of Measures of Health-Related Quality of Life at the End of Life

JM¹

2014

J Palliat Care Med

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Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial

Cited by 5 publications

References 47 publications

Challenges in a six-phase process of questionnaire adaptation: findings from the French translation of the Integrated Palliative care Outcome Scale

Challenges in a six-phase process of questionnaire adaptation: findings from the French translation of the Integrated Palliative care Outcome Scale

Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial

Report on the First Stages in the Translation of Measures of Health-Related Quality of Life at the End of Life

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