Translation, Validity and Internal Consistency of the Quality of Dying and Death Questionnaire for Brazilian families of patients that died from cancer: a cross-sectional and methodological study

ABSTRACT BACKGROUND: The Quality of Dying and Death Questionnaire (QoDD) may prove to be an important evaluation tool in the Brazilian context, and, therefore, can contribute to a more precise evaluation of the dying and death process, improving and guiding the end-of-life patient care. OBJECTIVE: To translate and cross-culturally adapt the QoDD into Brazilian Portuguese and measure its validity (convergent and known-groups) and internal consistency DESIGN AND SETTING: A cross-sectional, methodological study was conducted at the Hospital de Câncer de Barretos, Brazil METHODS: A total of 78 family caregivers participated in this study. Semantic, cultural, and conceptual equivalences were evaluated using the content validity index. The construct validity was assessed through convergent validation and known groups analysis [presence of family members at the place of death; feel at peace with dying; and place of death (hospital versus home; hospital versus Palliative Care)]. Internal consistency was evaluated using Cronbach's alpha. RESULTS: The questionnaire was translated into Brazilian Portuguese and presented evidence of a clear understanding of its content. Cronbach's alpha values were ≥ 0.70, except for the domains of treatment preference (α = 0.686) and general concerns (α = 0.599). The convergent validity confirmed a part of the previously hypothesized correlations between the Palliative Care Outcome Scale-Brazil (POS-Br) total scores and the QoDD domain scores. The QoDD-Br domains could distinguish the patients who died in palliative care and general wards. CONCLUSION: The QoDD-Br is a culturally adapted valid instrument, and may be used to assess the quality of death of cancer patients.


INTRODUCTION
The death process is subjectively determined and may be influenced by cultural factors, individual judgments, type and stage of the underlying disease, and the social and professional role with respect to the death experience. 1 The interest in promoting a "good death" has been increasingly discussed, mainly due to the increase in life expectancy of the population and advances in medicine. 1 The Institute of Medicine Committee on Care at the End of Life characterized highquality death as "death free from avoidable anguish and suffering for patients, families and their caregivers, according to the wishes of patients and caregivers and in line with clinical, cultural and ethical standards. " 2,3 The end-of-life stage leads to changes, which allows the development of standards that improve the quality of death (QOD). Simultaneously, a "good death" is equivalent to a death consistent with the patient's personality 4

and autonomy.
Therefore, QOD may be defined as the assessment of the last days of life and the moment of death, respecting the way that moment is prepared, faced, experienced and dealt with by those who have known terminal illness. 5 Different authors provide varied criteria for determining the QOD, such as reaffirming the need to prioritize the absence of pain during the end-of-life period.
However, there is a consensus that the quality of death and dying is greater than the control of physical symptoms (such as pain), since there are multiple dimensions inherent to this process. 6 Therefore, practical measures are necessary to improve this indicator in the Brazilian context.
Among all the instruments of the QOD assessment described in the literature, the "Quality of Dying and Death Questionnaire" (QoDD) is the most widely studied and best validated. 1,10,11 It was developed by Patrick et al. 4 due to a shortage of instruments for assessing the QOD. The study expected to provide a better evaluation of post death reports and the experience regarding the QOD and dying, as well as to evaluate the interventions that improve the quality of care at the end of life.

OBJECTIVE
The purpose of this study was to translate and cross-culturally adapt the QoDD into Brazilian Portuguese and measure its validity (convergent and known-groups) and internal consistency.

Study design
This was a descriptive, cross-sectional, and methodological study.

Setting
The study was conducted at Hospital do Câncer de Barretos (Barretos, São Paulo, Brazil), a reference hospital in Latin America for cancer treatment. It is an assistential, teaching, and research institution.

Patient and public involvement statement
Caregivers (family members) were not involved in the design or planning of the study; however, were informed regarding the nature and purpose of this study. Authorization for participation was obtained in the form of signed consent forms from the primary family caregiver. The entire validation process was performed following the permission of one of the authors of the original QoDD. 10

Phase I -Translation and cultural adaptation process
The cross-cultural adaptation of the QoDD was initiated after obtaining permission from the author of the original version. 10 International methodology adopted for the translation and cultural adaptation included translation, a synthesis of the translations, backtranslation, an expert panel, and a pretest according to the methodology proposed by Beaton et al. 14 and Souza and Rojjanasrirat. 15 Initially, the original questionnaire was translated from English into Portuguese by two independent translators, both native English speakers, without the knowledge of the issues addressed by the QoDD. The translated versions of the questionnaire were coded as T1 and T2.
The second step included a synthesis meeting of four special- was accepted for the evaluated item to be considered appropriate. 15 The pre-testing phase included 26 family caregivers who were >18 years, of either sex, considered the primary caregiver, aware that the patient's death was from cancer, and knew how to read.
Family caregivers with significant hearing loss that prevented them from telephonic communication were excluded. The family caregivers were contacted via telephone within 4-12 weeks after the date of death of their loved one. to be adequate. 16 For convergent construct validity, correlations between the QoDD-Br and the Palliative Care Outcome Scale-Brazil (POS-Br; an assessment tool designed to address multidimensional aspects of palliative care, such as physical and psychological symptoms, spiritual considerations, practical concerns, and emotional and psychosocial needs) 17,18 scores were hypothesized a priori by the researcher's judgment based on a clinical routine and the literature. Correlations with values ≥ 0.4 (moderate to highly strong) were considered acceptable. 19,20 In the knowngroups analysis, the groups were compared using the mean (standard deviation) of each domain, as measured by the QoDD-Br, to assess whether the instrument could discriminate between the groups as hypothesized.
Primary family caregivers of patients who died from cancer and were > 18 years of age were invited to participate in the study's validation step. They were selected through telephone contact, and they consented to answer the QoDD-Br questionnaire adapted to the Brazilian culture and the POS-Br. To preserve their mental health and avoid the worsening of their psychological condition due to participation in the study, the Patient Health Questionnaire-9 (PHQ-9) 21 was administered to screen for depressive symptoms and suicide risk. Family caregivers who selected option 1 -several days, 2 -more than half the days or 3 -almost every day in question 9 of the PHQ-9 questionnaire (suicidal ideation) or had a total score ≥ 12, were excluded. 22

Quality of Dying and Death Questionnaire (QoDD)
It comprised 31 items divided into six domains measuring aspects Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is a useful tool for the screening of depressive symp-

Phase I -Translation and cultural adaptation process translation
The title and 31 items were translated with similar meaning, with no grammatical or semantic distinctions between T1 and T2.
The original acronym was maintained, and Br was added to identify the Brazilian instrument: QoDD-Br. The back-translations (BT1 and BT2) did not indicate significant conceptual changes or inconsistencies in the translation process and were useful in guiding effective and consistent actions in the expert committee step.

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Each question has two parts. The first part will ask you how often X experienced each item using a scale where 0 is "none of the time" and 5 is "all of the time" 0.6 1 1 0.87

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Let us start with an example. In the last month of her/his life, how often did X listen to music? I would like you to use the first scale to tell me how often X listened to music during the last month of her/his life, with 0 being "none of the time" and 5 being "most of the time"      hospital versus PC hospital). The known-groups analysis showed that the instrument could discriminate between the family caregiver groups, as shown in Table 5.

DISCUSSION
This study translated, culturally adapted, and validated the QoDD for use in the Brazilian population. 14 The QODD has been widely used in QOD assessment, used and validated in different health care settings, such as in palliative care and Intensive Care Units. It is used to assess the QOD of patients reported by their family caregivers based on the six important domains of QOD symptoms: personal control, preparation for death, family concerns, treatment preferences, whole person concerns, and moment of death 4,25 Each society has its own behaviors, beliefs, attitudes, customs and social habits that must be considered in a translation and cross-cultural adaptation process. 15,26 During this process, it is possible to identify possible translation failures, that if left unresolved, may result in difficulties in the utilization of the construct and conduction of intercultural comparative studies. 14 As with the previous studies 24,27,28 internal consistency was also considered satisfactory (α = 0.95). In contrast, the Cronbach's α coefficients for the domains "treatment preference" and "whole person concerns" were both below 0.7 (α = 0.686 and α = 0.599, respectively). However, the comparison with the previous studies is limited, as the other studies did not report the Cronbach's α values for the QoDD domains.
Two previous validations conducted correlation analyses between the QoDD and POS scores. Both studies found negative correlation coefficients (r > 0.4) between the total QoDD and POS scores. Although a significant correlation between the two measures was not observed, the following three QoDD domains had significant correlations with the POS total score: "symptoms and personal control;" "preparation for death;" and "whole person concerns. " Unfortunately, comparisons of the POS correlations with the QoDD domains have not been previously reported, which makes comparisons difficult. In considering the QoDD a multidimensional tool, it was believed that the results should be presented not only for the total score, but also mainly for its domain scores. 24,27 In the known-groups analysis, the QoDD was able to discriminate distinct groups of patients as hypothesized. It should be noted that the QOD scores were higher in patients cared for by palliative care specialized teams than in patients who died in wards not specialized in PC. In contrast, unlike this study's hypothesis, there was no difference in scores between dying in the hospital or at home. This may be explained by the fact that patients who died at home were not cared for by a home care team. Many Brazilian patients face socio-economic difficulties (for e.g., poverty or lack of food and medicine) that can limit their end-of-life care conditions in addition to the poor access to palliative care, which should be offered by primary care teams.
The QoDD does not make it possible to assess the death and dying wishes of the patients, so it depends on the family caregivers. This evaluation is related to the memories of family caregivers in retrospective evaluation reports, but memory, emotions, and other person-related factors may bias their reports. 29,30 To minimize these effects, the family caregivers were contacted at least 4 weeks and no later than 12 weeks after the death of the patient.
The strength of this study is the QoDD application method, which was performed through telephonic communication. This type of contact allows the caregivers to be interviewed without needing to leave their residence to participate in the interview. Since Brazil is a continental country and considering that most family members return to their cities of origin after the patient's death, a QOD questionnaire valid for usage via telephone is certainly of great clinical utility.
Taking into account that Brazil is still a country with a poor QOD, 31 it is urgent to adequately measure the QOD so that measures may be adopted at the local and public health levels. The QoDD-Br could be used as an indicator of the quality of care and to compare different health care services. It may be an useful tool to measure improvements after interventions such as staff training, after the change in protocols and availability of financial resources.
This study has a few limitations. It was restricted to only one center in Brazil in a city located in the interior of São Paulo state. However, despite the great geographic expansion of the country, all five regions share the same language, and although there are certain cultural variations, this is not a factor that hampers the generalization power of the instrument to the Brazilian population as a whole. Other psychometric properties were not evaluated, including construct validity, reliability (intra-and inter-rater reliability), and measurement error. Although a wide variety of psychometric properties may be assessed, they are not necessarily investigated in all validation studies. Thus, different validation studies may even be complementary for evaluating the same instrument.

CONCLUSION
The QoDD-Br was culturally adapted and the psychometric properties of the convergent and known-groups validities, as well as the internal consistency were analyzed. In general, the items were adequately understood by the caregivers, and the psychometric properties were considered adequate. The QoDD-Br is ready to be used as a new indicator of the quality of the dying process in Brazil. Further studies with larger sample sizes should be conducted to provide a confirmatory factor analysis, others measures of reliability, standard error of measurement, minimal detectable change, and responsiveness analysis. How often did X appear to have her/his pain under control?