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ORIGINAL ARTICLE
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Pilot testing and vernacular translation of a questionnaire for assessment of satisfaction in patients on radiotherapy in India


 Department of Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India

Date of Submission23-May-2019
Date of Decision02-Oct-2019
Date of Acceptance02-Oct-2019
Date of Web Publication24-Nov-2020

Correspondence Address:
Tejpal Gupta,
Department of Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijc.IJC_466_19

PMID: 33402589

  Abstract 


Background: Patient satisfaction has emerged as a yardstick to measure success of healthcare ecosystems. OUTPATSAT-35RT is a questionnaire to assess patient satisfaction on outpatient radiotherapy (RT). However, it is yet to be translated and/or validated in any of the common Indian languages.
Methods: English version of OUTPATSAT-35RT was pilot tested in 20 patients with working knowledge of English undergoing fractionated radiotherapy. Subsequently, the questionnaire was translated into two Indian vernacular languages (Hindi and Marathi) using standardized methodology. The process included forward translation into vernacular language by two professional translators independently, generating an intermediate version of the questionnaire. The intermediate questionnaire was then back-translated into English by another duo of professional translators and compared with the English version of the original OUTPATSAT-35RT questionnaire for final reconciliation. This was subsequently administered to 20 patients each (fluent in respective vernacular language) for pilot testing. All 60 patients (20 per language) underwent semi-structured interviews for reporting any difficulty encountered during filling and suggesting any corrections/modifications to the questionnaire.
Results: The pilot testing of the English version of OUTPATSAT-35RT in 20 Indian patients did not reveal any difficulty or suggest corrections/modifications, leading to its successful translation into Hindi and Marathi languages. Pilot testing of the translated questionnaires in 20 patients each (fluent in the respective vernacular language) did not find any major difficulty. No corrections/modifications were suggested by the respondents resulting in adoption of the reconciled vernacular questionnaires as final Hindi and Marathi versions of OUTPATSAT-35RT questionnaire.
Conclusion: The English version of OUTPATSAT-35RT has been successfully translated into Hindi and Marathi languages using standardized methodology. Its psychometric properties are being tested for validation in a larger Indian cohort.


Keywords: Questionnaire, radiotherapy, satisfaction, translation
Key Message: OUTPATSAT-35RT is the first comprehensive questionnaire for the assessment of patient satisfaction on outpatient radiotherapy. The English version has been successfully pilot-tested and translated into Hindi and Marathi languages.



How to cite this URL:
Manjali JJ, Gupta T, Ghosh-Laskar S, Jalali R, Sarin R, Agarwal JP. Pilot testing and vernacular translation of a questionnaire for assessment of satisfaction in patients on radiotherapy in India. Indian J Cancer [Epub ahead of print] [cited 2021 Jul 29]. Available from: https://www.indianjcancer.com/preprintarticle.asp?id=301402



  Introduction Top


Cancer is one of the leading causes of morbidity and mortality worldwide[1] and not only imposes an increasing burden on the affected individuals and their families in all aspects but also causes an economic burden.[2] Despite considerable advances in cancer diagnostics and therapeutics over the last few decades, very little is known about patient satisfaction with provided care in the oncology setting. Satisfaction in simple terms is contentment and being at ease in one's situation. Patient satisfaction is measured as the gap between patients' perception of care and their needs and expectations i.e., perceived difference between expectations to what is received during the process of care.[3],[4] Patient satisfaction as an indicator of quality has now evolved into an outcome measure with patient satisfaction surveys being increasingly identified as established yardsticks to measure success of any healthcare ecosystem in general hospitals as well as specialty settings including oncology.[5],[6]

Radiotherapy (RT) remains an important and integral component in the multi-modality management of cancers in contemporary oncology practice. Conservative estimates suggest that over 60% of the patients with cancer require RT at some point in time during the evolution of their disease.[7] For the assessment of outpatient satisfaction in RT, a questionnaire OUTPATSAT-35RT [Figure 1] was developed by a French psycho-oncologist, adapted from a validated questionnaire for cancer in-patient satisfaction (INPATSAT32),[8] after taking into consideration all aspects affecting the satisfaction of patients undergoing ambulatory treatment. Instructions for ambulatory care were adapted and items that both patients and professionals found specific and important for the cancer outpatient settings were added. Originally constructed in French, it was successfully translated into Spanish and English and subsequently adopted by the European Organization for Treatment and Research of Cancer (EORTC) for usage in conjunction with its 30-item multi-dimensional core quality-of-life (QOL) questionnaire (QLQ-C30). The translated and validated versions of EORTC QLQ-C30 and its common site-specific modules such as head-neck cancer (HN35), breast cancer (BR23), and lung cancer (LC13) are readily available in several non-English languages and widely used across the world.[9] Two site-specific modules, the brain tumor module[10] and prostate cancer module[11] have previously been translated and validated in Indian vernacular languages such as Hindi and Marathi at the author's institute. Some studies have piloted, translated, and validated OUTPATSAT-35RT in diverse healthcare settings,[12],[13],[14] but, it is yet to be translated and/or validated in any of the common Indian languages.
Figure 1: English version of the OUTPATSAT-35RT questionnaire

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Aims and objectives

The aim of this study was to do pilot testing and translation of the English version of OUTPATSAT-35RT questionnaire into two vernacular languages commonly spoken in Western India such as Hindi and Marathi.


  Materials and Methods Top


Appropriate consent was taken from the developer of OUTPATSAT-35RT questionnaire for the pilot testing and translation of the English version into Indian vernacular languages. The study conducted in the RT department of a large tertiary-care comprehensive cancer center in Western India was duly approved by the Institutional Ethics Committee (IEC) that functions under the Declaration of Helsinki. Adult patients with pathologically proven diagnosis of cancer planned for fractionated RT (≥10 fractions) on ambulatory basis in the definitive, adjuvant, or palliative setting, with ability to read and understand the questionnaire in the appropriate language were accrued on the study. Patients who were unable to comprehend the questionnaire due to cognitive or physical impairment and those needing admission anytime during RT were excluded. All patients provided written informed consent for study participation.

Patients with working knowledge of English were administered the English version of OUTPATSAT-35RT questionnaire on the conclusion of planned RT regimen (±3 days). This is a structured questionnaire comprising 35 close-ended questions, divided into four sections related to doctors; RT technicians; services and care organization; and overall. A five-level Likert scale with response categories labelled as (1) “poor”, (2) “fair”, (3) “good” (4) “very good”, and (5) “excellent” is used for documenting response to individual items in the questionnaire, with a higher score indicating greater satisfaction with care and vice versa. Likert scale is a psychometric scale widely used for scaling responses (from one extreme to another) in questionnaire-based survey research. Besides, patients were also simultaneously administered the multi-dimensional core QOL questionnaire (EORTC QLQ-C30) in the same language as OUTPATSAT-35RT. The QLQ-C30 uses a modular approach to the assessment of QOL designed to assess specific issues regarding cancer and its treatment. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), one global health status/QOL scale, and several single items assessing additional symptoms commonly reported by the patients with cancer (dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and perceived financial impact of disease and/or its treatment.

Pilot testing of the OUTPATSAT-35RT questionnaire was done in two steps.[15] In the first step, each item of the questionnaire was pilot-tested on 20 patients who were representative in terms of the socio-demographic features (gender ratio, age distribution, education spectrum, and income group) and clinical characteristics (site, type, and stage of cancer) for which the questionnaire is designed. After filling the questionnaires, patients were interviewed either on the same day (or within 3 days of filling the questionnaire) using a standardized format [Online supplementary file S1 [Additional file 1]] to assess the appropriateness of the items in the questionnaire for the tested population. In the second step, the structured interview was directed to each module item separately. After pilot testing of the English version of OUTPATSAT-35RT, translation of the questionnaire was done according to standardized and validated EORTC methodology[15] for such translations [Figure 2]. This included forward translation of the English version of the questionnaire into Hindi and Marathi languages separately and independently by two professional translators each. A reconciled version was created by a third linguistic expert after merging information from both forward translated versions of the questionnaire in each language independently (intermediate version). This intermediate version (in both vernacular languages) was then back-translated independently into English by a separate duo of professional translators and compared with the English version of the original questionnaire for final reconciliation.[15] The final reconciled version was subsequently administered to 20 patients each (fluent in the respective vernacular language) for pilot testing. All 60 patients (20 per language: English, Hindi, and Marathi) underwent semi-structured interviews for reporting any difficulty encountered during filling and suggesting any corrections/modifications to the questionnaire. All modifications were incorporated to create the final version of the questionnaire in the respective language.
Figure 2: Flow chart depicting the European Organization for Research and Treatment of Cancer (EORTC) translation process for standardized QOL questionnaires

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  Results Top


The socio-demographic characteristics of the study cohort (N = 60) are briefly described in [Table 1] and were quite representative of the spectrum of the patients with cancer which are treated with ambulatory RT at any large tertiary-care cancer center across India. Pilot testing of the English version of OUTPATSAT-35RT questionnaire in 20 patients with working knowledge of English did not reveal any difficulty in filling-up the questionnaire and no corrections/modifications were suggested, leading to the next step of translation of the English version into Hindi and Marathi languages. Both the forward translated versions (in each language) were carefully reconciled by a third linguistic expert taking special care to adopting simple and easily understood words to create the intermediate version of the questionnaire in Hindi and Marathi. This reconciliated intermediate version of Hindi and Marathi questionnaires were administered to 20 patients each (fluent in respective language), in conjunction with the Hindi and Marathi versions of the EORTC QLQ-C30 for pilot testing followed by the semi-structured interviews. None of the respondents reported any difficulty in filling the vernacular version and no corrections/modifications to the questionnaire were suggested leading to the adoption of the reconciled intermediate versions as the final versions in Hindi and Marathi [Online supplementary file S2 [Additional file 2] ] and [Online supplementary file S3 respectively [Additional file 3]].
Table 1: Socio-demographic and clinical characteristics of the study cohort (n=60)

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All 60 patients answered every individual question of the OUTPATSAT-35RT and EORTC QLQ-C30 questionnaires in their respective languages. The individual mean scores and their standard deviation (SD) along with the median scores (range) of all 35 questions in the OUTPATSAT-35RT questionnaire for all 60 patients are summarized in [Table 2]. High scores (mean score >3.5) were documented for most individual questions suggesting reasonably high levels of patient satisfaction with RT services. Low satisfaction scores (mean score <3.5) were documented for following questions – item 29 (the ease of reaching the service by telephone?), item 30 (the waiting time before obtaining a medical consultation appointment?), item 32 (the ease of access – parking, means of transport…??), and item 33 (the ease of finding one's way to the different departments?).
Table 2: Mean with standard deviation (SD) and median (range) scores of individual questions in OUTPATSAT-35RT in all three languages combined (n=60)

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Patient responses to the semi-structured interview are compiled in [Table 3]. Question number 23 was reported to be difficult by two patients, while question numbers 10, 15, 19, 21, 28, and 33 were reported to be difficult by a single patient each. A few questions (numbers 2, 14, and 21) were reported as confusing by a single patient each while one question (number 21) was reported as having difficult words by one patient. None of the patients suggested any changes (corrections/modifications) to the questionnaire. After analysis of patient responses individually and collectively during the interview, it was evident that no question was repeatedly reported to be difficult, confusing, or upsetting and hence did not mandate any major changes in the content or wording of the questionnaires. The reconciled intermediate version of the questionnaires in both vernacular Indian languages was adopted as the final version of OUTPATSAT-35RT in Hindi and Marathi respectively. The mean (±SD) and median (range) scores of all individual questions of the EORTC QLQ-C30 for all 60 patients are compiled in [Table 4]. Higher scores for functional and global health status scales reflect healthy level of living, whereas lower scores for symptom scale reflects better symptom control. Although global health status has been demonstrated to be a major determinant of satisfaction of any therapy,[16] this study did not assess any correlation between the two.
Table 3: Composite patient response to individual questions of OUTPATSAT-35RT during the interview

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Table 4: Mean with standard deviation (SD) and median (range) scores of different domains of QLQ-C30 questionnaire* (n=60)

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  Discussion Top


Patient satisfaction has become an important endpoint in the assessment of the quality of care and is increasingly required by accreditation agencies during periodic monitoring quality of hospital care.[4] Moreover, patient compliance to treatment may be influenced by patient satisfaction with potential impact on disease outcomes.[16] Previously, the only available patient satisfaction questionnaire in any Indian vernacular language was the EXPECT questionnaire[17] which was developed and validated in Malayalam to assess preferences and expectations of patients undergoing palliative chemotherapy at a tertiary-care oncology center in South India.

The present study has resulted in pilot testing and successful translation of the English version of OUTPATSAT-35 RT questionnaire in two vernacular languages (Hindi and Marathi) commonly spoken in Western India. It is worth noting that language was not an impediment and all patients answered all questions in all three languages. The semi-structured interview of all included patients did not consistently or repeatedly find the questions in any language to be difficult, confusing, or upsetting, indicating that the wording used in all three languages was simple, clear, and easy to understand. The scores did not suggest any significant floor and ceiling effect, which if present would have mandated modifications in the questionnaire.[18] The generally high satisfaction scores attained for most questions in this study can be somewhat misleading due to relatively small sample size (N = 60) and potential bias based on patient's perception of likely negative impact on further treatment in case of reporting low levels of satisfaction.

The psychometric properties of OUTPATSAT-35RT have been tested and validated previously. The first validation study was conducted in the 416 patients undergoing ambulatory chemotherapy or radiotherapy in seven centers in France.[12] Confirmatory analyses revealed good convergent validity and excellent internal consistency, although some subscales within the OUTPATSAT-35RT were relatively highly correlated. Items and subscales of the OUTPATSAT-35RT and QLQ-C30 were not significantly correlated, suggesting that the two questionnaires were assessing quite distinct concepts. Subsequently, Arraras et al.[13] validated the questionnaire in a cohort of 100 Spanish patients reporting good convergent validity, discriminant validity, divergent validity and internal consistency on multitrait-scaling analysis. Psychometric properties of the questionnaire were further evaluated in a larger French cohort of 605 patients with cancer[14] using classical test theory (CTT) and item response theory (IRT). CTT analyses showed good psychometric properties (convergent validity, divergent validity, and internal consistency), but the IRT model revealed three mis-fitting and redundant items – “promptness” in the doctors' domain and “accessibility” and “environment” in the services/organization domain, for which refinement of the questionnaire was recommended. A cross-sectional study of 692 patients with cancer undergoing ambulatory treatment (RT or chemotherapy) was conducted in France using OUTPATSAT questionnaire to identify factors associated with patient satisfaction with care.[16] On multivariate analysis, poor perceived global health strongly predicted dissatisfaction with care (P < 0.0001). Patients treated by RT (vs patients treated by chemotherapy) reported lower levels of satisfaction with doctors' technical and interpersonal skills, information provided by caregivers, and waiting times. Patients with head and neck primary (vs other disease sites) and those living alone (vs unmarried or divorced) were less satisfied with information provided by doctors, and younger patients (<55 years) were less satisfied with doctors' availability. The same authors[19] also did a longitudinal assessment at three time points (beginning of treatment, end of treatment, and 3-months after treatment) to ascertain the influence of clinical and socio-demographic factors previously identified as potential determinants of satisfaction with care. Secondarily, the influence of longitudinal changes in self-reported QOL on variations in satisfaction with care, as measured by multi-dimensional questionnaires were investigated. By cross-sectional analysis, at the end of the treatment, patients who experienced a deterioration of their global health reported less satisfaction on most scales (p ≤ 0.001). Three months after treatment, the same patients had lower satisfaction scores only in the evaluation of doctors (p ≤ 0.002). Longitudinal analysis showed a significant direct relationship between global health status and satisfaction. Global health at baseline was largely and significantly associated with all satisfaction scores measured at the following assessment time points (P < 0.0001). Younger age (<55 years), RT (vs chemotherapy), and head and neck primary (vs other disease sites) were clinical factors significantly associated with less satisfaction on most scales evaluating doctors.

Although patient satisfaction has been increasingly recognized as an important benchmark in the healthcare industry resulting in several studies reporting patients' perception of quality of care, there is paucity of data regarding the perception of healthcare providers towards their own services. A 16-item questionnaire adapted and derived from INPATSAT32 and CASC (comprehensive assessment of satisfaction with care) questionnaires was served to 40 patients (undergoing RT) and 40 staff members (involved with delivery of care in the same department) at a tertiary-care institute in North India to assess satisfaction levels as well as agreement between the two groups of respondents.[20] Overall satisfaction levels of both groups regarding quality of care ranged from “good” to “excellent” with high levels of inter-rater agreement, prompting the conclusion that a high level of satisfaction can be achieved from consumers (patients), if service providers are trained to assess their needs and expectations and critically evaluate themselves.

Most of the patients with cancer need treatment both as in-patients as well as on ambulatory basis during the trajectory of their illness. Given the remarkably similar domains and significantly overlapping items between INPATSAT32 and OUTPATSAT35, the EORTC has recently developed the 33-item satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) and a seven-item complementary module (EORTC OUT-PATSAT7) specific for outpatient care setting,[21] using a rigorous three-phase process of revision, development of extended application, and pre-testing of the questionnaires.[22] A large-scale phase IV cross-cultural validation of the psychometric properties of the new questionnaire is currently underway.

Limitations

Despite the successful translation and pilot testing of the OUTPATSAT-35RT questionnaire, some caveats and limitations remain. The translation was limited to only two Indian languages; India being a culturally and linguistically diverse country, it would be appropriate to translate the questionnaire into other common Indian languages as well for wider applicability. The study only translated the OUTPATSAT-35RT questionnaire without validation testing of its psychometric properties in the Indian population. However, this is the first report from a larger ongoing study, which aims to test the psychometric properties of the questionnaire in a bigger Indian cohort of over 400 patients. Since this questionnaire was not designed to assess satisfaction in patients being treated with brachytherapy, patients receiving any form of brachytherapy (integral component of curative-intent radiotherapeutic management of gynecologic cancers) were systematically excluded introducing potential bias. Similarly, patients receiving single fraction RT or hypofractionated regimens (typically 2-5 fractions) were not included limiting the applicability of the questionnaire in that cohort. Another possible limitation is the missing pertinent content in the questionnaire itself. Though the OUTPATSAT-35RT addresses various domains that may influence satisfaction in patients undergoing ambulatory RT, some considerations peculiar to low-resource settings (developing countries) also need to be accounted for. The foremost among these is the issue of long waiting times (typically 4-6 weeks or even longer) for initiation of RT due to significant lack of infrastructure and resources in the country, particularly in public sector hospitals. Somewhat less important may be the forced necessity to wait for prolonged periods on the machine for daily treatment well beyond the scheduled and stipulated time of appointment due to various reasons. Finally, managing treatment interruptions due to machine breakdown can be quite challenging as it is difficult to readily transfer patients to other functioning units which may already be overburdened and working beyond capacity. Any such unintended interruption in treatment can significantly affect patient satisfaction due to anticipated inferior outcomes. Many of these concerns may not necessarily apply to the western world, wherein the number of patients on a given RT machine is significantly lesser than its capacity to treat. However, none of these real-world concerns of developing countries are reflected or addressed by the current version of the questionnaire.

As

The English version of OUTPATSAT-35 RT has been successfully translated into Hindi and Marathi languages using a standardized methodology. The psychometric properties of the questionnaire are currently being tested for validation in a larger Indian cohort.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Intramural study-specific research grant.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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