Skip to main content
Mijn bibliotheek
Shop
Nieuws Boeken Tijdschriften E-learning Web-tv Video Audio
Tips voor Mijn BSL
UITGEBREID ZOEKEN
Inloggen
Top
Quality of Life Research
Gepubliceerd in: Quality of Life Research 9/2021

02-04-2021

Enabling cross-cultural data pooling in trials: linguistic validation of head and neck cancer measures for Indian patients

Auteurs: Chindhu Shunmugasundaram, Haryana M. Dhillon, Phyllis N. Butow, Puma Sundaresan, Claudia Rutherford

Gepubliceerd in: Quality of Life Research | Uitgave 9/2021

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail
    Link delen
publish
Publiceer nu

Abstract

Background

Head and neck cancers (HNC) and their treatments cause dysfunction and distress. Ongoing psychological assessment using disease-specific patient-reported measures may optimize clinical decision-making, facilitate interventions to reduce psychosocial burden. As most such measures are developed in English, non-English speaking patients are disadvantaged. This study translated HNC-specific measures (Body Image Scale, Patient Concerns Inventory, Zung’s Self-Rating Anxiety and Depression Scales and Patient Health Questionnaire-9) into three Indian languages (Hindi, Tamil and Telugu) and linguistically validated them.

Methods

Translation followed established guidelines on translation and linguistic validation of measures. Process involved two independent forward translations, reconciliation, two independent backward translations by bilingual experts, and cognitive debriefing interviews with nine healthcare professionals (HCPs) and 29 HNC patients. Translated versions were compared with the original versions for semantic, cultural and conceptual equivalence.

Results

Overall, 17 Hindi items, 19 Tamil items and 13 Telugu items were identified to have semantic, cultural and/or conceptual issues. These were resolved to achieve equivalence with the original measures. Interviews with HCPs indicated that equivalent terms for words such as anxiety, panicky, sexuality, and self-conscious might be difficult to understand. Interviews with patients indicated all items were understandable, easy, sensitive, unambiguous and relevant. Hence, no further revisions were made.

Conclusions

The translated Hindi, Tamil and Telugu versions of the Body image scale, Patient concerns inventory, Zung’s self-rating anxiety and depression scales and Patient health questionnaire-9 measures are conceptually and linguistically validated and equivalent with the original English versions. Psychometric validation of these measures with relevant patient populations is needed.
vorige artikel Psychometric assessment of EQ-5D-5L and ReQoL measures in patients with anxiety and depression: construct validity and responsiveness
volgende artikel A psychometric evaluation of the Functional assessment of cancer therapy—kidney symptom index (FKSI-19) among renal cell carcinoma patients suggesting an alternative two-factor structure
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
1.
Vigneswaran, N., & Williams, M. D. (2014). Epidemiologic trends in head and neck cancer and aids in diagnosis. Oral and Maxillofacial Surgery Clinics, 26(2), 123–141.CrossRef
2.
Chaturvedi, P., et al. (2018). Outcome of head and neck squamous cell cancers in low-resource settings: Challenges and opportunities. Otolaryngologic Clinics of North America, 51(3), 619–629.PubMedCrossRef
3.
Bray, F., et al. (2018). Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68(6), 394–424.
4.
Warnakulasuriya, S. (2009). Global epidemiology of oral and oropharyngeal cancer. Oral Oncology, 45(4–5), 309–316.PubMedCrossRef
5.
Pulte, D., & Brenner, H. (2010). Changes in survival in head and neck cancers in the late 20th and early 21st century: A period analysis. The Oncologist, 15(9), 994–1001.PubMedPubMedCentralCrossRef
6.
Sharma, J. D., et al. (2019). Head and neck squamous cell carcinoma in young adults: A hospital-based study. Indian Journal of Medical and Paediatric Oncology, 40(5), 18.
7.
Poddar, A., et al. (2019). Incidence, prevalence, and mortality associated with head and neck cancer in India: Protocol for a systematic review. Indian Journal of Cancer, 56(2), 101.PubMedCrossRef
8.
Patel, U. A., et al. (2006). Advanced stage of head and neck cancer at a tertiary-care county hospital. The Laryngoscope, 116(8), 1473–1477.PubMedCrossRef
9.
Prabhash, K., et al. (2020). Indian clinical practice consensus guidelines for the management of squamous cell carcinoma of head and neck. Indian Journal of Cancer, 57(5), 1.CrossRef
10.
Cleeland, C. S., Sloan, J. A., & A.O. Group. (2010). Assessing the symptoms of cancer using patient-reported outcomes (ASCPRO): Searching for standards. Journal of Pain and Symptom Management, 39(6), 1077–1085.PubMedCrossRef
11.
Cleeland, C. S. (2007). Symptom burden: Multiple symptoms and their impact as patient-reported outcomes. Journal of the National Cancer Institute Monographs, 2007(37), 16–21.CrossRef
12.
Chassany, O., et al. (2002). Patient-reported outcomes: The example of health-related quality of life—a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Information Journal, 36(1), 209–238.CrossRef
13.
Wong, K. C., & Wang, Z. (2008). Importance of native language in a population-based health survey among ethnic Chinese in Australia. Australian and New Zealand Journal of Public Health, 32(4), 322–324.PubMedCrossRef
14.
Castles, S. (2000). International migration at the beginning of the twenty-first century: Global trends and issues. International Social Science Journal, 52(165), 269–281.CrossRef
15.
Le Gal, M., et al. (2010). Linguistic validation of six patient-reported outcomes instruments into 12 languages for patients with fibromyalgia. Joint, Bone, Spine, 77(2), 165–170.CrossRef
16.
Acquadro, C., et al. (2018). Emerging good practices for translatability assessment (TA) of patient-reported outcome (PRO) measures. Journal of Patient-Reported Outcomes, 2(1), 8.PubMedCentralCrossRef
17.
Skevington, S. M. (2002). Advancing cross-cultural research on quality of life: Observations drawn from the WHOQOL development. Quality of Life research, 11(2), 135–144.PubMedCrossRef
18.
Gunn, G. B., et al. (2012). Linguistic validation of the Greek MD Anderson symptom inventory–head and neck module. Forum of clinical oncology. NIH Public Access.
19.
Guillemin, F., Bombardier, C., & Beaton, D. (1993). Cross-cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines. Journal of Clinical Epidemiology, 46(12), 1417–1432.PubMedCrossRef
20.
Beaton, D. E., et al. (2000). Guidelines for the process of cross-cultural adaptation of self-report measures. Spine, 25(24), 3186–3191.PubMedCrossRef
21.
Skevington, S. M., Sartorius, N., & Amir, M. (2004). Developing methods for assessing quality of life in different cultural settings. Social Psychiatry and Psychiatric Epidemiology, 39(1), 1–8.PubMedCrossRef
22.
Kuliś, D., et al. (2017). EORTC quality of life group translation procedure. EORTC.
23.
Acquadro, C., et al. (2004). Linguistic validation manual for patient-reported outcomes (PRO) instruments. Mapi Research Institute.
24.
Flaherty, J. A., et al. (1988). Developing instruments for cross-cultural psychiatric research. Journal of Nervous and Mental Disease, 176(5), 257–263.CrossRefPubMed
25.
Nilsen, M. L., et al. (2019). Burden of treatment: Reported outcomes in a head and neck cancer survivorship clinic. The Laryngoscope, 129(12), E437–E444.PubMedCrossRef
26.
Terrell, J. E., et al. (2004). Clinical predictors of quality of life in patients with head and neck cancer. Archives of Otolaryngology-Head & Neck Surgery, 130(4), 401–408.CrossRef
27.
Gorman, L. M. (1998). The psychosocial impact of cancer on the individual, family, and society. Psychosocial nursing care along the cancer continuum, pp. 3–25.
28.
Holland, J. C. (2003). American Cancer Society Award lecture. Psychological care of patients: Psycho-oncology’s contribution. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 21(23 Suppl), 253.CrossRef
29.
30.
Kumar, C. S., & Parashar, N. (2015). Death anxiety, coping and spirituality among cancer patients. Indian Journal of Positive Psychology, 6(3), 291.
31.
Yadav, P., et al. (2019). Prevalence of depressive disorders among head-and-neck cancer patients: A hospital-based, cross-sectional study. Indian Journal of Psychiatry, 61(4), 409.PubMedPubMedCentralCrossRef
32.
33.
Sundaram, C. S., et al. (2019). A systematic review of body image measures for people diagnosed with head and neck cancer (HNC). Supportive Care in Cancer, 27, 3657–3666.CrossRef
34.
Shunmugasundaram, C., et al. (2020). What are the optimal measures to identify anxiety and depression in people diagnosed with head and neck cancer (HNC): A systematic review. Journal of Patient-Reported Outcomes, 4, 1–14.CrossRef
35.
Clerehan, R., Buchbinder, R., & Moodie, J. (2005). A linguistic framework for assessing the quality of written patient information: Its use in assessing methotrexate information for rheumatoid arthritis. Health Education Research, 20(3), 334–344.PubMedCrossRef
36.
Halliday, M. (1994). Machine translation: An introduction to functional grammar. Arnold.
37.
Meyer, C. F. (1989). Language, context, and text: Aspects of language in a social-semiotic perspective.
38.
Postal, P. M. (1968). Aspects of phonological theory. Harper & Row.
39.
Silverstein, M. (1972). Linguistic theory: Syntax, semantics, pragmatics. Annual Review of Anthropology, 1(1), 349–382.CrossRef
40.
Acquadro, C., et al. (2008). Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. Value in Health, 11(3), 509–521.PubMedCrossRef
41.
Leidy, N. K., & Vernon, M. (2008). Perspectives on patient-reported outcomes. PharmacoEconomics, 26(5), 363–370.PubMedCrossRef
42.
Worthington, R. P., & Gogne, A. (2011). Cultural aspects of primary healthcare in India: A case-based analysis. Asia Pacific Family Medicine, 10(1), 8.PubMedPubMedCentralCrossRef
43.
Barthakur, M. S., et al. (2017). Body image and sexuality in women survivors of breast cancer in India: Qualitative findings. Indian Journal of Palliative Care, 23(1), 13.PubMedPubMedCentralCrossRef
44.
Chaturvedi, S. K., et al. (2014). Communication in cancer care: psycho-social, interactional, and cultural issues. A general overview and the example of India. Frontiers in Psychology, 5, 1332.PubMedPubMedCentralCrossRef
45.
Fallowfield, L., & Jenkins, V. (1999). Effective communication skills are the key to good cancer care. European Journal of Cancer, 35(11), 1592–1597.PubMedCrossRef
46.
Saxena, S., Chandiramani, K., & Bhargava, R. (1998). WHOQOL-Hindi: A questionnaire for assessing quality of life in health care settings in India. National Medical Journal of India, 11, 160–165.PubMed
47.
D’cruz, A., et al. (2007). Validation of the University of Washington quality of life questionnaires for head and neck cancer patients in India. Indian Journal of Cancer, 44(4), 147.PubMedCrossRef
48.
Parmar, V., et al. (2005). Validation of EORTC quality-of-life questionnaire in Indian women with operable breast cancer. National Medical Journal of India, 18(4), 172.PubMed
49.
Chaukar, D., et al. (2005). Quality of life of head and neck cancer patient: Validation of the European Organization for Research and Treatment of Cancer QLQ-C30 and European Organization for Research and Treatment of Cancer QLQ-H&N35 in Indian patients. Indian Journal of Cancer, 42(4), 178.PubMed
50.
Investigators, F. (2011). Fluid lavage of open wounds (FLOW): A multicenter, blinded, factorial pilot trial comparing alternative irrigating solutions and pressures in patients with open fractures. Journal of Trauma and Acute Care Surgery, 71(3), 596–606.CrossRef
51.
Leyland-Jones, B., et al. (2015). Abstract S5–07: A randomized, open-label, multicenter, phase 3 study of epoetin alfa (EPO) plus standard supportive care versus standard supportive care in anemic patients with metastatic breast cancer (MBC) receiving standard chemotherapy. AACR.
52.
Reck, M., et al. (2014). Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): A phase 3, double-blind, randomised controlled trial. The Lancet Oncology, 15(2), 143–155.PubMedCrossRef
53.
Mehrotra, S. (2008). Psycho-oncology research in India: Current status and future directions. Journal of the Indian Academy of Applied Psychology, 34(1), 7–18.
54.
55.
Albach, C. A., Wagland, R., & Hunt, K. J. (2018). Cross-cultural adaptation and measurement properties of generic and cancer-related patient-reported outcome measures (PROMs) for use with cancer patients in Brazil: A systematic review. Quality of Life Research, 27(4), 857–870.PubMedCrossRef
Metagegevens
Titel
Enabling cross-cultural data pooling in trials: linguistic validation of head and neck cancer measures for Indian patients
Auteurs
Chindhu Shunmugasundaram
Haryana M. Dhillon
Phyllis N. Butow
Puma Sundaresan
Claudia Rutherford
Publicatiedatum
02-04-2021
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 9/2021
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-021-02837-x

Andere artikelen Uitgave 9/2021

Quality of Life Research 9/2021 Naar de uitgave

Correction

Correction to: Financial difficulties and patient‑reported outcomes among patients with advanced heart failure

OriginalPaper

The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)—a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer

OriginalPaper

Impact of Moringa Oleifera leaves supplementation on quality of life of people living with HIV: A double-blind randomized controlled trial

OriginalPaper

Psychometric properties of the Dutch-Flemish PROMIS® pediatric item banks Anxiety and Depressive Symptoms in a general population

OriginalPaper

Diabetes and health-related quality of life among American Indians: the role of psychosocial factors

OriginalPaper

The association between nonrestorative sleep and health-related quality of life in Chinese adults: a cross-sectional study