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Table 2 PROM usage and translations available in the multi-national studies

From: Systematic review of the use of translated patient-reported outcome measures in cancer trials

Reference

Number of sites and (number of countries) examples of recruiting countries

PRO endpoint

PROM data collected

Number of translated versions of PROM available and examples

Use of translated PROM reported

Armstrong et al. [19]

17 (3) USA, Canada, and UK

Secondary

FKSI-15a

35 (Hindi, Chinese, Arabic, Thai)

No

Yao et al. [20]

97 (25) Europe, Japan, South Korea

Secondary

FACT-Gb

71 (Italian, Japanese, Korean)

No

Schöffski et al., primary paper [21]

Hudgens et al., quality of life paper [22]

110 (22) USA, Western Europe, Asia, Eastern Europe

Exploratory

QLQ C-30a

EQ-5Da

93 (Spanish, Hindi, Mandarin)

180 (Spanish, Thai, Malaysian)

No

O’Shaughnessy et al. [23]

Approximately 65 North America, Europe, and Asia

Secondary

EORTC-C30b

EQ-5D-5Lb

BPI-SFb

99 (Bengali, Malay, Mandarin)

170 (Spanish, Serbian, Simplified Chinese)

52 (Simplified Chinese, Malay, French)

No

Senan et al. [24]

125 (21) NS

Secondary

Swallowing diaryb

Not known

No

Ryan et al. [25]

113 (19) NS

Secondary

EORTC QLQ-C30b

EQ-5Db

99 (Bengali, Malay, Mandarin)

180 (Spanish, Thai, Malaysian)

No

Verma et al., primary paper [26]

Welslau et al., secondary paper [27]

213 (26) Uk, South Korea, Germany

Secondary

Exploratory

FACT-B – TOI-PFBa [26, 27]a

DASa [27]a

56 (Urdu, Afrikaans, Hindi)

(not known)

Consent form and other written information translated (when applicable)b

Escudier et al. [28]

Multi-centre, (NS)

Secondary

Exploratory

FACIT-Fatiguea

EQ-5Da

SQLQa

Bespoke questionnaire adapted from OMDQ

64 (Vietnamese, Punjabi, Chinese)

180 (Spanish, Thai, Malaysian)

Not known

Not known

No

  1. NS, not stated; PROM Abbreviations: BPI-SF, Brief Pain Inventory – Short Form; DAS, Diarrhoea Assessment Scale; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer core quality of life—additional specific cancer modules include QLQ-EN24 (endometrial cancer) and QLQ-HDC29 (high-dose chemotherapy); EQ-5D-5L, Euro-Qol quality of life questionnaire; FACIT, Functional Assessment of Cancer Therapy includes a range of measures including FACT-B Breast Cancer module Scale, FACT-B TOI-PFB Trial Outcome Index Physical/Functional/Breast, FACIT-Fatigue Fatigue, FACT-G General, and FKSI-15 Kidney Symptom Index-15 items; HAD, Hospital Anxiety and Depression; KPS, Karnofksy Performance Status scale; OMDQ, Oral Mucositis Daily Questionnaire; MAT, MASCC Antiemesis Tool; MFI, Multidimensional Fatigue Inventory; RI, Rhodes Index of Nausea, Vomiting and Retching SDI-21 Social Difficulties Index; STAI-S, State Trait Anxiety Inventory; SQLQ, Supplementary quality of life questionnaire
  2. aReported in the paper, bstated in the protocol