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Danish translation and validation of the Geriatric 8 and the modified Geriatric 8 screening tools

  • Author Footnotes
    1 Joint first authors.
    Helena Møgelbjerg Ditzel
    Correspondence
    Corresponding author at: Odense University Hospital, Department of Oncology, Indgang 85, pavillon 1. sal, Kløvervænget 19, 5000 Odense C, Denmark.
    Footnotes
    1 Joint first authors.
    Affiliations
    Department of Oncology, Odense University Hospital, Odense, Denmark

    Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark
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  • Author Footnotes
    1 Joint first authors.
    Ann-Kristine Weber Giger
    Footnotes
    1 Joint first authors.
    Affiliations
    Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark

    Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark
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  • Agon Olloni
    Affiliations
    Department of Oncology, Odense University Hospital, Odense, Denmark

    Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark
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  • Kristoffer Kittelmann Brockhattingen
    Affiliations
    Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark
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  • Cecilia Margareta Lund
    Affiliations
    Department of Clinical Medicine, Copenhagen University Hospital, Herlev-Gentofte, Denmark

    Department of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, Copenhagen, Denmark
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  • Henrik Jørn Ditzel
    Affiliations
    Department of Oncology, Odense University Hospital, Odense, Denmark

    Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark
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  • Per Pfeiffer
    Affiliations
    Department of Oncology, Odense University Hospital, Odense, Denmark

    Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark
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  • Marianne Ewertz
    Affiliations
    Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark
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  • Jesper Ryg
    Affiliations
    Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark

    Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark
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  • Trine Lembrecht Jørgensen
    Affiliations
    Department of Oncology, Odense University Hospital, Odense, Denmark

    Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark
    Search for articles by this author
  • Author Footnotes
    1 Joint first authors.
Open AccessPublished:July 21, 2022DOI:https://doi.org/10.1016/j.jgo.2022.07.004

      Keywords

      1. Introduction

      Almost 50% of patients with cancer are diagnosed after the age of seventy, which has fueled geriatric oncology research. [
      • Ewertz M.
      • Christensen K.
      • Engholm G.
      • Kejs A.M.
      • Lund L.
      • Matzen L.E.
      • et al.
      Trends in cancer in the elderly population in Denmark, 1980-2012.
      ] Many investigations have underlined the importance of a comprehensive geriatric assessment (CGA) in older patients prior to oncologic treatment to improve treatment decisions and perform non-oncologic interventions. [
      • Lund C.M.
      • Vistisen K.K.
      • Olsen A.P.
      • Bardal P.
      • Schultz M.
      • Dolin T.G.
      • et al.
      The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO).
      ,
      • Mohile S.G.
      • Mohamed M.R.
      • Xu H.
      • Culakova E.
      • Loh K.P.
      • Magnuson A.
      • et al.
      Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study.
      ].
      The Geriatric 8 (G8) and the modified G8 (mG8) are health-care personnel-administered frailty screening tools increasingly used in oncology to identify older individuals with potential frailty through a short questionnaire easily implemented in research and clinical practice. [
      • Bellera C.A.
      • Rainfray M.
      • Mathoulin-Pélissier S.
      • Mertens C.
      • Delva F.
      • Fonck M.
      • et al.
      Screening older cancer patients: first evaluation of the G-8 geriatric screening tool.
      ,
      • Decoster L.
      • Van Puyvelde K.
      • Mohile S.
      • Wedding U.
      • Basso U.
      • Colloca G.
      • et al.
      Screening tools for multidimensional health problems warranting a geriatric assessment in older cancer patients: an update on SIOG recommendations†.
      ,
      • Martinez-Tapia C.
      • Canoui-Poitrine F.
      • Bastuji-Garin S.
      • Soubeyran P.
      • Mathoulin-Pelissier S.
      • Tournigand C.
      • et al.
      Optimizing the G8 screening tool for older patients with cancer: diagnostic performance and validation of a six-item version.
      ] Furthermore, they illuminate potential health concerns, which may otherwise go unidentified using the traditional Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), and can affect tolerability and treatment outcomes.
      The G8 consists of eight questions (scores from 0 to 17, frailty at ≤14) [
      • Bellera C.A.
      • Rainfray M.
      • Mathoulin-Pélissier S.
      • Mertens C.
      • Delva F.
      • Fonck M.
      • et al.
      Screening older cancer patients: first evaluation of the G-8 geriatric screening tool.
      ] and has demonstrated high sensitivity (85%) while maintaining good specificity (64%) in predicting CGA frailty. [
      • Garcia M.V.
      • Agar M.R.
      • Soo W.K.
      • To T.
      • Phillips J.L.
      Screening tools for identifying older adults with cancer who may benefit from a geriatric assessment: a systematic review.
      ,
      • van Walree I.C.
      • Scheepers E.
      • van Huis-Tanja L.
      • Emmelot-Vonk M.H.
      • Bellera C.
      • Soubeyran P.
      • et al.
      A systematic review on the association of the G8 with geriatric assessment, prognosis and course of treatment in older patients with cancer.
      ] The G8 has demonstrated a strong correlation between frailty and decreased survival as well as increased treatment toxicity, providing substantial clinical value. [
      • van Walree I.C.
      • Scheepers E.
      • van Huis-Tanja L.
      • Emmelot-Vonk M.H.
      • Bellera C.
      • Soubeyran P.
      • et al.
      A systematic review on the association of the G8 with geriatric assessment, prognosis and course of treatment in older patients with cancer.
      ]
      The mG8 consists of only six items (scores from 0 to 35, frailty at ≥6) [
      • Martinez-Tapia C.
      • Canoui-Poitrine F.
      • Bastuji-Garin S.
      • Soubeyran P.
      • Mathoulin-Pelissier S.
      • Tournigand C.
      • et al.
      Optimizing the G8 screening tool for older patients with cancer: diagnostic performance and validation of a six-item version.
      ] with an even higher sensitivity (87%) and specificity (89%) than the G8. [
      • van Walree I.C.
      • Scheepers E.
      • van Huis-Tanja L.
      • Emmelot-Vonk M.H.
      • Bellera C.
      • Soubeyran P.
      • et al.
      A systematic review on the association of the G8 with geriatric assessment, prognosis and course of treatment in older patients with cancer.
      ]
      Multiple Danish studies have used the G8, [
      • Lund C.M.
      • Vistisen K.K.
      • Olsen A.P.
      • Bardal P.
      • Schultz M.
      • Dolin T.G.
      • et al.
      The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO).
      ,
      • Winther S.B.
      • Liposits G.
      • Skuladottir H.
      • Hofsli E.
      • Shah C.H.
      • Poulsen L.
      • et al.
      Reduced-dose combination chemotherapy (S-1 plus oxaliplatin) versus full-dose monotherapy (S-1) in older vulnerable patients with metastatic colorectal cancer (NORDIC9): a randomised, open-label phase 2 trial.
      ,
      • Ørum M.
      • Jensen K.
      • Gregersen M.
      • Meldgaard P.
      • Damsgaard E.M.
      Impact of comprehensive geriatric assessment on short-term mortality in older patients with cancer-a follow-up study.
      ,
      • Jespersen E.
      • Winther S.B.
      • Minet L.R.
      • Möller S.
      • Pfeiffer P.
      Frailty screening for predicting rapid functional decline, rapid progressive disease, and shorter overall survival in older patients with gastrointestinal cancer receiving palliative chemotherapy - a prospective, clinical study.
      ] whereas only a few studies have investigated the mG8. However, Danish translation and validation has not been conducted for either tool.
      Herein, we report a Danish linguistic translation and validation of the G8 and the mG8.

      2. Materials and Methods

      The translation was conducted using the Professional Society for Health Economics and Outcomes Research (ISPOR) 10-step principles of good practice for the translation and cultural adaptation of patient-reported outcome measures. [
      • Wild D.
      • Grove A.
      • Martin M.
      • Eremenco S.
      • McElroy S.
      • Verjee-Lorenz A.
      • et al.
      Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR task force for translation and cultural adaptation.
      ] (Fig. 1.)
      Fig. 1
      Fig. 1Flow Chart of the Danish Translation and Validation of the Geriatric 8 and Modified Geriatric 8.
      Footnote: Geriatric 8 (G8), modified Geriatric 8 (mG8).

      2.1 Preparation

      The original authors of the G8 and mG8 authorized translation of each tool from the source language, English, to Danish. (Fig. 1).
      As both tools contain medical terminology, medical insight was required to achieve the most accurate translation. An expert panel of four physicians (two residents in Oncology, HD and AO, and two in Geriatrics, AG and KB) fluent in both languages was assembled. Three panelists were Danish native speakers, practicing academic level English, while one was an English native speaker practicing academic level Danish. The two panelists in charge of forward translation had background knowledge of both tools.

      2.2 Forward Translation and Reconciliation

      HD and AG individually translated each source material and subsequently compared these in a side-by-side review. Inconsistencies were reconciled until a mutually agreed-upon target language translation was attained (G8-DK version 1.3; mG8-DK version 1.3).

      2.3 Backward Translation and Review

      AO and KB individually translated the reconciled Danish translations back into English (G8 version 2.1 & 2.2; mG8 version 2.1 & 2.2). Backward translation review was, thereafter, carried out by the expert panel, reviewing each screening tool individually. The backward translation of each screening tool was compared to the source material to ensure the conceptual equivalence of the translation.

      2.4 Harmonization

      Harmonization was omitted as Danish is the only official language in the Kingdom of Denmark and consists of a homogeneous national norm of speech. [
      • Pedersen I.
      Traditional dialects of Danish and the de-dialectalization 19002000.
      ].

      2.5 Cognitive Debriefing

      Cognitive debriefing was conducted by interviewing two oncological physicians and five nurses to ensure that the Danish translation of both tools was cognitively equivalent to the source material, to identify potentially conceptually unsuitable items, to test potentially unresolved translation alternatives, and to highlight issues that cause confusion in clinical practice. All interviewees were native Danish speakers except one, and had no prior experience using either screening tool.
      The translated G8-DK version 3.1 and mG8-DK version 3.1 were completed during seven individual oncologic out-patient consultations and was observed by an interviewer (HD or AK). Observations regarding questionnaire completion were noted and included in the interview, directly following the patient consultation.
      Cognitive debriefing interviews utilized predefined areas of interest including comprehensibility, interpretation, concerns, structural setup, and additional comments. Questions were predominately open-ended and posed independently for each translated screening tool, with answers transcribed during the interview. (Supplementary Material).

      2.6 Cognitive Debriefing Review and Finalization

      Concerns mentioned by more than one interviewee, and deemed significant by unanimous vote by the expert panel, were included in the translated version prior to implementation (G8-DK version 4.1; mG8-DK version 4.1).

      2.7 Proofreading and Final Report

      Proofreading was carried out by AG and HD, correcting minor errors before finalization (G8-DK version 5.1; mG8-DK version 5.1, Supplementary Figs. 1 & 2). The final translational report was completed, containing the translation log, the various translation versions and authors, and cognitive debriefing interviews (Supplementary Material).

      3. Results

      A total of fourteen items were translated (G8: eight items, mG8: six items) with two items (Item C and H) from the G8, and two items (Items 3 and 6) from the mG8 requiring specific linguistic attention.
      Translational discrepancies were grouped into two categories; (1) problems related to language, vocabulary, or cultural differences and (2) a lack of matching definition. (Table 1) [
      • Blomqvist I.
      • Chaplin J.E.
      • Nilsson E.
      • Henje E.
      • Dennhag I.
      Swedish translation and cross-cultural adaptation of eight pediatric item banks from the patient-reported outcomes measurement information system (PROMIS)(®).
      ] Synonymous word choice without variation in intensity was not considered problematic.
      Table 1Translational discrepancies for the Geriatric 8 and Modified Geriatric 8.
      Table thumbnail fx1
      Footnote: Geriatric 8 (G8), modified Geriatric 8 (mG8).

      3.1 Forward Translation and Reconciliation

      Only a few minor discrepancies were identified with full agreement on the most accurate translation.

      3.1.1 G8

      When translating Item H, the word “medications” was translated to “slags medicin” i.e., “types of medications” and “receptpligte lægemidler” i.e., “prescription medications,” highlighting the unclear understanding of the word medications and its inclusion of non-prescription medicine. It was decided that specifying this would potentially affect the comparability of the translation and therefore, the ambiguous translation “types of medications” was used.

      3.1.2 mG8

      Like most other items, Item 5: PS was primarily directly translated as PS has not been linguistically validated in Danish. However, the word “disabled” has no direct translation and roughly translates to the word “handicapped.” As in English, “handicapped” is highly stigmatizing and includes various degrees of handicap. To solve this category 2 issue, a descriptive translation inspired by various non-validated translations of PS was chosen.

      3.2 Backward Translation and Review

      One backward translator used a more literal translational methodology and the other a more conceptual methodology. Through the backward translation review, it was found that a more literal translation was often more congruent with the source material.

      3.2.1 G8

      Backward translation review showed one category 2 issue within the translation of Item C: Mobility. The term “goes out” left much to interpretation as it can be understood as having the functional capability of going out of door or spending time outdoors e.g., shopping on a regular basis. This led to incongruent backward translations.

      3.2.2 MG8

      Likewise, backward translation review showed a category 2 issue in Item 6: Heart Failure. Coronary artery disease was reconciled to the Danish laymen's term “hjertekarsygdomme,” however, one of the backward translators had directly translated this to “cardiovascular disease,” which encompasses both cardio and vascular diseases. The more accurate medical term “Coronary artery disease,” i.e., “koronararterie sygdomme” was therefore chosen, as the screening tool will be utilized by healthcare professionals.

      3.3 Cognitive Debriefing and Review

      3.3.1 G8

      During cognitive debriefing review, the reconciled forward translation of Item C: “Goes Out” i.e., “kommer ud” was further changed to “færdes ude” i.e., “spending time outdoors regularly,” as this had been the source of much confusion during cognitive debriefing. This was universally accepted by the expert panel, as it was congruent with the validated Danish translation of the Mini Nutritional Assessment (MNA), on which the G8 is based.

      3.3.2 MG8

      No issues were identified.

      4. Discussion

      We successfully translated and validated the geriatric oncology screening tools, the G8 and mG8, into Danish. Due to the limited number of items in each screening tool, unanimous agreement was easily achieved during reconciliation and review.
      The ISPOR quality assurances guidelines were used to provide scientific transparency [
      • Pedersen I.
      Traditional dialects of Danish and the de-dialectalization 19002000.
      ]. Although intended for patient-reported outcome questionnaires, these guidelines are widely used in translational studies.
      The harmonization step in the ISPOR guidelines was omitted, thus, it can be argued that our translation is similar to the Functional Assessment of Chronic Illness Therapy translational methodology. [
      • Eremenco S.L.
      • Cella D.
      • Arnold B.J.
      A comprehensive method for the translation and cross-cultural validation of health status questionnaires.
      ] However, this methodology does not include cognitive debriefing, which was vital in our validation process.
      Cognitive debriefing was carried out in a representative clinical setting. This face validation highlighted the practical interpretation of each tool and led to important linguistic changes to the Danish translation of the G8. Per ISPOR recommendations, interviewees were native speakers, with one exception. As this medical professional utilized Danish on a layman and academic level daily, and given the simplicity of both screening tools, this was deemed of no consequence.
      Other than age, the G8 contains seven items from the MNA, while the mG8 contains three. The MNA has been linguistically validated in both Danish and French, and was consulted during the cognitive debriefing review. However, it is unclear whether the remaining items were originally developed in French or English, as printed in the source material. To our knowledge, the remaining items have not been linguistically translated into English or validated with native English speakers. Furthermore, PS has not been linguistically validated in Danish nor French.
      Numerous Danish geriatric oncology studies are underway intending to use the G8 and mG8. Thus, this translational study comes at an essential point of geriatric oncology research and is expected to be much employed in future research as well as clinical practice.

      Ethical Approval and Consent

      Approval waived by the Danish National Committee on Health Research Ethics, as this study is purely observational, and does not fall under the Medical Research Involving Human Subjects Act.

      Patient Consent for Publication

      Not applicable.

      Data Sharing Statement

      The translational report can be found in the supplementary material. All translations have been included in the translational report, including notes from the cognitive debriefing interviews. Physician and nurse completed DK-G8 and DK-mG8 screenings conducted prior to cognitive debriefing interviews can be requested within five years of publication.

      Competing Interest Statement

      The authors declare that they have no competing interests.

      Funding Statement

      This study is supported by t he Danish Cancer Society (grant #R247-A14382 ), Academy of Geriatric Cancer Research (AgeCare) , Odense University Hospital (grant #A4352 and 98-A4453 ), the University of Southern Denmark , the Region of Southern Denmark (grant # 20/44413 ), the Research Committee for the Department of Oncology , OUH , the Dagmar Marshall Fund, and the Agnes and Poul Friis Fund (grant #81008–005 ).

      Authors' Contributions

      HMD, AKWG, JR, ME, CML, PP, TLJ, and HJD were involved in the study conceptualization. ME, HJD, TLJ, JR, HMD, and AKWG conducted funding acquisition with input from CML and PP. HMD and AKWG were in charge of project administration, methodology, and investigation. HMD, AKWG, AO, and KB conducted data curation. HMD, AKWG conducted the formal analysis with supervision by TLJ. HMD and AKWG wrote the original draft with writing review and editing byTLJ, JR, ME, CML, PP, TLJ, HJD, AO, and KB.

      Acknowledgments

      The authors acknowledge the copyright holders and developers of the source G8 and mG8, C. Bellera, P. Souberyan, and E. Audureau, for allowing translation and validation, and Lise Eckhoff, M.D., pH.D., for giving valuable advice regarding translational methodology. Furthermore, the authors would like to thank the physicians and nurses from the Department of Oncology at Odense University Hospital for participating in the cognitive debriefing of the G8-DK and mG8-DK.

      Appendix A. Supplementary Data

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