International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome and experience measure for hand conditions (HAND-Q)

Kyra Sierakowski, Nicola R Dean, Andrea L Pusic, Stefan J Cano, Philip A Griffin, Gregory I Bain, Anne Klassen, Donald Lalonde, Kyra Sierakowski, Nicola R Dean, Andrea L Pusic, Stefan J Cano, Philip A Griffin, Gregory I Bain, Anne Klassen, Donald Lalonde

Abstract

Introduction: patient-reported outcome measures (PROMs) are instruments used to measure outcomes and experiences of healthcare from the patient perspective. The specific methodology used to develop a PROM should be communicated to establish the quality of the instrument. This mixed methods protocol describes the development of a cross-cultural, internationally applicable PROM for hand conditions, the HAND-Q.

Methods and analysis: The multiphase approach used for this study has been previously used with the development of other PROMs by our team (eg, BODY-Q, BREAST-Q, CLEFT-Q, FACE-Q). In Phase I, we establish what important concepts matter to patients with hand conditions. A conceptual framework is developed from a systematic review of existing PROMs in the field and an extensive international qualitative study. Interpretive description is the qualitative approach used. Item generation is based on the qualitative data. The preliminary scales will be created for each theme identified in the conceptual framework. These scales will be refined by cognitive debriefing interviews with participants and expert input. Phase II involves a large international sample of patients with varied hand conditions completing the field-test version of the HAND-Q. The scales will be refined using the modern psychometric approach of Rasch Measurement Theory. Analysis will result in a shortened set of clinically meaningful and scientifically robust HAND-Q scales.

Ethics and dissemination: This study is coordinated at Flinders University (Adelaide, Australia) where it has ethics board approval for phase I and phase II. Findings will be published in peer-reviewed journals and presented at local, national and international conferences.

Keywords: patient reported outcome measures; psychometrics; qualitative research.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow diagram illustrating the multiphase mixed methods approach to the development of the HAND-Q. QUAN, quantitative study component; QUAL, qualitative study component. Image reproduced from Wong Riff et al.

References

    1. Porter ME. What is value in health care?. N Engl J Med 2010;363:2477–81. 10.1056/NEJMp1011024
    1. Coronini-Cronberg S, Appleby J, Thompson J. Application of patient-reported outcome measures (PROMs) data to estimate cost-effectiveness of hernia surgery in England. J R Soc Med 2013;106:278–87. 10.1177/0141076813489679
    1. U.S. Department of Health and Human Services Food and Drug Administration. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009:65132–3.
    1. Aaronson N, Alonso J, Burnam A, Lohr KN, et al. . Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res 2002;11:193–205. 10.1023/A:1015291021312
    1. Wong Riff KW, Tsangaris E, Goodacre T, et al. . International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome instrument for children and young adults with cleft lip and/or palate (CLEFT-Q). BMJ Open 2017;7:e015467 10.1136/bmjopen-2016-015467
    1. Mokkink LB, Terwee CB, Patrick DL, et al. . The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res 2010;19:539–49. 10.1007/s11136-010-9606-8
    1. Leblanc MR, Lalonde J, Lalonde DH. A detailed cost and efficiency analysis of performing carpal tunnel surgery in the main operating room versus the ambulatory setting in Canada. Hand 2007;2:173–8. 10.1007/s11552-007-9043-5
    1. Thoma A, Strumas N, Rockwell G, et al. . The use of cost-effectiveness analysis in plastic surgery clinical research. Clin Plast Surg 2008;35:285–96. 10.1016/j.cps.2007.10.012
    1. Lalonde DH. Wide-awake flexor tendon repair. Plast Reconstr Surg 2009;123:623–5. 10.1097/PRS.0b013e318195664c
    1. Van Demark RE, Smith VJS, Fiegen A. Lean and Green Hand Surgery. J Hand Surg Am 2018;43:179–81. 10.1016/j.jhsa.2017.11.007
    1. Rhee PC, Fischer MM, Rhee LS, et al. . Cost Savings and Patient Experiences of a Clinic-Based, Wide-Awake Hand Surgery Program at a Military Medical Center: A Critical Analysis of the First 100 Procedures. J Hand Surg Am 2017;42 10.1016/j.jhsa.2016.11.019
    1. Cano SJ, Browne JP, Lamping DL, et al. . The Patient Outcomes of Surgery-Hand/Arm (POS-Hand/Arm): a new patient-based outcome measure. J Hand Surg Br 2004;29:477–85. 10.1016/J.JHSB.2004.06.002
    1. Macey AC, Burke FD, Abbott K, et al. . Outcomes of Hand Surgery. J Hand Surg Am 1995;20:841–55. 10.1016/S0266-7681(95)80059-X
    1. Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med 1996;29:602–8. 10.1002/(SICI)1097-0274(199606)29:6<602::AID-AJIM4>;2-L
    1. Chung KC, Pillsbury MS, Walters MR, et al. . Reliability and validity testing of the michigan hand outcomes questionnaire. J Hand Surg Am 1998;23:575–87. 10.1016/S0363-5023(98)80042-7
    1. Roh YH, Yang BK, Noh JH, et al. . Cross-cultural adaptation and validation of the Korean version of the Michigan hand questionnaire. J Hand Surg Am 2011;36:1497–503. 10.1016/j.jhsa.2011.06.006
    1. Öksüz Ç, Akel BS, Oskay D, et al. . Cross-cultural adaptation, validation, and reliability process of the Michigan Hand Outcomes Questionnaire in a Turkish population. J Hand Surg Am 2011;36:486–92. 10.1016/j.jhsa.2010.11.016
    1. Schønnemann JO, Larsen K, Hansen TB, et al. . Reliability and validity of the Danish version of the disabilities of arm, shoulder, and hand questionnaire in patients with fractured wrists. J Plast Surg Hand Surg 2011;45:35–9. 10.3109/2000656X.2011.554708
    1. Germann G, Harth A, Wind G, et al. . [Standardisation and validation of the German version 2.0 of the Disability of Arm, Shoulder,Hand (DASH) questionnaire]. Unfallchirurg 2003;106:13–19. 10.1007/s00113-002-0456-x
    1. Wild D, Grove A, Martin M, 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. Value Health 2005;8:94–104. 10.1111/j.1524-4733.2005.04054.x
    1. WHO (World Health Organization). Process of translation and adaptation of instruments.
    1. Patrick DL, Burke LB, Gwaltney CJ, et al. . Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1-eliciting concepts for a new PRO instrument. Value Health 2011;14:967–77. 10.1016/j.jval.2011.06.014
    1. Patrick DL, Burke LB, Gwaltney CJ, et al. . Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2-assessing respondent understanding. Value Health 2011;14:978–88. 10.1016/j.jval.2011.06.013
    1. Reeve BB, Wyrwich KW, Wu AW, et al. . ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res 2013;22:1889–905. 10.1007/s11136-012-0344-y
    1. Zywiel MG, Mahomed A, Gandhi R, et al. . Measuring expectations in orthopaedic surgery: a systematic review. Clin Orthop Relat Res 2013;471:3446–56. 10.1007/s11999-013-3013-8
    1. Sierakowski K, Evans Sanchez KA, Damarell RA, et al. . Measuring Quality of Life & Patient Satisfaction in Hand Conditions: A systematic review of currently available patient reported outcome instruments. Australasian Journal of Plastic Surgery. In Press 2018.
    1. Thorne S, Kirkham SR, MacDonald-Emes J. Interpretive description: A noncategorical qualitative alternative for developing nursing knowledge. Res Nurs Health 1997;20:169–77. 10.1002/(SICI)1098-240X(199704)20:2<169::AID-NUR9>;2-I
    1. Thorne S, Kirkham SR, MacDonald-Emes J. Interpretive description: a noncategorical qualitative alternative for developing nursing knowledge. Res Nurs Health 1997;20:169–77. 10.1002/(SICI)1098-240X(199704)20:2<169::AID-NUR9>;2-I
    1. Welford C, Murphy K, Casey D. Demystifying nursing research terminology. Part 1. Nurse Res 2011;18:38–43. 10.7748/nr2011.07.18.4.38.c8635
    1. Sandelowski M. Theoretical Saturation Given LM, The SAGE Encyclopedia of Qualitative Research Methods. Thousand Oaks: SAGE Publications, Inc, 2008.
    1. Pope C, Ziebland S, Mays N. Analysing qualitative data. BMJ 2000;320:114.
    1. Cohen DJ, Crabtree BF. Evaluative criteria for qualitative research in health care: controversies and recommendations. Ann Fam Med 2008;6:331–9. 10.1370/afm.818
    1. Collins D. Pretesting survey instruments: an overview of cognitive methods. Qual Life Res 2003;12:229–38. 10.1023/A:1023254226592
    1. Van Someren M, Barnard Y, Sandberg J. The think aloud method: a practical approach to modelling cognitive, 1994.
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. G R. Studies in mathematical psychology: 1. In: Institut. Dp, editor, 1960.
    1. Cano SJ, Hobart JC. The problem with health measurement. Patient Prefer Adherence 2011;5:279–90. 10.2147/PPA.S14399
    1. Hobart J, Cano S. Improving the evaluation of therapeutic interventions in multiple sclerosis: the role of new psychometric methods: Prepress Projects, 2009.
    1. Cano SJ, Klassen A, Pusic AL. The science behind quality-of-life measurement: a primer for plastic surgeons. Plast Reconstr Surg 2009;123:98e–106. 10.1097/PRS.0b013e31819565c1
    1. Pallant JF, Tennant A. An introduction to the Rasch measurement model: an example using the Hospital Anxiety and Depression Scale (HADS). Br J Clin Psychol 2007;46:1–18. 10.1348/014466506X96931
    1. Strauss ME, Smith GT. Construct validity: advances in theory and methodology. Annu Rev Clin Psychol 2009;5:1–25. 10.1146/annurev.clinpsy.032408.153639
    1. Mokkink LB, Terwee CB, Knol DL, et al. . The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol 2010;10:22 10.1186/1471-2288-10-22

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