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Ophthalmology
Protocol
Preference-based disease-specific health-related quality of life instrument for glaucoma: a mixed methods study protocol
  1. Sergei Muratov1,
  2. Dominik W Podbielski2,
  3. Susan M Jack3,
  4. Iqbal Ike K Ahmed2,4,
  5. Levine A H Mitchell1,
  6. Monika Baltaziak2,
  7. Feng Xie5
  1. 1Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  2. 2Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada
  3. 3School of Nursing, McMaster University, Hamilton, Ontario, Canada
  4. 4Trillium Health Partners, Mississauga, Ontario, Canada
  5. 5Department of Clinical Epidemiology and Biostatistics, McMaster University, Research Institute of St Joseph's Hamilton, and Program for Health Economics and Outcome Measures, Hamilton, Ontario, Canada
  1. Correspondence to Dr Feng Xie; fengxie{at}mcmaster.ca

Abstract

Introduction A primary objective of healthcare services is to improve patients' health and health-related quality of life (HRQoL). Glaucoma, which affects a substantial proportion of the world population, has a significant detrimental impact on HRQoL. Although there are a number of glaucoma-specific questionnaires to measure HRQoL, none is preference-based which prevent them from being used in health economic evaluation. The proposed study is aimed to develop a preference-based instrument that is capable of capturing important effects specific to glaucoma and treatments on HRQoL and is scored based on the patients' preferences.

Methods A sequential, exploratory mixed methods design will be used to guide the development and evaluation of the HRQoL instrument. The study consists of several stages to be implemented sequentially: item identification, item selection, validation and valuation. The instrument items will be identified and selected through a literature review and the conduct of a qualitative study. Validation will be conducted to establish psychometric properties of the instrument followed by a valuation exercise to derive utility scores for the health states described.

Ethics and dissemination This study has been approved by the Trillium Health Partners Research Ethics Board (ID number 753). All personal information will be de-identified with the identification code kept in a secured location including the rest of the study data. Only qualified and study-related personnel will be allowed to access the data. The results of the study will be distributed widely through peer-reviewed journals, conferences and internal meetings.

  • QUALITATIVE RESEARCH

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-012732

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    Footnotes

    • Contributors IIKA, FX, DWP and SM conceptualised the study. All authors have contributed to its design. SM prepared the initial draft of the manuscript and circulated it among the authors for review. All authors read and approved the final manuscript.

    • Funding This study is partially funded by a grant from the Glaucoma Research Society of Canada.

    • Competing interests SM, DWP, SMJ, LAHM, MB, FX none declared; IIKA is a consultant for a number of medical and surgical companies: Aerie Pharmaceuticals, Alcon, Allergan, Envisia Therapeutics, ForSight Labs, Glaukos, InnFocus, Iridex, Ivantis, Ono Pharma, PolyActiva and Transcend Medical.

    • Ethics approval This study has been approved by the Trillium Health Partners Research Ethics Board (ID number 753). The study will be conducted in accordance with the Canadian Tri-Council Statement policy: Ethical Conduct for Research involving Humans, 2nd edition. All personal information will be de-identified with the identification code kept in a secured location apart from the rest of the study data. Only qualified and study-related personnel will be allowed to access the data. The results of the study will be distributed widely through peer-reviewed journals, conferences and internal meetings.

    • Provenance and peer review Not commissioned; externally peer reviewed.