April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
Call Centre Methodology to Collect Quality of Life (QoL) Data in a Clinical Trial: A Case Study of Patients With Neovascular Age-Related Macular Degeneration (NV-AMD)
Author Affiliations & Notes
  • J. V. Loftus
    Outcomes Research, Pfizer, Ltd, London, Walton-on-the Hill, Tadworth Surrey, United Kingdom
  • A. Pleil
    Outcomes Research, Pfizer, Inc, La Jolla, California, California
  • J. Z. Li
    Outcomes Research, Pfizer, Inc, La Jolla, California, California
  • R. Hamill
    Quintiles Ltd, Livingston, Scotland, United Kingdom
  • Footnotes
    Commercial Relationships  J.V. Loftus, Pfizer Ltd, E; A. Pleil, Pfizer Inc, E; J.Z. Li, Pfizer Inc, E; R. Hamill, Quintiles ltd, E.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 509. doi:
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      J. V. Loftus, A. Pleil, J. Z. Li, R. Hamill; Call Centre Methodology to Collect Quality of Life (QoL) Data in a Clinical Trial: A Case Study of Patients With Neovascular Age-Related Macular Degeneration (NV-AMD). Invest. Ophthalmol. Vis. Sci. 2010;51(13):509.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : QoL data are often collected in multi-centre clinical trials using self- or interviewer-administered questionnaires. The former may result in missing data or data errors; the latter requires training of interviewers at study sites and may add variability to the data collected. To overcome these shortcomings, we developed a call-centre methodology. This research reports its development and use in a multi-centre clinical trial.

Methods: : Data for this analysis were collected from a large multicenter trial, NCT00605280. An interface between the main clinical trial database and the independent Call Centre was established. Once subjects entered the trial, subject identifier, status and visit history were automatically generated and sent to the Call Centre. This alerted the Call centre Agent to contact the clinical trial database for the subject contact and visit details. The agent organised calls to the subject’s home in order to administer the questionnaires at the appropriate timepoints. Three call backs were allowed at each scheduled call to ensure questionnaire completion. All QoL responses were directly entered into the call centre database. The status of the QoL visit information and completions were sent to the clinical trial database each week.

Results: : In this NV-AMD clinical trial, the completion rate of two QoL measures (National Eye Institute Vision Function Questionnaire 25 and the EuroQol Group’s EQ-5D questionnaire) produced an almost complete dataset; 97% of all completed interviews included both questionnaires, 54% were successfully completed on the first attempt, and 25% on the second attempt of contacting the subject. Only 3% of subjects could not be contacted at all, resulting in a minimal amount of missing data. Each questionnaire took 28 minutes on average.

Conclusions: : This call centre process demonstrates a viable and efficient method for administration of QoL measures and data collection. Completion rates were high; the level of missing data was low. The depth and quality of the data collected may contribute effectively to the QoL evidence base for macular disease.

Clinical Trial: : www.clinicaltrials.gov NCT00605280

Keywords: clinical research methodology • quality of life • age-related macular degeneration 

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