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Published in: Quality of Life Research 7/2018

Open Access 01-07-2018

The importance of content and face validity in instrument development: lessons learnt from service users when developing the Recovering Quality of Life measure (ReQoL)

Authors: Janice Connell, Jill Carlton, Andrew Grundy, Elizabeth Taylor Buck, Anju Devianee Keetharuth, Thomas Ricketts, Michael Barkham, Dan Robotham, Diana Rose, John Brazier

Published in: Quality of Life Research | Issue 7/2018

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Abstract

Purpose

Service user involvement in instrument development is increasingly recognised as important, but is often not done and seldom reported. This has adverse implications for the content validity of a measure. The aim of this paper is to identify the types of items that service users felt were important to be included or excluded from a new Recovering Quality of Life measure for people with mental health difficulties.

Methods

Potential items were presented to service users in face-to-face structured individual interviews and focus groups. The items were primarily taken or adapted from current measures and covered themes identified from earlier qualitative work as being important to quality of life. Content and thematic analysis was undertaken to identify the types of items which were either important or unacceptable to service users.

Results

We identified five key themes of the types of items that service users found acceptable or unacceptable; the items should be relevant and meaningful, unambiguous, easy to answer particularly when distressed, do not cause further upset, and be non-judgemental. Importantly, this was from the perspective of the service user.

Conclusions

This research has underlined the importance of service users’ views on the acceptability and validity of items for use in developing a new measure. Whether or not service users favoured an item was associated with their ability or intention to respond accurately and honestly to the item which will impact on the validity and sensitivity of the measure.
Literature
1.
go back to reference Department of Health (2010). The NHS outcomes framework 2011–2012, London: Department of Health. Department of Health (2010). The NHS outcomes framework 2011–2012, London: Department of Health.
2.
go back to reference US Department of Health and Human Services FDA Center for Drug Evaluation and Research, US Department of Health and Human Services FDA Center for Biologics Evaluation and Research, US Department of Health and Human Services FDA Center for Devices and Radiological Health. (2006). Guidance for industry: Patient-reported outcome measures: Use in medical product development to support labelling claims: Draft guidance. Health and Quality of Life Outcomes, 4, 1–20.CrossRef US Department of Health and Human Services FDA Center for Drug Evaluation and Research, US Department of Health and Human Services FDA Center for Biologics Evaluation and Research, US Department of Health and Human Services FDA Center for Devices and Radiological Health. (2006). Guidance for industry: Patient-reported outcome measures: Use in medical product development to support labelling claims: Draft guidance. Health and Quality of Life Outcomes, 4, 1–20.CrossRef
3.
go back to reference Fitzpatrick, R., Davey, C., Buxton, M., & Jones, D. (1998). Evaluating patient based outcome measures for use in clinical trials. Health Technology Assessment, 2, 1–74.PubMed Fitzpatrick, R., Davey, C., Buxton, M., & Jones, D. (1998). Evaluating patient based outcome measures for use in clinical trials. Health Technology Assessment, 2, 1–74.PubMed
4.
go back to reference Streiner, D. L., Norman, G. R., & Cairney, J. (2014). Health measurement scales: A practical guide to their development and use, (5th edn.). Oxford: Oxford University Press. Streiner, D. L., Norman, G. R., & Cairney, J. (2014). Health measurement scales: A practical guide to their development and use, (5th edn.). Oxford: Oxford University Press.
5.
go back to reference Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., et al. (2010). The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: An international Delphi study. Quality of Life Research, 19, 539–549.CrossRefPubMedPubMedCentral Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., et al. (2010). The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: An international Delphi study. Quality of Life Research, 19, 539–549.CrossRefPubMedPubMedCentral
6.
go back to reference Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011). 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 in Health, 14(8), 978–988.CrossRefPubMed Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011). 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 in Health, 14(8), 978–988.CrossRefPubMed
8.
go back to reference Staniszewska, S., Haywood, K. L., Brett, J., & Tutton, L. (2012). Patient and public involvement in patient-reported outcome measures. The Patient-Patient-Centered Outcomes Research, 5(2), 79–87.CrossRefPubMed Staniszewska, S., Haywood, K. L., Brett, J., & Tutton, L. (2012). Patient and public involvement in patient-reported outcome measures. The Patient-Patient-Centered Outcomes Research, 5(2), 79–87.CrossRefPubMed
9.
go back to reference Wiering, B., Boer, D., & Delnoij, D. (2017). Patient involvement in the development of patient-reported outcome measures: A scoping review. Health Expectations, 20(1), 11–23.CrossRefPubMed Wiering, B., Boer, D., & Delnoij, D. (2017). Patient involvement in the development of patient-reported outcome measures: A scoping review. Health Expectations, 20(1), 11–23.CrossRefPubMed
10.
11.
go back to reference Rose, D., Evans, J., Sweeney, A., & Wykes, T. (2011). A model for developing outcome measures from the perspectives of mental health service users. International Review of Psychiatry, 23(1), 41–46.CrossRefPubMed Rose, D., Evans, J., Sweeney, A., & Wykes, T. (2011). A model for developing outcome measures from the perspectives of mental health service users. International Review of Psychiatry, 23(1), 41–46.CrossRefPubMed
12.
go back to reference Groene, O. (2012). Patient and public involvement in developing patient-reported outcome measures. Patient, 5(2), 75–77.CrossRefPubMed Groene, O. (2012). Patient and public involvement in developing patient-reported outcome measures. Patient, 5(2), 75–77.CrossRefPubMed
13.
go back to reference Ennis, L., & Wykes, T. (2013). Impact of patient involvement in mental health research: Longitudinal study. British Journal of Psychiatry, 203(5), 381–386.CrossRefPubMed Ennis, L., & Wykes, T. (2013). Impact of patient involvement in mental health research: Longitudinal study. British Journal of Psychiatry, 203(5), 381–386.CrossRefPubMed
14.
go back to reference Jacobson, N., & Curtis, L. (2000). Recovery as policy in mental health services: Strategies emerging from the states. Psychiatric Rehabilitation Journal, 23(4), 333.CrossRef Jacobson, N., & Curtis, L. (2000). Recovery as policy in mental health services: Strategies emerging from the states. Psychiatric Rehabilitation Journal, 23(4), 333.CrossRef
15.
go back to reference Bracken, P., Thomas, P., Timimi, S., Asen, E., Behr, G., Beuster, C., et al. (2012). Psychiatry beyond the current paradigm. British Journal of Psychiatry, 201(6), 430–434.CrossRefPubMed Bracken, P., Thomas, P., Timimi, S., Asen, E., Behr, G., Beuster, C., et al. (2012). Psychiatry beyond the current paradigm. British Journal of Psychiatry, 201(6), 430–434.CrossRefPubMed
16.
go back to reference Bohanske, R. T., & Franczak, M. (2010). Transforming public behavioral health care: A case example of consumer-directed services, recovery, and the common factors. In B. L. Duncan, S. D. Miller, B. E. Wampold & M. A. Hubble (Eds.), The heart and soul of change: Delivering what works in therapy. American Psychological Association, Worcester, pp. 299–322.CrossRef Bohanske, R. T., & Franczak, M. (2010). Transforming public behavioral health care: A case example of consumer-directed services, recovery, and the common factors. In B. L. Duncan, S. D. Miller, B. E. Wampold & M. A. Hubble (Eds.), The heart and soul of change: Delivering what works in therapy. American Psychological Association, Worcester, pp. 299–322.CrossRef
18.
go back to reference Piat, M., Sabetti, J., & Bloom, D. (2010). The transformation of mental health services to a recovery-orientated system of care: Canadian decision maker perspectives. International Journal of Social Psychiatry, 56(2), 168–177.CrossRefPubMedPubMedCentral Piat, M., Sabetti, J., & Bloom, D. (2010). The transformation of mental health services to a recovery-orientated system of care: Canadian decision maker perspectives. International Journal of Social Psychiatry, 56(2), 168–177.CrossRefPubMedPubMedCentral
21.
go back to reference Hogan, M. F. (2003). The President’s new freedom commission: Recommendations to transform mental healthcare in America. Psychiatric Services, 54(11), 1467–1474.CrossRefPubMed Hogan, M. F. (2003). The President’s new freedom commission: Recommendations to transform mental healthcare in America. Psychiatric Services, 54(11), 1467–1474.CrossRefPubMed
22.
go back to reference Boardman, J., & Shepherd, G. (2013) Assessing recovery: Seeking agreement about the key domains. Report for the Department of Health. Unpublished (available from the authors). Boardman, J., & Shepherd, G. (2013) Assessing recovery: Seeking agreement about the key domains. Report for the Department of Health. Unpublished (available from the authors).
24.
go back to reference Connell, J., Brazier, J., O’Cathain, A., Lloyd-Jones, M., & Paisley, S. (2012). Quality of Life of People with Mental Health Problems: A synthesis of qualitative research. Health and Quality of Life Outcomes, 10(1), 138.CrossRefPubMedPubMedCentral Connell, J., Brazier, J., O’Cathain, A., Lloyd-Jones, M., & Paisley, S. (2012). Quality of Life of People with Mental Health Problems: A synthesis of qualitative research. Health and Quality of Life Outcomes, 10(1), 138.CrossRefPubMedPubMedCentral
25.
go back to reference Brazier, J., Connell, J., Papaioannou, D., Mukuria, C., Mulhern, B., Peasgood, T., et al. (2014). A systematic review, psychometric analysis and qualitative assessment of generic preference-based measures of health in mental health populations and the estimation of mapping functions from widely used specific measures. Health Technology Assessment, 18, 34.CrossRef Brazier, J., Connell, J., Papaioannou, D., Mukuria, C., Mulhern, B., Peasgood, T., et al. (2014). A systematic review, psychometric analysis and qualitative assessment of generic preference-based measures of health in mental health populations and the estimation of mapping functions from widely used specific measures. Health Technology Assessment, 18, 34.CrossRef
26.
go back to reference Connell, J., O’Cathain, A., & Brazier, J. (2014). Measuring quality of life in mental health: Are we asking the right questions? Social Science and Medicine, 120, 12–20.CrossRefPubMedPubMedCentral Connell, J., O’Cathain, A., & Brazier, J. (2014). Measuring quality of life in mental health: Are we asking the right questions? Social Science and Medicine, 120, 12–20.CrossRefPubMedPubMedCentral
27.
go back to reference Leamy, M., Bird, V., Le Boutillier, C., Williams, J., & Slade, M. (2011). Conceptual framework for personal recovery in mental health: Systematic review and narrative synthesis. British Journal of Psychiatry, 199, 445–452.CrossRefPubMed Leamy, M., Bird, V., Le Boutillier, C., Williams, J., & Slade, M. (2011). Conceptual framework for personal recovery in mental health: Systematic review and narrative synthesis. British Journal of Psychiatry, 199, 445–452.CrossRefPubMed
28.
go back to reference Keetharuth, A. D., Brazier, J. E., Connell, J., Bjorner, J. B., Carlton, J., Buck, T., E., et al (2018). Recovering Quality of Life (ReQoL): A new generic self-reported outcome measure for use with people experiencing mental health difficulties. British Journal of Psychiatry, 212, 42–49.CrossRefPubMed Keetharuth, A. D., Brazier, J. E., Connell, J., Bjorner, J. B., Carlton, J., Buck, T., E., et al (2018). Recovering Quality of Life (ReQoL): A new generic self-reported outcome measure for use with people experiencing mental health difficulties. British Journal of Psychiatry, 212, 42–49.CrossRefPubMed
29.
go back to reference Crawford, M. J., Robotham, D., Thana, L., Patterson, S., Weaver, T., Barber, R., et al. (2011). Selecting outcome measures in mental health: The views of service users. Journal of Mental Health, 20, 336–346.CrossRefPubMed Crawford, M. J., Robotham, D., Thana, L., Patterson, S., Weaver, T., Barber, R., et al. (2011). Selecting outcome measures in mental health: The views of service users. Journal of Mental Health, 20, 336–346.CrossRefPubMed
30.
go back to reference Huppert, F. A., & Whittington, J. E. (2003). Evidence for the independence of positive and negative well-being: Implications for quality of life assessment. British Journal of Health Psychology, 8(1), 107–122.CrossRefPubMed Huppert, F. A., & Whittington, J. E. (2003). Evidence for the independence of positive and negative well-being: Implications for quality of life assessment. British Journal of Health Psychology, 8(1), 107–122.CrossRefPubMed
31.
go back to reference Andresen, R., Oades, L., & Caputi, P. (2003). The experience of recovery from schizophrenia: Towards an empirically validated stage model. Australia & New Zealand Journal of Psychiatry, 37(5), 586–594.CrossRef Andresen, R., Oades, L., & Caputi, P. (2003). The experience of recovery from schizophrenia: Towards an empirically validated stage model. Australia & New Zealand Journal of Psychiatry, 37(5), 586–594.CrossRef
Metadata
Title
The importance of content and face validity in instrument development: lessons learnt from service users when developing the Recovering Quality of Life measure (ReQoL)
Authors
Janice Connell
Jill Carlton
Andrew Grundy
Elizabeth Taylor Buck
Anju Devianee Keetharuth
Thomas Ricketts
Michael Barkham
Dan Robotham
Diana Rose
John Brazier
Publication date
01-07-2018
Publisher
Springer International Publishing
Published in
Quality of Life Research / Issue 7/2018
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-018-1847-y

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