Skip to main content
Top
Gepubliceerd in:

05-08-2022

How do the number of missing daily diary days impact the psychometric properties and meaningful change thresholds arising from a weekly average summary score?

Auteurs: Pip Griffiths, Abi Williams, Elaine Brohan

Gepubliceerd in: Quality of Life Research | Uitgave 12/2022

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

Abstract

Purpose

Quality of life research often collects daily information and averages this over a week, producing a summary score. When data are missing, arbitrary rules (such as requiring at least 4/7 observations) are used to determine whether a patient’s summary score is created or set to missing. This simulation work aimed to assess the impact of missing data on the estimates produced by summary scores, the psychometric properties of the resulting summary score estimates and the impact on interpretation thresholds.

Methods

Complete longitudinal data were simulated for 1000 samples of 400 patients with different day-to-day variability. Data were deleted from these samples in line with missingness mechanisms to create scenarios with up to six days of missing data. Summary scores were created for complete and missing data scenarios. Summary score estimates, psychometric properties and meaningful change estimates were assessed for missing data scenarios compared to complete data.

Results

In most cases, the 4/7 day rule was supported, but this depended on daily variability. Fewer days of data were sometimes acceptable, but this was also dependent on the proportion of patients with missing data. Tables and figures allow researchers to assess the potential impact of missing data in their own studies.

Conclusions

This work suggests that the missing data rule used to create summary scores impacts on the estimate, measurement properties and interpretation thresholds. Although a general rule of 4/7 days is supported, the way the summary score is derived does not have a uniform impact across psychometric analyses. Recommendations are to use the 4/7 rule, but plan for sensitivity analyses with other missing data rules.
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
1.
go back to reference Okupa, A. Y., Sorkness, C. A., Mauger, D. T., Jackson, D. J., & Lemanske, R. F., Jr. (2013). Daily diaries vs retrospective questionnaires to assess asthma control and therapeutic responses in asthma clinical trials: Is participant burden worth the effort? Chest, 143(4), 993–999.CrossRef Okupa, A. Y., Sorkness, C. A., Mauger, D. T., Jackson, D. J., & Lemanske, R. F., Jr. (2013). Daily diaries vs retrospective questionnaires to assess asthma control and therapeutic responses in asthma clinical trials: Is participant burden worth the effort? Chest, 143(4), 993–999.CrossRef
2.
go back to reference Lewandowski, A. S., Palermo, T. M., Kirchner, H. L., & Drotar, D. (2009). Comparing diary and retrospective reports of pain and activity restriction in children and adolescents with chronic pain conditions. The Clinical journal of pain, 25(4), 299.CrossRef Lewandowski, A. S., Palermo, T. M., Kirchner, H. L., & Drotar, D. (2009). Comparing diary and retrospective reports of pain and activity restriction in children and adolescents with chronic pain conditions. The Clinical journal of pain, 25(4), 299.CrossRef
3.
go back to reference Bennett, A. V., Amtmann, D., Diehr, P., & Patrick, D. L. (2012). Comparison of 7-day recall and daily diary reports of COPD symptoms and impacts. Value in Health, 15(3), 466–474.CrossRef Bennett, A. V., Amtmann, D., Diehr, P., & Patrick, D. L. (2012). Comparison of 7-day recall and daily diary reports of COPD symptoms and impacts. Value in Health, 15(3), 466–474.CrossRef
4.
go back to reference Coons, S. J., Eremenco, S., Lundy, J. J., O’Donohoe, P., O’Gorman, H., & Malizia, W. (2015). Capturing patient-reported outcome (PRO) data electronically: The past, present, and promise of ePRO measurement in clinical trials. The Patient-Patient-Centered Outcomes Research, 8(4), 301–309.CrossRef Coons, S. J., Eremenco, S., Lundy, J. J., O’Donohoe, P., O’Gorman, H., & Malizia, W. (2015). Capturing patient-reported outcome (PRO) data electronically: The past, present, and promise of ePRO measurement in clinical trials. The Patient-Patient-Centered Outcomes Research, 8(4), 301–309.CrossRef
5.
go back to reference Stone, A. A., Shiffman, S., Schwartz, J. E., Broderick, J. E., & Hufford, M. R. (2002). Patient non-compliance with paper diaries. BMJ, 324(7347), 1193–1194.CrossRef Stone, A. A., Shiffman, S., Schwartz, J. E., Broderick, J. E., & Hufford, M. R. (2002). Patient non-compliance with paper diaries. BMJ, 324(7347), 1193–1194.CrossRef
6.
go back to reference Tiplady, B. (2010). Diary Design Considerations. EPro: Electronic Solutions for Patient-reported Data, 167. Tiplady, B. (2010). Diary Design Considerations. EPro: Electronic Solutions for Patient-reported Data, 167.
7.
go back to reference Bingham, C. O., Gaich, C. L., DeLozier, A. M., Engstrom, K. D., Naegeli, A. N., de Bono, S., Banerjee, P., & Taylor, P. C. (2019). Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: Rationale and implementation. Trials, 20(1), 1–8. Bingham, C. O., Gaich, C. L., DeLozier, A. M., Engstrom, K. D., Naegeli, A. N., de Bono, S., Banerjee, P., & Taylor, P. C. (2019). Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: Rationale and implementation. Trials, 20(1), 1–8.
8.
go back to reference Strunk, R. C., Bender, B., Young, D. A., Sagel, S., Glynn, E., Caesar, M., & Lawhon, C. (2002). Predictors of protocol adherence in a pediatric asthma clinical trial. Journal of allergy and clinical immunology, 110(4), 596–602.CrossRef Strunk, R. C., Bender, B., Young, D. A., Sagel, S., Glynn, E., Caesar, M., & Lawhon, C. (2002). Predictors of protocol adherence in a pediatric asthma clinical trial. Journal of allergy and clinical immunology, 110(4), 596–602.CrossRef
9.
go back to reference Holzbaur, E., & Ross, J. (2014). Risks, impacts, and mitigation of missing epro data on clinical trials. Value in Health, 17(3), A204.CrossRef Holzbaur, E., & Ross, J. (2014). Risks, impacts, and mitigation of missing epro data on clinical trials. Value in Health, 17(3), A204.CrossRef
10.
go back to reference Fairclough, D. L. (2010). Design and analysis of quality of life studies in clinical trials. CRC Press.CrossRef Fairclough, D. L. (2010). Design and analysis of quality of life studies in clinical trials. CRC Press.CrossRef
11.
go back to reference Coens, C., Pe, M., Dueck, A. C., Sloan, J., Basch, E., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Devlin, N., Dorme, L., Flechtner, H. H., Gotay, C., Griebsch, I., Groenvold, M., King, M., Kluetz, P. G., Koller, M., … Bottomley, A. (2020). International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: Recommendations of the SISAQOL Consortium. The Lancet Oncology, 21(2), e83–e96.CrossRef Coens, C., Pe, M., Dueck, A. C., Sloan, J., Basch, E., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Devlin, N., Dorme, L., Flechtner, H. H., Gotay, C., Griebsch, I., Groenvold, M., King, M., Kluetz, P. G., Koller, M., … Bottomley, A. (2020). International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: Recommendations of the SISAQOL Consortium. The Lancet Oncology, 21(2), e83–e96.CrossRef
12.
go back to reference Bell, M. L., & Fairclough, D. L. (2014). Practical and statistical issues in missing data for longitudinal patient-reported outcomes. Statistical methods in medical research, 23(5), 440–459.CrossRef Bell, M. L., & Fairclough, D. L. (2014). Practical and statistical issues in missing data for longitudinal patient-reported outcomes. Statistical methods in medical research, 23(5), 440–459.CrossRef
13.
go back to reference Bolger, N., Davis, A., & Rafaeli, E. (2003). Diary methods: Capturing life as it is lived. Annual review of psychology, 54(1), 579–616.CrossRef Bolger, N., Davis, A., & Rafaeli, E. (2003). Diary methods: Capturing life as it is lived. Annual review of psychology, 54(1), 579–616.CrossRef
14.
go back to reference Griffiths, P., Floden, L. L., & Hudgens, S. (2017, October). Scoring and interpretation of daily diary data in the presence of non-ignorable missing data. In QUALITY OF LIFE RESEARCH (Vol. 26, No. 1, pp. 70–70). VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS: SPRINGER. Griffiths, P., Floden, L. L., & Hudgens, S. (2017, October). Scoring and interpretation of daily diary data in the presence of non-ignorable missing data. In QUALITY OF LIFE RESEARCH (Vol. 26, No. 1, pp. 70–70). VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS: SPRINGER.
15.
go back to reference Griffiths, P., Floden, L., Doll, H., Morris, M., & Hudgens, S. (2018, October). Psychometric properties in the face of missing data-a simulation study assessing the effect of missing data on test-retest reliability in diary studies. In QUALITY OF LIFE RESEARCH (Vol. 27, pp. S55-S55). VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS: SPRINGER. Griffiths, P., Floden, L., Doll, H., Morris, M., & Hudgens, S. (2018, October). Psychometric properties in the face of missing data-a simulation study assessing the effect of missing data on test-retest reliability in diary studies. In QUALITY OF LIFE RESEARCH (Vol. 27, pp. S55-S55). VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS: SPRINGER.
16.
go back to reference Fayers, P. M., & Machin, D. (2013). Quality of life: The assessment, analysis and interpretation of patient-reported outcomes. John Wiley & Sons. Fayers, P. M., & Machin, D. (2013). Quality of life: The assessment, analysis and interpretation of patient-reported outcomes. John Wiley & Sons.
17.
go back to reference Higham, N. J. (2002). Computing the nearest correlation matrix—a problem from finance. IMA journal of Numerical Analysis, 22(3), 329–343.CrossRef Higham, N. J. (2002). Computing the nearest correlation matrix—a problem from finance. IMA journal of Numerical Analysis, 22(3), 329–343.CrossRef
18.
go back to reference Lawrance, R., Degtyarev, E., Griffiths, P., Trask, P., Lau, H., D’Alessio, D., Griebsch, I., Wallenstein, G., Cocks, K., & Rufibach, K. (2020). What is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials? Journal of Patient-Reported Outcomes, 4(1), 1–8.CrossRef Lawrance, R., Degtyarev, E., Griffiths, P., Trask, P., Lau, H., D’Alessio, D., Griebsch, I., Wallenstein, G., Cocks, K., & Rufibach, K. (2020). What is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials? Journal of Patient-Reported Outcomes, 4(1), 1–8.CrossRef
Metagegevens
Titel
How do the number of missing daily diary days impact the psychometric properties and meaningful change thresholds arising from a weekly average summary score?
Auteurs
Pip Griffiths
Abi Williams
Elaine Brohan
Publicatiedatum
05-08-2022
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 12/2022
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-022-03198-9