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Gepubliceerd in: Quality of Life Research 1/2021

07-09-2020

Do reminder emails and past due notifications improve patient completion and institutional data submission for patient-reported outcome measures?

Auteurs: Stephanie L. Pugh, Joseph P. Rodgers, Jennifer Moughan, Roseann Bonanni, Jaskaran Boparai, Ronald C. Chen, James J. Dignam, Deborah W. Bruner

Gepubliceerd in: Quality of Life Research | Uitgave 1/2021

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Abstract

Purpose

NRG Oncology, part of the National Cancer Institute’s National Clinical Trials Network, took efforts to increase patient-reported outcome measures (PROMs) completion and institutional data submission rates within clinical trials. Lack of completion diminishes power to draw conclusions and can be a waste of resources. It is hypothesized that trials with automatic email reminders and past due notifications will have PROM forms submitted more timely with higher patient completion.

Methods

Automatic emails sent to the research associate were added to selected NRG Oncology trials. Comparisons between trials with and without automatic emails were analyzed using Chi-square tests with respect to patient completion and timeliness of form submission rates. Multivariable analyses were conducted using repeated measures generalized estimating equations. If PROMs were not completed, a form providing the reason why was submitted and counted towards form submission.

Results

For both disease sites, form submission was significantly higher within 1 month of the form’s due date for the studies with automatic emails vs. those without (prostate: 79.7% vs. 75.7%, p < 0.001; breast: 59.2% vs. 31.3%, p < 0.001). No significant differences in patient completion were observed between the breast trials. The prostate trial with automatic emails had significantly higher patient completion but this result was not confirmed in the multivariable analysis.

Conclusions

Although patient completion rates were higher on trials with automatic emails, there may be confounding factors requiring future study. The automatic emails appeared to have increased the timeliness of form submission, thus supporting their continued use on NRG Oncology trials.
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Literatuur
1.
go back to reference Yang, L. Y., Manhas, D. S., Howard, A. F., & Olson, R. A. (2018). Patient-reported outcome use in oncology: A systematic review of the impact on patient-clinician communication. Supportive Care in Cancer, 26(1), 41–60.CrossRef Yang, L. Y., Manhas, D. S., Howard, A. F., & Olson, R. A. (2018). Patient-reported outcome use in oncology: A systematic review of the impact on patient-clinician communication. Supportive Care in Cancer, 26(1), 41–60.CrossRef
2.
go back to reference Stover, A. M., Tompkins Stricker, C., Hammelef, K., et al. (2019). Using stakeholder engagement to overcome barriers to implementing patient-reported outcomes (PROs) in cancer care delivery: Approaches from 3 prospective studies. Medical Care, 57(Suppl 5 Suppl 1), S92–S99.CrossRef Stover, A. M., Tompkins Stricker, C., Hammelef, K., et al. (2019). Using stakeholder engagement to overcome barriers to implementing patient-reported outcomes (PROs) in cancer care delivery: Approaches from 3 prospective studies. Medical Care, 57(Suppl 5 Suppl 1), S92–S99.CrossRef
3.
go back to reference Snyder, C. F., Aaronson, N. K., Choucair, A. K., et al. (2012). Implementing patient-reported outcomes assessment in clinical practice: A review of the options and considerations. Quality of Life Research, 21(8), 1305–1314.CrossRef Snyder, C. F., Aaronson, N. K., Choucair, A. K., et al. (2012). Implementing patient-reported outcomes assessment in clinical practice: A review of the options and considerations. Quality of Life Research, 21(8), 1305–1314.CrossRef
4.
go back to reference Atherton, P. J., Burger, K. N., Pederson, L. D., Kaggal, S., & Sloan, J. A. (2016). Patient reported outcomes questionnaire compliance in cancer cooperative group trials (Alliance N0992). Clinical Trials, 13(6), 612–620.CrossRef Atherton, P. J., Burger, K. N., Pederson, L. D., Kaggal, S., & Sloan, J. A. (2016). Patient reported outcomes questionnaire compliance in cancer cooperative group trials (Alliance N0992). Clinical Trials, 13(6), 612–620.CrossRef
5.
go back to reference Gilbert, M. R., Dignam, J. J., Armstrong, T. S., Wefel, J. S., Blumenthal, D. T., Vogelbaum, M. A., et al. (2014). Randomized clinical trial of bevacizumab for newly diagnosed glioblastoma. New England Journal of Medicine, 370(8), 699–708.CrossRef Gilbert, M. R., Dignam, J. J., Armstrong, T. S., Wefel, J. S., Blumenthal, D. T., Vogelbaum, M. A., et al. (2014). Randomized clinical trial of bevacizumab for newly diagnosed glioblastoma. New England Journal of Medicine, 370(8), 699–708.CrossRef
6.
go back to reference Klopp, A. H., Yeung, A. R., Deshmukh, S., Gil, K. M., Wenzel, L., Westin, S. N., et al. (2018). Patient-reported toxicity during pelvic intensity-modulated radiation therapy: NRG oncology-RTOG 1203. JCO, 36(24), 2538–2544.CrossRef Klopp, A. H., Yeung, A. R., Deshmukh, S., Gil, K. M., Wenzel, L., Westin, S. N., et al. (2018). Patient-reported toxicity during pelvic intensity-modulated radiation therapy: NRG oncology-RTOG 1203. JCO, 36(24), 2538–2544.CrossRef
7.
go back to reference Laack, N., Pugh, S. L., Brown, P., Fox, S., Wefel, J., Meyers, C., et al. (2019). Quality of life in patients receiving memantine for the prevention of cognitive dysfunction during whole-brain radiotherapy (WBRT): A randomized, double-blind, placebo-controlled trial. Neuro-Oncology Practice, 6(4), 274–282.CrossRef Laack, N., Pugh, S. L., Brown, P., Fox, S., Wefel, J., Meyers, C., et al. (2019). Quality of life in patients receiving memantine for the prevention of cognitive dysfunction during whole-brain radiotherapy (WBRT): A randomized, double-blind, placebo-controlled trial. Neuro-Oncology Practice, 6(4), 274–282.CrossRef
8.
go back to reference Lukka, H., Pugh, S. L., Bruner, D. W., Bahary, J. P., Lawton, C., Efstathiou, J., et al. (2018). Patient reported outcomes in NRG Oncology RTOG 0938, evaluating two ultrahypofractionated regimens for prostate cancer. International Journal of Radiation Oncology*Biology*Physics, 102(2), 287–295.CrossRef Lukka, H., Pugh, S. L., Bruner, D. W., Bahary, J. P., Lawton, C., Efstathiou, J., et al. (2018). Patient reported outcomes in NRG Oncology RTOG 0938, evaluating two ultrahypofractionated regimens for prostate cancer. International Journal of Radiation Oncology*Biology*Physics, 102(2), 287–295.CrossRef
9.
go back to reference Movsas, B., Hu, C., Sloan, J., et al. (2016). Quality of life analysis of a radiation dose-escalation study of patients with non-small-cell lung cancer: A secondary analysis of the Radiation Therapy Oncology Group 0617 randomized clinical trial. JAMA Oncology, 2(3), 359–367.CrossRef Movsas, B., Hu, C., Sloan, J., et al. (2016). Quality of life analysis of a radiation dose-escalation study of patients with non-small-cell lung cancer: A secondary analysis of the Radiation Therapy Oncology Group 0617 randomized clinical trial. JAMA Oncology, 2(3), 359–367.CrossRef
10.
go back to reference Wyatt, G., Pugh, S. L., Wong, R. K. W., Sagar, S. M., Lele, S. B., Koyfman, S. A., et al. (2016). Xerostomia health-related quality of life: NRG oncology/RTOG 0537. Quality of Life Research, 25(9), 2323–2333.CrossRef Wyatt, G., Pugh, S. L., Wong, R. K. W., Sagar, S. M., Lele, S. B., Koyfman, S. A., et al. (2016). Xerostomia health-related quality of life: NRG oncology/RTOG 0537. Quality of Life Research, 25(9), 2323–2333.CrossRef
11.
go back to reference Renovanz, M., Hechtner, M., Kohlmann, K., Janko, M., Nadji-Ohl, M., Singer, S., et al. (2018). Compliance with patient-reported outcome assessment in glioma patients: Predictors for drop out. NOP, 5(2), 129–138.CrossRef Renovanz, M., Hechtner, M., Kohlmann, K., Janko, M., Nadji-Ohl, M., Singer, S., et al. (2018). Compliance with patient-reported outcome assessment in glioma patients: Predictors for drop out. NOP, 5(2), 129–138.CrossRef
12.
go back to reference Bae, K., Bruner, D. W., Baek, S., Movsas, B., Corn, B. W., & Dignam, J. J. (2011). Patterns of missing mini mental status exam (MMSE) in radiation therapy oncology group (RTOG) brain cancer trials. Journal of Neuro-Oncology, 105(2), 383–395.CrossRef Bae, K., Bruner, D. W., Baek, S., Movsas, B., Corn, B. W., & Dignam, J. J. (2011). Patterns of missing mini mental status exam (MMSE) in radiation therapy oncology group (RTOG) brain cancer trials. Journal of Neuro-Oncology, 105(2), 383–395.CrossRef
13.
go back to reference Sloan, J. A., Berk, L., Roscoe, J., et al. (2007). Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. Journal of Clinical Oncology, 25(32), 5070–5077.CrossRef Sloan, J. A., Berk, L., Roscoe, J., et al. (2007). Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. Journal of Clinical Oncology, 25(32), 5070–5077.CrossRef
14.
go back to reference Gamper, E. M., Nerich, V., Sztankay, M., et al. (2017). Evaluation of noncompletion bias and long-term adherence in a 10-year patient-reported outcome monitoring program in clinical routine. Value Health, 20(4), 610–617.CrossRef Gamper, E. M., Nerich, V., Sztankay, M., et al. (2017). Evaluation of noncompletion bias and long-term adherence in a 10-year patient-reported outcome monitoring program in clinical routine. Value Health, 20(4), 610–617.CrossRef
15.
go back to reference Turner-Bowker, D. M., Hao, Y., Foley, C., Galipeau, N., Mazar, I., Krohe, M., et al. (2016). The use of patient-reported outcomes in advanced breast cancer clinical trials: A review of the published literature. Current Medical Research and Opinion, 32(10), 1709–1717.CrossRef Turner-Bowker, D. M., Hao, Y., Foley, C., Galipeau, N., Mazar, I., Krohe, M., et al. (2016). The use of patient-reported outcomes in advanced breast cancer clinical trials: A review of the published literature. Current Medical Research and Opinion, 32(10), 1709–1717.CrossRef
16.
go back to reference Roydhouse, J. K., Gutman, R., Bhatnagar, V., Kluetz, P. G., Sridhara, R., & Mishra-Kalyani, P. S. (2019). Analyzing patient-reported outcome data when completion differs between arms in open-label trials: An application of principal stratification. Pharmacoepidemiology and Drug Safety, 28(10), 1386–1394.CrossRef Roydhouse, J. K., Gutman, R., Bhatnagar, V., Kluetz, P. G., Sridhara, R., & Mishra-Kalyani, P. S. (2019). Analyzing patient-reported outcome data when completion differs between arms in open-label trials: An application of principal stratification. Pharmacoepidemiology and Drug Safety, 28(10), 1386–1394.CrossRef
17.
go back to reference Brown, P. D., Pugh, S. L., Laack, N. N., Wefel, J. S., Khuntia, D., Meyers, C., et al. (2013). Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: A randomized, double-blind, placebo-controlled trial. Neuro-Oncology, 15(10), 1429–1437.CrossRef Brown, P. D., Pugh, S. L., Laack, N. N., Wefel, J. S., Khuntia, D., Meyers, C., et al. (2013). Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: A randomized, double-blind, placebo-controlled trial. Neuro-Oncology, 15(10), 1429–1437.CrossRef
18.
go back to reference Basch, E. (2019). High compliance rates with patient-reported outcomes in oncology trials submitted to the US Food and Drug Administration. Journal of the National Cancer Institute, 111(5), 437–439.CrossRef Basch, E. (2019). High compliance rates with patient-reported outcomes in oncology trials submitted to the US Food and Drug Administration. Journal of the National Cancer Institute, 111(5), 437–439.CrossRef
19.
go back to reference Chafe, S., Moughan, J., McCormick, B., et al. (2013). Late toxicity and patient self-assessment of breast appearance/satisfaction on RTOG 0319: A phase 2 trial of 3-dimensional conformal radiation therapy-accelerated partial breast irradiation following lumpectomy for stages I and II breast cancer. International Journal of Radiation Oncology Biology Physics, 86(5), 854–859.CrossRef Chafe, S., Moughan, J., McCormick, B., et al. (2013). Late toxicity and patient self-assessment of breast appearance/satisfaction on RTOG 0319: A phase 2 trial of 3-dimensional conformal radiation therapy-accelerated partial breast irradiation following lumpectomy for stages I and II breast cancer. International Journal of Radiation Oncology Biology Physics, 86(5), 854–859.CrossRef
20.
go back to reference Buysse, D. J., et al. (1989). The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193–213.CrossRef Buysse, D. J., et al. (1989). The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193–213.CrossRef
21.
go back to reference Godin, G., Jobin, J., & Bouillon, J. (1986). Assessment of leisure time exercise behavior by self-report: A concurrent validity study. Canadian Journal of Public Health Revue Canadienne de Sante Publique, 77(5), 359–362.PubMed Godin, G., Jobin, J., & Bouillon, J. (1986). Assessment of leisure time exercise behavior by self-report: A concurrent validity study. Canadian Journal of Public Health Revue Canadienne de Sante Publique, 77(5), 359–362.PubMed
22.
go back to reference Gionet, N. J., & Godin, G. (1989). Self-reported exercise behavior of employees: A validity study. Journal of Occupational Medicine, 31(12), 969–973.CrossRef Gionet, N. J., & Godin, G. (1989). Self-reported exercise behavior of employees: A validity study. Journal of Occupational Medicine, 31(12), 969–973.CrossRef
23.
go back to reference Ameringer, S., Elswick, R. K., Jr., Menzies, V., et al. (2016). Psychometric evaluation of the patient-reported outcomes measurement information system fatigue-short form across diverse populations. Nursing Research, 65(4), 279–289.CrossRef Ameringer, S., Elswick, R. K., Jr., Menzies, V., et al. (2016). Psychometric evaluation of the patient-reported outcomes measurement information system fatigue-short form across diverse populations. Nursing Research, 65(4), 279–289.CrossRef
24.
go back to reference EuroQol Group. (1990). EuroQol–a new facility for the measurement of health-related quality of life. Health Policy, 16(3), 199–208.CrossRef EuroQol Group. (1990). EuroQol–a new facility for the measurement of health-related quality of life. Health Policy, 16(3), 199–208.CrossRef
25.
go back to reference Land, S. R., Ritter, M. W., Costantino, J. P., et al. (2007). Compliance with patient-reported outcomes in multicenter clinical trials: Methodologic and practical approaches. Journal of Clinical Oncology, 25(32), 5113–5120.CrossRef Land, S. R., Ritter, M. W., Costantino, J. P., et al. (2007). Compliance with patient-reported outcomes in multicenter clinical trials: Methodologic and practical approaches. Journal of Clinical Oncology, 25(32), 5113–5120.CrossRef
26.
go back to reference Mercieca-Bebber, R., Friedlander, M., Calvert, M., et al. (2017). A systematic evaluation of compliance and reporting of patient-reported outcome endpoints in ovarian cancer randomised controlled trials: Implications for generalisability and clinical practice. Journal of Patient-Reported Outcomes, 1(1), 5.CrossRef Mercieca-Bebber, R., Friedlander, M., Calvert, M., et al. (2017). A systematic evaluation of compliance and reporting of patient-reported outcome endpoints in ovarian cancer randomised controlled trials: Implications for generalisability and clinical practice. Journal of Patient-Reported Outcomes, 1(1), 5.CrossRef
27.
go back to reference Little, R. J. A., & Rubin, D. B. (2002). Statistical analysis with missing data (2nd ed.). New York, NY: Wiley.CrossRef Little, R. J. A., & Rubin, D. B. (2002). Statistical analysis with missing data (2nd ed.). New York, NY: Wiley.CrossRef
28.
go back to reference Fairclough, D. (2010). Design and analysis of quality of life studies in clinical trials (2nd ed.). Boca Raton, FL: Chapman & Hall/CRC.CrossRef Fairclough, D. (2010). Design and analysis of quality of life studies in clinical trials (2nd ed.). Boca Raton, FL: Chapman & Hall/CRC.CrossRef
29.
go back to reference Gwaltney, C. J., Shields, A. L., & Shiffman, S. (2008). Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: A meta-analytic review. Value Health, 11(2), 322–333.CrossRef Gwaltney, C. J., Shields, A. L., & Shiffman, S. (2008). Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: A meta-analytic review. Value Health, 11(2), 322–333.CrossRef
30.
go back to reference Brown, P. D., Gondi, V., Pugh, S. L., Tome, W. A., Wefel, J. S., Armstrong, T. S., et al. (2020). Hippocampal avoidance during whole-brain radiotherapy plus memantine for patients with brain metastases: Phase III trial NRG oncology CC001. Journal of Clinical Oncology, 38(10), 1019–1029.CrossRef Brown, P. D., Gondi, V., Pugh, S. L., Tome, W. A., Wefel, J. S., Armstrong, T. S., et al. (2020). Hippocampal avoidance during whole-brain radiotherapy plus memantine for patients with brain metastases: Phase III trial NRG oncology CC001. Journal of Clinical Oncology, 38(10), 1019–1029.CrossRef
31.
go back to reference Michalski, J. M., Moughan, J., Purdy, J., Bosch, W., Bruner, D. W., Bahary, J. P., et al. (2018). Effect of standard vs dose-escalated radiation therapy for patients with intermediate-risk prostate cancer: The NRG oncology RTOG 0126 randomized clinical trial. JAMA Oncology, 4(6), e180039.CrossRef Michalski, J. M., Moughan, J., Purdy, J., Bosch, W., Bruner, D. W., Bahary, J. P., et al. (2018). Effect of standard vs dose-escalated radiation therapy for patients with intermediate-risk prostate cancer: The NRG oncology RTOG 0126 randomized clinical trial. JAMA Oncology, 4(6), e180039.CrossRef
32.
go back to reference Rabinovitch, R., Moughan, J., Vicini, F., Pass, H., Wong, J., Chafe, S., et al. (2016). Long-term update of NRG oncology RTOG 0319: A phase 1 and 2 trial to evaluate 3-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for stage I and II breast carcinoma. International Journal of Radiation Oncology*Biology*Physics, 96(5), 1054–1059.CrossRef Rabinovitch, R., Moughan, J., Vicini, F., Pass, H., Wong, J., Chafe, S., et al. (2016). Long-term update of NRG oncology RTOG 0319: A phase 1 and 2 trial to evaluate 3-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for stage I and II breast carcinoma. International Journal of Radiation Oncology*Biology*Physics, 96(5), 1054–1059.CrossRef
33.
go back to reference Brown, P. D., Decker, P. A., Rummans, T. A., Clark, M. M., Frost, M. H., Ballman, K. V., et al. (2008). A prospective study of quality of life in adults with newly diagnosed high-grade gliomas: Comparison of patient and caregiver ratings of quality of life. American Journal of Clinical Oncology, 31(2), 163–168.CrossRef Brown, P. D., Decker, P. A., Rummans, T. A., Clark, M. M., Frost, M. H., Ballman, K. V., et al. (2008). A prospective study of quality of life in adults with newly diagnosed high-grade gliomas: Comparison of patient and caregiver ratings of quality of life. American Journal of Clinical Oncology, 31(2), 163–168.CrossRef
Metagegevens
Titel
Do reminder emails and past due notifications improve patient completion and institutional data submission for patient-reported outcome measures?
Auteurs
Stephanie L. Pugh
Joseph P. Rodgers
Jennifer Moughan
Roseann Bonanni
Jaskaran Boparai
Ronald C. Chen
James J. Dignam
Deborah W. Bruner
Publicatiedatum
07-09-2020
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 1/2021
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-020-02613-3

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