Scientific Communications

Explore our latest publications or search historical publications by journal, date, or therapeutic area.

Latest Publications


Publications, Presentations, and Posters
from the COS team.

Disease Specific Publications & Presentation

Regulatory Publications

  • Publications

    Althof, S. E., Rosen, R. C., DeRogatis, L., Corty, E., Quirk, F., & Symonds, T. (2005). Outcome measurement in female sexual dysfunction clinical trials: review and recommendations. Journal of Sex and Marital Therapy, 31(2), 153-166. doi:10.1080/00926230590909989

    Burbridge, C., Symonds, T., Humphrey, L., Arbuckle, R., Hirsch, I., & Whelan, L. (2013). Validation of the daily diary of fatigue symptoms—fibromyalgia (DFS-Fibro). Open Journal of Rheumatology and Autoimmune Diseases, 3(02), 92-103. doi:10.4236/ojra.2013.32014

    Byrom, B., Watson, C., Doll, H., Coons, S. J., Eremenco, S., Ballinger, R., . . . e, P. R. O. C. (2018). Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium. Value in Health, 21(6), 631-639. doi:10.1016/j.jval.2017.09.012

    Chan, E., Jamieson, C., Metin, H., & Hudgens, S. (2018). Missing data in patient-reported outcomes: regulatory, statistical, and operational perspectives. Value in Health, 21, S1-S268.

    Coplan, P. M., Cepeda, M. S., Petronis, K. R., DeVeaugh-Geiss, A., Barsdorf, A. I., Kern, D. M., & Fanelli, R. (2019). Postmarketing studies program to assess the risks and benefits of long-term use of extended-release/long-acting opioids among chronic pain patients. Postgraduate Medicine, 1-8. doi:10.1080/00325481.2019.1685793

    Fleming, S., Barsdorf, A. I., Howry, C., O'Gorman, H., & Coons, S. J. (2015). Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints. Ther Innov Regul Sci, 49(6), 797-804. doi:10.1177/2168479015609102

    Lasiter, L., Campbell, A., Basch, E., Hudgens, S., Stewart, M., Wu, J. J., . . . Allen, J. (2020). Use of Patient-Reported Outcomes to Understand & Measure the Patient Experience of Novel Cell and Gene Therapies. Therapeutic Innovation & Regulatory Science. doi:10.1007/s43441-020-00184-6

    Morris, S., Li, Y., Burbridge, C., Symonds, T., & Hudgens, S. (2015). AB0949 Development of the Multidimensional Daily Diary of Fatigue Symptoms-Fibromyalgia-17 Item Instrument (DFS-Fibro-17) in Fibromyalgia Patients. Annals of the Rheumatic Diseases, 74(Suppl 2), 1216. doi:10.1136/annrheumdis-2015-eular.4581

    Nixon, A., Doll, H., Kerr, C., Burge, R., & Naegeli, A. N. (2016). Interpreting change from patient reported outcome (PRO) endpoints: patient global ratings of concept versus patient global ratings of change, a case study among osteoporosis patients. Health Qual Life Outcomes, 14, 25. doi:10.1186/s12955-016-0427-5

    Rosa, K., Delgado-Herrera, L., Zeiher, B., Banderas, B., Arbuckle, R., Spears, G., & Hudgens, S. (2016). Psychometric assessment of the IBS-D Daily Symptom Diary and Symptom Event Log. Quality of Life Research, 25(12), 3197-3208. doi:10.1007/s11136-016-1335-1

    Symonds, T., Berzon, R., Marquis, P., Rummans, T. A., & Clinical Significance Consensus Meeting, G. (2002). The clinical significance of quality-of-life results: practical considerations for specific audiences. Mayo Clinic Proceedings, 77(6), 572-583. doi:10.4065/77.6.572

Methods Publications

  • Publications

    Gugiu, P. C. (2019). Chapter 13: Assessing Needs of a Community College: A Mixed Methods Case Study. In D. F. Russ-Eft, & Sleezer, C. M (Ed.), Case Studies in Needs Assessment. (pp. 170-182). Thousand Oaks, CA: SAGE Publications.

    Hudgens, S., Globe, D., Norquist, J., & Reeve, B. (2012, Jun 2-6). Utilization of Rasch Measurement Models for Assessing Validity: A Mixed Methods Approach. Paper presented at the ISPOR 17th Annual International Meeting, Washington, D.C.

    Hudgens, S., Globe, D., Norquist, J., & Reeve, B. (2012). Utilization of Rasch Measurement Models for Assessing Validity: A Mixed Methods Approach. On Demand Webcast, March 12, 2012.

    Hudgens, S., & Marquis, P. (2012). Rasch measurement: a mixed methods approach for assessing content validity. ISOQOL International Meeting proceedings. Budapest, Hungary, October 24-27. Quality of Life Research, 21( ), 40.

    Hudgens, S., & Misra, S. (2012). Perspectives on Mixed Methods to Assess Content Validity of a PRO Measure. ISOQOL International Meeting proceedings. Budapest, Hungary, October 24-27. Quality of Life Research, 21( ).

    Humphrey, L., Symonds, T., Gable, J., Abetz-Webb, L., Silverberg, J., Griffiths, P., . . . DeLozier, A. (2017). Mixed methods evaluation of an itch numeric rating scale among adult and adolescent patients with atopic dermatitis. Value in Health, 20(9), A806.

    Newton, L., DeLozier, A. M., Griffiths, P. C., Hill, J. N., Hudgens, S., Symonds, T., . . . Silverberg, J. I. (2019). Exploring content and psychometric validity of newly developed assessment tools for itch and skin pain in atopic dermatitis. Journal of patient-reported outcomes, 3(1), 42. doi:10.1186/s41687-019-0128-z

    Raine, R., Fitzpatrick, R., Barratt, H., Bevan, G., Black, N., Boaden, R., . . . Zwarenstein, M. (2016). Challenges, solutions and future directions in the evaluation of service innovations in health care and public health. Health Services and Delivery Research, 4(16). doi:10.3310/hsdr04160

    Ritenbaugh, C., Nichter, M., Nichter, M. A., Kelly, K. L., Sims, C. M., Bell, I. R., . . . Coons, S. J. (2011). Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format. BMC Complementary and Alternative Medicine, 11, 135. doi:10.1186/1472-6882-11-135

    Staunton, H., Willgoss, T., Nelsen, L., Burbridge, C., Sully, K., Rofail, D., & Arbuckle, R. (2019). An overview of using qualitative techniques to explore and define estimates of clinically important change on clinical outcome assessments. Journal of Patient Reported Outcomes, 3(1), 16. doi:10.1186/s41687-019-0100-y

    Willgoss, T., Humphrey, L., Symonds, T., & Cappelleri, J. (2014). Mixed methods for the development of clincial outcome assessments (COAs): Exploring further possibilities for mixed data collection and analysis. Value in Health, 17(3), A207.

Policy Publications

  • Publications

    Gugiu, P. C. (2019). Chapter 13: Assessing Needs of a Community College: A Mixed Methods Case Study. In D. F. Russ-Eft, & Sleezer, C. M (Ed.), Case Studies in Needs Assessment. (pp. 170-182). Thousand Oaks, CA: SAGE Publications.

    Hudgens, S., Globe, D., Norquist, J., & Reeve, B. (2012, Jun 2-6). Utilization of Rasch Measurement Models for Assessing Validity: A Mixed Methods Approach. Paper presented at the ISPOR 17th Annual International Meeting, Washington, D.C.

    Hudgens, S., Globe, D., Norquist, J., & Reeve, B. (2012). Utilization of Rasch Measurement Models for Assessing Validity: A Mixed Methods Approach. On Demand Webcast, March 12, 2012.

    Hudgens, S., & Marquis, P. (2012). Rasch measurement: a mixed methods approach for assessing content validity. ISOQOL International Meeting proceedings. Budapest, Hungary, October 24-27. Quality of Life Research, 21( ), 40.

    Hudgens, S., & Misra, S. (2012). Perspectives on Mixed Methods to Assess Content Validity of a PRO Measure. ISOQOL International Meeting proceedings. Budapest, Hungary, October 24-27. Quality of Life Research, 21( ).

    Humphrey, L., Symonds, T., Gable, J., Abetz-Webb, L., Silverberg, J., Griffiths, P., . . . DeLozier, A. (2017). Mixed methods evaluation of an itch numeric rating scale among adult and adolescent patients with atopic dermatitis. Value in Health, 20(9), A806.

    Newton, L., DeLozier, A. M., Griffiths, P. C., Hill, J. N., Hudgens, S., Symonds, T., . . . Silverberg, J. I. (2019). Exploring content and psychometric validity of newly developed assessment tools for itch and skin pain in atopic dermatitis. Journal of patient-reported outcomes, 3(1), 42. doi:10.1186/s41687-019-0128-z

    Raine, R., Fitzpatrick, R., Barratt, H., Bevan, G., Black, N., Boaden, R., . . . Zwarenstein, M. (2016). Challenges, solutions and future directions in the evaluation of service innovations in health care and public health. Health Services and Delivery Research, 4(16). doi:10.3310/hsdr04160

    Ritenbaugh, C., Nichter, M., Nichter, M. A., Kelly, K. L., Sims, C. M., Bell, I. R., . . . Coons, S. J. (2011). Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format. BMC Complementary and Alternative Medicine, 11, 135. doi:10.1186/1472-6882-11-135

    Staunton, H., Willgoss, T., Nelsen, L., Burbridge, C., Sully, K., Rofail, D., & Arbuckle, R. (2019). An overview of using qualitative techniques to explore and define estimates of clinically important change on clinical outcome assessments. Journal of Patient Reported Outcomes, 3(1), 16. doi:10.1186/s41687-019-0100-y

    Willgoss, T., Humphrey, L., Symonds, T., & Cappelleri, J. (2014). Mixed methods for the development of clincial outcome assessments (COAs): Exploring further possibilities for mixed data collection and analysis. Value in Health, 17(3), A207.

Real-World Evidence (RWE) Publications

  • Publications

    Gugiu, P. C. (2019). Chapter 13: Assessing Needs of a Community College: A Mixed Methods Case Study. In D. F. Russ-Eft, & Sleezer, C. M (Ed.), Case Studies in Needs Assessment. (pp. 170-182). Thousand Oaks, CA: SAGE Publications.

    Hudgens, S., Globe, D., Norquist, J., & Reeve, B. (2012, Jun 2-6). Utilization of Rasch Measurement Models for Assessing Validity: A Mixed Methods Approach. Paper presented at the ISPOR 17th Annual International Meeting, Washington, D.C.

    Hudgens, S., Globe, D., Norquist, J., & Reeve, B. (2012). Utilization of Rasch Measurement Models for Assessing Validity: A Mixed Methods Approach. On Demand Webcast, March 12, 2012.

    Hudgens, S., & Marquis, P. (2012). Rasch measurement: a mixed methods approach for assessing content validity. ISOQOL International Meeting proceedings. Budapest, Hungary, October 24-27. Quality of Life Research, 21( ), 40.

    Hudgens, S., & Misra, S. (2012). Perspectives on Mixed Methods to Assess Content Validity of a PRO Measure. ISOQOL International Meeting proceedings. Budapest, Hungary, October 24-27. Quality of Life Research, 21( ).

    Humphrey, L., Symonds, T., Gable, J., Abetz-Webb, L., Silverberg, J., Griffiths, P., . . . DeLozier, A. (2017). Mixed methods evaluation of an itch numeric rating scale among adult and adolescent patients with atopic dermatitis. Value in Health, 20(9), A806.

    Newton, L., DeLozier, A. M., Griffiths, P. C., Hill, J. N., Hudgens, S., Symonds, T., . . . Silverberg, J. I. (2019). Exploring content and psychometric validity of newly developed assessment tools for itch and skin pain in atopic dermatitis. Journal of patient-reported outcomes, 3(1), 42. doi:10.1186/s41687-019-0128-z

    Raine, R., Fitzpatrick, R., Barratt, H., Bevan, G., Black, N., Boaden, R., . . . Zwarenstein, M. (2016). Challenges, solutions and future directions in the evaluation of service innovations in health care and public health. Health Services and Delivery Research, 4(16). doi:10.3310/hsdr04160

    Ritenbaugh, C., Nichter, M., Nichter, M. A., Kelly, K. L., Sims, C. M., Bell, I. R., . . . Coons, S. J. (2011). Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format. BMC Complementary and Alternative Medicine, 11, 135. doi:10.1186/1472-6882-11-135

    Staunton, H., Willgoss, T., Nelsen, L., Burbridge, C., Sully, K., Rofail, D., & Arbuckle, R. (2019). An overview of using qualitative techniques to explore and define estimates of clinically important change on clinical outcome assessments. Journal of Patient Reported Outcomes, 3(1), 16. doi:10.1186/s41687-019-0100-y

    Willgoss, T., Humphrey, L., Symonds, T., & Cappelleri, J. (2014). Mixed methods for the development of clincial outcome assessments (COAs): Exploring further possibilities for mixed data collection and analysis. Value in Health, 17(3), A207.