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Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

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Abstract

New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

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Abbreviations

CAT:

Computer adaptive test

DCRI:

Duke Clinical Research Institute

EDC:

Electronic data capture

FDA:

US Food and Drug Administration

IRT:

Item Response Theory

IVRS:

Interactive Voice Response system

MRC:

Medical Research Council

NIH:

National Institutes of Health

PRO:

Patient-reported outcome

PROMIS:

Patient Reported Outcome Management Information System

T1:

First translational roadblock

T2:

Second translational roadblock

WBS:

Work breakdown structure

References

  1. Spitzer, W. O., State of science 1986: quality of life and functional status as target variables for research. J. Chronic. Dis. 40:465–471, 1987.

    Article  Google Scholar 

  2. Mark, D. B., Quality of life assessment. In: Califf, R. M., Mark, D. B., and Wagner, G. S. (Eds.), Acute Coronary Care, 2nd edition. Mosby-Year Book, Saint Louis, 1995.

    Google Scholar 

  3. Glasgow, R. E., Magid, D. J., Beck, A., Ritzwoller, D., and Estabrooks, P. A., Practical clinical trials for translating research to practice: design and measurement recommendations. Med. Care. 43:551–557, 2005.

    Article  Google Scholar 

  4. Glasgow, R. E., Green, L. W., Klesges, L. M., et al., External validity: we need to do more. Ann. Behav. Med. 31:105–108, 2006.

    Article  Google Scholar 

  5. Green, L. W., and Glasgow, R. E., Evaluating the relevance, generalization, and applicability of research: issues in external validation and translation methodology. Eval. Health Prof. 29:126–153, 2006.

    Article  Google Scholar 

  6. Green, L., and Ottoson, J., From efficacy to effectiveness to community and back: evidence-based practice vs. practice-based evidence. National Institutes of diabetes, Digestive and Kidney Diseases, National Institutes of Health. 2008.

  7. Tunis, S. R., Stryer, D. B., and Clancy, C. M., Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 290:1624–1632, 2003.

    Article  Google Scholar 

  8. Patient-Reported Outcomes Measurement System (PROMIS) Roadmap Initiative., National Institutes of Health. 2008; www.nihpromis.org: Accessed November 22, 2007.

  9. Ader, D. N., Developing the patient-reported outcomes measurement information system (PROMIS). Med. Care. 45:S1–S2, 2007.

    Article  Google Scholar 

  10. Cella, D., Yount, S., Rothrock, N., et al., The patient-reported outcomes measurement information system (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med. Care. 45:S3–S11, 2007.

    Article  Google Scholar 

  11. The Role of Purchasers and Payers in the Clinical Research Enterprise, Workshop Summary. National Academy, Washington, D.C., 2002.

    Google Scholar 

  12. Sung, N. S., Crowley, W. F., Jr., Genel, M., et al., Central challenges facing the national clinical research enterprise. JAMA. 289:1278–1287, 2003.

    Article  Google Scholar 

  13. Woolf, S. H., The meaning of translational research and why it matters. JAMA. 299:211–213, 2008.

    Article  Google Scholar 

  14. Mercer, S. L., DeVinney, B. J., Fine, L. J., Green, L. W., and Dougherty, D., Study designs for effectiveness and translation research: identifying trade-offs. Am. J. Prev. Med. 33:139–154, 2007.

    Article  Google Scholar 

  15. Fixsen, D. L., Naoom, S. F., Blase, K. A., Friedman, R. M., and Wallace, F., Implementation research: a synthesis of the literature. Tampa: National Implementation Research Network, Louise de la Parte Florida Mental Health Institute, University of South Florida. 2005; FMHI publication 231: Accessed November 17, 2007.

  16. Campbell, M., Fitzpatrick, R., Haines, A., et al., Framework for design and evaluation of complex interventions to improve health. BMJ. 321:694–696, 2000.

    Article  Google Scholar 

  17. Blackwood, B., Methodological issues in evaluating complex healthcare interventions. J. Adv. Nurs. 54:612–622, 2006.

    Article  Google Scholar 

  18. Byrne, M., Cupples, M. E., Smith, S. M., et al., Development of a complex intervention for secondary prevention of coronary heart disease in primary care using the UK Medical Research Council framework. Am. J. Manag. Care. 12:261–266, 2006.

    Google Scholar 

  19. Paul, G., Smith, S. M., Whitford, D., O’Kelly, F., and O’Dowd, T., Development of a complex intervention to test the effectiveness of peer support in type 2 diabetes. BMC Health Serv. Res. 7:136, 2007.

    Article  Google Scholar 

  20. Power, R., Langhaug, L. F., Nyamurera, T., Wilson, D., Bassett, M. T., and Cowan, F. M., Developing complex interventions for rigorous evaluation—a case study from rural Zimbabwe. Health Educ. Res. 19:570–575, 2004.

    Article  Google Scholar 

  21. Robinson, L., Francis, J., James, P., Tindle, N., Greenwell, K., and Rodgers, H., Caring for carers of people with stroke: developing a complex intervention following the Medical Research Council framework. Clin. Rehabil. 19:560–571, 2005.

    Article  Google Scholar 

  22. Rowlands, G., Sims, J., and Kerry, S., A lesson learnt: the importance of modelling in randomized controlled trials for complex interventions in primary care. Fam. Pract. 22:132–139, 2005.

    Article  Google Scholar 

  23. Eisenstein, E. L., Collins, R., Cracknell, B. S., et al., Sensible approaches for reducing clinical trial costs. Clin. Trials. 5:75–84, 2008.

    Article  Google Scholar 

  24. Freidman, L., Furberg, C. D., and DeMets, D. L., Fundamentals of Clinical Trials, 3rd edition. Mosby-Year Book, St. Louis, 1996.

    Google Scholar 

  25. Corrrigan, M., Cupples, M. E., Smith, S. M., et al., The contribution of qualitative research in designing a complex intervention for secondary prevention of coronary heart disease in two different healthcare systems. BMC Health Serv. Res. 6:90, 2006.

    Article  Google Scholar 

  26. Haynes, B., and Haines, A., Barriers and bridges to evidence based clinical practice. BMJ. 317:273–276, 1998.

    Article  Google Scholar 

  27. O’Cathain, A., Murphy, E., and Nicholl, J., Why, and how, mixed methods research is undertaken in health services research in England: a mixed methods study. BMC Health Serv. Res. 7:85, 2007.

    Article  Google Scholar 

  28. Altheide, D. L., and Johnson, J. M., Criteria for assessing interpretive validity in qualitative research. In: Denzin, N. K., and Lincoln, Y. S. (Eds.), Handbook of Qualitative Research. Sage, London, England, pp. 485–499, 1994.

    Google Scholar 

  29. Giacomini, M. K., and Cook, D. J., Users’ guides to the medical literature: XXIII. Qualitative research in health care A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA. 284:357–362, 2000.

    Article  Google Scholar 

  30. Giacomini, M. K., and Cook, D. J., Users’ guides to the medical literature: XXIII. Qualitative research in health care B. What are the results and how do they help me care for my patients? Evidence-Based Medicine Working Group. JAMA. 284:478–482, 2000.

    Article  Google Scholar 

  31. Marshall, M. N., Sampling for qualitative research. Fam. Pract. 13:522–525, 1996.

    Article  Google Scholar 

  32. Bradley, C. P., Turning anecdotes into data—the critical incident technique. Fam. Pract. 9:98–103, 1992.

    Article  Google Scholar 

  33. Evanston Northwestern Health., Functional Specification: Analysis Phase V1.1. PROMIS Project Documentation 08/31/2006. 2006.

  34. The United Kingdom’s Department of Health., Clinical Trials Tool Kit. www.ct-toolkit.ac.uk/route_maps/map_landing.cfm/cit_id=250. 2007; Accessed November 01, 2007.

  35. The Stanford/Packard Center for Translational Research in Medicine (SPCTRM)., http://clinicaltrials.stanford.edu/manual/process_map.html. 2007; Accessed November 01, 2007.

  36. The Center for Management Research in Healthcare., Trial Process Views for CALGB (2006) and the Vanderbilt Ingram Cancer Center (2004). http://www.cmrhc.org/publications/cat_view-2.html. 2006; Accessed November 01, 2007.

  37. Duke Clinical Research Institute., http://www.dcri.duke.edu/who_we_are/. 2007; Accessed November 01, 2007.

  38. US Food and Drug Administration., Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. www.promismap@dcri.com. 2006; Accessed March 29, 2008.

  39. U.S. Food and Drug Administration., Title 21 cde of federal regulations (21 CFR part 11): electronic records, electronic signatures. http://www.fda.gov/ora/compliance_ref/part11/. 2000; Accessed March 31, 2008.

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Acknowledgments

The authors thank Allyn Meredith, MA for her expert work in editing this manuscript. We are also indebted to this study’s focus group participants from the DCRI and to other members of the PROMIS network for their efforts in developing the initial set of process diagrams. This study, including author funding and manuscript preparation, was supported by The National Institutes of Health’s Patient Reported Outcomes RFA: Dynamic Outcome Assessment (5U01 AR052186-04)—a Roadmap Initiative, Kevin Weinfurt Principal Investigator. The funding body did not participate in the study design, in the collection analysis, and interpretation of data, in the writing of the manuscript, or in the decision to submit the manuscript for publication.

Competing Interests

The authors declare that they have no competing interests.

Authors’ Contributions

ELE and LWD participated in the conception and design of the study, analyzed and interpreted data, and drafted the manuscript. MN and KPW participated in the conception and design of the study, analyzed and interpreted data, and critically revised it for intellectual content. All authors read and approved the final manuscript.

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Authors and Affiliations

  1. Duke Clinical Research Institute, Duke University Medical Center, 2400 Pratt Street Room 0311, Durham, NC, 27705, USA

    Eric L. Eisenstein, Lawrence W. Diener & Kevin P. Weinfurt

  2. Duke Translational Medicine Institute, Duke University Medical Center, Hock Plaza, 2424 Erwin Rd. Suite 500, Durham, NC, 27705, USA

    Meredith Nahm

Authors
  1. Eric L. Eisenstein
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  2. Lawrence W. Diener
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  3. Meredith Nahm
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  4. Kevin P. Weinfurt
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Corresponding author

Correspondence to Eric L. Eisenstein.

Additional information

Lawrence W. Diener, Meredith Nahm and Kevin P. Weinfurt contributed equally to this work.

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Eisenstein, E.L., Diener, L.W., Nahm, M. et al. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study. J Med Syst 35, 1521–1530 (2011). https://doi.org/10.1007/s10916-010-9429-8

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  • DOI: https://doi.org/10.1007/s10916-010-9429-8

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