, Volume 19, Issue 2, pp 109–119 | Cite as

Beyond Efficacy and Effectiveness: Conducting Economic Analyses During Clinical Trials

  • Teresa M. Waters
  • Jeri A. LogemannEmail author
  • Barbara Roa Pauloski
  • Alfred W. Rademaker
  • Cathy L. Lazarus
  • Lisa A. Newman
  • Annette K. Hamner


Few studies have examined cost issues in the field of dysphagia. This study presents cost data collected during a clinical trial in speech–language pathology, demonstrating the types of cost analyses that can be conducted and highlighting obstacles and issues facing investigators who seek to conduct economic analyses in this arena. Seventy-nine patients were enrolled in the clinical trial to assess the impact of a swallowing intervention on swallowing and speech function. The patients were at least one year past treatment for head and neck cancer. No significant intervention differences were detected in these outcomes. A companion economic analysis was conducted in 37 of these patients using patient diaries and followup with identified health care providers. Analyses indicated that (1) the intervention did not significantly reduce health care expenditures; (2) indirect costs and costs of hospitalizations are both important factors to consider during a trial; and (3) health care costs of this population are high relative to the rest of the U.S. population. Attrition from the overall study population can pose a serious threat to the viability of an economic study. The article concludes with a discussion of how these issues can be addressed in future studies.


Swallowing therapy Efficacy Cost-effectiveness Clinical trials Deglutition Deglutition disorders 


  1. 1.
    Bennett, CL, Golub, R, Waters, TM, Tallman, MS, Rowe, JM 1997Economic analyses of phase III cooperative cancer group clinical trials: Are they feasible?Cancer Invest15227236PubMedGoogle Scholar
  2. 2.
    Bradlyn, AS, Pollock, BH 1996Quality-of-life research in the Pediatric Oncology Group: 1991–1995J Nat Cancer Inst204953Google Scholar
  3. 3.
    Kiebert, GM, Curran, D, Aaronson, NK 1998Quality of life as an endpoint in EORTC clinical trials. European Organization for Research and Treatment for CancerStat Med17561569CrossRefPubMedGoogle Scholar
  4. 4.
    Sprangers, MA, Cull, A, Groenvold, M, Bjordal, K, Blazeby, J, Aaronson, NK 1998The European Organization of Research and Treatment of Cancer approach to developing questionnaire modules: an update and overview. EORTC Quality of Life Study GroupQual Life Res7291300PubMedGoogle Scholar
  5. 5.
    Waters, TM, Bennett, CL, Vose, JM 1997Economic analyses of new technologies: The case of stem cell transplantationJ Clin Oncol1524PubMedGoogle Scholar
  6. 6.
    Yabroff, KR, Linas, BP, Schulman, K 1996Evaluation of quality of life for diverse patient populationsBreast Cancer Res Treat4087104PubMedGoogle Scholar
  7. 7.
    Ercoli, C, Graser, GN, Tallents, RH, Hagan, ME 1998Alternative procedure for making a metal suprastructure in a milled bar implant-supported overdentureJ Prosthet Dent80253258PubMedGoogle Scholar
  8. 8.
    Vohr, BR, Oh, W, Stewart, EJ, Bentkover, JD, Baggard, S, Lemons, J, Papile, LA, Pye, R 2001Comparison of costs and referral rates of 3 universal newborn hearing screening protocolsJ Pediatr.139238244CrossRefPubMedGoogle Scholar
  9. 9.
    Weirather, YP, Korth, N, White, KR, Downs, D, Woods–Kershner, N 1997Cost analysis of TEOAE-based universal newborn hearing screeningJ Commun Disord30477492CrossRefPubMedGoogle Scholar
  10. 10.
    Kezirian, EJ, Yueh, B 2001Accuracy of terminology and methodology in economic analyses in otolaryngologyOtolaryngol Head Neck Surg124496502CrossRefPubMedGoogle Scholar
  11. 11.
    Hatfield, D 1984Selected bibliography and glossary on DRG’s prospective pricingTher Recreation J185661PubMedGoogle Scholar
  12. 12.
    Rademaker, AW, Pauloski, BR, Logemann, JA, Shanahan, TK 1994Oropharyngeal swallow efficiency as a representative measure of swallowing functionJ Speech Hear Res37314325PubMedGoogle Scholar
  13. 13.
    Logemann, J 1993A manual for videofluoroscopic evaluation of swallowing2Pro-EdAustin, TXGoogle Scholar
  14. 14.
    Logemann, J 1998Evaluation and treatment of swallowing disorders2Pro-EdAustin, TXGoogle Scholar
  15. 15.
    Fisher, HB, Logemann, JA 1971The Fisher–Logemann Test of Articulation CompetenceHoughton MifflinBostonGoogle Scholar
  16. 16.
    Skelly, M, Spector, DJ, Donaldson, RC, Brodeur, A, Paletta, FX 1971Compensatory physiologic phonetics for the glossectomeeJ Speech Hear Disord36101114PubMedGoogle Scholar
  17. 17.
    Davis, J, Lazarus, C, Logemann, J, Hurst, P 1987Effect of a maxillary glossectomy prostheses on articulation and swallowingJ Prosthet Dent57715719PubMedGoogle Scholar
  18. 18.
    Wheeler, R, Logemann, J, Rosen, MS 1980A maxillary reshaping prosthesis: Its effectiveness in improving the speech and swallowing of postsurgical oral cancer patientsJ Prosthet Dent43491495PubMedGoogle Scholar
  19. 19.
    Guzman, J, Peloso, P, Bombardier, C 1999Capturing health care utilization after occupational low-back pain: development of an interviewer-administered questionnaireJ Clin Epidemiol52419427CrossRefPubMedGoogle Scholar
  20. 20.
    Norman, GR, McFarlane, AH, Streiner, DL, Neale, K 1982Health diaries: strategies for compliance and relation to other measuresMed Care20623629PubMedGoogle Scholar
  21. 21.
    Reuben, DB, Wong, RC, Walsh, KE, Hays, RD 1995Feasibility and accuracy of a postcard diary system for tracking healthcare utilization of community-dwelling older personsJ Am Geriatr Soc43550552PubMedGoogle Scholar
  22. 22.
    Gold, MR, Siegel, JE, Russell, LB, Weinstein, MC 1996Cost-effectiveness in health and medicineOxford University PressNew YorkGoogle Scholar
  23. 23.
    Shearer, G 2000The health care divide: unfair financial burdensThe Consumers UnionWashington DCGoogle Scholar

Copyright information

© Springer-Verlag 2004

Authors and Affiliations

  • Teresa M. Waters
    • 1
  • Jeri A. Logemann
    • 2
    Email author
  • Barbara Roa Pauloski
    • 2
  • Alfred W. Rademaker
    • 2
  • Cathy L. Lazarus
    • 2
  • Lisa A. Newman
    • 3
  • Annette K. Hamner
    • 3
  1. 1.Center for Health Services ResearchThe University of Tennessee Health Science CenterMemphisUSA
  2. 2.Department of Communication Sciences and DisordersNorthwestern UniversityEvanstonUSA
  3. 3.Department of Otolaryngology/Head and NeckSurgeryThe University of Tennessee Health Science CenterMemphisUSA

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