Skip to main content
    • Aa
    • Aa


  • Lukas P. Staub (a1), Suzanne Dyer (a2), Sarah J. Lord (a2) and R. John Simes (a2)

Objectives: The aim of this study is to review how health technology assessments (HTA) of medical tests incorporate intermediate outcomes in conclusions about the effectiveness of tests on improving health outcomes.

Methods: Systematic review of English-language test assessments in the HTA database from January 2005 to February 2010, supplemented by a search of the Web sites of International Network of Agencies for Health Technology Assessment (INAHTA) members.

Results: A total of 149 HTAs from eight countries were assessed. Half evaluated tests for screening or diagnosis, a third for disease classification (including staging, prognosis, monitoring), and a fifth for multiple purposes. In seventy-one HTAs (48 percent) only diagnostic accuracy was reported, while in seventeen (11 percent) evidence of health outcomes was reported in addition to accuracy. Intermediate outcomes, mainly the impact of test results on patient management, were considered in sixty-one HTAs (41 percent). Of these, forty-seven identified randomized trials or observational studies reporting intermediate outcomes. The validity of these intermediate outcomes as a surrogate for health outcomes was not consistently discussed; nor was the quality appraisal of this evidence. Clear conclusions about whether the test was effective were included in approximately 60 percent of HTAs.

Conclusions: Intermediate outcomes are frequently assessed in medical test HTAs, but interpretation of this evidence is inconsistently reported. We recommend that reviewers explain the rationale for using intermediate outcomes, identify the assumptions required to link intermediate outcomes and patient benefits and harms, and assess the quality of included studies.

Hide All
2. E Albon , A Tsourapas , E Frew , Structural neuroimaging in psychosis: A systematic review and economic evaluation. Health Technol Assess. 2008;12:iiiiv, ix-163.

3. PM Bossuyt , L Irwig , J Craig , P Glasziou . Diagnosis - Comparative accuracy: Assessing new tests against existing diagnostic pathways. BMJ. 2006;332:10891092.

4. PM Bossuyt , JG Lijmer , BW Mol , Randomised comparisons of medical tests: Sometimes invalid, not always efficient. Lancet. 2000;356:18441847.

5. PM Bossuyt , JB Reitsma , DE Bruns , Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD initiative. BMJ. 2003;326:4144.

7. DG Fryback , JR Thornbury . The efficacy of diagnostic imaging. Med Decis Making. 1991;11:8894.

8. PP Glasziou , JK Aronson . An introduction to monitoring therapeutic interventions in clinical practice. In: PP Glasziou , L Irwig , JK Aronson , eds. Evidence-based medical monitoring. Malden, MA: BMJ Books; 2008.

9. DC Grootendorst , KJ Jager , C Zoccali , FW Dekker . Screening: Why, when, and how. Kidney Int. 2009;76:694699.

10. GH Guyatt , PX Tugwell , DH Feeny , The role of before after studies of therapeutic impact in the evaluation of diagnostic technologies. J Chronic Dis. 1986;39:295304.

11. JPT Higgins , DG Altman . Chapter 8: Assessing risk of bias in included studies. In: JPT Higgins , S Green , eds. Cochrane handbook for systematic reviews of interventions. Version 5.0.1 (updated September 2008). CochraneCollaboration; 2008.

12. AR Jadad , RA Moore , D Carroll , Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials. 1996;17:112.

13. JA Knottnerus , C van Weel , JWM Muris . Evidence base of clinical diagnosis—Evaluation of diagnostic procedures. BMJ. 2002;324:477480.

14. JG Lijmer , M Leeflang , PM Bossuyt . Proposals for a phased evaluation of medical tests. Med Decis Making. 2009;29:E13E21.

15. SJ Lord , L Irwig , RJ Simes . When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials? Ann Intern Med. 2006;144:850855.

16. CA Meads , CF Davenport . Quality assessment of diagnostic before-after studies: Development of methodology in the context of a systematic review. BMC Med Res Methodol. 2009;9:3.

17. D Moher , KF Schulz , DG Altman . The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657662.

21. RF Pawson , TF Greenhalgh , GF Harvey , K Walshe . Realist review - a new method of systematic review designed for complex policy interventions. J Health Serv Res Policy. 2005;10:2134.

24. AM Scott , DH Gunawardana , D Bartholomeusz , PET changes management and improves prognostic stratification in patients with head and neck cancer: Results of a multicenter prospective study. J Nucl Med. 2008;49:15931600.

26. P Whiting , AW Rutjes , JB Reitsma , The development of QUADAS: A tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol. 2003;3:25.

Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

International Journal of Technology Assessment in Health Care
  • ISSN: 0266-4623
  • EISSN: 1471-6348
  • URL: /core/journals/international-journal-of-technology-assessment-in-health-care
Please enter your name
Please enter a valid email address
Who would you like to send this to? *


Type Description Title
Supplementary Materials

Staub Supplementary Materials
Staub Supplementary Materials

 PDF (40 KB)
40 KB


Full text views

Total number of HTML views: 3
Total number of PDF views: 22 *
Loading metrics...

Abstract views

Total abstract views: 135 *
Loading metrics...

* Views captured on Cambridge Core between September 2016 - 18th October 2017. This data will be updated every 24 hours.