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  • 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.

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1.AHRQ. Methods guide for medical test reviews (draft). Rockville, MD: Agency for Healthcare Research and Quality; 2010.
2.Albon E, Tsourapas A, Frew E, et al. Structural neuroimaging in psychosis: A systematic review and economic evaluation. Health Technol Assess. 2008;12:iiiiv, ix-163.
3.Bossuyt PM, Irwig L, Craig J, Glasziou P. Diagnosis - Comparative accuracy: Assessing new tests against existing diagnostic pathways. BMJ. 2006;332:10891092.
4.Bossuyt PM, Lijmer JG, Mol BW, et al. Randomised comparisons of medical tests: Sometimes invalid, not always efficient. Lancet. 2000;356:18441847.
5.Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD initiative. BMJ. 2003;326:4144.
6.EUnetHTA. HTA core model for diagnostic technologies v 1.0r. Copenhagen: European Network for Health Technology Assessment; 2008.
7.Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making. 1991;11:8894.
8.Glasziou PP, Aronson JK. An introduction to monitoring therapeutic interventions in clinical practice. In: Glasziou PP, Irwig L, Aronson JK, eds. Evidence-based medical monitoring. Malden, MA: BMJ Books; 2008.
9.Grootendorst DC, Jager KJ, Zoccali C, Dekker FW. Screening: Why, when, and how. Kidney Int. 2009;76:694699.
10.Guyatt GH, Tugwell PX, Feeny DH, et al. The role of before after studies of therapeutic impact in the evaluation of diagnostic technologies. J Chronic Dis. 1986;39:295304.
11.Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions. Version 5.0.1 (updated September 2008). CochraneCollaboration; 2008.
12.Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials. 1996;17:112.
13.Knottnerus JA, van Weel C, Muris JWM. Evidence base of clinical diagnosis—Evaluation of diagnostic procedures. BMJ. 2002;324:477480.
14.Lijmer JG, Leeflang M, Bossuyt PM. Proposals for a phased evaluation of medical tests. Med Decis Making. 2009;29:E13E21.
15.Lord SJ, Irwig L, Simes RJ. 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.Meads CA, Davenport CF. 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.Moher D, Schulz KF, Altman DG. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657662.
18.MSAC. Guidelines for the assessment of diagnostic technologies. Canberra: Medical Services Advisory Committee (MSAC), Commonwealth of Australia; 2005.
19.MSAC. Positron emission tomography for head and neck cancer. Canberra: Medical Services Advisory Committee (MSAC), Commonwealth of Australia; 2008.
20.NICE. Diagnostics assessment programme; Interim methods statement (March 2010). London: National Institute for Health and Clinical Excellence; 2010.
21.Pawson RF, Greenhalgh TF, Harvey GF, Walshe K. Realist review - a new method of systematic review designed for complex policy interventions. J Health Serv Res Policy. 2005;10:2134.
22.Pepe MS. Introduction. In: Pepe MS, ed. The statistical evaluation of medical tests for classification and prediction. Oxford: Oxford University Press; 2003.
23.Piper MA, Aronson N, Ziegler KM, et al. Special report: Fecal DNA analysis for colon cancer screening. Assessment program 21(6). Blue Cross Blue Shield Association; 2006.
24.Scott AM, Gunawardana DH, Bartholomeusz D, et al. 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.
25.Staub LP, Lord SJ, Simes RJ, et al. . Using patient management as a proxy for patient outcomes in test evaluation. Methods for Evaluating Medical Tests and Biomarkers 2nd Symposium; 1–2 July 2010; Birmingham: 41.
26.Whiting P, Rutjes AW, Reitsma JB, et al. 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.
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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
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