Hunink MGM, Krestin GP. Study design for concurrent development, assessment, and implementation of new diagnostic imaging technology. Radiology. 2002;222:604–14.
Article
PubMed
Google Scholar
Shah BR, Patel MR, Peterson ED, Douglas PS. Defining optimal research study design for cardiovascular imaging using computed tomography angiography as a model. Am J Cardiol. 2008;102:943–8.
Article
PubMed
Google Scholar
Bruns DE, Boyd JC. Assessing the impact of biomarkers on patient outcome: an obligatory step. Scand J Clin Lab Invest Suppl. 2010;242:85–9.
Article
PubMed
Google Scholar
Mitka M. Research offers only a limited view of imaging’s effect on patient outcomes. JAMA. 2010;303:599–600.
Article
CAS
PubMed
Google Scholar
Tatsioni A, Zarin DA, Aronson N, Samson DJ, Flamm CR, Schmid C, et al. Challenges in systematic reviews of diagnostic technologies. Ann Intern Med. 2005;142:1048–55.
Article
PubMed
Google Scholar
Ferrante di Ruffano L, Davenport C, Eisinga A, Hyde C, Deeks J. A capture-recapture analysis demonstrated that randomized controlled trials evaluating the impact of diagnostic tests on patient outcomes are rare. J Clin Epidemiol. 2012;65:282–7.
Article
PubMed
Google Scholar
Rodger M, Ramsay T, Fergusson D. Diagnostic randomized controlled trials: the final frontier. Trials. 2012;13:137.
Article
PubMed
PubMed Central
Google Scholar
IOM (Institute of Medicine). Initial National Priorities for Comparative Effectiveness Research. Washington, DC: The National Academies Press; 2009.
Google Scholar
National Institute for Health and Clinical Excellence [Internet]. Available from URL: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-diagnostics-guidance. Accessed 15 Sept 2015.
Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Mak. 1991;11:88–94.
Article
CAS
Google Scholar
Jarvik JG. Fundamentals of clinical research for radiologists. Am J Roentgenol. 2001;176:873–7.
Article
CAS
Google Scholar
Agency for Healthcare Research and Quality. Methods guide for medical test reviews. Rockville, MD; 2010. Available at URL: https://effectivehealthcare.ahrq.gov/ehc/products/246/558/Methods-Guide-for-Medical-Test-Reviews_Full-Guide_20120530.pdf. Accessed 15 Sept 2015.
Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336:1106e10.
Article
Google Scholar
National Institute for Health and Clinical Excellence. Diagnostics assessment programme manual. 2011. Available at URL: https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-diagnostics-guidance/Diagnostics-assessment-programme-manual.pdf. Accessed 15 Sept 2015.
Siontis KC, Siontis GCM, Contopoulos-Ioannidis DG, Ioannidis JPA. Diagnostic tests often fail to lead to changes in patient outcomes. J Clin Epidemiol. 2014;67:612–21.
Article
PubMed
Google Scholar
Delaney BC, Qume M, Moayyedi P, Logan RF, Ford AC, Elliott C, et al. Helicobacter pylori test and treat versus proton pump inhibitor in initial management of dyspepsia in primary care: multicentre randomised controlled trial (MRC-CUBE trial). BMJ. 2008;336:651–4.
Article
CAS
PubMed
PubMed Central
Google Scholar
Lijmer JG, Bossuyt PMM. Various randomized designs can be used to evaluate medical tests. J Clin Epidemiol. 2009;62:364–73.
Article
PubMed
Google Scholar
Goodacre S, Bradburn M, Fitzgerald P, Cross E, Collinson P, Gray A, et al. The RATPAC (Randomised Assessment of Treatment using Panel Assay of Cardiac markers) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department. Health Technol Assess. 2011;15:1–102.
Article
PubMed
PubMed Central
Google Scholar
de Bree R, van der Putten L, Hoekstra OS, Kuik DJ, Uyl-de Groot CA, van Tinteren H, et al. A randomized trial of PET scanning to improve diagnostic yield of direct laryngoscopy in patients with suspicion of recurrent laryngeal carcinoma after radiotherapy. Contemp Clin Trials. 2007;28:705–12.
Article
PubMed
Google Scholar
Valk PE. Randomized controlled trials are not appropriate for imaging technology evaluation. J Nucl Med. 2000;41:1125–6.
CAS
PubMed
Google Scholar
Bossuyt PM, Lijmer JG, Mol BW. Randomised comparisons of medical tests: sometimes invalid, not always efficient. Lancet. 2000;356:1844–7.
Article
CAS
PubMed
Google Scholar
Deeks JJ. Assessing outcomes following tests. In: Price CP, Christenson RH, editors. Evidence-based laboratory medicine: principles, practice and outcomes. 2nd ed. Washington D.C.: AACC Press; 2007. p. 95–111.
Google Scholar
Pletcher MJ, Pignone M. Evaluating the clinical utility of a biomarker: a review of methods for estimating health impact. Circulation. 2011;123:1116–24.
Article
PubMed
PubMed Central
Google Scholar
Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ. 2001;323:42–6.
Article
PubMed
PubMed Central
Google Scholar
Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008;336:601–5.
Article
PubMed
PubMed Central
Google Scholar
Savović J, Jones H, Altman D, Harris R, Jüni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomized controlled trials: combined analysis of meta-epidemiological studies. Health Technol Assess. 2012;16:1–82.
PubMed
Google Scholar
Ferrante di Ruffano L, Dinnes J, Taylor-Phillips S, Davenport C, Hyde C and Deeks JL. Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions. BMC Med Res Meth. 2017. doi:10.1186/s12874-016-0287-z.
Bossuyt PM, Irwig L, Craig J, Glasziou P. Comparative accuracy: assessing new tests against existing diagnostic pathways. BMJ. 2006;332:1089–92.
Article
PubMed
PubMed Central
Google Scholar
Moher D, Hopewell S, Schultz, Montori V, Gøtzsche P, Devereaux PJ, et al. CONSORT 2010 Explanation and elaboration: updated guidelines for reporting parallel group randomized trials. BMJ. 2010;340:c869.
Article
PubMed
PubMed Central
Google Scholar
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.
Article
PubMed
Google Scholar
Higgins JPT, Altman DG, Sterne JAC, Cochrane Statistical Methods Group, Cochrane Bias Methods Group, editors. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. The Cochrane Collaboration; 2011. Version 5.1.0 [updated March 2011]. Available from URL: http://handbook.cochrane.org/. Accessed 24 Nov 2012.
Bridgman S, Richards PJ, Walley G, MacKenzie G, Clement D, McCall I, et al. The effect of magnetic resonance imaging scans on knee arthroscopy: randomized controlled trial. Arthroscopy. 2007;23:1167–73.
Article
PubMed
Google Scholar
Martina B, Nordmann A, Dieterle T, Sigle JP, Bengel G, Kiefer G, et al. Impact of baseline echocardiography on treatment outcome in primary care patients with newly detected arterial hypertension: a randomized trial. Am J Hypertens. 2006;19:1150–5.
Article
PubMed
Google Scholar
Moe GW, Howlett J, Januzzi JL, Zowall H, Canadian Multicenter Improved Management of Patients With Congestive Heart Failure (IMPROVE-CHF) Study Investigators. N-terminal pro-B-type natriuretic peptide testing improves the management of patients with suspected acute heart failure: primary results of the Canadian prospective randomized multicenter IMPROVE-CHF study. Circulation. 2007;115:3103–10.
Article
CAS
PubMed
Google Scholar
Rodger MA, Bredeson CN, Jones G, Rasuli P, Raymond F, Clement AM, et al. The bedside investigation of pulmonary embolism diagnosis study: a double-blind randomized controlled trial comparing combinations of 3 bedside tests vs ventilation-perfusion scan for the initial investigation of suspected pulmonary embolism. Arch Intern Med. 2006;166:181–7.
Article
PubMed
Google Scholar
Mastenbroek S, Twisk M, van Echten-Arends J, Sikkema-Raddatz B, Korevaar JC, Verhoeve HR, et al. In vitro fertilization with preimplantation genetic screening. N Engl J Med. 2007;357:9–17.
Article
CAS
PubMed
Google Scholar
Anderson DR, Kahn SR, Rodger MA, Kovacs MJ, Morris T, Hirsch A, et al. Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: a randomized controlled trial. JAMA. 2007;298:2743–53.
Article
CAS
PubMed
Google Scholar
Brooks S, Cicuttini FM, Lim S, Taylor D, Stuckey SL, Wluka AE. Cost effectiveness of adding magnetic resonance imaging to the usual management of suspected scaphoid fractures. Br J Sports Med. 2005;39:75–9.
Article
CAS
PubMed
PubMed Central
Google Scholar
Takemura Y, Ebisawa K, Kakoi H, Saitoh H, Kure H, Ishida H, et al. Antibiotic selection patterns in acutely febrile new outpatients with or without immediate testing for C reactive protein and leucocyte count. J Clin Pathol. 2005;58:729–33.
Article
CAS
PubMed
PubMed Central
Google Scholar
Grimes DA, Schulz KF. Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol. 2005;105:1114–8.
Article
PubMed
Google Scholar
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408–12.
Article
CAS
PubMed
Google Scholar
Gravel J, Opatrny L, Shapiro S. The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say? Clin Trials. 2007;4:350–6.
Article
PubMed
Google Scholar
Bell ML, Fiero M, Horton NJ, Hsu CH. Handling missing data in RCTs; a review of the top medical journals. BMC Med Res Methodol. 2014;14:118.
Article
PubMed
PubMed Central
Google Scholar
Kruse RL, Alper BS, Reust C, Stevermer JJ, Shannon S, Williams RH. Intention-to-treat analysis: who is in? Who is out? J Fam Pract. 2002;51:969–71.
PubMed
Google Scholar
Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P. Reporting of sample size calculation in randomized controlled trials: review. BMJ. 2009;338:b1732.
Article
PubMed
PubMed Central
Google Scholar
Boutron I, Tubach F, Giraudeau B, Ravaud P. Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis. JAMA. 2003;290:1062–70.
Article
PubMed
Google Scholar
Jacquier I, Boutron I, Moher D, Roy C, Ravaud P. The reporting of randomizes clinical trials using a surgical intervention is in need of immediate improvement. A systematic review. Ann Surg. 2006;244:677–83.
Article
PubMed
PubMed Central
Google Scholar
Poolman RW, Struijs PAA, Krips R, Sierevelt IN, Marti RK, Farrokhyar F, et al. Reporting of Outcomes in orthopaedic randomized trials: Does blinding of outcome assessors matter? J Bone Joint Surg Am. 2007;89:550–8.
PubMed
Google Scholar
Boutron I, Tubach F, Giraudeau B, Ravaud P. Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol. 2004;57:543–50.
Article
PubMed
Google Scholar
Nikken JJ, Oei EH, Ginai AZ, et al. Acute peripheral joint injury: cost and effectiveness of low-field-strength MR imaging—results of randomized controlled trial. Radiology. 2005;236:958–67.
Article
PubMed
Google Scholar
Ferrante di Ruffano L, Hyde CJ, McCaffery KJ, Bossuyt PMM, Deeks JJ. Assessing the value of diagnostic tests–A framework for designing and evaluating trials. BMJ. 2012;344:e686.
Article
PubMed
Google Scholar
Hirji KF, Fagerland MW. Outcome based subgroup analysis: a neglected concern. Trials. 2009;10:33.
Article
PubMed
PubMed Central
Google Scholar
Hopewell S, Dutton S, Yu L-M, Chan A-W, Altman DG. The quality of reports of randomized trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ. 2010;340:c723.
Article
PubMed
PubMed Central
Google Scholar
Mills EJ, Wu P, Gagnier J, Devereaux PJ. The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemp Clin Trials. 2005;26:480–7.
Article
PubMed
Google Scholar
Appendix H. Appraisal checklists, evidence tables, GRADE and economic profiles. https://www.nice.org.uk/process/pmg20/resources/developing-nice-guidelines-the-manual-appendix-h-2549711485. Accessed 12 Jan 2017.
Chan A-W, Altman DG. Epidemiology and reporting of randomized trials published in PubMed journals. Lancet. 2005;365:1159–62.
Article
PubMed
Google Scholar
Oxford Centre for Evidence–Based Medicine [internet]. Available at URL: http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/. Accessed 15 Sept 2015.
Rothwell PM. External validity of randomized controlled trials: “To whom do the results of this trial apply?”. Lancet. 2005;365:82–93.
Article
PubMed
Google Scholar
Tanahatoe SJ, Lambalk CB, Hompes PG. The role of laparoscopy in intrauterine insemination: a prospective randomized reallocation study. Hum Reprod. 2005;20:3225–30.
Article
CAS
PubMed
Google Scholar