Empirical studies presenting an illustration of the headroom methodology
1	2013	Cao Q, Postmus D, Hillege HL, Buskens E. Probability elicitation to inform early health economic evaluations of new medical technologies: a case study in heart failure disease management. Value Health. 2013 Jun; 16(4):529–35. [47]
2	2015	Chapman AM, Taylor CA, Girling AJ. Early HTA to Inform Medical Device Development Decisions - The Headroom Method. In: XIII Mediterranean Conference on: Springer International Publishing; 2014. pp. 1151–4. (IFMBE Proceedings; vol. 41). [25]
3		Girling A, Lilford R, Cole A, Young T. Headroom approach to device development: current and future directions. Int J Technol Assess Health Care. 2015 Jan; 31(5):331–8. [24]
4	2016	Markiewicz K, van Til JA, IJzerman MJ. Commercial viability of medical devices using Headroom and return on investment calculation. Technological Forecasting and Social Change. 112 (November):338–46. [26]

Empirical studies presenting an early health economic model
5	2013	Retèl VP, Grutters JPC, van Harten WH, Joore MA. Value of research and value of development in early assessments of new medical technologies. Value Health. 2013 Jul;16(5):720–8 [29]
6*		Retèl VP, Joore MA, Drukker CA, Bueno-de-Mesquita JM, Knauer M, van Tinteren H, et al. Prospective cost-effectiveness analysis of genomic profiling in breast cancer. Eur J Cancer. 2013 Dec;49(18):3773–9. [39]
7		Koerber F, Rolauffs B, Rogowski W. Early evaluation and value-based pricing of regenerative medicine technologies. Regen Med. 2013 Nov;8(6):747–58. [30]
8	2015	Miquel-Cases A, Steuten LMG, Retèl VP, van Harten WH. Early stage cost-effectiveness analysis of a BRCA1-like test to detect triple negative breast cancers responsive to high dose alkylating chemotherapy. Breast. 2015 Aug;24(4):397–405. [32]
9		Brandes A, Sinner MF, Kääb S, Rogowski WH. Early decision-analytic modeling - a case study on vascular closure devices. BMC Health Serv Res. 2015 Oct 27;15:486. [31]
10	2016	de Windt TS, Sorel JC, Vonk LA, Kip MMA, IJzerman MJ, Saris DBF. Early health economic modelling of single-stage cartilage repair. Guiding implementation of technologies in regenerative medicine. J Tissue Eng Regen Med. 2016 Jul 12. [34]
11		Buisman LR, Luime JJ, Oppe M, Hazes JMW, Rutten-van Mölken MPMH. A five-year model to assess the early cost-effectiveness of new diagnostic tests in the early diagnosis of rheumatoid arthritis. Arthritis Res Ther. 2016 Jun 10;18(1):135. [38]
12*		Buisman LR, Rutten-van Mölken MPMH, Postmus D, Luime JJ, Uyl-de Groot CA, Redekop WK. The early bird catches the worm: early cost-effectiveness of new medical tests. Int J Technol Assess Health Care. 2016 Jan;32(1-2):46–53. [33]
13*		Miquel-Cases A, Retèl VP, van Harten WH, Steuten LMG. Decisions on Further Research for Predictive Biomarkers of High-Dose Alkylating Chemotherapy in Triple-Negative Breast Cancer: A Value of Information Analysis. Value Health. 2016 Jun;19(4):419–30. [37]
14		Kolominsky-Rabas PL, Kriza C, Djanatliev A, Meier F, Uffenorde S, Radeleff J, et al. Health Economic Impact of a Pulmonary Artery Pressure Sensor for Heart Failure Telemonitoring: A Dynamic Simulation. Telemedicine and e-Health. 2016 Oct;22(10):798–808. [36]
15		Luime JJ, Buisman LR, Oppe M, Hazes JMW, Rutten-van Mölken MPMH. Cost-Effectiveness Model for Evaluating New Diagnostic Tests in the Evaluation of Patients With Inflammatory Arthritis at Risk of Having Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Jul;68(7):927–35. [35]
16		Kip MMA, Steuten LMG, Koffijberg H, IJzerman MJ, Kusters R. Using expert elicitation to estimate the potential impact of improved diagnostic performance of laboratory tests: a case study on rapid discharge of suspected non-ST elevation myocardial infarction patients. J Eval Clin Pract. 2016 Oct 19. [45]

*Excluded from further review (see text for reason)