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Academic Publications

2023

 

108. Mitchell A & Goldstein DACost Savings and Increased Access with Ultra-Low dose Immunotherapy. In press at The Journal of Clinical Oncology.

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107. Peer CJ, Schmidt KT, Arisa O, Richardson WJ, Paydary K, Goldstein DA, Gulley JL, Figg WD, Ratain MJ. In Silico Re-Optimization of Atezolizumab Dosing using Population Pharmacokinetic and Exposure-Response Simulation. In press at The Journal of Clinical Pharmacology.

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106. Goldstein DA, Ginsberg GM, Hofnung-Gabbay D, De Abreu Lourenco R, Loong HH, Goh B, Chan KKW, Di Maio M, Perrone F, Hall PS, Zer A, Rosenbaum E.  Multinational Analysis of Health Care Costs Related to Extended-Interval Fixed Dosing of Checkpoint Inhibitors. In press at JAMA Network Open.

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105. Tannock IF, Goldstein DA, Ofer J, Gyawali B, Meirson T. Evaluating trials of adjuvant therapy: is there benefit for people with resected renal cancer? In press at Journal of Clinical Oncology.

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104. Icht O, Leader A, Batat E, Joseph L, Shochat T, Goldstein DA, Dudnik E, Spectre G, Raanani P, Hammerman A, Zer A. Arterial and venous thromboembolism in ALK-rearrangement positive non-small cell lung cancer: a population-based cohort study. In press at The Oncologist.

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103. Tschernichovsky R, Averbuch I, Goldstein DA, Mutai R, Dudnik E, Rotem O, Peled N, Laufer-Geva S, Goldberg Y, Zer A. BRCA Mutations Detected by Tumour Next-Generation-Sequencing in NSCLC: Impact on Response to Therapy and Disease Course. In press at Translational Lung Cancer Research.

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102. Meirson T, Goldstein DA, Gyawali B, Tannock IF. Review of the MonarchE Trial Suggests no Evidence to Support Use of Adjuvant Abemaciclib in Women with Breast Cancer. In press at Lancet Oncology.

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101. Wesevich A, Goldstein DA, Paydary K, Peer C, Figg W, Ratain M. Interventional Pharmacoeconomics for Immune Checkpoint Inhibitors through Alternative Dosing Strategies. In press at British Journal of Cancer.

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100. Averbuch I, Tschernichovsky R, Icht O, Goldstein DA, Mutai R, Dudnik E, Rotem O, Peled N, Allen AM, Laufer-Geva S, Goldberg Y, Zer A. Correlations between pathogenic variants in DNA repair genes and anticancer treatment efficacy in stage IV non-small cell lung cancer: A large real-world cohort and review of the literature. In press at Thoracic Cancer.

 

2022

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99. Hirsch I, Goldstein DA, Tannock IF, Butler MO, Gilbert DC. Optimising the dose and schedule of immune checkpoint inhibitors in cancer to allow global access. In press at Nature Medicine.

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98. Margalit O, Harmsen W, Shacham-Shmueli E, Voss M, Boursi B, Wagner A, Cohen R, Olswold C, Saltz L, Goldstein DA, Hurwitz H, Tebbutt N, Kabbinavar F, Adams R, Chibaudel B, Grothey A, Yoshino T, Zalcberg J, de Gramont A, Shi Q, Lenz HJ. Evaluating Sex as a Predictive Marker for Response to Bevacizumab in Metastatic Colorectal Carcinoma: Pooled Analysis of 3,369 Patients in the ARCAD DatabaseIn press at European Journal of Cancer.

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97. Patel A, Goldstein DA, Tannock IF. Improving access to immunotherapy in low- and middle-income countries. In press at Annals of Oncology. 

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96. Washington C, Goldstein DA, Moore A, Deville C. Health Disparities in Prostate Cancer and approaches to Advance Equitable Care. ASCO Educational Book.

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95. Peer CJ, Zimmerman SM, Figg WD, Goldstein DA, Ratain MJ. Subcutaneous Atezolizumab: A Jab Without a Benefit. In press at Clinical Pharmacology in Drug Development. 

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94. Goldstein DA, Harvey RD, Chan KKW. Enabling the sharing of single-dose vials through risk mitigation to decrease financial toxicity. In press at JAMA Oncology.

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93. Peer CJ, Heiss BL, Goldstein DA, Goodell JC, Figg WD, Ratain MJ. A pharmacokinetic simulation analysis of less frequent nivolumab and pembrolizumab dosing: pharmacoeconomic rationale for dose de-escalation. In press at The Journal of Clinical Pharmacology.

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92. Gordon N, Goldstein DA, Tadmor B, Stemmer SM, Greenberg D. Factors associated with off-label oncology prescriptions: The role of cost and financing in a universal healthcare system. In press at Frontiers in Pharmacology.

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91. Ratain MJ, Peer C, Figg W, Goldstein DA. Dose Optimization of Pembrolizumab: Less May Be More. In press at Clinical Pharmacology & Therapeutics.

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2021

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90. Strohben GW, Kacew A, Goldstein DA, Feldman R, Ratain MJ. Combination therapy patents - A new front in evergrenning. In press at Nature Biotechnology

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89. Jacobi O, Landman Y, Reinhorn D, Icht O, Sternschuss M, Rotem O, Finkel I, Allen A, Dudnik E, Goldstein DA, Zer A. The Relationship of Diabetes Mellitus to Efficacy of Immune Checkpoint Inhibitors in Patients with Advanced Non-Small Cell Lung Cancer. In press at Oncology.

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88. Moore M, Bar Y, Maurice-Dror C, Finkel I, Goldvaser H, Dudnik E, Goldstein DA, Gordon N, Billan S, Gutfeld O, Wolf I, Popovtzer A. Next Generation Sequencing in Thyroid Cancers - Do Targetable Alterations Lead to a Therapeutic Advantage? A Multicenter Experience. In press at Medicine

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87.Strohbehn GW & Goldstein DA. Registration Trials in Countries Without Access to United States Standards of Care - Pitfalls of Interpretation. In press at Nature Reviews Clinical Oncology. 

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86. Bhanvadia SK, Psutka SP, Burg ML, de Wit R, Dhillon H, Gyawali B, Morgans AK, Goldstein DA, Smith AB, Sun M, Penson DF. Financial Toxicity Amongst Patients With Prostate, Bladder, and Kidney Cancer: A Systematic Review and Call to Action. In press at European Urology Oncology

 

2020

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85. Tannock IF, Ratain MJ, Goldstein DA, Lichter AS, Rosner GL, Saltz LB. Near-Equivalence: Generating evidence to support alternative cost-effective treatments. In press at Journal of Clinical Oncology.

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84. Briggs AH, Goldstein DA, Kirwin E, Meacock R, Pandya A, Vanness D, Wisloff T. Estimating (quality-adjusted) life-year losses associated with deaths: with application to COVID-19. In press at Health Economics.

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83. Moore A, Peretz I, Yosef L, Goldstein DA, Goldvaser H,Horn S, Edel Y, Zer A. Potential Association Between Kaposi Sarcoma and Gout - an Exploratory Observational Study. In Press at Sarcoma.

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82. Goldstein DA, Strohbehn GW, Serritella AV, Hyman DA, Lichter AS, Ratain MJ. Interventional 

Pharmacoeconomics. The Cancer Journal. 2020.

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81. Borisovsky G, Goldstein DA, Elyakim N, Tamir SR. Transitional cell carcinoma and pseudocirrhosis - A case report and review of the literature. Journal of Gastrointestinal and Abdominal Radiology. 2020.

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80. Strohbehn GW, Goldstein DA, Ratain MJ. SARS-CoV-2 and oncology drugs: What do we mean when we talk about value? The Cancer Letter. 2020. 

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79. Goldstein DA, Ratain MJ, Saltz LB. Weight based Dosing of Pembrolizumab every 6 weeks in the Time of Coronavirus Disease 2019 (COVID-19). Jama Oncology. 2020.

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78. Peer CJ, Goldstein DA, Goodell JC, Nguyen R, Figg WD, Ratain MJ. Opportunities for using In Silico-Based Extended Dosing Regimens for Monoclonal Antibody Immune Checkpoint Inhibitors. British Journal of Clinical Pharmacology. 2020.

 

77. Reinhorn D, Jacobi O, Icht O, Dudnik E, Rotem O, Zer A, Goldstein DATreatment beyond progression with immune checkpoint inhibitors in non-small-cell lung cancer. Immunotherapy. 2020.

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76. Goldstein DA, Mayer C, Shochat T, Reinhorn D, Moore A, Sarfaty M, Yerushalmi R, Goldvaser H. The concordance of treatment decision guided by OncotypeDX and the PREDICT tool in real-world early-stage breast cancer. Cancer Medicine. 2020.

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75. Serritella AV, Strohbehn GW, Goldstein DA, Lichter AS, Ratain MJ. Interventional Pharmacoeconomics: A Novel Mechanism for Unlocking Value. Clinical Pharmacology and Therapeutics. 2020.

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74. Ben Aharon O, Magnezi R, Leshno M, Goldstein DAMature versus Registration Studies of Immuno-oncology Agents: Does Value Improve with Time? JCO Oncology Practice. 2020.

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73. Goldstein DA and Ratain MJ. Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Clinical Cancer Research. 2020.

 

72. Moore A, Den RB, Popovtzer A, Goldvaser H, Gordon N, Goldstein DAFractionation Scheme and Treatment Planning Method for Early Glottic Cancer in the United States – The Economic Impact of Different Medical Decisions. Head and Neck. 2020.

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2019

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71. Goldstein DA, Lichter A, Ratain MJ. Payer Funding of interventional pharmacoeconomic studies: a new 

paradigm. Health Affairs Blog. 2019.

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70. Goldstein DA and Ratain MJ. Alternative dosing regimens for atezolizumab: right dose, wrong frequency. Cancer Chemotherapy and Pharmacology. 2019.

 

69. Shlomai A, Leshno M, Goldstein DACabozantinib for patients with advanced hepatocellular carcinoma – a cost-effectiveness analysis. Therapeutic Advances in Gastroenterology. 2019. 

 

68. Gabbay I, Gabbay U, Goldstein DA, Nahum Y. Should every candidate for cataract extraction be scheduled to the preoperative clinic? The Rabin Medical Center experience. European Journal of Ophthalmology. 2019.

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67. Moore A, Den R, Gordon N, Sarfaty M, Kundel Y, Brenner B and Goldstein DAThe Financial Impact of Fractionation Scheme and Treatment Planning Method for Rectal Cancer in the United States. Clinical Colorectal Cancer, 2019.

 

66. Ben-Aharon O, Magnezi R, Leshno M, Goldstein DAMedian Survival or Mean Survival: Which Measure is The Most Appropriate for Patients, Physicians and Policy Makers? The Oncologist. 2019.

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65. Ratain M, Goldstein DA, Lichter A. Interventional Pharmacoeconomics: A New Discipline for a Cost-Constrained Environment. JAMA Oncology. 2019.

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64. Gershon N, Berchenko Y, Hall PS, Goldstein DACost Effectiveness and Affordability of Trastuzumab in sub-Saharan Africa for Early stage HER2 positive Breast Cancer. Cost Effectiveness and Resource Allocation. 2019.

 

63. Reinhorn D, Sarfaty M, Leshno M, Moore A, Neiman V, Rosenbaum E, Goldstein DAA cost-effectiveness analysis of Nivolumab and Ipilimumab versus Sunitinib in first line intermediate-poor risk advanced Renal Cell Carcinoma. The Oncologist. 2019.

 

62. Moore A, Stav I, Den R, Gordon N, Sarfaty M, Neiman V, Rosenbaum E and Goldstein DAThe Financial Impact of Hypofractionated Radiation for Localized Prostate Cancer in the United States. Journal of Oncology.  2019.

 

61. Goldstein DA and Den R. Patient-Centered Oncology or Population-Centered Oncology – Which do we want, and which tradeoffs are we willing to accept? The Oncologist. 2019.

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60. Mitchell AP, Rotter JS, Patel E, Richardson D, Wheeler SB, Basch E, Goldstein DAThe Impact of Reimbursement Incentives on Physician Practice in Oncology: A Systematic Review of the Literature. JAMA Oncology. 2019.

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2018

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59. Shlomai A, Leshno M, Goldstein DARegorafenib treatment for patients with hepatocellular carcinoma who progressed on sorafenib - A cost-effectiveness analysis. PLOS One. 2018.

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58. Stav I, Gyawali B, Goldstein DADuration of Adjuvant Immunotherapy – Biologic, Clinical and Economic Considerations. Medical Oncology. 2018.

 

57. Goldstein DWeight-based dosing vs fixed dosing of pembrolizumab: an economic analysis. Clinical Advances in Hematology and Oncology. 2018.

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56. Ratain MJ and Goldstein DATime is Money: Optimizing the Scheduling of Nivolumab. Journal of Clinical Oncology. 2018.

 

55. Gyawali B and Goldstein DAInformation Transparency in the Drug Approval Process. JAMA Oncology. 2018.

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54. Liran O, Prus J, Gordon N, Almog V, Gruenewald T, Goldstein DAA Real-World Analysis of Cancer Drug Wastage due to Oversized Vials. Journal of the American Pharmacists Association. 2018.

 

53. Ben-Aharon O and Goldstein DAImproving on Tail-of-the-Curve Evaluation With the American Society of Clinical Oncology Value Framework. JAMA Oncology. 2018.

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52. Goldstein DADenosumab for bone lesions in multiple myeloma - What is the value? Haematologica.  2018.

 

51. Sarfaty M, Hall PS, Chan KKW, Virik K, Leshno M, Gordon N, Moore A, Neiman V, Rosenbaum E, Goldstein DA

Cost-Effectiveness of Pembrolizumab in Second-Line Advanced Bladder Cancer. European Urology. 2018. 

 

50. Gyawali B and Goldstein DAThe FDA Approval of Adjuvant Sunitinib for Renal Cell Cancer: A Case of Regulatory Capture? JAMA Oncology. 2018.

 

49. Goldstein DA and Goulart B. Early Steps in the Value of Cancer Care - Many Paths Remain Unexplored. The Oncologist. 2018.

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48. Dudnik E, Moskovitz M, Daher S, Shamai S, Hanovich E, GrubsteinA, Shochat T, Zer A, Goldstein DA, Wollner M, Bar J, Merimsky O, Cyjon A, Shechtman Y, Abu-Amna M, Flex D, Roisman L, Hammerman A, Peled N. Efficacy and toxicity of nivolumab in advanced non-small cell lung cancer: the real-life data. Lung Cancer. 2017.

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47. Ben-Aharon O, Magnezi R, Leshno M, Goldstein DAAssociation of Immunotherapy With Durable Survival as Defined by Value Frameworks for Cancer Care. JAMA Oncology. 2018.

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46. Chen Q, Staton AD, Ayer T, Goldstein DA, Koff JL, Flowers CR. Exploring the Potential Cost-Effectiveness of Precision Medicine Treatment Strategies for Diffuse Large B-cell Lymphoma. Leukemia and Lymphoma. 2018.

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45. Goldstein DA, Hirsch A. A Policy That Encourages Wastage of Expensive Medications - The JW Modifier. JAMA Oncology. 2018.

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44. Gordon N, Greenberg D, Stemmer SM, Goldstein DATrajectories of injectable cancer drug costs following launch in the United States. Journal of Clinical Oncology. 2018.

 

43. Sarfaty M, Leshno M, Gordon N, Moore A, Neiman V, Rosenbaum E, Goldstein DACost-Effectiveness of Nivolumab in Advanced Renal Cell Carcinoma. European Urology. 2018.

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2017

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42. Goldstein DAAdjuvant Ipilimumab for Melanoma: The 1.8 Million Dollar Per Patient Regimen. JAMA Oncology. 2017.

 

41. Kohn C, Zeichner SB, Chen Q, Montero AJ, Goldstein DAFlowers CR. Reply to Benedict et al. Journal of Clinical Oncology. 2017.

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40. Goldstein DA, Bilal U, Prasad V. Pembrolizumab as first line therapy in PD-L1 positive advanced lung cancer: Is it as effective as we think it is? Cancer. 2017.

 

39. Goldstein DA, Gordon N, Davidescu M, Leshno M, Steuer CE, Patel N, Stemmer SM, Zer A. 

A Phamacoeconomic  Analysis of Personalized Dosing versus Fixed Dosing of Pembrolizumab in first-line PD-L1 positive Non-Small Cell Lung Cancer. The Journal of the National Cancer Institute. 2017.

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38. Goldstein DA, Clark J, Tu Y, Zhang J, Fang F, Goldstein R, Stemmer SM, Rosenbaum E. A global comparison of the cost of patented cancer drugs in relation to global differences in wealth. Oncotarget. 2017.

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37. Goldstein DA, Chen Q, Ayer T, Chan KKW, Virik K, Hammerman A, Brenner B, Flowers CR, Hall PS. Bevacizumab for metastatic colorectal cancer: A global cost-effectiveness analysis. Oncologist. 2017.

 

36. Karass M, Grossniklaus E, Seoud T, Jain S, Goldstein DAKaposi-sarcoma Inflammatory Cytokine Syndrome (KICS): A rare but treatable condition. Oncologist. 2017.

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35. Kohn C, Zeichner SB, Chen Q, Montero AJ, Goldstein DA, Flowers CR. The Cost-Effectiveness of Immune Checkpoint Inhibition in BRAF Wild-Type Advanced Melanoma. Journal of Clinical Oncology. 2017.

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34. Goldstein DAFinancial Toxicity in Cancer Care – Edging Toward Solutions. Cancer. 2017.

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33. DeFilipp Z, Rosand C, Goldstein DA, Master V, Carthon B, Harris W, Kucuk O, Al-Kadhimi Z, Cohen J, Flowers C, 

Lechowicz MJ, NookaA, Kaufman J, Langston A, Chen Z, Arora J, Waller E. Comparable outcomes following 2 or 3 cycles of high-dose chemotherapy and autologous stem cell transplantation for patients with relapsed/refractory germ cell tumors. Bone Marrow Transplantation. 2017.

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32. Zeichner SB, Goldstein DA, Kohn C, Flowers CR. Cost-effectiveness of precision medicine in gastrointestinal stromal tumor and gastric adenocarcinoma. J Gastrointest Oncol. 2017.

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2016

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31. Goldstein DAOpposition to Value-Based Cancer Care-Interests of Patients or Conflicts of Interest? Mayo Clinic Proceedings. 2016.

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30. Goldstein DA, Stemmer SM, Gordon N. The cost and value of cancer drugs – are new innovations outpacing our ability to pay? Isr J Health Policy Res. 2016.

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29. Zeichner SB, Kohn C, Goldstein DAEconomics of ramucirumab for metastatic colorectal cancer. Expert Review of Pharmacoeconomics & Outcomes Research. 2016.

 

28. Kamel R, Seoud T, Teniola O, Karass M, Grossniklaus E, OpreaIlies G, Goldstein DA, Jain S. Chemotherapy Used to Halt Lower GI Bleeding in a Rare Case of Metastatic Choriocarcinoma to the GI tract. Case Rep Oncol Med. 2016.

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27. Dudnik E, Yust-Katz S, Nechushtan H, Goldstein DA, Zer A, Flex D, Siegal T, Peled N. Intracranial response to nivolumab in NSCLC patients with untreated or progressing CNS metastases. Lung cancer. 2016.

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26. Goldstein DA, Sarfaty M. Cancer Drug Pricing and Reimbursement: Lessons for the United States From Around the World. Oncologist. 2016.

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25. Davis CC, Zelnak A, Eley JW, Goldstein DA, Switchenko JM, McKibbin T. Clinical Utility of Routine Cardiac Monitoring in Breast Cancer Patients Receiving Trastuzumab. Ann Pharmacother. 2016.

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24. Bupathi M, Ahn DH, Stephens JA, Reardon J, Goldstein DA, Bekaii-Saab T. Modified irinotecan and infusional 5-fluorouracil (mFOLFIRI) in patients with refractory advanced pancreas cancer (APC): A single institution experience. Medical Oncology. 2016.

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23. Goldstein DA, Krishna K, Flowers CR, El-Rayes BF, Bekaii-Saab T, Noonan AM. Cost description of chemotherapy regimens for the treatment of metastatic pancreas cancer. Medical Oncology. 2016.

 

22. Goldstein DAUsing QALYs in cost-effectiveness analyses – Do not throw out the baby or the bathwater. Journal of Oncology Practice, 2016.

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21. Goldstein DAUnderstanding the Value of Cancer Drugs – the devil is in the details. Cancer. 2016.

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20. Goldstein DAThe Ethical and Practical Challenges of Value Based Cancer care at the Bedside. JAMA Oncology.2016.

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19. Goldstein DA, Howard DH, Flowers CR. Perspectives in Oncology Drug Pricing-Reply. JAMA Oncology. 2016.

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18. Moss E, Goldstein DA, Flowers CR, Murphy DA. Primary Cardiac Lymphoma Mistaken for Left Ventricular Myxoma: Successful Robotic Excision and Early Chemotherapy. The Annals of Thoracic Surgery. 2016.

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17. Ahn DH, Williams TM, Goldstein DA, El-Rayes B, Bekaii-Saab T. Adjuvant therapy for pancreas cancer in an era of value based cancer care. Cancer Treat Rev. 2016.

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16. Goldstein DA, Zeichner SB, Bartnik CM, Neustadter E, Flowers CR. Metastatic Colorectal Cancer: A Systematic Review of the Value of Current Therapies. Clin Colorectal Cancer. 2016.

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2015

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15. Karass M, Grossniklaus E, Seoud T, Kamel R, Teniola O, Oprea G, Goldstein DA, Jain S. Metastatic colorectal cancer in a cirrhotic liver with synchronous hepatocellular carcinoma. Ann Transl Med. 2015.

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14. Goldstein DA, Zeichner SB. Strategies for individualizing management of patients with metastatic melanoma: a managed care perspective. Am J Manag Care. 2015. 

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13. Goldstein DA, Chen Q, Ayer T, Howard DH, Lipscomb J, Ramalingam SS, Khuri FR, Flowers CR. Necitumumab in Metastatic Squamous Cell Lung Cancer: Establishing a Value-Based Cost. JAMA Oncology. 2015.

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12. Goldstein DA, El-Rayes BF, Chen Q, Flowers CR. Reply to A Messori, et al, R Bordonaro, et al and G Fasola, et al. Journal of Clinical Oncology. 2015.

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11. Goldstein DA & El-Rayes B. Considering efficacy and cost, where does ramucirumab fit in the management of metastatic colorectal cancer? The Oncologist. 2015.

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10. Goldstein DA, BB Ahmad, Q. Chen, T. Ayer, D. Howard, J. Lipscomb, B El-Rayes, CR Flowers. Cost-effectiveness Analysis of Regorafenib for Metastatic Colorectal Cancer. Journal of Clinical Oncology. 2015.

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9. Goldstein DA, Shaib WL, Flowers CR. Costs and Effectiveness of Genomic Testing in the Management of Colorectal Cancer. Oncology (Williston Park). 2015.

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8. Goldstein DA, Chen Q, Ayer T, Howard DH, Lipscomb J, El-RayesBF, Flowers CR. First- and Second-Line Bevacizumab in Addition to Chemotherapy for Metastatic Colorectal Cancer: A United States-Based Cost-Effectiveness Analysis. J Clin Oncol. 2015.

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2014

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7. Goldstein DA, Chen Q, Ayer T, Howard DH, Lipscomb J, Harvey RD, El-Rayes BF, Flowers CR. Cost effectiveness analysis of pharmacokinetically guided 5 fluorouracil in FOLFOX chemotherapy for metastatic colorectal cancer. Clin Colorectal Cancer. 2014.

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6. W Shaib, D Goldstein, BF El Rayes. Peptide Vaccines for Treatment of Colon Cancer: Have We Made Progress? 

Current Colorectal Cancer Reports. 2014.

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5. Shams SR, Goldstein DA, Kaufman JL, MacKelfresh J, Flowers CR, Langston AA. Dermato-Neuro Syndrome in a Patient Treated WithAutologous Stem Cell Transplant for Scleromyxedema. ClinLymphoma Myeloma Leuk. 2014.

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2013

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4. Morris PG, Zhou XK, Milne GL, Goldstein D, Hawks LC, Dang CT, Modi S, Fornier MN, Hudis CA, Dannenberg AJ. Increased levels of urinary PGE-M, a biomarker of inflammation, occur in association with obesity, aging, and lung metastases in patients with breast cancer. Cancer Prev Res (Phila). 2013.

 

2011

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3. Robert Goldstein, Daniel Goldstein, Simon Chowdhury. Receptor Tyrosine Kinase Inhibitors for the Treatment of Metastatic Renal Cell Carcinoma. Drug Ther Bull. 2011.

 

2007

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2. J. Broome, J. Gordon, F. Victory, L. Clarke, D. Goldstein, N. Emmel. International health in medical education: students' experiences and views. Journal of Health Organisation and Management. 2007.

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2002

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1. Goldstein DInternational health BSc: The Students Perspective. StudentBMJ. 2002

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