Docetaxel with prednisone or prednisolone for the treatment of ...

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164 Appendix 9 Sanofi-Aventis 61 Bloomfield et al. 64 Study question Grade Comments Grade Comments 21. Details of the individuals from whom valuations were ✕ NA obtained are given Decision modelling 22. Details of any decision model used are given NA NA (e.g. decision tree, Markov model) 23. The choice of model used and the key input NA NA parameters on which it is based are adequately detailed and justified 24. All model outputs described adequately NA NA Discounting 25. Discount rate used for both costs and benefits ✕ Not undertaken as the median survival was ✕ less than 1 year 26. Do discount rates accord with NHS guidance? NA ✕ Allowance for uncertainty Stochastic analysis of patient-level data 27. Details of statistical tests and confidence intervals ✓ Student’s t-test, log transformation and ✕ are given for stochastic data non-parametric statistical tests all used to compare mean total cost and produce 95% CI. Only report Student’s t-test results due to similarity in results 28. Uncertainty around cost-effectiveness expressed ✓ Fieller’s theorem used to calculate 95% CI for ICER ✕ (e.g. CI around ICER, CEACs) 29. Sensitivity analysis used to assess uncertainty in ✓ One-way sensitivity analysis of unit costs and resource ✕ non-stochastic variables (e.g. unit costs, discount rates) use undertaken and analytic decisions (e.g. methods to handle missing data) Stochastic analysis of decision models 30. Are all appropriate input parameters included with NA NA uncertainty? 31. Is second-order uncertainty (uncertainty in means) NA NA included rather than first-order (uncertainty between patients)? continued
Sanofi-Aventis 61 Bloomfield et al. 64 Study question Grade Comments Grade Comments 32. Are the probability distributions adequately detailed NA NA and appropriate? 33. Sensitivity analysis used to assess uncertainty in NA NA non-stochastic variables (e.g. unit costs, discount rates) and analytic decisions (e.g. methods to handle missing data) Deterministic analysis 34. The approach to sensitivity analysis is given ✓ One-way sensitivity analysis ✓ Univariate analysis conducted for mean (e.g. univariate, threshold analysis) survival 35. The choice of variables for sensitivity analysis is justified ✓ Unit costs and overall level of resource use ✕ 36. The ranges over which the variables are varied ✓ Inpatient and outpatient costs ±25%, laboratory ✓ are stated and diagnostic costs ±50%, surgery costs ±500% Resource use within 95% CI Presentation of results 37. Incremental analysis is reported using appropriate ? Base case M + P dominates P – inappropriate ✓ decision rules calculation of negative ICER © Queen’s Printer and Controller of HMSO 2007. All rights reserved. 38. Major outcomes are presented in a disaggregated ✓ ✓ as well as aggregated form Health Technology Assessment 2007; Vol. 11: No. 2 39. Applicable to the NHS setting ? Assumptions for key cost components taken from ✓ 3 Canadian centres. It is unclear how generalisable these results are to a UK setting 165
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A systematic review and economic mo
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A systematic review and economic mo
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Objectives: A systematic review was
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Glossary and list of abbreviations
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Glossary Absolute risk reduction Th
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Glossary continued Expected value o
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Glossary continued Progression-free
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List of abbreviations ASCO American
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xvi Executive summary of study desi
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xviii Executive summary prednisone/
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Description of underlying health pr
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● Patients with severe fluid rete
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Search strategy As stated in Chapte
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consensus and, if necessary, a thir
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Quantity of research available A to
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TABLE 1 Summary of included RCTs St
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TABLE 2 Treatment comparisons relat
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tumour response was reported for on
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TABLE 4 Summary results table for d
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decrease in PSA level (51 and 39% c
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Survival (%) 100 80 60 40 20 0 0 co
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TABLE 8 Summary results table for d
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TABLE 9 Grade 3 or 4 adverse events
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Also used was the core questionnair
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these, 69 patients had measurable t
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Effectiveness of mitoxantrone plus
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over to receive additional mitoxant
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Progression-free survival It is not
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compared with corticosteroids. The
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statistically significant improveme
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Summary of studies included in the
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TABLE 19 Percentage of costs by res
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TABLE 21 Summary of submission by S
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TABLE 24 Other in-trial costs a bod
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TABLE 27 Cost-effectiveness results
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Introduction The review of cost-eff
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TABLE 28 Regression coefficients fr
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cancer QoL estimation. Studies whic
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Localised Metastatic mHRPC Bennet (
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TABLE 34 Unit costs of drugs from t
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were assigned to the total follow-u
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Probability cost-effective given da
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Probability cost-effective given da
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TABLE 43 Utility values including/e
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was set to be 1.5 years based on th
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Population value of implementation/
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76 Discussion (CCI-NOV22) and least
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78 Discussion subsequent chemothera
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Rodolphe Perard received funding fr
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84 References Compendium; 2004. URL
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86 References (D) in patients (pts)
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88 References 100. Aventis Pharma.
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90 References low-dose prednisone i
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92 References 180. Kozloff M, Robin
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94 References locally advanced pros
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96 References 251. Scholz MC, Guess
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Clinical effectiveness Searching fo
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1. Prostatic Intraepithelial Neopla
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19. donataxel 20. doxetal 21. doxmi
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6. Mitozantrone.ti,ab. 7. Mitoxantr
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Texot or Trazoteva or Trixotene or
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1. (docetaxel OR asodecel OR doxeta
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10. (index of wellbeing or quality
Page 133 and 134: Appendix 2 Excluded studies Study d
Page 135 and 136: Study details Reason for exclusion
Page 137 and 138: Meeting: 2004 ASCO Annual Meeting C
Page 139 and 140: Studies of clinical effectiveness w
Page 141 and 142: Using the method outlined by Parmar
Page 143 and 144: Appendix 6 Data extraction tables
Page 145 and 146: Study details and Participant detai
Page 175: Study details and Participant detai
Page 178 and 179: 158 Appendix 7 Ernst et al. 33 Qual
Page 181 and 182: Appendix 9 © Queen’s Printer and
Page 183: Sanofi-Aventis 61 Bloomfield et al.
Page 188 and 189: 168 Appendix 10 TABLE 51 Mean (SD)
Page 190 and 191: 170 Appendix 10 TABLE 54 Distributi
Page 192 and 193: 172 Appendix 10 TABLE 57 Mean stand
Page 194 and 195: 174 Appendix 11 TABLE 63 Drug and a
Page 196 and 197: 176 Appendix 12 Scenario: moderate
Page 198 and 199: 178 Appendix 13 ● You occasionall
Page 202 and 203: Members Chair, Professor Tom Walley
Page 204 and 205: Members Chair, Professor Bruce Camp
Page 207: Feedback The HTA Programme and the
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