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

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176 Appendix 12 Scenario: moderate disease (Chapman B) + Estramustine adverse events ● You have a bearable amount of pain and it is moderately well controlled by medication. ● You feel tense, worried, irritable, sad or depressed sometimes (only once or twice a week). ● Your ability to have sex and to enjoy it has been affected a fair amount by your condition. ● You have occasional difficulties or problems with urinating or bowel function (only once or twice a week). ● You have some difficulty doing usual activities. ● You do less than before and are tired quite a bit of the time. ● You need some assistance with some daily activities (for example, dressing, washing, using the toilet). In this scenario you are taking treatment for your condition, which may have the following additional effects: ● Severe vomiting. ● Breast development (in men). ● Chest pain.
Scenario 1: advanced disease – early (FACT-P) This scenario is based on a questionnaire which uses the following phrases to describe the level of impact of symptoms and impairments: ● not at all ● a little bit ● somewhat ● quite a bit ● very much. ● You have a little nausea and some lack of energy. ● You worry quite a bit about your condition getting worse and about dying. ● You feel somewhat sad and nervous. ● Your ability to work, your enjoyment of life and the quality of your sleep are somewhat reduced. ● Your appetite is restricted a little bit and you have lost a moderate amount of weight. ● You have general aches and pains that bother you somewhat. ● You experience significant pain in certain parts of your body which sometimes keeps you from doing things you want to do. ● You have a little trouble moving your bowels. ● You find it somewhat difficult to urinate and you may urinate more frequently than usual. These problems limit your activities somewhat. ● Your ability to have sex is severely affected by your condition. Scenario 2: advanced disease – moderate (FACT-P) This scenario is based on a questionnaire which uses the following phrases to describe the level of impact of symptoms and impairments: ● not at all ● a little bit ● somewhat ● quite a bit ● very much. ● You feel somewhat nauseated and feel lack of energy quite a bit. Appendix 13 Health Technology Assessment 2007; Vol. 11: No. 2 Health state descriptions based on FACT-P © Queen’s Printer and Controller of HMSO 2007. All rights reserved. ● You worry quite a bit about your condition getting worse and about dying. ● You feel sad and nervous quite a bit. ● Your ability to work, your enjoyment of life and the quality of your sleep are reduced quite a bit. ● Your appetite is somewhat reduced and you have lost quite a bit of weight. ● You have general aches and pains that bother you quite a bit. ● You often experience moderate to severe pain in certain parts of your body, particularly in your bones, which often keeps you from doing things you want to do. ● You have some trouble moving your bowels. ● You find it somewhat difficult to urinate and you may urinate more frequently than usual. These problems limit your activities somewhat. ● Your ability to have sex is severely affected by your condition. Scenario 3: advanced disease – late (FACT-P) This scenario is based on a questionnaire which uses the following phrases to describe the level of impact of symptoms and impairments: ● not at all ● a little bit ● somewhat ● quite a bit ● very much. ● You feel nausea quite a bit and are extremely tired a lot of the time. ● You worry very much about your condition getting worse and sometimes feel hopeless about the future. ● You feel very sad and nervous. ● Your ability to work, your enjoyment of life and the quality of your sleep are very much reduced. ● Your appetite is reduced quite a bit and you have lost a lot of weight. ● You have general aches and pains that bother you very much. ● You often experience severe pain in certain parts of your body, particularly in your bones, which often keeps you from doing things you want to do. 177
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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
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Appendix 2 Excluded studies Study d
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Study details Reason for exclusion
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Meeting: 2004 ASCO Annual Meeting C
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Studies of clinical effectiveness w
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Using the method outlined by Parmar
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Appendix 6 Data extraction tables
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Page 183 and 184: Sanofi-Aventis 61 Bloomfield et al.
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Page 202 and 203: Members Chair, Professor Tom Walley
Page 204 and 205: Members Chair, Professor Bruce Camp
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