Clinical Practice Guidelines for the management of locally advanced ...

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study type. Studies published before 1 April 2006 could be included in the systematic reviews. Studies published after this date could not be included in the evidence base for the recommendations but could be referred to in the text and were described in the Appendices to the topic- or question-specific reports (available on request from the Australian Cancer Network). The project team also hand-searched the reference lists of the relevant articles to identify additional articles that had not been detected through searches of the electronic databases. Bi-annual meetings of the guidelines Working Party provided a forum for discussing and sharing overlapping evidence, the discovery of unpublished literature and information from other key organisations or individuals. A2.1.4 Select, assess and summarise the literature The literature identified by the electronic database searches was assessed for relevance to each question. The following steps were taken to select and sort the literature, with the details and results summarised in topic- or question-specific reports (available on request from the Australian Cancer Network): 1. Define the inclusion criteria 2. Review titles and abstracts of retrieved citations to identify potentially relevant articles 3. Obtain the full text of potentially relevant articles 4. Determine whether the study described in each collected article met the pre-defined inclusion criteria 5. Determine whether systematic reviews accounted for all preceding literature 6. Prepare folders to file searches, background papers and reviewed articles for each question addressed Two independent assessors then assessed the quality of each of the included studies according to predefined criteria for the various study types. Any disagreements were adjudicated by a third reviewer. The quality criteria were: randomised controlled trials (RCTs): blinding, allocation concealment, follow up and intentionto-treat analysis and mode of randomisation systematic reviews: search strategy used, the inclusion criteria and their application, study quality assessment, summary descriptive tables, pooling methods and examination of heterogeneity quasi-randomised and cohort studies: subject selection, group comparability, comparability of outcome measurement, blinding and completeness of follow up. Criteria for the critical appraisal process are available on the Australian Cancer Network website (). Summaries of the studies were tabulated in PICO format and the relevant data extracted and summarised in tables. The data extraction was checked by a second assessor. These tables of study characteristics and evidence are included in the topic- or question-specific reports (available on request from the Australian Cancer Network). The reports also contain lists of collected studies that did not meet the inclusion criteria and the reason for their exclusion. 119 Appendices
A2.1.5 Critical appraisal and summary For each clinical question, the included studies and their results were summarised in a template (Template 1 in the Handbook 9 ). Each study was submitted to further critical appraisal. The level of the evidence, the quality of evidence as determined above, the size of effect and relevance of the evidence of each included study was documented. Details of the templates, rating systems, and criteria for the critical appraisal process are available on the Australian Cancer Network website (). Levels of evidence are outlined below. Table 1 Designations of levels of evidence according to type of research question (NHMRC, 2005) Level Intervention I A systematic review of level II studies II A randomised controlled trial III-1 A pseudo-randomised controlled trial (ie alternate allocation or some other method) III-2 A comparative study with concurrent controls: non-randomised, experimental trial cohort study case-control study interrupted time series with a control group III-3 A comparative study without concurrent controls: historical control study two or more single-arm studies interrupted time series without a parallel control group IV Case series with either post-test or pre-test/post-test outcomes Source: Development of clinical practice guidelines for the management of cutaneous melanoma and melanoma in special sites: Handbook for chapter leaders and expert working groups 9 , p18 A2.1.6 Assess the body of evidence and formulate recommendations The body of literature was assessed by each expert sub-committee in regard to the volume of the evidence, its consistency, clinical impact, generalisability and applicability. These aspects were graded and documented in a second template (Template 2 in the Handbook 9 ). Following grading of the body of evidence, expert sub-committees were asked to formulate a recommendation that related to the summarised body of evidence. This recommendation also had to be graded as follows: Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 120
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Clinical Practice Guidelines for th
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4 Biochemical relapse .............
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FOREWORD The management of prostate
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SUMMARY OF CLINICAL PRACTICE RECOMM
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SUMMARY OF RECOMMENDATIONS Chapter
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Chapter Recommendations Grade Refs
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1 INTRODUCTION 1.1 Natural history
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2 PSYCHOSOCIAL CARE The diagnosis a
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2.2 Effect of psychological and cog
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Evidence summary Level References T
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Recommendation Men with advanced pr
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An Australian cross-sectional study
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10. Dunn J, et al. A review of peer
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41. Sharpley CF, Christie DRH. An a
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different treatments from different
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Evidence summary Level References I
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Evidence summary Level References F
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Despite these reservations and the
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For non-metastatic disease there we
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Evidence summary Level References T
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monotherapy for low-to-intermediate
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Evidence summary Level References M
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for surgery, suggesting that surger
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Microscopic fully resected node pos
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All three trials demonstrated impro
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Evidence summary Level References B
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of an international multicentre ran
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45. Melton LJ, III, Alothman KI, Kh
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76. Little DJ, Kuban DA, Levy LB, Z
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105. Thompson IM, Tangen CM, Parade
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4.2 Androgen deprivation therapy (e
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Evidence summary Level References F
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therapy since such studies would be
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apparent in trials comparing CAB wi
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QLQ instrument published by Cleary
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Note: Larger well-powered studies h
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Eight trials examined acute toxicit
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half of patients experienced pain r
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olus) in addition to radiotherapy a
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References 1. Seidenfeld J, Samson
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Page 92 and 93: trial. European Journal of Cancer 1
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Page 96 and 97: the median overall survival for pat
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Page 100 and 101: with bone pain at study entry. At n
Page 102 and 103: Recently, there have been reports o
Page 104 and 105: of these studies 56, 58 and in the
Page 106 and 107: Side effects (toxicity) As these ra
Page 108 and 109: hydrocortisone respectively. Tannoc
Page 110 and 111: 5. Manikandan R, Srirangam SJ, Pear
Page 112 and 113: 33. Elomaa I, Kylmala T, Tammela T
Page 114 and 115: 60. Janknegt RA, Abbou CC, Bartolet
Page 116 and 117: physiotherapists, occupational ther
Page 118 and 119: 7.5 Q2: Symptom control There was e
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Page 122 and 123: 8. Hughes SL, Weaver FM, Giobbie-Hu
Page 124 and 125: 8 COMPLEMENTARY AND ALTERNATIVE (UN
Page 126 and 127: corresponding benefit in obstructiv
Page 128 and 129: 3. Eisenberg DM, Kessler RC, Van Ro
Page 130 and 131: areas of the state were more likely
Page 132 and 133: 8 Miller DC, Litwin MS, Bergman J,
Page 134 and 135: 10 EMERGING THERAPIES It is impossi
Page 136 and 137: APPENDIX 1 GUIDELINE DEVELOPMENT PR
Page 140 and 141: Grade of recommendation Description
Page 142 and 143: 2. National Health and Research Cou
Page 144 and 145: Dr Carole Pinnock AM Principal rese
Page 146 and 147: Surgery Professor Villis Marshall A
Page 148 and 149: APPENDIX 3 TNM CLASSIFICATION OF PR
Page 150 and 151: Summary Prostate T1 T2 T3 T4 N1 M1a
Page 152 and 153: APPENDIX 4 ABBREVIATIONS AND GLOSSA
Page 154 and 155: Glossary Actuarial survival A metho
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Page 162 and 163: APPENDIX 6 - ORGANISATIONS WHICH PR
Page 164 and 165: Consultant Urologist, Royal Brisban
Page 166 and 167: No conflict of interest to declare.
Page 168 and 169: Index to Clinical practice guidelin
Page 170 and 171: cardiovascular mortality 19, 54, 55
Page 172 and 173: androgen deprivation therapy (ADT)
Page 174 and 175: and surgery 32-34 survival 18 toxic
Page 176 and 177: and chemotherapy 89-90 see also bon
Page 178 and 179: spinal cord compression 62-63 see a
Page 180 and 181: systemic 141 Tasmania Association f
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