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

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APPENDIX 1 GUIDELINE DEVELOPMENT PROCESS A1.1 Introduction The Australian Cancer Network (ACN) initiated a proposal to develop the Clinical practice guidelines for the management of advanced prostate cancer. A decision to proceed was taken in September 2005. To better describe the scope of the guidelines, the title was changed to Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer. A Working Party composed of clinical specialists and consumers and a project team based in the Cancer Epidemiology Research Unit of Cancer Council New South Wales, carried out the work. The project team conducted literature searches, assisted in the critical evaluation of the literature and extracted the relevant data. Financial support was provided by Andrology Australia, the Prostate Cancer Foundation of Australia and ACN. NHMRC appointed a Guideline Assessment Reviewer (GAR) to both monitor and aid the development process. The development program was designed to meet the scientific rigour required by the guideline development process, which is the subject of a series of handbooks on the main stages involved in the development of clinical practice guidelines. 1–8 These handbooks have been previously condensed into a single volume—Development of clinical practice guidelines for the management of cutaneous melanoma and melanoma in special sites: a handbook for chapter leaders and expert working groups 9 —which outlines the major steps and expectations involved in developing guidelines and provided a clear path for everyone involved in the project. This handbook provides the definitions and protocols for developing research questions and search strategies, conducting searches and critical appraisal, summarising and assessing the relevant literature and finally, formulating the recommendations. It includes checklists and templates created to satisfy designated standards of quality and process. These condensed handbooks have been a most useful aid in the demanding and, for some, new process of developing guidelines. At its initial meetings the Guidelines Working Party prepared a table of topics and developed questions to address identified clinical needs. The questions were divided into different topics and subcommittees of the Guidelines Working Party were formed to address topics in their areas of expertise. A2.1 Steps in preparing clinical practice guidelines to NHMRC criteria A clear strategy was developed for every topic and each expert group followed the appropriate steps in preparing the guidelines. While each subcommittee received significant assistance from the project team skilled in methodology, the subcommittees themselves oversaw the synthesis of the evidence and formulation of the recommendations for their topics. The strategic steps followed are outlined below: 1. Structure the research questions 2. Develop a search strategy 3. Search the literature 4. Select, assess and summarise the literature 5. Critically appraise and summarise each selected article 6. Assess the body of evidence and formulate recommendations 117 Appendices
A2.1.1 Structure the research questions A wide range of questions was proposed for research. The questions focussed on interventions rather than diagnosis or prognosis. All proposed questions were reviewed on the basis of their purpose, scope and clinical importance to the target audience and were structured according to the PICO (populations, interventions, comparisons, outcomes) formulation. The questions were ranked and then 52 were identified as requiring systematic reviews. A2.1.2 Develop a search strategy Each research question was submitted to a search strategy based on the PICO formulation. Most searches were directed to prostate cancer as a generic base. Searches were limited or widened as necessary, but all maintained the PICO structure. Keywords were selected during the PICO process. Further sources for keywords or MESH and subject terms were derived from evidence-based material, systematically reviewed articles and appropriately relevant literature. A single systematic search strategy was derived from these terms and applied to all included electronic databases. A2.1.3 Search the literature Clinical practice guidelines should be based on systematic identification and synthesis of the best available scientific evidence. 1 All literature searches were conducted systematically using electronic databases concluding 1 April 2006. Examples include: Medline: bibliographic references and abstracts to articles in a range of languages on topics such as clinical medical information and biomedicine, and including the allied health fields, biological and physical sciences EMBASE: major pharmacological and biomedical database indexing drug information from 4550 journals published in 70 countries Cinahl: bibliographic references and abstracts to journal articles, book chapters, pamphlets, audiovisual materials, software, dissertations, critical paths, and research instruments on topics including nursing and allied health, biomedicine, consumer health, health sciences librarianship, behavioural sciences, management, and education Cochrane Library: regularly updated collection of evidence-based medicine databases, including The Cochrane Database of Systematic Reviews Clinical evidence: compendium of evidence on the effects of clinical interventions updated every six months published by the British Medical Journal Publishing Group Psychinfo: Bibliographic references and abstracts to journal articles, book chapters, dissertations and technical reports on psychology; social, clinical, cognitive and neuropsychology; psychiatry, sociology, anthropology and education, with source material from a wide range of languages. For each search, the following details were provided in topic- or question-specific reports (available on request from the Australian Cancer Network): electronic databases searched terms used to search the databases search inclusion or exclusion criteria language Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 118
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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
Page 86 and 87: References 1. Seidenfeld J, Samson
Page 88 and 89: Cooperative Group. Scandinavian Jou
Page 90 and 91: Oncology Group, TROG 96.05). Radiot
Page 92 and 93: trial. European Journal of Cancer 1
Page 94 and 95: 6 CASTRATION-RESISTANT PROSTATE CAN
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
Page 120 and 121: Informal or family caregivers deriv
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 138 and 139: study type. Studies published befor
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
Page 156 and 157: Effectiveness The extent to which a
Page 158 and 159: Lymph nodes Small, generally pea-si
Page 160 and 161: Each stage is divided into subgroup
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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