Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of

332 Pages·2012·3.35 MB·English

by  Ramsay C

Health Technology Assessment 2012; Vol. 16: No.411
Implications for research
Health Technology Assessment 2012; Vol. 16: No. 41 ISSN 1366-5278
ISSN 1366-5278 Acknowledgements
AbsCtroanctrtibution of authors
Remzi 2005
Rocco 2009
RLeifsetr eonfR caoebzsebtr e2v0i0a7tions
Salomon 2002
ExeAcpuSpticevhnerd osixeu c1mk m20a0r8y
PrBoSatioclvckago 2rl o0u0n7d 107
PMroSetoothdcoeodrld sfaohrl a2 0s0y5stematic review and economic modelling of the relative clinical benefit and cost-
efRfSeecosturiiclvts e2n0e0s4s of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised
prSoStsruetnnadgteath rcasam ann c2de0 rl0im4itations
1.C BToeanrcackklugasrwiooaun ns2d008
ORpTeeecnwo pamrroim s2te0an0tde3cattoiomnsy for further research
LaFpTuoanurdaiijsnecgr o2p0i0c7 prostatectomy
RoTbroatbicu lpsir o2s0t0a8tectomy
Systematic review and economic RaTtirouneasldeale 2010
Chapter 1
2. AWimagsn aenr d2 0O0b7jectives
Background
3. MWehtitheo 2d0s09
modelling of the relative clinical benefit Description of the underlying health problem
4. Cost-effectiveness
Evolution of prostate cancer diagnosis
5.D TAeipvmepeleosnpcdmaixlee 6nt of radical prostatectomy
and cost-effectiveness of laparoscopic 6.D RLeiessfcte roripef nteiocxencs luodf ethde s itnutderievse:n ctioomnsparative studies in which number of patients for each baseline clinical stage was unclear1 53
Current use in the UK NHS
surgery and robotic surgery for removal ApSApupemnpmdeinaxdr y2ix 7
SeACaimrhc ahor fas tcthrtaeet rerisegtviieciessw of the included studies 119159
Clinical effectiveness of robotic compared with laparoscopic techniques
of the prostate in men with localised ChaCpotAsetpr- pe2ef fnecdtixiv e8n ess of robotic compared with laparoscopic techniques
Quality of life for robotic compared with laparoscopic techniques
DDeestcariliepdt iroisnk ooff tbhiaes c aasrsee spsamthewnta fyor the included studies 197
Introduction
prostate cancer
ApPpreeonpdeixra 3ti ve characteristics of men undergoing radical prostatectomy
Appendix 9
DPatrae oepxetrraactitvioen le fvoerml o f prostate-specific antigen 131
Data tables 203
Perioperative care
ApSpuervnedililxa n4c e following radical prostatectomy
Appendix 10
Risk of bias form 139
Classification of reported adverse effects using the Clavien–Dindo classification of surgical complications68 259
ChaCpotcehr r3a ne risk of bias table (non-randomised studies)
C Ramsay, R Pickard, C Robertson, A Close, RMiske othf obdiass otof otlh (en osny-sratenmdoamtiics erde vsiteuwdi eosf) clinical effectiveness
MAepthpoednsdix 11
L Vale, N Armstrong, DA Barocas, CG Eden, ApInRpceelunssudiolitxsn 5 oa fn tdh ee xscylsutseiomna cticrit reerviaiew of economic evaluations 267
LiDsRta oetaaf sienoxcntlrusad cfeotidro ensx tsuctldruaisetieso gny 145
C Fraser, T Gurung, D Jenkinson, X Jia, TB Lam, AlQ-Suhaalitijyi 2a0s1se0ssment strategy
AnDAaasptatpa easnniadadliyxiss 1i2s20 03
ArAtCisbsoaesnstiss 2 mo0fe0 rn3otb oof tlieca erqniunigp mcuernvte s 269
G Mowatt, DE Neal, MC Robinson, J Royle,
Ball 2006
ChaBpatAreoprc p4ae sn 2d0ix1 103
SP Rushton, P Sharma, MDF Shirley and BChCaliyonasinctsia 2lo 0ef 0flaf3epcatroivsecnoepsics eoqfu ripomboetnitc compared with laparoscopic techniques 273
BQolueannz t2ity0 1a0nd quality of evidence
N Soomro BAroswsens 2s0m0e4nt of effectiveness
Appendix 14
CAarslssseossnm 2e0n1t0 of the learning curve
Estimates of numbers of survivors and mean duration of survival 275
DSahulm 2m00a9ry and conclusions of the evidence of comparative effectiveness
Doumerc 2010
DroAupinp e2n0d0ix9 15
Chapter 5
FicDarernas 2it0y 0c9harts describing the distribution of total costs and quality-adjusted life-years for the cohort of modelled
Methods for health economic evaluation
Formneanra f o2r0 e0a4ch analysis presented 277
Introduction
Fracalanza 2008
Systematic review of previous economic evaluations
HeGaMhltahev tTahemocdiahsnn o20lo0g6y Assessment programme
Gosseine 2009
Model health states and associated parameter values
Greco 2010
Costs
Guazzoni 2006
Utilities
Hu 2006
Data analysis
Jacobsen 2007
Sensitivity analyses
Joseph 2005
Joseph 2007
ChaJputrecrz o6k 2007
KRime s2u00lt7s of the health economic evaluation
KBraamseb-eccaks 2e 0a0n9alysis
LaSmuma m20a0ry9 of results of modelling cost-effectiveness of procedures
Loeb 2010
November 2012
ChaMpatelcro 7lm 2010
10.3310/hta16410 MDaristocruasnsa io20n04
MSeunmonm 2a0ry0 2of findings
MSillterer n2g0t0h7s and weaknesses
Nadler 2010
Namiki 2005
Chapter 8
Namiki 2006
Conclusions
Ou 2009
Implications for health care
Health Technology Assessment Poulakis 2007
Raventos Busquets 2007
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Systematic review and economic modelling
of the relative clinical benefit and cost-
effectiveness of laparoscopic surgery and
robotic surgery for removal of the prostate in
men with localised prostate cancer
C Ramsay,1* R Pickard,2 C Robertson,1 A Close,3
L Vale,1,4 N Armstrong,5 DA Barocas,6 CG Eden,7
C Fraser,1 T Gurung,1 D Jenkinson,1 X Jia,1 TB Lam,9
G Mowatt,1 DE Neal,10 MC Robinson,11 J Royle,8
SP Rushton,3 P Sharma,1 MDF Shirley3 and N Soomro12
1Health Services Research Unit, University of Aberdeen, Aberdeen, UK
2Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
3School of Biology, Newcastle University, Newcastle upon Tyne, UK
4Health Economics Group, Institute of Health and Society, Newcastle University,
Newcastle upon Tyne, UK
5Kleijnen Systematic Reviews Ltd, York, UK
6Department of Urologic Surgery, Vanderbilt University Medical Center,
Nashville, TN, USA
7Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK
8Department of Urology, Aberdeen Royal Infirmary, Grampian NHS Trust,
Aberdeen, UK
9Academic Urology Unit, University of Aberdeen, Aberdeen, UK
10Department of Oncology, University of Cambridge, Cambridge, UK
11Department of Cellular Pathology, Newcastle upon Tyne Hospitals NHS Foundation
Trust, Newcastle upon Tyne, UK
12Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust,
Newcastle upon Tyne, UK
*Corresponding author
Declared competing interests of authors: none

Published November 2012
DOI: 10.3310/hta16410
This report should be referenced as follows:
Ramsay C, Pickard R, Robertson C, Close A, Vale L, Armstrong N, et al. Systematic review and
economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and
robotic surgery for removal of the prostate in men with localised prostate cancer. Health Technol
Assess 2012;16(41).
Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Excerpta
Medica/EMBASE, Science Citation Index Expanded (SciSearch®) and Current Contents®/
Clinical Medicine.
NIHR Health Technology Assessment programme
iv
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DOI: 10.3310/hta16410 Health Technology Assessment 2012; Vol. 16: No. 41 v
Abstract
Systematic review and economic modelling of the relative
clinical benefit and cost-effectiveness of laparoscopic
surgery and robotic surgery for removal of the prostate in
men with localised prostate cancer
C Ramsay,1* R Pickard,2 C Robertson,1 A Close,3 L Vale,1,4 N Armstrong,5
DA Barocas,6 CG Eden,7 C Fraser,1 T Gurung,1 D Jenkinson,1 X Jia,1
TB Lam,9 G Mowatt,1 DE Neal,10 MC Robinson,11 J Royle,8 SP Rushton,3
P Sharma,1 MDF Shirley3 and N Soomro12
1Health Services Research Unit, University of Aberdeen, Aberdeen, UK
2Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
3School of Biology, Newcastle University, Newcastle upon Tyne, UK
4Health Economics Group, Institute of Health and Society, Newcastle University,
Newcastle upon Tyne, UK
5Kleijnen Systematic Reviews Ltd, York, UK
6Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
7Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK
8Department of Urology, Aberdeen Royal Infirmary, Grampian NHS Trust, Aberdeen, UK
9Academic Urology Unit, University of Aberdeen, Aberdeen, UK
10Department of Oncology, University of Cambridge, Cambridge, UK
11Department of Cellular Pathology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle
upon Tyne, UK
12Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
*Corresponding author
Background: Complete surgical removal of the prostate, radical prostatectomy, is the most
frequently used treatment option for men with localised prostate cancer. The use of
laparoscopic (keyhole) and robot-assisted surgery has improved operative safety but the
comparative effectiveness and cost-effectiveness of these options remains uncertain.
Objective: This study aimed to determine the relative clinical effectiveness and cost-
effectiveness of robotic radical prostatectomy compared with laparoscopic radical
prostatectomy in the treatment of localised prostate cancer within the UK NHS.
Data sources: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE,
BIOSIS, Science Citation Index and Cochrane Central Register of Controlled Trials were
searched from January 1995 until October 2010 for primary studies. Conference abstracts
from meetings of the European, American and British Urological Associations were also
searched. Costs were obtained from NHS sources and the manufacturer of the robotic
system. Economic model parameters and distributions not obtained in the systematic
review were derived from other literature sources and an advisory expert panel.
Review methods: Evidence was considered from randomised controlled trials (RCTs) and
non-randomised comparative studies of men with clinically localised prostate cancer (cT1
or cT2); outcome measures included adverse events, cancer related, functional, patient
© Queen’s Printer and Controller of HMSO 2012. This work was produced by Ramsay et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to NETSCC.
vi Abstract
driven and descriptors of care. Two reviewers abstracted data and assessed the risk of
bias of the included studies. For meta-analyses, a Bayesian indirect mixed-treatment
comparison was used. Cost-effectiveness was assessed using a discrete-event
simulation model.
Results: The searches identified 2722 potentially relevant titles and abstracts, from which
914 reports were selected for full-text eligibility screening. Of these, data were included
from 19,064 patients across one RCT and 57 non-randomised comparative studies, with
very few studies considered at low risk of bias. The results of this study, although
associated with some uncertainty, demonstrated that the outcomes were generally better
for robotic than for laparoscopic surgery for major adverse events such as blood
transfusion and organ injury rates and for rate of failure to remove the cancer (positive
margin) (odds ratio 0.69; 95% credible interval 0.51 to 0.96; probability outcome favours
robotic prostatectomy = 0.987). The predicted probability of a positive margin was 17.6%
following robotic prostatectomy compared with 23.6% for laparoscopic prostatectomy.
Restriction of the meta-analysis to studies at low risk of bias did not change the direction
of effect but did decrease the precision of the effect size. There was no evidence of
differences in cancer-related, patient-driven or dysfunction outcomes. The results of the
economic evaluation suggested that when the difference in positive margins is equivalent
to the estimates in the meta-analysis of all included studies, robotic radical prostatectomy
was on average associated with an incremental cost per quality-adjusted life-year that is
less than threshold values typically adopted by the NHS (£30,000) and becomes further
reduced when the surgical capacity is high.
Limitations: The main limitations were the quantity and quality of the data available on
cancer-related outcomes and dysfunction.
Conclusions: This study demonstrated that robotic prostatectomy had lower perioperative
morbidity and a reduced risk of a positive surgical margin compared with laparoscopic
prostatectomy although there was considerable uncertainty. Robotic prostatectomy will
always be more costly to the NHS because of the fixed capital and maintenance charges
for the robotic system. Our modelling showed that this excess cost can be reduced if
capital costs of equipment are minimised and by maintaining a high case volume for each
robotic system of at least 100–150 procedures per year. This finding was primarily driven
by a difference in positive margin rate. There is a need for further research to establish how
positive margin rates impact on long-term outcomes.
Funding: The National Institute for Health Research Health Technology
Assessment programme.
DOI: 10.3310/hta16410 Health Technology Assessment 2012; Vol. 16: No. 41 vii
Contents
List of abbreviations ix
Executive summary xi
1. Background 1
Description of the underlying health problem 1
Evolution of prostate cancer diagnosis 1
Development of radical prostatectomy 2
Description of the interventions 3
Current use in the UK NHS 6
Summary 8
Aim of the review 8
2. Description of the care pathway 9
Introduction 9
Preoperative characteristics of men undergoing radical prostatectomy 9
Preoperative level of prostate-specific antigen 9
Perioperative care 12
Surveillance following radical prostatectomy 14
3. Methods of the systematic review of clinical effectiveness 17
Methods 17
Inclusion and exclusion criteria 17
Data extraction strategy 18
Quality assessment strategy 19
Data analysis 19
Assessment of learning curves 20
4. Clinical effectiveness of robotic compared with laparoscopic techniques 23
Quantity and quality of evidence 23
Assessment of effectiveness 28
Assessment of the learning curve 43
Summary and conclusions of the evidence of comparative effectiveness 46
5. Methods for health economic evaluation 49
Introduction 49
Systematic review of previous economic evaluations 49
Methods 50
Model health states and associated parameter values 53
Costs 61
Utilities 65
Data analysis 66
Sensitivity analyses 67
6. Results of the health economic evaluation 71
Base-case analysis 71
Summary of results of modelling cost-effectiveness of procedures 76
© Queen’s Printer and Controller of HMSO 2012. This work was produced by Ramsay et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to NETSCC.
viii Contents
7. Discussion 79
Summary of findings 79
Strengths and weaknesses 83
8. Conclusions 89
Implications for health care 89
Implications for research 89
Acknowledgements 91
References 93
Appendix 1 Protocol 107
Appendix 2 Search strategies 119
Appendix 3 Data extraction form 131
Appendix 4 Risk of bias form 139
Appendix 5 List of included studies 145
Appendix 6 List of excluded studies: comparative studies in which number of patients
for each baseline clinical stage was unclear 153
Appendix 7 Characteristics of the included studies 159
Appendix 8 Detailed risk of bias assessment for the included studies 197
Appendix 9 Data tables 203
Appendix 10 Classification of reported adverse effects using the Clavien–Dindo
classification of surgical complications 259
Appendix 11 Results of the systematic review of economic evaluations 267
Appendix 12 Costs of robotic equipment 269
Appendix 13 Costs of laparoscopic equipment 273
Appendix 14 Estimates of numbers of survivors and mean duration of survival 275
Appendix 15 Density charts describing the distribution of total costs and quality-
adjusted life-years for the cohort of modelled men for each analysis presented 277
Health Technology Assessment programme 309