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Commissioning Through Evaluation Selective Dorsal Rhizotomy Final Commissioning through Evaluation Selective Dorsal Rhizotomy Final Report 28 September 2018 Table of Contents Commissioning through Evaluation ......................................................... 0 Selective Dorsal Rhizotomy ..................................................................... 0 Commissioning through Evaluation ......................................................... 0 Selective Dorsal Rhizotomy ..................................................................... 0 Project Details ......................................................................................... 6 Executive Summary ................................................................................. 7 Summary ................................................................................................ 7 Background ............................................................................................. 7 Methods ................................................................................................. 8 KiTEC Staff members ............................................................................. 12 Glossary of Terms and Abbreviations..................................................... 13 1. Description of the Project ............................................................... 16 1.1 Overview of Cerebral Palsy 16 1.2 Selective Dorsal Rhizotomy 17 1.3 Commissioning through Evaluation 18 2. Study Overview .............................................................................. 21 2.1 Study Background 21 2.2 Study working groups 22 2.3 Patient Database Structure 22 a. Database Overview 22 b. Changes to the database 24 c. Patient inclusion criteria for the database 24 d. Patient inclusion criteria for the SDR procedure 24 e. Patient exclusion criteria for the SDR procedure 25 2.4 Meetings 25 a. Site Visits 25 b. Steering Group Meetings 27 2.5 Provider Experience Questionnaire (PEQ) 28 2.6 Post-Operative Physiotherapy Services Questionnaire (POPSQ) 29 2.7 Interim Report 29 1 3. Research Governance, Ethics & Intellectual Property ...................... 30 3.1 Information governance requirements 30 3.2 Details of the Database System Used 30 3.3 Ethical considerations 32 4. Systematic Review.......................................................................... 33 4.1 Systematic Review Methodology 33 4.2 Systematic Review Results 35 4.3 Systematic Review Conclusions 48 4.4 Additional Studies Results 49 4.5 Additional Studies Conclusions 71 5. Methods ........................................................................................ 73 5.1 Sample Size 73 5.2 Data Completeness analysis methods 73 a. Active Surveillance 73 b. Data Completeness Overview 75 5.3 Recruitment and Baseline data analysis 75 5.4 Primary effectiveness and safety outcomes 76 a. GMFM-66 76 b. CP-QoL 77 c. Descriptive statistics for primary outcomes: GMFM-66, GMFM-66 Centiles, CP-QoL 78 d. Adverse Events 78 e. Primary effectiveness and safety outcomes: analysis 79 5.5 Secondary outcomes 80 a. Intraoperative Assessment 80 b. Physiotherapist assessment 81 c. Modified Ashworth Scale 82 d. Duncan-ely 82 e. MRC Strength Scale 82 f. Boyd and Graham test 83 g. Range of Motion (ROM) 84 h. Gait 84 i. Hip X-Ray 84 j. Spine X-Ray 84 k. Orthopaedic Surgery Likelihood 85 l. Secondary outcomes: analysis 85 5.6 PEQ analysis methods 85 5.7 POPSQ analysis methods 85 5.8 Statistical Packages 86 6. Results ........................................................................................... 87 6.1 Data Completeness 87 a. Active Surveillance 87 b. Data Completeness Overall 87 2 6.2 Patient Recruitment 89 6.3 Baseline Characteristics 93 6.4 Primary Outcome Measures 96 a. GMFM-66 96 b. CP-QoL – primary caregiver/parent version 103 c. CP-QoL – child version 108 d. Adverse Events 108 6.5 Secondary Outcome Measures 111 a. Intraoperative Assessment 111 b. Modified Ashworth Scale 113 c. Physiotherapy 116 d. Duncan-ely 118 e. MRC Strength Scale 119 f. Boyd and Graham 123 g. Range of Motion (ROM) 124 h. Gait 126 i. Hip X-Ray 129 j. Spine X-Ray 129 k. Orthopaedic Surgery Likelihood 130 7. Health Economics (HE) .................................................................. 133 7.1 HE: Introduction 133 7.2 HE: The incremental cost of SDR 135 7.3 HE: Children in the data 135 7.4 HE: Analysis applied to the cost data 136 7.5 HE: Results of the analysis of cost data 137 7.6 HE: Incremental Effectiveness of SDR 139 7.7 HE: Subgroup Analysis 141 7.8 HE: Results of the analysis of outcomes 142 7.9 HE: Cost-Effectiveness of SDR 143 7.10 HE: Cost Effectiveness Results 144 7.11 HE: Subgroup Analysis 146 7.12 HE: Discussion 149 7.13 HE: Conclusion 154 8. Provider Experience Questionnaire (PEQ) ..................................... 155 8.1 Background of the PEQ 155 8.2 Overview of the PEQ 156 a. PEQ Pre-data Collection Period 156 b. PEQ Data Collection Period 157 c. PEQ Sampling Frame 157 d. PEQ Structure 158 8.3 PEQ Information and Ethical Governance 158 e. PEQ Analysis Considerations 158 a. PEQ Information Governance Requirements 159 a. PEQ Ethical Considerations 159 8.4 PEQ Results 160 3 a. PEQ Respondents: Overview 160 b. PEQ: Overall Experience with SDR 162 c. PEQ: CtE SDR Selection Criteria 165 d. PEQ: SDR Operation Resources 166 e. PEQ: Referral Pathways 168 f. PEQ: SDR CtE Timelines 169 g. PEQ: Interaction with SDR families 170 h. PEQ: Interaction with External Bodies 172 i. PEQ: Additional Comments 174 8.5 PEQ Discussion 176 8.6 PEQ Conclusions 180 9. Post-Operative Physiotherapy Services Questionnaire (POPSQ) .... 181 9.1 POPSQ Project Background 181 9.2 POPSQ Design 182 a. POPSQ: Survey Design 182 a. POPSQ: Data Collection Issues 182 b. POPSQ: Analysis 183 9.3 POPSQ Information Governance Requirements 183 9.4 POPSQ Ethical Considerations 184 9.5 POPSQ Results 184 a. POPSQ: Pre-operative Evaluation 184 b. POPSQ: Post-Operative Evaluation 189 c. POPSQ: Post-Operative Specific Services 195 d. POPSQ: Feedback 197 e. CtE database post-SDR physiotherapy binary question results 201 9.6 POPSQ Discussion 202 9.7 POPSQ Conclusions 207 10. Discussion ................................................................................. 208 10.1 Principal Findings 208 10.2 Study strengths and limitations 212 11. Conclusions ............................................................................... 214 12. Acknowledgements ................................................................... 215 References .......................................................................................... 218 Appendix 1: Data Dictionary ................................................................ 223 Appendix 2: Patient information sheets (PIS) ....................................... 264 a. Parent Version of PIS 264 b. Child Version of PIS for Under 5 years of age 268 c. Child Version of PIS for 5 years of age and over 269 4 Appendix 3: Consent Form (database) ................................................. 270 Appendix 4: Database Changes ............................................................ 271 Appendix 5: HRA CtE SDR database approval ....................................... 275 Appendix 6: HRA CtE SDR database minor amendment........................ 280 Appendix 7: Systematic Review – search terminology .......................... 282 Appendix 8: PRISMA Flow Diagram ..................................................... 286 Appendix 9: GMFCS II and III outcome data ......................................... 287 a. Intraoperative Assessment – Levels II and III 287 b. Modified Ashworth Scale – GMFCS levels II and III 288 c. Physiotherapy – GMFCS levels II and III 292 d. Duncan-ely – GMFCS levels II and III 296 e. MRC Strength Scale – GMFCS Levels II and III 298 f. Boyd and Graham – GMFCS Levels II and III 306 g. Range of Motion (ROM) – GMFCS Levels II and III 307 h. Gait – GMFCS Levels II and III 311 i. Hip X-Ray – GMFCS Levels II and III 317 j. Spine X-Ray – GMFCS Levels II and III 318 k. Orthopaedic Surgery Likelihood – GMFCS Levels II and III 319 Appendix 10: PEQ data dictionary ....................................................... 324 Appendix 11: POPSQ paper version ..................................................... 329 Appendix 12: POPSQ HRA approval (copy) ........................................... 334 Appendix 13: Additional NHS England/NICE CtE Evaluation Questions . 339 5 Project Details Work package reference RX070 Work package name Commissioning through Evaluation: Selective Dorsal Rhizotomy Produced by KiTEC - King's Technology Evaluation Centre School of Biomedical Engineering and Imaging Sciences King's College London Becket House, 5th Floor 1 Lambeth Palace Road London SE1 7EU, United Kingdom Phone: +44 (0)20 7848 9528 Project Lead Peacock, Janet Authors (alphabetical) Bourmpaki, Elli Bunce, Catey Coker, Bola Eddy, Saskia Elstad, Maria Hussein, Ediz Keevil, Stephen Peacock, Janet Pennington, Mark Radhakrishnan, Muralikrishnan Summers, Jennifer Correspondence to Prof Janet Peacock, 0207 848 6649, [email protected] Date completed 28 September 2018 Version 1.0 6 Executive Summary Summary This report provides an evaluation of the effects of the surgical procedure, Selective Dorsal Rhizotomy (SDR) in eligible children with cerebral palsy and is part of the Commissioning through Evaluation (CtE) Programme led by NHS England. SDR was commissioned in five centres in 137 children from 2014-16 and outcome data were collected over a two-year post-surgery period. Data obtained included measures of Gross Motor Function Measure (GMFM-66), Cerebral Palsy
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