Appendices to palliative care case study

366 Pages·2016·4.75 MB·English

Co-funded by the
European Union

Case Study Appendices

Integrated assessment of home based palliative care with
and without reinforced caregiver support:
‘A demonstration of INTEGRATE-HTA methodological
guidances’

Brereton, L., Wahlster, P., Lysdahl, K.B., Mozygemba, K., Burns, J., Chilcott, J.B., Ward, S.,
Brönneke, J.B., Tummers, M., Van Hoorn, R., Pfadenhauer, L., Polus, S., Ingleton, C.,
Gardiner, C., Van Der Wilt, G.J., Gerhardus, A., Rohwer, A., Rehfuess, E., Oortwijn, W.,
Refolo, P., Sacchini, D., Leppert, W., Blazeviciene, A., Spagnolo A.G., Preston, L., Clark, J.,
Goyder, E., ON BEHALF OF THE INTEGRATE-HTA TEAM (2016).
Contents

Abbreviations ..........................................................................................................................................................7
Appendix 1 Definitions of terms used in the overall research question............................................................9
Appendix 2 HTA Terminology used within the report .................................................................................... 10
Appendix 3 Palliative Care (Terminology & Definitions) ................................................................................. 11
Appendix 4 Global/European policy context for palliative care ..................................................................... 13
Appendix 5 Palliative care service provision across Europe ........................................................................... 15
Appendix 6 Stakeholder input into each stage of the HTA Process ................................................................ 16
Appendix 7 Comprehensive specialist or intermediate p/care as defined in a systematic review ................ 17
Appendix 8 International variation in definitions & provision of palliative care ............................................ 18
Appendix 9 Palliative care policy context in England ...................................................................................... 26
Appendix 10 An overview of the NICE Technology Appraisal Guidance Development Process ...................... 30
Appendix 11 Decision makers, HTA Commissioning Agency ............................................................................ 32
Appendix 12 Stakeholder consultation in step 1 & 2 of the project ................................................................ 34
Appendix 13 Stakeholder Advisory panels in England ...................................................................................... 45
Appendix 14 Stakeholder Advisory Panels in Germany .................................................................................... 61
Appendix 15 Stakeholder Advisory Panels in Italy ............................................................................................ 62
Appendix 16 Stakeholder Advisory Panels in the Netherlands ........................................................................ 69
Appendix 17 Stakeholder Advisory Panels in Norway ...................................................................................... 73
Appendix 18 Stakeholder Advisory Panels in Lithuania .................................................................................... 78
Appendix 19 Stakeholder Advisory Panels in Poland ....................................................................................... 82
Appendix 20 Literature Review – A Review of Review ..................................................................................... 87
Appendix 21 Explanatory text – logic model for reinforced & non-reinforced models of h/based p/care ..... 87
Appendix 22 Systematic Review methods for the assessment of effectiveness ........................................... 162
Appendix 23 Stakeholders involved in the gap analysis for the effectiveness assessment ........................... 172
Appendix 24 Feedback from Stakeholders involved in the gap analysis for the effective assessment ......... 173
Appendix 25 Review of the economics of reinforced carer support and home care models ........................ 174
Appendix 26 Stakeholder engagement: Economics Workshop 5th February 2015 ......................................... 185
Appendix 27 Expert elicitation of resource impact of reinforced carer support ............................................ 197
Appendix 28 Stakeholder feedback for economic workshops ........................................................................ 210
Appendix 29 Ethics: Important aspects of complexity for HBPC ..................................................................... 211
Appendix 30 Socio-cultural: Main questions addressed in stakeholder consultation of step 1a & 1c ........... 216
Appendix 31 Socio-cultural: Preparation & questions addressed in the s/holder consultation of step 3 ...... 221
Appendix 32 S/cultural aspects relevant for HTA of (r)HBPC identified and weighted by s/holders .............. 232
Appendix 33 Socio-cultural: The framework category “user-professional-relationship & decision making .. 234
Appendix 34 Socio-cultural - Stakeholder feedback on taking part in stakeholder consultations .................. 235
Appendix 35 Summary of identified moderators ........................................................................................... 240
Appendix 36 Summary of patient preferences ................................................................................................ 247
Appendix 37 Feedback from s/holders advising on moderators of t/ment effect & patient preferences ..... 251
Appendix 38 CICI Framework .......................................................................................................................... 253
Appendix 39 Qualitative Review ...................................................................................................................... 264
Appendix 40 Effectiveness for caregiver ......................................................................................................... 300
Appendix 41 Effectiveness for patients ........................................................................................................... 304
Appendix 42 Cost Effectiveness ....................................................................................................................... 309
Appendix 43 Acceptability ............................................................................................................................... 312
Appendix 44 Meaningfulness .......................................................................................................................... 316
Appendix 45 Appropriateness ......................................................................................................................... 320
Appendix 46 Feasibility .................................................................................................................................... 321
Appendix 47 A Rapid Applicability Assessment of an HTA of Complex Interventions ..................................... 322
Appendix 48 Stakeholders involved in the ‘mock’ decision committee meeting ............................................ 356
Appendix 49 Scoring the HTA results............................................................................................................... 360
Appendix 50 Feedback from stakehodlers involved in the decision making meeting .................................... 362
Appendix 51 Stakeholder Advisory Panel Members in England ...................................................................... 364
Appendix 52 Project Advisory Board ............................................................................................................... 366
List of Tables

Table A1.1 Criterion of Interest ............................................................................................................................9
Table A8.1 A continuum of palliative care specialisation: definitions from the EAPC ...................................... 20
Table A8.2 Examples of services in each country at various levels of p/care service provision ....................... 21
Table A12.1 Methods used in England, Norway and Poland ............................................................................. 37
Table A12.2 Methods used in Germany, Italy, The Netherlands and Lithuania ................................................ 39
Table A12.3 Background details of the stakeholders involved in SAPs (Round 1) ............................................ 41
Table A12.4 Common Issue identified in the SAPs across seven countries ...................................................... 44
Table A13.1 Adaptions to the EUnetHTA Core Model ....................................................................................... 54
Table A13.2 Background details of the stakeholders involved in the England s/holder advisory panels ......... 55
Table A13.3 Brief summary of findings .............................................................................................................. 56
Table A15.1 Issues identified between lay people and professionals ............................................................... 67
Table A18.1 The findings from each professional ............................................................................................. 80
Table A20.1 Excluded Reviews........................................................................................................................... 91
Table A20.2 Definitions of terms used in review aims/objectives and examples of relevant outcomes ........ 102
Table A20.3 Characteristics of Included Reviews ........................................................................................... 103
Table A20.4 Components of models as reported at review level ................................................................... 121
Table A20.5 Quality appraisal form for the agreed included reviews ............................................................. 142
Table A20.6 Definition/description of intervention(s): ................................................................................... 143
Table A22.1 Search Terms ............................................................................................................................... 164
Table A22.2 Characteristics of included studies .............................................................................................. 167
Table A23.1 Stakeholders involved in the gap analysis for the effectiveness assessment ............................. 172
Table A24.1 Feedback from Stakeholders involved in the gap analysis for the effectiveness assessment .... 173
Table A25.1 Details of six home care studies reporting total costs................................................................. 179
Table A27.1 Health and social care palliative care resources ......................................................................... 199
Table A28.1 Feedback from Stakeholders involved in the gap analysis for the economic workshops ........... 210
Table A30.1 Professional Stakeholder Background Details (n=2) for those involved in Step 1a .................... 216
Table A30.2 Patient & Public Stakeholder Background Details (n=4) for those involved in Step 1c ............... 217
Table A31.1 Professional Stakeholder Background Details (n=3) for those involved in Step 1a .................... 221
Table A31.2 “User professional relationship and decision making” from different perspectives .................. 224
Table A32.1 Socio-cultural aspects relevant to (r)HBPC identified and weighted by stakeholders ................ 232
Table A33.1 “User professional relationship and decision making” from different perspectives: ................. 234
Table A34.1 Feedback from Stakeholders involved in Step 1a of the socio-cultural assessment ................... 235
Table A34.2 Feedback from Stakeholders involved in Step 1c of the socio-cultural assessment ................... 236
Table A34.3 Feedback from Stakeholders involved in Step 3 of the socio-cultural assessment ..................... 237
Table A34.4 Expert Background Information – Patient Preference – 24th April 2015 ..................................... 238
Table A35.1 Overview of the papers containing moderators for treatment (as found in review) ................. 240
Table A36.1 O/view of appraised papers containing info on patient preferences for t/ment outcome ....... 247
Table A37.1 Feedback from S/holders advising on moderators of treatment effect & patient pref .............. 251
Table A38.1 Domains of Context ..................................................................................................................... 258
Table A38.2 Delivery ........................................................................................................................................ 260
Table A38.3 Programming ............................................................................................................................... 262
Table A38.4 Context and Implementation Checklist ...................................................................................... 262
Table A39.1 Reporting Assessment Checklist (27) ........................................................................................... 267
Table A39.2 Assessment of Adequacy of Reporting ........................................................................................ 267
Table A39.3 Characteristics of included studies .............................................................................................. 269
Table A39.4 Quality of reporting of included studies ...................................................................................... 275
Table A47.1 General structure of consultation guide. ..................................................................................... 326
Table A47.2 UK ................................................................................................................................................. 332
Table A47.3 Germany ...................................................................................................................................... 334
Table A47.4 Poland ......................................................................................................................................... 337
Table A47.5 Example of questions included in the consultation guide ............................................................ 351
Table A48.1 Professional S/holder Background Details (n=11) for those involved in mock decision mtg ...... 356
Table A49.1 Scoring Scale Example ................................................................................................................. 360
Table A50.1 Feedback from Stakeholders involved in Step 1a of the socio-cultural assessment ................... 362
List of Figures

Figure A6.1 Stakeholder input into each stage of the HTA process ................................................................ 16
Figure A16.1 Logic model; summary of findings Netherlands ........................................................................... 72
Figure A20.1 PRISMA Flowchart ........................................................................................................................ 90
Figure A22.1 Flowchart outlining screening & identification of originally included studies from Gomes ..... 166
Figure A26.1 Reinforced home palliative care intervention theory ................................................................ 194
Figure A27.1 Average duration of palliative care following reinforced carer support .................................... 200
Figure A27.2 Proportion of admissions avoided with reinforced carer support ............................................. 201
Figure A27.3 Band 6 & 7 Specialist Nurse hours per week in conventional care ............................................ 202
Figure A27.4 Band 6/7 Specialist Nurse: Intervention effectiveness relative contact time ........................... 203
Figure A27.5 Proportion of out-of-hours GP consultations avoided ............................................................... 204
Figure A27.6 GP consultations avoided ........................................................................................................... 204
Figure A27.7 Proportion of transfers to care home delayed........................................................................... 205
Figure A27.8 Proportion of the palliative home care population that would be able and willing to take up 206
Figure A38.1 The Context and Implementation for Complex Intervention (CICI) framework ........................ 254
Figure A39.1 Best Fit Framework Synthesis..................................................................................................... 266
Figure A39.2 Flow chart of study selection process ........................................................................................ 268
Figure A47.1 Logic Model ................................................................................................................................ 325
Figure A47.2 Pilot testing in the integrated HTA process ................................................................................ 326

List of Boxes

Box A12.1 The EUnetHTA Core Model ............................................................................................................... 36
Box A13.1 Stakeholder feedback form .............................................................................................................. 58
Box A15.1 Adapted version of the EUnetHTA Core Model which supported Interviews with s/holders ………..63
Box A20.1 Search Terms .................................................................................................................................. 888
Abbreviations
This list gives some terms; others are explained in the text or in notes at the end of appendices.
A&E Accident & Emergency
ACD Appraisal Consultation Document
ACP Advance Care Plan
AHP Allied Health Professionals
ALS Amyotrophic lateral sclerosis
AMSTAR A Measurement Tool to Assess Systematic Reviews
AMKPS Australian-modified Karnofsky Performance Status
BMA British Medical Association
CBA Controlled Before & After Studies
CCG Clinical Commissioning Groups
CCT Controlled Clinical Trials
Cf E.g. (for example)
CHF Chronic Heart Failure
CME Continuing Medical Education
CICO Context and implementation for complex interventions
COPD Chronic Obstructive Pulmonary Disease
COPE Committee on Publications Ethics
DH Department of Health
DN District Nurse
EAPC European Association of Palliative Care
ED Emergency Department
EOL End of Life
ERG Evidence Review Group
EU European Union
EVIDEM Evidence and Value: Impact on Decision Making
FAD Final Appraisal Determination
GMC General Medical Council
GP General Practitioner
GPC Generalist Palliative Care
GSF Gold Standards Framework
HAH Hospice at Home
HBPC Home Based Palliative Care
HF Hearth Failure
HIV Human immunodeficiency virus
HRQoL Heart Related Quality of Life
HTA Health Technology Assessment
ICESCR International Covenant on Economic, Social and Cultural Rights
ICP Integrated Care Pathway
IPcOS Integrated Palliative Care Outcome Scale
INAHTA International Network of Agencies for Health Technology Assessment
IO International Organisations
ITSS Interrupted Time Series Studies
LA Local Authority
LCP Liverpool Care Pathway
MCCC Marie Curie Cancer Centre
MCDA Multiple Criteria Decision Analysis
MCDA Multi-criteria decision analysis
MCNS Marie Curie Nursing Service
MDT Multi-Disciplinary Team
MORECare Methods Of Researching End of life Care
MND Motor Neurone Disease
MRC Medical Research Council
MTA Multiple Technology Appraisal
NAO National Audit Office
NCPC National Council for Palliative Care
NHS National Health Service
NHS-EOLCP National Health Service End of Life Care Programme
NICE National Institute for Clinical Excellence
NIHR National Institute for Health Research
NRES National Research Ethics Service
NTCRP North Trent Cancer Research Panel
OACC Outcome Assessment and Complexity Collaborative
OT Occupational Therapy
PC Palliative Care
PCSAG Palliative Care Studies Advisory Group
PCT Palliative Care Team
PCTs Primary Care Trusts
PHAC Public Health Advisory Committees
PHCT Palliative Home Care Teams
PICO Population, Intervention, Comparator and Outcome
PPI Patient & Public Involvement
PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses
PRISMA Reflecting the Positive diveRsities of European PrIorities for reSearch & Measurement in
End-of-life cAre
PROMS Patient Reported Outcome Measures
QALYS Quality Adjusted Life Years
QOL Quality of Life
RCGP Royal College of General Practitioners
RCT Randomised Controlled Trial
RHBPC Reinforced Home Based Palliative Care
RIFM Reconstructing Interpretative Frames Method
SAP Stakeholder Advisory Panel
SCM Supportive Care Measure
SD Standard Deviation
SPC Specialist Palliative Care
STA Single Technology Appraisal
STH Sheffield Teaching Hospitals
TAC Public Health Advisory Committees
TAR Technology Assessment Report
TiDier Template for Intervention Description and Replication
UK United Kingdom
UN United Nations
USA United States of America
VOC Views of Care
WHO World Health Organisation
WP Work Package
Appendix 1 Definitions of terms used in the overall research question

Table A1.1 Criterion of Interest

Criterion of Interest
Effectiveness is defined as “The benefit (e.g. to health outcomes) of using a technology for a particular problem
under general or routine conditions, for example, by a physician in a community hospital or by a patient at
home.” (2) Clinical effectiveness is defined as “The extent to which a specific intervention, procedure, regimen, or
service does what it is intended to do under ordinary circumstances, rather than controlled conditions. Or more
specifically, the evaluation of benefit to risk of an intervention, in a standard clinical setting, using outcomes
measuring issues of importance to patients (e.g. ability to do daily activities, longer life, etc.)” (1).
Cost effectiveness is defined as an economic evaluation consisting of comparing various options, in which costs
are measured in monetary units, then aggregated, and outcomes are expressed in natural (non-monetary) units
(1).
Acceptability is defined as being agreeable to defined population groups, often those benefiting from / targets
groups affected by the intervention, those implementing an intervention and society at large (2).
Meaningfulness is defined as “the extent to which an intervention or activity is positively experienced by the
patient. Meaningfulness relates to the personal experience, opinions, values, thoughts, beliefs and interpretations
of patients or clients” (2).
Appropriateness is defined as “the extent to which an intervention or activity fits with or is apt in a situation.
Clinical appropriateness is about how an activity or intervention relates to the context in which care is given (2).
Feasibility is defined as “the extent to which an activity is practical and practicable. Clinical feasibility is about
whether or not an activity or intervention is physically, culturally or financially practical or possible within a given
context” (2).
Implementation is defined as “process, constellation of processes or means of assimilating or putting into use an
intervention - either evidence-based or theory-based – in an organisation or a setting” (3)

References
 INAHTA (International Network of Agencies for Health Technology Assessment) (2015) Technology
Assessment (HTA) Glossary. Available at http://inahta.episerverhotell.net/Glossary/#_G
 Joanna Briggs Institute. Joanna Briggs Institute reviewers' manual: 2014 edition. Adelaide, SA: Joanna
Briggs Institute; University of Adelaide; 2014.
http://joannabriggs.org/assets/docs/sumari/ReviewersManual-2014.pdf. [Context Link]
 Pfadenhuer, L., Rohwer, A., Burns, J., Booth, A., Lysdahl, K.B., Hofmann, B., Gerhardus, A.,
Mozygemba, K., Tummers, M., Wahlster, P., Rehfuess, E. (2016) Guidance for the Assessment
of Context and Implementation in Health Technology Assessments (HTA) and Systematic
Reviews of Complex Interventions: The Context and Implementation of Complex Interventions
(CICI) Framework [Online]. Available from: http://www.integrate-hta.eu/downloads/
Appendix 2 HTA Terminology used within the report
A Health Technology Assessment (HTA): the systematic evaluation of properties, effects, and/or
impacts of health care technology. It may address the direct, intended consequences of technologies
as well as their indirect, unintended consequences. Its main purpose is to inform technology-related
policymaking in health care. A HTA is conducted by interdisciplinary groups using explicit analytical
frameworks drawing from a variety of methods (INAHTA).
HTA terminology used within this report is consistent with the definitions provided by INAHTA –
International Network of Agencies for Health Technology Assessment (2013). INAHTA Health
Technology Assessment (HTA) Glossary is available from
http://inahta.episerverhotell.net/Glossary/#_G).