Antimicrobial stewardship in care homes for older people development of a core outcome set

Antimicrobial stewardship in care homes for older people: development of a core outcome set by Hoa Quoc Nguyen, BPharm A thesis submitted to: Faculty of Medicine, Health and Life Sciences School of Pharmacy Queen’s University, Belfast for the degree of Doctor of Philosophy November 2020 This thesis is dedicated to my late beloved grandfather, Doan Huu Tu, and my late beloved supporter, Professor Liam Murray Declaration I declare that: The thesis is not one for which a degree has been or will be conferred by any other university or institution; The thesis is not one for which a degree has already been conferred by this University; The work for the thesis is my own work and that, where material submitted by me for another degree or work undertaken by me as part of a research group has been incorporated into the thesis, the extent of the work thus incorporated has been clearly indicated The composition of the thesis is my own work Table of contents List of tables i List of figures iii Table of contents for appendices iv Acknowledgments viii List of abbreviations ix Abstract xi Publications xiii CHAPTER : General introduction 1.1 The ageing population 1.2 Older people and care homes 1.3 The need for antimicrobial stewardship in care homes 12 1.4 Core outcome sets 19 1.5 Overview of the research presented in this thesis 23 CHAPTER : Interventions to improve antimicrobial stewardship for older people in care homes: a systematic review 25 2.1 Introduction 26 2.2 Aims and Objectives 28 2.3 Research design and methodology 29 2.4 Results 34 2.5 Discussion 55 2.6 Conclusion 62 CHAPTER : Antimicrobial stewardship for older people in care homes: Outcomes of importance to researchers, healthcare professionals, and residents’ family members 63 3.1 Introduction 64 3.2 Aim and Objectives 65 3.3 Research design and methodology 66 3.4 Results 78 3.5 Discussion 98 3.6 Conclusion 106 CHAPTER : Development of a core outcome set for clinical trials aimed at improving antimicrobial stewardship in care homes 107 4.1 Introduction 108 4.2 Aim and Objectives 109 4.3 Research design and methodology 110 4.4 Results 123 4.5 Discussion 138 4.6 Conclusion 148 CHAPTER : Selection of outcome measurement instruments for a core outcome set for clinical trials aimed at improving antimicrobial stewardship in care homes 149 5.1 Introduction 150 5.2 Aim and Objectives 152 5.3 Research design and methodology 152 5.4 Results 166 5.5 Discussion 185 5.6 Conclusion 196 CHAPTER : General discussion and Conclusions 197 6.1 General discussion 198 6.2 Conclusions 213 REFERENCES 214 APPENDICES 237 List of tables Table 1.1 Common infections in care homes (Smith et al., 2008; Montoya and Mody, 2011) Table 1.2 Minimum requirements for an AMS programme (Fishman, 2012) 17 Table 2.1 Characteristics of included studies and effect of interventions 38 Table 2.2 Outcomes presented in included studies 47 Table 3.1 Overarching outcomes identified in a systematic review 78 Table 3.2 Participant demographics 79 Table 3.3 Outcomes deemed important by participants with illustrative quotes 81 Table 3.4 The refined list of outcomes related to AMS in care homes 96 Table 4.1 Inventory of outcomes by categories 124 Table 4.2 Demographic profile of participants in the Delphi panel 125 Table 4.3 Distribution of importance based on the scale used for each outcome in the first round 127 Table 4.4 Distribution of importance based on the scale used for each outcome in the second round 128 Table 4.5 Distribution of importance based on the scale used for each outcome in the third round 130 Table 4.6 Outcomes of importance and illustrative quotes after the first questionnaire 133 Table 4.7 Distribution of importance based on the scale used for outcomes after the online consensus exercise 135 Table 4.8 The core outcome set for use in trials aimed at improving AMS in care homes 137 Table 5.1 Measurement properties of an outcome measurement instrument (Prinsen et al., 2016a) 155 Table 5.2 Feasibility aspects defined by the COSMIN initiative (Prinsen et al., 2016a) 156 Table 5.3 Methodological quality of studies aimed at developing OMIs relevant to antimicrobial prescribing in care homes 170 i Table 5.4 Summary of quality assessment of ‘objective’ outcome measurement instruments 172 Table 5.5 Summary of quality assessment of ‘subjective’ outcome measurement instruments 173 Table 5.6 Demographic profile of participants in the Delphi panel 177 Table 5.7 Distribution of agreement levels for each OMI in the first round 179 Table 5.8 Distribution of agreement levels for each OMI in the second round 180 Table 5.9 The COS developed for trials aimed at improving AMS in care homes and recommended OMIs 182 ii List of figures Figure 1.1 Percentage population change by age group across the UK, mid-2018 to mid-2043 (Adapted from Northern Ireland Statistics and Research Agency, 2019) Figure 1.2 Change in percentage of people prescribed at least one antibiotic by the time of admission to care homes (Taken from Patterson et al., 2019) 14 Figure 1.3 Process of development of a COS 21 Figure 2.1 PRISMA flow diagram of screening process and reasons for exclusion of studies published until November 30th 2018 35 Figure 2.2 PRISMA flow diagram of screening process and reasons for exclusion of studies published until December 31th 2019 from updated search 36 Figure 2.3 Risk of bias: review authors’ judgements about each risk of bias item presented as percentages across all included studies 54 Figure 2.4 Risk of bias summary: review authors’ judgements about each risk of bias item for each included study 55 Figure 3.1 The process of compiling a refined list of outcomes for AMS in care homes 97 Figure 4.1 Online consensus exercise overview 122 Figure 4.2 Three-round Delphi flow chart 131 Figure 5.1 Quality assessment of outcome measurement instruments 158 Figure 5.2 Process of screening and selecting articles to extract relevant OMIs 168 Figure 5.3 Two-round Delphi flow chart 180 iii Table of contents for appendices Appendix 2.1 PRISMA Checklist 238 Appendix 2.2 Search strategies 241 Appendix 2.3 Data extraction form 261 Appendix 2.4 ‘Risk of bias’ assessment of included studies 268 Appendix 3.1 Invitation letter for researchers and healthcare professionals 273 Appendix 3.2 Researchers and healthcare professionals’ information sheet 274 Appendix 3.3 Invitation letter for family members of care home residents 278 Appendix 3.4 Care home family members’ information sheet 280 Appendix 3.5 Topic guides for interviews with researchers and healthcare professionals 286 Appendix 3.6 Topic guide for family members’ interview 292 Appendix 3.7 Researchers and healthcare professionals’ consent form 298 Appendix 3.8 Family members’ consent form 299 Appendix 3.9 Demographic details form – Researchers and healthcare professionals 300 Appendix 3.10 Demographic details form – Family members of care home residents 301 Appendix 3.11 Letter of ethical approval 302 Appendix 3.12 Completed COREQ checklist 306 Appendix 3.13 Outcomes excluded from the refined list and reasons for exclusion 310 Appendix 4.1 Experts’ Round questionnaire 313 Appendix 4.2 Public participants’ Round questionnaire 318 Appendix 4.3 Template recruitment email 323 Appendix 4.4 Experts’ study invitation letter 324 Appendix 4.5 Experts’ information sheet (except for care home managers/ staff) 325 Appendix 4.6 Care home managers/ staff’ information sheet 330 Appendix 4.7 Public participants’ study invitation letter 335 Appendix 4.8 Public participants’ information sheet 337 iv Appendix 4.9 COMET Initiative Plain Language Summary 343 Appendix 4.10 Expert consent form for Delphi consensus (except for care home managers/ staff) 345 Appendix 4.11 Care home managers/ staff consent form for Delphi consensus 346 Appendix 4.12 Public participant consent form for Delphi consensus 347 Appendix 4.13 First round email for experts 348 Appendix 4.14 First round email for public participants 349 Appendix 4.15 Background Information and Completion Instructions for experts 350 Appendix 4.16 Background Information and Completion Instructions for public participants 352 Appendix 4.17 COMET Initiative Delphi Process Plain Language Summary 354 Appendix 4.18 Email reminder for experts 356 Appendix 4.19 Email reminder for public participants 357 Appendix 4.20 Second round email for experts 358 Appendix 4.21 Second round email for public participants 359 Appendix 4.22 Third round email for experts 360 Appendix 4.23 Third round email for public participants 362 Appendix 4.24 Experts’ invitation email for consensus group meeting 364 Appendix 4.25 Public participants’ invitation email for consensus group meeting 365 Appendix 4.26 New experts’ invitation for consensus group meeting 366 Appendix 4.27 New public participants’ invitation for consensus group meeting 367 Appendix 4.28 Experts’ information sheet for consensus group meeting 369 Appendix 4.29 Public participants’ information sheet for consensus group meeting 374 Appendix 4.30 Experts’ instructions of the online consensus exercise 379 Appendix 4.31 Public participants’ instructions of the online consensus exercise 381 Appendix 4.32 List of included outcomes after the Delphi consensus 383 Appendix 4.33 Experts’ consent form for consensus meeting 385 Appendix 4.34 Public participants’ consent form for online consensus exercise 386 Appendix 4.35 First questionnaire for the online consensus exercise 387 Appendix 4.36 Second questionnaire for the online consensus exercise 392 v ... CM Antimicrobial stewardship outcomes for older people in care homes: perspectives of researchers, healthcare professionals, and family members of care home residents International Journal of. .. Mairead, Maureen, Nadia, Sarah, Caoimhe, Ameerah, Tahani, Dima, Lucy, Colleen, Bara? ?a, and Rineke My incredibly special thanks go to helpful staff at School of Pharmacy, especially Dr Roisin O’Hare,... Publications Manuscripts Nguyen HQ, Bradley DT, Tunney MM, Hughes CM Development of a core outcome set for clinical trials aimed at improving antimicrobial stewardship in care homes [Manuscript