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A protocol for a systematic review and meta-analysis to identify measures of breakthrough pain and evaluate their psychometric properties
  1. Katie Greenfield1,
  2. Simone Holley1,
  3. Daniel Eric Schoth1,
  4. Julie Bayliss2,
  5. Anna-Karenia Anderson3,
  6. Satbir Jassal4,
  7. Dilini Rajapakse2,
  8. Lorna Katharine Fraser5,
  9. Christine Mott6,
  10. Margaret Johnson7,
  11. Ian Wong8,
  12. Richard Howard9,
  13. Emily Harrop10,11,
  14. Christina Liossi1,9
  1. 1School of Psychology, University of Southampton, Southampton, Hampshire, UK
  2. 2The Louis Dundas Centre, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
  3. 3Paediatric Palliative Care, Royal Marsden Hospital NHS Trust, London, UK
  4. 4Paediatric Palliative Care, Rainbows Hospice for Children and Young People, Loughborough, Leicestershire, UK
  5. 5Martin House Research Centre, Department of Health Sciences, University of York, York, UK
  6. 6Paediatric Palliative Care, Hummingbird House Hospice, Brisbane, Queensland, Australia
  7. 7Patient & Pubic Representative c/o Public Health and Primary Care, University of Cambridge, Cambridge, UK
  8. 8School of Pharmacy, University College London, London, UK
  9. 9Department of Anaesthesia and Pain Medicine, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
  10. 10Paediatric Palliative Care, Helen & Douglas House Hospice, Oxford, UK
  11. 11Paediatric Palliative Care, Oxford University Hospitals NHS Trust, Oxford, UK
  1. Correspondence to Professor Christina Liossi; cliossi{at}


Introduction Breakthrough pain is common in children and adults with cancer and other conditions, including those approaching end-of-life, although it is often poorly managed, possibly partly due to a lack of validated assessment tools. This review aims to (1) identify all available instruments measuring breakthrough pain in infants, children, adolescents or adults and (2) critically appraise, compare and summarise the quality of the psychometric properties of the identified instruments using COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria.

Methods and analysis Two searches will be carried out between October 2019 and January 2020, one for each aim of the review. The Cochrane Library, International Prospective Register of Systematic Reviews, Embase, Cumulative Index of Nursing and Allied Health Literature, Medical Literature Analysis and Retrieval System Online (MEDLINE), PsycINFO, Web of Science Core Collection, Google Scholar, the ProQuest Dissertations & Theses Database, Evidence Search and OpenGrey databases will be searched from database inception until the date the search is conducted. Reference lists of eligible articles will be screened and authors in the field contacted. For search 1, articles will be screened by two reviewers by abstract, and full-text where necessary, to identify if a breakthrough pain assessment was used. Search 2 will then be conducted to identify studies evaluating measurement properties of these assessments. Two reviewers will screen articles from search 2 by title and abstract. All potentially relevant studies will be screened by full text by both reviewers. For search 2, data will be extracted in parallel with the quality assessment process, as recommended by COSMIN. Two reviewers will assess methodological quality using the COSMIN Risk of Bias checklist and the COSMIN updated criteria for good measurement properties. Findings will be summarised and, if possible, data will be pooled using meta-analysis. The quality of the evidence will be graded and summarised using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) guidelines.

Ethics and dissemination Results of this review will be submitted for publication in a peer review journal and presented at conferences.

PROSPERO registration number CRD42019155583.

  • pain management
  • neurological pain
  • cancer pain

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

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  • Contributors CL conceived the idea, KG, SH, DS and CL planned and designed the study protocol, data extraction and statistical analysis and wrote the first draft; ICKW, JB, SJ, DR, RH, MJ, EH, A-KA, CM and LKF provided critical insights. All authors have approved and contributed to the final written manuscript.

  • Funding This review is supported by Great Ormond Street Children’s Charity and SPARKS (Grant number: V5118).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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