Advertisement

Development and Evaluation of Complex Interventions in Palliative Care

  • Nilay HepgulEmail author
  • Wei Gao
  • Matthew Maddocks
  • Irene J. Higginson
Reference work entry

Abstract

Evaluations of complex interventions are of utmost importance to identify and deliver clinically and cost-effective palliative and end-of-life care for future populations. They are however challenging and resource intensive. The Medical Research Council (MRC) framework together with the Methods Of Researching End of Life Care (MORECare) collaboration provides clear standards on best research practice in evaluating services and treatments. These guidelines emphasize the need to consider implementation at all phases of evaluation, rather than only at the end. Furthermore, they highlight the need for flexible and pragmatic approaches to develop, examine, and evaluate complex interventions in palliative and end-of-life care. In this chapter we outline what a complex intervention is, discuss the challenges of developing and evaluating complex interventions in palliative and end-of-life care, and provide examples of complex interventions which have reached the evaluation phase.

References

  1. Anderson R. New MRC guidance on evaluating complex interventions. BMJ. 2008;337:a1937.CrossRefGoogle Scholar
  2. Ang K, Hepgul N, Gao W, Higginson IJ. Strategies used in improving and assessing the level of reporting of implementation fidelity in randomised controlled trials of palliative care complex interventions: a systematic review. Palliat Med. 2017.  https://doi.org/10.1177/0269216317717369.CrossRefGoogle Scholar
  3. Aoun SM, Nekolaichuk C. Improving the evidence base in palliative care to inform practice and policy: thinking outside the box. J Pain Symptom Manag. 2014;48:1222–35.CrossRefGoogle Scholar
  4. Bakitas MA, Lyons KD, Dixon J, Ahles TA. Palliative care program effectiveness research: developing rigor in sampling design, conduct, and reporting. J Pain Symptom Manag. 2006;31:270–84.CrossRefGoogle Scholar
  5. Booth S, Silvester S, Todd C. Breathlessness in cancer and chronic obstructive pulmonary disease: using a qualitative approach to describe the experience of patients and carers. Palliat Support Care. 2003;1:337–44.CrossRefGoogle Scholar
  6. Booth S, Farquhar M, Gysels M, Bausewein C, Higginson IJ. The impact of a breathlessness intervention service (BIS) on the lives of patients with intractable dyspnea: a qualitative phase 1 study. Palliat Support Care. 2006;4:287–93.CrossRefGoogle Scholar
  7. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321:694–6.CrossRefGoogle Scholar
  8. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, Guthrie B, Lester H, Wilson P, Kinmonth AL. Designing and evaluating complex interventions to improve health care. BMJ. 2007;334:455–9.CrossRefGoogle Scholar
  9. Casarett DJ, Karlawish JH. Are special ethical guidelines needed for palliative care research? J Pain Symptom Manag. 2000;20:130–9.CrossRefGoogle Scholar
  10. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRefGoogle Scholar
  11. Edmonds P, Vivat B, Burman R, Silber E, Higginson IJ. ‘Fighting for everything’: service experiences of people severely affected by multiple sclerosis. Mult Scler. 2007a;13:660–7.CrossRefGoogle Scholar
  12. Edmonds P, Vivat B, Burman R, Silber E, Higginson IJ. Loss and change: experiences of people severely affected by multiple sclerosis. Palliat Med. 2007b;21:101–7.CrossRefGoogle Scholar
  13. Edmonds P, Hart S, Wei G, Vivat B, Burman R, Silber E, Higginson IJ. Palliative care for people severely affected by multiple sclerosis: evaluation of a novel palliative care service. Mult Scler. 2010;16:627–36.CrossRefGoogle Scholar
  14. Eldridge SM, Ashby D, Feder GS, Rudnicka AR, Ukoumunne OC. Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care. Clin Trials. 2004;1:80–90.CrossRefGoogle Scholar
  15. Evans CJ, Benalia H, Preston NJ, Grande G, Gysels M, Short V, Daveson BA, Bausewein C, Todd C, Higginson IJ, Morecare. The selection and use of outcome measures in palliative and end-of-life care research: the MORECare International Consensus Workshop. J Pain Symptom Manag. 2013a;46:925–37.CrossRefGoogle Scholar
  16. Evans CJ, Harding R, Higginson IJ, Morecare. ‘Best practice’ in developing and evaluating palliative and end-of-life care services: a meta-synthesis of research methods for the MORECare project. Palliat Med. 2013b;27:885–98.CrossRefGoogle Scholar
  17. Farquhar MC, Higginson IJ, Fagan P, Booth S. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease. BMC Palliat Care. 2009;8:9.CrossRefGoogle Scholar
  18. Farquhar M, Higginson IJ, Fagan P, Booth S. Results of a pilot investigation into a complex intervention for breathlessness in advanced chronic obstructive pulmonary disease (COPD): brief report. Palliat Support Care. 2010;8:143–9.CrossRefGoogle Scholar
  19. Farquhar MC, Ewing G, Booth S. Using mixed methods to develop and evaluate complex interventions in palliative care research. Palliat Med. 2011;25:748–57.CrossRefGoogle Scholar
  20. Farquhar M, Preston N, Evans CJ, Grande G, Short V, Benalia H, Higginson IJ, Todd C, Morecare. Mixed methods research in the development and evaluation of complex interventions in palliative and end-of-life care: report on the MORECare consensus exercise. J Palliat Med. 2013;16:1550–60.CrossRefGoogle Scholar
  21. Farquhar MC, Prevost AT, Mccrone P, Brafman-Price B, Bentley A, Higginson IJ, Todd C, Booth S. Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial. BMC Med. 2014;12:194.CrossRefGoogle Scholar
  22. Farquhar MC, Prevost AT, Mccrone P, Brafman-Price B, Bentley A, Higginson IJ, Todd CJ, Booth S. The clinical and cost effectiveness of a Breathlessness Intervention Service for patients with advanced non-malignant disease and their informal carers: mixed findings of a mixed method randomised controlled trial. Trials. 2016;17:185.CrossRefGoogle Scholar
  23. Gruenewald DA, Higginson IJ, Vivat B, Edmonds P, Burman RE. Quality of life measures for the palliative care of people severely affected by multiple sclerosis: a systematic review. Mult Scler. 2004;10:690–704.CrossRefGoogle Scholar
  24. Gysels MH, Evans C, Higginson IJ. Patient, caregiver, health professional and researcher views and experiences of participating in research at the end of life: a critical interpretive synthesis of the literature. BMC Med Res Methodol. 2012;12:123.CrossRefGoogle Scholar
  25. Gysels M, Evans CJ, Lewis P, Speck P, Benalia H, Preston NJ, Grande GE, Short V, Owen-Jones E, Todd CJ, Higginson IJ. MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research. Palliat Med. 2013;27:908–17.CrossRefGoogle Scholar
  26. Harding R, Higginson IJ, Prisma. PRISMA: a pan-European co-ordinating action to advance the science in end-of-life cancer care. Eur J Cancer. 2010;46:1493–501.CrossRefGoogle Scholar
  27. Harding R, Simon ST, Benalia H, Downing J, Daveson BA, Higginson IJ, Bausewein C, Prisma. The PRISMA Symposium 1: outcome tool use. Disharmony in European outcomes research for palliative and advanced disease care: too many tools in practice. J Pain Symptom Manag. 2011;42:493–500.CrossRefGoogle Scholar
  28. Hepgul N, Gao W, Evans CJ, Jackson D, Van Vliet LM, Byrne A, Crosby V, Groves KE, Lindsay F, Higginson IJ, Neuro O. Integrating palliative care into neurology services: what do the professionals say? BMJ Support Palliat Care. 2017.  https://doi.org/10.1136/bmjspcare-2017-001354.CrossRefGoogle Scholar
  29. Higginson IJ. It would be NICE to have more evidence? Palliat Med. 2004;18:85–6.CrossRefGoogle Scholar
  30. Higginson IJ, Hart S, Silber E, Burman R, Edmonds P. Symptom prevalence and severity in people severely affected by multiple sclerosis. J Palliat Care. 2006a;22:158–65.CrossRefGoogle Scholar
  31. Higginson IJ, Vivat B, Silber E, Saleem T, Burman R, Hart S, Edmonds P. Study protocol: delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the effectiveness of a new palliative care service. BMC Palliat Care. 2006b;5:7.CrossRefGoogle Scholar
  32. Higginson IJ, Hart S, Burman R, Silber E, Saleem T, Edmonds P. Randomised controlled trial of a new palliative care service: compliance, recruitment and completeness of follow-up. BMC Palliat Care. 2008;7:7.CrossRefGoogle Scholar
  33. Higginson IJ, Mccrone P, Hart SR, Burman R, Silber E, Edmonds PM. Is short-term palliative care cost-effective in multiple sclerosis? A randomized phase II trial. J Pain Symptom Manag. 2009;38:816–26.CrossRefGoogle Scholar
  34. Higginson IJ, Evans CJ, Grande G, Preston N, Morgan M, Mccrone P, Lewis P, Fayers P, Harding R, Hotopf M, Murray SA, Benalia H, Gysels M, Farquhar M, Todd C, Morecare. Evaluating complex interventions in end of life care: the MORECare statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews. BMC Med. 2013;11:111.CrossRefGoogle Scholar
  35. Hui D, Parsons HA, Damani S, Fulton S, Liu J, Evans A, De La Cruz M, Bruera E. Quantity, design, and scope of the palliative oncology literature. Oncologist. 2011;16:694–703.CrossRefGoogle Scholar
  36. Hussain JA, White IR, Langan D, Johnson MJ, Currow DC, Torgerson DJ, Bland M. Missing data in randomized controlled trials testing palliative interventions pose a significant risk of bias and loss of power: a systematic review and meta-analyses. J Clin Epidemiol. 2016;74:57–65.CrossRefGoogle Scholar
  37. Lewin S, Hendry M, Chandler J, Oxman AD, Michie S, Shepperd S, Reeves BC, Tugwell P, Hannes K, Rehfuess EA, Welch V, Mckenzie JE, Burford B, Petkovic J, Anderson LM, Harris J, Noyes J. Assessing the complexity of interventions within systematic reviews: development, content and use of a new tool (iCAT_SR). BMC Med Res Methodol. 2017;17:76.CrossRefGoogle Scholar
  38. Lorenz KA, Lynn J, Dy SM, Shugarman LR, Wilkinson A, Mularski RA, Morton SC, Hughes RG, Hilton LK, Maglione M, Rhodes SL, Rolon C, Sun VC, Shekelle PG. Evidence for improving palliative care at the end of life: a systematic review. Ann Intern Med. 2008;148:147–59.CrossRefGoogle Scholar
  39. Medical Research Council. A framework for development and evaluation of RCTs for complex interventions to improve health. London: Medical Research Council; 2000.Google Scholar
  40. Oakley A, Strange V, Bonell C, Allen E, Stephenson J, RIPPLE Study Team. Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006;332:413–6.CrossRefGoogle Scholar
  41. Petticrew M. When are complex interventions ‘complex’? When are simple interventions ‘simple’? Eur J Pub Health. 2011;21:397–8.CrossRefGoogle Scholar
  42. Preston N, Short V, Hollingworth W, Mccrone P, Grande G, Evans C, Anscombe E, Benalia A, Higginson IJ, Todd C. MORECare research methods guidance development: recommendations for health economic evaluation in palliative and end of life care research [abstract]. Palliat Med. 2012;26:419.CrossRefGoogle Scholar
  43. Preston NJ, Fayers P, Walters SJ, Pilling M, Grande GE, Short V, Owen-Jones E, Evans CJ, Benalia H, Higginson IJ, Todd CJ, Morecare. Recommendations for managing missing data, attrition and response shift in palliative and end-of-life care research: part of the MORECare research method guidance on statistical issues. Palliat Med. 2013;27:899–907.CrossRefGoogle Scholar
  44. Tang ST, Mccorkle R. Appropriate time frames for data collection in quality of life research among cancer patients at the end of life. Qual Life Res. 2002;11:145–55.CrossRefGoogle Scholar
  45. Tieman J, Sladek R, Currow D. Changes in the quantity and level of evidence of palliative and hospice care literature: the last century. J Clin Oncol. 2008;26:5679–83.CrossRefGoogle Scholar
  46. Van Vliet LM, Gao W, Difrancesco D, Crosby V, Wilcock A, Byrne A, Al-Chalabi A, Chaudhuri KR, Evans C, Silber E, Young C, Malik F, Quibell R, Higginson IJ, Neuro O. How integrated are neurology and palliative care services? Results of a multicentre mapping exercise. BMC Neurol. 2016;16:63.CrossRefGoogle Scholar
  47. Vig E, Irwin S, Casarett D. Can my patient make that decision? Assessing capacity to make decisions about clinical care and research participation (516). J Pain Symptom Manag. 2010;39:413.CrossRefGoogle Scholar
  48. Visser C, Hadley G, Wee B. Reality of evidence-based practice in palliative care. Cancer Biol Med. 2015;12:193–200.PubMedPubMedCentralGoogle Scholar
  49. Wells M, Williams B, Treweek S, Coyle J, Taylor J. Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions. Trials. 2012;13:95.CrossRefGoogle Scholar
  50. Zimmermann C, Riechelmann R, Krzyzanowska M, Rodin G, Tannock I. Effectiveness of specialized palliative care: a systematic review. JAMA. 2008;299:1698–709.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Nilay Hepgul
    • 1
    Email author
  • Wei Gao
    • 1
  • Matthew Maddocks
    • 1
  • Irene J. Higginson
    • 1
  1. 1.Cicely Saunders Institute of Palliative Care, Policy and RehabilitationKing’s College LondonLondonUK

Personalised recommendations