What difference does patient and public involvement make and what are its pathways to impact? Qualitative study of patients and researchers from a cohort of randomised clinical trials

PLoS ONE

Volumn 10, Issue 6, 2015, Pages

  Dudley, Louise ^a   Gamble, Carrol ^a   Preston, Jennifer ^a   Buck, Deborah ^a   Hanley, Bec ^b   Williamson, Paula ^a   Young, Bridget ^a   Allam, Alison ^a   Bell, Philip ^a   Goodare, Heather ^a   Walker, Alison ^a  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

^b TwoCan Associates   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; COHORT ANALYSIS; DATA ANALYSIS; EVALUATION STUDY; HEALTH SURVEY; HUMAN; INFORMATION PROCESSING; MEDICAL PARAMETERS; MOTIVATION; PATIENT AND PUBLIC INVOLVEMENT; QUALITATIVE RESEARCH; SCIENTIST; SEMI STRUCTURED INTERVIEW; PATIENT PARTICIPATION; PERSONNEL; RANDOMIZED CONTROLLED TRIAL (TOPIC);

COHORT STUDIES; GOALS; HUMANS; PATIENT PARTICIPATION; QUALITATIVE RESEARCH; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH PERSONNEL;

EID: 84936886887     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0128817     Document Type: Article

References (44)

1. Goodlee F (2014) Towards the patient revolution. BMJ 348: doi: 10.1136/bmj.g1209
2. INVOLVE (2009) Research Design Services and public involvement. Eastleigh: INVOLVE.
3. Department of Health (2006) Best research for best health: a new national health research strategy. London: Department of Health. PMID: 17080885
4. National Institute of Health Research. Patient and public involvement. Available: http://www.nets.nihr. ac.uk/ppi. Accessed 5 December 2013.
5. Selby JV, Lipstein SH (2014) PCORI at 3 years-Progress, Lessons, and Plans. N Engl J Med 370: 592-95. doi: 10.1056/NEJMp1313061 PMID: 24521104
6. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada (2012) Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Available: http://pre.ethics.gc.ca/pdf/eng/tcps2/ TCPS-2-FINAL-Web.pdf. Accessed 23 May 2014.
7. National Health and Medical Research Council and Consumers' Health Forum of Australia (2002) Statement on consumer and community participation in health and medical research. Canberra: Australian Government. doi: 10.1186/1478-4505-11-26 PMID: 23898969
8. National Institute of Health Research Health Technology Assessment Programme. Available: http:// www.hta.ac.uk/investigators/TSCDataMonitoringCommitteeGuidance.pdf. Accessed 31 January 2014.
9. Medical Research Council (1998) Guidelines for good clinical practice in clinical trials. Surrey: Aldridge Print Group.
10. Delbanco T, Berwick DM, Boufford JI, Edgman-Levitan S, Ollenschla¨ger G, Plamping D, et al. (2001) Healthcare in a land called PeoplePower: nothing about me without me. Health Expect 4: 144-50. PMID: 11493320
11. Department of Health (2010) Equity and excellence: liberating the NHS. London: Department of Health.
12. Gradinger F, Britten N, Wyatt K, Froggatt K, Gibson A, Jacoby A, et al. (2013) Values associated with public involvement in health and social care research: a narrative review. Health Expect doi: 10.1111/ hex.12158 Available: http://onlinelibrary.wiley.com/doi/10.1111/hex.12158/full. Accessed 23 May 2014.
13. Staley K (2009) Exploring impact: Public involvement in NHS, public health and social care research. Eastleigh: INVOLVE.
14. Barber R, Boote JD, Parry GD, Cooper CL, Yeeles P, Cook S (2012) Can the impact of public involvement on research be evaluated? A mixed methods study. Health Expect 15: 229-241. doi: 10.1111/j.1369-7625.2010.00660.x PMID: 21324054
15. Brett J, Staniszewska S, Mockford C, Herron-Marx S, Hughes J, Tysall C, et al. (2012) Mapping the impact of patient and public involvement on health and social care research: A systematic review. Health Expect doi: 10.1111/j.1369-7625.2012.00795.x Available: http://onlinelibrary.wiley.com/doi/10.1111/j. 1369-7625.2012.00795.x/abstract. Accessed 23 May 2014.
16. Barber R, Beresford P, Boote J, Cooper C, Faulker A (2011) Evaluating the impact of service user involvement on research: a prospective case study. Int J Consum Stud 35: 609-615.
17. Edwards V, Wyatt K, Logan S (2011) Consulting parents about the design of a randomized controlled trial of osteopathy for children with celebral palsy. Health expect 14: 429-438. doi: 10.1111/j.1369-7625.2010.00652.x PMID: 21244590
18. Szmukler G, Staley K, Kabir T (2011) Service user involvement in research. Asia Pac Psychiatry 3: 180-186.
19. Boote J, Baird W, Sutton A (2011) Public involvement in the design and conduct of clinical trials: a narrative review of case examples. Trials 12(Suppl 1): A82
20. Bengtsson-Tops A, Svensson B (2012) Mental health users' experiences of being interviewed by another user in a research project: a qualitative study. J Ment Health 19: 237-242.
21. Guarino P, Elbourne D, Carpenter J, Peduzzi P (2006) Consumer involvement in consent document development: a multicentre cluster randomized trial to assess study participants understanding. Clin Trials 3: 19-30. PMID: 16539087
22. Bastian H (2005) Consumer and researcher collaboration in trials: Filling the gaps. Clin Trials 2: 3-4. PMID: 16279573
23. Staniszewska S, Adebajo A, Barder R, Beresford P, Brady LM, Brett J, et al. (2011) Developing the evidence base of patient and public involvement in health and social care research: the case for measuring impact. Int J Consum Stud 35: 628-632.
24. Gamble C, Dudley L, Allam A, Bell P, Goodare H, Hanley B, et al. (2014) Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open 4: e005234 doi: 10.1136/bmjopen-2014-005234 PMID: 25056972
25. Buck D, Gamble C, Dudley L, Preston J, Hanley B, Williamson PR, et al. (2014) From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials. BMJ Open 4: e006400 doi: 10.1136/bmjopen-2014-006400 PMID: 25475243
26. Dudley L, Gamble C, Allam A, Bell P, Buck D, Goodare H, et al. (2015) A little more conversation please? Qualitative study of researchers' and patients' interview accounts of training for patient and public involvement in clinical trials. Trials 16: 190 doi: 10.1186/s13063-015-0667-4 PMID: 25928689
27. Bryman A, Burgess R (2004) Analyzing Qualitative Data. London: Routledge.
28. th ed. London: Sage. pp. 199-266.
29. National Institute for Health Research. INVOLVE. Available: http://www.invo.org.uk/. Accessed 24 March 2014.
30. NHS North West and the Research Design Service North West. North West People in Research Forum. Available: http://www.northwestpeopleinresearchforum.org. Accessed 24 March 2014.
31. Bowen GA (2008) Naturalistic inquiry and the saturation concept: a research note. J. Qual. Res 8: 137-152.
32. Glaser B, Strauss A (1967) The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine. doi: 10.1007/s11126-014-9330-6 PMID: 25417121
33. Strauss A, Corbin J (1998) The basis of qualitative research: techniques and procedures for developing grounded theory. Thousand Oaks, CA: Sage.
34. Seale C, Silverman D (1997) Ensuring rigour in qualitative research. Eur J Public Health 7: 379-84
35. Murphy E, Dingwall R, Greatbatch D, Parker S, Watson P (1998) Qualitative research methods in health technology assessment: a review of the literature. Health Technol Assess 2: 16 PMID: 9919458
36. Snape D, Kirkham J, Preston J, Popay J, Brrtten N, Collins M, et al. (2014) Exploring areas of consensus and conflict around values underpinning public involvement in health and social care research: a modified Delphi study. BMJ Open 4: e004217. doi: 10.1136/bmjopen-2013-004217 PMID: 24413356
37. PiiAF Study Group. The Public Involvement Impact Assessment Framework: executive Summary. Available: http://piiaf.org.uk/documents/exec-summary-0114.pdf. Accessed 5 March 2014.
38. INVOLVE (2012) Briefing notes for researchers: public involvement in NHS, public health and social care research. Eastleigh: INVOLVE.
39. NHS National Institute for Health Research. Going the extra mile: Improving the nation's health and wellbeing through public involvement in research. National Institute for Health Research. Available: http://www.nihr.ac.uk/get-involved/Extra%20Mile2.pdf.
40. Barbour RS. (2001) Checklists for improving rigour in qualitative research: a case of the tail wagging the dog? BMJ 322: 1115. PMID: 11337448
41. Gamble C, Dudley L, Allam A, Bell P, Goodare H, Hanley B, et al. (2014) An evidence base to optimise methods for involving patient and public contributors in clinical trials: a systematic investigation of a cohort of Health Technology Assessment funded clinical trials. NIHR HS&DR: In Press.
42. Chapple A, Rogers A (1998) Explicit guidelines for qualitative research: a step in the right direction, a defence of the "soft" option, or a form of sociological imperialism? Fam Pract 15: 556-561. PMID: 10078797
43. Sandelowski M (2001) Real qualitative researchers do not count: the use of numbers in qualitative research. Res Nurs Health 24: 230-240. PMID: 11526621
44. Onwuegbuzie AJ, Teddlie C (2003) Framework for analysing data in mixed methods research. In: Tashakkori A, Teddlie C, editors. Handbook of mixed methods in social and behavioural research. Thousand Oaks, CA: Sage. pp. 351-384.