A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: The INVESTIGATE-I study

Trials

Volumn 16, Issue 1, 2015, Pages

  Hilton, Paul ^a,h   Armstrong, Natalie ^b   Brennand, Catherine ^c   Howel, Denise ^d   Shen, Jing ^d   Bryant, Andrew ^d   Tincello, Douglas G ^b   Lucas, Malcolm G ^e   Buckley, Brian S ^f   Chapple, Christopher R ^g   Homer, Tara ^d   Vale, Luke ^d   McColl, Elaine ^c,d   Beeby, Andrew ⁱ   Sill, Richard ^j   Ballard, Paul ^k   Murdoch, Megan ^l   Mangera, Altaf ^m   Osman, Nadir ^m   Black, Angela ^l   Dixon, Liz ^l   Robson, Wendy ^l   Rose, Janet ⁿ   Howlett, Helen ^o   Farrell, Corrine ^o   Barlow, Lucy ^p   Thomas, Rebecca ^p   Fowler, Victoria ^q   Behan, Miss Katie ^q   Hulton, Susannah ^m   Potts, Julie ^r   Anderson, Colette ^r   Phelps, Miss Victoria ^r   Speed, Chris ^s   O'Rourke, Shelley ^s   Wood, Ruth ^s   Doughty, Julie ^s   Potts, Pauline ^s   more..

^a NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY OF LEICESTER   (United Kingdom)

^c NEWCASTLE UNIVERSITY   (United Kingdom)

^d NEWCASTLE UNIVERSITY   (United Kingdom)

^e MORRISTON HOSPITAL   (United Kingdom)

^f NATIONAL UNIVERSITY OF IRELAND   (Ireland)

^g ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

^h ROYAL VICTORIA INFIRMARY   (United Kingdom)

ⁱ QUEEN ELIZABETH HOSPITAL   (United Kingdom)

^j WANSBECK GENERAL HOSPITAL   (United Kingdom)

^k SOUTH TEES HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^l University in Newcastle upon Tyne   (United Kingdom)

^m Sheffield   (United Kingdom)

ⁿ South Tees ^*  (United Kingdom)

^o Wansbeck   (United Kingdom)

^p NONE   (United Kingdom)

^q Leicester Hospitals   (United Kingdom)

^r South Tees   (United Kingdom)

^s NONE

more..

Author keywords

Feasibility studies; Interview studies; Pilot studies; Randomised controlled trial; Stress urinary incontinence; Urodynamics

Indexed keywords

ADULT; ADVERSE OUTCOME; ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; FEASIBILITY STUDY; FEMALE; FOLLOW UP; HEALTH ECONOMICS; HUMAN; INTERMETHOD COMPARISON; INTERVIEW; INVASIVE PROCEDURE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NON INVASIVE PROCEDURE; OUTCOME ASSESSMENT; PREOPERATIVE EVALUATION; RANDOMIZED CONTROLLED TRIAL; STRESS INCONTINENCE; URINARY TRACT SURGERY; URODYNAMICS; BLADDER; CLINICAL TRIAL; COST BENEFIT ANALYSIS; ECONOMICS; ENGLAND; HEALTH CARE COST; MIDDLE AGED; NATIONAL HEALTH SERVICE; PATHOPHYSIOLOGY; PATIENT SATISFACTION; PILOT STUDY; PREDICTIVE VALUE; PREOPERATIVE CARE; QUESTIONNAIRE; TELEPHONE; TREATMENT OUTCOME; URINARY INCONTINENCE, STRESS; UROLOGIC EXAMINATION;

ADULT; COST-BENEFIT ANALYSIS; DIAGNOSTIC TECHNIQUES, UROLOGICAL; ENGLAND; FEASIBILITY STUDIES; FEMALE; HEALTH CARE COSTS; HUMANS; INTERVIEWS AS TOPIC; MIDDLE AGED; PATIENT SATISFACTION; PILOT PROJECTS; PREDICTIVE VALUE OF TESTS; PREOPERATIVE CARE; STATE MEDICINE; SURVEYS AND QUESTIONNAIRES; TELEPHONE; TREATMENT OUTCOME; URINARY BLADDER; URINARY INCONTINENCE, STRESS; URODYNAMICS;

EID: 84941281068     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0928-2     Document Type: Article

References (68)

1. Farage MA, Miller KW, Berardesca E, Maibach HI. Psychosocial and societal burden of incontinence in the aged population: a review. Arch Gynecol Obstet. 2008;277:285-90.
2. Hajjar RR. Psychosocial impact of urinary incontinence in the elderly population. Clin Geriat Med. 2004;20:553-64.
3. Shaw C. A review of the psychosocial predictors of help-seeking behaviour and impact on quality of life in people with urinary incontinence. J Clin Nurs. 2001;10:15-24.
4. Wyman JF, Harkins SW, Choi SC, Taylor JR, Fantl JA. Psychosocial impact of urinary incontinence in women. Obstet Gynecol. 1987;70:378-81.
5. Moore KH, Wagner TH, Subak L, de Wachter S, Dudding T, Hu TW. Economics of urinary and faecal incontinence and prolapse. In: Abrams P, Khoury S, Cardozo L, Wein A, editors. Incontinence - 5th International Consultation on Incontinence, Paris, 2012. Arnhem, Netherlands: ICUD-EAU; 2013. p. 1832-62.
6. Milsom I, Altman D, Cartright R, Lapitan M, Nelson R, Sillen U, et al. Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal incontinence (AI). In: Abrams P, Khoury S, Cardozo L, Wein A, editors. Incontinence - 5th International Consultation on Incontinence, Paris, 2012. Arnhem, Netherlands: ICUD-EAU; 2013. p. 15-108.
7. Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol. 2000;53:1150-7.
8. Adekanmi OA, Edwards GJ, Barrington JW. The variation in urodynamic practice in the United Kingdom. J Obstet Gynecol. 2002;22:48-50.
9. National Collaborating Centre for Women's & Children's Health. Urinary incontinence - the management of urinary incontinence in women. London: Commissioned by the National Institute for Health & Clinical Excellence; 2006.
10. National Collaborating Centre for Women's & Children's Health. Urinary incontinence in women - update. London: Commissioned by the National Institute for Health & Care Excellence; 2013.
11. National Institute for Health & Care Excellence. Urinary incontinence - the management of urinary incontinence in women. London: National Institute for Health & Care Excellence; 2013.
12. National Institute for Health & Clinical Excellence. Urinary incontinence - the management of urinary incontinence in women. London: National Institute for Health and Clinical Excellence; 2006.
13. Hilton P. Long-term follow up studies in pelvic floor dysfunction: the Holy Grail or a realistic aim? BJOG. 2008;115:135-43.
14. Hospital Episode Statistics. Department of Health. 2014. Available from: http://www.hesonline.nhs.uk . Accessed 26 April 2014.
15. Department of Health. Payment by Results in the NHS: tariff for 2012 to 2013. 2013 (updated 25/3/2013); Available from: https://www.gov.uk/government/publications/confirmation-of-payment-by-results-pbr-arrangements-for-2012-13 .
16. Medicines and Healthcare Products Regulatory Agency. A summary of the evidence on the benefits and risks of vaginal mesh implants. London: Medicines and Healthcare Products Regulatory Agency; 2014.
17. van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, Bongers MY, et al. Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial. Neurourol Urodyn. 2012;31:1118-23.
18. van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, van der Vaart CH, et al. Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered. BMC Women's Health. 2009;9:22.
19. Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C, et al. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012;366:1987-97.
20. Cohen J. Statistical power analysis for the behavioural sciences. 2nd ed. Hillsdale, New Jersey: Lawrence Erlbaum Associates; 1988.
21. van Leijsen SA, Kluivers KB, Mol BW, Hout J, Milani AL, Roovers JP, et al. Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial. Obstet Gynecol. 2013;121:999-1008.
22. Giarenis I, Cardozo LD. What is the value of urodynamic studies before stress incontinence surgery? BJOG. 2013;120:130-2.
23. Brubaker L. An evidence-based approach to urodynamic testing. BJOG. 2013;120:127-9.
24. Clement KD, Lapitan MCM, Omar MI, Glazener CMA. Urodynamic studies for management of urinary incontinence in children and adults. Cochrane Database Syst Rev. 2013;1, CD003195.
25. Martin JL, Williams KS, Abrams KR, Turner DA, Sutton AJ, Chapple C, et al. Systematic review and evaluation of methods of assessing urinary incontinence. Health Technol Assess. 2006;10:1-132. iii-iv.
26. Griffiths D, Kondo A, Bauer S, Diamant N, Liao L, Schafer W, et al. Dynamic testing. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence - 3rd International Consultation on Incontinence. Plymouth: Health Publications Ltd; 2005. p. 585-674.
27. Rosier PFWM, Kuo H-C, de Gennaro M, Kakizaki H, Hashim H, van Meel TD, et al. Urodynamic testing. In: Abrams P, Khoury S, Cardozo L, Wein A, editors. Incontinence - 5th International Consultation on Incontinence, Paris, 2012. Arnhem, Netherlands: ICUD-EAU; 2013. p. 429-506.
28. Buckley BS, Grant AM, Tincello DG, Wagg AS, Firkins L. Prioritising reseach: patients, carers and clinicians working together to identify and prioritise clinical uncertainties in urinary incontinence. Neurourol Urodyn. 2010;29:708-14.
29. James Lind Alliance. Urinary incontinence - tackling treatment uncertainties together. Report of the final priority setting workshop 6 November 2008 2009. Available from: http://www.jla.nihr.ac.uk/priority-setting-partnerships/urinary-incontinence . Accessed 7 September 2015.
30. Weber AM, Taylor RJ, Wei JT, Lemack G, Piedmonte MR, Walters MD. The cost-effectiveness of preoperative testing (basic office assessment vs. urodynamics) for stress urinary incontinence in women. BJU Int. 2002;89:356-63.
31. Brookes ST, Donovan JL, Wright M, Jackson S, Abrams P. A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence. Am J Obstet Gynecol. 2004;191:73-82.
32. Ward K, Hilton P. Multicentre randomised trial of TVT and colposuspension: 5 year follow-up. BJOG. 2008;115:226-33.
33. MacLean AB, Cardozo L. Recommendations arising from the 42nd Study Group. In: MacLean AB, Cardozo L, editors. Incontinence in Women. London: RCOG Press; 2002. p. 433-41.
34. RCOG. Surgical treatment of urodynamic stress incontinence. Guideline No 35 2003. Available from: https://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg35/ .
35. Fowler G, Richmond D. Urodynamics: a mandatory preoperative investigation? Obstet Gynaecol. 2006;8:86-90.
36. Basu M, Duckett JR, Moran P, Freeman R. Clinicians' views on the NICE guideline on the management of female urinary incontinence. J Obstet Gynaecol. 2009;29:529-32.
37. Agur W, Housami F, Drake M, Abrams P. Could the National Institute for Health and Clinical Excellence guidelines on urodynamics in urinary incontinence put some women at risk of a bad outcome from stress incontinence surgery? BJU Int. 2009;103:635-9.
38. Majumdar A, Latthe P, Toozs-Hobson P. Urodynamics prior to treatment as an intervention: a pilot study. Neurourol Urodyn. 2010;29:522-6.
39. Murdoch M, McColl E, Howel D, Deverill M, Buckley BS, Lucas MG, et al. INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing. Trials. 2011;12:169.
40. Armstrong N, Hilton P. Doing diagnosis: whether and how clinicians use a diagnostic tool of uncertain clinical utility. Soc Sci Med. 2014;120:208-14.
41. Hilton P, Bryant A, Howel D, McColl E, Buckley BS, Lucas MG, et al. Assessing professional equipoise and views about a future clinical trial of invasive urodynamics prior to surgery for stress urinary incontinence in women: A survey within a mixed methods feasibility study. Neurourol Urodyn. 2012;31:1223-30.
42. Homer T, Vale L, Shen J, Hilton P, on behalf og the INVESTIGATE studies group. The results of a cost-utility analysis and a value of information analysis on the feasibility of a future randomised control trial on invasive urodynamic testing prior to surgery for stress urinary incontinence in women. Proceedings of International Society for Pharmacoeconomics and Outcomes Research (ISPOR), 17th Annual European Congress; 2014 November 2014; Amsterdam, Netherlands
43. Department of Health. NHS Research Governance Framework for Health and Social Care 2005. Available from: http://webarchive.nationalarchives.go .
44. Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;10:67.
45. Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, et al. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013;14:353.
46. Charlesworth G, Burnell K, Hoe J, Orrell M, Russell I. Acceptance checklist for clinical effectiveness pilot trials: a systematic approach. BMC Med Res Methodol. 2013;13:78.
47. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10:307-12.
48. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1.
49. Ramsay IN, Ali HM, Hunter M, Stark D, Donaldson K. A randomized controlled trial of urodynamic investigations prior to conservative treatment of urinary incontinence in the female. Int Urogynecol J Pelvic Floor Dysfunct. 1995;6:277-81.
50. Allahdin S, Bain C, Glazener C. Feasibility study for a randomised controlled trial evaluating the use of absorbable mesh, polydioxanone and polyglactin sutures for anterior and posterior vaginal wall prolapse repairs. Christchurch, New Zealand: International Continence Society; 2006. p. 412. abstract.
51. Kitchener HC, Dunn G, Lawton V, Reid F, Nelson L, Smith AR. Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial. BJOG. 2006;113:1007-13.
52. Hagen S, Stark D, Glazener C, Sinclair L, Ramsay I. A randomized controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:45-51.
53. Jenkinson C, Layte R. Development and testing of the UK SF-12 (short form health survey). J Health Serv Res Policy. 1997;2:14-8.
54. Brooks R. EuroQol: the current state of play. Health Policy. 1996;37:53-72.
55. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23:322-30.
56. Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. BJOG. 1997;104:1374-9.
57. Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fanti JA. Health-related quality of life measures for women with urinary incontinence: The incontinence impact questionnaire and the urogenital distress inventory. Qual Life Res. 1994;3:291-306.
58. Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine; 1967.
59. Hilton P, McColl E, Howel D, Deverill M, Buckley BS, Lucas MG, et al. INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a pragmatic multicentre pilot study to assess the feasibility of a future randomised controlled trial. Protocol version 1.2 2012. Available from: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0017/54350/PRO-09-22-136.pdf .
60. Shanyinde M, Pickering RM, Weatherall M. Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Med Res Methodol. 2011;11:117.
61. McCann SK, Campbell MK, Entwistle VA. Reasons for participating in randomised controlled trials: conditional altruism and considerations for self. Trials. 2010;11:31.
62. Rosenbaum JR, Wells CK, Viscoli CM, Brass LM, Kernan WN, Horwitz RI. Altruism as a reason for participation in clinical trials was independently associated with adherence. J Clin Epidemiol. 2005;58:1109-14.
63. Truong TH, Weeks JC, Cook EF, Joffe S. Altruism among participants in cancer clinical trials. Clin Trials. 2011;8:616-23.
64. Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2, e000496.
65. Rolstad S, Adler J, Ryden A. Response burden and questionnaire length: is shorter better? A review and meta-analysis. Value Health. 2011;14:1101-8.
66. Edwards PJ, Roberts I, Clarke MJ, DiGuiseppi C, Wentz R, Kwan I, et al. Methods to increase response to postal and electronic questionnaires. Cochrane Database System Rev. 2009;3, MR000008.
67. Brueton VC, Tierney JF, Stenning S, Meredith S, Harding S, Nazareth I, et al. Strategies to improve retention in randomised trials: a Cochrane systematic review and meta-analysis. BMJ Open. 2014;4, e003821.
68. Cook JA, Hislop J, Adewuyi TE, Harrild K, Altman DG, Ramsay C, et al. Assessing methods to specify the target difference for a randomised controlled trial - DELTA (Difference ELicitation in TriAls) review. Health Technol Assess. 2014;18:v-vi.