- About this Journal ·
- Abstracting and Indexing ·
- Advance Access ·
- Aims and Scope ·
- Annual Issues ·
- Article Processing Charges ·
- Articles in Press ·
- Author Guidelines ·
- Bibliographic Information ·
- Citations to this Journal ·
- Contact Information ·
- Editorial Board ·
- Editorial Workflow ·
- Free eTOC Alerts ·
- Publication Ethics ·
- Reviewers Acknowledgment ·
- Submit a Manuscript ·
- Subscription Information ·
- Table of Contents
BioMed Research International
Volume 2013 (2013), Article ID 139813, 8 pages
Factors Influencing Women's Decision to Participate or Not in a Surgical Randomised Controlled Trial for Surgical Treatment of Female Stress Urinary Incontinence
1Division of Applied Health Sciences, University of Aberdeen, 2nd Floor, Aberdeen Maternity Hospital,
Foresterhill, Aberdeen AB25 2ZD, UK
2Division of Applied Health Sciences, University of Aberdeen, Academic Urology Unit, 2nd Floor Health Sciences Building, Foresterhill, Aberdeen AB25 2ZD, UK
Received 29 April 2013; Accepted 29 July 2013
Academic Editor: Charnita M. Zeigler-Johnson
Copyright © 2013 Alyaa Mostafa et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
- R. Kunz, G. Vist, and A. D. Oxman, “Randomisation to protect against selection bias in healthcare trials,” Cochrane Database of Systematic Reviews, no. 2, Article ID MR000012, 2007.
- R. S. McLeod, J. G. Wright, M. J. Solomon, X. Hu, B. C. Walters, and A. Lossing, “Randomized controlled trials in surgery: issues and problems,” Surgery, vol. 119, no. 5, pp. 483–486, 1996.
- N. J. O. Birkmeyer, J. N. Weinstein, A. N. A. Tosteson et al., “Design of the spine patient outcomes research trial (SPORT),” Spine, vol. 27, no. 12, pp. 1361–1372, 2002.
- V. A. Jenkins, L. J. Fallowfield, A. Souhami, and M. Sawtell, “How do doctors explain randomised clinical trials to their patients?” European Journal of Cancer, vol. 35, no. 8, pp. 1187–1193, 1999.
- M. Hussain-Gambles, “South Asian patients' views and experiences of clinical trial participation,” Family Practice, vol. 21, no. 6, pp. 636–642, 2004.
- P. J. Easterbrook and D. R. Matthews, “Fate of research studies,” Journal of the Royal Society of Medicine, vol. 85, no. 2, pp. 71–76, 1992.
- G. Holden, G. Rosenberg, K. Barker, S. Tuhrim, and B. Brenner, “The recruitment of research participants: a review,” Social Work in Health Care, vol. 19, no. 2, pp. 1–44, 1993.
- M. E. Charlson and R. I. Horwitz, “Applying results of randomised trials to clinical practice: impact of losses before randomisation,” British Medical Journal, vol. 289, no. 6454, pp. 1281–1284, 1984.
- A. M. McDonald, R. C. Knight, M. K. Campbell et al., “What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies,” Trials, vol. 7, article 9, 2006.
- G. M. Swanson and A. J. Ward, “Recruiting minorities into clinical trials: toward a participant-friendly system,” Journal of the National Cancer Institute, vol. 87, no. 23, pp. 1747–1759, 1995.
- N. S. Abraham, P. Hewett, J. M. Young, and M. J. Solomon, “Non-entry of eligible patients into the Australasian Laparoscopic Colon Cancer Study,” ANZ Journal of Surgery, vol. 76, no. 9, pp. 825–829, 2006.
- N. Bijker, J. L. Peterse, I. S. Fentiman et al., “Effects of patient selection on the applicability of results from a randomised clinical trial (EORTC 10853) investigating breast-conserving therapy for DCIS,” British Journal of Cancer, vol. 87, no. 6, pp. 615–620, 2002.
- M. J. Henzlova, G. H. Blackburn, E. J. Bradley, et al., “Patient perception of a long-term clinical trial: experience using a close-out questionnaire in the Studies of Left Ventricular Dysfunction (SOLVD) trial,” Controlled Clinical Trials, vol. 15, no. 4, pp. 284–293, 1994.
- P. W. Plaisier, M. Y. Berger, R. L. van der Hul et al., “Unexpected difficulties in randomizing patients in a surgical trial: a prospective study comparing extracorporeal shock wave lithotripsy with open cholecystectomy,” World Journal of Surgery, vol. 18, no. 5, pp. 769–772, 1994.
- R. S. McLeod, “Issues in surgical randomized controlled trials,” World Journal of Surgery, vol. 23, no. 12, pp. 1210–1214, 1999.
- K. M. Taylor, R. G. Margolese, and C. L. Soskolne, “Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer,” The New England Journal of Medicine, vol. 310, no. 21, pp. 1363–1367, 1984.
- C. E. Schwartz and B. H. Fox, “Who says yes? Identifying selection biases in a psychosocial intervention study of multiple sclerosis,” Social Science and Medicine, vol. 40, no. 3, pp. 359–370, 1995.
- F. L. Rapport and C. J. Maggs, “Titmuss and the gift relationship: altruism revisited,” Journal of Advanced Nursing, vol. 40, no. 5, pp. 495–503, 2002.
- M. R. Mueller, “Clinical, technical, and social contingencies and the decisions of adults with HIV/AIDS to enroll in clinical trials,” Qualitative Health Research, vol. 14, no. 5, pp. 704–713, 2004.
- J. L. Donovan, L. Brindle, and N. Mills, “Capturing users' experiences of participating in cancer trials,” European Journal of Cancer Care, vol. 11, no. 3, pp. 210–214, 2002.
- K. Featherstone and J. L. Donovan, “Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial,” British Medical Journal, vol. 317, no. 7167, pp. 1177–1180, 1998.
- I. Russell, “Evaluating new surgical procedures,” British Medical Journal, vol. 311, no. 7015, pp. 1243–1244, 1995.
- T. A. Wadden and D. B. Sarwer, “Behavioral assessment of candidates for bariatric surgery: a patient-oriented approach,” Surgery for Obesity and Related Diseases, vol. 2, no. 2, pp. 171–179, 2006.
- D. B. Sarwer, S. Ritter, T. A. Wadden, J. C. Spitzer, M. L. Vetter, and R. H. Moore, “Physicians' attitudes about referring their type 2 diabetes patients for bariatric surgery,” Surgery for Obesity and Related Diseases, vol. 8, no. 4, pp. 381–386, 2012.
- A. Mostafa, W. Agur, M. Abdel-All, et al., “A multicentre prospective randomised study of single-incision mini-sling (Ajust) versus tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence: pain profile and short-term outcomes,” European Journal of Obstetrics and Gynecology, vol. 165, no. 1, pp. 115–121, 2012.
- A. Mostafa, W. Agur, M. Abdel-All, et al., “Multicentre prospective randomised study of single-incision midurethral sling (SIMS- Ajust) versus tension-free vaginal tapeobturator (TVT-OTM) in management of female stress urinary incontinence (SUI): a minimum of one year follow-up,” Urology. In press.
- M. Abdel-Fattah, W. Agur, M. Abdel-All et al., “Prospective multi-centre study of adjustable single-incision mini-sling (Ajust) in the management of stress urinary incontinence in women: 1-year follow-up study,” BJU International, vol. 109, no. 6, pp. 880–886, 2012.
- A. R. B. Smith, R. Dmochowski, P. Hilton, et al., “Surgery for urinary incontinence,” in Incontinence, Health Publication, Plymouth, UK, 2009.
- P. Assassa, P. Moran, J. Duckett, and B. Bsug, “Stress incontinence surgery in the UK. Pre-operative work up and intra-operative complications. Analysis of the British Society of Urogynaecology database,” International Urogynecology Journal, vol. 21, supplement 1, pp. S1–S428, 2010.
- R. Angioli, F. Plotti, L. Muzii, R. Montera, P. B. Panici, and M. A. Zullo, “Tension-free vaginal tape versus transobturator suburethral tape: five-year follow-up results of a prospective, randomised trial,” European Urology, vol. 58, no. 5, pp. 671–677, 2010.
- M. Abdel-Fattah, I. Ramsay, S. Pringle et al., “Randomised prospective single-blinded study comparing ‘inside-out’ versus ‘outside-in’ transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study,” BJOG: An International Journal of Obstetrics and Gynaecology, vol. 117, no. 7, pp. 870–878, 2010.
- National Institute for Health and Clinical Excellence (NICE) and National Collaborating Centre for Women's and Childrens Health, Urinary Incontinence; The Management of Urinary Incontinence in Women, 2006.
- S. Ross, A. Grant, C. Counsell, W. Gillespie, I. Russell, and R. Prescott, “Barriers to participation in randomised controlled trials: a systematic review,” Journal of Clinical Epidemiology, vol. 52, no. 12, pp. 1143–1156, 1999.
- M. Glogowska, S. Roulstone, P. Enderby, T. Peters, and R. Campbell, “Who's afraid of the randomised controlled trial? Parents' views of an SLT research study,” International Journal of Language and Communication Disorders, vol. 36, supplement, pp. 499–504, 2001.
- B. R. Cassileth, E. J. Lusk, D. S. Miller, and S. Hurwitz, “Attitudes toward clinical trials among patients and the public,” Journal of the American Medical Association, vol. 248, no. 8, pp. 968–970, 1982.
- E. J. Emanuel and W. B. Patterson, “Ethics of randomized clinical trials,” Journal of Clinical Oncology, vol. 16, no. 1, pp. 365–371, 1998.
- S. K. McCann, M. K. Campbell, and V. A. Entwistle, “Reasons for participating in randomised controlled trials: conditional altruism and considerations for self,” Trials, vol. 11, article 31, 2010.
- E. G. Bevan, L. C. Chee, S. M. McGhee, and G. T. McInnes, “Patients' attitudes to participation in clinical trials,” British Journal of Clinical Pharmacology, vol. 35, no. 2, pp. 204–207, 1993.
- J. F. Bergmann, O. Chassany, J. Gandiol et al., “A randomized clinical trial of the effect of informed consent on the analgesic activity of placebo and naproxen in cancer pain,” Clinical Trials and Meta-Analysis, vol. 29, no. 1, pp. 41–47, 1994.
- D. G. Tincello, S. Kenyon, M. Slack et al., “Colposuspension or TVT with anterior repair for urinary incontinence and prolapse: results of and lessons from a pilot randomised patient-preference study (CARPET 1),” BJOG: An International Journal of Obstetrics and Gynaecology, vol. 116, no. 13, pp. 1809–1814, 2009.
- P. McCulloch, I. Taylor, M. Sasako, B. Lovett, and D. Griffin, “Randomised trials in surgery: problems and possible solutions,” British Medical Journal, vol. 324, no. 7351, pp. 1448–1451, 2002.
- L. E. Moody, S. J. Gregory, T. Bocanegra, and F. Vasey, “Factors influencing post-menopausal African-American women's participation in a clinical trial,” Journal of the American Academy of Nurse Practitioners, vol. 7, no. 10, pp. 483–488, 1995.