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Patient perception of a randomised, controlled trial of laryngeal reinnervation versus thyroplasty for unilateral vocal fold paralysis

Published online by Cambridge University Press:  08 July 2015

M Mat Baki ,
R Yu ,
J S Rubin ,
E Chevretton ,
G Sandhu  and
M A Birchall
M Mat Baki
Affiliation:
Ear Institute, University College London, UK Royal National Throat, Nose and Ear Hospital, University College London Hospital NHS Trust, UK Faculty of Medicine, Universiti Kebangsaan Malaysia, Bangi, Malaysia
R Yu
Affiliation:
Joint Research Office, University College London, UK
J S Rubin
Affiliation:
Royal National Throat, Nose and Ear Hospital, University College London Hospital NHS Trust, UK
E Chevretton
Affiliation:
Guy's and St Thomas' NHS Trust, London, UK
G Sandhu
Affiliation:
Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK
M A Birchall*
Affiliation:
Ear Institute, University College London, UK Royal National Throat, Nose and Ear Hospital, University College London Hospital NHS Trust, UK Department of Otolaryngology, University of California, Davis, USA
*
Address for correspondence: Dr Martin Anthony Birchall, Professorial Unit, Royal National Throat, Nose and Ear Hospital, 330 Grays Inn Road, London WC1X 8DA, UK E-mail: [email protected]
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Abstract

Objectives:

To explore unilateral vocal fold paralysis patients' perception of a proposed randomised, controlled trial of laryngeal reinnervation versus thyroplasty, and to identify patients' concerns regarding their voice.

Methods:

Seventeen patients from five voice clinics in London were identified as being eligible for the randomised, controlled trial. Eleven of these patients (9 females and 2 males; age range, 18–65 years) were interviewed using a semi-structured topic guide (they were given a minimum of 2 weeks to read through the study information sheet). The interviews were recorded, transcribed and analysed using thematic analysis.

Results:

The patients were satisfied with the clarity of the information sheet. Most of them perceived that reinnervation was a more ‘attractive’ option than thyroplasty. This may have been the result of certain phraseology used in the information sheet and by recruiters. Patients' main concern was reduced voice strength and the effects of this on work and social life.

Conclusion:

Phraseology that needed changing was identified; these changes may optimise the recruitment process for a trial. We propose using the voice handicap index 10 as the primary measure of outcome in the proposed randomised, controlled trial.

Keywords

Randomized Controlled TrialLaryngeal ReinnervationLaryngeal Nerve InjuriesThyroplastyVocal Cord Paralysis
Type
Main Articles
Information
The Journal of Laryngology & Otology , Volume 129 , Issue 7 , July 2015 , pp. 693 - 701
Copyright
Copyright © JLO (1984) Limited 2015 

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References

1Fang, T-J, Li, H-Y, Gliklich, RE, Chen, Y-H, Wang, P-C, Chuang, H-F. Quality of life measures and predictors for adults with unilateral vocal cord paralysis. Laryngoscope 2008;118:1837–41CrossRefGoogle ScholarPubMed
2Smith, E, Gray, S, Verdolini, K, Lemke, J. Effects of voice disorders on quality of life. Otolaryngol Head Neck Surg 1995;113:P121CrossRefGoogle Scholar
3Isshiki, N, Okamura, H, Ishikawa, T. Thyroplasty type I (lateral compression) for dysphonia due to vocal cord paralysis or atrophy. Acta Otolaryngol 1975;80:465–73CrossRefGoogle ScholarPubMed
4McCulloch, TM, Hoffman, HT. Medialization laryngoplasty with expanded polytetrafluoroethylene. Surgical technique and preliminary results. Ann Otol Rhinol Laryngol 1998;107:427–32CrossRefGoogle ScholarPubMed
5Isshiki, N, Tanabe, M, Sawada, M. Arytenoid adduction for unilateral vocal cord paralysis. Arch Otolaryngol 1978;104:555–8CrossRefGoogle ScholarPubMed
6Crumley, RL, Izdebski, K. Voice quality following laryngeal reinnervation by ansa hypoglossi transfer. Laryngoscope 1986;96:611–16CrossRefGoogle ScholarPubMed
7Mallur, PS, Rosen, CA. Vocal fold injection: review of indications, techniques, and materials for augmentation. Clin Exp Otorhinolaryngol 2010;3:177–82CrossRefGoogle ScholarPubMed
8Carroll, TL, Rosen, CA. Long-term results of calcium hydroxylapatite for vocal fold augmentation. Laryngoscope 2011;121:313–19CrossRefGoogle ScholarPubMed
9McLean-Muse, A, Montgomery, WW, Hillman, RE, Varvares, M, Bunting, G, Doyle, P et al. Montgomery Thyroplasty Implant for vocal fold immobility: phonatory outcomes. Ann Otol Rhinol Laryngol 2000;109:393–400Google ScholarPubMed
10Leder, SB, Sasaki, CT. Long-term changes in vocal quality following Isshiki thyroplasty type I. Laryngoscope 1994;104:275–7CrossRefGoogle ScholarPubMed
11Ryu, IS, Nam, SY, Han, MW, Choi, S-H, Kim, SY, Roh, J-L. Long-term voice outcomes after thyroplasty for unilateral vocal fold paralysis. Arch Otolaryngol Head Neck Surg 2012;103:347–51Google Scholar
12Crumley, RL, Izdebski, K, McMicken, B. Nerve transfer versus Teflon® injection for vocal cord paralysis: a comparison. Laryngoscope 1988;98:1200–4CrossRefGoogle ScholarPubMed
13Lee, WT, Milstein, C, Hicks, D, Akst, LM, Esclamado, RM. Results of ansa to recurrent laryngeal nerve reinnervation. Otolaryngol Head Neck Surg 2007;136:450–4CrossRefGoogle ScholarPubMed
14Lorenz, RR, Esclamado, RM, Teker, AM, Strome, M, Scharpf, J, Hicks, D et al. Ansa cervicalis-to-recurrent laryngeal nerve anastomosis for unilateral vocal fold paralysis: experience of a single institution. Ann Otol Rhinol Laryngol 2008;117:40–5CrossRefGoogle ScholarPubMed
15Wang, W, Chen, D, Chen, S, Li, D, Li, M, Xia, S et al. Laryngeal reinnervation using ansa cervicalis for thyroid surgery-related unilateral vocal fold paralysis: a long-term outcome analysis of 237 cases. PloS One 2011;6:e19128Google ScholarPubMed
16Aynehchi, BB, McCoul, ED, Sundaram, K. Systematic review of laryngeal reinnervation techniques. Otolaryngol Head Neck Surg 2010;143:749–59CrossRefGoogle ScholarPubMed
17Paniello, RC, Edgar, JD, Kallogjeri, D, Piccirillo, JF. Medialization versus reinnervation for unilateral vocal fold paralysis: a multicenter randomized clinical trial. Laryngoscope 2011;121:2172–9CrossRefGoogle ScholarPubMed
18Ross, S, Grant, A, Counsell, C, Gillespie, W, Russell, I, Prescott, R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol 1999;52:1143–56CrossRefGoogle ScholarPubMed
19Lovato, LC, Hill, K, Hertert, S, Hunninghake, DB, Probstfield, JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials 1997;18:328–52CrossRefGoogle ScholarPubMed
20McCulloch, P, Taylor, I, Sasako, M, Lovett, B, Griffin, D. Randomised trials in surgery: problems and possible solutions. BMJ 2002;324:1448–51CrossRefGoogle Scholar
21Ergina, PL, Cook, JA, Blazeby, JM, Boutron, I, Clavien, P-A, Reeves, BC et al. Challenges in evaluating surgical innovation. Lancet 2009;374:1097–104CrossRefGoogle ScholarPubMed
22Abraham, NS, Young, JM, Solomon, MJ. A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials. Surgery 2006;139:469–83CrossRefGoogle ScholarPubMed
23Murtagh, MJ, Thomson, RG, May, CR, Rapley, T, Heaven, BR, Graham, RH et al. Qualitative methods in a randomised controlled trial: the role of an integrated qualitative process evaluation in providing evidence to discontinue the intervention in one arm of a trial of a decision support tool. Qual Saf Health Care 2007;16:224–9CrossRefGoogle Scholar
24Lewin, S, Glenton, C, Oxman, AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ 2009;339:b3496CrossRefGoogle ScholarPubMed
25Charles, C, Whelan, T, Gafni, A, Reyno, L, Redko, C. Doing nothing is no choice: lay constructions of treatment decision-making among women with early-stage breast cancer. Sociol Health Ill 1998;20:71–95CrossRefGoogle Scholar
26Mills, N, Donovan, JL, Smith, M, Jacoby, A, Neal, DE, Hamdy, FC. Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. Control Clin Trials 2003;24:272–82CrossRefGoogle ScholarPubMed
27Ellis, PM, Butow, PN, Tattersall, MH. Informing breast cancer patients about clinical trials: a randomized clinical trial of an educational booklet. Ann Oncol 2002;13:1414–23CrossRefGoogle ScholarPubMed
28Edwards, SJL, Braunholtz, DA, Lilford, RJ, Stevens, AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999;318:1407–9CrossRefGoogle ScholarPubMed
29Donovan, J. Quality improvement report. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: Presenting unbiased information to patients can be difficult. BMJ 2002;325:766–70CrossRefGoogle ScholarPubMed
30Donovan, JL, Lane, JA, Peters, TJ, Brindle, L, Salter, E, Gillatt, D et al. Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol 2009;62:29–36CrossRefGoogle ScholarPubMed
31Daugherty, C, Ratain, MJ, Grochowski, E, Stocking, C, Kodish, E, Mick, R et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 1995;13:1062–72CrossRefGoogle ScholarPubMed
32Featherstone, K, Donovan, JL. “Why don't they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomised controlled trial. Soc Sci Med 2002;55:709–19CrossRefGoogle Scholar
33Bevan, E, Chee, L, McGhee, S, McInnes, G. Patients' attitudes to participation in clinical trials. Br J Clin Pharmacol 1993;35:204–7CrossRefGoogle ScholarPubMed
34Schwartz, CE, Fox, BH. Who says yes? Identifying selection biases in a psychosocial intervention study of multiple sclerosis. Soc Sci Med 1995;40:359–70CrossRefGoogle Scholar
35Alderson, P. Equipoise as a means of managing uncertainty: personal, communal and proxy. J Med Ethics 1996;22:135–9CrossRefGoogle ScholarPubMed
36Hertegård, S, Hallén, L, Laurent, C, Lindström, E, Olofsson, K, Testad, P et al. Cross-linked hyaluronan versus collagen for injection treatment of glottal insufficiency: 2-year follow-up. Acta Otolaryngol 2004;124:1208–14CrossRefGoogle Scholar
37Jacobson, BH, Johnson, A, Grywalski, C, Silbergleit, A, Jacobson, G, Benninger, MS et al. The Voice Handicap Index (VHI): development and validation. Am J Speech Lang Pathol 1997;6:66–70CrossRefGoogle Scholar
38Lau, DP, Lee, GA, Wong, SM, Lim, VP, Chan, YH, Tan, NG et al. Injection laryngoplasty with hyaluronic acid for unilateral vocal cord paralysis. Randomized controlled trial comparing two different particle sizes. J Voice 2010;24:113–18CrossRefGoogle ScholarPubMed
39Rosen, CA, Lee, AS, Osborne, J, Zullo, T, Murry, T. Development and validation of the voice handicap index-10. Laryngoscope 2004;114:1549–56CrossRefGoogle ScholarPubMed
40Rosen, CA, Murry, T, Zinn, A, Zullo, T, Sonbolian, M. Voice handicap index change following treatment of voice disorders. J Voice 2000;14:619–23CrossRefGoogle ScholarPubMed
41Hogikyan, ND, Rosen, CA. A review of outcome measurements for voice disorders. Otolaryngol Head Neck Surg 2002;126:562–72CrossRefGoogle ScholarPubMed
42Deary, IJ, Webb, A, MacKenzie, K, Wilson, JA, Carding, PN. Short, self-report voice symptom scales: psychometric characteristics of the voice handicap index-10 and the vocal performance questionnaire. Otolaryngol Head Neck Surg 2004;131:232–5CrossRefGoogle ScholarPubMed
43Misono, S, Merati, AL. Evidence-based practice: evaluation and management of unilateral vocal fold paralysis. Otolaryngol Clin North Am 2012;45:1083–108CrossRefGoogle ScholarPubMed