Skip to main content
×
×
Home

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

  • M Mat Baki (a1) (a2) (a3), R Yu (a4), J S Rubin (a2), E Chevretton (a5), G Sandhu (a6) and M A Birchall (a1) (a2) (a7)...
Abstract
AbstractObjectives:

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.

Copyright
Corresponding author
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: m.birchall@ucl.ac.uk
References
Hide All
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;118:1837–41
2Smith E, Gray S, Verdolini K, Lemke J. Effects of voice disorders on quality of life. Otolaryngol Head Neck Surg 1995;113:P121
3Isshiki N, Okamura H, Ishikawa T. Thyroplasty type I (lateral compression) for dysphonia due to vocal cord paralysis or atrophy. Acta Otolaryngol 1975;80:465–73
4McCulloch TM, Hoffman HT. Medialization laryngoplasty with expanded polytetrafluoroethylene. Surgical technique and preliminary results. Ann Otol Rhinol Laryngol 1998;107:427–32
5Isshiki N, Tanabe M, Sawada M. Arytenoid adduction for unilateral vocal cord paralysis. Arch Otolaryngol 1978;104:555–8
6Crumley RL, Izdebski K. Voice quality following laryngeal reinnervation by ansa hypoglossi transfer. Laryngoscope 1986;96:611–16
7Mallur PS, Rosen CA. Vocal fold injection: review of indications, techniques, and materials for augmentation. Clin Exp Otorhinolaryngol 2010;3:177–82
8Carroll TL, Rosen CA. Long-term results of calcium hydroxylapatite for vocal fold augmentation. Laryngoscope 2011;121:313–19
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;109:393400
10Leder SB, Sasaki CT. Long-term changes in vocal quality following Isshiki thyroplasty type I. Laryngoscope 1994;104:275–7
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;103:347–51
12Crumley RL, Izdebski K, McMicken B. Nerve transfer versus Teflon® injection for vocal cord paralysis: a comparison. Laryngoscope 1988;98:1200–4
13Lee WT, Milstein C, Hicks D, Akst LM, Esclamado RM. Results of ansa to recurrent laryngeal nerve reinnervation. Otolaryngol Head Neck Surg 2007;136:450–4
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;117:40–5
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:e19128
16Aynehchi BB, McCoul ED, Sundaram K. Systematic review of laryngeal reinnervation techniques. Otolaryngol Head Neck Surg 2010;143:749–59
17Paniello RC, Edgar JD, Kallogjeri D, Piccirillo JF. Medialization versus reinnervation for unilateral vocal fold paralysis: a multicenter randomized clinical trial. Laryngoscope 2011;121:2172–9
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;52:1143–56
19Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials 1997;18:328–52
20McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ 2002;324:1448–51
21Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien P-A, Reeves BC et al. Challenges in evaluating surgical innovation. Lancet 2009;374:1097–104
22Abraham NS, Young JM, Solomon MJ. A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials. Surgery 2006;139:469–83
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;16:224–9
24Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ 2009;339:b3496
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;20:7195
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;24:272–82
27Ellis PM, Butow PN, Tattersall MH. Informing breast cancer patients about clinical trials: a randomized clinical trial of an educational booklet. Ann Oncol 2002;13:1414–23
28Edwards SJL, Braunholtz DA, Lilford RJ, Stevens AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999;318:1407–9
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;325:766–70
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;62:2936
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;13:1062–72
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;55:709–19
33Bevan E, Chee L, McGhee S, McInnes G. Patients' attitudes to participation in clinical trials. Br J Clin Pharmacol 1993;35:204–7
34Schwartz CE, Fox BH. Who says yes? Identifying selection biases in a psychosocial intervention study of multiple sclerosis. Soc Sci Med 1995;40:359–70
35Alderson P. Equipoise as a means of managing uncertainty: personal, communal and proxy. J Med Ethics 1996;22:135–9
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;124:1208–14
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;6:6670
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;24:113–18
39Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope 2004;114:1549–56
40Rosen CA, Murry T, Zinn A, Zullo T, Sonbolian M. Voice handicap index change following treatment of voice disorders. J Voice 2000;14:619–23
41Hogikyan ND, Rosen CA. A review of outcome measurements for voice disorders. Otolaryngol Head Neck Surg 2002;126:562–72
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;131:232–5
43Misono S, Merati AL. Evidence-based practice: evaluation and management of unilateral vocal fold paralysis. Otolaryngol Clin North Am 2012;45:1083–108
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

The Journal of Laryngology & Otology
  • ISSN: 0022-2151
  • EISSN: 1748-5460
  • URL: /core/journals/journal-of-laryngology-and-otology
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Keywords:

Metrics

Full text views

Total number of HTML views: 1
Total number of PDF views: 51 *
Loading metrics...

Abstract views

Total abstract views: 321 *
Loading metrics...

* Views captured on Cambridge Core between September 2016 - 16th December 2017. This data will be updated every 24 hours.