PMID- 16911778
OWN - NLM
STAT- MEDLINE
DCOM- 20061016
LR  - 20220330
IS  - 1477-7525 (Electronic)
IS  - 1477-7525 (Linking)
VI  - 4
DP  - 2006 Aug 15
TI  - The OnyCOE-t questionnaire: responsiveness and clinical meaningfulness of a 
      patient-reported outcomes questionnaire for toenail onychomycosis.
PG  - 50
AB  - BACKGROUND: This research was conducted to confirm the validity and reliability 
      and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t, a 
      questionnaire specifically designed to measure patient-reported outcomes (PRO) 
      associated with toenail onychomycosis. METHODS: 504 patients with toenail 
      onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or 
      without target toenail debridement in the IRON-CLAD trial completed the OnyCOE-t 
      at baseline, weeks 6, 12, 24, and 48. The OnyCOE-t is composed of 6 multi-item 
      scales and 1 single-item scale. These include a 7-item Toenail Symptom 
      assessment, which comprises both Symptom Frequency and Symptom Bothersomeness 
      scales; an 8-item Appearance Problems scale; a 7-item Physical Activities 
      Problems scale; a 1-item Overall Problem scale; a 7-item Stigma scale; and a 
      3-item Treatment Satisfaction scale. In total, 33 toenail onychomycosis-specific 
      items are included in the OnyCOE-t. Clinical data, in particular the percent 
      clearing of mycotic involvement in the target toenail, and OnyCOE-t responses 
      were used to evaluate the questionnaire's reliability, validity, responsiveness, 
      and the minimally clinical important difference (MCID). RESULTS: The OnyCOE-t was 
      shown to be reliable and valid. Construct validity and known groups validity were 
      acceptable. Internal consistency reliability of multi-item scales was 
      demonstrated by Cronbach's alpha > .84. Responsiveness was good, with the 
      Treatment Satisfaction, Symptom Frequency, Overall Problem, and Appearance 
      Problem scales demonstrating the most responsiveness (Guyatt's statistic of 1.72, 
      1.31, 1.13, and 1.11, respectively). MCID was evaluated for three different 
      clinical measures, and indicated that approximately an 8.5-point change (on a 0 
      to 100 scale) was clinically meaningful based on a 25% improvement in target nail 
      clearing. CONCLUSION: The OnyCOE-t questionnaire is a unique, toenail-specific 
      PRO questionnaire that can be used with confidence in future studies of toenail 
      onychomycosis. MCID was evaluated for three different clinical measures, and 
      indicated that approximately a 7-point change (on a 0 to 100 scale) was 
      clinically meaningful based on a 12.5% improvement in target nail clearing.
FAU - Potter, Lori P
AU  - Potter LP
AD  - Ovation Research Group, San Francisco, CA, USA. lori39@earthlink.net
FAU - Mathias, Susan D
AU  - Mathias SD
FAU - Raut, Monika
AU  - Raut M
FAU - Kianifard, Farid
AU  - Kianifard F
FAU - Tavakkol, Amir
AU  - Tavakkol A
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
DEP - 20060815
PL  - England
TA  - Health Qual Life Outcomes
JT  - Health and quality of life outcomes
JID - 101153626
RN  - 0 (Antifungal Agents)
RN  - 0 (Naphthalenes)
RN  - G7RIW8S0XP (Terbinafine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antifungal Agents/therapeutic use
MH  - Debridement
MH  - Female
MH  - Foot Dermatoses/drug therapy/physiopathology/psychology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nails/drug effects/*physiopathology
MH  - Naphthalenes/therapeutic use
MH  - Onychomycosis/*drug therapy/physiopathology/psychology
MH  - Patient Satisfaction
MH  - Psychometrics/*instrumentation
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - *Sickness Impact Profile
MH  - *Surveys and Questionnaires
MH  - Terbinafine
MH  - *Treatment Outcome
PMC - PMC1560108
EDAT- 2006/08/17 09:00
MHDA- 2006/10/17 09:00
PMCR- 2006/08/15
CRDT- 2006/08/17 09:00
PHST- 2006/03/25 00:00 [received]
PHST- 2006/08/15 00:00 [accepted]
PHST- 2006/08/17 09:00 [pubmed]
PHST- 2006/10/17 09:00 [medline]
PHST- 2006/08/17 09:00 [entrez]
PHST- 2006/08/15 00:00 [pmc-release]
AID - 1477-7525-4-50 [pii]
AID - 10.1186/1477-7525-4-50 [doi]
PST - epublish
SO  - Health Qual Life Outcomes. 2006 Aug 15;4:50. doi: 10.1186/1477-7525-4-50.