JOURNAL OF THE AMERICAN PODIATRIC MEDICAL ASSOCIATION
`
`VOLUME
`
`91 NUMBER 10 NOVEMBER/DECEMBER 2001
`
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`ORIGINAL ARTICLES
`
`Reduction of Peak Pressure on the Forefoot with a Rigid Rocker-Bottom
`Postoperative Shoe
`Eric Fuller, Stephen Schroeder, and Jenifer Edwards
`
`Evaluation of Pressure Threshold Prior to Foot Ulceration
`Mitchell A. Barber, Janice Conolley, Cecily M. Spaulding, et al
`
`The Effect of Customized Insoles on the Reduction of Postwork Discomfort
`Ellen Sobel, Steven J. Levitz, Mark A. Caselli, el al
`
`Patient Satisfaction with Oral versus Nonoral Therapeutic Approaches
`in Onychomycosis
`David M. Stier, Douglas Gause, Warren S. Joseph, et al
`
`Survey of the Effects of Aerobic Dance on the Lower Extremity
`in Aerobic Instructors
`Verona du Toit and Richard Smith
`
`The Role of Revascularization in Transmetatarsal Amputations
`Javier La Fontaine, Alex Fleyze/man, Gary Flothenberg, et al
`
`
`
`CLINICALLY SPEAKING
`
`Internal Fixation of a Displaced Tibial Sesamoid Fracture
`Jay Riley and Marc Selner
`
`
`
`CLINICAL PATHOLOGY
`
`Terbinafine-Associated Taste Disturbance with Normal Taste Threshold Scores
`Harvey Lemont and Marc Sabo
`
`wvvw.japmaonline.org
`
`Complete table of contents inside
`
`CFAD v. Anacor, |PR2015—O1776 ANACOR EX. 2163 — 1/9
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`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2163 - 1/9
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`

`

`EDITORIAL STAFF
`
`Warren S. Joseph, DPM
`Editor
`
`Annette Theuring
`Managing Editor (on leave)
`
`Jo Deckert
`Acting Managing Editor
`
`Glenn B. Gastwirth, DPM
`Executive Editor
`
`Susan Cooke Anastasi
`Production Editor
`
`Oedipa Anne Rice
`Editorial Assistant
`
`EDITORIAL ADVISORY BOARD
`
`Alan S. Banks, DPM
`Michael S. Downey, DPM
`Lester J. Jones, DPM
`
`Adam S. Landsman, DPM, PhD
`Stephen J. Miller, DPM
`Jeffrey M. Robbins, DPM
`
`William H. Sanner, DPM
`Ellen Sobel, DPM, PhD
`Gregg Young, DPM
`
`David G. Armstrong, DPM
`Bryan D. Caldwell, DPM, MS
`Thomas J. Chang, DPM
`Howard J. Dananberg, DPM
`Donna DeFronzo, DPM
`A. Lee Dellon, MD
`Vincent Giacalone, DPM
`Howard Hillstrom, PhD
`Dennis Janisse, CPed
`Molly S. Judge, DPM
`Kevin A. Kirby, DPM
`
`CONTRIBUTING EDITORS
`
`Mark Kosinski, DPM
`Donald Kushner, DPM
`Leonard A. Levy, DPM
`Kieran T. Mahan, DPM
`Thomas McPoil, PhD, PT, ATC
`Hylton B. Menz, BPod (Hons)
`Gerit D. Mulder, DPM
`Benno M. Nigg, PhD
`Jeffrey C. Page, DPM
`Craig B. Payne, DipPod(NZ), MPH
`Robert D. Phillips, DPM
`
`JOURNAL INFORMATION
`
`Jane Pontious, DPM
`Douglas H. Richie, Jr., DPM
`Ronald L. Valmassy, DPM
`George F‘. Wallace, DPM
`Gerard V. Yu, DPM
`
`Clinical Pathology
`Harvey Lemont, DPM
`
`Publication Designer
`Jo Deckert
`
`The Journal of the American Podiatric Medical Association (ISSN
`87507315) is published monthly, except bimonthly in July-August and
`November-December, by the American Podiatric Medical Association,
`9312 Old Georgetown Road, Bethesda, Maryland 20814-1698. Period-
`icals postage is paid at Bethesda, Maryland, and additional mailing
`offices.
`
`Subscriptions
`
`A ($50.00) subscription to the Journal of the American Podiatric
`Medical Association is included in the annual membership dues of the
`American Podiatric Medical Association. Subscriptions are unavailable
`to nonmembers who are eligible for membership.
`Subscriptions for all others m the United States are $115.00 prepaid;
`foreign subscriptions are $138.00 prepaid. Single copies are $15.00
`prepaid. Remittances should be made payable to the American
`Podiatric Medical Association. For additional information, telephone
`301-581-9200.
`
`Editorial Content
`
`All expressions of opinion and all other statements are published
`on the authority of the writer(s) over whose signature they appear, and
`are not to be regarded as expressing the views of the American
`Podiatric Medical Association.
`
`Manuscripts should be submitted to Editor, Journal of the
`American Podiatric Medical Association, 9312 Old Georgetown Road,
`Bethesda, Maryland 20814-1698; phone: 301581-9200; fax: 301-530-2752.
`Editorial copy must conform to the JAPMA Guidelines for Authors.
`Manuscripts are considered for publication with the understanding
`that they have not been published in whole or in part in another
`publication.
`
`Advertising
`Acceptance and publication of an advertisement does not imply
`endorsement or approval of the company, product, or service by the
`Journal or tile American Podiatric Medical Association.
`Matters regarding commercial advertisement should be directed to
`The Walchli Tauber Group, Inc., 112 W. Pennsylvania Avenue, #201, Bel
`Air, Maryland 21014.
`Advertising copy must conform to Association standards.
`
`Change of Address
`Notice of change of address should be received six weeks before
`the change is to become effective. Changes should be sent to the
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`must be given. Postmaster send address changes to the Journal of the
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`Bethesda, Maryland 20814-1698.
`
`General Information
`The Journal is indexed i.n Index Medicus of the National Library of
`Medicine and Excerpta Medica.
`Copyright ©2001 by the American Podiatric Medical Association. All
`rights reserved. No part of this publication may be reproduced,
`displayed, or transmitted in any form or by any means, electronic or
`mechanical, including photocopying or by any information storage or
`retrieval system, without prior written permission from the publisher,
`with the exception that photocopies may be made for the noncom-
`mercial purpose of educational or scientific advancement.
`This publication is printed on acid-free paper.
`Printed at Cadmus Professional Communications, Inc., Easton,
`Maryland.
`Printed in the United States of America
`
`A-4
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`Journal of the American Podiatric Medical Association
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`ThlS material may be prolec1ed by Copyright law (Title 17 U 5 Code)
`
`Patient Satisfaction with Oral versus
`Nonoral Therapeutic Approaches in
`Onychomycosis
`
`David M. Stier, MD*
`Douglas Gause, DrPH1-
`Warren S. Joseph, DPM1:
`Jeffrey R. Schein, DrPH, MPH§
`Jeanette M. Broering, RN, MS, MPHII
`Karen L. Warolin, MPH1]
`Joseph J. Doyle, RPh, MBAIII
`
`The follow-up results of a 9-month observational study of 150 onychomy-
`cosis patients treated with a variety of mechanical, topical, and oral ther-
`apies by podiatric physicians and dermatologists are presented. Changes
`from baseline in toenail condition and patient satisfaction were assessed
`at 4- and 9-month follow-up. At 9 months, patients who had received oral
`therapy reported significantly fewer onychomycosis-related problems in
`social situations, including embarrassment or self-consciousness about
`the appearance of nails, avoidance of contact by others, being perceived
`as unclean or untidy, and the desire to keep their nails concealed. Pa-
`tient-reported satisfaction with the treatment program was significantly
`higher for those receiving oral therapy than for those receiving nonoral
`therapy. (J Am Podiatr Med Assoc 91(10): 521-527, 2001)
`a—
`
`Onychomycosis of the nail is a common condition,
`and clinicians often fail to appreciate the seriousness
`with which many patients regard it. This unsightly
`and uncomfortable fungal infection can impair physi-
`*Submitted as Vice President, The Lewin Group, San Fran-
`cisco, CA.
`1’Assistant Director, Health Economics and Outcomes Re-
`search, Novartis Pharmaceuticals Corp, East Hanover, NJ.
`isubmitted as Associate Professor of Medicine and Chief,
`Infectious Diseases, Pennsylvania College of Podiatric Medi-
`cine, Philadelphia, PA.
`§Submitted as Executive Director, Health Economics and
`Outcomes Research, Novartis Pharmaceuticals Corp, East
`Hanover, NJ. Mailing address: Janssen Pharmaceutica, Inc,
`1125 Trenton-Harbourton Roads, Titusville, NJ 08580.
`l|Submitted as Project Director, The Lewin Group, San
`Francisco, CA.
`1lSubmitted as Database Manager/Analyst, The Lewin
`Group, San Francisco, CA.
`lllsubmitted as Outcomes Research Manager, Novartis
`Pharmaceuticals Corp, East Hanover, NJ.
`This study was underwritten by Novartis Pharmaceuticals
`Corp, East Hanover, NJ.
`
`cal functioning, limit choice of footwear, negatively
`affect self—esteem, and give rise to self—consciousness,
`anxiety, depression, and the fear of contagion to oth-
`ers.1« 2 Studies indicate that these factors can detract
`
`from a patient’s overall quality of life.3
`Traditional podiatric treatments, such as debride-
`ment and topical medications, may improve a pa-
`tients comfort and appearance, but they do not cure
`Onychomycosis. New oral antifungal agents, such as
`terbinafine and itraconazole, have been shown to be
`effective in treating onychomycosis.4) 5 Since these
`drugs have the potential to clear the infecting organ-
`isms and produce a clinical cure, they are likely to re-
`quire a shorter duration of therapy and significantly
`fewer office visits than palliative treatments, such as
`debridement or topical therapy. Overall, this makes
`oral agents cost—effective.5v 7 Recent analysis has
`shown that potential cost—effectiveness is driven by
`significantly higher clinical improvement rates in pa-
`tients treated with oral antifungal agents? However,
`
`Volume 91 - Number 10 - November/December 2001
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`when physicians make treatment choices they must
`also consider patient satisfaction and potential ef-
`fects on quality of life.
`This study evaluated changes in toenail condition
`and in satisfaction with treatment in patients with
`onychomycosis who received a variety of mechanical,
`topical, and oral therapies during a 9-month observa-
`tion period. Patient and clinician assessment of
`symptoms, quality of life, and patient satisfaction at
`baseline were reported previously.9 Patient outcomes
`were assessed according to the various treatment op-
`tions. The resulting observations illustrate important
`differences in the ways that clinicians approach
`treatment for different age groups and how the type
`of treatment (oral antifungal therapy or other thera-
`pies) relates to self—reported clinical improvement
`and patient satisfaction.
`
`Methods
`
`This longitudinal study collected comprehensive ob-
`servational data from patients with onychomycosis
`for a 9-month period. Treatment for onychomycosis
`consisted of mechanical therapy (nail debridement),
`topical medication (clotrimazole, Fungi-Nail [Kramer
`Laboratories, Inc, Miami, Florida], terbinafine, ci-
`clopirox olamine, clotrimazole and betamethasone,
`econazole, tolnaftate [none of which were approved
`by the US Food and Drug Administration for ony-
`chomycosis at the time of study]), oral medication
`(terbinafme, itraconazole, fluconazole), or surgery,
`as deemed necessary by the clinicians. Investigators
`in the study were instructed to treat patients as they
`would normally to avoid influencing the choice of
`products or approaches to therapy. Data collected at
`entry and at two follow-up visits were compared to
`assess changes in nail condition, patient satisfaction,
`and quality of life.
`
`Data Collection, Entry, and Retrieval
`
`Patients at eight sites in the US were invited to par-
`ticipate in the study during routine office visits to
`their dermatologist or podiatric physician. Study
`sites Were comprised of three podiatric medical cen-
`ters and five dermatology centers. Enrollment was
`offered to patients 18 years or older who were liter-
`ate in English and who had a clinical diagnosis of
`onychomycosis as confirmed by the appearance of
`onycholysis and subungual hyperkeratosis. Patients
`on oral antifimgal drug therapy at the time of enroll-
`ment were excluded.
`
`At enrollment (baseline visit), patients completed
`an informed-consent form and received a physical
`
`examination by their physician to document the de-
`gree of nail involvement. Any existing conditions
`known to affect immune function were noted. The
`
`study coordinator or health-care provider completed
`a baseline information form for each patient, which
`provided data on the patients clinical history, nail as-
`sessment, current manifestations, treatment, and any
`laboratory tests that were performed at the time of
`the visit. Such tests included fungal diagnostic tests,
`chemistry panels, pregnancy tests, urinalysis, and
`hematology tests.
`
`At enrollment, patients also were asked to complete
`a questionnaire on demographics, medical history,
`and baseline health-related quality of life. Questions
`addressed areas of general concern, including physi-
`cal functioning, social functioning, pain, health dis-
`tress, and stigma. The questionnaire also included
`disease-specific items concerning onychomycosis,
`such as the ability to perform physical activities (for
`example, standing, playing tennis, or dancing) and
`the burden associated with caring for nail discol-
`oration, thickening, soreness, or redness. These ques-
`tions were derived from previous studies and have
`been researched extensively and validated in patients
`with onychomycosis and other conditions.3> “H2 The
`
`quality-of-life questionnaire was administered again
`at 4 and 9 months after enrollment.
`
`A second clinical evaluation was performed 4
`months after enrollment. Patients at six of the eight
`study sites also participated in a final clinical exami-
`nation at 9 months. Patients were asked to use a 5-
`item scale to rate their satisfaction with the nail
`treatment program. This scale was administered at
`baseline, 4 months, and 9 months.
`Uniform questionnaires and procedural manuals
`were used to ensure the consistency and quality of
`data collected across sites. All data were collected
`and maintained in a confidential database at a cen-
`
`tralized patient-tracking facility. To ensure patient
`confidentiality, project team members were required
`to sign confidentiality agreements before receiving
`access to patient questionnaires. In addition, all pa-
`tient identifiers were removed when the data were
`merged into the database.
`
`This article analyzes the demographic and clinical
`characteristics of the full sample, as reported by the
`physician, the patient, or both. Longitudinal compar-
`isons are presented for the 4- and 9-month visits, in-
`cluding physician global assessment of changes in
`nails compared with baseline, changes in therapy as
`a function of initial therapy, physician and patient as-
`sessments of nail improvement, and changes in pa-
`tients’ self—reported satisfaction with their treatment.
`Data comparisons were also made on the basis of
`
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`oral versus nonoral treatment. Patients in the oral
`therapy group were defined as those treated by any
`form of oral medication or any combination of oral
`plus topical medication. Patients grouped under
`nonoral therapy were those treated with topical nail
`therapy, such as debridement, topical medication, or
`any combination of topical treatments. When appro-
`priate, comparisons for significant differences were
`calculated by means of either a chi-square test or a
`Student’s t-test.
`
`Resufls
`
`Patients
`
`A total of 160 patients were invited to participate.
`Nine (5.6%) declined and one was excluded for hav-
`ing fingernail rather than toenail onychomycosis.
`Thus, a total of 150 patients were enrolled in the
`study. Three of these patients, however, were found
`to be taking oral antifungal drug therapy at the time
`of enrollment and were excluded from all analyses.
`The final full sample at baseline was 147 patients
`(mean age, 59.9 =_- 16.2 years), with 54% younger than
`age 65. The study enrolled slightly more men than
`women. Approximately half of the patients visited a
`dermatologist (51%), while the remainder (49%) visit-
`ed a podiatric physician (Table 1).
`Of the 147 patients included in the analysis, 50%
`had onychomycosis for 4 years or more, and 47% had
`received previous treatment for onychomycosis. At
`baseline, patients had a mean of 5.3 i 3.2 toenails af-
`fected by onychomycosis (range: 1 to 10 toenails).
`Table 1 compares patient demographics and data
`for oral versus nonoral therapies. At the baseline
`visit, 58 patients (39%) received a prescription for an
`oral antifungal medication. Of these 58 patients, 53
`received oral therapy only. Of the 53 patients, 39 pa-
`tients (74%) received terbinafme, 13 (24%) received
`itraconazole, and 1 (2%) received fluconazole. Nine
`patients (6%) received no treatment for their ony-
`chomycosis at the initial visit. One of these patients
`started oral therapy 4 weeks later and for analytic
`purposes was included in the oral therapy group.
`One patient started nail debridement 4 weeks after
`the baseline visit and was included in the nonoral
`therapy group. The remaining 7 patients received de-
`bridements at the 4-month visit and also were includ-
`ed in the nonoral group.
`Patients who received oral therapy had a mean of
`5.6 :1: 3.4 toenails involved at baseline while patients
`receiving nonoral therapy had a mean of 5.0 : 3.0
`toenails involved. Patients receiving oral antifungal
`therapy were significantly more likely to be under
`
`the care of a dermatologist than a podiatric physician
`(P = .001). On average, the 58 patients receiving oral
`medication were younger (52.5 1 15.7 years) than the
`89 patients not receiving oral medication (64.7 : 14.8
`years) (P = .001).
`
`Clinical Tests and Procedures
`
`Fewer than half of the patients underwent onychomy-
`cosis-related laboratory tests at baseline or at either
`follow-up visit. The majority of laboratory tests were
`performed at baseline. The most common tests were
`potassium hydroxide (KOH) preparation and fungal
`culture. The likelihood of the patient having had a
`KOH test to confirm the diagnosis at baseline was
`significantly greater if the patient was receiving oral
`therapy (43% on oral therapy received a KOH test
`versus 4% on nonoral therapy; P = .001). The differ-
`ence at baseline was not significant for fungal culture
`tests, although it was more common in patients re-
`ceiving oral therapy (26% oral versus 16% nonoral).
`Of the seven patients on whom fungal cultures were
`performed at the 9-month visit, all appeared to be
`treatment failures.
`
`Podiatric physicians performed significantly more
`nail debridements than did dermatologists. Of those
`patients who visited a podiatric physician, 85% un-
`derwent debridement, while 5% of patients treated by
`a dermatologist underwent this procedure (P < .001).
`
`Patient Improvement and Satisfaction
`
`At the 4- and 9-month follow—up visits, physicians
`noted improvement in 81% and 83%, respectively, of
`patients on oral therapy but in only 39% and 35% (at 4
`and 9 months, respectively) of patients on nonoral
`therapy (Fig. 1). This difference in improvement for
`oral versus nonoral therapy was significant (P = .001).
`For patients on oral therapy, the mean number of af-
`fected toenails reported by physicians declined from
`5.6 at baseline to 4.5 at 4 months and to 3.8 at 9
`months.
`Patients who were treated with debridement or
`topical agents had longer courses of treatment than
`those who received oral medication. Of the patients
`whose initial therapy included oral antifungal medi-
`cation, only 7 patients (12%) were still taking oral an-
`tifungal medication at the 4-month follow—up, and
`only 1 (2%) at the 9-month follow-up was still taking
`the medication. In contrast, of the 64 patients treated
`with debridement at baseline, 52 (81%) were still re-
`ceiving this treatment at the 4-month follow-up, and
`36 (56%) at the 9-month follow-up. Also, 31 (62%) of
`the 50 patients who were started on topical antifungal
`
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`Table 1. Baseline Patient Demographic and Clinical Data (N = 147):j_
`
`Pvaluea
`Nonoral Treatment (%)
`Oral Treatment (%)
`Total No. (%)
` jj_
`
`Number of patients treated”
`Gender
`
`147 (100)
`
`Female
`Male
`Age
`
`64 or younger
`65 or older
`Race
`
`White
`Black
`Hispanic
`Mixed race
`Not reported
`Type of specialist
`
`Dermatologist
`Podiatric physician
`Prior onychomycosis treatment
`
`No
`Yes
`Unknown
`Years with onychomycosis
`Less than 1
`1-2
`3-4
`More than 4
`Unknown
`Mean number of affected toenails (1: SD)
`
`61 (41)
`86 (59)
`
`79 (54)
`68 (46)
`
`114 (78)
`7 (5)
`11 (7)
`2 (1)
`13(9)
`
`75 (51)
`72 (49)
`
`75 (51)
`69 (47)
`3(2)
`
`11 (7)
`16(11)
`10(7)
`74 (50)
`36 (24)
`5.3 : 3.2
`
`58 (39)
`
`20 (34)
`38 (66)
`
`45 (78)
`13 (22)
`
`48 (83)
`3(5)
`4(7)
`0 (0)
`3(5)
`
`54 (93)
`4 (7)
`
`24 (41)
`32 (55)
`2 (3)
`
`3(5)
`8(14)
`3(5)
`32 (55)
`12 (21)
`5.6 : 3.4
`
`89 (61)
`
`41 (46)
`48 (54)
`
`34 (38)
`55 (62)
`
`66 (74)
`4 (4)
`7 (8)
`2 (2)
`10 (11)
`
`21 (24)
`68 (76)
`
`51 (57)
`37 (42)
`1 (1)
`
`8 (9)
`8(9)
`7(8)
`42 (47)
`24 (27)
`5.0 1 3.0
`
`NS
`
`aPvalue between oral versus nonoral group calculated by means of chi-square test.
`“Not all baseline demographic and clinical data were available for all patients. Depending on the variable, data were avail-
`able for 55 to 58 patients in the oral therapy group and 80 to 89 patients in the nonoral therapy group.
`Abbreviation: NS, not significant.
`
`fioral 1 Nonoral
`
`N=2O
`
`\l01
`
`N01(.110
`
`
`
`
`
`PatientImprovement(%)
`
`9 "“°“”‘3
`
`PF0T0°0' Visits
`
`Figure 1. Global physician-reported change in nail in-
`volvement at 4- and 9-month protocol visits, by base-
`line treatment. P: .001.
`
`medication at baseline were stiH using this medica-
`tion at 4 months, and 21 (42%) were still using it at 9
`II10I'tthS.
`
`Patient—reported improvements during the 9-month
`period favored oral therapy over nonoral therapy.
`Mean satisfaction scores were higher for patients re-
`ceiving oral therapy (Fig. 2). These patients were sig-
`nificantly more likely to perceive improvements in
`parameters related to nail care, such as time spent,
`inconvenience, pain, and discomfort. Patients on oral
`therapy also reported significantly fewer problems
`with their onychomycosis in social situations, such
`as embarrassment, self-consciousness, avoidance of
`contact by others, being perceived as unclean, and
`concealment of nails. Patients on oral therapy also
`reported significantly fewer problems with activities
`and hobbies requiring bare feet. Finally, these pa-
`_
`_
`_
`“ems reported 3 reducuon "1 °Verau Problems relat‘
`ing to their nails (Table 2).
`
`Journal of the American Podiatric Medical Association
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`A
`
`+ Oral
`
`-I- Nonoral
`
`B
`
`+ Oral
`
`-I- Nonoral
`
`5
`
`4
`
`3
`
`*
`
`.5
`3
`.59.1’
`U:
`5
`
`c 8
`
`'3
`2 2
`
`1
`
`Baseline
`
`4 months
`
`9 months
`
`Toenail Improvement
`
`w
`
`5
`
`4
`
`3
`
`2 1
`
`Baseline
`
`4 months
`
`9 months
`
`Toenail Appearance
`
`.5
`
`5S
`
`.9
`U)
`E
`
`C $§
`
`Figure 2. Patient-reported mean scores for satisfaction with toenail appearance and improvement (scale ranges
`from 1 to 5; higher scores indicate greater satisfaction). *P< .001; "P < .05.
`
`Satisfaction with nail treatment was related to im-
`
`provement in the patients nail condition. At the 9-
`month follow—up visit, among the patients who had
`improved, 68% were satisfied with their toenail ap-
`pearance, 63% were satisfied with their degree of im-
`provement, and 66% were satisfied with the treatment
`program. Male patients were more satisfied with the
`improvement than their female counterparts. In the
`questionnaire responses at 9 months, women report-
`ed being significantly less satisfied than men did for
`measures of discomfort in wearing shoes (quality—of—
`
`life score of 61.5 versus 86.3 in men; P = .001), restric-
`tion of shoe options (quality-of—1ife score of 59.0 ver-
`sus 82.8; P = .001), and the need to conceal their toe-
`nails (qua1ity—of—life score of 73.3 versus 89.3; P < .01).
`Women also reported being more embarrassed (quali-
`ty-of—life score of 71.8 versus 81.4) and more self-con-
`scious (quality-of—life score of 71.7 versus 82.5) about
`their toenail condition than men, but these differ-
`ences were not statistically significant.
`At the 9-month endpoint of the study, patient—re-
`ported satisfaction with the treatment program was
`
`?_:_.
`Table 2. Mean Improvement from Baseline to 9 Months in Patients’ Perception of Seriousness of Problems Stemming
`from Fungal Nail Condition
`Problem
`Oral Treatment
`Nonoral Treatment
`Pvaluea
`
`< .05
`0.10
`0.54
`Time/inconvenience in caring for/treating nails
`< .05
`-0.03
`0.40
`Pain/discomfort in caring for/treating nails
`< .05
`0.33
`0.90
`Embarrassed by appearance of nails
`< .01
`0.33
`1.15
`Self-conscious about appearance of nails
`< .05
`0.06
`0.41
`People avoiding contact with patient
`< .05
`0.06
`0.44
`Being seen as unclean/untidy
`< .05
`0.11
`0.46
`Discomfort/pain from wearing shoes
`< .05
`-0.06
`0.50
`Not wearing desired type of shoe
`< .01
`-0.05
`0.61
`Activities requiring bare feet in public
`NS
`0.05
`005
`Hobbies requiring time on feet
`NS
`0.18
`-0.05
`Performing activities requiring being on feet
`NS
`0.28
`0.45
`Concern about nails in intimate settings
`NS
`0.02
`0.10
`Social activities in groups
`NS
`0.03
`0.29
`Activities for fun and recreation
`< .05
`0.20
`0.64
`Concealing nails, keeping shoes on
`< .05
`0.27
`0.71
`Overall problem in life
`Improvement is reported as mean change in score (range: -0.06 to 1.15) from baseline to 9 months; positive change denotes
`improvement.
`flPva|ue between oral versus nonoral group calculated by means of Student’s t-test.
`Abbreviation: NS, not significant.
`
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`+ Oral + Nonoral
`
`significantly higher for those on oral therapy than for
`those on nonoral therapy (Fig. 3). At baseline, pa-
`tients in the nonoral therapy group reported higher
`satisfaction scores with treatment than did patients
`in the oral therapy group (54.7 for the nonoral group
`versus 30.3 for the oral group; P < .05). However, at
`the 4- and 9-month follow-ups, oral therapy patients
`reported higher treatment satisfaction scores than
`nonoral therapy patients, with scores of 79.0 (versus
`62.5 for nonoral; not significant) at 4 months and 90.8
`(versus 68.0 for nonoral; P < .05) at 9 months (Fig. 3).
`
`
`
`ScaleScore
`
`Discussion
`
`This observational study demonstrated that clinical
`improvement of onychomycosis and patient satisfac-
`tion were significantly higher in patients treated with
`oral antifungal therapy than those who received
`nonoral therapy. Although improvement occurred in
`both groups, patient and physician assessments re-
`ported significantly more improvement for patients
`receiving oral therapy. This effect was noted in both
`the 4- and 9-month time frames. Patients reported sig-
`nificantly greater reductions in onychomycosis-related
`problems in 11 of 16 problem categories studied, and
`the direction of the effect favored oral treatment regi-
`mens in three of the five remaining categories. Thus,
`both subjective patient report and more objective
`physician tally of the extent of nail involvement point
`toward a greater clinical benefit with oral medication
`than topical treatment.
`Baseline patient satisfaction scores were higher in
`the nonoral group. This reflects treatment rendered
`prior to study enrollment. However, at both the 4-
`and 9-month follow—up visits, patient satisfaction
`scores were higher in patients on oral medication
`treatment programs. Therefore, a crossover effect in
`treatment satisfaction occurs, with patients on oral
`therapy becoming more satisfied with their treat-
`ment program over time (at both 4- and 9-month fol-
`low—up visits with the difference being significant at 9
`months) than patients on nonoral therapy (Fig. 3).
`Oral therapy patients demonstrated a greater than
`60-point overall improvement in their scores for
`treatment satisfaction, whereas nonoral therapy pa-
`tients showed only a 18-point increase (Fig. 3). Be-
`cause of the way data were stratified for analysis, no
`comparison was made between patients receiving
`oral therapy alone and those receiving both oral and
`topical care, who were included in the oral therapy
`group. It would be interesting to see if such patients
`had greater satisfaction over the entire study period.
`Patients whose onychomycosis improved were
`more satisfied with their treatment than patients who
`
`Baseline
`
`4 months
`
`Patient Satisfaction
`
`9 months
`
`Figure 3. Patient satisfaction with treatment program for
`oral versus nonoral therapy (scores obtained by trans-
`forming categorical data to a linear scale of 0 to 100;
`100 signifies optimal health or functioning). ‘P < .05.
`
`reported no or minimal improvement in their fungal
`nail condition. They felt less restricted in the time re-
`quired to treat their nails, had less pain and discom-
`fort, and were less embarrassed and self-conscious
`about the appearance of their nails. This was espe-
`cially true among women. Studies have shown that,
`particularly with chronic conditions, such qua1ity-of-
`life improvements represent an important measure
`of treatment efficacy. 13
`The problems created by toenail onychomycosis
`are often regarded as more cosmetic than medical.9
`The current study shows, however, that this condi-
`tion presents a considerable medical challenge to
`physicians and a significant burden to patients. In
`fact, many patients are so concerned about their ony-
`chomycosis that it affects their mental health, social
`functioning, and overall well-beingfi *4
`In terms of cost advantages, oral antifungal agents
`have been shown to be the most cost-effective thera-
`py for toenail onychomycosis? Oral antifungals have
`extended bioavailability within the nail plate, even
`after treatment is discontinued, which may increase
`efficacy and help reduce treatment times.15~ 1“ This is
`consistent with the findings presented in this study:
`considerably fewer oral therapy patients were still on
`treatment at 4 and 9 months as compared to patients
`on nonoral therapy. While nonoral treatments are
`generally palliative and require continued care, oral
`therapy is curative and reduces treatment time and
`cost. The standard duration of oral antifungal admin-
`istration is 3 months, and clinical improvement of the
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`nail continues up to 10 to 12 months, which is the
`time required for nail outgrowth.” 13
`In addition to clinical manifestations of the nail, a
`definitive diagnosis of onychomycosis should be
`made on the basis of KOH and fungal culture labora-
`tory tests.19 However, in this observational study,
`physicians were allowed to treat patients as they nor-
`mally would and not all patients underwent laboratory
`tests to confirm diagnosis, since this was not a re-
`quirement for study enrollment. What was required
`for study enrollment was a clinical finding for a diag-
`nosis of onychomycosis.
`Podiatric physicians, who treat onychomycosis pa-
`tients over a long-term course of therapy, are clearly
`concerned about their patients’ clinical, symptomatic,
`and quality—of—life improvement over time. On the basis
`of both physicians’ assessments and patients’ per-
`spectives, the results of this study demonstrate that
`oral therapy offers significant improvement in patient
`outcomes as compared with nonoral therapy. These
`outcomes include clinical evaluations, quality of life,
`and patient satisfaction. Podiatric physicians should
`consider oral antifungal therapy the treatment of
`choice for many patients with toenail onychomycosis.
`
`Acknowledgment. Stephanie G. Phillips, PhD, and
`Oliver J. Yun, MA, ELS, for assistance in manuscript
`preparation.
`
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