Validity and reliability of patient-centered outcome measures inoral dysesthesiaRicheal Ni Riordain, BDS, MFD RCSI, PhD,a

Elizabeth Moloney, BDS, MFDS RCSI, MB MCh BAO,b Kathleen O’Sullivan, BSc, MSc,c andChristine McCreary, MA, MD, FDS (OM) RCPS, FFD RCSI,d Cork, IrelandCORK UNIVERSITY DENTAL SCHOOL AND UNIVERSITY COLLEGE CORK

Objective. The objective of this study was to investigate the validity and reliability of a quality of life instrument inpatients with oral dysesthesia.Study design. Forty-five individuals newly diagnosed with oral dysesthesia (37 women, 8 men) were enrolled in thisstudy. Individuals were interviewed using the Visual Analogue Scale (VAS), and the Oral Health Impact Profile (OHIP-14). Construct validity and internal reliability were examined.Results. Patient rating of pain experienced, using VAS, correlated with OHIP-14 scores (P � .05), demonstratingconstruct validity. OHIP-14 demonstrated good internal consistency with Cronbach’s alpha of 0.79. The correcteditem-total correlations for items 3 (painful aching) and 12 (difficulty doing usual jobs) were below the recommendedminimum of 0.20. Cronbach’s alpha increased to 0.81 with the exclusion of these 2 items from OHIP-14.Conclusions. The OHIP-14 questionnaire appeared to perform relatively well in the 45 patients with oral dysesthesiaenrolled in this study, demonstrating validity and reliability in the assessment of the effect of oral dysesthesia onquality of life. However, the exclusion of items 3 and 12 from the questionnaire should be considered in future studies

with this patient population. (Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2011;112:597-601)

In the past number of years, the use of patient-centeredoutcome measures in general medicine has increasedsubstantially.1 These have focused mainly on the pa-tients’ own perceptions of the impact of their health ontheir quality of life.2 The World Health Organization(WHO) recognizes Quality of Life (QoL) not only asthe absence of disease or infirmity but the ability of aperson to lead a productive and enjoyable life.3 Theoral cavity is thought to contribute to QoL throughenhancing self-esteem, self-expression, communica-tion, and increased facial esthetic value.4 Locker et al.5

defined oral health–related quality of life (OHRQoL) as“the extent to which oral disorders affect functioningand psychosocial well-being.”

Within the dental community, the measurement ofQoL has been used with a focus on its relevance in thefield of restorative dentistry, with reports of the impact

aClinical Fellow in Oral Medicine, Cork University Dental Schooland Hospital, Wilton, Cork, Ireland.bMedical Intern, College of Medicine, University College Cork,Ireland.cLecturer and Director of Statistical Consultancy Unit, UniversityCollege Cork, Ireland.dSenior Lecturer/Consultant in Oral Medicine, Cork University Den-tal School and Hospital, Wildon, Cork, Ireland.Received for publication Feb 11, 2011; returned for revision May 17,2011; accepted for publication Jun 22, 2011.1079-2104/$ - see front matter© 2011 Mosby, Inc. All rights reserved.

doi:10.1016/j.tripleo.2011.06.031

of tooth loss on daily life6,7 and the influence of variousprosthetic treatment options on patients.8,9 Limited us-age of both generic and specific measures has beendocumented in oral medicine practice.10 The specificinstruments that have been used as outcome measuresin oral medicine–based studies have been OHRQoLmeasures. In a recent review article by Ni Riordain andMcCreary,10 the authors found that Medical OutcomeSurvey Short Form 36 Health Survey (SF-36) and OralHealth Impacts Profile 14 (OHIP-14) were the mostcommonly used quality of life instruments in oral med-icine.

Oral dysesthesia (OD), or burning mouth syndrome,is defined as “a burning sensation for which no dentalor medical cause can be found.”11 Also included in thedefinition is that the burning sensation is not alwaysconfined to the tongue and further symptoms could beoral dryness and/or loss of taste. Zakrzewska et al.12

emphasized the importance of the use of the termsyndrome, as patients can present with a variety ofsymptoms, including burning sensation, subjective xe-rostomia, oral paresthesia, dysgeusia, loss of taste, andaltered smell. Clinical and laboratory-based examina-tions of patients are used to exclude any underlyinglocal or systemic factors causing to the aforementionedsymptoms before a diagnosis of primary or idiopathicOD is reached.13

The negative impact of OD on the quality of life of

patients has been documented in the literature.14,15 In

597

OOOOE598 Ni Riordain et al. November 2011

light of the importance attached to the validity andreliability of QoL instruments used, the aims of thisstudy are to investigate the validity and reliability of anOHRQoL measure in patients with oral dysesthesia. Itis hoped that this study can provide direction to clini-cians and researchers regarding the suitability of thisinstrument in future research projects.

STUDY DESIGNStudy participants

All new patients referred to the Oral Medicine Unitof Cork Dental Hospital with symptoms, includingburning sensation, subjective xerostomia, oral paresthe-sia, dysgeusia, loss of taste, and altered smell, under-went a full history, including a detailed drug historyand medical history, a thorough clinical examination,and a set of special tests, including laboratory evalua-tions, before a diagnosis of OD was made. Forty-fiveindividuals (37 women, 8 men, mean age 61 years,SD � 9 years, range 38-83 years) newly diagnosedwith OD were enrolled in this study. Only patients withidiopathic or primary OD, based on the classificationoutlined by Scala et al.,13 were included in this study.

Inclusion criteriaInclusion criteria were a clinical history of burning

sensation, subjective xerostomia, oral paresthesia, dys-geusia, loss of taste, and altered smell. Patients withthese symptoms underwent a full history, including adetailed drug history and medical history, a thoroughclinical examination and a set of special tests, includinglaboratory evaluations (full blood count, B12, folateand ferritin levels, blood glucose, urea and electrolytes,thyroid function tests. and autoantibody screen) andswabs for Candida, using blood or chocolate agar,16

before a definitive diagnosis of OD was made. Wholeunstimulated and stimulated saliva flow rates were re-corded. Urea and electrolytes were tested to check forany evidence of dehydration that could possibly predis-pose to Candida. Thyroid function tests were carriedout because of the proposed link between hypothyroid-ism and burning mouth syndrome17 and a full autoan-tibody screen was conducted, including antibodies toRo and La.

Exclusion criteriaExclusion criteria included a positive drug history of

previous psychotropic medications, including antide-pressants and anticonvulsants, as these medicationscould influence the scores generated from the QoLscale used. Patients with previous diseases associatedwith somatic symptoms, such as fibromyalgia andchronic backache, were excluded, again because of the

influence of these conditions on responses to the out-

come measures used. With regard to sialometry, thenormal flow rate of unstimulated whole saliva use inthis study was approximately 0.3 mL/min, and that ofstimulated whole saliva was about 1 to 2 mL/min.Subjects whose unstimulated whole saliva flow ratewas less than 0.1 mL/min or whose stimulated flow ratewas less than 0.5 mL/min were considered to haveobjective dry mouth. Other exclusion criteria includedevidence of mucosal disease or biochemical and/orhematological abnormalities. Therefore, only patientswith idiopathic or primary OD, based on the classifi-cation outlined by Scala et al.,13 were included in thisstudy.

Patients who consented to be enrolled in this studywere then interviewed using the following outcomemeasures: a 10-cm Visual Analogue Scale (VAS) andthe Oral Health Impact Profile (OHIP-14). Ethical ap-proval for this study was granted by the Clinical Re-search Ethics Committee of the Cork Teaching Hospi-tals.

Outcome measuresOral Health Impact Profile. The Oral Health Impact

Profile (OHIP-14) (Appendix 1; available at www.ooooe.net) is a shortened version of OHIP-49,18 de-signed to measure the frequency of difficulties pa-tients experience associated with the mouth, teeth, ordentures in the recent past. These questionnaireswere developed based on Locker’s model of oralhealth19 and include 7 domains: functional limita-tion, pain, psychological discomfort, physical dis-ability, psychological disability, social disability,and handicap. Patients are asked to rate each ques-tion on a 5-point Likert-type scale from 0 (never) to4 (very often). Two measures can be created from theOHIP-14: an unweighted additive measure (0-56)and a weighted impact measure (0-14). The weightswere developed by determining the proportion ofpeople who deemed one impact within each domainas more unpleasant than the other impact in thatdomain.20 Investigation by Allen and Locker21 has dem-onstrated the limited benefits of weighted over un-weighted scores. The unweighted additive scoring systemwas, therefore, used in this study.

Visual Analogue Scale. The VAS consists of a 10-cm, vertical or horizontal line with verbal anchorslabeling each end. Greater reliability has been demon-strated with the horizontal version,22 where the left endof the line, or 0, represents no pain (none) and the rightend of the line, or 10, represents the worst pain imag-inable (agonizing). Patients are asked to mark the line

to indicate the intensity of their pain.

OOOOEVolume 112, Number 5 Ni Riordain et al. 599

Psychometric testingA valid questionnaire has content that reflects the

underlying symptoms of the conditions in question,represents the content domains, and reflects the under-lying theories of the constructs that it claims to mea-sure.23 Construct validity assesses the ability of thequestionnaire to reflect theories and traits underlyingoral dysesthesia. This was tested using OHIP-14 andVAS scores. It was anticipated that patients with ahigher VAS score would obtain a poorer OHIP-14score. Patients’ rating of pain experienced, using VASand OHP-14 scores, was correlated.

Internal consistency is used to measure the reliabilityof a questionnaire. It measures the correlation betweenitems in the instrument. If questionnaire items addresssimilar issues, their scores will correlate with one an-other. When the correlations are too high, this suggestsa redundancy or overlap between items. Correlationsbetween items in OHIP-14 and for each domain wereassessed using Cronbach’s alpha.24 Values of Cron-bach’s alpha are less than or equal to 1. It is, however,unlikely that it will attain either of these extreme val-ues. The following are levels for alpha according to DeVellis25: less than 0.60 is unacceptable, 0.60 to 0.65 isundesirable, 0.65 to 0.70 is minimally acceptable, 0.70to 0.80 is respectable, 0.80 to 0.90 is very good, and forgreater than 0.90, consider shortening the scale (redun-dant items). Corrected item-total correlations, correla-tion between each individual item, and the total scoreomitting the item, were computed. It is recommendedthat corrected item-total correlation should be above0.20.26

RESULTSForty-five patients were enrolled in this study, 37 of

whom were women and 8 men, between the ages of 38and 83 years (mean age 61 years, SD 9 years). Becauseof the variety in presenting symptoms in patients withOD, Table I displays the symptoms reported by thepatients on presentation to the oral medicine clinic. Themean VAS score was 6.8 (SD � 2.4) and the meanOHIP-14 score was 20.8 (SD � 10.1).

Patients’ rating of pain experienced, using VAS, was

Table I. Symptoms reportedYes (%) No (%)

Burning sensation 39 (86.67) 6 (13.33)Dry mouth 4 (8.89) 41 (91.11)Excess saliva 1 (2.22) 44 (97.78)Taste disturbance 7 (15.56) 37 (84.44)Altered sensation 2 (4.44) 43 (95.56)

moderately and significantly correlated with OHIP-14

scores (r � 0.32, P � .05), demonstrating constructvalidity.

Cronbach’s alpha for each of the 7 domains werefunctional limitation 0.362, physical pain –0.134, psy-chological discomfort 0.442, physical disability 0.603,psychological disability 0.602, social disability 0.544,and handicap 0.260.

The corrected item-total correlations for OHIP-14ranged from 0.09 (item 3, painful aching) to 0.69 (item7, diet unsatisfactory). The corrected item-total corre-lations of items 3, painful aching (0.09), and 12, diffi-culty doing usual jobs (0.18), were below the recom-mended minimum of 0.20 (Table II).

Cronbach’s alpha for all 14 items of OHIP-14 com-bined was 0.79, demonstrating good internal consis-tency, which increases to 0.81 following the exclusionof items 3 and 12 from the 14-item questionnaire.

DISCUSSIONQoL represents the effect of an illness on a patient, as

perceived by the patient, and can result in additionalinformation in commonly recorded medical or epide-miologic data. Parkerson et al.27 demonstrated that QoLmeasures can provide information on the health statusof patients with diabetes mellitus that cannot be ob-tained from an examination of the clinical measures. Infact, QoL is becoming increasingly accepted as one ofthe most important outcome measures in the evaluationof any treatment or health-related intervention.28

The importance of stringent development and vali-dation processes for these quality of life measures can-not be underestimated. Kirshner and Guyatt29 outlineda framework for assessing QoL instruments. Thisframework highlights areas of development and valida-

Table II. Oral Health Impact Profile-14 corrected item-total correlations

Corrected item-totalcorrelation

Trouble pronouncing any words 0.48Sense of taste has worsened 0.23Painful aching 0.09Uncomfortable to eat 0.40Self-conscious 0.27Tense 0.55Diet unsatisfactory 0.69Interrupt meals 0.41Difficult to relax 0.66Embarrassed 0.42Irritable 0.61Difficulty doing usual jobs 0.18Life less satisfying 0.45Totally unable to function 0.35

tion that are critical to the construction of a robust QoL

OOOOE600 Ni Riordain et al. November 2011

instrument. When using previously developed mea-sures on a population group, it is important to establishvalidity and reliability to ensure that content of theinstrument being used reflects the underlying symp-toms of the conditions in question. The reliability andvalidity of an OHRQoL measure in patients with ODhas not yet been reported in the current literature,although reports are available with other conditions inthe field of oral medicine. In 2 articles regarding orallichen planus (OLP), Hegarty et al.30 and McGrath etal.31 investigated the reliability, validity, and sensitivityto treatment of 2 OHRQoL measures: OHIP-14 and theOral Health Quality of Life Instrument (OHQoL). Theauthors tested for construct and criterion validity, in-ternal reliability, and sensitivity in a cohort of patientswith OLP. They concluded that both instruments per-formed well in patients with OLP. Mumcu et al.32

investigated the QoL of Turkish patients with Behçet’sdisease and also examined the performance of OHIP-14and OHQoL in the same population. The multidimen-sional properties of OHIP-14 were statistically tested,using factor analysis, by Mumcu et al.33 in patients withboth Behçet’s disease and recurrent aphthous stomati-tis. The Turkish version of both OHIP-14 and OHQoLdemonstrated validity and reliability; OHIP-14 wasalso found to be sensitive to clinical parameters andtreatment modalities.

According to De Vellis,25 there are 3 means bywhich validity can be examined: content validity, cri-terion validity, and construct validity. A test for crite-rion validity is carried out by investigating the correla-tion between the questionnaire and a “gold standard”instrument. This test of validity is not always carriedout because of the absence of an existing “gold stan-dard” measure. For example, Whalley et al.,34 in thevalidation of a Quality of Life Index for Atopic Der-matitis (QoLIAD), stated that no existing QoL measurecould be considered as a “gold standard” for atopicdermatitis and therefore the authors did not test forcriterion validity. In fact, Streiner and Norman26 re-ported that the use of inadequate “gold standard” in-struments in the assessment of criterion validity resultsin unreliability of this form of validity. Criterion wastherefore not carried out in this study because of a lackof an established “gold standard” outcome measure.Construct validity was investigated, with OHIP-14demonstrating construct validity owing to the correla-tion between VAS and OHIP-14 scores.

The Cronbach’s alpha of 0.79 for OHIP-14 achievedfor this cohort of patients with OD was what could beconsidered “respectable.”25 It is interesting that withthe exclusion of items 3 (painful aching) and 12 (dif-ficulty doing usual jobs), both of which had corrected

item-total correlations below the recommended 0.20,26

Cronbach’s alpha increased to 0.81. This value foralpha would, according to De Vellis,25 be regarded as“very good.”

Item 3 in OHIP-14 refers to the domain of physicalpain, “Have you had a painful aching in your mouth?”The symptoms of OD would not commonly include a“painful aching,” with the most common descriptor ofpatient discomfort being “burning.”35 In fact, the do-main of Physical Pain, which includes item 3, has anegative value for alpha, which may indicate that the 2items in this domain do not actually form a useful scale.

Item 12 is in the domain of social disability andrefers to “difficulty doing your usual jobs.” Frequently,patients with OD have reported relief when their mindis occupied with their “usual jobs” and exacerbationduring times of rest and relaxation. It is therefore un-derstandable that this item would not score highly inthis patient cohort. Further confirmation of exacerba-tion during periods of rest and relaxation is the highcorrected item-total correlation recorded for item 9,difficult to relax, with patients reporting increase insymptoms toward the end of the day.36

In conclusion, this study demonstrated that theOHIP-14 questionnaire appears to perform relativelywell, demonstrating validity and reliability, in the as-sessment of the effect oral dysesthesia has on QoL inpatients defined as those with idiopathic or primary ODbased on the classification outlined by Scala et al.,13

and the inclusion criteria of the 45 patients enrolled inthis study. However, the exclusion of items 3 (painfulaching) and 12 (difficulty doing usual jobs) from theOHIP-14 questionnaire should be considered in futurestudies with this patient population.

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Reprint requests:

Richeal Ni Riordain, BDS, MFD RCSI, PhDUniversity Dental School and HospitalOral MedicineWiltonCork, Ireland

richeal.niriordain@gmail.com

□ very often

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Appendix 1. ContinuedDimensions Questions

Psychological disability Have you found it difficult to relaxbecause of problems with yourteeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Have you been a bit embarrassedbecause of problems with yourteeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Social disability Have you been a bit irritable withother people because of problemswith your teeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Have you had difficulty doing yourusual jobs because of problems withyour teeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Handicap Have you felt that life in general wasless satisfying because of problemswith your teeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Have you been totally unable tofunction because of problems withyour teeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Appendix 1. Oral Health Impact Profile (OHIP-14)Dimensions Questions

Functional limitations Have you had trouble pronouncing anywords because of problems withyour teeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Have you felt that your sense of tastehas worsened because of problemswith your teeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Physical pain Have you had painful aching in yourmouth?□ never□ hardly ever□ occasionally□ fairly often□ very often

Have you found it uncomfortable toeat any foods because of problemswith your teeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Psychological discomfort Have you been self-conscious becauseof your teeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Have you felt tense because ofproblems with your teeth, mouth, ordentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Physical disability Has your diet been unsatisfactorybecause of problems with yourteeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often□ very often

Have you had to interrupt mealsbecause of problems with yourteeth, mouth, or dentures?□ never□ hardly ever□ occasionally□ fairly often