Patient-centred outcome measures for oral mucosal disease are sensitive to treatment

Patient-centred outcome measures for oral mucosal disease are sensitive to treatment

Int. J. Oral Maxillofac. Surg. 2003; 32: 334–336 doi:10.1054/ijom.2002.0377, available online at http://www.sciencedirect.com Evidence-Based Therapy ...

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Int. J. Oral Maxillofac. Surg. 2003; 32: 334–336 doi:10.1054/ijom.2002.0377, available online at http://www.sciencedirect.com

Evidence-Based Therapy Oral Medicine

Patient-centred outcome measures for oral mucosal disease are sensitive to treatment

C. McGrath1, A. M. Hegarty2, T. A. Hodgson2, S. R. Porter2 1

Periodontology & Public Health, Faculty of Dentistry, Prince Philip Dental Hospital, University of Hong Kong, 34 Hospital Road, Hong Kong SAR, China; 2Department of Oral Medicine, Eastman Dental Institute for Oral Health Care Sciences, UCL, University of London, 256 Gray’s Inn Road, London WC1X 8LD, UK

C. McGrath, A. M. Hegarty, T. A. Hodgson, S. R. Porter: Patient-centred outcome measures for oral mucosal disease are sensitive to treatment. Int. J. Oral Maxillofac. Surg. 2003; 32: 334–336.  2003 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Science Ltd. All rights reserved. Abstract. The aim of this study was to evaluate the sensitivity of two patient-centred outcome measures to the topical application of a corticosteroid (betamethasone) in the treatment of oral lichen planus (OLP). Forty-eight patients with clinical and histological features of OLP were recruited to take part in a 6-week study of the effectiveness of topical betamethasone for the treatment of symptomatic OLP. Participants completed a questionnaire incorporating the 16-item UK Oral Health Related Quality Of Life measure (OHQOL-UK) and the 14-item Oral Health Impact Profile (OHIP-14), rated their pain on ‘global’ and visual analogue scales (VAS) and underwent an oral examination, at the start and end of the trial. Four (8%) patients failed to complete the study. The clinical signs of OLP had improved for half (22) of the patients following treatment. Twenty-nine (66%) reported that their oral pain had reduced (‘global’ scale). More objectively, there were significant differences in VAS ratings of pain (P=0.005), OHIP-14 scores (P=0.036) and OHQOL-UK scores (P=0.003) between the start and end of the trial. In conclusion, both OHQOL-UK and OHIP-14, patient-centred outcome measures are sensitive to the clinical effects of topical betamethasone in the treatment of oral lichen planus.

Introduction The importance of embracing patients’ views in assessing oral health needs and in treatment planning has been widely advocated2. To that end a number of different patient centred oral health status measures have been developed over the past decade, to assess the physical, social and psychological consequences of oral health and thus the impact of oral health status on quality of life11. These measures are suggested 0901-5027/03/030334+03 $30.00/0

to complement traditional clinical oral health status measures; to improve communication between patients and their clinical attendants, and provide greater understanding of the consequences of oral disease upon day to day living and life quality6. Some of these measures are being employed routinely in relevant national epidemiological studies7,9 and also are commonly used among various oral health specialties; particularly cariology5 and oral rehabilitation3. An initial study

Key words: corticosteroids; oral lichen planus; outcome measures. Accepted for publication 19 December 2002

of the impact of oral mucosal lesions on the life quality of patients suggests that these instruments appear to perform well in the management of oral mucosal disease, demonstrating acceptable psychometric properties in terms of validity and reliability to support their more widespread use13,4. If the measure of quality of life is to play a role in the evaluation of the effectiveness of oral medicine care, it must demonstrate sensitivity to treatment.

 2003 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Science Ltd. All rights reserved.

Patient-centred outcome measures: are they sensitive to treatment? The aim of this study was thus to determine the sensitivity of two patient centred outcome measures: the short form Oral Health Impact Profile, OHIP-14 and the UK Oral Health Related Quality Of Life measure, OHQOL-UK, to the treatment of a topical betamethasone for patients with erosive or ulcerative oral lichen planus. The following hypotheses were tested: i. significantly less pain (rated on a visual analogue scale, VAS) is experienced following the topical application of betamethasone, ii. significant differences in scores derived from the two patient centred questionnaires exist between before and after treatment, iii. differences in OHIP-14 and OHQOL-UK scores following treatment are correlated. Material and methods Patient group

Table 1. Profile of the group Number (%) Gender Female Male

35 (79.6) 9 (20.4)

Ethnicity White Non-white groups

28 (63.6) 16 (36.4)

Clinical lesion Erosions Ulcers

34 (77.3) 10 (22.7)

Global rating of pain No pain Mild/discomforting

4 (9.1) 31 (70.5)

Distressing/horrible/ excruciating

9 (6.8) Mean, SD (Median, iqr*)

Age

54.55, 12.70 (53.0, 46.3–60.0)

VAS value

36.09, 26.86 (24.5, 16.0–55.0)

OHQOL-UK scores

43.00, 8.11 (43.0, 38.0–47.0)

OHIP scores

14.81 (12.21) (12.5, 4.3–24.5)

The study group comprised 48 patients (38 female, group median age 53 years) with clinical and histopathological evidence of erosive or ulcerative oral lichen planus attending the Oral Medicine unit of the Eastman Dental Institute for Oral Health Care Sciences, UCL, University of London, UK. Local ethical approval was obtained, and written consent obtained from all participants. Each patient was prescribed topical betamethasone phosphate (0.5 mg tablet dissolved in 10 ml water, the resulting solution held in the mouth for 3 min and then expectorated) to be used as a mouthrinse four times daily for six weeks.

model of ‘structure-function-abilityparticipation’15, which incorporates both negative and positive influences of health. Patients also rated the pain they were currently experiencing from their lesions on a visual analogue scale (VAS) from 0–100, zero representing ‘no pain’ and 100 ‘worse pain imaginable’ and on a ‘global scale’ (no pain to excruciating pain)4. Clinical oral examinations were carried out after patients had completed the questionnaire and ‘blind’ of the examiner.

Data collection

Data analysis

The data collection consisted of a selfcompleted structured questionnaire and an oral examination, conducted prior to patients using the topical steroid agent, Betnesol and six-weeks later following their continual use of the agent. The self-completed questionnaire incorporated the two patient-centred outcome measures; the short form Oral Health Impact Profile—OHIP-1412 and the 16-item UK Oral Health Related Quality Of Life measure—OHQOL-UK8. These measures are based on two conceptually distinct models of oral health, the former based on the World Health Organization (WHO) model of ‘diseaseimpairment-disability-handicap’14 and the latter on an updated WHO

Scores were derived from both patientcentred questionnaires by summating

*Iqr=interquartile range.

335

the responses to each of the individual questions within the measures. For further information about the scoring systems can be found elsewhere4. Differences in mean VAS, OHIP-14 and OHQOL-UK scores before and after treatment were assessed using paired sample t-tests. Spearman’s correlation coefficients were examined to determine the correlations between the difference in OHIP-14 and the difference in OHQOLUK scores before and after treatment. Results Four participants (8%) failed to complete the clinical trial and were excluded from the analysis. One patient was found to have histopathological features of moderate oral epithelial dysplasia adjacent to a site of oral lichen planus and three patients were unable to return following their initial clinical assessment due to medical or social reasons. Prior to commencing betamethasone most of the remaining 44 patients (31, 71%) rated the pain of their oral lichen planus as ‘mild or discomforting’. On a VAS pain scale from 0–100, the mean VAS value was 36 and median value 25. Their mean OHQOL-UK was 43, as was their median value. Their mean OHIP score was 14.81 with a median value of 12.5 (Table 1). Following the use of the topical betamethasone, half (22, 50%) of the patients showed signs of improvements clinically. Two-thirds (26, 66%) rated the pain they experience on the ‘global’ scale as reduced. They also rated the pain they experienced on a VAS (0–100) significantly less after the use of Betnesol compared to when they started the trial (P<0.01). There was also significant difference in the impact oral health had on their life quality following the use of Betnesol. There were significant variations in both OHQOL-UK (P<0.01)

Table 2. Outcomes following the use of betamethasone

VAS Start of trial OHQOL-UK Start of trial OHIP Start of trial

Start Mean (SD*) Median (iqr**)

End Mean (SD*) Median (iqr**)

36.09 (26.86) 24.5 (16, 55)

25.66 (21.01) 18.0 (9.25, 41.75)

P<0.01

43.00 (8.10) 43 (38, 47)

47.46 (9.81) 47 (43, 48.75)

P<0.01

14.81 (12.21) (12.5, 4.3–24.5)

11.27 (10.20) (9.0, 3.0–16.3)

P<0.05

*SD=standard deviation, **iqr=interquartile range.

P value

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McGrath et al.

Table 3. Correlation between OHIP-14 and OHQOL-UK scores Spearman’s correlation coefficient Baseline OHIP-14 and OHQOL-UK scores OHIP-14 and OHQOL-UK scores at end of trial Change in OHIP-14 and change in OHQOL-UK over the trial period

0.73* 0.54* 0.42**

*P<0.001, **P<0.01.

and OHIP-14 (P<0.05) scores following treatment (Table 2). Differences in OHQOL-UK before and after treatment were significantly and moderately correlated with differences in OHIP-14 scores before and after treatment, P<0.01, (Table 3). Discussion The patient response rate was high with only 8% drop out. The mean OHIP-14 score of 14.81 and median value of 12.5 indicated many patients perceived their oral health status as impairing their life in various ways. This represents a considerable greater mean OHIP-14 score compared to the general UK population norms, as described in the most recent adult dental health survey (1998) in the UK9. Likewise the mean and median OHQOL-UK scores (43) indicated a reduced oral health related quality of life and it too is considerably lower than reported national norms for OHQOLUK in the UK7. Many of the patients had some benefit from the use of topical betamethasone, as observed clinically by the overall improvement in lesion severity. Many patients also benefited by experiencing less pain, both on the ‘global scale’ and VAS following therapy. While there is limited evidence from randomized controlled trials of the efficacy of topical corticosteroids in the management of oral lichen planus, the present results confirm those of other open studies1,10. In the present study there was an association between ‘before and after’ OHQOL-UK and OHIP-14 following the use of betamethasone. There was a significant decrease in OHIP-14 scores, indicative of a reduction in the ‘burden’ of oral disease and an increase in OHQOL-UK scores, indicative of an enhancement in oral health related quality of life. This has implications in two areas. Firstly, it demonstrates the sensitivity of both of these patient-centred oral health related quality of life measures for the management of oral mucosal disease and thus, are welcome adjunct outcome tools in measuring

effectiveness and cost-effectiveness of care. Secondly, these measures represent patient views about their response to therapy and, therefore are potential outcome measures in controlled clinical trials, enhancing evidence based research. Although the OHQOL-UK measure appeared to be more sensitive to the treatment than the OHIP-14 measure (P=0.003 vs P=0.036), the OHQOLUK may not necessarily be more superior in assessing the management of oral mucosal disease, as both instruments were only moderately correlated at the end of the study. The mean difference in OHQOL-UK scores was also only moderately correlated with the mean difference in OHIP-14 scores over the study period. This indicates that while they are measuring some aspects of the same concept—‘quality of life’, they hold true to their conceptually distinct frameworks and models14,15. Thus, both measures are suitable for oral mucosal disease and together capture both the disease burden and positive, enhancing oral health influences. In conclusion, both patient-centred outcome measures, OHQOL-UK and OHIP-14, demonstrated sensitivity in the management of erosive or ulcerative oral lichen planus with topical betamethasone treatment. There is thus a need to undertake more extensive studies of other immunologically-mediated oral mucosal diseases to establish the precise role of patient-centred outcome measures in evaluating the effectiveness of relevant oral health care.

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Address: Professor Stephen Porter Department of Oral Medicine Eastman Dental Institute for Oral Health Care Science UCL, University of London, 256 Gray’s Inn Road London WC1X 8LD UK Tel: 020 7915 1197 Fax: 020 7915 2341 E-mail: [email protected]