UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study

Mayke B G Koek, Erik Buskens, Paul H A Steegmans, Huib van Weelden, Carla A F M Bruijnzeel-Koomen, Vigfús Sigurdsson, Mayke B G Koek, Erik Buskens, Paul H A Steegmans, Huib van Weelden, Carla A F M Bruijnzeel-Koomen, Vigfús Sigurdsson

Abstract

Background: Home ultraviolet B (UVB) treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis").

Methods: We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI) and the Self Administered PASI (SAPASI) scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006.

Discussion: In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population. Because, in addition to effectiveness, aspects such as quality of life and cost-effectiveness are also taken into consideration, this study will produce valuable evidence to either support or discourage prescription of home UVB phototherapy.

Trial registration: Current controlled trials/Nederlands Trial register: ISRCTN83025173. Clinicaltrials.gov: NCT00150930.

Figures

Figure 1
Figure 1
Timetable. Schematic representation of successive time points for data collection, reported for all outcome measures and questionnaires. * 23 irradiations: outcome measurement was planned at approximately 23 irradiations, with a minimum of 20 and a maximum of 26 irradiations. ** End of therapy: measurement was planned at the end of the treatment. When more than 46 irradiations were needed, measurement was planned at 46 irradiations. *** Follow-up: Starting at the end of the therapy (or at the 46th irradiation, see **), follow-up measurements were planned every 2 months, for up to 1 year after the last irradiation.

References

    1. Milstein HJ, Vonderheid EC, Van Scott EJ, Johnson WC. Home ultraviolet phototherapy of early mycosis fungoides: preliminary observations. J Am Acad Dermatol. 1982;6:355–362.
    1. Resnik KS, Vonderheid EC. Home UV phototherapy of early mycosis fungoides: long-term follow-up observations in thirty-one patients. J Am Acad Dermatol. 1993;29:73–77.
    1. Larko O, Swanbeck G. Home solarium treatment of psoriasis. Br J Dermatol. 1979;101:13–16. doi: 10.1111/j.1365-2133.1979.tb15286.x.
    1. Jordan WP, Jr, Clarke AM, Hale RK. Long-term modified Goeckerman regimen for psoriasis using an ultraviolet B light source in the home. J Am Acad Dermatol. 1981;4:584–591.
    1. Gerritsen MJP. [Home treatment of psoriasis using ultraviolet B irradiation] Ned Tijdschr Dermatol Venereol. 2000;10:101–102.
    1. Sarkany RPE, Anstey A, Diffey BL, Jobling R, Langmack K, McGregor JM, Moseley H, Murphy GM, Rhodes LE, Norris PG. Home phototherapy: report on a workshop of the British Photodermatology Group, December 1996. Br J Dermatol. 1999;140:195–199.
    1. Prince A, van Leussen J. [Home treatment of psoriasis using ultraviolet B irradiation] Ned Tijdschr Geneeskd. 1994;138:373–374.
    1. Lowe NJ. Home ultraviolet phototherapy. Semin Dermatol. 1992;11:284–286.
    1. Cameron H, Yule S, Moseley H, Dawe RS, Ferguson J. Taking treatment to the patient: development of a home TL-01 ultraviolet B phototherapy service. Br J Dermatol. 2002;147:957–965. doi: 10.1046/j.1365-2133.2002.04860.x.
    1. Feldman SR, Clark A, Reboussin DM, Fleischer ABJ. An assessment of potential problems of home phototherapy treatment of psoriasis. Cutis. 1996;58:71–73.
    1. Abel EA. Considerations in the use of home ultraviolet radiation therapy for psoriasis. Cutis. 1985;35:127–8, 130.
    1. Paul BS, Stern RS, Parrish JA, Arndt KA. Low-intensity selective UV phototherapy. A clinical trial in outpatient therapy for psoriasis. Arch Dermatol. 1983;119:122–124. doi: 10.1001/archderm.119.2.122.
    1. Physicians change attitude about home UVB treatment. National Psoriasis Foundation Bulletin. 1991;22:15.
    1. Koek MBG, Buskens E, Bruijnzeel-Koomen CAFM, Sigurdsson V. Home UVB phototherapy for psoriasis: Discrepancy between literature, guidelines, general opinions and actual use. Results of a literature review, a web search, and a questionnaire among dermatologists. Br J Dermatol. 2006;154:701–711.
    1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chron Dis. 1967;20:637–648. doi: 10.1016/0021-9681(67)90041-0.
    1. van Vloten WA. [Home treatment of psoriasis using ultraviolet-B irradiation] Ned Tijdschr Geneeskd. 1993;137:2525–2526.
    1. Pocock SJ. Clinical trials A practical approach. Chichester: John Wiley & sons; 1993. The size of a clinical trial. pp. 123–141.
    1. Spuls PI, Witkamp L, Bossuyt PM, Bos JD. A systematic review of five systemic treatments for severe psoriasis. Br J Dermatol. 1997;137:943–949. doi: 10.1046/j.1365-2133.1997.19902071.x.
    1. Pocock SJ. Clinical trials A practical approach. Chichester: John Wiley & sons; 1993. Methods of Randomization. pp. 66–89.
    1. van Weelden H, De La Faille HB, Young E, van der Leun JC. A new development in UVB phototherapy of psoriasis. Br J Dermatol. 1988;119:11–19. doi: 10.1111/j.1365-2133.1988.tb07096.x.
    1. Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157:238–244.
    1. Fleischer AB, Jr., Rapp SR, Reboussin DM, Vanarthos JC, Feldman SR. Patient measurement of psoriasis disease severity with a structured instrument. J Invest Dermatol. 1994;102:967–969. doi: 10.1111/1523-1747.ep12384205.
    1. Fleischer AB, Jr., Feldman SR, Dekle CL. The SAPASI is valid and responsive to psoriasis disease severity changes in a multi-center clinical trial. J Dermatol. 1999;26:210–215. doi: 10.1159/000053514.
    1. Walker SL, Hawk JLM, Young AR. Acute and Chronic Effects of Ultraviolet Radiation on the Skin. In: Freedberg IM, Eisen AZ, Wolff K, Austen KF, Goldsmith LA and Katz SI, editor. Fitzpatrick's Dermatology in General Medicine Volume 1. 6th. The McGraw-Hill Companies; 2003. p. 1275.
    1. Fitzpatrick TB, Ortonne J. Normal Skin Color and General Considerations of Pigmentary Disorders. In: Freedberg IM, Eisen AZ, Wolff K, Austen KF, Goldsmith LA and Katz SI, editor. Fitzpatrick's Dermatology in General Medicine Volume 1. 6th. The McGraw-Hill Companies; 2003. p. 819.
    1. Finlay AY, Kelly SE. Psoriasis--an index of disability. Clin Exp Dermatol. 1987;12:8–11. doi: 10.1111/j.1365-2230.1987.tb01844.x.
    1. Finlay AY, Khan GK, Luscombe DK, Salek MS. Validation of Sickness Impact Profile and Psoriasis Disability Index in Psoriasis. Br J Dermatol. 1990;123:751–756. doi: 10.1111/j.1365-2133.1990.tb04192.x.
    1. Ware JE, Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483.
    1. Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, Sprangers MA, te VA, Verrips E. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998;51:1055–1068. doi: 10.1016/S0895-4356(98)00097-3.
    1. Essink-Bot ML, Stouthard ME, Bonsel GJ. Generalizability of valuations on health states collected with the EuroQolc-questionnaire. Health Econ. 1993;2:237–246.
    1. The EuroQol Group EuroQol* - a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. van Roijen L, Essink-Bot ML, Koopmanschap MA, Bonsel G, Rutten FF. Labor and health status in economic evaluation of health care. The Health and Labor Questionnaire. Int J Technol Assess Health Care. 1996;12:405–415.
    1. Koopmanschap MA, Rutten FF, van Ineveld BM, van Roijen L. The friction cost method for measuring indirect costs of disease. J Health Econ. 1995;14:171–189. doi: 10.1016/0167-6296(94)00044-5.
    1. GCP preparatory committee (translated from english) [Good Clinical Practice for trials on medical products in the European Community] The Hague, CIP-Gegevens Koninklijke Bibliotheek; 1993.
    1. Efron B, Tibshirani RJ. An introduction to the bootstrap. New York, Chapman & Hall, Inc.; 1993. (Monographs on statistics and applied probability). Cox DR.
    1. van Hout BA, Al MJ, Gordon GS, Rutten FF. Costs, effects and C/E-ratios alongside a clinical trial. Health Econ. 1994;3:309–319.

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