The efficacy of a health-related quality-of-life intervention during 48 weeks of biologic treatment of patients with moderate to severe psoriasis: Study protocol for a multicenter randomized controlled trial

Trials

Volumn 13, Issue , 2012, Pages

  Prinsen, Cecilia A C ^a   Spuls, Phyllis I ^a   Sprangers, Mirjam A G ^a   de Rie, Menno A ^a   Legierse, Catharina M ^a   de Korte, John ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

Author keywords

Biologic; Dermatology; Etanercept; Health related quality of life; Intervention; Patient reported outcomes; Psoriasis; Randomized controlled trial; Skindex 29

Indexed keywords

ETANERCEPT;

ARTICLE; CLINICAL PROTOCOL; DERMATOLOGIST; DISEASE SEVERITY; FOLLOW UP; HEALTH STATUS; HUMAN; MEDICAL EDUCATION; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; PROSPECTIVE STUDY; PSORIASIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SKINDEX 29; STRUCTURED QUESTIONNAIRE;

ADULT; FEMALE; HUMANS; IMMUNOGLOBULIN G; IMMUNOLOGIC FACTORS; MALE; NETHERLANDS; PSORIASIS; QUALITY OF LIFE; RECEPTORS, TUMOR NECROSIS FACTOR; RESEARCH DESIGN; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84870498258     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-236     Document Type: Article

References (31)

1. Food and Drug Administration. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims 2009, Washington, United States: U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry.
2. WHOQOL Group Study protocol for the World Health Organization project to develop a Quality of Life assessment instrument (WHOQOL). Qual Life Res 1993, 2:153-159. WHOQOL Group.
3. Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol 2001, 137:280-284.
4. Gelfand JM, Weinstein R, Porter SB, Neimann AL, Berlin JA, Margolis DJ. Prevalence and treatment of psoriasis in the United Kingdom: a population-based study. Arch Dermatol 2005, 141:1537-1541. 10.1001/archderm.141.12.1537, 16365254.
5. Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 2002, 288:3027-3034. 10.1001/jama.288.23.3027, 12479768.
6. Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 2004, 22:714-724. 10.1200/JCO.2004.06.078, 14966096.
7. de Korte J, de Waard-van der Valk PG, Sprangers MA, Damstra RJ, Kunkeler AC, Lijnen RL, Oranje AP, de Rie MA, der Spek FB, Hol CW, van de Kerkhof PC. A comparison of twice-daily calcipotriol ointment with once-daily short-contact dithranol cream therapy: quality-of-life outcomes of a randomized controlled trial of supervised treatment of psoriasis in a day-care setting. Br J Dermatol 2008, 158:375-381.
8. Katugampola RP, Lewis VJ, Finlay AY. The Dermatology Life Quality Index: assessing the efficacy of biological therapies for psoriasis. Br J Dermatol 2007, 156:945-950. 10.1111/j.1365-2133.2007.07817.x, 17388922.
9. de Korte J, Mombers FM, Sprangers MA, Bos JD. The suitability of quality-of-life questionnaires for psoriasis research: a systematic literature review. Arch Dermatol 2002, 138:1221-1227. 10.1001/archderm.138.9.1221, 12224984.
10. Velikova G, Brown JM, Smith AB, Selby PJ. Computer-based quality of life questionnaires may contribute to doctor-patient interactions in oncology. Br J Cancer 2002, 86:51-59. 10.1038/sj.bjc.6600001, 2746549, 11857011.
11. Gottlieb AB, Matheson RT, Lowe N, Krueger GG, Kang S, Goffe BS, Gaspari AA, Ling M, Weinstein GD, Nayak A, Gordon KB, Zitnik R. A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol 2003, 139:1627-1632.
12. Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, Gottlieb AB, . Etanercept Psoriasis Study Group Etanercept as monotherapy in patients with psoriasis. N Engl J Med 2003, 349:2014-2022. 10.1056/NEJMoa030409, 14627786, Etanercept Psoriasis Study Group.
13. Boehncke WH, Brasie RA, Barker J, Chimenti S, Daudén E, de Rie M, Dubertret L, Giannetti A, Katsambas A, Kragballe K, Naeyaert JM, Ortonne JP, Peyrí J, Prinz JC, Saurat JH, Strohal R, van de Kerkhof P, Sterry W, . European Dermatology Expert Group Recommendations for the use of etanercept in psoriasis: a European dermatology expert group consensus. J Eur Acad Dermatol Venereol 2006, 20:988-998. European Dermatology Expert Group.
14. Ahmad K, Rogers S. Two years of experience with etanercept in recalcitrant psoriasis. Br J Dermatol 2007, 156:1010-1014. 10.1111/j.1365-2133.2007.07829.x, 17408393.
15. Dutch Society for Dermatology and Venereology (NVDV) and the Institute for Healthcare Improvement (CBO) Photo(chemo)therapy and systemic therapy in severe chronic plaque-psoriasis 2003, Leiden, The Netherlands: Van Zuiden Communications, Dutch Society for Dermatology and Venereology (NVDV) and the Institute for Healthcare Improvement (CBO).
16. Nast A, Kopp I, Augustin M, Banditt KB, Boehncke WH, Follmann M, Friedrich M, Huber M, Kahl C, Klaus J, Koza J, Kreiselmaier I, Mohr J, Mrowietz U, Ockenfels HM, Orzechowski HD, Prinz J, Reich K, Rosenbach T, Rosumeck S, Schlaeger M, Schmid-Ott G, Sebastian M, Streit V, Weberschock T, Rzany B. German evidence-based guidelines for the treatment of psoriasis vulgaris (short version). Arch Dermatol Res 2007, 299:111-138. 10.1007/s00403-007-0744-y, 1910890, 17497162.
17. Nast A, Kopp IB, Augustin M, Banditt KB, Boehncke WH, Follmann M, Friedrich M, Huber M, Kahl C, Klaus J, Koza J, Kreiselmaier I, Mohr J, Mrowietz U, Ockenfels HM, Orzechowski HD, Prinz J, Reich K, Rosenbach T, Rosumeck S, Schlaeger M, Schmid-Ott G, Sebastian M, Streit V, Weberschock T, Rzany B, . Deutsche Dermatologische Gesellschaft (DDG); Berufsverband Deutscher Dermatologen (BVDD) Evidence-based (S3) guidelines for the treatment of psoriasis vulgaris. J Dtsch Dermatol Ges 2007, 5(Suppl 3):1-119. Deutsche Dermatologische Gesellschaft (DDG); Berufsverband Deutscher Dermatologen (BVDD).
18. Smith CH, Anstey AV, Barker JN, Burden AD, Chalmers RJ, Chandler D, Finlay AY, Griffiths CE, Jackson K, McHugh NJ, McKenna KE, Reynolds NJ, Ormerod AD, . British Association of Dermatologists British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol 2005, 153:486-497. 10.1111/j.1365-2133.2005.06893.x, 16120132, British Association of Dermatologists.
19. Papp KA. The long-term efficacy and safety of new biological therapies for psoriasis. Arch Dermatol Res 2006, 298:7-15. 10.1007/s00403-006-0660-6, 1461773, 16691429.
20. Chren MM, Lasek RJ, Quinn LM, Covinsky KE. Convergent and discriminant validity of a generic and a disease-specific instrument to measure quality of life in patients with skin disease. J Invest Dermatol 1997, 108:103-107. 10.1111/1523-1747.ep12285650, 8980297.
21. Chren MM, Lasek RJ, Flocke SA, Zyzanski SJ. Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Arch Dermatol 1997, 133:1433-1440. 10.1001/archderm.1997.03890470111018, 9371029.
22. Both H, Essink-Bot ML, Busschbach J, Nijsten T. Critical review of generic and dermatology-specific health-related quality of life instruments. J Invest Dermatol 2007, 127:2726-2739. 10.1038/sj.jid.5701142, 17989733.
23. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use. Clin Exp Dermatol 1994, 19:210-216. 10.1111/j.1365-2230.1994.tb01167.x, 8033378.
24. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality of life into practice: What do dermatology life quality index scores mean?. J Invest Dermatol 2005, 125:659-664. 10.1111/j.0022-202X.2005.23621.x, 16185263.
25. Ong LM, Visser MR, Lammes FB, de Haes JC. Doctor-patient communication and cancer patients' quality of life and satisfaction. Patient Educ Couns 2000, 41:145-156. 10.1016/S0738-3991(99)00108-1, 12024540.
26. Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 1992, 305:160-164. 10.1136/bmj.305.6846.160, 1883187, 1285753.
27. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30:473-483. 10.1097/00005650-199206000-00002, 1593914.
28. Fredriksson T, Pettersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 1978, 157:238-244. 10.1159/000250839, 357213.
29. Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res 2008, 17:179-193. 10.1007/s11136-007-9295-0, 18175207.
30. Feldman SR, Kimball AB, Krueger GG, Woolley JM, Lalla D, Jahreis A. Etanercept improves the health-related quality of life of patients with psoriasis: results of a phase III randomized clinical trial. J Am Acad Dermatol 2005, 53:887-889. 10.1016/j.jaad.2005.06.053, 16243150.
31. Krueger GG, Langley RG, Finlay AY, Griffiths CE, Woolley JM, Lalla D, Jahreis A. Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial. Br J Dermatol 2005, 153:1192-1199. 10.1111/j.1365-2133.2005.06948.x, 16307657.