PROSPERO International prospective register of systematic reviews A systematic review of the impact on quality of life of topical, systemic and biologic therapies for psoriasis Faraz Ali, Andrea Cueva, Ausama Atwan, Sam Salek, Andrew Finlay, Vincent Piguet, Jui Vyas Citation Faraz Ali, Andrea Cueva, Ausama Atwan, Sam Salek, Andrew Finlay, Vincent Piguet, Jui Vyas. A systematic review of the impact on quality of life of topical, systemic and biologic therapies for psoriasis. PROSPERO 2015:CRD42015009193 Available from http://www.crd.york.ac.uk/prospero_rebranding/display_record.asp?id=crd42015009193 Review question(s) What evidence is there that any therapies for psoriasis have an impact on Health-Related Quality of Life? Searches The following databases to be searched: OVID MEDLINE OVID MEDLINE: In Process EMBASE Web of Science Core Collection Scopus Cochrane Databas Trials registers: The metaregister of Controlled Trials (http://www.isrctn.com). The US National Institutes of Health Ongoing Trials Register (www.clinicaltrials.gov). The Australian New Zealand Clinical Trials Registry (www.anzctr.org.au). The World Health Organization International Clinical Trials Registry platform (www.who.int/trialsearch). The EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/). Types of study to be included We included randomised controlled trials including cross-over trials and trials with open-label extensions. Only papers where the total scores for the QoL tools were provided were included. An exception is when the QoL questionnaires are validated to be reported as subscales. Condition or domain being studied Psoriasis and Quality of Life outcomes Participants/ population Types of participants Page: 1 / 5
Adults (age 18 and over) of either sex and of any ethnicity, with a clinical diagnosis of psoriasis. We included all subtypes of psoriasis. If the subjects suffer with a co-morbidity such as psoriatic arthritis, a skin-related quality of life scale must be included Exclusion criteria: - Psoriatic arthritis studies where it is not possible to differentiate arthritis quality of life from psoriasis quality of life data will be excluded. - Studies which include any patient less than 18 years of age. - Articles where the change in QoL values cannot be reliably calculated will be excluded. This includes graphical representation. - For consistency, QoL data only presented as sub-scales, where total scores are usually calculated, were excluded. Abstracts and posters where further data is not available upon contacting the author, were also excluded. Intervention(s), exposure(s) We included all randomised controlled trials with any intervention used for the treatment of psoriasis including, but not limited to: systemic therapy, topical therapy and psychological therapy. Comparator(s)/ control These trials included comparisons of any intervention with placebo or another active intervention. Outcome(s) Primary outcomes All quality of life scores with any quality of life scale Secondary outcomes 1. Psoriasis Area and Severity Index (PASI) score or 2. The proportion of participants attaining PASI 50, 75, and 90, defined as a 50%, 75%, or 90% reduction in PASI score relative to the baseline PASI score immediately prior to treatment initiation or 3. If 1 or 2 not available, the primary Psoriasis Severity Scale used will be recorded Data extraction, (selection and coding) Selection of studies: Two authors (FA and AC) will independently compare the titles and abstracts of the studies retrieved by the searches with the inclusion criteria. They will examine the full texts of studies that potentially meet the criteria, as well as the studies whose abstracts do not provide sufficient information. A third author (AA) will resolve any disagreements in terms of final study selection. We will record the reasons for exclusion of studies. Data extraction and management: Two authors (FA and AC) will independently extract data using a data extraction form based on the 'Checklist of items to consider in data collection or data extraction' found in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). A third author (AA) will resolve any disagreements. Two authors (FA and AC) will pilot the data collection form prior to use. Risk of bias (quality) assessment Two authors (FA and AC) will independently assess the methodological quality of included studies using the The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2011). The risk of bias will be graded as 'low', 'high', or 'unclear' Page: 2 / 5
for each of the following domains: (a) random sequence generation; (b) allocation concealment; (c) blinding of participants, personnel, and outcome assessment; (d) incomplete outcome data; (e) selective outcome reporting (we will check trial databases to ensure that reported outcomes match to those prospectively listed); and (f) other sources of bias. Strategy for data synthesis Data will be analysed using SPSS version 22 and Microsoft Excel 2011. The data will be mostly qualitative and descriptive, with basic quantitative analyses. A brief summary of the interventions along with quality of life outcomes will be aggregated. Analysis of subgroups or subsets Interventions will be grouped and analysed according to quality of life outcomes. Dissemination plans Abstracts at conferences and article publication Contact details for further information Dr Faraz Ali Department of Dermatology and Wound Healing 3rd Floor, Glamorgan House University Hospital of Wales Cardiff CF14 4XN alifm@cardiff.ac.uk Organisational affiliation of the review Cardiff University Review team Dr Faraz Ali, Department of Dermatology, School of Medicine, Cardiff University, 3rd Floor Glamorgan House, Heath Park, Cardiff, Wales, UK Dr Andrea Cueva, Ecuadorian National government through the National Institution of Higher Education, Science, Technology and Innovation (SENESCYT) Dr Ausama Atwan, Department of Dermatology, School of Medicine, Cardiff University, 3rd Floor Glamorgan Professor Sam Salek, Department of Pharmacy, University of Hertfordshire, Hatfield and Institute for Medicines Development, Cardiff, UK Professor Andrew Finlay, Department of Dermatology, School of Medicine, Cardiff University, 3rd Floor Glamorgan Page: 3 / 5
Professor Vincent Piguet, Department of Dermatology, School of Medicine, Cardiff University, 3rd Floor Glamorgan Dr Jui Vyas, Department of Dermatology, School of Medicine, Cardiff University, 3rd Floor Glamorgan House, Heath Park, Cardiff, Wales, UK Anticipated or actual start date 01 November 2014 Anticipated completion date 30 October 2015 Funding sources/sponsors Cardiff University Conflicts of interest AY Finlay is joint copyright owner of the DLQI and Cardiff University receives some income from the use of the DLQI. AYF has had paid consultancies or advisory boards with Novartis, Napp Pharmaceuticals, Pfizer, Sanofi, and Galderma. VP has received educational and/or research grants from Abbvie, Cellgene, Novartis, J&J. SS has received educational and/or research grants from Sanofi, Novartis, BMS, Pfizer & Sevier. F Ali, A Cueva and J Vyas declare no conflicts of interest. Language English Country Wales Subject index terms status Subject indexing assigned by CRD Subject index terms Health; Humans; Life; Psoriasis; Quality of Life Stage of review Completed but not published Date of registration in PROSPERO 13 May 2015 Date of publication of this revision 20 October 2015 DOI 10.15124/CRD42015009193 Stage of review at time of this submission Started Completed Preliminary searches Yes Yes Piloting of the study selection process Yes Yes Formal screening of search results against eligibility criteria Yes Yes Data extraction Yes No Page: 4 / 5
Powered by TCPDF (www.tcpdf.org) Risk of bias (quality) assessment No No Data analysis No No PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Page: 5 / 5