1. Reporting of outcomes in randomized controlled trials on nail psoriasis; a Systematic Review.
C.I.M. Busard, J.Y.C. Nolte, M.C. Pasch, Ph.I. Spuls
Department of Dermatology, Academic Medical Center, Amsterdam, The Netherlands
Department of Dermatology, Radboud university medical center, Nijmegen, The Netherlands
Journal reference

2. Prof. dr. Ph.I. Spuls and drs. C.I.M. Busard
Department of Dermatology Academic Medical Centre Meibergdreef AZ Amsterdam The Netherlands T /2587 F

3. Introduction What’s already known?
Heterogeneity in outcomes restricts data comparability between nail psoriasis trials

4. Methods
Objective:
Identify all outcome instruments previously and currently used in RCTs on nail psoriasis
Categorize identified outcome instruments in corresponding outcome domains
First step towards develop a Core Outcome Set (COS) for nail psoriasis

5. Methods Inclusion: Literature search up to 23 November 2015:
RCTs on any type of intervention
nail psoriasis as main clinical feature
psoriasis of the skin or joints and nail involvement
Literature search up to 23 November 2015:
Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, EMBASE, LILACS and trial registers
Study registration: CSG-COUSIN and COMET

6. Methods Two reviewers independently extracted the data
Trial characteristics
All reported outcome instruments, except for outcomes related to safety
Outcome instruments categorized in corresponding domains and defined as composite (e.g. NAPSI) or stand-alone (e.g. subungual hyperkeratosis) instruments

7. Results 335 references 99 selected for full text examination
65 RCTs; 37 published, 28 awaiting publication or ongoing
4 Outcome domains identified:
Clinical signs
Quality of life
Symptoms
Delivery of care

8. Results Clinical signs
73.8% of studies assessed one or more types of NAPSI
Wide variations in NAPSI assessment (e.g. different scales) and reporting (e.g. NAPSI 50)
Target and modified NAPSI were most commonly used
45.7% did not adequately report the characteristics of NAPSI
The use of other composite outcome instruments was rare

9. Results

10. Results Clinical signs
Outcome instruments ‘global assessment’ and ‘nail features or characteristics’ were reported in 38.5% and 35.4% of studies respectively
As with NAPSI, wide variations in reporting of these instruments were identified (e.g. six different scales were used for global assessment)
Pitting, subungual hyperkeratosis and onycholysis most commonly assessed nail features

11. Results

12. Results ‘Quality of life’ assessed in 43.1% of studies
Only 3.1% of studies used a nail-psoriasis specific QoL instrument (e.g. NPQ10 or NAPPA-QoL)
‘Symptoms’ assessed in 7.7% of studies
Assessment of symptoms limited to pain or discomfort
‘Delivery of care’ assessed in 7.7% of studies
Items such as acceptability of treatment, treatment satisfaction and patient preference were assessed using point scales or a single question

13. Discussion What does this study add?
A limited number of outcome instruments is used, but heterogeneity within these instruments and in reporting of instruments is substantial
Patient reported outcomes are uncommonly investigated

14. Discussion What does this study add?
Characteristics of outcome instruments are often insufficient reported
As different disciplines are involved active collaboration between research groups (e.g. COUSIN, OMERACT, IDEOM) is needed in the process towards Core Outcome Set (COS) development
see

15. Drs. Celine Busard Dr. Marcel Pasch
Jessica Nolte Prof. Phyllis Spuls

16. Call for correspondence
Why not join the debate on this article through our correspondence section?
Rapid responses should not exceed 350 words, four references and one figure
Further details can be found here