Field: Internal medicine

Location: Royal Brisbane and Women's Hospital

Type of student: Extra-curricular only (this represents volunteer research opportunities that students may do during spare time and holiday periods) 

Type of work: Systematic review

 

Brief synopsis:

Initial Approach: Search MEDLINE, Cochrane library and EMBASE. Search terms:

PUBMED:

http://work.cochrane.org/pubmed

Drug search terms below 1-7

1. Secukinumab

2. Ixekizumab

3. Adalimumab

4. Infliximab

5. Golimumab

6. Etanercept

7. Certolizumab

AND

#1 randomized controlled trial [pt]
#2 controlled clinical trial [pt]
#3 randomized [tiab]
#4 placebo [tiab]
#5 drug therapy [sh]
#6 randomly [tiab]
#7 trial [tiab]
#8 groups [tiab]
#9 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8
#10 animals [mh] NOT humans [mh]
#11 #9 NOT #10

Bibliographical references of individual publications will also be checked to identify any other relevant studies.  Inclusion criteria for studies included in analysis:

Disease state: psoriatic arthritis, psoriasis, ankylosing spondylitis or non-radiographic axial SpA

Randomised controlled trial

Double-blinded trial

Anti-TNF OR anti-IL-17 included in at least one of the treatment arms, can have active comparators like a TNF arm in an anti-IL-17 study.

Adult participants

English language trial

Adverse events of IBD flare or de novo diagnosis reported

No publication date restrictions

The number of articles excluded from the search by title, abstract and full text review will be recorded with reasons for exclusion.

Then extract data from the primary paper and place into a spreadsheet with the following headers

First Author

Year of Publication

Volume of publication

Page numbers of publication

Disease state: (ankylosing spondylitis, psoriatic arthritis or non-radiographic axial SpA)

Participant ethnicity

Mean participant age

% male participants

Excluded pts with history of IBD Y/N (Some studies excluded active IBD but not history of IBD)

Excluded active IBD Y/N (if the above if Y, then this has to be N)

Primary Outcome: eg. ASAS40

Arm 1 treatment (eg. adalimumab 40mg every other week)

Arm 2 treatment

Arm 3 treatment (if applicable)

No of participants in Arm 1: eg. 200

No of participants in Arm 2:

No of participants in Arm 3:

Length of Trial: (eg. 6 months)

Number of de novo new IBD diagnoses Arm 1: eg. 20 (20 new diagnoses)

Number of de novo new IBD diagnoses Arm 2: eg. 20 (20 new diagnoses)

Number of flares of known IBD Arm 1: eg. 20 (20 episodes)

Number of flares of known IBD Arm 2: eg. 20 (20 episodes)

Number of participants with de novo new IBD diagnoses Arm 1: eg. 10 (20 people)

Number of participants with de novo new IBD diagnoses Arm 2: eg. 10 (20 people)

Number of participants with known IBD Arm 1: eg. 20 (20 episodes)

Number of participants with known IBD Arm 2: eg. 20 (20 episodes)

 

The quality of all articles will recorded using the Jadad score by two reviewers.

 

Literature Analysis Plan:

Once all searches completed note number of total articles

Review articles by title (exclude those that clearly will not reach inclusion criteria, if in doubt then don’t exclude) Note number excluded in this process

Review the abstracts (exclude those that do not reach inclusion, note this number)

Get full papers, review full text and extract data into spreadsheet (those that do not meet criteria exclude (with reasons, and note the number)

Do Jadad score on the papers and record in another spreadsheet.

 

Analysis plan.

For each study, the incidence of the 2 adverse events will be calculated according to the number of events/patient-years exposure.

 

Real World Evidence Section

Real world evidence will be searched for and collected using the same strategy but excluding trials. Due to the large heterogeneity present in real world data it is unlikely that it will be able to be meta-analysed. It is therefore likely that this section will be a systemic review and descriptive analysis of the data. However, this will be assessed when the systemic review is completed.

 

 

Prerequisite skills: None

Time frame: 12 months

Website: N/A

Associate Professor Philip Robinson

Associate Professor Philip Robinson

Academic Title-Associate Professor
Royal Brisbane Clinical Unit Faculty of Medicine