PMID- 27793184
OWN - NLM
STAT- MEDLINE
DCOM- 20180108
LR  - 20220317
IS  - 2046-4053 (Electronic)
IS  - 2046-4053 (Linking)
VI  - 5
IP  - 1
DP  - 2016 Oct 28
TI  - Identifying placebo responders and predictors of response in osteoarthritis: a 
      protocol for individual patient data meta-analysis.
PG  - 183
LID - 183
AB  - BACKGROUND: The management of osteoarthritis (OA) is unsatisfactory, as most 
      treatments are not clinically effective over placebo and most drugs have 
      considerable side effects. On average, 75 % of the analgesic effect from OA 
      treatments in clinical trials can be attributed to a placebo response, and this 
      response varies greatly from patient to patient. This individual patient data 
      (IPD) meta-analysis aims to identify placebo responders and the potential 
      determinants of the placebo response in OA. METHODS: This study is undertaken in 
      conjunction with the OA Trial Bank, an ongoing international consortium aiming to 
      collect IPD from randomised controlled trials (RCTs) for all treatments of OA. 
      RCTs for each treatment of OA have been systematically searched for, and authors 
      of the relevant trials have been contacted to request the IPD. We will use the 
      IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The 
      IPD in placebo groups will be used to investigate the placebo response according 
      to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain 
      reduction). Responders to placebo will be compared with non-responders to 
      identify predictors of response. The quality of the trials will be assessed and 
      potential determinants will be examined using multilevel logistic regression 
      analyses. DISCUSSION: This study explores the varying magnitude of the placebo 
      response and the proportion of participants that experience a clinically 
      important placebo effect in OA RCTs. Potential determinants of the placebo 
      response will also be investigated. These determinants may be useful for future 
      studies as it may allow participants to be stratified into groups based on their 
      likely response to placebo. The results of this study may also be useful for 
      pharmaceutical companies, who could improve the design of their studies in order 
      to separate the specific treatment from the non-specific contextual (i.e. 
      placebo) effects. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016033212.
FAU - Fu, Yu
AU  - Fu Y
AD  - School of Healthcare, University of Leeds, Leeds, UK.
FAU - Persson, Monica S M
AU  - Persson MS
AD  - Academic Rheumatology, University of Nottingham, Clinical Sciences Building, City 
      Hospital, Nottingham, NG5 1PB, UK.
AD  - Arthritis Research UK Pain Centre, Nottingham, UK.
FAU - Bhattacharya, Archan
AU  - Bhattacharya A
AD  - Arthritis Research UK Centre for Sports, Exercise and Osteoarthritis, Nottingham, 
      UK.
AD  - Academic Orthopaedics, Trauma and Sports Medicine, Queens Medical Centre, 
      University of Nottingham, Nottingham, UK.
FAU - Goh, Siew-Li
AU  - Goh SL
AD  - Academic Rheumatology, University of Nottingham, Clinical Sciences Building, City 
      Hospital, Nottingham, NG5 1PB, UK.
AD  - Arthritis Research UK Centre for Sports, Exercise and Osteoarthritis, Nottingham, 
      UK.
AD  - Sports Medicine Unit, University of Malaya, Kuala Lumpur, Malaysia.
FAU - Stocks, Joanne
AU  - Stocks J
AD  - Academic Rheumatology, University of Nottingham, Clinical Sciences Building, City 
      Hospital, Nottingham, NG5 1PB, UK.
AD  - Arthritis Research UK Pain Centre, Nottingham, UK.
FAU - van Middelkoop, Marienke
AU  - van Middelkoop M
AD  - Department of General Practice, Erasmus MC Medical University, Rotterdam, The 
      Netherlands.
FAU - Bierma-Zeinstra, Sita M A
AU  - Bierma-Zeinstra SM
AD  - Department of General Practice, Erasmus MC Medical University, Rotterdam, The 
      Netherlands.
FAU - Walsh, David
AU  - Walsh D
AD  - Academic Rheumatology, University of Nottingham, Clinical Sciences Building, City 
      Hospital, Nottingham, NG5 1PB, UK.
AD  - Arthritis Research UK Pain Centre, Nottingham, UK.
FAU - Doherty, Michael
AU  - Doherty M
AD  - Academic Rheumatology, University of Nottingham, Clinical Sciences Building, City 
      Hospital, Nottingham, NG5 1PB, UK.
AD  - Arthritis Research UK Pain Centre, Nottingham, UK.
FAU - Zhang, Weiya
AU  - Zhang W
AD  - Academic Rheumatology, University of Nottingham, Clinical Sciences Building, City 
      Hospital, Nottingham, NG5 1PB, UK. weiya.zhang@nottingham.ac.uk.
AD  - Arthritis Research UK Pain Centre, Nottingham, UK. weiya.zhang@nottingham.ac.uk.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20161028
PL  - England
TA  - Syst Rev
JT  - Systematic reviews
JID - 101580575
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
SB  - IM
MH  - Anti-Inflammatory Agents, Non-Steroidal/*therapeutic use
MH  - Humans
MH  - Osteoarthritis, Knee/*drug therapy
MH  - *Placebo Effect
MH  - *Randomized Controlled Trials as Topic
MH  - Systematic Reviews as Topic
PMC - PMC5084436
OTO - NOTNLM
OT  - Individual patient data meta-analysis
OT  - Osteoarthritis
OT  - Placebo response
EDAT- 2016/10/30 06:00
MHDA- 2018/01/09 06:00
PMCR- 2016/10/28
CRDT- 2016/10/30 06:00
PHST- 2016/03/16 00:00 [received]
PHST- 2016/10/21 00:00 [accepted]
PHST- 2016/10/30 06:00 [pubmed]
PHST- 2018/01/09 06:00 [medline]
PHST- 2016/10/30 06:00 [entrez]
PHST- 2016/10/28 00:00 [pmc-release]
AID - 10.1186/s13643-016-0362-x [pii]
AID - 362 [pii]
AID - 10.1186/s13643-016-0362-x [doi]
PST - epublish
SO  - Syst Rev. 2016 Oct 28;5(1):183. doi: 10.1186/s13643-016-0362-x.