PTH150: An exploration of data integrity and trustworthiness in
clinical trials included in Cochrane reviews of interventions for pain
Background & Aims
Randomized clinical trials (RCTs) are
foundational to clinical decision-making and
guideline recommendations. Fabricated,
falsified and untrustworthy information may
be increasing within medical literature given
systemic pressures to publish and
advances in technology.
Primary Aim:
To examine characteristics of RCTs
included within four systematic reviews
within the Pain, Palliative & Supportive
Care (PaPaS) Cochrane group for
indicators of data trustworthiness and
integrity issues
Methods
The 4 selected reviews evaluated pain as a
primary outcome and represented acute
and chronic pain, pharmacological and
non-pharmacological interventions.
45 individual studies were assessed.
• 7 studies were excluded due to being
published in a language other than
English or due to lack of ability to access
the study.
Studies were assessed utilizing selected
questions from the:
• Cochrane Pregnancy & Childbirth groups
Trustworthiness Screening Tool (CPC-
TST)1
• REAPPRAISED Checklist for Evaluation
of Publication Integrity2
McKenzie Ferguson, PharmD, BCPS1,3; Darius Fisher, PharmD1; Grady Graham, PharmD1; Samantha Triplett,
PharmD1; Neil O’Connell, PhD, MSc2,3; Andrew Moore, DSc3
1
Southern Illinois University Edwardsville, USA; 2Brunel University London; 3Cochrane Pain, Palliative and
Supportive Care Editorial Board Members
Results Conclusions
Titles reviewed: • Each PaPaS review included at least one
study that presented some concerns
1. Transcutaneous electrical nerve stimulation for acute pain (19 studies) pertaining to the integrity and/or
trustworthiness of the data.
2. Amitriptyline for neuropathic pain in adults (16 studies)
• Overall, threats to the validity of the
3. Nalbuphine for postoperative pain in children (7 studies) review conclusions were considered to
be low.
4. Acupuncture of neuropathic pain in adults (3 studies)
• Studies with identified risks should be
CPC-TST REAPPRAISED investigated further, including author
Review contact and clarification, as needed. This
(# risks / # of studies with risk) (# risks / # of studies with risk)
is particularly important when multiple
1 10 / 9 29 / 18
threats are noted within a single study,
2 7/3 24 / 15 and where that study is included in
analyses.
3 5/5 11 / 7
4 5/3 3/2
• Select features from the CPC-TST and
REAPPRAISED risk identifiers may be
Concerns with randomization
9/27 (33%)
Lack of author contribution
41/67 (61%) useful for authors to incorporate into
techniques statement
study protocols, to aid study selection,
Lack of prospective registration 8/27 (30%) Discrepancy in data 10/67 (15%) and for ensuring data incorporated into
systematic reviews is assessed for
Feasibility of attrition 3/27 (11%) Error in % calculation 5/67 (7%)
trustworthiness and integrity.
Retraction notices 3/27 (11%) Other reasons 11/67 (16%)
Number of randomized controlled
Identical baseline characteristics 2/27 (7%) trials published ± 1 year of study 0/0 (0%) Select References:
publication 1. Li W, Bordewijk EM, Mol BW. Assessing
Research Misconduct in Randomized
Implausible results 2/27 (7%) Controlled Trials. Obstet Gynecol. 2021 Sep
1;138(3):338-347. PMID: 34352811.
In most cases, studies with concerns identified by the CPC-TST were not included in 2. Grey A, Bolland MJ, Avenell A, Klein AA,
pooled primary analyses of the Cochrane reviews. For REAPPRAISED, overall threats Gunsalus CK. Check for publication integrity
to validity were judged to be low. before misconduct. Nature. 2020
Jan;577(7789):167-169. PMID: 31911697.
No authors have any conflicts of interest or financial relationships related to this work.