• Faiuna Haseeb

Student thesis: Master of Philosophy


ABSTRACT: A SYSTEMATIC REVIEW OF REPORTED OUTCOMES IN VENTILATOR ASSOCIATED PNEUMONIA RANDOMISED CONTROLLED TRIALS INTRODUCTION AND OBJECTIVES Standardised core outcome sets facilitate the comparison of interventions across clinical trials with similar eligibility criteria. There is no core outcome set for randomised controlled trials (RCTs) of patients with ventilator-associated pneumonia (VAP). We performed a methodological systematic review of outcomes reported in randomised controlled trials of patients with VAP. METHODS PubMed and the Cochrane library were searched for randomised controlled trials including adult patients with VAP, indexed from 1st January 2009 to 31st December 2019. Trial outcomes (primary and secondary) were identified. RESULTS One hundred randomised controlled trials were identified, in which the trial interventions were antibiotics, 82/100 (82%), anti-inflammatories, 8/100 (8%), precision medicine, 6/100 (6%), bronchoscopy, 2/100 (2%), prone positioning, 1/100 (1%) and vitamins, 1/100 (1%). A total of 741 outcome measures were identified, including 117 outcome measures reported as primary outcomes. (Table 1) Microbiological outcomes were the most frequently reported in 138/741 (18.6%) outcomes, with 10 variations in definition. Treatment success, reported in 16.7% of outcomes, had 28 variations in definition and together with laboratory and physiological outcomes which were reported in 5.8% of outcomes, with 22 variations in definition, were the most heterogenous of the outcome categories. Treatment success was most often selected as the primary outcome yet was undefined in 57.8% of these outcomes. (Table 1) Adverse events were reported in only 47% of trials and 9.6% of outcomes, with 21 variations in definition. This is inadequate, given that bodies such as the CONSORT group stipulate that adverse events are reported in all randomised controlled trials, to reduce harm to patients. Only 1/741 (0.13%) outcomes assessed quality of life impact. (Table1) This was from an economic rather than a patient perspective, indicating a lack of patient involvement in outcome selection. CONCLUSION Numerous outcome measures have been reported in randomised controlled trials including patients with VAP. A range of different definitions are used for specific outcome measures. Developing a core outcome set for clinical trials including patients with VAP is urgently required.
Date of Award1 Aug 2022
Original languageEnglish
Awarding Institution
  • The University of Manchester
SupervisorAlexander Mathioudakis (Supervisor) & Timothy Felton (Supervisor)

Cite this