Consumer engagement and patient reported outcomes in perioperative clinical trials in Australia: a systematic review

Abstract

Background: Consumer engagement in clinical research is increasingly being prioritized by major funders such as the Australian National Health and Medical Research Council. Methods: We performed a systematic literature search of the Cochrane library, Embase, CINAHL PubMed and Medline to identify randomized clinical trials in surgery with perioperative outcomes conducted in Australia. All publications underwent review and thematic analysis to identify levels of consumer engagement and the inclusion of patient-reported outcome measures (PROMS). Results: From 5373 records, the full texts of 809 articles were retrieved, of which 41 clinical trials met the inclusion criteria. PROMS were identified in 63% of the trials as a primary or secondary outcome. Despite multiple available checklists and analysis tools, less than 2% of studies documented any consumer engagement apart from PROMS. Conclusion: There was very little consumer engagement in formulation, management, conduct and dissemination of the trial findings.'integrated, planned, and personalised approach to patient care before, during, and after any surgical procedure involving anaesthesia '. 11 Consumer engagement should assist these aims.For medical research, there are (often mandatory) growing requirements to incorporate the consumer encompassing the patient, patient's family or carer into all steps of the process, from identification of the research question, trial management, document writing, dissemination and translation of the results. 3,12,13 Although the adoption of consumer engagement is relevant and justifiable, experience to date suggests increasing expense and mostly 'tokenistic' approaches. 14 It is unclear what best practice approaches or evaluation methods are available or should be used. [15][16][17] Medical research includes both quantitative and qualitative approaches, mainly focusing on endpoints and/or outcomes that are perceived to benefit the patient (consumer). 17,18 In Australia, there has been no review to date identifying consumer engagement in perioperative medicine research or to classify or define the levels and types of consumer engagement. In 1996, the UK National Institute of Health Research established and funded an INVOLVE supporting the National Health Service to include and understand the consumer perspective. 19 The supporting statement of INVOLVE is 'research being carried out 'with' or 'by' members of the public rather than "to", "about" or "for" them'. 19 Patient-reported outcome measures

Patient-centered precision care in anaesthesia – the PC-square (PC)2 approach

“…Anaesthesia providers often find themselves inadequately informed about the most common side effects of anaesthesia and perioperative care. These side effects include perioperative neurocognitive dysfunctions (PND) including postoperative delirium (POD), hypothermia, dehydration, and various patient-reported outcomes (PROs) such as nausea, vomiting, severe pain, stress, and anxiety [1].…”

“…Anaesthesia providers often find themselves inadequately informed about the most common side effects of anaesthesia and perioperative care. These side effects include perioperative neurocognitive dysfunctions (PND) including postoperative delirium (POD), hypothermia, dehydration, and various patient-reported outcomes (PROs) such as nausea, vomiting, severe pain, stress, and anxiety [ 1 ]. Medium and long-term outcomes of anaesthesia, such as health-related quality of life, development of chronic pain, psychological/emotional and mental well being or fatigue, are not systematically reported (30).…”

Patient and public involvement in pragmatic trials: online survey of corresponding authors of published trials

“…13,14 Previous reviews of RCTs found low prevalence of PPI, with inconsistent reporting. [15][16][17][18][19][20][21] However, no trial-specific reporting guidelines require authors to indicate whether their trial included PPI (although the generic Guidance for Reporting Involvement of Patients and the Public [GRIPP2] 22 checklist may be used when PPI was part of an intervention), and journals rarely require PPI to be reported. 17 Relying…”

A mixed methods study protocol to identify research priorities for perioperative medicine in Australia

“… 19 , 20 Shaping of the research agenda for perioperative medicine research is through funders and research bodies, with little to no input from consumers being reported. 21 , 22 , 23 A priority setting agenda in perioperative medicine in Australia should benefit all clinicians and guide future research in the areas of greatest need. Identifying the essential unanswered questions should lead to the reduction in ‘waste’ or ‘wrong answers’ in future research.…”