Intraoperative pharmacologic opioid minimisation strategies and patient-centred outcomes after surgery: a scoping review.

BACKGROUND: Postoperative patient-centred outcome measures are essential to capture the patient's experience after surgery. Although a large number of pharmacologic opioid minimisation strategies (i.e. opioid alternatives) are used for patients undergoing surgery, it remains unclear which strategies are most promising in terms of patient-centred outcome improvements. This scoping review had two main objectives: (1) to map and describe evidence from clinical trials assessing the patient-centred effectiveness of pharmacologic intraoperative opioid minimisation strategies in adult surgical patients, and (2) to identify promising pharmacologic opioid minimisation strategies. METHODS: We searched MEDLINE, Embase, CENTRAL, Web of Science, and CINAHL databases from inception to February 2023. We included trials investigating the use of opioid minimisation strategies in adult surgical patients and reporting at least one patient-centred outcome. Study screening and data extraction were conducted independently by at least two reviewers. RESULTS: Of 24,842 citations screened for eligibility, 2803 trials assessed the effectiveness of intraoperative opioid minimisation strategies. Of these, 457 trials (67,060 participants) met eligibility criteria, reporting at least one patient-centred outcome. In the 107 trials that included a patient-centred primary outcome, patient wellbeing was the most frequently used domain (55 trials). Based on aggregate findings, dexmedetomidine, systemic lidocaine, and COX-2 inhibitors were promising strategies, while paracetamol, ketamine, and gabapentinoids were less promising. Almost half of the trials (253 trials) did not report a protocol or registration number. CONCLUSIONS: Researchers should prioritise and include patient-centred outcomes in the assessment of opioid minimisation strategy effectiveness. We identified three potentially promising pharmacologic intraoperative opioid minimisation strategies that should be further assessed through systematic reviews and multicentre trials. Findings from our scoping review may be influenced by selective outcome reporting bias. STUDY REGISTRATION: OSF - https://osf.io/7kea3.

Effectiveness of dexmedetomidine during surgery under general anaesthesia on patient-centred outcomes: a systematic review and Bayesian meta-analysis protocol.

INTRODUCTION: Dexmedetomidine is a promising pharmaceutical strategy to minimise opioid use during surgery. Despite its growing use, it is uncertain whether dexmedetomidine can improve patient-centred outcomes such as quality of recovery and pain. METHODS AND ANALYSIS: We will conduct a systematic review and meta-analysis following the recommendations of the Cochrane Handbook for Systematic Reviews. We will search MEDLINE, Embase, CENTRAL, Web of Science and CINAHL approximately in October 2023. We will include randomised controlled trials evaluating the impact of systemic intraoperative dexmedetomidine on patient-centred outcomes. Patient-centred outcome definition will be based on the consensus definition established by the Standardised Endpoints in Perioperative Medicine initiative (StEP-COMPAC). Our primary outcome will be the quality of recovery after surgery. Our secondary outcomes will be patient well-being, function, health-related quality of life, life impact, multidimensional assessment of postoperative acute pain, chronic pain, persistent postoperative opioid use, opioid-related adverse events, hospital length of stay and adverse events. Two reviewers will independently screen and identify trials and extract data. We will evaluate the risk of bias of trials using the Cochrane Risk of Bias Tool (RoB 2.0). We will synthesise data using a random effects Bayesian model framework, estimating the probability of achieving a benefit and its clinical significance. We will assess statistical heterogeneity with the tau-squared and explore sources of heterogeneity with meta-regression. We have involved patient partners, clinicians, methodologists, and key partner organisations in the development of this protocol, and we plan to continue this collaboration throughout all phases of this systematic review. ETHICS AND DISSEMINATION: Our systematic review does not require research ethics approval. It will help inform current clinical practice guidelines and guide development of future randomised controlled trials. The results will be disseminated in open-access peer-reviewed journals, presented at conferences and shared among collaborators and networks. PROSPERO REGISTRATION NUMBER: CRD42023439896.

Intraoperative pharmacologic opioid minimisation strategies and patient-centred outcomes after surgery: a scoping review protocol.

INTRODUCTION: For close to a century opioid administration has been a standard of care to complement anaesthesia during surgery. Considering the worldwide opioid epidemic, this practice is now being challenged and there is a growing use of systemic pharmacological opioid minimising strategies. Our aim is to conduct a scoping review that will examine clinical trials that have evaluated the impact of intraoperative opioid minimisation strategies on patient-centred outcomes and identify promising strategies. METHODS AND ANALYSIS: Our scoping review will follow the framework developed by Arksey and O'Malley. We will search MEDLINE, Embase, CENTRAL, Web of Science and CINAHL from their inception approximately in March 2023. We will include randomised controlled trials, assessing the impact of systemic intraoperative pharmacologic opioid minimisation strategies on patient-centred outcomes. We define an opioid minimisation strategy as any non-opioid drug with antinociceptive properties administered during the intraoperative period. Patient-centred outcomes will be defined and classified based on the consensus definitions established by the Standardised Endpoints in Perioperative Medicine initiative (StEP-COMPAC group) and informed by knowledge users and patient partners. We will use a coproduction approach involving interested parties. Our multidisciplinary team includes knowledge users, patient partners, methodologists and knowledge user organisations. Knowledge users will provide input on methods, outcomes, clinical significance of findings, implementation and feasibility. Patient partners will participate in assessing the relevance of our design, methods and outcomes and help to facilitate evidence translation. We will provide a thorough description of available clinical trials, compare their reported patient-centred outcome measures with established recommendations and identify promising strategies. ETHICS AND DISSEMINATION: Ethics approval is not required for the review. Our scoping review will inform future research including clinical trials and systematic reviews through identification of important intraoperative interventions. Results will be disseminated through a peer-reviewed publication, presentation at conferences and through our network of knowledge user collaborators. REGISTRATION: Open Science Foundation (currently embargoed).

Bringing the patient voice into the operating room: engaging patients in surgical safety research with the Operating Room Black Box®.

BACKGROUND: Surgery is one of the most common patient experiences in the health care system. Yet, efforts to engage patients in surgical safety research have not matched those of other health care fields. This is a critical issue given the nature of surgery inhibits patients' abilities to advocate for themselves as they are typically under anesthetic when the procedure is performed. We partnered with patients throughout our research program, which uses the Operating Room Black Box® to enhance surgical patient safety through transparent and proactive analysis of human factors to detect and prevent avoidable errors. MAIN BODY: In this article, we outline the need for, and our approach to, patient engagement in surgical safety research. Our approach included a series of planned activities and skill development opportunities designed to build capacity and bring together patients, clinicians, and researchers to inform research and practice. We also conducted evaluation surveys during the first year of our program, which have indicated a positive experience by both patient partners and the research team. CONCLUSION: We believe our approach can serve as an important first step toward building a model for patient engagement in the surgical safety field and could significantly contribute to improved quality of care and outcomes for surgical patients.

Although surgery is one of the most common patient experiences, patients have not been engaged in surgical safety research. Patients were engaged as patient advisors in the use of the Operating Room Black Box^® at The Ottawa Hospital. The Operating Room Black Box^® is a tool that is used in the operating room (OR) which captures audio, video, patient vital signs and other information that are analyzed for research purposes. The aim of the OR Black Box^® is to learn from experience and improve practice and care. Patient advisors influenced the nature of the activities undertaken, co-developed the communication materials for patients, evaluated patient engagement practices, and disseminated the research results. These patient engagement activities are an important first step in engaging patients in surgical safety research.

Establishment of a consensus definition for mesenchymal stromal cells (MSC) and reporting guidelines for clinical trials of MSC therapy: a modified Delphi study protocol.

INTRODUCTION: Despite being more than two decades of research, mesenchymal stromal cell (MSC) treatments are still struggling to cross the translational gap. Two key issues that likely contribute to these failures are (1) the lack of clear definition for MSC and (2) poor quality of reporting in MSC clinical studies. To address these issues, we propose a modified Delphi study to establish a consensus definition for MSC and reporting guidelines for clinical trials of MSC therapy. METHODS AND ANALYSIS: We will conduct a three-round international modified Delphi survey. Findings from a recent scoping review examining how MSCs are defined and reported in preclinical and clinical studies were used to draft the initial survey for round 1 of our Delphi. Participants will include a 'core group' of individuals as well as researchers whose work was captured in our scoping review. The core group will include stakeholders from different research fields including developmental biology, translational science, research methods, regulatory practices, scholarly journal editing and industry. The first two survey rounds will be online, and the final round will take place in person. Each participant will be asked to rate their agreement on potential MSC definition characteristics and reporting items using a Likert scale. After each round, we will analyse the data to determine which items have reached consensus for inclusion/exclusion, and then develop a revised questionnaire for any new items, or items that did not reach consensus. ETHICS AND DISSEMINATION: This study received ethical approval from the Ottawa Health Research Network Research Ethics Board. To support the dissemination of our findings, we will use an evidence-based 'integrated knowledge translation' approach to engage knowledge users from the inception of the research. This will allow us to develop a tailored end-of-project knowledge translation plan to support and ensure dissemination and implementation of the Delphi results.

Implementation of the Operating Room Black Box Research Program at the Ottawa Hospital Through Patient, Clinical, and Organizational Engagement: Case Study.

BACKGROUND: A large proportion of surgical patient harm is preventable; yet, our ability to systematically learn from these incidents and improve clinical practice remains limited. The Operating Room Black Box was developed to address the need for comprehensive assessments of clinical performance in the operating room. It captures synchronized audio, video, patient, and environmental clinical data in real time, which are subsequently analyzed by a combination of expert raters and software-based algorithms. Despite its significant potential to facilitate research and practice improvement, there are many potential implementation challenges at the institutional, clinician, and patient level. This paper summarizes our approach to implementation of the Operating Room Black Box at a large academic Canadian center. OBJECTIVE: We aimed to contribute to the development of evidence-based best practices for implementing innovative technology in the operating room for direct observation of the clinical performance by using the case of the Operating Room Black Box. Specifically, we outline the systematic approach to the Operating Room Black Box implementation undertaken at our center. METHODS: Our implementation approach included seeking support from hospital leadership; building frontline support and a team of champions among patients, nurses, anesthesiologists, and surgeons; accounting for stakeholder perceptions using theory-informed qualitative interviews; engaging patients; and documenting the implementation process, including barriers and facilitators, using the consolidated framework for implementation research. RESULTS: During the 12-month implementation period, we conducted 23 stakeholder engagement activities with over 200 participants. We recruited 10 clinician champions representing nursing, anesthesia, and surgery. We formally interviewed 15 patients and 17 perioperative clinicians and identified key themes to include in an information campaign run as part of the implementation process. Two patient partners were engaged and advised on communications as well as grant and protocol development. Many anticipated and unanticipated challenges were encountered at all levels. Implementation was ultimately successful, with the Operating Room Black Box installed in August 2018, and data collection beginning shortly thereafter. CONCLUSIONS: This paper represents the first step toward evidence-guided implementation of technologies for direct observation of performance for research and quality improvement in surgery. With technology increasingly being used in health care settings, the health care community should aim to optimize implementation processes in the best interest of health care professionals and patients.