Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury.

BACKGROUND: The effect of a liberal transfusion strategy as compared with a restrictive strategy on outcomes in critically ill patients with traumatic brain injury is unclear. METHODS: We randomly assigned adults with moderate or severe traumatic brain injury and anemia to receive transfusion of red cells according to a liberal strategy (transfusions initiated at a hemoglobin level of ≤10 g per deciliter) or a restrictive strategy (transfusions initiated at ≤7 g per deciliter). The primary outcome was an unfavorable outcome as assessed by the score on the Glasgow Outcome Scale-Extended at 6 months, which we categorized with the use of a sliding dichotomy that was based on the prognosis of each patient at baseline. Secondary outcomes included mortality, functional independence, quality of life, and depression at 6 months. RESULTS: A total of 742 patients underwent randomization, with 371 assigned to each group. The analysis of the primary outcome included 722 patients. The median hemoglobin level in the intensive care unit was 10.8 g per deciliter in the group assigned to the liberal strategy and 8.8 g per deciliter in the group assigned to the restrictive strategy. An unfavorable outcome occurred in 249 of 364 patients (68.4%) in the liberal-strategy group and in 263 of 358 (73.5%) in the restrictive-strategy group (adjusted absolute difference, restrictive strategy vs. liberal strategy, 5.4 percentage points; 95% confidence interval, -2.9 to 13.7). Among survivors, a liberal strategy was associated with higher scores on some but not all the scales assessing functional independence and quality of life. No association was observed between the transfusion strategy and mortality or depression. Venous thromboembolic events occurred in 8.4% of the patients in each group, and acute respiratory distress syndrome occurred in 3.3% and 0.8% of patients in the liberal-strategy and restrictive-strategy groups, respectively. CONCLUSIONS: In critically ill patients with traumatic brain injury and anemia, a liberal transfusion strategy did not reduce the risk of an unfavorable neurologic outcome at 6 months. (Funded by the Canadian Institutes of Health Research and others; HEMOTION ClinicalTrials.gov number, NCT03260478.).

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.

Patient perspectives on intraoperative blood transfusion: A qualitative interview study with perioperative patients.

BACKGROUND: While red blood cell (RBC) transfusions are frequently administered during surgery, little is known about patient perspectives regarding intraoperative transfusion. The aim of this study was to understand patient perspectives about intraoperative RBC transfusion and explore their willingness to engage in transfusion prevention strategies. STUDY DESIGN AND METHODS: This descriptive qualitative study used semi-structured patient interviews before and after surgery. Purposive sampling was used to select adult patients with varying perioperative courses, including having perioperative transfusion or postoperative anemia. Inductive and deductive thematic analyses were conducted to identify themes. RESULTS: Twenty patients (nine preoperative and 11 postoperative patients) were interviewed. The following themes were identified: Risk-benefit perception of transfusion, transfusion acceptance, trust, patient involvement in transfusion decisions, acceptance of transfusion prevention interventions, and communication. Patients perceived transfusions as low-risk compared to the surgery itself. Factors influencing transfusion acceptance included trust in the healthcare system and the perception of the treatability of transfusion-related complications. Some patients preferred to defer transfusion decision making to the perioperative team, citing trust in professional judgment and building a positive relationship with their surgeon. Others wished for their preferences to be incorporated into transfusion decisions. Some desired detailed blood consent conversations and most were willing to participate in strategies to reduce intraoperative transfusion. CONCLUSION: In our sample, patients consider intraoperative transfusions as low-risk high-reward interventions and trust the healthcare system and perioperative team to guide intraoperative transfusion decision making. However, preoperative transfusion consent discussions were recalled as being superficial and lacking nuance. Targeted strategies are required to improve blood consent discussions to better integrate patient preferences.

Interdisciplinary strategies to prevent long-term and detrimental opioid use following trauma: a stakeholder consensus study.

OBJECTIVE: Prolonged opioid use is common following traumatic injuries. Although preventive strategies have been recommended, the evidence supporting their use is low. The objectives of this study were to select interdisciplinary strategies to prevent long-term, detrimental opioid use in trauma patients for further evaluation and to identify implementation considerations. DESIGN: A consensus study using the nominal group technique. SETTING: Four trauma systems in Canada. SUBJECTS: Participants included expert clinicians and decision makers, and people with lived experience. METHODS: Participants had to discuss the relevance and implementation of 15 strategies and then rank them using a 7-point Likert scale. Implementation considerations were identified through a synthesis of discussions. RESULTS: A total of 41 expert stakeholders formed the nominal groups. Overall, eight strategies were favored: 1) using multimodal approach for pain management, 2) professional follow-up in physical health, 3) assessment of risk factors for opioid misuse, 4) physical stimulation, 5) downward adjustment of opioids based on patient recovery, 6) educational intervention for patients, 7) training offered to professionals on how to prescribe opioids, and 8) optimizing communication between professionals working in different settings. Discussions with expert stakeholders revealed the rationale for the selected strategies and identified issues to consider when implementing them. CONCLUSION: This stakeholder consensus study identified, for further scientific study, a set of interdisciplinary strategies to promote appropriate opioid use following traumatic injuries. These strategies could ultimately decrease the burden associated with long-term opioid use.

Perioperative Use of Gabapentinoids for the Management of Postoperative Acute Pain: A Systematic Review and Meta-analysis.

BACKGROUND: Widely used for acute pain management, the clinical benefit from perioperative use of gabapentinoids is uncertain. The aim of this systematic review was to assess the analgesic effect and adverse events with the perioperative use of gabapentinoids in adult patients. METHODS: Randomized controlled trials studying the use of gabapentinoids in adult patients undergoing surgery were included. The primary outcome was the intensity of postoperative acute pain. Secondary outcomes included the intensity of postoperative subacute pain, incidence of postoperative chronic pain, cumulative opioid use, persistent opioid use, lengths of stay, and adverse events. The clinical significance of the summary estimates was assessed based on established thresholds for minimally important differences. RESULTS: In total, 281 trials (N = 24,682 participants) were included in this meta-analysis. Compared with controls, gabapentinoids were associated with a lower postoperative pain intensity (100-point scale) at 6 h (mean difference, -10; 95% CI, -12 to -9), 12 h (mean difference, -9; 95% CI, -10 to -7), 24 h (mean difference, -7; 95% CI, -8 to -6), and 48 h (mean difference, -3; 95% CI, -5 to -1). This effect was not clinically significant ranging below the minimally important difference (10 points out of 100) for each time point. These results were consistent regardless of the type of drug (gabapentin or pregabalin). No effect was observed on pain intensity at 72 h, subacute and chronic pain. The use of gabapentinoids was associated with a lower risk of postoperative nausea and vomiting but with more dizziness and visual disturbance. CONCLUSIONS: No clinically significant analgesic effect for the perioperative use of gabapentinoids was observed. There was also no effect on the prevention of postoperative chronic pain and a greater risk of adverse events. These results do not support the routine use of pregabalin or gabapentin for the management of postoperative pain in adult patients.

Educational needs and preferences of adult patients with acute pain: a mixed-methods systematic review.

ABSTRACT: Many patients experience acute pain, which has been associated with numerous negative consequences. Pain education has been proposed as a strategy to improve acute pain management. However, studies report limited effects with educational interventions for acute pain in adults, which can be explained by the underuse of the person-centered approach. Thus, we aimed to systematically review and synthetize current evidence from quantitative, qualitative and mixed-methods studies describing patients' needs and preferences for acute pain education in adults. We searched original studies and gray literature in 7 databases, from January 1990 to October 2023. Methodological quality was assessed with the Mixed Methods Appraisal Tool. A total of 32 studies were included (n = 1847 patients), two-thirds of which were qualitative studies of high methodological quality. Most of the studies were conducted over the last 15 years in patients with postsurgical and posttraumatic pain, identified as White, with a low level of education. Patients expressed the greatest need for education when it came to what to expect in pain intensity and duration, as well how to take the medication and its associated adverse effects. The most frequently reported educational preferences were for in-person education while involving caregivers and to obtain information first from physicians, then by other professionals. This review has highlighted the needs and preferences to be considered in pain education interventions, which should be embedded in an approach cultivating communication and partnership with patients and their caregivers. The results still need to be confirmed with different patient populations.

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.

Educational needs and preferences of adult patients with acute or chronic pain: a mixed methods systematic review protocol.

OBJECTIVES: This review will aim to synthesize the available quantitative and qualitative evidence on the educational needs and preferences of adult patients with acute or chronic pain. INTRODUCTION: Acute and chronic pain are prevalent problems and are associated with significant individual and societal consequences. Education is a critical component of pain management. However, the impact of educational interventions on pain outcomes remains limited. The lack of patient input--what patients want to know and how they want to be informed--is one of the main issues underlying intervention design. INCLUSION CRITERIA: We will include qualitative, quantitative, and mixed methods studies describing the educational needs and preferences of adult patients with acute or chronic pain. METHODS: This review will follow the JBI guidelines for mixed methods systematic reviews. We will search MEDLINE (PubMed), Embase (Ovid), PsycINFO (Ovid), CINAHL (EBSCO), the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, and ProQuest Dissertations and Theses. The search strategy will commence from the year 1990 onward and there will be no language restrictions. The retrieved titles, abstracts, and full-text reports will be screened by pairs of independent reviewers. These pairs of reviewers will also independently extract data using the JBI tools for mixed methods systematic reviews. Methodological quality will be assessed using the mixed methods appraisal tool. A convergent integrated approach to synthesis and integration of the quantitative and qualitative data will be used. REVIEW REGISTRATION: PROSPERO CRD42022303834.

Understanding Intraoperative Transfusion Decision-Making Variability: A Qualitative Study.

There is evidence of significant intraoperative red blood cell (RBC) transfusion variability that cannot be explained by case-mix, and may reflect unwarranted transfusions. The objective was to explore the source of intraoperative RBC transfusion variability by eliciting the beliefs of anesthesiologists and surgeons that underlie transfusion decisions. Interviews based on the Theoretical Domains Framework were conducted to identify beliefs about intraoperative transfusion. Content analysis was performed to group statements into domains. Relevant domains were selected based on frequency of beliefs, perceived influence on transfusion, and the presence of conflicting beliefs within domains. Of the 28 transfusion experts recruited internationally (16 anesthesiologists, 12 surgeons), 24 (86%) were Canadian or American and 11 (39%) identified as female. Eight relevant domains were identified: (1) Knowledge (insufficient evidence to guide intraoperative transfusion), (2) Social/professional role and identity (surgeons/anesthesiologists share responsibility for transfusions), (3) Beliefs about consequences (concerns about morbidity of transfusion/anemia), (4) Environmental context/resources (transfusions influenced by type of surgery, local blood supply, cost of transfusion), (5) Social influences (institutional culture, judgment by peers, surgeon-anesthesiologist relationship, patient preference influencing transfusion decisions), (6) Behavioral regulation (need for intraoperative transfusion guidelines, usefulness of audits and educational sessions to guide transfusion), (7) Nature of the behaviors (overtransfusion remains commonplace, transfusion practice becoming more restrictive over time), and (8) Memory, attention, and decision processes (various patient and operative characteristics are incorporated into transfusion decisions). This study identified a range of factors underlying intraoperative transfusion decision-making and partly explain the variability in transfusion behavior. Targeted theory-informed behavior-change interventions derived from this work could help reduce intraoperative transfusion variability.

Intraoperative Blood Management Strategies for Patients Undergoing Noncardiac Surgery: The Ottawa Intraoperative Transfusion Consensus.

Importance: There is marked variability in red blood cell (RBC) transfusion during the intraoperative period. The development and implementation of existing clinical practice guidelines have been ineffective in reducing this variability. Objective: To develop an internationally endorsed consensus statement about intraoperative transfusion in major noncardiac surgery. Evidence Review: A Delphi consensus survey technique with an anonymous 3-round iterative rating and feedback process was used. An expert panel of surgeons, anesthesiologists, and transfusion medicine specialists was recruited internationally. Statements were informed by extensive preparatory work, including a systematic reviews of intraoperative RBC guidelines and clinical trials, an interview study with patients to explore their perspectives about intraoperative transfusion, and interviews with physicians to understand the various behaviors that influence intraoperative transfusion decision-making. Thirty-eight statements were developed addressing (1) decision-making (interprofessional communication, clinical factors, procedural considerations, and audits), (2) restrictive transfusion strategies, (3) patient-centred considerations, and (4) research considerations (equipoise, outcomes, and protocol suspension). Panelists were asked to score statements on a 7-point Likert scale. Consensus was established with at least 75% agreement. Findings: The 34-member expert panel (14 of 33 women [42%]) included 16 anesthesiologists, 11 surgeons, and 7 transfusion specialists; panelists had a median of 16 years' experience (range, 2-50 years), mainly in Canada (52% [17 of 33]), the US (27% [9 of 33]), and Europe (15% [5 of 33]). The panel recommended routine preoperative and intraoperative discussion between surgeons and anesthesiologists about intraoperative RBC transfusion as well as postoperative review of intraoperative transfusion events. Point-of-care hemoglobin testing devices were recommended for transfusion guidance, alongside an algorithmic transfusion protocol with a restrictive hemoglobin trigger; however, more research is needed to evaluate the use of restrictive triggers in the operating room. Expert consensus recommended a detailed preoperative consent discussion with patients of the risks and benefits of both anemia and RBC transfusion and routine disclosure of intraoperative transfusion. Postoperative morbidity and mortality were recommended as the most relevant outcomes associated with intraoperative RBC transfusion, and transfusion triggers of 70 and 90 g/L were considered acceptable hemoglobin triggers to evaluate restrictive and liberal transfusion strategies, respectively, in clinical trials. Conclusions and Relevance: This consensus statement offers internationally endorsed expert guidance across several key domains on intraoperative RBC transfusion practice for noncardiac surgical procedures for which patients are at medium or high risk of bleeding. Future work should emphasize knowledge translation strategies to integrate these recommendations into routine clinical practice and transfusion research activities.

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).

Perioperative use of gabapentinoids for the management of postoperative acute pain: protocol of a systematic review and meta-analysis.

BACKGROUND: Opioids are commonly used for the management of postoperative pain, but their use is limited by important adverse events, such as respiratory depression and the potential for addiction. Multimodal opioid-sparing analgesia regimens can be effectively employed to manage postoperative pain and reduce exposure to opioids. Gabapentinoids (pregabalin and gabapentin) represent an attractive class of drugs for use in multimodal regimens. The American Pain Society recommends the use of gabapentinoids during the perioperative period; however, evidence to inform such a recommendation is unclear. METHODS: We will conduct a systematic review and meta-analysis of randomized clinical trials evaluating the use of systemic gabapentinoids, in comparison to other analgesic regimens or placebo in adult patients undergoing surgery. We will search MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), the Web of Science, and ClinicalTrials.gov databases for relevant citations. Our primary outcome will be intensity of postoperative acute pain (12 h). Our secondary outcomes will be postoperative pain intensity at 6, 24, 48 h, and 72 h, cumulative dose of opioids administered within 24, 48, and 72 h following surgery, the length of stay, chronic pain, and adverse events. Two investigators will independently select trials and extract data. We will evaluate the risk of bias of included trials using the Cochrane risk of bias tools. We will represent pooled continuous data as weighted mean differences and pooled dichotomous data as risk ratios with a 95% confidence interval. We will use random effect models and assess statistical heterogeneity with the I2 index. DISCUSSION: Our study will provide the best level of evidence to inform the effect of gabapentinoids in the management of postoperative acute pain. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017067029.