BACKGROUND:Improving comfort during and after surgery is a key concern for anaesthetists and other clinicians. With the inclusion of patient and public involvement, we undertook a Delphi consensus process to update previously recommended endpoints to be used in clinical trials evaluating treatments aiming to improve patient comfort after surgery. METHODS:We undertook a systematic review to identify domains and outcome measures of patient comfort used in perioperative studies. Focus groups, workshops, and a multi-round Delphi consensus process that included clinician-researchers and a patient experience and consumer group updated a recommended list of standardised endpoints focused on patient comfort. Consensus was defined as a median item score of 7 or greater and at least 70% of responses achieving a score of 7 or greater on a 9-point Likert scale. Additional ratings were done to determine validity, reliability, feasibility, and patient-centredness. Qualitative analyses were undertaken to identify themes. RESULTS:Response rates for each of the Delphi rounds were 100%. A final list of eight defined endpoints was identified: supplementary analgesic use, subjective analgesic effectiveness, pain intensity (at rest, during movement, and at 12, 24, and 72 h), postoperative nausea and vomiting (PONV, at 0-6 h, at 6-24 h, and overall), postdischarge nausea and vomiting (PDNV), severe PONV, quality of recovery (QoR-15), and time to mobilisation. All endpoints were assessed as valid, reliable, and feasible measures of patient comfort and were considered patient-centred. Patient and public involvement highlighted the importance of clear communication and shared decision-making to enhance comfort through the surgical journey. CONCLUSIONS:We recommend that at least some of these standardised endpoints be included as outcome measures in clinical trials assessing patient comfort and pain after surgery. SYSTEMATIC REVIEW PROTOCOL:Open Science Framework (10.17605/OSF.IO/DJQFE).
Dunn, Lauren K. MD, PhD; Grant, Michael C. MD; Gan, Tong J. MD, MBA, MHS Author Information
INTRODUCTION:Pre-operative group sessions incorporating patient education and behaviour change interventions, known as 'surgery schools', are becoming increasingly common before major elective surgery across the world. However, there is a lack of conclusive evidence regarding the effectiveness of surgery schools, and the development and delivery of these complex interventions lacks standardisation. METHODS:In collaboration with the Perioperative Quality Initiative, we aimed to develop evidence- and expertise-based consensus statements and recommendations regarding the definition, design, content, and outcomes of surgery schools. Thirty-two international multidisciplinary experts in surgery school and pre-operative preparation attended a series of virtual meetings based on a modified Delphi methodology. A systematic review and additional targeted literature searches were used to propose statements for the definition, design, content and outcomes of surgery schools. Statements and recommendations were discussed iteratively and refined in multiple rounds, until agreement was reached. RESULTS:Consensus was reached on a definition of surgery school, as well as three statements and 18 recommendations in relation to: scope; outcomes; intervention development; delivery; inclusivity; and educational content of surgery schools. Seventeen areas were highlighted as priorities for future research. DISCUSSION:These consensus statements and recommendations are intended to help clinicians and service managers who plan to develop and implement surgery schools. They may improve the quality of those programmes and help to standardise their content. We also hope that this work will influence government strategy and policy in relation to the design, delivery and funding of peri-operative optimisation pathways.
PURPOSE:Intravenous ibuprofen (IVIB) is safe and effective for the management of pain and fever in children and adults, but requires evaluation in older patients. This retrospective study aimed to evaluate the safety and efficacy of IVIB in older patients (age ≥60 years). METHODS:A post hoc subgroup analysis was performed with data from four prospective clinical studies in which IVIB was administered for the treatment of pain and/or fever in hospitalized patients every 6 hours for up to 5 days. Efficacy was assessed using total morphine requirement and the visual analogue scale to evaluate pain. Safety was assessed by adverse event (AE) monitoring. FINDINGS:Of 1041 patients treated, 757 patients were 18 to 59 years old and 284 were ≥60 years old. Among older patients, 61 received placebo, and 223 received IVIB. All patients were included in the safety assessment; 591 patients from two placebo-controlled trials were included in the efficacy analysis. In both age cohorts, the incidence of AEs was higher in the placebo group, and the incidence of serious AEs was similar between treatment groups. In older patients, IVIB treatment resulted in a 24.0% reduction in pain at rest (P = 0.008), a 20.0% reduction in pain with movement (P = 0.001) between 6 and 24 hours postsurgery, and a 23.2% reduction in total morphine requirement (P = 0.031) compared with placebo. IMPLICATIONS:IVIB was well-tolerated and reduced postoperative opioid consumption and pain severity in older patients. These findings suggest IVIB is a safe and effective nonopioid analgesic for perioperative pain management in older individuals.
BACKGROUND:A transient inhibition of GI motility (postoperative ileus) can occur after colorectal surgery and may lead to complications and prolonged hospitalization. OBJECTIVE:To examine the effect of TU-100, a Japanese herbal medicine, on the acceleration of GI recovery after bowel resection. DESIGN:Proof-of-concept, randomized, double-blinded, placebo-controlled phase 2 trial (NCT04742907). SETTINGS:Thirty-six US hospital sites. PATIENTS:Patients undergoing elective bowel resection. INTERVENTIONS:Placebo, TU-100 7.5 g/d, or TU-100 15 g/d given orally from postoperative day 1 for 10 days or less while hospitalized. MAIN OUTCOME MEASURES:The primary end point was time to GI recovery, a composite representing upper (first toleration of clear liquids) and lower (first bowel movement or absence of distention and presence of bowel sounds and flatus) GI motility. Multiple GI- and discharge-related outcomes were also evaluated. RESULTS:A total of 392 patients received at least 1 dose. TU-100 7.5 g/d was not associated with a statistically significant difference for GI recovery (HR 1.17 [95% CI, 0.91-1.50]). However, a higher proportion of patients in the 7.5 g/d group achieved GI recovery by postoperative day 2 versus the placebo group (78.1% vs 66.9%, p = 0.047). Median length of stay was significantly shorter in the 7.5 g/d (2 days) vs placebo (3 days [ p = 0.03]) group. Patient-reported nausea and abdominal bloating bothersomeness were lower in the early postoperative period for 7.5 g/d versus placebo group. Overall, no significant differences between 15 g/d and placebo were noted. LIMITATIONS:Limited dosing and short evaluation window (short hospital stay). CONCLUSIONS:Compared with the placebo, TU-100 7.5 g/d was associated with consistent, encouraging trends in efficacy outcomes, including more patients achieving GI recovery by postoperative day 2, with fewer bothersome GI symptoms. A statistically significant difference in hospital stay was noted for patients receiving 7.5 g/d versus placebo, despite relatively short stays, with drug administration not begun until postoperative day 1, and used in conjunction with enhanced recovery after surgery pathways. Further studies are warranted. See Video Abstract . EVALUACIN DEL TU DAIKENCHUTO, UN MEDICAMENTO TRADICIONAL JAPONS KAMPO, COMO COMPLEMENTO PARA MEJORAR LA RECUPERACIN TRAS LA CIRUGA, CON EL FIN DE ACELERAR LA RECUPERACIN GASTROINTESTINAL TRAS UNA RESECCIN INTESTINAL RESULTADOS DE UN ENSAYO DE PRUEBA DE CONCEPTO, FASE II, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO:ANTECEDENTES:Tras una cirugía colorrectal puede producirse una inhibición transitoria de la motilidad gastrointestinal (íleo posoperatorio) que puede dar lugar a complicaciones y prolongar la hospitalización.OBJETIVO:Examinar el efecto del TU-100, un medicamento a base de hierbas japonesas, en la aceleración de la recuperación gastrointestinal tras una resección intestinal.DISEÑO:Ensayo de fase II de prueba de concepto, aleatorizado, doble ciego y controlado con placebo (NCT04742907).ENTORNO:Treinta y seis centros hospitalarios de Estados Unidos.PACIENTES:Pacientes sometidos a resección intestinal electiva.INTERVENCIONES:Placebo, TU-100 7,5 g/día o TU-100 15 g/día por vía oral desde el primer día postoperatorio durante ≤10 días mientras permanecieran hospitalizados.PRINCIPALES MEDIDAS DE RESULTADO:El criterio de valoración principal fue el tiempo hasta la recuperación gastrointestinal, un compuesto que representa la motilidad gastrointestinal superior (primera tolerancia de líquidos claros) e inferior ([primera evacuación intestinal] o [ausencia de distensión y presencia de ruidos intestinales y flatulencia]). También se evaluaron múltiples resultados relacionados con el tracto gastrointestinal y el alta hospitalaria.RESULTADOS:Un total de 392 pacientes recibieron ≥1 dosis. TU-100 7,5 g/día no se asoció con una diferencia estadísticamente significativa en la recuperación gastrointestinal (razón de riesgo = 1,17 [IC del 95 %: 0,91, 1,50]). Sin embargo, una mayor proporción de pacientes del grupo de 7,5 g/día logró la recuperación gastrointestinal al segundo día después de la operación en comparación con el placebo (78,1 % frente a 66,9 %, p = 0,047). La duración media de la estancia fue significativamente más corta en el grupo de 7,5 g/día (2 días) que en el de placebo (3 días [ p = 0,03]). Las molestias por náuseas y distensión abdominal notificadas por los pacientes fueron menores en el periodo postoperatorio temprano con 7,5 g/día en comparación con el placebo. En general, no se observaron diferencias significativas entre 15 g/día y el placebo.LIMITACIONES:Dosificación limitada y ventana de evaluación corta (estancia hospitalaria corta).CONCLUSIONES:En comparación con el placebo, 7,5 g/día de TU-100 se asoció con tendencias consistentes y alentadoras en los resultados de eficacia, incluyendo un mayor número de pacientes que lograron la recuperación gastrointestinal al segundo día postoperatorio con síntomas gastrointestinales menos molestos. Se observó una diferencia estadísticamente significativa en la estancia hospitalaria para 7,5 g/día frente al placebo, a pesar de las estancias relativamente cortas, de que la administración del fármaco no se iniciara hasta el primer día postoperatorio y del uso con vías de recuperación mejorada después de la cirugía. Se justifican más estudios. ( AI-generated translations ).
From the Division of Anesthesiology, Critical Care & Pain Medicine, Department of Anesthesiology & Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas. Accepted for publication December 19, 2024. Reprints will not be available from the authors. Conflicts of Interest, Funding: Please see DISCLOSURES at the end of this article. Address correspondence to Tong J. Gan, MD, MBA, MHS, FRCA, Division of Anesthesiology, Critical Care & Pain Medicine, The University of Texas MD Anderson Cancer Center, Unit-409, 1515 Holcombe Blvd, Houston, TX 77030. Address e-mail to [email protected].
We commend the retrospective subgroup analysis by Gan et al. for addressing a vital concern in geriatric pharmacotherapy-balancing analgesic efficacy with safety in older patients. Although their findings reinforce the utility of intravenous ibuprofen for acute postoperative pain, we offer further perspectives on patient selection, comorbid risk profiles, and polypharmacy, particularly in frail or polymorbid geriatric populations. This letter expands on practical and clinical considerations in translating these findings into real-world settings.
Arterial pressure monitoring and management are mainstays of haemodynamic therapy in patients having surgery. This article presents updated consensus statements and recommendations on perioperative arterial pressure management developed during the 11th POQI PeriOperative Quality Initiative (POQI) consensus conference held in London, UK, on June 4–6, 2023, which included a diverse group of international experts. Based on a modified Delphi approach, we recommend keeping intraoperative mean arterial pressure ≥60 mm Hg in at-risk patients. We further recommend increasing mean arterial pressure targets when venous or compartment pressures are elevated and treating hypotension based on presumed underlying causes. When intraoperative hypertension is treated, we recommend doing so carefully to avoid hypotension. Clinicians should consider continuous intraoperative arterial pressure monitoring as it can help reduce the severity and duration of hypotension compared to intermittent arterial pressure monitoring. Postoperative hypotension is often unrecognised and might be more important than intraoperative hypotension because it is often prolonged and untreated. Future research should focus on identifying patient-specific and organ-specific hypotension harm thresholds and optimal treatment strategies for intraoperative hypotension including choice of vasopressors. Research is also needed to guide monitoring and management strategies for recognising, preventing, and treating postoperative hypotension.
Postoperative gastrointestinal disorder (POGD) was a common complication after surgery under anesthesia. Strategies in combination with Traditional Chinese Medicine and Western medicine showed some distinct effects but standardized clinical practice guidelines were not available. Thus, a multidisciplinary expert team from various professional bodies including the Perioperative and Anesthesia Professional Committees of the Chinese Association of Integrative Medicine (CAIM), jointly with Gansu Province Clinical Research Center of Integrative Anesthesiology/Anesthesia and Pain Medical Center of Gansu Provincial Hospital of Traditional Chinese Medicine and WHO Collaborating Center for Guideline Implementation and Knowledge Translation/Chinese Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Center/Gansu Provincial Center for Medical Guideline Industry Technology/Evidence-based Medicine Center of Lanzhou University, was established to develop evidence-based guidelines. Clinical questions (7 background and 12 clinical questions) were identified through literature reviews and expert consensus meetings. Based on systematic reviews/meta-analyses, evidence quality was analyzed and the advantages and disadvantages of interventional measures were weighed with input from patients' preferences. Finally, 20 recommendations were developed through the Delphi-based consensus meetings. These recommendations included disease definitions, etiologies, pathogenesis, syndrome differentiation, diagnosis, and perioperative prevention and treatment.
Background: Postoperative ileus (POI) is a common complication after colorectal surgery, leading to increased hospital stay and costs. This study aimed to explore patient comorbidities that contribute to the development of POI in the colorectal surgical population and compare machine learning (ML) model accuracy to existing risk instruments. Study Design: In a retrospective study, data were collected on 316 adult patients who underwent colorectal surgery from January 2020 to December 2021. The study excluded patients undergoing multi-visceral resections, re-operations, or combined primary and metastatic resections. Patients lacking follow-up within 90 days after surgery were also excluded. Eight different ML models were trained and cross-validated using 29 patient comorbidities and four comorbidity risk indices (ASA Status, NSQIP, CCI, and ECI). Results: The study found that 6.33% of patients experienced POI. Age, BMI, gender, kidney disease, anemia, arrhythmia, rheumatoid arthritis, and NSQIP score were identified as significant predictors of POI. The ML models with the greatest accuracy were AdaBoost tuned with grid search (94.2%) and XG Boost tuned with grid search (85.2%). Conclusions: This study suggests that ML models can predict the risk of POI with high accuracy and may offer a new frontier in early detection and intervention for postoperative outcome optimization. ML models can greatly improve the prediction and prevention of POI in colorectal surgery patients, which can lead to improved patient outcomes and reduced healthcare costs. Further research is required to validate and assess the replicability of these results.