Pub Date : 2025-02-04DOI: 10.1016/j.bjao.2024.100374
Karen D. Coulman , Lucy Elliott , Natalie S. Blencowe , Joyce Yeung , Leila Rooshenas , Robert J. Hinchliffe , Ronelle Mouton
Background
Interventions from RCTs can only be replicated and implemented if reported in sufficient detail. This study developed frameworks to assist researchers with describing, monitoring, and reporting the key components of anaesthetic interventions in trials.
Methods
This study comprised three phases: (1) initial framework development—text describing the delivery of anaesthetic interventions was coded and categorised into components using thematic analysis; (2) refinement of frameworks—facilitated structured group discussions were conducted with perioperative clinicians, researchers, and journal editors to elicit additional framework categories and consider clarity and feasibility; (3) framework testing and further refinement—cognitive interviews with professionals undertaking trials evaluating anaesthesia interventions to test the feasibility of using the frameworks in contemporary perioperative trials.
Results
Three frameworks were developed for general, regional, and sedation anaesthesia interventions. Data saturation of categories within the frameworks was reached after inclusion of 15 RCTs for general and regional anaesthesia, and 13 for sedation. Each framework is structured into three main sections: (1) professional(s) delivering the intervention; (2) setting; and (3) intervention components, with descriptions of the preoperative, intraoperative, and postoperative stages unique to each anaesthetic intervention. Each framework deconstructs an anaesthetic intervention into component parts to support researchers with the design and reporting of RCTs. Final frameworks are available at: https://anaesthesiaframeworks.blogs.bristol.ac.uk/.
Conclusions
We provide novel frameworks to be used during the design of perioperative trials to facilitate the design, delivery, and reporting of anaesthesia interventions.
{"title":"Frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trials","authors":"Karen D. Coulman , Lucy Elliott , Natalie S. Blencowe , Joyce Yeung , Leila Rooshenas , Robert J. Hinchliffe , Ronelle Mouton","doi":"10.1016/j.bjao.2024.100374","DOIUrl":"10.1016/j.bjao.2024.100374","url":null,"abstract":"<div><h3>Background</h3><div>Interventions from RCTs can only be replicated and implemented if reported in sufficient detail. This study developed frameworks to assist researchers with describing, monitoring, and reporting the key components of anaesthetic interventions in trials.</div></div><div><h3>Methods</h3><div>This study comprised three phases: (1) initial framework development—text describing the delivery of anaesthetic interventions was coded and categorised into components using thematic analysis; (2) refinement of frameworks—facilitated structured group discussions were conducted with perioperative clinicians, researchers, and journal editors to elicit additional framework categories and consider clarity and feasibility; (3) framework testing and further refinement—cognitive interviews with professionals undertaking trials evaluating anaesthesia interventions to test the feasibility of using the frameworks in contemporary perioperative trials.</div></div><div><h3>Results</h3><div>Three frameworks were developed for general, regional, and sedation anaesthesia interventions. Data saturation of categories within the frameworks was reached after inclusion of 15 RCTs for general and regional anaesthesia, and 13 for sedation. Each framework is structured into three main sections: (1) professional(s) delivering the intervention; (2) setting; and (3) intervention components, with descriptions of the preoperative, intraoperative, and postoperative stages unique to each anaesthetic intervention. Each framework deconstructs an anaesthetic intervention into component parts to support researchers with the design and reporting of RCTs. Final frameworks are available at: <span><span>https://anaesthesiaframeworks.blogs.bristol.ac.uk/</span><svg><path></path></svg></span>.</div></div><div><h3>Conclusions</h3><div>We provide novel frameworks to be used during the design of perioperative trials to facilitate the design, delivery, and reporting of anaesthesia interventions.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100374"},"PeriodicalIF":0.0,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143151350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-04DOI: 10.1016/j.bjao.2025.100377
Anton Utas , Stefanie Seifert , Knut Taxbro
Background
Breast cancer is the most prevalent malignancy affecting women. However, the optimal strategy for patients requiring long-term central venous catheters in breast cancer treatment remains uncertain. Previous investigations involving a mixed cancer population have shown a higher frequency of adverse events among patients receiving peripherally implanted central catheters (PICCs) compared with totally implanted central catheters (PORTs). Our study aimed to compare catheter-related adverse events in breast cancer patients.
Methods
We conducted a post hoc analysis of a previously published multicentre RCT known as PICCPORT. Data pertaining to baseline characteristics, insertion specifics, complication rates, and patient satisfaction were collected for breast cancer patients who required long-term central venous catheters for cancer treatment. The primary endpoint was a composite variable encompassing thrombotic, occlusive, infectious, or mechanical complications, while patient satisfaction served as a secondary endpoint.
Results
Our analysis included 80 patients receiving PORT and 78 patients receiving PICC. There was no statistically significant difference in the incidence of complications between the PICC and PORT groups. Interestingly, PICC insertion was less painful than PORT insertion, although both groups reported low levels of pain.
Conclusions
While acknowledging the limitations of an underpowered post hoc subgroup analysis, our findings suggest that the well-established superiority of PORTs in terms of adverse events among cancer patients might not be as substantial for breast cancer patients in particular. Ultimately, the optimal strategy for selecting long-term access devices in breast cancer patients remains to be determined.
Clinical trial registration
NCT01971021.
{"title":"Peripherally inserted central catheters versus implanted port catheters in patients with breast cancer: a post hoc analysis of the PICCPORT randomised controlled trial","authors":"Anton Utas , Stefanie Seifert , Knut Taxbro","doi":"10.1016/j.bjao.2025.100377","DOIUrl":"10.1016/j.bjao.2025.100377","url":null,"abstract":"<div><h3>Background</h3><div>Breast cancer is the most prevalent malignancy affecting women. However, the optimal strategy for patients requiring long-term central venous catheters in breast cancer treatment remains uncertain. Previous investigations involving a mixed cancer population have shown a higher frequency of adverse events among patients receiving peripherally implanted central catheters (PICCs) compared with totally implanted central catheters (PORTs). Our study aimed to compare catheter-related adverse events in breast cancer patients.</div></div><div><h3>Methods</h3><div>We conducted a <em>post hoc</em> analysis of a previously published multicentre RCT known as PICCPORT. Data pertaining to baseline characteristics, insertion specifics, complication rates, and patient satisfaction were collected for breast cancer patients who required long-term central venous catheters for cancer treatment. The primary endpoint was a composite variable encompassing thrombotic, occlusive, infectious, or mechanical complications, while patient satisfaction served as a secondary endpoint.</div></div><div><h3>Results</h3><div>Our analysis included 80 patients receiving PORT and 78 patients receiving PICC. There was no statistically significant difference in the incidence of complications between the PICC and PORT groups. Interestingly, PICC insertion was less painful than PORT insertion, although both groups reported low levels of pain.</div></div><div><h3>Conclusions</h3><div>While acknowledging the limitations of an underpowered <em>post hoc</em> subgroup analysis, our findings suggest that the well-established superiority of PORTs in terms of adverse events among cancer patients might not be as substantial for breast cancer patients in particular. Ultimately, the optimal strategy for selecting long-term access devices in breast cancer patients remains to be determined.</div></div><div><h3>Clinical trial registration</h3><div>NCT01971021.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100377"},"PeriodicalIF":0.0,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143151351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-04DOI: 10.1016/j.bjao.2024.100375
Marie C. Hyslop , Diana E. Papaioannou , Robert Bolt , Matthew J. Wilson , Michael Bradburn , Janet Clarkson , Esther Herbert , Nicholas Ireland , Jennifer Kettle , Amanda Loban , Amy C. Norrington , Christopher Vernazza , Christopher Deery
Background
Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin vs midazolam in the premedication of anxious children, before surgery. The trial ran between 2019 and 2022, closing early because of recruitment futility. This paper describes the challenges that arose during the trial and offers recommendations for the design of future perioperative trials.
Methods
A case-based approach was used to identify barriers to recruitment. As part of a qualitative sub-study, semi-structured interviews with local site teams, participants, and caregivers also explored barriers and enablers to recruitment.
Results
Issues encountered included time sensitivity within pressured environments; feasibility of paediatric assent; research pharmacy availability; variation in anaesthetist equipoise; multifactorial decision-making issues in premedication selection; and the Associate Principal Investigator scheme being unable to support trials within anaesthetic trainee rotations. Future paediatric perioperative medicine trials could consider funding for research pharmacy outside of working hours; conducting risk assessments for study drugs to be held on theatre admission units; and a tailored design of site feasibility assessments to help address variation in practice. Challenges remain for the feasibility of including anaesthetic trainees within the Associate Principal Investigator scheme structure.
Conclusions
There are significant challenges to recruitment for paediatric clinical trials in anaesthesia and perioperative medicine. The MAGIC trial highlighted variations within anaesthetic practice at individual, local, and regional levels. Lessons learned from the MAGIC trial identifies specific barriers to paediatric trial enrolment, offer solutions and discusses ongoing challenges.
Clinical trial registration
ISRCTN registry: ISRCTN18296119.
{"title":"Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial)","authors":"Marie C. Hyslop , Diana E. Papaioannou , Robert Bolt , Matthew J. Wilson , Michael Bradburn , Janet Clarkson , Esther Herbert , Nicholas Ireland , Jennifer Kettle , Amanda Loban , Amy C. Norrington , Christopher Vernazza , Christopher Deery","doi":"10.1016/j.bjao.2024.100375","DOIUrl":"10.1016/j.bjao.2024.100375","url":null,"abstract":"<div><h3>Background</h3><div>Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin <em>vs</em> midazolam in the premedication of anxious children, before surgery. The trial ran between 2019 and 2022, closing early because of recruitment futility. This paper describes the challenges that arose during the trial and offers recommendations for the design of future perioperative trials.</div></div><div><h3>Methods</h3><div>A case-based approach was used to identify barriers to recruitment. As part of a qualitative sub-study, semi-structured interviews with local site teams, participants, and caregivers also explored barriers and enablers to recruitment.</div></div><div><h3>Results</h3><div>Issues encountered included time sensitivity within pressured environments; feasibility of paediatric assent; research pharmacy availability; variation in anaesthetist equipoise; multifactorial decision-making issues in premedication selection; and the Associate Principal Investigator scheme being unable to support trials within anaesthetic trainee rotations. Future paediatric perioperative medicine trials could consider funding for research pharmacy outside of working hours; conducting risk assessments for study drugs to be held on theatre admission units; and a tailored design of site feasibility assessments to help address variation in practice. Challenges remain for the feasibility of including anaesthetic trainees within the Associate Principal Investigator scheme structure.</div></div><div><h3>Conclusions</h3><div>There are significant challenges to recruitment for paediatric clinical trials in anaesthesia and perioperative medicine. The MAGIC trial highlighted variations within anaesthetic practice at individual, local, and regional levels. Lessons learned from the MAGIC trial identifies specific barriers to paediatric trial enrolment, offer solutions and discusses ongoing challenges.</div></div><div><h3>Clinical trial registration</h3><div>ISRCTN registry: ISRCTN18296119.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100375"},"PeriodicalIF":0.0,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143151353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-03DOI: 10.1016/j.bjao.2024.100376
Chien-Cheng Liu , Kuo-Chuan Hung , Yu-Yu Li , Eagle Yi-Kung Huang , Chin-Chen Chu , Lok-Hi Chow , Ping-Heng Tan
<div><h3>Background</h3><div>Previous research has shown that type 1 interferons (IFN), such as IFN-α and IFN-ß, possess antiviral and antinociception effects. Elevated levels of microRNA-29a (miR-29a) have been observed during inflammatory pain, and as miR-29a targets the type 1 IFN receptor (IFNR1), our study aimed to investigate the involvement of miR-29a, type 1 IFN, and IFNR1 in inflammatory pain.</div></div><div><h3>Methods</h3><div>Inflammatory pain was induced in male rats using complete Freund's adjuvant (CFA). The changes in miR-29a, IFN-ß, and IFNR1 were measured on Days 2, 3, 5, 7, and 10 post-CFA injection and expression of IFNR1, phospho-ERK (phosphorylated extracellular signal-regulated kinase) (p-ERK), extracellular signal-regulated kinase (ERK), and IFN-stimulated gene 15 (ISG15) were measured in rats that received an miR-29a inhibitor or miR-29a mimic.</div></div><div><h3>Results</h3><div>Our results demonstrated elevated miR-29a expression (CFA 3 days: mean difference [95% confidence interval, CI]: 0.860 [0.657–1.062]; CFA 5 days: mean difference [95% CI]: 1.120 [0.917–1.322], <em>P</em><0.001, <em>n</em>=6) and decreased IFNR1 expression (CFA 3 days: mean difference [95% CI]: −0.300 [−0.470 to −0.130]; CFA 5 days: mean difference [95% CI]: −0.330 [−0.515 to −0.145], <em>P</em>=0.004, <em>n</em>=6) from Days 3–5 post-CFA induction, with IFN-ß expression showing a significant increase from Day 2 (F [3.30, 16.5]=34.3 for factor time, <em>P</em>≤0.01, <em>n</em>=6). Treatment with an miR-29a inhibitor alleviated CFA-induced mechanical allodynia and thermal hyperalgesia by Day 5 (<em>P</em><0.001, <em>n</em>=9), concomitant with upregulation of IFNR1 and ISG15 expression, and downregulation of p-ERK (IFNR1; CFA 5 days + miR-29a inhibitor <em>vs</em> CFA 5 days; mean difference [95% CI]: 30.00 [20.31–39.69]; ISG15 conjugates; CFA 5 days + miR-29a inhibitor <em>vs</em> CFA 5 days, mean difference [95% CI]: 1.000 [0.9144–1.086]; free ISG15, mean difference [95% CI]: 2.402 [2.171–2.633]; p-ERK; CFA 5 days + miR-29a inhibitor <em>vs</em> CFA 5 days, mean difference [95% CI]: −32.00 [−34.10 to −29.90], <em>P</em><0.001, <em>n</em>=9). Furthermore, in naïve rats, administration of an miR-29a mimic-induced mechanical allodynia, which was reversed by an ERK antagonist (<em>P</em><0.001, <em>n</em>=6), associated with decreased IFNR1 and increased p-ERK expression (IFNR1; miR-29a mimic + dimethyl sulfoxide <em>vs</em> naïve; mean difference [95% CI]: −57.00 [−65.78 to −48.22]; miR-29a mimic + ASN007 <em>vs</em> naïve; mean difference [95% CI]: −60.00 [−71.00 to −49.00]. p-ERK; miR-29a mimic + dimethyl sulfoxide <em>vs</em> naïve, mean difference [95% CI]: 52.00 [47.01–56.99]; miR-29a mimic + ASN007 <em>vs</em> naïve, mean difference [95% CI]: 47.00 [42.51–51.49]; <em>P</em><0.001, <em>n</em>=6).</div></div><div><h3>Conclusions</h3><div>Inhibiting miR-29a expression attenuates inflammatory pain by modulating IFNR1, ISG15, and p
{"title":"The concerted actions of microRNA-29a and interferon-β modulate complete Freund's adjuvant-induced inflammatory pain by regulating the expression of type 1 interferon receptor, interferon-stimulated gene 15, and p-extracellular signal-regulated kinase","authors":"Chien-Cheng Liu , Kuo-Chuan Hung , Yu-Yu Li , Eagle Yi-Kung Huang , Chin-Chen Chu , Lok-Hi Chow , Ping-Heng Tan","doi":"10.1016/j.bjao.2024.100376","DOIUrl":"10.1016/j.bjao.2024.100376","url":null,"abstract":"<div><h3>Background</h3><div>Previous research has shown that type 1 interferons (IFN), such as IFN-α and IFN-ß, possess antiviral and antinociception effects. Elevated levels of microRNA-29a (miR-29a) have been observed during inflammatory pain, and as miR-29a targets the type 1 IFN receptor (IFNR1), our study aimed to investigate the involvement of miR-29a, type 1 IFN, and IFNR1 in inflammatory pain.</div></div><div><h3>Methods</h3><div>Inflammatory pain was induced in male rats using complete Freund's adjuvant (CFA). The changes in miR-29a, IFN-ß, and IFNR1 were measured on Days 2, 3, 5, 7, and 10 post-CFA injection and expression of IFNR1, phospho-ERK (phosphorylated extracellular signal-regulated kinase) (p-ERK), extracellular signal-regulated kinase (ERK), and IFN-stimulated gene 15 (ISG15) were measured in rats that received an miR-29a inhibitor or miR-29a mimic.</div></div><div><h3>Results</h3><div>Our results demonstrated elevated miR-29a expression (CFA 3 days: mean difference [95% confidence interval, CI]: 0.860 [0.657–1.062]; CFA 5 days: mean difference [95% CI]: 1.120 [0.917–1.322], <em>P</em><0.001, <em>n</em>=6) and decreased IFNR1 expression (CFA 3 days: mean difference [95% CI]: −0.300 [−0.470 to −0.130]; CFA 5 days: mean difference [95% CI]: −0.330 [−0.515 to −0.145], <em>P</em>=0.004, <em>n</em>=6) from Days 3–5 post-CFA induction, with IFN-ß expression showing a significant increase from Day 2 (F [3.30, 16.5]=34.3 for factor time, <em>P</em>≤0.01, <em>n</em>=6). Treatment with an miR-29a inhibitor alleviated CFA-induced mechanical allodynia and thermal hyperalgesia by Day 5 (<em>P</em><0.001, <em>n</em>=9), concomitant with upregulation of IFNR1 and ISG15 expression, and downregulation of p-ERK (IFNR1; CFA 5 days + miR-29a inhibitor <em>vs</em> CFA 5 days; mean difference [95% CI]: 30.00 [20.31–39.69]; ISG15 conjugates; CFA 5 days + miR-29a inhibitor <em>vs</em> CFA 5 days, mean difference [95% CI]: 1.000 [0.9144–1.086]; free ISG15, mean difference [95% CI]: 2.402 [2.171–2.633]; p-ERK; CFA 5 days + miR-29a inhibitor <em>vs</em> CFA 5 days, mean difference [95% CI]: −32.00 [−34.10 to −29.90], <em>P</em><0.001, <em>n</em>=9). Furthermore, in naïve rats, administration of an miR-29a mimic-induced mechanical allodynia, which was reversed by an ERK antagonist (<em>P</em><0.001, <em>n</em>=6), associated with decreased IFNR1 and increased p-ERK expression (IFNR1; miR-29a mimic + dimethyl sulfoxide <em>vs</em> naïve; mean difference [95% CI]: −57.00 [−65.78 to −48.22]; miR-29a mimic + ASN007 <em>vs</em> naïve; mean difference [95% CI]: −60.00 [−71.00 to −49.00]. p-ERK; miR-29a mimic + dimethyl sulfoxide <em>vs</em> naïve, mean difference [95% CI]: 52.00 [47.01–56.99]; miR-29a mimic + ASN007 <em>vs</em> naïve, mean difference [95% CI]: 47.00 [42.51–51.49]; <em>P</em><0.001, <em>n</em>=6).</div></div><div><h3>Conclusions</h3><div>Inhibiting miR-29a expression attenuates inflammatory pain by modulating IFNR1, ISG15, and p","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100376"},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143151352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-30DOI: 10.1016/j.bjao.2024.100372
Akshay Shah , Hayley G. Evans , Antony J.R. Palmer , Alan M. MacDonald , Martha Belete , Linda von Neree , Michael M.F. Murphy , Simon J. Stanworth , Robbie Foy , for the NIHR Blood and Transplant Research Unit in Data Driven Transfusion Practice
Background
Perioperative red blood cell (RBC) transfusion is a common intervention in patients undergoing surgery but there is marked variation in practice. Key performance indicators (KPIs) are central to identifying deviation from agreed standards and improving clinical outcomes. We aimed to identify KPIs which can potentially be measured from routinely collected electronic healthcare records.
Methods
We undertook a three-stage process. First, we completed a scoping review to identify potential KPIs from relevant literature and clinical guidelines. Next, we conducted a modified RAND consensus process with a multidisciplinary panel including medical professionals, patients and public involvement members. The consensus panel rated these KPIs according to importance and feasibility.
Results
We identified 28 candidate KPIs covering the entire perioperative RBC transfusion process. The majority of the KPIs focused on improving patient care around the time of decision to transfuse RBCs and transfusion safety. Clinical outcome KPIs included hospital length of stay, hospital acquired infection, mortality, and hospital readmission at 30 and 90 days. Five candidate KPIs were judged as unimportant whilst there were concerns around the feasibility of measurement using routine data for 14 candidate KPIs. The panel identified nine potential KPIs for future testing.
Conclusions
Using a systematic, stepwise, transparent approach, we have identified a set of 28 KPIs for assessment, monitoring, and improvement of perioperative RBC transfusion. Future research is needed to further validate this set for external use and benchmarking between hospitals and departments.
{"title":"Development of a key performance indicator set for perioperative red blood cell transfusion","authors":"Akshay Shah , Hayley G. Evans , Antony J.R. Palmer , Alan M. MacDonald , Martha Belete , Linda von Neree , Michael M.F. Murphy , Simon J. Stanworth , Robbie Foy , for the NIHR Blood and Transplant Research Unit in Data Driven Transfusion Practice","doi":"10.1016/j.bjao.2024.100372","DOIUrl":"10.1016/j.bjao.2024.100372","url":null,"abstract":"<div><h3>Background</h3><div>Perioperative red blood cell (RBC) transfusion is a common intervention in patients undergoing surgery but there is marked variation in practice. Key performance indicators (KPIs) are central to identifying deviation from agreed standards and improving clinical outcomes. We aimed to identify KPIs which can potentially be measured from routinely collected electronic healthcare records.</div></div><div><h3>Methods</h3><div>We undertook a three-stage process. First, we completed a scoping review to identify potential KPIs from relevant literature and clinical guidelines. Next, we conducted a modified RAND consensus process with a multidisciplinary panel including medical professionals, patients and public involvement members. The consensus panel rated these KPIs according to importance and feasibility.</div></div><div><h3>Results</h3><div>We identified 28 candidate KPIs covering the entire perioperative RBC transfusion process. The majority of the KPIs focused on improving patient care around the time of decision to transfuse RBCs and transfusion safety. Clinical outcome KPIs included hospital length of stay, hospital acquired infection, mortality, and hospital readmission at 30 and 90 days. Five candidate KPIs were judged as unimportant whilst there were concerns around the feasibility of measurement using routine data for 14 candidate KPIs. The panel identified nine potential KPIs for future testing.</div></div><div><h3>Conclusions</h3><div>Using a systematic, stepwise, transparent approach, we have identified a set of 28 KPIs for assessment, monitoring, and improvement of perioperative RBC transfusion. Future research is needed to further validate this set for external use and benchmarking between hospitals and departments.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100372"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143151222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-22DOI: 10.1016/j.bjao.2024.100365
Adam Scorer , Rani Chahal , Louise Ellard , Paul S. Myles , William P.L. Bradley
The Rapid Infusion Catheter (RIC) has transformed intravenous (i.v.) access, allowing for rapid fluid delivery peripherally. It may negate the need for a central vein sheath to be placed. This review explores the clinical utility of RICs while addressing technical considerations and potential risks.
The RIC is a large-bore i. v. sheath available in two sizes. Its maximal flow rate is 1200 ml min−1, making it advantageous in significant blood loss scenarios such as trauma and major surgeries. Insertion involves the Seldinger technique.
Monitoring and maintaining the RIC is crucial to detect and address immediate complications such as occlusions, infiltration, phlebitis, and extravasation of infusate. Although the related complications share similarities with those of other peripheral i. v. cannulae, they have a lower risk of occlusion and accidental displacement. Catheter removal should be considered once the patient is stable or alternative access is available to avoid infectious complications. Removal of the RIC needs to be performed by those educated in RIC management.
Maximal flow rate is an essential factor in assessing the performance of i. v. cannulae, and studies have shown that RICs outperform other peripheral and central catheters in this regard.
In conclusion, RIC offers advantages over large-bore central venous access for large-volume rapid infusions, including ease of insertion and reduced severe complications. The RIC demonstrates lower thrombosis rates and a different complication profile than peripherally inserted central catheters.
Understanding the characteristics and applications of RICs can help healthcare professionals make informed decisions about their use in various medical scenarios.
{"title":"Effective utilisation of rapid infusion catheters in perioperative care: a narrative review","authors":"Adam Scorer , Rani Chahal , Louise Ellard , Paul S. Myles , William P.L. Bradley","doi":"10.1016/j.bjao.2024.100365","DOIUrl":"10.1016/j.bjao.2024.100365","url":null,"abstract":"<div><div>The Rapid Infusion Catheter (RIC) has transformed intravenous (i.v.) access, allowing for rapid fluid delivery peripherally. It may negate the need for a central vein sheath to be placed. This review explores the clinical utility of RICs while addressing technical considerations and potential risks.</div><div>The RIC is a large-bore i. v. sheath available in two sizes. Its maximal flow rate is 1200 ml min<sup>−1</sup>, making it advantageous in significant blood loss scenarios such as trauma and major surgeries. Insertion involves the Seldinger technique.</div><div>Monitoring and maintaining the RIC is crucial to detect and address immediate complications such as occlusions, infiltration, phlebitis, and extravasation of infusate. Although the related complications share similarities with those of other peripheral i. v. cannulae, they have a lower risk of occlusion and accidental displacement. Catheter removal should be considered once the patient is stable or alternative access is available to avoid infectious complications. Removal of the RIC needs to be performed by those educated in RIC management.</div><div>Maximal flow rate is an essential factor in assessing the performance of i. v. cannulae, and studies have shown that RICs outperform other peripheral and central catheters in this regard.</div><div>In conclusion, RIC offers advantages over large-bore central venous access for large-volume rapid infusions, including ease of insertion and reduced severe complications. The RIC demonstrates lower thrombosis rates and a different complication profile than peripherally inserted central catheters.</div><div>Understanding the characteristics and applications of RICs can help healthcare professionals make informed decisions about their use in various medical scenarios.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100365"},"PeriodicalIF":0.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143151224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-17DOI: 10.1016/j.bjao.2024.100373
Jan A. van Niekerk , Thomas Kleyenstuber , Zainub Jooma
Background
Caesarean section is a common surgical procedure, accounting for almost a third of all surgical procedures in low- middle-income countries. Enhanced recovery after Caesarean section (ERAC) programmes are rarely implemented in resource-limited settings. This study evaluated a tailored enhanced recovery programme's impact on quality of recovery after elective Caesarean section in a Johannesburg public hospital.
Methods
This was a prospective, observational, before–after cohort study. Fifty-two patients (aged ≥18 yr) undergoing elective Caesarean section were analysed, comprising a pre-ERAC cohort (n=25), analysed from 8 to 22 April 2024 and a post-ERAC cohort (n=27), analysed from 3 to13 June 2024. The primary outcome was postpartum recovery measured by the Obstetric Quality of Recovery-10 score.
Results
There was a significant improvement in Obstetric Quality of Recovery-10 scores post-ERAC, with a difference in medians of 9 between cohorts (95% confidence interval: 6–14; P<0.001). There was also a significant reduction in opioid consumption with a median decrease of 10 mg oral morphine equivalent in the post-ERAC cohort in the first 24 h after operation (95% confidence interval: −26 to 6; P<0.001). Time to urinary catheter removal, time to first oral intake, time to first mobilisation, and preoperative fasting for liquids all showed significant improvement in the post-ERAC cohort. There was no difference in length of stay and other secondary outcomes.
Conclusion
This study demonstrates that ERAC implementation in a resource-limited setting is feasible and can enhance maternal recovery after elective Caesarean section. These findings highlight the potential for ERAC programs to significantly improve patient-centred outcomes in low-middle income countries.
{"title":"Evaluating the impact of an enhanced recovery programme on the Obstetric Quality-of-Recovery score (ObsQoR-10) after elective Caesarean section in a South African public hospital: a prospective before–after study","authors":"Jan A. van Niekerk , Thomas Kleyenstuber , Zainub Jooma","doi":"10.1016/j.bjao.2024.100373","DOIUrl":"10.1016/j.bjao.2024.100373","url":null,"abstract":"<div><h3>Background</h3><div>Caesarean section is a common surgical procedure, accounting for almost a third of all surgical procedures in low- middle-income countries. Enhanced recovery after Caesarean section (ERAC) programmes are rarely implemented in resource-limited settings. This study evaluated a tailored enhanced recovery programme's impact on quality of recovery after elective Caesarean section in a Johannesburg public hospital.</div></div><div><h3>Methods</h3><div>This was a prospective, observational, before–after cohort study. Fifty-two patients (aged ≥18 yr) undergoing elective Caesarean section were analysed, comprising a pre-ERAC cohort (<em>n</em>=25), analysed from 8 to 22 April 2024 and a post-ERAC cohort (<em>n</em>=27), analysed from 3 to13 June 2024. The primary outcome was postpartum recovery measured by the Obstetric Quality of Recovery-10 score.</div></div><div><h3>Results</h3><div>There was a significant improvement in Obstetric Quality of Recovery-10 scores post-ERAC, with a difference in medians of 9 between cohorts (95% confidence interval: 6–14; <em>P</em><0.001). There was also a significant reduction in opioid consumption with a median decrease of 10 mg oral morphine equivalent in the post-ERAC cohort in the first 24 h after operation (95% confidence interval: −26 to 6; <em>P</em><0.001). Time to urinary catheter removal, time to first oral intake, time to first mobilisation, and preoperative fasting for liquids all showed significant improvement in the post-ERAC cohort. There was no difference in length of stay and other secondary outcomes.</div></div><div><h3>Conclusion</h3><div>This study demonstrates that ERAC implementation in a resource-limited setting is feasible and can enhance maternal recovery after elective Caesarean section. These findings highlight the potential for ERAC programs to significantly improve patient-centred outcomes in low-middle income countries.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100373"},"PeriodicalIF":0.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11787429/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143082500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-09DOI: 10.1016/j.bjao.2024.100366
Brad Sheridan , Zane Perkins
Background
Literature on prehospital anaesthesia predominantly focuses on preparation and induction, while there is limited guidance on anaesthesia maintenance. The hypothesis of this study was that for prehospital trauma patients, protocols and practice for anaesthesia maintenance may vary considerably between services. Hence, we sought to describe the practice of prehospital anaesthesia maintenance for trauma patients in Australia, New Zealand, and the UK.
Methods
An online practice survey of prehospital and retrieval services in Australia, New Zealand, and the UK was conducted from May to September 2022. Branching logic of between five and 140 questions covered services' background information, protocols relating to anaesthesia maintenance, and perceived effectiveness and governance.
Results
Forty-two services were approached with an 81% response rate. While most services (88%) had some form of maintenance protocol, only 14% had one specific for trauma patients. Most services (61%) used a combination of intermittent boluses and continuous infusions. Ketamine and midazolam were the favoured hypnotics, and fentanyl the favoured opioid. However, there was considerable variation in drug selection and dosing, and in the detail contained within protocols. There was high self-reported confidence in effectiveness and governance of anaesthesia maintenance practices.
Conclusions
Protocols for anaesthesia maintenance in prehospital trauma patients show considerable variation in content and detail across the surveyed services. Further consideration of pharmacokinetics and the specific aims of anaesthesia maintenance is warranted. More research is needed to establish the optimal choice of drugs, dosing, delivery, and adjustment criteria for anaesthesia maintenance in prehospital trauma patients.
{"title":"Maintenance of prehospital anaesthesia in trauma patients: inconsistencies and variability in practice","authors":"Brad Sheridan , Zane Perkins","doi":"10.1016/j.bjao.2024.100366","DOIUrl":"10.1016/j.bjao.2024.100366","url":null,"abstract":"<div><h3>Background</h3><div>Literature on prehospital anaesthesia predominantly focuses on preparation and induction, while there is limited guidance on anaesthesia maintenance. The hypothesis of this study was that for prehospital trauma patients, protocols and practice for anaesthesia maintenance may vary considerably between services. Hence, we sought to describe the practice of prehospital anaesthesia maintenance for trauma patients in Australia, New Zealand, and the UK.</div></div><div><h3>Methods</h3><div>An online practice survey of prehospital and retrieval services in Australia, New Zealand, and the UK was conducted from May to September 2022. Branching logic of between five and 140 questions covered services' background information, protocols relating to anaesthesia maintenance, and perceived effectiveness and governance.</div></div><div><h3>Results</h3><div>Forty-two services were approached with an 81% response rate. While most services (88%) had some form of maintenance protocol, only 14% had one specific for trauma patients. Most services (61%) used a combination of intermittent boluses and continuous infusions. Ketamine and midazolam were the favoured hypnotics, and fentanyl the favoured opioid. However, there was considerable variation in drug selection and dosing, and in the detail contained within protocols. There was high self-reported confidence in effectiveness and governance of anaesthesia maintenance practices.</div></div><div><h3>Conclusions</h3><div>Protocols for anaesthesia maintenance in prehospital trauma patients show considerable variation in content and detail across the surveyed services. Further consideration of pharmacokinetics and the specific aims of anaesthesia maintenance is warranted. More research is needed to establish the optimal choice of drugs, dosing, delivery, and adjustment criteria for anaesthesia maintenance in prehospital trauma patients.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100366"},"PeriodicalIF":0.0,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11764628/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-27DOI: 10.1016/j.bjao.2024.100363
Oliver J.H. Baker, Rama Varadan
Background
Previous UK studies found that only 50–67% of patients are aware that anaesthetists are qualified doctors, and public knowledge of anaesthetists' roles was poor. This study aimed to assess patients' knowledge of anaesthetists and anaesthesia, to identify if there has been any improvement over the past two decades. A secondary aim was to determine if exposure to anaesthetists during day case surgery improved patient knowledge.
Methods
This UK-based, single-centre, cross-sectional study included 150 patients attending for day case surgery. Patients were given a questionnaire on their knowledge of anaesthetists and anaesthesia both before and after surgery. Patients were included if they had not yet been pre-assessed by an anaesthetist, if they were over 18 years old and if they were not healthcare professionals.
Results
All 150 patients completed both preoperative and postoperative questionnaires. 51.3% were female and the median age was 51.6 years (range 18–90 years). Before surgery, only 39.3% of patients knew that anaesthetists were doctors, despite 82.4% having had previous anaesthetics. After surgery, this reduced to 38%. There was no significant improvement in patients' knowledge of anaesthetists’ roles both inside and outside of operating theatres in postoperative questionnaires (p>0.05). Patients most frequently recognised that anaesthetists work in operating theatres (80%), intensive care units (54%), medical emergency teams (52.7%), and on labour wards (50%). Furthermore, 76.6% of patients recalled seeing an anaesthetist before previous operations and 81.3% were aware that general anaesthesia involved volatile gases or intravenous drugs.
Conclusions
This study found that many patients are not aware that anaesthetists are medically qualified. Exposure to anaesthetists on the day of surgery did not improve patients' knowledge of the roles of anaesthetists or their knowledge of anaesthesia itself.
{"title":"Assessing UK patients' knowledge of anaesthetists and anaesthesia","authors":"Oliver J.H. Baker, Rama Varadan","doi":"10.1016/j.bjao.2024.100363","DOIUrl":"10.1016/j.bjao.2024.100363","url":null,"abstract":"<div><h3>Background</h3><div>Previous UK studies found that only 50–67% of patients are aware that anaesthetists are qualified doctors, and public knowledge of anaesthetists' roles was poor. This study aimed to assess patients' knowledge of anaesthetists and anaesthesia, to identify if there has been any improvement over the past two decades. A secondary aim was to determine if exposure to anaesthetists during day case surgery improved patient knowledge.</div></div><div><h3>Methods</h3><div>This UK-based, single-centre, cross-sectional study included 150 patients attending for day case surgery. Patients were given a questionnaire on their knowledge of anaesthetists and anaesthesia both before and after surgery. Patients were included if they had not yet been pre-assessed by an anaesthetist, if they were over 18 years old and if they were not healthcare professionals.</div></div><div><h3>Results</h3><div>All 150 patients completed both preoperative and postoperative questionnaires. 51.3% were female and the median age was 51.6 years (range 18–90 years). Before surgery, only 39.3% of patients knew that anaesthetists were doctors, despite 82.4% having had previous anaesthetics. After surgery, this reduced to 38%. There was no significant improvement in patients' knowledge of anaesthetists’ roles both inside and outside of operating theatres in postoperative questionnaires (p>0.05). Patients most frequently recognised that anaesthetists work in operating theatres (80%), intensive care units (54%), medical emergency teams (52.7%), and on labour wards (50%). Furthermore, 76.6% of patients recalled seeing an anaesthetist before previous operations and 81.3% were aware that general anaesthesia involved volatile gases or intravenous drugs.</div></div><div><h3>Conclusions</h3><div>This study found that many patients are not aware that anaesthetists are medically qualified. Exposure to anaesthetists on the day of surgery did not improve patients' knowledge of the roles of anaesthetists or their knowledge of anaesthesia itself.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100363"},"PeriodicalIF":0.0,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11743334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143017229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-24DOI: 10.1016/j.bjao.2024.100362
Philippa Lloyd , Alexander J. Fowler , Anna Wozniak , William Rattenberry , Sara Scott , Vikas Tripurneni , Mark Earl , Rupert M. Pearse , Sarah-Louise Watson , Tom.E.F. Abbott , Sarah Hare
Background
Increasing awareness of the potential environmental impact of volatile anaesthetic agents has stimulated increased use of total i.v. anaesthesia. However, consolidated comparative evidence of the environmental impact of anaesthetic agents across the whole life cycle is lacking.
Methods
We performed a systematic review and narrative evidence synthesis of the environmental impact of anaesthetic agents stratified by drug life cycle. We searched MEDLINE (PubMed), Excerpta Medica dataBASE (EMBASE), Cumulative index to nursing and allied health literature (CINAHL), and DrugBank, from inception until 05 March 2023, for studies describing the environmental impact of anaesthetic drugs on the WHO essential medicine list. Independent review and data extraction were performed by pairs of reviewers. Data on any aspect of cradle-to-grave life cycle analysis were reported, with narrative synthesis grouped according to life cycle domains.
Results
From 15 229 records, 42 unique reports met our inclusion criteria. The predominant environmental impact of inhalation anaesthetic agents is atmospheric release, contributing to global warming. This may be improved with the emergence of more efficacious scavenging and capture systems. Packaging and waste contributed most to the environmental impact of i.v. anaesthetic agents. There is increasing concern over the ecological impact of i.v. agents entering water sources, either by disposal of unused medication or through the excretion of drug post-administration.
Conclusions
There is increasing concern about the global warming impact of inhalation anaesthetic agents. However, there are insufficient ‘cradle-to-grave’ comparative analyses of the environmental impact of i.v. and inhalation anaesthesia to form evidence-based conclusions. Further research is urgently needed to guide clinical practice.
{"title":"Environmental impact of commonly used anaesthetic agents: systematic literature review with narrative synthesis","authors":"Philippa Lloyd , Alexander J. Fowler , Anna Wozniak , William Rattenberry , Sara Scott , Vikas Tripurneni , Mark Earl , Rupert M. Pearse , Sarah-Louise Watson , Tom.E.F. Abbott , Sarah Hare","doi":"10.1016/j.bjao.2024.100362","DOIUrl":"10.1016/j.bjao.2024.100362","url":null,"abstract":"<div><h3>Background</h3><div>Increasing awareness of the potential environmental impact of volatile anaesthetic agents has stimulated increased use of total i.v. anaesthesia. However, consolidated comparative evidence of the environmental impact of anaesthetic agents across the whole life cycle is lacking.</div></div><div><h3>Methods</h3><div>We performed a systematic review and narrative evidence synthesis of the environmental impact of anaesthetic agents stratified by drug life cycle. We searched MEDLINE (PubMed), Excerpta Medica dataBASE (EMBASE), Cumulative index to nursing and allied health literature (CINAHL), and DrugBank, from inception until 05 March 2023, for studies describing the environmental impact of anaesthetic drugs on the WHO essential medicine list. Independent review and data extraction were performed by pairs of reviewers. Data on any aspect of cradle-to-grave life cycle analysis were reported, with narrative synthesis grouped according to life cycle domains.</div></div><div><h3>Results</h3><div>From 15 229 records, 42 unique reports met our inclusion criteria. The predominant environmental impact of inhalation anaesthetic agents is atmospheric release, contributing to global warming. This may be improved with the emergence of more efficacious scavenging and capture systems. Packaging and waste contributed most to the environmental impact of i.v. anaesthetic agents. There is increasing concern over the ecological impact of i.v. agents entering water sources, either by disposal of unused medication or through the excretion of drug post-administration.</div></div><div><h3>Conclusions</h3><div>There is increasing concern about the global warming impact of inhalation anaesthetic agents. However, there are insufficient ‘cradle-to-grave’ comparative analyses of the environmental impact of i.v. and inhalation anaesthesia to form evidence-based conclusions. Further research is urgently needed to guide clinical practice.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100362"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11732243/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}