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Queensland adult ECMO retrieval service: A description of the service and analysis of outcomes 昆士兰成人ECMO检索服务:服务描述和结果分析。
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-02-20 DOI: 10.1016/j.ccrj.2026.100165
Nihal Kumta MB, BS, FANZCA, FCICM , Germaine M. Kenny PGcert (ICU), PGcert (health management) , Jason Meyer BN, MSc , James R. Winearls BSc, MB, BS, FRCP, FCICM , James McCullough MB, ChB, MMed, FCICM , Kiran Shekar MB, BS, PhD, FCICM, FCCCM , Jayshree Lavana MB, BS, MD(medicine), FCICM , Anand Krishnan MB, BS, FCICM , Kyle C. White MB, BS, MPH, FRACP, FCICM , David A. Cook MB, BS, PhD, FANZCA, FCICM , Christopher J. Joyce MB, ChB, PhD, FANZCA, FCICM

Objective

To describe the Queensland Adult ECMO Retrieval Service (QAERS) and assess observed mortality of patients retrieved and treated with ECMO, against benchmarks.

Design

Data was retrospectively collected from clinical and quality assurance databases at the three QAERS hospitals. Demographic data, diagnostic category, and hospital mortality were collected for patients referred to QAERS. Additional data was collected on patients receiving ECMO either before or after transport to a receiving hospital (ECMO patients), enabling calculation of RESP or SAVE scores. In ECMO patients with cardiogenic shock, individual risk of deaths were calculated by SAVE score. Monte Carlo analysis generated a discrete probability distribution function (PDF) of expected number of deaths, with 95 % confidence intervals (CI). The observed number of deaths was compared to this PDF. This was repeated for ECMO patients with respiratory failure, using RESP score.

Setting

ICUs in Queensland and Northern NSW.

Participants

All patients referred to QAERS from May 2017 to December 2023.

Main outcome measures

Predicted and observed mortality of ECMO patients with cardiogenic shock or respiratory failure.

Results

237 patients were referred. 135 were retrieved, with 77 transported on ECMO. 11 commenced ECMO after transfer, giving a total of 88 ECMO patients. 35 ECMO patients had cardiogenic shock and 53 had respiratory failure. 16 cardiogenic shock patients died (95 % CI of PDF 17–28). 7 respiratory failure patients died (95 % CI of PDF 8–19).

Conclusions

Observed mortality of patients retrieved and treated with ECMO was lower than mortality predicted by SAVE and RESP scores.
目的:描述昆士兰成人ECMO检索服务(QAERS),并根据基准评估ECMO检索和治疗患者的观察死亡率。设计:回顾性地从QAERS三家医院的临床和质量保证数据库中收集数据。收集转介QAERS的患者的人口统计数据、诊断类别和住院死亡率。在运送到接收医院之前或之后收集接受ECMO的患者(ECMO患者)的其他数据,从而计算RESP或SAVE评分。在合并心源性休克的ECMO患者中,通过SAVE评分计算个体死亡风险。蒙特卡罗分析生成预期死亡人数的离散概率分布函数(PDF),置信区间(CI)为95%。将观察到的死亡人数与该PDF进行比较。使用RESP评分对伴有呼吸衰竭的ECMO患者进行重复研究。环境:昆士兰和新南威尔士州北部的icu。参与者:2017年5月至2023年12月期间所有QAERS患者。主要结局指标:预测和观察心源性休克或呼吸衰竭的ECMO患者死亡率。结果:237例患者转诊。取出135例,经ECMO转运77例。11例转移后开始ECMO,共计88例。ECMO患者心源性休克35例,呼吸衰竭53例。16例心源性休克患者死亡(95% CI: PDF 17-28)。7例呼吸衰竭患者死亡(95% CI: PDF 8-19)。结论:ECMO患者的观察死亡率低于SAVE和RESP评分预测的死亡率。
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引用次数: 0
Temporal trends in post-extubation respiratory management and reintubation risk factors in Japan: A retrospective multicenter cohort study 日本拔管后呼吸管理和再插管危险因素的时间趋势:一项回顾性多中心队列研究。
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-02-25 DOI: 10.1016/j.ccrj.2026.100170
Toshinori Maezawa MD , Masaaki Sakuraya MD, MPH , Akihiro Takaba MD

Objective

Non-invasive ventilation (NIV) and high-flow nasal cannula (HFNC) have been used to prevent reintubation. We aimed to describe the utilisation patterns and analyze temporal trends of NIV and HFNC after extubation.

Design

Retrospective multicenter cohort study using the Japanese Intensive care PAtient Database (JIPAD) from 2018 to 2022.

Setting

Facilities that consecutively registered cases in JIPAD during the study period.

Participants

We included adult patients (>18 years) who were receiving mechanical ventilation at the time of intensive care unit (ICU) admission, with a duration of mechanical ventilation of at least 24 h.

Interventions

None.

Main outcome measures

Temporal trends in the utilisation of NIV and HFNC after extubation over the 5-year study period.

Results

We included 12,687 eligible patients from 40 ICUs. Based on the Cochran–Armitage test, the proportion of patients receiving NIV decreased from the years 2018 to 2022 (6.7-3.9 %, P for trend <0.001), while that receiving HFNC significantly increased (15.9-28.0 %, P for trend <0.001). After multivariable adjustment (with 2018 as the reference year) and relative to oxygen therapy, the year 2022 was associated with a significant decrease in NIV (adjusted odds ratio, 0.67; 95 % confidence interval, 0.52-0.88) and a significant increase in HFNC (adjusted odds ratio, 1.89; 95 % confidence interval, 1.62-2.21).

Conclusions

We analysed over 12,000 patients in this retrospective multicenter cohort study. The proportion of HFNC use after extubation increased, while NIV use decreased, and these changes remained significant after multivariable analysis. Further research is warranted to clarify appropriate indications for NIV and HFNC after extubation.
目的:采用无创通气(NIV)和高流量鼻插管(HFNC)预防再插管。我们的目的是描述使用模式,并分析拔管后NIV和HFNC的时间趋势。设计:2018 - 2022年使用日本重症患者数据库(JIPAD)进行回顾性多中心队列研究。环境:在研究期间连续在JIPAD登记病例的设施。参与者:我们纳入了在重症监护病房(ICU)入院时接受机械通气的成年患者(bb0 - 18岁),机械通气持续时间至少为24小时。干预措施:无。主要结局指标:5年研究期间拔管后使用NIV和HFNC的时间趋势。结果:我们纳入了来自40个icu的12,687例符合条件的患者。根据Cochran-Armitage检验,从2018年到2022年,接受NIV的患者比例下降(6.7% - 3.9%,P为趋势)。结论:我们在这项回顾性多中心队列研究中分析了超过12,000名患者。拔管后使用HFNC的比例增加,而使用NIV的比例减少,多变量分析后这些变化仍然显著。有必要进一步研究以明确拔管后NIV和HFNC的适当适应症。
{"title":"Temporal trends in post-extubation respiratory management and reintubation risk factors in Japan: A retrospective multicenter cohort study","authors":"Toshinori Maezawa MD ,&nbsp;Masaaki Sakuraya MD, MPH ,&nbsp;Akihiro Takaba MD","doi":"10.1016/j.ccrj.2026.100170","DOIUrl":"10.1016/j.ccrj.2026.100170","url":null,"abstract":"<div><h3>Objective</h3><div>Non-invasive ventilation (NIV) and high-flow nasal cannula (HFNC) have been used to prevent reintubation. We aimed to describe the utilisation patterns and analyze temporal trends of NIV and HFNC after extubation.</div></div><div><h3>Design</h3><div>Retrospective multicenter cohort study using the Japanese Intensive care PAtient Database (JIPAD) from 2018 to 2022.</div></div><div><h3>Setting</h3><div>Facilities that consecutively registered cases in JIPAD during the study period.</div></div><div><h3>Participants</h3><div>We included adult patients (&gt;18 years) who were receiving mechanical ventilation at the time of intensive care unit (ICU) admission, with a duration of mechanical ventilation of at least 24 h.</div></div><div><h3>Interventions</h3><div>None.</div></div><div><h3>Main outcome measures</h3><div>Temporal trends in the utilisation of NIV and HFNC after extubation over the 5-year study period.</div></div><div><h3>Results</h3><div>We included 12,687 eligible patients from 40 ICUs. Based on the Cochran–Armitage test, the proportion of patients receiving NIV decreased from the years 2018 to 2022 (6.7-3.9 %, P for trend &lt;0.001), while that receiving HFNC significantly increased (15.9-28.0 %, P for trend &lt;0.001). After multivariable adjustment (with 2018 as the reference year) and relative to oxygen therapy, the year 2022 was associated with a significant decrease in NIV (adjusted odds ratio, 0.67; 95 % confidence interval, 0.52-0.88) and a significant increase in HFNC (adjusted odds ratio, 1.89; 95 % confidence interval, 1.62-2.21).</div></div><div><h3>Conclusions</h3><div>We analysed over 12,000 patients in this retrospective multicenter cohort study. The proportion of HFNC use after extubation increased, while NIV use decreased, and these changes remained significant after multivariable analysis. Further research is warranted to clarify appropriate indications for NIV and HFNC after extubation.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"28 1","pages":"Article 100170"},"PeriodicalIF":1.7,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147357396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A pilot, parallel-group, blinded, placebo-controlled, randomiseD, pRagmatic clinical trial investigating the Effect of temazepAM on objective and subjective measures of sleep in critically ill patients (the DREAM trial) 一项试点、平行组、盲法、安慰剂对照、随机、实用的临床试验,研究替马西泮对危重患者客观和主观睡眠测量的影响(DREAM试验)。
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-02-19 DOI: 10.1016/j.ccrj.2026.100169
Laurie Showler MBChB , Yasmine Ali Abdelhamid MBBS, PhD , Melissa J. Ankravs BPharm, MClinPharm , Jeremy Goldin MBBS, MM , Mark P. Plummer MBBS, PhD , Brianna Tascone BBiomed (Hons) , Kathleen Byrne RN, MNSc , Andrew Perkins BSc, RPSGT , Kirk Kee MBBS, PhD , Cara Moore MBBS , Barry Johnston MB, BCh, BAO, MBioethics , Jeffrey Presneill MBBS, MBiostat, PhD , Adam M. Deane MBBS, PhD

Objective

Patients in the intensive care unit (ICU) suffer from disturbed sleep and pharmacological sleep aids are frequently prescribed despite limited data on their efficacy. The objective of this study was to assess the effect of a single nocturnal dose of the benzodiazepine temazepam on sleep duration and quality in ICU patients.

Design

Prospective, single-centre, blinded, placebo-controlled, parallel-group, randomised clinical trial.

Setting

A tertiary ICU in Australia.

Participants

Adult ICU patients whose treating clinician considered that a pharmacological sleep aid was indicated.

Interventions

A single weight- and age-adjusted dose of temazepam (10–30 mg) or a matching placebo was administered enterally at 21:00 h.

Main outcome measures

The primary outcome was total sleep time between 21:00 and 07:00 h by hourly structured nurse assessment. Secondary outcomes included the evaluation of sleep quality, independently determined by the bedside nurse and patient using the Richards-Campbell Sleep Questionnaire.

Results

Between October 2020 and May 2024, 56 patients received temazepam (n = 28) or placebo (n = 28). The mean (standard deviation) total sleep time with temazepam was 349 (120) vs. placebo 291 (124) minutes; difference = 57 min (95% confidence intervals: −11 to 130); p = 0.10. No differences in total Richards-Campbell Sleep Questionnaire sleep quality were observed when assessed by the nurse (57 (17) vs. 49 (23), p = 0.15) or by the patient (50 (28) vs. 51 (23), p = 0.70).

Conclusion

A single dose of temazepam was not observed to improve the duration or quality of nocturnal sleep for patients in the ICU.

Trial registration

Retrospectively registered with the Australian and New Zealand Clinical Trials Registry on 11th June 2021 (ACTRN 12621000742875).
目的:重症监护病房(ICU)的患者患有睡眠障碍,药物助眠药物被频繁使用,尽管其疗效数据有限。本研究的目的是评估夜间单剂量苯二氮卓类药物替马西泮对ICU患者睡眠时间和质量的影响。设计:前瞻性、单中心、盲法、安慰剂对照、平行组、随机临床试验。环境:澳大利亚的一所三级ICU。受试者:临床医生认为需要药物助眠的ICU成年患者。干预措施:在21:00 h肠内给予单剂量的体重和年龄调整剂量的替马西泮(10- 30mg)或匹配的安慰剂。主要结果测量:主要结果是由每小时结构化护士评估的21:00至07:00 h之间的总睡眠时间。次要结果包括睡眠质量评估,由床边护士和患者使用Richards-Campbell睡眠问卷独立确定。结果:2020年10月至2024年5月期间,56例患者接受了替马西泮(n = 28)或安慰剂(n = 28)治疗。替马西泮组的平均(标准差)总睡眠时间为349(120)分钟,安慰剂组为291(124)分钟;差异= 57分钟(95%置信区间:-11至130);P = 0.10。由护士(57(17)对49 (23),p = 0.15)或由患者(50(28)对51 (23),p = 0.70)评估的Richards-Campbell睡眠问卷的总睡眠质量无差异。结论:单剂量替马西泮未观察到改善ICU患者夜间睡眠时间或质量。试验注册:于2021年6月11日在澳大利亚和新西兰临床试验注册中心回顾性注册(ACTRN 12621000742875)。
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引用次数: 0
Can intraocular pressure serve as a non-invasive surrogate marker for intracranial pressure following traumatic brain injury? 眼压能否作为创伤性脑损伤后颅内压的无创替代指标?
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-02-23 DOI: 10.1016/j.ccrj.2025.100161
Bao N. Nguyen BOptom, PhD, Ella Stathis BSc(Hons), Bang V. Bui BSc(Optom), MOptom, PhD, Lauren N. Ayton BOptom, PhD, David B. Grayden BSc, BE(Hons), PhD, Sam E. John BE(Medical Electronics), ME(Electronics), PhD, Janine Stubbs BSc(Hons), MBiostat, PhD, Andrew Morokoff MBBS, PhD, FRACS, Olivia Gigli BBiomedSc(Hons), Brianna Tascone BBiomedSc(Hons), Ryan Nolan MBBS, BSc(Hons), MRCP(UK), Emily J. See MBBS, BMedSci, MSc(Oxon), PhD, FRACP, FCICM, Adam M. Deane MBBS, PhD, FRACP, FCICM, Yasmine Ali Abdelhamid MBBS, PhD, FRACP, FCICM
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引用次数: 0
A comparison of sodium concentration measured in laboratory autoanalyser versus point-of-care blood gas machine: A retrospective, multicentre, analytical study in a large adult intensive care unit population 实验室自动分析仪与现场血气机测量钠浓度的比较:一项针对大型成人重症监护病房人群的回顾性、多中心分析研究
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2025-12-01 Epub Date: 2025-12-05 DOI: 10.1016/j.ccrj.2025.100149
Keegan Hunter BMedSc MD , Chris Anstey MBBS BSc MSc FANZCA FCICM PhD , Alexander Nesbitt BSc MBBS FCICM AFHEA , Karthik Venkatesh BMed MD FCICM , Dinesh Parmar MD FRCA FCICM , Amanda Corley RN PhD , Marissa Daniels MBBS , Jatinder Grewal FCICM, FANZCA, GchPOM , Kevin B. Laupland MD, PhD , Mahesh Ramanan BSc(Med) MBBS(Hons) MMed(Clin Epi) FCICM , Alexis Tabah MD FCICM , James McCullough MMed FCICM , Aashish Kumar MBBS FCICM , Antony G. Attokaran MBBS FCICM FRACP , Stephen Luke MBBS BSc(Hons) FCICM , Peter Garrett MBBS, BSc(Hons) FCICM FACEM FCEM , Stephen Whebell MBBS FCICM , Sebastiaan Blank FCICM , Philippa McIlroy BPhty (Hons) MBBS FCICM , Kyle C. White BSc MBBS MPH FCICM FRACP

Objective

Discrepancies between laboratory sodium and point-of-care arterial blood gas sodium values may lead to delayed interpretation of, and intervention on, the results. We studied the mean difference between these two techniques and assessed the degree of agreement.

Design

A multicentre, retrospective, observational study was conducted.

Setting

Twelve intensive care units in Queensland, Australia, with tertiary-level hospitals accounting for 81% of admissions were included in the study.

Participants

Adult patients with at least one paired laboratory sodium and arterial blood gas measurement during their intensive care unit admission were a part of this study.

Main outcome measures

Main outcome measures included mean difference between laboratory sodium and point-of-care sodium measurement, with a positive difference demonstrating laboratory sodium values higher than arterial blood gas sodium values.

Results

A total of 65,042 patients with 224,383 paired samples were included in the analysis. The Bland–Altman mean difference of laboratory sodium and arterial blood gas sodium was 0.72 mmol/L (95% limit of agreement [LoA]: 4.35) with a Deming regression slope of 0.93 (95% confidence interval: 0.92, 0.94) and intercept +10.07 (p < 0.001). On subgroup analysis of hyponatraemia, eunatraemia and hypernatraemia a mean difference (95% LoA) of 1.53 mmol/L (4.21), 0.15 mmol/L (4.39), and −1.02 mmol/L (5.37), was calculated, respectively. Patients with severe hyperglycaemia and normal albumin had a mean difference (95% LoA) of −1.85 mmol/L (4.78). Analysis of mild, moderate, and severe subgroups within both hyponatraemic and hypernatraemic samples showed increasing mean differences, with severe hyponatraemia showing a mean difference of 2.01 mmol/L (95% LoA: 8.08) and severe hypernatraemia showing a mean difference of −4.7 mmol/L (95% LoA: 15.46).

Conclusions

Point-of-care arterial blood gas sodium measurements show small mean differences in eunatraemia and good agreement with paired laboratory samples in adult intensive care unit patients. Caution should be applied when interchanging results between laboratory and point-of-care sodium values in patients with moderate to severe dysnatraemia, as serial measurements using different methods during treatment are unlikely to be within a clinically acceptable range. This is important when caring for patient groups with severe hyponatraemia and induced hypernatraemia, and serial measurement may be better achieved with point-of-care testing due to a combination of ease of access, repeatability, and lower cost.
目的实验室钠值与现场动脉血气钠值的差异可能导致对结果的延迟解释和干预。我们研究了这两种技术之间的平均差异,并评估了一致程度。设计进行一项多中心、回顾性、观察性研究。研究对象为澳大利亚昆士兰州的12个重症监护病房,其中三级医院占入院人数的81%。在重症监护病房入院期间,至少有一次配对实验室钠和动脉血气测量的成年患者是本研究的一部分。主要结果测量包括实验室钠和护理点钠测量的平均差异,阳性差异表明实验室钠值高于动脉血气钠值。结果共纳入65,042例患者和224,383例配对样本。实验室钠和动脉血气钠的Bland-Altman平均差值为0.72 mmol/L(95%一致限[LoA]: 4.35), Deming回归斜率为0.93(95%可信区间:0.92,0.94),截断量为+10.07 (p < 0.001)。对低钠血症、低钠血症和高钠血症进行亚组分析,分别计算出1.53 mmol/L(4.21)、0.15 mmol/L(4.39)和- 1.02 mmol/L(5.37)的平均LoA差异(95% LoA)。严重高血糖患者与白蛋白正常患者的平均差异(95% LoA)为- 1.85 mmol/L(4.78)。对低钠血症和高钠血症样本中轻度、中度和重度亚组的分析显示,平均差异越来越大,重度低钠血症的平均差异为2.01 mmol/L (95% LoA: 8.08),重度高钠血症的平均差异为- 4.7 mmol/L (95% LoA: 15.46)。结论监护点动脉血气钠测量结果显示成人重症监护病房患者血钠含量差异较小,且与配对实验室样本吻合较好。在中度至重度钠血症患者的实验室和护理点钠值互换结果时应谨慎,因为在治疗期间使用不同方法的连续测量不太可能在临床可接受的范围内。这在治疗患有严重低钠血症和诱发性高钠血症的患者群体时很重要,并且由于易于获取、可重复性和成本较低,通过即时检测可以更好地实现系列测量。
{"title":"A comparison of sodium concentration measured in laboratory autoanalyser versus point-of-care blood gas machine: A retrospective, multicentre, analytical study in a large adult intensive care unit population","authors":"Keegan Hunter BMedSc MD ,&nbsp;Chris Anstey MBBS BSc MSc FANZCA FCICM PhD ,&nbsp;Alexander Nesbitt BSc MBBS FCICM AFHEA ,&nbsp;Karthik Venkatesh BMed MD FCICM ,&nbsp;Dinesh Parmar MD FRCA FCICM ,&nbsp;Amanda Corley RN PhD ,&nbsp;Marissa Daniels MBBS ,&nbsp;Jatinder Grewal FCICM, FANZCA, GchPOM ,&nbsp;Kevin B. Laupland MD, PhD ,&nbsp;Mahesh Ramanan BSc(Med) MBBS(Hons) MMed(Clin Epi) FCICM ,&nbsp;Alexis Tabah MD FCICM ,&nbsp;James McCullough MMed FCICM ,&nbsp;Aashish Kumar MBBS FCICM ,&nbsp;Antony G. Attokaran MBBS FCICM FRACP ,&nbsp;Stephen Luke MBBS BSc(Hons) FCICM ,&nbsp;Peter Garrett MBBS, BSc(Hons) FCICM FACEM FCEM ,&nbsp;Stephen Whebell MBBS FCICM ,&nbsp;Sebastiaan Blank FCICM ,&nbsp;Philippa McIlroy BPhty (Hons) MBBS FCICM ,&nbsp;Kyle C. White BSc MBBS MPH FCICM FRACP","doi":"10.1016/j.ccrj.2025.100149","DOIUrl":"10.1016/j.ccrj.2025.100149","url":null,"abstract":"<div><h3>Objective</h3><div>Discrepancies between laboratory sodium and point-of-care arterial blood gas sodium values may lead to delayed interpretation of, and intervention on, the results. We studied the mean difference between these two techniques and assessed the degree of agreement.</div></div><div><h3>Design</h3><div>A multicentre, retrospective, observational study was conducted.</div></div><div><h3>Setting</h3><div>Twelve intensive care units in Queensland, Australia, with tertiary-level hospitals accounting for 81% of admissions were included in the study.</div></div><div><h3>Participants</h3><div>Adult patients with at least one paired laboratory sodium and arterial blood gas measurement during their intensive care unit admission were a part of this study.</div></div><div><h3>Main outcome measures</h3><div>Main outcome measures included mean difference between laboratory sodium and point-of-care sodium measurement, with a positive difference demonstrating laboratory sodium values higher than arterial blood gas sodium values.</div></div><div><h3>Results</h3><div>A total of 65,042 patients with 224,383 paired samples were included in the analysis. The Bland–Altman mean difference of laboratory sodium and arterial blood gas sodium was 0.72 mmol/L (95% limit of agreement [LoA]: 4.35) with a Deming regression slope of 0.93 (95% confidence interval: 0.92, 0.94) and intercept +10.07 (p &lt; 0.001). On subgroup analysis of hyponatraemia, eunatraemia and hypernatraemia a mean difference (95% LoA) of 1.53 mmol/L (4.21), 0.15 mmol/L (4.39), and −1.02 mmol/L (5.37), was calculated, respectively. Patients with severe hyperglycaemia and normal albumin had a mean difference (95% LoA) of −1.85 mmol/L (4.78). Analysis of mild, moderate, and severe subgroups within both hyponatraemic and hypernatraemic samples showed increasing mean differences, with severe hyponatraemia showing a mean difference of 2.01 mmol/L (95% LoA: 8.08) and severe hypernatraemia showing a mean difference of −4.7 mmol/L (95% LoA: 15.46).</div></div><div><h3>Conclusions</h3><div>Point-of-care arterial blood gas sodium measurements show small mean differences in eunatraemia and good agreement with paired laboratory samples in adult intensive care unit patients. Caution should be applied when interchanging results between laboratory and point-of-care sodium values in patients with moderate to severe dysnatraemia, as serial measurements using different methods during treatment are unlikely to be within a clinically acceptable range. This is important when caring for patient groups with severe hyponatraemia and induced hypernatraemia, and serial measurement may be better achieved with point-of-care testing due to a combination of ease of access, repeatability, and lower cost.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 4","pages":"Article 100149"},"PeriodicalIF":1.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145684685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Building the future of ICU care: Is our digital foundation strong enough? A multicentre survey of Australian and New Zealand intensive care units 构建ICU护理的未来:我们的数字基础是否足够强大?澳大利亚和新西兰重症监护病房的多中心调查
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2025-12-01 Epub Date: 2025-10-17 DOI: 10.1016/j.ccrj.2025.100133
Kristen S. Gibbons PhD , Renate Le Marsney MPH , Andrew Goodwin PhD , Rayna Reddy BSc , Patricia Gilholm PhD , David Pilcher MBBS, FCICM , Ben Gelbart MBBS, FRACP, FCICM, PhD , the Australian and New Zealand Intensive Care Society Paediatric Study Group (ANZICS PSG)

Objectives

The objective of this study was to assess data-related resources, infrastructure, and capabilities in Australia and New Zealand (ANZ) intensive care units (ICUs).

Design

Electronic multicentre survey was conducted.

Setting

ANZ ICUs between June and October 2024.

Participants

All ANZ ICUs contributing to the Australian and New Zealand Intensive Care Society Adult Patient Database and/or Australian and New Zealand Paediatric Intensive Care Registry were included in this study.

Interventions

There are none to declare.

Main outcome measures

The main outcome measures included types of medical records, digital data capture and research availability, digital enhancement plans, staffing, and research collaboration.

Results

Of 209 ICUs, 112 (54%) responded; 13 paediatric, 21 mixed, and 78 adult ICUs, with responses from all ANZ jurisdictions. Overall, 59% used paper records (5 paediatric and 61 mixed/adult), 28% digitised (7 paediatric and 24 mixed/adult), and 59% electronic health records (EHRs; 10 paediatric and 56 mixed/adult), with most EHRs introduced within the last decade (76%). In units with an EHR, 59% collected data secondly or minutely in the EHR and >75% collected EHR data on patient demographics, clinical notes, laboratory results, medications, fluids, bedside monitors, and respiratory support devices. Data Managers were employed within 45% of ICUs, with 96% able to extract data for audit and 92% for research. Respondents reported frustrations with delayed EHR implementation and limited data extraction mechanisms.

Conclusions

Substantial variability exists across ANZ ICUs in digital health adoption, data capture, and data management resources. Quantifying differences in digital information, improving data extraction, and building collaborative networks are key steps for supporting research and innovation across units.
本研究的目的是评估澳大利亚和新西兰(ANZ)重症监护病房(icu)的数据相关资源、基础设施和能力。设计进行电子多中心调查。在2024年6月至10月之间设置anz ICUs。本研究纳入了澳大利亚和新西兰重症监护协会成人患者数据库和/或澳大利亚和新西兰儿科重症监护登记处的所有ANZ icu。干预措施:没有需要申报的。主要结果测量指标主要结果测量指标包括医疗记录类型、数字数据捕获和研究可用性、数字增强计划、人员配备和研究协作。结果209例icu中,112例(54%)有应答;13个儿科icu, 21个混合icu和78个成人icu,来自所有澳新银行辖区的回复。总体而言,59%的人使用纸质记录(5名儿科和61名混合/成人),28%的人使用数字化记录(7名儿科和24名混合/成人),59%的人使用电子健康记录(EHRs; 10名儿科和56名混合/成人),大多数电子健康记录是在过去十年引入的(76%)。在有电子病历的单位中,59%的人在电子病历中第一时间或每分钟收集数据,75%的人收集电子病历中关于患者人口统计、临床记录、实验室结果、药物、液体、床边监护仪和呼吸支持设备的数据。45%的icu聘用了数据管理人员,其中96%的icu能够提取数据用于审计,92%的icu能够提取数据用于研究。受访者表示对电子病历延迟实施和有限的数据提取机制感到失望。结论ANZ icu在数字健康采用、数据采集和数据管理资源方面存在显著差异。量化数字信息差异、改进数据提取和建立协作网络是支持跨单位研究和创新的关键步骤。
{"title":"Building the future of ICU care: Is our digital foundation strong enough? A multicentre survey of Australian and New Zealand intensive care units","authors":"Kristen S. Gibbons PhD ,&nbsp;Renate Le Marsney MPH ,&nbsp;Andrew Goodwin PhD ,&nbsp;Rayna Reddy BSc ,&nbsp;Patricia Gilholm PhD ,&nbsp;David Pilcher MBBS, FCICM ,&nbsp;Ben Gelbart MBBS, FRACP, FCICM, PhD ,&nbsp;the Australian and New Zealand Intensive Care Society Paediatric Study Group (ANZICS PSG)","doi":"10.1016/j.ccrj.2025.100133","DOIUrl":"10.1016/j.ccrj.2025.100133","url":null,"abstract":"<div><h3>Objectives</h3><div>The objective of this study was to assess data-related resources, infrastructure, and capabilities in Australia and New Zealand (ANZ) intensive care units (ICUs).</div></div><div><h3>Design</h3><div>Electronic multicentre survey was conducted.</div></div><div><h3>Setting</h3><div>ANZ ICUs between June and October 2024.</div></div><div><h3>Participants</h3><div>All ANZ ICUs contributing to the Australian and New Zealand Intensive Care Society Adult Patient Database and/or Australian and New Zealand Paediatric Intensive Care Registry were included in this study.</div></div><div><h3>Interventions</h3><div>There are none to declare.</div></div><div><h3>Main outcome measures</h3><div>The main outcome measures included types of medical records, digital data capture and research availability, digital enhancement plans, staffing, and research collaboration.</div></div><div><h3>Results</h3><div>Of 209 ICUs, 112 (54%) responded; 13 paediatric, 21 mixed, and 78 adult ICUs, with responses from all ANZ jurisdictions. Overall, 59% used paper records (5 paediatric and 61 mixed/adult), 28% digitised (7 paediatric and 24 mixed/adult), and 59% electronic health records (EHRs; 10 paediatric and 56 mixed/adult), with most EHRs introduced within the last decade (76%). In units with an EHR, 59% collected data secondly or minutely in the EHR and &gt;75% collected EHR data on patient demographics, clinical notes, laboratory results, medications, fluids, bedside monitors, and respiratory support devices. Data Managers were employed within 45% of ICUs, with 96% able to extract data for audit and 92% for research. Respondents reported frustrations with delayed EHR implementation and limited data extraction mechanisms.</div></div><div><h3>Conclusions</h3><div>Substantial variability exists across ANZ ICUs in digital health adoption, data capture, and data management resources. Quantifying differences in digital information, improving data extraction, and building collaborative networks are key steps for supporting research and innovation across units.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 4","pages":"Article 100133"},"PeriodicalIF":1.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145324281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Documentation and evaluation of care of dying patients 临终病人护理的记录和评估
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2025-12-01 Epub Date: 2025-10-16 DOI: 10.1016/j.ccrj.2025.100136
Maria de Freitas BM BS, BSc, BMedSci, Lucinda Roberts MBBS, Alexandra Cockroft MBChB, BSc, Graeme Duke MBBS, MD, FCICM, FANZCA

Objective

Evaluate the quality of documentation and delivery of EOLC in the Intensive Care Unit (ICU) during the COVID-19 pandemic and compare with a pre-pandemic audit.

Design

Retrospective clinical audit of medical records of patients who died in ICU during the COVID-19 pandemic, January 2021 to February 2022, using the Documentation and Evaluation of Care of Dying Equation (DECODE) survey tool.

Setting

Three metropolitan adult ICUs in Victoria, Australia.

Main outcomes

DECODE audit score, patient characteristics, demographics, end of life planning, quality of death indicators, management of dying.

Results

There were 194 deaths over a 14-month period. 2 cases were excluded. Patients wishes were documented in 83 (43%) cases. A total of 175 patients (91%) were receiving active treatment 24 h before death. A total of 166 deaths (86%) were expected and occurred a mean of 4.5 (IQR 2-9) days from admission to ICU. A total of 52 (27%) had palliative or symptom control care plans. The median DECODE score was 14 (IQR 12-15) with statistical variation across the three sites (p=0.001). Compared to pre pandemic audits, the DECODE score was higher (p=0.001) despite pandemic restrictions.

Conclusion

EOLC in ICU remains challenging due to diagnostic dilemmas, prognostic uncertainty, and short time-frames. Assessment of quality of EoLC care helps assess and possibly improve provision of care. The DECODE questionnaire provides a semi-objective measure of quality of care provided to the dying patient in ICU.
目的评价2019冠状病毒病大流行期间重症监护病房(ICU) EOLC的记录和交付质量,并与大流行前审计进行比较。设计采用死亡方程的文献记录和评估(DECODE)调查工具,对2021年1月至2022年2月COVID-19大流行期间在ICU死亡的患者的医疗记录进行回顾性临床审计。澳大利亚维多利亚州的三个大都市成人icu。主要结局:decode审核评分、患者特征、人口统计学、生命终结计划、死亡质量指标、死亡管理。结果14个月内死亡194例。2例被排除。83例(43%)患者的愿望得到了记录。175例患者(91%)在死亡前24小时接受了积极治疗。预计共发生166例死亡(86%),平均发生时间为入住ICU后4.5 (IQR 2-9)天。共有52人(27%)有姑息治疗或症状控制护理计划。DECODE评分中位数为14 (IQR 12-15),三个位点之间存在统计学差异(p=0.001)。与大流行前的审计相比,尽管有大流行限制,但DECODE评分更高(p=0.001)。结论由于诊断困难、预后不确定和时间短,ICU的eolc仍然具有挑战性。对EoLC护理质量的评估有助于评估并可能改善护理的提供。DECODE问卷对ICU临终病人的护理质量提供了半客观的衡量。
{"title":"Documentation and evaluation of care of dying patients","authors":"Maria de Freitas BM BS, BSc, BMedSci,&nbsp;Lucinda Roberts MBBS,&nbsp;Alexandra Cockroft MBChB, BSc,&nbsp;Graeme Duke MBBS, MD, FCICM, FANZCA","doi":"10.1016/j.ccrj.2025.100136","DOIUrl":"10.1016/j.ccrj.2025.100136","url":null,"abstract":"<div><h3>Objective</h3><div>Evaluate the quality of documentation and delivery of EOLC in the Intensive Care Unit (ICU) during the COVID-19 pandemic and compare with a pre-pandemic audit.</div></div><div><h3>Design</h3><div>Retrospective clinical audit of medical records of patients who died in ICU during the COVID-19 pandemic, January 2021 to February 2022, using the Documentation and Evaluation of Care of Dying Equation (DECODE) survey tool.</div></div><div><h3>Setting</h3><div>Three metropolitan adult ICUs in Victoria, Australia.</div></div><div><h3>Main outcomes</h3><div>DECODE audit score, patient characteristics, demographics, end of life planning, quality of death indicators, management of dying.</div></div><div><h3>Results</h3><div>There were 194 deaths over a 14-month period. 2 cases were excluded. Patients wishes were documented in 83 (43%) cases. A total of 175 patients (91%) were receiving active treatment 24 h before death. A total of 166 deaths (86%) were expected and occurred a mean of 4.5 (IQR 2-9) days from admission to ICU. A total of 52 (27%) had palliative or symptom control care plans. The median DECODE score was 14 (IQR 12-15) with statistical variation across the three sites (<em>p=0.001</em>). Compared to pre pandemic audits, the DECODE score was higher (<em>p=0.001</em>) despite pandemic restrictions.</div></div><div><h3>Conclusion</h3><div>EOLC in ICU remains challenging due to diagnostic dilemmas, prognostic uncertainty, and short time-frames. Assessment of quality of EoLC care helps assess and possibly improve provision of care. The DECODE questionnaire provides a semi-objective measure of quality of care provided to the dying patient in ICU.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 4","pages":"Article 100136"},"PeriodicalIF":1.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145324280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Six years of a clinical communication intervention in shared decision-making to promote documentation of goals of care for critically ill patients with a life-limiting illness 六年的临床沟通干预,共同决策,以促进文件化的护理目标,危重患者的生命限制疾病
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2025-12-01 Epub Date: 2025-10-17 DOI: 10.1016/j.ccrj.2025.100117
Georgia Peters BSc, MBBS (Hons), M Bioeth , Sharyn Milnes RN, GradCert CCN, GradCert Ed, GradDip AdEd, M Bioeth , Nicholas Simpson MBBS, FACEM, FCICM, PGDipEcho, GCHE , Olivia Gedye MBBS, FdnPallMed (cllinical) , Nima Kakho MBBS, FCICM , Charlie Corke MBBS, FCICM , Michael Bailey PhD, MSc, BSc (Hons) , Neil R. Orford MBBS, FCICM, FANZCA, PGDipEcho, PhD

Objective

Describe the association between the implementation of a shared decision-making (SDM) program and documentation of goals of care for critically ill patients with life-limiting illness (LLI).

Methods

A prospective longitudinal cohort study was conducted from 1st January 2015 to 30th September 2020 in an Australian tertiary teaching hospital. Adult patients with LLI admitted to the intensive care unit (ICU) were included. A SDM program consisting of communication training, a new goals of care form, and clinical support was implemented. The primary outcome was the proportion of patients with a documented SDM discussion. Secondary outcomes included patient treatment preferences and hospital utilisation parameters.

Results

A total of 1178 patients with LLI were admitted to the ICU during the study period and included in the study. Following the introduction of an SDM program, the proportion of patients with a documented SDM discussion increased from 22 % at baseline to a peak of 68 % at year five, then 60 % in year six of the study (adjusted odds ratio: 1.49, 95 % confidence interval: 1.38–1.60; p < 0.0001). Patients who had documented SDM were more likely to be older, female, frail, and have a prior advance care plan. SDM discussions resulted in higher rates of documented deterioration treatment preference plan (p < 0.0001), an increased ICU length of stay (3 vs. 2 days, p < 0.0001), referrals to palliative care services (p = 0.002), and a higher mortality rate. Time to death was significantly shorter in decedents with documented SDM compared to those without it (12 vs. 49 days, p < 0.0001).

Conclusion

The implementation of a comprehensive clinical communication training program was associated with increased documentation of shared decision-making discussions for patients in ICU with LLI, which corresponded with changes in patient treatment preferences and healthcare utilisation by decedents. Further research is required to understand the impact of these conversations from the perspective of patients and their families.
目的探讨共享决策(SDM)方案的实施与危重症限制性疾病(LLI)患者护理目标的记录之间的关系。方法于2015年1月1日至2020年9月30日在澳大利亚某三级教学医院进行前瞻性纵向队列研究。纳入重症监护病房(ICU)的成年LLI患者。实施了由沟通培训、新的护理形式目标和临床支持组成的SDM计划。主要结局是有记录的SDM讨论的患者比例。次要结局包括患者治疗偏好和医院利用参数。结果共1178例LLI患者在研究期间入住ICU并纳入研究。引入SDM计划后,记录SDM讨论的患者比例从基线时的22%增加到第五年的68%,然后在研究的第六年增加到60%(调整后的优势比:1.49,95%置信区间:1.38-1.60;p < 0.0001)。有记录的SDM患者更可能是老年人,女性,体弱,并且有事先的护理计划。SDM讨论导致记录的恶化率更高(p < 0.0001), ICU住院时间增加(3天vs. 2天,p < 0.0001),转介到姑息治疗服务(p = 0.002),死亡率更高。记录在案的SDM患者的死亡时间明显短于无SDM患者(12天vs 49天,p < 0.0001)。结论全面的临床沟通培训计划的实施与ICU中LLI患者共同决策讨论的记录增加有关,这与患者治疗偏好和死者医疗保健利用的变化相对应。需要进一步的研究来从患者及其家属的角度理解这些对话的影响。
{"title":"Six years of a clinical communication intervention in shared decision-making to promote documentation of goals of care for critically ill patients with a life-limiting illness","authors":"Georgia Peters BSc, MBBS (Hons), M Bioeth ,&nbsp;Sharyn Milnes RN, GradCert CCN, GradCert Ed, GradDip AdEd, M Bioeth ,&nbsp;Nicholas Simpson MBBS, FACEM, FCICM, PGDipEcho, GCHE ,&nbsp;Olivia Gedye MBBS, FdnPallMed (cllinical) ,&nbsp;Nima Kakho MBBS, FCICM ,&nbsp;Charlie Corke MBBS, FCICM ,&nbsp;Michael Bailey PhD, MSc, BSc (Hons) ,&nbsp;Neil R. Orford MBBS, FCICM, FANZCA, PGDipEcho, PhD","doi":"10.1016/j.ccrj.2025.100117","DOIUrl":"10.1016/j.ccrj.2025.100117","url":null,"abstract":"<div><h3>Objective</h3><div>Describe the association between the implementation of a shared decision-making (SDM) program and documentation of goals of care for critically ill patients with life-limiting illness (LLI).</div></div><div><h3>Methods</h3><div>A prospective longitudinal cohort study was conducted from 1st January 2015 to 30th September 2020 in an Australian tertiary teaching hospital. Adult patients with LLI admitted to the intensive care unit (ICU) were included. A SDM program consisting of communication training, a new goals of care form, and clinical support was implemented. The primary outcome was the proportion of patients with a documented SDM discussion. Secondary outcomes included patient treatment preferences and hospital utilisation parameters.</div></div><div><h3>Results</h3><div>A total of 1178 patients with LLI were admitted to the ICU during the study period and included in the study. Following the introduction of an SDM program, the proportion of patients with a documented SDM discussion increased from 22 % at baseline to a peak of 68 % at year five, then 60 % in year six of the study (adjusted odds ratio: 1.49, 95 % confidence interval: 1.38–1.60; p &lt; 0.0001). Patients who had documented SDM were more likely to be older, female, frail, and have a prior advance care plan. SDM discussions resulted in higher rates of documented deterioration treatment preference plan (p &lt; 0.0001), an increased ICU length of stay (3 vs. 2 days, p &lt; 0.0001), referrals to palliative care services (p = 0.002), and a higher mortality rate. Time to death was significantly shorter in decedents with documented SDM compared to those without it (12 vs. 49 days, p &lt; 0.0001).</div></div><div><h3>Conclusion</h3><div>The implementation of a comprehensive clinical communication training program was associated with increased documentation of shared decision-making discussions for patients in ICU with LLI, which corresponded with changes in patient treatment preferences and healthcare utilisation by decedents. Further research is required to understand the impact of these conversations from the perspective of patients and their families.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 4","pages":"Article 100117"},"PeriodicalIF":1.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145324262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Redefining success: Incorporating long-term survival outcomes into routine benchmarking 重新定义成功:将长期生存结果纳入常规基准
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2025-12-01 Epub Date: 2025-10-22 DOI: 10.1016/j.ccrj.2025.100138
Paul Secombe FCICM PhD, Edward Litton FCICM PhD, Shaila Chavan MSPH, Jennifer Hogan RN, Sue Huckson BAppSci RN, Tamishta Hensman FCICM MBBS, Chong Tien Goh FCICM MBBS, Craig Carr PH.D, Jason McClure FCICM MBBS, David Pilcher FCICM MBBS
{"title":"Redefining success: Incorporating long-term survival outcomes into routine benchmarking","authors":"Paul Secombe FCICM PhD,&nbsp;Edward Litton FCICM PhD,&nbsp;Shaila Chavan MSPH,&nbsp;Jennifer Hogan RN,&nbsp;Sue Huckson BAppSci RN,&nbsp;Tamishta Hensman FCICM MBBS,&nbsp;Chong Tien Goh FCICM MBBS,&nbsp;Craig Carr PH.D,&nbsp;Jason McClure FCICM MBBS,&nbsp;David Pilcher FCICM MBBS","doi":"10.1016/j.ccrj.2025.100138","DOIUrl":"10.1016/j.ccrj.2025.100138","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 4","pages":"Article 100138"},"PeriodicalIF":1.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145365869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The influence of consent models on recruitment rates in randomised trials in critical care: A systematic review 同意模式对重症监护随机试验招募率的影响:一项系统综述
IF 1.7 4区 医学 Q3 CRITICAL CARE MEDICINE Pub Date : 2025-12-01 Epub Date: 2025-10-16 DOI: 10.1016/j.ccrj.2025.100119
Mahesh Ramanan FCICM PhD , Aashish Kumar FCICM MBBS , Laurent Billot AStat MRes , John Myburgh FCICM PhD , Balasubramanian Venkatesh FCICM MD

Objectives

To determine whether type of consent model was associated with recruitment rate in critical care randomised clinical trials (RCT).

Data sources

PubMed was searched for relevant articles.

Study selection

Individual patient RCTs in critical care with a primary outcome of mortality published between 1990 and 2020 were included.

Data extraction

Two authors independently reviewed titles, abstracts, and full-text articles for eligibility, and data was entered into a structured custom database.

Data synthesis

186 RCTs were included, of which 141(75.8%) used a priori consent, while 45 (24.2%) used alternative consent models, including consent waiver and consent-to-continue. The alternate consent RCTs recruited significantly larger sample sizes (median 680 patients, IQR 300–2410) compared to the a priori group (350 patients, IQR 118–725) over similar recruitment periods (mean 3.06 years for both). The unadjusted mean weekly recruitment rate was significantly higher in the alternate consent group (mean difference +8.57 patients per week, 95% CI: 5.02–12.12). After adjustment for number of recruiting sites, diagnostic group of patients included, intervention type, investigator-initiated trial, and continent of primary trial sponsor, the alternate consent group still had a significantly higher mean weekly recruitment rate (mean difference +6.78 patients per week, 95% CI, 3.30–10.26). The proportion of RCTs that were ceased early and that reached target recruitment were similar between the two groups, as were rates of withdrawn consent.

Conclusion

Alternate consent models for critical care RCTs were associated with higher recruitment rates compared to a priori consent. A study-within-a-trial analysis may be required for definitive evaluation.

Registration

PROSPERO Record ID: Record ID: CRD42020215950.
目的探讨危重症随机临床试验(RCT)中同意模型类型与招募率的相关性。数据来源检索pubmed相关文章。研究选择纳入1990年至2020年间发表的以死亡率为主要结局的危重病患者个体随机对照试验。数据提取:两位作者独立审查标题、摘要和全文文章的资格,并将数据输入结构化的自定义数据库。纳入186项随机对照试验,其中141项(75.8%)使用先验同意,而45项(24.2%)使用替代同意模型,包括同意放弃和同意继续。与先验组(350例患者,IQR 118-725)相比,备用同意随机对照试验在相似的招募期(两组平均3.06年)招募了更大的样本量(中位680例患者,IQR 300-2410)。候补同意组未经调整的平均每周招募率显著更高(平均差异+8.57例/周,95% CI: 5.02-12.12)。在调整了招募地点的数量、纳入的患者诊断组、干预类型、研究者发起的试验和主要试验发起者的大陆后,备用同意组的平均每周招募率仍然显著更高(平均差异+6.78例/周,95% CI, 3.30-10.26)。两组间早期终止和达到目标招募的随机对照试验比例相似,撤回同意率也相似。结论与先验同意模型相比,危重病随机对照试验的替代同意模型与更高的招募率相关。可能需要一项试验中研究分析来确定评价。RegistrationPROSPERO记录ID:记录ID: CRD42020215950。
{"title":"The influence of consent models on recruitment rates in randomised trials in critical care: A systematic review","authors":"Mahesh Ramanan FCICM PhD ,&nbsp;Aashish Kumar FCICM MBBS ,&nbsp;Laurent Billot AStat MRes ,&nbsp;John Myburgh FCICM PhD ,&nbsp;Balasubramanian Venkatesh FCICM MD","doi":"10.1016/j.ccrj.2025.100119","DOIUrl":"10.1016/j.ccrj.2025.100119","url":null,"abstract":"<div><h3>Objectives</h3><div>To determine whether type of consent model was associated with recruitment rate in critical care randomised clinical trials (RCT).</div></div><div><h3>Data sources</h3><div>PubMed was searched for relevant articles.</div></div><div><h3>Study selection</h3><div>Individual patient RCTs in critical care with a primary outcome of mortality published between 1990 and 2020 were included.</div></div><div><h3>Data extraction</h3><div>Two authors independently reviewed titles, abstracts, and full-text articles for eligibility, and data was entered into a structured custom database.</div></div><div><h3>Data synthesis</h3><div>186 RCTs were included, of which 141(75.8%) used <em>a priori</em> consent, while 45 (24.2%) used alternative consent models, including consent waiver and consent-to-continue. The alternate consent RCTs recruited significantly larger sample sizes (median 680 patients, IQR 300–2410) compared to the <em>a priori</em> group (350 patients, IQR 118–725) over similar recruitment periods (mean 3.06 years for both). The unadjusted mean weekly recruitment rate was significantly higher in the alternate consent group (mean difference +8.57 patients per week, 95% CI: 5.02–12.12). After adjustment for number of recruiting sites, diagnostic group of patients included, intervention type, investigator-initiated trial, and continent of primary trial sponsor, the alternate consent group still had a significantly higher mean weekly recruitment rate (mean difference +6.78 patients per week, 95% CI, 3.30–10.26). The proportion of RCTs that were ceased early and that reached target recruitment were similar between the two groups, as were rates of withdrawn consent.</div></div><div><h3>Conclusion</h3><div>Alternate consent models for critical care RCTs were associated with higher recruitment rates compared to <em>a priori</em> consent. A study-within-a-trial analysis may be required for definitive evaluation.</div></div><div><h3>Registration</h3><div>PROSPERO Record ID: Record ID: <span><span>CRD42020215950</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 4","pages":"Article 100119"},"PeriodicalIF":1.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145324182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Critical Care and Resuscitation
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