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Article ; Online: Divergent confidence intervals among pre-specified analyses in the HiSTORIC stepped wedge trial: An exploratory post-hoc investigation.

Parker, Richard A / Keerie, Catriona / Weir, Christopher J / Anand, Atul / Mills, Nicholas L

2022 Volume 17, Issue 7, Page(s) e0271027

Abstract: Background: The high-sensitivity cardiac troponin on presentation to rule out myocardial infarction (HiSTORIC) study was a stepped-wedge cluster randomised trial with long before-and-after periods, involving seven hospitals across Scotland. Results were ...

Abstract	Background: The high-sensitivity cardiac troponin on presentation to rule out myocardial infarction (HiSTORIC) study was a stepped-wedge cluster randomised trial with long before-and-after periods, involving seven hospitals across Scotland. Results were divergent for the binary safety endpoint (type 1 or type 4b myocardial infarction or cardiac death) across certain pre-specified analyses, which warranted further investigation. In particular, the calendar-matched analysis produced an odds ratio in the opposite direction to the primary logistic mixed-effects model analysis. Methods: Several post-hoc statistical models were fitted to each of the co-primary outcomes of length of hospital stay and safety events, which included adjusting for exposure time, incorporating splines, and fitting a random time effect. We improved control of patient characteristics over time by adjusting for multiple additional covariates using different methods: direct inclusion, regression adjustment for propensity score, and weighting. A data augmentation approach was also conducted aiming to reduce the effect of sparse data bias. Finally, the raw data was examined. Results: The new statistical models confirmed the results of the pre-specified trial analysis. In particular, the observed divergence between the calendar-matched and other analyses remained, even after performing the covariate adjustment methods, and after using data augmentation. Divergence was particularly acute for the safety endpoint, which had an event rate of 0.36% overall. Examining the raw data was particularly helpful to assess the sensitivity of the results to small changes in event rates and identify patterns in the data. Conclusions: Our experience reveals the importance of conducting multiple pre-specified sensitivity analyses and examining the raw data, particularly for stepped wedge trials with low event rates or with a small number of sites. Before-and-after analytical approaches that adjust for differences in patient populations but avoid direct modelling of the time trend should be considered in future stepped wedge trials with similar designs.
MeSH term(s)	Bias ; Confidence Intervals ; Humans ; Myocardial Infarction/diagnosis ; Research Design ; Sample Size
Language	English
Publishing date	2022-07-01
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0271027
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Article ; Online: Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol.

Murray, Sarah / Thompson, Jessica / Townsend, Rosie C / Deidda, Manuela / Boyd, Kathleen Anne / Norman, Jane E / Norrie, John / Boardman, James P / Luyt, Karen / Khalil, Asma / Bick, Debra / Reed, Keith / Denton, Jane / Fenwick, Natasha / Keerie, Catriona / Reynolds, Rebecca / Stock, Sarah Jane

BMJ open

2024 Volume 14, Issue 1, Page(s) e078778

Abstract: Introduction: The aim of the STOPPIT-3 study is to determine the clinical and cost effectiveness of antenatal corticosteroids (ACS) prior to planned birth of twins in a multicentre placebo-controlled trial with internal pilot.: Methods and analysis: ... ...

Abstract	Introduction: The aim of the STOPPIT-3 study is to determine the clinical and cost effectiveness of antenatal corticosteroids (ACS) prior to planned birth of twins in a multicentre placebo-controlled trial with internal pilot. Methods and analysis: This study will comprise a multicentre, double-blinded, randomised, placebo-controlled trial in at least 50 UK obstetric units. The target population is 1552 women with a twin pregnancy and a planned birth between 35 and 38+6 weeks' gestation recruited from antenatal clinics. Women will be randomised to Dexamethasone Phosphate (24 mg) or saline administered via two intramuscular injections 24 hours apart, 24-120 hours prior to scheduled birth. Outcomes: The primary outcome is need for respiratory support within 72 hours of birth. Secondary and safety outcomes will be included. Cognitive and language development at age 2 years will be assessed in a subset of participants using the Parent report of Children's Abilities-Revised questionnaire. We will also determine the cost effectiveness of the treatment with ACS compared with placebo. Ethics and dissemination: STOPPIT-3 has been funded and approved by the National Institute of Healthcare Research. It has been approved by the West Midlands Research Ethics Committee (22/WM/0018). The results will be disseminated via publication in peer-reviewed journals and conference presentation and will also be communicated to the public via links with charity partners and social media. Trial sponsor: The University of Edinburgh and Lothian Health Board ACCORD, The Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ. Trial registration number: ISRCTN59959611.
MeSH term(s)	Child ; Pregnancy ; Female ; Humans ; Child, Preschool ; Adrenal Cortex Hormones/therapeutic use ; Pregnancy, Twin ; Twins ; Gestational Age ; France ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
Chemical Substances	Adrenal Cortex Hormones
Language	English
Publishing date	2024-01-18
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2023-078778
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Article ; Online: Protocol of a randomised trial of teriparatide followed by zoledronic acid to reduce fracture risk in adults with osteogenesis imperfecta.

Hald, Jannie D / Keerie, Catriona / Weir, Christopher J / Javaid, Muhammad K / Lam, Wayne / Osborne, Patricia / Walsh, Jennifer / Langdahl, Bente L / Ralston, Stuart H

BMJ open

2023 Volume 13, Issue 11, Page(s) e078164

Abstract: Introduction: Osteogenesis imperfecta (OI) is a rare genetic disease associated with multiple fractures throughout life. It is often treated with osteoporosis medications but their effectiveness at preventing fractures is unknown. The Treatment of ... ...

Abstract	Introduction: Osteogenesis imperfecta (OI) is a rare genetic disease associated with multiple fractures throughout life. It is often treated with osteoporosis medications but their effectiveness at preventing fractures is unknown. The Treatment of Osteogenesis Imperfecta with Parathyroid Hormone and Zoledronic Acid trial will determine if therapy with teriparatide (TPTD) followed by zoledronic acid (ZA) can reduce the risk of clinical fractures in OI. Methods and analysis: Individuals aged ≥18 years with a clinical diagnosis of OI are eligible to take part. At baseline, participants will undergo a spine X-ray, and have bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) at the spine and hip. Information on previous fractures and previous bone targeted treatments will be collected. Questionnaires will be completed to assess pain and other aspects of health-related quality of life (HRQoL). Participants will be randomised to receive a 2-year course of TPTD injections 20 µg daily followed by a single intravenous infusion of 5 mg ZA, or to receive standard care, which will exclude the use of bone anabolic drugs. Participants will be followed up annually, have a repeat DXA at 2 years and at the end of study. Spine X-rays will be repeated at the end of study. The duration of follow-up will range between 2 and 8 years. The primary endpoint will be new clinical fractures confirmed by X-ray or other imaging. Secondary endpoints will include participant reported fractures, BMD and changes in pain and HRQoL. Ethics and dissemination: The study received ethical approval in December 2016. Following completion of the trial, a manuscript will be submitted to a peer-reviewed journal. The results will inform clinical practice by determining if TPTD/ZA can reduce the risk of fractures in OI compared with standard care. Trial registration number: ISRCTN15313991.
MeSH term(s)	Humans ; Adult ; Adolescent ; Zoledronic Acid/therapeutic use ; Teriparatide/therapeutic use ; Osteogenesis Imperfecta/complications ; Osteogenesis Imperfecta/drug therapy ; Bone Density Conservation Agents/therapeutic use ; Quality of Life ; Fractures, Bone/prevention & control ; Fractures, Bone/complications ; Bone Density ; Pain/drug therapy ; Randomized Controlled Trials as Topic
Chemical Substances	Zoledronic Acid (6XC1PAD3KF) ; Teriparatide (10T9CSU89I) ; Bone Density Conservation Agents
Language	English
Publishing date	2023-11-22
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2023-078164
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Article: Modified-release morphine or placebo for chronic breathlessness: the MABEL trial protocol.

Date, Kathryn / Williams, Bronwen / Cohen, Judith / Chaudhuri, Nazia / Bajwah, Sabrina / Pearson, Mark / Higginson, Irene / Norrie, John / Keerie, Catriona / Tuck, Sharon / Hall, Peter / Currow, David / Fallon, Marie / Johnson, Miriam

ERJ open research

2023 Volume 9, Issue 4

Abstract: Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the ... ...

Abstract	Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the relief of chronic breathlessness in common long-term conditions, but questions remain around clinical effectiveness, safety and longer term (>7 days) administration. This trial will evaluate the effectiveness of low-dose oral modified-release morphine in chronic breathlessness. This is a multicentre, parallel group, double-blind, randomised, placebo-controlled trial. Participants (n=158) will be opioid-naïve with chronic breathlessness due to heart or lung disease, cancer or post-coronavirus disease 2019. Participants will be randomised 1:1 to 5 mg oral modified-release morphine/placebo twice daily and docusate/placebo 100 mg twice daily for 56 days. Non-responders at Day 7 will dose escalate to 10 mg morphine/placebo twice daily at Day 15. The primary end-point (Day 28) measure will be worst breathlessness severity (previous 24 h). Secondary outcome measures include worst cough, distress, pain, functional status, physical activity, quality of life, and early identification and management of morphine-related side-effects. At Day 56, participants may opt to take open-label, oral modified-release morphine as part of usual care and complete quarterly breathlessness and toxicity questionnaires. The study is powered to be able to reject the null hypothesis and an embedded normalisation process theory-informed qualitative substudy will explore the adoption of morphine as a first-line pharmacological treatment for chronic breathlessness in clinical practice if effective.
Language	English
Publishing date	2023-08-14
Publishing country	England
Document type	Journal Article
ZDB-ID	2827830-6
ISSN	2312-0541
ISSN	2312-0541
DOI	10.1183/23120541.00167-2023
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Article ; Online: A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, and topical and oral analgesia (OPPORTUNITY): a two-centre, open-label, randomised controlled feasibility trial.

Simpson, A Hamish R W / Clement, Nicholas D / Simpson, Sharon A / Pandit, Hemandt / Smillie, Susie / Leeds, Anthony R / Conaghan, Philip G / Kingsbury, Sarah R / Hamilton, David / Craig, Peter / Ray, David / Keerie, Catriona / Kinsella, Elaine / Bell-Higgs, Anna / McGarty, Arlene / Beadle, Christine / Howie, Colin R / Norrie, John

The Lancet. Rheumatology

2024 Volume 6, Issue 4, Page(s) e237–e246

Abstract: Background: Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the ... ...

Abstract	Background: Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the preoperative period. Therefore, we aimed to assess feasibility, acceptability, and recruitment and retention rates of a preoperative package of non-operative care in patients awaiting knee replacement surgery. Methods: We did an open-label, randomised controlled, feasibility trial in two secondary care centres in the UK. Eligible participants were aged 15-85 years, on the waiting list for a knee arthroplasty for osteoarthritis, and met at least one of the thresholds for one of the four components of the preoperative package of non-operative care intervention (ie, weight loss, exercise therapy, use of insoles, and analgesia adjustment). Participants were randomly assigned (2:1) to either the intervention group or the standard of care (ie, control) group. All four aspects of the intervention were delivered weekly over 12 weeks. Participants in the intervention group were reviewed regularly to assess adherence. The primary outcome was acceptability and feasibility of delivering the intervention, as measured by recruitment rate, retention rate at follow-up review after planned surgery, health-related quality of life, joint-specific scores, and adherence (weight change and qualitative interviews). This study is registered with ISRCTN, ISRCTN96684272. Findings: Between Sept 3 2018, and Aug 30, 2019, we screened 233 patients, of whom 163 (73%) were excluded and 60 (27%) were randomly assigned to either the intervention group (n=40) or the control group (n=20). 34 (57%) of 60 participants were women, 26 (43%) were men, and the mean age was 66·8 years (SD 8·6). Uptake of the specific intervention components varied: 31 (78%) of 40 had exercise therapy, 28 (70%) weight loss, 22 (55%) analgesia adjustment, and insoles (18 [45%]). Overall median adherence was 94% (IQR 79·5-100). At the final review, the intervention group lost a mean of 11·2 kg (SD 5·6) compared with 1·3 kg (3·8) in the control group (estimated difference -9·8 kg [95% CI -13·4 to -6·3]). A clinically significant improvement in health-related quality o life (mean change 0·078 [SD 0·195]) were reported, and joint-specific scores showed greater improvement in the intervention group than in the control group. No adverse events attributable to the intervention occurred. Interpretation: Participants adhered well to the non-operative interventions and their health-related quality of life improved. Participant and health professional feedback were extremely positive. These findings support progression to a full-scale effectiveness trial. Funding: Versus Arthritis.
MeSH term(s)	Aged ; Female ; Humans ; Male ; Analgesia ; Feasibility Studies ; Osteoarthritis/therapy ; Quality of Life ; Weight Loss
Language	English
Publishing date	2024-02-26
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial
ISSN	2665-9913
ISSN (online)	2665-9913
DOI	10.1016/S2665-9913(23)00337-5
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Article ; Online: A plea for TDM-based optimisation for treatment of Crohn's disease - Authors' reply.

Kennedy, Nicholas A / Keerie, Catriona / Mowat, Craig / Satsangi, Jack

The lancet. Gastroenterology & hepatology

2017 Volume 2, Issue 2, Page(s) 81–82

MeSH term(s)	Crohn Disease/drug therapy ; Humans
Language	English
Publishing date	2017-01-12
Publishing country	Netherlands
Document type	Letter ; Comment
ISSN	2468-1253
ISSN (online)	2468-1253
DOI	10.1016/S2468-1253(16)30222-9
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Article ; Online: Data sharing in clinical trials - practical guidance on anonymising trial datasets.

Keerie, Catriona / Tuck, Christopher / Milne, Garry / Eldridge, Sandra / Wright, Neil / Lewis, Steff C

Trials

2018 Volume 19, Issue 1, Page(s) 25

Abstract: Background: There is an increasing demand by non-commercial funders that trialists should provide access to trial data once the primary analysis is completed. This has to take into account concerns about identifying individual trial participants, and ... ...

Abstract	Background: There is an increasing demand by non-commercial funders that trialists should provide access to trial data once the primary analysis is completed. This has to take into account concerns about identifying individual trial participants, and the legal and regulatory requirements. Methods: Using the good practice guideline laid out by the work funded by the Medical Research Council Hubs for Trials Methodology Research (MRC HTMR), we anonymised a dataset from a recently completed trial. Using this example, we present practical guidance on how to anonymise a dataset, and describe rules that could be used on other trial datasets. We describe how these might differ if the trial was to be made freely available to all, or if the data could only be accessed with specific permission and data usage agreements in place. Results: Following the good practice guidelines, we successfully created a controlled access model for trial data sharing. The data were assessed on a case-by-case basis classifying variables as direct, indirect and superfluous identifiers with differing methods of anonymisation assigned depending on the type of identifier. A final dataset was created and checks of the anonymised dataset were applied. Lastly, a procedure for release of the data was implemented to complete the process. Conclusions: We have implemented a practical solution to the data anonymisation process resulting in a bespoke anonymised dataset for a recently completed trial. We have gained useful learnings in terms of efficiency of the process going forward, the need to balance anonymity with data utilisation and future work that should be undertaken.
MeSH term(s)	Clinical Trials as Topic ; Data Anonymization ; Datasets as Topic ; Humans ; Information Dissemination ; Practice Guidelines as Topic
Language	English
Publishing date	2018-01-10
Publishing country	England
Document type	Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-017-2382-9
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Article ; Online: Early diagnosis of brain tumours using a novel spectroscopic liquid biopsy.

Brennan, Paul M / Butler, Holly J / Christie, Loren / Hegarty, Mark G / Jenkinson, Michael D / Keerie, Catriona / Norrie, John / O'Brien, Rachel / Palmer, David S / Smith, Benjamin R / Baker, Matthew J

Brain communications

2021 Volume 3, Issue 2, Page(s) fcab056

Abstract: Early diagnosis of brain tumours is challenging and a major unmet need. Patients with brain tumours most often present with non-specific symptoms more commonly associated with less serious diagnoses, making it difficult to determine which patients to ... ...

Abstract	Early diagnosis of brain tumours is challenging and a major unmet need. Patients with brain tumours most often present with non-specific symptoms more commonly associated with less serious diagnoses, making it difficult to determine which patients to prioritize for brain imaging. Delays in diagnosis affect timely access to treatment, with potential impacts on quality of life and survival. A test to help identify which patients with non-specific symptoms are most likely to have a brain tumour at an earlier stage would dramatically impact on patients by prioritizing demand on diagnostic imaging facilities. This clinical feasibility study of brain tumour early diagnosis was aimed at determining the accuracy of our novel spectroscopic liquid biopsy test for the triage of patients with non-specific symptoms that might be indicative of a brain tumour, for brain imaging. Patients with a suspected brain tumour based on assessment of their symptoms in primary care can be referred for open access CT scanning. Blood samples were prospectively obtained from 385 of such patients, or patients with a new brain tumour diagnosis. Samples were analysed using our spectroscopic liquid biopsy test to predict presence of disease, blinded to the brain imaging findings. The results were compared to the patient's index brain imaging delivered as per standard care. Our test predicted the presence of glioblastoma, the most common and aggressive brain tumour, with 91% sensitivity, and all brain tumours with 81% sensitivity, and 80% specificity. Negative predictive value was 95% and positive predictive value 45%. The reported levels of diagnostic accuracy presented here have the potential to improve current symptom-based referral guidelines, and streamline assessment and diagnosis of symptomatic patients with a suspected brain tumour.
Language	English
Publishing date	2021-03-30
Publishing country	England
Document type	Journal Article
ISSN	2632-1297
ISSN (online)	2632-1297
DOI	10.1093/braincomms/fcab056
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Article ; Online: Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar.

Woodfield, Julie / Edlmann, Ellie / Black, Polly L / Boyd, Julia / Copley, Phillip Correia / Cranswick, Gina / Eborall, Helen / Keerie, Catriona / Khan, Sadaquate / Lawton, Julia / Lowe, David J / Norrie, John / Niven, Angela / Reed, Matthew J / Shenkin, Susan Deborah / Statham, Patrick / Stoddart, Andrew / Tomlinson, James / Brennan, Paul M

BMJ open

2022 Volume 12, Issue 7, Page(s) e057753

Abstract: Introduction: Fractures of the odontoid process frequently result from low impact falls in frail or older adults. These are increasing in incidence and importance as the population ages. In the UK, odontoid fractures in older adults are usually managed ... ...

Abstract	Introduction: Fractures of the odontoid process frequently result from low impact falls in frail or older adults. These are increasing in incidence and importance as the population ages. In the UK, odontoid fractures in older adults are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony healing does not always occur in older adults, and bony healing is not associated with quality of life, functional, or pain outcomes. Further, hard collars can cause complications such as skin pressure ulcers, swallowing difficulties and difficulties with personal care. We hypothesise that management with no immobilisation may be superior to management in a hard collar for older or frail adults with odontoid fractures. Methods and analyses: This is the protocol for the Duration of External Neck Stabilisation (DENS) trial-a non-blinded randomised controlled trial comparing management in a hard collar with management without a collar for older (≥65 years) or frail (Rockwood Clinical Frailty Scale ≥5) adults with a new odontoid fracture. 887 neurologically intact participants with any odontoid process fracture type will be randomised to continuing with a hard collar (standard care) or removal of the collar (intervention). The primary outcome is quality of life measured using the EQ-5D-5L at 12 weeks. Secondary outcomes include pain scores, neck disability index, health and social care use and costs, and mortality. Ethics and dissemination: Informed consent for participation will be sought from those able to provide it. We will also include those who lack capacity to ensure representativeness of frail and acutely unwell older adults. Results will be disseminated via scientific publication, lay summary, and visual abstract. The DENS trial received a favourable ethical opinion from the Scotland A Research Ethics Committee (21/SS/0036) and the Leeds West Research Ethics Committee (21/YH/0141). Trial registration number: NCT04895644.
MeSH term(s)	Aged ; Fractures, Bone ; Frail Elderly ; Humans ; Odontoid Process/injuries ; Pain ; Quality of Life ; Randomized Controlled Trials as Topic ; Spinal Fractures/therapy
Language	English
Publishing date	2022-07-15
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-057753
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Article ; Online: Is rapid acute coronary syndrome evaluation with high-sensitivity cardiac troponin less costly? An economic evaluation.

Danagoulian, Shooshan / Miller, Joseph / Cook, Bernard / Gunaga, Satheesh / Fadel, Raef / Gandolfo, Chaun / Mills, Nicholas L / Modi, Shalini / Mahler, Simon A / Levy, Phillip D / Parikh, Sachin / Krupp, Seth / Abdul-Nour, Khaled / Klausner, Howard / Rockoff, Steven / Gindi, Ryan / Lewandowski, Aaron / Hudson, Michael / Perrotta, Giuseppe /

Zweig, Bryan / Lanfear, David / Kim, Henry / Shaheen, Elizabeth / Darnell, Gale / Nassereddine, Hashem / Hawatian, Kegham / Tang, Amy / Keerie, Catriona / McCord, James

Journal of the American College of Emergency Physicians open

2024 Volume 5, Issue 2, Page(s) e13140

Abstract: Objective: Protocols to evaluate for myocardial infarction (MI) using high-sensitivity cardiac troponin (hs-cTn) have the potential to drive costs upward due to the added sensitivity. We performed an economic evaluation of an accelerated protocol (AP) ... ...

Abstract	Objective: Protocols to evaluate for myocardial infarction (MI) using high-sensitivity cardiac troponin (hs-cTn) have the potential to drive costs upward due to the added sensitivity. We performed an economic evaluation of an accelerated protocol (AP) to evaluate for MI using hs-cTn to identify changes in costs of treatment and length of stay compared with conventional testing. Methods: We performed a planned secondary economic analysis of a large, cluster randomized trial across nine emergency departments (EDs) from July 2020 to April 2021. Patients were included if they were 18 years or older with clinical suspicion for MI. In the AP, patients could be discharged without further testing at 0 h if they had a hs-cTnI < 4 ng/L and at 1 h if the initial value were 4 ng/L and the 1-h value ≤7 ng/L. Patients in the standard of care (SC) protocol used conventional cTn testing at 0 and 3 h. The primary outcome was the total cost of treatment, and the secondary outcome was ED length of stay. Results: Among 32,450 included patients, an AP had no significant differences in cost (+$89, CI: -$714, $893 hospital cost, +$362, CI: -$414, $1138 health system cost) or ED length of stay (+46, CI: -28, 120 min) compared with the SC protocol. In lower acuity, free-standing EDs, patients under the AP experienced shorter length of stay (-37 min, CI: -62, 12 min) and reduced health system cost (-$112, CI: -$250, $25). Conclusion: Overall, the implementation of AP using hs-cTn does not result in higher costs.
Language	English
Publishing date	2024-04-02
Publishing country	United States
Document type	Journal Article
ISSN	2688-1152
ISSN (online)	2688-1152
DOI	10.1002/emp2.13140
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