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AbstractObjectiveTo determine outcomes and safety of endovascular treatment for acute ischaemic stroke, due to proximal intracranial vessel occlusion in the anterior circulation, in routine clinical practice.DesignOngoing, prospective, observational cohort study.Setting16 centres that perform endovascular treatment in the Netherlands.Participants1488 patients included in the Multicentre Randomised Controlled Trial of Endovascular Treatment for Acute Ischaemic Stroke in the Netherlands (MR CLEAN) Registry who had received endovascular treatment, including stent retriever thrombectomy, aspiration, and all alternative methods for acute ischaemic stroke within 6.5 hours from onset of symptoms between March 2014 and June 2016.Main outcome measuresThe primary outcome was the modified Rankin Scale (mRS) score, ranging from 0 (no symptoms) to 6 (death) at 90 days after the onset of symptoms. Secondary outcomes were excellent functional outcome (mRS score 0-1), good functional outcome (mRS score 0-2), and favourable functional outcome (mRS score 0-3) at 90 days; score on the extended thrombolysis in cerebral infarction scale at the end of the intervention procedure; National Institutes of Health Stroke Scale score 24-48 hours after intervention; and complications that occurred during intervention, hospital admission, or three months’ follow up period. Outcomes and safety variables in the MR CLEAN Registry were compared with the MR CLEAN trial intervention and control arms.ResultsA statistically significant shift was observed towards better functional outcome in patients in the MR CLEAN Registry compared with the MR CLEAN trial intervention arm (adjusted common odds ratio 1.30, 95% confidence interval 1.02 to 1.67) and the MR CLEAN trial control arm (1.85, 1.46 to 2.34). The reperfusion rate, with successful reperfusion defined as a score of 2B-3 on the extended thrombolysis in cerebral infarction score, was 58.7%, the same as for patients in the MR CLEAN trial. Duration from onset of stroke to start of endovascular treatment and from onset of stroke to successful reperfusion or last contrast bolus was one hour shorter for patients in the MR CLEAN Registry. Symptomatic intracranial haemorrhage occurred in 5.8% of patients in the MR CLEAN Registry compared with 7.7% in the MR CLEAN trial intervention arm and 6.4% in the MR CLEAN trial control arm.ConclusionIn routine clinical practice, endovascular treatment for patients with acute ischaemic stroke is at least as effective and safe as in the setting of a randomised controlled trial.

Observational studies have suggested that accelerated surgery is associated with improved outcomes in patients with a hip fracture. The HIP ATTACK trial assessed whether accelerated surgery could reduce mortality and major complications. HIP ATTACK was an international, randomised, controlled trial done at 69 hospitals in 17 countries. Patients with a hip fracture that required surgery and were aged 45 years or older were eligible. Research personnel randomly assigned patients (1:1) through a central computerised randomisation system using randomly varying block sizes to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care. The coprimary outcomes were mortality and a composite of major complications (ie, mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding) at 90 days after randomisation. Patients, health-care providers, and study staff were aware of treatment assignment, but outcome adjudicators were masked to treatment allocation. Patients were analysed according to the intention-to-treat principle. This study is registered at ClinicalTrials.gov (NCT02027896). Between March 14, 2014, and May 24, 2019, 27 701 patients were screened, of whom 7780 were eligible. 2970 of these were enrolled and randomly assigned to receive accelerated surgery (n=1487) or standard care (n=1483). The median time from hip fracture diagnosis to surgery was 6 h (IQR 4–9) in the accelerated-surgery group and 24 h (10–42) in the standard-care group (p<0·0001). 140 (9%) patients assigned to accelerated surgery and 154 (10%) assigned to standard care died, with a hazard ratio (HR) of 0·91 (95% CI 0·72 to 1·14) and absolute risk reduction (ARR) of 1% (−1 to 3; p=0·40). Major complications occurred in 321 (22%) patients assigned to accelerated surgery and 331 (22%) assigned to standard care, with an HR of 0·97 (0·83 to 1·13) and an ARR of 1% (−2 to 4; p=0·71). Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared with standard care. Canadian Institutes of Health Research.

To evaluate the changes in productivity when scribes were used by emergency physicians in emergency departments in Australia and assess the effect of scribes on throughput. Randomised, multicentre clinical trial. Five emergency departments in Victoria used Australian trained scribes during their respective trial periods. Sites were broadly representative of Australian emergency departments: public (urban, tertiary, regional referral, paediatric) and private, not for profit. 88 physicians who were permanent, salaried employees working more than one shift a week and were either emergency consultants or senior registrars in their final year of training; 12 scribes trained at one site and rotated to each study site. Physicians worked their routine shifts and were randomly allocated a scribe for the duration of their shift. Each site required a minimum of 100 scribed and non-scribed shifts, from November 2015 to January 2018. Physicians' productivity (total patients, primary patients); patient throughput (door-to-doctor time, length of stay); physicians' productivity in emergency department regions. Self reported harms of scribes were analysed, and a cost-benefit analysis was done. Data were collected from 589 scribed shifts (5098 patients) and 3296 non-scribed shifts (23 838 patients). Scribes increased physicians' productivity from 1.13 (95% confidence interval 1.11 to 1.17) to 1.31 (1.25 to 1.38) patients per hour per doctor, representing a 15.9% gain. Primary consultations increased from 0.83 (0.81 to 0.85) to 1.04 (0.98 to 1.11) patients per hour per doctor, representing a 25.6% gain. No change was seen in door-to-doctor time. Median length of stay reduced from 192 (interquartile range 108-311) minutes to 173 (96-208) minutes, representing a 19 minute reduction (P<0.001). The greatest gains were achieved by placing scribes with senior doctors at triage, the least by using them in sub-acute/fast track regions. No significant harm involving scribes was reported. The cost-benefit analysis based on productivity and throughput gains showed a favourable financial position with use of scribes. Scribes improved emergency physicians' productivity, particularly during primary consultations, and decreased patients' length of stay. Further work should evaluate the role of the scribe in countries with health systems similar to Australia's. ACTRN12615000607572 (pilot site); ACTRN12616000618459.

Delayed admission of myocardial infarction (MI) patients is an important prognostic factor. In the present nationwide registry (TURKMI-2), we evaluated the treatment delays and outcomes of patients with acute MI during the Covid-19 pandemic and compaired with a recentpre-pandemic registry (TURKMI-1). The pandemic and pre-pandemic studies were conducted prospectively as 15-day snapshot registries in the same 48 centers. The inclusion criteria for both registries were aged ≥18 years and a final diagnosis of acute MI (AMI) with positive troponin levels. The only difference between the 2 registries was that the pre-pandemic (TURKMI-1) registry (n=1872) included only patients presenting within the first 48 hours after symptom-onset. TURKMI-2 enrolled all consecutive patients (n=1113) presenting with AMI during the pandemic period. A comparison of the patients with acute MI presenting within the 48-hour of symptom-onset in the pre-pandemic and pandemic registries revealed an overall 47.1% decrease in acute MI admissions during the pandemic. Median time from symptom-onset to hospital-arrival increased from 150 min to 185 min in patients with ST elevation MI (STEMI) and 295 min to 419 min in patients presenting with non-STEMI (NSTEMI) (p-values <0.001). Door-to-balloon time was similar in the two periods (37 vs. 40 min, p=0.448). In the pandemic period, percutaneous coronary intervention (PCI) decreased, especially in the NSTEMI group (60.3% vs. 47.4% in NSTEMI, p<0.001; 94.8% vs. 91.1% in STEMI, p=0.013) but the decrease was not significant in STEMI patients admitted within 12 hours of symptom-onset (94.9% vs. 92.1%; p=0.075). In-hospital major adverse cardiac events (MACE) were significantly increased during the pandemic period [4.8% vs. 8.9%; p<0.001; age- and sex-adjusted Odds ratio (95% CI) 1.96 (1.20-3.22) for NSTEMI, p=0.007; and 2.08 (1.38-3.13) for STEMI, p<0.001]. The present comparison of 2 nationwide registries showed a significant delay in treatment of patients presenting with acute MI during the COVID-19 pandemic. Although PCI was performed in a timely fashion, an increase in treatment delay might be responsible for the increased risk of MACE. Public education and establishing COVID-free hospitals are necessary to overcome patients' fear of using healthcare services and mitigate the potential complications of AMI during the pandemic. (Anatol J Cardiol 2020; 24: 334-42).

The optimal management for acute traumatic cervical spinal cord injury (SCI) is unknown. To determine whether early surgical decompression results in better motor recovery than delayed surgical treatment in patients with acute traumatic incomplete cervical SCI associated with preexisting canal stenosis but without bone injury. This multicenter randomized clinical trial was conducted in 43 tertiary referral centers in Japan from December 2011 through November 2019. Patients aged 20 to 79 years with motor-incomplete cervical SCI with preexisting canal stenosis (American Spinal Injury Association [ASIA] Impairment Scale C; without fracture or dislocation) were included. Data were analyzed from September to November 2020. Patients were randomized to undergo surgical treatment within 24 hours after admission or delayed surgical treatment after at least 2 weeks of conservative treatment. The primary end points were improvement in the mean ASIA motor score, total score of the spinal cord independence measure, and the proportion of patients able to walk independently at 1 year after injury. Among 72 randomized patients, 70 patients (mean [SD] age, 65.1 [9.4] years; age range, 41-79 years; 5 [7%] women and 65 [93%] men) were included in the full analysis population (37 patients assigned to early surgical treatment and 33 patients assigned to delayed surgical treatment). Of these, 56 patients (80%) had data available for at least 1 primary outcome at 1 year. There was no significant difference among primary end points for the early surgical treatment group compared with the delayed surgical treatment group (mean [SD] change in ASIA motor score, 53.7 [14.7] vs 48.5 [19.1]; difference, 5.2; 95% CI, -4.2 to 14.5; P = .27; mean [SD] SCIM total score, 77.9 [22.7] vs 71.3 [27.3]; P = .34; able to walk independently, 21 of 30 patients [70.0%] vs 16 of 26 patients [61.5%]; P = .51). A mixed-design analysis of variance revealed a significant difference in the mean change in ASIA motor scores between the groups (F1,49 = 4.80; P = .03). The early surgical treatment group, compared with the delayed surgical treatment group, had greater motor scores than the delayed surgical treatment group at 2 weeks (mean [SD] score, 34.2 [18.8] vs 18.9 [20.9]), 3 months (mean [SD] score, 49.1 [15.1] vs 37.2 [20.9]), and 6 months (mean [SD] score, 51.5 [13.9] vs 41.3 [23.4]) after injury. Adverse events were common in both groups (eg, worsening of paralysis, 6 patients vs 6 patients; death, 3 patients vs 3 patients). These findings suggest that among patients with cervical SCI, early surgical treatment produced similar motor regain at 1 year after injury as delayed surgical treatment but showed accelerated recovery within the first 6 months. These exploratory results suggest that early surgical treatment leads to faster neurological recovery, which requires further validation. ClinicalTrials.gov Identifier: NCT01485458; umin.ac.jp/ctr Identifier: UMIN000006780.

Background Delayed treatment of tuberculosis (TB) cases increases the risk of death and rate of infection in the community. Early diagnosis and initiation of treatment is essential for effective TB control. The aim of this study was to assess length of delays and analyze predictors of treatment delay of newly diagnosed TB patients. Methods A cross-sectional study was conducted in Dessie city and surroundings from April1, 2016 to January 30, 2017. Fifteen health facilities of study area were selected randomly and 382 adult TB patients were included consecutively. Data were collected using a questionnaire and analyzed using SPSS version 20.0. Delay was analyzed at three levels (patient, health system and total) using median as cut-off. Logistic regression analysis was performed to investigate predictors of delays. A p -value of ≤0.05 at multivariate analysis was considered statistically significant. Results The median total, patients’ and health system’s delay was 36 [interquartile range (IQR): 24, 64], 30 (IQR: 15, 60) and 6 (IQR: 4, 8) days, respectively. About 41 and 47% of patients had prolonged patients’ and total delay, respectively. Practicing self-medication [adjusted odds ratio (AOR): 3.0; 95% CI: 1.3–5.6], having more than three family member in the household (AOR: 1.6; 95% CI: 1.02–2.50), older age (≥55 years) (AOR: 2.7; 95% CI: 1.27–5.83), being smear negative pulmonary tuberculosis (AOR: 2.3; 95% CI: 1.25–4.21) and extrapulmonary tuberculosis (AOR: 2.3; 95% CI: 1.28–4.07) were independent predictors of patients’ delay. Initial visit of general practitioners (AOR: 2.57; 95% CI: 1.43–4.63) and more than one health care visit (AOR: 2.12; 95% CI: 1.30–3.46) were independent predictors of health system’s delay. However, patients’ delay was shorter among widowed/divorced patients (AOR: 0.3; 95% CI: 0.1–0.8). Lower level of education [illiterate (AOR: 0.42; 95% CI: 0.20–0.92), grade 1–8 (AOR: 0.38; 95% CI: 0.18–0.81)] and diagnosis of TB using a chest X-ray (AOR, 0.32; 95% CI, 0.16–0.68) significantly reduce health system’s delay. Conclusion About half of TB patients delayed beyond 36 days before starting treatment, and the late patient health seeking behavior was the major contributor of total delay. Development and implementation of strategies aimed at addressing identified factors should be recognized in order to reduce TB treatment delay. Further well designed research is needed to explore additional risk factors of delayed treatment.

Background Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management. The CRADLE vital signs alert device accurately measures blood pressure and heart rate, calculates the shock index (heart rate divided by systolic blood pressure) and alerts the user to compromise through a traffic light system reflecting previously validated shock index thresholds. Methods This is a planned secondary analysis of data from the CRADLE-3 trial from ten clusters across Africa, India and Haiti where the device and training package were randomly introduced. Referral data were prospectively collected for a 4-week period before, and a 4-week period 3 months after implementation. Referrals from primary or secondary care facilities to higher level care for any cause were recorded. The denominator was the number of women seen for maternity care in these facilities. Results Between April 1 2016 and Nov 30th, 2017 536,223 women attended maternity care facilities. Overall, 3.7% ( n  = 2784/74,828) of women seen in peripheral maternity facilities were referred to higher level care in the control period compared to 4.4% ( n  = 3212/73,371) in the intervention period (OR 0.89; 0.39–2.05) (data for nine sites that were able to collect denominator). Of these 0.29% ( n  = 212) pre-intervention and 0.16% ( n  = 120) post-intervention were referred to higher-level facilities for maternal haemorrhage. Although overall referrals did not significantly reduce there was a significant reduction in referrals for obstetric haemorrhage (OR 0.56 (0.39–0.65) following introduction of the device with homogeneity (i-squared 26.1) between sites. There was no increase in any bleeding-related morbidity (maternal death or emergency hysterectomy). Conclusions Referrals for obstetric haemorrhage reduced following implementation of the CRADLE Vital Signs Alert Device, occurring without an increase in maternal death or emergency hysterectomy. This demonstrates the potential benefit of shock index in management pathways for obstetric haemorrhage and targeting limited resources in low- middle- income settings. Trial registration This study is registered with the ISRCTN registry, number ISRCTN41244132 (02/02/2016).

Background Many Canadian adolescents and young adults with mental health problems face delayed detection, long waiting lists, poorly accessible services, care of inconsistent quality and abrupt or absent inter-service transitions. To address these issues, ACCESS Open Minds, a multi-stakeholder network, is implementing and systematically evaluating a transformation of mental health services for youth aged 11 to 25 at 14 sites across Canada. The transformation plan has five key foci: early identification, rapid access, appropriate care, the elimination of age-based transitions between services, and the engagement of youth and families. Methods The ACCESS Open Minds Research Protocol has multiple components including a minimum evaluation protocol and a stepped-wedge cluster randomized trial, that are detailed in this paper. Additional components include qualitative methods and cost-effectiveness analyses. The services transformation is being evaluated at all sites via a minimum evaluation protocol. Six sites are participating in the stepped-wedge trial whereby the intervention (a service transformation along the key foci) was rolled out in three waves, each commencing six months apart. Two sites, one high-population and one low-population, were randomly assigned to each of the three waves, i.e., randomization was stratified by population size. Our primary hypotheses pertain to increased referral numbers, and reduced wait times to initial assessment and to the commencement of appropriate care. Secondary hypotheses pertain to simplified pathways to care; improved clinical, functional and subjective outcomes; and increased satisfaction among youth and families. Quantitative measures addressing these hypotheses are being used to determine the effectiveness of the intervention. Discussion Data from our overall research strategy will help test the effectiveness of the ACCESS Open Minds transformation, refine it further, and inform its scale-up. The process by which our research strategy was developed has implications for the practice of research itself in that it highlights the need to actively engage all stakeholder groups and address unique considerations in designing evaluations of complex healthcare interventions in multiple, diverse contexts. Our approach will generate both concrete evidence and nuanced insights, including about the challenges of conducting research in real-world settings. More such innovative approaches are needed to advance youth mental health services research. Trial registration number Clinicaltrials.gov, ISRCTN23349893 (Retrospectively registered: 16/02/2017).

Background and purpose Patients with acute ischaemic stroke and a large vessel occlusion who present to a non‐endovascular‐capable centre often require inter‐hospital transfer for thrombectomy. Whether the inter‐hospital transfer time is associated with 3‐month functional outcome is poorly known. Methods Acute stroke patients enrolled between January 2015 and December 2022 in the prospective French multicentre Endovascular Treatment of Ischaemic Stroke registry were retrospectively analysed. Patients with an anterior circulation large vessel occlusion transferred from a non‐endovascular to a comprehensive stroke centre for thrombectomy were eligible. Inter‐hospital transfer time was defined as the time between imaging in the referring hospital and groin puncture for thrombectomy. The relationship between transfer time and favourable 3‐month functional outcome (modified Rankin Scale 0–2) was assessed through a mixed logistic regression model adjusting for centre and symptom‐onset‐to‐referring‐hospital imaging time, age, sex, diabetes, referring hospital National Institutes of Health Stroke Scale score, Alberta Stroke Programme Early Computed Tomography Score, occlusion site and intravenous thrombolysis use. Results Overall, 3769 patients were included (median inter‐hospital transfer time 161 min, interquartile range 128–195; 46% with favourable outcome). A longer transfer time was independently associated with lower rates of favourable outcome (p < 0.001). Compared to patients with transfer time below 120 min, there was a 15% reduction in the odds of achieving favourable outcome for transfer times between 120 and 180 min (adjusted odds ratio 0.85; 95% confidence interval 0.67–1.07), and a 36% reduction for transfer times beyond 180 min (adjusted odds ratio 0.64; 95% confidence interval 0.50–0.81). Conclusions A shorter inter‐hospital transfer time is strongly associated with favourable 3‐month functional outcome. A speedier inter‐hospital transfer is of critical importance to improve outcome.

Choice of initial antiretroviral therapy regimen may help children with HIV maintain optimal, continuous therapy. We assessed treatment-naïve children for differences in time to treatment disruption across randomly-assigned protease inhibitor versus non-nucleoside reverse transcriptase inhibitor-based initial antiretroviral therapy. We performed a secondary analysis of a multicenter phase 2/3, randomized, open-label trial in Europe, North and South America from 2002 to 2009. Children aged 31 days to <18 years, who were living with HIV-1 and treatment-naive, were randomized to antiretroviral therapy with two nucleoside reverse transcriptase inhibitors plus a protease inhibitor or non-nucleoside reverse transcriptase inhibitor. Time to first documented treatment disruption to any component of antiretroviral therapy, derived from treatment records and adherence questionnaires, was analyzed using Kaplan-Meier estimators and Cox proportional hazards models. The modified intention-to-treat analysis included 263 participants. Seventy-two percent (n = 190) of participants experienced at least one treatment disruption during study. At 4 years, treatment disruption probabilities were 70% (protease inhibitor) vs. 63% (non-nucleoside reverse transcriptase inhibitor). The unadjusted hazard ratio (HR) for treatment disruptions comparing protease inhibitor vs. non-nucleoside reverse transcriptase inhibitor-based regimens was 1.19, 95% confidence interval [CI] 0.88-1.61 (adjusted HR 1.24, 95% CI 0.91-1.68). By study end, treatment disruption probabilities converged (protease inhibitor 81%, non-nucleoside reverse transcriptase inhibitor 84%) with unadjusted HR 1.11, 95% CI 0.84-1.48 (adjusted HR 1.13, 95% CI 0.84-1.50). Reported reasons for treatment disruptions suggested that participants on protease inhibitors experienced greater tolerability problems. Children had similar time to treatment disruption for initial protease inhibitor and non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy, despite greater reported tolerability problems with protease inhibitor regimens. Initial pediatric antiretroviral therapy with either a protease inhibitor or non-nucleoside reverse transcriptase inhibitor may be acceptable for maintaining optimal, continuous therapy.