Importance Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete. Objective As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances. Evidence A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders. Findings The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline’s core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses. Conclusions and Relevance CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.

/pdf/guidelines-for-reporting-trial-protocols-and-completed-3lwuc7s6hf.pdf

Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement.

BACKGROUND
Paediatric cervical spine injury (CSI) after blunt trauma is rare but can have severe consequences. Clinical decision rules (CDRs) have been developed to guide clinical decision-making, minimise unnecessary tests and associated risks, whilst detecting all significant CSIs. Several validated CDRs are used to guide imaging decision-making in adults following blunt trauma and clinical criteria have been proposed as possible paediatric-specific CDRs. Little information is known about their accuracy.


OBJECTIVES
To assess and compare the diagnostic accuracy of CDRs or sets of clinical criteria, alone or in comparison with each other, for the evaluation of CSI following blunt trauma in children.


SEARCH METHODS
For this update, we searched CENTRAL, MEDLINE, Embase, and six other databases from 1 January 2015 to 13 December 2022. As we expanded the index test eligibility for this review update, we searched the excluded studies from the previous version of the review for eligibility. We contacted field experts to identify ongoing studies and studies potentially missed by the search. There were no language restrictions.


SELECTION CRITERIA
We included cross-sectional or cohort designs (retrospective and prospective) and randomised controlled trials that compared the diagnostic accuracy of any CDR or clinical criteria compared with a reference standard for the evaluation of paediatric CSI following blunt trauma. We included studies evaluating one CDR or comparing two or more CDRs (directly and indirectly). We considered X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) of the cervical spine, and clinical clearance/follow-up as adequate reference standards.


DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles and abstracts for relevance, and carried out eligibility, data extraction and quality assessment. A third review author arbitrated. We extracted data on study design, participant characteristics, inclusion/exclusion criteria, index test, target condition, reference standard and data (diagnostic two-by-two tables) and calculated and plotted sensitivity and specificity on forest plots for visual examination of variation in test accuracy. We assessed methodological quality using the Quality Assessment of Diagnostic Accuracy Studies Version 2 tool. We graded the certainty of the evidence using the GRADE approach.


MAIN RESULTS
We included five studies with 21,379 enrolled participants, published between 2001 and 2021. Prevalence of CSI ranged from 0.5% to 1.85%. Seven CDRs were evaluated. Three studies reported on direct comparisons of CDRs. One study (973 participants) directly compared the accuracy of three index tests with the sensitivities of NEXUS, Canadian C-Spine Rule and the PECARN retrospective criteria being 1.00 (95% confidence interval (CI) 0.48 to 1.00), 1.00 (95% CI 0.48 to 1.00) and 1.00 (95% CI 0.48 to 1.00), respectively. The specificities were 0.56 (95% CI 0.53 to 0.59), 0.52 (95% CI 0.49 to 0.55) and 0.32 (95% CI 0.29 to 0.35), respectively (moderate-certainty evidence). One study (4091 participants) compared the accuracy of the PECARN retrospective criteria with the Leonard de novo model; the sensitivities were 0.91 (95% CI 0.81 to 0.96) and 0.92 (95% CI 0.83 to 0.97), respectively. The specificities were 0.46 (95% CI 0.44 to 0.47) and 0.50 (95% CI 0.49 to 0.52) (moderate- and low-certainty evidence, respectively). One study (270 participants) compared the accuracy of two NICE (National Institute for Health and Care Excellence) head injury guidelines; the sensitivity of the CG56 guideline was 1.00 (95% CI 0.48 to 1.00) compared to 1.00 (95% CI 0.48 to 1.00) with the CG176 guideline. The specificities were 0.46 (95% CI 0.40 to 0.52) and 0.07 (95% CI 0.04 to 0.11), respectively (very low-certainty evidence). Two additional studies were indirect comparison studies. One study (3065 participants) tested the accuracy of the NEXUS criteria; the sensitivity was 1.00 (95% CI 0.88 to 1.00) and specificity was 0.20 (95% CI 0.18 to 0.21) (low-certainty evidence). One retrospective study (12,537 participants) evaluated the PEDSPINE criteria and found a sensitivity of 0.93 (95% CI 0.78 to 0.99) and specificity of 0.70 (95% CI 0.69 to 0.72) (very low-certainty evidence). We did not pool data within the broader CDR categories or investigate heterogeneity due to the small quantity of data and the clinical heterogeneity of studies. Two studies were at high risk of bias. We identified two studies that are awaiting classification pending further information and two ongoing studies.


AUTHORS' CONCLUSIONS
There is insufficient evidence to determine the diagnostic test accuracy of CDRs to detect CSIs in children following blunt trauma, particularly for children under eight years of age. Although most studies had a high sensitivity, this was often achieved at the expense of low specificity and should be interpreted with caution due to a small number of CSIs and wide CIs. Well-designed, large studies are required to evaluate the accuracy of CDRs for the cervical spine clearance in children following blunt trauma, ideally in direct comparison with each other.

Triage tools for detecting cervical spine injury in paediatric trauma patients.

OBJECTIVE
The objective of this review is to identify the level of discomfort caused by immobilization as reported by trauma victims, and to map all the interventions in the prehospital context where they have been implemented and evaluated in order to reduce discomfort in adult victims of trauma.


INTRODUCTION
Immobilization is a cause of discomfort for trauma victims, which has important implications for the deterioration of vital signs and quality of life. However, discomfort caused by immobilization remains an under-explored topic by the scientific community.


INCLUSION CRITERIA
This scoping review will consider studies of adult victims of trauma, aged 18 years or over, in prehospital emergency care. Studies that focused on interventions designed to reduce immobilization discomfort, implemented and evaluated by health professionals, of any form, duration, frequency, and dose will be considered.


METHODS
An initial search of PubMed and CINAHL will be undertaken, followed by a second search for published and unpublished studies without time restrictions, in major health care-related electronic databases. Studies in English, French, Spanish, and Portuguese will be included. Data extraction will be performed independently by two reviewers in a tabular format and will include details about the level of discomfort, interventions, populations, study methods, and outcomes of interest. A narrative synthesis will accompany the results and will describe how they relate to the review objectives.


REVIEW REGISTRATION NUMBER
OSF https://osf.io/4scg5/.

Prehospital interventions to reduce discomfort caused by immobilization in adult trauma victims: a scoping review protocol.

Objective: The objective of this review is to identify the level of discomfort caused by immobilization as reported by trauma victims, and to map all the interventions in the prehospital context where they have been implemented and evaluated in order to reduce discomfort in adult victims of trauma. Introduction: Immobilization is a cause of discomfort for trauma victims, which has important implications for the deterioration of vital signs and quality of life. However, discomfort caused by immobilization remains an under-explored topic by the scientific community. Inclusion criteria: This scoping review will consider studies of adult victims of trauma, aged 18 years or over, in prehospital emergency care. Studies that focus on interventions designed to reduce immobilization discomfort, implemented and evaluated by health professionals, of any form, duration, frequency, and dose will be considered. Methods: An initial search of PubMed and CINAHL will be undertaken, followed by a second search for published and unpublished studies without time restrictions, in major health care–related electronic databases. Studies in English, French, Spanish, and Portuguese will be included. Data extraction will be performed independently by 2 reviewers in a tabular format and will include details about the level of discomfort, interventions, populations, study methods, and outcomes of interest. A narrative synthesis will accompany the results and will describe how they relate to the review objectives. Review registration number: OSF https://osf.io/4scg5/ 

Prehospital interventions to reduce discomfort caused by immobilization in adult trauma victims: a scoping review protocol

Background Injury prevention interventions are often implemented at the group level via communities, hospitals, schools, etc, making cluster randomisation a suitable approach to evaluation. The stepped-wedge cluster randomised trial (SW-CRT) design has become increasingly popular for evaluating interventions in real-world settings. Method In this commentary, we describe the methodological characteristics of the SW-CRT design and highlight key threats to validity, relevant design and analytical issues, and scenarios in which the SW-CRT design might be a reasonable design choice. We illustrate these key points using a recently completed SW-CRT: the prehospital Canadian C-Spine trial. Results Seven potential biases associated with SW-CRTs, including: (1) secular trends, (2) confounding by external factors, (3) identification and recruitment bias, (4) contamination, (5) late and early transitioning, (6) risks of baseline imbalances due to small numbers of clusters and (7) statistical issues are discussed, along with potential mitigation strategies. Conclusion The SW-CRT design offers a pragmatic approach to evaluating injury prevention interventions that may involve a staggered rollout across services or regions. The design allows an intervention to be rolled out to all participating sites and provides an opportunity to efficiently evaluate effectiveness. It is important, however, for researchers to consider the unique design and analytic issues associated with the SW-CRT design. Mitigating potential threats to validity when using the SW-CRT design helps ensure robust evaluation of injury prevention interventions. 

Evaluation of injury prevention interventions using the stepped wedge cluster randomised trial design: key considerations

Background: Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs). Less than 1.0% (1/100) of these patients have a neck bone fracture. Even less (1/200, 0.5%) have a spinal cord injury or nerve damage. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, cervical collar, and head immobilizers. Importantly, prolonged immobilization is often unnecessary; it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly. We therefore developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury. We successfully taught Ottawa paramedics to use the CCR in the field in a single-center study.
Objective: This study aimed to improve patient care and health system efficiency and outcomes by allowing paramedics to assess eligible low-risk trauma patients with the CCR and selectively transport them without immobilization to the ED.
Methods: We propose a pragmatic stepped-wedge cluster randomized design with health economic evaluation, designed collaboratively with knowledge users. Our 36-month study will consist of a 12-month setup and training period (year 1), followed by the stepped-wedge trial (year 2) and a 12-month period for study completion, analyses, and knowledge translation. A total of 12 Ontario paramedic services of various sizes distributed across the province will be randomly allocated to one of three sequences. Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention. Data will be collected on all eligible patients in each paramedic service for a total duration of 12 months. A major strength of our design is that each community will have implemented the CCR by the end of the study.
Results: Interim results are expected in December 2019 and final results in 2020. If this multicenter trial is successful, we expect the Ontario Ministry of Health will recommend that paramedics evaluate all eligible patients with the CCR in the Province of Ontario.
Conclusions: We conservatively estimate that in Ontario, more than 60% of all eligible trauma patients (300,000 annually) could be transported safely and comfortably, without c-spine immobilization devices. This will significantly reduce patient pain and discomfort, paramedic intervention times, and ED length of stay, thereby improving access to paramedics and ED care. This could be achieved rapidly and with lower health care costs compared with current practices (possible cost saving of Can $36 [US $25] per immobilization or Can $10,656,000 [US $7,335,231] per year).
Trial Registration: ClinicalTrials.gov NCT02786966; https://clinicaltrials.gov/ct2/show/NCT02786966.

/pdf/pragmatic-strategy-empowering-paramedics-to-assess-low-risk-1vjku0ck0i.pdf

Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial.

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Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial.