Use of scratchcards for allocation concealment in a prehospital randomised controlled trial.

BACKGROUND: Rapid Analgesia for Prehospital Hip Disruption was a small study designed to determine the feasibility of undertaking a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics administering Fascia Iliaca Compartment Block as early prehospital pain relief to patients with a fractured hip. The objective was to devise a simple and effective method of random allocation concealment suitable for use by paramedics while in the emergency prehospital setting. METHODS: Scratchcards were produced using scratch-off silver stickers which concealed the trial arm allocation. Paramedics were each allocated a unique range of consecutive numbers, used as both the scratchcard number and the patient's study ID. The cards were designed to allow the paramedic to write on the incident number, date and signature. A small envelope holding the cards was prepared for each paramedic. The study took place between 28 June 2016 and 31 July 2017 in the Swansea area. RESULTS: Nineteen trial paramedics used 71 scratchcards throughout the study and reported no problems randomly allocating patients using the scratchcards. Five protocol deviations were reported in relation to scratchcard use. On auditing the scratchcards, all unused cards were located, and no evidence of tampering with the silver panel was found. CONCLUSION: Paramedics can use scratchcards as a method of randomly allocating patients in trials in prehospital care. In the future, a method that allows only the top card to be selected and a more protective method of storing the cards should be used. Scratchcards can be considered for wider use in RCTs in the emergency prehospital setting. TRIAL REGISTRATION NUMBER: ISRCTN60065373; Post-results.

Clinical and cost-effectiveness of paramedic administered fascia iliaca compartment block for emergency hip fracture (RAPID 2)-protocol for an individually randomised parallel-group trial.

BACKGROUND: Approximately 75,000 people fracture a hip each year in the UK. This painful injury can be devastating-with a high associated mortality rate-and survivors likely to be more dependent and less mobile. Pain relief at the scene of injury is known to be inadequate. Intravenous morphine is usually given by paramedics, but opioids are less effective for dynamic pain and can cause serious side effects, including nausea, constipation, delirium and respiratory depression. These may delay surgery, require further treatment and worsen patient outcomes. We completed a feasibility study of paramedic-provided fascia iliaca compartment block (FICB), testing the intervention, trial methods and data collection. The study (RAPID) demonstrated that a full trial was feasible. In this subsequent study, we aim to test safety, clinical and cost-effectiveness of paramedic-provided FICB as pain relief to patients with suspected hip fracture in the prehospital environment. METHODS: We will conduct a pragmatic multi-centre individually randomised parallel-group trial, with a 1:1 allocation between usual care (control) and FICB (intervention). Hospital clinicians in five sites (paired ambulance services and receiving hospitals) in England and Wales will train 220 paramedics to administer FICB. The primary outcome is change in pain score from pre-randomisation to arrival at the emergency department. One thousand four hundred patients are required to find a clinically important difference between trial arms in the primary outcome (standardised statistical effect ~ 0.2; 90% power, 5% significance). We will use NHS Digital (England) and the SAIL (Secure Anonymised Information Linkage) databank (Wales) to follow up patient outcomes using routine anonymised linked data in an efficient study design, and questionnaires to capture patient-reported outcomes at 1 and 4 months. Secondary outcomes include mortality, length of hospital stay, job cycle time, prehospital medications including morphine, presence of hip fracture, satisfaction, mobility, and NHS costs. We will assess safety by monitoring serious adverse events (SAEs). DISCUSSION: The trial will help to determine whether paramedic administered FICB is a safe, clinically and cost-effective treatment for suspected hip fracture in the pre-hospital setting. Impact will be shown if and when clinical guidelines either recommend or reject the use of FICB in routine practice in this context. TRIAL REGISTRATION: ISRCTN15831813 . Registered on 22 September 2021.

At-a-glance monitoring: covert observations of anesthesiologists in the operating room.

BACKGROUND: Patient monitoring displays are designed to improve patient safety, and yet little is known about how anesthesiologists interact with these displays. Previous studies of clinician behavior used an observer in the operating room, which may have altered behavior. We describe a covert observation technique to determine how often and for how long anesthesiologists actually look at the monitoring display during different segments of the maintenance phase of anesthesia, and to determine whether this changed with more than 1 anesthesia provider or during concomitant activities such as reading. METHODS: Five staff anesthesiologists, 2 anesthesia fellows, 3 anesthesia residents, and 2 medical students were covertly videotaped across 10 dual anesthesia provider cases and 10 solo cases. Videotapes were later segmented (5 minutes postinduction [early maintenance], mid-maintenance, and immediately before the drapes came down [late maintenance]) and coded for looking behavior at the patient monitor, anesthesia chart, and other reading material. RESULTS: Anesthesiologists looked at the monitor in 1- to 2-second glances, performed frequently throughout the 3 segments of maintenance anesthesia. Overall, the patient monitor was looked at only 5 of the analyzed time, which is less than has previously been reported. Monitoring behavior was constant across the segments of maintenance anesthesia and was not significantly affected by the number of anesthesia providers or role (trainee vs. senior). In contrast, charting behavior and other reading material viewing changed significantly over the analyzed segments of maintenance anesthesia. CONCLUSIONS: The presence of "at-a-glance monitoring" has implications for the design of patient monitoring displays. Displays should be developed to optimize the information obtained from brief glances at the monitor.

Defining the reliability of sonoanatomy identification by novices in ultrasound-guided pediatric ilioinguinal and iliohypogastric nerve blockade.

BACKGROUND: The ilioinguinal (II)/iliohypogastric (IH) nerve block is a safe, frequently used block that has been improved in efficacy and safety by the use of ultrasound guidance. We assessed the frequency with which pediatric anesthesiologists with limited experience with ultrasound-guided regional anesthesia could correctly identify anatomical structures within the inguinal region. Our primary outcome was to compare the frequency of correct identification of the transversus abdominis (TA) muscle with the frequency of correct identification of the II/IH nerves. We used 2 ultrasound machines with different capabilities to assess a potential equipment effect on success of structure identification and time taken for structure identification. METHODS: Seven pediatric anesthesiologists with <6 mo experience with ultrasound-guided regional anesthesia performed a total of 127 scans of the II region in anesthetized children. The muscle planes and the II and IH nerves were identified and labeled. The ultrasound images were reviewed by a blinded expert to mark accuracy of structure identification and time taken for identification. Two ultrasound machines (Sonosite C180plus and Micromaxx, both from Sonosite, Bothell, WA) were used. RESULTS: There was no difference in the frequency of correct identification of the TA muscle compared with the II/IH nerves (chi(2) test, TA versus II, P = 0.45; TA versus IH, P = 0.50). Ultrasound machine selection did show a nonsignificant trend in improving correct II/IH nerve identification (II nerve chi(2) test, P = 0.02; IH nerve chi(2) test, P = 0.04; Bonferroni corrected significance 0.17) but not for the muscle planes (chi(2) test, P = 0.83) or time taken (1-way analysis of variance, P = 0.07). A curve of improving accuracy with number of scans was plotted, with reliability of TA recognition occurring after 14-15 scans and II/IH identification after 18 scans. CONCLUSIONS: We have demonstrated that although there is no difference in the overall accuracy of muscle plane versus II/IH nerve identification, the muscle planes are reliably identified after fewer scans of the inguinal region. We suggest that a reliable end point for the inexperienced practitioner of ultrasound-guided II/IH nerve block may be the TA/internal oblique plane where the nerves are reported to be found in 100% of cases.

Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study.

OBJECTIVE: To explore patients' experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury. DESIGN: Qualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture. SETTING: Patients treated by paramedics in the catchment area of one emergency department in South Wales. PARTICIPANTS: Six patients and one carer of a patient who received fascia iliaca compartment block (FICB). INTERVENTION: FICB administered to patients with suspected hip fracture by trained paramedics. We randomly allocated eligible patients to FICB-a local anaesthetic injection directly into the hip region-or usual care-most commonly morphine-using audited scratch cards. OUTCOMES: Acceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants' consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member. RESULTS: Patients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury. CONCLUSIONS: This study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting. TRIAL REGISTRATION NUMBER: ISRCTN60065373.

Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study.

BACKGROUND: In managing hip fracture, effective pain relief before admission to hospital is difficult without risking side effects. Although emergency departments routinely use fascia iliaca compartment block (FICB), there has been little evaluation of its use by paramedics before hospital admission. We aimed to assess whether a multi-centre randomised trial to evaluate FICB was feasible. METHODS: Volunteer paramedics used scratchcards to allocate patients with hip fracture at random between FICB and pain relief as usual. Primary outcomes were mortality and quality of life. We also measured adverse events, costs, final diagnosis, length of stay in hospital, pain scores and quality of care and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on the recruitment of paramedics and patients, delivery of FICB, retrieval of outcome data, safety, acceptability, and diagnostic accuracy of hip fracture. RESULTS: We effectively met all progression criteria: we recruited 19 paramedics who randomly allocated 71 patients between trial arms between 28 June 2016 and 31 July 2017; 57 (31 experimental arm, 26 usual care arm, 80% overall) retrospectively consented to follow-up. Just over half (17/31) of experimental participants received FICB; all others had contraindications, including nine taking anticoagulants. Four of the 31 participants assigned FICB and six of the 26 assigned usual care died within 6 months of hospital admission. Serious adverse events were also similar: 3/35 experimental versus 4/36 in usual care. Paramedics' recognition of hip fracture had sensitivity of 49/64 (77%) with a positive predictive value of 46/57 (81%). We received quality of life questionnaires for 30 of 49 patients (61%) at 1 month and 12 of 17 (71%) at 6 months. Patient satisfaction was similar: experimental mean 3.4 (n = 20) versus 3.5 (n = 13) for usual care. CONCLUSIONS: RAPID met all progression criteria within reasonable limits. As equipoise remains, we plan to undertake a fully powered multi-centre trial to test clinical and cost effectiveness of paramedic-administered FICB at the scene of hip fracture. TRIAL REGISTRATION: ISRCTN 60065373 sought 5 November 2015.

Paramedics' experiences of administering fascia iliaca compartment block to patients in South Wales with suspected hip fracture at the scene of injury: results of focus groups.

OBJECTIVES: To explore paramedics' experience of delivering fascia iliaca compartment block (FICB) to patients with suspected hip fracture at the scene of injury. DESIGN: Focus groups within a randomised controlled trial. SETTING: Paramedics based at ambulance stations in the catchment area of one Emergency Department in South Wales, recruited and trained in a feasibility study about an alternative to routine prehospital pain management for patients with suspected hip fracture. PARTICIPANTS: 11 paramedics. INTERVENTION: Paramedic-administered FICB to patients with suspected hip fracture. We randomly allocated eligible patients to FICB, a local anaesthetic injection directly into the hip region-or usual care, most commonly morphine - using audited scratch cards. OUTCOMES: Paramedics' experiences of administering FICB gathered through thematic analysis of interview transcripts by two researchers, one paramedic and one lay member. RESULTS: Respondents believed that FICB was a suitable intervention for paramedics to deliver. It aligned with routine practice and was within people's capabilities. They said it took up to 10 minutes longer than usual care to prepare and deliver, in part due to nervousness and unfamiliarity with a new procedure. They praised the training provided but said they were anxious about causing harm by injecting into the wrong location. Confidence increased after one paramedic team successfully treated a patient for local anaesthetic toxicity. Reported challenges related to the emergency context: patients often waited many hours for ambulance arrival; moving patients exacerbated their pain; family and neighbours were present as paramedics administered treatment. CONCLUSIONS: Paramedics are willing and able to administer FICB to patients with suspected hip fracture before ambulance transport to hospital. Feasibility study findings will inform further research. TRIAL REGISTRATION NUMBER: ISRCTN60065373; Pre results.

A novel vibrotactile display to improve the performance of anesthesiologists in a simulated critical incident.

BACKGROUND: Current methods of information transfer in the operating room between monitor and anesthesiologist rely on visual and auditory modalities. These modalities can easily become overloaded in a high cognitive workload situation, such as in a critical incident. The use of vibrotactile communication has been shown to improve information transfer in other high cognitive workload environments such as aviation. We designed a novel waist-mounted vibrotactile display to be worn by the anesthesiologist to test if a vibrotactile display could improve the clinical response time to begin treating a simulated case of anaphylaxis when compared with a group using traditional information displays. In addition, we evaluated differences in situational awareness (SA) between the two groups. METHODS: Twenty-four volunteer anesthesiologists were randomized to diagnose and treat a simulated case of anaphylaxis using the vibrotactile display and standard monitoring (vibrotactile display group) or standard monitoring alone (control group). The time taken to administer epinephrine was measured, and objective post hoc analysis of participant SA was performed. RESULTS: Participants in the vibrotactile group took 4.08 min (95% CI = 1.22) to deliver definitive treatment compared with 7.21 min (95% CI = 2.07) for the control group (P < 0.05). Despite the reduced time to treatment, no improvement in SA was measured. CONCLUSION: Our study provides evidence that vibrotactile communication can reduce response time to critical incidents.

A knowledge authoring tool for clinical decision support.

Anesthesiologists in the operating room are unable to constantly monitor all data generated by physiological monitors. They are further distracted by clinical and educational tasks. An expert system would ideally provide assistance to the anesthesiologist in this data-rich environment. Clinical monitoring expert systems have not been widely adopted, as traditional methods of knowledge encoding require both expert medical and programming skills, making knowledge acquisition difficult. A software application was developed for use as a knowledge authoring tool for physiological monitoring. This application enables clinicians to create knowledge rules without the need of a knowledge engineer or programmer. These rules are designed to provide clinical diagnosis, explanations and treatment advice for optimal patient care to the clinician in real time. By intelligently combining data from physiological monitors and demographical data sources the expert system can use these rules to assist in monitoring the patient. The knowledge authoring process is simplified by limiting connective relationships between rules. The application is designed to allow open collaboration between communities of clinicians to build a library of rules for clinical use. This design provides clinicians with a system for parameter surveillance and expert advice with a transparent pathway of reasoning. A usability evaluation demonstrated that anesthesiologists can rapidly develop useful rules for use in a predefined clinical scenario.

Rapid analgesia for prehospital hip disruption (RAPID): protocol for feasibility study of randomised controlled trial.

BACKGROUND: Adequate pain relief at the point of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilise and whose long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia iliaca compartment block (FICB) is a procedure routinely undertaken by doctors and nurses in the emergency department for patients with hip fracture but not yet evaluated for use by paramedics at the scene of emergency calls. In this feasibility study, we aim to test whether FICB administered by paramedics at the scene of participants' hip fractures is feasible, safe and acceptable. This will enable us to decide whether to proceed to a fully powered, multi-centre pragmatic randomised trial to evaluate whether the procedure is effective for patients and worthwhile for the NHS. METHODS/DESIGN: In this study, we propose to recruit ten paramedics in an urban area of South Wales. We will train them to carry out FICB when they attend patients with hip fracture. We will randomly allocate eligible patients to FICB or usual care using audited scratch cards. We will follow up participants to assess measurability of key outcomes including quality of life, pain scores, adverse events, length of stay in hospital, acceptability to patients and compliance of paramedics. We will assess whether the findings meet specified feasibility criteria and, if so, plan a full trial. DISCUSSION: This study will enable us to recommend whether to undertake a definitive trial of FICB by paramedics for hip fracture. TRIAL REGISTRATION: ISRCTN60065373.

Systematic differences in electropherogram peak heights reported by different versions of the GeneScan software.

DNA profiling using STRs on the 310 and 3100 Genetic Analyzers routinely generates electropherograms that are analyzed with the GeneScan software available from the instrument's manufacturer, Applied Biosystems. Users have been able to choose from three different smoothing options that have been known to result in significant differences in the peak heights that are reported. Improvements in the underlying algorithm of the most recent version of the software also result in significant and somewhat predictable differences in peak height values. Laboratories that have performed validation studies using older versions of GeneScan should either reanalyze the data generated in those validation studies with the newest version of the software or otherwise take into consideration the systematically higher peak height values obtained as they begin following the recommendation of the manufacturer and use the new algorithm.

Multivariate analysis in clinical monitoring: detection of intraoperative hemorrhage and light anesthesia.

The number of vital sign variables measured during a typical surgery is beyond the simultaneous surveillance capabilities of most experienced clinicians. Most intraoperative events cause trend changes in multiple variables, and many clinical events can only be detected by investigating the inter-relationship between the direction and amplitude of these trend changes in the whole measurement array. We have compared the techniques of principal component analysis (PCA) and factor analysis (FA) in extracting latent variables to represent the underlying physiological mechanism. The detection performance of each method was tested on three simulated cases of intraoperative hemorrhage and a case of variation in depth of anesthesia. The results show that although the detection schemes based on PCA and FA both reduce dimensionality and detect changes in the variance, the FA-based method performs better in detecting subtle changes in the correlation structure.