Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 26
Filter
1.
BMC Health Serv Res ; 24(1): 741, 2024 Jun 17.
Article in English | MEDLINE | ID: mdl-38886764

ABSTRACT

OBJECTIVE: Describe the screening, referral, and treatment delivery associated with an opt-out tobacco treatment program (TTP) implemented in six hospitals varying in size, rurality and patient populations. METHODS: Between March 6, 2021 and December 17, 2021, adult patients (≥ 18 years) admitted to six hospitals affiliated with the Medical University of South Carolina were screened for smoking status. The hospitals ranged in size from 82 to 715 beds. Those currently smoking were automatically referred to one of two tobacco treatment options: 1) Enhanced care (EC) where patients could receive a bedside consult by a trained tobacco treatment specialist plus an automated post-discharge follow-up call designed to connect those smoking to the South Carolina Quitline (SCQL); or 2) Basic care (BC) consisting of the post-discharge follow-up call only. An attempt was made to survey patients at 6-weeks after hospitalization to assess smoking status. RESULTS: Smoking prevalence ranged from 14 to 49% across the six hospitals; 6,000 patients were referred to the TTP.The delivery of the bedside consult varied across the hospitals with the lowest in the Charleston hospitals which had the highest caseload of referred patients per specialist. Among patients who received a consult visit during their hospitalization, 50% accepted the consult, 8% opted out, 3% claimed not to be current smokers, and 38% were unavailable at the time of the consult visit. Most of those enrolled in the TTP were long-term daily smokers.Forty-three percent of patients eligible for the automated post-discharge follow-up call answered the call, of those, 61% reported smoking in the past seven days, and of those, 34% accepted the referral to theSCQL. Among the 986 of patients surveyed at 6-weeks after hospitalization quit rates ranged from 20%-30% based on duration of reported cessation and were similar between hospitals and for patients assigned to EC versus BC intervention groups. CONCLUSION: Findings demonstrate the broad reach of an opt-out TTP. Elements of treatment delivery can be improved by addressing patient-to-staffing ratios, improving systems to prescribe stop smoking medications for patients at discharge and linking patients to stop smoking services after hospital discharge.


Subject(s)
Smoking Cessation , Humans , South Carolina , Male , Female , Adult , Middle Aged , Smoking Cessation/methods , Smoking Cessation/statistics & numerical data , Referral and Consultation/statistics & numerical data , Aged
2.
Res Sq ; 2023 Sep 08.
Article in English | MEDLINE | ID: mdl-37720041

ABSTRACT

Objective: To describe the implementation an opt-out tobacco treatment program (TTP) in 6 diverse hospitals located in different regions of South Carolina. Methods: Between March 8, 2021 and December 17, 2021, adult patients (≥ 18 years) admitted to 6 hospitals affiliated with the Medical University of South Carolina (MUSC) were screened for their cigarette status. Patients who smoked cigarettes were referred to an TTP offering a brief bedside consult and automated post-discharge follow-up calls with an opportunity to receive a referral to the South Carolina Quitline (SCQL). The hospitals included in this study ranged in size from 82 to 715 beds with diverse patient populations. Herein, we report on the results of screening and referring patients to the TTP, delivery of smoking cessation treatments, and patient smoking status assessed in a sample of patients followed 6-weeks after discharge from the hospital. Results: Smoking prevalence ranged from 14-49% across the 6 hospitals. Among eligible patients reached, 85.6% accepted the bedside consult. Only 3.4% of patients reached were deemed ineligible because they claimed not to be currently smoking cigarettes. The automated post-discharge follow-up calls were answered by 43% of patients, with about a third of those who had relapsed back to smoking accepting the offer of a referral to the SCQL. Overall, about half of the 6,000 patients referred to the TTP received some type of treatment. Self-reported smoking abstinence rates assessed 6-weeks after discharge were similar across the five acute care hospitals ranging from about 20-30%. Conclusion: The findings demonstrate the broad reach of implementing an opt-out TTP for patients in hospitals of varying size, rurality and patient populations.

3.
J Interpers Violence ; 38(23-24): 11999-12024, 2023 12.
Article in English | MEDLINE | ID: mdl-37530462

ABSTRACT

Technology-facilitated abuse in relationships (TAR) is a widespread social problem that has a significant impact on victim-survivors. Most contemporary evidence on TAR focuses on victim-survivor and practitioner perspectives rather than those of perpetrators who choose to enact this form of harm. Addressing this deficit, this study explored perpetrators' discourses on emotions and motivations associated with engaging in TAR. Using story completion method, 35 self-identified perpetrators of TAR completed story stems describing scenarios that may precede the use of abusive online behaviors. Reflexive thematic analysis generated three themes. Abusive behaviors and negative emotions speaks to maladaptive experiences of anger and/or sadness that can precede a decision to use TAR. A loss of trust, a desire for control describes potential motives for using TAR. Finally, inhibitors of abusive behavior investigates rationales perpetrators use for avoidance of TAR behaviors, suggesting avenues for working with perpetrators to refrain from using TAR. We conclude by discussing policy, practice, and research recommendations including strategies for technology designers and suggestions for primary prevention and response to TAR.


Subject(s)
Emotions , Motivation , Humans , Emotions/physiology , Anger/physiology , Aggression , Trust
4.
Violence Against Women ; : 10778012231185541, 2023 Jul 24.
Article in English | MEDLINE | ID: mdl-37487222

ABSTRACT

Body-worn cameras (BWCs) have been promoted internationally to enhance responses to domestic and family violence (DFV). However, little is known about their utility, benefits, and limitations. Drawing upon the insights of DFV practitioners who support victim/survivors in the Australian states of Queensland and Western Australia, this article finds that while BWCs can capture some DFV incidents, they are unable to show their full context and impacts. BWC footage may also have consequences for "nonideal" victim/survivors, including wrongful criminalization and the removal of children. Ultimately, we argue that trauma-informed responses are vital for BWC use in DFV cases to improve frontline responses.

5.
Violence Against Women ; 29(5): 987-1004, 2023 04.
Article in English | MEDLINE | ID: mdl-35989678

ABSTRACT

This article draws on interviews with 20 Australian women subjected to technology-facilitated coercive control (TFCC), foregrounding their accounts of grief and institutional betrayal. Findings show that while the harms of TFCC were significant, survivors' experiences were often minimized and dismissed by justice institutions. Women experienced grief due to abuse and separation from partners who had betrayed them. This loss was compounded when seeking help. We propose that disenfranchised grief is an underexplored response to domestic violence and institutional betrayal as well as a potential intervention site, particularly in relation to technology-facilitated abuse.


Subject(s)
Betrayal , Disenfranchised Grief , Humans , Female , Darkness , Australia , Coercion
6.
Violence Against Women ; 28(15-16): 3703-3725, 2022 12.
Article in English | MEDLINE | ID: mdl-34894895

ABSTRACT

In 2014, a taskforce was assembled to address increasing rates of domestic violence in Queensland, Australia. The Not Now, Not Ever report outlines a strategy to address domestic violence through 121 recommendations. This plan for reform resulted in a series of changes, particularly for agencies such as the Queensland Police Service (QPS). This study examines the impact of the recommendations on police-recorded domestic violence incidents in the state. Findings indicate that the changes resulted in an initial significant increase, followed by a significant decreasing trend in police-recorded incidents. However, this impact is not experienced equally across regions and districts.


Subject(s)
Domestic Violence , Police , Humans , Queensland , Australia
7.
ERJ Open Res ; 7(1)2021 Jan.
Article in English | MEDLINE | ID: mdl-33614773

ABSTRACT

Patients' experiences of NTM pulmonary disease highlight important and unmet needs for better pharmacological treatment and education of medical staff https://bit.ly/3mjrlwh.

9.
Health Technol Assess ; 22(45): 1-134, 2018 08.
Article in English | MEDLINE | ID: mdl-30168413

ABSTRACT

BACKGROUND: Traumatic brain injury (TBI) is a major cause of disability and death in young adults worldwide. It results in around 1 million hospital admissions annually in the European Union (EU), causes a majority of the 50,000 deaths from road traffic accidents and leaves a further ≈10,000 people severely disabled. OBJECTIVE: The Eurotherm3235 Trial was a pragmatic trial examining the effectiveness of hypothermia (32-35 °C) to reduce raised intracranial pressure (ICP) following severe TBI and reduce morbidity and mortality 6 months after TBI. DESIGN: An international, multicentre, randomised controlled trial. SETTING: Specialist neurological critical care units. PARTICIPANTS: We included adult participants following TBI. Eligible patients had ICP monitoring in place with an ICP of > 20 mmHg despite first-line treatments. Participants were randomised to receive standard care with the addition of hypothermia (32-35 °C) or standard care alone. Online randomisation and the use of an electronic case report form (CRF) ensured concealment of random treatment allocation. It was not possible to blind local investigators to allocation as it was obvious which participants were receiving hypothermia. We collected information on how well the participant had recovered 6 months after injury. This information was provided either by the participant themself (if they were able) and/or a person close to them by completing the Glasgow Outcome Scale - Extended (GOSE) questionnaire. Telephone follow-up was carried out by a blinded independent clinician. INTERVENTIONS: The primary intervention to reduce ICP in the hypothermia group after randomisation was induction of hypothermia. Core temperature was initially reduced to 35 °C and decreased incrementally to a lower limit of 32 °C if necessary to maintain ICP at < 20 mmHg. Rewarming began after 48 hours if ICP remained controlled. Participants in the standard-care group received usual care at that centre, but without hypothermia. MAIN OUTCOME MEASURES: The primary outcome measure was the GOSE [range 1 (dead) to 8 (upper good recovery)] at 6 months after the injury as assessed by an independent collaborator, blind to the intervention. A priori subgroup analysis tested the relationship between minimisation factors including being aged < 45 years, having a post-resuscitation Glasgow Coma Scale (GCS) motor score of < 2 on admission, having a time from injury of < 12 hours and patient outcome. RESULTS: We enrolled 387 patients from 47 centres in 18 countries. The trial was closed to recruitment following concerns raised by the Data and Safety Monitoring Committee in October 2014. On an intention-to-treat basis, 195 participants were randomised to hypothermia treatment and 192 to standard care. Regarding participant outcome, there was a higher mortality rate and poorer functional recovery at 6 months in the hypothermia group. The adjusted common odds ratio (OR) for the primary statistical analysis of the GOSE was 1.54 [95% confidence interval (CI) 1.03 to 2.31]; when the GOSE was dichotomised the OR was 1.74 (95% CI 1.09 to 2.77). Both results favoured standard care alone. In this pragmatic study, we did not collect data on adverse events. Data on serious adverse events (SAEs) were collected but were subject to reporting bias, with most SAEs being reported in the hypothermia group. CONCLUSIONS: In participants following TBI and with an ICP of > 20 mmHg, titrated therapeutic hypothermia successfully reduced ICP but led to a higher mortality rate and worse functional outcome. LIMITATIONS: Inability to blind treatment allocation as it was obvious which participants were randomised to the hypothermia group; there was biased recording of SAEs in the hypothermia group. We now believe that more adequately powered clinical trials of common therapies used to reduce ICP, such as hypertonic therapy, barbiturates and hyperventilation, are required to assess their potential benefits and risks to patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34555414. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 45. See the NIHR Journals Library website for further project information. The European Society of Intensive Care Medicine supported the pilot phase of this trial.


Subject(s)
Brain Injuries, Traumatic/therapy , Hypothermia, Induced/economics , Hypothermia, Induced/methods , Intracranial Pressure/physiology , Adolescent , Adult , Age Factors , Aged , Brain Injuries, Traumatic/epidemiology , Brain Injuries, Traumatic/mortality , Child , Child, Preschool , Cost-Benefit Analysis , Female , Glasgow Outcome Scale , Humans , Hypothermia, Induced/mortality , Length of Stay , Male , Middle Aged , Pneumonia, Ventilator-Associated/epidemiology , Quality of Life , Quality-Adjusted Life Years , State Medicine , Technology Assessment, Biomedical , Time-to-Treatment , Young Adult
10.
Sci Rep ; 8(1): 7877, 2018 05 18.
Article in English | MEDLINE | ID: mdl-29777174

ABSTRACT

Macro-modeling of cerebral blood flow can help determine the impact of thermal intervention during instances of head trauma to mitigate tissue damage. This work presents a bioheat model using a 3D fluid-porous domain coupled with intersecting 1D arterial and venous vessel trees. This combined vascular porous (VaPor) model resolves both cerebral blood flow and energy equations, including heat generated by metabolism, using vasculature extracted from MRI data and is extended using a tree generation algorithm. Counter-current flows are expected to increase thermal transfer within the brain and are enforced using either the vascular structure or flow reversal, represented by a flow reversal constant, C R . These methods exhibit larger average brain cooling (from 0.56 °C ± <0.01 °C to 0.58 °C ± <0.01 °C) compared with previous models (0.39 °C) when scalp temperature is reduced. An greater reduction in core brain temperature is observed (from 0.29 °C ± <0.01 °C to 0.45 °C ± <0.01 °C) compared to previous models (0.11 °C) due to the inclusion of counter-current cooling effects. The VaPor model also predicts that a hypothermic average temperature (<36 °C) can be reached in core regions of neonatal models using scalp cooling alone.


Subject(s)
Brain/physiology , Cerebrovascular Circulation/physiology , Hypothermia/physiopathology , Models, Biological , Algorithms , Body Temperature , Brain/diagnostic imaging , Humans , Magnetic Resonance Imaging , Porosity
12.
PLoS One ; 12(12): e0189872, 2017.
Article in English | MEDLINE | ID: mdl-29287066

ABSTRACT

OBJECT: Magnetic resonance spectroscopic imaging (MRSI) is increasingly used in medicine and clinical research. Previous reliability studies have used small samples and focussed on limited aspects of variability; information regarding 1.5T versus 3T performance is lacking. The aim of the present work was to measure the inter-session, intra-session, inter-subject, within-brain and residual variance components using both 1.5T and 3T MR scanners. MATERIALS AND METHODS: Eleven healthy volunteers were invited for MRSI scanning on three occasions at both 1.5T and 3T, with four scans acquired at each visit. We measured variance components, correcting for grey matter and white matter content of voxels, of metabolite peak areas and peak area ratios. RESULTS: Residual variance was in general the largest component at 1.5T (8.6-24.6%), while within-brain variation was the largest component at 3T (12.0-24.7%). Inter-subject variation was around 5%, while inter- and intra-session variance were both generally small. CONCLUSION: Multiple variance contributions associated with MRSI measurements were quantified and the performance of 1.5T and 3T MRI scanners compared using data from the same group of subjects. Residual error is much lower at 3T, but other variance components remain important.


Subject(s)
Brain/diagnostic imaging , Magnetic Resonance Spectroscopy/methods , Adult , Female , Humans , Male , Young Adult
13.
Crit Care Med ; 45(5): 883-890, 2017 May.
Article in English | MEDLINE | ID: mdl-28277415

ABSTRACT

OBJECTIVES: Hypothermia reduces intracranial hypertension in patients with traumatic brain injury but was associated with harm in the Eurotherm3235Trial. We stratified trial patients by International Mission for Prognosis and Analysis of Clinical Trials in [Traumatic Brain Injury] (IMPACT) extended model sum scores to determine where the balance of risks lay with the intervention. DESIGN: The Eurotherm3235Trial was a randomized controlled trial, with standardized and blinded outcome assessment. Patients in the trial were split into risk tertiles by IMPACT extended model sum scores. A proportional hazard analysis for death between randomization and 6 months was performed by intervention and IMPACT extended model sum scores tertiles in both the intention-to-treat and the per-protocol populations of the Eurotherm3235Trial. SETTING: Forty-seven neurologic critical care units in 18 countries. PATIENTS: Adult traumatic brain injury patients admitted to intensive care who had suffered a primary, closed traumatic brain injury; increased intracranial pressure; an initial head injury less than 10 days earlier; a core temperature at least 36°C; and an abnormal brain CT. INTERVENTION: Titrated Hypothermia in the range 32-35°C as the primary intervention to reduce raised intracranial pressure. MEASUREMENTS AND MAIN RESULTS: Three hundred eighty-six patients were available for analysis in the intention-to-treat and 257 in the per-protocol population. The proportional hazard analysis (intention-to-treat and per-protocol populations) showed that the treatment effect behaves similarly across all risk stratums. However, there is a trend that indicates that patients in the low-risk group could be at greater risk of suffering harm due to hypothermia. CONCLUSIONS: Hypothermia as a first line measure to reduce intracranial pressure to less than 20 mm Hg is harmful in patients with a lower severity of injury and no clear benefit exists in patients with more severe injuries.


Subject(s)
Brain Injuries, Traumatic/mortality , Brain Injuries, Traumatic/therapy , Hypothermia, Induced/methods , Adult , Age Factors , Female , Glasgow Coma Scale , Humans , Intensive Care Units , Intracranial Pressure/physiology , Male , Middle Aged , Risk Assessment , Risk Factors , Single-Blind Method
15.
N Engl J Med ; 373(25): 2403-12, 2015 Dec 17.
Article in English | MEDLINE | ID: mdl-26444221

ABSTRACT

BACKGROUND: In patients with traumatic brain injury, hypothermia can reduce intracranial hypertension. The benefit of hypothermia on functional outcome is unclear. METHODS: We randomly assigned adults with an intracranial pressure of more than 20 mm Hg despite stage 1 treatments (including mechanical ventilation and sedation management) to standard care (control group) or hypothermia (32 to 35°C) plus standard care. In the control group, stage 2 treatments (e.g., osmotherapy) were added as needed to control intracranial pressure. In the hypothermia group, stage 2 treatments were added only if hypothermia failed to control intracranial pressure. In both groups, stage 3 treatments (barbiturates and decompressive craniectomy) were used if all stage 2 treatments failed to control intracranial pressure. The primary outcome was the score on the Extended Glasgow Outcome Scale (GOS-E; range, 1 to 8, with lower scores indicating a worse functional outcome) at 6 months. The treatment effect was estimated with ordinal logistic regression adjusted for prespecified prognostic factors and expressed as a common odds ratio (with an odds ratio <1.0 favoring hypothermia). RESULTS: We enrolled 387 patients at 47 centers in 18 countries from November 2009 through October 2014, at which time recruitment was suspended owing to safety concerns. Stage 3 treatments were required to control intracranial pressure in 54% of the patients in the control group and in 44% of the patients in the hypothermia group. The adjusted common odds ratio for the GOS-E score was 1.53 (95% confidence interval, 1.02 to 2.30; P=0.04), indicating a worse outcome in the hypothermia group than in the control group. A favorable outcome (GOS-E score of 5 to 8, indicating moderate disability or good recovery) occurred in 26% of the patients in the hypothermia group and in 37% of the patients in the control group (P=0.03). CONCLUSIONS: In patients with an intracranial pressure of more than 20 mm Hg after traumatic brain injury, therapeutic hypothermia plus standard care to reduce intracranial pressure did not result in outcomes better than those with standard care alone. (Funded by the National Institute for Health Research Health Technology Assessment program; Current Controlled Trials number, ISRCTN34555414.).


Subject(s)
Brain Injuries/complications , Hypothermia, Induced , Intracranial Hypertension/therapy , Adult , Arterial Pressure/physiology , Barbiturates/therapeutic use , Brain Injuries/mortality , Brain Injuries/physiopathology , Brain Injuries/therapy , Combined Modality Therapy , Decompressive Craniectomy , Humans , Intensive Care Units , Intention to Treat Analysis , Intracranial Hypertension/etiology , Intracranial Pressure/physiology , Middle Aged , Treatment Outcome
16.
MAGMA ; 28(3): 251-7, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25312604

ABSTRACT

OBJECT: We sought to measure brain metabolite levels in healthy older people. MATERIALS AND METHODS: Spectroscopic imaging at the level of the basal ganglia was applied in 40 participants aged 73-74 years. Levels of the metabolites N-acetyl aspartate (NAA), choline, and creatine were determined in "institutional units" (IU) corrected for T1 and T2 relaxation effects. Structural imaging enabled determination of grey matter (GM), white matter (WM), and cerebrospinal fluid content. ANOVA analysis was carried out for voxels satisfying quality criteria. RESULTS: Creatine levels were greater in GM than WM (57 vs. 44 IU, p < 0.001), whereas choline and NAA levels were greater in WM than GM [13 vs. 10 IU (p < 0.001) and 76 versus 70 IU (p = 0.03), respectively]. The ratio of NAA/cre was greater in WM than GM (2.1 vs. 1.4, p = 0.001) as was that of cho/cre (0.32 vs. 0.16, p < 0.001). A low voxel yield was due to brain atrophy and the difficulties of shimming over an extended region of brain. CONCLUSION: This study addresses the current lack of information on brain metabolite levels in older adults. The normal features of ageing result in a substantial loss of reliable voxels and should be taken into account when planning studies. Improvements in shimming are also required before the methods can be applied more widely.


Subject(s)
Aspartic Acid/analogs & derivatives , Basal Ganglia/metabolism , Choline/metabolism , Creatine/metabolism , Magnetic Resonance Imaging/methods , Proton Magnetic Resonance Spectroscopy/methods , Aged , Aspartic Acid/metabolism , Basal Ganglia/anatomy & histology , Female , Humans , Image Interpretation, Computer-Assisted/methods , Male , Molecular Imaging/methods , Reproducibility of Results , Sensitivity and Specificity , Tissue Distribution
17.
NMR Biomed ; 27(2): 183-90, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24273188

ABSTRACT

MRSI permits the non-invasive mapping of brain temperature in vivo, but information regarding its reliability is lacking. We obtained MRSI data from 31 healthy male volunteers [age range, 22-40 years; mean ± standard deviation (SD), 30.5 ± 5.0 years]. Eleven subjects (age range, 23-40 years; mean ± SD, 30.5 ± 5.2 years) were invited to receive four point-resolved spectroscopy MRSI scans on each of 3 days in both 1.5-T (TR/TE = 1000/144 ms) and 3-T (TR/TE = 1700/144 ms) clinical scanners; a further 20 subjects (age range, 22-40 years; mean ± SD, 30.5 ± 4.9 years) were scanned on a single occasion at 3 T. Data were fitted in the time domain to determine the water-N-acetylaspartate chemical shift difference, from which the temperature was estimated. Temperature data were analysed using a linear mixed effects model to determine variance components and systematic temperature changes during the scanning sessions. To characterise the effects of instrumental drift on apparent MRSI brain temperature, a temperature-controlled phantom was constructed and scanned on multiple occasions. Components of apparent in vivo temperature variability at 1.5 T/3 T caused by inter-subject (0.18/0.17 °C), inter-session (0.18/0.15 °C) and within-session (0.36/0.14 °C) effects, as well as voxel-to-voxel variation (0.59/0.54 °C), were determined. There was a brain cooling effect during in vivo MRSI of 0.10 °C [95% confidence interval (CI): -0.110, -0.094 °C; p < 0.001] and 0.051 °C (95% CI: -0.054, -0.048 °C; p < 0.001) per scan at 1.5 T and 3 T, respectively, whereas phantom measurements revealed minimal drift in apparent MRSI temperature relative to fibre-optic temperature measurements. The mean brain temperature at 3 T was weakly associated with aural (R = 0.55, p = 0.002) and oral (R = 0.62, p < 0.001) measurements of head temperature. In conclusion, the variability associated with MRSI brain temperature mapping was quantified. Repeatability was somewhat higher at 3 T than at 1.5 T, although subtle spatial and temporal variations in apparent temperature were demonstrated at both field strengths. Such data should assist in the efficient design of future clinical studies.


Subject(s)
Algorithms , Body Temperature/physiology , Brain/physiology , Magnetic Resonance Imaging/methods , Magnetic Resonance Spectroscopy/methods , Thermography/methods , Adult , Humans , Male , Reproducibility of Results , Sensitivity and Specificity , Young Adult
18.
Crit Care ; 18(6): 710, 2014 Dec 22.
Article in English | MEDLINE | ID: mdl-25672818

ABSTRACT

Brain injuries caused by stroke are common and costly in human and resource terms. The result of stroke is a cascade of molecular and physiological derangement, cell death, damage and inflammation in the brain. This, together with infection, if present, commonly results in patients having an increased temperature, which is associated with worse outcome. The usual clinical goal in stroke is therefore to reduce temperature to normal, or below normal (hypothermia) to reduce swelling if brain pressure is increased. However, research evidence does not yet conclusively show whether or not cooling patients after stroke improves their longer-term outcome (reduces death and disability). It is possible that complications of cooling outweigh the benefits. Cooling therapy may reduce damage and potentially improve outcome, and head cooling targets the site of injury and may have fewer side effects than systemic cooling, but the evidence base is unclear.


Subject(s)
Brain/physiology , Hypothermia, Induced/methods , Nasopharynx , Stroke/therapy , Humans
19.
Trials ; 14: 277, 2013 Sep 03.
Article in English | MEDLINE | ID: mdl-24004918

ABSTRACT

BACKGROUND: Clinical trials in traumatic brain injury (TBI) are challenging. Previous trials of complex interventions were conducted in high-income countries, reported long lead times for site setup and low screened-to-recruitment rates.In this report we evaluate the internal pilot phase of an international, multicentre TBI trial of a complex intervention to assess: design and implementation of an online case report form; feasibility of recruitment (sites and patients); feasibility and effectiveness of delivery of the protocol. METHODS: All aspects of the pilot phase of the trial were conducted as for the main trial. The pilot phase had oversight by independent Steering and Data Monitoring committees. RESULTS: Forty sites across 12 countries gained ethical approval. Thirty seven of 40 sites were initiated for recruitment. Of these, 29 had screened patients and 21 randomized at least one patient. Lead times to ethics approval (6.8 weeks), hospital approval (18 weeks), interest to set up (61 weeks), set up to screening (11 weeks), and set up to randomization (31.6 weeks) are comparable with other international trials. Sixteen per cent of screened patients were eligible. We found 88% compliance rate with trial protocol. CONCLUSION: The pilot data demonstrated good feasibility for this large international multicentre randomized controlled trial of hypothermia to control intracranial pressure. The sample size was reduced to 600 patients because of homogeneity of the patient group and we showed an optimized cooling intervention could be delivered. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN34555414.


Subject(s)
Brain Injuries/therapy , Hypothermia, Induced , Intracranial Hypertension/therapy , Intracranial Pressure , Brain Injuries/diagnosis , Brain Injuries/mortality , Brain Injuries/physiopathology , Europe , Feasibility Studies , Humans , Hypothermia, Induced/adverse effects , Hypothermia, Induced/mortality , India , Intracranial Hypertension/diagnosis , Intracranial Hypertension/mortality , Intracranial Hypertension/physiopathology , Pilot Projects , Sample Size , Time Factors , Treatment Outcome
SELECTION OF CITATIONS
SEARCH DETAIL
...