scholarly journals Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Chun Yang ◽  
Xianjian Huang ◽  
Junfeng Feng ◽  
Li Xie ◽  
Jiyuan Hui ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Decompressive Craniectomy ◽  
Epidural Hematoma ◽  
Controlled Trial ◽  
Economic Benefits ◽  
Brain Herniation ◽  
Post Injury ◽  
Randomized Controlled ◽  
Cerebral Herniation ◽  
Acute Epidural Hematoma

Abstract Background: Expeditiously surgical evacuation of acute epidural hematoma (AEDH) is an attainable gold standard and is often expected to have a good clinical outcome for patients with surgical indications. However, controversy exists on the optimal surgical treatment for AEDH, especially for patients with brain herniation. Neurosurgeons are confronted by the decision to evacuate the hematoma with decompressive craniectomy or craniotomy. Here, we present the protocol for a randomized controlled trial targeted at comparing the outcome and economic benefits of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury (TBI) patients with cerebral herniation undergoing evacuation of AEDH.Methods/design: Patients of both genders, aged from 18 to 65 years, presenting to the emergency room with a clinical and radiological diagnosis of AEDH with herniation, comply with other inclusion and exclusion criteria are enrolled. Clinical information, including diagnosis of AEDH, clinical radiological information and treatment procedures, follow-up data of 1, 3 and 6 months post injury are collected on 120 eligible patients, randomized into groups of decompressive craniectomy versus craniotomy in a 1:1 ratio among 51 centers. The primary outcome is the Glasgow Outcome Score-Extended (GOSE) at 6 months post-injury. Secondary outcomes include incidence of post-operative cerebral infarction, incidence of additional craniocerebral surgery, and other evaluation indicator within 6 months post-injury.Discussion: This study is expected to help neurosurgeons make a better decision to evacuate the epidural hematoma with or without a DC, especially for patients with brain herniation, and improve current situation of lack of general evidence.Trial registration: Clinicaltrials.gov: NCT 04261673 (Registration date: 04 February 2020)

scholarly journals Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Chun Yang ◽  
Xianjian Huang ◽  
Junfeng Feng ◽  
Li Xie ◽  
Jiyuan Hui ◽  
...  
Keyword(s):  
Epidural Hematoma ◽  
Controlled Trial ◽  
Brain Herniation ◽  
Post Injury ◽  
Link Type ◽  
Randomized Evaluation ◽  
Surgical Options ◽  
Acute Epidural Hematoma ◽  
Treatment Procedures

Abstract Background The expeditious surgical evacuation of acute epidural hematoma (AEDH) is an attainable gold standard and is often expected to have a good clinical outcome for patients with surgical indications. However, controversy exists on the optimal surgical options for AEDH, especially for patients with brain herniation. Neurosurgeons are confronted with the decision to evacuate the hematoma with decompressive craniectomy (DC) or craniotomy. Methods/design Patients of both sexes, age between 18 and 65 years, who presented to the emergency room with a clinical and radiological diagnosis of AEDH with herniation, were assessed against the inclusion and exclusion criteria to be enrolled in the study. Clinical and radiological information, including diagnosis of AEDH, treatment procedures, and follow-up data at 1, 3, and 6 months after injury, was collected from 120 eligible patients in 51 centers. The patients were randomized into groups of DC versus craniotomy in a 1:1 ratio. The primary outcome was the Glasgow Outcome Score-Extended (GOSE) at 6 months post-injury. Secondary outcomes included incidence of postoperative cerebral infarction, incidence of additional craniocerebral surgery, and other evaluation indicators within 6 months post-injury. Discussion This study is expected to support neurosurgeons in their decision to evacuate the epidural hematoma with or without a DC, especially in patients with brain herniation, and provide additional evidence to improve the knowledge in clinical practice. Trial registration ClinicalTrials.govNCT 04261673. Registered on 04 February 2020

scholarly journals Acute plate fixation of displaced midshaft clavicular fractures is not associated with earlier return of normal shoulder function when union is achieved

2021 ◽  
Vol 2 (7) ◽  
pp. 522-529
Author(s):  
Jamie A. Nicholson ◽  
Nick D. Clement ◽  
Andrew D. Clelland ◽  
Deborah J. MacDonald ◽  
A. Hamish R. W. Simpson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Nonoperative Management ◽  
Controlled Trial ◽  
Plate Fixation ◽  
Shoulder Function ◽  
Dash Score ◽  
Post Injury ◽  
Early Recovery ◽  
Specific Patient ◽  
Randomized Controlled

Aims It is unclear whether acute plate fixation facilitates earlier return of normal shoulder function following a displaced mid-shaft clavicular fracture compared with nonoperative management when union occurs. The primary aim of this study was to establish whether acute plate fixation was associated with a greater return of normal shoulder function when compared with nonoperative management in patients who unite their fractures. The secondary aim was to investigate whether there were identifiable predictors associated with return of normal shoulder function in patients who achieve union with nonoperative management. Methods Patient data from a randomized controlled trial were used to compare acute plate fixation with nonoperative management of united fractures. Return of shoulder function was based on the age- and sex-matched Disabilities of the Arm, Shoulder and Hand (DASH) scores for the cohort. Independent predictors of an early recovery of normal shoulder function were investigated using a separate prospective series of consecutive nonoperative displaced mid-shaft clavicular fractures recruited over a two-year period (aged ≥ 16 years). Patient demographics and functional recovery were assessed over the six months post-injury using a standardized protocol. Results Data from the randomized controlled trial consisted of 86 patients who underwent operative fixation compared with 76 patients that united with nonoperative treatment. The recovery of normal shoulder function, as defined by a DASH score within the predicted 95% confidence interval for each respective patient, was similar between each group at six weeks (operative 26.7% vs nonoperative 25.0%, p = 0.800), three months (52.3% vs 44.2%, p = 0.768), and six months post-injury (86.0% vs 90.8%, p = 0.349). The mean DASH score and return to work were also comparable at each timepoint. In the prospective cohort, 86.5% (n = 173/200) achieved union by six months post-injury (follow-up rate 88.5%, n = 200/226). Regression analysis found that no specific patient, injury, or fracture predictor was associated with an early return of function at six or 12 weeks. Conclusion Return of normal shoulder function was comparable between acute plate fixation and nonoperative management when union was achieved. One in two patients will have recovery of normal shoulder function at three months, increasing to nine out of ten patients at six months following injury when union occurs, irrespective of initial treatment. Cite this article: Bone Jt Open 2021;2(7):522–529.

Four Quadrant Osteoplastic Decompressive Craniotomy versus Conventional Decompressive Craniectomy for Traumatic Brain Injury: A Randomized Controlled Trial

2017 ◽  
Vol 14 (02/03) ◽  
pp. 156-162 ◽  
Author(s):  
Siddharth Vankipuram ◽  
Sumeet Sasane ◽  
Anil Chandra ◽  
Bal Ojha ◽  
Sunil Singh ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Decompressive Craniectomy ◽  
Controlled Trial ◽  
Midline Shift ◽  
Randomized Controlled ◽  
Decompressive Craniotomy ◽  
Four Quadrant ◽  
Brain Width

Abstract Objective Four quadrant osteoplastic decompressive craniotomy (FoQOsD) has been described as a novel technique in the management of patients with traumatic brain injury requiring decompressive surgery. There has not been a randomized controlled trial comparing its outcomes with conventional decompressive craniectomy (DECRA) as yet. Methods A randomized controlled trial of 55 patients was conducted, of whom 29 underwent DECRA and 26 patients underwent FoQOsD. The preoperative baseline demographics, clinical conditions, and radiologic features were similar in both the groups. Clinical outcome was decided by the use of Glasgow coma outcome scale extended (GOS-e) at 3 months. Radiographic outcomes were assessed by measurement of the change in midline shift and brain width expansion (ipsilateral and contra-lateral to hematoma) on the postoperative computed tomographic (CT) scan. Results No significant differences were identified in baseline demographics, clinical condition, Rotterdam CT score, and radiographic characteristics between both the groups. At 3-month follow-up, the mean GOS-e score was comparable in both the groups (3.23 in DECRA group and 3.35 in FoQOsD group, p = 0.856). Mortality analysis at 3 months revealed that nine patients died in the DECRA group and eight died in FoQOsD group. Postoperative imaging characteristics, including Rotterdam score, also did not differ significantly. The percentage reduction in midline shift and percentage brain width expansion on the postoperative CT scan was similar in both the groups (p > 0.05). Conclusion FoQOsD appears to be at least as efficacious as DECRA in providing equivalent clinical outcomes with the added benefit of avoiding a second surgery.

Patient cost-benefits of realtime teledermatology-a comparison of data from Northern Ireland and New Zealand

2000 ◽  
Vol 6 (2) ◽  
pp. 97-101 ◽  
Author(s):  
A M M Oakley ◽  
P Kerr ◽  
M Duffill ◽  
M Rademaker ◽  
P Fleischl ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Northern Ireland ◽  
Controlled Trial ◽  
Health Centre ◽  
Economic Benefits ◽  
Costs And Benefits ◽  
Face To Face ◽  
Cost Benefits ◽  
Randomized Controlled

As part of a randomized controlled trial of the costs and benefits of realtime teledermatology in comparison with conventional face-to-face appointments, patients were asked to complete a questionnaire at the end of their consultation. One hundred and nine patients took part in an initial teledermatology consultation and 94 in a face-to-face consultation. The proportion of patients followed up by the dermatologist was almost the same after teledermatology 24 as after a hospital appointment 26 and for similar reasons. Two hundred and three questionnaires were completed after the first visit and a further 20 after subsequent visits. Patients seen by teledermatology at their own health centre travelled an average of 12 km, whereas those who attended a conventional clinic travelled an average of 271 km. The telemedicine group spent an average of 51 min attending the appointment compared with 4.3 h for those seen at the hospital. The results of the present study, as in a similar study conducted in Northern Ireland, show that the economic benefits of teledermatology favour the patient rather than the health-care system.

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (12) ◽  
pp. 4464-4482 ◽  
Author(s):  
Diane L. Kendall ◽  
Megan Oelke Moldestad ◽  
Wesley Allen ◽  
Janaki Torrence ◽  
Stephen E. Nadeau
Keyword(s):  
Randomized Controlled Trial ◽  
Response Latency ◽  
Controlled Trial ◽  
Semantic Knowledge ◽  
Semantic Feature ◽  
Feature Analysis ◽  
Group Differences ◽  
Randomized Controlled ◽  
Confrontation Naming ◽  
Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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