Neurosurgeons’ experiences of conducting and disseminating clinical research in low- and middle-income countries: a qualitative study protocol

Low-income and middle-income countries (LMICs) face the greatest burden of neurotrauma. However, most of the research published in scientific journals originates from high-income countries, suggesting those in LMICs are either not engaging in research or are not publishing it. Evidence originating in high-income countries may not be generalisable to LMICs; therefore, it is important to nurture research capacity in LMICs so that a relevant evidence base can be developed. However, little is published about specific challenges or contextual issues relevant to increasing research activity of neurosurgeons in LMICs. Therefore, the aim of this study was to understand neurosurgeons’ experiences of, aspirations for and ability to conduct and disseminate clinical research in LMICs.Methods and analysisThis is a pragmatic qualitative study situated within the naturalistic paradigm using focus groups and interviews with a purposive sample of neurosurgeons from LMICs. First, we will conduct asynchronous online focus groups with 36 neurosurgeons to broadly explore issues relevant to the study aim. Second, we will select 20 participants for follow-up semistructured interviews to explore concepts in more depth and detail than could be achieved in the focus group. Interviews will be audio-recorded and transcribed verbatim. A thematic analysis will be conducted following Braun and Clarke’s six stages and will be supported by NVIVO software.Ethics and disseminationThe University of Cambridge Psychology Research Ethics Committee reviewed this study and provided a favourable opinion in January 2020 (REF PRE.2020.006). Participants will provide informed consent, be able to withdraw at any time and will have their contributions kept confidential. The findings of the study will be shared with relevant stakeholders and disseminated in conference presentations and journal publications.</jats:sec

Incremental Prognostic Value of Coagulopathy in Addition to the Crash Score in Traumatic Brain Injury Patients

Abstract: Background/objective: Multivariable prognostic scores play an important role for clinical decision-making, information giving to patients/relatives, benchmarking and guiding clinical trial design. Coagulopathy has been implicated on trauma and critical care outcomes, but few studies have evaluated its role on traumatic brain injury (TBI) outcomes. Our objective was to verify the incremental prognostic value of routine coagulopathy parameters in addition to the CRASH-CT score to predict 14-day mortality in TBI patients. Methods: This is a prospective cohort of consecutive TBI patients admitted to a tertiary university hospital Trauma intensive care unit (ICU) from March/2012 to January/2015. The prognostic performance of the coagulation parameters platelet count, prothrombin time (international normalized ratio, INR) and activated partial thromboplastin time (aPTT) ratio was assessed through logistic regression adjusted for the original CRASH-CT score. A new model, CRASH-CT-Coag, was created and its calibration (Brier scores and Hosmer–Lemeshow (H–L) test), discrimination [area under the receiver operating characteristic curve (AUC-ROC) and the integrated discrimination improvement (IDI)] and clinical utility (net reclassification index) were compared to the original CRASH-CT score. Results: A total 517 patients were included (median age 39 years, 85.1% male, median admission glasgow coma scale 8, neurosurgery on 44.9%). The 14-day mortality observed and predicted by the original CRASH-CT was 22.8% and 26.2%, respectively. Platelet count 1.2 and aPTT ratio > 1.2 were present on 11.3%, 65.0% and 27.2%, respectively, (at least one of these was altered on 70.6%). All three variables maintained statistical significance after adjustment for the CRASH-CT score. The CRASH-CT-Coag score outperformed the original score on calibration (brier scores 0.122 ± 0.216 vs 0.132 ± 0.202, mean difference 0.010, 95% CI 0.005–0.019, p = 0.036, respectively) and discrimination (AUC-ROC 0.854 ± 0.020 vs 0.813 ± 0.024, p = 0.014; IDI 5.0%, 95% CI 1.3–11.0%). Both scores showed the satisfactory H–L test results. The net reclassification index favored the new model. Considering the strata of low ( 30%) risk of death, the CRASH-CT-Coag model yielded a global net correct reclassification of 22.9% (95% CI 3.8–43.4%). Conclusions: The addition of early markers of coagulopathy—platelet count, INR and aPTT ratio—to the CRASH-CT score increased its accuracy. Additional studies are required to externally validate this finding and further investigate the coagulopathy role on TBI outcomes

Incremental Prognostic Value of Coagulopathy in Addition to the Crash Score in Traumatic Brain Injury Patients

Abstract: Background/objective: Multivariable prognostic scores play an important role for clinical decision-making, information giving to patients/relatives, benchmarking and guiding clinical trial design. Coagulopathy has been implicated on trauma and critical care outcomes, but few studies have evaluated its role on traumatic brain injury (TBI) outcomes. Our objective was to verify the incremental prognostic value of routine coagulopathy parameters in addition to the CRASH-CT score to predict 14-day mortality in TBI patients. Methods: This is a prospective cohort of consecutive TBI patients admitted to a tertiary university hospital Trauma intensive care unit (ICU) from March/2012 to January/2015. The prognostic performance of the coagulation parameters platelet count, prothrombin time (international normalized ratio, INR) and activated partial thromboplastin time (aPTT) ratio was assessed through logistic regression adjusted for the original CRASH-CT score. A new model, CRASH-CT-Coag, was created and its calibration (Brier scores and Hosmer–Lemeshow (H–L) test), discrimination [area under the receiver operating characteristic curve (AUC-ROC) and the integrated discrimination improvement (IDI)] and clinical utility (net reclassification index) were compared to the original CRASH-CT score. Results: A total 517 patients were included (median age 39 years, 85.1% male, median admission glasgow coma scale 8, neurosurgery on 44.9%). The 14-day mortality observed and predicted by the original CRASH-CT was 22.8% and 26.2%, respectively. Platelet count 1.2 and aPTT ratio > 1.2 were present on 11.3%, 65.0% and 27.2%, respectively, (at least one of these was altered on 70.6%). All three variables maintained statistical significance after adjustment for the CRASH-CT score. The CRASH-CT-Coag score outperformed the original score on calibration (brier scores 0.122 ± 0.216 vs 0.132 ± 0.202, mean difference 0.010, 95% CI 0.005–0.019, p = 0.036, respectively) and discrimination (AUC-ROC 0.854 ± 0.020 vs 0.813 ± 0.024, p = 0.014; IDI 5.0%, 95% CI 1.3–11.0%). Both scores showed the satisfactory H–L test results. The net reclassification index favored the new model. Considering the strata of low ( 30%) risk of death, the CRASH-CT-Coag model yielded a global net correct reclassification of 22.9% (95% CI 3.8–43.4%). Conclusions: The addition of early markers of coagulopathy—platelet count, INR and aPTT ratio—to the CRASH-CT score increased its accuracy. Additional studies are required to externally validate this finding and further investigate the coagulopathy role on TBI outcomes

Decompressive craniotomy: an international survey of practice.

Funder: National Institute for Health Research; doi: http://dx.doi.org/10.13039/501100000272Funder: University of Cambridge and the Royal College of Surgeons of EnglandBACKGROUND: Traumatic brain injury (TBI) and stroke have devastating consequences and are major global public health issues. For patients that require a cerebral decompression after suffering a TBI or stroke, a decompressive craniectomy (DC) is the most commonly performed operation. However, retrospective non-randomized studies suggest that a decompressive craniotomy (DCO; also known as hinge or floating craniotomy), where a bone flap is replaced but not rigidly fixed, has comparable outcomes to DC. The primary aim of this project was to understand the current extent of usage of DC and DCO for TBI and stroke worldwide. METHOD: A questionnaire was designed and disseminated globally via emailing lists and social media to practicing neurosurgeons between June and November 2019. RESULTS: We received 208 responses from 60 countries [40 low- and middle-income countries (LMICs)]. DC is used more frequently than DCO, however, about one-quarter of respondents are using a DCO in more than 25% of their patients. The three top indications for a DCO were an acute subdural hematoma (ASDH) and a GCS of 9-12, ASDH with contusions and a GCS of 3-8, and ASDH with contusions and a GCS of 9-12. There were 8 DCO techniques used with the majority (60/125) loosely tying sutures to the bone flap. The majority (82%) stated that they were interested in collaborating on a randomized trial of DCO vs. DC. CONCLUSION: Our results show that DCO is a procedure carried out for TBI and stroke, especially in LMICs, and most commonly for an ASDH. The majority of the respondents were interested in collaborating on a is a future randomized trial

Neurosurgeons’ experiences of conducting and disseminating clinical research in low- and middle-income countries: a qualitative study protocol

Low-income and middle-income countries (LMICs) face the greatest burden of neurotrauma. However, most of the research published in scientific journals originates from high-income countries, suggesting those in LMICs are either not engaging in research or are not publishing it. Evidence originating in high-income countries may not be generalisable to LMICs; therefore, it is important to nurture research capacity in LMICs so that a relevant evidence base can be developed. However, little is published about specific challenges or contextual issues relevant to increasing research activity of neurosurgeons in LMICs. Therefore, the aim of this study was to understand neurosurgeons’ experiences of, aspirations for and ability to conduct and disseminate clinical research in LMICs.Methods and analysisThis is a pragmatic qualitative study situated within the naturalistic paradigm using focus groups and interviews with a purposive sample of neurosurgeons from LMICs. First, we will conduct asynchronous online focus groups with 36 neurosurgeons to broadly explore issues relevant to the study aim. Second, we will select 20 participants for follow-up semistructured interviews to explore concepts in more depth and detail than could be achieved in the focus group. Interviews will be audio-recorded and transcribed verbatim. A thematic analysis will be conducted following Braun and Clarke’s six stages and will be supported by NVIVO software.Ethics and disseminationThe University of Cambridge Psychology Research Ethics Committee reviewed this study and provided a favourable opinion in January 2020 (REF PRE.2020.006). Participants will provide informed consent, be able to withdraw at any time and will have their contributions kept confidential. The findings of the study will be shared with relevant stakeholders and disseminated in conference presentations and journal publications.</jats:sec

Remote Follow-Up Technologies in Traumatic Brain Injury: A Scoping Review.

Traumatic brain injury (TBI) remains a leading cause of death and disability worldwide. Motivations for outcome data collection in TBI are threefold: to improve patient outcomes, to facilitate research, and to provide the means and methods for wider injury surveillance. Such data play a pivotal role in population health, and ways to increase the reliability of data collection following TBI should be pursued. As a result, technology-aided follow-up of patients with neurotrauma is on the rise; there is, therefore, a need to describe how such technologies have been used. A scoping review was conducted and reported using the PRISMA extension (PRISMA-ScR). Five electronic databases (Embase, MEDLINE, Global Health, PsycInfo, and Scopus) were searched systematically using keywords derived from the concepts of "telemedicine," "TBI," "outcome assessment," and "patient-generated health data." Forty studies described follow-up technologies (FUTs) utilizing telephones (52.5%, n = 21), short message service (SMS; 10%, n = 4), smartphones (22.5%, n = 9), videoconferencing (10%, n = 4), digital assistants (2.5%, n = 1), and custom devices (2.5%, n = 1) among cohorts of patients with TBI of varying injury severity. Where reported, clinical facilitators, remote follow-up timing and intervals between sessions, synchronicity of follow-up instances, proxy involvement, outcome measures utilized, and technology evaluation efforts are described. FUTs can aid more temporally sensitive assessments and capture fluctuating sequelae, a benefit of particular relevance to TBI cohorts. However, the evidence base surrounding FUTs remains in its infancy, particularly with respect to large samples, low- and middle-income patient cohorts, and the validation of outcome measures for deployment via such remote technology

Long-term Dysphagia following Acoustic Neuroma Surgery: Prevalence, Severity, and Predictive Factors

Background Acoustic neuroma (AN) may compress the cerebellum and brainstem and may cause dysfunction of bulbar cranial nerves. Objective To describe swallowing function outcomes in the late postoperative period after AN surgery. Methods This cohort study included patients operated on between 1999–2014, with a mean follow up of 6.4 ± 4.5 years. The swallowing function was assessed through the functional oral intake scale (FOIS). The primary outcome was defined by scores 5 to 1, which implied oral feeding restriction or adaptation. Risks factors were identified through multivariate logistic regression. Results 101 patients were evaluated. As many as 46 (45.5%) presented dysphagia on the late postoperative period. Women comprised 77.2%, and the mean age was 47.1 ± 16.0 years (range 19–80). Dysphagic patients presented more type II neurofibromatosis (NF II) (32.6% vs. 10.9%, p = 0.007), larger tumors (3.8 ± 1.1 vs. 3.1 ± 1.0 cm, p < 0.001), partial resection (50.0% vs. 85.5%, p < 0.001) and needed more surgeries (≥2, 39.1% vs. 18.2%, p = 0.019). Important peripheral facial palsy (PFP) (House–Brackmann [HB] grade ≥3) was present before the surgery on 47.5% and worsened on 55.4%. Postoperative PFP (p < 0.001), but not preoperative PFP, was predictive of postoperative dysphagia. On multivariate analysis, the following factors were risk factors for dysphagia: NF II (OR 5.54, p = 0.034), tumor size (each 1 cm, OR 2.13, p = 0.009), partial resection (OR 5.23, p = 0.022) and postoperative HB grade ≥3 (OR 12.99, p = 0.002). Conclusions Dysphagia after AN surgery is highly correlated to postoperative facial motor function. NF II, tumor size, and extent of resection were also predictive of this morbidity in the late postoperative period

External validation of the Glasgow coma scale-pupils in low- to middle-income country patients with traumatic brain injury: Could "motor score-pupil" have higher prognostic value?

BACKGROUND: The objective of this study is to validate the admission Glasgow coma scale (GCS) associated with pupil response (GCS-P) to predict traumatic brain injury (TBI) patient's outcomes in a low- to middle-income country and to compare its performance with that of a simplified model combining the better motor response of the GCS and the pupilar response (MS-P). METHODS: This is a prospective cohort of patients with TBI in a tertiary trauma reference center in Brazil. Predictive values of the GCS, GCS-P, and MS-P were evaluated and compared for 14 day and in-hospital mortality outcomes and length of hospital stay (LHS). RESULTS: The study enrolled 447 patients. MS-P demonstrated better discriminative ability than GCS to predict mortality (AUC 0.736 × 0.658; P < 0.001) and higher AUC than GCS-P (0.736 × 0.704, respectively; P = 0.073). For hospital mortality, MS-P demonstrated better discrimination than GCS (AUC, 0.750 × 0.682; P < 0.001) and higher AUC than GCS-P (0.750 × 0.714; P = 0.027). Both scores were good predictors of LHS (r2 = 0.084 [GCS-P] × 0.079 [GCS] × 0.072 [MS-P]). CONCLUSION: The predictive value of the GCS, GCS-P, and MS-P scales was demonstrated, thus contributing to its external validation in low- to middle-income country

Neurotrauma clinicians' perspectives on the contextual challenges associated with traumatic brain injury follow up in low-income and middle-income countries: A reflexive thematic analysis.

BACKGROUND: Traumatic brain injury (TBI) is a major global health issue, but low- and middle-income countries (LMICs) face the greatest burden. Significant differences in neurotrauma outcomes are recognised between LMICs and high-income countries. However, outcome data is not consistently nor reliably recorded in either setting, thus the true burden of TBI cannot be accurately quantified. OBJECTIVE: To explore the specific contextual challenges of, and possible solutions to improve, long-term follow-up following TBI in low-resource settings. METHODS: A cross-sectional, pragmatic qualitative study, that considered knowledge subjective and reality multiple (i.e. situated within the naturalistic paradigm). Data collection utilised semi-structured interviews, by videoconference and asynchronous e-mail. Data were analysed using Braun and Clarke's six-stage Reflexive Thematic Analysis. RESULTS: 18 neurosurgeons from 13 countries participated in this study, and data analysis gave rise to five themes: Clinical Context: What must we understand?; Perspectives and Definitions: What are we talking about?; Ownership and Beneficiaries: Why do we do it?; Lost to Follow-up: Who misses out and why?; Processes and Procedures: What do we do, or what might we do? CONCLUSION: The collection of long-term outcome data plays an imperative role in reducing the global burden of neurotrauma. Therefore, this was an exploratory study that examined the contextual challenges associated with long-term follow-up in LMICs. Where technology can contribute to improved neurotrauma surveillance and remote assessment, these must be implemented in a manner that improves patient outcomes, reduces clinical burden on physicians, and does not surpass the comprehension, capabilities, or financial means of the end user. Future research is recommended to investigate patient and family perspectives, the impact on clinical care teams, and the full economic implications of new technologies for follow-up