Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis

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Despite advancements in healthcare focusing primarily on communicable diseases, TBI remains a leading cause of death and disability worldwide, significantly affecting the quality of life of patients and their families. Recent interest has surged in platelet-rich plasma (PRP) as a novel treatment for TBI, necessitating a comprehensive review of its therapeutic benefits. Methodology The study will source articles from PubMed, EMBASE, SCOPUS, and the Cochrane Central Register of Controlled Trials, targeting a range of studies including randomized controlled trials (RCTs), observational studies, and cohort studies. The review will exclude case series, review articles, and studies not reported in English. The primary aim is to collate evidence-based data on TBI management, with particular focus on the Indian healthcare context, evaluating the efficacy of current treatments and the potential role of PRP in enhancing neurological function and recovery post-TBI. Data management will involve a rigorous selection process, with independent reviewers conducting initial screenings and resolving discrepancies through discussion or arbitration. A PRISMA flow diagram will illustrate the study selection procedure, and a standardized form will be used for data extraction, ensuring thoroughness and consistency. Conclusion By highlighting current knowledge gaps, this systematic review and meta-analysis will guide future research directions and clinical practice, potentially revolutionizing TBI management strategies in LMICs. This protocol underscores the necessity for high-quality, evidence-based approaches to TBI treatment, aiming to improve patient outcomes through enhanced management practices. 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F1000Research 2024, 13 :407 ( https://doi.org/10.12688/f1000research.148645.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis [version 1; peer review: 2 approved with reservations] Gaurav Mittal https://orcid.org/0000-0002-4830-0534 1 , Roshan Prasad https://orcid.org/0000-0002-1958-2026 2 , Tangmi Djabo Eric Adrien https://orcid.org/0000-0002-3421-6112 3,4 Gaurav Mittal https://orcid.org/0000-0002-4830-0534 1 , Roshan Prasad https://orcid.org/0000-0002-1958-2026 2 , Tangmi Djabo Eric Adrien https://orcid.org/0000-0002-3421-6112 3,4 PUBLISHED 26 Apr 2024 Author details Author details 1 Neurology, Mahatma Gandhi Institute of Medical Sciences, Wardha, Maharashtra, India 2 Neurology, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India 3 Association of Future African Neurosurgeons, Yaounde, Centre, Cameroon 4 Department of Medicine, Université Technologique Bel Campus, Kinshasa, Democratic Republic of the Congo Gaurav Mittal Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Resources, Software, Supervision, Visualization, Writing – Original Draft Preparation Roshan Prasad Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Resources, Software, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Tangmi Djabo Eric Adrien Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Project Administration, Resources, Software, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract Abstract* Introduction This systematic review and meta-analysis protocol aims to evaluate the management of traumatic brain injury (TBI) in India, addressing a critical gap in the understanding and treatment of TBI in low- and middle-income countries (LMICs). Despite advancements in healthcare focusing primarily on communicable diseases, TBI remains a leading cause of death and disability worldwide, significantly affecting the quality of life of patients and their families. Recent interest has surged in platelet-rich plasma (PRP) as a novel treatment for TBI, necessitating a comprehensive review of its therapeutic benefits. Methodology The study will source articles from PubMed, EMBASE, SCOPUS, and the Cochrane Central Register of Controlled Trials, targeting a range of studies including randomized controlled trials (RCTs), observational studies, and cohort studies. The review will exclude case series, review articles, and studies not reported in English. The primary aim is to collate evidence-based data on TBI management, with particular focus on the Indian healthcare context, evaluating the efficacy of current treatments and the potential role of PRP in enhancing neurological function and recovery post-TBI. Data management will involve a rigorous selection process, with independent reviewers conducting initial screenings and resolving discrepancies through discussion or arbitration. A PRISMA flow diagram will illustrate the study selection procedure, and a standardized form will be used for data extraction, ensuring thoroughness and consistency. Conclusion By highlighting current knowledge gaps, this systematic review and meta-analysis will guide future research directions and clinical practice, potentially revolutionizing TBI management strategies in LMICs. This protocol underscores the necessity for high-quality, evidence-based approaches to TBI treatment, aiming to improve patient outcomes through enhanced management practices. READ ALL READ LESS Keywords management, traumatic brain injury, india, systematic review, meta-analysis, protocol Corresponding Author(s) Gaurav Mittal ( [email protected] ) Close Corresponding author: Gaurav Mittal Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Mittal G et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Mittal G, Prasad R and Eric Adrien TD. Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis [version 1; peer review: 2 approved with reservations] . F1000Research 2024, 13 :407 ( https://doi.org/10.12688/f1000research.148645.1 ) First published: 26 Apr 2024, 13 :407 ( https://doi.org/10.12688/f1000research.148645.1 ) Latest published: 26 Apr 2024, 13 :407 ( https://doi.org/10.12688/f1000research.148645.1 ) 1. Introduction While LMICs (Low – middle income countries) have made significant improvements to their healthcare systems by concentrating on communicable diseases (CDs), 1 Traumatic brain injury (TBI) is the leading cause of death and disability globally and a significant public health concern. Numerous physical, mental, and emotional impairments may result from it, which could significantly lower the quality of life for those who are affected as well as their families. Even with advances in TBI therapy, no recovery fully restores neurological function. 2 , 3 No proven therapy completely restores neurological function, despite advancements in the management of traumatic brain injury. Recently, there has been a growing interest in platelet-rich plasma (PRP) as a potential treatment for traumatic brain injury. Platelet-rich plasma (PRP) is a blood product that contains a high concentration of platelets that are rich in growth factors and other bioactive molecules that can aid in tissue regeneration and repair. PRP has been used to reduce inflammation and speed up healing in a variety of clinical settings, and there is mounting evidence that it may also be beneficial for treating traumatic brain injury. PRP has the potential to treat traumatic brain injury (TBI), but in order to assess its efficacy and safety, a comprehensive analysis of the available data is required. A review of this kind would offer a thorough and trustworthy strength of evidence to reveal new information and direct future studies and clinical practices. This protocol describes how to carry out a thorough analysis of PRP’s therapeutic benefit in the treatment of traumatic brain injury. The purpose of this study is to compile evidence-based data on TBI management in low- and middle-income nations like India. Building up the infrastructure that sup-ports the healthcare system is a crucial strategy for India’s healthcare system to be sustainable. 4 1.1 Rationale Traumatic brain injury (TBI) and its aftermath are thought to be a global health concern nowadays. They significantly affect patient function, quality of life, and social impact globally. Traumatic brain injury (TBI) can cause a variety of long-term problems, including headaches, erratic sleep patterns, psychosis, mood, behavioural, and anxiety disorders, and psychosis. 5 In the coming years, there will likely be a rise in the incidence of traumatic brain injury (TBI) due to the increased use of motor vehicles, which is a major cause of traffic accidents and TBI development. There are projections that indicate both global population growth and density will contribute to this in-crease. As of 2018, an estimated 69 million people had suffered traumatic brain injury (TBI), with the majority of these cases occurring as a result of traffic accidents, which have a particularly serious effect in low- and middle-income countries (LMICs). 6 The prevention of traumatic brain injury (TBI) has focused on treatment strategies that lessen the injury’s immediate to moderate-term effects in addition to surveillance systems and programs for the purpose of preventing TBI. These methods include pharmacological treatment with steroids, muscle relaxants, anticonvulsants, antidepressants, stimulants, anti-anxiety drugs, and more, as well as rehabilitation therapy. 7 Treatment for traumatic brain injury (TBI) that enhances long-term functionality and quality of life by promoting neurological regeneration, restoration, and repair is more well-established than the modalities mentioned above. Novel approaches to treating a range of diseases, including traumatic brain injury (TBI), have been made possible by biotechnology breakthroughs such as platelet-rich plasma (PRP). Platelet-rich preparations, such as platelet-rich plasma (PRP), are essentially the platelet-rich fraction of blood obtained by centrifuging fresh blood. They have the potential to accelerate healing, stimulate bone and tissue regeneration, and improve bone density. 8 Apart from the previously mentioned potential advantages, PRP is inexpensive, non-invasive, adaptable, has a simple preparation process, and has an excellent biosafety profile. Apart from its ability to reduce inflammation, platelet-derived growth factor (PDGF), insulin-like growth factor 1 (IGF-1), transforming growth factor-N (TGF-β), endothelial growth factor (EGF), and vascular endothelial growth factor (VEGF) are among the growth factors that PRP can inhibit and stimulate locally. In addition to promoting vascularization and collagen synthesis, the growth factors mentioned above are also responsible for stimulating keratinocyte proliferation and attracting local fibroblasts and stem cells. 9 , 10 1.2 Aims of the study Primary aim: To assess the management of TBI in India. Secondary aim: 1. To review and summarize the existing literature on the management of TBI in India. 2. To evaluate the efficacy of the management of patients with traumatic brain in-jury. 3. To evaluate the neurological functional recovery post-TBI patient. 4. To identify gaps in current knowledge and highlight areas for further research and investigation regarding the management of TBI in LMICs in India. Protocol 2. Methods 2.1 The population of study Patients with traumatic brain injury(ies), regardless of age or gender. 2.2 Period of study From January 2024 to February 14, 2024. 2.3 Inclusion criteria All randomized controlled trials (RCTs), non-randomized con-trolled clinical trials, observational studies, case-control and prospective cohort studies describing the management of traumatic brain injury. Only articles reported in English will be included. 2.4 Exclusion criteria Case series, case reports, abstract-only articles, letters to the editor, conference proceedings, review articles, articles with missing data in other languages, and those reporting animal studies will be excluded. Studies describing the management of traumatic brain injury and other disease conditions in animals will al-so be excluded. 2.5 Information source and Search Strategy Articles for our study will be sourced from PubMed, EMBASE, SCOPUS, Web of Science, and Cochrane Central. 2.5.1 Search strategy (“manage”[All Fields] OR “managed”[All Fields] OR “management s”[All Fields] OR “managements”[All Fields] OR “manager”[All Fields] OR “manager s”[All Fields] OR “managers”[All Fields] OR “manages”[All Fields] OR “managing”[All Fields] OR “managment”[All Fields] OR “organization and administration”[MeSH Terms] OR (“organization”[All Fields] AND “administration”[All Fields]) OR “organization and administration”[All Fields] OR “management”[All Fields] OR “disease manage-ment”[MeSH Terms] OR (“disease”[All Fields] AND “management”[All Fields]) OR “disease management”[All Fields]) AND (“brain injuries, traumatic”[MeSH Terms] OR (“brain”[All Fields] AND “injuries”[All Fields] AND “traumatic”[All Fields]) OR "trau-matic brain injuries”[All Fields] OR (“traumatic”[All Fields] AND “brain”[All Fields] AND “injury”[All Fields]) OR “traumatic brain injury”[All Fields]) AND (“india”[MeSH Terms] OR “india”[All Fields] OR “india s”[All Fields] OR “indias”[All Fields]) AND (“systematic review”[Publication Type] OR “systematic reviews as topic”[MeSH Terms] OR “systematic review”[All Fields]) AND (“meta analysis”[Publication Type] OR “meta analysis as topic”[MeSH Terms] OR “meta analysis”[All Fields]) 2.5.2 Translations Management: “manage”[All Fields] OR “managed”[All Fields] OR “management’s”[All Fields] OR “managements”[All Fields] OR “manager”[All Fields] OR “manager’s”[All Fields] OR “managers”[All Fields] OR “manages”[All Fields] OR “managing”[All Fields] OR “managment”[All Fields] OR “organization and administration”[MeSH Terms] OR (“organization”[All Fields] AND “administration”[All Fields]) OR “organization and administration”[All Fields] OR “management”[All Fields] OR “disease manage-ment”[MeSH Terms] OR (“disease”[All Fields] AND “management”[All Fields]) OR “disease management”[All Fields] Traumatic Brain Injury: “brain injuries, traumatic”[MeSH Terms] OR (“brain”[All Fields] AND “injuries”[All Fields] AND “traumatic”[All Fields]) OR “traumatic brain in-juries”[All Fields] OR (“traumatic”[All Fields] AND “brain”[All Fields] AND “injury”[All Fields]) OR “traumatic brain injury”[All Fields] India: “india”[MeSH Terms] OR “india”[All Fields] OR “india’s”[All Fields] OR “indias”[All Fields] Systematic Review: “systematic review”[Publication Type] OR “systematic reviews as topic”[MeSH Terms] OR “systematic review”[All Fields] Meta-analysis: “meta-analysis”[Publication Type] OR “meta-analysis as topic”[MeSH Terms] OR “meta-analysis”[All Fields] Search results from PubMed on 11/02/2024 at 09:23:08 have been shown in Table 1 . Table 1. Search results from PubMed on 11/02/2024 at 09:23:08. Search Query #6 Search: #1 AND #2 AND #3 AND #4 AND #5 #5 Meta-analysis #4 Systematic review #3 Search: India [All Fields] #2 Search: Traumatic Brain Injury [All Fields] #1 Search: Management [All Fields] 3. Data management 3.1 Study selection Two independent reviewers who are blinded will perform a preliminary screening of titles and abstracts after downloading and uploading the database literature search result to Rayyan (ref). This will help to avoid duplication of studies. Any disagreements that arise will be discussed and settled by the review team; if an agreement cannot be reached, an independent author will act as an arbitrator. The selected papers will then go through a second round of full-text screening to ensure they meet our inclusion requirements, followed by a final screening to assess bi-as risk. Using a PRISMA flow diagram, this study selection procedure will be illustrated. 3.2 Data extraction There will be two steps in the data extraction process. We will perform a preliminary pilot extraction. The process will entail the authors selecting ten (10) articles at random and extracting data from them according to the goals and study outcomes. The purpose of the pilot phase is to verify the consistency of the extraction process and identify any unclear or missing data. Once the pilot phase is over, a meeting of the authors will take place to decide on the right data to extract. The primary data extraction phase, which comes next, will involve a detailed review of the studies that satisfy the eligibility requirements in order to extract established data. 3.3 Charting the data This section explains how the data for this systematic review and meta-analysis will be recorded and charted in order to guarantee openness and the reproducibility of the procedures involved. In order to chart the data and find answers to our research questions and study objectives, the following procedures will be followed: 3.3.1 Data extraction: A standardized extraction form will be used to extract the important data from each study that is part of the review. This data extraction will com-prise the following: the year of publication, the study design, the sample size, the severity of traumatic brain injury, the drug dosage (such as propranolol or platelet rich plasma, etc), the timing and duration, the outcome measures, and the main conclusions. At least two separate reviewers will handle the extraction process in order to guarantee accuracy and minimize bias. 3.3.2 Data organization: Tabulated and standardized data format will be used to arrange the extracted data in order to facilitate comparison and analysis. We’ll use readily readable tables and graphs created by applications such as Microsoft Excel. 3.3.3 Statistical analysis: The I2 statistic will be used to determine the homogeneity be-tween the studies. A fixed-effects model will be used in the meta-analysis if the results indicate a low level of heterogeneity (I 2 50%). 3.3.4 Assessment of heterogeneity: Using suitable statistical tests, such as the chi squared or I2 statistic, heterogeneity will be evaluated to make sure that variable results from various studies are taken into account when performing statistical analysis. 3.3.5 Analysing and synthesizing the drug’s neuroprotective effects: Results from all of the studies on the neuroprotective effects of propranolol in the treatment of traumatic brain injury will be examined. Its effects on synaptic plasticity, neuronal regeneration, lowering neuronal damage, neuroinflammation, and oxidative stress are among these. 3.3.6 Tabular and graphical representation: We will use clear tables and accurate graphical representations, such as forest plots, to present the collected data for the synthesized outcome measures. This procedure will make understanding the specific study results and the overall meta-analysis results easier. 3.3.7 Quality assessment: Every study will undergo an independent evaluation to identify any potential sources of bias using the Cochrane risk-of-bias tool and overall study quality. We’ll assess the evidence’s quality using the GRADE method. We will be able to fully comprehend the role of propranolol in treating traumatic brain injury (TBI), pinpoint knowledge gaps, and produce tangible evidence to direct clinical practice and future research by adhering to this strict and impartial system of data charting. 4. Measurement of effect This systematic review and meta-analysis will primarily focus on the neuroprotective effects of medications on patients who have suffered from traumatic brain injury (TBI) in terms of effect measurement. The main goals of the study will be to improve quality of life, motor function, and cognitive function. Reductions in oxidative stress, neuroinflammation, and neuronal injury will be the secondary outcome metrics. Patients with traumatic brain injury (TBI) will have the effects of propranolol assessed using validated clinical measures such as the Glasgow Outcome Scale (GOS), the Extrapyramidal Symptom Rating Scale (ESRS), and the Quality-of-Life Inventory (QOLIBRI). In addition, neuroimaging methods like magnetic resonance imaging (MRI), positron emission tomography (PET), and functional MRI will be employed to evaluate alterations in brain structure and function. We will compare the efficacy of propranolol with other treatments for traumatic brain injury, such as corticosteroids and hyperbaric oxygen therapy. The evaluation of propranolol’s safety profile will also involve tracking adverse effects like weariness, light-headedness, and insomnia. Include plans for dissemination of the study outcome (including the associated data) once completed. 4.1 Study status Once this protocol is thoroughly peer reviewed by 2 peer reviewers the authors will start writing the review article keeping in mind the insights of the reviewers. Hence, the status of the article is the protocol 5. Discussion and Conclusion The outcomes assessed here include the frequency of complications, the death rate, cognitive function, functional recovery, and any other pertinent indicators of brain injury recovery. Primary outcome being mortality rate, the incidence of complications and cognitive function. Secondary outcomes being pain scores and mean length of hospital stay. 5.1 Risk of bias individual studies Using the Newcastle-Ottawa Scale (NOS), a method for estimating the risk of bias in observational studies, three authors will separately evaluate the quality of the studies. Research that receive a NOS score of 4 or higher will be deemed to have minimal bias risk and will be incorporated into reviews and meta-analyses. 5.2 Data synthesis Numerous studies have looked into the management of traumatic brain injury (TBI) using platelet rich plasma, propranolol etc. Regarding propranolol, these studies have demonstrated that giving low-dose propranolol to TBI patients at an early stage can shorten their hospital stay and mortality rate. Propranolol improves cerebral per-fusion by lowering sympathetic discharge and catecholamine release associated with paroxysmal sympathetic hyperactivity. It does this by lowering tachycardia, hypertension, hyperthermia, cerebral oedema, metabolism, and hypoxia. Propranolol can cross the blood-brain barrier. More investigation is required to completely comprehend propranolol’s neuroprotective mechanisms in traumatic brain injury and to establish the best dosage and administration guidelines. 5.3 Subgroup analysis To reduce the possibility of bias in the event that there is a lot of heterogeneity, we will categorize the results and perform a pooled subgroup analysis. 5.4 Patient and public involvement Since we are using previously published studies, no patients will be involved in this study. 5.5 Strength of body of evidence The validity and applicability of the evidence that has been compiled from this review will be evaluated using the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) algorithm. 5.6 Ethics and dissemination: Because it is a novel method of assessing the volume of literature on the topic, this systematic review of published articles on “management of traumatic brain injury in India" will not need ethical approval because it is a secondary analysis. The Cochrane Handbook for systematic reviews and meta-analyses of diagnostic test accuracy guide-lines will be adhered to in this study. 11 In order to protect human subjects and ensure responsible research practices, we have followed ethical principles and guidelines during the conduct of this study. First off, the data in this review originate from pub-lished, publicly accessible literature, suggesting that the authors of the original studies have already gotten informed consent. Our privacy policies protect patients’ and their families’ identity and we never gather personally identifiable information. 12 We will follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines to ensure that our findings are comprehensible, thorough, and repeatable. In order to maintain scientific rigor, we make an effort to reduce bias and maintain transparency throughout the planning, gathering, analyzing, interpreting, and reporting of our review. 13 In order to do this, we will adhere to a predetermined protocol that is listed in the International Prospective Register of Systematic Reviews (PROSPERO), which specifies the goals, qualifying requirements, search approach, synthesis techniques, and scheduled analyses. 14 Publication of our review to enable clinicians, researchers, and policymakers to critically evaluate and apply the findings. 15 Additionally, we offer an assessment of the risk of bias and a summary of findings table that employs GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) to aid readers in understanding the calibre and potency of the evidence. 16 As part of the dissemination strategy, we plan to submit our study to a peer-reviewed journal in the field of neurology and neurosciences, providing open access to ensure a wider reach and impact of our findings. We also aim to present the results in conferences and meetings, targeting not only academics but also healthcare professionals, policymakers, and patient advocacy groups who can use our findings to in-form the improvement of paediatric traumatic brain injury care in LMICs. 17 Ultimately, this section on Ethics and Dissemination highlights our dedication to carrying out a transparent and morally sound systematic review and meta-analysis that can support better clinical practices and policies to enhance patient outcomes and quality of life, as well as the evidence-based management of pediatric traumatic brain injury patients in LMICs. 5.7 Limitations It may be necessary to address certain significant limitations despite the meticulous procedures employed in this systematic review and meta-analysis. First and fore-most, there may be a bias in the publications that are published because studies with significant findings are more likely to be published than those with smaller findings. Furthermore, because we limited our search to English-language publications, we might have missed relevant research that was only available in other languages. Furthermore, there is a chance that some of the included studies in the systematic review were biased, which could affect our study’s results. 6. Conclusion In conclusion, the goal of this protocol for a systematic review and meta-analysis is to give a thorough understanding of how propranolol helps TBI patients by protecting their brains. By carefully analyzing the data, we hope to determine whether propranolol can help TBI patients recover better and to pinpoint any knowledge gaps. Author contributions Conceptualization, Gaurav Mittal and Roshan Prasad; methodology, Tangmi Djabo Eric Adrien; software, Gaurav Mittal; validation, Roshan Prasad, Gaurav Mittal and Tangmi Djabo Eric Adrien; formal analysis, Tangmi Djabo Eric Adrien; data curation, Gaurav Mittal; writing—original draft preparation, Gaurav Mittal.; writing—review and editing, Roshan Prasad; visualization, Tangmi Djabo Eric Adrien; supervision, Tangmi Djabo Eric Adrien; project administration, Tangmi Djabo Eric Adrien. All authors have read and agreed to publish version of the manuscript and Tangmi Djabo Eric Adrien is identified as guarantor of the manuscript.” Data availability Underlying data No data is associated with this article. Extended data Reporting guidelines ‘PRISMA-P’ checklist for ‘Management of Traumatic Brain Injury in India: A Protocol for Systematic Review and Meta-analysis’. 10.5281/zenodo.10685436 . 18 Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). References 1. Adrien T, Mbougo J, Muili A, et al. : An E-survey study protocol for the perception of African healthcare professionals on the in-trathecal injection of antitetanic serum for the treatment of tetanus. J. Surg. Protoc. Res. Methodol. 2023; 2023 . Publisher Full Text 2. Emhemed MS, Murhega RB, Stanley AC, et al. : Evaluating the efficacy and safety of tumor treating fields versus laser interstitial thermal therapy in glioblastoma treatment: a comprehensive systematic review and meta-analysis. J. Surg. Protoc. Res. Methodol. 2023; 2023 : snad015. Publisher Full Text 3. Eric D, Adrien T, Mustapha Jolayemi M, et al. : A systematic review of the therapeutic effect of platelet-rich plasma for treating traumatic brain injury: A Study Protocol. J. Surg. Protoc. Res. Methodol. 2023; 2023 . Publisher Full Text 4. Muili AO, Tangmi A, Shariff S, et al. : Exploring strategies for building a sustainable healthcare system in AFRICA: lessons from JAPAN and SWITZERLAND. Ann. Med. Surg. 86 : 1563–1569. PubMed Abstract | Publisher Full Text | Free Full Text 5. Stone JE, Fung TS, Machan M, et al. : Ultrasound-guided platelet-rich plasma injections for post-traumatic greater occipital neu-ralgia: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2021; 7 : 130. PubMed Abstract | Publisher Full Text | Free Full Text 6. Hyder AA, Wunderlich CA, Puvanachandra P, et al. : The impact of traumatic brain injuries: A global perspective. NeuroReha-bilitation. 2007; 22 : 341–353. PubMed Abstract | Publisher Full Text 7. Chen N-F, Sung C-S, Wen Z-H, et al. : Therapeutic Effect of Platelet-Rich Plasma in Rat Spinal Cord Injuries. Front. Neurosci. 2018; 12 : 252. PubMed Abstract | Publisher Full Text | Free Full Text 8. Lundin A, De Boussard C, Edman G, et al. : Symptoms and disability until 3 months after mild TBI. Brain Inj. 2006; 20 : 799–806. PubMed Abstract | Publisher Full Text 9. Ducic I, Sinkin JC, Crutchfield KE: Interdisciplinary treatment of post-concussion and post-traumatic headaches: Post-Concussion and Post-Traumatic Headaches. Microsurgery. 2015; 35 : 603–607. PubMed Abstract | Publisher Full Text 10. Georges A, Das MJ: Traumatic Brain Injury. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023. 11. Higgins JP, Green S: Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series. 12. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects|Re-search, Methods, Statistics|JAMA|JAMA Network. 13. Standards for design and measurement would make clinical research reproducible and usable|PNAS. 14. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation|The BMJ. 15. Page MJ, McKenzie JE, Bossuyt PM, et al. : The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021; 372 : n71. PubMed Abstract | Publisher Full Text | Free Full Text 16. Guyatt GH, Oxman AD, Vist GE, et al. : Rating Quality of Evidence and Strength of Recommendations: GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008; 336 : 924–926. PubMed Abstract | Publisher Full Text | Free Full Text 17. Brownson RC, Fielding JE, Green LW: Building capacity for evidence-based public health: Reconciling the pulls of practice and the push of research. Annu. Rev. Public Health. 2018; 39 : 27–53. PubMed Abstract | Publisher Full Text | Free Full Text 18. Mittal G: PRISMA-P Checklist for ‘Management of Traumatic Brain Injury in India: A Protocol for Systematic Review and Meta-analysis’. Zenodo. 2024. Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 26 Apr 2024 ADD YOUR COMMENT Comment Author details Author details 1 Neurology, Mahatma Gandhi Institute of Medical Sciences, Wardha, Maharashtra, India 2 Neurology, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India 3 Association of Future African Neurosurgeons, Yaounde, Centre, Cameroon 4 Department of Medicine, Université Technologique Bel Campus, Kinshasa, Democratic Republic of the Congo Gaurav Mittal Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Resources, Software, Supervision, Visualization, Writing – Original Draft Preparation Roshan Prasad Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Resources, Software, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Tangmi Djabo Eric Adrien Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Project Administration, Resources, Software, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 26 Apr 2024, 13:407 https://doi.org/10.12688/f1000research.148645.1 Copyright © 2024 Mittal G et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Mittal G, Prasad R and Eric Adrien TD. Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis [version 1; peer review: 2 approved with reservations] . F1000Research 2024, 13 :407 ( https://doi.org/10.12688/f1000research.148645.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 26 Apr 2024 Views 0 Cite How to cite this report: Servadei F. Reviewer Report For: Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis [version 1; peer review: 2 approved with reservations] . F1000Research 2024, 13 :407 ( https://doi.org/10.5256/f1000research.162982.r295523 ) The direct URL for this report is: https://f1000research.com/articles/13-407/v1#referee-response-295523 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 12 Jul 2024 Franco Servadei , Humanitas Univeristy, Milan, Italy Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.162982.r295523 This is an interesting paper about a systematic review of management of traumatic Brain Injury in a large LMIC (India) I do not consider the methodology of the research already well discussed by the first reviewer (Jose Antonio Gonzalez) ... Continue reading READ ALL This is an interesting paper about a systematic review of management of traumatic Brain Injury in a large LMIC (India) I do not consider the methodology of the research already well discussed by the first reviewer (Jose Antonio Gonzalez) The problem is the clinical relevance of the study and its implication. In the abstract, it is stated “The primary aim is to collate evidence-based data on TBI management, with particular focus on the Indian healthcare context, evaluating the efficacy of current treatments and the potential role of PRP in enhancing neurological function and recovery post-TBI.” It seems that the interest of the study is only focus is seeing a possible efficacy of the “treatments” (which? Surgical? medical? In the acute phase? In the late recovery phase?) and of the PRP (potential, not much is reported until now) In the discussion “The outcomes assessed here include the frequency of complications, the death rate, cognitive function, functional recovery, and any other pertinent indicators of brain injury recovery. Primary outcome being mortality rate, the incidence of complications and cognitive function. Secondary outcomes being pain scores and mean length of hospital stay” It is difficult in any country to extract from published outcomes of TBI data which are not mortality and Glasgow Outcome score. More to have data on complications (which???) and cognitive performances you will probably need a prospective study. In the conclusion section:” in conclusion, the goal of this protocol for a systematic review and meta-analysis is to give a thorough understanding of how propranolol helps TBI patients by protecting their brains.” There is the sudden appearance of the propranolol as a goal of the study As far as the clinical part of the study is concerned, I invite the authors to better target the study: may be initially a study with a systematic review of epidemiology, incidence and outcomes (whenever possible) of TBI in India will be enough …. Is the rationale for, and objectives of, the study clearly described? No Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Traumatic brain Injury I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Servadei F. Reviewer Report For: Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis [version 1; peer review: 2 approved with reservations] . F1000Research 2024, 13 :407 ( https://doi.org/10.5256/f1000research.162982.r295523 ) The direct URL for this report is: https://f1000research.com/articles/13-407/v1#referee-response-295523 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Gonzalez JA. Reviewer Report For: Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis [version 1; peer review: 2 approved with reservations] . F1000Research 2024, 13 :407 ( https://doi.org/10.5256/f1000research.162982.r277712 ) The direct URL for this report is: https://f1000research.com/articles/13-407/v1#referee-response-277712 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 12 Jun 2024 Jose Antonio Gonzalez , Department of Statistics and Operations Research, Universitat Politecnica de Catalunya, Barcelona, Catalonia, Spain Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.162982.r277712 The manuscript under review introduces a protocol for a systematic review about management of TBI in India. Registered protocols for studies in general, or systematic reviews in particular, are essential for several reasons, which appear described in the PRISMA-P publication, ... Continue reading READ ALL The manuscript under review introduces a protocol for a systematic review about management of TBI in India. Registered protocols for studies in general, or systematic reviews in particular, are essential for several reasons, which appear described in the PRISMA-P publication, already referenced in this manuscript, and I am more than satisfied that the authors include these important references among their bibliography. My first recommendation would be: please include with your paper a copy of the PRISMA-P checklist fulfilled. with indications about whether the topic was considered or not and, in case it was, the place in the text where it was addressed. Obviously, if that task is useful to the authors to detect any point susceptible to improve, I strongly encourage them to strengthten them in order to follow the checklist as close as possible. I have found some sentences which are not clear to me. For instance, "2.1 The population of study" does not mention "India" especifically, neither "2.3 Inclusion criteria"; although the search strategy does include this word. Moreover, I wonder what is the purpose of Table 1 and the sentence that mentions it: " Search results from PubMed on 11/02/2024 at 09:23:08 have been shown in Table 1 ". Please clarify it. In "3.1 Study selection", the reference in "... uploading the database literature search result to Rayyan (ref) " is missing. "3.3": I don't think that Charting the data is an appropriate name for this section. "Charting" is just a simple stage in data management. Consider PRISMA and PRISMA-P for inspiration. "3.3.3 Statistical analysis". This is, for me, one of the key items in your research, and it needs to be enhanced. First, the authors should mention which precise statistical software are planning to use. Second, I was surprised to read that " A fixed-effects model will be used ..." when I 2 < 50%. This threshold is not just arbitrary, in my opinion it does not make sense. A value for such an indicator close to 50% reveals notable heterogeneity already, and a fixed-effects model would be a wrong decision, clearly. I would advise the authors not to employ fixed-effects models (as homogeneity is not expected in such an investigation), it could be fully justified only with I 2 equal to 0 or very close to it. Third: I think that the authors should specify in this protocol which group analysis will be performed, and I would recommend at least one, separating RCT studies from observational ones. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Statistics in clinical research, systematic reviews I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Gonzalez JA. Reviewer Report For: Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis [version 1; peer review: 2 approved with reservations] . F1000Research 2024, 13 :407 ( https://doi.org/10.5256/f1000research.162982.r277712 ) The direct URL for this report is: https://f1000research.com/articles/13-407/v1#referee-response-277712 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 26 Apr 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 1 26 Apr 24 read read Jose Antonio Gonzalez , Universitat Politecnica de Catalunya, Barcelona, Spain Franco Servadei , Humanitas Univeristy, Milan, Italy Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Servadei F. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 12 Jul 2024 | for Version 1 Franco Servadei , Humanitas Univeristy, Milan, Italy 0 Views copyright © 2024 Servadei F. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This is an interesting paper about a systematic review of management of traumatic Brain Injury in a large LMIC (India) I do not consider the methodology of the research already well discussed by the first reviewer (Jose Antonio Gonzalez) The problem is the clinical relevance of the study and its implication. In the abstract, it is stated “The primary aim is to collate evidence-based data on TBI management, with particular focus on the Indian healthcare context, evaluating the efficacy of current treatments and the potential role of PRP in enhancing neurological function and recovery post-TBI.” It seems that the interest of the study is only focus is seeing a possible efficacy of the “treatments” (which? Surgical? medical? In the acute phase? In the late recovery phase?) and of the PRP (potential, not much is reported until now) In the discussion “The outcomes assessed here include the frequency of complications, the death rate, cognitive function, functional recovery, and any other pertinent indicators of brain injury recovery. Primary outcome being mortality rate, the incidence of complications and cognitive function. Secondary outcomes being pain scores and mean length of hospital stay” It is difficult in any country to extract from published outcomes of TBI data which are not mortality and Glasgow Outcome score. More to have data on complications (which???) and cognitive performances you will probably need a prospective study. In the conclusion section:” in conclusion, the goal of this protocol for a systematic review and meta-analysis is to give a thorough understanding of how propranolol helps TBI patients by protecting their brains.” There is the sudden appearance of the propranolol as a goal of the study As far as the clinical part of the study is concerned, I invite the authors to better target the study: may be initially a study with a systematic review of epidemiology, incidence and outcomes (whenever possible) of TBI in India will be enough …. Is the rationale for, and objectives of, the study clearly described? No Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Traumatic brain Injury I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Servadei F. Peer Review Report For: Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis [version 1; peer review: 2 approved with reservations] . F1000Research 2024, 13 :407 ( https://doi.org/10.5256/f1000research.162982.r295523) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-407/v1#referee-response-295523 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Gonzalez J. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 12 Jun 2024 | for Version 1 Jose Antonio Gonzalez , Department of Statistics and Operations Research, Universitat Politecnica de Catalunya, Barcelona, Catalonia, Spain 0 Views copyright © 2024 Gonzalez J. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The manuscript under review introduces a protocol for a systematic review about management of TBI in India. Registered protocols for studies in general, or systematic reviews in particular, are essential for several reasons, which appear described in the PRISMA-P publication, already referenced in this manuscript, and I am more than satisfied that the authors include these important references among their bibliography. My first recommendation would be: please include with your paper a copy of the PRISMA-P checklist fulfilled. with indications about whether the topic was considered or not and, in case it was, the place in the text where it was addressed. Obviously, if that task is useful to the authors to detect any point susceptible to improve, I strongly encourage them to strengthten them in order to follow the checklist as close as possible. I have found some sentences which are not clear to me. For instance, "2.1 The population of study" does not mention "India" especifically, neither "2.3 Inclusion criteria"; although the search strategy does include this word. Moreover, I wonder what is the purpose of Table 1 and the sentence that mentions it: " Search results from PubMed on 11/02/2024 at 09:23:08 have been shown in Table 1 ". Please clarify it. In "3.1 Study selection", the reference in "... uploading the database literature search result to Rayyan (ref) " is missing. "3.3": I don't think that Charting the data is an appropriate name for this section. "Charting" is just a simple stage in data management. Consider PRISMA and PRISMA-P for inspiration. "3.3.3 Statistical analysis". This is, for me, one of the key items in your research, and it needs to be enhanced. First, the authors should mention which precise statistical software are planning to use. Second, I was surprised to read that " A fixed-effects model will be used ..." when I 2 < 50%. This threshold is not just arbitrary, in my opinion it does not make sense. A value for such an indicator close to 50% reveals notable heterogeneity already, and a fixed-effects model would be a wrong decision, clearly. I would advise the authors not to employ fixed-effects models (as homogeneity is not expected in such an investigation), it could be fully justified only with I 2 equal to 0 or very close to it. Third: I think that the authors should specify in this protocol which group analysis will be performed, and I would recommend at least one, separating RCT studies from observational ones. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Statistics in clinical research, systematic reviews I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Gonzalez JA. Peer Review Report For: Management of traumatic brain injury in India: A protocol for systematic review and meta-analysis [version 1; peer review: 2 approved with reservations] . F1000Research 2024, 13 :407 ( https://doi.org/10.5256/f1000research.162982.r277712) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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