An Unexpected Turn: Management of a Life-Threatening Infection Following Liposuction Procedure.

This case report presents a rare case of necrotizing fasciitis (NF) following liposuction and lipofilling surgery in a young woman. Despite prompt diagnosis and aggressive management with multiple debridements, broad-spectrum antibiotics, and supportive care, the patient experienced a protracted course with severe complications, including intra-abdominal collection recurrence, heart failure, and sepsis. The presence of resistant bacteria (extended-spectrum beta-lactamases (ESBLs)-producing Escherichia coli and methicillin-resistant Staphylococcus aureus (MRSA)) further challenged the treatment. This case highlights the importance of early recognition and aggressive management of NF, particularly in patients with risk factors following cosmetic surgery. In addition, it raises awareness of the potential for heart failure as a complication in this context and warrants further investigation.

A Case of Tizanidine Withdrawal Syndrome: Features and Management in the Emergency Department.

Anxiety medications, muscle relaxants, and sleeping pills have the potential to cause complications, side effects, and withdrawal symptoms if not prescribed and managed appropriately. Tizanidine, a short-acting muscle relaxant, acts on central alpha-2-adrenergic receptors to reduce spasticity. However, abrupt withdrawal of tizanidine can lead to symptoms such as hypertension, reflex tachycardia, hypertonicity, and anxiety as a result of high adrenergic activity. Few cases have been reported on tizanidine withdrawal syndrome. Here, we are presenting a rare occurrence of tizanidine withdrawal syndrome in a patient presenting to the emergency department with vomiting, generalized tremor, dysthermia, hypertension, and tachycardia. We discuss the management approach used to stabilize the patient and successfully control the symptoms by reintroducing a low therapeutic dose of tizanidine.

From Heat Stroke to Multi-Organ Failure: A Survivor's Case Report.

A heat stroke (HS) is a medical emergency that can occur when the body is unable to cool itself down after overexertion in a hot condition. It is characterized by a high body temperature (usually greater than 40.5 degrees Celsius or 104.9 degrees Fahrenheit) and altered mental status. HS can cause a wide range of physiological changes in the body, including damage to the brain, heart, liver, kidneys, and muscles. In the case report presented, the patient was a 40-year-old man who developed severe HS. His condition rapidly deteriorated, and he developed multi-organ failure, involving the brain, liver, kidneys, muscles, and hematological system. The patient was admitted to the intensive care unit (ICU) and intubated, despite aggressive treatment. After an 18-day stay in the ICU, the patient achieved full recovery except for myopathy, which necessitated physiotherapy.

A Case of Leptomeningeal Carcinomatosis Manifesting With Vertigo in the Setting of Intracranial Hypertension.

Leptomeningeal carcinomatosis (LMC) is a rare condition where malignant cells infiltrate the leptomeninges of the central nervous system. We present a case of a 51-year-old male with stage IV adenocarcinoma of the lung who developed recurrent vertigo. The patient initially received a diagnosis of peripheral vertigo, but his symptoms worsened over time and were associated with headache, vomiting, and one episode of seizure. Upon readmission, based on his normal neuroimaging results, normal CSF examination with elevated opening pressure, and papilledema on fundoscopic examination, a diagnosis of pseudotumor cerebri was made. The result of CSF cytology revealed the presence of malignant cells confirming the presence of LMC. This case highlights the importance of considering LMC as a potential cause for unusual neurological symptoms in patients with advanced malignancy, particularly when other conditions like pseudotumor cerebri could obscure its presentation. It is crucial to rule out malignancy through CSF cytology in patients presenting with vertigo and/or other vestibulocochlear symptoms before making an alternative diagnosis that could present similarly.

A Rare Presentation of Artery of Percheron Infarct: A Case Report.

The artery of Percheron (AOP), a variation of the thalamic vasculature, supplies both the thalamus and the midbrain. An infarct in this area is characterized by wide neurological abnormalities, the most common of which are altered mental state, decreased degree of consciousness, and memory impairment. AOP infarcts tend to be missed during the initial computed tomography (CT) scan. The number of reports on AOP infarction has been increasing, highlighting the range of clinical presentations and challenges that clinicians can face. This case study discusses a 58-year-old male patient who was diagnosed with stroke in AOP territory without any clear neurological symptoms, and it serves as a model for patients with similar conditions.

Pure Isolated Internuclear Ophthalmoplegia as Presentation of Midbrain Ischemic Stroke: A Case Report.

Internuclear ophthalmoplegia (INO) is a condition characterized by impaired ocular movement, leading to an inability to perform coordinated lateral gaze, resulting in ophthalmoplegia. This impairment results from damage to the medial longitudinal fasciculus (MLF), which can occur because of various types of lesions localized in the pons or midbrain. In this case, we report on a 67-year-old man with multiple comorbidities who arrived at the emergency department with complaints of sudden dizziness and an unsteady gait. During the examination, he exhibited left INO, which was characterized by limited left eye adduction and multidirectional nystagmus of the right eye when performing right lateral gaze.

Comparing the Effectiveness of Intravenous Tissue Plasminogen Activator and Dual Antiplatelet Therapy in Patients With Minor Stroke: A Meta-Analysis.

The aim of this study was to compare the outcomes between dual antiplatelet therapy (DAPT) versus intravenous tissue plasminogen activator (IV t-PA) in patients with minor stroke. This meta-analysis follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Two authors independently conducted online database searches using PubMed, Web of Science, and EMBASE to identify articles published in English language from inception to September 5, 2023. Outcomes assessed in this meta-analysis included all-cause mortality, stroke incidence, and functional outcomes (measured by modified ranking scale (mRS) scores of 0 to 1). A total of three studies fulfilled the eligibility criteria and included in the final analysis. Pooled analysis showed that the risk of all-cause mortality was not significantly different between the t-PA group and DAPT group (relative risk (RR): 1.14, 95% confidence interval (CI): 0.32-4.06). Compared with those treated with DAPT, there was no significant difference in t-PA in terms of the number of patients with a favorable functional outcome (defined as an mRS score of 0-1). The risk of stroke was not significantly different between the t-PA group and DAPT group (RR: 1.11, 95% CI: 0.68 to 1.82). The analysis, based on three studies, revealed no significant differences between t-PA and DAPT regarding all-cause mortality, stroke incidence, and functional outcomes.

Safety and Efficacy of Efpeglenatide in Patients With Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials.

The aim of this study was to assess the efficacy and safety of efpeglenatide in patients with type 2 diabetes (T2D). The study was reported according to the 2020 guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Web of Science, PubMed, and Scopus databases were searched by two authors independently, with no restriction on language and year of publication, using the following key terms: (efpeglenatide) OR (glucagon-like peptide-1 receptor agonist) AND (type 2 diabetes) OR (diabetes) OR (T2DM) AND (HbA1c) OR (FSG) OR (fasting serum glucose) OR (weight) OR (bodyweight) OR (adverse events) OR (safety) OR (AE). Outcomes assessed in this meta-analysis included change in hemoglobin A1C (HbA1C) from baseline (%), change in weight from baseline (Kg), and change in fasting serum glucose (FSG) from baselines. For the safety analysis, we assessed total adverse events and gastrointestinal (GI) adverse events. A total of four studies fulfilled the inclusion and exclusion criteria and were included in this meta-analysis, encompassing six randomized controlled trials (RCTs). Compared with a control group, efpeglenatide lowered the HbA1c (mean difference (MD): -0.81, 95% confidence interval (CI): -1.01 to -0.60), body weight (MD: -1.15, 95% CI: -1.82 to -0.47), and FSG (MD: -0.98, 95% CI: -1.19 to -0.77). However, the risk of GI-related adverse events was significantly higher in the efpeglenatide group compared to the control group.

Acute Pancreatitis Secondary to Intragastric Balloon: A Case Report and Literature Review.

Intragastric balloon (IGB) is a common minimally invasive procedure used for obesity management and weight reduction. It can be used alone, sequentially, with concomitant therapies, or as a bridge to longer-term weight-loss interventions, such as bariatric surgery. Although the insertion procedure is easy and generally well tolerated by patients, a few complications can occur with varying degrees of severity ranging from mild to severe and life-threatening. Acute pancreatitis is a rare complication of IGB but has been reported in the literature. We present a case in which the patient had a history of IGB insertion complicated by acute pancreatitis. The diagnosis of acute pancreatitis due to the IGB insertion was made after excluding other possible causes of acute pancreatitis. The patient was hospitalized and managed conservatively.

DVT as the Initial Presentation of Multiple Myeloma: A Rare Case Report and Literature Review.

Multiple myeloma patients are recognized to have a higher risk of venous thrombosis. The cause of this could be attributed to several risk factors, such as circulating prothrombotic microparticles, disease-specific variables, and alterations in coagulation and fibrinolysis factors. Recent research has revealed that these individuals also experience greater arterial thrombosis, including acute myocardial infarction and stroke. In this case report, we present the clinical profile and management of a 42-year-old patient who presented with signs and symptoms of deep venous thrombosis (DVT) and was diagnosed with multiple myeloma. The aim of this case report is to highlight a rare clinical presentation and diagnostic workup in a patient with multiple myeloma. Additionally, we discuss the possible factors provoking the development of DVT as a first presentation before treatment initiation and their possible mechanisms.

Non-typeable Haemophilus influenza ventriculitis, a case report and literature review.

Introduction: and importance: Haemophilus influenza severe presentations have decreased dramatically after the Hib vaccination was introduced. However, due to the emergence of Multi-drug resistance organisms, severe presentations like meningitis and ventriculitis may occur. Case presentation: Here, we have described a rarely reported case of non-typeable Haemophilus influenza ventriculitis in a previously healthy patient. MRI of the head with contrast was suggestive of tiny foci of diffusion restriction in occipital horns of bilateral ventricles with minimal intraventricular pus formation. The diagnosis was confirmed based on blood culture results and MRI findings as the patient refused to have a lumbar puncture procedure for CSF analysis. The patient was treated with intravenous antibiotics and showed a good response. Clinical discussion: In the post-HiB immunization era, we have seen a decline in invasive diseases caused by Type B Haemophilus influenza. However, non-typeable Haemophilus influenzae is now on the rise. Central nervous system infection due to non-typable Haemophilus influenza is infrequent as this organism is predominantly a respiratory mucosal pathogen resulting in acute and chronic respiratory tract infections. Multi-drug resistance of non-typeable Haemophilus influenzae is also becoming a cause of concern. Conclusion: Ventriculitis secondary to non-typeable beta-lactamase non-producing, ampicillin-resistant (BLNAR) Haemophilus influenza is rare, and more such cases need to be reported within the adult population to avoid under-recognition.

Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension.

Importance: Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis. Objective: To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports. Findings: The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18). Conclusions and Relevance: This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension.

Importance: Complete information in a trial protocol regarding study outcomes is crucial for obtaining regulatory approvals, ensuring standardized trial conduct, reducing research waste, and providing transparency of methods to facilitate trial replication, critical appraisal, accurate reporting and interpretation of trial results, and knowledge synthesis. However, recommendations on what outcome-specific information should be included are diverse and inconsistent. To improve reporting practices promoting transparent and reproducible outcome selection, assessment, and analysis, a need for specific and harmonized guidance as to what outcome-specific information should be addressed in clinical trial protocols exists. Objective: To develop harmonized, evidence- and consensus-based standards for describing outcomes in clinical trial protocols through integration with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for outcome-specific reporting to be addressed in clinical trial protocols. Findings: The scoping review and consultation with experts identified 108 recommendations relevant to outcome-specific reporting to be addressed in trial protocols, the majority (72%) of which were not included in the SPIRIT 2013 statement. All recommendations were consolidated into 56 items for Delphi voting; after the Delphi survey process, 19 items met criteria for further evaluation at the consensus meeting and possible inclusion in the SPIRIT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 9 items that elaborate on the SPIRIT 2013 statement checklist items and are related to completely defining and justifying the choice of primary, secondary, and other outcomes (SPIRIT 2013 statement checklist item 12) prospectively in the trial protocol, defining and justifying the target difference between treatment groups for the primary outcome used in the sample size calculations (SPIRIT 2013 statement checklist item 14), describing the responsiveness of the study instruments used to assess the outcome and providing details on the outcome assessors (SPIRIT 2013 statement checklist item 18a), and describing any planned methods to account for multiplicity relating to the analyses or interpretation of the results (SPIRIT 2013 statement checklist item 20a). Conclusions and Relevance: This SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement provides 9 outcome-specific items that should be addressed in all trial protocols and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

Uridine monophosphate (UMP)-responsive developmental and epileptic encephalopathy: A case report of two siblings and a review of literature.

Developmental and epileptic encephalopathy type 50 is an autosomal recessive disorder caused by pathogenic variants in CAD. This gene encodes a multifunctional enzyme involved in the initial steps of de novo pyrimidine synthesis. Uridine treatment has been shown to be effective in this disease. Here, we report two siblings with CAD pathogenic variants who presented with developmental regression and intractable epilepsy. Treatment with oral uridine monophosphate (UMP) resulted in remarkable and rapid clinical improvement in terms of developmental progress and seizure control. We also reviewed previous literature and summarized all reported patients to date.

Systematic scoping review identifies heterogeneity in outcomes measured in adolescent depression clinical trials.

OBJECTIVES: The objective of this review was to identify outcomes reported in adolescent major depressive disorder trials and quantify outcome heterogeneity. STUDY DESIGN AND SETTING: Three databases were searched to identify trials evaluating therapies for major depressive disorder in adolescents published from 2008 to 2017. Identified outcomes were thematically grouped and mapped into predefined outcome core areas (physiological/clinical, life impact, resource use, adverse events, and death). Outcome heterogeneity was quantified using descriptive analyses. RESULTS: Of 2,686 articles yielded from the search, 42 articles describing 32 trials were included. A total of 434 outcomes measured using 118 different outcome measurement instruments were grouped into 86 unique outcome terms. Most outcome terms mapped to the physiological/clinical core area (62%), followed by the life impact (27%). Nearly half (45%) were reported in only a single trial each. Of 18 primary outcomes reported, 13 (72%) were each only reported in a single trial. "Depressive symptom severity", reported in 30 trials (94%), was measured using 19 different outcome measurement instruments. CONCLUSION: Heterogeneity exists in the outcomes and outcome measurement instruments used in adolescent depression trials. To enable reproducibility, comparison, and synthesis of trial results, a standard set of agreed-on outcomes and methods of measurement is needed.

Primary outcome reporting in adolescent depression clinical trials needs standardization.

BACKGROUND: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. METHODS: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as "fully reported", "partially reported", or "not reported" for each checklist item, as applicable. RESULTS: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6 to 17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. CONCLUSIONS: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed.

Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT).

BACKGROUND: Inadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impacts evidence-based decision-making by patients, clinicians, and policy-makers. To facilitate harmonized and transparent reporting of outcomes in trial protocols and published reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is being developed. The final product will provide unique InsPECT extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines. METHODS: The InsPECT SPIRIT and CONSORT extensions will be developed in accordance with the methodological framework created by the EQUATOR (Enhancing the Quality and Transparency of Health Research Quality) Network for reporting guideline development. Development will consist of (1) the creation of an initial list of candidate outcome reporting items synthesized from expert consultations and a scoping review of existing guidance for reporting outcomes in trial protocols and reports; (2) a three-round international Delphi study to identify additional candidate items and assess candidate item importance on a 9-point Likert scale, completed by stakeholders such as trial report and protocol authors, systematic review authors, biostatisticians and epidemiologists, reporting guideline developers, clinicians, journal editors, and research ethics board representatives; and (3) an in-person expert consensus meeting to finalize the set of essential outcome reporting items for trial protocols and reports, respectively. The consensus meeting discussions will be independently facilitated and informed by the empirical evidence identified in the primary literature and through the opinions (aggregate rankings and comments) collected via the Delphi study. An integrated knowledge translation approach will be used throughout InsPECT development to facilitate implementation and dissemination, in addition to standard post-development activities. DISCUSSION: InsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.

Outcomes reported in randomised clinical trials of major depressive disorder treatments in adolescents: a systematic scoping review protocol.

INTRODUCTION: Major depressive disorder (MDD) is a common mental health condition in adolescents. Randomised clinical trials (RCTs) are the gold standard for assessing the safety and efficacy of interventions in this population. Heterogeneity in the outcomes measured and reported between RCTs limits the ability to compare, contrast, and combine trial results in a clinically meaningful way. There is currently no core outcome set (COS) available for use in RCTs evaluating interventions in adolescents with MDD. We will conduct a systematic scoping review of outcomes reported in adolescent depression RCTs to assess the variability of trial outcomes and to inform the development of a COS for adolescent MDD. METHODS AND ANALYSIS: We will apply methods based on the Joanna Briggs Institute scoping review methods manual. RCTs evaluating any treatment intervention for adolescent MDD published in the last 10 years will be located using an electronic bibliographic database search (MEDLINE, PsycINFO and Cochrane Central Register of Controlled Trials). Title and abstract screening, full-text screening, and data charting of eligible studies will be performed in duplicate. Outcomes identified will be mapped to an outcome-domain framework. Data analysis will include summary statistics of the characteristics of the included trials and outcomes. ETHICS AND DISSEMINATION: The results of this review will inform the development of a COS for adolescent MDD. The development and implementation of a COS for RCTs evaluating interventions in adolescents with MDD promise to help reduce variability in trial outcome selection, definition, measurement and reporting, ultimately facilitating evidence synthesis that will help to identify the best treatment practices for adolescents with MDD.

Guidance for reporting outcomes in clinical trials: scoping review protocol.

INTRODUCTION: Patients, families and clinicians rely on published research to help inform treatment decisions. Without complete reporting of the outcomes studied, evidence-based clinical and policy decisions are limited and researchers cannot synthesise, replicate or build on existing research findings. To facilitate harmonised reporting of outcomes in published trial protocols and reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is under development. As one of the initial steps in the development of InsPECT, a scoping review will identify and synthesise existing guidance on the reporting of trial outcomes. METHODS AND ANALYSIS: We will apply methods based on the Joanna Briggs Institute scoping review methods manual. Documents that provide explicit guidance on trial outcome reporting will be searched for using: (1) an electronic bibliographic database search; (2) a grey literature search; and (3) solicitation of colleagues for guidance documents using a snowballing approach. Reference list screening will be performed for included documents. Search results will be divided between two trained reviewers who will complete title and abstract screening, full-text screening and data charting. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute or refine InsPECT content and to assess the need for the development of additional items. Data analysis will explore common features of guidance and use quantitative measures (eg, frequencies) to characterise guidance and its sources. ETHICS AND DISSEMINATION: A paper describing the review findings will be published in a peer-reviewed journal. The results will be used to inform the InsPECT development process, helping to ensure that InsPECT provides an evidence-based tool for standardising trial outcome reporting.

Genotype-phenotype analysis of CYP2C19 in healthy saudi individuals and its potential clinical implication in drug therapy.

UNLABELLED: CYP2C19 is a cytochrome P450 enzyme, which is involved in the metabolism of some clinically important medications and is encoded by a highly polymorphic gene. There is no available data on the distribution of the CYP2C19 *4 and *17 mutant alleles in the Saudi Arabian population. The aim of the study was to determine different CYP2C19 mutant allele (*2, *4 and *17) frequencies in healthy Saudi subjects and to determine genotype frequencies for these mutations. The CYP2C19 genotypes were then classified into phenotypes. RESULT: In 201 adults of Saudi ethnicity, the allele frequencies were CYP2C19*1 (62.9%), *17 (25.7%), *2 (11.2%) and *4 (0.2%). The most prevalent genotype combinations were CYP2C19 *1/*1 (40.3%) and *1/*17 (30.4%). The distribution of CYP2C19 phenotypes was divided into extensive metabolizers (EM) 77.6%, intermediate metabolizers (IM) 14.9%, ultra-rapid metabolizers (UM) 7% and poor metabolizers (PM) 0.4%. This finding has important clinical implications for the use of CYP2C19 metabolized medications in the Saudi population and further studies are needed.