Pub Date : 2024-07-25DOI: 10.1101/2024.07.24.24310953
Harrison J Hansford, Rachelle Buchbinder, Joshua R Zadro, James H McAuley, Manuela L Ferreira, Adriane Lewin, Richard S Page, Ian A Harris
Background: The smallest worthwhile effect (SWE) is the minimum benefit required in addition to that from a comparator, for an intervention to be considered worthwhile by patients. We aimed to estimate the SWE for rotator cuff repair (with decompression and debridement) compared to either decompression and debridement alone or to non-surgical treatment for people with atraumatic shoulder pain. Methods: Benefit-harm trade-off study. We recruited English speaking adults aged 45-75 years with shoulder pain of intensity ≥4 (on a 0-10 scale) for ≥6 months to our online survey through paid advertising on Facebook. Participants must have sought care in the past 6-months and could not have had recent shoulder surgery or significant recent shoulder trauma. Participants were explained three treatments: rotator cuff repair (with subacromial decompression and debridement), subacromial decompression and debridement alone and non-surgical treatment. Participants completed the benefit-harm trade-off survey to determine the SWE of improvements in pain and function for rotator cuff repair compared to the other treatments and again after one week to assess reliability. We used univariable linear regression to estimate associations between baseline characteristics and SWE. Results: We recruited 56 participants. The mean (standard deviation) age was 58.4 (6.7) years and 39 (70%) were female. For rotator cuff repair to be worthwhile compared to decompression and debridement alone participants needed to see at least a median 40% (interquartile range (IQR) 20-62.5) between-group improvement in pain and function. Compared to non-surgical treatment, the SWE was a median 40% (IQR 30-60). On the Western Ontario Rotator Cuff (WORC) Index the SWE values equate to a between-group improvement of 28/100 points (533/2100 on the raw WORC score). Female sex was associated with larger SWEs for both comparisons. Reliability analyses were underpowered, 25/56(45%) provided follow-up data; the intraclass correlation coefficient estimates ranged from 0.60-0.77. Conclusions: This SWE indicates the benefit required by people with shoulder pain to consider the costs and risks of surgical rotator cuff repair worthwhile is larger than previously estimated minimum clinically important differences (13.5-28/100 on the WORC Index). This SWE may be used to inform the design or interpret the findings of trials of these comparisons.
{"title":"The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study","authors":"Harrison J Hansford, Rachelle Buchbinder, Joshua R Zadro, James H McAuley, Manuela L Ferreira, Adriane Lewin, Richard S Page, Ian A Harris","doi":"10.1101/2024.07.24.24310953","DOIUrl":"https://doi.org/10.1101/2024.07.24.24310953","url":null,"abstract":"Background: The smallest worthwhile effect (SWE) is the minimum benefit required in addition to that from a comparator, for an intervention to be considered worthwhile by patients. We aimed to estimate the SWE for rotator cuff repair (with decompression and debridement) compared to either decompression and debridement alone or to non-surgical treatment for people with atraumatic shoulder pain.\u0000Methods: Benefit-harm trade-off study. We recruited English speaking adults aged 45-75 years with shoulder pain of intensity ≥4 (on a 0-10 scale) for ≥6 months to our online survey through paid advertising on Facebook. Participants must have sought care in the past 6-months and could not have had recent shoulder surgery or significant recent shoulder trauma. Participants were explained three treatments: rotator cuff repair (with subacromial decompression and debridement), subacromial decompression and debridement alone and non-surgical treatment. Participants completed the benefit-harm trade-off survey to determine the SWE of improvements in pain and function for rotator cuff repair compared to the other treatments and again after one week to assess reliability. We used univariable linear regression to estimate associations between baseline characteristics and SWE.\u0000Results: We recruited 56 participants. The mean (standard deviation) age was 58.4 (6.7) years and 39 (70%) were female. For rotator cuff repair to be worthwhile compared to decompression and debridement alone participants needed to see at least a median 40% (interquartile range (IQR) 20-62.5) between-group improvement in pain and function. Compared to non-surgical treatment, the SWE was a median 40% (IQR 30-60). On the Western Ontario Rotator Cuff (WORC) Index the SWE values equate to a between-group improvement of 28/100 points (533/2100 on the raw WORC score). Female sex was associated with larger SWEs for both comparisons. Reliability analyses were underpowered, 25/56(45%) provided follow-up data; the intraclass correlation coefficient estimates ranged from 0.60-0.77. Conclusions: This SWE indicates the benefit required by people with shoulder pain to consider the costs and risks of surgical rotator cuff repair worthwhile is larger than previously estimated minimum clinically important differences (13.5-28/100 on the WORC Index). This SWE may be used to inform the design or interpret the findings of trials of these comparisons.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"69 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141774072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract: Background: Skin fibrosis, characterized by excessive extracellular matrix deposition, leads to hypertrophic scars and keloids, which are both common and often detrimental conditions. Angiotensin-converting enzyme (ACE) inhibitors have shown promise in animal studies and limited clinical trials for reducing scar formation. However, the causal relationship between ACE inhibition and skin fibrosis remains unclear. Methods: This study employed two-sample Mendelian randomization (MR) analysis to investigate the causal effect of ACE inhibition on skin fibrotic diseases. We utilized genetic variants associated with serum ACE levels, ACE inhibition, and effect of decreasing blood pressure by ACE inhibition as instrumental variables. We analyzed the association between these exposures and the incidence of skin fibrosis, hypertrophic scars, and keloids using various MR methods. Results: We found no significant causal relationship between genetically proxied serum ACE levels, or local skin tissue ACE expression and the risk of skin fibrosis, hypertrophic scars, or keloids. Additionally, there was no direct causal relationship between the effect of ACE inhibitors on blood pressure reduction and the risk of skin fibrotic diseases. However, we observed a significant negative association between systolic blood pressure (SBP) and the risk of hypertrophic scars. Conversely, we found a positive association between β-blockers and the risk of skin fibrosis. Conclusion: Our findings suggest that ACE inhibitors do not have a direct causal effect on the risk of skin fibrotic diseases, including hypertrophic scars and keloids. This challenges the potential of ACE inhibitors as a therapeutic option for preventing or treating these conditions.
{"title":"Reevaluating the Role of ACE Inhibitors in Skin Fibrosis Risk: Evidence from Mendelian Randomization","authors":"Yangyang Wei, Ziqi Wan, Yiwen Jiang, Zhengye Liu, Ming Yang, Jieying Tang","doi":"10.1101/2024.07.23.24310902","DOIUrl":"https://doi.org/10.1101/2024.07.23.24310902","url":null,"abstract":"Abstract: Background: Skin fibrosis, characterized by excessive extracellular matrix deposition, leads to hypertrophic scars and keloids, which are both common and often detrimental conditions. Angiotensin-converting enzyme (ACE) inhibitors have shown promise in animal studies and limited clinical trials for reducing scar formation. However, the causal relationship between ACE inhibition and skin fibrosis remains unclear.\u0000Methods: This study employed two-sample Mendelian randomization (MR) analysis to investigate the causal effect of ACE inhibition on skin fibrotic diseases. We utilized genetic variants associated with serum ACE levels, ACE inhibition, and effect of decreasing blood pressure by ACE inhibition as instrumental variables. We analyzed the association between these exposures and the incidence of skin fibrosis, hypertrophic scars, and keloids using various MR methods.\u0000Results: We found no significant causal relationship between genetically proxied serum ACE levels, or local skin tissue ACE expression and the risk of skin fibrosis, hypertrophic scars, or keloids. Additionally, there was no direct causal relationship between the effect of ACE inhibitors on blood pressure reduction and the risk of skin fibrotic diseases. However, we observed a significant negative association between systolic blood pressure (SBP) and the risk of hypertrophic scars. Conversely, we found a positive association between β-blockers and the risk of skin fibrosis.\u0000Conclusion: Our findings suggest that ACE inhibitors do not have a direct causal effect on the risk of skin fibrotic diseases, including hypertrophic scars and keloids. This challenges the potential of ACE inhibitors as a therapeutic option for preventing or treating these conditions.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141774105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-12DOI: 10.1101/2024.07.11.24310287
Rahma Menshawey, Esraa Menshawey
Background: Appendicitis is the inflammation of the vermiform appendix, and it is the most common abdominal surgical emergency in the world. Its diagnosis, however, has many pitfalls including lack of a pathognomonic sign or symptoms, and the low predictive value of laboratory testing. Appendicitis is a leading cause of malpractice concerns. Methods: Using Google Case Law, we used the search terms appendicitis, and malpractice to identify appendicitis litigation cases. We included cases published since 2020. We included any case where a confirmed diagnosis of appendicitis was made. We included cases filed for malpractice due to complications of appendicitis and its treatment. Outcomes of interest included: the state the case was published, the defendants, the date of when the patient first complained of abdominal pain to when they had had an appendectomy/treatment, diagnostics and consultations, medical and legal issues, and final verdict/opinion/decisions on the cases. Results: A total of 44 cases were identified, which were screened for inclusion. A total of 14 cases met the inclusion criteria and were analyzed. Most cases did not present in an atypical way, the majority of patients presented with clear statements of abdominal pain of varying severity. The majority of the defendants were MDs and hospitals. The average time from symptom to diagnosis was 2.4 +/- 2.1 days, while the longest time for diagnosis was 7 days. The leading medico-legal issues were failure to diagnose and delayed diagnosis, while among the cases, 35.7% had outcomes in favor of the plaintiff. Conclusions: Appendicitis remains an area of high risk of litigation. Malpractice suits are often due to failure to diagnose and failure to treat, but there maybe proactive measures to address the modern pitfalls to promote a decreased litigation risk and patient safety
{"title":"Even A Worm Will Turn: Appendicitis Malpractice Litigation Since 2020","authors":"Rahma Menshawey, Esraa Menshawey","doi":"10.1101/2024.07.11.24310287","DOIUrl":"https://doi.org/10.1101/2024.07.11.24310287","url":null,"abstract":"Background: Appendicitis is the inflammation of the vermiform appendix, and it is the most common abdominal surgical emergency in the world. Its diagnosis, however, has many pitfalls including lack of a pathognomonic sign or symptoms, and the low predictive value of laboratory testing. Appendicitis is a leading cause of malpractice concerns. Methods: Using Google Case Law, we used the search terms appendicitis, and malpractice to identify appendicitis litigation cases. We included cases published since 2020. We included any case where a confirmed diagnosis of appendicitis was made. We included cases filed for malpractice due to complications of appendicitis and its treatment. Outcomes of interest included: the state the case was published, the defendants, the date of when the patient first complained of abdominal pain to when they had had an appendectomy/treatment, diagnostics and consultations, medical and legal issues, and final verdict/opinion/decisions on the cases.\u0000Results: A total of 44 cases were identified, which were screened for inclusion. A total of 14 cases met the inclusion criteria and were analyzed. Most cases did not present in an atypical way, the majority of patients presented with clear statements of abdominal pain of varying severity. The majority of the defendants were MDs and hospitals. The average time from symptom to diagnosis was 2.4 +/- 2.1 days, while the longest time for diagnosis was 7 days. The leading medico-legal issues were failure to diagnose and delayed diagnosis, while among the cases, 35.7% had outcomes in favor of the plaintiff. Conclusions: Appendicitis remains an area of high risk of litigation. Malpractice suits are often due to failure to diagnose and failure to treat, but there maybe proactive measures to address the modern pitfalls to promote a decreased litigation risk and patient safety","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141608963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-03DOI: 10.1101/2024.07.02.24309865
Albertus Ari Adrianto, Ignatius Riwanto, Udadi Sadhana, Dewi Kartikawati Paramita, Henry Setyawan, Kevin Christian Tjandra, Danendra Rakha Putra Respati, Derren David Christian Homenta Rampengan, Roy Novri Ramadhan, Gastin Gabriel Jangkang, Endang Mahati
Background Colorectal cancer (CRC) ranks third globally in cancer-related mortality, with rising incidence, particularly in Asia, projecting a 60% surge by 2030. Metastatic CRC (mCRC) presents a significant challenge with a grim 5-year survival rate of 14%. Emerging evidence suggests that tumors with DNA mismatch repair deficiency (dMMR) and high microsatellite instability (MSI-H) respond well to immune checkpoint inhibitors (ICIs), marking a paradigm shift in therapeutic approaches. This systematic review and meta-analysis aim to comprehensively assess Pembrolizumab, Nivolumab, and the combination of Nivolumab and Ipilimumab in advanced CRC, considering their significant antitumor efficacy in MSI-H/dMMR mCRC. Methods Following PRISMA guidelines and Cochrane Handbook standards, this study covers 2014 to 2024, involving advanced CRC patients treated with ICIs. A comprehensive literature search employed 12 independent authors across eight databases. Parameters such as overall survival, progression-free survival, and objective response rate were extracted. The Cochrane Collaboration's Risk of Bias version 2 tool assessed risk. Statistical analysis utilized mean difference and risk ratios with random-effect models due to anticipated heterogeneity. Robustness was ensured through publication bias analysis and sensitivity meta-analysis. Linear regression explored associations in subgroup analysis. Results The meta-analysis evaluated ORR and OS across different immunotherapy interventions. Nivolumab, Nivolumab+Ipilimumab, and Pembrolizumab exhibited varying ORR and OS effect sizes with corresponding heterogeneity levels. Progression-free survival (PFS) analysis also showed diverse effect sizes and heterogeneity levels across the three interventions. The study provides a comprehensive overview of response rates and survival outcomes for these immunotherapies in advanced CRC. Conclusions The study concludes that combination immunotherapy, particularly Nivolumab and Ipilimumab, presents a promising avenue for advanced CRC treatment, showing superior efficacy. Pembrolizumab monotherapy also exhibited promise. While the study offers valuable insights, the identified heterogeneity emphasizes the need for additional research. Adverse effects were generally low, supporting the viability of the studied immunotherapies. The study acknowledges limitations and calls for ongoing investigation to refine and validate these findings, marking a pioneering effort in systematically comparing short-term and long-term effects of anti-CTLA-4 and anti-PD-1 therapies in CRC.
{"title":"The Efficacy and Safety of Pembrolizumab, Ipilimumab, and Nivolumab Monoteraphy and Combination for Colorectal Cancer: A Systematic Review and Meta-Analysis","authors":"Albertus Ari Adrianto, Ignatius Riwanto, Udadi Sadhana, Dewi Kartikawati Paramita, Henry Setyawan, Kevin Christian Tjandra, Danendra Rakha Putra Respati, Derren David Christian Homenta Rampengan, Roy Novri Ramadhan, Gastin Gabriel Jangkang, Endang Mahati","doi":"10.1101/2024.07.02.24309865","DOIUrl":"https://doi.org/10.1101/2024.07.02.24309865","url":null,"abstract":"Background Colorectal cancer (CRC) ranks third globally in cancer-related mortality, with rising incidence, particularly in Asia, projecting a 60% surge by 2030. Metastatic CRC (mCRC) presents a significant challenge with a grim 5-year survival rate of 14%. Emerging evidence suggests that tumors with DNA mismatch repair deficiency (dMMR) and high microsatellite instability (MSI-H) respond well to immune checkpoint inhibitors (ICIs), marking a paradigm shift in therapeutic approaches. This systematic review and meta-analysis aim to comprehensively assess Pembrolizumab, Nivolumab, and the combination of Nivolumab and Ipilimumab in advanced CRC, considering their significant antitumor efficacy in MSI-H/dMMR mCRC. Methods Following PRISMA guidelines and Cochrane Handbook standards, this study covers 2014 to 2024, involving advanced CRC patients treated with ICIs. A comprehensive literature search employed 12 independent authors across eight databases. Parameters such as overall survival, progression-free survival, and objective response rate were extracted. The Cochrane Collaboration's Risk of Bias version 2 tool assessed risk. Statistical analysis utilized mean difference and risk ratios with random-effect models due to anticipated heterogeneity. Robustness was ensured through publication bias analysis and sensitivity meta-analysis. Linear regression explored associations in subgroup analysis. Results The meta-analysis evaluated ORR and OS across different immunotherapy interventions. Nivolumab, Nivolumab+Ipilimumab, and Pembrolizumab exhibited varying ORR and OS effect sizes with corresponding heterogeneity levels. Progression-free survival (PFS) analysis also showed diverse effect sizes and heterogeneity levels across the three interventions. The study provides a comprehensive overview of response rates and survival outcomes for these immunotherapies in advanced CRC. Conclusions The study concludes that combination immunotherapy, particularly Nivolumab and Ipilimumab, presents a promising avenue for advanced CRC treatment, showing superior efficacy. Pembrolizumab monotherapy also exhibited promise. While the study offers valuable insights, the identified heterogeneity emphasizes the need for additional research. Adverse effects were generally low, supporting the viability of the studied immunotherapies. The study acknowledges limitations and calls for ongoing investigation to refine and validate these findings, marking a pioneering effort in systematically comparing short-term and long-term effects of anti-CTLA-4 and anti-PD-1 therapies in CRC.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141549775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.1101/2024.06.28.24309663
Nienke N. Hagedoorn, Megan Birkhold, Shruti Murthy, Meera D. Rathan, Christian S. Marchello, John A. Crump
Objective: We aimed to review global studies reporting on mortality, morbidity, and post-operative complications in patients with typhoid intestinal perforation (TIP). Summary Background Data: TIP is a serious and life-threatening complication of typhoid fever that requires emergency surgery and an important driver of typhoid burden. Methods: We searched multiple databases for articles reporting case-fatality ratio (CFR) or complications in patients with TIP undergoing surgery published from 1980 through 30 January 2024. We described the prevalence of each reported complication. Of patients with TIP, we pooled CFR using random-effects meta-analysis and stratified by United Nations region, sex, and number of perforations per patient. Results: We included 46 articles reporting on 4,317 patients with TIP. The most prevalent post-operative complications were wound or surgical site infection in 1,537 (50.7%) of 3,030 patients, wound dehiscence in 308 (16.1%) of 1,909, and chest infection in 136 (15.6%) of 872. Overall, the pooled CFR (95%CI) of patients with TIP was 15.6% (12.5-18.9%), and was 20.5% (17.1-23.9%) in 30 observations from the African region, 5.7% (2.6-9.6%) in 15 observations from the Asian region, and 12.2% (0.90-30.4%) in three observations from the Americas. The Pearsons correlation coefficient of median year of data collection and CFR was -0.01 (p=0.95) for Africa and -0.69 (p <0.01) for Asia. Conclusions Disability and death associated with TIP remains substantial. Efforts to reduce the occurrence of TIP through typhoid prevention with vaccine and non-vaccine measures, and increased access to and quality of surgical services for those with TIP are warranted.
{"title":"Mortality, morbidity, and post-operative complications of typhoid intestinal perforations: global systematic review and meta-analysis","authors":"Nienke N. Hagedoorn, Megan Birkhold, Shruti Murthy, Meera D. Rathan, Christian S. Marchello, John A. Crump","doi":"10.1101/2024.06.28.24309663","DOIUrl":"https://doi.org/10.1101/2024.06.28.24309663","url":null,"abstract":"Objective:\u0000We aimed to review global studies reporting on mortality, morbidity, and post-operative complications in patients with typhoid intestinal perforation (TIP).\u0000Summary Background Data: TIP is a serious and life-threatening complication of typhoid fever that requires emergency surgery and an important driver of typhoid burden.\u0000Methods:\u0000We searched multiple databases for articles reporting case-fatality ratio (CFR) or complications in patients with TIP undergoing surgery published from 1980 through 30 January 2024. We described the prevalence of each reported complication. Of patients with TIP, we pooled CFR using random-effects meta-analysis and stratified by United Nations region, sex, and number of perforations per patient. Results: We included 46 articles reporting on 4,317 patients with TIP. The most prevalent post-operative complications were wound or surgical site infection in 1,537 (50.7%) of 3,030 patients, wound dehiscence in 308 (16.1%) of 1,909, and chest infection in 136 (15.6%) of 872. Overall, the pooled CFR (95%CI) of patients with TIP was 15.6% (12.5-18.9%), and was 20.5% (17.1-23.9%) in 30 observations from the African region, 5.7% (2.6-9.6%) in 15 observations from the Asian region, and 12.2% (0.90-30.4%) in three observations from the Americas. The Pearsons correlation coefficient of median year of data collection and CFR was -0.01 (p=0.95) for Africa and -0.69 (p <0.01) for Asia. Conclusions Disability and death associated with TIP remains substantial. Efforts to reduce the occurrence of TIP through typhoid prevention with vaccine and non-vaccine measures, and increased access to and quality of surgical services for those with TIP are warranted.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141512047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction Primary intracerebral hemorrhage (ICH) is known to have poor management outcome. Very elderly patients (age > 80) might have significantly higher incidence of worse management morbidity and mortality after primary ICH. The aim of this study was to explore presenting status and pre-existing comorbidities in octogenarians and compare the inpatient management outcomes with younger counterparts. Methods The Stony Brook ICH database is a retrospective cohort of 814 patients that presented with primary ICH from January 2011 to January 2021. Demographic data, presenting symptoms, pre-existing medical conditions, and imaging findings were recorded. Inpatient outcomes and functional state presented as modified Rankin Scale (MRS) at discharge were evaluated. Results Our results indicate octogenarians had significantly higher baseline MRS and comorbidities such as hypertension, hyperlipidemia, and atrial fibrillation at presentation. Similarly, usage of statins, antiplatelets, and anticoagulants were significantly higher in this age group. Octogenarians were also found to have higher average volume of hematoma at presentation. Our results indicate significantly higher discharge MRS, and inpatient mortality in the very elderly group. Conclusion Present study demonstrates a wide variety of pre-existing factors that correlate with worse outcomes amongst octogenarians presenting with primary ICH. Given the importance of aging population as a major healthcare issue in many parts of world, it is crucial to continue exploring these associations in future research. Findings of this study can be utilized to plan further prospective studies on this topic.
导言：众所周知，原发性脑出血（ICH）的治疗效果不佳。高龄患者（80 岁以上）在原发性 ICH 后的发病率和死亡率明显更高。本研究旨在探讨八旬老人的发病状况和原有合并症，并将其住院治疗结果与年轻患者进行比较。方法 石溪 ICH 数据库是一个回顾性队列，包含 2011 年 1 月至 2021 年 1 月期间 814 名原发性 ICH 患者。数据库记录了患者的人口统计学数据、主要症状、既往病史和影像学检查结果。评估了住院结果和出院时的功能状态（以改良兰金量表（MRS）表示）。结果 我们的研究结果表明，八旬老人的基线 MRS 和合并症（如高血压、高脂血症和心房颤动）明显较高。同样，该年龄组使用他汀类药物、抗血小板药物和抗凝药物的比例也明显较高。八旬老人发病时的平均血肿量也较高。我们的研究结果表明，高龄组患者的出院 MRS 和住院死亡率明显更高。结论 目前的研究表明，八旬老人患原发性 ICH 的预后较差与多种原有因素有关。鉴于人口老龄化在世界许多地区都是一个重要的医疗保健问题，在未来的研究中继续探索这些关联至关重要。本研究的结果可用于规划有关该主题的进一步前瞻性研究。
{"title":"Trends and Predictors of Outcomes of Primary Intracerebral Hemorrhage in Very Elderly Patients.","authors":"Kevin Gilotra, Melissa Janssen, Xiaoyue Zhang, Racheed Mani, Sujith Swarna, Cassie Wang, Reza Dashti","doi":"10.1101/2024.06.27.24309617","DOIUrl":"https://doi.org/10.1101/2024.06.27.24309617","url":null,"abstract":"Introduction Primary intracerebral hemorrhage (ICH) is known to have poor management outcome. Very elderly patients (age > 80) might have significantly higher incidence of worse management morbidity and mortality after primary ICH. The aim of this study was to explore presenting status and pre-existing comorbidities in octogenarians and compare the inpatient management outcomes with younger counterparts. Methods The Stony Brook ICH database is a retrospective cohort of 814 patients that presented with primary ICH from January 2011 to January 2021. Demographic data, presenting symptoms, pre-existing medical conditions, and imaging findings were recorded. Inpatient outcomes and functional state presented as modified Rankin Scale (MRS) at discharge were evaluated. Results Our results indicate octogenarians had significantly higher baseline MRS and comorbidities such as hypertension, hyperlipidemia, and atrial fibrillation at presentation. Similarly, usage of statins, antiplatelets, and anticoagulants were significantly higher in this age group. Octogenarians were also found to have higher average volume of hematoma at presentation. Our results indicate significantly higher discharge MRS, and inpatient mortality in the very elderly group. Conclusion Present study demonstrates a wide variety of pre-existing factors that correlate with worse outcomes amongst octogenarians presenting with primary ICH. Given the importance of aging population as a major healthcare issue in many parts of world, it is crucial to continue exploring these associations in future research. Findings of this study can be utilized to plan further prospective studies on this topic.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141512048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-25DOI: 10.1101/2024.06.25.24309413
James Thomas Bennett, Sarah Shirley, Bettina Wilm, Patricia Murray, Mark Field
Objectives Post-operative acute kidney injury (AKI) is a common complication of surgery to repair the thoracoabdominal aorta, and is associated with increased risks of dialysis and early mortality. Perfusion techniques are routinely used during surgery to reduce renal injury. We conducted a systematic review of renal and mortality outcomes by perfusion technique, to evaluate their effectiveness in providing kidney protection.
{"title":"Kidney Protection During Surgery on the Thoracoabdominal Aorta: A Systematic Review","authors":"James Thomas Bennett, Sarah Shirley, Bettina Wilm, Patricia Murray, Mark Field","doi":"10.1101/2024.06.25.24309413","DOIUrl":"https://doi.org/10.1101/2024.06.25.24309413","url":null,"abstract":"<strong>Objectives</strong> Post-operative acute kidney injury (AKI) is a common complication of surgery to repair the thoracoabdominal aorta, and is associated with increased risks of dialysis and early mortality. Perfusion techniques are routinely used during surgery to reduce renal injury. We conducted a systematic review of renal and mortality outcomes by perfusion technique, to evaluate their effectiveness in providing kidney protection.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"206 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141512049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-24DOI: 10.1101/2024.06.23.24309367
Chonnawee Chaisawasthomrong, Atthaporn Boongird
Abstract Background: The indication for surgical intervention in spontaneous intracerebral hemorrhage remains controversial, particularly regarding the benefits of early hematoma drainage via open craniotomy. This study aimed to identify the maximum hematoma volume suitable for conservative treatment and the volume that represents an absolute indication for surgery in patients with basal ganglia hemorrhage. Methods: A retrospective analysis was performed on the medical records of patients admitted for basal ganglia hemorrhage from 2019 to 2021. The data encompassed personal history, general information and diagnostic imaging records, particularly CT brain scans from the initial ER visit, were examined to ascertain hematoma volume. The comparison focused on evaluating the outcomes of patients who received medical treatment compared to those who underwent surgical intervention, mainly considering various hematoma volumes, and was conducted using multivariate logistic analysis. Results: In a study of 387 cases of basal ganglia hemorrhage, analysis of medical treatment alone across various hematoma volumes revealed that the group with volumes between 10 and 39.9 ml showed no significant difference in mortality compared to the group with volumes less than 10 ml. The Receiver Operating Characteristics (ROC) curve identified a 45.3 ml cutoff for survival prediction with medical treatment alone. Notably, patients in the subgroup undergoing surgical intervention with a hematoma volume less than 30 ml exhibited significantly higher mortality than those who did not undergo surgery. Conversely, there was a pronounced and statistically significant trend toward increased survival in the group with a hematoma volume of at least 60 ml. Conclusions: The application of medical treatment alone is suitable for hematoma volumes ranging from 0 to 45.3 ml, whereas volumes of 60 ml or more serve as a clear indication for surgical intervention in patients with basal ganglia hemorrhage.
{"title":"Determining the optimal hematoma volume-based thresholds for surgical and medical strategies in basal ganglia hemorrhage","authors":"Chonnawee Chaisawasthomrong, Atthaporn Boongird","doi":"10.1101/2024.06.23.24309367","DOIUrl":"https://doi.org/10.1101/2024.06.23.24309367","url":null,"abstract":"Abstract Background: The indication for surgical intervention in spontaneous intracerebral hemorrhage remains controversial, particularly regarding the benefits of early hematoma drainage via open craniotomy. This study aimed to identify the maximum hematoma volume suitable for conservative treatment and the volume that represents an absolute indication for surgery in patients with basal ganglia hemorrhage. Methods: A retrospective analysis was performed on the medical records of patients admitted for basal ganglia hemorrhage from 2019 to 2021. The data encompassed personal history, general information and diagnostic imaging records, particularly CT brain scans from the initial ER visit, were examined to ascertain hematoma volume. The comparison focused on evaluating the outcomes of patients who received medical treatment compared to those who underwent surgical intervention, mainly considering various hematoma volumes, and was conducted using multivariate logistic analysis. Results: In a study of 387 cases of basal ganglia hemorrhage, analysis of medical treatment alone across various hematoma volumes revealed that the group with volumes between 10 and 39.9 ml showed no significant difference in mortality compared to the group with volumes less than 10 ml. The Receiver Operating Characteristics (ROC) curve identified a 45.3 ml cutoff for survival prediction with medical treatment alone. Notably, patients in the subgroup undergoing surgical intervention with a hematoma volume less than 30 ml exhibited significantly higher mortality than those who did not undergo surgery. Conversely, there was a pronounced and statistically significant trend toward increased survival in the group with a hematoma volume of at least 60 ml. Conclusions: The application of medical treatment alone is suitable for hematoma volumes ranging from 0 to 45.3 ml, whereas volumes of 60 ml or more serve as a clear indication for surgical intervention in patients with basal ganglia hemorrhage.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"62 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141512094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-21DOI: 10.1101/2024.06.20.24309240
Matthew J Bancroft, Eleanor Moncur, Amy L Peters, Linda D'Antona, Lewis Thorne, Laurence D Watkins, Brian L Day, Ahmed K Toma
Intracranial pressure (ICP) is typically measured with the head in a neutral position whilst the body is in an upright or supine posture. The effect of body position on ICP is well studied, with ICP greater when supine than when upright. In daily life the head is frequently moved away from the neutral position but how this impacts ICP dynamics is unclear. Knowledge of ICP dynamics in different head-on-body positions may improve future treatments that restore normal ICP dynamics such as cerebrospinal fluid (CSF) drainage shunts. We recruited 57 relatively well, ambulatory patients undergoing clinical ICP monitoring for investigation of possible CSF dynamics disturbances. Forty-one patients were non-shunted, seven had a working shunt and nine had a malfunctioning shunt. We measured ICP and ICP pulsatility (pulse amplitude) over 10 or 20s in different combinations of head and body positions. Positions included right and left head turn and forward tilt in upright (seated, standing) and supine body positions, and right and left lateral tilt and backward tilt in upright body positions. ICP increased by 3-9 mmHg, on average, when the head moved away from neutral to each head position in upright and supine body positions, except for head forward tilt when supine, where ICP did not change. The increase in ICP with head turn and forward tilt in upright body positions was larger in patients with a malfunctioning shunt than with no shunt or a functioning shunt. Pulsatility also increased by 0.5-2 mmHg on average when the head moved away from neutral to each head position in upright and supine body positions, except for head forward tilt in upright body positions where pulsatility slightly decreased by 0.7 mmHg on average. ICP and pulsatility generally increase when the head is moved away from the neutral position, but this depends on a combination of head and body position and shunt status. We propose our results can be explained by a combination of changes to neck vasculature and head orientation relative to gravity. Our findings provide potential reason for patient reports that ICP-related symptoms can be induced and/or exacerbated by head movement and could explain behaviours that avoid excess head movement, such as turning the body rather than the head when looking to the side.
{"title":"Intracranial pressure and pulsatility in different head and body positions","authors":"Matthew J Bancroft, Eleanor Moncur, Amy L Peters, Linda D'Antona, Lewis Thorne, Laurence D Watkins, Brian L Day, Ahmed K Toma","doi":"10.1101/2024.06.20.24309240","DOIUrl":"https://doi.org/10.1101/2024.06.20.24309240","url":null,"abstract":"Intracranial pressure (ICP) is typically measured with the head in a neutral position whilst the body is in an upright or supine posture. The effect of body position on ICP is well studied, with ICP greater when supine than when upright. In daily life the head is frequently moved away from the neutral position but how this impacts ICP dynamics is unclear. Knowledge of ICP dynamics in different head-on-body positions may improve future treatments that restore normal ICP dynamics such as cerebrospinal fluid (CSF) drainage shunts.\u0000We recruited 57 relatively well, ambulatory patients undergoing clinical ICP monitoring for investigation of possible CSF dynamics disturbances. Forty-one patients were non-shunted, seven had a working shunt and nine had a malfunctioning shunt. We measured ICP and ICP pulsatility (pulse amplitude) over 10 or 20s in different combinations of head and body positions. Positions included right and left head turn and forward tilt in upright (seated, standing) and supine body positions, and right and left lateral tilt and backward tilt in upright body positions.\u0000ICP increased by 3-9 mmHg, on average, when the head moved away from neutral to each head position in upright and supine body positions, except for head forward tilt when supine, where ICP did not change. The increase in ICP with head turn and forward tilt in upright body positions was larger in patients with a malfunctioning shunt than with no shunt or a functioning shunt. Pulsatility also increased by 0.5-2 mmHg on average when the head moved away from neutral to each head position in upright and supine body positions, except for head forward tilt in upright body positions where pulsatility slightly decreased by 0.7 mmHg on average.\u0000ICP and pulsatility generally increase when the head is moved away from the neutral position, but this depends on a combination of head and body position and shunt status. We propose our results can be explained by a combination of changes to neck vasculature and head orientation relative to gravity. Our findings provide potential reason for patient reports that ICP-related symptoms can be induced and/or exacerbated by head movement and could explain behaviours that avoid excess head movement, such as turning the body rather than the head when looking to the side.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"168 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141512050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction The current literature suggests hyperglycemia can predict poor outcomes in patients with primary intracerebral hemorrhage (ICH). Chronic hyperglycemia is seen in patients with preexisting diabetes (DM), however, acute hyperglycemia in non-diabetic patients is defined as stress-induced hyperglycemia (SIH). This study explored the influence of hyperglycemia on outcomes of primary ICH patients both in the presence and absence of pre-existing DM. Methods Data regarding admission glucose, pre-existing DM, inpatient mortality, and modified Rankin scale (mRS) scores at discharge were available for 636 patients admitted to Stony Brook Hospital from January 2011 to December 2022 with a primary diagnosis of ICH. Regression models were used to compare outcomes between patients with admission hyperglycemia and/or pre-existing DM to a control group of normoglycemic and non-diabetic ICH patients. Results Patients with SIH had higher inpatient mortality rates and worse mRS scores at discharge (p<0.001). An association with higher mortality and worse mRS scores at discharge was also seen in patients with hyperglycemia secondary to DM, although the strength of this association was weaker when compared to patients with SIH. Conclusion In conclusion, our study's findings suggest that SIH may play a greater role in predicting poor outcomes at discharge rather than a history of poorly controlled DM with chronic hyperglycemia. To develop a more thorough understanding of this topic, prospective studies evaluating the effect of changes in serum glucose during hospital stay on short and long-term outcomes is needed.
导言：目前的文献表明，高血糖可预测原发性脑内出血（ICH）患者的不良预后。慢性高血糖见于原有糖尿病（DM）患者，然而，非糖尿病患者的急性高血糖被定义为应激诱发的高血糖（SIH）。本研究探讨了高血糖对存在或不存在糖尿病的原发性 ICH 患者预后的影响。方法：2011 年 1 月至 2022 年 12 月期间，石溪医院收治了 636 名主要诊断为 ICH 的患者，这些患者的入院血糖、原有 DM、住院死亡率和出院时的改良 Rankin 评分（mRS）均有相关数据。回归模型用于比较入院时有高血糖和/或已有糖尿病的患者与血糖正常和无糖尿病 ICH 患者对照组的预后。结果SIH患者的住院死亡率较高，出院时的mRS评分较差（p<0.001）。继发于 DM 的高血糖患者的死亡率更高，出院时的 mRS 评分更差，但与 SIH 患者相比，这种关联的强度较弱。结论总之，我们的研究结果表明，在预测出院时的不良预后方面，SIH 的作用可能比慢性高血糖且 DM 控制不佳的病史更大。为了更透彻地了解这一主题，需要开展前瞻性研究，评估住院期间血清葡萄糖的变化对短期和长期预后的影响。
{"title":"Stress-induced hyperglycemia predicts poor outcomes in primary ICH patients","authors":"Kevin Gilotra, Jade Basem, Melissa Janssen, Sujith Swarna, Racheed Mani, Benny Ren, Reza Dashti","doi":"10.1101/2024.06.19.24309206","DOIUrl":"https://doi.org/10.1101/2024.06.19.24309206","url":null,"abstract":"Introduction\u0000The current literature suggests hyperglycemia can predict poor outcomes in patients with\u0000primary intracerebral hemorrhage (ICH). Chronic hyperglycemia is seen in patients with preexisting diabetes (DM), however, acute hyperglycemia in non-diabetic patients is defined as stress-induced hyperglycemia (SIH). This study explored the influence of hyperglycemia on outcomes of primary ICH patients both in the presence and absence of pre-existing DM. Methods\u0000Data regarding admission glucose, pre-existing DM, inpatient mortality, and modified\u0000Rankin scale (mRS) scores at discharge were available for 636 patients admitted to Stony Brook\u0000Hospital from January 2011 to December 2022 with a primary diagnosis of ICH. Regression\u0000models were used to compare outcomes between patients with admission hyperglycemia and/or\u0000pre-existing DM to a control group of normoglycemic and non-diabetic ICH patients. Results\u0000Patients with SIH had higher inpatient mortality rates and worse mRS scores at discharge\u0000(p<0.001). An association with higher mortality and worse mRS scores at discharge was also seen\u0000in patients with hyperglycemia secondary to DM, although the strength of this association was\u0000weaker when compared to patients with SIH. Conclusion\u0000In conclusion, our study's findings suggest that SIH may play a greater role in predicting\u0000poor outcomes at discharge rather than a history of poorly controlled DM with chronic\u0000hyperglycemia. To develop a more thorough understanding of this topic, prospective studies\u0000evaluating the effect of changes in serum glucose during hospital stay on short and long-term\u0000outcomes is needed.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141512095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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