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Nevin Manimala Statistics

Early identification of bleeding in trauma patients: external validation of traumatic bleeding scores in the Swiss Trauma Registry

Crit Care. 2022 Sep 28;26(1):296. doi: 10.1186/s13054-022-04178-8.

ABSTRACT

BACKGROUND: Early identification of bleeding at the scene of an injury is important for triage and timely treatment of injured patients and transport to an appropriate facility. The aim of the study is to compare the performance of different bleeding scores.

METHODS: We examined data from the Swiss Trauma Registry for the years 2015-2019. The Swiss Trauma Registry includes patients with major trauma (injury severity score (ISS) ≥ 16 and/or abbreviated injury scale (AIS) head ≥ 3) admitted to any level-one trauma centre in Switzerland. We evaluated ABC, TASH and Shock index (SI) scores, used to predict massive transfusion (MT) and the BATT score and used to predict death from bleeding. We evaluated the scores when used prehospital and in-hospital in terms of discrimination (C-Statistic) and calibration (calibration slope). The outcomes were early death within 24 h and the receipt of massive transfusion (≥ 10 Red Blood cells (RBC) units in the first 24 h or ≥ 3 RBC units in the first hour).

RESULTS: We examined data from 13,222 major trauma patients. There were 1,533 (12%) deaths from any cause, 530 (4%) early deaths within 24 h, and 523 (4%) patients who received a MT (≥ 3 RBC within the first hour). In the prehospital setting, the BATT score had the highest discrimination for early death (C-statistic: 0.86, 95% CI 0.84-0.87) compared to the ABC score (0.63, 95% CI 0.60-0.65) and SI (0.53, 95% CI 0.50-0.56), P < 0.001. At hospital admission, the TASH score had the highest discrimination for MT (0.80, 95% CI 0.78-0.82). The positive likelihood ratio for early death were superior to 5 for BATT, ABC and TASH. The negative likelihood ratio for early death was below 0.1 only for the BATT score.

CONCLUSIONS: The BATT score accurately estimates the risk of early death with excellent performance, low undertriage, and can be used for prehospital treatment decision-making. Scores predicting MT presented a high undertriage rate. The outcome MT seems not appropriate to stratify the risk of life-threatening bleeding.

TRIAL REGISTRATION: Clinicaltrials.gov, NCT04561050 . Registered 15 September 2020.

PMID:36171598 | DOI:10.1186/s13054-022-04178-8

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Nevin Manimala Statistics

Assessing the psychometric performance of EQ-5D-5L in dementia: a systematic review

Health Qual Life Outcomes. 2022 Sep 28;20(1):139. doi: 10.1186/s12955-022-02036-3.

ABSTRACT

BACKGROUND: EQ-5D is widely used for valuing changes in quality of life for economic evaluation of interventions for people with dementia. There are concerns about EQ-5D-3L in terms of content validity, poor inter-rater agreement and reliability in the presence of cognitive impairment, but there is also evidence to support its use with this population. An evidence gap remains regarding the psychometric properties of EQ-5D-5L.

OBJECTIVES: To report psychometric evidence around EQ-5D-5L in people with dementia.

METHODS: A systematic review identified primary studies reporting psychometric properties of EQ-5D-5L in people with dementia. Searches were completed up to November 2020. Study selection, data extraction and quality assessment were undertaken independently by at least 2 researchers.

RESULTS: Evidence was extracted from 20 articles from 14 unique studies covering a range of dementia severity. Evidence of known group validity from 5 of 7 studies indicated that EQ-5D-5L distinguishes severity of disease measured by cognitive impairment, depression, level of dependence and pain. Convergent validity (9 studies) showed statistically significant correlations of weak and moderate strengths, between EQ-5D-5L scores and scores on other key measures. Statistically significant change was observed in only one of 6 papers that allowed this property to be examined. All seven studies showed a lack of inter-rater reliability between self and proxy reports with the former reporting higher EQ-5D-5L scores than those provided by proxies. Five of ten studies found EQ-5D-5L to be acceptable, assessed by whether the measure could be completed by the PwD and/or by the amount of missing data. As dementia severity increased, the feasibility of self-completing EQ-5D-5L decreased. Three papers reported on ceiling effects, two found some evidence in support of ceiling effects, and one did not.

CONCLUSIONS: EQ-5D-5L seems to capture the health of people with dementia on the basis of known-group validity and convergent validity, but evidence is inconclusive regarding the responsiveness of EQ-5D-5L. As disease progresses, the ability to self-complete EQ-5D-5L is diminished.

PMID:36171595 | DOI:10.1186/s12955-022-02036-3

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Nevin Manimala Statistics

Descriptive study of foodborne disease using disease monitoring data in Zhejiang Province, China, 2016-2020

BMC Public Health. 2022 Sep 28;22(1):1831. doi: 10.1186/s12889-022-14226-1.

ABSTRACT

BACKGROUND: This study aimed to identify the epidemiology, seasonality, aetiology and clinical characteristics of sporadic foodborne diseases in Zhejiang province during 2016-2020.

METHODS: Descriptive statistical methods were used to analyze the data from surveillance network established by the Zhejiang Provincial Center for Disease Control and Prevention. There were 31 designated hospitals in all 11 cities which were selected using probability proportionate to size sampling method.

RESULTS: During the study period, the surveillance system received 75,124 cases with 4826 (6.42%) hospitalizations from 31 hospitals. The most common cause was Norovirus, 6120 cases (42.56%), followed by Salmonella, 3351 cases (23.30%). A significant seasonal trend was observed for the V. parahaemolyticus, with the highest rates over the summer period, peaking in August, 1171 cases (38.75%), a similar trend was also observed with Salmonella and Diarrheagenic E. coli. Norovirus infections showed the highest rate in November (904, 14.77%) and March (660,10.78%), the lowest in August, 215 cases (3.51%). Patients between 19 ~ 40 years were more likely to infected by Norovirus, V. parahaemolyticus and Diarrheagenic E. coli, patients below 1 year were the highest among patients with Salmonella infection, 881 cases (26.3%). The Norovirus, V. parahaemolyticus and Diarrheagenic E. coli infection with the highest positive detection rates among the workers were observed. The largest number cases of food categories were from aquatic product infection. The private home was the most common exposure setting.

CONCLUSION: Our study highlighted the necessity for conducting an active, comprehensive surveillance for pathogens in all age groups, to monitor the changing dynamics in the epidemiology and aetiology of foodborne diseases to guide policies that would reduce related illnesses.

PMID:36171585 | DOI:10.1186/s12889-022-14226-1

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Nevin Manimala Statistics

Validating ORR and PFS as surrogate endpoints in phase II and III clinical trials for NSCLC patients: difference exists in the strength of surrogacy in various trial settings

BMC Cancer. 2022 Sep 29;22(1):1022. doi: 10.1186/s12885-022-10046-z.

ABSTRACT

OBJECTIVE: This study aims to systematically validate the performance of surrogate endpoints in phase II and III clinical trials for NSCLC patients under various trial settings.

METHODS: A literature search retrieved all registered phase II and III trials of NSCLC patients in which OS, with at least one of ORR and PFS, were reported. Associations between surrogate and true endpoints were assessed on two levels. On the arm level, three pairs of correlations, i.e., ORR vs. median OS, ORR vs. median PFS, and median PFS vs. median OS, were analysed using Spearman’s rho. On the trial level, similarly, three pairs of correlations, i.e., ΔORR vs. HR of OS, ΔORR vs. HR of PFS, and HR of PFS vs. HR of OS, were analysed using Spearman’s rho and weighted linear regression model respectively. Finally, sensitivity analyses were performed to explore surrogacy under various trial settings.

RESULTS: At arm level, three pairs of correlations are all high (Spearman’s rho = 0.700, 0.831, 0.755, respectively). At trial level, there is a low correlation between ΔORR and HR of OS, a high correlation between ΔORR and HR of PFS and a moderate correlation between HR of PFS and HR of OS (Spearman’s rho = 0.462, 0.764, 0.584, respectively). In the sensitivity analysis, we find correlations between surrogate and true endpoints vary by different trial settings. It is noteworthy that the strength of surrogacy of these intermediate endpoints in targeted therapy is greater than that in immunotherapy.

CONCLUSION: According to the arm-level and trial level-analysis, we suggest that in phase II and III trials of targeted therapy and immunotherapy for NSCLC patients: 1) ORR lacks validity for the surrogacy of OS, excluding in first-line therapy, and 2) ORR may be an appropriate surrogate endpoint for PFS, and 3) PFS may be considered a modest surrogacy for OS, with better performance in first-line therapy trials. Moreover, to provide more convincing evidence of surrogacy of the surrogate endpoints, patient-level analyses are in desperate need.

PMID:36171546 | DOI:10.1186/s12885-022-10046-z

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Nevin Manimala Statistics

Levels of depressive symptoms in cardiac patients attending cardiac rehabilitation with a history of depression: pre Covid-19 and Covid-19 period comparison

BMC Cardiovasc Disord. 2022 Sep 28;22(1):427. doi: 10.1186/s12872-022-02867-4.

ABSTRACT

BACKGROUND: The large-scale changes in cardiac rehabilitation (CR) programme delivery in response to COVID-19 has led to diminished provision. The influence of these service changes on the depression symptoms of patients in CR programmes is unknown. Our study investigated the extent of depressive symptoms prior to and during the COVID-19 periods in patients with a previous history of depression at the start of CR.

METHODS: Use of Registry routine practice data, National Audit of Cardiac Rehabilitation (NACR), from COVID-19 period Feb 2020 and Jan 2021, as well as pre COVID-19 period Feb 2019 and Jan 2020, was extracted. Depressive symptoms were defined according to Hospital Anxiety and Depression Score ≥ 8. Chi-square tests and independent samples t-tests were used to investigate baseline characteristics. Additionally, a binary logistic regression to examine the factors associated with high levels of depressive symptoms.

RESULTS: In total 3661 patients with a history of depression were included in the analysis. Patients attending CR during COVID-19 were found to be 11% more likely to have high levels of acute depressive symptoms compared to patients attending CR prior to COVID-19. Physical inactivity, increased anxiety, a higher total number of comorbidities, increased weight, and living in the most deprived areas were statistically significant factors associated with high levels of acute depressive symptoms at the start of CR following multivariate adjustments.

CONCLUSION: Our research suggests that following a cardiac event patients with prior history of depression have high levels of acute depressive symptoms at CR baseline assessment. This finding exists in both the pre Covid-19 and Covid-19 periods in patients with a history of depression.

PMID:36171545 | DOI:10.1186/s12872-022-02867-4

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Nevin Manimala Statistics

Prevalence of pain and its association with quality of life of patients with heart failure in a developing country: findings from a multicenter cross-sectional study

BMC Cardiovasc Disord. 2022 Sep 28;22(1):426. doi: 10.1186/s12872-022-02864-7.

ABSTRACT

BACKGROUND: Heart failure (HF) is considered one of the main causes of morbidity and death among chronic diseases worldwide. Patients have increasingly reported chronic pain in long-standing heart failure as a disturbing symptom. Its unknown etiology and mechanism, in addition to its insidious progressive nature, made both the doctor and the patient not notice it until it affects the quality of life (QoL) and general health status. The primary objective of this study is to find the prevalence of pain in chronic heart failure patients and its impact on their QoL. The secondary objective is to determine the predictors of QoL in HF patients.

METHODS: A multicenter cross-sectional design was used. The European Quality of Life scale five dimensions scale and the Brief Pain Inventory were adopted to evaluate QoL and pain, respectively. The Statistical Package for the Social Sciences version 25 was applied to present the data. The Mann-Whitney U, Kruskal-Wallis, and Cronbach alpha tests were used.

RESULTS: The final study had a total of 142 individuals. The prevalence of pain among HF patients was 84.5%. Knee pain was the main complaint among patients. Our patients’ median pain severity score was 18 [5.00-25.00], while the median pain interference score was 39 [24.75-53.00]. They had a median EQ-5D score of 0.34 [0.0-0.6] and an EQ-VAS score of 50 [30-70]. Pain severity (p = 0.004 and p < 0.001, respectively) and pain interference (p < 0.001 and p = 0.001, respectively) were found to significantly associated with both QoL scores; the visual analogue scale (EQ-VAS) and EQ-5D-5L. In multivariate analysis, monthly income was the only variable significantly correlated with EQ-VAS and EQ-5D-5L, along with pain variables.

CONCLUSIONS: Pain is a common symptom among patients with HF and is significantly associated with their QoL. Low income is also highly associated with poor QoL. Definitive guidelines should be achieved to increase awareness and understanding of the importance of pain management, reaching a higher QoL level, less pain, and good adherence to HF medications.

PMID:36171539 | DOI:10.1186/s12872-022-02864-7

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Nevin Manimala Statistics

In vitro evaluation of fissure sealants’ wear under erosive, abrasive and erosive/abrasive conditions

Eur Arch Paediatr Dent. 2022 Sep 28. doi: 10.1007/s40368-022-00757-z. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate and compare the wear of selected resin-based fissure sealants with different compositions properties under erosive, abrasive, and erosive/abrasive conditions.

METHODS: Forty-five samples of the following resin-based fissure sealants were prepared: Fissurit (fluoride free), Fissurit F (with fluoride), Fissurit FX (55 wt.% filler content), Grandio Seal (70 wt.% nano-filler content) and bovine enamel. Fifteen samples from each material were randomly allocated into three groups according to the wear condition they would be subjected to as follows: erosive condition (citric acid, 1 min, pH 2.3), abrasive condition (120 brushing strokes at 2 N, toothpaste slurry RDA value = 69), and erosive/abrasive condition (combination of both). The wear challenges were repeated six times each day for 10 days. The material wear was measured using a stylus profilometer. Kruskal-Wallis and Conover’s test was applied to compare the resulting material wear between the groups.

RESULTS: Under erosive conditions, Grandio Seal and Fissurit FX showed statistically significantly the least material wear. Under abrasive and erosive/abrasive conditions, Grandio Seal showed statistically significantly the least material wear. Fissurit F showed statistically significantly the highest material wear under abrasive and erosive/abrasive conditions, after dental enamel (p < 0.05).

CONCLUSION: Higher filler content in sealants leads to better wear resistance. Incorporating fluoride into sealants seems to reduce their wear resistance at similar filler contents.

PMID:36171525 | DOI:10.1007/s40368-022-00757-z

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Nevin Manimala Statistics

Knowledge and awareness of sickle cell disease: a cross sectional study amongst unmarried adults in Nigeria’s capital city

J Community Genet. 2022 Sep 28. doi: 10.1007/s12687-022-00607-x. Online ahead of print.

ABSTRACT

Sickle cell disease is a genetic disorder characterised by the tendency of haemoglobin to polymerise and deform red blood cells to a sickle or crescent shape; this consequently results in vaso-occlusive condition. A better knowledge and awareness about sickle cell disease amongst the population can help reduce its prevalence. This study aimed at assessing awareness and knowledge of unmarried adults in Nigeria’s capital. A cross sectional survey was undertaken amongst unmarried individuals residing in the Federal Capital Territory. Questionnaires were administered to participants using convenience sampling strategy. Data were analysed using Statistical Package for Social Sciences version 25. Descriptive and inferential statistical analyses were carried out. A total of 1423 questionnaires were completed and returned, response rate was 83.71%, male participants were in the majority as indicated by 52% of the sample, and the dominant age group was 21 to 30 years (47.90%). Almost all the study participants (92.50%), have heard about sickle cell disease. Knowledge about sickle cell disease was average, as mean score for all the participants was 9.01 ± 3.18, with a range of 0 to 17. Some misconceptions were observed, for instance some participants believed that bacterial or viral infections could cause sickle cell disease. Male participants had a higher knowledge score compared to females (p < 0.001), and older participants were more knowledgeable about sickle cell disease (p < 0.001). This study identified that knowledge gaps exist about sickle cell disease. Emergent findings can underpin government, policymakers’ and stakeholders’ contextual strategies to prevent sickle cell through public health enlightenment and other relevant means.

PMID:36171517 | DOI:10.1007/s12687-022-00607-x

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Nevin Manimala Statistics

Does pregabalin act in pain control after lateral pharyngoplasties and tonsillectomies? A pilot study

Sleep Breath. 2022 Sep 29. doi: 10.1007/s11325-022-02715-x. Online ahead of print.

ABSTRACT

OBJECTIVE: Some studies have pointed to gabapentinoids as promising medications in postoperative pain control. The objective of the present study was to evaluate the efficacy of pregabalin in reducing postoperative pain in tonsillectomy and lateral pharyngoplasties.

STUDY DESIGN: Double-blind randomized controlled trial.

SETTING: Tertiary care center.

METHODS: A double-blind randomized controlled trial was conducted with patients undergoing tonsillectomies and lateral pharyngoplasties between Aug 29, 2017, and Oct 31, 2020. Data of interest such as opioid consumption, pain scores, and adverse outcomes such as dizziness, nausea, headache, and sedation within 7 days following surgeries were analyzed.

RESULTS: No statistically significant difference was observed in pain scores and opioid consumption between the groups studied in the pilot project. The use of pregabalin was associated with lower incidence of dizziness compared to controls.

CONCLUSION: Gabapentinoids, especially pregabalin, are drugs whose potential for controlling pain after pharyngeal surgery, such as tonsillectomy and sleep apnea surgery, still needs to be more fully evaluated. After the conclusion of the present study, we hope to answer this question about the role of pregabalin in oropharyngeal surgeries.

PMID:36171512 | DOI:10.1007/s11325-022-02715-x

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Nevin Manimala Statistics

Learning curve for the surgical time of laparoscopic cholecystectomy performed by surgical trainees using the three-port method: how many cases are needed for stabilization?

Surg Endosc. 2022 Sep 28. doi: 10.1007/s00464-022-09666-0. Online ahead of print.

ABSTRACT

BACKGROUND: The assessment of laparoscopic cholecystectomy (LC) skills using operating times has not been well reported. We examined the total and partial operating times for LC procedures performed by surgical trainees to determine the required number of surgeries until the surgical time stabilizes.

METHODS: We reviewed the video records of 514 consecutive LCs using the three-port method, performed by 16 surgical trainees. The total and partial surgical times were calculated and correlated to the surgeons’ experience.

RESULTS: The median total surgical time for a trainee’s first LC was 112 (range 71-226) minutes. It reduced rapidly after the first 20 LCs and plateaued to its minimum after approximately 60 cases. A statistically significant time decrease was observed between the first 10 (median, range 112, 46-252 min) and the next 50-59 cases (64, 34-198 min), but not between the 50-59 and the subsequent 100-109 cases (71, 33-127 min). The total times taken by trainees who had performed > 50 operations were not significantly different from those taken by instructors during the study period. Surgery for 125 patients with acute cholecystitis took a significantly longer time (median 99 vs. 74 min with non-acute cholecystitis); however, the abovementioned time reduction findings showed similar results regardless of the patient’s acute inflammation status. The partial operating times around the cervical/cystic duct and gallbladder bed reduced uniformly between the first 10 and the following 50-59 cases. Although time variations in total and cervical/cystic duct operating times were not correlated to the surgical experience, time fluctuation of gallbladder bed procedures reduced after 60 cases.

CONCLUSION: The time required to perform an LC was inversely correlated with the experience of surgical trainees and halved after the first 60 cases. The surgical experience required for LC time stabilization is approximately 60 cases.

PMID:36171452 | DOI:10.1007/s00464-022-09666-0