Tag: nevin manimala

PLoS One. 2022 Jun 10;17(6):e0269455. doi: 10.1371/journal.pone.0269455. eCollection 2022.

ABSTRACT

Untreated pain after surgery leads to poor patient satisfaction, longer hospital length of stay, lower health-related quality of life, and non-compliance with rehabilitation regimens. The aim of this study is to characterize the structure of acute pain trajectories during the postsurgical hospitalization period and quantify their association with pain at 30-days and 1-year after surgery. This cohort study included 2106 adult (≥18 years) surgical patients who consented to participate in the SATISFY-SOS registry (February 1, 2015 to September 30, 2017). Patients were excluded if they did not undergo invasive surgeries, were classified as outpatients, failed to complete follow up assessments at 30-days and 1-year following surgery, had greater than 4-days of inpatient stay, and/or recorded fewer than four pain scores during their acute hospitalization period. The primary exposure was the acute postsurgical pain trajectories identified by a machine learning-based latent class approach using patient-reported pain scores. Clinically meaningful pain (≥3 on a 0-10 scale) at 30-days and 1-year after surgery were the primary and secondary outcomes, respectively. Of the study participants (N = 2106), 59% were female, 91% were non-Hispanic White, and the mean (SD) age was 62 (13) years; 41% of patients underwent orthopedic surgery and 88% received general anesthesia. Four acute pain trajectory clusters were identified. Pain trajectories were significantly associated with clinically meaningful pain at 30-days (p = 0.007), but not at 1-year (p = 0.79) after surgery using covariate-adjusted logistic regression models. Compared to Cluster 1, the other clusters had lower statistically significant odds of having pain at 30-days after surgery (Cluster 2: [OR = 0.67, 95%CI (0.51-0.89)]; Cluster 3:[OR = 0.74, 95%CI (0.56-0.99)]; Cluster 4:[OR = 0.46, 95%CI (0.26-0.82)], all p<0.05). Patients in Cluster 1 had the highest cumulative likelihood of pain and pain intensity during the latter half of their acute hospitalization period (48-96 hours), potentially contributing to the higher odds of pain during the 30-day postsurgical period. Early identification and management of high-risk pain trajectories can help in ascertaining appropriate pain management interventions. Such interventions can mitigate the occurrence of long-term disabilities associated with pain.

PMID:35687544 | DOI:10.1371/journal.pone.0269455

Plast Reconstr Surg. 2022 Jun 13. doi: 10.1097/PRS.0000000000009307. Online ahead of print.

ABSTRACT

BACKGROUND: Social media has altered the mechanisms by which published research is disseminated and accessed. The objective of this study was to measure the effect of promotion on research article dissemination, influence, and impact in Plastic and Reconstructive Surgery.

METHODS: All articles published in Plastic and Reconstructive Surgery from January 1, 2016-December 31, 2018 were obtained and reviewed to determine inclusion/exclusion and for the Altmetric Attention Score (AAS), citations, relative citation rate (RCR), and 16 unique promotional tags (journal club, editor’s pick, press release, patient safety, etc.) as indexed on the Plastic and Reconstructive Surgery website. 1,502 articles were included in the analysis. Statistical analysis was completed using descriptive statistics, Pearson’s correlations, and Student t-tests where appropriate with a predetermined level of significance of p≤0.05.

RESULTS: A total of 637 articles (42.4%) had a promotional tag, while 252 (16.8%) had multiple tags. Articles with promotional tags had higher AAS (30.35 vs 8.22; p<0.001), more citations (11.96 vs 8.47; p<0.001), and a higher RCR (2.97 vs 2.06; p<0.001) compared to articles without a tag. Articles with multiple tags had higher AAS (50.17 vs 17.39; p<0.001), more citations (15.78 vs 9.47; p<0.001), and a higher RCR (3.67 vs 2.51; p<0.001) compared to articles with only one tag. As the number of tags increased for an article, AAS (p<0.001), citation count (p<0.001), and RCR (p<0.001) likewise increased.

CONCLUSIONS: This analysis strongly suggests that promotion of research articles is associated with significantly wider dissemination, broader visibility, and more subsequent citations in the literature.

PMID:35687416 | DOI:10.1097/PRS.0000000000009307

Am J Clin Nutr. 2022 Jun 10:nqac159. doi: 10.1093/ajcn/nqac159. Online ahead of print.

ABSTRACT

BACKGROUND: The causal effects of moderate alcohol consumption on cardiovascular diseases (CVDs) are continuously debated, especially on coronary heart disease (CHD).

OBJECTIVES: We aimed to explore the causal associations of alcohol consumption with CVDs and all-cause mortality among Chinese males.

METHODS: A prospective cohort study was conducted in 40,386 Chinese males, with 17,676 being genotyped for the rs671 variant in the aldehyde dehydrogenase 2 (ALDH2) gene. Cox proportional hazards model was conducted to estimate the effects of self-reported alcohol consumption. Mendelian randomization (MR) analysis was performed to explore the causality using rs671 as an instrumental variable.

RESULTS: During the follow-up of 303,353 person-years, 2,406 incident CVD and 3,195 all-cause mortality were identified. J-shaped associations of self-reported alcohol consumption with incident CVD and all-cause mortality were observed, showing decreased risks for light (≤25 g/day) and moderate drinkers (25-≤60 g/day). However, MR analyses revealed a linear association of genetically predicted alcohol consumption with the incident CVD (Ptrend = 0.02), including both CHD (Ptrend = 0.03) and stroke (Ptrend = 0.02). The HRs (95% CIs) for incident CVD across increasing tertiles of genetically predicted alcohol consumption were 1 (reference), 1.18 (1.01, 1.38), and 1.22 (1.03, 1.46). After excluding heavy drinkers, the risk of incident CVD and all-cause mortality was increased by 27% and 20% per standard drink increment of genetically predicted alcohol consumption, respectively.

CONCLUSIONS: Our analyses extend the evidence of the harmful effect of alcohol consumption to total CVD (including CHD) and all-cause mortality, highlighting the potential health benefits of lowering alcohol consumption, even among light-to-moderate male drinkers.

PMID:35687413 | DOI:10.1093/ajcn/nqac159

Plast Reconstr Surg. 2022 Jun 10. doi: 10.1097/PRS.0000000000009293. Online ahead of print.

ABSTRACT

BACKGROUND: Research in plastic surgery often includes bilateral procedures. This gives rise to issues with clustered data. Clustering is when individual data points within a data set are internally related. However, many authors do not account for clustering within their data which can lead to incorrect statistical conclusions.

METHODS: In February 2020, we searched PubMed to investigate the prevalence of reporting issues with bilateral breast procedures in plastic surgery literature. The review focused on breast surgery, since it often involves bilateral procedures and therefore clustering. Based on the review, we developed guidelines for how to identify and address clustered data. The guidelines were modified by a multidisciplinary group consisting of a biostatistician with expertise in clustered data at the Section of Biostatistics, University of Copenhagen, and three medical doctors and PhDs with expertise in statistical analysis and scientific methodology from the Copenhagen University Hospital, Rigshospitalet.

RESULTS: A total of 113 studies were included in the review. Seventy-five studies (66%) contained clustered data, but only 8 studies (11%) took clustering into account in the statistical analysis. These results were used to develop the CLUDA (CLUstered DAta) reporting guidelines which consists of two sections: one to identify clustering and one for reporting and analyzing clustered data.

CONCLUSIONS: Clustered data is abundant in plastic surgery literature, and we propose using the CLUDA reporting guidelines to identify and report clustered data and to consult a biostatistician when designing the study.

PMID:35687407 | DOI:10.1097/PRS.0000000000009293

Lymphat Res Biol. 2022 Jun 10. doi: 10.1089/lrb.2021.0076. Online ahead of print.

ABSTRACT

Background: Lymphatic endothelial cells production or modification were closely related to the extracellular matrix (ECM) molecules. The serum hyaluronic acid (HA), laminin (LN), procollagen type III N-peptide (PIIINP), and collagen type IV (CGIV) levels were researched to explore the clinical significance of serum ECM proteins in the diagnosis and differentiation of lymphedema. Methods: Fifty-five patients were enrolled. They were divided into primary lymphedema (PLE), secondary lymphedema (SLE), and venous edema (VE) groups. Twenty-two healthy controls were also recruited as normal control (NC). Serum HA, LN, PIIINP, and CGIV levels of all subjects were assessed using chemiluminescence immunoassay. Statistical analysis and receiver operating characteristic (ROC) curves were used to data analysis. Results: The serum levels of CGIV were significantly decreased in both PLE and SLE groups compared with those in the NC group. Reduced serum CGIV levels were associated with the severity of lymphedema. The serum levels of CGIV and PIIINP were identified decreased in both PLE and SLE groups compared with those in the VE group. However, the levels of serum HA and LN were not observed significantly changed in both PLE and SLE groups than those in NC or VE group. Furthermore, ROC curve indicated that serum CGIV and PIIINP were capable of providing good diagnostic and differential diagnostic efficacy at the most appropriate cutoff point value. Conclusion: The serum levels of CGIV may have clinical significance in the diagnosis of lymphedema. CGIV and PIIINP may play a role in the differentiation of lymphedema from VE.

PMID:35687386 | DOI:10.1089/lrb.2021.0076

JMIR Form Res. 2022 Jun 10;6(6):e36052. doi: 10.2196/36052.

ABSTRACT

BACKGROUND: We piloted a web-based, provider-driven mobile app (DialysisConnect) to fill the communication and care coordination gap between hospitals and dialysis facilities.

OBJECTIVE: This study aimed to describe the development and pilot implementation of DialysisConnect.

METHODS: DialysisConnect was developed iteratively with focus group and user testing feedback and was made available to 120 potential users at 1 hospital (hospitalists, advanced practice providers [APPs], and care coordinators) and 4 affiliated dialysis facilities (nephrologists, APPs, nurses and nurse managers, social workers, and administrative personnel) before the start of the pilot (November 1, 2020, to May 31, 2021). Midpilot and end-of-pilot web-based surveys of potential users were also conducted. Descriptive statistics were used to describe system use patterns, ratings of multiple satisfaction items (1=not at all; 3=to a great extent), and provider-selected motivators of and barriers to using DialysisConnect.

RESULTS: The pilot version of DialysisConnect included clinical information that was automatically uploaded from dialysis facilities, forms for entering critical admission and discharge information, and a direct communication channel. Although physicians comprised most of the potential users of DialysisConnect, APPs and dialysis nurses were the most active users. Activities were unevenly distributed; for example, 1 hospital-based APP recorded most of the admissions (280/309, 90.6%) among patients treated at the pilot dialysis facilities. End-of-pilot ratings of DialysisConnect were generally higher for users versus nonusers (eg, “I can see the potential value of DialysisConnect for my work with dialysis patients”: mean 2.8, SD 0.4, vs mean 2.3, SD 0.6; P=.02). Providers most commonly selected reduced time and energy spent gathering information as a motivator (11/26, 42%) and a lack of time to use the system as a barrier (8/26, 31%) at the end of the pilot.

CONCLUSIONS: This pilot study found that APPs and nurses were most likely to engage with the system. Survey participants generally viewed the system favorably while identifying substantial barriers to its use. These results inform how best to motivate providers to use this system and similar systems and inform future pragmatic research in care coordination among this and other populations.

PMID:35687405 | DOI:10.2196/36052

Pain Med. 2022 Jun 10;23(Supplement_1):S1-S53. doi: 10.1093/pm/pnac046.

ABSTRACT

There have been some modest recent advancements in the research of Complex Regional Pain Syndrome, yet the amount and quality of the work in this complicated multifactorial disease remains low (with some notable exceptions; e.g., the recent work on the dorsal root ganglion stimulation). The semi-systematic (though in some cases narrative) approach to review is necessary so that we might treat our patients while waiting for “better research.” This semi-systematic review was conducted by experts in the field, (deliberately) some of whom are promising young researchers supplemented by the experience of “elder statesman” researchers, who all mention the system they have used to examine the literature. What we found is generally low- to medium-quality research with small numbers of subjects; however, there are some recent exceptions to this. The primary reason for this paucity of research is the fact that this is a rare disease, and it is very difficult to acquire a sufficient sample size for statistical significance using traditional statistical approaches. Several larger trials have failed, probably due to using the broad general diagnostic criteria (the “Budapest” criteria) in a multifactorial/multi-mechanism disease. Responsive subsets can often be identified in these larger trials, but not sufficient to achieve statistically significant results in the general diagnostic grouping. This being the case the authors have necessarily included data from less compelling protocols, including trials such as case series and even in some instances case reports/empirical information. In the humanitarian spirit of treating our often desperate patients with this rare syndrome, without great evidence, we must take what data we can find (as in this work) and tailor a treatment regime for each patient.

PMID:35687369 | DOI:10.1093/pm/pnac046

J Obstet Gynaecol. 2022 Jun 10:1-6. doi: 10.1080/01443615.2022.2074787. Online ahead of print.

ABSTRACT

Maternity statistics of England in 2020 showed rise in Caesarean Section (CS) rate to 31%. Some studies correlated adverse gynaecological symptoms e.g. menstrual irregularities and pelvic pain to ‘niche’ formation at CS scar site. Niche formation was speculated to cause myometrial hypertrophy aggravating these symptoms. This was a prospective comparative histological study including 52 consecutive benign hysterectomy specimens which were categorised into 2 groups: (i) specimens with CS scar (n = 22), (ii) specimens with no CS scar (n = 30). Median (IQ range) uteri weight was 97.2grms (43.5-226) and 91.7grms (35.7-201.7) in study and control groups, respectively (p = .991). Mean (±SD) thickness of anterior myometrial wall was 18.7 mm (±3.6) and 19.4 mm (±4.5) in study and control groups, respectively (p = .58). Mean (±SD) thickness of posterior myometrial wall was 19.1 mm (±3.7) and 18.7 mm (±3.9) in study and control groups, respectively (p = .78). The assumption that CS scar causes myometrial hypertrophy was not demonstrated in this study.IMPACT STATEMENTWhat is already known on this subject? Maternity statistics world-wide show a continuous rise in the rate of Caesarean Section (CS) operation. The CS scar is assumed to be related to adverse clinical gynaecological symptoms such as intermenstrual bleeding, dysmenorrhoea, dyspareunia and chronic pelvic pain; however, the mechanism of this association is not clear. Further, little is known about the effects of CS scar on uterine wall morphology and function.What do the results of this study add? This study was the first prospective series in the literature to compare the uteri with scar with those without in respect of weight and myometrial wall thickness. It was not able to demonstrate the association between having CS scar and myometrial hypertrophy which was hypothesised to be the cause of adverse gynaecological symptoms. However, the microscopic examination of the CS scar revealed adenomyosis, haemorrhage and/or chronic inflammation in most cases.What are the implications of these findings for clinical practice and/or future research? The clinical implication of the histological changes shown in the CS scar requires large comparative clinical studies.

PMID:35687352 | DOI:10.1080/01443615.2022.2074787

JAMA Netw Open. 2022 Jun 1;5(6):e2216183. doi: 10.1001/jamanetworkopen.2022.16183.

ABSTRACT

IMPORTANCE: Ensuring patients have access to safe and efficacious medicines in a timely manner is an essential goal for regulatory agencies, one which has particular importance in oncology because of the substantial unmet need for new therapies. The 2 largest regulatory agencies, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have pivotal global roles, and their recommendations and approvals are frequently followed by other national regulators.

OBJECTIVE: To compare market authorization dates for new oncology therapies approved in the US and Europe over the past decade and to examine and contrast the regulatory activities of the FDA and EMA in the approval of new cancer medicines.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study reviewed the FDA and EMA regulatory databases to identify new oncology therapies approved in both the US and Europe from 2010 to 2019, and characterization of the timings of regulatory activities. Statistical analysis was performed from January to April 2022.

MAIN OUTCOMES AND MEASURES: Regulatory approval date, review time, submission of market authorization application, accelerated approval or conditional marketing authorization status and proportion of approvals prior to peer-reviewed publication of pivotal trial results.

RESULTS: In total, 89 new concomitant oncology therapies were approved in the US and Europe from 2010 to 2019. The FDA approved 85 oncology therapies (95%) before European authorization and 4 therapies (5%) after. The median (IQR) delay in market authorization for new oncology therapies in Europe was 241 (150-370) days compared with the US. The median (IQR) review time was 200 (155-277) days for the FDA and 426 (358-480) days for the EMA. Sixty-four new licensing applications (72%) were submitted to the FDA first, compared with 21 (23%) to the EMA. Thirty-five oncology therapies (39%) were approved by the FDA prior to pivotal study publication, whereas only 8 (9%) by the EMA.

CONCLUSION AND RELEVANCE: In this cross-sectional study, new oncology therapies were approved earlier in the US than Europe. The FDA received licensing applications sooner and had shorter review times. However, more therapies were approved prior to licensing study publication, leaving uncertainty for practitioners regarding clinical utility and safety of newly approved therapies.

PMID:35687337 | DOI:10.1001/jamanetworkopen.2022.16183

JAMA Netw Open. 2022 Jun 1;5(6):e2216393. doi: 10.1001/jamanetworkopen.2022.16393.

ABSTRACT

IMPORTANCE: An adequate system for triaging patients with head trauma in prehospital settings and choosing optimal medical institutions is essential for improving the prognosis of these patients. To our knowledge, there has been no established way to stratify these patients based on their head trauma severity that can be used by ambulance crews at an injury site.

OBJECTIVES: To develop a prehospital triage system to stratify patients with head trauma according to trauma severity by using several machine learning techniques and to evaluate the predictive accuracy of these techniques.

DESIGN, SETTING, AND PARTICIPANTS: This single-center retrospective cohort study was conducted by reviewing the electronic medical records of consecutive patients who were transported to Tokyo Medical and Dental University Hospital in Japan from April 1, 2018, to March 31, 2021. Patients younger than 16 years with cardiopulmonary arrest on arrival or with a significant amount of missing data were excluded.

MAIN OUTCOMES AND MEASURES: Machine learning-based prediction models to detect the presence of traumatic intracranial hemorrhage were constructed. The predictive accuracy of the models was evaluated with the area under the receiver operating curve (ROC-AUC), area under the precision recall curve (PR-AUC), sensitivity, specificity, and other representative statistics.

RESULTS: A total of 2123 patients (1527 male patients [71.9%]; mean [SD] age, 57.6 [19.8] years) with head trauma were enrolled in this study. Traumatic intracranial hemorrhage was detected in 258 patients (12.2%). Among several machine learning algorithms, extreme gradient boosting (XGBoost) achieved the mean (SD) highest ROC-AUC (0.78 [0.02]) and PR-AUC (0.46 [0.01]) in cross-validation studies. In the testing set, the ROC-AUC was 0.80, the sensitivity was 74.0% (95% CI, 59.7%-85.4%), and the specificity was 74.9% (95% CI, 70.2%-79.3%). The prediction model using the National Institute for Health and Care Excellence (NICE) guidelines, which was calculated after consultation with physicians, had a sensitivity of 72.0% (95% CI, 57.5%-83.8%) and a specificity of 73.3% (95% CI, 68.7%-77.7%). The McNemar test revealed no statistically significant differences between the XGBoost algorithm and the NICE guidelines for sensitivity or specificity (P = .80 and P = .55, respectively).

CONCLUSIONS AND RELEVANCE: In this cohort study, the prediction model achieved a comparatively accurate performance in detecting traumatic intracranial hemorrhage using only the simple pretransportation information from the patient. Further validation with a prospective multicenter data set is needed.

PMID:35687335 | DOI:10.1001/jamanetworkopen.2022.16393