Tag: statistics

Ann Surg. 2021 Oct 8. doi: 10.1097/SLA.0000000000005251. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the survival impact of low-titer group O whole blood (LTOWB) in injured pediatric patients who require massive transfusion.

SUMMARY BACKGROUND DATA: Limited data are available regarding the effectiveness of LTOWB in pediatric trauma.

METHODS: A prospective observational study of children requiring massive transfusion after injury at UPMC Children’s Hospital of Pittsburgh, an urban academic pediatric Level 1 trauma center. Injured children ages 1-17 years who received a total of >40 mL/kg of LTOWB and/or conventional components over the 24 hours after admission were included. Patient characteristics, blood product utilization and clinical outcomes were analyzed using Kaplan-Meier survival curves, log rank tests and Cox proportional hazards regression analyses. The primary outcome was 28-day survival.

RESULTS: Of patients analyzed, 27/80 (33%) received LTOWB as part of their hemostatic resuscitation. The LTOWB group was comparable to the component therapy group on baseline demographic and physiologic parameters except: older age, higher body weight and lower red blood cell and plasma transfusion volumes. After adjusting for age, total blood product volume transfused in 24 hours, admission base deficit, international normalized ratio (INR) and injury severity score (ISS), children who received LTOWB as part of their resuscitation had significantly improved survival at both 72 hours and 28 days post-trauma (Adjusted Odds Ratio (AOR) 0.23, p = 0.009 and AOR 0.41, p = 0.02, respectively); 6-hour survival was not statistically significant (AOR = 0.51, p = 0.30). Survivors at 28-days in the LTOWB group had reduced hospital LOS, ICU LOS and ventilator days compared to the CT group.

CONCLUSIONS: Administration of LTOWB during the hemostatic resuscitation of injured children requiring massive transfusion was independently associated with improved 72-hour and 28-day survival.

PMID:35129530 | DOI:10.1097/SLA.0000000000005251

Ann Surg. 2021 Oct 8. doi: 10.1097/SLA.0000000000005240. Online ahead of print.

ABSTRACT

OBJECTIVE: : Economic evaluation of early surgery compared to the endoscopy-first approach in chronic pancreatitis.

SUMMARY BACKGROUND DATA: In patients with painful chronic pancreatitis and a dilated main pancreatic duct, early surgery, as compared with an endoscopy-first approach, leads to more pain reduction with fewer interventions. However, it is unknown if early surgery is more cost-effective than the endoscopy-first approach.

METHODS: The multicenter Dutch ESCAPE trial randomized patients with chronic pancreatitis and a dilated main pancreatic duct between early surgery (surgery within 6 weeks) or the endoscopy-first approach in 30 centers (April 2011 – September 2016). Healthcare utilization was prospectively recorded up to 18 months after randomization. Unit costs of resources were determined, and cost-effectiveness and cost-utility analyses were performed from societal and healthcare perspectives. Primary outcomes were the costs per unit decrease on the Izbicki pain score and per gained quality-adjusted life-year.

RESULTS: In total, 88 patients were included in the analysis, with 44 patients randomized to each group. Total costs were lower in the early surgery group but did not reach statistical significance (mean difference €????4,815 (95 per cent bias-corrected and accelerated confidence interval €????13,113 to €3,411; P=0.25). Early surgery had a probability percentage of 88.4% of being more cost-effective than the endoscopy-first approach at a willingness-to-pay threshold of €0 per day per unit decrease on the Izbicki pain score. The probability percentage per additional gained QALY was 75.7% at a willingness-to-pay threshold of €50,000.

CONCLUSION: In patients with painful chronic pancreatitis and a dilated main pancreatic duct, early surgery was more cost-effective than the endoscopy-first approach.

PMID:35129523 | DOI:10.1097/SLA.0000000000005240

Ann Surg. 2021 Oct 13. doi: 10.1097/SLA.0000000000005254. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine if minimally invasive right colectomy with intracorporeal anastomosis improves postoperative recovery compared to extracorporeal anastomosis.

BACKGROUND: Previous trials have shown that intracorporeal anastomosis improves postoperative recovery; however, it has not yet been evaluated in a setting with optimized perioperative care or with patient-related outcome measures.

METHODS: This was a multicenter, triple-blind, randomized clinical trial at two high-volume colorectal centers with strict adherence to optimized perioperative care pathways. The patients underwent robotic right colectomy with either intracorporeal or extracorporeal anastomosis. The primary outcome was patient-reported postoperative recovery measured using the “Quality of Recovery-15” questionnaire (QoR-15). ClinicalTrials.gov NCT03130166.

RESULTS: A total of 89 patients were randomized and analyzed according to the “Intention-to-treat”-principle. We found no statistically significant differences in patient-reported recovery between the groups. Postoperative pain, nausea, time to ambulation, time to first passage of flatus/stool, length of hospital stay, and pathophysiological tests showed no differences either. The duration of time to create the anastomosis was significantly longer with intracorporeal anastomosis (17 vs. 13 min, P = .003), while all other intraoperative, postoperative, and pathology variables showed no difference.

CONCLUSION: There were no significant differences in postoperative recovery between the two groups.

PMID:35129520 | DOI:10.1097/SLA.0000000000005254

Ann Surg. 2021 Oct 22. doi: 10.1097/SLA.0000000000005261. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to examine associations between the oral, fecal, and mucosal microbiome communities and adenoma formation.

SUMMARY BACKGROUND DATA: Data are limited regarding the relationships between microbiota and preneoplastic colorectal lesions.

METHODS: Individuals undergoing screening colonoscopy were prospectively enrolled and divided into adenoma and nonadenoma formers. Oral, fecal, non-adenoma and adenoma-adjacent mucosa were collected along with clinical and dietary information. 16S rRNA gene libraries were generated using V4 primers. DADA2 processed sequence reads and custom R-scripts quantified microbial diversity. Linear regression identified differential taxonomy and diversity in microbial communities and machine learning identified adenoma former microbial signatures.

RESULTS: One hundred four subjects were included, 46% with adenomas. Mucosal and fecal samples were dominated by Firmicutes and Bacteroidetes whereas Firmicutes and Proteobacteria were most abundant in oral communities. Mucosal communities harbored significant microbial diversity that was not observed in fecal or oral communities. Random forest classifiers predicted adenoma formation using fecal, oral, and mucosal amplicon sequence variant (ASV) abundances. The mucosal classifier reliably diagnosed adenoma formation with an area under the curve (AUC) = 0.993 and an out-of-bag (OOB) error of 3.2%. Mucosal classifier accuracy was strongly influenced by five taxa associated with the family Lachnospiraceae, genera Bacteroides and Marvinbryantia, and Blautia obeum. In contrast, classifiers built using fecal and oral samples manifested high OOB error rates (47.3% and 51.1%, respectively) and poor diagnostic abilities (fecal and oral AUC = 0.53).

CONCLUSION: Normal mucosa microbial abundances of adenoma formers manifest unique patterns of microbial diversity that may be predictive of adenoma formation.

PMID:35129506 | DOI:10.1097/SLA.0000000000005261

Subst Abus. 2022;43(1):801-808. doi: 10.1080/08897077.2021.2010255.

ABSTRACT

Background: Two Way Prayer Meditation (TWPM) is a spiritual intervention that holds promise for improving the psychospiritual well-being of individuals in recovery from substance use disorders (SUD). This study aimed to identify moderators of TWPM’s treatment effects. Moderators tested included gender, race/ethnicity, age, education, religious/spiritual affiliation, and most often used substance. Methods: This study employed a randomized controlled trial design with pretest and posttest. In total, 134 adults in four residential recovery programs participated in the study and were randomly assigned to the TWPM group or the treatment as usual control group. Linear mixed modeling was used to assess the moderating effect of each hypothesized moderator in the form of interaction tests. Sensitivity analyses were conducted by excluding cases with more than a minimum number of missing items. Results: There were no significant moderators for psychological distress, self-esteem, and most of the spiritual well-being outcomes. Both the primary and sensitivity analyses showed education significantly moderated TWPM’s effect on overall spirituality self-ranking. Specifically, TWPM’s positive effect on overall spirituality self-ranking was greater in the master’s degree subgroup than in the less than high school subgroup. Conclusion: TWPM’s treatment effects on most outcomes were not found to vary by the tested participant characteristics. The only statistically significant finding suggests clinicians may need to adjust TWPM workshop/teaching content, delivery style, or language used to reach clients with lower levels of education. Future better-powered studies are recommended to continue exploring the potential moderating effects of race/ethnicity, education, spiritual/religious affiliation, and most often used substance.

PMID:35129421 | DOI:10.1080/08897077.2021.2010255

Ann Surg. 2021 Nov 11. doi: 10.1097/SLA.0000000000005296. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the long-term and short-term outcomes of minimally invasive esophagectomy (MIE) compared with open esophagectomy (OE) in localized esophageal squamous cell carcinoma (ESCC) patients in real-world settings.

BACKGROUND: MIE is an alternative to OE, despite the limited evidence regarding its effect on long-term survival.

METHODS: We recruited 5822 consecutive patients with resectable ESCC in two typical high-volume centers in southern and northern China, 1453 of whom underwent MIE. Propensity score-based overlap weighted regression adjusted for multifaceted confounding factors was used to compare outcomes in the MIE and OE groups.

RESULTS: Five-year overall survival (OS) was 62.7% in the MIE group and 57.7% in the OE group. The overlap weighted Cox regression showed slightly better OS in the MIE group (HR 0.93, 95% CI: 0.82-1.06). Although duration of surgery was longer and treatment cost higher in the MIE group than in the OE group, the number of lymph nodes harvested was larger, the proportion of intraoperative blood transfusions lower, and postoperative complications less in the MIE group. 30-day (RR 0.77, 0.38-1.55) and 90-day (RR 0.79, 0.46-1.35) mortality were lower in the MIE group versus the OE group, although not statistically significant. These findings were consistent across different analytic approaches and subgroups, notably in the subset of ESCC patients with large tumors.

CONCLUSIONS: MIE can be performed safely with OS comparable to OE for patients with localized ESCC, indicating MIE may be recommended as the primary surgical approach for resectable ESCC in health facilities with requisite technical capacity.

PMID:35129490 | DOI:10.1097/SLA.0000000000005296

Zhongguo Xue Xi Chong Bing Fang Zhi Za Zhi. 2021 Dec 21;33(6):626-628. doi: 10.16250/j.32.1374.2021044.

ABSTRACT

OBJECTIVE: To investigate the epidemiological characteristics and diagnosis of malaria cases in Nantong City from 2015 to 2020, so as to provide insights into the prevention of re-establishment of imported malaria and consolidation of malaria elimination achievements in the city.

METHODS: The epidemic data of malaria in Nantong City from 2015 to 2020 were captured from the National Notifiable Disease Report System, the Information Management System for Parasitic Disease Control and individual epidemiological survey reports of malaria cases. The malaria parasite species, source of infections, population distribution, temporal distribution, spatial distribution and diagnosis of imported malaria cases were descriptively and statistically analyzed.

RESULTS: A total of 241 malaria cases were reported in Nantong City from 2015 to 2020, and all were overseas imported cases, including 191 cases with Plasmodium falciparum malaria (79.25%), 8 cases with P. vivax malaria (3.32%), 33 cases with P. ovale malaria (13.69%) and 9 cases with P. malaria malaria (3.73%). Overseas imported malaria cases acquired infections from 34 countries in Asia, Africa and Latin America, and 97.93% of the cases were infected in Africa, and 90.04% (217/241) were reported in Chongchuan District, Hai’an City and Haimen District. Imported malaria cases were aged from 20 to 68 years, and a median age of 45 (13) years, and 97.10% were male. The median duration between returning to China and malaria onset was 7 (9) days among all imported malaria cases, and the median duration from initial diagnosis to definitive diagnosis was 2 (2) days. There were 167 cases that were initially diagnosed as malaria, with a correct rate of 69.29%, and 53.53 (129/241) of malaria cases were diagnosed at city-level medical institutions and 41.49% (100/241) at county-level medical institutions. In addition, the proportion of malaria cases reported by city-level medical institutions increased from 39.62% in 2015 to 81.25% in 2020 (χ² = 6.94, P < 0.01).

CONCLUSIONS: The accuracy of initial malaria diagnosis requires to be improved in Nantong City. Malaria control knowledge should be specially given to migrant workers to shorten the duration of seeking medical care, and malaria training requires to be intensified among healthcare professionals to improve the diagnostic capability of imported malaria cases and the cure of severe P. falciparum malaria cases.

PMID:35128894 | DOI:10.16250/j.32.1374.2021044

Zhen Ci Yan Jiu. 2022 Jan 25;47(1):53-8. doi: 10.13702/j.1000-0607.201042.

ABSTRACT

OBJECTIVE: To investigate the short-term effect and safety on female abdominal obesity and defecation function in treatment with acupoint embedding therapy at different abdominal layers under B ultrasound.

METHODS: A total of 102 female patients with abdominal obesity were randomly divided into 3 groups, i.e. a deep embedding group (34 cases, 1 case dropped out), a shallow embedding group (34 cases, 3 cases dropped out) and a sham-embedding group (34 cases, 6 cases dropped out). Finally, 92 cases were included in the three groups. Under B ultrasound, in the deep embedding group, the absor-bable surgical suture were embedded in subcutaneous fat layer and muscle layer. In the shallow embedding group, the absorbable surgical suture was embedded in the fat layer and in the sham-embedding group, no suture was embedded. The acupoints for embedding therapy included Zhongwan (CV12), Guanyuan (CV4), bilateral Guanmen (ST22), bilateral Tianshu (ST25), bilateral Daimai (GB26) and bilateral Shuidao (ST28). The acupoint embedding therapy was exerted once every two weeks, for 4 times totally. Before and after treatment, the changes in abdominal obesity indicators (waist circumference ［WC］, body fat rate ［BFR］, body mass index ［BMI］, abdominal subcutaneous fat thickness ［ASFT］) and defecation function indicators (spontaneous bowel movement times ［SBMs］ and Bristol stool scale ［BSS］) were observed and the safety indicators were assessed.

RESULTS: After treatment, WC, BFR, BMI and ASFT were lower than those before treatment in both the deep embedding group and the shallow embedding group (P<0.05), those values in the deep embedding group were reduced more obviously as compared with the shallow embedding group (P<0.05). SBMs and BSS after treatment were increased as compared with those before treatment in both the deep embedding group and the shallow embedding group (P<0.05) and the increase in the deep embedding group was more obvious than in the shallow embedding group (P<0.05). The abdominal obesity indicators and defecation function indicators after treatment were not different statistically as compared with those before treatment in the sham-embedding group (P>0.05). The pain score of acupuncture in either the deep embedding group or the shallow embedding group was higher than in the sham-embedding group (P<0.05). The acceptance was more than 2 points in all of the three groups and there was no statistical significance among groups (P>0.05).

CONCLUSION: Acupoint embedding therapy in both the deep and the shallow subcutaneous layers under B ultrasound may regulate the indicators of female abdominal obesity safely. The acupoint embedding therapy in the deep layer is more effective on abdominal obesity and defecation improvement as compared with that exerted in the shallow layer.

PMID:35128871 | DOI:10.13702/j.1000-0607.201042

Zhen Ci Yan Jiu. 2022 Jan 25;47(1):33-8. doi: 10.13702/j.1000-0607.20210059.

ABSTRACT

OBJECTIVE: To observe the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on the motor function and the expression of glial fibrillary acidic protein (GFAP) and microtubule associated protein 2 (MAP2) in cerebral ischemic penumbra of rats with middle cerebral artery occlusion (MCAO) and explore the mechanism of taVNS in the improvement of motor function in MCAO rats.

METHODS: A total of 48 male SD rats were randomized into a sham-operation group, a model group, a transcutaneous auricular non-vagus nerve stimulation (tnVNS) group and a taVNS group, with 12 rats in each group. The suture-occluded method was adopted to prepare MCAO rat model. The auricular rim was stimulated in the tnVNS group and the concha stimulated in the taVNS group, 2 mA in intensity, 10 Hz in frequency, 30 min each time, once a day, for 14 days consecutively. The nerve functional assessment was recorded in each group. The expressions of nicotinic acetylcholine receptor (α7nAchR) in the cerebral ischemic penumbra and the spleen were detected by using Western blot. With the immunofluorescence, the expressions of GFAP and MAP2 were detected.

RESULTS: After modeling, compared with the sham-operation group, the nerve functional score was increased in the model group, the tnVNS group and the taVNS group (P<0.01), suggesting the success of modeling. After treatment, the score was increased in the model group (P<0.01) as compared with the sham-operation group. Compared with the model group, the neurological deficit score was reduced in the taVNS group (P<0.01). Compared with the sham-operation group, GFAP expression was increased and MAP2 expression was reduced remarkably in the cerebral ischemic penumbra in the model group (P<0.05). In comparison with the model group, GFAP expression was reduced, while MAP2 expression was increased remarkably in the cerebral ischemic penumbra in the taVNS group (P<0.05). There were no significant differences in the abovementioned indexes between the model group and tnVNS group (P>0.05). The differences in the expression of α7nAchR in the cerebral ischemic penumbra and the spleen had no statistical significance among groups (P>0.05).

CONCLUSION: TaVNS is effective on neuroprotection in MCAO rats, which may be related to its function of inhibition of GFAP expression and promotion of MAP2 expression in the ischemic penumbra.

PMID:35128868 | DOI:10.13702/j.1000-0607.20210059

Zhen Ci Yan Jiu. 2022 Jan 25;47(1):39-45. doi: 10.13702/j.1000-0607.20210738.

ABSTRACT

OBJECTIVE: To observe the effect of electroacupuncture(EA)at “Baihui”(GV20) and “Shenting” (GV24) on the expression of melatonin synthesis rate-limiting enzyme-arylalkylamine N-acetyltransferase(AANAT)in pineal gland of rats with focal cerebral ischemia-reperfusion injury, so as to explore the mechanism of EA underlying improving ischemia-reperfusion injury.

METHODS: Forty-eight SD rats were randomly divided into sham operation, model, EA and non-acupoint groups, with 12 rats in each group. The focal cerebral ischemia-reperfusion injury rat model was established by occlusion of the middle cerebral artery. Rats of the EA group received EA at GV20 and GV24, while those in the non-acupoint group received EA at non-acupoints below the costal margins on both sides for 20 min, once daily for 7 days. The neurological deficit score (0 to 4 points) was given after successful modeling according to Longa’s method. Morris water maze test was used to assess the cognitive function of rat. ELISA was used to detect the plasma melatonin content, and PCR and Western blot were used to detect the mRNA and protein expressions of AANAT in the pineal gland, separately. Immunofluorescence staining was used to detect the activation of astrocytes and neuronal injury in the hippocampus.

RESULTS: After focal cerebral ischemia-reperfusion injury and compared with the sham operation group, the neurological deficit score, the escape latency, and the expression of GFAP were significantly increased (P<0.01)，while the times of platform quadrant crossing, the secretion of melatonin at 24:00，AANAT mRNA and protein expression levels and NeuN protein expression were significantly down-regulated (P<0.01). After EA at GV20 and GV24, the above-mentioned indexes all reversed in the EA group relative to the model group, and there were significant differences between the two groups(P<0.01). Compared with the model group, the changes of the abovementioned indexes in the non-acupoint group were not statistically significant (P>0.05).

CONCLUSION: EA at GV20 and GV24 can alleviate neurological deficit and improve cognitive function in cerebral ischemia-reperfusion rats，which may be related to its effects in up-regulating endogenous melatonin levels, inhibiting the activation of astrocytes and protecting damaged neurons in the hippocampus.

PMID:35128869 | DOI:10.13702/j.1000-0607.20210738