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Nevin Manimala Statistics

Estimates of Resting Energy Expenditure and Total Energy Expenditure Using Predictive Equations for Individuals After Bariatric Surgery: a Systematic Review with Meta-analysis

Obes Surg. 2023 Oct 27. doi: 10.1007/s11695-023-06908-5. Online ahead of print.

ABSTRACT

PURPOSE: Patients after metabolic bariatric surgery (MBS) require attention to maintain energy balance and avoid weight regain. Predictive equations for resting energy expenditure (REE) and total energy expenditure (TEE) are needed since gold standard methods like calorimetry and doubly labeled water are rarely available in routine clinical practice. This study aimed to determine which predictive equation for REE and TEE has the lowest bias in subjects after MBS.

METHODS: MEDLINE, Embase, Web of Science, and CENTRAL searches were performed. Meta-analyses were performed with the data calculated by the predictive equations and measured by the gold standard methods for those equations that had at least two studies with these data. The DerSimonian and Laird random-effects model and the I2 statistic were used to quantify heterogeneity in the quantitative analyses. The risk of bias was assessed using the Joanna Briggs Institute critical appraisal checklist.

RESULTS: Seven studies were included. The present study found that the Mifflin St. Jeor (1990) equation had the lowest bias (mean difference = – 39.71 kcal [95%CI = – 128.97; 49.55]) for calculating REE in post-BS individuals. The Harris-Benedict (1919) equation also yielded satisfactory results (mean difference = – 54.60 kcal [95%CI = – 87.92; – 21.28]).

CONCLUSION: The predictive equation of Mifflin St. Jeor (1990) was the one that showed the lowest bias for calculating the REE of patients following MBS.

PMID:37889369 | DOI:10.1007/s11695-023-06908-5

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Nevin Manimala Statistics

Oscillating Gradient Diffusion-Weighted MRI for Risk Stratification of Uterine Endometrial Cancer

J Magn Reson Imaging. 2023 Oct 27. doi: 10.1002/jmri.29106. Online ahead of print.

ABSTRACT

BACKGROUND: Oscillating gradient diffusion-weighted imaging (DWI) enables elucidation of microstructural characteristics in cancers; however, there are limited data to evaluate its utility in patients with endometrial cancer.

PURPOSE: To investigate the utility of oscillating gradient DWI for risk stratification in patients with uterine endometrial cancer compared with conventional pulsed gradient DWI.

STUDY TYPE: Retrospective.

SUBJECTS: Sixty-three women (mean age: 58 [range: 32-85] years) with endometrial cancer.

FIELD STRENGTH/SEQUENCE: 3 T MRI including DWI using oscillating gradient spin-echo (OGSE) and pulsed gradient spin-echo (PGSE) research sequences.

ASSESSMENT: Mean value of the apparent diffusion coefficient (ADC) values for OGSE (ADCOGSE ) and PGSE (ADCPGSE ) as well as the ADC ratio (ADCOGSE /ADCPGSE ) within endometrial cancer were measured using regions of interest. Prognostic factors (histological grade, deep myometrial invasion, lymphovascular invasion, International Federation of Gynecology and Obstetrics [FIGO] stage, and prognostic risk classification) were tabulated.

STATISTICAL TESTS: Interobserver agreement was analyzed by calculating the intraclass correlation coefficient. The associations of ADCOGSE , ADCPGSE , and ADCOGSE /ADCPGSE with prognostic factors were examined using the Kendall rank correlation coefficient, Mann-Whitney U test, and receiver operating characteristic (ROC) curve. A P value of <0.05 was statistically significant.

RESULTS: Compared with ADCOGSE and ADCPGSE , ADCOGSE /ADCPGSE was significantly and strongly correlated with histological grade (observer 1, τ = 0.563; observer 2, τ = 0.456), FIGO stage (observer 1, τ = 0.354; observer 2, τ = 0.324), and prognostic risk classification (observer 1, τ = 0.456; observer 2, τ = 0.385). The area under the ROC curves of ADCOGSE /ADCPGSE for histological grade (observer 1, 0.92, 95% confidence intervals [CIs]: 0.83-0.98; observer 2, 0.84, 95% CI: 0.73-0.92) and prognostic risk (observer 1, 0.80, 95% CI: 0.68-0.89; observer 2, 0.76, 95% CI: 0.63-0.86) were significantly higher than that of ADCOGSE and ADCPGSE .

DATA CONCLUSION: The ADC ratio obtained via oscillating gradient and pulsed gradient DWIs might be useful imaging biomarkers for risk stratification in patients with endometrial cancer.

LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY: Stage 2.

PMID:37886909 | DOI:10.1002/jmri.29106

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Nevin Manimala Statistics

Predictors, mediators, and moderators of response to digital interventions for eating disorders: A systematic review

Int J Eat Disord. 2023 Oct 27. doi: 10.1002/eat.24078. Online ahead of print.

ABSTRACT

OBJECTIVE: Digital interventions show promise as an effective prevention or self-management option for eating disorders (EDs). However, it remains unclear how, for whom, and through what mechanisms they work in this population, as a synthesis of outcome predictors, moderators, and mediators is lacking. This systematic review synthesized empirical research investigating predictors, mediators, and moderators of response to digital interventions for EDs.

METHOD: Six databases were searched (PROSPERO CRD42022295565) for studies that assessed predictors, moderators, or mediators of response (i.e., uptake, drop-out, engagement, and symptom level change) to a digital prevention or treatment program for EDs. Variables were grouped into several overarching categories (demographic, symptom severity, psychological, etc.) and were synthesized qualitatively across samples without a formally diagnosed ED (typically prevention-focused) and samples with a formally diagnosed ED (typically treatment-focused).

RESULTS: Eighty-six studies were included. For studies recruiting samples without a formal diagnosis (n = 70 studies), most predictors explored were statistically unrelated to outcome, although participant age, baseline symptom severity, confidence to change, motivation, and program engagement showed preliminary evidence of prognostic potential. No robust moderators or mediators were identified. Few studies recruiting samples with a formal diagnosis emerged (n = 16), of which no reliable predictors, moderators, or mediators were identified.

DISCUSSION: It remains unclear how, for whom, and under what circumstances digital programs targeting EDs work. We offer several recommendations for future research with the aim of advancing understanding of client characteristics and intervention elements that signal success from this intervention modality.

PUBLIC SIGNIFICANCE: Digital interventions have shown potential as an effective, scalable, and accessible intervention option for EDs. However, responsiveness varies, so advancing understanding of predictors, mediators, and moderators of outcome to digital interventions for EDs is needed. Such knowledge is important for enabling safe and efficient treatment matching, and for informing future development of effective digital interventions.

PMID:37886906 | DOI:10.1002/eat.24078

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Nevin Manimala Statistics

The effect of erector spinae plane block on the use of anesthetic medications in lumbar spine surgery

Agri. 2023 Oct;35(4):228-235. doi: 10.14744/agri.2022.48992.

ABSTRACT

OBJECTIVES: To reduce the drug side effects and facilitate the emergence from anesthesia after complex spine surgery, various methods have been proposed. One of these methods is ESPB, which has been less studied. Hence, we conducted this study to evaluate the effectiveness of ESPB on the use of anesthetic drugs in lumbar spine surgery.

METHODS: In this study, 70 patients undergoing lumbar spine fusion surgery were studied. Patients were randomly divided into two groups: the case group (n=35), in which bilateral ESPB was done, and the control group (n=35). After standard anesthesia protocols, anesthesia was maintained with isoflurane in both groups. Intraoperative isoflurane and perioperative opioid consumption were recorded. Statistical analysis was performed using SPSS software version 21.

RESULTS: Intraoperative use of fentanyl in the case group was significantly lower than the control group (14.29±21.5 vs. 65.96±73.33 µg, p<0.001). Furthermore, isoflurane consumption in the intervention group compared to the controls was significantly lower (20.71±5.02 versus 28.83±8.68 mL, p<0.001). Moreover, the emergence time was significantly shorter in the case group than in the control group (8.49±4.30 minutes versus 15.00±4.94, p<0.001). In the post-anesthesia care unit 1 h after surgery, the pain scores in the case group were significantly lower than the controls (p<0.001).

CONCLUSION: ESPB under ultrasound guidance is an effective method of regional anesthesia/analgesia for lumbar spine surgery (fusion) by decreasing the consumption of anesthetics during and following the surgery.

PMID:37886866 | DOI:10.14744/agri.2022.48992

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Nevin Manimala Statistics

Pain beliefs of cancer patients and associated factors

Agri. 2023 Oct;35(4):244-253. doi: 10.14744/agri.2022.55798.

ABSTRACT

OBJECTIVES: The aim is to determine the pain beliefs and related factors of cancer patients.

METHODS: The study was designed as a descriptive and analytical type. It was completed between January and June 2019 with 100 individuals who were 18 years of age or older, who were receiving chemotherapy, and who agreed to participate in the study. Data were collected using a patient information form, a pain assessment form, and the Pain Beliefs Scale.

RESULTS: In the results of the regression analysis, the psychological belief scores of those who acted nervously were statistically 0.408 points higher than those who acted calmly. Organic beliefs scores were statistically 0.814 points and 0.599 points higher in basically literate and primary school graduates, respectively, compared to university graduates. They were 0.372 points higher for those whose income was less than their expenditure compared to those whose income was balanced with their expenditure, 0.414 points higher in those who had experienced pain in the last 6 months compared to those who had not, and 0.561 points higher in those who did not use non-pharmacological methods in pain control compared to those who did. Those who expressed pain verbally were found to have points that were 0.447 higher than those who did not say they had pain.

CONCLUSION: Based on the results obtained, it is recommended that cancer patients be given training that will improve self-management and self-efficacy with cognitive-behavioral methods, taking into account their pain beliefs and affecting factors, in order for them to be successful in pain management.

PMID:37886863 | DOI:10.14744/agri.2022.55798

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Nevin Manimala Statistics

Comparison of the effectiveness of transversus abdominis plane block with laparoscopy or ultrasonography in laparoscopic cholecystectomy operations

Agri. 2023 Oct;35(4):254-264. doi: 10.14744/agri.2022.01709.

ABSTRACT

OBJECTIVES: This study aims to compare the effectiveness of the Transversus Abdominis Plane (TAP) block applied to reduce postoperative pain in laparoscopic cholecystectomy surgery by ultrasonography (USG) and laparoscopy.

METHODS: A total of 170 patients who underwent laparoscopic cholecystectomy were divided into three groups. Group L received TAP block by laparoscopy, Group U received TAP block by USG, and the control group (Group C) did not receive TAP block. Bilateral subcostal 15 mL 0.5% bupivacaine was used for the TAP block. We recorded patients’ demographic data and hemodynamic parameters, surgery time, anesthesia time, time of first postoperative analgesic need, visual analog scale (VAS) scores, time to first flatulence and stool, degree of nausea-vomiting, and the Turkish Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R-T) scores.

RESULTS: We observed no statistically significant differences between the groups in terms of age, gender, or American Society of Anesthesiologists scores, and body mass index was higher in Group U compared to the other groups (p<0.05). The VAS score was significantly higher in the control group at all times compared to the other two groups (p<0.001). VAS measurements were higher in Group U at postoperative 1st and 12th h compared to Group L (p<0.001). Surgery time and anesthesia time were significantly different between the groups (p=0.001). Group C showed high VAS scores, high pain severity by APS-POQ-R-T at the 24th postoperative hour, and low sleep quality and patient satisfaction.

CONCLUSION: For laparoscopic cholecystectomy surgery, applying TAP block with the help of USG is effective in postoperative pain management. Applying TAP block with laparoscopy is easy since it does not require additional preparation or equipment during the procedure and may be preferred in the absence of a USG device.

PMID:37886858 | DOI:10.14744/agri.2022.01709

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Nevin Manimala Statistics

Neonatal outcomes according to different degrees of maternal morbidity: cross-sectional evidence from the Perinatal Information System (SIP) of the CLAP network

Glob Health Action. 2023 Dec 31;16(1):2269736. doi: 10.1080/16549716.2023.2269736. Epub 2023 Oct 27.

ABSTRACT

BACKGROUND: The burden of maternal morbidity in neonatal outcomes can vary with the adequacy of healthcare provision and tool implementation to improve monitoring. Such information is lacking in Latin American countries, where the decrease in severe maternal morbidity and maternal death remains challenging.

OBJECTIVES: To determine neonatal outcomes according to maternal characteristics, including different degrees of maternal morbidity in Latin American health facilities.

METHODS: This is a secondary cross-sectional analysis of the Perinatal Information System (SIP) database from eight health facilities in five Latin American and Caribbean countries. Participants were all women delivering from August 2018 to June 2021, excluding cases of abortion, multiple pregnancies and missing information on perinatal outcomes. As primary and secondary outcome measures, neonatal near miss and neonatal death were measured according to maternal/pregnancy characteristics and degrees of maternal morbidity. Estimated adjusted prevalence ratios (PRadj) with their respective 95% CIs were reported.

RESULTS: In total 85,863 live births were included, with 1,250 neonatal near miss (NNM) cases and 695 identified neonatal deaths. NNM and neonatal mortality ratios were 14.6 and 8.1 per 1,000 live births, respectively. Conditions independently associated with a NNM or neonatal death were the need for neonatal resuscitation (PRadj 16.73, 95% CI [13.29-21.05]), being single (PRadj 1.45, 95% CI [1.32-1.59]), maternal near miss or death (PRadj 1.64, 95% CI [1.14-2.37]), preeclampsia (PRadj 3.02, 95% CI [1.70-5.35]), eclampsia/HELPP (PRadj 1.50, 95% CI [1.16-1.94]), maternal age (years) (PRadj 1.01, 95% CI [<1.01-1.02]), major congenital anomalies (PRadj 3.21, 95% CI [1.43-7.23]), diabetes (PRadj 1.49, 95% CI [1.11-1.98]) and cardiac disease (PRadj 1.65, 95% CI [1.14-2.37]).

CONCLUSION: Maternal morbidity leads to worse neonatal outcomes, especially in women suffering maternal near miss or death. Based on SIP/PAHO database all these indicators may be helpful for routine situation monitoring in Latin America with the purpose of policy changes and improvement of maternal and neonatal health.

PMID:37886828 | DOI:10.1080/16549716.2023.2269736

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Nevin Manimala Statistics

Cumulative pregnancy rates of two strategies: Day 3 fresh embryo transfer followed by Day 3 or Day 5/6 vitrification and embryo transfer: a randomized controlled trial

Hum Reprod. 2023 Oct 26:dead222. doi: 10.1093/humrep/dead222. Online ahead of print.

ABSTRACT

STUDY QUESTION: Are cumulative pregnancy rates better if supernumerary embryos are vitrified on Day 5/6 instead of Day 3?

SUMMARY ANSWER: The results do not show a significant difference in cumulative pregnancy rates between the Day 3 and Day 5/6 vitrification groups.

WHAT IS KNOWN ALREADY: Pregnancy and live birth rates following IVF or ICSI treatment are higher after extended embryo culture and blastocyst transfer (Day 5/6) compared to cleavage-stage (Day 3) transfer. Cumulative pregnancy rates from one oocyte retrieval (OR) cycle show no significant difference after fresh and frozen embryo transfers, but only one study has used vitrification for the cryopreservation of supernumerary embryos while four studies have used a slow freezing protocol.

STUDY DESIGN, SIZE, DURATION: Our prospective randomized controlled trial was performed in an academic centre between January 2018 and August 2020. Patients were randomized into vitrification Day 3 (n = 80) or Day 5/6 (n = 81) groups. The primary outcome was the cumulative ongoing pregnancy rate (cOPR), considering only the first pregnancy for each couple. The power calculation revealed that 75 patients were required in each group, when assuming a 50% cOPR with four embryo transfers in the vitrification Day 3 group vs two transfers in the vitrification Day 5/6 group.

PARTICIPANTS/MATERIALS, SETTING, METHODS: Patients <38 years undergoing their first or second OR cycles were randomized at the start of the first cycle. Up to two cycles were included in the analysis. A fresh embryo transfer was performed on Day 3. Supernumerary embryos (with ≥6 cells, <25% fragmentation, and equal blastomeres) or blastocysts (with expansion grade ≥2 with inner cell mass and trophectoderm score A/B) were vitrified on Day 3 or Day 5/6, respectively, and then transferred at a later date. A time-to-event analysis was performed with the patient’s first ongoing pregnancy as the event of interest and the number of embryo transfers as the time component. The statistical comparison was performed by a Cox proportional hazards model. Cumulative costs of vitrification on Day 3 vs Day 5/6 were explored and compared using Mann-Whitney U tests.

MAIN RESULTS AND THE ROLE OF CHANCE: By December 2021, 233 transfers (96 fresh and 137 frozen) in 77 patients were performed in the vitrification Day 3 group and 201 transfers (88 fresh and 113 frozen) in 77 patients were performed in the vitrification Day 5/6 group. The time-to-event analysis did not show a difference between the two arms with regard to the patient’s first ongoing pregnancy as the primary study outcome (hazard ratio [HR] 1.25, 95% CI 0.82; 1.92, P = 0.30). The cumulative ongoing pregnancy rate after eight transfers (from one or two ORs) was 57% in the vitrification Day 3 group vs 58% in the vitrification Day 5/6 group. The median number of embryo transfers until a pregnancy was achieved was five vs four, respectively, in the vitrification Day 3 group vs the Day 5/6 group. Similar results were found for the secondary study outcome, i.e. clinical pregnancy with foetal heart rate (HR 1.19, 95% CI 0.78; 1.80, P = 0.41). The cumulative clinical pregnancy rate (cCPR) after eight embryo transfers was 62% in the vitrification Day 3 group vs 59% in the vitrification Day 5/6 group. The median number of transfers until a pregnancy was achieved was four in both groups. The healthcare consumption pattern differed between the two groups and we observed higher costs for the vitrification Day 3 group compared to the vitrification Day 5/6 group, although these differences were not statistically significant.

LIMITATIONS, REASONS FOR CAUTION: Although our power calculation revealed that only 75 patients were needed in each study group (β = 0.87, α < 0.05), the numbers were low. Also, different numbers of single and double embryo transfers were performed between the two groups, which may have affected the results. The cost analysis was performed on a subset of the patients and is therefore exploratory.

WIDER IMPLICATIONS OF THE FINDINGS: Our study shows no difference in the cumulative pregnancy rate nor costs after fresh and frozen embryo transfers of at most two sequential OR cycles between the Day 3 and Day 5/6 vitrification groups; however, obstetric and perinatal outcomes should be taken into account to determine the best strategy.

STUDY FUNDING/COMPETING INTEREST(S): This study was funded as an investigator-sponsored study of S.D. by Merck nv/sa Belgium, an affiliate of Merck KGaA, Darmstadt, Germany, and by Gedeon Richter Benelux (PA18-0162). The authors declare no conflict of interest related to this study.

TRIAL REGISTRATION NUMBER: NCT04196036.

TRIAL REGISTRATION DATE: 15 January 2018.

DATE OF FIRST PATIENT’S ENROLMENT: 15 January 2018.

PMID:37886820 | DOI:10.1093/humrep/dead222

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Signal detection statistics of adverse drug events in hierarchical structure for matched case-control data

Biostatistics. 2023 Oct 26:kxad029. doi: 10.1093/biostatistics/kxad029. Online ahead of print.

ABSTRACT

The tree-based scan statistic is a data mining method used to identify signals of adverse drug reactions in a database of spontaneous reporting systems. It is particularly beneficial when dealing with hierarchical data structures. One may use a retrospective case-control study design from spontaneous reporting systems (SRS) to investigate whether a specific adverse event of interest is associated with certain drugs. However, the existing Bernoulli model of the tree-based scan statistic may not be suitable as it fails to adequately account for dependencies within matched pairs. In this article, we propose signal detection statistics for matched case-control data based on McNemar’s test, Wald test for conditional logistic regression, and the likelihood ratio test for a multinomial distribution. Through simulation studies, we demonstrate that our proposed methods outperform the existing approach in terms of the type I error rate, power, sensitivity, and false detection rate. To illustrate our proposed approach, we applied the three methods and the existing method to detect drug signals for dizziness-related adverse events related to antihypertensive drugs using the database of the Korea Adverse Event Reporting System.

PMID:37886808 | DOI:10.1093/biostatistics/kxad029

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Nevin Manimala Statistics

Trends and long-term variation explaining nutritional determinants of child linear growth: analysis of Bangladesh Demographic and Health Surveys 1996-2018

Public Health Nutr. 2023 Oct 27:1-30. doi: 10.1017/S1368980023002288. Online ahead of print.

ABSTRACT

OBJECTIVE: Examining the height-for-age z-score (HAZ) of 0-35 months children along with stunting prevalence to identify trends, changes, and available nutrition-sensitive and specific determinants that could help explain the long-term variation in child linear growth using successive Bangladesh Demographic and Health Surveys (BDHS) data from 1996 to 2018.

DESIGN: The BDHS pooled data is used for determining the key outcome variables HAZ, stunting, and severe stunting. Trends, kernel-weighted local polynomial smoothing illustrations, pooled multivariable Linear Probability Model (LPM), Ordinary Least Squares method (OLS), and regression decomposition were used.

PARTICIPANTS: Mothers having 0-35 months children, the most critical age range for growth faltering.

RESULTS: The mean HAZ increased by 0.91(±1.53) with 0.041 annual average change, while the percentages of stunting (-26.63 ±0.54) and severe stunting (-21.12 ±0.48) showed a reduction with 1.21 and 0.96 average annual changes, respectively. The average HAZ improvement (0.42 ±1.56) in urban areas was less than the rural areas (1.16 ±1.44). Similar patterns followed for stunting and severe stunting. The prenatal doctor visits (3064.65%), birth in a medical facility (1054.32%), breastfeeding initiation (153.18%), and asset index (144.73%) demonstrated a huge change. The findings of OLS, PLS, and regression decomposition identified asset index, birth order, paternal and maternal education, bottle-fed, prenatal doctor visit, birth in a medical facility, vaccination, maternal BMI, and ever-breastfed as influencing factors to predict the long-term changes of stunting and severe stunting.

CONCLUSION: The nutrition-sensitive and specific factors identified through regression decomposition describing long-term variation in child linear growth should be focused further to attain the sustainable development goals (SDGs).

PMID:37886806 | DOI:10.1017/S1368980023002288