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Nevin Manimala Statistics

Prophylactic drainage versus non-drainage following gastric cancer surgery: a meta-analysis of randomized controlled trials and observational studies

World J Surg Oncol. 2023 Jun 3;21(1):166. doi: 10.1186/s12957-023-03054-1.

ABSTRACT

BACKGROUND: The role of prophylactic drainage (PD) in gastrectomy for gastric cancer (GC) is not well-established. The purpose of this study is to compare the perioperative outcomes between the PD and non-drainage (ND) in GC patients undergoing gastrectomy.

METHODS: A systematic review of electronic databases including PubMed, Embase, Web of Science, the Cochrane Library, and China National Knowledge Infrastructure was performed up to December 2022. All eligible randomized controlled trials (RCTs) and observational studies were included and meta-analyzed separately. The registration number of this protocol is PROSPERO CRD42022371102.

RESULTS: Overall, 7 RCTs (783 patients) and 14 observational studies (4359 patients) were ultimately included. Data from RCTs indicated that patients in the ND group had a lower total complications rate (OR = 0.68; 95%CI:0.47-0.98; P = 0.04; I2 = 0%), earlier time to soft diet (MD = – 0.27; 95%CI: – 0.55 to 0.00; P = 0.05; I2 = 0%) and shorter length of hospital stay (MD = – 0.98; 95%CI: – 1.71 to – 0.26; P = 0.007; I2 = 40%). While other outcomes including anastomotic leakage, duodenal stump leakage, pancreatic leakage, intra-abdominal abscess, surgical-site infection, pulmonary infection, need for additional drainage, reoperation rate, readmission rate, and mortality were not significantly different between the two groups. Meta-analyses on observational studies showed good agreement with the pooled results from RCTs, with higher statistical power.

CONCLUSION: The present meta-analysis suggests that routine use of PD may not be necessary and even harmful in GC patients following gastrectomy. However, well-designed RCTs with risk-stratified randomization are still needed to validate the results of our study.

PMID:37270519 | DOI:10.1186/s12957-023-03054-1

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Flexible hidden Markov models for behaviour-dependent habitat selection

Mov Ecol. 2023 Jun 3;11(1):30. doi: 10.1186/s40462-023-00392-3.

ABSTRACT

BACKGROUND: There is strong incentive to model behaviour-dependent habitat selection, as this can help delineate critical habitats for important life processes and reduce bias in model parameters. For this purpose, a two-stage modelling approach is often taken: (i) classify behaviours with a hidden Markov model (HMM), and (ii) fit a step selection function (SSF) to each subset of data. However, this approach does not properly account for the uncertainty in behavioural classification, nor does it allow states to depend on habitat selection. An alternative approach is to estimate both state switching and habitat selection in a single, integrated model called an HMM-SSF.

METHODS: We build on this recent methodological work to make the HMM-SSF approach more efficient and general. We focus on writing the model as an HMM where the observation process is defined by an SSF, such that well-known inferential methods for HMMs can be used directly for parameter estimation and state classification. We extend the model to include covariates on the HMM transition probabilities, allowing for inferences into the temporal and individual-specific drivers of state switching. We demonstrate the method through an illustrative example of plains zebra (Equus quagga), including state estimation, and simulations to estimate a utilisation distribution.

RESULTS: In the zebra analysis, we identified two behavioural states, with clearly distinct patterns of movement and habitat selection (“encamped” and “exploratory”). In particular, although the zebra tended to prefer areas higher in grassland across both behavioural states, this selection was much stronger in the fast, directed exploratory state. We also found a clear diel cycle in behaviour, which indicated that zebras were more likely to be exploring in the morning and encamped in the evening.

CONCLUSIONS: This method can be used to analyse behaviour-specific habitat selection in a wide range of species and systems. A large suite of statistical extensions and tools developed for HMMs and SSFs can be applied directly to this integrated model, making it a very versatile framework to jointly learn about animal behaviour, habitat selection, and space use.

PMID:37270509 | DOI:10.1186/s40462-023-00392-3

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Psychotic-like experiences in non-clinical subgroups with and without specific beliefs

BMC Psychiatry. 2023 Jun 3;23(1):397. doi: 10.1186/s12888-023-04876-9.

ABSTRACT

BACKGROUND: Assuming a transdiagnostic and extended psychosis phenotype, psychotic-like experiences (PLEs) and psychotic symptoms are on a phenomenological and temporal continuum between clinical and non-clinical populations. Recent research points towards differences in PLE proneness in different subgroups and clinical impact of different PLE subtypes. This study examines the prevalence of PLEs in three groups of individuals with and without specific sets of beliefs aiming to elucidate the question whether proneness to PLEs varies according to traditional versus less traditional supernatural beliefs.

METHODS: The anonymized 16-item version of the Prodromal Questionnaire (PQ-16) was used to assess PLEs in three groups including individuals with religious beliefs (RB), belief in esoterism and paranormal phenomena (EB), and those embedded in scientific evidence approach and scepticism towards para-scientific theories (non-believers, NB). Male and female participants between 18 and 90 years were eligible for participation.

RESULTS: The sample comprised 159 individuals including 41 RB individuals, 43 EB individuals, and 75 NB individuals. The mean PQ-16 score of the EB individuals (6.86 ± 4.13) was significantly higher compared to NB individuals (3.43 ± 2.99) and to RB individuals (3.38 ± 3.23) with almost twice the score (both p-values < 0.001). There was no significant difference between the PQ-16 scores of the NB group and the RB group (p = 0.935). No significant impact of age (p = 0.330) and gender (p = 0.061) was found on the PQ16-Score. Group affiliation to esoterism was associated with a higher PQ-16 score compared to group affiliation to religious beliefs (p < 0.001) and group affiliation to scepticism (p = 0.011), while the latter two did not differ significantly (p = 0.735). No significant difference was found between the three groups in the degree of distress related to the affirmatively answered PQ-16 items (p = 0.74).

CONCLUSION: Under the assumption of a transdiagnostic psychosis phenotype, our findings provide more insight which subgroups within non-clinical samples have a higher likelihood of reporting PLEs.

PMID:37270507 | DOI:10.1186/s12888-023-04876-9

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Cross-sectional analysis characterizing the use of rank preserving structural failure time in oncology studies: changes to hazard ratio and frequency of inappropriate use

Trials. 2023 Jun 3;24(1):373. doi: 10.1186/s13063-023-07412-y.

ABSTRACT

BACKGROUND: Rank preserving structural failure time (RPSFT) is a statistical method to correct or adjust for crossover in clinical trials, by estimating the counterfactual effect on overall survival (OS) when control arm patients do not receive the interventional drug when their tumor progresses. We sought to examine the strength of correlation between differences in uncorrected and corrected OS hazard ratios and percentage of crossover, and characterize instances of fundamental and sequential efficacy.

METHODS: In a cross-sectional analysis (2003-2023), we reviewed oncology randomized trials that used RPSFT analysis to adjust the OS hazard ratio for patients who crossed over to an anti-cancer drug. We calculated the percentage of RPSFT studies evaluating a drug for fundamental efficacy (with or without a standard of care (SOC)) or sequential efficacy and the correlation between the OS hazard ratio difference (unadjusted and adjusted) and the percentage of crossover.

RESULTS: Among 65 studies, the median difference between the uncorrected and corrected OS hazard ratio was -0.1 (quartile 1, quartile 3 : -0.3 to -0.06). The median percentage of crossover was 56% (quartile 1, quartile 3: 37% to 72%). All studies were funded by the industry or had authors who were employees of the industry. Twelve studies (19%) tested a drug’s fundamental efficacy when there was no SOC; 34 studies (52%) tested a drug’s fundamental efficacy when there was already a SOC; and 19 studies (29%) tested a drug’s sequential efficacy. The correlation between the uncorrected and corrected OS hazard ratio difference and the percentage of crossover was 0.44 (95% CI: 0.21 to 0.63).

CONCLUSIONS: RPSFT is a common tactic used by the industry to reinterpret trial results. Nineteen percent of RPSFT use is appropriate. We recognize that while crossover can bias OS results, the allowance and handling of crossover in trials should be limited to appropriate circumstances.

PMID:37270500 | DOI:10.1186/s13063-023-07412-y

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Assessment of autoantibodies in paediatric population with primary immunodeficiencies: a pilot study

BMC Immunol. 2023 Jun 3;24(1):8. doi: 10.1186/s12865-023-00543-6.

ABSTRACT

BACKGROUND: The correlation between primary immunodeficiencies (PIDs) and autoimmunity shows ethnic and geographical diversity. The aim of our study was to accumulate more data in paediatric PID population.

METHODS: 58 children aged 1-17 and with PID (study group) and 14 age-matched immunocompetent individuals (control group) were included in the study. Serum levels of 17 different specific IgG antibodies against autoantigens were measured by means of a quantitative enzyme immunoassay. Immunoglobulin levels were analysed in relation to a detailed medical examination.

RESULTS: Autoantibodies against one or more antigens were detected in the sera of 24.14% (n = 14) subjects in the study group. The most frequent were anti-thyroid peroxidase (anti-TPO) antibodies (n = 8; 13.8%). Anti-TPO antibody levels were elevated more often in PID patients with a positive family history of autoimmune diseases (p = 0.04). The screening for anti-deamidated gliadin peptide (DGP) and anti-tissue transglutaminase (tTG) antibodies in our series allowed identifying two previously undiagnosed cases of coeliac disease in PID patients. There was no statistically significant difference between the study and the control group in terms of the autoantibodies prevalence.

CONCLUSIONS: This study provides data on the prevalence of autoantibodies in paediatric population diagnosed with PID. Selected autoantibodies (i.e. anti-tTG, anti-DGP) might be useful for the screening of PID to avoid the delay of diagnosis of an autoimmune disease.

PMID:37270495 | DOI:10.1186/s12865-023-00543-6

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Artificial intelligence in the diagnosis of dental diseases on panoramic radiographs: a preliminary study

BMC Oral Health. 2023 Jun 3;23(1):358. doi: 10.1186/s12903-023-03027-6.

ABSTRACT

BACKGROUND: Artificial intelligence (AI) has been introduced to interpret the panoramic radiographs (PRs). The aim of this study was to develop an AI framework to diagnose multiple dental diseases on PRs, and to initially evaluate its performance.

METHODS: The AI framework was developed based on 2 deep convolutional neural networks (CNNs), BDU-Net and nnU-Net. 1996 PRs were used for training. Diagnostic evaluation was performed on a separate evaluation dataset including 282 PRs. Sensitivity, specificity, Youden’s index, the area under the curve (AUC), and diagnostic time were calculated. Dentists with 3 different levels of seniority (H: high, M: medium, L: low) diagnosed the same evaluation dataset independently. Mann-Whitney U test and Delong test were conducted for statistical analysis (ɑ=0.05).

RESULTS: Sensitivity, specificity, and Youden’s index of the framework for diagnosing 5 diseases were 0.964, 0.996, 0.960 (impacted teeth), 0.953, 0.998, 0.951 (full crowns), 0.871, 0.999, 0.870 (residual roots), 0.885, 0.994, 0.879 (missing teeth), and 0.554, 0.990, 0.544 (caries), respectively. AUC of the framework for the diseases were 0.980 (95%CI: 0.976-0.983, impacted teeth), 0.975 (95%CI: 0.972-0.978, full crowns), and 0.935 (95%CI: 0.929-0.940, residual roots), 0.939 (95%CI: 0.934-0.944, missing teeth), and 0.772 (95%CI: 0.764-0.781, caries), respectively. AUC of the AI framework was comparable to that of all dentists in diagnosing residual roots (p > 0.05), and its AUC values were similar to (p > 0.05) or better than (p < 0.05) that of M-level dentists for diagnosing 5 diseases. But AUC of the framework was statistically lower than some of H-level dentists for diagnosing impacted teeth, missing teeth, and caries (p < 0.05). The mean diagnostic time of the framework was significantly shorter than that of all dentists (p < 0.001).

CONCLUSIONS: The AI framework based on BDU-Net and nnU-Net demonstrated high specificity on diagnosing impacted teeth, full crowns, missing teeth, residual roots, and caries with high efficiency. The clinical feasibility of AI framework was preliminary verified since its performance was similar to or even better than the dentists with 3-10 years of experience. However, the AI framework for caries diagnosis should be improved.

PMID:37270488 | DOI:10.1186/s12903-023-03027-6

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Dexmedetomidine versus haloperidol for sedation of non-intubated patients with hyperactive delirium during the night in a high dependency unit: study protocol for an open-label, parallel-group, randomized controlled trial (DEX-HD trial)

BMC Anesthesiol. 2023 Jun 3;23(1):193. doi: 10.1186/s12871-023-02158-1.

ABSTRACT

BACKGROUND: Delirium is common in critically ill patients. Haloperidol has long been used for the treatment of delirium. Dexmedetomidine has recently been used to treat delirium among intubated critically ill patients. However, the efficacy of dexmedetomidine for delirium in non-intubated critically ill patients remains unknown. We hypothesize that dexmedetomidine is superior to haloperidol for sedation of patients with hyperactive delirium, and would reduce the prevalence of delirium among non-intubated patients after administration. We will conduct a randomized controlled trial to compare dexmedetomidine and haloperidol for the treatment of nocturnal hyperactive delirium in non-intubated patients in high dependency units (HDUs).

METHODS: This is an open-label, parallel-group, randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for nocturnal hyperactive delirium in non-intubated patients at two HDUs of a tertiary hospital. We will recruit consecutive non-intubated patients who are admitted to the HDU from the emergency room, and allocate them in a 1:1 ratio to the dexmedetomidine or haloperidol group in advance. The allocated investigational drug will be administered only when participants develop hyperactive delirium (Richmond Agitation-Sedation Scale [RASS] score ≥1 and a positive score on the Confusion Assessment Method for the ICU between 19:00 and 6:00 the next day) during the night at an HDU. Dexmedetomidine is administered continuously, while haloperidol is administered intermittently. The primary outcome is the proportion of participants who achieve the targeted sedation level (RASS score of between -3 and 0) 2h after the administration of the investigational drug. Secondary outcomes include the sedation level and prevalence of delirium on the day following the administration of the investigational drugs, and safety. We plan to enroll 100 participants who develop nocturnal hyperactive delirium and receive one of the two investigational drugs.

DISCUSSION: This is the first randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for sedation of non-intubated critically ill patients with hyperactive delirium in HDUs. The results of this study may confirm whether dexmedetomidine could be another option to sedate patients with hyperactive delirium.

TRIAL REGISTRATION: Japan Registry of Clinical Trials, jRCT1051220015, registered on 21 April 2022.

PMID:37270483 | DOI:10.1186/s12871-023-02158-1

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Prostate cancer risk prediction based on clinical factors and prostate-specific antigen

BMC Urol. 2023 Jun 3;23(1):100. doi: 10.1186/s12894-023-01259-w.

ABSTRACT

INTRODUCTION: The incidence rate of prostate cancer (PCa) has continued to rise in Korea. This study aimed to construct and evaluate a 5-year PCa risk prediction model using a cohort with PSA < 10 ng/mL by incorporating PSA levels and individual factors.

METHODS: The PCa risk prediction model including PSA levels and individual risk factors was constructed using a cohort of 69,319 participants from the Kangbuk Samsung Health Study. 201 registered PCa incidences were observed. A Cox proportional hazards regression model was used to generate the 5-year risk of PCa. The performance of the model was assessed using standards of discrimination and calibration.

RESULTS: The risk prediction model included age, smoking status, alcohol consumption, family history of PCa, past medical history of dyslipidemia, cholesterol levels, and PSA level. Especially, an elevated PSA level was a significant risk factor of PCa (hazard ratio [HR]: 1.77, 95% confidence interval [CI]: [1.67-1.88]). This model performed well with sufficient discrimination ability and satisfactory calibration (C-statistic: 0.911, 0.874; Nam-D’Agostino test statistic:19.76, 4.21 in the development and validation cohort, respectively).

CONCLUSIONS: Our risk prediction model was effective in predicting PCa in a population according to PSA levels. When PSA levels are inconclusive, an assessment of both PSA and specific individual risk factors (e.g., age, total cholesterol, and family history of PCa) could provide further information in predicting PCa.

PMID:37270476 | DOI:10.1186/s12894-023-01259-w

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Instrument-assisted soft tissue mobilization versus myofascial release therapy in treatment of chronic neck pain: a randomized clinical trial

BMC Musculoskelet Disord. 2023 Jun 3;24(1):457. doi: 10.1186/s12891-023-06540-5.

ABSTRACT

OBJECTIVE: The purpose of this study was to investigate the effect of instrument-assisted soft tissue mobilization (IASTM) versus myofascial release therapy (MRT) on college students with chronic mechanical neck pain (CMNP).

METHODS: Thirty-three college students with a mean age of 21.33 ± 0.98 involved in distance learning due to the Corona Virus 2019 (COVID-19) restriction were randomized to receive either IASTM on the upper trapezius and levator scapulae muscles or MRT. Researchers measured their pain with a visual analog scale (VAS), function with neck disability index (NDI), and pain pressure threshold (PPT) with a pressure algometer. The subjects received eight therapy sessions over four weeks and outcome measures were assessed pre and post-intervention. The study was registered as a clinical trial on clinicaltrials.gov (registration number: NCT05213871).

RESULT: Unpaired t-test showed no statistical significance between the two groups post-intervention regarding improvement in pain, function, and PPT (p > 0.05).

CONCLUSION: This study showed insignificant differences between groups. However, we did not use a control group, indicating that the improvement in outcomes may not have been caused by the intervention.

STUDY DESIGN: Quasi-experimental two groups pre-posttest clinical trial.

LEVEL OF EVIDENCE: Therapy, level 2b.

PMID:37270471 | DOI:10.1186/s12891-023-06540-5

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Effects of Right Lateral Position on Changes of Fetal Hemodynamics in Late Pregnancy

J Ultrasound Med. 2023 Jun 3. doi: 10.1002/jum.16261. Online ahead of print.

ABSTRACT

OBJECTIVE: We aim to evaluate the effect of right lateral position on fetal hemodynamics (including umbilical artery [UA] and middle cerebral artery (MCA) blood flow-velocity waveform).

METHODS: In total, 150 low-risk singleton full-term pregnant women were included in the study from November 2021 to January 2022. Doppler flow velocity waveforms of the fetal UA and MCA tested by ultrasound were collected in gestation of 37-40 weeks. Computational analysis was performed using the one-way ANOVA test.

RESULTS: Compared with the maternal left lateral position, there was a significant increase in Doppler indices of UA-RI (P = .033), UA-S/D (P = .019) and MCA-PSV (P = .021) and a significant decrease in MCA-RI (P = .030) in the supine position group. There was no statistical significance in all Doppler indices between the left and right lateral position (P > .05). Among the Doppler indices of three different maternal positions, there was no significance in both UA-PI and MCA-PI (P > .05).

CONCLUSION: There were no significant differences on changes of the fetal hemodynamics between left and right lateral positions. Pregnant women could adopt to lie in the left or right lateral position alternately to relieve the discomfort in late pregnancy.

PMID:37269215 | DOI:10.1002/jum.16261