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Effect of modified radical laparoscopic hysterectomy versus open radical hysterectomy on short-term clinical outcomes in early-stage cervical cancer: a single-center, prospective, randomized controlled trial

World J Surg Oncol. 2023 Jun 3;21(1):167. doi: 10.1186/s12957-023-03044-3.

ABSTRACT

BACKGROUND: The long-term prognosis of minimally invasive surgery and open surgery for early cervical cancer is controversial. This study mainly discusses the feasibility and effectiveness of the endocutter in radical laparoscopic hysterectomy for early cervical cancer.

METHODS: A single-center, prospective, randomized controlled trial of modified radical laparoscopic hysterectomy on patients with FIGO stage IA1 (lymphovascular invasion), IA2, and IB1 cervical cancer, between January 2020 and July 2021. Patients were randomly assigned into laparoscopic radical hysterectomy (LRH) and open radical hysterectomy (ORH) groups. The ORH group used right-angle sealing forceps for vaginal stump closure, whereas the LRH group used endoscopic staplers. The primary outcomes included the evaluation of the patient’s perioperative indicators, as well as short- and long-term complications. Recurrence and overall survival were considered secondary outcomes.

RESULTS: As of July 2021, 17 patients were enrolled in the laparoscopic surgery group and 17 in the open surgery group. The hospitalization time of the laparoscopic group was significantly shorter than those of the open group (15 min vs. 9 min, P < 0.001). The vaginal stump closure time in the laparoscopic group was longer than that in the open surgery group, and the difference was statistically significant (P < 0.001). Post-operative catheter removal (P = 0.72), drainage tube removal time (P = 0.27), number of lymph node dissections (P = 0.72), and incidence of intraoperative and post-operative complications between the two groups (P > 0.05). The median blood loss in the laparoscopic group was 278 ml, and it was 350 ml in the laparotomy group. The intraoperative blood transfusion rate was lower in the laparoscopic group; however, these differences did not reach statistical significance (P = 0.175). Vaginal margin pathology and peritoneal lavage cytology were negative, and all the patient’s vaginal stumps healed without infection. The median follow-up time of the laparoscopic group was 20.5 months, and it was 22 months for the open surgery group. There was no recurrence in all patients during the follow-up period.

CONCLUSIONS: Modified LRH with endocutter closure of the vaginal stump is an effective approach and not inferior to ORH in treating patients with early-stage cervical cancer.

TRIAL REGISTRATION: ChiCTR2000030160, date of registration February 26, 2020 ( https://www.chictr.org.cn/showprojen.aspx?proj=49809 ).

PMID:37270549 | DOI:10.1186/s12957-023-03044-3

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Area-specific covid-19 effects on health services utilization in the Democratic Republic of the Congo using routine health information system data

BMC Health Serv Res. 2023 Jun 3;23(1):575. doi: 10.1186/s12913-023-09547-9.

ABSTRACT

BACKGROUND: Since March 2020, the COVID-19 pandemic has shocked health systems worldwide. This analysis investigated the effects of the pandemic on basic health services utilization in the Democratic Republic of the Congo (DRC) and examined the variability of COVID effects in the capital city Kinshasa, in other urban areas, and in rural areas.

METHODS: We estimated time trends models using national health information system data to replicate pre-COVID-19 (i.e., January 2017-February 2020) trajectories of health service utilization, and then used those models to estimate what the levels would have been in the absence of COVID-19 during the pandemic period, starting in March 2020 through March 2021. We classified the difference between the observed and predicted levels as the effect of COVID-19 on health services. We estimated 95% confidence intervals and p-values to examine if the effect of the pandemic, nationally and within specific geographies, was statistically significant.

RESULTS: Our results indicate that COVID-19 negatively impacted health services and subsequent recovery varied by service type and by geographical area. COVID-19 had a lasting impact on overall service utilization as well as on malaria and pneumonia-related visits among young children in the DRC. We also found that the effects of COVID-19 were even more immediate and stronger in the capital city of Kinshasa compared with the national effect. Both nationally and in Kinshasa, most affected services had slow and incomplete recovery to expected levels. Therefore, our analysis indicates that COVID-19 continued to affect health services in the DRC throughout the first year of the pandemic.

CONCLUSIONS: The methodology used in this article allows for examining the variability in magnitude, timing, and duration of the COVID effects within geographical areas of the DRC and nationally. This analytical procedure based on national health information system data could be applied to surveil health service disruptions and better inform rapid responses from health service managers and policymakers.

PMID:37270545 | DOI:10.1186/s12913-023-09547-9

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Clustering trunk movements of children and adolescents with neurological gait disorders undergoing robot-assisted gait therapy: the functional ability determines if actuated pelvis movements are clinically useful

J Neuroeng Rehabil. 2023 Jun 3;20(1):71. doi: 10.1186/s12984-023-01200-0.

ABSTRACT

INTRODUCTION: Robot-assisted gait therapy is frequently used for gait therapy in children and adolescents but has been shown to limit the physiological excursions of the trunk and pelvis. Actuated pelvis movements might support more physiological trunk patterns during robot-assisted training. However, not every patient is expected to react identically to actuated pelvis movements. Therefore, the aim of the present study was to identify different trunk movement patterns with and without actuated pelvis movements and compare them based on their similarity to the physiological gait pattern.

METHODS AND RESULTS: A clustering algorithm was used to separate pediatric patients into three groups based on different kinematic reactions of the trunk to walking with and without actuated pelvis movements. The three clusters included 9, 11 and 15 patients and showed weak to strong correlations with physiological treadmill gait. The groups also statistically differed in clinical assessment scores, which were consistent with the strength of the correlations. Patients with a higher gait capacity reacted with more physiological trunk movements to actuated pelvis movements.

CONCLUSION: Actuated pelvis movements do not lead to physiological trunk movements in patients with a poor trunk control, while patients with better walking functions can show physiological trunk movements. Therapists should carefully consider for whom and why they decide to include actuated pelvis movements in their therapy plan.

PMID:37270537 | DOI:10.1186/s12984-023-01200-0

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Hip effusion/synovitis influences results after multiple drilling core decompression for bone marrow edema syndrome of hip

BMC Surg. 2023 Jun 3;23(1):151. doi: 10.1186/s12893-023-02066-8.

ABSTRACT

BACKGROUND: At present, it is not known whether hip effusion/synovitis affects the therapeutic effect of multiple drilling core decompression (MDCD) in patients with bone marrow edema syndrome of hip (BMESH). The aims were to assess hip effusion/synovitis and its relationship with results of MDCD in patients with BMESH.

METHODS: The data of undergoing arthroscopic-assisted MDCD for treatment of BMESH with hip effusion/synovitis by one surgeon were retrospectively reviewed from the associated medical records at the Affiliated Hospital of Zunyi Medical University (2016-2019). Seven patients (9 hips) participated in this study. Patients were followed up at 1, 2, 3, 6, 12 and 24 months. Data included demographics and clinical outcomes. The pre- and postoperative pain and functional outcomes were measured with the visual analogue scale (VAS), Harris Hip Score (HHS), Hip Outcome Score Activities of Daily Living subscale (HOS-ADL), International Hip Outcome Tool-12 (iHOT-12) and range of motion (ROM).

RESULTS: Seven patients (9 hips) were followed up. Disappearance of hip pain immediately obtained at rest after surgery. All of 7 patients returned to their former activity level at postoperative 3 months, bone marrow edema had disappeared on Magnetic Resonance Imaging (MRI). The VAS, HHS, HOS-ADL, iHOT-12, and ROM at postoperative 1 month had a significant difference (P < 0.05) compared with preoperative. It was also statistically significant (P < 0.05) when compared with other time points. At the final follow-up, all patients had no limited ROM, which was symmetrical with the contralateral of hip joint. Hip effusion/synovitis were observed in 9 hips. Labral tears, cartilage fissure, and loose bodies were observed in 1 hip, respectively. Kirschner wire tracks bleeding occurred in 1 hip. No other complications occurred.

CONCLUSIONS: Hip effusion/synovitis could affect the clinical outcomes after MDCD in patients with BMESH. Arthroscopic procedure of hip effusion/synovitis can shorten postoperative pain relief time, disappearance time of bone marrow edema on MRI. It can simultaneously diagnose and treat other concomitant intraarticular pathologies, and be a safe operation with fewer complications.

PMID:37270523 | DOI:10.1186/s12893-023-02066-8

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Clinical characteristics and treatment patterns of pregnant women with hypertension in primary care in the Federal Capital Territory of Nigeria: cross-sectional results from the hypertension treatment in Nigeria Program

BMC Pregnancy Childbirth. 2023 Jun 3;23(1):416. doi: 10.1186/s12884-023-05723-1.

ABSTRACT

BACKGROUND: Hypertensive disorders of pregnancy, including hypertension, are a leading cause of maternal mortality in Nigeria. However, there is a paucity of data on pregnant women with hypertension who receive care in primary health care facilities. This study presents the results from a cross-sectional analysis of pregnant women enrolled in the Hypertension Treatment in Nigeria Program which is aimed at integrating and strengthening hypertension care in primary health care centres.

METHODS: A descriptive analysis of the baseline results from the Hypertension Treatment in Nigeria Program was performed. Baseline blood pressures, treatment and control rates of pregnant women were analysed and compared to other adult women of reproductive age. A complete case analysis was performed, and a two-sided p value < 0.05 was considered statistically significant.

RESULTS: Between January 2020 to October 2022, 5972 women of reproductive age were enrolled in the 60 primary healthcare centres participating in the Hypertension Treatment in Nigeria Program and 112 (2%) were pregnant. Overall mean age (SD) was 39.6 years (6.3). Co-morbidities were rare in both groups, and blood pressures were similar amongst pregnant and non-pregnant women (overall mean (SD) first systolic and diastolic blood pressures were 157.4 (20.6)/100.7 (13.6) mm Hg and overall mean (SD) second systolic and diastolic blood pressures were 151.7 (20.1)/98.4 (13.5) mm Hg). However, compared to non-pregnant women, pregnant women had a higher rate of newly diagnosed hypertension (65.2% versus 54.4% p = 0.02) and lower baseline walk-in treatment (32.1% versus 42.1%, p = 0.03). The control rate was numerically lower among pregnant patients (6.3% versus 10.2%, p = 0.17), but was not statistically significant. Some pregnant patients (8.3%) were on medications contraindicated in pregnancy, and none of the pregnant women were on aspirin for primary prevention of preeclampsia.

CONCLUSIONS: These findings indicate significant gaps in care and important areas for future studies to improve the quality of care and outcomes for pregnant women with hypertension in Nigeria, a country with the highest burden of maternal mortality globally.

PMID:37270521 | DOI:10.1186/s12884-023-05723-1

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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