Outcome Bias Research Articles

Effects of Hyrax Maxillary Expander on Nasal Cavity and Upper Airway in Adolescents: A Systematic Review and Meta-Analysis

Background: Whether Hyrax maxillary expander is an effective treatment for maxillary transverse deficiency as well as expansion of the upper airway is still controversial. The study’s purpose was to evaluate 3D changes in upper airway dimensions of adolescent patients measured primarily by cone-beam computed tomography (CBCT) after rapid maxillary expansion (RME) with the Hyrax maxillary expander. Methods: Studies up to 1 April 2024 were searched in the following databases: PubMed/MEDICINE, Web of Science, Cochrane Library, and Embase. Inclusion criteria were clinical trials and cohort studies that assessed the effect of RME in adolescent patients with upper airway stenosis using CBCT-based three-dimensional analysis. The risk of bias in the study outcomes was assessed using the Cochrane Collaboration’s risk of bias tool, the GRADE method, and a tool for evaluating non-randomized controlled study (non-RCT) literature from a previous systematic review, depending on the types of articles. The study was reported in accordance with PRISMA guidelines. Results: The study conducted a random effects meta-analysis of mean differences and 95% confidence intervals for changes in upper airway volumes, including the nasal cavity (NC), in the outcomes of 16 included studies, followed by subgroup analyses. Conclusion: A significant increase in nasopharynx volume was observed after rapid maxillary expansion (RME) by Hyrax maxillary expander (MD = 0.69, 95% CI (0.09~1.28), p = 0.02).

Objective and subjective physical activity assessment in obese patients with eating disorders

Abstract Background Discrepancies between objective and subjective measures of physical activity have been reported in healthy populations but remain unexplored in adults with obesity and psychosomatic disorders. Exercise is key for reducing these disorders, yet physiological and psychosomatic factors may complicate valid activity assessments in this population. Here, we compare self-reporting with actigraph data in a clinical setting. Methods Over two years, 27 obese patients (21 female, 6 male; 43±14 yrs; 41.3±5.7 kg·m−2) with eating disorders (EDE-Q) were recruited from an Austrian Psychosomatic Center. Total physical activity was assessed using the metabolic equivalent (MET min/w) and sitting time (min/d). Objective data were collected using the SenseWear® wristband (SWA) during weeks 3-4 of patients’ clinical stay. SWA was worn for ≥18 h/d on ≥ 4 days, including one weekend day. Patients self-administered the International Physical Activity Questionnaire (IPAQ-SF) in alignment with the ∼7 days of SWA wear. Concurrent validity - SWA as a criterion - was assessed using regression analyses, and proportional bias was examined with regression and equality line similarity analyses. Results Comparison showed an overestimation of total activity (+45%; p<.001) and underestimation of sitting time (-28%; p<.001) with IPAQ-SF vs SWA. Within-patient correlations were poor for MET (r=.92, p<.001) and impractical for sitting time (r=.27, p=.018), with a proportional bias for both outcomes (p≤.001). Converting objective to subjective measures yielded typical errors of 232 (total activity) and 90 min (sitting time). Conclusions The observed disparities emphasize the need to integrate sensor-based assessment of physical activity into clinical practice or tailored public health initiatives for adult obesity and psychosomatic disorders. However, further research is needed to evaluate the long-term impact of incorporating accurate SWA data on intervention efficacy in this vulnerable group. Key messages • There was strong evidence for meaningful differences in objective vs subjective physical activity assessments in obese patients with eating disorders. • Integrating objective measures into treatment seems crucial to improve exercise-guided interventions and address the global obesity and psychosomatic disorders pandemic.

Assessment of inverse publication bias in safety outcomes: an empirical analysis

BackgroundThe aims of this study were to assess the presence of inverse publication bias (IPB) in adverse events, evaluate the performance of visual examination, and explore the impact of considering effect direction in statistical tests for such assessments.MethodsWe conducted a cross-sectional study using the SMART Safety, the largest dataset for evidence synthesis of adverse events. The visual assessment was performed using contour-enhanced funnel plots, trim-and-fill funnel plots, and sample-size-based funnel plots. Two authors conducted visual assessments of these plots independently, and their agreements were quantified by the kappa statistics. Additionally, IPB was quantitatively assessed using both the one- and two-sided Egger’s and Peters’ tests.ResultsIn the SMART Safety dataset, we identified 277 main meta-analyses of safety outcomes with at least 10 individual estimates after dropping missing data. We found that about 13.7–16.2% of meta-analyses exhibited IPB according to the one-sided test results. The kappa statistics for the visual assessments roughly ranged from 0.3 to 0.5, indicating fair to moderate agreement. Using the one-sided Egger’s test, 57 out of 72 (79.2%) meta-analyses that initially showed significant IPB in the two-sided test changed to non-significant, while the remaining 15 (20.8%) meta-analyses changed from non-significant to significant.ConclusionsOur findings provide supporting evidence of IPB in the SMART Safety dataset of adverse events. They also suggest the importance of researchers carefully accounting for the direction of statistical tests for IPB, as well as the challenges of assessing IPB using statistical methods, especially considering that the number of studies is typically small. Qualitative assessments may be a necessary supplement to gain a more comprehensive understanding of IPB.

Perioperative Analgesic Interventions for Reduction of Persistent Postsurgical Pain After Total Hip and Knee Arthroplasty: A Systematic Review and Meta-analysis.

High pain levels immediately after surgery have been associated with persistent postsurgical pain. Still, it is uncertain if analgesic treatment of immediate postsurgical pain prevents the development of persistent postsurgical pain. We searched MEDLINE, CENTRAL, and Embase up to September 12, 2023, for randomized controlled trials investigating perioperative analgesic interventions and with reported pain levels 3 to 24 months after total hip or knee arthroplasty in patients with osteoarthritis. The primary outcome was pain score 3 to 24 months after surgery, assessed at rest and during movement separately. Two authors independently screened, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2 tool. We conducted meta-analyses and tested their robustness with trial sequential analyses and worst-best and best-worst case analyses. We included 49 trials with 68 intervention arms. All but 4 trials were at high risk of bias for the primary outcome. Moreover, the included trials were heterogeneous in terms of exclusion criteria, baseline pain severity, and which cointerventions the participants were offered. For pain at rest, no interventions demonstrated a statistically significant difference between intervention and control. For pain during movement, perioperative treatment with duloxetine (7 trials with 641 participants) reduced pain scores at 3 to 24 months after surgery (mean difference -4.9 mm [95% confidence interval {CI}, -6.5 to -3.4] on the 0-100 visual analog scale) compared to placebo. This difference was lower than our predefined threshold for clinical importance of 10 mm. We found no perioperative analgesic interventions that reduced pain 3 to 24 months after total hip or knee arthroplasty for osteoarthritis. The literature on perioperative analgesia focused little on potential long-term effects. We encourage the assessment of long-term pain outcomes.

Assessment of the effect of using intrauterine platelet-rich-plasma on the success of assisted reproduction: a systematic review and meta-analysis of randomized controlled trials

Intrauterine administration of platelet-rich-plasma (PRP) has shown potential in improving pregnancy outcomes in assisted reproductive technology (ART). However, the efficacy of PRP in enhancing clinical pregnancy and live birth rates remains a topic of debate. This meta-analysis evaluated the effectiveness of intrauterine PRP administration in improving clinical pregnancy and live birth rates. A systematic search of electronic databases was conducted to identify randomized controlled trials (RCTs) comparing intrauterine PRP administration with control in women undergoing ART. The primary outcomes were clinical pregnancy rates and live birth rates. Data were extracted and pooled using a random-effects model to calculate odds ratios (ORs) with 95% confidence intervals (CIs). Heterogeneity was assessed using the I² statistic. Nineteen RCTs involving 1,918 participants were included for clinical pregnancy rates, and six RCTs involving 777 participants were included for live birth rates. The pooled OR for clinical pregnancy rates was 2.49 (95% CI: 1.84, 3.35), indicating a significant improvement in the PRP group. For live birth rates, the pooled OR was 3.28 (95% CI: 1.18, 9.09), also favouring the PRP group. Moderate heterogeneity was observed for clinical pregnancy rates (I²=43%), while substantial heterogeneity was observed for live birth rates (I²=77%). Funnel plots showed no significant publication bias for either outcome. Intrauterine PRP administration significantly improves clinical pregnancy and live birth rates in women undergoing ART. The pooled ORs of 2.49 for clinical pregnancy rates and 3.28 for live birth rates support the potential clinical utility of PRP in enhancing ART outcomes.

Gender differences in spine surgery for degenerative lumbar disease: prospective cohort study.

Despite efforts toward achieving gender-based equality in clinical trial enrollment, females are frequently underrepresented and gender-specific data analysis is lacking. Identifying and addressing gender bias in medical decision-making and outcome reporting may facilitate more equitable healthcare delivery. This study aimed to determine if gender differences exist in the clinical evaluation and surgical management of patients with degenerative lumbar conditions. Consecutive adult patients undergoing spinal surgery for degenerative lumbar conditions (disc herniation [DH], spinal canal stenosis [SCS], and degenerative spondylolisthesis [DS]) were prospectively enrolled across 16 tertiary academic centers. Outcome domains included pain, disability, health-related quality of life (HRQOL), expectations of surgery, and satisfaction with surgical outcome. Covariates pertaining to the preoperative use of healthcare resources, diagnostic testing, and visits to healthcare providers were compared between genders before and after propensity score matching for 13 baseline demographic and procedural variables. Data were analyzed for 5038 patients (2396 female, 2642 male) with degenerative spinal pathologies including SCS (40.2%), DS (33.2%), and DH (26.6%). Surgical treatment effect was similar for both genders. For all conditions, female patients had worse pre- and postoperative pain, disability, and HRQOL. Significant gender differences were identified for marital status, education, employment status, exercise activities, and disability claims. Female patients were more likely to use select medications, diagnostic imaging tests, and nonsurgical therapeutic interventions, and access various healthcare providers. Findings were similar following post hoc propensity score matching. In this multicenter, prospective, observational cohort study, male and female patients benefitted similarly from surgery for degenerative lumbar spine disease. However, female patients had worse preoperative clinical assessment scores and were more likely to use select healthcare resources.

Automated peritoneal dialysis versus continuous ambulatory peritoneal dialysis for people with kidney failure.

Peritoneal dialysis (PD) is a home-based kidney replacement therapy (KRT) performed in people with kidney failure. PD can be performed by manual filling and draining of the abdominal cavity, i.e. continuous ambulatory PD (CAPD), or using a device connected to the PD catheter that is programmed to perform PD exchanges, i.e. automated PD (APD). APD is considered to have several advantages over CAPD, such as a lower incidence of peritonitis, fewer mechanical complications, and greater psychosocial acceptability. Acknowledging the increasing uptake of APD in incident and prevalent patients undergoing PD, it is important to re-evaluate the evidence on the comparative clinical and patient-reported outcomes of APD compared to CAPD. This is an update of a Cochrane review published in 2007. To compare clinical and patient-reported outcomes of APD to CAPD in people with kidney failure. In this update, we searched the Cochrane Kidney and Transplant Register of Studies until 29 August 2024. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov. Randomised controlled trials (RCTs) comparing APD with CAPD in adults (≥ 18 years) with kidney failure. Two authors independently screened the search results and extracted data. Data synthesis was performed using random-effects meta-analyses, expressing effect estimates as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous data and mean differences (MD) with 95% CIs for continuous data. Certainty in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two RCTs (131 randomised people) comparing APD with CAPD were included in this update. One RCT had a follow-up of six months, and one RCT had a follow-up of 24 months. The risk of bias in the included studies was mostly low, except for the high risk of performance bias for subjective outcomes. The evidence is very uncertain about the effect of APD compared to CAPD on death, hospitalisations, PD-related peritonitis, change of dialysis modality, residual kidney function, health-related quality of life (HRQoL), overhydration, blood pressure, exit-site infections, tunnel infections, mechanical complications, PD catheter removal, or dialysis adequacy measures. These results were largely based on low to very low certainty evidence; hence, caution is warranted when drawing conclusions. Insufficient evidence exists to decide between APD and CAPD in kidney failure patients with regard to clinical and patient-reported outcomes. Therefore, current evidence is insufficient as a guide for clinical practice. Given that the sample sizes of existing studies are generally small with insufficient follow-up, there is a need for large-scale, multicentre studies. Future research should focus on possible differences between APD and CAPD in residual kidney function, euvolaemia, and patient-reported outcomes such as HRQoL, symptoms, patient satisfaction and life participation.

Gender stereotypes in artificial intelligence within the accounting profession using large language models

This study investigates how artificial intelligence (AI) perpetuates gender stereotypes in the accounting profession. Through experiments employing large language models (LLMs), we scrutinize how these models assign gender labels to accounting job titles. Our findings reveal differing tendencies among LLMs, with one favouring male labels, another female labels, and a third showing a balanced approach. Statistical analyses indicate significant disparities in labelling patterns, and job titles classified as male are associated with higher salary ranges, suggesting gender-related bias in economic outcomes. This study reaffirms existing literature on gender stereotypes in LLMs and uncovers specific biases in the accounting context. It underscores the transfer of biases from the physical to the digital realm through LLMs and highlights broader implications across various sectors. We propose raising public awareness as a means to mitigate these biases, advocating for proactive measures over relying solely on human intervention.

Social Desirability Bias in a Randomized Controlled Trial That Included Breastfeeding Promotion in Western Kenya

BackgroundBreastfeeding promotion is associated with improved measures of breastfeeding practice; however, most studies rely on participant-reported outcomes. ObjectivesThis study aimed to evaluate the likelihood of bias in self-reported breastfeeding outcomes. MethodsWe used data from the WASH Benefits randomized controlled trial in Kenya (clinicaltrials.gov NCT01704105), which included intervention arms that received infant and young child feeding messages (nutrition group) and arms that did not (non-nutrition group) to examine recall bias in the assessment of early initiation of breastfeeding (EIBF) and exclusive breastfeeding (EBF) duration. Pregnant women were eligible for inclusion, but 40% of infants were born before the first visit by the health promoter. We used the random variability in the timing of the infant birth relative to the first contact with the health promoter to examine recall bias in EIBF. We used ≤5 rounds of repeated surveys to examine bias in recall of EBF duration. ResultsThere was a significant effect of the intervention group on EIBF [prevalence ratio: 1.50, 95% confidence interval (CI): 1.43, 1.57] and a significant difference in the duration of EBF [nutrition group: 6.0 mo; interquartile range (IQR): 3.0–6.0; nonnutrition group: 3.0 mo; IQR: 0.5–6.0; P < 0.001]. There was not a significant interaction with birth timing relative to the first contact with the health promoters (P = 0.915), suggesting that the observed main effect on EIBF was due to recall bias. We found that 75.9% of mothers who initially reported having ceased EBF before 6 mo in the nutrition group changed their response to 6 mo or later in subsequent surveys. Only 32.5% of mothers in the non-nutrition group followed this pattern. ConclusionsThese data provide strong evidence of bias in reporting of breastfeeding practices in this nonblinded intervention trial and should serve as a caution to researchers who rely on self-reported outcomes of behavior change interventions.This trial was registered at clinicaltrials.gov as NCT01704105.

Is previous prostatectomy a risk factor for postoperative complications following minimally invasive inguinal hernia repair? A systematic review and meta-analysis.

The literature indicates that patients with prior pelvic surgery, particularly radical prostatectomy, pose challenges in minimally invasive inguinal hernia repair (IHR). However, there is no conclusive evidence regarding the impact of pelvic surgery on postoperative complications. To address this gap, we conducted a systematic review and meta-analysis to evaluate the influence of previous prostatectomy in men undergoing MIS IHR. We searched Cochrane Central, Scopus, SciELO, Lilacs, and PubMed/MEDLINE for studies comparing men undergoing MIS IHR after prostatectomy with men without previous pelvic surgery. Key outcomes evaluated included recurrence, overall postoperative complications, seroma, hematoma, surgical site infection (SSI), conversion rates, and operative time. Out of 402 screened studies, 9 met the inclusion criteria. Among the included studies, three analyzed totally extraperitoneal (TEP) technique, while four analyzed transabdominal preperitoneal (TAPP) and two presented both techniques together. The analysis comprised 189,183 patients, of which 4551 (2.4%) had a history of prostatectomy. The analysis revealed that post-prostatectomy patients presented higher postoperative complications (3.7% vs. 1.9%; RR 1.9; 95% CI [1.23; 2.94]; P = 0.004) and seroma (1.6% vs. 0.9%; RR 1.58; 95% CI [1.23; 2.04]; P < 0.001) following MIS IHR. Additionally, patients with a previous prostatectomy presented an increased operative time (MD 21.25min; 95% CI [19.1; 23.4]; P < 0.001). No significant differences were observed in recurrence (0.98% vs. 0.92%; RR 1.1; 95% CI [0.8; 1.53]; P = 0.54), SSI (0.07% VS. 0.07%; RR 0.99; 95% CI [0.34; 2.9]; P = 0.98), hematoma (3.6% vs. 1.2%; RR 3.18; 95% CI [0.84; 12.1]; P = 0.09), and conversion rates (1.1% vs. 0.9%; RR 1.26; 95% CI [0.91; 1.72]; P = 0.16). However, subgroup analysis of TEP technique in patients with previous prostatectomy showed higher conversion rates (2.4% vs. 0%; RR 20; 95% CI [2.9; 138.2]; P < 0.01). Analysis using funnel plots showed the absence of publication bias in the study outcomes. This comprehensive analysis indicates that patients with a history of prostatectomy undergoing MIS IHR may present higher postoperative complications and an increased operative time. Further comparative studies are needed to evaluate the cumulative impact of MIS IHR in patients with previous prostatectomy.

The impact of smoking on ventral and inguinal hernia repair: a systematic review and meta-analysis.

Individual studies indicate poorer outcomes for smokers after hernia repair. Previous meta-analyses have examined the impact of smoking on specific outcomes such as recurrence and surgical site infection, but there has been a lack of comprehensive consensus or systematic review on this subject. Addressing this gap, our study undertakes a systematic review and meta-analysis to assess the impact of smoking on the outcomes of ventral hernia repair (VHR) and inguinal hernia repair. A thorough search of Cochrane Central, Scopus, SciELO, and PubMed/MEDLINE, focusing on studies that examined the effect of smoking on inguinal and VHR outcomes was conducted. Key outcomes evaluated included recurrence, reoperation, surgical site occurrences (SSO), surgical site infection (SSI), and seroma. Out of 3296 screened studies, 42 met the inclusion criteria. These comprised 25 studies (69,295 patients) on VHR and 17 studies (204,337 patients) on inguinal hernia repair. The analysis revealed that smokers had significantly higher rates of recurrence (10.4% vs. 9.1%; RR 1.48; 95% CI [1.15; 1.90]; P < 0.01), SSO (13.6% vs. 12.7%; RR 1.44; 95% CI [1.12; 1.86]; P < 0.01) and SSI (6.6% vs. 4.2%; RR 1.64; 95% CI [1.38; 1.94]; P < 0.01) following VHR. Additionally, smokers undergoing inguinal hernia repair showed higher recurrence (9% vs. 8.7%; RR 1.91; 95% CI [1.21; 3.01]; P < 0.01), SSI (0.6% vs. 0.3%; RR 1.6; 95% CI [1.21; 2.0]; P < 0.001), and chronic pain (9.9% vs. 10%; RR 1.24; 95% CI [1.06; 1.45]; P < 0.01) rates. No significant differences were observed in seroma (RR 2.63; 95% CI [0.88; 7.91]; P = 0.084) and reoperation rates (RR 1.48; 95% CI [0.77; 2.85]; P = 0.236) for VHR, and in reoperation rates (RR 0.99; 95% CI [0.51; 1.91]; P = 0.978) for inguinal hernias between smokers and non-smokers. Analysis using funnel plots and Egger's test showed the absence of publication bias in the study outcomes. This comprehensive meta-analysis found statistically significant increases in recurrence rates, and immediate postoperative complications, such as SSO and SSI following inguinal and VHR. Also, our subgroup analysis suggests that the MIS approach seems to be protective of adverse outcomes in the smokers group. However, our findings suggest that these findings are not of clinical relevance, so our data do not support the necessity of smoking cessation before hernia surgery. More studies are needed to elucidate the specific consequences of smoking in both inguinal and ventral hernia repair. ID CRD42024517640.

Preventable sources of bias in subgroup analyses and secondary outcomes of randomized trials

BackgroundRandomized controlled trials are the gold standard for determining treatment efficacy in medicine. To deter harmful practices such as p-hacking and hypothesizing after the results are known, any analysis of subgroups and secondary outcomes must be documented and pre-specified. However, they can still introduce bias (and routinely do) if they are not treated with the same consideration as the primary analysis. MethodsWe describe several sources of bias that affect subgroup and secondary outcome analyses using published randomized trials and causal directed acyclic graphs (DAGs). ResultsWe use the RECOVERY and START trials to elucidate sources of bias in analyses of subgroups and secondary outcomes. Chance imbalance can occur if the distribution of prognostic variables is not sought for any given subgroup analysis as for the main analysis. This differential distribution of prognostic variables can also occur in analyses of secondary outcomes. Selection bias can occur if the subgroup variable is causally related to staying in the trial. Given loss to follow up is not normally addressed in subgroups, attrition bias can pass unnoticed in these cases. In every case, the solution is to take the same considerations for these analyses as we do for primary analyses. ConclusionsApproval of treatments and clinical decisions can occur based on results from subgroup or secondary outcome analyses. Thus, it is important to give them the same treatment as primary analyses to avoid preventable biases.

Kinesin-1-transported liposomes prefer to go straight in 3D microtubule intersections by a mechanism shared by other molecular motors

Kinesin-1 ensembles maneuver vesicular cargoes through the three-dimensional (3D) intracellular microtubule (MT) network. To define how such cargoes navigate MT intersections, we first determined how many kinesins from an ensemble on a lipid-based cargo simultaneously engage a MT, and then determined the directional outcomes (straight, turn, terminate) for liposome cargoes at perpendicular MT intersections. Run lengths of 350-nm diameter liposomes decorated with up to 20, constitutively active, truncated kinesin-1 KIF5B (K543) were longer than single motor transported cargo, suggesting multiple motor engagement. However, detachment forces of lipid-coated beads with ~20 kinesins, measured using an optical trap, showed no more than three simultaneously engaged motors, with a single engaged kinesin predominating, indicating anticooperative MT binding. At two-dimensional (2D) and 3D in vitro MT intersections, liposomes frequently paused (~2 s), suggesting kinesins simultaneously bind both MTs and engage in a tug-of-war. Liposomes showed no directional outcome bias in 2D (1.1 straight:turn ratio) but preferentially went straight (1.8 straight:turn ratio) in 3D intersections. To explain these data, we developed a mathematical model of liposome transport incorporating the known mechanochemistry of kinesins, which diffuse on the liposome surface, and have stiff tails in both compression and extension that impact how motors engage the intersecting MTs. Our model predicts the ~3 engaged motor limit observed in the optical trap and the bias toward going straight in 3D intersections. The striking similarity of these results to our previous study of liposome transport by myosin Va suggests a "universal" mechanism by which cargoes navigate 3D intersections.

P-028 Pregnancy and perinatal outcomes in male patients with temporary ejaculation failure undergoing assisted reproductive technology

Abstract Study question When temporary ejaculation failure occurs on the oocyte retrieval day, choose surgical sperm retrieval or oocyte cryopreservation? Summary answer TESA-ICSI and oocyte cryopreservation are both relatively efficient and safe way. Embryos have better developmental potential through TESA-ICSI. What is known already Nearly 9% of men among couples who use assisted reproductive technology have temporary ejaculation failure (TEF) on the oocyte retrieval day. If they fail to provide semen sample, the couples may face three choices (1. surgical sperm retrieval; 2. oocyte cryopreservation; 3. canceling the oocyte retrieval). The aim of the study was to compare the impact of testicular sperm aspiration (TESA) or oocyte cryopreservation on the clinical outcomes of intracytoplasmic sperm injection (ICSI) patients with TEF. Study design, size, duration The retrospective study included 345 male patients with TEF in our University-affiliated IVF center from 2015 to 2021. Participants/materials, setting, methods Three hundred and forty-five male patients were divided into two groups. Two hundred patients chose TESA-ICSI (the TESA group), while another 145 patients chose oocyte cryopreservation, waiting for the man’s next successful sperm ejaculation and subsequent ICSI (the frozen oocyte group). We investigated the embryo development, pregnancy and perinatal outcome, and included the data from fresh embryo transfer (ET) cycle. Herein, all patients in the frozen oocyte group received hormone replacement and fresh ET. Main results and the role of chance Firstly, there were no significant difference in the female BMI, FSH, antral follicle count (AFC), AMH, and male semen quality between the two groups. For embryo development, both two groups have the similar normal fertilization rate (71.5% vs 69.7%, P = 0.242). However, the frozen oocyte group has lower rate of Day3 high quality embryo (31.1% vs 49.3%, P &amp;lt; 0.001), available embryo rate (49.8% vs 55.8%, P = 0.043), and available blastocyst rate (18.6% vs 33.7%, P &amp;lt; 0.001). For pregnancy outcome, the clinical pregnancy rate (44.2% vs 50.0%), pregnancy loss rate (4.8% vs 2.9%) and live birth rate (38.5% vs 46.1%) were similar. And there were no significant differences in the rates of Gestational diabetes mellitus, hypertensive disorders of pregnancy, placenta previa and fetal malformation between the two groups. Limitations, reasons for caution This study only included data from fresh embryo cycles, not yet from thawed embryo cycles. Although we presented complete embryo development data for each couple, there may be some bias in pregnancy and perinatal outcomes due to the lack of data from thawed embryo cycles. Wider implications of the findings The present study suggested that TESA-ICSI and oocyte cryopreservation are both relatively efficient and safe way to help the patients encountering TEF. Due to the embryos with better developmental potential through TESA-ICSI, choosing the surgical sperm retrieval might have more have more advantages, and this has to be further verified. Trial registration number REC No. (2023(S142))

Aerobic Training With Blood Flow Restriction on Muscle Hypertrophy and Strength: Systematic Review and Meta-analysis.

de Lemos Muller, CH, Farinha, JB, Leal-Menezes, R, and Ramis, TR. Aerobic training with blood flow restriction on muscle hypertrophy and strength: systematic review and meta-analysis. J Strength Cond Res 38(7): 1341-1349, 2024-Integrating strength and endurance training in a single exercise session, even on separate days, can be physically demanding and time-consuming. Therefore, there is a growing interest in identifying efficient training methods that can concurrently enhance cardiovascular and neuromuscular performance through a singular training modality. This study conducted a systematic review and meta-analysis to explore the effects of aerobic training with blood flow restriction (AT + BFR) on muscle hypertrophy and strength gains in healthy individuals. Our study was registered at PROSPERO and used multiple databases (PubMed, Embase, Scopus, and Web of Science), seeking clinical trials that examined AT + BFR influence on muscle hypertrophy and strength gains in individuals aged 18-60 years and comparing with aerobic training without BFR. The risk of bias and method quality were assessed using the ROB2.0 tool and PEDro scale, respectively, and the quality of evidence was evaluated with the GRADE method. A random-effects model was used for meta-analysis, and standardized mean difference (SMD) was calculated for each outcome. Of 4,462 records, 29 full texts were assessed for eligibility, with 7 articles meeting the inclusion criteria. The results indicated that AT + BFR was more beneficial for inducing muscle hypertrophy than aerobic training without BFR (SMD [95% CI] = 0.86 [0.37-1.35]; I2 = 42%). Furthermore, AT + BFR was associated with greater improvements in muscle strength (SMD [95% CI] = 0.41 [0.10-0.72]; I2 = 0%). Despite the generally high risk of bias for both outcomes, these encouraging findings underscore the clinical significance of AT + BFR as a compelling tool for enhancing neuromuscular parameters.

Comparative Evaluation of Gingival Health Among Children With Stainless Steel Crowns and Stainless Steel Bands: A Split-Mouth Randomized Controlled Trial.

Introduction Putting in stainless steel crowns as a post-endodontic restoration and space maintainers as a post-extraction applianceto maintain the space for the eruption of underlying teeth in case of early loss in children are some of the most commonly practised proceduresthat pediatric dentists undertake in their day-to-day lives. Maintaining good oral hygiene for better gingival health is important. If it is not taken care of,gradual destruction of supporting soft and hard tissues of the teeth occurs. There were numerous studies conducted over the past few years,but no split-mouth study compares the crowns and bands. Hence, this study compares the gingival health between stainless steel crowns and band and loop space maintainers. Materials and methods This split-mouth randomised controlled trial included 31 children aged between four and nine years who had stainless steel crowns on one side and a band and loop space maintainer on the other side of the mandibular arch. The split-mouth study was carried out to minimise the outcome bias as oral hygiene practices differ from one individual to another. Presence/absence of bleeding on probing (BOP)and the Gingival Index (GI) using theLoeandSilness GI were assessed at baseline and at six months. Data was entered in an Excel sheet (Microsoft Corporation,Redmond, Washington, United States) and analysed in IBMSPSSStatistics for Windows, Version 23, (Released 2015; IBM Corp., Armonk, New York, United States). The significance level was fixed as 5% (α = 0.05). The Shapiro-Wilktest was used to assess the normality of parameters of gingival health. The parameters are described in terms of mean, standard deviation, frequency and percentages. Intragroup analysis was done using Friedman tests across the timelines. Intergroup analysis using Mann-Whitney U tests was done between the groups at different timelines. Results At the beginning of the study, 46 children (22 girlsand 24 boys) were enrolled considering the dropout. However, 15 children did not attend the follow-up review, resulting in a loss to follow-up. Consequently, only 31 children, each with a band and loop space maintainer and a stainless steel crown, were included for the final interpretation of the results in this study. At one month, both BOP and GI were significantly different (p<0.05) between the stainless steelcrown and stainless steel band where the crown showed better gingival health and absence of bleeding than the band and loop. At three months and six months, gingival health improved in both groups, but there was no significant difference between the groups. The Friedman test revealed that both the stainless steel crown and stainless steel band groups had a significant difference at six months from baseline. Mann-Whitney tests were done to analyse the difference in parameters at baseline and at six months between both groups. There was no significant difference in the baseline in the parameters between the groups. Conclusion Within the limitations of the study, this study concludes that the gingival health based on BOP and GI shows a significant difference across the timeline within the groups, namely, stainless steel crown and stainless steel band, but no significant difference between the groups at various timelines.

Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients.

The risk of cytomegalovirus (CMV) infection in solid organ transplant recipients has resulted in the frequent use of prophylaxis to prevent the clinical syndrome associated with CMV infection. This is an update of a review first published in 2005 and updated in 2008 and 2013. To determine the benefits and harms of antiviral medications to prevent CMV disease and all-cause death in solid organ transplant recipients. We contacted the information specialist and searched the Cochrane Kidney and Transplant Register of Studies up to 5 February 2024 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov. We included randomised controlled trials (RCTs) and quasi-RCTs comparing antiviral medications with placebo or no treatment, comparing different antiviral medications or different regimens of the same antiviral medications for CMV prophylaxis in recipients of any solid organ transplant. Studies examining pre-emptive therapy for CMV infection are studied in a separate review and were excluded from this review. Two authors independently assessed study eligibility, risk of bias and extracted data. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. This 2024 update found four new studies, bringing the total number of included studies to 41 (5054 participants). The risk of bias was high or unclear across most studies, with a low risk of bias for sequence generation (12), allocation concealment (12), blinding (11) and selective outcome reporting (9) in fewer studies. There is high-certainty evidence that prophylaxis with aciclovir, ganciclovir or valaciclovir compared with placebo or no treatment is more effective in preventing CMV disease (19 studies: RR 0.42, 95% CI 0.34 to 0.52), all-cause death (17 studies: RR 0.63, 95% CI 0.43 to 0.92), and CMV infection (17 studies: RR 0.61, 95% CI 0.48 to 0.77). There is moderate-certainty evidence that prophylaxis probably reduces death from CMV disease (7 studies: RR 0.26, 95% CI 0.08 to 0.78). Prophylaxis reduces the risk of herpes simplex and herpes zoster disease, bacterial and protozoal infections but probably makes little to no difference to fungal infection, acute rejection or graft loss. No apparent differences in adverse events with aciclovir, ganciclovir or valaciclovir compared with placebo or no treatment were found. There is high certainty evidence that ganciclovir, when compared with aciclovir, is more effective in preventing CMV disease (7 studies: RR 0.37, 95% CI 0.23 to 0.60). There may be little to no difference in any outcome between valganciclovir and IV ganciclovir compared with oral ganciclovir (low certainty evidence). The efficacy and adverse effects of valganciclovir or ganciclovir were probably no different to valaciclovir in three studies (moderate certainty evidence). There is moderate certainty evidence that extended duration prophylaxis probably reduces the risk of CMV disease compared with three months of therapy (2 studies: RR 0.20, 95% CI 0.12 to 0.35), with probably little to no difference in rates of adverse events. Low certainty evidence suggests that 450 mg/day valganciclovir compared with 900 mg/day valganciclovir results in little to no difference in all-cause death, CMV infection, acute rejection, and graft loss (no information on adverse events). Maribavir may increase CMV infection compared with ganciclovir (1 study: RR 1.34, 95% CI: 1.10 to 1.65; moderate certainty evidence); however, little to no difference between the two treatments were found for CMV disease, all-cause death, acute rejection, and adverse events at six months (low certainty evidence). Prophylaxis with antiviral medications reduces CMV disease and CMV-associated death, compared with placebo or no treatment, in solid organ transplant recipients. These data support the continued routine use of antiviral prophylaxis in CMV-positive recipients and CMV-negative recipients of CMV-positive organ transplants.

The Performance of Different Parametric Ultrasounds in Prostate Cancer Diagnosis: Correlation with Radical Prostatectomy Specimens.

Prostate cancer is a prevalent cancer among men. Multiparametric ultrasound [mpUS] is a diagnostic instrument that uses various types of ultrasounds to diagnose it. This systematic review aims to evaluate the performance of different parametric ultrasounds in diagnosing prostate cancer by associating with radical prostatectomy specimens. A review was performed on various ultrasound parameters using five databases. Systematic review tools were utilized to eliminate duplicates and identify relevant results. Reviewers used the Quality Assessment of Diagnostic Accuracy Results [QUADAS-2] to evaluate the bias and applicability of the study outcomes. Between 2012 and 2023, eleven studies were conducted to evaluate the performance of the different ultrasound parametric procedures in detecting prostate cancer using grayscale TRUS, SWE, CEUS, and mpUS. The high sensitivity of these procedures was found at 55%, 88.6%, 81%, and 74%, respectively. The specificity of these procedures was found to be 93.4%, 97%, 88%, and 59%, respectively. This high sensitivity and specificity may be associated with the large lesion size. The studies revealed that the sensitivity of these procedures in diagnosing clinically significant prostate cancer was 55%, 73%, 70%, and 74%, respectively, while the specificity was 61%, 78.2%, 62%, and 59%, respectively. The mpUS procedure provides high sensitivity and specificity in PCa detection, especially for clinically significant prostate cancer.

Viral clearance as a surrogate of clinical efficacy for COVID-19 therapies in outpatients: a systematic review and meta-analysis

Surrogates of antiviral efficacy are needed for COVID-19. We aimed to investigate the relationship between the virological effect of treatment and clinical efficacy as measured by progression to severe disease in outpatients treated for mild-to-moderate COVID-19. In this systematic review and meta-analysis, we searched PubMed, Scopus, and medRxiv from database inception to Aug 16, 2023, for randomised placebo-controlled trials that tested virus-directed treatments (ie, any monoclonal antibodies, convalescent plasma, or antivirals) in non-hospitalised individuals with COVID-19. We only included studies that reported both clinical outcomes (ie, rate of disease progression to hospitalisation or death) and virological outcomes (ie, viral load within the first 7 days of treatment). We extracted summary data from eligible reports, with discrepancies resolved through discussion. We used an established meta-regression model with random effects to assess the association between clinical efficacy and virological treatment effect, and calculated I2 to quantify residual study heterogeneity. We identified 1718 unique studies, of which 22 (with a total of 16 684 participants) met the inclusion criteria, and were in primarily unvaccinated individuals. Risk of bias was assessed as low in 19 of 22 studies for clinical outcomes, whereas for virological outcomes, a high risk of bias was assessed in 11 studies, some risk in ten studies, and a low risk in one study. The unadjusted relative risk of disease progression for each extra log10 copies per mL reduction in viral load in treated compared with placebo groups was 0·12 (95% CI 0·04-0·34; p<0·0001) on day 3, 0·20(0·08-0·50; p=0·0006) on day 5, and 0·53 (0·30-0·94; p=0·030) on day 7. The residual heterogeneity in our meta-regression was estimated as low (I2=0% [0-53] on day 3, 0% [0-71] on day 5, and 0% [0-43] on day 7). Despite the aggregation of studies with differing designs, and evidence of risk of bias in some virological outcomes, this review provides evidence that treatment-induced acceleration of viral clearance within the first 5days after treatment is a potential surrogate of clinical efficacy to prevent hospitalisation with COVID-19. This work supports the use of viral clearance as an early phase clinical trial endpoint of therapeutic efficacy. Australian Government Department of Health, Medical Research Future Fund, and Australian National Health and Medical Research Council.

One thought too few: An adaptive rationale for punishing negligence.

Why do we punish negligence? Some current accounts raise the possibility that it can be explained by the kinds of processes that lead us to punish ordinary harmful acts, such as outcome bias, character inference, or antecedent deliberative choices. Although they capture many important cases, these explanations fail to account for others. We argue that, in addition to these phenomena, there is something unique to the punishment of negligence itself: People hold others directly responsible for the basic fact of failing to bring to mind information that would help them to avoid important risks. In other words, we propose that at its heart negligence is a failure of thought. Drawing on the current literature in moral psychology, we suggest that people find it natural to punish such failures, even when they do not arise from conscious, volitional choice. This raises a question: Why punish somebody for a mental event they did not exercise deliberative control over? Drawing on the literature on how thoughts come to mind, we argue that punishing a person for such failures will help prevent their future occurrence, even without the involvement of volitional choice. This provides new insight on the structure and function of our tendency to punish negligent actions. (PsycInfo Database Record (c) 2024 APA, all rights reserved).