Serious Risk Of Bias Research Articles

A systematic review of observational studies on the association between diet quality patterns and visceral adipose tissue.

Beyond obesity, visceral adipose tissue (VAT) has emerged as an important predictor of chronic disease, but the role of diet quality patterns (DQP) in VAT development is not well defined. Therefore, we conducted a systematic review of how various DQP are associated with VAT via literature searches in PubMed and EMBASE. We included observational investigations in disease-free adults/adolescents that related DQP to VAT assessed by imaging methods. The studies were evaluated separately for a priori and a posteriori DQP and according to design differences. Study quality was assessed using the Risk of Bias in Non-randomised Studies of Interventions tool. Of the 1807 screened articles, thirty-five studies met the inclusion criteria. The majority of a priori indices, for example, the Healthy Eating Index, showed significant inverse associations with VAT, while only a small proportion of a posteriori patterns were related to VAT. Results did not differ substantially by the method of exposure and outcome assessment or between studies with (n 20) or without (n 15) body-size adjustment, but significant findings were more common in younger v. older individuals, USA v. other populations and investigations with moderate v. serious risk of bias. The heterogeneity of the existing literature limited the ability to quantify the magnitude of the associations across studies. These findings suggest that a high-quality diet, as assessed by a priori DQP, is generally inversely associated with VAT, but results for a posteriori DQP are less consistent. As associations persisted after adjusting for body size, diet quality may beneficially influence VAT beyond its association with obesity.

Conducting observational analyses with the target trial emulation approach: a methodological systematic review

ObjectivesTarget trial emulation is an approach that is increasingly used to improve transparency in observational studies and help mitigate biases. For studies declaring that they emulated a target trial, we...

Seizure outcomes in patients with brain metastases and epilepsy: A systematic review on the efficacy of antitumor treatment and antiseizure medication

Abstract Background Epilepsy is a common symptom in patients with brain metastases (BMs), and because of the rising incidence of BMs, adequate seizure management is warranted. We conducted a systematic review on seizure outcomes after antitumor treatment and antiseizure medication (ASM) in patients with BMs from solid tumors and epilepsy. Methods A literature search was performed in six databases up to February 2024. Extracted outcomes were rates for (1) seizure freedom; (2) ≥50% seizure reduction; and (3) treatment failure (for ASM only). Weighted averages (WAs) were calculated for outcomes after surgery at 6 months follow-up. Quality assessment of the included studies was performed using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool. Results We retrieved 2244 references, of which 16 studies were eligible for inclusion. Eight studies were at critical, and 8 studies at serious risk of bias. The WA of seizure freedom rates at 6 months after surgical resection was 64% (based on 3 studies at serious risk of bias, n=151 patients). Results on ASM efficacy and tolerability were unreliable, as all eligible studies for these outcomes were at critical risk of bias. Conclusions Limited available evidence from heterogeneous study populations demonstrated that in the majority of patients with epilepsy due to BMs, seizure freedom 6 months after surgical resection may be reached. No substantial evidence on ASM efficacy and tolerability in patients with epilepsy due to BMs is available. High-quality cohort studies are warranted to expand the evidence on seizure outcomes after antitumor and ASM treatment.

Encouraging New Moms to Move More-Are We Missing the Mark? A Systematic Review With Meta-Analysis of the Effect of Exercise Interventions on Postpartum Physical Activity Levels and Cardiorespiratory Fitness.

OBJECTIVE: To determine if current exercise interventions were effective at improving physical activity (PA) levels and/or cardiorespiratory fitness (CRF) in postpartum women. DESIGN: Intervention systematic review with meta-analysis. LITERATURE SEARCH: CINAHL, Embase, Medline, PsycINFO, and SPORTDiscus were searched from inception to March 2024. STUDY SELECTION CRITERIA: Participants: postpartum women; intervention: exercise; control: standard care; outcomes: PA levels and/or CRF. DATA SYNTHESIS: Random effects meta-analysis using standardized mean differences (SMDs). Risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB 2) and Risk of Bias in Non-Randomized Studies - Intervention (ROBINS-I). RESULTS: A total of 6041 studies were screened, and 29 were eligible for inclusion. Nineteen studies with adequate control data included outcomes related to PA levels (n = 12) or CRF (n = 7) and were pooled in meta-analyses. There was a small to moderate improvement in CRF (SMD, 0.65; 95% CI [confidence interval]: 0.20, 1.10; I2 = 61%). There was no improvement in PA levels (SMD, -0.13; 95% CI: -0.53, 0.26; I2 = 90%). Frequency, intensity, type, and time of the exercise interventions varied. Twenty-three studies were at high or serious risk of bias. CONCLUSIONS: Postpartum exercise interventions may improve CRF but have an unclear effect on PA levels. Despite numerous exercise interventions to improve health outcomes postpartum, parameters were inconsistent. J Orthop Sports Phys Ther 2024;54(11):687-701. Epub 9 October 2024. doi:10.2519/jospt.2024.12666.

Home use of mifepristone for medical abortion: a systematic review

BackgroundIn many countries, persons seeking medical abortion with mifepristone followed by misoprostol can self-administer the second drug, misoprostol, at home, but self-administration of the first drug, mifepristone, is not allowed...

Comprehensive geriatric assessment, and related interventions, to improve outcomes for older patients undergoing transcatheter aortic valve implantation (TAVI): a systematic review.

Transcatheter aortic valve implantation (TAVI) is a treatment for people with severe symptomatic aortic stenosis, particularly those living with frailty. Increasing frailty is associated with poorer outcomes post-TAVI. Comprehensive Geriatric Assessment (CGA) has been shown in other settings to improve outcomes in those with frailty, including perioperatively. This systematic review aims to determine whether CGA, or interventions targeting its components, improves outcomes for older people undergoing TAVI. EMBASE, MEDLINE, CINAHL and Cochrane CENTRAL were searched on 09/01/23 and then the search was rerun on the 16/04/24. The review was registered on PROSPERO (CRD42022299955). Included studies had to evaluate either CGA, or a single- or multi-domain intervention targeting components of CGA, in those aged ≥ 65. From 4091 papers, 24 met the inclusion criteria. Two studies assessed CGA pre-TAVI and reported mixed improvements in functional independence but no change in length of stay or post-operative delirium, although both studies had a serious risk of bias. Fifteen papers described an exercise-based intervention, and 1 paper detailed a Cognitive Behavioural Therapy-based intervention. Seven studies evaluated a multi-component intervention. There were conflicting results reported for the multi-component and single-component interventions. All studies had at least a moderate risk of bias. There is a lack of evidence to determine whether CGA, or related interventions, improve outcomes for older adults undergoing-TAVI. The evidence for perioperative CGA, and the results of this review, support the need for well-designed trials evaluating whether CGA improves outcomes post-TAVI for older adults living with frailty.

Enzymatic TherapyversusVATS for pleural infections: a systematic review and meta-analysis

QuestionParapneumonic pleural infections are frequently encountered, but the optimal treatment regimen remains controversial. The aim of this systematic review was to investigate whether immediate video-assisted thoracoscopic surgery (VATS) has advantages over intrapleural enzymatic therapy (IET).MethodsWe searched MEDLINE, Embase, and Web of Science Core Collection till November 2023 and included studies comparing IET and VATS in adult patients with parapneumonic pleural infections. Primary outcome was length of hospital stay (LOS), secondary outcomes included mortality and morbidity. Study quality was assessed using ROBINS-I and RoB 2. Inverse variance random-effects meta-analysis was performed.ResultsWe screened 2263 articles, eight were included in the final analysis, covering 1023 patients (n=465 IET (mostly single agent IET); n=558 VATS). Six were non-randomized studies (n=5 with serious risk of bias) comprising 964 patients, and two were small, randomized feasibility studies (n=1 with high risk of bias), comprising 59 patients. In the meta-analysis, LOS in non-randomized studies was shorter for patients treated by VATS (mean difference 4.2 days; 95%CI 1.5 to 7.0). However, no significant difference was reported in the randomized feasibility studies. Mortality and morbidity rates showed no significant difference.InterpretationIn this meta-analysis of non-randomized studies with a high risk of selection bias, VATS appears superior to IET regarding LOS in the treatment of parapneumonic pleural infections, without increased mortality and morbidity rate. Two recently published randomized feasibility studies failed to confirm this finding, but were not designed to detect a difference in LOS. This meta-analysis highlights the need for high quality studies.

Are prophylactic antibiotics effective in preventing osteoradionecrosis after high-risk dental extractions?

A systematic review and meta-analysis. To assess and compare the effectiveness of different adjunctive treatments during tooth extraction in post-radiotherapy head and neck patients for preventing osteoradionecrosis (ORN). Two independent reviewers conducted an electronic search through PubMed, Embase, Cochrane Libraries, Scopus and Web of Science databases using relevant search terms. Additionally, references of relevant articles were manually searched for eligible studies. Included were full-length articles (randomized controlled trials (RCTs), clinical trials, or observational studies) published in English, reporting on ORN occurrence after dental extraction, with or without adjunctive interventions, in patients who had previous radiotherapy. Data extraction was similarly performed by two independent researchers. For quality assessment, bias in observational studies was evaluated using the ROBINS-I tool, while the RoB 2 tool was used for RCTs. One-arm meta-analyses estimated pooled ORN prevalence rates for different adjunctive treatments based on patient-level outcomes. For studies with direct comparisons between two modalities, pooled odds ratios for ORN were calculated using pairwise meta-analyses. This systematic review followed PRISMA guidelines and was registered in the PROSPERO database. A total of 29 studies with 1520 patients were included, comprising 4 RCTs, 4 prospective studies, and 21 retrospective observational studies. Five adjunctive treatment modalities around the time of dental extractions were identified: hyperbaric oxygen (HBO), pentoxifylline-tocopherol (PENTO), antibiotics (ABX), platelet-rich fibrin and photobiomodulation. Of the 25 observational studies included, 11 had a serious risk of bias, while all RCTs but 1 had low risk of bias. Egger's test showed no publication bias for the HBO and ABX groups (p > 0.05). Antibiotics were used in 17 studies, with significant variations in preoperative and postoperative protocols. Most studies utilized penicillin or clindamycin. The pooled prevalence of ORN was significantly lower in the HBO (4.6%), PENTO (3.4%), and ABX (3.8%) groups compared to the Control (17.6%), as indicated by the non-overlapping 95% CIs between the Control and any of the intervention groups. In studies with direct comparisons, HBO exhibited lower odds of developing ORN than the Control (odds ratio [OR] = 0.27) and ABX (OR = 0.57), although these differences were not statistically significant. HBO, PENTO, and ABX show similar reduction in ORN rates compared to no intervention. Given its cost-effectiveness and accessibility, ABX may be the most practical prophylactic modality at present.

Evidence Following Conditional NICE Technology Appraisal Recommendations: A Critical Analysis of Methods, Quality and Risk of Bias.

The National Institute for Health and Care Excellence (NICE) may approve health technologies on condition of more evidence generated only in research (OiR) or only with research (OwR). NICE specifies the information needed to comply with its request, although it may not necessarily guarantee good quality and timely evidence for re-appraisal, before reaching a final decision. This study aimed to critically appraise the methods, quality and risk of bias of evidence generated in response to NICE OiR and OwR technology appraisal (TA) and highly specialised technologies (HSTs) recommendations. NICE TAs (between March 2000 and September 2020) and HST evaluations (to October 2023) of medicines were reviewed. Conditional recommendations were analysed to identify the evidence requested by NICE for re-appraisal. The new evidence was analysed for compliance with NICE's request and assessed using the Cochrane Collaboration's tools for risk of bias in randomised trials and the ROBINS-I tool for non-randomised evidence. NICE made 54 conditional recommendations from TAs (13 OiR and 41 OwR) and five conditional recommendations for HSTs (all OwR). Of these, 16 TAs presented additional evidence for re-appraisal (9 OiR [69%] and 7 OwR [17%]) and three HSTs (3 OwR [60%]). Two of the nine re-appraised TAs with OiR recommendation and four of the seven OwR complied fully with NICE's request for further evidence, while all three from the HSTs complied. The majority of re-appraised TAs and HSTs included evidence that was deemed to be at serious, high, moderate or unclear risk of bias. Among the 26 randomised controlled trials from TAs assessed, eight were categorised as having low risk of bias in all domains and ten had at least one domain as a high risk of bias. Reporting was unclear for the remainder. Twenty-two non-randomised studies, primarily single-arm studies, were susceptible to biases mostly due to the selection of participants and to confounding. Two HSTs provided evidence from randomised controlled trials which were classified as unclear or high risk of bias. All non-randomised evidence from HSTs were categorised as moderate or serious risk of bias. There is widespread non-compliance with agreed data requests and important variation in the quality of evidence submitted in response to NICE conditional approval recommendations. Quality standards ought to be stipulated in respect to evidence contributing to re-appraisals following NICE conditional approval recommendations.

Effects of Non-Invasive Brain Stimulation for Degenerative Cerebellar Ataxia: A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aimed to assess the effectiveness of non-invasive brain stimulation (NIBS), including repetitive transcranial magnetic stimulation (rTMS) and transcranial electrical stimulation (tES), as a neurological intervention for degenerative cerebellar ataxia (DCA) based on preregistration (PROSPERO: CRD42023379192). We aimed to explore clinical outcomes and examine the parameters associated with NIBS efficacy in DCA patients. The PubMed, Cochrane Library, CHINAL, and PEDro databases were searched for relevant randomized controlled trials (RCTs). Data extraction, quality assessment, and heterogeneity analyses were conducted; the Grading, Recommendations, Assessment, Development, and Evaluation was used to assess the quality of evidence and a meta-analysis was performed. Seventeen RCTs that included 661 patients on the scale for assessment and rating of ataxia (SARA) and 606 patients on the International Cooperative Ataxia Rating Scale (ICARS) were included. These RCTs showed a serious risk of bias (RoB) and low certainty of evidence for both outcomes. NIBS significantly reduced SARA (MD = -2.49, [95% confidence interval: -3.34, -1.64]) and ICARS (-5.27 [-7.06, -3.47]); the subgroup analysis showed significant effects: rTMS and tES reduced both outcomes. However, there were no significant differences in the effects of rTMS and tES. Additional subgroup analysis indicated the impact of rTMS frequency and the total number of tES sessions on ataxia. Non-invasive brain stimulation may reduce ataxia in DCA patients, but the estimated effect size may change in future studies because the RoB was serious and the certainty of evidence was low, and the heterogeneity was high. To establish evidence for selecting NIBS methods and parameters, continued high-quality RCTs are required.

Time to pars plana vitrectomy in adults with retained lens fragments: a systematic review and meta-analysis

ObjectiveTo compare visual outcomes and complication risk based on the timing of pars plana vitrectomy (PPV) following cataract surgery with retained lens fragments. MethodsMEDLINE (Ovid), EMBASE, and Cochrane Library were searched between 2000 to February 2022 for studies comparing visual outcomes and complications based on time to PPV. Discrete outcomes were analyzed using a random-effects meta-analysis model on Review Manager (RevMan 5.4). The certainty of evidence of outcomes was evaluated using the Grading of Recommendations, Assessment, Development and Evaluation approach. ResultsTen studies and 1,693 eyes were included. The incidence of patients achieving a final best-corrected visual acuity (BCVA) of >6/12 Snellen may be similar among patients receiving PPV within 1 week or after 1 week of cataract surgery (RR = 1.06, 95% CI = [0.96, 1.17], p = 0.25), and patients receiving PPV within 1 month or after 1 month of cataract surgery (RR = 1.12, 95% CI = [0.95, 1.32]; p = 0.18). Incidence of glaucoma or elevated intraocular pressure for patients may be similar among patients receiving PPV within 1 week or after 1 week of cataract surgery (RR = 1.08, 95% CI = [0.62, 1.87]; p = 0.79), and patients receiving PPV within 1 month or after 1 month of cataract surgery (RR = 0.33, 95% CI = [0.09, 1.23]; p = 0.10). ConclusionIncidence of patients achieving a final BCVA of >6/12 Snellen or postoperative adverse effects was similar between patients who underwent early and late PPV following cataract surgery. However, all studies had an overall serious risk of bias, primarily because of confounding and reporting bias.

Alcohol consumption and frailty risk: a dose-response meta-analysis of cohort studies.

While previous studies suggest that light-to-moderate alcohol consumption may reduce the frailty risk, the dose-response relationship is still under question. To address the knowledge gap, we conducted a systematic review and dose-response meta-analysis of cohort studies to examine the association of alcohol consumption with the risk of both prefrailty and frailty in adults. We searched MEDLINE (Ovid), PubMed and Scopus to identify relevant cohort studies published before 8 May 2024. The dose-response meta-analysis was performed to investigate the associations between alcohol drinking and the risk of developing pre-frailty and frailty. We used random-effects models to calculate pooled relative risks (RR) with 95% CIs. We included nine cohort studies with 64 769 participants and 15 075 cases, of which eight studies were rated to have a serious risk of bias as assessed by the ROBINS tool. Based on our analysis, each 12g increase in alcohol intake did not appear to be associated with risks of prefrailty (RR: 1.08, 95% CI 0.89, 1.31; I2= 91%, n = 3; GRADE = very low) and frailty (RR: 0.94, 95% CI 0.88, 1.00; I2= 63%, n = 9; GRADE = low). The nonlinear dose-response meta-analysis indicates a slight inverse association with frailty risk up to an alcohol intake of 20 grams per day, beyond which an upward trend is observed. The inverse association found between moderate alcohol consumption and frailty risk appears to be stronger among older adults, which might be due to the lower and less popular alcohol consumption among older people than the general population. However, because this finding is based on low-quality evidence, more research is needed to develop specific dietary recommendations for alcohol consumption, particularly among young people.

Social connection interventions and depression in young adults: a systematic review and meta-analysis.

Early adulthood is a period which may increase vulnerability to loneliness and mental health difficulties among young adults. Social networks play an important role in buffering against adverse mental health, but there is a lack of evidence around whether social connection interventions could play a role in preventing mental health difficulties for young adults. A systematic review and meta-analysis was conducted (PROSPERO ID: CRD42023395595). PubMed, PsycInfo, and Scopus were searched (01 January 2000-01 January 2023). Studies were eligible if they (i) were quantitative, (ii) included young adults (18-24 years) from the general population, (iii) tested a social intervention which aimed to increase the quantity or quality of social connections or reduce loneliness, (iv) had a comparison group, and (v) measured depression and loneliness/social connection as outcomes. Following study screening and selection, the data extraction and risk of bias assessments were independently conducted in duplicate. The Cochrane RoB-2 tool and ROBINS-I tool were used to assess risk of bias. Results were narratively synthesised and random effects meta-analysis with standardised mean differences was conducted. Six studies were included; four in-person interventions with higher education students, one online intervention with higher education students, and one intervention for youth involved in street life. The studies were mostly rated as having some or moderate concerns with risk of bias. The interventions were associated with an overall mean reduction in depression for young adults (SMD = -0.19; 95% CI, -0.33 to -0.05; p = 0.008; 4 studies, excluding studies with serious risk of bias). All interventions had beneficial effects on a range of diverse social connection outcomes, but there was no overall statistically significant mean reduction in loneliness for young adults in pooled analyses (SMD = -0.10; 95% CI, -0.24 to 0.05; p = 0.188; 3 studies). Social connection interventions show some promise in improving depression and social connection outcomes in young adults but more high-quality research, across diverse settings, is needed in this area.

Immediate or delayed trial without catheter in acute urinary retention in males: A systematic review.

To compare the success of establishing spontaneous micturition following immediate trial without catheter (TWOC) to delayed TWOC in males catheterized for acute urinary retention. In this systematic review, we included studies reporting success rates of immediate TWOC or delayed TWOC (≤30 days) among males ≥18 years of age catheterized for acute urinary retention. We excluded studies on suprapubic catheterization, postoperative/perioperative catheterization and urinary retention related to trauma. We searched the following databases: MEDLINE, Embase, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Open Grey and Clinicaltrials.gov. The search was concluded on 30 November 2022. There were no restrictions on language or publication date. Risk of bias was assessed using the ROB 2.0 and ROBINS-I tools. We did random-effects restricted maximum likelihood model meta-analyses. Certainty of evidence was assessed using GRADE. We included 61 studies. In two randomized controlled trials (RCTs), both with some concerns for risk of bias, including in total 174 participants, the relative success rate was 1.22 (95% CI 0.84-1.76) favouring delayed TWOC. In two comparative cohort studies, both with serious risk of bias, including 642 participants, the relative success rate was 1.18 (0.94-1.47) favouring delayed TWOC. One study was excluded from this meta-analysis because of critically low quality. Four studies reporting success rates for cohorts with immediate TWOC, all with serious risk of bias, including 409 participants, had an overall success rate of 47% (29-66). Fifty-two studies reporting success rates for cohorts with delayed TWOC, all with serious risk of bias, including 12 489 participants, had an overall success rate of 53% (49-56). The certainty of the evidence was considered low for the RCTs and very low for the rest. There was a limited number of appropriately designed studies addressing the research question directly. The evidence favours neither approach.

Peri-ictal psychiatric manifestations in people with epilepsy: An umbrella review.

We aimed to conduct an umbrella review to summarize the existing evidence regarding the prevalence of peri-ictal psychiatric manifestations (PM) in people with epilepsy (PWE) including pre-ictal, ictal, and postictal stages. Databases were searched up to June 2023 for systematic reviews (SR) of observational studies that included patients with epilepsy peri-ictal PM. Data selection, data extraction, and risk of bias assessment (with the AMSTAR-2 instrument) were performed by two independent reviewers. We performed a narrative synthesis using previous guidelines. We used a self-developed decision table according to the GRADE system adapted for narrative outcomes if the certainty of outcomes was not determined by systematic review authors. Four SRs were included comprising 66 primary studies (n = 10 217). Three SRs evaluated one period (pre-ictal, ictal, and postictal), and one did not determine it. During the pre-ictal period, the more prevalent symptom was confusion, although with a low certainty (due to the heterogeneity and serious risk of bias). One systematic review that only included case reports evaluated the ictal period, finding mood/anxiety disorders, psychosis, and personality changes. The postictal period included the most PM (anxiety: 45.0% and depressive symptoms: 43.0%), with very low certainty, due to risk of bias, potential publication bias, heterogeneity, and failure to report the confidence intervals. With very low certainty, epileptic periods are characterized by a wide spectrum of PM, being postictal symptoms the most prevalent, predominantly anxiety, and depressive symptoms. Further understanding of these PM of epilepsy could improve the attention of the people with epilepsy. In this review of reviews, we summarize the frequency in which psychiatric manifestations occur in relation to an epileptic seizure. A total of 10 217 patients were reported in the reviews. The most common manifestations included symptoms of anxiety and depression, as well as changes in the normal behavior of the patient. These manifestations occurred most frequently right after the seizure finished.

Precision treatment of beta-cell monogenic diabetes: a systematic review

BackgroundBeta-cell monogenic forms of diabetes have strong support for precision medicine. We systematically analyzed evidence for precision treatments for GCK-related hyperglycemia, HNF1A-, HNF4A- and HNF1B-diabetes, and mitochondrial diabetes (MD) due to m.3243 A > G variant, 6q24-transient neonatal diabetes mellitus (TND) and SLC19A2-diabetes.MethodsThe search of PubMed, MEDLINE, and Embase for individual and group level data for glycemic outcomes using inclusion (English, original articles written after 1992) and exclusion (VUS, multiple diabetes types, absent/aggregated treatment effect measures) criteria. The risk of bias was assessed using NHLBI study-quality assessment tools. Data extracted from Covidence were summarized and presented as descriptive statistics in tables and text.ResultsThere are 146 studies included, with only six being experimental studies. For GCK-related hyperglycemia, the six studies (35 individuals) assessing therapy discontinuation show no HbA1c deterioration. A randomized trial (18 individuals per group) shows that sulfonylureas (SU) were more effective in HNF1A-diabetes than in type 2 diabetes. Cohort and case studies support SU’s effectiveness in lowering HbA1c. Two cross-over trials (each with 15–16 individuals) suggest glinides and GLP-1 receptor agonists might be used in place of SU. Evidence for HNF4A-diabetes is limited. Most reported patients with HNF1B-diabetes (N = 293) and MD (N = 233) are on insulin without treatment studies. Limited data support oral agents after relapse in 6q24-TND and for thiamine improving glycemic control and reducing/eliminating insulin requirement in SLC19A2-diabetes.ConclusionThere is limited evidence, and with moderate or serious risk of bias, to guide monogenic diabetes treatment. Further evidence is needed to examine the optimum treatment in monogenic subtypes.

P-348 Reduced uterine volume after children, adolescent, and young adult chemotherapy exposure. a systematic review and bayesian network meta-analysis

Abstract Study question What is the long-term impact on uterine volume of a childhood and adolescent, and young adult (AYA) exposure to chemotherapy? Summary answer Compared to the control group, uterine volume was clinically significantly decreased after chemotherapy and even more after radio-chemotherapy. What is known already Uterine damage is well-described after pelvic radiotherapy or total body irradiation (TBI) with decreased uterine volume and high obstetrical morbidity. Few studies have reported smaller uterus in AYA cancer survivors treated with chemotherapy only. In these studies, uterus volume was mostly assessed by a transabdominal and/or transvaginal ultrasonography, and primary diagnosis, age at treatment and chemotherapy regimen were heterogeneous. The uterine impact of chemotherapy is still little investigated. Study design, size, duration A systematic review and meta-analysis on comparative studies. Searches were conducted on Medline, Embase and the Cochrane Library from 1990 to April 2023, using the main following search terms: cancer survivors, bone marrow transplantation, chemotherapy, radiotherapy, uterine volume. All studies reporting uterine volume in adult females who have received chemotherapy and/or radiotherapy during childhood and AYA < 25 years were included. Participants/materials, setting, methods Two independent reviewers carried out the study selection, the bias assessment using the ROBINS-I tool and data extraction. The primary outcome was the uterine volume in mL. A Bayesian network meta-analysis (NMA) with meta-regression on parity and serious risk of bias was performed using a random-effects model. Furthermore sensitivity analyses were performed. Therapies were ranked by the surface under the cumulative ranking curve (SUCRA). Differences in means (MD) with 95% credible intervals (CrI) are reported. Main results and the role of chance After review of 2 328 abstracts, 4 studies were selected for the meta-analysis. Uterine volume was assessed through ultrasonography in three articles and magnetic resonance imaging in one. Uterine volume data were available for 245 females after chemotherapy, 153 after radio-chemotherapy and 257 without cancer females (controls). SUCRA were 0.980 for control, 0.510 for chemotherapy and 0.009 for radio-chemotherapy. One study did not display data by parity (n = 165) and had a serious risk of bias, and was excluded in sensitivity analysis. SUCRA showed the same ranking order. In nulliparous females, compared to the control group (n = 152), uterine volume was decreased in the chemotherapy group (n = 138, MD = -12 mL; 95% CrI, -33, 5.7), and even more in the radio-chemotherapy group (n = 97, MD= -30 mL; 95% Crl -50, -13). In parous females, compared to the control group (n = 41), the decrease in the uterine volume tended to be similar in chemotherapy and radio-chemotherapy groups (MD = -27 mL; 95% CrI, -54, 3.2 with n = 43 and -30 mL; 95% CrI, -50, -13 with n = 19, respectively). Limitations, reasons for caution The own responsibility of chemotherapy for inducing uterine damage is hard to be asserted because of the heterogeneity of radiology assay, and of the diversity of chemotherapy regimens, the lack of data concerning the Cyclophosphamide Equivalent dose, and about the hormonal status at the time of the uterine evaluation. Wider implications of the findings Our results suggest a high probability that a childhood and AYA exposure to chemotherapy could induce uterine damage. Further studies are needed to evaluate the potential obstetrical impact of uterine damage caused by chemotherapy alone. Trial registration number PROSPERO CRD42023440219

Treatment Outcomes of Lip Taping in Patients with Non-syndromic Cleft Lip and/or Palate: A Systematic Review and Meta-analysis.

To conduct a systematic review of the data in peer-reviewed medical literature and evaluate the effectiveness of lip taping as a pre-surgical naso-alveolar molding (NAM) technique in infants with cleft lip and/or palate. An electronic search of various databases for relevant studies, regardless of date, from inception to June 2023 was carried out and evaluated. After completing the electronic search and applying our inclusion/exclusion criteria, 6 studies-2 randomized control trials, 2 non-randomized studies, and 2 case series-were included. Data extraction of relevant articles was done independently by 2 authors. Quality assessment was done using the JBI prevalence critical appraisal tool and certainty of evidence was carried out by GRADE approach. Nasolabial Aesthetics, Dentoalveolar Relationship. A total of six studies were included in the current review. Meta-analysis was carried out, and forest plots were obtained for a single mean from the lip-taping group. 3 studies had a low risk of bias, while 3 studies displayed a serious risk of bias. Significant improvement in various outcome measures was noted with lip taping when compared with the control group although the certainty of evidence was very low. When compared to no therapy, lip taping appears to ameliorate dentoalveolar measurements and nasolabial aesthetics. To increase our knowledge of lip taping, more research will be needed in the future, as there are not many studies to prove lip taping is better than other treatment approaches.

Abstract PO1-22-06: Pre-operative radiotherapy followed by mastectomy and breast reconstruction – a systematic review of oncological and reconstructive outcomes

Abstract Background Pre-operative radiotherapy (PRT) followed by mastectomy and autologous breast reconstruction for locally advanced breast cancer has the potential to reduce the deleterious impact of radiotherapy on the reconstructed breast and expedite treatment without impact on oncologic control. The PRADA feasibility study (Lancet Oncol 2022; 23: 682-90) has previously demonstrated the technique is technically feasible and safe in modern breast oncology practice, however, there is a clear necessity for longer term outcome data to precisely determine clinical efficacy. In order to understand and appraise this evidence gap, we performed a systematic review focused on oncologic and reconstructive outcomes of PRT followed by mastectomy and breast reconstruction. Methods A prospectively registered search (PROSPERO ID: CRD42023349524) of Medline (Ovid), EMBASE (Ovid), EMCARE (Ovid) and CINAHL (EBSCO) databases was performed in August 2022 for studies reporting NART prior to mastectomy and breast reconstruction. Oncological and aesthetic outcomes were extracted with risk of bias (ROBINS-I) and methodological quality assessed (STROBE checklist) for each study. Results Twenty one published articles (18 papers and 3 abstracts) were identified reporting the outcomes of 1,126 patients with median follow-up between 19.0-212.4 months. Seventeen studies were non randomised single-centre cohort studies (12 retrospective and 5 prospective). Patients received neoadjuvant chemotherapy in 18 studies. The majority of studies were of low methodological quality and at serious risk of bias. Rates of locoregional recurrence and overall survival ranged between 0-21.7% and 79.8%-98.3% respectively. Rates of flap loss or necrosis ranged from 0-12.0%. Rates of revisional procedures ranged between 0-35.3%. Patient-reported outcomes were reported in 8 studies and were mostly ‘good’ or ‘excellent’. Conclusion The published literature described a heterogeneity of outcome for patients undergoing NART prior to mastectomy and breast reconstruction. This reflects a large number of small retrospective single-centre cohort studies of low methodological quality at risk of bias. There is a clear need for a prospective randomised controlled trial appraising the outcomes of PRT in the context of autologous breast reconstruction. Citation Format: Ken Ho, Joseph Ward, Chiugo Ike, Paul Thiruchelvam, Aadil Khan, Daniel Leff. Pre-operative radiotherapy followed by mastectomy and breast reconstruction – a systematic review of oncological and reconstructive outcomes [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-22-06.

The effectiveness of virtual reality training on knowledge, skills and attitudes of health care professionals and students in assessing and treating mental health disorders: a systematic review

Background Virtual reality (VR) training can enhance health professionals’ learning. However, there are ambiguous findings on the effectiveness of VR as an educational tool in mental health. We therefore reviewed the existing literature on the effectiveness of VR training on health professionals’ knowledge, skills, and attitudes in assessing and treating patients with mental health disorders.MethodsWe searched MEDLINE, PsycINFO (via Ovid), the Cochrane Library, ERIC, CINAHL (on EBSCOhost), Web of Science Core Collection, and the Scopus database for studies published from January 1985 to July 2023. We included all studies evaluating the effect of VR training interventions on attitudes, knowledge, and skills pertinent to the assessment and treatment of mental health disorders and published in English or Scandinavian languages. The quality of the evidence in randomized controlled trials was assessed with the Cochrane Risk of Bias Tool 2.0. For non-randomized studies, we assessed the quality of the studies with the ROBINS-I tool.ResultsOf 4170 unique records identified, eight studies were eligible. The four randomized controlled trials were assessed as having some concern or a high risk of overall bias. The four non-randomized studies were assessed as having a moderate to serious overall risk of bias. Of the eight included studies, four used a virtual standardized patient design to simulate training situations, two studies used interactive patient scenario training designs, while two studies used a virtual patient game design. The results suggest that VR training interventions can promote knowledge and skills acquisition.ConclusionsThe findings indicate that VR interventions can effectively train health care personnel to acquire knowledge and skills in the assessment and treatment of mental health disorders. However, study heterogeneity, prevalence of small sample sizes, and many studies with a high or serious risk of bias suggest an uncertain evidence base. Future research on the effectiveness of VR training should include assessment of immersive VR training designs and a focus on more robust studies with larger sample sizes.Trial registrationThis review was pre-registered in the Open Science Framework register with the ID-number Z8EDK.