Categories
Nevin Manimala Statistics

Gretl-variation graph evaluation TooLkit

Bioinformatics. 2024 Dec 24:btae755. doi: 10.1093/bioinformatics/btae755. Online ahead of print.

ABSTRACT

MOTIVATION: As genome graphs are powerful data structures for representing the genetic diversity within populations, they can help identify genomic variations that traditional linear references miss, but their complexity and size makes the analysis of genome graphs challenging. We sought to develop a genome graph analysis tool that helps these analyses to become more accessible by addressing the limitations of existing tools. Specifically, we improve scalability and user-friendliness, and we provide many new statistics tailored to variation graphs for graph evaluation, including sample-specific features.

RESULTS: We developed an efficient, comprehensive, and integrated tool, gretl, to analyze genome graphs and gain insights into their structure and composition by providing a wide range of statistics. gretl can be utilised to evaluate different graphs, compare the output of graph construction pipelines with different parameters, as well as perform an in-depth analysis of individual graphs, including sample-specific analysis. With the assistance of gretl, novel patterns of genetic variation and potential regions of interest can be identified, for later, more detailed inspection. We demonstrate that gretl outperforms other tools in terms of speed, particularly for larger genome graphs.

AVAILABILITY: Commented Rust source code and documentation is available under MIT license at https://github.com/MoinSebi/gretl together with Python scripts and step-by-step usage examples. The package is available at Bioconda for easy installation.

SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.

PMID:39719064 | DOI:10.1093/bioinformatics/btae755

Categories
Nevin Manimala Statistics

Identification of plasma protein biomarkers for endometriosis and the development of statistical models for disease diagnosis

Hum Reprod. 2024 Dec 24:deae278. doi: 10.1093/humrep/deae278. Online ahead of print.

ABSTRACT

STUDY QUESTION: Can a panel of plasma protein biomarkers be identified to accurately and specifically diagnose endometriosis?

SUMMARY ANSWER: A novel panel of 10 plasma protein biomarkers was identified and validated, demonstrating strong predictive accuracy for the diagnosis of endometriosis.

WHAT IS KNOWN ALREADY: Endometriosis poses intricate medical challenges for affected individuals and their physicians, yet diagnosis currently takes an average of 7 years and normally requires invasive laparoscopy. Consequently, the need for a simple, accurate non-invasive diagnostic tool is paramount.

STUDY DESIGN, SIZE, DURATION: This study compared 805 participants across two independent clinical populations, with the status of all endometriosis and symptomatic control samples confirmed by laparoscopy. A proteomics workflow was used to identify and validate plasma protein biomarkers for the diagnosis of endometriosis.

PARTICIPANTS/MATERIALS, SETTING, METHODS: A proteomics discovery experiment identified candidate biomarkers before a targeted mass spectrometry assay was developed and used to compare plasma samples from 464 endometriosis cases, 153 general population controls, and 132 symptomatic controls. Three multivariate models were developed: Model 1 (logistic regression) for endometriosis cases versus general population controls, Model 2 (logistic regression) for rASRM stage II to IV (mild to severe) endometriosis cases versus symptomatic controls, and Model 3 (random forest) for stage IV (severe) endometriosis cases versus symptomatic controls.

MAIN RESULTS AND THE ROLE OF CHANCE: A panel of 10 protein biomarkers were identified across the three models which added significant value to clinical factors. Model 3 (severe endometriosis vs symptomatic controls) performed the best with an area under the receiver operating characteristic curve (AUC) of 0.997 (95% CI 0.994-1.000). This model could also accurately distinguish symptomatic controls from early-stage endometriosis when applied to the remaining dataset (AUCs ≥0.85 for stage I to III endometriosis). Model 1 also demonstrated strong predictive performance with an AUC of 0.993 (95% CI 0.988-0.998), while Model 2 achieved an AUC of 0.729 (95% CI 0.676-0.783).

LIMITATIONS, REASONS FOR CAUTION: The study participants were mostly of European ethnicity and the results may be biased from undiagnosed endometriosis in controls. Further analysis is required to enable the generalizability of the findings to other populations and settings.

WIDER IMPLICATIONS OF THE FINDINGS: In combination, these plasma protein biomarkers and resulting diagnostic models represent a potential new tool for the non-invasive diagnosis of endometriosis.

STUDY FUNDING/COMPETING INTEREST(S): Subject recruitment at The Royal Women’s Hospital, Melbourne, was supported in part by funding from the Australian National Health and Medical Research Council (NHMRC) project grants GNT1105321 and GNT1026033 and Australian Medical Research Future Fund grant no. MRF1199715 (P.A.W.R., S.H.-C., and M.H.). Proteomics International has filed patent WO 2021/184060 A1 that relates to endometriosis biomarkers described in this manuscript; S.B., R.L., and T.C. declare an interest in this patent. J.I., S.B., C.L., D.I., H.L., K.P., M.D., M.M., M.R., P.T., R.L., and T.C. are shareholders in Proteomics International. Otherwise, the authors have no conflicts of interest.

TRIAL REGISTRATION NUMBER: N/A.

PMID:39719050 | DOI:10.1093/humrep/deae278

Categories
Nevin Manimala Statistics

Biosimilars versus the originator of follitropin alfa for ovarian stimulation in ART: a systematic review and meta-analysis

Hum Reprod. 2024 Dec 24:deae274. doi: 10.1093/humrep/deae274. Online ahead of print.

ABSTRACT

STUDY QUESTION: Is the probability of pregnancy different between women using biosimilars versus the originator of follitropin alfa for ovarian stimulation in ART?

SUMMARY ANSWER: Meta-analysis of eight randomized clinical trials (RCTs) suggests that live birth, clinical, and ongoing pregnancy rates are significantly lower with biosimilars of follitropin alfa compared to the originator.

WHAT IS KNOWN ALREADY: All biosimilars of follitropin alfa have received regulatory approval by demonstrating non-inferiority in the number of retrieved oocytes compared to the originator. Nevertheless, the most clinically relevant outcome in ART for both clinicians and patients is live birth. A meta-analysis published in 2021 suggested that biosimilars of follitropin alfa are associated with lower live birth rates compared to the originator. Since then, more relevant RCTs have been published, and thus an updated critical synthesis of the available evidence is urgently warranted.

STUDY DESIGN, SIZE, DURATION: A systematic review and meta-analysis were performed to compare biosimilars versus the originator of follitropin alfa in women undergoing ovarian stimulation for ART. A literature search was conducted until January 2024 in MEDLINE, Embase, Cochrane CENTRAL, Scopus, Web of Science, WHO, Clinicaltrials.gov, and others to identify eligible RCTs. The primary outcome was live birth. Secondary outcomes included clinical and ongoing pregnancy, duration of gonadotrophin administration and total FSH dose, number of oocytes retrieved, and ovarian hyperstimulation syndrome (OHSS).

PARTICIPANTS/MATERIALS, SETTING, METHODS: Data were extracted independently by two reviewers. Quality was assessed using the RoB-2 Tool by Cochrane, and a sensitivity analysis was performed by excluding studies having high risk of bias. Meta-analysis was performed using the random or fixed effects model depending on the presence or not of significant (>50%) statistical heterogeneity (I2). Results were combined using the intention-to-treat principle and are reported as risk ratio (RR) or weighted-mean-difference (WMD) with 95% CIs.

MAIN RESULTS AND THE ROLE OF CHANCE: Eight RCTs (n = 2987) (published between 2015 and 2023) were identified, assessing seven biosimilar products of follitropin alfa. The number of patients included in the eligible studies ranged from 100 to 1100. Three of the RCTs were deemed to be at high risk of bias. The duration of gonadotrophin administration was shorter in the biosimilars group (WMD: -0.19 days, 95% CI: -0.34 to -0.05; I2 = 0%, 5 studies, n = 2081), while no difference was observed in the total dose of FSH (WMD: -34.69 IUs, 95% CI: -74.54 to 5.16; I2 = 15.53%, 5 studies, n = 2081). No difference was observed in the number of oocytes retrieved (WMD: 0.27, 95% CI: -0.43 to 0.96; I2 = 10.7%, 6 studies, n = 1527) and OHSS rates (RR: 1.17, 95% CI: 0.90-1.52; I2 = 0%, 8 studies, n = 2986) between the two groups. A significantly lower live birth rate was observed using the biosimilars of follitropin alfa compared to the originator in women undergoing ovarian stimulation for ART (RR: 0.83, 95% CI: 0.72-0.96; I2 = 0%, 6 studies, n = 2335; moderate certainty of evidence). Similarly, clinical pregnancy (RR: 0.82, 95% CI: 0.73-0.92; I2 = 0%, 7 studies, n = 2876; low certainty of evidence) and ongoing pregnancy rates (RR: 0.81, 95% CI: 0.70-0.94; I2 = 0%, 7 studies, n = 1886; low certainty of evidence) were lower in the biosimilars group. These results were not materially altered in the sensitivity analyses performed where studies deemed at high risk of bias were excluded.

LIMITATIONS, REASONS FOR CAUTION: This meta-analysis included RCTs evaluating seven different biosimilars of follitropin alfa; however, pooled data appeared to be homogeneous. No data were available comparing biosimilars of follitropin alfa with the originator regarding cumulative live birth rate per aspiration or the probability of live birth in frozen thawed cycles. The population examined in the eligible RCTs includes mainly normal responders and no RCTs were identified focusing on poor or high responders.

WIDER IMPLICATIONS OF THE FINDINGS: Clinicians should be informed that although biosimilars of follitropin alfa produce similar number of oocytes with the originator, pregnancy rates after a fresh transfer are likely to be lower. Future research should focus on optimizing the production and use of biosimilars of follitropin alfa, so that they lead to pregnancy rates comparable to the originator.

STUDY FUNDING/COMPETING INTEREST(S): No external funding was used for this study. K.I.K. and A.S. have no competing interest to disclose. E.M.K. reports personal fees and non-financial support from Merck, Ferring, IBSA, and Vianex. B.W.M. has been supported by an investigator grant from NHMRC, has received consulting fees from Organon, Merck, and Norgine, research support and non-financial support from Merck KGaA, Darmstadt, Germany. B.W.M. also reports having stocks from OBsEva. C.A.V. reports grants, personal fees, and non-financial support from Merck KGaA, Darmstadt, Germany, personal fees, and non-financial support from Merck, Sharpe and Dohme, personal fees and non-financial support from Organon, grants and non-financial support from Ferring, personal fees from IBSA, and personal fees and non-financial support from Gedeon Richter and Vianex.

REGISTRATION NUMBER: Protocol for the systematic review registered in The International Prospective Register of Systematic Reviews (PROSPERO; CRD42024498237).

PMID:39719046 | DOI:10.1093/humrep/deae274

Categories
Nevin Manimala Statistics

A pilot study of transcriptomic preimplantation genetic testing (PGT-T): towards a new step in embryo selection?

Hum Reprod. 2024 Dec 24:deae265. doi: 10.1093/humrep/deae265. Online ahead of print.

ABSTRACT

STUDY QUESTION: Is it possible to predict an euploid chromosomal constitution and identify a transcriptomic profile compatible with extended embryonic development from RNA sequencing (RNA-Seq) data?

SUMMARY ANSWER: It has been possible to obtain a karyotype comparable to preimplantation genetic testing for aneuploidy (PGT-A), in addition to a transcriptomic signature of embryos which might be suggestive of improved implantation capacity.

WHAT IS KNOWN ALREADY: Conventional assessment of embryo competence, based on morphology and morphokinetic, lacks knowledge of molecular aspects and faces controversy in predicting ploidy status. Understanding the embryonic transcriptome is crucial, as gene expression influences development and implantation. PGT has improved pregnancy rates, but problems persist when high-quality euploid embryos do not reach term. In fact, only around 50-60% implant, of which 10% result in miscarriage. Comprehensive approaches, including RNA-Seq, offer the potential to discover molecular markers of reproductive competence, and could theoretically be combined with extended-embryo culture platforms up to Day 14 that can be utilized as a proxy to study embryo development at post-implantation stages.

STUDY DESIGN, SIZE, DURATION: This prospective pilot cohort study was conducted from March 2023 to August 2023. A total of 30 vitrified human blastocysts with previous PGT-A diagnosis on Day 5 (D5) or Day 6 (D6) of development were analysed: n = 15 euploid and n = 15 aneuploid. Finally, 21 embryo samples were included in the study; the rest (n = 9) were excluded due to poor quality pre-sequencing data (n = 7) or highly discordant data (n = 2).

PARTICIPANTS/MATERIALS, SETTING, METHODS: Following warming and re-expansion, embryos underwent a second trophectoderm (TE) biopsy. The embryos were then cultured until day 11 to assess their development. Biopsy analysis by RNA-Seq, studied the differential expressed genes (DEG) to compare embryos which did not or did attach to the plate: unattached embryos (n = 12) versus attached embryos (n = 9). Thus, we also obtained a specific transcriptomic signature of embryos with a “theoretical” capacity for sustained implantation, based on plate attachment on day 11.

MAIN RESULTS AND THE ROLE OF CHANCE: The digital karyotype obtained by RNA-Seq showed good concordance with the earlier PGT-A data, with a sensitivity of 0.81, a specificity of 0.83, a Cohen’s Kappa of 0.66, and an area under the ROC of 0.9. At the gene level, 76 statistically significant DEGs were found in the comparison unattached versus attached embryos (Padj < 0.05; FC > 1). To address the functional implications of these differences, significantly deregulated pathways according to GO and KEGG categories were identified. The mural trophectoderm (TE) of the unattached blastocysts showed 63 significantly deregulated terms, displaying upregulation in autophagy, apoptosis, protein kinase and ubiquitin-like protein ligase activity, and downregulation of ribosome, spliceosome, kinetochore, segregation, and chromosome condensation processes. The overall transcriptomic signature specific to embryos still attached to the plate on day 11 (with a theoretically higher implantation capacity) consists of 501 genes, including: EMP2, AURKB, FOLR1, NOTCH3, LRP2, FZD5, MDH1, APOD, GPX8, COLEC12, HSPA1A, CMTM7, BEX3, which are related to implantation and embryonic development (raw P-value < 0.05; shrunk LFC > 1.1). These findings indicate that it might be possible to identify euploid embryos with a greater capacity for implantation and development, after excluding those embryos that present chromosomal alterations.

LIMITATIONS, REASONS FOR CAUTION: This study included a small sample size, remarkable variability between samples, and low success rate of RNA amplification. Also, structural chromosomal abnormalities were not included, and it was not possible to diagnose mosaic embryos. TE biopsy does not assure the chromosomal status of the whole embryo. The maximum day for in vitro development was Day 11, and attachment to the plate on this day does not provide a clear indication of implantation capacity and viability, which was not tested in this study.

WIDER IMPLICATIONS OF THE FINDINGS: The short-term goals following on from this pilot study is to expand the sample size with embryos of more complex abnormalities, and to perform a prospective in vitro preclinical validation. In a more distant future and with optimal results, this technique could have clinical application, thus increasing clinical outcomes by assessing both chromosomal content and transcriptomic profiling.

STUDY FUNDING/COMPETING INTEREST(S): The Institut Valencià de Competitivitat Empresarial (IVACE) (IMIDCA/2022/39) and Generalitat Valenciana (CIACIF/2021/11) supported the present study. A.C. is an employee of JUNO Genetics. He has received honoraria for an IBSA lecture and a Merck lecture. He is also a minor shareholder of IVIRMA Global. The other authors have no conflicts of interest to declare.

TRIAL REGISTRATION NUMBER: N/A.

PMID:39719045 | DOI:10.1093/humrep/deae265

Categories
Nevin Manimala Statistics

Magnetic Resonance Imaging does not distinguish Kallmann syndrome from normosmic isolated hypogonadotropic hypogonadism

Endocr Connect. 2024 Dec 1:EC-24-0437. doi: 10.1530/EC-24-0437. Online ahead of print.

ABSTRACT

INTRODUCTION AND OBJECTIVES: Isolated hypogonadotropic hypogonadism (IHH) may be associated with pituitary gland and olfactory system disorders. We aimed to correlate findings of Magnetic Resonance Imaging (MRI) of the pituitary gland and olfactory system in IHH patients with the patients’ olfactory phenotype.

PATIENTS AND METHODS: The present research was a single-center retrospective case-control study. MRI patterns of pituitary gland and olfactory system were studied in 46 patients, of whom 29 (63%) were classified on the basis of olfactometry as having Kallmann syndrome (KS) (16 patients with anosmia; 13 patients with hyposmia) and 17 (37%) as having normosmic IHH (nIHH). Results were compared with age- and sex-matched healthy controls. Genetic diagnosis was conducted in all IHH patients based on next-generation sequencing (NGS).

RESULTS: Almost 70% prevalence of pituitary hypoplasia was observed in IHH subjects. Olfactory Bulb (OB) abnormalities were identified in 80.4% of all patients, both the KS (82.8%) and the nIHH (76.5%) subjects. Incidence of unilaterally abnormal, hypoplastic Olfactory Sulcus (OS) was equally frequent in nIHH and KS. Statistically, piriform cortical thickness was significantly lower in all patient groups than in controls.

CONCLUSIONS: MRI cannot exclusively differentiate between KS and nIHH, as both conditions may present with OB and OS abnormalities. A surprisingly high frequency of olfactory system abnormalities was observed in nIHH patients, while anterior pituitary hypoplasia was prevalent across all IHH patients. Notably, OB abnormalities were more predominant in KS patients than in those with nIHH.

PMID:39719010 | DOI:10.1530/EC-24-0437

Categories
Nevin Manimala Statistics

All Enabling Technology Is Not Created Equal: Comparing Outcomes of Computer-Assisted Fluoroscopic Navigation Versus Robotic-Assisted Total Hip Arthroplasty

J Am Acad Orthop Surg Glob Res Rev. 2024 Dec 23;8(12). doi: 10.5435/JAAOSGlobal-D-24-00324. eCollection 2024 Dec 1.

ABSTRACT

BACKGROUND: Computer-assisted fluoroscopic navigation and robotic technologies aim to optimize implant placement and alignment in primary total hip arthroplasty (THA) to improve patient outcomes. This study uses a retrospective hospital billing database covering 1,300 hospitals to compare the clinical and economic effect of these technologies.

METHODS: The study compared patients undergoing THA with robotic versus computer-assisted fluoroscopic navigation technologies between January 1, 2016, and September 30, 2021, using the Premier Healthcare Database. Primary outcomes were operating room time and readmission rates. Secondary outcomes were length of stay, discharge status, revision rates within 90- and 365-day follow-up, and hospital costs. Baseline covariate differences between the two cohorts were balanced using fine stratification methodology and analyzed using generalized linear models. A sensitivity analysis was conducted using the nearest neighbor matching as the covariate balancing technique.

RESULTS: The cohorts included 4,378 fluoroscopically navigated THA and 10,423 robotic-assisted THA procedures with 90-day follow-up. Operating room time was markedly lower with fluoroscopic navigation compared with robotic-assisted technology (137.74 vs. 156.00 minutes; P < 0.001). Hip-related readmission rates were markedly lower (P < 0.001) for fluoroscopic navigation for both 90- and 365-day follow-up, by 43% and 40% respectively, compared with robotic-assisted technology. Results showed increased discharge ratio to home/home health, reduced length of stay, and lower hospital costs for fluoroscopic navigation compared with robotic-assisted technology. Revision rates were similar for both cohorts.

CONCLUSION: Using computer-assisted fluoroscopic navigation in THA was associated with markedly lower operating room time and readmission rates while also having improved healthcare outcomes and costs compared with robotic-assisted technology.

PMID:39719008 | DOI:10.5435/JAAOSGlobal-D-24-00324

Categories
Nevin Manimala Statistics

Challenges and Lessons Learned in Managing Web-Based Survey Fraud for the Garnering Effective Outreach and Research in Georgia for Impact Alliance-Community Engagement Alliance Survey Administrations

JMIR Public Health Surveill. 2024 Dec 24;10:e51786. doi: 10.2196/51786.

ABSTRACT

BACKGROUND: Convenience, privacy, and cost-effectiveness associated with web-based data collection have facilitated the recent expansion of web-based survey research. Importantly, however, practical benefits of web-based survey research, to scientists and participants alike, are being overshadowed by the dramatic rise in suspicious and fraudulent survey submissions. Misinformation associated with survey fraud compromises data quality and data integrity with important implications for scientific conclusions, clinical practice, and social benefit. Transparency in reporting on methods used to prevent and manage suspicious and fraudulent submissions is key to protecting the veracity of web-based survey data; yet, there is limited discussion on the use of antideception strategies during all phases of survey research to detect and eliminate low-quality and fraudulent responses.

OBJECTIVE: This study aims to contribute to an evolving evidence base on data integrity threats associated with web-based survey research by describing study design strategies and antideception tools used during the web-based administration of the Garnering Effective Outreach and Research in Georgia for Impact Alliance-Community Engagement Alliance (GEORGIA CEAL) Against COVID-19 Disparities project surveys.

METHODS: GEORGIA CEAL was established in response to the COVID-19 pandemic and the need for rapid, yet, valid, community-informed, and community-owned research to guide targeted responses to a dynamic, public health crisis. GEORGIA CEAL Surveys I (April 2021 to June 2021) and II (November 2021 to January 2022) received institutional review board approval from the Morehouse School of Medicine and adhered to the CHERRIES (Checklist for Reporting Results of Internet E-Surveys).

RESULTS: A total of 4934 and 4905 submissions were received for Surveys I and II, respectively. A small proportion of surveys (Survey I: n=1336, 27.1% and Survey II: n=1024, 20.9%) were excluded due to participant ineligibility, while larger proportions (Survey I: n=1516, 42.1%; Survey II: n=1423, 36.7%) were flagged and removed due to suspicious activity; 2082 (42.2%) and 2458 (50.1%) of GEORGIA CEAL Surveys I and II, respectively, were retained for analysis.

CONCLUSIONS: Suspicious activity during GEORGIA CEAL Survey I administration prompted the inclusion of additional security tools during Survey II design and administration (eg, hidden questions, Completely Automated Public Turing Test to Tell Computers and Humans Apart verification, and security questions), which proved useful in managing and detecting fraud and resulted in a higher retention rate across survey waves. By thorough discussion of experiences, lessons learned, and future directions for web-based survey research, this study outlines challenges and best practices for designing and implementing a robust defense against survey fraud. Finally, we argue that, in addition to greater transparency and discussion, community stakeholders need to be intentionally and mindfully engaged, via approaches grounded in community-based participatory research, around the potential for research to enable scientific discoveries in order to accelerate investment in quality, legitimate survey data.

PMID:39718988 | DOI:10.2196/51786

Categories
Nevin Manimala Statistics

Associations between breastfeeding and breast cancer risk through mammographic breast density in a cohort of Korean women

Int J Epidemiol. 2024 Dec 16;54(1):dyae165. doi: 10.1093/ije/dyae165.

ABSTRACT

BACKGROUND: Mammographic breast density has been suggested to play a role as a mediator between the risk factors for breast cancer (BC) and BC risk. We investigated the extent to which never breastfeeding is a risk factor for BC and how this risk is further mediated by increased mammographic breast density.

METHODS: This retrospective cohort study included 4 136 723 women aged ≥40 years who underwent mammographic screening between 2009 and 2010 and were followed up until 31 December 2020. Breastfeeding information was obtained by using a self-administered questionnaire. Mammographic breast density was extracted from national BC screening results, which were assessed by trained radiologists and categorized into dense and fatty breasts. We estimated the hazard ratios (HRs) and the proportion of the associations between breastfeeding and BC risk mediated by breast density.

RESULTS: The HR of never breastfeeding on BC risk was 1.34 (95% CI, 1.32-1.37) when adjusted for only parity, body mass index and smoking status, which were selected as covariates through a directed acyclic graph and 1.21 (95% CI, 1.19-1.23) when breast density was additionally adjusted. The proportion of the association between never breastfeeding and BC risk mediated by breast density in total, pre- and post-menopausal women was 35.48%, 17.86% and 24.0%, respectively (all P < 0.001). The HR of never breastfeeding on BC risk was 1.10 (95% CI, 1.08-1.12) when adjusted for nine known breast cancer risk factors and 1.09 (95% CI, 1.07-1.12) when breast density was additionally adjusted. The proportion of the association between never breastfeeding and BC risk mediated by breast density in the total, pre- and post-menopausal women was 7.50%, 3.71% and 12.21%, respectively (all P < 0.001).

CONCLUSIONS: Our findings suggest that the association between never breastfeeding and BC risk may be mediated by breast density. However, the HR and proportion of medications varied according to the adjusted covariates, highlighting that variables for adjustment should be selected based on directed acyclic graphs.

PMID:39718984 | DOI:10.1093/ije/dyae165

Categories
Nevin Manimala Statistics

Clinical and patient-reported outcomes in women offered oncoplastic breast-conserving surgery as an alternative to mastectomy: ANTHEM multicentre prospective cohort study

Br J Surg. 2024 Dec 24;112(1):znae306. doi: 10.1093/bjs/znae306.

ABSTRACT

BACKGROUND: Oncoplastic breast-conserving surgery may be a better option than mastectomy, but high-quality comparative evidence is lacking. The aim of the ANTHEM study (ISRCTN18238549) was to explore clinical and patient-reported outcomes in a multicentre cohort of women offered oncoplastic breast-conserving surgery as an alternative to mastectomy with or without immediate breast reconstruction.

METHODS: Women with invasive/pre-invasive breast cancer who were offered oncoplastic breast-conserving surgery with volume replacement or displacement techniques to avoid mastectomy were recruited prospectively. Demographic, operative, oncological, and 3- and 12-month complication data were collected. The proportion of women choosing oncoplastic breast-conserving surgery and the proportion in whom breast conservation was successful were calculated. Participants completed the validated BREAST-Q questionnaire at baseline, 3 months after surgery, and 12 months after surgery. Questionnaires were scored according to the developers’ instructions and scores for each group were compared over time.

RESULTS: In total, 362 women from 32 UK breast units participated, of whom 294 (81.2%) chose oncoplastic breast-conserving surgery. Of the oncoplastic breast-conserving surgery patients in whom postoperative margin status was reported, 210 of 255 (82.4%) had clear margins after initial surgery and only 10 (3.9%) required completion mastectomy. Major complications were significantly more likely after immediate breast reconstruction. Women having oncoplastic breast-conserving surgery with volume displacement techniques reported significant improvements in baseline ‘satisfaction with breasts’ and ‘psychosocial well-being’ scores at 3 and 12 months, but both oncoplastic breast-conserving surgery groups reported significant decreases in ‘physical well-being: chest’ at 3 and 12 months.

CONCLUSION: Oncoplastic breast-conserving surgery allows greater than 95% of women to avoid mastectomy, with lower major complication rates than immediate breast reconstruction, and may improve satisfaction with outcome. Oncoplastic breast-conserving surgery should be offered as an alternative to mastectomy in all women in whom it is technically feasible.

PMID:39718969 | DOI:10.1093/bjs/znae306

Categories
Nevin Manimala Statistics

Self-gripping mesh in laparoscopic inguinal hernia repair: A comparative study about surgical time, post-operative pain and recurrence

J Minim Access Surg. 2024 Dec 24. doi: 10.4103/jmas.jmas_62_24. Online ahead of print.

ABSTRACT

INTRODUCTION: In laparoscopic inguinal hernia repair (LIHR), fixation means for meshes (FMMs) are commonly used to reduce hernia recurrence risk. Their use may result in post-operative pain (PP) and may even increase surgical time (ST). Recently, self-gripping meshes (SGMs) have been developed, which leave aside fixation devices; they could potentially reduce PP and even decrease ST. Our primary outcome was to compare ST, PP and recurrence rates in LIHR using SGM versus FMM.

PATIENTS AND METHODS: A comparative retrospective study with prospective case registry was conducted. All patients who underwent LIHR with transabdominal pre-peritoneal approach from January to December 2022 in a high-volume centre were analysed. Patients were divided into two groups according to the type of mesh used in surgery (SGM vs. FMM). Demographic variables, hernia type and size, mesh type and size, ST, PP, recurrence and other morbidities were compared between the groups.

RESULTS: A total of 411 LIHRs were performed during the period, of which 283 were included in the study. Of these, 234 patients were repaired with FMM and 49 with SGM. ST had a statistically significant reduction in the SGM group (P = 0.0004) with a mean time of 58.9 min (±13.6), compared to 68.1 min (±18.9) for the FMM group. A trend towards lower PP in the SGM group was noted (P = 0.08). No recurrences were found in the SGM group with a median follow-up of 18 months (interquartile range: 3).

CONCLUSIONS: SGMs have proven to be a safe, efficient and fast for LIHR in our series. They are a feasible alternative for LIHR, reducing ST and potentially reducing PP. Prospective randomised trials are needed to confirm this trend, along with a longer follow-up period to determine potential advantages in terms of recurrences.

PMID:39718940 | DOI:10.4103/jmas.jmas_62_24