Category: Nevin Manimala

BMJ Open. 2023 Oct 16;13(10):e066378. doi: 10.1136/bmjopen-2022-066378.

ABSTRACT

OBJECTIVE: To examine characteristics of clinician input to the pan-Canadian Oncology Drug Review (pCODR) for cancer drug funding recommendations from 2016 to 2020.

DESIGN, SETTING AND PARTICIPANTS: Descriptive, cross-sectional study including 62 reimbursement decisions from pCODR from 2016 to 2020.

INTERVENTIONS: pCODR recommendations were analysed for the number of clinicians consulted on each submission, affiliation, number of submissions per clinician, declared financial conflicts of interest (FCOIs), randomisation, type of blinding, primary endpoint, study phase, and whether the study demonstrated improvement in overall survival (OS) and progression-free survival (PFS).

MAIN OUTCOME MEASURES: The main outcome was clinician support for the initial funding recommendation. Secondary outcome measures were the association between clinician FCOIs and clinical benefit in positive recommendations.

RESULTS: The study consisted of 62 submissions, in which 48 included clinician input. A total of 129 unique clinicians provided 342 consultations. The majority (59%) provided input on less than 5 submissions; however, a small proportion (4%) consulted on over 10. Nearly all clinicians were physicians (125; 96%). From the 342 consultations, 228 declared financial conflicts (67%). The most common conflicts were payments for advisory roles (51%) and honorariums (23%). Of the 48 cancer drugs under review, clinicians recommended funding 46 (96%). Only 12 (25%) demonstrated substantial benefit, according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale score. Drugs recommended for funding were more likely to have improved PFS and OS data. However, most cancer drugs supported by clinicians demonstrated no change in health-related quality of life (HRQoL), including one that demonstrated worsened HRQoL. There was no statistically significant difference between FCOI status and recommending drugs with health gains.

CONCLUSION: Clinicians offer crucial information on funding decisions. However, we found clinicians strongly supported funding nearly all cancer drugs under review, despite most not offering substantial benefit to patients nor gains in quality of life. While these drugs might be helpful options in clinical practice, funding numerous cancer drugs may be unsustainable for public health systems.

PMID:37844982 | DOI:10.1136/bmjopen-2022-066378

Int J Gynecol Cancer. 2023 Oct 16:ijgc-2023-004401. doi: 10.1136/ijgc-2023-004401. Online ahead of print.

ABSTRACT

OBJECTIVE: In Belgium there is no centralization of surgery for ovarian cancer, with more than 100 centers treating around 800 cases per year. In 2017 a network with several collaborating hospitals was established to centralize surgery for ovarian cancer (UCLouvain Network of Gynecological Oncology; UNGO) following publication of the European Society of Gynecological Oncology (ESGO) recommendations and quality criteria for surgery of advanced ovarian cancer. We obtained ESGO accreditation in 2019.

METHODS: We retrospectively collected data associated with patients undergoing surgery in our institution from 2007 to 2016, before the creation of the network (cohort 1) and, following the establishment of UNGO (2017-2021), patients undergoing surgery were prospectively registered in a REDCap database (cohort 2). The outcomes of the two cohorts were compared.

RESULTS: A total of 314 patients underwent surgery in our institution from 2007 and 2021: 7.5 patients/year in cohort 1 (retrospective, 2007-2016) and 40.8 patients/year in cohort 2 (after network creation, 2017-2021). Median disease-free survival was increased from 16.5 months (range 13.2-20.4) in cohort 1 to 27.1 months (range 21.5-33.2) in cohort 2 (p=0.0004). In cohort 2, the rate of patients with residual disease at the end of the surgery was significantly less (18.7% vs 8.8%, p=0.023), although more patients in cohort 1 received neoadjuvant chemotherapy (89% vs 54%, p<0.001). However, there was a higher rate of complications in the patients in cohort 2 (18.8% vs 30%, p=0.041).

CONCLUSION: Our study shows that, with the help of ESGO and its recommendations, we have been able to create an efficient advanced ovarian cancer centralized network and this may provide an improvement in the quality of care.

PMID:37844964 | DOI:10.1136/ijgc-2023-004401

Neurosciences (Riyadh). 2023 Oct;28(4):220-226. doi: 10.17712/nsj.2023.4.20230021.

ABSTRACT

OBJECTIVES: To compare the effectiveness of aspirin-clopidogrel dual antiplatelet therapy (DAPT) with aspirin or clopidogrel antiplatelet monotherapy (AM) in patients with ischemic stroke.

METHODS: It was a single-center, retrospective cross-sectional study of medical records of ischemic stroke patients admitted at King Abdulaziz University Hospital between January 2015 and October 2019. The primary endpoints were ischemic stroke recurrence, rehospitalization, and all-cause mortality between DAPT and AM. Kaplan-Meier and Cox proportional hazard analyses were employed in univariate and multivariate time-to-event analyses.

RESULTS: The median time to recurrence of ischemic stroke was 15.0 months (95% confidence interval [CI], 8.586-23.01) for DAPT and 20.4 months (95% CI, 9.872-30.928) for the AM. The median survival time until all-cause mortality was 8.0 months (95% CI, 2.893-13.107) for DAPT and 14.1 months (95% CI, 8.173-19.97) for the AM. No statistically significant reductions in the instantaneous risks of recurrence (hazard ratio [HR], 1.27; 95% CI, 0.59-2.72; p=0.54), re-hospitalization (HR, 0.95; 95% CI, 0.59-1.48; p= 0.77), and mortality (HR, 1.04; 95% CI, 0.48-2.26; p=0.92) were found between the DAPT and AM groups.

CONCLUSION: The DAPT was not superior to AM in reducing recurrence and mortality events in patients with ischemic stroke. Rehospitalization due to the sequelae of the composite of stroke, angina, and myocardial infarction was higher in the DAPT group.

PMID:37844946 | DOI:10.17712/nsj.2023.4.20230021

Cir Cir. 2023;91(5):698-702. doi: 10.24875/CIRU.22000004.

ABSTRACT

BACKGROUND: Testicular infiltration is infrequent in pediatric patients with leukemia and can be confused with other testicular conditions.

OBJECTIVE: To analyze the presence of clinical and radiological features suggestive of testicular disease and its histological association with leukemia infiltration.

METHOD: Retrospective and analytical observational study that included patients with diagnosis of leukemia who underwent biopsy for suspected testicular infiltration. The relationship with the variables analyzed were diagnosis, reason for taking the biopsy, ultrasound findings, stage of treatment, induration, increased volume and pain, with testicular infiltration.

RESULTS: Eighteen patients were included; 11 of them with microlithiasis, of which one 1 reported infiltration (odds ratio: 0.075; p = 0.026), no association was found between ultrasound findings and the presence of infiltration. Clinical findings were significantly associated with positive biopsies.

CONCLUSIONS: No risk association was found with the ultrasound findings such as microlithiasis and hypoechoic imaging. The clinically evident testicular disease (testicular enlargement and testicular induration) has a significant statistic association with the presence of leukemia infiltration.

PMID:37844902 | DOI:10.24875/CIRU.22000004

Cir Cir. 2023;91(5):690-697. doi: 10.24875/CIRU.22000309.

ABSTRACT

BACKGROUND: Colorectal anastomosis leak (AL) is the most feared complication of rectal cancer surgery (1-19%) as it increases morbidity and mortality and worsens oncological outcomes in terms of local recurrence and survival. The publication of the REAL-score index makes it possible to predict the risk of AL and compare the expected results with those obtained.

METHOD: Observational, descriptive, longitudinal and retrospective study of patients operated on for rectal cancer at the Miguel Servet University Hospital, in Zaragoza, Spain, in 2019. Statistical analysis of morbidity and mortality outcome variables and the REAL-score index using ROC curves.

RESULTS: Of 80 patients operated on for rectal cancer, colorectal anastomosis was performed in 52 and temporary ileostomy in 11 (21.2%). Morbidity was high (38.4%), but severe only in 7.7% (Clavien-Dindo IIIb), with no deaths. There were four dehiscences: one type B and three type C. A direct relationship between high risk of AL and the practice of temporary stoma is observed when the cut-off point of the REAL-score exceeds 14.74%.

CONCLUSIONS: REAL-score can help in decision-making in rectal cancer surgery. Above a cut-off point, the risk of AL would imply a selective ileostomy.

PMID:37844900 | DOI:10.24875/CIRU.22000309

Cir Cir. 2023;91(5):703-708. doi: 10.24875/CIRU.21000797.

ABSTRACT

BACKGROUND: Developmental dysplasia of the hip (DDH) is a complex clinical entity that is usually underdiagnosed, if not detected and managed early, will turn the affected individual into a disabled being, with negative social, economic and emotional effects.

OBJECTIVE: To determine the capacity for the timely radiographic detection of DDH before and after an educational intervention.

METHOD: An educational intervention is carried out in family medicine resident, where they are given training on detection in DDH radiographic projections. Pre- and post-training evaluation is carried out. Statistical analysis is performed using Student’s t and χ², taking p ≤ 0.05 as significant.

RESULTS: 94 residents participated. In the pre-intervention evaluation, 87.2% had no knowledge of the early detection protocol (p = 0.525). It was observed that 98.9% incorrectly drew the Perkins line (p = 0.427), 96.8% the Hilgenreiner line (p = 0.177) and 87.2% did not consider the data of bilateral dysplasia (p = 0.956). After the educational intervention, 87.2% correctly drew the Perkins line (p = 0.926), 97.8% the Hilgenreiner line (p = 0.325) and 78.7% if they considered the data of bilateral dysplasia (p = 0.826).

CONCLUSIONS: After this training, 80% of family medicine residents were able to detect DDH in a timely manner.

PMID:37844899 | DOI:10.24875/CIRU.21000797

Cir Cir. 2023;91(5):641-647. doi: 10.24875/CIRU.23000311.

ABSTRACT

OBJECTIVE: In this randomized and prospective research, we aimed to relieve surgical and muscle-related pain early after lumbar disc operations with caudal preemptive analgesia.

MATERIALS AND METHODS: A total of 120 patients with single-level lumbar disc herniation were included in this study. The caudal epidural injection was performed for all patients 20 min before surgery. The patients were divided into three groups. Non-steroidal anti-inflammatory drugs or tramadol use were recorded. Pre-operative and post-operative pain was interpreted through a visual analog scale.

RESULTS: There was a difference between the groups in all post-operative measurements (p < 0.05), between Group 1 and Group 3, and between Group 2 and Group 3. A statistical significance has been achieved between the groups at the 1^st h, 2^nd h, 4^th h, and 24^th h (p < 0.05). The difference between the pain intensities of the patients at the 24^th h and the 1^st week was statistically significant in Groups 1 and 2 (p < 0.05). Evaluation of the effects of medical treatments reduced the severity of back pain and foot pain.

CONCLUSION: The preemptive bupivacaine or in combination with methylprednisolone caudal injection is an effective and safe method to reduce post-operative pain and ameliorate functional capacity for the treatment of lumbar disc herniation.

PMID:37844891 | DOI:10.24875/CIRU.23000311

Cir Cir. 2023;91(5):627-632. doi: 10.24875/CIRU.22000578.

ABSTRACT

OBJECTIVE: Acidosis is the most dangerous complication in subarachnoid hemorrhage (SAH). This study aimed to investigate the effect of acidic cerebrospinal fluid on central canal structures after SAH.

MATERIALS AND METHODS: Twenty-eight hybrid rabbits were studied. Blood and cerebrospinal fluid pH values were recorded before/during/after the experimental procedures. The structures related to the central canals at the level of C5 of the cervical spinal cord were then examined histopathologically. The relationship between pH values of ependymal cells and degenerated epithelial cell densities was statistically analyzed.

RESULTS: Mean blood pH values and degenerated ependymal cell density (n/mm²) were as follows: 7.351 ± 0.033/23 ± 7 in control, 7.322 ± 0.059/78 ± 13 in SHAM, and 7.261 ± 0.048/254 ± 62 in study animals. Gross examinations revealed swelling, edema, pia-arachnoid adhesions, ventral canal dilatation, arachnoiditis, central canal hemorrhage, occlusions, and dilatation in the spinal cord.

CONCLUSION: Cerebrospinal fluid acidosis-induced central channel pathologies should be considered an important complication of SAH following SAH.

PMID:37844888 | DOI:10.24875/CIRU.22000578

Cir Cir. 2023;91(5):658-663. doi: 10.24875/CIRU.22000419.

ABSTRACT

BACKGROUND: Open abdomen is an alternative for the management of trauma patient, and negative pressure therapy of the wound using VAC^® device is a genuine sort of treatment. Although the device poses technical advantages, risks are present and a critical complication is the enteroatmospheric fistula formation (EAF).

OBJECTIVE: To analize the role of negative pressure therapy length and VAC^® device number of changes on the EAF formation in trauma patients udergoing open abdomen.

METHOD: Cut-off points were calculated using receiver operational characteristics curve. Values were compared with Student’s t or Mann-Withney U tests, considering statistically significant p < 0.05.

RESULTS: EAF were present in 39 cases (5.9%). A significant difference in the presence of EAF was present in patients with negative pressure therapy of the wound length ≥ 11.2 days (46.9 vs. 1.3%; relative risk [RR]: 3.67; 95% confidence interval [95% IC]: 2.4-6.68; p = 0.017) and when ≥ 2.6 VAC^® device changes were performed (34.6 vs. 0.5%; RR: 6.92; 95% IC: 1.1-4.3; p < 0.001).

CONCLUSIONS: At our institution, the practice of >3 VAC^® device changes and length of therapy > 11 days should be carefully considered leading to reduce the risk of EAF formation.

PMID:37844886 | DOI:10.24875/CIRU.22000419

Cir Cir. 2023;91(5):596-600. doi: 10.24875/CIRU.22000203.

ABSTRACT

OBJECTIVE: To compare the protective effect of nitroglycerin ointment 2% and Dimethylsulfoxide (DMSO) in dorsal flaps of the rat.

METHODS: A blind, experimental study was conducted in 24 male Wistar rats, with a mean weight of 320 (286-376) grams. Group 1: Control. Petrolatum jelly (Vaseline), n = 8, Group 2: Nitroglycerin (NTG) ointment 2% (Nitro-Bid, Altana Co.) n = 8, and Group 3: DMSO gel 90% (Neogen corp. Lexington KY, 40611), n = 8.

RESULTS: A total of 24 rats were operated on in the 6-month period of this study. Using a non-parametric Mann-Whitney U-test analysis, a statistically significant p was obtained between the control group and 2% NTG ointment, both in the area of necrosis and in the healthy area (p = 0.026). In contrast, the comparison between DMSO [CH3) 2SO] and the control group (p = 0.180) and between both study groups, with a p = 0.18, was not significant.

CONCLUSIONS: Our study concluded that there is a protective effect of 2% NTG ointment for flap survival in relation to the control group (petrolatum). DMSO administered topically did not show a protective effect, compared to the control group.

PMID:37844881 | DOI:10.24875/CIRU.22000203