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Nevin Manimala Statistics

Development of a Simplified Patient-Centered Pelvic Floor Surgery Complication Scale

Female Pelvic Med Reconstr Surg. 2021 Sep 30. doi: 10.1097/SPV.0000000000001099. Online ahead of print.

ABSTRACT

OBJECTIVES: There does not currently exist a complication scale to evaluate pelvic reconstructive surgery (PRS) that takes in account patient-centered outcomes. The purpose of this study was to characterize and compare patient and surgeon responses to a simplified, patient-centered version of the previously described Pelvic Floor Complication Scale (PFCS).

METHODS: This is a multicenter (4 female pelvic medicine and reconstructive surgery practices) cross-sectional study of patients and surgeons. Using focus groups and telephone surveys, the original PFCS questionnaire was simplified. One hundred and twenty-four patients were recruited 6-12 months after PRS. Fifty-seven surgeons were recruited via electronic questionnaires. Surgeons and patients were asked to rank the severity and bother of each complication on a scale of 0 to 5 (0, none; 1, mild; 3, moderate; 5, major).

RESULTS: Patients rated bother higher than severity for 36 of 38 complications (all differences ≤0.5 points). For statistical analysis, the highest response to patient bother/severity was chosen to weigh in favor of the patient. Patient bother/severity scores were significantly different (±0.5 points) for 27 of 38 complications compared with surgeon responses. Surgeon scores were higher for 5 complications (0.5-1.9 point differences) related to major injury requiring repair and wound breakdown. Patient scores were higher for 22 complications with the highest differences related to dyspareunia, constipation, or new/persistent urinary incontinence.

CONCLUSIONS: This mixed methods investigation revealed key differences between how patients and surgeons value PRS complications. Surgeons scored major surgical injuries higher than patients, whereas patients rated issues that many surgeons consider quality-of-life outcomes higher due to potential long-term bother. These data will be used to create a simplified, patient-centered PFCS.

PMID:34608035 | DOI:10.1097/SPV.0000000000001099

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Percutaneous Tibial Nerve Stimulation in Diabetic and Nondiabetic Women With Overactive Bladder Syndrome: A Retrospective Cohort Study

Female Pelvic Med Reconstr Surg. 2021 Sep 30. doi: 10.1097/SPV.0000000000001036. Online ahead of print.

ABSTRACT

OBJECTIVES: The primary objective of this study was to compare optimal response (“very much better” or “much better” on the Patient Global Impression of Improvement [PGI-I] index) to posterior tibial nerve stimulation (PTNS) for overactive bladder (OAB) in patients with and without diabetes mellitus. Secondary outcomes included longitudinal data regarding PTNS use in patients with diabetes and controls.

METHODS: We performed a retrospective cohort analysis of women in our tertiary care center who completed at least 10 weekly and 1 maintenance PTNS treatments for OAB, excluding patients who were treated with PTNS for a non-OAB primary diagnosis. Participants were grouped into those with diabetes mellitus and those without. Previous research demonstrated a 20% difference in subjective response to anticholinergics in persons with diabetes versus persons without diabetes with OAB. To demonstrate a 20% difference in optimal PGI-I with 80% power, our analysis required 92 patients in each group.

RESULTS: We identified 356 patients: 96 with diabetes mellitus, and 260 controls. There was no statistically significant difference in the primary outcome, with 43 (44.8%) of 96 persons with diabetes versus 115 (44.2%) of 260 controls demonstrating optimal PGI-I response (P = 0.92). Among patients with diabetes, no baseline variables were found to predict treatment response, including hemoglobin A1C greater than 7%, diabetes with sequelae, or higher Charlson Comorbidity Index.

CONCLUSIONS: In women undergoing PTNS for OAB, the optimal PGI-I response rate is similar in patients with and without diabetes.

PMID:34608031 | DOI:10.1097/SPV.0000000000001036

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Fecal Putative Uropathogen Abundance and Antibiotic Resistance Gene Carriage in Women With Refractory Recurrent Urinary Tract Infection Treated With Fecal Microbiota Transplantation

Female Pelvic Med Reconstr Surg. 2021 Oct 1. doi: 10.1097/SPV.0000000000001090. Online ahead of print.

ABSTRACT

OBJECTIVE: The aims of this study were to describe the fecal relative abundance of potentially uropathogenic bacteria and to analyze antibiotic resistance genes before and after fecal microbiota transplantation in women with recurrent urinary tract infection (UTI).

METHODS: Shotgun sequencing was performed on fecal samples from 3 donors and 4 women with recurrent UTI who underwent transplantation. Recipient samples were sequenced at baseline and at 4 time points through 6 months postintervention. Relative fecal uropathogen abundance was analyzed by species and participant using descriptive statistics. Antibiotic resistance gene abundance was assigned, normalized, and compared between donors and recipients at baseline and postintervention using an abundance bar plot, nonmetric multidimensional scaling, and pairwise permutational multivariate analysis of variance.

RESULTS: The median (range) relative abundance of Escherichia coli in all fecal samples from women with recurrent UTI was 0% (0%-5.10%); Enterococcus faecalis, 0% (0%-0.20%); Enterococcus faecium, 0% (0%-1.90%); Klebsiella pneumoniae, 0% (0%-0.10%); and Pseudomonas aeruginosa, 0% (0%-0.10%). Gut microbes carried genes conferring resistance to antibiotics used for UTI. No significant difference was seen in antibiotic resistance gene carriage after transplantation compared with baseline (P=0.22, R2=0.08 at 3 months). Antibiotic gene composition and abundance were significantly associated with the individual from whom the sample came (P=0.004, R2=0.78 at 3 months).

CONCLUSIONS: Exploratory analysis of gut microbiomes in women with recurrent UTI identifies no or low relative putative uropathogen abundance for all species examined. Antibiotic resistance gene carriage persisted after fecal microbiota transplantation, although conclusions are limited by small sample size.

PMID:34608030 | DOI:10.1097/SPV.0000000000001090

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Glaucoma Prevalence and Glaucoma Surgical Considerations in Prosthetic Replacement of the Ocular Surface Ecosystem Device Use

Eye Contact Lens. 2021 Sep 29. doi: 10.1097/ICL.0000000000000846. Online ahead of print.

ABSTRACT

OBJECTIVES: The purpose of this study was to identify patients with glaucoma and corneal/ocular surface disease who have been fit with Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE; BostonSight, Needham, MA) devices and to understand the PROSE device fit experience in patients with glaucoma at Weill Cornell Medicine (WCM).

METHODS: This is a retrospective chart review of patients older than 18 years who underwent PROSE device fitting at WCM. Records were reviewed for demographic information and ophthalmic variables. Descriptive statistics were performed.

RESULTS: Between 2011 and 2017, 281 patients underwent PROSE device fitting at WCM, of whom 24 patients (8.5%) had a glaucoma diagnosis and 17 patients (6.0%) were identified as glaucoma suspect. Ocular surface disease was the most common indication for PROSE device wear (58.3%). Five patients had a history of incisional glaucoma surgery in the eye undergoing PROSE device fitting: three valved glaucoma drainage implants and two trabeculectomies. Three of these eyes were successfully fit with PROSE devices.

CONCLUSIONS: Patients fitted with Prosthetic Replacement of the Ocular Surface Ecosystem devices at WCM had a higher prevalence of glaucoma than in the general population. Among patients with incisional glaucoma surgery, PROSE device fitting was challenging, with a 40% failure rate.

PMID:34608029 | DOI:10.1097/ICL.0000000000000846

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Corneal Structural Changes in Congenital Glaucoma

Eye Contact Lens. 2021 Sep 30. doi: 10.1097/ICL.0000000000000844. Online ahead of print.

ABSTRACT

OBJECTIVE: To identify corneal structure differences on quantitative high-frequency ultrasound biomicroscopy (UBM) among subjects with congenital glaucoma compared with controls.

METHODS: This prospective case-control study evaluated 180 UBM images from 44 eyes of 30 subjects (18 control and 12 glaucoma, mean age 5.2±8.0 years, range 0.2-25.8 years) enrolled in the Pediatric Anterior Segment Imaging and Innovation Study (PASIIS). ImageJ was used to quantify a comprehensive set of corneal structures according to 21 quantitative parameters. Statistical analysis compared corneal measurements in glaucoma subtypes and age-matched controls with significance testing and mixed effects models.

RESULTS: Significant differences between congenital glaucoma cases and controls were identified in 16 of 21 measured parameters including angle-to-angle, central and peripheral corneal thicknesses, scleral integrated pixel density, anterior corneal radius of curvature, and posterior corneal radius of curvature. Eight parameters differed significantly between primary congenital glaucoma and glaucoma following congenital cataract surgery.

CONCLUSION: Multiple measurable corneal structural differences exist between congenital glaucoma and control eyes, and between primary and secondary congenital glaucoma, including but not limited to corneal width and thickness. The structural differences can be quantified from UBM image analysis. Further studies are needed to determine whether corneal features associated with glaucoma can be used to diagnose or monitor progression of congenital glaucoma.

PMID:34608027 | DOI:10.1097/ICL.0000000000000844

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Intravenous Tranexamic Acid is Associated With a Clinically Significant Reduction in Blood Loss in Craniosynostosis Surgery

J Craniofac Surg. 2021 Sep 29. doi: 10.1097/SCS.0000000000008234. Online ahead of print.

ABSTRACT

Blood loss is a potential cause of morbidity and mortality in craniosynostosis surgery. Recent reports have suggested that the use of tranexamic acid (TXA), an antifibrinolytic agent, mitigates this blood loss. A retrospective cohort study of patients undergoing craniosynostosis surgery at a tertiary craniofacial hospital in Sydney was undertaken. Primary outcomes were blood loss and transfusion requirements. Two groups were compared: those who received intravenous prophylactic TXA and those who underwent surgery without TXA. Statistical analysis was performed with Student t test and the Mann-Whitney U test for nonparametric results. We identified 206 patients who underwent craniosynostosis surgery over an 8 year period; 78 control patients and 128 patients that received TXA. Tranexamic acid was found to result in a weight-adjusted calculated blood loss mean difference of 9.6 ml/kg across all procedures (P = 0.0332 95% confidence interval 0.7734-18.4266). The actual blood loss reduction achieved with TXA was 6.7 ml/kg in spring cranioplasties, compared to 15.2 ml/kg in fronto-orbital remodeling procedures. There was a statistically and clinically significant reduction in postoperative transfusion incidence, with transfusions required in 27% of controls and 6% of TXA patients (P < 0.0001). The number needed to treat to prevent giving a unit of blood postoperatively was 4.8. There wxere no incidences of TXA-specific complications. This study found that TXA is a safe and effective method of decreasing blood loss and transfusion requirements in patients undergoing craniosynostosis surgery. The clinical benefit of TXA is particularly evident in the more invasive craniosynostosis surgeries.

PMID:34608008 | DOI:10.1097/SCS.0000000000008234

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Treatment of Benign Lesion of Levels I or II of the Parotid Gland: Long Term Results of Partial Superficial Parotidectomy

J Craniofac Surg. 2021 Sep 29. doi: 10.1097/SCS.0000000000008226. Online ahead of print.

ABSTRACT

The correct surgical approach to benign parotid gland tumors is still matter of debate, it should be chosen considering the possibility of local recurrence or facial nerve complications in case of “not necessary” facial nerve dissection. In the era of minimally invasive surgery, more sparing approaches such as extracapsular dissection or partial superficial parotidectomy (PSP) are gaining popularity. The aim of the study is to present surgical results and long-term outcomes of PSP (level I or II) in a large group of patients. Six hundred fifty-one patients who underwent parotid surgery between 2004 and 2020 were initially considered. Five hundred forty patients with benign lesions treated with PSP, enucleation, ECD were enrolled. Clinical features, surgical data, postoperative scarring, seroma, dehiscence, neuroma, outcomes as Frey syndrome, and delayed facial nerve dysfunction have been evaluated. 65.5% PSP, 25.2% enucleation, and 9.2% extracapsular dissection. No statistical difference in surgical time has been found (P 0.16). P > 0.05 for seroma, neuroma, Frey syndrome, and facial palsy between different type of surgery. Frey syndrome in PSP: 6/135 (4.4%) in 2004 to 2012 and 2/219 (0.9%) in 2013 to 2020. The reduction between periods is significant (P < 0.04). Recurrence: 0.8% (3/354) for PSP patients, 3.4% (5/136) in enucleation and 10% (5/50) in ECD (P = 0.02). Partial superficial parotidectomy can be considered a minimally invasive and quick procedure with low complication rate. Our data seem to support this statement (large case series and long-term follow-up).

PMID:34608007 | DOI:10.1097/SCS.0000000000008226

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Clinical Study of Cranioplasty Combined With Ipsilateral Ventriculoperitoneal Shunt in the Treatment of Skull Defects With Hydrocephalus

J Craniofac Surg. 2021 Sep 29. doi: 10.1097/SCS.0000000000008227. Online ahead of print.

ABSTRACT

OBJECTIVE: To explore the clinical effect and safety of cranioplasty combined with ipsilateral ventriculoperitoneal shunts in the treatment of skull defects with hydrocephalus.

METHODS: The clinical data of 78 patients with skull defects with hydrocephalus were analyzed retrospectively. All patients were treated with cranioplasty and ventriculoperitoneal shunts in 1 stage, including 35 cases of cranioplasty combined with ipsilateral ventriculoperitoneal shunts (ipsilateral operation group) and 43 cases of contralateral operations (contralateral operation group).

RESULTS: The incision length (28.97 ± 4.55 cm), operation time (139.00 ± 42.27 minutes), and intraoperative hemorrhage (174.57 ± 79.35 mL) in the ipsilateral operation group were significantly better than those in the contralateral operation group (respectively they were 37.15 ± 5.83 cm, 214.07 ± 34.35 minutes, and 257.21 ± 72.02 mL), and the difference was statistically significant (t = 6.786, 8.656, and 4.815, all P < 0.05). The degree of postoperative hydrocephalus was significantly improved in both groups, but there was no statistically significant difference in the degree of hydrocephalus between the 2 groups (P > 0.05). Among the postoperative complications, there was no statistically significant difference in infection, epilepsy, subdural effusion, titanium plate effusion, or excessive cerebrospinal fluid drainage between the 2 groups (P > 0.05), but the incidence of intracranial hemorrhage in the ipsilateral operation group (2.86%) was significantly lower than that in the contralateral operation group (20.93%, χ2 = 4.138, P = 0.042). The postoperative Glasgow Coma Scale scores of the 2 groups were improved compared with those before the operation (P < 0.05), and there was no statistically significant difference in the postoperative Glasgow Coma Scale scores (P > 0.05). At 6 months after surgery, there was no statistically significant difference in Glasgow Outcome Scale effectiveness between the 2 groups (χ2 = 0.005, P = 0.944).

CONCLUSIONS: Cranioplasty combined with ipsilateral ventriculoperitoneal shunt has the same therapeutic effect as a contralateral operation, but it has the advantage of a short operation time, less intraoperative trauma, less bleeding, and less risk of intracranial hemorrhage, which is suitable for clinical applications.

PMID:34608006 | DOI:10.1097/SCS.0000000000008227

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The Value of Ultrashort Echo Time MR in Depiction of the Eustachian Tube at 3 Tesla

Otol Neurotol. 2021 Sep 30. doi: 10.1097/MAO.0000000000003363. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate the feasibility of ultrashort echo time (UTE) imaging in the visualization of Eustachian tubes (ETs).

METHODS: The local institutional review board approved the study protocol. Twenty volunteers were involved in this study. The scanning scheme consisted of T2-sampling perfection with application-optimized contrasts by using different flip angle evolutions (T2-SPACE) MR imaging with water excitation, a UTE scan with a prototype sequence and a CT scan. The UTE images were compared with both the T2-SPACE and CT images. The quality of the images was rated by two radiologists blindly. Interobserver agreement was assessed using the kappa statistic. Statistical analysis was performed using SPSS software (version 17, SPSS Inc.). A value of p < 0.05 was considered statistically significant.

RESULTS: For all subjects, the T2-SPACE images successfully displayed the cartilaginous part of the ET (Fig. 1). The CT images fully showed the bony part of the ET for all the subjects (Fig. 2). The UTE images successfully displayed both the cartilaginous and bony parts of the ET (Fig. 3). However, the UTE images showed the cartilaginous and bony portions of the ET as a whole.

CONCLUSIONS: By analyzing the depiction of the ET from UTE images and comparing it with that from MR and CT images, we found that UTE images could display not only the cartilaginous structure of the ET that cannot be seen by conventional MR sequences, but also the bony structure that previously could only be seen on CT images. This imaging modality could help provide a convenient and new method to display the overall shape of the ET.

PMID:34607998 | DOI:10.1097/MAO.0000000000003363

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Validation of a Moroccan Arabic Version of the Tinnitus Handicap Inventory (THI-M)

Otol Neurotol. 2021 Sep 30. doi: 10.1097/MAO.0000000000003311. Online ahead of print.

ABSTRACT

OBJECTIVE: Cultural adaptation of the tinnitus handicap inventory questionnaire to the Moroccan dialect version.

METHOD: We conducted a prospective study over a 3 years period (January 2017-January 2020) in the Otolaryngology Department of Casablanca University hospital. Translation was produced by a forward-backward procedure with analysis of the psychometric properties of the Moroccan version of the tinnitus handicap inventory.

RESULTS: The final Moroccan version of Tinnitus Handicap Inventory (THI) was given to 83 otosclerosis patients suffering from tinnitus. They filled the questionnaire twice before surgery and 1 year after surgery.The item-total correlations are all statistically significant (p < 0.001) and vary between 0.279 (item 15) and 0.817 (item 12).The internal consistency of the Moroccan version of THI, assessed through Cronbach’s α, was found to be excellent at 0.953. The interclass correlation showed an excellent reliability for all subscales (0.999-1).THI scores decreased significantly from baseline to 1-year postoperative follow-up on all subscale scores, indicating clinical improvement.

CONCLUSION: The Moroccan version of THI has a good reliability comparable with translations in other languages and the original version. It is a valid tool to assess tinnitus improvement after otosclerosis surgery.

PMID:34607993 | DOI:10.1097/MAO.0000000000003311