Prospective Nonrandomized Study Research Articles

A prospective non-randomized feasibility study of an online membership-based fitness program for promoting physical activity in people with mobility impairments

BackgroundPeople with mobility limitations have a disproportionately higher rate of acquiring secondary conditions such as obesity, cardiovascular comorbidity, pain, fatigue, depression, deconditioning, and type 2 diabetes. These conditions often result from poor access to home and community-based health promotion/wellness programs. The aim of this project was to determine the feasibility of delivering an online community membership-based fitness program for individuals with mobility impairments.MethodsFor this prospective single-arm study, participants were recruited from members of a community fitness facility that serves people with physical disabilities and chronic health conditions. While all members had access to the online platform, individuals had to opt-in to participate in the research component. Activity options included 16 pre-recorded videos and 9 live exercise classes. During the 8-week program, participants had an opportunity to earn three exercise incentives for reaching certain activity milestones. Enrollment percentage, attendance, and attrition were tracked to assess program feasibility and acceptability. Changes in participant-reported outcomes including self-reported physical activity, psychosocial outcomes, and health-related quality of life (HRQOL) were examined using non-parametric analyses.ResultsA total of 146 eligible individuals were screened of which 33 enrolled (22.6%). Two participants withdrew from the study, so a total of 31 were used for analyses. Participants included 29 women and 12 Black people with an average age of 60 (± 15.9) years. Health conditions included stroke, post-polio, arthritis, neuropathy, cerebral palsy, and obesity. Ten participants used an assistive device to get around inside the home. Twenty-six participants (78.8%) completed the online program, and 5 participants earned all 3 participation incentives. The mean number of live Zoom exercise classes attended by the participants was 12.8 (range = 0–43) over 8 weeks; 3 of 31 participants did not attend any classes. On average, participants watched 128 min (range = 0–704 min) of pre-recorded videos; 6 of 31 participants did not view any pre-recorded videos. Self-reported physical activity showed the largest improvement (11.15 units; 95% CI, 3.08, 19.56) with an effect size of 0.51 (Cohen’s d).ConclusionsThis pilot study of an online membership-based fitness program for people with mobility impairments demonstrated preliminary effectiveness in increasing physical activity and was found to be feasible and acceptable. Feasibility endpoints do indicate potential to improve retention. These results suggest that online delivery of exercise programs can broaden the reach of specialized community fitness programs and is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy.Trial registrationClinicalTrials.gov, NCT05138809. Registered September 2, 2021, ClinicalTrials.gov PRS: Record Summary NCT05138809.

Maternal-related factors associated with development and improvement of peripartum cardiomyopathy and therapeutic outcomes of bromocriptine

HIGHLIGHTS Younger age, black race, normotension, and multiparity indicate a poorer prognosis for peripartum cardiomyopathy recovery, while bromocriptine therapy reduces adverse events. ABSTRACT Objectives: This study aimed to fill the significant knowledge gap regarding peripartum cardiomyopathy (PPCM), a heart failure phenotype linked to pregnancy. The main objectives were to explore the factors influencing the development and progression of PPCM and to assess the outcomes of bromocriptine.Materials and Methods: Systematic search across PubMed, ScienceDirect, and Cochrane Library identified studies until December 2022. This study includes non-randomized prospective and retrospective studies, as well as relevant randomized controlled trials. Risk factors were compared between the recovered and non-recovered PPCM groups, and bromocriptine therapy outcomes were evaluated against standard heart failure treatment as the primary endpoint.Results: The analysis included 24 observational studies and 1 randomized controlled trial involving 1,651 PPCM patients; 9 studies evaluating the outcomes of bromocriptine therapy. The most prevalent factors were caesarean delivery (proportion=53%, 95%CI=41%-66%) and anemia (proportion=51%, 95%CI=38%-65%). Non-recovered patients were younger (MD=-1.04 years old, 95%CI=-1.82-(-0.27), p=0.008) and predominantly black (RR=1.82, 95%CI=1.43-2.31, p <0.001). Hypertensive disorders and primiparity were found less among non-recovered patients (RR=0.73, 95%CI=0.60-0.88, p=0.001; RR=0.81, 95%CI=0.66-0.99, p=0.04, respectively). Non-recovered patients also exhibited higher baseline serum creatinine levels, lower LVEF, larger left ventricular end-systolic diameter (LVESD), larger left ventricular end-diastolic diameter (LVEDD), and lower fractional shortening (all P-values<0.05). Furthermore, bromocriptine significantly reduced major adverse cardiac events (MACE), mortality, and increased LVEF (all P-values<0.05).Conclusion: Younger maternal age, black race, absence of hypertension, and multiparity are associated with poorer prognosis for PPCM recovery. Bromocriptine therapy demonstrates superior benefits in reducing adverse events in PPCM.

Progressive Muscle Relaxation Training During Pregnancy: Effects on Mental State, Delivery and Labour Pain – a Prospective Study

AbstractProgressive muscle relaxation is a widely used technique for relaxation, but studies are rare about efficacy on pregnancy and perinatal outcomes. Aim of our study was to determine whether progressive muscle relaxation affects anxiety and depression levels of pregnant women, pregnancy outcomes, labour pain and analgesic requirements.156 pregnant women were enrolled in a prospective non-randomized controlled cohort study. The control group received standard antenatal care and classes only, while the intervention group additionally received progressive muscle relaxation training once a week for six weeks. Anxiety, depression and current strain were measured in a pretest-posttest experimental design using self-report scales at baseline (1st survey), 5 weeks later (2nd survey) and during puerperium (3rd survey). Numeric Rating scales were used for measuring labour pain and satisfaction with analgesic treatment in the 3rd survey.Fifty complete questionnaires from each group were analysed. There were no differences in mental status between the groups at baseline. Progressive muscle relaxation training significantly reduced depression levels. Trait anxiety, reflecting a person’s basic anxiety decreased significantly in both groups during puerperium. No differences in pregnancy outcomes, labour pain and analgesic requirements could be shown within both groups in general. Nonetheless, women attending more than five progressive muscle relaxation courses reported significantly less labour pain within the group and compared to controls.Pregnant women could benefit from progressive muscle relaxation training if used continuously. Relaxation methods should be a substantial part of prenatal care and available for everyone.

Three and twelve-month analysis of the PROM-Q study: comparison of patient-reported outcome measures using the BREAST-Q questionnaire in pre- vs. sub-pectoral implant-based immediate breast reconstruction.

Implant-based breast reconstruction (IBR) is being increasingly performed with implant placed above the pectoral muscle (pre-pectoral), instead of below the pectoral muscle (sub-pectoral). Currently, there is a lack of comparative data on clinical and patient-perceived outcomes between pre- vs. sub-pectoral IBR. We investigated whether this difference in surgical approach influenced clinical or patient-perceived outcomes. This prospective non-randomised longitudinal cohort study (ClinicalTrials.gov identifier: NCT04842240) recruited patients undergoing immediate IBR at the Leeds Breast Unit (Sep 2019-Sep 2021). Data collection included patient characteristics and post-operative complications. Patient-Reported Outcome Measures were collected using the BREAST-Q questionnaire at baseline, 2 weeks, 3- and 12-months post-surgery. Seventy-eight patients underwent IBR (46 patients pre-pectoral; 59% vs. 32 patients sub-pectoral; 41%). Similar complication rates were observed (15.2% pre-pectoral vs. 9.4% sub-pectoral; p = 0.44). Overall implant loss rate was 3.8% (6.5% pre-pectoral vs. 0% sub-pectoral; p = 0.13). Respective median Breast-Q scores for pre- and sub-pectoral IBR at 3 months were: breast satisfaction (58 vs. 48; p = 0.01), psychosocial well-being (60 vs. 57; p = 0.9), physical well-being (68 vs. 76; p = 0.53), and Animation Q scores (73 vs. 76; p = 0.45). Respective Breast-Q scores at 12 months were: breast satisfaction (58 vs. 53; p = 0.3), psychosocial well-being (59 vs. 60; p = 0.9), physical well-being (68 vs. 78; p = 0.18), and Animation Q scores (69 vs. 73; p = 0.4). This study demonstrates equivalent clinical and patient-perceived outcomes between pre- and sub-pectoral IBR. The study findings can be utilised to aid informed decision making regarding either surgical option.

Agreement and repeatability of scotopic pupil size measurement with the 2WIN-S portable refractor in Chinese adults

To assess the agreement and repeatability of scotopic pupil size measurement using 2WIN-S (Adaptica, Padova, Italy) portable refractor in Chinese adults. This prospective non-randomized open-label controlled study assessed the scotopic pupil size of 100 right eyes using OPD-Scan III (Optical path difference) (Nidek Technologies, Gamagori, Japan) and 2WIN-S. OPD-Scan III and 2WIN-S measure pupil size using infrared light and detector, while 2WIN-S measures bilateral eyes simultaneously, OPD-Scan III measures unilateral eyes individually. Participants were first measured once using OPD-Scan III and two consecutive measurements were performed using 2WIN-S after 15 min of rest interval. The primary outcome was to evaluate the agreement between 2WIN-S and OPD-Scan III, and the secondary outcome was to evaluate the repeatability of 2WIN-S. Scotopic pupil size of 100 right eyes of 100 adults (28 male and 72 female) aged 18–53 years (mean 36 ± 12 years) was assessed using OPD-Scan III and 2WIN-S, respectively. The mean scotopic pupil size of OPD-Scan III and 2WIN-S was recorded to be 6.24 ± 0.88 mm and 6.27 ± 0.81 mm, respectively. For the mean scotopic pupil size of OPD-Scan III and 2WIN-S the difference was − 0.03 mm (95%CI − 0.10 to 0.04 mm), p = 0.445, the 95% limits of agreement (LOA) was − 0.71 to 0.66 mm. ICC between the two devices was 0.92 (95% CI 0.88–0.94) (ICC > 0.9 indicates excellent consistency). Coefficients of repeatability (CoR) of 2WIN-S was 0.37, which has a high repeatability. For the mean scotopic pupil size of 2WIN-S of the repeated measurements, the difference was -0.04 mm (95%CI − 0.08 to 0.01 mm), p = 0.019, the 95% limits of agreement (LOA) was − 0.41 to 0.32 mm, with a narrow LOA. However, the majority of the variations were less than ± 0.50 mm (98% of scotopic pupil size measurements were below this threshold), within the clinically acceptable range (± 0.50 mm). Our study showed excellent agreement between 2WIN-S and OPD-Scan III (ICC > 0.9) and a good repeatability of 2WIN-S (CoR = 0.37). This study suggests a novel technique for measuring pupillary responses in low light conditions, which can be considered an alternative to OPD-Scan III in clinical settings.

Cubital vein access provides a practical alternative to internal jugular vein access for coronary sinus catheter placement

AbstractBackgroundInsertion of electrode catheters into the coronary sinus (CS) through the right internal jugular vein (RIJV) carries risks of pneumothorax and severe hematoma formation. This study was performed to compare the safety and feasibility of catheterization through the left cubital superficial vein versus the RIJV.MethodsThis prospective nonrandomized study involved consecutive patients who underwent catheter ablation from September 2021 to February 2023. Blind puncture techniques were used in the left cubital vein group; ultrasound‐guided insertion was performed in the RIJV group. The success rates of sheath insertion and CS catheterization, the procedure and fluoroscopy times of CS cannulation, and complications were compared between groups.ResultsThe left cubital vein group comprised 152 patients, and the RIJV group comprised 58 patients. The sheath insertion success rate was significantly lower in the cubital vein group than in the RIJV group (84.9% vs 100%, respectively; p = .0008). In the cubital vein group, blind puncture attempts failed in 20 patients; three patients developed guidewire‐induced venous injury. One arterial puncture occurred in the RIJV group. After successful sheath insertion, no significant differences were observed in the CS cannulation success rate (97% vs 100%, p = .55), procedure time (median [range], 93 [51–174] vs 74 [44–129] s; p = .19), or fluoroscopy time (median [range], 66 [36–134] vs 48 [30–92] s; p = .17). No serious complications requiring procedural discontinuation occurred.ConclusionThe left cubital vein approach is practical, offering a viable alternative to the RIJV approach.

Impact of Knack Manoeuvre Among Women with Urinary Incontinence: A Quasi Experimental Study

ABSTRACT Objective: The Objective of the study is to assess the effectiveness of Knack manoeuvre among women with urinary incontinence. Methods: A quasi-experimental study with a repeated measures design was used to conduct study at Saveetha Medical College Hospital. Experimental group received Knack manoeuvre for 6 months and control group received routine care. The sample size was 100, which was recruited by purposive sampling technique. The data were collected with structured questionnaire, and questionnaire for urinary incontinence diagnosis and biophysiological parameters were assessed by abdominal leak peak pressure (ALPP). Results: The study results depict that frequency and percentage distribution of pretest and post-test level of ALPP. Between group comparison of post-test at 6 months of control and experimental showed significance (P < 0.001). There was a progressive decrease in ALPP of control and experimental groups. Conclusion: To our knowledge, this is the first prospective nonrandomized study that assesses the efficacy of the Knack manoeuvre on urine incontinence by assessing biophysiological parameters.

P-795 Robust and simple in vitro maturation of ovarian tissue oocytes

Abstract Study question Using in-vitro gametogenesis results in mice, can we perform simple, robust in-vitro maturation (IVM) of oocytes from human ovarian tissue? Summary answer In vitro oogenesis in mice reveals 3 phases of oocyte maturation, IVD, IVG, and IVM. In vivo IVD and IVG simplifes a more robust IVM. What is known already For fertility preservation in cancer patients, IVM of GV’s obtained from ovary tissue with live birth has been achieved, but the results are variable, and great effort has gone into trying to make the “right” culture media, and most are given booster shots of gonadotropin with questionable results. It is easy to obtain many GV oocytes from tiny follicles using open cortical dissection. But it still has remained a puzzle how to do robust IVM in the best way. Study design, size, duration A total of 146 females underwent ovary tissue cryopreservation since 1977. The most recent 38 consecutive such patients between 2 and 38 years of age underwent in-vitro maturation of oocytes (IVM) derived from their ovarian tissue. This is a prospective non-randomized pilot study based upon our results with in vitro oogenesis. Participants/materials, setting, methods After ovarian cortex dissection, the spent media is examined for cumulous complexes (CC’s), which were placed in culture with widely varying concentrations of FSH and HCG, and in a variety of different media. Based on now established mechanisms of in vitro oogenesis, we postulated that the specific media for IVM and the concentrations of HCG would not impact results. There was no prior hormone administration. Main results and the role of chance The harvested germinal vesicle oocyte developed into mature metaphase II oocytes with simple culture media just as well as with “IVM media”, and with HCG concentration from 10 mIU/l to 1000 mIU/l. Of the 38 cases, 18 had had previous chemotherapy or were pre-pubertal. None of these had CC’s. Of the 20 who were post-pubertal and had not yet undergone chemotherapy, the number of CC’s averaged 20 per patient. Of a total of 402 GV oocytes, 137 became mature MII’s (34.1%), varying between 20% and 56%. The only case with low maturation rate (9%) occurred when the cumulus was stripped immediately instead of at 24 hours. Thus mature oocytes can robustly and easily be obtained from ovary tissue with simple media and no need for ovarian stimulation. Furthermore, ovarian stimulation and ovulation are not necessary for oocyte maturation. Oocytes that have just exited IVD that have been exposed to less than 7 days of gonadotropin (IVG) will not mature. Those oocytes exposed to more than 11 days of IVG will degenerate. Thus about 35% of oocytes at any given time will have already been properly prepared in vivo for IVM. Limitations, reasons for caution This is an early proof of concept study in humans with only 30 participants. However, it is completely consistent with what we have predicted from in vitro oogenesis in the mouse. Wider implications of the findings Ovary tissue freezing along with robust IVM will at once provide cancer patients with two possibilities for fertility preservation, without having to delay cancer treatment. Four months of in vivo IVD (non-hormonal) followed by 11 days of IVG (FSH) have already prepared oocytes for IVM. Trial registration number not applicable

Management of Massive Irreparable Posterosuperior Cuff Tears: A Systematic Review for Clinical & Functional & Radiological Outcomes

Abstract Background The management of massive irreparable cuff tears (MIRCT) remains a highly controversial subject with many possible surgical and non-surgical interventions and no clear evidence regarding the most effective and beneficial intervention. Different management options include: conservative management, partial repair, tendon transfer, superior capsular reconstruction, subacromial spacer insertion, reverse total shoulder arthroplasty (RTSA). Aim of the Work The aim of this systematic review is to compare the various methods of management of posterosuperior cuff tears without arthropathy to reach the most effective and sustainable mode of management. Patients and Methods A randomized controlled trial, non-randomized clinical trials, prospective and retrospective comparative cohort studies and case series. We will exclude cross-sectional studies, case reports and literature not in English. Results There is no high quality evidence on management of MIRCT. There was no Level I or II evidence. We included 69 papers that studied different modalities of management of MIRCT, 31 of level III and the remaining were of level IV evidence. Consequently, it’s still difficult to recommend one method of management over the other regarding the management of irreparable cuff tears. Patient age, demands, expectations, thorough clinical examination, surgeon experience and preference are still a major deciding factor when choosing and appropriate method. Conclusion Due to the unavailability of high-quality clinical studies available for guiding management of irreparable MRCT, it is consequently not possible to recommend for or against any specific treatment strategy. Rather, clinical experience, patient factors, patient expectations, and rotator cuff tear characteristics should guide clinical decision-making. Physical therapy compared to surgical treatments may have inferior outcomes. Standardized data collection, reporting and terminology are key to enhancing the quality of evidence-based medicine.

Antiepileptic Drugs as Prophylaxis for Seizures after Excision of Brain Tumors

Abstract Background Seizures are the most common & most serious side effect of cranial surgery. The latter condition requires chronic treatment with Antiepileptic drugs (AEDs) and comes with relevant socioeconomic sequelae. The routine prophylactic use of AEDs for people undergoing tumor resection has remained controversial due to the risk of postoperative seizures. Some Neurosurgeons are advocates to the use of AEDs to reduce the risk of these seizures. Objective To evaluate the efficacy of prophylactic AEDs routinely in brain tumor patients without previous history of seizures. Primary objective has been to identify the efficacy of AEDs in perioperative seizure prophylaxis. Secondary objective has been to highlight the most common type of post-operative AEDs. Methods All available studies from 2000-2021 including randomized or non-randomized clinical trials, prospective or retrospective observational cohort studies, and case series of six or more cases that address these criteria have been collected. Results Our search concluded that the most common type of post-operative seizure is the Early seizure which is of total 87 patients representing 12.3% of seizure reported patients, yet when comparing the P-value between the Early & late seizure it has a P-value of 0.415 which is nonsignificant rendering the comparison redundant. The Most common types of AED used are Phenytoin (PHT) 89 (71.8%) & Levetiracetam (LEV) 109 (81.8%). To measure the efficacy of AEDs two groups of patients with no history of AED administration or seizures preoperatively were created, one the control group of 268 participants were not administered AEDs postoperatively only 32 (11.94%) of them suffered from seizures postoperatively. The other group of 171 participants were administered the AEDs postoperatively only 25 (14.62%) of these participants suffered from postoperative seizure. Comparing both of these results statistically it had a P-value of 0.416 which is non-Significant statistically. On interpreting these results was that the AED have no influence in controlling the seizures. Conclusion Postoperative seizures are one of the main complications of brain tumor surgery. Neurosurgeons have a strong belief more of tradition that preventing seizures with Anti-Epileptic Drugs (AEDs) as a sort of seizure prophylaxis is not only effective but also necessary. Finally, there is not enough evidence of sufficient quality available to suggest that antiepileptic drugs AEDs treatment can or cannot be recommended to reduce Post-craniotomy seizures.

The Immediate and Delayed Maximal Non-Irritating Skin Testing Concentrations of β-lactam Antibiotics

BackgroundMaximal skin testing (ST) nonirritant concentrations (NICs) are consistent for penicillin and aminopenicillin amongst guidelines. However, there is variability amongst guidelines for maximal ST NICs of cephalosporins. ObjectiveTo determine maximal immediate and delayed ST NICs of 15 β-lactams in β-lactam-tolerant and β-lactam-naïve participants. MethodsWe performed a single-center, nonrandomized prospective study between September 2019 and January 2022 in adult participants. Participants received skin prick testing (SPT) and intradermal test (IDT) injections at six increasing concentrations of 1 or more β-lactams. A concentration was considered irritant when more than 5% of participants had a positive test. A positive test was defined as a wheal ≥3 mm than negative control accompanied by a ≥5 mm flare for SPT/IDT and induration ≥5 mm with associated erythema at 48 hours for delayed readings (dIDT). Sensitivity analyses using 3 alternative IDT positive criteria were conducted. ResultsA total of 747 participants with a median age of 64 (IQR 54-72), 52% males, 85% White, and 92% Non-Hispanic underwent 20,858 skin tests. All undiluted SPT concentrations were nonirritant. We found the following maximal IDT/dIDT NICs (mg/ml): ampicillin (41.6/125), ampicillin-sulbactam (93.8/187.5), aztreonam (6.3/25), cefazolin (55/165), cefepime (35/140), cefoxitin (45/90), ceftaroline (7.5/15), ceftriaxone (58.3/175), cefuroxime (55/110), ertapenem (16.6/50), imipenem-cilastin (6.3/25), meropenem (8.3/25), nafcillin (31.3/62.5), oxacillin (20.9/83.5), and piperacillin-tazobactam (112.5/225). dIDTs were almost all completely non-irritant close or at undiluted concentrations. There were no differences when we applied 3 IDT positivity criteria to our raw data. ConclusionOur results suggest that SPTs with undiluted stock β-lactam antibiotic concentrations are nonirritant. Compared to previously published nonirritant concentrations, we propose a 2 to 50-fold increase to the maximal IDT and dIDT NICs of 15 β-lactam antibiotics. When performing dIDTs, a higher concentration should be used rather than the same IDT concentration.

The Impact of the New Families Home Visiting Program on Depressive Symptoms Among Norwegian Fathers Postpartum: A Nonrandomized Controlled Study.

Becoming a parent is a vulnerable life transition and may affect parents' mental health. Depressive symptoms may occur in fathers, as well as mothers, during pregnancy and the postpartum period. The health service is expected to have a family perspective, aiming to support both parents. Despite this goal, mothers traditionally receive more support than fathers. Home visiting programs may provide enhanced guidance for new fathers and increased mental health support. The aim of this study was therefore to assess possible differences in level of depressive symptom in fathers receiving the New Families home visiting program compared with those receiving standard care from the Norwegian Child Health Service. A prospective nonrandomized controlled study with a parallel group design was performed. The Edinburg Postnatal Depression Scale (EPDS) was used to measure depressive symptoms in fathers (N = 197) at 28 weeks of their partners' pregnancy (T1), at 6 weeks (T2), and 3 months postpartum (T3), in the intervention and the control group. The results indicate a prevalence of depressive symptoms (EPDS score ≥ 10) in Norwegian fathers of 3.1% at T1, 3.9% at T2, and 2.2% at T3 for the full sample. No significant EPDS score differences were found between the intervention and the control group at six weeks and three months postpartum. This suggests that the intervention had no clear impact on depressive symptoms during this time-period.

A prospective comparison of WALANT technique and general anesthesia in forefoot surgery

IntroductionWide Awake Local Anesthesia No Tourniquet (WALANT) technique has been widely used in hand surgery, but there are few prospective data on its use in forefoot surgery. HypothesisThe WALANT technique reduces pain compared to general anesthesia for bone surgery on the first ray of forefoot. MethodsThis was a prospective, longitudinal, comparative, non-randomized cohort study in adult patients undergoing bone surgery on the first ray of forefoot. The primary objective was the level of pain (0–10 visual analogic scale) 4 h after the procedure with WALANT technique versus general anesthesia supplemented by ropivacaine infiltration. ResultsA total 37 patients were analyzed in the WALANT group and 24 in the general anesthesia group (women, 90.2%; mean age, 51.3 years; hallux valgus, 85.2%; first metatarsal osteotomy, 80.3%). After generalized linear regression adjusted on a priori defined factors, there was no statistically difference for pain ≤3 at 4 h in WALANT vs. general anesthesia (odds-ratio 1.66; 95% CI, 0.17–20.49; p = 0.2548). At 24 h, pain level was also comparable in the two groups. Time spent in operating room was significantly shorter with WALANT (40.8 vs. 49.7 min; p = 0.0001). Mean length of stay in the recovery room was also significantly shorter with WALANT (4.4 vs. 75.6 min; p < 0.0001). Anxiety before/after surgery, uptake of analgesic/anti-inflammatory drugs and quality of life were comparable in the two anesthesia groups. ConclusionPostoperative pain with WALANT technique or general anesthesia was comparable. Time spent in the operating room and in recovery room was significantly shorter with WALANT technique. Level of evidenceIII; prospective non-randomized comparative study.

Endonasal versus supraorbital approach for anterior skull base meningiomas: Results and quality of life assessment from a single-surgeon cohort

ObjectiveIn this prospective non-randomized study we reported our experience related to planum sphenoidale (PS) and tuberculum sellae (TS) meningiomas in a similar cohort of patients operated via the endonasal or the supraorbital route. A comprehensive quality of life analysis has been performed. MethodsBeing comparable in general features, between November 2017 to January 2020, a total of 20 patients with anterior skull base meningioma were included. Hence, 10 patients were treated using the supraorbital keyhole procedure (SO) while 10 patients received an endoscopic endonasal approach (EEA). Both surgical techniques were analyzed and compared. Quality of life has been analyzed with the SF-36 questionnaire. ResultsTwenty patients were identified who underwent either EEA (n=10) or SO (n=10). The average extent of resection achieved was not significantly different between the 2 groups. Post-operatively, the EEA group demonstrated a longer hospital stay and bed days compared with SO patients as well as a longer surgical time. There was a significant rate of more CSF leakage after EEA then after SO (20% vs 0%, p=0,0491). The follow-up period resulted shorter in the SO group, with a slight increased recurrence rate. Overall, no differences in visual outcome were detected. There were no differences in terms of quality of life between the two groups in all the explored items. ConclusionsIn this single-center single-surgeon study of similarly sized and located PS and TS meningiomas, EEA showed longer hospital stays with higher degree of CSF leak compared with the SO group. Supraorbital craniotomy via eyebrow incision reported a comparable quality of life results, even if with a slightly higher percentage of recurrence and less follow-up.

The potential of indocyanine green fluorescence detection in surgical cut margin of breast conserving surgery.

Fluorescence-guided surgery (FGS) is a cutting-edge technology that uses near-infrared (NIR) fluorescence imaging to guide surgeons in surgery. Indocyanine green (ICG) is a fluorescent dye, which can be used for in vivo imaging of tumor cells. We aimed to explore the use of ICG fluorescence-guided technology as a rapid intraoperative margin assessment method for breast cancer surgery. In addition, we also compared the dose selection of ICG. This was a non-randomized prospective cohort study. Data were collected between August 2021 and October 2022 in the Division of Breast Surgery, Department of General Surgery, Nanjing Drum Tower Hospital, the Affiliated Hospital of Medical School, Nanjing University. Upon specimen removal, tumor margins were immediately analyzed by ICG fluorescence detection and then sent to the pathology department for intraoperative frozen section analysis and subsequent routine pathological examination. Abnormal margin rates were calculated and compared using intraoperative frozen section analysis and under the guidance of ICG fluorescence. The study included 69 cases of breast cancer patients who underwent tumor resection assisted by ICG fluorescence-guided technology, including 18 patients with a 0.5 mg/kg dose and 51 patients with a 1.0 mg/kg dose. According to the study findings, the ICG test achieved a sensitivity of 81.82% and a specificity of 75.82%. At a dose of 0.5 mg/kg, the sensitivity was 66.67% whereas the specificity was 93.33%. At the dose of 1 mg/kg, the sensitivity was 87.5%, and the specificity was 74.42%. Similarly, for intraoperative frozen section analysis, the sensitivity was 81.82%, but the specificity was enhanced to 94.83%. Positive surgical cut margin was not identified in 2/69 by ICG fluorescence and frozen section analysis respectively. The sensitivity of ICG fluorescence detection is comparable to that of frozen section analysis, but the specificity is poor. The sensitivity increased and the specificity decreased at 1 mg/kg compared to the 0.5 mg/kg dose. ICG fluorescence can be used as a supplementary tool for frozen section analysis. These findings support further development and clinical performance assessment of ICG fluorescence.

Integration of Acute Malnutrition Treatment Into Integrated Community Case Management in Three Districts in Southern Mali: An Economic Evaluation.

Enabling community health workers (CHWs) to treat acute malnutrition improves treatment access and coverage. However, data on the cost and cost-effectiveness of this approach is limited. We aimed to cost the treatment at scale and determine the cost-effectiveness of different levels of supervision and technical support. This economic evaluation was part of a prospective nonrandomized community intervention study in 3 districts in Mali examining the impact of different levels of CHW and health center supervision and support on treatment outcomes for children with severe acute malnutrition. Treatment admission and outcome data were extracted from the records of 120 participating health centers and 169 CHW sites. Cost data were collected from accountancy records and through key informant interviews. Results were presented as cost per child treated and cured. Modeled scenario sensitivity analyses were conducted to determine how cost-efficiency and cost-effectiveness estimates change in an equal scale scenario and/or if the supervision had been done by government staff. In the observed scenario, with an unequal number of children, the average cost per child treated was US$203.40 in Bafoulabé where a basic level of supervision and support was provided, US$279.90 in Kayes with a medium level of supervision, and US$253.9 in Kita with the highest level of supervision. Costs per child cured were US$303.90 in Bafoulabé, US$324.90 in Kayes, and US$311.80 in Kita, with overlapping uncertainty ranges. Additional supervision has the potential to be a cost-effective strategy if supervision costs are reduced without compromising the quality of supervision. Further research should aim to better adapt the supervision model and associated tools to the context and investigate where efficiencies can be made in its delivery.

Clinical results with a multifocal intraocular lens with a novel optical design

BackgroundTo evaluate the optical performance and safety of a new multifocal lens with a novel optical design featuring two additional foci (or intensifiers) in patients with cataract and presbyopia.MethodsIn this single-center, non-randomized prospective observational study, 31 patients underwent implantation of the new multifocal IOL between March 2020 and November 2021 at a tertiary clinical center in Buenos Aires and Ramos Mejia, Argentina. Postoperative examinations with emphasis on uncorrected and corrected visual acuity at distance and near and at two different intermediate distances (80 cm and 60 cm) were performed during the 3 postoperative months.ResultsOf the 31 patients who underwent implantation of the new IOL, 30 underwent bilateral surgery (61 eyes in total). At 3 months, all 61 eyes had an uncorrected distance visual acuity (UCDVA) of at least 0.15 logMAR; 57 eyes (93%) had an uncorrected distance visual acuity (UCDVA) of 0.1 logMAR and 27 eyes (44%) had an UCDVA of 0.0 logMAR. At 80 cm, 60 eyes (98%) had an uncorrected intermediate visual acuity (UCIVA) of at least 0.1 log MAR and 48 eyes (79%) had an UCIVA of 0.0 logMAR.ConclusionThe new multifocal IOL with a novel optical concept (5 foci) showed a wide range of visual acuity especially at intermediate and near distances in patients undergoing cataract surgery. Uncorrected visual acuity was excellent at all tested distances, monocularly and binocularly, spectacle independence and patient satisfaction were high.

Low-Dose Planned Glucarpidase Allows Safe Outpatient High-Dose Methotrexate Treatment for CNS Lymphoma.

High-dose methotrexate (HD-MTX) is the backbone of curative therapy for CNS lymphoma. Because of toxicity, MTX is administered in the inpatient setting along with hyperhydration and monitoring until MTX clearance is documented (3-5 days). Frequent hospitalizations result in patient time away from work, home, and exposure to potential iatrogenic/nosocomial complications. Here, we aim to demonstrate feasibility of HD-MTX administration in the outpatient setting with low-dose glucarpidase facilitating clearance. This is a prospective nonrandomized study of outpatient HD-MTX followed by glucarpidase 2000u (ClinicalTrials.gov identifier: NCT03684980). Eligible patients had CNS lymphoma, creatinine <1.3 mg/dL, and previously tolerated HD-MTX. Patients were enrolled between May 2020 December 2021 for one HD-MTX treatment. Patients could re-enroll for subsequent doses of HD-MTX as eligibility and slots permitted. MTX 3.5 g/m2 was administered once over 2 hours, preceded by standard hydration and followed by an additional 2 hours of dextrose 5% in water with NaHCO3 75 mEq at 150 cc/h. Glucarpidase 2000u was administered once in the clinic 24 hours later. The primary end point was MTX level 48 hours after HD-MTX. Twenty doses of outpatient HD-MTX with glucarpidase were administered to seven patients. After 20 of 20 (100%) treatments, serum MTX levels were reduced to <100 nmol/L. Treatments were well-tolerated, and no admissions were required. One patient received additional outpatient hydration for elevated creatinine. Development of antiglucarpidase antibody was rare and did not affect treatment. Outpatient HD-MTX with glucarpidase is safe and well-tolerated and has the potential to alter standard treatment for CNS lymphoma.

The effect of adhesiolysis on stoma takedown in patients with end colostomy

AIM: the optimal extent of adhesiolysis for stoma takedown after Hartmann’s procedure is still unknown. This study is for evaluation the early and late results after partial and total dissection of adhesions during Hartmann’s reversal (HR).PATIENTS AND METHODS: a prospective non-randomized study included 99 patients with end colostomy. Fifty patients were included in the main group, in which partial adhesiolysis was performed during HR, and 49 — were the control group, in which complete dissection of adhesions was performed. The groups did not differ in the basic demographic characteristics, number of previous operations, and the severity of the adhesions.RESULTS: the operation time in the groups of partial and total adhesiolysis was 222 vs 205 minutes, respectively (p = 0.9). Injury of the intestinal wall occurred in 18 patients in the main group, and in 19 controls (p = 0.8). The postoperative stay was 12 in the main group vs 11 in the control (p = 0.7). The morbidity rate in the main group was 42% (n = 21), in controls — 29% (n = 14) (p = 0.2). Reoperations were performed in 4 patients of the main group, no reoperations in the control group were required, but no significant differences were obtained (p = 0.5). In the group of partial adhesiolysis, 1 fatal outcome was registered. By the regression analysis, the only factor increasing the likelihood of postoperative complications was a BMI &gt; 35 kg/m2 (OR = 5.3; 95% CI: 1.5–21.2; p = 0.01).CONCLUSION: total adhesiolysis does not affect the operation time and traumatism of Hartmann reversal, does not increase morbidity rate.

Efficacy and safety of two disposable circumcision suture devices for circumcision in adults: a prospective comparative multicenter study.

The objective of this study was to evaluate and compare efficacy and safety of two different Disposable circumcision suture devices (DCSDs). A prospective comparative non-randomized multicenter study was performed between November 2019 and February 2023. Patients underwent circumcision using a DCSD (CircCurerTM or the ZSR® device) according to the surgeon preference and device availability. A total of 378 patients were circumcised; 184 using CircCurerTM and 194 patients using ZSR®. No differences in baseline characteristics were observed. CircCurer and ZSR Groups showed similar rates of operative time (7.7 ±2.1 vs 7.3 ±2.0 min), surgical site infection (1.1% Vs 1.5%), edema (13% Vs 8.2%), hematomas (2.7% Vs 1.1%), and postoperative pain (2.5 Vs 2.0 points). ZSR Group had a significantly higher rate of clip fallout (62.9% Vs 38%, p < 0.001). At 2 months, patients of both groups reported a median satisfaction of 9 (8-9) points. Main limitation consist in non-randomized study. DCSDs seem to be effective and safe, with short operative times, uncommon and mild complications, and high patient satisfaction. ZSR® device has a higher rate of spontaneous staple dropout.