Prospective Non-inferiority Study Research Articles

P-585 Vaginal progesterone associated with oral dydrogesterone versus vaginal progesterone for luteal support in letrozole-hcg cycles for thawed embryo transfer: a non-inferiority prospective cohort study

Abstract Study question Does micronized vaginal progesterone (MVP) associated with oral dydrogesterone (DYG) an alternative for luteal support in Letrozole-hcg cycles for thawed embryo transfer? Summary answer The association of MVP and DYG is a non-inferior alternative to only MVP for luteal support in thawed embryo transfer in Letrozole-hcg cycles. What is known already Endometrial preparation is essential for thawed embryo transfer. Several protocols involving different luteal support with progesterones are available. Moreover, the presence of corpus luteum decreases the obstetrical morbidity mainly linked to hypertensive disorders. Letrozole-hcg administration is a good alternative for frozen embryo transfer (FET). However, the literature lacks information about the comparison among the different protocols for luteal support in Letrozole-hcg cycles. Dydrogesterone is an oral progesterone with some unique characteristics which could be utilized with some advantage for luteal support, including oral administration and some immunological activity. Study design, size, duration This is a prospective non-inferiority cohort study performed at an infertility clinic including patients performing the first FET cycle during 2023. Reproductive outcomes were compared between patients receiving 600 mg (3x200 mg) of MPV or 40 mg of DYG plus 400 mg of MVP after Letrozole-hcg administration. Participants/materials, setting, methods All patients (aged 23-39 years) undergoing their first FET cycle during 2023 were included in this study (n = 169), divided into two groups: MVP+DYG (n = 54) or MVP (n = 115) for luteal support after Letrozole-hcg. Letrozole was administered for 5 days (2,5 mg/bid) and hcg was done when a dominant follicle reached 18 mm with a follicular endometrium measuring at least 7 mm. Main results and the role of chance Both groups were equivalent in terms of age, infertility aetiology, BMI and AMH (P > 0.05). Moreover, the proportion of cleavage or blastocyst stage was also similar between both groups (57% blastocyst transfer for MVP+DYG and 50% blastocyst transfer for MVP group, P > 0.05). The number of transferred embryos was (mean ±SD) 1.6±0.5 for both groups, P > 0.05. Furthermore, the number of top-quality embryos (cleavage stage or blastocyst) was also similar, P > 0.05. Moreover, clinical pregnancy (> 12 weeks) was 42% in MVP+DYG group versus 31% in the MVP group (-0.22-1.27, P = 0.156) and the early pregnancy loss per positive hcg test did not differ (18% for MVP+DGY and 22% for MVP, P = 0.687). In addition, we performed a multivariable analysis controlling possible confounders for clinical pregnancy: BMI, age, AMH, embryo quality, infertility aetiology and embryo stage during the transfer, and only age (0.86; 95%CI -0.229 to -0.064, P = 0.001) was related to clinical pregnancy. Limitations, reasons for caution The main limitation is the cohort design of our study, with an inherent risk of bias (selection bias). Moreover, we calculated this study to achieve the power for a non-inferiority comparison, not superiority comparison. Wider implications of the findings This is the first study comparing MVP+DYG to only MVP in patients submitted to FET using the Letrozole-hcg protocol. We demonstrated in this non-inferiority study the usefulness of adding DYG. Moreover, our results were promising showing a trend towards better pregnancy rates after MVP+DYG. Trial registration number not applicable

MRI versus Dual-Energy CT in Local-Regional Staging of Gastric Cancer.

Background Preoperative local-regional tumor staging of gastric cancer (GC) is critical for appropriate treatment planning. The comparative accuracy of multiparametric MRI (mpMRI) versus dual-energy CT (DECT) for staging of GC is not known. Purpose To compare the diagnostic accuracy of personalized mpMRI with that of DECT for local-regional T and N staging in patients with GC receiving curative surgical intervention. Materials and Methods Patients with GC who underwent gastric mpMRI and DECT before gastrectomy with lymphadenectomy were eligible for this single-center prospective noninferiority study between November 2021 and September 2022. mpMRI comprised T2-weighted imaging, multiorientational zoomed diffusion-weighted imaging, and extradimensional volumetric interpolated breath-hold examination dynamic contrast-enhanced imaging. Dual-phase DECT images were reconstructed at 40 keV and standard 120 kVp-like images. Using gastrectomy specimens as the reference standard, the diagnostic accuracy of mpMRI and DECT for T and N staging was compared by six radiologists in a pairwise blinded manner. Interreader agreement was assessed using the weighted κ and Kendall W statistics. The McNemar test was used for head-to-head accuracy comparisons between DECT and mpMRI. Results This study included 202 participants (mean age, 62 years ± 11 [SD]; 145 male). The interreader agreement of the six readers for T and N staging of GC was excellent for both mpMRI (κ = 0.89 and 0.85, respectively) and DECT (κ = 0.86 and 0.84, respectively). Regardless of reader experience, higher accuracy was achieved with mpMRI than with DECT for both T (61%-77% vs 50%-64%; all P < .05) and N (54%-68% vs 51%-58%; P = .497-.005) staging, specifically T1 (83% vs 65%) and T4a (78% vs 68%) tumors and N1 (41% vs 24%) and N3 (64% vs 45%) nodules (all P < .05). Conclusion Personalized mpMRI was superior in T staging and noninferior or superior in N staging compared with DECT for patients with GC. Clinical trial registration no. NCT05508126 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Méndez and Martín-Garre in this issue.

VMAT with DIBH in hypofractionated radiotherapy for left-sided breast cancer after breast-conserving surgery: results of a non-inferiority clinical study.

The purpose of this study was to show the safety of volumetric modulated arc therapy (VMAT) with deep inspiration breath-hold (DIBH) in hypofractionated radiotherapy for left-sided breast cancer after breast-conserving surgery in a clinical setting. Twenty-five Japanese women, aged 20-59years, who were enrolled in this prospective non-inferiority study received VMAT under the condition of DIBH with 42.4Gy/16 fractions for whole-breast irradiation (WBI) ± boost irradiation for the tumor bed to show the non-inferiority of VMAT with DIBH to conventional fractionated WBI with free breathing. The primary endpoint was the rate of occurrence of radiation dermatitis of Grade 3 or higher or pneumonitis of Grade 2 or higher within 6months after the start of radiotherapy. This study was registered with UMIN00004321. All of the enrolled patients completed the planned radiotherapy without interruption. The evaluation of adverse events showed that three patients (12.0%) had Grade 2 radiation dermatitis. There was no other Grade 2 adverse event and there was no patient with an adverse event of Grade 3 or higher. Those results confirmed our hypothesis that the experimental treatment method is non-inferior compared with our historical results. There was no patient with locoregional recurrence or metastases. In conclusion, VMAT under the condition of DIBH in hypofractionated radiotherapy for left-sided breast cancer after breast-conserving surgery can be performed safely in a clinical setting.

Diagnostic Agreement Between TEG5000 and TEG6S in the Assessment of Hemostasis in Pediatric Cardiac Surgery: A Prospective Non-inferiority Study.

Thromboelastography (TEG) is a point-of-care test (POCT) used to analyze the hemostatic properties of whole blood. TEG® 5000and TEG® 6s (Haemonetics Corp, USA) measure the same parameters describing clot viscoelasticity using different methodologies. The purpose of this study was to evaluate agreement between TEG5000 and TEG6s measurements. We analyzed prospectively collected tests resulting from paired blood samples in cardiac surgery pediatric patients at one hour (T0) and 24 h (T1) postoperatively. Each citrated sample was utilized for TEG® 5000 and TEG ®6s. Six specific TEG parameters were analyzed and compared: R kaolin time (RK), R kaolin heparinase (RKH) time, K kaolin time (KK), K kaolin heparinase time KH (KKH), Maximum Amplitude kaolin (MAK), Maximal Amplitude Kaolin Heparinase (MAKH). We enrolled 30 patients. Median (interquartile range) patients' age was 206 (20-597) days. All surgical patients underwent correction except 5 who were palliated. At T0, RK and RKH showed an average (standard deviation) % bias of 15.8 (31) and 16.1 (28), respectively, with similar results at T1. A % bias of -6 (23) and - 6 [15] in MAK was found at T0 and T1, respectively. Similarly, MAKH % bias was 1.5 (22) and 7.6 (29) at T0 and T1, respectively. At both timepoints, low % biases (< ± 6%) were demonstrated in KK and KKH. All parameters showed improved coagulation from T0 to T1, but without significant interaction between type of device and time. Analysis of the entire pool of 60 paired samples showed no agreement in diagnostic performance (within the range vs. outside the range) in 12 (20%), 5 (9.8%), 1 (1.7%), 4 (7.8%), 9 (15%), and 5 (9.8%) cases for RK, RKH, MAK, MAKH, KK and KKH, respectively. We observed substantial agreement in MAK and KK in a cohort of pediatric patients undergoing uncomplicated cardiac surgery. Our findings suggest that TEG®5000 and TEG®6s are interchangeable for assessing these parameters.

Can All Weightbearing Stable Weber B Fractures Be Treated Functionally with Orthoses? – a Prospective Non-Inferiority Study Comparing Weightbearing Stable Fractures with and without Stress Instability

Can All Weightbearing Stable Weber B Fractures Be Treated Functionally with Orthoses? – a Prospective Non-Inferiority Study Comparing Weightbearing Stable Fractures with and without Stress Instability

A Prospective, Randomized, Non-inferiority Trial to Compare the Efficacy of 3% Povidone-Iodine Foam Dressing and Silver Foam Dressing in the Treatment of Pressure Injuries

Background: As chronic wounds such as pressure injuries (PIs) are frequently colonized and can easily deteriorate into infection, it is important to reduce their bacterial load, for which antimicrobial dressings can be needed. This study aims to evaluate the efficacy of a 3% povidone-iodine (PVP-I) foam dressing compared to that of a silver foam dressing.Methods: This prospective non-inferiority study was conducted between 2016 and 2019 at three sites in South Korea. A total of 80 PI subjects were randomized to be dressed with either PVP-I foam (experimental group) or silver foam (control group) for up to 8 weeks.Results: Based on the Pressure Ulcer Scale for Healing (PUSH) tool, 25.0% of the experimental groups and 17.5% of the control groups (χ&lt;sup&gt;2&lt;/sup&gt;=0.743, P=0.389) healed by more than 70%. The degree of reduction in wound size was analyzed using Image J, and the experimental and control groups decreased by 41.6%±35.3% and 49.7%±38.2% (t=–0.986, P=0.327), respectively. A Kaplan-Meier survival analysis to confirm the time to heal showed that if more than 30% of the PUSH score was healed, the time to heal was 27.0±9.3 days and 18.0±2.8 days in the two groups (χ&lt;sup&gt;2&lt;/sup&gt;=3.225, P=0.073), respectively. The healing rates at 50 days were 85.8%±8.9% and 93.9%±5.7% in the two groups (P=0.073), respectively. There were no statistically significant differences between the groups in all results.Conclusion: This study demonstrated the non-inferiority of the 3% PVP-I foam dressing compared to the silver foam dressing for PI treatment.

Exploratory study: Evaluation of a symptom checker effectiveness for providing a diagnosis and evaluating the situation emergency compared to emergency physicians using simulated and standardized patients.

The overloading of health care systems is an international problem. In this context, new tools such as symptom checker (SC) are emerging to improve patient orientation and triage. This SC should be rigorously evaluated and we can take a cue from the way we evaluate medical students, using objective structured clinical examinations (OSCE) with simulated patients. The main objective of this study was to evaluate the efficiency of a symptom checker versus emergency physicians using OSCEs as an assessment method. We explored a method to evaluate the ability to set a diagnosis and evaluate the emergency of a situation with simulation. A panel of medical experts wrote 220 simulated patients cases. Each situation was played twice by an actor trained to the role: once for the SC, then for an emergency physician. Like a teleconsultation, only the patient's voice was accessible. We performed a prospective non-inferiority study. If primary analysis had failed to detect non-inferiority, we have planned a superiority analysis. The SC established only 30% of the main diagnosis as the emergency physician found 81% of these. The emergency physician was also superior compared to the SC in the suggestion of secondary diagnosis (92% versus 52%). In the matter of patient triage (vital emergency or not), there is still a medical superiority (96% versus 71%). We prove a non-inferiority of the SC compared to the physician in terms of interviewing time. We should use simulated patients instead of clinical cases in order to evaluate the effectiveness of SCs.

Fluorescent Indocyanine Green versus Technetium-99m and Blue Dye for Bilateral SENTinel Lymph Node Detection in Stage I–IIA Cervical Cancer (FluoreSENT): protocol for a non-inferiority study

IntroductionNowadays, two predominant methods for detecting sentinel lymph nodes (SLNs) in cervical cancer are in use. The most conventional method is a combination of a radiotracer, technetium-99m (99mTc) and blue...

Gastric variceal bleeding treated through endoscopic ultrasound-guided coiling and N-butyl-2-cyanoacrylate application.

To evaluate efficacy and safety between dual angiotherapy (endocoil plus N-butyl-cyanoacrylate) guided by endoscopic ultrasound) versus N-butyl-cyanoacrylate in the secondary prophylaxis of gastroesophageal varices (GOV). Prospective non-inferiority study comparing two gastric variceal eradication techniques. We evaluated technical and clinical success, GOV occlusion and eradication, rebleeding, reoperation, GOV-free period, complications, and mortality. Chi square for categorical variables and Student's t for numerical variables with a significance level of 0.05. There were 68 patients (average age 55.5 ± 10 years, women 44 (64.7%) and average body mass index 25.7 ± 3.5 kg/m2). The most frequent cause was alcoholic steatohepatitis (58%). Dual therapy had greater technical (100% vs. 94.3%) and clinical (100% vs. 85%) success. Obliteration was faster (100 vs. 79.2%). This group only required one session. The GOV size was 24 ± 14 mm and 1-2 endocoils were placed. The median follow-up was 221 days. The reoperation-free rate was high (100% vs. 94%; p = 0.9). Dual angiotherapy guided by endoscopic ultrasound and cyanoacrylate injection are effective for the eradication of GOV without differences in adverse event rates.

OC-0832 DAHANCA 27, a national prospective non-inferiority study of surgery versus RT for T1a glottic cancer

OC-0832 DAHANCA 27, a national prospective non-inferiority study of surgery versus RT for T1a glottic cancer

Undifferentiated Dyspnea with Point-of-Care Ultrasound, Primary Emergency Physician Compared with a Dedicated Emergency Department Ultrasound Team.

Emergency physicians (EPs) perform critical actions while operating with diagnostic uncertainty. Point-of-care ultrasound (POCUS) is useful in evaluation of dyspneic patients. In prior studies, POCUS is often performed by ultrasound (US) teams without patient care responsibilities. This study evaluates the effectiveness of POCUS in narrowing diagnostic uncertainty in dyspneic patients when performed by treating EPs vs. separate US teams. This multicenter, prospective noninferiority cohort study investigated the effect of a POCUS performing team in patient encounters for dyspnea. Before-and-after surveys assessing medical decision-making were administered to attending physicians. Primary outcome was change in most likely diagnosis after POCUS. This was assessed for noninferiority between encounters where the primary or US team performed POCUS. Secondary outcomes included change in differential diagnosis, confidence in diagnosis, interventions considered, and image quality. There were 156 patient encounters analyzed. In the primary team group, most likely diagnosis changed in 40% (95% confidence interval 28-52%) of encounters vs. 32% (95% confidence interval 22-41%) in the US team group. This was noninferior using an a priori specified margin of 20% (p < .0001). Post-POCUS differential decreased by a mean 1.8 diagnoses and was equivalent within a margin of 0.5 diagnoses between performing teams (p = 0.034). Other outcomes were similar between groups. POCUS performed by primary teams was noninferior to POCUS performed by US teams for changing the most likely diagnosis, and equivalent when considering mean reduction in number of diagnoses. POCUS performed by treating EPs reduces cognitive burden in dyspneic patients.

Follow-up with Telemedicine in Early Discharge for COPD Exacerbations: Randomized Clinical Trial (TELEMEDCOPD-Trial)

The results reported by different studies on telemonitoring in patients with chronic obstructive pulmonary disease (COPD) have been contradictory, without showing clear benefits to date. The objective of this study was to ascertain whether an early discharge and home hospitalization telehealth program for patients with COPD exacerbation is as effective as and more efficient than a traditional early discharge and home hospitalization program. A prospective experimental non-inferiority study, randomized into two groups (telemedicine/control) was conducted. The telemedicine group underwent monitoring and was required to transmit data on vital constants and ECGs twice per day, with a subsequent telephone call and 2 home visits by healthcare staff (intermediate and at discharge). The control group received daily visits. The main variable was time until first exacerbation. The secondary variables were: number of exacerbations; use of healthcare resources; satisfaction; quality of life; anxiety-depression; and therapeutic adherence, measured at one and 6 months of hospital discharge. A total of 116 patients were randomized (58 to each group) without significant differences in baseline characteristics or time until first exacerbation, i.e. median 48 days (pp. 25–75:23–120) in the control group, and 47 days (pp. 25–75:19–102) in the intervention group; p = 0.52). A significant decrease in the number of visits was observed in the intervention versus the control group, 3.8 ± 1 vs 5.1 ± 2(p = 0.001), without significant differences in the number of exacerbations. In conclusion follow-up via a telemedicine program in early discharge after hospitalization is as effective as conventional home follow up, being the cost of either strategy not significantly different.

A prospective comparative study of two methods for the individual calculation of 131I activity in the treatment of hyperthyroidism

ObjectiveRadioiodine (131I) is an established modality of definitive treatment of hyperthyroidism. In spite of the vast experience available, there are still several aspects to be clarified, such as whether fixed or calculated doses should be used. The aim of this study was to assess whether efficacy of this treatment could be improved by implementing a simple dosimetric calculation method including ultrasonographic estimation of thyroid volume and a single measurement of 24-h 131I thyroid uptake. MethodsA prospective non-inferiority study was designed to compare two procedures to calculate radioiodine activity: the “semi-fixed” dose method (A), and the “calculated” dose method (B). The first consisted of activity escalation (185MBq steps) based on etiology of hyperthyroidism, 131I uptake, and treatment objective. The second method was based on the “dosimetric compromise” concept, considering 24-h uptake and thyroid volume as the only factors and using a standard half-life of 5.5 days. The target absorbed dose was 150Gy, but after a preliminary analysis (first 100 cases) it was increased to 200Gy in diffuse toxic goiters (DTGs). ResultsA total of 212 patients were included. Method B was at least as effective in terms of final and functional outcome, with a trend to more success and less hypothyroidism. In addition, activities administered were significantly lower. ConclusionIn radioiodine therapy of hyperthyroidism, a simple dosimetric method that provided results at least equal to those of a fixed dose-based method, with lower administered activities, could be implemented.

174 Evaluation of Undifferentiated Dyspnea with Point of Care Ultrasound Performed by Primary Emergency Department Physician Compared to a Dedicated Emergency Department Ultrasound Team

Undifferentiated dyspnea is among the most challenging emergency department (ED) presentations. Emergency physicians (EP) must often perform critical actions while operating with diagnostic uncertainty. Point of care ultrasound (POCUS) has been shown to be highly beneficial in the initial evaluation of dyspneic patients but prior studies often study POCUS performed by experts or a dedicated physician ultrasound (US) team. Performance of POCUS by the primary treating team is often limited by the time and workflow constraints. This study aims to evaluate the effectiveness of POCUS in narrowing diagnostic uncertainty and guiding initial management of acutely dyspneic patients when performed by treating EP compared to a dedicated US team. This is a multi-center, prospective non-inferiority cohort study investigating the effect of POCUS on the differential diagnosis of patients presenting with undifferentiated dyspnea. During the initial evaluation of these patients, the primary attending provider completed a survey evaluating initial differential diagnosis and treatment plan. The provider team or a separate US team then performed targeted POCUS on the patient. After POCUS, the treating provider completed a second survey to evaluate changes in differential and management. The primary outcome was change in the most likely diagnosis and was assessed for non-inferiority between primary and US team performed POCUS using an a priori specified non-inferiority margin of 20%. Secondary outcomes included change in number of diagnoses considered, change in confidence in diagnosis assessed on a Likert-like scale, and change in interventions. We enrolled physicians evaluating 156 patients presenting with undifferentiated dyspnea at a university affiliated ED or a community hospital ED. In 40% (95% CI, 28 - 52%) of studies performed by the primary team the most likely diagnosis changed compared to 32% (95% CI, 22 - 41%) for studies performed by the US team. This was declared non-inferior using a margin of 20% (p < .0001). Post-POCUS differentials decreased by a mean 1.8 diagnoses and this change was equivalent within a margin of 0.5 diagnoses between primary and US team performed studies (p = 0.034). Secondary outcomes were also notable for a modest change in any management being considered (34% primary team vs 32% US team), an increase in post-POCUS confidence in diagnosis (0.7 vs 0.6-point increase), and 3 cases of cardiac tamponade were found when COPD or CHF was the initial suspected diagnosis. POCUS performed both by the primary team and a dedicated US team resulted in a significant narrowing of the differential diagnosis, a change in the primary diagnosis and an increase in confidence of diagnosis. The change in primary diagnosis was non-inferior when comparing primary to US team performed studies and the two groups were equivalent when considering change in confidence in diagnosis as well as mean reduction in number of diagnoses. There was also no significant difference in effect between performing sites. POCUS is a valuable tool for limiting the cognitive burden in the initial evaluation of undifferentiated dyspneic ED patients when performed in a targeted fashion.

Single-Sampling Strategy vs. Multi-Sampling Strategy for Blood Cultures in Sepsis: A Prospective Non-inferiority Study.

BackgroundOptimal sampling is critical for the performance of blood cultures (BCs). Most guidelines recommend collecting 40 ml of blood, divided between two venipuncture sites, i.e., multi-sampling strategy (MSS). Sampling through a single venipuncture site, i.e., single-sampling strategy (SSS) is easier; however, the diagnostic performance of SSS compared to MSS remains unknown. Thus, we aimed to study if SSS is non-inferior to MSS for detection of pathogenic microorganisms.MethodsA prospective, paired, non-inferiority design was used. Patients with clinically suspected sepsis admitted to an Emergency Department were included. Six BC bottles were simultaneously collected, consisting of four BC bottles from the first arm and two from the other arm. SSS consisted of BC bottles 1, 2, 3, and 4, and MSS consisted of BC bottles 1, 2, 5, and 6. Samples were incubated in a BacT/ALERT BC system.ResultsThe final analysis included 549 episodes. Pathogenic microorganisms were detected in 162 cases (29.5%) with MSS and 160 cases (29.1%) with SSS, yielding an absolute difference of 0.36%, with a 95% confidence interval of -1.33 to 2.06%, which did not exceed the predefined non-inferiority margin of 5%. MSS tended to produce more contaminant growth (7.3% of cases) than SSS (5.3% of cases; p = 0.072).ConclusionThe study showed that SSS was non-inferior to MSS in detecting pathogenic microorganisms and supports the use of SSS as a routine method.

Estudio prospectivo comparativo de dos métodos de cálculo individual de la actividad de 131I en el tratamiento del hipertiroidismo

ObjectiveRadioiodine (131I) is an established modality of definitive treatment of hyperthyroidism. In spite of the vast experience available, there are still several aspects to be clarified, such as whether fixed or calculated doses should be used. The aim of this study was to assess whether efficacy of this treatment could be improved by implementing a simple dosimetric calculation method including ultrasonographic estimation of thyroid volume and a single measurement of 24-hour 131I thyroid uptake. MethodsA prospective non-inferiority study was designed to compare two procedures to calculate radioiodine activity: the «semi-fixed» dose method (A), and the «calculated» dose method (B). The first consisted of activity escalation (185MBq steps) based on etiology of hyperthyroidism, 131I uptake, and treatment objective. The second method was based on the «dosimetric compromise» concept, considering 24-hour uptake and thyroid volume as the only factors and using a standard half-life of 5.5 days. The target absorbed dose was 150Gy, but after a preliminary analysis (first 100 cases) it was increased to 200Gy in diffuse toxic goiters (DTGs). ResultsA total of 212 patients were included. MethodB was at least as effective in terms of final and functional outcome, with a trend to more success and less hypothyroidism. In addition, activities administered were significantly lower. ConclusionIn radioiodine therapy of hyperthyroidism, a simple dosimetric method that provided results at least equal to those of a fixed dose-based method, with lower administered activities, could be implemented.

The Standardization of Outpatient Procedure (STOP) Narcotics after anorectal surgery: a prospective non-inferiority study to reduce opioid use.

Prescription of opioid medication after ambulatory anorectal surgery may be excessive and lead to opioid misuse. The purpose of this study was to evaluate the efficacy of a multi-modality opioid-sparing approach to control postoperative pain and reduce opioid prescriptions after outpatient anorectal surgery. A prospective non-inferiority pre- and post-intervention study was completed at three academic hospitals. Patients included were 18-75years of age who had outpatient anorectal surgeries. The Standardization of Outpatient Procedure (STOP) Narcotics intervention was implemented, which is a multi-pronged analgesia bundle integrating patient education, health care provider education, and intra-/postoperative analgesia focused on multi-modal pain control strategies and opioid-reduced prescriptions. The primary outcome was patient-reported average pain in the first 7 postoperative days. Secondary outcomes included patient-reported quality of pain management, medication utilization, prescription refills and medication disposal. Ninety-three patients had outpatient anorectal surgery (42 pre-intervention and 51 post-intervention). No difference was seen in average postoperative pain in the pre- vs. post-intervention groups (2.8 vs. 2.6 on an 11-point scale, p = 0.33) or patient-reported quality of pain control (good/very good in 57% vs. 63%, p = 0.58). The median oral morphine equivalents (OME) prescribed was significantly less [112.5 (IQR 50-150) pre-intervention vs. 50 (IQR 50-50) post-intervention, p < 0.001]. In the post-intervention group, only 45% of patients filled their opioid prescription and median opioid use was 12.5 OME (2.5 pills). While pain control after anorectal surgery must consider the individual patient's needs, a standardized pain care bundle significantly decreased opioid prescribing without an increase in patient-reported postoperative pain.

The effect of preoperative erector spinae plane vs. paravertebral blocks on patient-controlled oxycodone consumption after video-assisted thoracic surgery: A prospective randomized, blinded, non-inferiority study

Study objectiveTo investigate the effective analgesia for video-assisted thoracic surgery. DesignIn this prospective non-inferiority study, we evaluated the postoperative analgesic effect of preoperative ultrasound-guided Erector Spinae Plane blocks (ESPB) on T4 and T6 levels in patients undergoing video-assisted thoracic surgery in comparison with paravertebral block (PVB) at the same intervertebral spaces. SettingA university hospital. Patients66 patients scheduled to undergo video-assisted thoracic surgery under general anesthesia were included. InterventionsPatients were randomly allocated to receive ultrasound-guided ESP blocks on T4 and T6 levels (Group ESPB, n = 33) or PVB (Group PVB, n = 33) with 30 mL 0.4% ropivacaine 30 min before anesthesia induction. A continuous flurbiprofen (8 mg/h) was infused postoperatively through a single-use infusion device and intravenous oxycodone supplied as analgesic rescue if needed, with bolus of oxycodone (1 mg) and lockout time being 10 min. MeasurementsThe primary outcome was the postoperative oxycodone consumption at 48 h. Main resultsIntraoperative use of sufentanil and remifentanil were comparable between these two groups. Pain scores, oxycodone rescue and Quality of Recovery (QoR) 15 on postoperative day 1 and 2 were equivalent between these two groups. Postoperative oxycodone consumption was 7.9 ± 8.7 boluses in ESPB group and 6.9 ± 6.3 boluses in PVB group at 48 h. The cumulative 48 h difference i.e. Oxycodone boluseswith ESPB minus Oxycodone boluseswith PVB was 2 (95% CI -1, 5.6). The lower limit of the 95% CI for this difference was −1, which was within the predefined non-inferiority margin of −10 (Δ). ConclusionsUltrasound-guided ESPB applied before video assisted thoracic surgery was non-inferior in analgesic effect compared with PVB in terms of pain score, analgesic rescue consumption and quality of recovery. Brief summary statementPreoperative Erector spinae plane blocks (ESPB), when in combination with round-the-clock NSAIDs, offered equivalent analgesia and quality of recovery after video assisted thoracic lung surgery compared with paravertebral blocks. Patients who received ESP blocks had similar consumption of oxycodone and length of hospital stay.

Computer-Aided Diagnosis System for the Evaluation of Thyroid Nodules on Ultrasonography: Prospective Non-Inferiority Study according to the Experience Level of Radiologists.

ObjectiveTo determine whether a computer-aided diagnosis (CAD) system for the evaluation of thyroid nodules is non-inferior to radiologists with different levels of experience.Materials and MethodsPatients with thyroid nodules with a decisive diagnosis of benign or malignant nodule were consecutively enrolled from November 2017 to September 2018. Three radiologists with different levels of experience (1 month, 4 years, and 7 years) in thyroid ultrasound (US) reviewed the thyroid US with and without using the CAD system. Statistical analyses included non-inferiority testing of the diagnostic accuracy for malignant thyroid nodules between the CAD system and the three radiologists with a non-inferiority margin of 10%, comparison of the diagnostic performance, and the added value of the CAD system to the radiologists.ResultsAltogether, 197 patients were included in the study cohort. The diagnostic accuracy of the CAD system (88.48%, 95% confidence interval [CI] = 82.65–92.53) was non-inferior to that of the radiologists with less experience (1 month and 4 year) of thyroid US (83.03%, 95% CI = 76.52–88.02; p < 0.001), whereas it was inferior to that of the experienced radiologist (7 years) (95.76%, 95% CI = 91.37–97.96; p = 0.138). The sensitivity and negative predictive value of the CAD system were significantly higher than those of the less-experienced radiologists were, whereas no significant difference was found with those of the experienced radiologist. A combination of US and the CAD system significantly improved sensitivity and negative predictive value, although the specificity and positive predictive value deteriorated for the less-experienced radiologists.ConclusionThe CAD system may offer support for decision-making in the diagnosis of malignant thyroid nodules for operators who have less experience with thyroid US.

The Standardization of Outpatient Procedure (STOP) Narcotics: A Prospective Health Systems Intervention to Reduce Opioid Use in Ambulatory Breast Surgery.

During the past 15years, opioid-related overdose death rates for women have increased 471%. Many surgeons provide opioid prescriptions well in excess of what patients actually use. This study assessed a health systems intervention to control pain adequately while reducing opioid prescriptions in ambulatory breast surgery. This prospective non-inferiority study included women 18-75years of age undergoing elective ambulatory general surgical breast procedures. Pre- and postintervention groups were compared, separated by implementation of a multi-pronged, opioid-sparing strategy consisting of patient education, health care provider education and perioperative multimodal analgesic strategies. The primary outcome was average pain during the first 7 postoperative days on a numeric rating scale of 0-10. The secondary outcomes included medication use and prescription renewals. The average pain during the first 7 postoperative days was non-inferior in the postintervention group despite a significant decrease in median oral morphine equivalents (OMEs) prescribed (2.0/10 [100 OMEs] pre-intervention vs 2.1/10 [50 OMEs] post-intervention; p = 0.40 [p < 0.001]). Only 39 (44%) of the 88 patients in the post-intervention group filled their rescue opioid prescription, and 8 (9%) of the 88 patients reported needing an opioid for additional pain not controlled with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) postoperatively. Prescription renewals did not change. A standardized pain care bundle was effective in minimizing and even eliminating opioid use after elective ambulatory breast surgery while adequately controlling postoperative pain. The Standardization of Outpatient Procedure Narcotics (STOP Narcotics) initiative decreases unnecessary and unused opioid medication and may decrease risk of persistent opioid use. This initiative provides a framework for future analgesia guidelines in ambulatory breast surgery.