Prospective Interventional Cohort Study Research Articles

Effects of robotic-assisted early mobilization versus conventional mobilization in intensive care unit patients: prospective interventional cohort study with retrospective control group analysis

BackgroundApproximately one in three survivors of critical illness suffers from intensive-care-unit-acquired weakness, which increases mortality and impairs quality of life. By counteracting immobilization, a known risk factor, active mobilization may mitigate its negative effects on patients. In this single-center trial, the effect of robotic-assisted early mobilization in the intensive care unit (ICU) on patients’ outcomes was investigated.MethodsWe enrolled 16 adults scheduled for lung transplantation to receive 20 min of robotic-assisted mobilization and verticalization twice daily during their first week in the ICU (intervention group: IG). A control group (CG) of 13 conventionally mobilized patients after lung transplantation was recruited retrospectively. Outcome measures included the duration of mechanical ventilation, length of ICU stay, muscle parameters evaluated by ultrasound, and quality of life after three months.ResultsDuring the first week in the ICU, the intervention group received a median of 6 (interquartile range 3–8) robotic-assisted sessions of early mobilization and verticalization. There were no statistically significant differences in the duration of mechanical ventilation (IG: median 126 vs. CG: 78 h), length of ICU stay, muscle parameters evaluated by ultrasound, and quality of life after three months between the IG and CG.ConclusionIn this study, robotic-assisted mobilization was successfully implemented in the ICU setting. No significant differences in patients’ outcomes were observed between conventional and robotic-assisted mobilization. However, randomized and larger studies are necessary to validate the adequacy of robotic mobilization in other cohorts.Trial registration: This single-center interventional trial was registered in clinicaltrials.gov as NCT05071248 on 27/08/2021.

Evaluation of a new device to treat negative dysphotopsia.

To evaluate the efficacy and safety of Negative Dysphotopsia (ND) Ring implantation for treating and preventing ND. Multicentric tertiary eye hospitals. Prospective interventional cohort study. 22 patients with ND were enrolled. Eyes with other ocular structural pathologies (corneal, macular, optic nerve head, retinal, neuro-ophthalmological) were excluded. In 15 eyes, the ring was implanted to treat ND (therapeutic group), and in 7 eyes, it was implanted during cataract surgery of the fellow eye as a prophylactic measure (prophylactic group) to prevent the occurrence of ND. Preoperative evaluation included video recording of the patients' complaints aside complete eye examination. Postoperatively, patients were interviewed to confirm resolution of complaints related to ND. The intraoperative difficulties and postoperative adverse events were recorded. A minimum follow-up of 1 year was completed for all eyes. In the therapeutic group, 14 of 15 eyes (93.3%) patients reported complete resolution of ND on the first postoperative day while 1 patient reported persistence of a smaller and lighter temporal shadow. No ND was reported by any patient in any of the 7 eyes treated prophylactically. No significant adverse intraoperative event was recorded; however, vitreous upthrust was noted in 2 of 22 eyes (9.0%). No permanent drop in visual acuity was recorded in the therapeutic group. ND Ring implantation was an easy, safe, and effective approach for both treating and preventing ND.

Introduction of a novel neonatal warming device in Malawi: an implementation science study.

Neonatal hypothermia significantly contributes to infant morbidity and mortality in low-resource settings like Malawi. Kangaroo mother care (KMC) is essential but faces challenges in providing continuous thermal support. The Dream Warmer is a neonatal warming device that was developed to complement KMC. We studied its implementation outside a research environment. Using an implementation science approach, we conducted a prospective interventional cohort study in two hospitals and four health centres in Malawi. Through audits and surveys, we assessed the effect of the Dream Warmer on neonatal hypothermia as well as healthcare provider (HCP) and parent attitudes regarding thermoregulation and related issues. The Dream Warmer raised no safety concerns and effectively treated hypothermia in 90% of uses. It was positively received by HCPs and parents, who reported it had a favourable effect on the care of small and sick newborns. Challenges identified included a scarcity of water and electricity, lack of availability of the device and HCPs forgetting to prepare it in advance of need or to use it when indicated. Feedback for future training was obtained. The Dream Warmer's strong safety and effectiveness performance is consistent with results from strict research studies. Training materials can be adapted to optimize integration into daily practice and provide educational content for parents. The Dream Warmer is a safe and effective device to treat neonatal hypothermia, particularly when KMC is insufficient. We gained an understanding of how to optimize implementation through robust HCP and family education to help combat hypothermia.

Clinical Supervision in Improving the Quality of Nursing Care: Empowerment of Medical-Surgical Hospitalization Teams

Objective. To analyze the impact of clinical supervision on the improvement of positivity rates and quality indicators of nursing practice for medical-surgical patients in a private healthcare unit. Methodology. Prospective interventional cohort study with a quantitative approach, to study the effect of supervision on indicators and indices of quality of care. Materials and Method. A quantitative approach through an interventional prospective cohort study and simple random sampling. Results. Of the n = 764 records of audits conducted on the quality of nursing practice that were analyzed, there were higher scores and positivity indices in both services after the implementation of clinical supervision. Conclusion. The practice of clinical supervision allows for the strategic monitoring of teams according to the results of audits on nursing care practices, thus raising the indices of positivity and quality indicators of nursing care practices with a direct impact on the patient.

Quality of Life Outcomes Among Patients Being Screened for Cytomegalovirus Retinitis in Thailand

ABSTRACT Purpose Cytomegalovirus (CMV) retinitis can have debilitating impacts on quality of life (QOL), but few contemporary studies have characterized these ramifications. This study assessed the impact of CMV retinitis on vision-related QOL for those living with HIV/AIDS in Thailand. Methods QOL was assessed as part of a prospective interventional cohort study of patients referred to a tertiary hospital in Thailand for CMV retinitis screening. A validated vision-related QOL questionnaire was administered at the baseline screening visit and at the 6-month study visit. Multivariable linear regression models were performed to determine the effect of CMV retinitis diagnosis on QOL score. Results A total of 152 participants completed the QOL questionnaire at their initial clinic visit. At baseline, a diagnosis of CMV retinitis diagnosis was significantly associated with decreased QOL score: unilateral retinitis was associated with a 0.11 (95% CI: −0.26–0.03) decrement in QOL, and bilateral retinitis was associated with a 0.33 (95% CI: −0.51–0.16) decrement (joint P-value = 0.0009). For the 78 participants with a 6-month visit, changes in QOL from baseline were small and not significant. A diagnosis of CMV retinitis was still associated with decreased QOL score at 6 months (joint P-value = 0.03). Conclusions This study found that vision-related QOL was lower in those with CMV retinitis, especially with bilateral involvement, and did not improve after treatment among those with follow-up. These findings reinforce the debilitating clinical manifestations of this disease, and support efforts for earlier screening to detect CMV retinitis before impacts on QOL have occurred.

Evaluation of the functional outcome following endoscopic decompression of retrocalcaneal bursitis

<b>Introduction:</b> Retro calcaneal bursitis is an inflammation of the bursa located between the posterior surface of the heel bone and the anterior surface of the Achilles tendon. This study was conducted to evaluate the clinical efficacy of endoscopic decompression and debridement in patients with retrocalcaneal bursitis who had not responded to conservative treatment. Our primary objective was to estimate the improvement in American Orthopaedic Foot and Ankle Society (AOFAS) score after surgery, and our secondary objectives were to estimate the average surgical duration and the incidence of post-operative complications.<br /> <b>Material and methods:</b> This was a single-centre intervention study at a tertiary institution's level. Included in the study were all patients who were diagnosed with retrocalcaneal bursitis and who had failed a minimum 6-month trial of conservative treatment. 36 patients (36 heels) underwent endoscopic decompression.<br /> <b>Results:</b> A prospective interventional cohort study was conducted on a total of 36 adult patients (18-70 years) with clinical and radiological findings suggestive of retrocalcaneal bursitis, duration of failed conservative treatment prior to surgery > 6 months, and refractoriness to other forms of non-operative treatment like steroid injections regardless of duration. There were no patients lost to follow-up. The mean duration of follow-up was 6 months [6 months to 2 years]. The average pre-operative AOFAS score was 56.42 6.8, ranging from 44 to 70. The difference between preoperative and postoperative AOFAS scores at 1 week, 2 weeks, 4 weeks, 3 months, and 6 months was statistically significant (p 0.0001).<br /> <b>Conclusion:</b> In patients with retrocalcaneal bursitis, arthroscopic decompression is a safe, effective, and simple procedure. Within the first three months, the majority of study participants experienced pain relief and a significant improvement in function.

Pre-operative erector spinae plane block should be considered a viable option for laparoscopic colectomies.

The Erector Spinae Plane (ESP) block is a recent development in the field of regional anaesthesia and has been increasingly explored for abdominal surgeries to reduce opioid use and improve pain control. Colorectal cancer is the commonest cancer in multi-ethnic Singapore and requires surgery for curative treatment. ESP is a promising alternative in colorectal surgeries, but few studies have evaluated its efficacy in such surgeries. Therefore, this study aims to evaluate the use of ESP blocks in laparoscopic colorectal surgeries to establish its safety and efficacy in this field. A prospective two-armed interventional cohort study comparing T8-T10 ESP blocks with conventional multimodal intravenous analgesia for laparoscopic colectomies was conducted in a single institution in Singapore. The decision for doing an ESP block versus conventional multimodal intravenous analgesia was made by a consensus between the attending surgeon and anesthesiologist. Outcomes measured were total intra-operative opioid consumption, post-operative pain control and patient outcome. Post-operative pain control was measured by pain score, analgesia use, and amount of opioids consumed. Patient outcome was determined by presence of ileus. A total of 146 patients were included, of which 30 patients received an ESP block. Overall, the ESP group had a significantly lower median opioid usage both intra-operatively and post-operatively (p = 0.031). Fewer patients required patient-controlled analgesia and rescue analgesia post-operatively for pain control (p < 0.001) amongst the ESP group. Pain scores were similar and post-operative ileus was absent in both groups. Multivariate analysis found that the ESP block had an independent effect on reducing intra-opioid consumption (p = 0.014). Multivariate analysis of post-operative opioid use and pain scores did not yield statistically significant results. The ESP block was an effective alternative regional anaesthesia for colorectal surgery that reduced intra-operative and post-operative opioid use while attaining satisfactory pain control.

Gut Microbiota Signatures Are Associated With Psychopathological Profiles in Patients With Ulcerative Colitis: Results From an Italian Tertiary IBD Center.

Several patients with ulcerative colitis (UC) suffer from psychiatric disorders, such as major depressive disorder, anxiety, or bipolar disorder, and show specific personality traits. Despite this, there are few data about personality profiles' characterization in UC patients and about correlation of their psychopathological profile with their intestinal microbiota.The aim of our study is to analyze the psychopathological and personality profile of UC patients and correlate it with specific signatures of their gut microbiota. This is a prospective interventional longitudinal cohort study. We enrolled consecutive patients affected by UC attending to the IBD Unit of Center for Digestive Disease of "A. Gemelli" IRCCS Hospital in Rome and a group of healthy subjects, matched for specific characteristics. Each patient was evaluated by a gastroenterologist and a psychiatrist. Moreover, all participants underwent psychological tests and a collection of stool samples. We recruited 39 UC patients and 37 healthy subjects. Most patients showed high level of alexithymia, anxiety symptoms, depressive symptoms, as well as neuroticism and hypochondria, with obsessive-compulsive features at the behavioral level, which significantly impaired their quality of life and abilities at work. Gut microbiota analysis in UC patients demonstrated an increase in actinobacteria, Proteobacteria and Saccharibacteria (TM7), with a reduction in verrucomicrobia, euryarchaeota and tenericutes. Our study confirmed the presence of high levels of psycho-emotional distress in UC patients, alongside alterations of the intestinal microbiota, and highlighted some families and genera of bacteria (Enterobacteriaceae, Streptococcus, Veillonella, Klebsiella, and Clostridiaceae) as potential markers of an altered gut-brain axis in these patients.

Outcomes after bilateral implantation of AcrySof IQ PanOptix trifocal intraocular lens: a prospective interventional study.

Implantation of multifocal intraocular lenses (IOLs) is becoming increasingly popular for the treatment of visual demands at various distances in patients undergoing phacoemulsification cataract surgery. We aimed to assess the visual performance and rates of photic phenomena, posterior capsule opacification (PCO), and spectacle independence in patients with bilateral implantation of the AcrySof® IQ PanOptix® multifocal IOL model TFNT00 at one and six months postoperatively. This prospective interventional cohort study included adult patients who underwent uneventful phacoemulsification cataract surgery with bilateral implantation of AcrySof® IQ PanOptix® IOL. Uncorrected and corrected visual acuities at far, intermediate, and near distances were measured preoperatively and at the one- and six-month postoperative follow-up examinations. The rates of photic phenomena, postoperative need for near and distance spectacles, and PCO were also recorded. We included 164 eyes of 82 patients with a male-to-female ratio of 38 (46.3%) to 44 (53.7%) and a mean (standard deviation [SD]) age of 52.37 (7.62) years. There were statistically significant improvements in the visual acuities of both eyes across all distances at the one- and six-month follow-up examinations compared to the preoperative values (all P < 0.001), except for corrected near visual acuity in the right eye (P > 0.05) at six-month. We also detected significant postoperative improvements in visual acuities of both eyes across all distances at the six-month follow-up compared to values at the one-month follow-up (all P < 0.05), except for corrected near visual acuity in the right eye (P > 0.05). The photic phenomenon was reported by 12 (14.6%) of the 82 patients at the six-month postoperative follow-up. Five (6.1%) and eight (9.8%) of the 82 patients reported using spectacles for distance and near, respectively. Additionally, PCO developed in 19 (11.6%) of the 164 included eyes, although it was not clinically significant at six months. The AcrySof® IQ PanOptix® IOL model TFNT00 is recommended for use, given its excellent performance in all ranges of vision, a high rate of spectacle independence, and a good safety profile. Future comparative studies with longer follow-up periods are warranted to verify superiority of its performance over that of other available multifocal IOLs.

PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety.

To compare the efficacy and safety of the PRESERFLO™ MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG) after one year. Institutional prospective interventional cohort study comparing eyes with POAG, which had received the PRESERFLO™ MicroShunt versus trabeculectomy. The MicroShunt group was matched with the trabeculectomy group for age, known duration of disease, and number and classes of intraocular pressure (IOP) lowering medications to have similar conjunctival conditions. The study is part of the Dresden Glaucoma and Treatment Study, using a uniform study design, with the same inclusion and exclusion criteria, follow-ups and standardized definitions of success and failure for both procedures. mean diurnal IOP (mdIOP, mean of 6 measurements), peak IOP, and IOP fluctuations. success rates, number of IOP lowering medications, visual acuity, visual fields, complications, surgical interventions, and adverse events. Sixty eyes of 60 patients, 30 in each group, were analyzed after 1-year follow-ups. Median [Q25, Q75] mdIOP (mmHg) dropped from 16.2 [13.8-21.5] to 10.5 [8.9-13.5] in the MicroShunt and from 17.6 [15.6-24.0] to 11.1 [9.5-12.3] in the trabeculectomy group, both without glaucoma medications. Reduction of mdIOP (P = .596), peak IOP (P = .702), and IOP fluctuations (P = .528) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy group, especially in the early postoperative period (P = .018). None of the patients experienced severe adverse events. Both procedures are equally effective and safe in lowering mdIOP, peak IOP and IOP fluctuations in patients with POAG, one year after surgery. NCT02959242.

One in four women with stress urinary incontinence who are taught "the knack" maneuver adopt this motor pattern while coughing: A prospective interventional cohort study.

Do women with stress urinary incontinence (SUI) who receive instruction to perform the knack maneuver as part of a 12-week pelvic floor muscle training (PFMT) program perform it during voluntary coughing without specific instruction to do so, and are subjective and objective outcomes better among those who do than among those who do not demonstrate the knack during voluntary coughing? Secondary analysis of a prospective interventional cohort. Women with SUI. 12-week PFMT intervention including instruction to perform the knack. Performance of the knack before a voluntary cough as confirmed through ultrasound imaging. SUI severity determined subjectively (International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms[ICIQ-FLUTS] overall score, ICIQ-FLUTS UI subscale score, 3-day bladder diary) and objectively (30-minpad test). Outcome data were available from 69 participants. At baseline, no participants performed the knack when asked to cough. At follow-up, more participants performed the knack during a voluntary cough [18/69 (26%), 95% confidence interval [CI] 15%-35%] than at baseline. The extent of improvement in SUI symptoms was not different between participants who did and did not demonstrate the knack during a voluntary cough [FLUTS-UI subscale score (d = 0.31, 95% CI -0.78 to 2.77, n = 69), FLUTS overall score (d = 0.26, 95% CI -1.52-4.23, n = 69), 30-minpad test (d = 0.03, 95% CI -9.35 to 10.32, n = 69), 3-day bladder diary (d = 0.03, 95% CI -4.07 to 3.60, n = 51)]. Approximately one in four women appear to adopt the knack as a motor response to a cough command, however, adopting the knack was not independently associated with greater improvements in SUI.

Effect of low-level laser therapy on post-extraction hemostasis in patients with hemophilia — A prospective cohort study

Dental extraction in hemophiliacs can be complicated by perilous bleeding. Although developments in local hemostatics and factor replacement have made outpatient extraction feasible, there is no standard protocol for preventing hemorrhagic exigency. Low-level laser therapy (LLLT) has firmly established role in hemostasis due to its ability to seal vessels, but this function has not been conclusively established in hemophiliac patients. The objective of our study was to evaluate the effectiveness of LLLT as compared with the standard protocol alone in achieving post-extraction hemostasis.A prospective interventional cohort study was designed and consisted of 60 patients with hemophilia A or B, who reported to the Maulana Azad Institute of Dental Sciences, New Delhi between October 2021 and March 2022. These were divided equally into test and control groups, both following the standard protocol. In the test group, extraction sockets were exposed to LLLT. The study assessed time required, instance of rebleeding, and additional methods employed for hemostasis in each group.The results showed a 22.42% reduction in average time taken to achieve hemostasis in the test group as compared with the control group. The tranexamic acid pack was replaced in two cases in both groups after 60 min of procedure. Three cases in the control group required suturing, and one case required cauterization. Rebleeding occurred in four cases in the test group and in 13 cases among the controls. Postoperative factor was infused in three and 12 cases in the test and control groups, respectively.The authors believe that perioperative use of LLLT should be encouraged because it demonstrated a significantly reduced time for hemostasis among hemophilia patients.

National implementation of an optimal standardised technique for right-sided colon cancer: protocol of an interventional sequential cohort study (Right study)

PurposeMinimally invasive right hemicolectomy (MIRH) is the cornerstone of treatment for patients with right-sided colon cancer. This operation has evolved during recent decades, with many innovations and improvements but this has also resulted in high variability of uptake with subsequent substantial variableness. The aim of this ongoing study is to identify current surgical variations, determine the most optimal and standardised MIRH and nationally train and implement that technique to improve short-term clinical and long-term oncological outcomes.MethodsThe Right study is a national multicentre prospective interventional sequential cohort study. Firstly, current local practice was evaluated. Subsequently, a standardised surgical technique for right-sided colon cancer was determined using the Delphi consensus method, and this procedure was trained during hands-on courses. The standardised MIRH will be implemented with proctoring (implementation cohort), after which the performance will be monitored (consolidation cohort). Patients who will receive a minimally invasive (extended) right hemicolectomy for cT1-3N0-2M0 colon cancer will be included. The primary outcome is patient safety reflected in the 90-day overall complication rate according to the Clavien–Dindo classification. Secondary outcomes will include intraoperative complications, 90-day mortality rate, number of resected tumour-positive lymph nodes, completeness of mesocolic excision, surgical quality score, locoregional and distant recurrence and 5-year overall survival. A total number of 1095 patients (365 per cohort) will be included.DiscussionThe Right study is designed to safely implement the best surgical practice concerning patients with right-sided colon cancer aiming to standardise and improve the surgical quality of MIRH at a national level.Trial registrationClinicalTrials.gov: NCT04889456, May 2021.

The Relationship Between Esophageal Pressure and Diaphragm Thickening Fraction in Spontaneously Breathing Sedated Children: A Feasibility Study.

Diaphragm ultrasound is a novel alternative to esophageal pressure measurements in the evaluation of diaphragm function and activity, but data about its reliability in a pediatric setting are lacking. We aimed to compare the esophageal pressure swing (∆Pes, gold standard) with the diaphragmatic thickening fraction (DTF) as a measure of inspiratory effort in sedated children. Additionally, we studied the effect of positive end-expiratory pressure (PEEP) on the end-expiratory thickness of the diaphragm (DTee). Prospective open-label non-randomized interventional physiological cohort study. Operating room in tertiary academic hospital. Children 28 days to 13 years old scheduled for elective surgery with general anesthesia, spontaneously breathing through a laryngeal mask airway, were eligible for inclusion. Exclusion criteria were disorders or previous surgery of the diaphragm, anticipated difficult airway or acute cardiopulmonary disease. All measurements were performed prior to surgery. Patients were subjected to different levels of respiratory load, PEEP and anesthetic depth in a total of seven respiratory conditions. The esophageal pressure and diaphragm thickening fraction were simultaneously recorded for five breaths at each respiratory condition. The relation between ∆Pes and DTF was studied in a mixed model. We analyzed 407 breaths in 13 patients. Both DTF (p = 0.03) and ∆Pes (p = 0.002) could detect respiratory activity, and ∆Pes and DTF were associated across respiratory conditions (p < 0.001; R2 = 31%). With increasing inspiratory load, ∆Pes increased significantly, while DTF did not (p = 0.08). Additionally, DTee did not differ significantly between 10, 5, and 0 cm H2O PEEP (p = 0.08). In spontaneously breathing sedated children and across different respiratory conditions, DTF could differentiate minimal or no inspiratory effort from substantial inspiratory effort and was associated with ∆Pes. Increased efforts resulted in higher ∆Pes but not larger DTF.

The furosemide stress test predicts the timing of continuous renal replacement therapy initiation in critically ill patients with acute kidney injury: a double-blind prospective intervention cohort study

BackgroundContinuous renal replacement therapy (CRRT) remains a crucial treatment for critically ill patients with acute kidney injury (AKI), although the timing of its initiation is still a matter of contention. Furosemide stress testing (FST) may be a practical and beneficial prediction instrument. This research was meant to examine if FST can be used to identify high-risk patients for CRRT.MethodsThis study is a double-blind, prospective interventional cohort study. For patients with AKI receiving intensive care unit (ICU) income, FST was selected with furosemide 1 mg/kg intravenous (1.5 mg/kg intravenous if a loop diuretic was received within 7 days). Urinary volume more than 200 ml at 2 h after FST was FST-responsive, less than 200 ml was FST-nonresponsive. The FST results are kept strictly confidential from the clinician, who decides whether to initiate CRRT based on laboratory testing and clinical symptoms other than the FST data. The FST data are concealed from both the patients and the clinician.ResultsFST was delivered to 187 of 241 patients who satisfied the inclusion and exclusion criteria, with 48 patients responding to the test and 139 patients not responding. 18/48 (37.5%) of the FST-responsive patients received CRRT, while 124/139 (89.2%) of the FST-nonresponsive patients received CRRT. There was no significant difference between the CRRT and non-CRRT groups in terms of general health and medical history (P > 0.05). Urine volume after 2 h of FST was considerably lower in the CRRT group than in the non-CRRT group (35 ml, IQR5-143.75 versus 400 ml, IQR210-890; P = 0.000). FST non-responders were 2.379 times more likely to initiate CRRT than FST responders (95% CI 1.644–3.443, P = 0.000). The area under the curve (AUC) for initiating CRRT was 0.966 (cutoff of 156 ml, sensitivity of 94.85%, specificity of 98.04%, P < 0.001).ConclusionThis study demonstrated that FST is a safe and practical approach for predicting the initiation of CRRT in critically ill AKI patients.Trial registrationwww.chictr.org.cn, ChiCTR1800015734, Registered 17 April 2018.

Association of fluvoxamine with mortality and symptom resolution among inpatients with COVID-19 in Uganda: a prospective interventional open-label cohort study

Prior research suggests that fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) used for the treatment of obsessive-compulsive disorder and major depressive disorder, could be repurposed against COVID-19. We undertook a prospective interventional open-label cohort study to evaluate the efficacy and tolerability of fluvoxamine among inpatients with laboratory-confirmed COVID-19 in Uganda. The main outcome was all-cause mortality. Secondary outcomes were hospital discharge and complete symptom resolution. We included 316 patients, of whom 94 received fluvoxamine in addition to standard care [median age, 60 years (IQR = 37.0); women, 52.2%]. Fluvoxamine use was significantly associated with reduced mortality [AHR = 0.32; 95% CI = 0.19–0.53; p < 0.001, NNT = 4.46] and with increased complete symptom resolution [AOR = 2.56; 95% CI = 1.53–5.51; p < 0.001, NNT = 4.44]. Sensitivity analyses yielded similar results. These effects did not significantly differ by clinical characteristic, including vaccination status. Among the 161 survivors, fluvoxamine was not significantly associated with time to hospital discharge [AHR 0.81, 95% CI (0.54–1.23), p = 0.32]. There was a trend toward greater side effects with fluvoxamine (7.45% versus 3.15%; SMD = 0.21; χ2 = 3.46, p = 0.06), most of which were light or mild in severity and none of which were serious. One hundred mg of fluvoxamine prescribed twice daily for 10 days was well tolerated and significantly associated with reduced mortality and with increased complete symptom resolution, without a significant increase in time to hospital discharge, among inpatients with COVID-19. Large-scale randomized trials are urgently needed to confirm these findings, especially for low- and middle-income countries, where access to vaccines and approved treatments against COVID-19 is limited.

Right Study: Implementation of Optimized and Standardized Surgical Technique for Right-Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study: Rationale and Study Protocol

Right Study: Implementation of Optimized and Standardized Surgical Technique for Right-Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study: Rationale and Study Protocol

Subjective and objective evaluation of corneal haze after accelerated corneal crosslinking for corneal ectasias.

To evaluate the relationship between subjective (slit lamp examination [SLE]) and objective (densitometry) measurements of corneal haze after accelerated corneal crosslinking (aCXL), assess the relationship between densitometry and corrected distance visual acuity (CDVA), and determine the effect of baseline characteristics on densitometry after aCXL in eyes with progressive keratoconus and other ectasias. Kensington Eye Institute and Bochner Eye Institute, Toronto, Canada. Retrospective analysis of a prospective interventional cohort study. Scheimpflug-derived corneal densitometry, CDVA, maximum keratometry (Kmax ), and central corneal thickness were measured preoperatively and up to 1year after aCXL, and post-operative haze was estimated with SLE (n=483 eyes). A random effect model was used to examine the relationship between post-operative subjective haze with SLE and densitometry. Linear mixed models were used to examine the relationship between densitometry, pre-operative baseline characteristics, and CDVA. There was a significant association between subjective haze with SLE and densitometry (p < 0.001). There was a significant relationship between CDVA and densitometry: for every 10 GSUs of increased densitometry in the 0-2 mm zone, CDVA worsened by approximately half a Snellen line (p < 0.001). Age and pre-operative Kmax were significant predictors of densitometry. For every 10 years of age, densitometry increased by 0.68 GSUs (95% CI [0.27 to 1.07], p < 0.001). For every 10 D of increased preoperative Kmax , densitometry increased by 0.69 GSUs (95% CI [0.41 to 0.98], p < 0.001). Subjective haze after aCXL estimated with SLE, is significantly associated with densitometry. Increased densitometry after aCXL is associated with a reduction in CDVA.

Abstract B062: Optimizing the PRE-ACT educational intervention to promote decision making about clinical trials among racial and ethnic minorities: The role of the research navigator

Abstract Background Representation in clinical trials that reflects the growing racial/ethnic population diversity in United States is a matter of health equity. Barriers to participation are multifactorial, ranging from awareness of trials, opportunity to participate, and decision making. PRE-ACT is a web-based patient tailored educational tool, previously demonstrated in a randomized controlled trial to improve knowledge and decrease attitudinal barriers to clinical trials participation. However, PRE-ACT enrolled a predominantly white population and subgroup analysis did not show benefit among the non-white participants. The primary objective of this intervention is to improve preparation for consideration of clinical trials using tailored, patient-specific information to address barriers related to knowledge and attitudes among racial/ethnic minority cancer patients (pts). This intervention will adapt the PRE-ACT model to racial/ethnic minorities at a large hybrid academic-community practice healthcare organization (HCO) and incorporate the use of research navigators. Methods This is a prospective interventional cohort study. After IRB approval, eligible pts will be recruited from medical oncology clinics throughout the HCO, including community clinics. They must be 18 or older, have a diagnosis of cancer undergoing oncological work-up, treatment, or surveillance, self-identify with a non-white race or Hispanic ethnicity, and have a life expectancy &amp;gt;3 months. Self-administered surveys will collect demographics and socioeconomic status indicators. Clinical data will be obtained by chart review. A survey will assess knowledge and attitudes towards clinical trials, being administered before and after the intervention. Intervention will consist of research navigator-facilitated 30-minute tailored educational encounter including short videos and discussion based on pts’ responses from the pre-intervention survey. The primary outcome is change in knowledge and attitudes after the intervention. Secondary outcomes are clinical trials participation rates after intervention, compared to historical trends at the HCO. Chi-square test will be used for pre-post comparison using the composite posttest results as observed values and the composite pretest results as expected values; a threshold of 0.05 will be used to determine significant difference. Results This protocol is undergoing review with implementation predicted for the fall of 2022. We expect to accrue 600 patients over the span of 4 years. Conclusions Novel strategies are needed to improve access to clinical trials among racial/ethnic minorities. Understanding and addressing knowledge and attitudes towards clinical trials participation is a key step in this process. We describe a proposed adaptation to the PRE-ACT model utilizing a research navigator framework to address knowledge and attitudinal barriers to participation in clinical trials among minority patients at a large HCO. Citation Format: Annie L. Zhang, Valerie Vinson, Kevin C. Hoy Jr., Violeta Uy, Kristina Austin, Erika Trapl, Jamie Shoag, Debora Bruno. Optimizing the PRE-ACT educational intervention to promote decision making about clinical trials among racial and ethnic minorities: The role of the research navigator [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B062.

Short-term Weight Trajectory of Severely Obese Individuals With and Without Pathogenic Satiety-Regulation Melanocortin 3/4 Receptor (MC3/4R) Mutations From a Multi-ethnic Asian Large Bariatric Surgery Program.

The melanocortin (3 or 4) receptor (MC3/4R) is involved in regulating satiety and body weight. Therefore, pathogenic mutation in MC3/4R is associated with severe obesity, for which bariatric surgery is one of the treatment options. However, there is limited data on whether individuals with MC3/4R mutation will have differential weight response to surgery, especially among the Asian populations-the epi-center of the evolving global obesity epidemic. From our large prospective Obesity-Metabolism & Intervention Cohort Study (OMICS; N = 654, recruited between 2007 and 2022), 5 individuals with pathogenic MC3/4R mutations ("case") were identified using candidate-genes panel next-generation sequencing (Illumina iSeq). These subjects were carefully propensity score-matched (baseline body mass index [BMI], age, sex, ethnicity, proportion with diabetes, type of bariatric surgery) in a 1:4 ratio to other controls. We performed linear mixed model analysis (for repeated measurements) to compare their longitudinal weight trajectories (percentage total weight loss, %TWL) over 12 months. The 5 cases with MC3/4R mutations were 48 ± 11 years, BMI 40.8 ± 11.2 kg/m2, 60% with diabetes, and all males. Their weight at baseline (pre-op), and 6 months and 12 months after surgery were 120 ± 38, 100 ± 31, and 101 ± 30 kg, respectively. Compared with propensity score-matched controls (N = 20), linear mixed model analysis suggested no difference in surgically induced %TWL (β coefficient = -5.8 ± 3.7, P = .13) over 12 months between the groups. Therefore, we conclude that rare pathogenic MC3/4R mutations do not significantly modify weight change (%TWL) in response to bariatric surgery.