Prospective Interventional Cohort Study Research Articles

Early Changes in the Bone Mineral Density on Dual-energy X-ray Absorptiometry Scan of Patients Undergoing Primary Cemented Total Knee Arthroplasty: A Prospective Cohort Study

Background: The known risk factors of osteoarthritis (OA) knee are aging and obesity while the risk factors of osteoporosis are aging and low body weight, so the relationship between all three is complex. Currently, the dual-energy X-ray absorptiometry (DXA) test is the gold standard in osteoporosis diagnostics. Many epidemiologic studies have revealed increased bone mineral density (BMD) in individuals with OA knee. The impact of total knee arthroplasty (TKA) on BMD levels is not fully understood. Concern has been raised regarding the increased risk of femoral and spine fractures early after TKA. Hence, we conducted this study to measure the BMD changes in the hip and spine in patients receiving TKA. Materials and Methods: It was a prospective interventional cohort study conducted from December 2018 to December 2020. The study included 43 patients admitted for elective TKA after applying the relevant inclusion and exclusion criteria. Patients were analyzed with DXA scans both preoperatively and 6 months postoperatively. Results: When we studied all the patients as one single sample, the initial observation was that at the 6-month follow-up, the patients showed a statistically significant improvement in the femur BMD score while the change in spine BMD was statistically insignificant. However, when subsets of the study sample, i.e. preoperatively normal, osteopenic, and osteoporotic patients, underwent further analysis, we found that out of 18 patients having normal BMD preoperatively, one patient developed osteopenia and another developed osteoporosis upon postoperative follow-up DXA scan. Similarly, one out of the eight patients, having osteoporosis preoperatively, improved a grade to osteopenia upon postoperative follow-up DXA scan. However, these changes were not statistically significant. Conclusions: we conclude that there is no statistically significant change in both the femur and the spine BMD at least 6-month follow-up postprimary TKA.

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.

Эффективность синустрабекулэктомии в современной клинической практике

Aim: to assess the hypotensive effect of sinustrabeculectomy (STE) carried out within the "cascade" treatment algorithm for glaucoma. Patients and Methods: this open prospective interventional single-center cohort study was performed in 443 consequently included patients who underwent surgery for primary open-angle non-compensated glaucoma (POAG) and then were under follow-up for 6–24 months. The STE outcomes were evaluated using commonly accepted criteria of "complete success" and "qualified success", as well as "qualified failure" and "complete failure". The analysis of postoperative intraocular pressure (IOP) changes over time was performed using statistical methods. Results: the "complete success" of surgical operation achieved in 305 (68.9%) cases was associated with a significant and long-lasting decrease (at least for two years) in IOP values. The "qualified success", assuming that the renewal of medication therapy was an essential condition for maintaining a steady IOP was reported in 118 (26.6%) cases. Thus, the surgical treatment in combination with the postoperative hypotensive therapy helped to normalize IOP for at least two years in 423 (95.5%) patients of the study group. The "complete" STE failure due to the loss of filtration and the onset of indications for repeat surgery was reported in 20 (4.5%) cases. The triple combination treatment of glaucoma does not preclude from initiating further surgical IOP normalization and can be used safely prior to planned STE. A statistically significant IOP decrease from the baseline was achieved in all patients (even in the "complete failure" cases) at all 3 endpoints of the study (at 6, 12 and 24 months). The most pronounced and stable decrease in IOP during a two-year follow-up was associated with the "complete success" STE. Conclusion: a statistically significant IOP decrease from the baseline was achieved in all patients even after the "complete failure" of the surgical treatment at all endpoints of the study. The most pronounced and stable decrease in IOP during a two-year follow-up was associated with the "complete success" STE. The preoperative IOP level did not correlate with the results of STE and cannot be considered as a factor predicting its success or failure. Keywords: glaucoma, sinustrabeculectomy , intraocular pressure, glaucoma surgery, cascade algorithm, complete success, qualified success, complete failure. For citation: Antonova A.V., Nikolaenko V.P., Brzhesky V.V., Vuks A.Ya. The efficacy of sinustrabeculectomy in the modern clinical practice. Russian Journal of Clinical Ophthalmology. 2023;23(1):21–26 (in Russ.). DOI: 10.32364/2311-7729-2023-23-1-21-26.

Ocular surface changes before and after upper eye lid blepharoplasty

Background: Blepharoplasty has been the most effective treatment for upper eyelid dermatochalasis. Dry eye disease after blepharoplasty can only be detected after sufficient time to allow for resolution of the early and intermediate sicca symptoms. Aim of work: studying the ocular surface changes before and after upper eyelid blepharoplasty.Patients and methods: our prospective interventional cohort study conducted on 30 patients, (aged between 40 and 60 years) underwent upper eye lid blepharoplasty. Results: The included 30 subjects were females only aged from 40 years to 60 years with the Mean ± standard deviation were 51.07±4.93 years. The values of tear meniscus height, depth, and cross-section area decreased significantly at 1 month postoperatively, then started to increase after 3 months postoperative and returned like preoperative after 6 months.Conclusion: Upper eye lid blepharoplasty can affect the ocular surface and tear film stability. The values of tear meniscus height, depth, and cross-section area and dry eye tests except the ocular surface staining decreased significantly at 1 month postoperatively, then started to increase after 3 months postoperative and returned like preoperative after 6 months.

An Explorative Investigation of the Effect of Naturalistic Light on Agitation-Associated Behavior in Nursing Home Residents With Dementia: A Pilot Study.

To study the effect of naturalistic light, programmed to replicate the spectrum distribution of natural light from dusk to dawn, on agitation measured with a Cohen-Mansfield Agitation Inventory-inspired score of nursing home residents with dementia. Though the effects of different types of light on the sleep-wake patterns of senior adults and people with dementia have been examined in several studies, the effects of naturalistic light systems, as a possible nonpharmacological intervention to improve sleep and reduce agitation, have yet to be extensively evaluated due to the relative novelty of the technology. The study was designed as a 6-month pilot study of a prospective interventional longitudinal cohort study, with five participants recruited from a single department of a Danish nursing home. The effect of naturalistic lighting on agitation-associated behaviors was recorded over a 3-day period pre- and postintervention. Results: An overall 71.2% reduction in the frequency of agitation-associated behaviors was recorded, with the frequency of some behaviors even reduced by 100%. This pilot study estimates that naturalistic lighting may be a promising nonpharmacological intervention to improve the overall agitation of nursing home residents with dementia, with a possible added benefit of an improved work environment for the staff. This study, therefore, finds indication for the performance of a randomized controlled trial with the same intervention and a larger cohort.

Effectiveness of Adherence to a Mediterranean Diet in the Management of Overweight Women: The Prospective Interventional Cohort Study

Evidence indicates that unhealthy eating habits constitute multilevel obstacles threatening health and well-being. Studies suggest that consumer choices have turned irremovably towards Western diets. The Mediterranean diet (MD) is considered one of the most effective in preventing and treating overweight and obesity, yet its results and associations are ambiguous. This explanatory research aims to examine the effect of the MD on anthropometric and biochemical variables in 181 females from an Eastern European country. The sample was divided into three distinct clusters based on age (tricenarian, quadragenarian, and quinquagenarian). Anthropometric and biochemical examinations in the three-month MD program plan failed to provide convincing evidence of the benefits of the MD on selected integrands. However, total body fat (FATP) values between groups showed a significant difference (p ≤ 0.032) between groups A and C (p ≤ 0.029), which can be attributed to the age of the cohort (30-39 vs. 50-60 years). Values in groups A and B (p ≤ 0.001) and C and A (p ≤ 0.001) were significant between the cohorts but did not indicate any changes in visceral fat (VFATL) in the individual groups. The presented findings can have implications for further investigation and the development of more comprehensive instruments, incorporating critical add-on constituents that will be appropriate to monitor, evaluate, and predict body weight management in experimentation.

Nasal microbiome disruption and recovery after mupirocin treatment in Staphylococcus aureus carriers and noncarriers

Nasal decolonization procedures against the opportunistic pathogen Staphylococcus aureus rely on topical antimicrobial drug usage, whose impact on the nasal microbiota is poorly understood. We examined this impact in healthy S. aureus carriers and noncarriers. This is a prospective interventional cohort study of 8 S. aureus carriers and 8 noncarriers treated with nasal mupirocin and chlorhexidine baths. Sequential nasal swabs were taken over 6 months. S. aureus was detected by quantitative culture and genotyped using spa typing. RNA-based 16S species-level metabarcoding was used to assess the living microbial diversity. The species Dolosigranulum pigrum, Moraxella nonliquefaciens and Corynebacterium propinquum correlated negatively with S. aureus carriage. Mupirocin treatment effectively eliminated S. aureus, D. pigrum and M. nonliquefaciens, but not corynebacteria. S. aureus recolonization in carriers occurred more rapidly than recolonization by the dominant species in noncarriers (median 3 vs. 6 months, respectively). Most recolonizing S. aureus isolates had the same spa type as the initial isolate. The impact of mupirocin-chlorhexidine treatment on the nasal microbiota was still detectable after 6 months. S. aureus recolonization predated microbiota recovery, emphasizing the strong adaptation of this pathogen to the nasal niche and the transient efficacy of the decolonization procedure.

Effect of angiotensin receptor neprilysin inhibitor in patients of heart failure with reduced ejection fraction with reduced ejection fraction with cardiorenal syndrome type-1

Background: Heart failure is recognized as one of the most common indications for hospitalization. The dysfunction of either the heart or the kidneys affect the functioning of each other and thus play an important role in the quality of life.Methods: This study is a Prospective interventional Cohort study over a period of 18 months in 125 patients. The patients were divided into two broad treatment groups. The primary end point of the study was to quantify the response of ARNI for renal recovery in patients of cardio-renal syndrome and improvement in cardiovascular parameters by measuring the change in urine output, estimated glomerular filtration rate, serum creatinine, change in weight of the patients, control of blood pressure and change in left ventricular ejection fraction. The secondary end-points were evaluated during the 60 days follow up period post admissions.Results: Cardio-renal syndrome was seen in 39% of the patients. On screening e-GFR was 91±14 and 49±8 for group 1and 2 respectively, the median age, UACR was 59 years ,1.0 mg/mmol respectively for both the groups and 19% had micro albuminuria. ACEIs had more reports of hyperkalemia (8/32, 25%), and greater deterioration of renal parameters (10/32, 34%) needing discontinuation of the drug in some patients. Patients also developed cough (6/32, 20%) needing replacement with ARBs. ARNI group developed more hypotension (6/31, 20%). In all cardiovascular and renal end points except UACR, ARNI showed better recovery profile in CRS-1patients including diabetics.Conclusions: This study showed beneficial effects of ARNI in heart failure patients with cardio-renal syndrome.

Long-term Outcomes With Islet-Alone and Islet-After-Kidney Transplantation for Type 1 Diabetes in the Clinical Islet Transplantation Consortium: The CIT-08 Study.

To determine long-term outcomes for islet-alone and islet-after-kidney transplantation in adults with type 1 diabetes complicated by impaired awareness of hypoglycemia. This was a prospective interventional and observational cohort study of islet-alone (n = 48) and islet-after-kidney (n = 24) transplant recipients followed for up to 8 years after intraportal infusion of one or more purified human pancreatic islet products under standardized immunosuppression. Outcomes included duration of islet graft survival (stimulated C-peptide ≥0.3 ng/mL), on-target glycemic control (HbA1c <7.0%), freedom from severe hypoglycemia, and insulin independence. Of the 48 islet-alone and 24 islet-after-kidney transplantation recipients, 26 and 8 completed long-term follow-up with islet graft function, 15 and 7 withdrew from follow-up with islet graft function, and 7 and 9 experienced islet graft failure, respectively. Actuarial islet graft survival at median and final follow-up was 84% and 56% for islet-alone and 69% and 49% for islet-after-kidney (P = 0.007) with 77% and 49% of islet-alone and 57% and 35% of islet-after-kidney transplantation recipients maintaining posttransplant HbA1c <7.0% (P = 0.0017); freedom from severe hypoglycemia was maintained at >90% in both cohorts. Insulin independence was achieved by 74% of islet-alone and islet-after-kidney transplantation recipients, with more than one-half maintaining insulin independence during long-term follow-up. Kidney function remained stable during long-term follow-up in both cohorts, and rates of sensitization against HLA were low. Severe adverse events occurred at 0.31 per patient-year for islet-alone and 0.43 per patient-year for islet-after-kidney transplantation. Islet transplantation results in durable islet graft survival permitting achievement of glycemic targets in the absence of severe hypoglycemia for most appropriately indicated recipients having impaired awareness of hypoglycemia, with acceptable safety of added immunosuppression for both islet-alone and islet-after-kidney transplantation.

Transcutaneous electrical nerve inhibition using medium frequency alternating current

Transcutaneous medium-frequency alternating electrical current is defined as an alternating current between 1 and 10 kHz and is capable of producing an instant, reversible block. This study aims to evaluate the efficacy of sensory perception and force production of the index and middle finger after transcutaneous medium-frequency alternating electrical current stimulation of the distal median nerve. A single-center prospective interventional cohort study was conducted in adult healthy volunteers at the Jessa Hospital, Hasselt, Belgium. Two different electrodes (PALS & 3M) were placed on the distal median nerve, which was located using a Sonosite X-Porte Ultrasound transducer, with the first electrode being placed on the skin at the level of the transverse carpal ligament and the second electrode 7 cm proximally to the first electrode. The tactile sensation was evaluated with Semmes–Weinstein monofilament test and sensation of pressure/pain was evaluated with an algometer. Peak force production was assessed with an electronic dynamometer. All measurements were performed at baseline and tMFAEC stimulation frequencies of 2 and 10 kHz in a randomized manner. Statistical analysis was performed with a one-way ANOVA with repeated measures test or a Friedman rank sum test, followed by the Wilcoxon signed rank test adjusted with Bonferroni correction. A p-value < 0.05 was considered statistically significant. From 9 to 13th of April 2021, 25 healthy volunteers were included in the Jessa Hospital, Hasselt, Belgium. A statistically significant reduction in tactile sensation during 2 kHz and 10 kHz stimulation compared to baseline was observed (2.89 ± 0.22 (PALS2); 3.35 ± 0.25 (3M2) and 2.14 ± 0.12 (PALS10); 2.38 ± 0.12 (3M10) versus − 1.75 ± 0.09 (baseline), p < 0.0001). 3M electrodes showed a tendency towards the elevation of pressure pain threshold compared to baseline. No significant difference in mean peak forces of the index and middle fingers after transcutaneous medium-frequency alternating electrical current stimulation with 2 and 10 kHz was found. This study demonstrates that transcutaneous medium-frequency alternating electrical current stimulation on the distal median nerve inhibits tactile sensory nerve activity in the index and middle finger when stimulation of 2 kHz and, to a lesser extent, 10 kHz was applied. A reduction of motor nerve activity was not observed but force production measurements may be prone to error.Trial registration: clinicaltrials.gov on 01/04/2021. NCT-Number: NCT04827173.

Cardiopulmonary exercise testing for cardiovascular risk assessment in patients undergoing gastric and oesophageal cancer surgery: results from a prospective interventional cohort study

BackgroundCardiopulmonary exercise testing (CPET) has shown to be useful for preoperative risk stratification in various types of intra-abdominal and thoracic surgery. However, data about the predictive value of CPET for...

Outcome of Patients with Sepsis Admitted in Intensive Care Unit of a Tertiary Care Hospital in India

Introduction: Sepsis has a death rate of ∼25% globally and its clinical treatment presents an important clinical challenge. The rapid progression of sepsis requires correspondingly swift adjustments in therapy, and accurate identification of disease severity is therefore vitally important for predicting prognosis, treatment, preventing complications, reducing complication and mortality. With this background, the present research is aimed to study the relation of serum procalcitonin levels in cases with sepsis, to calculate APACHE II scores and to correlate the levels of serum PCT levels with APACHE II Score with the outcome.&#x0D; Methodology: This was a prospective observational non interventional cohort study was conducted in the Clinic of Intensive Care unit of a tertiary care hospital and medical college in western India from May 2020 to December 2020.&#x0D; Results: A total of 75 patients, admitted to the ICU with the diagnosis of sepsis, were included in this prospective observational study. Of them 47 (62.7%) were males and highest cases were aged between 60 to 69 years. Of the total 75 patients, 47 (62.7%) patients were survivors. Age, gender and involvement of system were not associated with mortality while lower APACHE II score and presence of co-morbidities were significantly associated with mortality.&#x0D; Conclusion: From this study we conclude that the lower APCHE II score and presence of co-morbidity significantly increases the mortality in ICU patients admitted with sepsis.

Checklists in Healthcare: Operational Improvement of Standards using Safety Engineering - Project CHOISSE — A framework for evaluating the effects of checklists on surgical team culture

The CHOISSE multi-stage framework for evaluating the effects of electronic checklist applications (e-checklists) on surgical team members' perception of their roles, performance, communication, and understanding of checklists is introduced via a pilot study. A prospective interventional cohort study design was piloted to assess the effectiveness of the framework and the sociotechnical effects of the e-checklist. A Delphi process was used to design the stages of the framework based on literature and expert consensus. The CHOISSE framework was applied to guide the implementation and evaluation of e-checklists on team culture for ten pilot teams across the US over a 24-week period. The pilot results revealed more engagement by surgeons than non-surgeons, and significant increases in surgeons’ perception of communication and engagement during surgery with a small sample. Mixed methods analysis of the data and lessons learned were used to identify iterative improvements to the CHOISSE framework and to inform future studies.

High-intensity laser therapy of patients with atrophic scars: results of a comparative prospective interventional cohort study

BACKGROUND: Scars of various sizes and localization are formed in more than 100 million patients annually. Atrophic scarring defects of the skin are verified in more than 80% of patients with acne and in 30% of patients with other injuries. Different skin remodeling technologies have different effectiveness, which actualizes the search for optimal methods of scar correction. The most promising of them are combinations of high-intensity laser radiation.&#x0D; AIMS: Determination of therapeutic effects of high-intensity laser therapy in patients with atrophic skin scars.&#x0D; MATERIALS AND METHODS: A prospective interventional cohort comparative study of the therapeutic effects of high-intensity laser therapy in patients with atrophic skin scars was conducted. In patients with emerging scars, a combination of homogeneous photothermolysis by long-pulse Nd:YAG laser radiation (l=1.064 microns) followed by fractional ablative photothermolysis of CO2 laser (l=10.6 microns) was used, and in patients with mature scars, a combination of homogeneous photothermolysis of long-pulse Nd:YAG laser (l=1.064 microns) and planar laser photodestruction of CO2 laser (l=10.6 microns).&#x0D; 115 patients with the diagnosis of "atrophic scars" (ICD-X, Class XII "Diseases of the skin and subcutaneous tissue", L90.5) were examined, among which groups with emerging (49 patients) and mature (66 patients) scars were identified. Empirical research methods ― clinical, instrumental, and medico-sociological ― have been applied. The analysis of the obtained data was carried out using the methods of descriptive, parametric and multifactorial statistics with the determination of the specific weight of the studied features.&#x0D; RESULTS: The improvement of the clinical status, pronounced remodeling of the skin in the area of atrophic scars, under the influence of various combinations of high-intensity laser therapy was revealed. An increase in the quality of life indicators according to the Skindex-29 and Dermatology Life Quality Index (DLQI) scales was determined, more pronounced in the groups of patients with atrophic scars in comparison with the group of patients with mature scar deformities. Combinations of high-intensity laser therapy have a favorable safety profile, are characterized by a high degree of compliance and satisfaction with the results of treatment. The effectiveness of variant high-intensity laser therapy in patients with atrophic scars is 8690%.&#x0D; CONCLUSIONS: Combinations of high-intensity laser therapy in patients with developing atrophic scars cause dermoplastic and fibromodeling therapeutic effects, in patients with mature ones ― reepithelizing, fibrocorrecting therapeutic effects.

Real-time diabetic retinopathy screening by deep learning in a multisite national screening programme: a prospective interventional cohort study

Diabetic retinopathy is a leading cause of preventable blindness, especially in low-income and middle-income countries (LMICs). Deep-learning systems have the potential to enhance diabetic retinopathy screenings in these settings, yet prospective studies assessing their usability and performance are scarce. We did a prospective interventional cohort study to evaluate the real-world performance and feasibility of deploying a deep-learning system into the health-care system of Thailand. Patients with diabetes and listed on the national diabetes registry, aged 18 years or older, able to have their fundus photograph taken for at least one eye, and due for screening as per the Thai Ministry of Public Health guidelines were eligible for inclusion. Eligible patients were screened with the deep-learning system at nine primary care sites under Thailand's national diabetic retinopathy screening programme. Patients with a previous diagnosis of diabetic macular oedema, severe non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy; previous laser treatment of the retina or retinal surgery; other non-diabetic retinopathy eye disease requiring referral to an ophthalmologist; or inability to have fundus photograph taken of both eyes for any reason were excluded. Deep-learning system-based interpretations of patient fundus images and referral recommendations were provided in real time. As a safety mechanism, regional retina specialists over-read each image. Performance of the deep-learning system (accuracy, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) were measured against an adjudicated reference standard, provided by fellowship-trained retina specialists. This study is registered with the Thai national clinical trials registry, TCRT20190902002. Between Dec 12, 2018, and March 29, 2020, 7940 patients were screened for inclusion. 7651 (96·3%) patients were eligible for study analysis, and 2412 (31·5%) patients were referred for diabetic retinopathy, diabetic macular oedema, ungradable images, or low visual acuity. For vision-threatening diabetic retinopathy, the deep-learning system had an accuracy of 94·7% (95% CI 93·0-96·2), sensitivity of 91·4% (87·1-95·0), and specificity of 95·4% (94·1-96·7). The retina specialist over-readers had an accuracy of 93·5 (91·7-95·0; p=0·17), a sensitivity of 84·8% (79·4-90·0; p=0·024), and specificity of 95·5% (94·1-96·7; p=0·98). The PPV for the deep-learning system was 79·2 (95% CI 73·8-84·3) compared with 75·6 (69·8-81·1) for the over-readers. The NPV for the deep-learning system was 95·5 (92·8-97·9) compared with 92·4 (89·3-95·5) for the over-readers. A deep-learning system can deliver real-time diabetic retinopathy detection capability similar to retina specialists in community-based screening settings. Socioenvironmental factors and workflows must be taken into consideration when implementing a deep-learning system within a large-scale screening programme in LMICs. Google and Rajavithi Hospital, Bangkok, Thailand. For the Thai translation of the abstract see Supplementary Materials section.

Does Mandibular Condylar Morphology After Fracture Healing Predict Functional Outcomes in Patients Treated With Closed Reduction?

The purpose of the study is to assess the healing temporomandibular joint morphology and function after closed treatment of unilateral mandibular condylar fracture. A prospective interventional cohort study was designed in patients recruited from the outpatient department who underwent closed reduction for unilateral condylar fractures, and mean mouth opening, mean maximum protrusion, laterotrusion, and radiological pattern of healing were noted. Forty patients in the age group of 18-50years (mean 24.5years) were included. The difference between the pretreatment mean mouth opening (26.94mm), mean maximum protrusion (1.22mm), and laterotrusion (3.82mm and 1.45mm) values and the 6-month post-treatment values (46.3mm, 4.45mm, and 11.82mm and 9.82mm, respectively) was found to be statistically significant (P<.001). Deranged pretreatment occlusion seen in 20 cases was improved in 18 patients (85%) at the 6-month post-treatment visit, with persisting malocclusion in 2 patients (5%). Clinically, cases that had healed with the anatomical pattern (M1) were found to have significantly better clinical outcomes (P value<.05) than that achieved with cases healed with spherical pattern (M2), L-shaped pattern (M3), or detached pattern (M4). On radiographs, the greatest improvement (21.16mm) in mean mouth opening values was seen in the M1 group (anatomical pattern), followed by similar improvement in groups M2 and M3 (18.39 and 18.66mm, respectively). Least improvement (7.06mm) was seen in the single case of the M4 group (detached pattern), although the 6-month post-treatment value was still an acceptable one (34mm). Favorable functional outcomes can be achieved after closed treatment, including adequate mouth opening, pain-free jaw excursions, and stable occlusion, with the anatomical healing pattern showing the most superior results and the detached pattern being associated with relatively poorer outcomes compared with other healing patterns.