Prospective Cohort Pilot Research Articles

Erector spinae plane block, neuropathic pain and quality oflife after video-assisted thoracoscopy surgery. Pilot, observational study.

The erector spinae plane block (ESPB) is a valuable alternative for pain management after video-assisted thoracoscopy surgery (VATS). The incidence of postoperative chronic neuropathic pain (CNP) is high while the quality of life (QoL) after VATS remains unknown. We hypothesised that patients with ESPB would have a low incidence of acute and CNP and would report a good QoL up to three months after VATS. We conducted a single-centre prospective pilot cohort study from January to April 2020. ESPB after VATS was the standard practice. The primary outcome was the incidence of CNP three months postoperatively. Secondary outcomes included QoL assessed by the EuroQoL questionnaire three months after surgery and pain control at the Post-Anaesthesia Care Unit (PACU), 12 and 24 hours postoperatively. We conducted a single-centre prospective pilot cohort study from January to April 2020. ESPB after VATS was the standard practice. The primary outcome was the incidence of CNP three months postoperatively. Secondary outcomes included QoL assessed by the EuroQoL questionnaire three months after surgery and pain control at the Post-Anaesthesia Care Unit (PACU), 12 and 24 hours postoperatively. We conducted a single-centre prospective pilot cohort study from January to April 2020. ESPB after VATS was the standard practice. The primary outcome was the incidence of CNP three months postoperatively. Secondary outcomes included QoL assessed by the EuroQoL questionnaire three months after surgery and pain control at the Post-Anaesthesia Care Unit (PACU), 12 and 24 hours postoperatively.

Variable Frailty Categorization Among Real-World Patient with Multiple Myeloma: A Prospective Cohort Study (MFRAIL)

Introduction Multiple Myeloma (MM) is a non-curable cancer of older adults. Frailty has emerged as one important high-risk factor which confers a poor prognosis with reduced progression free survival, increased toxicity, higher rates of drug discontinuation and worse overall survival. Several tools have emerged for evaluation of frailty in MM in recent years. These include non-cancer specific geriatric assessment tools such as the Fried frailty index or more specific MM tools such as the International Myeloma Working Group (IMWG) frailty index, simplified frailty index or the Mayo frailty index. Uptake of these measures across clinical settings has been variable, leading to a gap in knowledge about the prevalence of geriatric impairments among MM patients as well as the proportion of patients classified as frail using these different scoring systems. The MFRAIL study is an ongoing prospective, multicentre study evaluating the association of different frailty assessment tools at baseline and longitudinally over time with clinical outcomes. In this abstract we present an interim analysis after at least 50% of patients have been enrolled. We describe baseline characteristics from the initial 57 patients enrolled into the study with the specific objective of 1) to report the prevalence of geriatric impairments among MM patients prior to therapy initiation 2) characterize the proportion of patients classified as frail using different frailty assessment tools. Methods The MFRAIL is an ongoing, prospective pilot cohort study being conducted at three sites within Ontario, Canada which was initiated in August 2021. Multiple myeloma patients aged >18 initiating a new line of therapy are enrolled in the preceding six weeks. Demographic and MM-specific factors are collected at baseline and at 12 months following treatment along with MM response criteria, toxicity and health care utilization. Additional collected measures include: comorbidities, physical performance measures (NIH 4 meter walk test and grip strength), cognition, patient reported outcome of quality of life and depression. Frailty assessment tools measured include the IMWG frailty index (Palumbo et al. Blood 2015), simplified frailty index (Facon et al. Leukemia 2020), Mayo frailty index (Milani et al. AJH 2016) and the Fried frailty index (modified from Fried et al. J Gerontol A Biol Sci Med Sci 2001). Results A total of 57 patients were enrolled in the study (data cut off June 1/2022) with baseline characteristics summarized in Table 1. The median age of the patients was 71 (range 47-93) with 61% males. A total of 26% and 35% of the patients had an ECOG and CCI status of 2 or higher, respectively. Polypharmacy was common with over 50% of the patients being prescribed five or more medications at baseline. Geriatric impairments were common with over 1/3 of the patients reporting at least one deficit in ADLs or IADLs. Additionally, cognitive impairment was present in 19.3% of the patients. With regards to treatment details, 61.4% of the enrolled patients received first line treatment (ASCT eligible 34.3%, ASCT ineligible 65.7%), 26.3% second line and the remainder third line and beyond. Immunomodulatory-based treatments were the most common with 57.8% of the patients utilizing these agents. Empiric dose reduction outside the product monograph was observed in 17.5% of the patients with the majority of dose reductions (80%) done for agents other than dexamethasone alone among those patients. The prevalence of frailty in our cohort ranged from 12.3% (Fried frailty index), 17.5% (Mayo frailty index), 38.6% (IMWG frailty index) to 52.6% (simplified frailty score). Similarly, the number of patients classified as fit/robust also varied ranging from 15.8% (Mayo frailty index), 25.3% (fried frailty index), 33.3% (IMWG frailty index) and 47.3% (simplified frailty score). Conclusion Impairments in geriatric domain are common among real-world patients with MM emphasizing the need to incorporate these assessments in routine clinical practise. Additionally, prevalence of patients classified as frail versus fit varies depending upon the assessment tool utilized with no uniform definition of frailty in routine clinical practise. Further work is needed in both evaluating and standardizing frailty assessment tools in different clinical settings and with different therapeutic modalities to further optimize outcomes in this high-risk patient subgroup. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Abstract 11030: Decreased CD34 + Cell Count is Associated With Coronary Allograft Vasculopathy in Heart Transplant Recipients

Introduction: The underlying mechanisms of coronary allograft vasculopathy (CAV) after heart transplantation remain incompletely understood. Hypothesis: As CD34 + cells represent one of the key determinants of coronary vascular homeostasis we investigated the potential association between CAV and CD34 + cell count in heart transplant recipients. Methods: In a single-center prospective pilot cohort study we included 59 adult heart transplant recipients without history of congenital heart disease, multi-organ transplantation or oncologic therapy. All patients underwent coronary CT angiography and the presence of CAV was defined in accordance with the ISHT criteria. At the time of CT angiography, we collected blood samples and measured CD34 + cell count using Beckman-Coulter Navios EX flow cytometry with standard antibodies according to ISAGE protocol as well as biomarkers of angiogenesis using Luminex assay kit. Results: CAV was present in 15 patients (25%; Group A) and absent in 42 patients (75%; Group B). The two groups did not differ in age (62±11 years in Group A vs. 60±11 years in Group B, P=0.56), gender (male: 100% vs. 80% in Group B, P=0.07), heart failure etiology (ischemic: 53% vs. 43%, P=0.50), presence of hypertension (60% vs. 63%, P=0.80), diabetes (33% vs. 25%, P=0.54) or renal insufficiency (53% vs. 43%, P=0.50). Also, donor age (44±14 years in Group A vs. 43±12 years in Group B, P=0.66), allograft ischemic time (202±72 min vs. 190±68 min, P=0.57), tacrolimus trough levels (8.8±3.8 μg/L vs. 7.4±1.9 μg/L, P=0.14), MMF dose (2067±442 mg vs. 2178±606 mg; P=0.52) and statin therapy (86% vs. 75%; P=0.36) were comparable. While total leukocyte count was similar in both groups (7.7±2.1x10 9 /L in Group A vs. 6.8±2.2x10 9 /L in Group B, P=0.60), we found significantly lower CD34 + cell count in Group A compared to Group B (1.33±0.45x10 6 /L vs. 2.23±1.45x10 6 /L, P=0.02). Conversely, VEGF serum levels were significantly lower in Group A than in Group B (0.09±0.06 ng/L vs. 0.14±0.09 ng/L; P=0.03). Conclusions: Decreased CD34 + cell count and increased VEGF serum levels appear to be associated with CAV in heart transplant recipients. Further studies are warranted to investigate the potential of CD34 + cells in prevention and treatment of CAV in this patient cohort.

Correct dosing of Prothrombinex-VF in normalising elevated international normalised ratio in critically ill patients: a prospective cohort pilot study.

Prothrombinex-VF is being increasingly used as an off-label therapy to correct non-warfarin-related elevations in international normalised ratio (INR) in the critically ill. Currently there are no dosing guidelines for such use. To validate a prediction equation, embedded in a smartphone application (app), to guide dosing of Prothrombinex-VF in critically ill patients. A prospective pilot cohort study of critically ill adult patients with elevated INRs who were treated with Prothrombinex-VF. The main outcome measured was INR following Prothrombinex-VF administration. Of the 31 patients included, five (16%) were taking warfarin prior to admission and 14 (45%) had chronic liver disease. There was a significant decrease in INR after Prothrombinex-VF treatment (P < 0.001) and a significant correlation between the app's predicted INRs and the measured INRs (r=0.63 and P < 0.001). The app's predicted INRs were less accurate for patients with chronic liver disease than for those without. Overall, the app's recommendations achieved an INR either similar to (29.6%) or better than (55.6%) what would have been achieved had the warfarin reversal guidelines been applied to dose the Prothrombinex-VF. The app appeared to be reasonably accurate at predicting normalisation of elevated INRs after administration of Prothrombinex-VF, especially among patients without liver disease. Its dosing recommendations were similar to or possibly better than preexisting warfarin reversal guidelines in over 85% of the situations analysed, if we assume a higher dose of Prothrombinex-VF would achieve a greater reduction in INR than a lower dose.

Intracoronary epinephrine during cardiac resuscitation for patients undergoing percutaneous coronary intervention for acute myocardial infarction (iCPR study)

Abstract Background Despite significant progress in cardiopulmonary resuscitation (CPR), outcomes remain relatively poor. Epinephrine administration remains a cornerstone in the treatment of in-hospital cardiac arrest. Various routes of administration, including intravenous, intramuscular, intraosseous and endotracheal routes have been studied; however, the optimal route is debated. Purpose The purpose of this study was to compare patient outcomes following peripheral intravenous (IV), central IV, or arterial intracoronary (IC) epinephrine administration in patients undergoing CPR in the catheterization laboratory. Methods This was a prospective two-center pilot cohort study conducted in high-volume percutaneous coronary intervention (PCI) facilities in the republic of Lithuania. The study enrolled patients with acute myocardial infarction (AMI) who suffered a cardiac arrest in the cardiac catheterization laboratory during PCI. Cardiac resuscitation was performed according to the European Resuscitation Council Guidelines. Central IV was the first choice for epinephrine administration if it was available. However, in cases without central access, the route of epinephrine administration (peripheral IV or arterial IC) was at the discretion of the physician. The primary endpoint was the rate of return of spontaneous circulation (ROSC). We tested for overall differences in patient characteristics and outcomes between groups using Chi-Square (or Kruskal-Wallis) tests and used the Holm-Bonferroni adjustment (or Dunn's tests) for subsequent pairwise tests. We also performed logistic regression. Results There were 158 participants in this study, with 48 (30.4%), 50 (31.6%), and 60 (38.0%) receiving epinephrine via central IV, IC, and peripheral IV routes, respectively. The median age was 71 [61, 80] years and 56% of participants were men. Patient characteristics were similar across routes, except for age (higher for peripheral IV than IC), serum potassium (although no significant post-hoc differences), hemoglobin (lowest in peripheral route), and heart rhythm before CPR (higher rates of electromechanical dissociation in peripheral route). There were 111 (70%) patients who achieved the primary outcome of ROSC (Table 1). Peripheral IV administration was associated with 7-fold decreased odds of achieving ROSC (odds ratio = 0.14, 95% confidence interval = 0.05–0.36, p&amp;lt;0.0001) compared to central IV (no difference between central IV and IC; p=0.9343). By itself, adrenaline route yielded an area under the receiver operating characteristic curve of 0.73, indicating good predictive ability. Conclusion Epinephrine administration route was a significant predictor of ROSC for patients with AMI undergoing CPR in the catheterization laboratory. ROSC rates for patients who received epinephrine via IC or central IV were superior to those who received it via peripheral IV. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Baylor Health Care System Foundation (USA)National Interventional Cardiology Association (Lithuania)

An exploratory analysis of leukocyte telomere length among pregnant and non-pregnant people

BackgroundLeukocyte telomere length (LTL) is a biomarker that is affected by older age, psychosocial stress, and medical comorbidities. Despite the relevance of these factors to obstetric practice, little is known about LTL in pregnancy. Our study explored longitudinal LTL dynamics in pregnant and non-pregnant people. ObjectiveThis pilot study compares changes in LTL between pregnant and non-pregnant people over time, explores potential correlations between LTL and mental health measures, and investigates associations between short first-trimester LTL and adverse pregnancy outcomes. Study designThis was a prospective pilot cohort study of nulliparous pregnant and non-pregnant people between ages 18 and 50 who presented for care at a single institution from January to November 2020. Pregnant people were enrolled between 10 and 14 weeks gestation. Participants had two blood samples drawn for LTL; the first on the day of enrollment and the second on postpartum day 1 (pregnant cohort) or 7 months later (non-pregnant cohort). LTL was measured using quantitative PCR. The primary outcome was the difference between pregnant and non-pregnant people in LTL change between the two timepoints (basepair difference per 30-day period). Secondary outcomes included differences in responses to the Patient Health Questionnaire-9 (PHQ-9) and a survey about stress related to COVID-19. Differences in LTL were tested using t-tests and linear regression models, both crude and adjusted for age. A subgroup analysis was conducted within the pregnant cohort to examine whether shorter first-trimester LTL was associated with adverse pregnancy outcomes. We conducted t-tests to compare LTL between people with and without each categorical outcome and computed Pearson correlation coefficients between LTL and continuous outcomes such as gestational age at delivery. Results46 pregnant and 30 non-pregnant people were enrolled; 44 pregnant and 18 non-pregnant people completed all LTL assessments. There were no between-group differences in LTL change (−4.2 ± 22.2 bp per 30 days pregnant versus −6.4 ± 11.2 bp per 30 days non-pregnant, adjusted beta 2.1, 95% CI -9.0-13.2, p = 0.60). The prevalence of depression and pandemic-related stress were both low overall. The two groups did not differ in PHQ-9 scores, and no correlations were significant between LTL and PHQ-9 scores. Among the 44 pregnant people, shorter first-trimester LTL was significantly correlated with earlier gestational age at delivery (r = 0.35, p = 0.02). ConclusionIn this exploratory pilot cohort of reproductive-aged people with low levels of psychological stress, we described baseline changes in LTL over time in pregnant and non-pregnant participants. We found a correlation between shorter first-trimester LTL and earlier gestational age at delivery, which warrants further investigation in a larger cohort.

Effective Outcome of HBOT as an Adjuvant Therapy in Patients Diagnosed with COVID-19 in a Tertiary Care Hospital - A Preliminary Study.

IntroductionHyperbaricoxygen therapy (HBOT) is breathing100% oxygen in pressurised chamber. This therapy ensures quick oxygen delivery to the bloodstream. In patients with severe COVID-19 pneumonia, progressive hypoxemia occurs. Oxygen therapy hasa significant role in its management.Aim of the studyThe objective was to study the efficacy of hyperbaric oxygen therapy (HBOT) as adjuvant therapy for reducing the requirement of additional oxygen supplementationin patients with moderate to severe ARDS diagnosed with COVID-19.MethodsA single-centre prospective pilot cohort study was conducted ata tertiary care hospital from December 2020 to February 2021 over two months. Fifty patients with COVID-19 needingoxygen, satisfying the selection criteria, were included. Hyperbaricoxygen therapy wasgiven to all patients. The patient received30-45 minutes of hyperbaric oxygen with 15 minutes of pressurizing and depressurizing at 2.0 atmosphere absolute (ATA) with or without airbrakesas per the critical care team. Oxygen requirement, PaO2, andcondition at discharge were considered as primary outcome variables.ResultsAmong the 50 participants studied, the mean age was 53.64±13.26 years. Out of 50 participants, 49(98.00%) had PaO2≤80 mmHg, and one (2.00%) had >80 PaO2. All the participants 50(100%) had PaO2 as 90 mmHg after three sittings.ConclusionThis studyshows promising results in using HBOT to overcome respiratory failure in COVID-19. HBOT reduced the need for oxygen by improving the oxygen saturation levels.

Impact of a surgical ward breakfast buffet on nutritional intake in postoperative patients: A prospective cohort pilot study.

An early return to normal intake and early mobilization enhances postoperative recovery. However, one out of six surgical patients is undernourished during hospitalization and approximately half of the patients eat 50% or less of the food provided to them. We assessed the use of newly introduced breakfast buffets in two wards for gastrointestinal and oncological surgery and determined the impact on postoperative protein and energy intake. A prospective pilot cohort study was conducted to assess the impact of the introduction of breakfast buffets in two surgical wards. Adult patients had the opportunity to choose between an attractive breakfast buffet and regular bedside breakfast service. Primary outcomes were protein and energy intake during breakfast. We asked patients to report the type of breakfast service and breakfast intake in a diary over a seven-day period. Prognostic factors were used during multivariable regression analysis. A total of 77 patients were included. The median percentage of buffet use per patient during the seven-day study period was 50% (IQR 0-83). Mean protein intake was 14.7 g (SD 8.4) and mean energy intake 332.3 kcal (SD 156.9). Predictors for higher protein intake included the use of the breakfast buffet (β = 0.06, p = 0.01) and patient weight (β = 0.13, p = 0.01). Both use of the breakfast buffet (β = 1.00, p = 0.02) and Delirium Observation Scale scores (β = -246.29, p = 0.02) were related to higher energy intake. Introduction of a breakfast buffet on a surgical ward was associated with higher protein and energy intake and it could be a promising approach to optimizing such intake in surgical patients. Large, prospective and preferably randomized studies should confirm these findings.

Criteria-led discharge for simple appendicitis in children: A pilot study.

AimCriteria‐led discharge (CLD) protocols have been suggested to increase efficiency of discharge from hospital following surgical interventions. Our aim was to assess the feasibility, clinical outcomes and parental satisfaction following the introduction of a pilot CLD for simple appendicitis (SA) in children.MethodsA prospective pilot cohort study was conducted including paediatric patients with SA who were managed with CLD and a control group who were managed with standard discharge procedures. A CLD pro forma was developed, standardising care guidelines and clinical criteria indicators to be met for children to be discharged post‐operatively. A post‐discharge parent survey was also utilised. The primary outcome measure was post‐operative length of stay (pLOS), with secondary outcomes of post‐operative complication rates and parental satisfaction.ResultsThe control group consisted of 31 patients and CLD group 35 patients. There was no difference in the median pLOS (24 [16.7–44.6] vs. 25.3 [19.1–50.1] h, P = 0.3). Furthermore, there were no significant differences on any of the secondary outcomes. Parental confidence with time of discharge was very high in both control (85.7%) and CLD (88.2%) groups (P = 1.0).ConclusionThe introduction of CLD is safe and feasible. Whilst this pilot has not demonstrated a reduction in pLOS, our data suggest that it is well accepted by the parents.

Highly Specific Droplet-Digital PCR Detection of Universally Methylated Circulating Tumor DNA in Endometrial Carcinoma.

No circulating biomarker is available for endometrial carcinoma (EC). We aimed to identify DNA positions universally hypermethylated in EC, and to develop a digital droplet PCR (ddPCR) assay for detection of hypermethylated circulating tumor DNA (meth-ctDNA) in plasma from patients with EC. DNA positions hypermethylated in EC, and without unspecific hypermethylation in tissue/cell types releasing circulating cell-free DNA in plasma, were identified in silico from TCGA/Gene Expression Omnibus (GEO) data. A methylation-specific ddPCR (meth-ddPCR) assay following bisulfite conversion of DNA extracted from plasma was optimized for detection of meth-ctDNA according to dMIQE guidelines. Performances were validated on a retrospective cohort (n = 78 tumors, n = 30 tumor-adjacent tissues), a prospective pilot cohort (n = 33 stage I-IV patients), and 55 patients/donors without cancer. Hypermethylation of zinc finger and SCAN domain containing 12 (ZSCAN12) and/or oxytocin (OXT) classified EC samples from multiple noncancer samples with high diagnostic specificity/sensitivity [>97%; area under the curve (AUC) = 0.99; TCGA/GEO tissues/blood samples]. These results were confirmed in the independent retrospective cohort (AUC = 0.99). Meth-ddPCR showed a high analytical specificity (limit of blank = 2) and sensitivity (absolute lower threshold of detection = 50 pgmethDNA/mLplasma). In the pilot cohort, meth-ctDNA was detected in pretreatment plasma samples from 9/11 and 5/20 patients with advanced and non-advanced EC, respectively. 2 of 9 patients had ctDNA detected after macroscopic complete surgery and experienced progression within 6 months. No healthy donors had any copy of hypermethylated DNA detected in plasma. Meth-ddPCR of ZSCAN12/OXT allows a highly specific and sensitive detection of ctDNA in plasma from patients with EC and appears promising for personalized approaches for these patients.

Feasibility of Specimen Self-collection in Young Children Undergoing SARS-CoV-2 Surveillance for In-Person Learning

There is an urgent need to assess the feasibility of COVID-19 surveillance measures in educational settings. To assess whether young children can feasibly self-collect SARS-CoV-2 samples for surveillance testing over the course of an academic year. This prospective pilot cohort study was conducted from September 10, 2020, to June 10, 2021, at a K-8 school in San Mateo County, California. The research consisted of quantitative data collection efforts: (1) demographic data collected, (2) student sample self-collection error rates, and (3) student sample self-collection time durations. Students were enrolled in a hybrid learning model, a teaching model in which students were taught in person and online, with students having the option to attend virtually as needed. Data were collected under waiver of consent from students participating in weekly SARS-CoV-2 testing. Errors over time for self-collection of nasal swabs such as contaminated swabs and inadequate or shallow swabbing; time taken for sample collection. Of 296 participants, 148 (50.0%) were boys and 148 (50.0%) were girls. A total of 87 participants (29.2%) identified as Asian; 2 (0.6%), Black or African American; 13 (4.4%), Hispanic/Latinx; 103 (34.6%), non-Hispanic White; 87 (29.2%), multiracial; and 6 (2.0%), other. The median school grade was fourth grade. From September 2020 to March 2021, a total of 4203 samples were obtained from 221 students on a weekly basis, while data on error rates were collected. Errors occurred in 2.7% (n = 107; 95% CI, 2.2%-3.2%) of student encounters, with the highest rate occurring on the first day of testing (20 [10.2%]). There was an overall decrease in error rates over time. From April to June 2021, a total of 2021 samples were obtained from 296 students on a weekly basis while data on encounter lengths were collected. Between April and June 2021, 193 encounters were timed. The mean duration of each encounter was 70 seconds (95% CI, 66.4-73.7 seconds). Mastery of self-collected lower nasal swabs is possible for children 5 years and older. Testing duration can be condensed once students gain proficiency in testing procedures. Scalability for larger schools is possible if consideration is given to the resource-intensive nature of the testing and the setting's weather patterns.

Local versus general anesthesia transperineal prostate biopsy: Tolerability, cancer detection, and complications.

ObjectivesTo compare data on transperineal template biopsy (TPTB) under general anesthesia (GA) compared with local anesthesia (LA) procedures using the PrecisionPoint™ Transperineal Access System (PPTAS) in relation to tolerability, cancer detection rate, complications, and cost.MethodsA prospective pilot cohort study of patients undergoing transperineal biopsy was performed. Patients were excluded if they had concurrent flexible cystoscopy or language barriers. Patients had a choice of GA or LA. A prospective questionnaire on Days 0, 1, 7, and 30 was applied. The primary outcome was patient tolerability. Secondary outcomes were cancer detection rate, complication rate, and theater utilization.ResultsThis study included 80 patients (40 GA TPTB and 40 LA PPTAS). Baseline characteristics including age, prostate‐specific antigen (PSA), digital rectal examination (DRE), findings, and prostate volume were comparable between the groups (p = 0.3790, p = 0.9832, p = 0.444, p = 0.3939, respectively). Higher median prostate imaging‐reporting and data system (PI‐RADS) score of 4 (interquartile range [IQR] 2) versus 3 (IQR 1) was noted in the LA group (p = 0.0326). Pain was higher leaving recovery in the GA group however not significantly (p = 0.0555). Median pain score at LA infiltration was 5/10 (IQR 3), with no difference in pain at Days 1, 7, or 30 (p = 0.2722, 0.6465, and 0.8184, respectively). For GA versus LA, the overall cancer detection rate was 55% versus 55% (p = 1.000) with clinically significant cancer in 22.5% versus 35% (p = 0.217). Acute urinary retention (AUR) occurred in 5% of GA and 2.5% of LA patients (p = 1.000). The GA cohort spent longer in theater and in recovery with a median of 93.5 min versus 57 min for the LA group (p = <0.0001).ConclusionThis study demonstrates that transperineal biopsy is safely performed under LA with no difference between the cohorts in relation cancer detection or AUR. LA biopsy also consumed less theater and recovery resources. A further larger prospective randomized controlled trial is required to confirm the findings of this study.

Computer-assisted implant placement and full-arch immediate loading with digitally prefabricated provisional prostheses without cast: a prospective pilot cohort study

BackgroundImmediate loading of implant-supported full-arch rehabilitations has become routine practice when treating edentulous patients. The combination of static computer-aided implant surgery (s-CAIS) and digital prosthetic workflow could eliminate several treatment steps and facilitate prostheses delivery.The aim of this study is to evaluate the 1-year results of digitally prefabricated polymethyl methacrylate (PMMA) provisional prostheses without a cast for full-arch computer-assisted immediate loading.Materials and methodsA digital pre-operative treatment planning was realized for all patients: dental implants and screw-retained abutments were selected in the planning software and two surgical templates were fabricated for each patient. The first template was mucosa or teeth-supported to drill the holes for fixating pins, while the second template was placed after raising a full-thickness flap and was supported by pins as well as soft or hard tissue distal support. Furthermore, based on the surgical planning, interim prostheses were digitally designed and milled of PMMA resin blocks with subsequent pink resin veneering. Osteotomies and implant placement were performed through the surgical guides and all implants were immediately loaded with prefabricated full-arch interim prostheses directly connected to titanium copings with a flowable resin.ResultsA total of 55 dental implants were placed in ten patients. In all cases, interim prostheses allowed the insertion of titanium copings without the need of access hole enlargement or adaptation. All the prostheses had 1 year of functional loading to simulate the long provisional phase. No screw loosening occurred at the first removal of the prostheses after implant osseointegration. No fracture occurred during the whole period. After 1 year, the mean marginal bone loss level was 0.37 ± 0.06 mm, while the implant survival rate was 98.18% (n=54/55), with just one implant failing but not affecting final prosthesis delivery to the patient.ConclusionsWithin the limitations of the present study, the authors concluded that digitally prefabricated provisional prostheses for full-arch immediate loading with s-CAIS could be a valid alternative treatment modality. Milled PMMA restorations proved to be durable enough during the long provisional phase, without prosthetic complications.

Resonance frequency analysis with two different devices after conventional implant placement with ridge preservation: A prospective pilot cohort study.

Primary and secondary implant stability is of high importance for survival and success of dental implants in the short and long term. Measurements of implant stability during healing provide the opportunity to monitor the course of the osseointegration process. To compare implant stability quotient (ISQ) by resonance frequency analysis (RFA), recorded with two different devices after implant placement. Patients with the need of single tooth extraction in posterior sites of the maxilla and the mandible were treated in a surgical center. All patients received additional augmentation with a bovine bone substitute and platelet-rich fibrin (PRF) after atraumatic tooth extraction. After a healing period of 10 weeks, 28 self-tapping titanium-implants were placed. Implant stability was recorded with two different devices (Osstell and Penguin) at the time of implant insertion (T0), 10 days later (T1), and after 7 (T2), or 17 weeks (T3). No implant was lost, and no postoperative complication occurred during follow-up. Patient cohort comprised 9 female (32.1%) and 19 male patients (67.9%), with a mean age of 52.8 years, 64.3 years, respectively. Mean overall insertion torque was 43.6Ncm at implant placement with no significant difference between implant location, age, or gender. No patient dropped out. During observation period, a significant increase in mean ISQ was recorded with both devices. Significant positive correlations between insertion torque and ISQ were recorded with both devices at T0, T2, and T3. No significant differences were observed in ISQ-values between both devices, and measuring directions at any point of measurement. Within the limitations of this cohort study, both devices were suitable for RFA-measurement and revealed comparable results. Due to the cordless design, handling of the Penquin device was more comfortable. Reusability of the Penguin MultiPeg-transducers may offer an additional benefit with regard on ecological aspects.

Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy

BackgroundA new technology in cancer treatment, the MR-linac, provides online magnetic resonance-guided radiotherapy (MRgRT) that combines real-time visualization of the tumor and surrounding tissue with radiation therapy to deliver treatment more accurately. Online MRgRT makes it possible to minimize treatment volume, potentially reducing acute treatment toxicity. Patient-reported outcomes (PRO) add the patient perspective to evaluating treatment toxicity related to new technology. The objective of this mixed-methods study was to develop and explore the content validity of a set of PRO items to evaluate acute pelvic toxicity to radiotherapy including online MRgRT.MethodsA literature review and chart audit were conducted to identify symptomatic adverse events (AEs) to be selected from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) library and European Organisation for Research and Treatment of Cancer (EORTC) item library. To validate the content, the item set was applied in a prospective pilot cohort of patients referred for primary pelvic RT with curative intent. Patients reported symptoms weekly during RT (4–8 weeks) and the subsequent 4 weeks. Follow-up reports were collected at 8, 12, and 24 weeks after RT. To ensure symptom coverage clinician-reported toxicity and individual patient interviews were conducted. The symptomatic AEs were included in the final item set if ≥20% of patients reported them.ResultsEighteen acute symptomatic AEs were selected for the initial item set. Forty patients (32 prostate cancer, 8 cervical cancer) were included in the pilot study. Patients with prostate cancer and those with cervical cancer both reported all 18 acute AEs. However, vomiting was not reported by > 20% of patients thus excluded from the item set. Adding a few diagnosis-specific AEs to the final item set was required for both prostate and cervical cancer patients.ConclusionsA PRO item set for patients with pelvic cancer treated with radiotherapy with a curative intent was developed and content validity explored. In the pilot study, the item set captured the most common acute symptomatic AEs for patients with prostate and cervical cancer related to pelvic RT including online MRgRT. Further validation of the content in broader disease sites would be needed in future studies.

Analysis of Falls Efficacy Scale and Vulnerable Elders Survey as Predictors of Falls.

IntroductionFalls are the leading cause of injury-related death among older adults according to the Centers for Disease Control and Prevention (CDC). The Falls Efficacy Scale (FES) and Vulnerable Elder Survey (VES-13) are validated screening tools used to assess concern of falling, health deterioration and functional decline. We set out to determine if the FES or VES-13 could serve as a predictor of falls among older adults in the Emergency Department (ED) setting.MethodsThis prospective pilot cohort study was conducted at a Level 1 Trauma Center. ED patients aged ≥65 were eligible for the study if they had a mechanical fall risk defined by CDC criteria. After consent and enrollment, FES and the VES surveys were completed. Participants were followed by phone quarterly, and results of the one-year follow-up self-report of fall history described. ResultsThere were 200 subjects enrolled and after excluding those that were withdrawn, deceased, or lost to follow-up, 184 were available for analysis of their follow-up visit at 12 months. A greater proportion of the participants were women (108 (58.7%) vs 76 (41.3%); P=0.88). The average age of the study participants was 74.2±7.3 years. There was no significant difference in age between men and women (median: 73 vs 73; p=0.47). At the follow-up visit, 33 (17.9%) had a reported fall. The mean age did not significantly differ when comparing those with versus without a fall (75.6 vs 73.9; p=0.24). There was no significant difference in the proportion with a VES-13 ≥ 3 when comparing those with and without a reported fall (45.5% vs 37.8%; p = 0.41). The median FES score did not differ among those with as compared to without a fall (11 vs 10; p=0.12).ConclusionsSubjects who had a VES-13 score of ≥3 were statistically no more likely to have fallen than those with a score of <3. Additionally, the FES score did not statistically differ when comparing those who had fallen to those who had not. Further research into alternative screening methods in the ED setting for fall risk is recommended.

Malignant Pleural Effusions Impact on Fatigue (IMPE-F): A Prospective Observational Cohort Pilot Study

Introduction: Cancer-related fatigue is well described. Fatigue in patients with a malignant pleural effusion (MPE) has not been directly studied. Methods: A prospective observational cohort pilot study ‘Do Interventions for Malignant Pleural Effusions (MPE) impact on patient reported fatigue levels (IMPE-F study)’ is planned to determine whether pleural interventions reduce fatigue in MPE. Fatigue will be assessed with a validated patient reported outcome measure, FACIT-F. Discussion: MPE-F has funding from Rocket Medical Plc, and is part of a Masters in Clinical Research at Newcastle University. Respondent fatigue will be addressed by the investigators going through the questionnaire with the participants. Inclusion criteria are all patients above 18 years of age with a presumed MPE undergoing a procedure and able to consent. The expected number of participants is 50. Trial registration: The IMPE-F study has Research Ethics Committee (REC) [20/YH/0224] and Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approvals [IRAS project ID: 276451]. The study has been adopted on National Institute for Health Research portfolio [CPMS ID 46430].

Lessons Learned From the First Pilot Study of the Compensatory Reserve Index After Congenital Heart Surgery Requiring Cardiopulmonary Bypass.

Early warning systems that utilize dense physiologic data and machine learning may aid prediction of decompensation after congenital heart surgery (CHS). The Compensatory Reserve Index (CRI) analyzes changing features of the pulse waveform to predict hemodynamic decompensation in adults, but it has never been studied after CHS. This study sought to understand the feasibility, safety, and potential utility of CRI monitoring after CHS with cardiopulmonary bypass (CPB). A single-center prospective pilot cohort of patients undergoing pulmonary valve replacement was studied. Compensatory Reserve Index was continuously measured from preoperative baseline through the first 24 postoperative hours. Average CRI values during selected procedural phases were compared between patients with an intensive care unit (ICU) length of stay (LOS) <3 days versus LOS ≥3 days. Twenty-three patients were enrolled. On average, 17,445 (±3,152) CRI data points were collected and 0.33% (±0.40) of data were missing per patient. There were no adverse events related to monitoring. Five (21.7%) patients had an ICU LOS ≥3 days. Compared to the ICU LOS <3 days group, the ICU LOS ≥3 days group had a greater decrease in CRI from baseline to immediately after CPB (-0.3 ± 0.1 vs -0.1 ± 0.2, P = .003) and were less likely to recover to baseline CRI during the monitoring period (20% vs 83%, P = .017). Compensatory Reserve Index monitoring after CHS with CPB seems feasible and safe. Early changes in CRI may precede meaningful clinical outcomes, but this requires further study.

A prospective observational cohort pilot study of the association between midazolam use and delirium in elderly endoscopy patients

BackgroundMidazolam is a benzodiazepine commonly used in procedural sedation and general anaesthesia. Current anaesthetic guidelines advise the avoidance of benzodiazepines in elderly patients due to concerns of an increased risk of delirium. Delirium is associated with significant patient morbidity and mortality, while also increasing health costs. Despite this, midazolam is often used in elderly patients undergoing low risk procedures due to the benefits of rapid onset, anxiolysis and haemodynamic stability compared to other sedatives. To date, studies describing the relationship between midazolam use and delirium in elderly patients undergoing low risk procedures, such as endoscopy, are limited.MethodThis was a prospective observational cohort pilot study identifying the prevalence of delirium pre-procedure and incidence of delirium post-procedure in elderly endoscopy patients receiving midazolam. The study population was elderly patients greater than 65 years of age, without underlying cognitive dysfunction, undergoing elective endoscopy. Electronic databases were used for collection of demographic and clinical information. Delirium was identified through the administration of the Family Confusion Assessment Method survey; this was administered to carers of the study population 24–48 h pre and post procedure to categorically identify the presence or absence of delirium.ResultsFifty-eight participants were recruited for this study and eighteen were subsequently excluded based upon additional exclusion criteria. Forty patients were included in the final results. American Society of Anaesthesiology Classification (ASA) of patients were as follows: 1 (9 patients), 2 (12 Patients), 3 (16 Patients) and 4 (3 patients). Patients underwent gastroscopy, colonoscopy or combined gastroscopy and colonoscopy. This study identified no cases of delirium in elderly patients after administration of midazolam for elective endoscopy procedures 24–48 h post-procedure. Additionally, a high proportion of elderly patients were found to have received midazolam.ConclusionNo episodes of delirium were identified in this study. This finding runs counter to current guideline recommendations regarding midazolam use in the elderly patient and that elderly patients undergoing elective endoscopy represent a significantly different patient population compared to those previously studied. This study suggests that in the study population that the risk of delirium in patients exposed to midazolam in elective endoscopy was not demonstrated and that it may be safe to perform experimental studies to elucidate the safety of midazolam in larger studies.

Comparing the effects of alcohol sclerotherapy with those of surgery on anti-Müllerian hormone and ovarian reserve after endometrioma treatment. A prospective multicenter pilot cohort study

Study ObjectiveTo compare the effects of ultrasound-guided aspiration and ethanol sclerotherapy with those of laparoscopic surgery on anti-Müllerian hormone (AMH) levels and ovarian reserve in benign-appearing ovarian endometrioma. DesignA prospective, cohort pilot study. SettingMultiple centers, Spain. PatientsForty patients with a suspected ovarian endometrioma with a maximum diameter of 35–100 mm. Serum hormonal concentrations were analyzed in 26 of these women. InterventionsTwo groups: one that received US-guided aspiration plus alcohol sclerotherapy (n = 16) and the other that underwent laparoscopic cystectomy (n = 10). Measurements and Main ResultsWe studied serum hormonal concentrations (AMH, FSH and 17-β-estradiol) and antral follicle counts (AFC) in each patient at baseline, and after the procedures and pregnancies. No differences were found when comparing AMH and FSH concentrations before and after each procedure. 17-β-estradiol concentrations were significantly increased after alcohol sclerotherapy (p < 0.001). AFC recovery after 6 months seemed to be higher after sclerotherapy than after surgery. Three patients became pregnant in the sclerotherapy group. ConclusionThis pilot study indicated that alcohol sclerotherapy preserves fertility in patients with endometriomas better than surgery, with significant increases in serum estradiol concentrations, possible AFC recovery and spontaneous pregnancies observed in the patients after sclerotherapy.