Clinical Comparison Study Research Articles

Validation of Saliva as the Clinical Specimen Type for a University-Wide COVID-19 Surveillance Program.

At the beginning of the COVID-19 pandemic, the Georgia Institute of Technology made the decision to keep the university doors open for on-campus attendance. To manage COVID-19 infection rates, internal resources were applied to develop and implement a mass asymptomatic surveillance program. The objective was to identify infections early for proper follow-on verification testing, contact tracing, and quarantine/isolation as needed. Program success depended on frequent and voluntary sample collection from over 40,000 students, faculty, and staff personnel. At that time, the nasopharyngeal (NP) swab, not saliva, was the main accepted sample type for COVID-19 testing. However, due to collection discomfort and the inability to be self-collected, the NP swab was not feasible for voluntary and frequent self-collection. Therefore, saliva was selected as the clinical sample type and validated. A saliva collection kit and a sample processing and analysis workflow were developed. The results of a clinical sample-type comparison study between co-collected and matched NP swabs and saliva samples showed 96.7% positive agreement and 100% negative agreement. During the Fall 2020 and Spring 2021 semesters, 319,988 samples were collected and tested. The program resulted in maintaining a low overall mean positivity rate of 0.78% and 0.54% for the Fall 2020 and Spring 2021 semesters, respectively. For this high-throughput asymptomatic COVID-19 screening application, saliva was an exceptionally good sample type.

Optimal caudal needle angulation for lumbar medial branch denervation: A 3D cadaveric and clinical imaging comparison study

BackgroundLumbar medial branch (MB) radiofrequency ablation is a common intervention to treat facetogenic low back pain. The consensus among spine pain interventionalists is that capturing a greater length of the MB correlates with a longer duration of pain relief. Therefore, there has been interest in defining optimal needle angles to achieve parallel cannula placement. Presently, there is inconsistency regarding the optimal caudal needle angles. ObjectivesThe objectives of this study were to: 1) use a dissection-based 3D modelling methodology to quantify optimal caudal needle angles from cadaveric models; and 2) compare optimal cadaver-derived caudal needle angles with real-world patient-derived needle angles. MethodsEighteen formalin embalmed lumbosacral spine specimens were dissected, digitized, and modelled in 3D. Virtual needles were simulated and placed parallel with the L1-L5 MBs. Cadaver-derived caudal needle angles were measured from the high-fidelity 3D models with optimally placed virtual needles. Lateral fluoroscopic images of patients (n = 200) that received lumbar MB denervation were reviewed to measure patient-derived caudal needle angles (L3-L5 MB levels). Descriptive statistics were used to analyze the cadaver (L1-L5 MB levels) and patient-derived (L3-L5 MB levels) caudal needle angles. The cadaver and patient-derived mean caudal needle angles for L3-L5 MB levels were compared. ResultsThere was variability in the cadaver-derived mean caudal needle angles. The lowest mean caudal needle angle was the L1 MB level measured at 41.57 ± 8.56° (range: 27.14° - 53.96°). The highest was the L5 MB level with a mean caudal needle angle of 60.79 ± 8.55° (range: 46.97° - 79.74°). A total of 123 patients were included and 369 caudal needle angles (L3-L5 MB levels) were measured and analyzed. There was variability in the patient-derived mean caudal needle angles. The patient-derived mean caudal needle angles were 29.18 ± 8.77° (range: 11.80° - 61.31°), 33.34 ± 7.23° (range: 16.40° - 54.15°), and 49.08 ± 8.87° (range: 26.45° - 76.95°) for the L3, L4, and L5 MB levels, respectively. There was a significant difference in mean caudal needle angle between cadaver and patient-derived needle angles at the L3, L4, and L5 MB levels. ConclusionsAnalysis of cadaver-derived needle angles versus patient-derived data suggests optimization of lumbar MB denervation requires greater caudal angulation to achieve parallel needle placement. Further research is required to assess the clinical implications.

Clinical comparison study of square flap method and five-flap Z-plasty technique for correction of post-burn axillary contractures: Analysis of length gain and evaluation of functional outcome

IntroductionWhile there is no consensus on the best surgical procedure for post-burn axillary contractures, it is crucial to consider the elongation rate along the scar axis as a useful measurement index for determining the optimal surgical approach. The square flap and five flap z-plasty techniques are commonly employed scar lengthening procedures to address scar contractures in the axilla. These approaches successfully disrupt the linear scar, leading to significant elongation while reducing transverse tension. Our study aims to compare the increase in band length and functional results of these two approaches for treating post-burn contractures in the axilla. MethodsA retrospective study was carried out utilizing data from 34 patients with mild-to-moderate band-like contractures located on the anterior or posterior axillary lines who underwent surgical correction through either the square flap method or five-flap z-plasty technique. The effectiveness of surgical methods was evaluated using two objective indices: improvement in contracture band length and improvement in abduction angle at the shoulder joint. ResultsAll patients achieved complete contracture release. There is no statistically significant difference between the two groups regarding the improvement in the degree of abduction postoperatively. Although there was a significant increase in the length of the contracture band postoperatively in both groups, the average increase in length for cases treated with a square flap was significantly greater than those managed with a five-flap Z-plasty (87.7 ± 44.8 % vs. 38.80 ± 11.119 %,) respectively. ConclusionThe square flap technique is considered a better alternative to the commonly used 5-flap Z-plasty method because it can achieve higher elongation in the contracture band, restore joint function, and create optimal shape when dealing with single linear band contractures over the axilla.

Sample Size Estimation and Statistical Analysis of Cholangiography Robots

In recent years, with the continuous innovation of medical devices encouraged by the government and the investment and attention of enterprises in research and development, coupled with the relevant requirements of the CDE (Center for Drug Evaluation) of the National Medical Products Administration, in order to improve the efficiency of trials and accelerate the launch of cholangiography robots, medical device research and development enterprises are increasingly focusing on the design of clinical trial plans, adopting more scientific, reliable, efficient and standardized statistical designs. Insufficient sample size may lead to issues with sample representativeness, while human centered trials are very expensive, and excessive sample size could increase the difficulty of clinical research. Therefore, this study used the "golden rule" of RCT (Randomized Controlled Trials), combined with the outcome indicators, test level, confidence, dropout rate, etc., to estimate the number of cases in the clinical efficacy comparison study of the cholangiography robot.

MicroRNA-329-3p inhibits the Wnt/β-catenin pathway and proliferation of osteosarcoma cells by targeting transcription factor 7-like 1.

An important factor in the emergence and progression of osteosarcoma (OS) is the dysregulated expression of microRNAs (miRNAs). Transcription factor 7-like 1 (TCF7L1), a member of the T cell factor/lymphoid enhancer factor (TCF/LEF) transcription factor family, interacts with the Wnt signaling pathway regulator β-catenin and acts as a DNA-specific binding protein. This study sought to elucidate the impact of the interaction between miR-329-3p and TCF7L1 on the growth and apoptosis of OS and analyze the regulatory expression relationship between miRNA and mRNA in osteosarcoma cells using a variety of approaches. MiR329-3p was significantly downregulated, while TCF7L1 was considerably up-regulated in all examined OS cell lines. Additionally, a clinical comparison study was performed using the TCGA database. Subsequently, the regulatory relationship between miR-329-3p and TCF7L1 on the proliferation and apoptosis of OS cells was verified through in vitro and in vivo experiments. When miR-329-3p was transfected into the OS cell line, the expression of TCF7L1 decreased, the proliferation of OS cells was inhibited, the cytoskeleton disintegrated, and the nucleus condensed to form apoptotic bodies. The expression of proteins that indicate apoptosis increased simultaneously. The cell cycle was arrested in the G0/G1 phase, and the G1/S transition was blocked. The introduction of miR-329-3p also inhibited downstream Cyclin D1 of the Wnt pathway. Xenograft experiments indicated that the overexpression of miR-329-3p significantly inhibited the growth of OS xenografts in nude mice, and the expression of TCF7L1 and c-Myc in tumor tissues decreased. MiR-329-3p was significantly reduced in OS cells and played a suppressive role in tumorigenesis and proliferation by targeting TCF7L1 both in vitro and in vivo. Osteosarcoma cell cycle arrest and pathway inhibition were observed upon the regulation of TCF7L1 by miR-329-3p. Summarizing these results, it can be inferred that miR-329-3p exerts anticancer effects in osteosarcoma by inhibiting TCF7L1.

Mechanical Fractionation of Adipose Tissue-A Scoping Review of Procedures to Obtain Stromal Vascular Fraction.

Clinical indications for adipose tissue therapy are expanding towards a regenerative-based approach. Adipose-derived stromal vascular fraction consists of extracellular matrix and all nonadipocyte cells such as connective tissue cells including fibroblasts, adipose-derived stromal cells (ASCs) and vascular cells. Tissue stromal vascular fraction (tSVF) is obtained by mechanical fractionation, forcing adipose tissue through a device with one or more small hole(s) or cutting blades between syringes. The aim of this scoping review was to assess the efficacy of mechanical fractionation procedures to obtain tSVF. In addition, we provide an overview of the clinical, that is, therapeutic, efficacy of tSVF isolated by mechanical fraction on skin rejuvenation, wound healing and osteoarthritis. Procedures to obtain tissue stromal vascular fraction using mechanical fractionation and their associated validation data were included for comparison. For clinical outcome comparison, both animal and human studies that reported results after tSVF injection were included. We categorized mechanical fractionation procedures into filtration (n = 4), centrifugation (n = 8), both filtration and centrifugation (n = 3) and other methods (n = 3). In total, 1465 patients and 410 animals were described in the included clinical studies. tSVF seems to have a more positive clinical outcome in diseases with a high proinflammatory character such as osteoarthritis or (disturbed) wound healing, in comparison with skin rejuvenation of aging skin. Isolation of tSVF is obtained by disruption of adipocytes and therefore volume is reduced. Procedures consisting of centrifugation prior to mechanical fractionation seem to be most effective in volume reduction and thus isolation of tSVF. tSVF injection seems to be especially beneficial in clinical applications such as osteoarthritis or wound healing. Clinical application of tSVF appeared to be independent of the preparation procedure, which indicates that current methods are highly versatile.

Effect of dexmedetomidine added to retrobulbar blockade with lignocaine and bupivacaine in dogs undergoing enucleation surgery.

To investigate the effect of the addition of dexmedetomidine (BLD) to retrobulbar blockade with combined lignocaine and bupivacaine on nociception. A total of 17 eyes from 15 dogs. Prospective, randomized, masked clinical comparison study. Dogs undergoing unilateral enucleation were randomly assigned into two groups; a retrobulbar administration of lignocaine and bupivacaine in a 1:2 volume ratio combined with either BLD or 0.9% saline (BLS). The total volume of the intraconal injection was calculated at 0.1 mL/cm cranial length. Intraoperative parameters were recorded: heart rate (HR), respiratory rate (RR), end-tidal CO2 (EtCO2 ) arterial blood pressure (BP), and inspired isoflurane concentration (ISOinsp). Pain scores, heart rate and RR were recorded postoperatively. Dogs receiving BLD (n = 8) had significantly lower intraoperative RR (p = 0.007), and significantly lower ISOinsp (p = 0.037) than dogs in the BLS group (n = 9). Postoperatively heart rate was significantly lower in the BLD group at 1 min (p = 0.025) and 1 h (p = 0.022). There were no other significant differences in intraoperative or postoperative parameters, or in postoperative pain scores (p = 0.354). Dogs receiving BLD had a higher rate of anesthetic events of bradycardia and hypertension (p = 0.027). Analgesic rescue was not needed in either group. The addition of BLD to retrobulbar anesthesia did not result in a detectable difference in pain scores relative to blockade with lignocaine and bupivacaine alone. Dogs receiving retrobulbar BLD had a significantly lower intraoperative RR and isoflurane requirement and an increased incidence of intraoperative bradycardia and hypertension.

A Clinical Study of Nasal Polyposis and Comparison of the Different Methods of its Management.

The online version contains supplementary material available at 10.1007/s12070-023-03583-x.

Internal Brace Ligament Augmentation versus Anatomical Repair with Hamstrings of the ACL – A Clinical Data Comparison Study

AIM: Investigation into the clinical results of internal brace ligament augmentation technique compared to the simple anatomical repair of the anterior cruciate ligament (ACL). METHODS: From May 2016 to November 2019, 128 patients underwent an operation using the internal brace technique. During the same time, 104 patients were operated on using the simple anatomical ACL repair. The mean age was 22.5-year-old for the first group and 26.8-year- old for the second one. The minimum follow-up was 24 months. All the patients performed an X-ray and magnetic resonance imaging. Two hypotheses were raised to assess the superiority of the internal brace technique versus the anatomical one in the early post-operative phase and the rehabilitation one. RESULTS: The mean operation time was 71 (65–75) min for the internal brace (IB) and 62 (55–65) for the anatomical. We had two post-operative infected knees in the first group (IB) and no infection in the second one. The clinical stability test results were much better in the IB group using the KT 1000. The rehabilitation phase showed a superior IB technique. The return to sport-time of the sportsmen was 6 months for the first group and 7–8 months for the anatomical. All the IB-operated patients found physiotherapy significantly easier than the anatomical ones. CONCLUSIONS: IB-technique performs better clinical outcomes than the anatomical repair. The presence of a foreign body (Ultrabraid) inside the knee may be a risk factor contributing toward the elevated infection rate. The IB technique costs are significantly more expensive compared to the anatomical but the low physiotherapy costs compensate for the final result.

MICRO-COMPUTED TOMOGRAPHY ASSESSMENT OF THE ROOT CANAL SYSTEM

Introduction: The root canal system (RCS) is among the complex parts of the body that consists of several anatomical variations. The RCS has also been classified according to different classifications. In one of the classification systems, the RCS consists of the main canal, lateral canal, collateral canal, secondary canal, intercanal, accessory canal (AC), and recurrent canal, whereas in the other classification system, which was presented by the American Association of Endodontists (AAE) in 2020, the RCS consists of the C-shaped canal, lateral canal, furcation canal, and AC. Many researches have already been conducted on using micro-CT in describing the RCS classification in various teeth groups in the jaws. The micro-CT is a method used for the endodontic study, including the morphological study of the RCS. It is one of the non-destructive and high-resolution techniques that is beneficial in obtaining three-dimensional (3D) teeth structures. The method is similar to computed tomography and allows obtaining sections as well as 3D reconstruction of the studied object. Based on the above-mentioned findings, the authors discussed that canals are usually more long oval or ribbon-shaped at the coronal levels, then become oval or round shaped about 1 mm from the apical foramen, indicating that canal shape and number change in the apical third. Conclusion and future perspectives: The micro-CT could be a useful technology in the clinical study of canals, developmental grooves, and comparison of treatment and diagnostic strategies.

Agreement between standard and continuous wireless vital sign measurements after major abdominal surgery: a clinical comparison study

Objective. Continuous wireless monitoring outside the post-anesthesia or intensive care units may enable early detection of patient deterioration, but good accuracy of measurements is required. We aimed to assess the agreement between vital signs recorded by standard and novel wireless devices in postoperative patients. Approach. In 20 patients admitted to the post-anesthesia care unit, we compared heart rate (HR), respiratory rate (RR), peripheral oxygen saturation (SpO2), and systolic and diastolic blood pressure (SBP and DBP) as paired data. The primary outcome measure was the agreement between standard wired and wireless monitoring, assessed by mean bias and 95% limits of agreement (LoA). LoA was considered acceptable for HR and PR, if within ±5 beats min−1 (bpm), while RR, SpO2, and BP were deemed acceptable if within ±3 breaths min−1 (brpm), ±3%-points, and ±10 mmHg, respectively. Main results. The mean bias between standard versus wireless monitoring was −0.85 bpm (LoA −6.2 to 4.5 bpm) for HR, −1.3 mmHg (LoA −19 to 17 mmHg) for standard versus wireless SBP, 2.9 mmHg (LoA −17 to 22) for standard versus wireless DBP, and 1.7% (LoA −1.4 mmHg to 4.8 mmHg) for SpO2, comparing standard versus wireless monitoring. The mean bias of arterial blood gas analysis versus wireless SpO2 measurements was 0.02% (LoA −0.02% to 0.06%), while the mean bias of direct observation of RR compared to wireless measurements was 0.0 brpm (LoA −2.6 brpm to 2.6 brpm). 80% of all values compared were within predefined clinical limits. Significance. The agreement between wired and wireless HR, RR, and PR recordings in postoperative patients was acceptable, whereas the agreement for SpO2 recordings (standard versus wireless) was borderline. Standard wired and wireless BP measurements may be used interchangeably in the clinical setting.

Clinical comparison and functional study of the L703P: a recurrent mutation in human SCN4A that causes sodium channel myotonia

The non-dystrophic myotonias are inherited skeletal muscle disorders characterized by skeletal muscle stiffness after voluntary contraction, without muscle atrophy. Based on their clinical features, non-dystrophic myotonias are classified into myotonia congenita, paramyotonia congenita, and sodium channel myotonia. Using whole-exome next-generation sequencing, we identified a L703P mutation (c.2108T>C, p.L703P) in SCN4A in a Chinese family diagnosed with non-dystrophic myotonias. The clinical findings of patients in this family included muscle stiffness and hypertrophy. The biophysical properties of wildtype and mutant channels were investigated using whole-cell patch clamp. L703P causes both gain-of-function and loss-of-function changes in Nav1.4 properties, including decreased current density, impaired recovery, enhanced activation and slow inactivation. Our study demonstrates that L703P is a pathogenic variant for myotonia, and provides additional electrophysiological information for understanding the pathogenic mechanism of SCN4A-associated channelopathies.

Quality and Vitality of Autologous Fat Grafts Harvested by Different Techniques: A Clinical Comparison Study.

Unpredictable outcomes with autologous fat grafting due to reabsorption processes present a major challenge for healthcare providers and patients. A higher number of viable adipocytes is considered to result in a higher volume being retained. Although various adverse factors have been extensively researched, other potential parameters have been less investigated or even neglected. The aim of this study was to investigate the harvesting process of adipose tissue as the primary cause of cell damage and to determine the risk factors associated with low cell survival. Thirty-nine male and female subjects undergoing planned elective liposuction or abdominoplasty were enrolled. Forty-seven lipoaspirates harvested by different liposuction techniques were analyzed. RNA isolation and real-time polymerase chain reaction was performed to elucidate differences in the expression of various adipocyte markers. Furthermore, scanning electron microscopy was performed on various samples to determine the cell damage caused by the different techniques. A statistically significant lower expression of peroxisome proliferator-activated receptor γ was detected in subjects with a higher BMI. A trend towards a lower expression of perilipin 1 in lipoaspirates harvested by a super wet + ultrasound technique, compared with dry and super wet techniques, was shown. The lowest level of cell damage determined from scanning electron microscopy images was in lipoaspirates harvested by the super wet + ultrasound technique, and this level was statistically significantly different from those obtained by the 2 other techniques. Optimization of the outcome in autologous fat grafting may be feasible by targeting and optimizing the harvesting process as a main risk factor for impaired adipocyte viability. Ultrasound-assisted liposuction might be considered a suitable harvesting technique.

Commentary on: Quality and Vitality of Autologous Fat Grafts Harvested by Different Techniques: A Clinical Comparison Study.

Commentary on: Quality and Vitality of Autologous Fat Grafts Harvested by Different Techniques: A Clinical Comparison Study.

Validation of a New High-Throughput BD COR System Using the BD CTGCTV2 Assay

This study determined the precision and reproducibility of results for the BD CTGCTV2 (CTGCTV2) assay on the BD COR System (COR). The clinical performance of the CTGCTV2 assay conducted on COR was compared with its performance on the BD MAX System (MAX) for detecting Chlamydia trachomatis, Neisseria gonorrhoeae, or Trichomonas vaginalis. The multiday precision and multisite reproducibility studies were conducted using contrived panels of positive and negative urine and PreservCyt specimens. A total of 433 panel members, generated from remnant clinical specimens, were tested in the clinical comparison study. Each panel member was tested three times on MAX and three times on COR. The results in the same testing group were compared for agreement by target. The cycle threshold scores from MAX and COR were analyzed by paired t-test and Deming regression. The CTGCTV2 assay on COR showed high reproducibility in the multiday and multisite precision analysis. The point estimates of positive percent agreement and negative percent agreement in the clinical comparison study for all three targets were greater than 95%, with all corresponding lower bounds of two-sided 95% CIs greater than 90%. Cycle threshold score comparison showed no systematic difference between the two systems. The results of this study show equivalent performance of the CTGCTV2 assay on the MAX and COR systems.

Comparison of effectiveness and safety of epsilon-aminocaproic acid and tranexamic acid in adult patients undergoing cardiac surgery

Objective: The objective of the study is to evaluate the effectiveness and safety of epsilon-aminocaproic acid (EACA) and tranexamic acid (TXA) in reducing bleeding, re-exploration, and blood transfusion in patients who underwent a cardiac surgical procedure for mitral valve replacement on cardiopulmonary bypass. Methods: A single-center, prospective, randomized, and double-blind clinical comparison study was conducted after obtaining institutional ethical approval; sixty patients of either gender between 18 and 60 years of age were randomly divided into two batches: EACA batch (n = 30) given 100 mg/kg EACA as a bolus during induction of anesthesia and then infused at 20 mg/kg/h during surgery and 6 h after surgery and TXA batch (n = 30) given TXA 20 mg/kg/h as a bolus during induction of anesthesia and then infused at 2 mg/kg/h during surgery and 6 h after surgery. The patient parameters, blood loss, transfusion requirements in the first 24 h, and other complications were recorded. Results: Blood loss per hour through the chest tube drain was significantly lower for the first 6 postoperative hours in the TXA than in the EACA (P < 0.05). The total postoperative blood loss was 416 ± 47.74 ml and 489 ± 42.12 ml in 24 h (P = 0.0001), and the blood transfusion requirement was 0.45 ± 0.62 units and 0.86 ± 0.87 units (P = 0.0481) in the TXA and EACA, respectively. The re-exploration rate was 3.34% and 13.34% in TXA and EACA (P = 0.0629). Five percent of the patients reported seizures in the study (P > 0.05). The findings of this study suggested that prophylactic therapy with EACA or TXA was effective and safer in reducing perioperative blood loss in cardiac surgical procedures with mitral valve replacement. Furthermore, TXA was significantly more effective than EACA.

Identification of thresholds for accuracy comparisons of heart rate and respiratory rate in neonates.

Background: Heart rate (HR) and respiratory rate (RR) can be challenging to measure accurately and reliably in neonates. The introduction of innovative, non-invasive measurement technologies suitable for resource-constrained settings is limited by the lack of appropriate clinical thresholds for accuracy comparison studies. Methods: We collected measurements of photoplethysmography-recorded HR and capnography-recorded exhaled carbon dioxide across multiple 60-second epochs (observations) in enrolled neonates admitted to the neonatal care unit at Aga Khan University Hospital in Nairobi, Kenya. Trained study nurses manually recorded HR, and the study team manually counted individual breaths from capnograms. For comparison, HR and RR also were measured using an automated signal detection algorithm. Clinical measurements were analyzed for repeatability. Results: A total of 297 epochs across 35 neonates were recorded. Manual HR showed a bias of -2.4 (-1.8%) and a spread between the 95% limits of agreement (LOA) of 40.3 (29.6%) compared to the algorithm-derived median HR. Manual RR showed a bias of -3.2 (-6.6%) and a spread between the 95% LOA of 17.9 (37.3%) compared to the algorithm-derived median RR, and a bias of -0.5 (1.1%) and a spread between the 95% LOA of 4.4 (9.1%) compared to the algorithm-derived RR count. Manual HR and RR showed repeatability of 0.6 (interquartile range (IQR) 0.5-0.7), and 0.7 (IQR 0.5-0.8), respectively. Conclusions: Appropriate clinical thresholds should be selected a priori when performing accuracy comparisons for HR and RR. Automated measurement technologies typically use a smoothing or averaging filter, which significantly impacts accuracy. A wider spread between the LOA, as much as 30%, should be considered to account for the observed physiological nuances and within- and between-neonate variability and different averaging methods. Wider adoption of thresholds by data standards organizations and technology developers and manufacturers will increase the robustness of clinical comparison studies.

Identification of thresholds for accuracy comparisons of heart rate and respiratory rate in neonates

Background: Heart rate (HR) and respiratory rate (RR) can be challenging to measure accurately and reliably in neonates. The introduction of innovative, non-invasive measurement technologies suitable for resource-constrained settings is limited by the lack of appropriate clinical thresholds for accuracy comparison studies. Methods: We collected measurements of photoplethysmography-recorded HR and capnography-recorded exhaled carbon dioxide across multiple 60-second epochs (observations) in enrolled neonates admitted to the neonatal care unit at Aga Khan University Hospital in Nairobi, Kenya. Trained study nurses manually recorded HR, and the study team manually counted individual breaths from capnograms. For comparison, HR and RR also were measured using an automated signal detection algorithm. Clinical measurements were analyzed for repeatability. Results: A total of 297 epochs across 35 neonates were recorded. Manual HR showed a bias of -2.4 (-1.8%) and a spread between the 95% limits of agreement (LOA) of 40.3 (29.6%) compared to the algorithm-derived median HR. Manual RR showed a bias of -3.2 (-6.6%) and a spread between the 95% LOA of 17.9 (37.3%) compared to the algorithm-derived median RR, and a bias of -0.5 (1.1%) and a spread between the 95% LOA of 4.4 (9.1%) compared to the algorithm-derived RR count. Manual HR and RR showed repeatability of 0.6 (interquartile range (IQR) 0.5-0.7), and 0.7 (IQR 0.5-0.8), respectively. Conclusions: Appropriate clinical thresholds should be selected a priori when performing accuracy comparisons for HR and RR. Automated measurement technologies typically use a smoothing or averaging filter, which significantly impacts accuracy. A wider spread between the LOA, as much as 30%, should be considered to account for the observed physiological nuances and within- and between-neonate variability and different averaging methods. Wider adoption of thresholds by data standards organizations and technology developers and manufacturers will increase the robustness of clinical comparison studies.

Identification of thresholds for accuracy comparisons of heart rate and respiratory rate in neonates

Background: Heart rate (HR) and respiratory rate (RR) can be challenging to measure accurately and reliably in neonates. The introduction of innovative, non-invasive measurement technologies suitable for resource-constrained settings is limited by the lack of appropriate clinical thresholds for accuracy comparison studies. Methods: We collected measurements of photoplethysmography-recorded HR and capnography-recorded exhaled carbon dioxide across multiple 60-second epochs (observations) in enrolled neonates admitted to the neonatal care unit at Aga Khan University Hospital in Nairobi, Kenya. Trained study nurses manually recorded HR, and the study team manually counted individual breaths from capnograms. For comparison, HR and RR also were measured using an automated signal detection algorithm. Clinical measurements were analyzed for repeatability. Results: A total of 297 epochs across 35 neonates were recorded. Manual HR showed a bias of -2.4 (-1.8%) and a spread between the 95% limits of agreement (LOA) of 40.3 (29.6%) compared to the algorithm-derived median HR. Manual RR showed a bias of -3.2 (-6.6%) and a spread between the 95% LOA of 17.9 (37.3%) compared to the algorithm-derived median RR, and a bias of -0.5 (1.1%) and a spread between the 95% LOA of 4.4 (9.1%) compared to the algorithm-derived RR count. Manual HR and RR showed repeatability of 0.6 (interquartile range (IQR) 0.5-0.7), and 0.7 (IQR 0.5-0.8), respectively. Conclusions: Appropriate clinical thresholds should be selected a priori when performing accuracy comparisons for HR and RR. Automated measurement technologies typically use median values rather than counts, which significantly impacts accuracy. A wider spread between the LOA, as much as 30%, should be considered to account for the observed physiological nuances and within- and between-neonate variability and different averaging methods. Wider adoption of thresholds by data standards organizations and technology developers and manufacturers will increase the robustness of clinical comparison studies.

Effects of perioperative saphenous and sciatic nerve blocks, lumbosacral epidural or morphine–lidocaine–ketamine infusion on postoperative pain and sedation in dogs undergoing tibial plateau leveling osteotomy

ObjectiveTo compare the quality of postoperative analgesia and sedation after preoperative saphenous and sciatic nerve blockade, preoperative lumbosacral epidural injection and perioperative intravenous (IV) morphine, lidocaine and ketamine infusions in dogs undergoing stifle arthroscopy and tibial plateau leveling osteotomy (TPLO) under general anesthesia. Study designProspective, blinded, randomized, clinical comparison study. AnimalsA total of 45 dogs weighing 33.9 (15.9–56.7) kg and aged 5.2 (1.0–12.0) years, mean (range), undergoing elective unilateral TPLO for spontaneous cranial cruciate ligament rupture. MethodsClient-owned dogs were enrolled. Dogs were randomly assigned to one of three groups: group MLK, perioperative IV morphine, lidocaine and ketamine infusion; group EPID, lumbosacral epidural with ropivacaine and morphine; or group SSNB, saphenous and sciatic nerve blockade with ropivacaine. Routine stifle arthroscopy followed by TPLO surgery was performed. Sedation and pain scores were assessed at 0, 2, 4, 8 and 24 hours following extubation. Rescue analgesia was administered as prescribed by Glasgow composite pain score–short form score >5. ResultsSedation scores for MLK were higher than EPID and SSNB. Pain scores for SSNB were lower than those for EPID and MLK. No significant differences were found in anesthesia duration or surgery duration among groups. No dogs required rescue analgesia. Conclusions and clinical relevanceAlthough analgesia was adequate in all groups, the best combination of analgesia without increased sedation was recorded for SSNB.