Category: Nevin Manimala

J Clin Anesth. 2021 Apr 3;71:110257. doi: 10.1016/j.jclinane.2021.110257. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: There is no established analgesic method for postoperative total knee arthroplasty. We comprehensively compared the analgesic methods for postoperative total knee arthroplasty.

DESIGN: A network meta-analysis of randomised controlled trials was used to compare 18 interventions, which were ranked by six outcome indices, to select the best modality.

SETTING: Postoperative recovery room and inpatient ward.

PATIENTS: 98 randomised controlled trials involving 7452 patients (ASA I-III) were included in the final analysis.

INTERVENTIONS: Studies that included the use of at least one of the following 12 nerve block(fascia iliaca compartment block (FIB), FNB, cFNB, single femoral nerve block (sFNB), adductor canal block (ACB), sciatic nerve block (SNB), obturator nerve block (ONB), continuous posterior lumbar plexus block (PSOAS), FNB + SNB, ACB + LIA, FNB + LIA, PCA + FNB).

MEASUREMENTS: Pain intensity was compared using Visual Analogue Scale (VAS). Also, postoperative complications, function score, hospital length of stay, morphine consumption and patient satisfaction were measured.

MAIN RESULTS: For visual analogue scale scores, continuous femoral nerve block (FNB) and FNB + sciatic nerve block (SNB) were the the most effective interventions. For reducing postoperative complications, fascia iliaca compartment block, FNB, SNB, and obturator nerve block showed the best results. For reducing postoperative morphine consumption, adductor canal block (ACB) + local infiltration analgesia (LIA) and FNB + SNB were preferred. For function scores (range of motion, Timed-Up-and-Go test), ACB and LIA were optimal choices. For reducing hospital length of stay and patient satisfaction, ACB + LIA and FNB + LIA were best, respectively.

CONCLUSIONS: Peripheral nerve block, especially FNB and ACB, is a better option than other analgesic methods, and its combination with other methods can be beneficial. Peripheral nerve block is a safe and effective postoperative analgesia method. However, our findings can only provide objective evidence. Clinicians should choose the treatment course based on the individual patient’s condition and clinical situation.

PMID:33823459 | DOI:10.1016/j.jclinane.2021.110257

Int J Pediatr Otorhinolaryngol. 2021 Mar 29;144:110699. doi: 10.1016/j.ijporl.2021.110699. Online ahead of print.

ABSTRACT

BACKGROUND: Recent studies have shown that a short lingual frenulum is a potential risk factor for obstructive sleep apnea syndrome (OSAS) in children. A short frenulum leads to abnormal orofacial development and may consequently contribute to sleep-disordered breathing by narrowing the upper airways and increasing the risk of upper-airway collapsibility. The aim of this study was to assess the impact of a short lingual frenulum on the risk of OSAS in children.

METHODS: Children from pre-, primary, secondary, and high school, aged 3-17 years, were included in the study. Parents/guardians were asked to fill in the Pediatric Sleep Questionnaire (PSQ), and then, children at risk of OSAS were enrolled in the study group. A control group was established randomly from patients with negative PSQ results. A physical examination, including measurements of head-forward posture (HFP) and length of the free tongue, inter-incisor distance and subjective high-arched palate evaluation was performed in children from both groups.

RESULTS: A total of 1,500 PSQ questionnaires were distributed, and less than half (713) were returned correctly filled in. In the second part of the study, 135 children were evaluated: 67 in the study group and 68 in the control group. The mean ages were 9.4 ± 3.0 and 9.5 ± 3.1 years, respectively. Children in the study group had significantly shorter lingual frenula, higher HFP measures, and had a higher prevalence of a high-arched palate. Based on statistical analysis, a short lingual frenulum (OR 5.02 [1.58-15.94]).

CONCLUSIONS: The study identified a relationship between a short lingual frenulum and the risk of OSAS in children. Detecting and addressing ankyloglossia in children is necessary before it leads to orofacial changes, malocclusion, and consequently, sleep apnea. Furthermore, OSAS was associated with higher HFP, but no relationship was found between the two parameters.

PMID:33823467 | DOI:10.1016/j.ijporl.2021.110699

J Chromatogr A. 2021 Mar 23;1644:462094. doi: 10.1016/j.chroma.2021.462094. Online ahead of print.

ABSTRACT

We set up an automated screening process to routinely test 10 chiral supercritical fluid chromatography (SFC) methods – five columns combined with two co-solvents – as part of a chiral separation lab workflow. Proprietary software tools enabled automated method screening of racemates, parallel evaluation of the resulting chromatograms for enantiomer separation and report generation. This process is largely automated and resulted in an efficient and reliable lab process with a minimum requirement for human intervention. Screenings were conducted on a test set of 756 racemates that were selected with focus on structural variation and on 2667 proprietary samples from lab routines. Statistical analysis revealed that up to 92% of the tested racemic mixtures could be successfully separated with at least one of the tested conditions of the screening. Process efficiency was further increased by identification of optimal method screening sequence, re-definition of the optimal column set and project-specific adaptations considering reduced structural variation of the analytes. This study illustrates the usefulness of consistent chromatographic data sets to accelerate and facilitate the identification of chiral methods to separate enantiomers by automated processing and statistical analysis.

PMID:33823386 | DOI:10.1016/j.chroma.2021.462094

Geriatr Nurs. 2021 Apr 3;42(3):643-649. doi: 10.1016/j.gerinurse.2021.03.016. Online ahead of print.

ABSTRACT

This study explored the association of back pain and heart failure (HF) with health outcomes among community-dwelling older adults. Older adults who completed a follow-up in the 11th year (2007-2008) of the Health, Aging, and Body Composition (Health ABC) study were included. The mean age was 83.4 ± 2.78 years. Back pain and heart failure were reported by 55.40% (n = 657) and 8.09 % (n = 96) of the total subjects (N = 1186), respectively. Regression analysis indicated that older adults with back pain reported worse depressive symptoms, fatigue, and physical performance and function compared with those without back pain (p < 0.05), and HF presence increased fatigue levels and decreased physical function (p < 0.05) among older adults with back pain. The high incidence and negative impact of back pain highlight the need to develop strategies for pain management among older adults with and without HF.

PMID:33823422 | DOI:10.1016/j.gerinurse.2021.03.016

Eur J Cancer. 2021 Apr 3;149:49-60. doi: 10.1016/j.ejca.2021.03.007. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Trial designs using multiple primary endpoints (MPEs) are increasing in phase III cancer trials. Our objectives were to describe the incidence of MPEs in recently published phase III trials testing systemic treatments in patients with advanced cancer; the main characteristics of trials adopting MPEs; the presence of mature results for all endpoints in the primary publication; consistency between results of each endpoint and authors’ conclusions.

METHODS: Articles of randomised phase III trials conducted in patients with advanced cancer, published between 2017 and 2020, were retrieved from PubMed. The main outcome was the proportion of trials with MPEs. In principle, according to regulatory agencies, we considered two distinct cases: (i) MPEs correspond to ‘multiple chances’ for the success of experimental treatment, needing adjustment for multiplicity, and (ii) a positive result depends on the success in all MPEs (‘co-primary’ endpoints).

RESULTS: Out of 235 eligible trials, 27 trials (12%) adopted MPE, mostly overall survival (OS) and progression-free survival (PFS). The proportion of trials with MPEs increased over time, from 6% in 2017 to 20% in 2020 (p = 0.025). MPEs were adopted in 16% of for-profit trials versus 4% of non-profit trials (p = 0.006). The proportion of trials adopting MPEs was particularly high with immunotherapy (53%, p < 0.00001). Out of 27 trials with MPEs, 10 (37%) adopted an explicit definition of ‘co-primary’ endpoints, but only 1/10 declared the positivity of both endpoints critical for interpretation. Most trials (23, 85%) planned correction for multiplicity. Of 21 publications with positive conclusions, only 12 had a statistically significant positive result in both primary endpoints. In four cases (15%), positive conclusions were based on PFS results alone.

CONCLUSIONS: Adoption of MPEs in randomised trials in oncology is quite common. Only a minority of trials respect recommendations by regulatory agencies about the adoption of MPEs, definition of ‘co-primary’ endpoints and correction for multiplicity.

PMID:33823362 | DOI:10.1016/j.ejca.2021.03.007

Pediatr Neurol. 2021 Mar 8;119:15-21. doi: 10.1016/j.pediatrneurol.2021.02.010. Online ahead of print.

ABSTRACT

BACKGROUND: Levetiracetam is a relatively new-generation antiseizure drug approved for the treatment of focal and generalized seizures. Despite its favorable side effect profile and minimal drug-drug interactions, neuropsychiatric side effects are reported in up to 13% of children. A few case series have suggested that supplementation of pyridoxine may mitigate these side effects, but controlled trials are lacking. To address this issue, a randomized interventional study was carried out in a pediatric tertiary hospital to qualify and quantify the potential beneficial effect of pyridoxine in attenuating the neuropsychiatric side effects of levetiracetam in children.

METHODS: A total of 105 children with epilepsy who were taking levetiracetam (as a monotherapy or an adjunct) who showed behavioral symptoms coinciding with the start of levetiracetam, were included. Patients randomly and blindly received either a therapeutic (pyridoxine group, 46 of 105, 44%) or a homeopathic dose of pyridoxine (placebo, 59 of 105, 56%). A 30-item behavioral checklist was used to qualify and quantify the behavioral side effects at baseline and at different time points following initiation of treatment.

RESULTS: Both placebo and pyridoxine groups experienced a statistical reduction in behavioral scores when compared with baseline. Our study indicated that although there was a placebo effect, the improvement in neuropsychiatric symptoms was more prominent in children who received therapeutic doses of pyridoxine.

CONCLUSIONS: These data provide clinicians with pertinent evidence-based information that suggests that a trial of pyridoxine in patients who experience behavioral side effects due to the use of levetiracetam may avoid unnecessary change of antiseizure medications.

PMID:33823377 | DOI:10.1016/j.pediatrneurol.2021.02.010

J Pediatr Nurs. 2021 Apr 3;61:102-108. doi: 10.1016/j.pedn.2021.03.024. Online ahead of print.

ABSTRACT

PURPOSE: This study was designed to evaluate the short- and long-term effects of a scenario simulation-based education intervention on parental anxiety about fever in their children.

DESIGN AND METHODS: This experimental research was conducted using a two-group pretest-posttest design. One hundred and sixty parents of 3-month to 5-year-old children enrolled in preschools and kindergartens with childcare services were recruited as participants using cluster random sampling. The participants were divided randomly into an experimental group (80) and a control group (80). The former participated in a scenario simulation-based education intervention and received a fever education booklet. The latter received the booklet only. Data were collected using the Children’s Fever Anxiety Inventory at three time points: before the intervention (pretest, T1) and at six-month (T2) and 12-month (T3) posttests.

RESULTS: Significant intergroup differences in fever anxiety were found at both T2 and T3 (p < .001). For both groups, the scores at T2 and T3 were significantly lower than at T1 (p < .001) and the difference between T2 and T3 did not attain statistical significance (p > .05). Although both groups experienced reduced fever anxiety over time, this reduction was significantly greater in the experimental group than in the control group (p < .001).

CONCLUSION: Simulation-based education may be used in conjunction with the traditional fever education booklet to further reduce parent fever anxiety over time.

PRACTICE IMPLICATIONS: This simulation-based education approach significantly and positively impacts parental anxiety about fever in their children. Furthermore, the approach may be generalizable to other childhood healthcare settings.

PMID:33823379 | DOI:10.1016/j.pedn.2021.03.024

Contemp Clin Trials. 2021 Apr 3:106378. doi: 10.1016/j.cct.2021.106378. Online ahead of print.

ABSTRACT

Efficient identification of the optimal dose and dosing scheme is one of the most critical and challenging tasks in early-phase oncology trials. The results are far-reaching because advancing a sub-optimal dose to late-stage development may not only jeopardize patients’ safety or fail to deliver desired efficacy, but also be costly to sponsors as refined doses must be evaluated further before seeking regulatory approval. A good dose-escalation design is anticipated to yield high accuracy of selecting the correct dose while using fewer patients and keeping the trial duration short. Recently, treating a single patient at each lower dose level until certain events are triggered to switch to larger cohorts has gained much popularity. We name this approach “Single Patient Acceleration” (SPA), which is essentially a variant of the Accelerated Titration Design (ATD) by Simon et al. [25]. Although literature on novel dose-escalation methods is abundant in the past decade, there is a surprisingly lack of research on evaluating the ATD/SPA framework. In this article, we conduct comprehensive simulations to evaluate the performance of dose-escalation designs with or without SPA, and show that SPA improves design efficiency with similar or better accuracy to those without the “single patient” component under certain circumstances (e.g., slow initial enrollment, or the true maximum tolerated dose is at higher candidate dose levels). Potential safety concerns as a cost of efficiency improvement are also investigated in a quantitative manner to illustrate a comprehensive benefit-risk profile of SPA. Practical considerations and recommendations in using SPA are also discussed.

PMID:33823296 | DOI:10.1016/j.cct.2021.106378

Mol Cell Proteomics. 2021 Apr 3:100076. doi: 10.1016/j.mcpro.2021.100076. Online ahead of print.

ABSTRACT

Proteogenomics approaches often struggle with the distinction between true and false peptide-to-spectrum matches as the database size enlarges. However, features extracted from tandem mass spectrometry intensity predictors can enhance the peptide identification rate and can provide extra confidence for peptide-to-spectrum matching in a proteogenomics context. To that end, features from the spectral intensity pattern predictors MS²PIP and Prosit were combined with the canonical scores from MaxQuant in the Percolator post-processing tool for protein sequence databases constructed out of ribosome profiling and nanopore RNA-seq analyses. The presented results provide evidence that this approach enhances both the identification rate as well as the validation stringency in a proteogenomic setting.

PMID:33823297 | DOI:10.1016/j.mcpro.2021.100076

Ann Vasc Surg. 2021 Apr 3:S0890-5096(21)00241-7. doi: 10.1016/j.avsg.2021.01.118. Online ahead of print.

ABSTRACT

INTRODUCTION: Persistent type II endoleaks (ELIIp) occur in 8% to 23% of patients submitted to endovascular aneurysm repair (EVAR) and may lead to aneurysm progression and rupture. Intraoperative embolization of the abdominal aortic aneurysm (AAA) sac is effective to prevent their occurrence, however a method to achieve complete sac thrombosis has not been standardized yet. Aim of our study was to identify factors associated with prevention of ELIIp after intraoperative embolization, in order to optimize technical details.

METHODS: Patients at high risk for ELIIp, who underwent EVAR with AAA – sac coil embolization were prospectively collected into a dedicated database from January 2012 to March 2015. The endoluminal residual sac volume (ERV), not occupied by the endograft [ERV= AAA total volume (TV) – (AAA-thrombus volume (THV) + endograft volume (EgV)] was calculated on preoperative computed tomography and the concentration of coils implanted (CCoil= n coils implanted/ERV) for each patient was evaluated. AAA volumetric evaluation was conducted by dedicated vessels analysis software (3Mensio). ELIIp presence was evaluated by contrast-enhanced ultrasound at 6 and 12-month. Patients with ELIIp at 12 months (Group 1) were clustered and compared to patients without ELIIp (Group 2), in order to evaluate the incidence of ELIIp in patients undergone to preventive AAA-sac embolization, and identify the predictors of ELIIp prevention. Morphological potential risk factors for ELIIp such as TV, THV, VR% and EgV were also considered in all patients. Statistical correlation was assessed by Fisher Exact Test.

RESULTS: Among 326 patients undergone to standard EVAR, 61 (19% – M: 96.7%, median age: 72 (IQR: 8) years, median AAA diameter: 57(IQR: 7) mm) were considered at high risk for ELIIp and were submitted to coil embolization. The median AAA total volume (TV) and median ERV were 156 (IQR: 59) cc and 46 (IQR: 26) cc, respectively. The median number and concentration of coils (IMWCE-38-16-45 Cook M-Ray) positioned in AAA-sac were 5 (IQR: 1) coils and 0.17 coil/cm³ (range 0.02-1.20). Among this high-risk population, the incidence of ELIIp was 29.5% and 23% at 6 and 12-month, respectively. Fourteen patients (23%) were clustered in Group1 and 47 (77%) in Group 2. Both groups were homogeneous for clinical characteristics and preoperative morphological risk factors. There were no differences in the preoperative median TV, AAA-thrombus volume (THV), %VR, EgV and number of implanted coils between Group1 and Group2. Patients in Group1 had a significantly higher ERV [59 (IQR: 13) cm³ vs 42 (IQR: 27) cm³, P = .002] and lower CCoil [0.09 (IQR: 0.03) vs 0.18 (IQR: 0.21), P = .006] than patients of Group2. ELIIp was significantly related to the presence of ERV > 49 cm³ (86 % vs 42 %, Group1 and Group2 respectively, P = .006) and CCoil < 0.17coil/ cm³ (100% vs 68%, Group1 e Group2 respectively, P = .014).

CONCLUSION: According with our results, Coil concentration and endoluminal residual volume can affect the efficacy of the AAA – sac embolization in the prevention of ELIIp, moreover CCoil ≥ 0.17coil/ cm³ maight be considered to determine the tailored number of coils.

PMID:33823259 | DOI:10.1016/j.avsg.2021.01.118