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Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial

J Bone Joint Surg Am. 2024 May 7. doi: 10.2106/JBJS.23.00719. Online ahead of print.

ABSTRACT

BACKGROUND: The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown.

METHODS: In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications.

RESULTS: A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration.

CONCLUSIONS: Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively.

LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

PMID:38713762 | DOI:10.2106/JBJS.23.00719

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Nurses’ knowledge, Practice, and Associated Factors Towards Adult Palliative Care: A Cross-sectional Study

J Hosp Palliat Nurs. 2024 May 6. doi: 10.1097/NJH.0000000000001035. Online ahead of print.

ABSTRACT

The demand for palliative care is increasing rapidly, but inadequate knowledge and practice remain a significant issue. This study aimed to assess nurses’ knowledge, practice, and associated factors toward adult palliative care. A cross-sectional study was conducted including 277 randomly selected nurses from May through September 2021. The data related to knowledge were gathered using the Palliative Care Quiz for Nursing, and an observational checklist to assess the practice was used. EpiData and SPSS software were used for data entry and analysis, respectively. Descriptive statistics and bivariable and multivariable analyses were also applied. Depending on the value of the adjusted odds ratio with a 95% confidence level, statistical significance was declared at a P value of .05. Findings showed that 43.2% and 47% of nurses had good knowledge and practice in palliative care, respectively. The odds of trained nurses having good knowledge were 9.65 times higher than those who did not. There were 2.7 times more odds of practicing palliative care among nurses with good knowledge than those with poor knowledge. Overall, over half of the nurses have poor knowledge and practice in palliative care. To enhance their knowledge and practice, formal palliative care education and training will be beneficial.

PMID:38713759 | DOI:10.1097/NJH.0000000000001035

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Impact of liver fibrosis on COVID-19 in-hospital mortality in Southern Italy

PLoS One. 2024 May 7;19(5):e0296495. doi: 10.1371/journal.pone.0296495. eCollection 2024.

ABSTRACT

BACKGROUND & AIMS: SARS-Cov-2 infection manifests as a wide spectrum of clinical presentation and even now, despite the global spread of the vaccine, contagiousness is still elevated. The aim of the study was the evaluation of the impact of liver fibrosis assessed by FIB-4 and liver impairment, assessed by cytolysis indices, on intrahospital mortality in COVID-19 subjects.

METHODS: This is a retrospective observational cohort study, which involved 23 COVID Hospital Units in Campania Region, Italy. Exposure variables were collected during hospital admission and at discharge. According to FIB-4 values, we subdivided the overall population in three groups (FIB-4<1.45; 1.45<FIB-4<3.25; FIB-4>3.25), respectively group 1,2,3.

RESULTS: At the end of the study, 938 individuals had complete discharged/dead data. At admission, 428 patients were in group 1 (45.6%), 387 in group 2 (41.3%) and 123 in group 3 (13.1%). Among them, 758 (81%) subjects were discharged, while the remaining 180 (19%) individuals died. Multivariable Cox’s regression model showed a significant association between mortality risk and severity of FIB-4 stages (group 3 vs group 1, HR 2.12, 95%CI 1.38-3.28, p<0.001). Moreover, Kaplan-Meier analysis described a progressive and statistically significant difference (p<0.001 Log-rank test) in mortality according to FIB-4 groups. Among discharged subjects, 507 showed a FIB-4<1.45 (66.9%, group 1), 182 a value 1.45<FIB-4<3.25 (24.1%, group 2) and 69 a FIB-4>3.25 (9.0%, group 3). Among dead subjects, 42 showed a FIB-4<1.45 (23.3%, group 1), 62 a value 1.45<FIB-4<3.25 (34.4%, group 2) and 76 a FIB-4>3.25 (42.3%, group 3).

CONCLUSIONS: FIB-4 value is significantly associated with intrahospital mortality of COVID-19 patients. During hospitalization, particularly in patients with worse outcomes, COVID-19 seems to increase the risk of acute progression of liver damage.

PMID:38713731 | DOI:10.1371/journal.pone.0296495

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Every sip counts: Understanding hydration behaviors and user-acceptability of digital tools to promote adequate intake during early and late pregnancy

PLOS Digit Health. 2024 May 7;3(5):e0000499. doi: 10.1371/journal.pdig.0000499. eCollection 2024 May.

ABSTRACT

Maintaining adequate hydration over the course of pregnancy is critical for maternal and fetal health and reducing risks for adverse pregnancy outcomes (e.g., preeclampsia, low placental and amniotic fluid volume). Recent evidence suggests that women may be at risk for under-hydration in the second and third trimesters when water needs begin to increase. Scant research has examined pregnant women’s knowledge of hydration recommendations, water intake behaviors, and willingness to use digital tools to promote water intake. This study aimed to: 1) describe hydration recommendation knowledge and behaviors by the overall sample and early vs late pregnancy, and 2) identify habits and barriers of using digital tools. Pregnant women (N = 137; M age = 30.9 years; M gestational age = 20.9) completed a one-time, 45-minute online survey. Descriptive statistics quantified women’s knowledge of hydration recommendations, behaviors, and attitudes about utilizing digital tools to promote adequate intake, and Mann-Whitney U and chi-squared tests were used to determine group differences. Most women lacked knowledge of and were not meeting hydration recommendations (63%, 67%, respectively) and were not tracking their fluid consumption (59%). Knowledge of hydration recommendations differed by time of pregnancy, such that women in later pregnancy reported 82 ounces compared to women in early pregnancy (49 ounces). Common barriers included: forgetting to drink (47%), not feeling thirsty (47%), and increased urination (33%). Most were willing to use digital tools (69%) and believed a smart water bottle would help them achieve daily fluid recommendations (67%). These initial findings suggest that pregnant women may benefit from useful strategies to increase knowledge, decrease barriers, and maintain adequate hydration, specifically earlier in pregnancy. These findings will inform the design of a behavioral intervention incorporating smart connected water bottles, wearables for gesture detection, and behavior modification strategies to overcome barriers, promote proper hydration and examine its impact on maternal and infant health outcomes.

PMID:38713720 | DOI:10.1371/journal.pdig.0000499

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Cognitive Behavioral Therapy for Symptom Preoccupation Among Patients With Premature Ventricular Contractions: Nonrandomized Pretest-Posttest Study

JMIR Cardio. 2024 May 7;8:e53815. doi: 10.2196/53815.

ABSTRACT

BACKGROUND: Premature ventricular contractions (PVCs) are a common cardiac condition often associated with disabling symptoms and impaired quality of life (QoL). Current treatment strategies have limited effectiveness in reducing symptoms and restoring QoL for patients with PVCs. Symptom preoccupation, involving cardiac-related fear, hypervigilance, and avoidance behavior, is associated with disability in other cardiac conditions and can be effectively targeted by cognitive behavioral therapy (CBT).

OBJECTIVE: The aim of this study was to evaluate the effect of a PVC-specific CBT protocol targeting symptom preoccupation in patients with symptomatic idiopathic PVCs.

METHODS: Nineteen patients diagnosed with symptomatic idiopathic PVCs and symptom preoccupation underwent PVC-specific CBT over 10 weeks. The treatment was delivered by a licensed psychologist via videoconference in conjunction with online text-based information and homework assignments. The main components of the treatment were exposure to cardiac-related symptoms and reducing cardiac-related avoidance and control behavior. Self-rated measures were collected at baseline, post treatment, and at 3- and 6-month follow-ups. The primary outcome was PVC-specific QoL at posttreatment assessment measured with a PVC-adapted version of the Atrial Fibrillation Effects on Quality of Life questionnaire. Secondary measures included symptom preoccupation measured with the Cardiac Anxiety Questionnaire. PVC burden was evaluated with 5-day continuous electrocardiogram recordings at baseline, post treatment, and 6-month follow-up.

RESULTS: We observed large improvements in PVC-specific QoL (Cohen d=1.62, P<.001) and symptom preoccupation (Cohen d=1.73, P<.001) post treatment. These results were sustained at the 3- and 6-month follow-ups. PVC burden, as measured with 5-day continuous electrocardiogram, remained unchanged throughout follow-up. However, self-reported PVC symptoms were significantly lower at posttreatment assessment and at both the 3- and 6-month follow-ups. Reduction in symptom preoccupation had a statistically significant mediating effect of the intervention on PVC-specific QoL in an explorative mediation analysis.

CONCLUSIONS: This uncontrolled pilot study shows preliminary promising results for PVC-specific CBT as a potentially effective treatment approach for patients with symptomatic idiopathic PVCs and symptom preoccupation. The substantial improvements in PVC-specific QoL and symptom preoccupation, along with the decreased self-reported PVC-related symptoms warrant further investigation in a larger randomized controlled trial.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05087238; https://clinicaltrials.gov/study/NCT05087238.

PMID:38713500 | DOI:10.2196/53815

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Health Literacy and Health Care System Confidence as Determinants of Attitudes to Vaccines in France: Representative Cross-Sectional Study

JMIR Public Health Surveill. 2024 May 7;10:e45837. doi: 10.2196/45837.

ABSTRACT

BACKGROUND: Health literacy involves individuals’ knowledge, personal skills, and confidence to take action to evaluate and appraise health-related information and improve their health or that of their community.

OBJECTIVE: This study aimed to analyze the association between health literacy and attitude toward vaccines, adjusted with other factors.

METHODS: We used the SLAVACO Wave 3, a survey conducted in December 2021 among a sample of 2022 individuals, representative of the French adult population. We investigated factors associated with the attitude toward vaccines using respondents’ different sociodemographic data, health literacy levels, and the health care system confidence levels using a multinomial logistic regression analysis.

RESULTS: Among the participants, 440.4 (21.8%) were classified as “distrustful of vaccines in general,” 729.2 (36.1%) were “selectively hesitant,” and 852.4 (42.2%) were “nonhesitant.” In our model, the level of health literacy was not statistically different between the “distrustful of vaccines in general” and the “selectively hesitant” (P=.48), but it was associated with being a “nonhesitant” (adjusted odds ratio [aOR] 1.86, 95% CI 1.25-2.76). The confidence in the health care system was a strong predictor for a “nonhesitant” attitude toward vaccines (aOR 12.4, 95% CI 7.97-19.2). We found a positive correlation of 0.34 (P<.001) between health literacy and confidence in the health care system, but the interaction term between health literacy and health care system confidence was not significant in our model.

CONCLUSIONS: Health literacy was associated with a “nonhesitant” attitude toward vaccines. The findings demonstrated that health literacy and confidence in the health care system are modestly correlated. Therefore, to tackle the subject of vaccine hesitancy, the main focus should be on increasing the population’s confidence and on increasing their health literacy levels or providing vaccine information addressing the needs of less literate citizens.

PMID:38713494 | DOI:10.2196/45837

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Focused Ultrasound as a Novel Non-Invasive Method for the Delivery of Gold Nanoparticles to Retinal Ganglion Cells

Transl Vis Sci Technol. 2024 May 1;13(5):5. doi: 10.1167/tvst.13.5.5.

ABSTRACT

PURPOSE: The blood-retinal barrier (BRB) restricts the delivery of intravenous therapeutics to the retina, necessitating innovative approaches for treating retinal disorders. This study sought to explore the potential of focused ultrasound (FUS) to non-invasively deliver intravenously administered gold nanoparticles (AuNPs) across the BRB. FUS-BRB modulation can offer a novel method for targeted retinal therapy.

METHODS: AuNPs of different sizes and shapes were characterized, and FUS parameters were optimized to permeate the BRB without causing retinal damage in a rodent model. The delivery of 70-kDa dextran and AuNPs to the retinal ganglion cell (RGC) layer was visualized using confocal and two-photon microscopy, respectively. Histological and statistical analyses were conducted to assess the effectiveness and safety of the procedure.

RESULTS: FUS-BRB modulation resulted in the delivery of dextran and AuNPs to the RGC and inner nuclear layer. Smaller AuNPs reached the retinal layers to a greater extent than larger ones. The delivery of dextran and AuNPs across the BRB with FUS was achieved without significant retinal damage.

CONCLUSIONS: This investigation provides the first evidence, to our knowledge, of FUS-mediated AuNP delivery across the BRB, establishing a foundation for a targeted and non-invasive approach to retinal treatment. The results contribute to developing promising non-invasive therapeutic strategies in ophthalmology to treat retinal diseases.

TRANSLATIONAL RELEVANCE: Modifying the BRB with ultrasound offers a targeted and non-invasive delivery strategy of intravenous therapeutics to the retina.

PMID:38713474 | DOI:10.1167/tvst.13.5.5

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Social Determinants of Health and the Availability of Cancer Clinical Trials in the United States

JAMA Netw Open. 2024 May 1;7(5):e2410162. doi: 10.1001/jamanetworkopen.2024.10162.

NO ABSTRACT

PMID:38713468 | DOI:10.1001/jamanetworkopen.2024.10162

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Use of a Large Language Model to Assess Clinical Acuity of Adults in the Emergency Department

JAMA Netw Open. 2024 May 1;7(5):e248895. doi: 10.1001/jamanetworkopen.2024.8895.

ABSTRACT

IMPORTANCE: The introduction of large language models (LLMs), such as Generative Pre-trained Transformer 4 (GPT-4; OpenAI), has generated significant interest in health care, yet studies evaluating their performance in a clinical setting are lacking. Determination of clinical acuity, a measure of a patient’s illness severity and level of required medical attention, is one of the foundational elements of medical reasoning in emergency medicine.

OBJECTIVE: To determine whether an LLM can accurately assess clinical acuity in the emergency department (ED).

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study identified all adult ED visits from January 1, 2012, to January 17, 2023, at the University of California, San Francisco, with a documented Emergency Severity Index (ESI) acuity level (immediate, emergent, urgent, less urgent, or nonurgent) and with a corresponding ED physician note. A sample of 10 000 pairs of ED visits with nonequivalent ESI scores, balanced for each of the 10 possible pairs of 5 ESI scores, was selected at random.

EXPOSURE: The potential of the LLM to classify acuity levels of patients in the ED based on the ESI across 10 000 patient pairs. Using deidentified clinical text, the LLM was queried to identify the patient with a higher-acuity presentation within each pair based on the patients’ clinical history. An earlier LLM was queried to allow comparison with this model.

MAIN OUTCOMES AND MEASURES: Accuracy score was calculated to evaluate the performance of both LLMs across the 10 000-pair sample. A 500-pair subsample was manually classified by a physician reviewer to compare performance between the LLMs and human classification.

RESULTS: From a total of 251 401 adult ED visits, a balanced sample of 10 000 patient pairs was created wherein each pair comprised patients with disparate ESI acuity scores. Across this sample, the LLM correctly inferred the patient with higher acuity for 8940 of 10 000 pairs (accuracy, 0.89 [95% CI, 0.89-0.90]). Performance of the comparator LLM (accuracy, 0.84 [95% CI, 0.83-0.84]) was below that of its successor. Among the 500-pair subsample that was also manually classified, LLM performance (accuracy, 0.88 [95% CI, 0.86-0.91]) was comparable with that of the physician reviewer (accuracy, 0.86 [95% CI, 0.83-0.89]).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of 10 000 pairs of ED visits, the LLM accurately identified the patient with higher acuity when given pairs of presenting histories extracted from patients’ first ED documentation. These findings suggest that the integration of an LLM into ED workflows could enhance triage processes while maintaining triage quality and warrants further investigation.

PMID:38713466 | DOI:10.1001/jamanetworkopen.2024.8895

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Periprosthetic Joint Infection in Patients With Arthroplasty Undergoing Perioperative Colonoscopy

JAMA Netw Open. 2024 May 1;7(5):e2410123. doi: 10.1001/jamanetworkopen.2024.10123.

ABSTRACT

IMPORTANCE: Periprosthetic joint infection (PJI) is a rare but devastating complication. Most patients undergoing total joint arthroplasty (TJA) also need routine screening colonoscopy, in which transient bacteremia may be a potential source for hematogenous PJI. Patients and surgeons must decide on an optimal time span or sequence for these 2 generally elective procedures, but no such guidelines currently exist.

OBJECTIVE: To evaluate associations of colonoscopy with the risk of post-TJA PJI for the development of clinical practice recommendations for colonoscopy screening in patients undergoing TJA.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study of Military Health System (MHS) beneficiaries older than 45 years who underwent TJA from January 1, 2010, to December 31, 2016, used propensity score matching and logistic regression to evaluate associations of colonoscopy with PJI risk. Statistical analyses were conducted between January and October 2023.

EXPOSURE: Colonoscopy status was defined by Current Procedural Terminology code for diagnostic colonoscopy within 6 months before or 6 months after TJA.

MAIN OUTCOMES AND MEASURES: Periprosthetic joint infection status was defined by a PJI International Classification of Diseases code within 1 year after TJA and within 1 year from the post-TJA index colonoscopy date.

RESULTS: Analyses included 243 671 patients (mean [SD] age, 70.4 [10.0] years; 144 083 [59.1%] female) who underwent TJA in the MHS from 2010 to 2016. In the preoperative colonoscopy cohort, 325 patients (2.8%) had PJI within 1 year postoperatively. In the postoperative colonoscopy cohort, 138 patients (1.8%) had PJI within 1 year from the index colonoscopy date. In separate analyses of colonoscopy status within 6 months before and 6 months after TJA, younger age, male sex, and several chronic health conditions (diabetes, kidney disease, and pulmonary disease) were each associated with higher PJI risk. However, no association was found with PJI risk for perioperative colonoscopy preoperatively (adjusted odds ratio, 1.10; 95% CI, 0.98-1.23) or postoperatively (adjusted odds ratio, 0.90; 95% CI, 0.74-1.08).

CONCLUSIONS AND RELEVANCE: In this large retrospective cohort of patients undergoing TJA, perioperative screening colonoscopy was not associated with PJI and should not be delayed for periprocedural risk. However, health conditions were independently associated with PJI and should be medically optimized.

PMID:38713465 | DOI:10.1001/jamanetworkopen.2024.10123