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Nevin Manimala Statistics

Favorable Early Patient-Reported Outcome Measures and Clinical Retear Rates in High-Risk Rotator Cuff Repairs Augmented with a Reinforced Bio-Inductive Implant at One-Year Follow Up

Surg Technol Int. 2024 Oct 16;45:sti45/1719. Online ahead of print.

ABSTRACT

INTRODUCTION: The purpose of this article is to examine the risk of early clinical rotator cuff repair failures in high-risk patients who were augmented with a reinforced bio-inductive implant (RBI).

MATERIALS AND METHODS: A retrospective chart review was performed identifying full-thickness rotator cuff repairs (RCR) augmented with an RBI. Inclusion criteria for “high risk of retear” were: large (>3cm) and massive (>5cm, >/= 2 tendons) tears, anterior to posterior (AP) tear >2.5cm, infraspinatus fatty atrophy (Goutalier >/= 2), recurrent tears, and at least one comorbidity (diabetes, hypertension, active smoker). ROM, VAS, and ASES scores were collected at preoperative, three-month, six-month, and 12-month visits. Clinical failures were defined as complete retear based upon imaging, repeat rotator cuff surgery, VAS score >5 at one-year postoperative, and ASES MCID <27-point improvement.

RESULTS: Forty-nine patients were found to have undergone RCR with an RBI augmentation. Mean follow up was 26.1 months. Clinical healing rate was 94% (46/49). The need for surgical intervention post RCR was 8.2% (4/49). The complication rate was 14.3% (7/49). VAS scores at three, six, and 12 months compared to preop revealed statistically significant decreases at all timepoints (D-3.9, D-4.6, D-5.2, respectively, p<0.001). ASES scores at three, six, and 12 months compared to pre-surgical scores met the MCID and were found to have statistically significant improvements at all timepoints (D30.7, D40.8, D49.8, respectively, p<0.001). Shoulder ROM (forward flexion/abduction) at three, six, and 12 months compared to preop was found to be statistically significant at all timepoints (p<0.01).

CONCLUSION: The addition of an RBI to RCR in patients at high risk of failure demonstrated favorable outcomes in terms of range of motion, pain, and functional outcome scores with a low rate of clinical retear at a minimum of one-year follow up.

CLINICAL RELEVANCE: Many risk factors have been attributed to high retear rates and poor clinical outcomes in patients undergoing RCR. Numerous variations to RCR have been explored to aid in outcomes and decrease failures. This manuscript is the first to examine the use of an RBI as an RCR augment. The implant’s bio-inductive properties and strength profile demonstrate promising benefits at early timepoints in this study, indicating that it can improve patient-reported outcomes while decreasing clinical failures in patients at high risk of retear.

PMID:39413362

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Nevin Manimala Statistics

Suicide Mortality Among Nurses in the United States: Incidence, Factors Associated with Suicide, Circumstances Preceding Suicide, and Methods of Suicide

Issues Ment Health Nurs. 2024 Oct 16:1-10. doi: 10.1080/01612840.2024.2405844. Online ahead of print.

ABSTRACT

The aim of this review was to identify and integrate evidence on suicide mortality among U.S. nurses. To the best of our knowledge, this represents the first review to focus exclusively on suicide among U.S. nurses. Electronic medical databases, reference lists, and supplementary files were searched to identify studies that examined suicide mortality among U.S. nurses. In total, n = 28 studies were included: n = 14 were cohort, n = 10 were epidemiological, and n = 4 utilized mixed methods. Many studies had unique aims, included different nurse groups and referent populations, and utilized a variety of statistical procedures. However, when taken together, four categories were assessed across these n = 28 cumulative studies: incidence of suicide, factors associated with suicide, circumstances preceding suicide, and methods of suicide among U.S. nurses. Taken together, continued surveillance of suicide incidence among U.S. nurses is important, as evidence largely suggests nurses experience elevated suicide incidence when compared to select referent groups. Additional research on factors associated with suicide and circumstances preceding suicide are also needed, particularly among male nurses. Finally, additional research regarding the leading method of suicide, leading substance implicated in self-poisoning, and sex-differentiated suicide methods are also important. Collectively, these data are needed to inform intervention and surveillance strategies.

PMID:39413353 | DOI:10.1080/01612840.2024.2405844

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Nevin Manimala Statistics

Multivariate Bayesian Analyses in Nursing Research: An Introductory Guide

Biol Res Nurs. 2024 Oct 16:10998004241292644. doi: 10.1177/10998004241292644. Online ahead of print.

ABSTRACT

In the era of precision health, nursing research has increasingly focused on the analysis of large, multidimensional data sets containing multiple correlated phenotypes (e.g., symptoms). This presents challenges for statistical analyses, especially in genetic association studies. For example, the inclusion of multiple symptoms within a single model can raise concerns about multicollinearity, while individual SNP-symptom analyses may obscure complex relationships. As such, many traditional statistical approaches often fall short in providing a comprehensive understanding of the complexity inherent in many nursing-focused research questions. Multivariate Bayesian approaches offer the unique advantage of allowing researchers to ask questions that are not feasible with traditional approaches. Specifically, these methods support the simultaneous exploration of multiple phenotypes, accounting for the underlying correlational structure between variables, and allow for formal incorporation of existing knowledge into the statistical model. By doing so, they may provide a more realistic view of statistical relationships within a biological system, potentially uncovering new insights into well-established and undiscovered connections, such as the probabilities of association and direct versus indirect effects. This valuable information can help us better understand our phenotypes of interest, leading to more effective nurse-led intervention and prevention programs. To illustrate these concepts, this paper includes an application section covering two specific multivariate Bayesian analysis software programs, bnlearn and mvBIMBAM, with an emphasis on interpretation and extension to nursing research. To complement the paper, we provide access to a detailed online tutorial, including executable R code and a synthetic data set, so the concepts can be more easily extended to other research questions.

PMID:39413351 | DOI:10.1177/10998004241292644

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Nevin Manimala Statistics

Analysis of Opioid Prescribing Trends Following Thyroidectomy and Parathyroidectomy Before and After the 2021 American Academy of Otolaryngology-Head and Neck Surgery Opioid Prescribing Clinical Practice Guidelines

Otolaryngol Head Neck Surg. 2024 Oct 16. doi: 10.1002/ohn.1008. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the trends in opioid and nonopioid prescribing for thyroidectomy and parathyroidectomy before and after the publication of guidelines by the American Academy of Otolaryngology-Head and Neck Surgery in April 2021.

STUDY DESIGN: Retrospective.

SETTING: Eighty-three health care organizations in the United States that contribute to the TriNetX database.

METHODS: Deidentified patient data were retrieved from the TriNetX. Patients who were prescribed either opioids or nonopioid analgesic within 1 to 5 days following thyroid surgery and parathyroidectomy were included. Evaluation of the prescription trends was performed by interrupted time series analysis in Statistical Analysis System 9.4 with significance set at P < .05 to assess trends before and after the new opioid prescription guidelines.

RESULTS: For thyroid surgery, there was an immediate effect of the guideline change indicated by a 3.3% decrease in the opioid prescription trend (P = .03) and a significant increase in nonopioid use of overtime by 0.13% every 3 months (P < .0001). The opioid prescription trend following parathyroidectomy significantly decreased over time by 0.28% every 3 months (P < .0001), while the nonopioid prescription trend increased by 0.14% (P < .0001).

CONCLUSION: There was an associated immediate reduction in the opioid prescribing trend for thyroidectomy, but the change was not sustained overtime. There was an associated decrease in the opioid prescribing trend for parathyroidectomy, but not immediately after the initial publication of the prescription guidelines.

LEVEL OF EVIDENCE: Level III.

PMID:39413345 | DOI:10.1002/ohn.1008

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Nevin Manimala Statistics

Tenecteplase vs Alteplase in Acute Ischemic Stroke Within 4.5 Hours: A Systematic Review and Meta-Analysis of Randomized Trials

Neurology. 2024 Nov 12;103(9):e209903. doi: 10.1212/WNL.0000000000209903. Epub 2024 Oct 16.

ABSTRACT

BACKGROUND AND OBJECTIVES: The current European Stroke Organisation expedited recommendation on tenecteplase (TNK) for acute ischemic stroke (AIS) advocates that TNK 0.25 mg/kg can be used alternatively to alteplase (tissue plasminogen activator [TPA]) for AIS of <4.5 hours duration, based on a meta-analytical approach establishing noninferiority. Since the publication of these guidelines, 4 additional randomized controlled clinical trials (RCTs) have provided further insight.

METHODS: We conducted an updated systematic review and meta-analysis including all available RCTs that investigated efficacy and safety of TNK 0.25 mg/kg compared with TPA for the treatment of AIS within 4.5 hours of onset. The primary outcome was defined as the excellent functional outcome at 3 months (modified Rankin Scale [mRS] score 0-1), whereas good functional outcome (mRS score 0-2), reduced disability at 3 months (≥1-point reduction across all mRS scores), symptomatic intracranial hemorrhage (sICH), and 3-month mortality were evaluated as secondary outcomes. Pooled estimates were calculated with random-effects model. A prespecified subgroup analysis was performed stratifying for TNK formulation, that is, original TNK vs biocopy: recombinant human TNK tissue-type plasminogen activator that is available in China and has a different production process.

RESULTS: Eleven RCTs were included comprising a total of 3,788 patients treated with TNK vs 3,757 patients treated with TPA. TNK was associated with higher likelihood of excellent functional outcome (risk ratio [RR] 1.05, 95% CI 1.01-1.10; p = 0.012; I2 = 0%; risk difference 2.95%; 95% CI 0.76%-5.14%; p = 0.008; I2 = 0%) and reduced disability at 3 months (common odds ratio 1.10, 95% CI 1.01-1.19; p = 0.034; I2 = 0%) compared with TPA while good functional outcome (RR 1.03, 95% CI 0.99-1.07; p = 0.142; I2 = 28%) was similar between the groups. Regarding safety outcomes, similar rates of sICH (RR 1.12, 95% CI 0.83-1.53; p = 0.456; I2 = 0%) and 3-month mortality (RR 0.97, 95% CI 0.82-1.15; p = 0.727; I2 = 12%) were observed. When stratified for TNK regimen (original vs biocopy), statistical significance in achieving an excellent functional outcome at 3 months was retained for the original TNK (RR 1.05, 95% CI 1.00-1.10; p = 0.044; I2 = 0%).

DISCUSSION: The updated meta-analysis confirms similar safety between TNK 0.25 mg/kg and TPA, while showing that TNK is superior to TPA regarding excellent functional outcome and reduced disability at 3 months. These findings support transitioning to TNK in clinical practice.

PMID:39413337 | DOI:10.1212/WNL.0000000000209903

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Nevin Manimala Statistics

Effects of Social Determinants of Health on Acute Stroke Care Among Patients With Acute Ischemic Stroke: A Retrospective Cohort Study

Neurology. 2024 Nov 12;103(9):e209951. doi: 10.1212/WNL.0000000000209951. Epub 2024 Oct 16.

ABSTRACT

BACKGROUND AND OBJECTIVES: Social determinants of health (SDOH) are important contributors to poor stroke-related outcomes. While some have suggested that this association is driven by the increased incidence of stroke observed with poor SDOH, others have raised concerns regarding disparities in acute stroke care. This study aimed to determine the association between SDOH and the administration of thrombolytic therapy and mechanical thrombectomy among patients with acute ischemic stroke.

METHODS: A retrospective cohort analysis was conducted using Texas Emergency Department Public Use Data (2016-2019), including adult patients diagnosed with acute ischemic stroke. The risk ratios (RRs) of administering thrombolysis and thrombectomy based on variables representing SDOH and a collective measure (Social Vulnerability Index [SVI]) were computed using mixed-effects Poisson regression models accounting for the nested nature of patients in hospitals and neighborhoods. The Charlson comorbidity score was considered as a covariate.

RESULTS: Of the 139,852 patients with ischemic stroke (female, 51.7%; White, 67.2%; Black, 16.6%; Hispanic, 25.1%), 16,831 (12.3%) received thrombolytic therapy and 5,951 (4.3%) received mechanical thrombectomy. Age older than 65 years (RR 0.578 [0.537-0.621]) vs 18-45 years, Black (RR 0.801 [0.761-0.844]) vs White, Hispanic (RR 0.936 [0.895-0.98]) vs non-Hispanic, Medicare/Medicaid/Veterans Affairs (VA) (RR 0.917 [0.882-0.954]) or uninsured (RR 0.883 [0.833-0.935]) vs private insurance, and rural (RR 0.782 [0.723-0.845]) vs urban dwelling were less likely to be associated with thrombolysis. Patients in the highest quintile based on the SVI were less likely to receive thrombolysis than those in the lowest quintile (RR 0.926 [0.867-0.989]). Patients were less likely to receive thrombectomy if they were 65 years and older (RR 0.787 [0.691-0.895]), belonged to the Black race (RR 0.745 [0.679-0.818]) or Hispanic ethnicity (RR 0.919 [0.851-0.992]), had Medicare/Medicaid/VA insurance (RR 0.909 [0.851-0.971]), or were from a rural area (RR 0.909 [0.851-0.971]). Similarly, SVI decreased the likelihood of undergoing mechanical thrombectomy (RR 0.842 [0.747-0.95]).

DISCUSSION: Despite many improvements in stroke management, SDOH continue to be a significant driver of treatment access for acute ischemic stroke. While our findings are limited to Texas, our results should raise awareness and promote more studies regarding the effects of these SDOH at the national and international levels.

PMID:39413335 | DOI:10.1212/WNL.0000000000209951

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Nevin Manimala Statistics

Dosimetry in MRgPT: Impact of magnetic fields on TLD dose response during proton irradiation

Med Phys. 2024 Oct 16. doi: 10.1002/mp.17454. Online ahead of print.

ABSTRACT

BACKGROUND: Proton beam therapy, when integrated with MRI guidance, presents complex dosimetric challenges due to interactions with magnetic fields. Prior research has emphasized the nuanced impact of magnetic fields on dosimetry. For thermoluminescent dosimeters (TLDs) the electron-return effect, alongside small air cavities surrounding the pellets, can lead to nonuniform dose distributions. Future MR-guided proton therapy will require reliable methods for end-to-end tests and dosimetric audits, which so far are often performed using TLDs equipped with phantoms. This implicates the necessity of accounting for these interactions.

PURPOSE: This study investigates the influence of magnetic fields on TLDs at two proton energies, using magnetic field strengths of 0, 0.25, and 1 T $1 ,mathrm{T}$ , aiming to clarify their impact on dose measurement accuracy.

METHODS: The study was conducted at a synchrotron-based ion beam therapy beam line, enhanced by a resistive dipole magnet for creating magnetic fields up to 1 T $1 ,mathrm{T}$ to simulate MR-guided proton therapy. Individual correction factors were applied for TLD measurements. The impact of air gaps on the TLD signal was evaluated using three dedicated TLD holders with air gaps of 0.1, 0.25, and 0.5 mm surrounding the TLD pellets using the highest available proton energy of 252.7 M e V $252.7 ,mathrm{M}mathrm{emathrm{V}}$ . Additionally, the influence of the magnetic field strength on the TLD response was evaluated for two proton energies of 97.4 M e V $97.4 ,mathrm{M}mathrm{emathrm{V}}$ and 252.7 M e V $252.7 ,mathrm{M}mathrm{emathrm{V}}$ .

RESULTS: The study found no statistically significant variation in TLD dose response attributable to changes in the air gap or the presence of magnetic fields. A power analysis indicated an upper limit on a potential change in dose-response as small as 1.5%.

CONCLUSIONS: The findings suggested that the impact of air gap variations and magnetic field strengths on the TLD response was below the detection threshold of TLD sensitivity. This emphasizes the suitability of TLDs for dose measurement in MR-guided proton therapy, indicating that additional correction factors may not be necessary despite the influence of magnetic fields.

PMID:39413314 | DOI:10.1002/mp.17454

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Nevin Manimala Statistics

Social Determinants in COVID-19 Experiences of Children With Disabilities Receiving School-Based Services in Chicago: Mixed-Methods Study of Parent/Guardian Perspectives

J Dev Behav Pediatr. 2024 Sep-Oct 01;45(5):e483-e491. doi: 10.1097/DBP.0000000000001294. Epub 2024 Jun 21.

ABSTRACT

OBJECTIVE: To identify the impact of social determinants on the experiences of children with disabilities and their families during the COVID-19 pandemic from the perspective of parents/guardians.

METHODS: A mixed-methods study engaged parents/guardians of children with Individualized Education Programs (IEPs) in July to August 2021 at a developmental/behavioral pediatrics clinic in 1 urban academic medical center. All parents/guardians completed study-specific surveys on experiences and impact of COVID-19. A subset completed semi-structured interviews. Analysis included descriptive statistics and Fisher exact tests for survey questions and thematic analysis to code interviews and identify themes. Results were corroborated by experts in developmental/behavioral pediatrics and special education.

RESULTS: Participants included 24 parents/guardians representing 27 children (mean = 7.37 years). A majority attended public school (78%) and identified as non-White (78%). Most commonly, the children’s disabilities were autism (52%), attention-deficit hyperactivity disorder (37%), and speech/language impairment (33%). The services received by children most commonly were speech/language (89%) and physical/occupational (70%) therapies. Five themes emerged about the impact of social determinants on experiences during COVID-19 related to: adapting to disruption of routines, attendance/engagement in learning, interruption of IEP services, support for children and families, and challenges with technology.

CONCLUSION: Social determinants, such as housing, income, insurance, and quality of education, affected the experiences of families and their ability to adapt to the needs of children with disabilities in the setting of COVID-19 pandemic-related changes.

PMID:39413306 | DOI:10.1097/DBP.0000000000001294

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A Comparison of Parent-Reported Severe Autism With Mild/Moderate Autism Among US Children

J Dev Behav Pediatr. 2024 Sep-Oct 01;45(5):e422-e430. doi: 10.1097/DBP.0000000000001306. Epub 2024 Aug 13.

ABSTRACT

OBJECTIVE: An expert commission has proposed the term “profound” autism for children on the spectrum who are minimally verbal or nonverbal and have intellectual disability (ID), behavioral challenges, and co-occurring conditions. It is unknown whether parents’ rating of “severe” autism aligns with the definition of “profound” autism. Using the National Survey of Children’s Health, we sought to (1) estimate the prevalence of parent-reported severe autism, (2) identify child characteristics that are associated with severe autism, (3) compare health care utilization, and (4) compare caregiver stress and resilience between families of children with severe versus mild/moderate autism.

METHODS: Parent responses on the 2018 to 2019 NSCH were used to compare school-age children with parent-reported severe autism and those with mild/moderate autism. Descriptive statistics, χ 2 tests, and logistic regression were used for statistical analysis.

RESULTS: Among parents of 1,368 US children with autism, 10.1% characterized their child’s autism as severe, a prevalence of 1 in 333. Parents of children with severe autism were more likely to report ID (45% vs 12.1%, p < 0.001), language delay (88% vs 58.7%, p < 0.001), and difficulties in dressing and bathing (67% vs 19.2%, p < 0.001). Children with severe autism had more behavioral problems and co-occurring conditions but were no more likely to see specialists or receive autism-specific behavioral therapy. Their caregivers reported more stress and less resilience.

CONCLUSION: The characteristics of “profound” autism and parent-reported “severe” autism significantly overlap, allowing the use of the NSCH for studies of this vulnerable population. Children with profound/severe autism could benefit from more behavioral therapy, specialty care, and family support.

PMID:39413304 | DOI:10.1097/DBP.0000000000001306

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Hardware Removal After Lisfranc ORIF Results in Improved Physical Function

J Orthop Trauma. 2024 Oct 15. doi: 10.1097/BOT.0000000000002927. Online ahead of print.

ABSTRACT

OBJECTIVES: The purpose of this study was to investigate whether HWR after Lisfranc ORIF resulted in significant impact via PROMIS physical function (PF) and pain intensity (PI) scores.

METHODS: Design: Retrospective cohort.

SETTING: Level-1 trauma center.

PATIENT SELECTION CRITERIA: Adult patients with isolated Lisfranc injuries who were treated via ORIF between 2002-2023 that had PROMIS PF and PI scores through 6 months follow-up were included. Patients were excluded if they received index treatment other than ORIF or underwent secondary surgical intervention prior to HWR. A sub analysis was performed at 1 year follow- up.

OUTCOME MEASURES AND COMPARISONS: Primary outcomes were PROMIS PF and PI scores. The Wilcoxon signed-rank test compared differences between PROMIS scores within the HWR group. The Wilcoxon ranked-sum test compared differences between HWR vs no HWR. Distributive MCID was calculated using the 0.5 SD method.

RESULTS: There were 482 patients (489 feet) identified with isolated Lisfranc injuries. Seventy-seven feet underwent ORIF followed by HWR. Thirty feet underwent ORIF without HWR. The average age of the no HWR group was 45.8 (18.0-81.3) versus the HWR group which was 38.7 (18.3-74.1) (p=0.053). Nineteen (63.3%) were female in the no HWR group compared to 33 (42.9%) in the HWR group (p=0.084). HWR occurred an average of 4.43 months after ORIF. Patients who underwent HWR had a statistically significant increase in average PF scores (39.7 to 45.9, p<0.001) at their standard 6 week (1.5 month) postoperative visit. HWR patients had a non-significant decrease in average PI scores (56.5 to 53.9, p=0.24). Compared to those with retained hardware, the HWR group demonstrated a statistically significant net improvement in PF and PI scores from surgery, with an average improvement of 5.6 and 1.7, respectively (P=0.002, 0.008).

CONCLUSIONS: Patients experienced significant improvement in PROMIS PF scores for Lisfranc ORIF at 6 weeks after HWR. Compared to patients with retained hardware, they also experienced significant improvement in PROMIS PF and PI scores.

LEVEL OF EVIDENCE: III.

PMID:39413293 | DOI:10.1097/BOT.0000000000002927