Tag: statistics

Ann Vasc Surg. 2024 May 28:S0890-5096(24)00248-6. doi: 10.1016/j.avsg.2024.03.029. Online ahead of print.

ABSTRACT

OBJECTIVES: In 2019, Bard Peripheral Vascular Inc (BV; now Becton, Dickinson and Company; Sparks, Maryland) received FDA approval to begin marketing the The WavelinQ™ EndoAVF System through a process known as 510(k) authorization. Such authorization relies on BV proving that the new WavelinQ™ EndoAVF System was of “substantial equivalence” to the WavelinQ™ 4F EndoAVF System. We set forth to analyze patient problems and device issues reported for the new device and determine if they were significantly different from the predicate device its 510(k) approval was based on.

METHODS: FDA database Manufacturer and User Facility Device Experience (MAUDE) was queried for all adverse report events for the WavelinQ™ EndoAVF System and WavelinQ™ 4F EndoAVF System. Data was collected on patient issues and device issues. Fisher’s Exact test was utilized.

RESULTS: There was a total of 125 reports for the WavelinQ™ 4F EndoAVF System and 78 for the WavelinQ™ EndoAVF System. There was a significant increase in patient problem “hypertension” (0% vs. 5.1%; p=0.02) for the WavelinQ™ EndoAVF System but a statistically significant decrease in device issue “failure to align” for the WavelinQ™ EndoAVF System (24.8% vs. 10.3%; p=<0.01).

CONCLUSION: There were changes in device and patient outcomes between the WavelinQ™ EndoAVF System and WavelinQ™ 4F EndoAVF System. While we noted a decrease in device problem “failure to align”, there was an overall increase in patients’ “hypertension” rates. This highlights the importance of the FDA MAUDE reporting in ensuring that device safety is maintained when devices are approved for marketing through the 510(k) process.

PMID:38815918 | DOI:10.1016/j.avsg.2024.03.029

Ann Vasc Surg. 2024 May 28:S0890-5096(24)00233-4. doi: 10.1016/j.avsg.2024.04.002. Online ahead of print.

ABSTRACT

OBJECTIVES: The frequency of distal lower extremity bypass (LEB) for infra-popliteal critical limb threatening ischemia (IP-CLTI) has significantly decreased. Our goal was to analyze the contemporary outcomes and factors associated with failure of LEB to para-malleolar and pedal targets.

METHODS: We queried the VQI infra-inguinal database from 2003-2021 to identify LEB to para-malleolar or pedal/plantar targets. Primary outcomes were graft patency, major adverse limb events [vascular re-intervention, above ankle amputation] (MALE), and amputation-free survival at 2 years. Standard statistical methods were utilized.

RESULTS: We identified 2331 LEB procedures (1265 anterior tibial at ankle/dorsalis pedis, 783 posterior tibial at ankle, 283 tarsal/plantar). The prevalence of LEB bypasses to distal targets has significantly decreased from 13.37% of all LEB procedures in 2003 to 3.51% in 2021 (p<0.001). The majority of cases presented with tissue loss (81.25. Common post-operative complications included major adverse cardiac events (8.9%) and surgical site infections (3.6%). Major amputations occurred in 16.8% of patients at 1 year. Post-operative mortality at 1 year was 10%. On unadjusted Kaplan-Meier survival analysis at 2 years, primary patency was 50.56%±3.6%, MALE was 63.49%±3.27%, and amputation-free survival was 71.71%±0.98%. In adjusted analyses [adjusted for comorbidities, indication, conduit type, urgency, prior vascular interventions, graft inflow vessel (femoral/popliteal), concomitant inflow procedures, surgeon and center volume] conduits other than GSV (p<0.001) were associated with loss of primary patency and increased MALE. High center volume (>5 procedures/year) was associated with improved primary patency (p=0.015), and lower MALE (p=0.021) at 2 years.

CONCLUSIONS: Despite decreased utilization, open surgical bypass to distal targets at the ankle remains a viable option for treatment of IP-CLTI with acceptable patency and amputation-free survival rates at 2 years. Bypasses to distal targets should be performed at high volume centers to optimize graft patency and limb salvage and minimize re-interventions.

PMID:38815913 | DOI:10.1016/j.avsg.2024.04.002

J Pediatr Ophthalmol Strabismus. 2024 May 30:1-6. doi: 10.3928/01913913-20240409-02. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the effect of botulinum toxin A injection on the frequency of horizontal nystagmus in children.

METHODS: This was a non-randomized before-and-after clinical trial evaluating a cohort of children with horizontal nystagmus before and after treatment with botulinum toxin A. The toxin was injected under general anesthesia with spontaneous ventilation without intubation using the Mendonça forceps and the effect was evaluated by analyzing the frequency of the oscillation in Hertz (Hz) on video registrations before and after treatment.

RESULTS: The current study found a statistically significant difference on the frequency of the nystagmus in children before and after the injection of botulinum toxin A, with the mean frequency decreasing from 1.55 ± 0.94 Hz before treatment to 1.04 ± 0.87 Hz at 1 month post-injection (P < .001) and to 1.27 ± 0.87 Hz at 6 months post-injection (P = .002). When comparing the data 1 and 6 months post-injection, this study found a significant increase (P = .001) in the frequency of the nystagmus.

CONCLUSIONS: The injection of botulinum toxin A is effective in reducing the frequency of oscillations in children with horizontal nystagmus both 1 and 6 months after the procedure, and can be used as a first-line, less invasive treatment aiming to decrease the frequency of oscillation. [J Pediatr Ophthalmol Strabismus. 20XX;X(X):XXX-XXX.].

PMID:38815100 | DOI:10.3928/01913913-20240409-02

JMIR Cancer. 2024 May 30;10:e52156. doi: 10.2196/52156.

ABSTRACT

BACKGROUND: WeChat (Tencent) is one of the most important information sources for Chinese people. Relevantly, various health-related data are constantly transmitted among WeChat users. WeChat public accounts (WPAs) for health are rapidly emerging. Health-related WeChat public accounts have a significant impact on public health. Because of the rise in web-based health-seeking behavior, the general public has grown accustomed to obtaining cancer information from WPAs. Although WPAs make it easy for people to obtain health information, the quality of the information is questionable.

OBJECTIVE: This study aims to assess the quality and suitability of cancer-related WeChat public accounts (CWPAs).

METHODS: The survey was conducted from February 1 to 28, 2023. Based on the WPA monthly list provided by Qingbo Big Data, 28 CWPAs in the WeChat communication index were selected as the survey sample. Quality assessment of the included CWPAs was performed using the HONcode instrument. Furthermore, suitability was measured by using the Suitability Assessment of Materials. A total of 2 researchers conducted the evaluations independently.

RESULTS: Of the 28 CWPAs, 12 (43%) were academic and 16 (57%) were commercial. No statistical difference was found regarding the HONcode scores between the 2 groups (P=.96). The quality of the academic and commercial CWPAs evaluated using the HONcode instrument demonstrated mean scores of 5.58 (SD 2.02) and 5.63 (SD 2.16), respectively, corresponding to a moderate class. All CWPAs’ compliance with the HONcode principles was unsatisfactory. A statistically significant difference between the 2 groups was observed in the Suitability Assessment of Materials scores (P=.04). The commercial WPAs reached an overall 55.1% (SD 5.5%) score versus the 50.2% (SD 6.4%) score reached by academic WPAs. The suitability of academic and commercial CWPAs was considered adequate.

CONCLUSIONS: This study revealed that CWPAs are not sufficiently credible. WPA owners must endeavor to create reliable health websites using approved tools such as the HONcode criteria. However, it is necessary to educate the public about the evaluation tools of health websites to assess their credibility before using the provided content. In addition, improving readability will allow the public to read and understand the content.

PMID:38814688 | DOI:10.2196/52156

Chaos. 2024 May 1;34(5):053143. doi: 10.1063/5.0207411.

ABSTRACT

This study establishes a reaction-diffusion system to capture the dynamics of rumor propagation, considering two possibilities of contact transmission. The sufficient and necessary conditions for a positive equilibrium point are provided, and the Turing instability conditions for this equilibrium point are derived. Furthermore, utilizing variational inequalities, a first-order necessary condition for parameter identification based on optimal control is established. During the numerical simulation process, the correctness of the Turing instability conditions is verified, and optimal control-based parameter identification is applied to the target pattern. Additionally, statistical methods are employed for pattern parameter identification. The identification results demonstrate that optimal control-based parameter identification exhibits higher efficiency and accuracy. Finally, both theories’ parameter identification principles are extended to a small-world network, yielding consistent conclusions with continuous space.

PMID:38814676 | DOI:10.1063/5.0207411

Chaos. 2024 May 1;34(5):053142. doi: 10.1063/5.0202872.

ABSTRACT

The Koper model is a prototype system with two slow variables and one fast variable that possesses small-amplitude oscillations (SAOs), large-amplitude oscillations (LAOs), and mixed-mode oscillations (MMOs). In this article, we study a pair of identical Koper oscillators that are symmetrically coupled. Strong symmetry breaking rhythms are presented of the types SAO-LAO, SAO-MMO, LAO-MMO, and MMO-MMO, in which the oscillators simultaneously exhibit rhythms of different types. We identify the key folded nodes that serve as the primary mechanisms responsible for the strong nature of the symmetry breaking. The maximal canards of these folded nodes guide the orbits through the neighborhoods of these key points. For all of the strong symmetry breaking rhythms we present, the rhythms exhibited by the two oscillators are separated by maximal canards in the phase space of the oscillator.

PMID:38814674 | DOI:10.1063/5.0202872

JAMA Netw Open. 2024 May 1;7(5):e2413874. doi: 10.1001/jamanetworkopen.2024.13874.

NO ABSTRACT

PMID:38814646 | DOI:10.1001/jamanetworkopen.2024.13874

JAMA Netw Open. 2024 May 1;7(5):e2413869. doi: 10.1001/jamanetworkopen.2024.13869.

ABSTRACT

IMPORTANCE: Cigarette smoking is a primary risk factor for chronic lower respiratory disease (CLRD) and is associated with worse symptoms among people with CLRD. It is important to evaluate the economic outcomes of smoking in this population.

OBJECTIVE: To estimate smoking prevalence and cigarette smoking-attributable health care expenditures (SAHEs) for adults with CLRD in the US.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from the 2014-2018 and 2020 National Health Interview Surveys (NHIS) and the 2020 Medical Expenditure Panel Survey. The final study population, stratified by age 35 to 64 years and 65 years or older, was extracted from the 2014-2018 NHIS data. The data analysis was performed between February 1 and March 31, 2024.

EXPOSURES: Cigarette smoking, as classified into 4 categories: current smokers, former smokers who quit less than 15 years ago, former smokers who quit 15 or more years ago, and never smokers.

MAIN OUTCOMES AND MEASURES: Smoking-attributable health care expenditures were assessed using a prevalence-based annual cost approach. Econometric models for the association between cigarette smoking and health care utilization were estimated for 4 types of health care services: inpatient care, emergency department visits, physician visits, and home health visits.

RESULTS: In the 2014-2018 NHIS study sample of 13 017 adults, 7400 (weighted 62.4%) were aged 35 to 64 years, 5617 (weighted 37.6%) were 65 years or older, and 8239 (weighted 61.9%) were female. In 2020, among 11 211 222 adults aged 35 to 64 with CLRD, 3 508 504 (31.3%) were current smokers and 3 496 790 (31.2%) were former smokers. Total SAHEs in 2020 for this age group were $13.6 billion, averaging $2752 per current smoker and $1083 per former smoker. In 2020, 7 561 909 adults aged 65 years or older had CLRD, with 1 451 033 (19.2%) being current smokers and 4 104 904 (54.3%) being former smokers. Total SAHEs in 2020 for the older age group were $5.3 billion, averaging $1704 per current smoker and $682 per former smoker. In sum, SAHEs for adults with CLRD aged 35 years or older amounted to $18.9 billion in 2020.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of adults with CLRD, cigarette smoking was associated with a substantial health care burden. The higher per-person SAHEs for current smokers compared with former smokers suggest potential cost savings of developing targeted smoking cessation interventions for this population.

PMID:38814643 | DOI:10.1001/jamanetworkopen.2024.13869

JAMA Netw Open. 2024 May 1;7(5):e2413878. doi: 10.1001/jamanetworkopen.2024.13878.

ABSTRACT

IMPORTANCE: The decision for surgical vs nonsurgical treatment for hip fracture can be complicated among community-dwelling people living with dementia.

OBJECTIVE: To compare outcomes of community-dwelling people living with dementia treated surgically and nonsurgically for hip fracture.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cross-sectional study undertook a population-based analysis of national Medicare fee-for-service data. Participants included community-dwelling Medicare beneficiaries with dementia and an inpatient claim for hip fracture from January 1, 2017, to June 30, 2018. Analyses were conducted from November 10, 2022, to October 17, 2023.

EXPOSURE: Surgical vs nonsurgical treatment for hip fracture.

MAIN OUTCOMES AND MEASURES: The primary outcome was mortality within 30, 90, and 180 days. Secondary outcomes consisted of selected post-acute care services.

RESULTS: Of 56 209 patients identified with hip fracture (73.0% women; mean [SD] age, 86.4 [7.0] years), 33 142 (59.0%) were treated surgically and 23 067 (41.0%) were treated nonsurgically. Among patients treated surgically, 73.3% had a fracture of the femoral head and neck and 40.2% had moderate to severe dementia (MSD). Among patients with MSD and femoral head and neck fracture, 180-day mortality was 31.8% (surgical treatment) vs 45.7% (nonsurgical treatment). For patients with MSD treated surgically vs nonsurgically, the unadjusted odds ratio (OR) of 180-day mortality was 0.56 (95% CI, 0.49-0.62; P < .001) and the adjusted OR was 0.59 (95% CI, 0.53-0.66; P < .001). Among patients with mild dementia and femoral head and neck fracture, 180-day mortality was 26.5% (surgical treatment) vs 34.9% (nonsurgical treatment). For patients with mild dementia who were treated surgically vs nonsurgically for femoral head and neck fracture, the unadjusted OR of 180-day mortality was 0.67 (95% CI, 0.60-0.76; P < .001) and the adjusted OR was 0.71 (95% CI, 0.63-0.79; P < .001). For patients with femoral head and neck fracture, there was no difference in admission to a nursing home within 180 days when treated surgically vs nonsurgically.

CONCLUSIONS AND RELEVANCE: In this cohort study of community-dwelling patients with dementia and fracture of the femoral head and neck, patients with MSD and mild dementia treated surgically experienced lower odds of death compared with patients treated nonsurgically. Although avoiding nursing home admission is important to persons living with dementia, being treated surgically for hip fracture did not necessarily confer a benefit in that regard. These data can help inform discussions around values and goals with patients and caregivers when determining the optimal treatment approach.

PMID:38814642 | DOI:10.1001/jamanetworkopen.2024.13878

JAMA Netw Open. 2024 May 1;7(5):e2413884. doi: 10.1001/jamanetworkopen.2024.13884.

ABSTRACT

IMPORTANCE: Although new parents’ mental health is known to decline, less is known about changes in therapy attendance, especially among military service members.

OBJECTIVE: To investigate changes in therapy attendance among new parents and by parental leave length.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study of US Army and Navy service members from January 1, 2013, to December 31, 2019, compared parents’ monthly therapy attendance with matched nonparents’ across childbirth and compared mothers’ weekly therapy attendance before vs after returning to work. Eligible monthly sample members included service members with first births from January 1, 2014, to December 31, 2017, and 12 months of data before to 24 months after birth and nonparents with 36 months of data. Eligible weekly sample members included mothers with first births from January 1, 2013, to June 30, 2019, and data from 12 months before to 6 months after birth and nonparents with 18 months of data. Data analysis was performed from July 1, 2023, to January 15, 2024.

EXPOSURE: Those exposed to parenthood had no prior children, acquired a dependent younger than 1 year, and, for mothers, had an inpatient birth. Unexposed matches did not add a dependent younger than 1 year.

MAIN OUTCOMES AND MEASURES: Monthly counts of mental health therapy sessions and any therapy sessions (weekly).

RESULTS: The monthly sample included 15 554 193 person-month observations, representing 321 200 parents and matches, including 10 193 mothers (3.2%; mean [SD] age, 25.0 [4.9] years), 50 865 nonmother matches (15.8%; mean [SD] age, 25.0 [5.0] years), 43 365 fathers (13.5%; mean [SD] age, 26.4 [4.8] years), and 216 777 nonfather matches (67.5%; mean [SD] age, 26.4 [4.8] years). The weekly sample included 17 464 mothers. Mothers went to 0.0712 fewer sessions at 1 month post partum (95% CI, -0.0846 to -0.0579) compared with 10 months before birth. Fathers went to 0.0154 fewer sessions in the month of birth (95% CI, -0.0194 to -0.0114) compared with 10 months before. Parents with preexisting treatment needs had larger decreases in treatment. Weekly therapy attendance increased by 0.555 percentage points (95% CI, 0.257-0.852) when mothers returned to work from 6 weeks of leave and 0.953 percentage points (95% CI, 0.610-1.297) after 12 weeks of leave.

CONCLUSIONS AND RELEVANCE: In this cohort study of new parents, therapy attendance decreased around childbirth, especially among parents with prior mental health needs and mothers with longer maternity leaves. These findings suggest that more accessible treatment, including home visits or telehealth appointments, is needed.

PMID:38814641 | DOI:10.1001/jamanetworkopen.2024.13884