Tag: statistics

Cephalalgia. 2023 Jul;43(7):3331024231187132. doi: 10.1177/03331024231187132.

ABSTRACT

OBJECTIVE: To investigate the efficacy and safety of injecting onabotulinum toxin A (BTA) towards the sphenopalatine ganglion (SPG) using the MultiGuide® in patients with persistent idiopathic facial pain (PIFP).

METHODS: This cross-over, exploratory study compared the injection of 25 units BTA versus placebo in patients who met modified ICDH-3 criteria for PIFP. Daily pain diaries were registered for a 4-week baseline, a 12-week follow-up after each injection, and an 8-week conceptual washout period in between. The primary efficacy endpoint was the change from baseline to weeks 5-8 in average pain intensity using a numeric rating scale. Adverse events were recorded.

RESULTS: Of 30 patients who were randomized to treatment, 29 were evaluable. In weeks 5-8, there was no statistically significant difference in average pain intensity between BTA versus placebo (0.00; 95% CI = -0.57 to 0.57) (P = 0.996). Following both BTA and placebo injections, five participants reported at least a 30% reduction in average pain during weeks 5-8 (P = 1.000). No serious adverse events were reported. Post-hoc analyses indicated a possible carry-over effect.

CONCLUSIONS: Injection of BTA toward the SPG with the MultiGuide® did not appear to provide a reduction in pain reduction at 5-8 weeks, although this finding may be influenced by a carry-over effect. The injection appears to otherwise be safe and well-tolerated in patients with PIFP.Trial Registration: The study protocol is registered in ClinicalTrial.gov (NCT03462290) and EUDRACT (number: 2017-002518-30).

PMID:37435807 | DOI:10.1177/03331024231187132

Elife. 2023 Jul 12;12:e83868. doi: 10.7554/eLife.83868. Online ahead of print.

ABSTRACT

Calcineurin B homologous protein 3 (CHP3) is an EF-hand Ca²⁺-binding protein involved in regulation of cancerogenesis, cardiac hypertrophy and neuronal development through interactions with sodium/proton exchangers (NHEs) and signalling proteins. While the importance of Ca²⁺ binding and myristoylation for CHP3 function has been recognized, the underlying molecular mechanism remained elusive. In this study, we demonstrate that Ca²⁺ binding and myristoylation independently affect the conformation and functions of human CHP3. Ca²⁺ binding increased local flexibility and hydrophobicity of CHP3 indicative of an open conformation. The Ca²⁺-bound CHP3 exhibited a higher affinity for NHE1 and associated stronger with lipid membranes compared to the Mg²⁺-bound CHP3, which adopted a closed conformation. Myristoylation enhanced the local flexibility of CHP3 and decreased its affinity to NHE1 independently of the bound ion, but did not affect its binding to lipid membranes. The data exclude the proposed Ca²⁺-myristoyl switch for CHP3. Instead, a Ca²⁺-independent exposure of the myristoyl moiety is induced by binding of the target peptide to CHP3 enhancing its association to lipid membranes. We name this novel regulatory mechanism ‘target-myristoyl switch’. Collectively, the interplay of Ca²⁺ binding, myristoylation, and target binding allows for a context-specific regulation of CHP3 functions.

PMID:37435805 | DOI:10.7554/eLife.83868

Curr Med Res Opin. 2023 Jul 12:1-18. doi: 10.1080/03007995.2023.2234727. Online ahead of print.

ABSTRACT

OBJECTIVE: To describe utilization patterns, negative clinical outcomes and economic burden of patients diagnosed with osteoarthritis (OA) of the hip and/or knee who received a prescription for tramadol or non-tramadol opioids vs. non-opioid drugs.

METHODS: Optum Healthcare Solutions, Inc. commercial claims data were used (1/2012-3/2017). Adults with ≥2 diagnoses of OA of the hip and/or knee, and ≥30 days supply of pain medications were identified during the three-year period from the date of first prescription (index date) after the first OA diagnosis. Drug utilization statistics in the follow-up period were summarized by initial treatment (i.e., tramadol, non-tramadol opioids, non-opioid drugs). Opioid initiators were matched to those initiated on non-opioid treatments using a propensity score model accounting for baseline characteristics. Matched pairs analysis compared outcomes for these cohorts.

RESULTS: Of 62,715 total patients, 15,270 (24.3%) initiated treatment with opioids, including 3,513 (5.6%) on tramadol and 11,757 (18.7%) on non-tramadol opioids. Opioid initiators had more comorbidities, higher baseline healthcare costs, and were more likely to have OA of the hip. Among non-opioid initiators, 27.5% switched to tramadol and 63% switched to non-tramadol opioids. Among tramadol initiators, 71% switched to non-tramadol opioids. Patients initiated on opioids had 20.4% (p < 0.01) higher all-cause healthcare costs and higher percentages experiencing multiple negative clinical outcomes (all p < 0.01) compared to matched controls.

CONCLUSIONS: Most patients with OA of the hip and/or knee either initiate on or switch to opioids for long-term management of OA-related pain despite known risks. This highlights the need for new treatments that delay or prevent use of opioids.

PMID:37435803 | DOI:10.1080/03007995.2023.2234727

J Am Heart Assoc. 2023 Jul 12:e029617. doi: 10.1161/JAHA.123.029617. Online ahead of print.

ABSTRACT

Background Clinical risk factors, a single blood pressure (BP) measurement, current biomarkers, and biophysical parameters can effectively identify risk of early-onset preeclampsia but have limited ability to predict later-onset preeclampsia and gestational hypertension. Clinical BP patterns hold promise to improve early risk stratification for hypertensive disorders of pregnancy. Methods and Results After excluding preexisting hypertension, heart, kidney, or liver disease, or prior preeclampsia, the retrospective cohort (n=249 892) all had systolic BP <140 mm Hg and diastolic BP <90 mm Hg or a single BP elevation ≤20 weeks’ gestation, prenatal care at <14 weeks’ gestation, and a still or live birth delivery at Kaiser Permanente Northern California hospitals (2009-2019). The sample was randomly split into development (N=174 925; 70%) and validation (n=74 967; 30%) data sets. Predictive performance of multinomial logistic regression models for early-onset (<34 weeks) preeclampsia, later-onset (≥34 weeks) preeclampsia, and gestational hypertension was evaluated in the validation data set. There were 1008 (0.4%), 10 766 (4.3%), and 11 514 (4.6%) patients with early-onset preeclampsia, later-onset preeclampsia, and gestation hypertension, respectively. Models with 6 systolic BP trajectory groups (0-20 weeks’ gestation) plus standard clinical risk factors performed substantially better than risk factors alone to predict early- and later-onset preeclampsia and gestational hypertension, with C-statistics (95% CIs) of 0.747 (0.720-0.775), 0.730 (0.722-0.739), and 0.768 (0.761-0.776) versus 0.688 (0.659-0.717), 0.695 (0.686-0.704) and 0.692 (0.683-0.701), respectively, with excellent calibration (Hosmer-Lemeshow P=0.99, 0.99, and 0.74, respectively). Conclusions Early pregnancy BP patterns up to 20 weeks’ gestation plus clinical, social, and behavioral factors more accurately discriminate hypertensive disorders of pregnancy risk among low-to-moderate risk pregnancies. Early pregnancy BP trajectories improve risk stratification to reveal higher-risk individuals hidden within ostensibly low-to-moderate risk groups and lower-risk individuals considered at higher risk by US Preventive Services Task Force criteria.

PMID:37435795 | DOI:10.1161/JAHA.123.029617

J Korean Acad Nurs. 2023 Jun;53(3):340-358. doi: 10.4040/jkan.23039.

ABSTRACT

PURPOSE: This study aimed to develop an instrument to showcase Dignity in Care of Terminally Ill Patients for Nurses and to examine its validity and reliability.

METHODS: A total of 58 preliminary items on dignity in care of terminally ill patients for nurses were selected using content validity analysis and expert opinions on 97 candidate items derived through a literature review and qualitative focus group interviews. Questionnaires were administered to 502 nurses caring for terminally ill cancer patients at hospice and palliative care institutions. The data were analyzed using item analysis, exploratory and confirmatory factor analysis, convergent and discriminant validity, and Pearson correlation for criterion validity, reliability was tested using Cronbach’s alpha.

RESULTS: The final instrument consisted of 25 items, with four factors identified through confirmatory factor analysis. Four factors-ethical values and moral attitudes, interaction-based communication, maintaining comfort, professional insight and competence-accounted for 61.8% of the total variance. Cronbach’s α for total items was .96, and test-retest reliability of intraclass correlation coefficient was .90.

CONCLUSION: Since its validity and reliability have been verified through various methods, the Dignity in Care Scale of Terminally Ill Patients for Nurses can be used for develop nursing interventions and improve dignity in care of terminally ill patients.

PMID:37435764 | DOI:10.4040/jkan.23039

J Korean Acad Nurs. 2023 Jun;53(3):324-339. doi: 10.4040/jkan.23021.

ABSTRACT

PURPOSE: This study aimed to valuate the reliability and validity of the Korean version of the 5C Psychological Antecedents of Vaccination (K-5C) scale.

METHODS: The English version of the 5C scale was translated into Korean, following the World Health Organization guidelines. Data were collected from 316 community-dwelling adults. Content validity was evaluated using the content validity index, while construct validity was evaluated through confirmatory factor analysis. Convergent validity was examined by assessing the correlation with vaccination attitude, and concurrent validity was evaluated by examining the association with coronavirus disease 2019 (COVID-19) vaccination status. Internal consistency and test-retest reliability were also evaluated.

RESULTS: Content validity results indicated an item-level content validity index ranging from .83 to 1, and scale-level content validity index, averaging method was .95. Confirmatory factor analysis supported the fit of the measurement model, comprising a five-factor structure with a 15-item questionnaire (RMSEA = .05, SRMR = .05, CFI = .97, TLI = .96). Convergent validity was acceptable with a significant correlation between each sub-scale of the 5C scale and vaccination attitude. In concurrent validity evaluation, confidence, constraints, and collective responsibility of the 5C scale were significant independent predictors of the current COVID-19 vaccination status. Cronbach’s alpha for each subscale ranged from .78 to .88, and the intraclass correlation coefficient for each subscale ranged from .67 to .89.

CONCLUSION: The Korean version of the 5C scale is a valid and reliable tool to assess the psychological antecedents of vaccination among Korean adults.

PMID:37435763 | DOI:10.4040/jkan.23021

J Korean Acad Nurs. 2023 Jun;53(3):275-294. doi: 10.4040/jkan.22109.

ABSTRACT

PURPOSE: This study aimed to develop an evidence-based extracorporeal membrane oxygenation (ECMO) nursing protocol for critically ill patients receiving ECMO treatment by using an adaptation process, and to verify the effects of the protocol.

METHODS: The protocol was developed according to the adaptation guidelines. A non-randomized controlled trial was conducted to test the protocol’s effects. Data were collected between April 2019 and March 2021. The differences in physiological indicators and complication rates between the two groups were investigated using a chart review to evaluate patient outcomes. The nurses’ outcome variables were evaluated using a questionnaire.

RESULTS: First, after reviewing 11 guidelines by appraisal of the guidelines for research and evaluation collaboration II, 5 guidelines with a standardization grade of over 50 points were selected. An ECMO nursing protocol was developed based on these guidelines. Second, there were no statistically significant differences in physiological indicators between the two groups of patients. However, the experimental group showed a statistically significant decrease in the infection rate (p = .026) and pressure injury rates (p = .041). The levels of satisfaction with ECMO nursing care, and empowerment and performance of the nurses who used the ECMO nursing protocol were higher than those of nurses who did not (p < .001).

CONCLUSION: This protocol may help prevent infections and pressure injuries in patients, and improve nurses’ satisfaction and empowerment. The nursing protocol developed for critically ill patients receiving ECMO treatment can be utilized in evidence-based nursing practice.

PMID:37435760 | DOI:10.4040/jkan.22109

J Phycol. 2023 Jul 12. doi: 10.1111/jpy.13365. Online ahead of print.

ABSTRACT

Kelp species provide many ecosystem services associated with their three-dimensional structures. Among these, fast-growth, canopy-forming species, like giant kelp Macrocystis pyrifera, are the foundation of kelp forests across many temperate reefs. Giant kelp populations have experienced regional declines in different parts of the world. Giant kelp canopy is very dynamic and can take years to recover from disturbance, challenging comparisons of standing biomass with historical baselines. The Santa Barbara Coastal LTER (SBC LTER), curates a time series of Landsat sensed surface cover and biomass for giant kelp in the west coast of North America. In the last decade, this resource has been fundamental to understanding the species’ population dynamics and drivers. However, simple ready-to-use summary statistics aimed at classifying regional kelp decline or recovery are not readily available to stakeholders and coastal managers. To this end, we describe here two simple metrics made available through the R package kelpdecline. First, the proportion of Landsat pixels in decline (PPD), in which current biomass is compared with a historical baseline, and second, a pixel occupancy trend (POT), in which current year pixel occupancy is compared to the time-series long probability of occupancy. The package produces raster maps and output tables summarizing kelp decline and trends over a 0.25 × 0.25° scale. Using kelpdecline, we show how sensitivity analysis on PPD parameter variation can increase the confidence of kelp decline estimates.

PMID:37435715 | DOI:10.1111/jpy.13365

Ann R Coll Surg Engl. 2023 Jul 12. doi: 10.1308/rcsann.2023.0011. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim was to study the effect of incisional negative pressure wound therapy (iNPWT) in wound healing compared with standard sterile gauze dressings after major lower extremity amputation in patients with peripheral arterial disease (PAD).

METHODS: This prospective, randomised controlled trial included 50 patients undergoing major lower extremity amputations for PAD. Patients were randomised into iNPWT and standard dressing groups. The patency of blood vessels at the level of the stump was ensured with or without revascularisation. The primary outcome was wound-related complications such as surgical site infection (SSI), wound dehiscence, seroma/haematoma formation or the need for revision amputation. The secondary outcome was the time taken for the eligibility of prosthesis placement.

RESULTS: It was found that only 12% of the patients in the iNPWT group had SSI compared with 36% in the standard dressing group (p = 0.047). Rates of wound dehiscence, seroma/haematoma formation and revision amputation were decreased in the iNPWT group but this was not statistically significant (p > 0.05). There was a significant reduction in the time taken for eligibility of prosthesis placement in the iNPWT group (5.12 ± 1.53 vs 6.8 ± 1.95 weeks, p = 0.002).

CONCLUSIONS: iNPWT is effective in reducing the incidence of SSI and the time taken for rehabilitation in patients undergoing major lower limb amputation due to PAD.

PMID:37435705 | DOI:10.1308/rcsann.2023.0011

Paediatr Anaesth. 2023 Jul 12. doi: 10.1111/pan.14728. Online ahead of print.

ABSTRACT

BACKGROUND: As illicit substance use can present several perioperative concerns, effective means to identify such practices are necessary to ensure patient safety. Identification of illicit substance use in pediatric patients may be problematic as screening may rely on parental reporting.

AIMS: The current study compares answers regarding use of illicit substances between a survey completed by the patient and the preoperative survey completed by parents or guardians.

METHODS: The study included patients presenting for surgery at Nationwide Children’s Hospital, ranging in age from 12 to 21 years. After consent, patients completed a survey of six drop-down questions using an iPad. The six questions involved the patient’s history of alcohol, tobacco, marijuana, vaping, and opioid use. The results were compared to the answers obtained from the parents during a preoperative phone call.

RESULTS: The study cohort included surveys from 250 patients with a median age of 16 years. Survey data showed a statistically higher reporting of substance use or abuse from the patient study survey in comparison to the routine parental preoperative survey. Alcohol report rates were highest with 69 (27.6%) patients reporting use compared to only 5 parental reports (2%). There was a similar discrepancy in reported rates of vaping use (40 patient reports, 16.0% vs. 11 parental reports, 4.4%) and illicit substance use including marijuana (52 patient reports, 20.8% vs. 11 parental reports, 4.4%). Reported rates of tobacco use were lowest among the survey responses with 12 patient reports (4.8%) and 5 parental reports (2.0%).

CONCLUSIONS: Identifying illicit substance and tobacco use via a phone survey of parents is inaccurate and does not allow for proper identification of use of these substances in patients ≤21 years of age presenting for surgery. An anonymous 2-min survey completed by the patient more correctly identifies these issues.

PMID:37435702 | DOI:10.1111/pan.14728