Tag: statistics

J Appl Clin Med Phys. 2023 Jul 11:e14093. doi: 10.1002/acm2.14093. Online ahead of print.

ABSTRACT

BACKGROUND: Dynamic tumor motion tracking is used in robotic radiosurgery for targets subject to respiratory motion, such as lung and liver cancers. Different methods of measuring tracking error have been reported, but the differences among these methods have not been studied, and the optimal method is unknown.

PURPOSE: The purpose of this study was to assess and compare tracking errors encountered with individual patients using different evaluation methods for method optimization.

METHODS: We compared the beam’s eye view (BEV), machine learning (ML), log (addition error: AE), and log (root sum square: RSS) methods. Log (AE) and log (RSS) were calculated from log files. These tracking errors were compared, and the optimal evaluation method was ascertained. A t-test was performed to evaluate statistically significant differences. Here, the significance level was set at 5%.

RESULTS: The mean values of BEV, log (AE), log (RSS), and ML were 2.87, 3.91, 2.91, and 3.74 mm, respectively. The log (AE) and ML were higher than BEV (p < 0.001), and log (RSS) was equivalent to the BEV, suggesting that the log (RSS) calculated with the log file method can substitute for the BEV calculated with the BEV method. As RSS error calculation is simpler than BEV calculation, using it may improve clinical practice throughput.

CONCLUSION: This study clarified differences among three tracking error evaluation methods for dynamic tumor tracking radiotherapy using a robotic radiosurgery system. The log (RSS) calculated by the log file method was found to be the best alternative to BEV method, as it can calculate tracking errors more easily than the BEV method.

PMID:37431706 | DOI:10.1002/acm2.14093

Pharm Stat. 2023 Jul 11. doi: 10.1002/pst.2325. Online ahead of print.

ABSTRACT

The role and value of statistical contributions in drug development up to the point of health authority approval are well understood. But health authority approval is only a true ‘win’ if the evidence enables access and adoption into clinical practice. In today’s complex and evolving healthcare environment, there is additional strategic evidence generation, communication, and decision support that can benefit from statistical contributions. In this article, we describe the history of medical affairs in the context of drug development, the factors driving post-approval evidence generation needs, and the opportunities for statisticians to optimize evidence generation for stakeholders beyond health authorities in order to ensure that new medicines reach appropriate patients.

PMID:37431704 | DOI:10.1002/pst.2325

Hypertension. 2023 Jul 11. doi: 10.1161/HYPERTENSIONAHA.122.20361. Online ahead of print.

ABSTRACT

BACKGROUND: Early delivery in preterm preeclampsia may reduce the risks for the patient, but consequences of prematurity may be substantial for the baby. This trial evaluated whether the implementation of a risk stratification model could safely reduce prematurity.

METHODS: This was a stepped-wedge cluster-randomized trial in seven clusters. Patients presenting with suspected or confirmed preeclampsia between 20⁺⁰ and 36⁺⁶ gestational weeks were considered eligible. At the start of the trial, all centers were allocated in the preintervention phase, and patients enrolled in this phase were managed according to local treatment guidance. Subsequently, every 4 months, 1 randomly allocated cluster transitioned to the intervention. Patients enrolled in the intervention phase had sFlt-1 (soluble fms-like tyrosine kinase-1)/PlGF (placental growth factor) ratio and preeclampsia integrated estimate of risk assessments performed. If sFlt-1/PlGF ≤38 and preeclampsia integrated estimate of risk <10%, patients were considered low risk and clinicians received recommendations to defer delivery. If sFlt-1/PlGF >38 and preeclampsia integrated estimate of risk ≥10%, patients were considered not low risk, and clinicians received recommendations to increase surveillance. The primary outcome was the proportion of patients with preterm preeclampsia delivered prematurely out of total deliveries.

RESULTS: Between March 25, 2017 and December 24, 2019, 586 and 563 patients were analyzed in the intervention and usual care groups, respectively. The event rate was 1.09% in the intervention group, and 1.37% in the usual care group. After prespecified adjustments for variation between and within clusters over time, the adjusted risk ratio was 1.45 ([95% CI, 1.04-2.02]; P=0.029), indicating a higher risk of preterm deliveries in the intervention group. Post hoc analysis including calculation of risk differences did not show evidence of statistical differences. Abnormal sFlt-1/PlGF was associated with a higher rate of identifying preeclampsia with severe features.

CONCLUSIONS: The introduction of an intervention based on biomarkers and clinical factors for risk stratification did not lead to reductions in preterm deliveries. Further training on the interpretation of disease severity in preeclampsia and the development of additional risk stratification is needed before adoption into clinical practice.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT03073317.

PMID:37431663 | DOI:10.1161/HYPERTENSIONAHA.122.20361

Nucl Med Rev Cent East Eur. 2023;26(0):85-95. doi: 10.5603/NMR.2023.0011.

ABSTRACT

INTRODUCTION: Nuclear medicine (NM) methods play an important role in the evaluation of renal function in a wide range of clinical indications. The aim of our study was to evaluate the correlation between measured GFR (mGFR) obtained by the three-plasma sample slope-intercept NM method (TPSM) – reference method vs. estimated GFR (eGFR) using Fleming’s single plasma sample method (SPSM) at 120 min, 180 min, and 240 min and correlation of reference method with eGFR with camera-based Gates’ protocol.

MATERIAL AND METHODS: A total of 82 subjects (33 male/49 female) with a mean age of 54.87 ± 15.65 years were included and mGFR value was obtained by the three-plasma sample slope-intercept NM method and eGFR was obtained with Fleming’s single sample method. eGFR was also quantified with the camera-based Gates’ protocol after i.v. application of [99mTc]Tc-DTPA.

RESULTS: Our study revealed a very strong positive significant correlation between all three SPSMs with the TPSM as the reference method. Between the Gates’ method and the TPSM in the group of patients with mGFR ≥ 61-84 mL/min/1.73 m2 and mGFR ≥ 84 mL/min/1.73 m2, a moderate positive statistically significant correlation was obtained.

CONCLUSIONS: The SPSM method shows a very strong correlation with the reference and low bias in all three groups of patients and can be routinely used for GFR estimation.

PMID:37431648 | DOI:10.5603/NMR.2023.0011

Asian Cardiovasc Thorac Ann. 2023 Jul 11:2184923231187681. doi: 10.1177/02184923231187681. Online ahead of print.

ABSTRACT

BACKGROUND: Mitral valve surgery in octogenarians is a clinical challenge due to the impact of inherent, age-related comorbidities. Within the context of an aging population, the number of mitral surgery candidates over 80 has been gradually increasing. We sought to evaluate our institutional experience with mitral valve surgery in octogenarians to identify factors that may prove useful during the process of clinical decision-making.

METHODS: We retrospectively reviewed our institutional database for all patients over 80 years of age who underwent mitral valve surgery in our department from October 2002 up to February 2021. The primary endpoints of our study were 30-day all-cause mortality and long-term survival after the first postoperative month.

RESULTS: In total, 99 octogenarians underwent mitral valve surgery for various types of mitral pathology. In particular, 70 patients underwent mitral valve replacement with or without concomitant procedures and 29 underwent mitral valve repair with or without concomitant procedures. There was no difference between the two approaches in terms of 30-day mortality and long-term survival. Chronic kidney disease and total operative time were independent predicting factors for 30-day mortality. Etiology of mitral valve pathology and EuroSCORE II was independent predicting factors for long-term survival.

CONCLUSIONS: The type of mitral valve surgery did not affect 30-day and long-term mortality rates in our study. Renal impairment and EuroSCORE II were independent predictors of 30-day mortality and long-term prognosis, respectively. Rheumatic valve disease was also associated with a poorer prognosis.

PMID:37431635 | DOI:10.1177/02184923231187681

Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2023 Jul 10. doi: 10.5507/bp.2023.027. Online ahead of print.

ABSTRACT

PURPOSE: Pleomorphic adenoma (PA), the most common benign tumour of the parotid gland, requires accurate preoperative diagnosis owing to its capacity for malignant transformation. The aim of this study was to evaluate our experience with ultrasound-guided fine-needle aspiration biopsy (FNAB) in the diagnostic algorithm for patients with PA and to assess clinical outcomes for those with different surgical approaches.

MATERIAL AND METHODS: We carried out a retrospective analysis of patients treated for parotid gland mass between 2010 and 2016. These had had preoperative FNAB and had undergone subsequent surgery.

RESULTS: 165 patients had FNAB with the result of PA and the definitive histology confirmed PA in 159 cases (96.4%). On the other hand, in 179 patients, the definitive histology showed PA and the preoperative FNAB result corresponded in 159 cases (88.9%). The measured sensitivity, specificity and accuracy of ultrasound-guided FNAB in the diagnosis of PA were, respectively, 88.83%, 96.23% and 92.31%. Most of the patients underwent superficial or partial superficial parotidectomy, followed by extracapsular dissection which was associated with statistically lower risk of facial nerve injury (P=0.04).

CONCLUSION: Ultrasound-guided FNAB is simple, accurate and valuable in the diagnosis of PA and provides results that can lead to the choice of less invasive operative treatment.

PMID:37431621 | DOI:10.5507/bp.2023.027

Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2023 Jul 10. doi: 10.5507/bp.2023.025. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine the prognostic potential of S100B protein in patients with craniocerebral injury, correlation between S100B protein and time, selected internal diseases, body habitus, polytrauma, and season.

METHODS: We examined the levels of S100B protein in 124 patients with traumatic brain injury (TBI).

RESULTS: The S100B protein level 72 h after injury and changes over 72 h afterwards are statistically significant for prediction of a good clinical condition 1 month after injury. The highest sensitivity (81.4%) and specificity (83.3%) for the S100B protein value after 72 h was obtained for a cut-off value of 0.114. For the change after 72 h, that is a decrease in S100B value, the optimal cut-off is 0.730, where the sum of specificity (76.3%) and sensitivity (54.2%) is the highest, or a decrease by 0.526 at the cut-off value, where sensitivity (62.5%) and specificity (62.9%) are more balanced. The S100B values were the highest at baseline; S100B value taken 72 h after trauma negatively correlated with GCS upon discharge or transfer (r=-0.517, P<0.0001). We found no relationship between S100B protein and hypertension, diabetes mellitus, BMI, or season when the trauma occurred. Changes in values and a higher level of S100B protein were demonstrated in polytraumas with a median of 1.070 (0.042; 8.780) μg/L compared to isolated TBI with a median of 0.421 (0.042; 11.230) μg/L.

CONCLUSION: S100B protein level with specimen collection 72 h after trauma can be used as a complementary marker of patient prognosis.

PMID:37431619 | DOI:10.5507/bp.2023.025

Stat Methods Med Res. 2023 Jul 11:9622802231181704. doi: 10.1177/09622802231181704. Online ahead of print.

ABSTRACT

Parallel design and crossover design are two of the most frequently used designs for studying drug-gene interactions. Due to the concerns of statistical power and ethics, it is often more prudent to use the crossover design while allowing the patients to have choices of not switching the treatment if the first stage treatment is effective. This complicates the calculation of the required sample size to achieve pre-specified statistical power. We propose a method to determine the required sample size with a closed-form formula. The proposed approach is applied to determine the sample size of an adaptive crossover trial in studying gene-drug interaction in treating atrial fibrillation, the most common cardiac arrhythmia in clinical practice. Our simulation study confirms the power achieved by the sample size determined using the proposed approach. Issues related to the adaptive crossover trial are also discussed and practical guidelines are provided.

PMID:37431594 | DOI:10.1177/09622802231181704

Curr Med Imaging. 2023 Jul 11. doi: 10.2174/1573405620666230711090648. Online ahead of print.

ABSTRACT

BACKGROUND: There are no studies investigating the relationship between cone beam computed tomography (CBCT) and nasal passage findings and vertical facial development. The aim of this study is to determine the relationship between nasal cavity anatomy and vertical development of patients.

METHODS: A total of 60 CBCTs were examined, and Class I malocclusion individuals were divided into two groups (30 each) according to vertical facial development. All nasal cavity findings were recorded in the study. Vertical facial development, nasal septum, nasal cavity width, thickness and angle were evaluated. Mann-Whitney U Test was used, and Student’s t test was used for the comparison of two groups with normal distribution. Significance was evaluated at p<0.01 and p<0.05 levels.

RESULTS: Statistical analysis showed a relationship between vertical facial development and nasal cavity findings. Nasal septum deviation was mild to moderate in the hyperdivergent group, while septal deviation was absent in the hypodivergent group. A statistically significant difference was found in the width, distance (x-y) and angle of the nasal cavity from the hyperdivergent group in Class I vertical subgroups (p<0.05).

CONCLUSION: When compared between low-angle and high-angle groups, statistically significant differences were observed in anterior face height, nasal passage angle, and distance between the outermost points of the nasal cavity.

PMID:37431582 | DOI:10.2174/1573405620666230711090648

Worldviews Evid Based Nurs. 2023 Jul 11. doi: 10.1111/wvn.12666. Online ahead of print.

ABSTRACT

BACKGROUND: It has been suggested that nursing shift-to-shift handover should be a more team-based dialogue with and for the patient rather than about a patient.

AIM: The aim of this study was to evaluate patient participation in relation to the implementation of the person-centered handover (PCH).

METHOD: A pretest-posttest design was used without a comparison group, including patients from nine units in a university hospital at pretest (n = 228) and after implementing PCH (posttest, n = 253) per the framework integrated-Promoting Action on Research Implementation in Health Services. The PCH is inspired by an Australian bedside handover model. The Patient Preferences for the Patient Participation tool was used to rate the preference for and experience of participation on 12 items, combined into three levels of preference-based participation (insufficient-fair-sufficient).

RESULTS: There were no differences regarding experience or preference-based participation between patients at pretest-posttest; however, posttest patients experienced participation in the item Reciprocal communication to a lesser extent than the pretest patients. Only 49% of the posttest group received PCH; of those not receiving PCH, some would have wanted PCH (27%), while some would have declined (24%). Patients receiving PCH had sufficient participation (82%), to a greater extent, regarding the item Sharing one’s symptoms with staff than patients at pretest (72%). Patients receiving PCH also had sufficient participation, to a greater extent, than patients at posttest who did not receive, but would have wanted PCH, regarding four items: (1) sharing one’s symptoms with staff, (2) reciprocal communication, (3) being told what was done, and (4) taking part in planning.

LINKING EVIDENCE TO ACTION: Most patients want to be present at PCH. Therefore, nurses should ask for the patients’ preferences regarding PCH and act accordingly. Not inviting patients who want PCH could contribute to insufficient patient participation. Further studies are needed to capture what assistance nurses would want in identifying and acting in alignment with patient preferences.

PMID:37431567 | DOI:10.1111/wvn.12666