Tag: statistics

World Neurosurg. 2022 Oct 29:S1878-8750(22)01507-8. doi: 10.1016/j.wneu.2022.10.090. Online ahead of print.

ABSTRACT

BACKGROUND: Simulation-based neurosurgical training allows the development of surgical skills outside the operating room. However, the use of nonstandardized materials and poor haptic feedback remain the primary limitations of the surgical simulators. Therefore, this work proposes a comprehensive scheme for scalp and dura surrogate synthesis and their standardization for neurosurgical training.

METHODS: Eight different variants of silicone-based scalp (S1-S8) and dura (D1-D8) surrogates were synthesized. The samples were evaluated by 26 neurosurgeons. They provided their feedback in a Likert scale questionnaire. Kruskal-Wallis test with Dunn multiple comparisons was used for statistical analysis of surgeons’ scores. The samples were mechanically characterized using Shore A hardness and dynamic nanoindentation testing.

RESULTS: The highest mean Likert score values were obtained for S3 scalp and D8 dura variants. The comparison of S3 and D8 with the rest of the variants in the respective groups was statistically significant in 21 of 28 instances. The average Shore A hardness and storage modulus of the S3 variant were 21.9 DU and 505.3 kPa, respectively. The corresponding values for the D8 variant were 32.5 DU and 632 kPa, respectively.

CONCLUSIONS: This study proposes a method for the synthesis, evaluation, and standardization of scalp and dura surrogates. The study achieved standardized silicone compositions along with a recommendable range of Shore hardness and viscoelastic moduli values for the scalp and dura surrogates. This work can be extended for the standardization of surrogates for other tissues involved in neurosurgical simulators.

PMID:36415013 | DOI:10.1016/j.wneu.2022.10.090

SLAS Discov. 2022 Oct 28:S2472-5552(22)13705-6. doi: 10.1016/j.slasd.2022.10.004. Online ahead of print.

ABSTRACT

For process optimisation Design of Experiments (DoE) has long been established as a more powerful strategy than a One Factor at a Time approach. Nevertheless, DoE is not widely used especially in the field of cell-based bioassay development although it is known that complex interactions often exist. We believe that biopharmaceutical manufacturers are reluctant to move beyond standard practices due to the perceived costs, efforts, and complexity. We therefore introduce the integrated DoE (ixDoE) approach to target a smarter use of DoEs in the bioassay setting, specifically in optimising resources and time. Where in a standard practice 3 to 4 separate DoEs would be performed, our ixDoE approach includes the necessary statistical inference from only a single experimental set. Hence, we advocate for an innovative, ixDoE approach accompanied by a suitable statistical analysis strategy and present this as a practical guide for a typical bioassay development from basic research to biopharmaceutical industry.

PMID:36415004 | DOI:10.1016/j.slasd.2022.10.004

BMC Sports Sci Med Rehabil. 2022 Nov 22;14(1):196. doi: 10.1186/s13102-022-00593-0.

ABSTRACT

BACKGROUND: The performing of jump and landing in futsal simultaneous with divided attention is one of the most common mechanisms of non-contact anterior cruciate ligament (ACL) injury. Neuromuscular training has effectively reduced the risk of ACL injury, but the effect of neurocognitive training has received less attention. This study investigated the effect of combining 8 weeks of neuromuscular training with dual cognitive tasks on the landing mechanics of futsal players with knee ligament dominance defects.

METHODS: Thirty male futsal players (mean ± SD: age: 21.86 ± 3.27 years) with knee ligament dominance defects were purposefully identified by the tuck jump test and were randomly divided into the intervention and the control group. The intervention group performed dual task (DT) training for three weekly sessions for 8 weeks and 60 min each, while the control group only did activities of daily living. During the drop vertical jump test, 2D landing kinematics in two moments of initial contact (IC) and full flexion (FF) were assessed. Data were analyzed by means of 2 × 2 repeated measures ANOVA followed by post hoc comparison (Bonferroni) at the significance level of (α ≤ 0.05).

RESULTS: A significant improvement was observed in the intervention group compared to the control group for the dynamic knee valgus at IC (F_1,28 = 6.33; P = 0.02, ES = 0.31) and FF (F_1,28 = 13.47; P = 0.003, ES = 0.49), knee flexion at IC (F_1,28 = 20.08; P = 0.001, ES = 0.41) and FF (F_1,28 = 13.67; P = 0.001, ES = 0.32), ankle dorsiflexion at IC (F_1,28 = 37.17; P = 0.001, ES = 0.72) and FF (F_1,28 = 14.52; P = 0.002, ES = 0.50), and trunk flexion at FF (F_1,28 = 20.48; P = 0.001, ES = 0.59) angles. Changes in the trunk flexion at IC (F_1,28 = 0.54; P = 0.47, ES = 0.03) and trunk lateral flexion at IC (F_1,28 = 0.006; P = 0.93, ES = 0.00) and FF (F_1,28 = 2.44; P = 0.141, ES = 0.148) angles were not statistically significant.

CONCLUSIONS: DT training compared to the control group improved landing mechanics in futsal players with knee ligament dominance defects.

TRIAL REGISTRATION: Current Controlled Trials using the IRCT website with ID number IRCT20210602051477N1 prospectively registered on 20/06/2021.

PMID:36415003 | DOI:10.1186/s13102-022-00593-0

J Dent. 2022 Dec;127:104346. doi: 10.1016/j.jdent.2022.104346. Epub 2022 Oct 28.

ABSTRACT

OBJECTIVES: To compare the degree of satisfaction (SD) and the impact on oral health-related quality of life (OHRQoL) of edentulous patients treated with conventional complete dentures (CCDs) and mandibular overdentures (IODs) with a short anteroposterior spread (S-APS) or a large antero-posterior spread (L-APS).

MATERIALS AND METHODS: Edentulous patients were treated with CCDs and subsequently randomly allocated to receive a bar clip mandibular overdenture retained by 2 interforaminal implants (Control) or 4 (Test: 2 additional implants distal to the mental foramen). The Oral Health Impact Profile Edent questionnaire (OHIP-20E) and the Visual Analogue Scale (VAS) were applied at a mean follow-up of 38.5 months to assess the impact on OHRQoL and DS, respectively. Comparisons between the type of prosthesis and the extension of the AP spread were made with Student’s t test for paired samples and for independent samples, respectively, at a significance level of 5%.

RESULTS: The IODs had significantly lower OHRQoL values ​​in the dimensions “functional limitation” (p=0.03), “physical pain” (p=0.02), “psychological discomfort” (p<0.01), “disability physical” (p<0.01) and “general score” (p<0.01) (n=20 patients). The IODs presented DS values ​​significantly for “aesthetics” (p=0.04), “stability” (p=0.03), “masticatory capacity” (p<0.01), “function” (p<0.01) and “oral condition” (p=0.03). The S-APS group (control) resulted in significantly lower values ​​in the dimensions “physical pain” (p<0.01) and “general score” (p<0.01) and no domain with statistical difference in the VAS scale.

CONCLUSIONS: IODs significantly improved OHRQoL and DS. The increase in AP spread did not result in benefits for the patient’s OHRQOL and DS in this clinical study. (Study Protocol Number: 1.452.492) CLINICAL SIGNIFICANCE: Implantology has experienced in the last 20 years a permanent evolution that aim at increasing predictability and improving long-term clinical performance. Placement of short implants distally to the mental foramen, for instance, and the resulting increase of the anterior-posterior spread, is a promising approach and is worthy of investigation.

PMID:36414990 | DOI:10.1016/j.jdent.2022.104346

Matern Health Neonatol Perinatol. 2022 Nov 22;8(1):9. doi: 10.1186/s40748-022-00144-y.

ABSTRACT

BACKGROUND: Reducing the global new-born mortality is a paramount challenge for humanity. There are approximately 786,323 live births in the UK each year according to the office for National Statistics; around 10% of these newborn infants require assistance during this transition after birth. Each year around, globally around 2.5 million newborns die within their first month. The main causes are complications due to prematurity and during delivery. To act in a timely manner and prevent further damage, health professionals should rely on accurate monitoring of the main vital signs heart rate and respiratory rate.

AIMS: To present a clinical perspective on innovative, non-invasive methods to monitor heart rate and respiratory rate in babies highlighting their advantages and limitations in comparison with well-established methods.

METHODS: Using the data collected in our recently published systematic review we highlight the barriers and facilitators for the novel sensor devices in obtaining reliable heart rate measurements. Details about difficulties related to the application of sensors and interfaces, time to display, and user feedback are explored. We also provide a unique overview of using a non-invasive respiratory rate monitoring method by extracting RR from the pulse oximetry trace of newborn babies.

RESULTS: Novel sensors to monitor heart rate offer the advantages of minimally obtrusive technologies but have limitations due to movement artefact, bad sensor coupling, intermittent measurement, and poor-quality recordings compared to gold standard well established methods. Respiratory rate can be derived accurately from pleth recordings in infants.

CONCLUSION: Some limitations have been identified in current methods to monitor heart rate and respiratory rate in newborn babies. Novel minimally invasive sensors have advantages that may help clinical practice. Further research studies are needed to assess whether they are sufficiently accurate, practical, and reliable to be suitable for clinical use.

PMID:36414979 | DOI:10.1186/s40748-022-00144-y

Trials. 2022 Nov 22;23(1):951. doi: 10.1186/s13063-022-06909-2.

ABSTRACT

BACKGROUND: Tai Chi (TC), as one of mild to moderate exercise therapies specifically recommended by clinical practice guideline from the American College of Physician, is a viable option for chronic non-specific low back pain (CNLBP) treatment. Nevertheless, limited studies focused on the effect of different weekly frequencies of TC in elders with CNLBP. This superiority study aims to compare the differences of TC with different weekly frequencies in elders with CNLBP on the premise of proving its effectiveness, and identifying whether mindfulness mediates the effect of TC on treatment outcomes.

METHODS: In total, 284 senior citizens with CNLBP will be recruited in this single-centre, randomised, single-blinded (outcome assessors, data managers and the statistician), parallel controlled trial. Participants will be randomly divided into either one of three TC groups (1, 3, or 5 sessions/week, on the basis of weekly health educational lectures) or weekly health educational lectures, sustaining for 12 weeks, followed by 12 weeks of follow-up after the end of intervention. The primary outcome (the changes of LBP intensity at rest) will be measured at baseline before randomisation and immediately after the completion of weeks 4, 8 and 12 of the intervention, and the end of follow-up (week 24) using the visual analogue scale (VAS, 0-10 cm) to put a mark on the VAS scale to show how severities of their average low back pain have been over the past 24 h. Secondary outcomes, including Beck Depression Inventory-II, Pain Catastrophising Scale and Five Facet Mindfulness Questionnaire, Oswestry Disability Index and Short Form-36, will be measured at baseline and immediately after the completion of week 12 of the intervention and end of follow-up. The intention-to-treat and per-protocol principles will be used to analyse outcomes with a setting at α = 0.05 as statistical significance.

DISCUSSION: This comprehensive and detailed protocol will be the first trial to compare the effectiveness of different weekly frequencies of TC in elders with CNLBP. The outcomes may provide valuable data about the choice of the ideal number of sessions to further normalise the application of exercise for clinicians.

TRIAL REGISTRATION: Chinese clinical trial registry ChiCTR2200058190 . Registered on 1 April 2022.

PMID:36414978 | DOI:10.1186/s13063-022-06909-2

J Pharm Policy Pract. 2022 Nov 21;15(1):88. doi: 10.1186/s40545-022-00476-2.

ABSTRACT

BACKGROUND: High-risk medications use at home entails an increased risk of significant harm to the patient. While interventions and strategies to improve medications care have been implemented in hospitals, it remains unclear how this type of medications care is provided in the home care setting. The objective was to describe home care nurses’ management of high-risk medications.

METHODS: A cross-sectional, descriptive design was set up in home care nurses in Flanders, Belgium. Participants were recruited through convenience sampling and could be included in the study if they provided medications care and worked as a home care nurses. Participants completed an online structured questionnaire. Questions were asked about demographic information, work experience, nurses’ general attitude regarding high-risk medications, contact with high-risk medications and the assessment of risk and severity of harm, specific initiatives undertaken to improve high-risk medications care and the use of additional measures when dealing with high-risk medications. Descriptive statistics were used.

RESULTS: A total of 2283 home care nurses participated in this study. In our study, 98% of the nurses reported dealing high-risk medications. Home care nurses dealt the most with anticoagulants (96%), insulin (94%) and hypnotics and sedatives (87%). Most nurses took additional measures with high-risk medications in less than 25% of the cases, with the individual double check being the most performed measure for all high-risk medications except lithium. Nurses employed by an organization received support mostly in the form of a procedure while self-employed nurses mostly look for support through external organizations and information sources.

CONCLUSIONS: The study shows several gaps regarding high-risk medications care, which can imply safety risks. Implementation and evaluation of more standardized high-risk medications care, developing and implementing procedures or guidelines and providing continuous training for home care nurses are advised.

PMID:36414977 | DOI:10.1186/s40545-022-00476-2

BMC Pulm Med. 2022 Nov 22;22(1):433. doi: 10.1186/s12890-022-02236-z.

ABSTRACT

BACKGROUND: It is fundamental to optimize and retain health-related quality of life (HRQoL) in the long term in patients with home mechanical ventilation (HMV). Therefore, this study aimed to evaluate the evolution of the HRQoL in patients already established on HMV across a period of 5 years and whether the HRQoL is associated with mortality.

METHODS: This was a 5-year longitudinal cohort study conducted in an Outpatient Ventilation Clinic. Consecutive patients on HMV for at least 30 days responded to the Severe Respiratory Insufficiency (SRI) questionnaire at inclusion and again at 5 years.

RESULTS: A total of 104 patients were included (male 56.7%, median age 69 [P25;P75] [61;77] years). Almost half of the patients had COPD (49.0%). Patients were on HMV for a median of 43.5 [22;85.5] months, with overall good adherence (median 8 [6;9] daily hours). Fifty-seven (54.8%) patients were alive at 5 years. In surviving patients, the only difference with statistical significance was in the attendant symptoms and sleep subscale, with patients scoring 7.1 [-4.5;25] points higher in the final questionnaire (p = 0.002). Survivors had significantly better scores in the SRI at inclusion than deceased patients (median 59.6 [49.2;71.7] vs 48.7 [38.4;63.2]; p = 0.004).

CONCLUSIONS: These results shows that HRQoL remains stable in surviving patients with HMV at five years. It also suggests that SRI can be of important prognostic value and help predict the terminal phase of the disease course in patients with long-term HMV.

PMID:36414964 | DOI:10.1186/s12890-022-02236-z

J Headache Pain. 2022 Nov 22;23(1):148. doi: 10.1186/s10194-022-01519-4.

ABSTRACT

BACKGROUND: Headache recurrence is a common feature of acute therapies, whether approved or still in development, and continues to be a significant problem for both the patient and the clinician. Further complicating this issue is lack of standardization in definitions of recurrence used in clinical trials, as well as disparity in patient characteristics, rendering a comparison of different acute medications challenging. Recurrence has serious clinical implications, which can include an increased risk for new-onset chronic migraine and/or development of medication overuse headache. The aim of this review is to illustrate variability of recurrence rates depending on prevailing definitions in the literature for widely used acute treatments for migraine and to emphasize sustained response as a clinically relevant endpoint for measuring prolonged efficacy. BODY: A literature search of PubMed for articles of approved acute therapies for migraine that reported recurrence rates was performed. Study drugs of interest included select triptans, gepants, lasmiditan, and dihydroergotamine mesylate. An unpublished post hoc analysis of an investigational dihydroergotamine mesylate product that evaluated recurrence rates using several different definitions of recurrence common in the literature is also included. Depending on the criteria established by the clinical trial and the definition of recurrence used, rates of recurrence vary considerably across different acute therapies for migraine, making it difficult to compare results of different trials to assess the sustained (i.e., over a single attack) and the prolonged (i.e., over multiple attacks) efficacy of a particular study medication.

CONCLUSION: A standardized definition of recurrence is necessary to help physicians evaluate recurrence rates of different abortive agents for migraine. Sustained pain relief or freedom may be more comprehensive efficacy outcome measures than recurrence. Future efficacy studies should be encouraged to use the recommended definition of sustained pain freedom set by the International Headache Society.

PMID:36414952 | DOI:10.1186/s10194-022-01519-4

BMC Public Health. 2022 Nov 21;22(1):2141. doi: 10.1186/s12889-022-14575-x.

ABSTRACT

BACKGROUND: The proportion of women with family planning needs increased from 74 to 76% between 2000 and 2019, and this improvement has not transcended to a fertility rate stall or decrease in sub-Saharan Africa (SSA). In the face of a continuous increase in the fertility rate in SSA, population experts agreed that the efficient use of reliable family planning methods such as long-acting reversible and permanent contraceptive methods (LARC/PMs) could help reduce the high fertility rate and associated adverse reproductive health outcomes in the region. However, despite the effectiveness of LARC/PMs, its use remains elusive in SSA. Thus, this study examines the prevalence and factors associated with the use of LARC/PMs among women who desire no more children in high-fertility countries in SSA.

METHODS: Secondary datasets from the demographic health surveys conducted in 20 countries in SSA between 2010 and 2019 were included in the study. A total sample size of 46,290 sexually active women of reproductive age who desire no more children and who met the study inclusion criteria was pooled and analysed. Prevalence of LARC/PMs use was displayed using a graph whilst binary logistic regression was used to determine the associated factors, and results were presented as unadjusted odds ratio and adjusted odds ratio with a statistical significance of p < 0.05.

RESULTS: The prevalence of LARC/PMs use among women who desire no more children was 7.5%. Ranging from 20.9% in Senegal and as low as 0.4% in Congo. Women within the richest wealth index [aOR = 1.18, 95% CI = 1.03-1.36] and those exposed to mass media [aOR = 1.54, 95% CI = 1.41-1.68] had higher odds of LARC/PMs use among sexually active women of reproductive age who desire no more children compared to those within poorest wealth index and women with no mass media exposure.

CONCLUSION: The study concluded that LARC/PMs use among sexually active women who desire no more children was very low, and women within the richest wealth index and those with mass media exposure were likely to use LARC/PMs. Interventions that will encourage using LARC/PMs should be prioritised to reduce fertility rates in SSA.

PMID:36414944 | DOI:10.1186/s12889-022-14575-x