Tag: statistics

Cardiovasc Diabetol. 2022 Aug 10;21(1):153. doi: 10.1186/s12933-022-01592-8.

ABSTRACT

BACKGROUND: Prediabetes is an important risk factor of cardiovascular disease (CVD) and is associated with subclinical atherosclerosis. However, the evidence of prediabetes as a cardiovascular risk factor is mainly derived from middle-aged adults. Recently, multiple studies supported that prediabetes in older adults would not lead to higher risk of CVD or mortality. We aimed to investigate the age-specific difference in the association between prediabetes and subclinical atherosclerosis in a Chinese prospective cohort study.

METHODS: We included 4739 individuals aged ≥ 40 years and without diagnosed diabetes or CVD history, and divided them into middle-aged adults (age < 60) and older adults (age ≥ 60). Fasting plasma glucose (FPG), 2-h post-load plasma glucose (2 h-PPG) and glycated hemoglobin (HbA1c) were measured at baseline to identify prediabetes status. At follow-up visits, subclinical atherosclerosis status was assessed by branchial-ankle pulse wave velocity (baPWV) and carotid intima-media thickness (CIMT). Logistic regression analysis, restricted cubic splines and cross-lagged path analysis were used in statistical analysis.

RESULTS: 1634 participants aged over 60 years, and 64.3% of them had prediabetes. 3105 participants aged 40-59 years, and 49.3% of them had prediabetes. We found that prediabetes was associated with increased risk of subclinical atherosclerosis in middle-aged adults, but the association attenuated substantially in older adults. Impaired glucose tolerance (IGT), compared to normal glucose tolerance, was associated with 39% lower risk of increased baPWV only in older adults. In accordance, the association between 2 h-PPG and risk of increased baPWV was “U-shaped” in older adults, while risk of elevated baPWV increased linearly with 2 h-PPG in middle-aged adults. In the cross-lagged analysis, increase in FPG and 2 h-PPG tended not to precede increase in baPWV in older adults, but appeared to increase simultaneously with baPWV in middle-aged ones.

CONCLUSION: Our results indicated that prediabetes might be less related to subclinical atherosclerosis in older adults than in middle-aged adults and suggested that age was important to consider in the care of adults with prediabetes.

PMID:35948892 | DOI:10.1186/s12933-022-01592-8

BMC Urol. 2022 Aug 10;22(1):124. doi: 10.1186/s12894-022-01080-x.

ABSTRACT

BACKGROUND: At present, there is no specific research on the factors affecting the success rate of urethroplasty in patients with DSD. The purpose of this study is to explore the factors affecting the success of urethroplasty in DSD patients, and to provide some reference for the surgical treatment of DSD patients undergoing urethroplasty.

METHOD: We reviewed patients with DSD who underwent urethroplasty from January 2016 to December 2019 retrospectively. Patients were divided into four groups: the successful group, the urethrocutaneous fistula group, the urethral diverticulum group, and the urethral stricture group. Risk factors were determined from the following data included the DSD classification, the age of first operation, length of urethral defect, degree of hypospadias, cryptorchidism, micropenis, gonad type, hormone therapy before operation, transposition of penis and scrotum, surgical strategy, urethral covering material, and postoperative catheter removal time. We explored the difference of each factor between four groups through the comparative study of single factor and multifactor logistic regression analysis of related factors.

RESULT: 122 cases were enrolled in this group (n = 122), 12 cases were lost to follow-up. Median follow-up was 28 months (12-55 months).We found the success rate of operation decreased with longer urethral defect (B = – 0.473, P = 0.005). The success rate of operation was higher in staged operation and TPIT (TPIT = Transverse Preputial Island Tube operation)-related operation than primary operation (B = 1.238, P = 0.006) and TPIT-nonrelated operation (B = 2.293, P = 0.001). Although there was a significant difference between the age of the first operation and the occurrence of urethrocutaneous fistula (P = 0.006 < 0.05), there was no significant difference in logistic regression analysis (P = 0.161 > 0.05). The incidence of urethrocutaneous fistula was lower in TPIT-related operation than in TPIT-nonrelated operation (B = – 2.507, P = 0.000). The incidence of postoperative urethral diverticulum was lower in staged operation than in primary operation (B = – 1.737, P = 0.015).

CONCLUSION: For patients with disorder of sex development undergoing urethroplasty, the length of urethral defect is an independent risk factor affecting both the success rate of operation and the urethrocutaneous fistula. The age of the first operation has a statistically significant effect on the occurrence of postoperative urethrocutaneous fistula, but it is not an independent factor. Urethrocutaneous fistula is less found in TPIT-related operation in the study. Staged operation is an independent protective factor for postoperative urethral diverticulum compared with one-stage operation but isn’t related to urethrocutaneous fistula.

PMID:35948888 | DOI:10.1186/s12894-022-01080-x

BMC Geriatr. 2022 Aug 10;22(1):656. doi: 10.1186/s12877-022-03354-3.

ABSTRACT

BACKGROUND: The lower extremity may play a crucial role in compensating for gait perturbations. The study aimed to explore the mechanism of perturbation compensation by investigating the gait characteristics and lower extremity joint moment effects in young (YS) and older subjects (OS) during the first recovery gait following slipping (slipping_Rec1) and stumbling (stumbling_Rec1).

METHOD: An automatic perturbation-triggered program was developed using D-Flow software based on the Gait Real-time Analysis Interactive Lab to induce the two aforementioned perturbations. Marker trajectories and ground reaction forces were recorded from 15 healthy YS (age: 26.53 ± 3.04 years; body height: 1.73 ± 0.07 m; body mass: 66.81 ± 11.44 kg) and 15 healthy OS (age: 68.33 ± 3.29 years; body height: 1.76 ± 0.10 m; body mass: 81.13 ± 13.99 kg). The Human Body Model was used to compute the variables of interest. One-way analysis of variance and independent samples t-test statistical analyses were performed.

RESULTS: In slipping_Rec1 and stumbling_Rec1, the change in gait pattern was mainly reflected in a significant increase in step width, no alterations in step length and stance/swing ratio were revealed. Based on perturbed task specificity, lower extremity joint moments increased or decreased at specific phases of the gait cycle in both YS and OS in slipping_Rec1 and stumbling_Rec1 compared to normal gait. The two perturbed gaits reflected the respective compensatory requirements for the lower extremity joints, with both sagittal and frontal joint moments producing compensatory effects. The aging effect was not reflected in the gait pattern, but rather in the hip extension moment during the initial stance of slipping_Rec1.

CONCLUSIONS: Slipping appears to be more demanding for gait recovery than stumbling. Gait perturbation compensatory mechanisms for OS should concentrate on ankle strategy in the frontal plane and counter-rotation strategy around the hip.

PMID:35948887 | DOI:10.1186/s12877-022-03354-3

BMC Prim Care. 2022 Aug 11;23(1):202. doi: 10.1186/s12875-022-01798-5.

ABSTRACT

BACKGROUND: People with poorly managed diabetes are at greater risk of periodontal disease. Periodontal disease that is not effectively managed can affect glycaemic levels. Diabetes care providers, including general practitioners and diabetes educators, are encouraged to promote oral health of their clients. However, valid and reliable oral health screening tools that assess the risk of poor oral health, that are easy to administer among non-dental professionals, currently do not exist. Existing screening tools are difficult to incorporate into routine diabetes consultations due to their length. Thus, this study aimed to develop and pilot a short oral health screening tool that would identify risk of existing oral diseases and encourage appropriate referrals to the dental service.

METHODS: A three-item screening tool was developed after a comprehensive review of the literature and consensus from an expert panel. The tool was then piloted as part of a larger cross-sectional survey of 260 adults with diabetes who were accessing public diabetes clinics at two locations in Sydney, Australia. As part of the survey, participants completed the three-item screening tool and a 14-item validated tool, the Oral Health Impact Profile (OHIP-14), which has been used previously in the preliminary validation of screening tools. Sensitivity and specificity analyses were then undertaken comparing the results of the two tools.

RESULTS: A statistically significant correlation was found between the shorter screening tool and the OHIP-14 (rho = 0.453, p < 0.001), indicating adequate validity. The three-item tool had high sensitivity (90.5%, 95% CI 84.9%, 94.7%), with a specificity of 46.3% (95% CI 37.7%, 55.2%). The negative predictive value was 81.4% (95% CI 71.3, 89.3). No single item performed as well regarding sensitivity and negative predictive value when compared to the three items collectively.

CONCLUSIONS: The three-item screening tool developed was found to be valid and sensitive in identifying risk of poor oral health, requiring oral health referrals, among people with diabetes in this pilot. This is a simple, accessible tool that diabetes care providers could incorporate into their routine consultations. Further validation against comprehensive dental assessments is needed to reassess the tool’s specificity and sensitivity in diverse settings.

PMID:35948883 | DOI:10.1186/s12875-022-01798-5

BMC Ophthalmol. 2022 Aug 10;22(1):341. doi: 10.1186/s12886-022-02556-y.

ABSTRACT

BACKGROUND: The aim was to evaluate the safety and efficacy of a trifocal intraocular lens (IOL) for the correction of presbyopia and to assess patient satisfaction.

METHODS: Records from three centres were reviewed to select presbyopic patients having undergone bilateral refractive lens exchange and implantation of the AT LISA tri 839MP multifocal IOL. Postoperatively, monocular and binocular distance, intermediate and near visual acuities, corrected and uncorrected, and subjective refraction were measured. Patients also completed a quality of life questionnaire. Safety evaluation included IOL stability and postoperative complications.

RESULTS: 72 eyes (36 patients) were analysed. No clinically significant difference between pre- and postoperative corrected distance visual acuity (CDVA) was found for monocular or binocular measurements. Mean postoperative monocular CDVA was 0.02 ± 0.04 logMAR. Mean refractive values all improved statistically significantly compared with preoperative baseline (p ≤ 0.0064). Overall, 82.4% of eyes had spherical equivalent within ± 0.5 D and 97.1% within ± 1.0 D of emmetropia with a mean accuracy of -0.10 ± 0.41 D. Spectacle independence for distance, intermediate and near visual acuity was 87.5%, 84.4% and 78.1% respectively, and 78.1% of patients were satisfied with their postoperative, spectacle-free vision. Eight eyes received Nd:YAG laser treatment. No other IOL-related safety issues were reported.

CONCLUSION: AT LISA tri 839MP multifocal IOL bilaterally implanted in presbyopic patients provided excellent distance, intermediate and near visual outcomes with very accurate correction of refraction. These results were associated with a high level of spectacle independence and patient satisfaction.

TRIAL REGISTRATION: Trial registered on https://clinicaltrials.gov/ under the identification NCT03790592 (31/12/2018).

PMID:35948879 | DOI:10.1186/s12886-022-02556-y

BMC Prim Care. 2022 Aug 11;23(1):205. doi: 10.1186/s12875-022-01793-w.

ABSTRACT

BACKGROUND: Depression is a major public health concern, which is most pronounced in population segments with a lower social-economic status (SES). E-health interventions for depressive complaints are proven to be effective, but their reach needs to be improved, especially among people with a lower socioeconomic status (SES). Implementing e-health interventions in the primary care setting with SES-sensitive guidance from General Practice nurses (GP nurses) may be a useful strategy to increase the reach of e-health in lower SES groups. We implemented an evidence-based online intervention that targets depressive complaints in primary care.

METHODS: A pragmatic cluster-randomised trial was conducted in two parallel groups where a SES sensitive (SES-sens) implementation strategy with additional face-to-face guidance by GP nurses was compared to an all-SES implementation strategy. The primary outcome was the percentage of lower SES participants in either condition. Participation was defined as completing at least 1 face-to-face session and 2 online exercises. Participation rates were evaluated using logistic mixed modelling.

RESULTS: In both conditions, the participation rates of lower SES participants were quite high, but were notably lower in the SES-sens implementation condition (44%) than in the all-SES implementation condition (58%). This unexpected outcome remained statistically significant even after adjusting for potential confounders between the conditions (Odds Ratio 0.43, 95%-CI 0.22 to 0.81). Less guidance was provided by the GP nurses in the SES-sens group, contrary to the implementation instructions.

CONCLUSIONS: From a public health point of view, it is good news that a substantial number of primary care patients with a lower SES level used the implemented e-health intervention. It is also positive that an all-SES implementation strategy performed well, and even outperformed a SES-sensitive strategy. However, this was an unexpected finding, warranting further research into tailoring implementation strategies of e-health interventions towards specific target groups in the primary care setting.

TRIAL REGISTRATION: Netherlands Trial Register, identifier: NL6595 , registered on 12 November 2017.

PMID:35948866 | DOI:10.1186/s12875-022-01793-w

Orthopedics. 2022 Aug 10:1-5. doi: 10.3928/01477447-20220805-01. Online ahead of print.

ABSTRACT

We compared the strength of screw vs suture button fixation in the Latarjet procedure for shoulder dislocation through biomechanical testing in a cadaver model. Cadavers were assigned randomly to receive screw or suture button fixation (both groups, n=5). The anteroposterior radius of the glenoid was measured, and a bony defect was created on the anteroinferior rim of the glenoid, equal to 25% of the width of the anteroposterior radius of the glenoid surface. The coracoid process was transferred into the newly created bony defect of the glenoid and fixed with two 3.5-mm partially threaded cannulated screws or 2 surgical buttons. All samples underwent tensile testing in the anteroinferior direction. Statistical analysis was performed to compare mean forces at failure between groups (alpha=.05). The mean force at failure was higher in the screw group (295 N; range, 103-534 N) than in the suture button group (133 N; range, 74-270 N) (P=.045). We found no difference between groups in ability to withstand a force of 150 N, which is the reported mean daily force threshold borne by the shoulder (P=.52). Screw fixation withstood a higher failure load than suture button fixation, indicating that screw fixation is a biomechanically superior option in the Latarjet procedure. The fixation methods did not differ in their ability to withstand the mean force borne by the shoulder during activities of daily living; thus, suture button fixation should be considered as an option in the Latarjet procedure. [Orthopedics. 20XX;XX(X):xx-xx.].

PMID:35947455 | DOI:10.3928/01477447-20220805-01

J Perinat Med. 2022 Aug 11. doi: 10.1515/jpm-2022-0076. Online ahead of print.

ABSTRACT

OBJECTIVES: Maternal urogenital infections during pregnancy are worldwide frequent problem. The aim was to analyze influence of maternal genitourinary infection on fetal cardiac function, pregnancy development and obstetrical outcomes.

METHODS: This was a single-center cohort study on fetuses (average at 28th week) in two groups: with maternal urogenital infections (study group n=49) and control group with no infections (n=59). Parvovirus B19, toxoplasmosis, cytomegalovirus, herpes simplex infections, congenital malformations, fetal growth restriction, chronic maternal diseases, as well as patients with body mass index (BMI) >25 kg/m2 were excluded. We analyzed: maternal age, time of delivery, neonatal birth weight, Apgar scores, average time of hospitalization of newborns after birth and several fetal echocardiographic parameters.

RESULTS: The only statistical differences was found for shorter isovolumetric relaxation time (IRT) (40 ± 10 vs. 45 ± 9; p=0.03) and longer ejection time (ET) [ms] for right ventricle (RV) (176 ± 24 vs. 164 ± 18; p=0.01). Thick placenta was observed more frequent in study group than in controls (36.7 vs. 16.9%; p= 0.02).

CONCLUSIONS: The missing link for explanation of these findings was coincidence with thick placenta. This is probably the first observation suggesting that thick placenta (>5 cm) may affect fetal RV function in normal heart anatomy: prolongation of right ventricular ET and shortening of fetal right ventricular IVRT.

PMID:35947453 | DOI:10.1515/jpm-2022-0076

JMIR Res Protoc. 2022 Aug 10;11(8):e35442. doi: 10.2196/35442.

ABSTRACT

BACKGROUND: More sensitive and less burdensome efficacy end points are urgently needed to improve the effectiveness of clinical drug development for Alzheimer disease (AD). Although conventional end points lack sensitivity, digital technologies hold promise for amplifying the detection of treatment signals and capturing cognitive anomalies at earlier disease stages. Using digital technologies and combining several test modalities allow for the collection of richer information about cognitive and functional status, which is not ascertainable via conventional paper-and-pencil tests.

OBJECTIVE: This study aimed to assess the psychometric properties, operational feasibility, and patient acceptance of 10 promising technologies that are to be used as efficacy end points to measure cognition in future clinical drug trials.

METHODS: The Method for Evaluating Digital Endpoints in Alzheimer Disease study is an exploratory, cross-sectional, noninterventional study that will evaluate 10 digital technologies’ ability to accurately classify participants into 4 cohorts according to the severity of cognitive impairment and dementia. Moreover, this study will assess the psychometric properties of each of the tested digital technologies, including the acceptable range to assess ceiling and floor effects, concurrent validity to correlate digital outcome measures to traditional paper-and-pencil tests in AD, reliability to compare test and retest, and responsiveness to evaluate the sensitivity to change in a mild cognitive challenge model. This study included 50 eligible male and female participants (aged between 60 and 80 years), of whom 13 (26%) were amyloid-negative, cognitively healthy participants (controls); 12 (24%) were amyloid-positive, cognitively healthy participants (presymptomatic); 13 (26%) had mild cognitive impairment (predementia); and 12 (24%) had mild AD (mild dementia). This study involved 4 in-clinic visits. During the initial visit, all participants completed all conventional paper-and-pencil assessments. During the following 3 visits, the participants underwent a series of novel digital assessments.

RESULTS: Participant recruitment and data collection began in June 2020 and continued until June 2021. Hence, the data collection occurred during the COVID-19 pandemic (SARS-CoV-2 virus pandemic). Data were successfully collected from all digital technologies to evaluate statistical and operational performance and patient acceptance. This paper reports the baseline demographics and characteristics of the population studied as well as the study’s progress during the pandemic.

CONCLUSIONS: This study was designed to generate feasibility insights and validation data to help advance novel digital technologies in clinical drug development. The learnings from this study will help guide future methods for assessing novel digital technologies and inform clinical drug trials in early AD, aiming to enhance clinical end point strategies with digital technologies.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35442.

PMID:35947423 | DOI:10.2196/35442

JMIR Res Protoc. 2022 Aug 10;11(8):e35729. doi: 10.2196/35729.

ABSTRACT

BACKGROUND: The health, social, and economic costs of sexually transmitted infections (STIs) represent a major public health concern. Young people are considered one of the groups most at risk for acquiring and transmitting STIs. Correct and consistent condom use has been shown to be the most effective method for reducing STIs; however, condoms are often not used properly. Evidence shows that brief behavior change interventions that focus on skills, communication, and motivation to acquire safe sex practices should be adopted into routine care to reduce STIs. Funding for sexual health services in England has declined dramatically, so novel ways of reducing clinic attendance are being sought. The home-based intervention strategy (HIS-UK) to promote condom use among young men has shown promise in feasibility and pilot studies by demonstrating high acceptability of the intervention in participant and health professional feedback, including aiding men to find condoms they like and feel more confident when using condoms.

OBJECTIVE: The aim of this study is to determine the effectiveness and cost-effectiveness of HIS-UK when compared to usual condom distribution care among young men.

METHODS: The 3 trial arms consisting of “e-HIS” (HIS-UK delivered digitally), “ProHIS” (HIS-UK delivered face-to-face), and control condition (usual National Health Service [NHS] care) will be compared against the following 3 primary outcomes: the extent to which correct and consistent condom use is increased; improvement of condom use experiences (pleasure as well as fit and feel); and decrease in chlamydia test positivity. Eligibility criteria include men aged 16-25 years at risk of STIs through reporting of condom use errors (ie, breakage or slippage) or condomless penile-vaginal or penile-anal intercourse with casual or new sexual partners during the previous 3 months. Prospective participants will be recruited through targeted advertisements and an opportunistic direct approach at selected sexual health and genitourinary medicine services and university-associated health centers and general practitioner practices. Community and educational establishments will be used to further advertise the study and signpost men to recruitment sites. Participants will be randomly allocated to 1 of 3 trial arms. A repeated measures design will assess the parallel arms with baseline and 12 monthly follow-up questionnaires after intervention and 3 chlamydia screening points (baseline, 6, and 12 months).

RESULTS: Recruitment commenced in March 2020. Due to the COVID-19 pandemic, the study was halted and has since reopened for recruitment in Summer 2021. A 30-month recruitment period is planned.

CONCLUSIONS: If effective and cost-effective, HIS-UK can be scaled up into routine NHS usual care to reduce both STI transmission in young people and pressure on NHS resources. This intervention may further encourage sexual health services to adopt digital technologies, allowing for them to become more widely available to young people while decreasing health inequalities and fear of stigmatization.

TRIAL REGISTRATION: ISRCTN Registry ISRCTN11400820; https://www.isrctn.com/ISRCTN11400820.

PMID:35947422 | DOI:10.2196/35729