Tag: statistics

Games Health J. 2023 Jul 10. doi: 10.1089/g4h.2023.0004. Online ahead of print.

ABSTRACT

Introduction: Early mobilization after surgery is crucial for reducing postoperative complications and restoring patients’ fitness and ability to care for themselves. Immersive, activity-promoting fitness games in virtual reality (VR) can be used as a low-cost motivational adjunct to standard physiotherapy to promote recovery after surgery. In addition, they have potentially positive effects on mood and well-being, which are often compromised after colorectal surgery. The purpose of this pilot study was to evaluate the feasibility and clinical outcomes of a VR-based intervention that provides additional mobilization. Methods: Patients undergoing curative surgery for colorectal cancer were randomly assigned to an intervention group or a control group. Participants in the intervention group (VR group) received daily bedside fitness exercises using immersive, activity-promoting, virtual reality fitness games in addition to standard care during their postoperative hospital stay. Results: A total of 62 patients were randomized. The feasibility outcomes were in line with the predefined goals. In the VR group, an improvement in overall mood (+0.76 points; 95% confidence interval [CI] 0.39 to 1.12; P < 0.001) and a shift toward positive feelings were observed. The median length of hospital stay was 7.0 days in the VR group compared with 9.0 days in the control group, but the difference (2.0 days) did not reach statistical significance (95% CI -0.0001 to 3.00; P = 0.076). Surgical outcomes, health status, and measures of distress did not differ between groups. Conclusions: The study demonstrated the feasibility of a VR intervention that improved overall mood and showed a desirable effect on feelings and length of hospital stay after colorectal surgery. The results should stimulate further research investigating the potential of VR as an adjunct to physiotherapy to enhance mobilization after surgery.

PMID:37428543 | DOI:10.1089/g4h.2023.0004

JMIR Res Protoc. 2023 Jul 10;12:e46649. doi: 10.2196/46649.

ABSTRACT

BACKGROUND: Health care services are being challenged by an increasing number of patients and limited resources. Hence, research investigating options to reduce costs and increase effectiveness is warranted. Digital outpatient services can provide flexible and tailored follow-up, improve patients’ health literacy, and facilitate the identification of adverse courses of disease. However, previous research largely focused on disease-specific contexts and outcomes. Therefore, research on digital services investigating generic outcomes such as health literacy is warranted.

OBJECTIVE: This article aims to describe the “digital outpatient service” intervention and present the protocol for an ongoing multicenter, nonrandomized trial evaluating this intervention.

METHODS: Based on previous experiences and evidence-based knowledge, we developed this intervention through patient-journey maps in collaboration with each clinical specialty. The patients gain access to a mobile app for self-monitoring and patient-reported outcomes and a chat for contact between the patients and health care workers. The health care workers’ dashboard includes a traffic light system to draw attention to the most urgent patient reports. In this multicenter, non-randomized controlled trial, patients are allocated to the control group receiving standard care or the 6-month intervention. Eligible patients are aged 18 years or older who receive outpatient care at the neurology, lung, pain, or cancer departments at 2 university hospitals in Norway. Our evaluation will include patient-reported outcomes, qualitative interviews, and clinical measures. The primary outcome will be health literacy using the Health Literacy Questionnaire. A sample size of 165 participants is split into a 1:2 ratio in favor of the intervention. We will analyze quantitative data in SPSS (IBM Corp) using descriptive statistics and logistic regression, and qualitative data using thematic analysis.

RESULTS: This trial started in September 2021, and the intervention started in January 2022. Recruitment has ended, with 55 patients in the control group and 107 patients in the intervention group. Follow-up is expected to end in July 2023, with results expected to be obtained in December 2023.

CONCLUSIONS: This study will evaluate an intervention facilitated by an already certified digital multicomponent solution, with intervention content based on patient-reported outcomes, health literacy, and self-monitoring. The intervention is specifically tailored to each participating center and the needs of their patients using patient journey maps. The comprehensive and generic evaluation of this digital outpatient service intervention is a strength as it targets a heterogeneous sample of patients. Thus, this study will provide important knowledge about the applicability and effects of digital health care services. As a result, patients and health care workers will gain a new, evidence-based understanding of whether and how digital tools may be used in clinical care.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05068869; https://clinicaltrials.gov/ct2/show/NCT05068869.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46649.

PMID:37428533 | DOI:10.2196/46649

J Med Internet Res. 2023 Jul 10;25:e45922. doi: 10.2196/45922.

ABSTRACT

BACKGROUND: Oral anticoagulation is the cornerstone treatment of several diseases. Its management is often challenging, and different telemedicine strategies have been implemented to support it.

OBJECTIVE: The aim of the study is to systematically review the evidence on the impact of telemedicine-based oral anticoagulation management compared to usual care on thromboembolic and bleeding events.

METHODS: Randomized controlled trials were searched in 5 databases from inception to September 2021. Two independent reviewers performed study selection and data extraction. Total thromboembolic events, major bleeding, mortality, and time in therapeutic range were assessed. Results were pooled using random effect models.

RESULTS: In total, 25 randomized controlled trials were included (n=25,746 patients) and classified as moderate to high risk of bias by the Cochrane tool. Telemedicine resulted in lower rates of thromboembolic events, though not statistically significant (n=13 studies, relative risk [RR] 0.75, 95% CI 0.53-1.07; I²=42%), comparable rates of major bleeding (n=11 studies, RR 0.94, 95% CI 0.82-1.07; I²=0%) and mortality (n=12 studies, RR 0.96, 95% CI 0.78-1.20; I²=11%), and an improved time in therapeutic range (n=16 studies, mean difference 3.38, 95% CI 1.12-5.65; I²=90%). In the subgroup of the multitasking intervention, telemedicine resulted in an important reduction of thromboembolic events (RR 0.20, 95% CI 0.08-0.48).

CONCLUSIONS: Telemedicine-based oral anticoagulation management resulted in similar rates of major bleeding and mortality, a trend for fewer thromboembolic events, and better anticoagulation quality compared to standard care. Given the potential benefits of telemedicine-based care, such as greater access to remote populations or people with ambulatory restrictions, these findings may encourage further implementation of eHealth strategies for anticoagulation management, particularly as part of multifaceted interventions for integrated care of chronic diseases. Meanwhile, researchers should develop higher-quality evidence focusing on hard clinical outcomes, cost-effectiveness, and quality of life.

TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020159208; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=159208.

PMID:37428532 | DOI:10.2196/45922

Breastfeed Med. 2023 Jul 10. doi: 10.1089/bfm.2022.0239. Online ahead of print.

ABSTRACT

Objective: To determine the prevalence of ankyloglossia in diamniotic monochorionic and diamniotic dichorionic twins, as well as to verify the relationship between gender and type of pregnancy. Study Design: A cross-sectional observational study, carried out with 52 pairs of dichorionic/diamniotic twins and 49 monochorionic/diamniotic pairs. The data collection was carried out through the analysis of medical records and the results of the Neonatal Screening of the Tongue Frenulum Assessment Protocol in Babies, and corresponded to the period of 2 years (2020-2022). Statistical analysis of data was performed, considering the significance value of 5%. The study was approved by the Human Research Ethics Committee of the institution. Results: The statistical analysis of multiple logistic regression between the two groups of twins (Mono/Di and Di/Di) according to the socioeconomic, demographic, and clinical-epidemiological profile was statistically significant for some variables. The prevalence of ankyloglossia, according to the type of twin pregnancy, showed a statistically significant difference. There was no statistical difference in relation to sex and ankyloglossia, or between couples diagnosed with ankyloglossia according to the type of pregnancy. Conclusion: Monochorionic/diamniotic twins had a higher prevalence of ankyloglossia, regardless of gender.

PMID:37428528 | DOI:10.1089/bfm.2022.0239

J Med Internet Res. 2023 Jul 10;25:e37140. doi: 10.2196/37140.

ABSTRACT

BACKGROUND: Latinx populations are severely underrepresented among organ donors compared with the non-Hispanic White population. The Promotoras de Donación e-learning module was developed to train Latinx lay health educators (ie, promotoras) to discuss deceased organ donation and promote donor designation within their communities.

OBJECTIVE: This paper described the results of 2 studies designed to assess the direct and indirect effects of the module on promotoras’ and mature Latinas’ organ donation and donor designation knowledge, attitudes, and behaviors.

METHODS: In partnership with 4 community-based promotoras organizations, we designed 2 nonrandomized, quasiexperimental pragmatic studies to evaluate the Promotoras de Donación e-learning module, with participating promotoras and mature Latinas serving as their own controls. Brief surveys were administered to participating promotoras before and after module completion to assess changes in organ donation knowledge and support and communication confidence (study 1). Promotoras participating in the first study were asked to hold at least 2 group conversations about organ donation and donor designation with mature Latinas (study 2); paper-pencil surveys were completed by all participants before and after the group conversations. Descriptive statistics, means and SDs, and counts and percentages were used as appropriate to categorize the samples. Paired sample 2-tailed t test was used to assess changes in knowledge of and support for organ donation and confidence in discussing donation and promoting donor designation from pre- to posttest.

RESULTS: Overall, 40 promotoras completed this module (study 1). Increases in organ donation knowledge (mean 6.0, SD 1.9 to mean 6.2, SD 2.9) and support (mean 3.4, SD 0.9 to mean 3.6, SD 0.9) were observed from pre- to posttest; however, these changes did not reach statistical significance. A statistically significant increase in communication confidence was found (mean 692.1, SD 232.4 to mean 852.3, SD 139.7; P=.01). The module was well received, with most participants deeming it well organized, presenting new information, and providing realistic and helpful portrayals of donation conversations. A total of 52 group discussions with 375 attendees were led by 25 promotoras (study 2). The trained promotora-led group discussions about organ donation resulted in increased support for organ donation in promotoras and mature Latinas from pre- to posttest. Knowledge of the steps to become an organ donor and belief that the process is easy to perform increased in mature Latinas from pre- to posttest by 30.7% and 15.2%, respectively. In total, 5.6% (21/375) of attendees submitted completed organ donation registration forms.

CONCLUSIONS: This evaluation provides preliminary support for the module’s direct and indirect effects on organ donation knowledge, attitudes, and behaviors. The need for additional modifications to and future evaluations of the module are discussed.

PMID:37428526 | DOI:10.2196/37140

J Spinal Cord Med. 2023 Jul 10:1-9. doi: 10.1080/10790268.2023.2231674. Online ahead of print.

ABSTRACT

PURPOSE: To examine the interrelationship of pulse duration and pulse frequency on torque production and muscle fatigue in both impaired and non-impaired skeletal muscle of men and women.

METHODS: Individuals with [n = 14 (6 females), 38 ± 13 yr; 175 ± 11 cm; 76 ± 20 kg] and without [n = 14 (6 females), 29 ± 8 yr; 175 ± 9 cm; 74 ± 14 kg] spinal cord injury (SCI) participated. Muscle torque was recorded during a series of NMES-induced isometric muscle contractions using different combinations of pulse durations and frequencies. Additionally, two different muscle fatigue protocols (20 and 50 Hz/200µs) were utilized to elicit repeat isometric muscle contractions (1s on and 1s off × 3 min).

RESULTS: There was a statistically significant linear trend for pulse charge (the product of pulse frequency and pulse duration) on isometric torque production in participants without (p < 0.001, η² = 0.79), and in participants with SCI (p < 0.001, η² = 0.66), with higher total pulse charge generating higher torque values. Participants with SCI had significantly greater muscle fatigue for both muscle fatigue protocols (p < 0.05).

CONCLUSIONS: NMES protocols should consider using longer pulse durations with lower frequencies to maximize force production for individuals with SCI. However, because mechanisms of muscle fatigue may be different for impaired muscle when compared to non-impaired muscle, further studies on protocols to offset fatigue are warranted.

PMID:37428446 | DOI:10.1080/10790268.2023.2231674

Spine Deform. 2023 Jul 10. doi: 10.1007/s43390-023-00719-5. Online ahead of print.

ABSTRACT

PURPOSE: Assess normative values of sagittal spinal and lower extremity alignment in asymptomatic volunteers of three difference races.

METHODS: Asymptomatic volunteers between the ages of 18-80 years were enrolled prospectively and then analyzed retrospectively from six different centers. Volunteers included reported no significant neck or back pain, nor any known spinal disorder(s). All volunteers underwent a standing full-body or full-spine low dose stereoradiograph. Volunteers were grouped into three main races; Asian (A), Arabo-Bèrbère (B), and Caucasian (C). The Asian volunteers included in this study were from Japan and Singapore.

RESULTS: There were statistical differences in the Age, ODI, and BMI of the volunteers from the three different races. Asian volunteers had the lowest age (A: 36.7, B: 45.5, C: 42.0) and BMI (A: 22.1, B: 27.1, C: 27.3). Pelvic morphology including pelvic incidence (A: 51.0, B: 52.0, C: 52.5, p = 0.37), pelvic tilt (A: 11.9, B: 12.3, C: 12.9, p = 0.44), and sacral slope (A: 39.1, B: 39.7, C: 39.6, p = 0.77) were similar amongst the 3 races. Regional spinal alignment was different between the groups. Thoracic Kyphosis (A: 32.9, B: 43.3, C: 40.0, p < 0.0001) and Lumbar lordosis (A: – 54.2, B: – 60.4, C: – 59.6, p < 0.0001) were lower in Asians compared to Caucasian and Arabo-Bèrbère volunteers despite having similar pelvic incidence.

CONCLUSION: Volunteers in the Asian group had lower lumbar lordosis and thoracic kyphosis when compared to the Arabo-Bèrbère and Caucasian groups while all groups had similar pelvic morphology. Thoracic Kyphosis had no correlation with Pelvic Incidence, while Lumbar Lordosis correlated well with both Thoracic Kyphosis and Pelvic Incidence. Thoracic kyphosis may be an independent variable in establishing adequate lumbar lordosis and varies based on an individual’s race.

PMID:37428432 | DOI:10.1007/s43390-023-00719-5

Aging Clin Exp Res. 2023 Jul 10. doi: 10.1007/s40520-023-02475-y. Online ahead of print.

ABSTRACT

BACKGROUND: Several tools have revealed an association between potentially inappropriate medications (PIM) and adverse outcomes, but the one most fitted for the rural population has not been determined.

AIMS: We investigated the performance of the Screening Tool of Older Persons’ Prescriptions (STOPP) and Screening Tool to Alert doctors to the Right Treatment (START) in identifying inappropriate prescribing and its association with adverse outcomes among older rural primary health care users.

METHODS: A cohort of consenting outpatients aged ≥ 65 years in a rural Greek primary care center was assessed for PIM and potential prescribing omissions (PPO) using the START/STOPP version 2 criteria. Medications, comorbidities, functional status, and laboratory data were recorded along with 6-month incidence of emergency department visits, hospitalization, and death prospectively.

RESULTS: Among 104 participants (median age 78 years, 49.1% women, receiving a median of 6 drugs), PPO was found in 78% and PIMs in 61%. PIM was multivariately correlated with multimorbidity (p = 0.029) and polypharmacy (p < 0,001), while drug-PPO was only associated with multimorbidity (p = 0.039). The number of PIM predicted emergency department visits and hospitalizations at 6-month follow-up (p value 0.011), independent of age, sex, frailty, comorbidities, and total medication number.

DISCUSSION: The START/STOPP tool is useful in identifying inappropriate prescribing patterns leading to increased utilization of acute care services in older adults followed at a rural primary care setting.

CONCLUSION: Inappropriate prescribing as identified by the START/STOPP criteria is prevalent among older adults with multimorbidity in rural primary care, and independently associated with future acute care visits.

PMID:37428424 | DOI:10.1007/s40520-023-02475-y

Ir J Med Sci. 2023 Jul 10. doi: 10.1007/s11845-023-03454-y. Online ahead of print.

ABSTRACT

BACKGROUND: It is known that vertical transmission of various infections poses a potential risk to the fetus, especially in early pregnancy. Potential effects of SARS-CoV-2 infection on early pregnancy and placental formation and functions still remain unknown.

AIM: To determine the alterations of prenatal aneuploidy screening markers in a group of pregnant women who were SARS-CoV-2 positive during the first trimester. The secondary goal was to assess pregnancy loss rates.

METHOD: The study group consisted of pregnant women who were diagnosed with mild forms of SARS-CoV-2 infection before the screening test at any time in early pregnancy. The control group included pregnant women who were not diagnosed with SARS-CoV-2 infection during their pregnancy. SARS-CoV-2 infection was detected by RT-PCR in the nasopharyngeal swab samples. Multivariate linear regression analysis was performed due to evaluate effect of SARS-CoV-2 infection on NT and serum aneuploidy screening parameters taking maternal age and gestational age which the COVID-19 RT-PCR test result was positive into account.

RESULTS: We did not find any significant difference between the COVID-19-positive and COVID-negative groups in gestational age at screening, sonographic measurements of CRL, NT, and serum levels of PAPP-A, free hCG, and triple test serum markers even after accounting for maternal age and gestational age which the COVID-19 RT-PCR test result was positive. There was no statistically significant difference in pregnancy loss.

CONCLUSIONS: We did not find any evidence for unfavorable prenatal biochemical, ultrasound markers of fetal aneuploidy screening tests, and pregnancy loss rates in our study group.

PMID:37428422 | DOI:10.1007/s11845-023-03454-y

EJNMMI Res. 2023 Jul 10;13(1):66. doi: 10.1186/s13550-023-01015-z.

ABSTRACT

BACKGROUND: This study aimed to retrospectively evaluate the feasibility of total-body ¹⁸F-FDG PET/CT ultrafast acquisition combined with a deep learning (DL) image filter in the diagnosis of colorectal cancers (CRCs).

METHODS: The clinical and preoperative imaging data of patients with CRCs were collected. All patients underwent a 300-s list-mode total-body ¹⁸F-FDG PET/CT scan. The dataset was divided into groups with acquisition durations of 10, 20, 30, 60, and 120 s. PET images were reconstructed using ordered subset expectation maximisation, and post-processing filters, including a Gaussian smoothing filter with 3 mm full width at half maximum (3 mm FWHM) and a DL image filter. The effects of the Gaussian and DL image filters on image quality, detection rate, and uptake value of primary and liver metastases of CRCs at different acquisition durations were compared using a 5-point Likert scale and semi-quantitative analysis, with the 300-s image with a Gaussian filter as the standard.

RESULTS: All 34 recruited patients with CRCs had single colorectal lesions, and the diagnosis was verified pathologically. Of the total patients, 11 had liver metastases, and 113 liver metastases were detected. The 10-s dataset could not be evaluated due to high noise, regardless of whether it was filtered by Gaussian or DL image filters. The signal-to-noise ratio (SNR) of the liver and mediastinal blood pool in the images acquired for 10, 20, 30, and 60 s with a Gaussian filter was lower than that of the 300-s images (P < 0.01). The DL filter significantly improved the SNR and visual image quality score compared to the Gaussian filter (P < 0.01). There was no statistical difference in the SNR of the liver and mediastinal blood pool, SUVmax and TBR of CRCs and liver metastases, and the number of detectable liver metastases between the 20- and 30-s DL image filter and 300-s images with the Gaussian filter (P > 0.05).

CONCLUSIONS: The DL filter can significantly improve the image quality of total-body ¹⁸F-FDG PET/CT ultrafast acquisition. Deep learning-based image filtering methods can significantly reduce the noise of ultrafast acquisition, making them suitable for clinical diagnosis possible.

PMID:37428417 | DOI:10.1186/s13550-023-01015-z