Tag: statistics

JCI Insight. 2022 Jun 28:e159930. doi: 10.1172/jci.insight.159930. Online ahead of print.

ABSTRACT

Disrupted liver regeneration following hepatectomy represents an “undruggable” clinical challenge associated with poor patient outcomes. Yes-associated protein (YAP), a transcriptional co-activator which is repressed by the Hippo pathway, is instrumental in liver regeneration. We have previously described an alternative, Hippo-independent mechanism of YAP activation mediated by tyrosine-protein phosphatase non-receptor type 11 (SHP2) inhibition. Herein, we examined the effects of YAP activation with a selective SHP1/SHP2 inhibitor, NSC-87877, on liver regeneration in murine partial hepatectomy models. In our studies, NSC-87877 led to accelerated hepatocyte proliferation, improved liver regeneration, and decreased markers of injury following partial hepatectomy. The effects of NSC-87877 were lost in mice with hepatocyte-specific Yap/Taz deletion, which demonstrated dependence on these molecules for the enhanced regenerative response. Furthermore, administration of NSC-87877 to murine models of non-alcoholic steatohepatitis was associated with improved survival and decreased markers of injury post-hepatectomy. Evaluation of transcriptomic changes in the context of NSC-87877 administration revealed reduction in fibrotic signaling and augmentation of cell cycle signaling. Cytoprotective changes included downregulation of Nr4a1, an apoptosis inducer. Collectively, the data suggest that SHP2 inhibition induces a pro-proliferative and cytoprotective enhancement of liver regeneration dependent on YAP.

PMID:35763355 | DOI:10.1172/jci.insight.159930

BMJ Open. 2021 Dec 30;11(12):e052922. doi: 10.1136/bmjopen-2021-052922.

ABSTRACT

INTRODUCTION: Postpartum depression affects 10%-15% of women and has a recurrence rate of 40% in subsequent pregnancies. Women who develop postpartum depression are suspected to be more sensitive to the rapid and large fluctuations in sex steroid hormones, particularly estradiol, during pregnancy and postpartum. This trial aims to evaluate the preventive effect of 3 weeks transdermal estradiol treatment immediately postpartum on depressive episodes in women at high risk for developing postpartum depression.

METHODS AND ANALYSIS: The Maternal Mental Health Trial is a double-blind, randomised and placebo-controlled clinical trial. The trial involves three departments of obstetrics organised under Copenhagen University Hospital in Denmark. Women who are singleton pregnant with a history of perinatal depression are eligible to participate. Participants will be randomised to receive either transdermal estradiol patches (200 µg/day) or placebo patches for 3 weeks immediately postpartum. The primary outcome is clinical depression, according to the Diagnostic and Statistical Manual of Mental Disorders-V criteria of Major Depressive Disorder with onset at any time between 0 and 6 months postpartum. Secondary outcomes include, but are not limited to, symptoms of depression postpartum, exclusive breastfeeding, cortisol dynamics, maternal distress sensitivity and cognitive function. The primary statistical analysis will be performed based on the intention-to-treat principle. With the inclusion of 220 participants and a 20% expected dropout rate, we anticipate 80% power to detect a 50% reduction in postpartum depressive episodes while controlling the type 1 error at 5%.

ETHICS AND DISSEMINATION: The study protocol is approved by the Regional Committees on Health Research Ethics in the Capital Region of Denmark, the Danish Medicines Agency and the Centre for Data Protection Compliance in the Capital Region of Denmark. We will present results at scientific meetings and in peer-reviewed journals and in other formats to engage policymakers and the public.

TRIAL REGISTRATION NUMBER: NCT04685148.

PMID:35763351 | DOI:10.1136/bmjopen-2021-052922

Rev Med Inst Mex Seguro Soc. 2022 May 2;60(3):289-296.

ABSTRACT

BACKGROUND: The recent pandemic has presented several challenges in relation to patient safety with the increase of cognitive, depressive and anxiety symptoms in health workers due to the fear of being infected from COVID-19.

OBJECTIVE: To determine the relationship between anxiety, depression and fear of COVID-19, with the perception of the patient safety environment in medical residents.

MATERIAL AND METHODS: Observational, cross-sectional, prospective and analytical study. 258 subjects were surveyed. Medical residents who agreed to participate, whose age or sex was of no importance, were included. It was assessed the perception of the patient safety environment through the self-administered Agency for Healthcare Research and Quality (AHRQ) questionnaire; the depression and anxiety symptoms by using Beck’s self-applied inventories for each entity, and the fear of COVID-19 by using a scale developed with the same name. The Pearson correlation coefficient was calculated.

RESULTS: A negative linear relationship was found within most of the dimensions explored by the AHRQ questionnaire and the Beck Anxiety Inventory. This relationship was observed too with the Beck Depression Inventory, except in 3 of those dimensions. No statistically significant relationship was found in the Fear of COVID-19 scale.

CONCLUSIONS: There is a relationship between the degree of anxiety and depression symptoms in residents with the results in the AHRQ questionnaire; however, this result is not reproducible with the Fear of COVID-19 test or other sociodemographic measurement parameters.

PMID:35763344

JMIR Perioper Med. 2022 Jun 28;5(1):e35997. doi: 10.2196/35997.

ABSTRACT

BACKGROUND: Postoperative care is influenced by various factors such as compliance, comprehension, retention of instructions, and other unaccounted elements. It is imperative that patients adhere to the instructions and prescribed regimen for smooth and placid healing. ExoDont, an Android-based mobile health app, was designed to ensure a smooth postoperative period for patients after a dental extraction. Besides providing postoperative instructions at defined intervals, the app also sends drug reminders as an added advantage over other available, conventional methods.

OBJECTIVE: The aim of this study was to compare the compliance rate of individuals with respect to the prescribed regimen and postoperative instructions. Additionally, we aimed to assess any changes in the postoperative complication rate of patients assigned to 3 categories: the verbal, verbal plus written, and ExoDont app-based delivery groups.

METHODS: We conducted a pilot, nonrandomized, and prospective comparative study in which patients after tooth extraction were assigned to 3 groups-verbal (Group A), verbal plus written (Group B), and ExoDont app-based delivery (Group C)-based on the eligibility criteria, and a 1-week follow-up was planned to obtain the responses regarding compliance and postoperative complications from the participants.

RESULTS: In total, 90 patients were recruited and equally divided into 3 groups. Compliance to prescribed drug was found to be the highest in Group C, where of the 30 participants, 25 (83%) and 28 (93%) followed the entire course of antibiotics and analgesics, respectively. For postoperative instructions, higher compliance was observed in Group C in relation to compliance to diet restrictions (P=.001), not rinsing for 24 hours (P<.001), and warm saline rinses after 24 hours (P=.001). However, the difference was not significant for smoking restrictions (P=.07) and avoiding alcohol (P=.16). Moreover, the difference in postoperative complication rate was not statistically significant among the 3 groups (P=.31).

CONCLUSIONS: As evident from the results, it is anticipated that the ExoDont app will be helpful in circumventing the unaccounted possibilities of missing the prescribed dosage and postoperative instructions and ensuring the smooth recovery of patients after dental extraction. However, future studies are required to establish this app-based method of delivery of postoperative instructions as a viable option in routine clinical practice.

PMID:35763332 | DOI:10.2196/35997

J Med Internet Res. 2022 Jun 28;24(6):e36809. doi: 10.2196/36809.

ABSTRACT

BACKGROUND: Emerging studies have shown the effectiveness of mobile health (mHealth) interventions in reducing depressive symptoms among people living with HIV. Most of these studies included only short-term follow-up, with limited data on long-term effects.

OBJECTIVE: The purpose of this study is to assess the long-term effects of a randomized controlled trial called Run4Love on depressive symptoms among people living with HIV at 1-year and 3-year follow-ups.

METHODS: A total of 300 people living with HIV with depressive symptoms were recruited and randomized to an intervention or a control group in Guangzhou, China, from September 2017 to January 2018. The intervention group received a 3-month Run4Love program, including adapted evidence-based cognitive behavioral stress management courses and exercise promotion via WeChat (Tencent), a popular social media app. The control group received usual care and a brochure on nutrition. The primary outcome was reduction in depressive symptoms, measured using the Center for Epidemiological Studies-Depression (CES-D) scale. Data used in this study were collected at baseline and at the 1-year and 3-year follow-ups. Generalized estimating equations were used to examine the group differences at 1-year and 3-year follow-ups.

RESULTS: Approximately half of the participants completed the assessment at 1-year (149/300, 49.7%) and 3-year (177/300, 59%) follow-ups. At 1-year follow-up, participants in the intervention group reported significant reduction in depressive symptoms compared with the control group (CES-D: from 23.9 to 18.1 in the intervention group vs from 24.3 to 23.3 in the control group; mean -4.79, SD 13.56; 95% CI -7.78 to -1.81; P=.002). At 3-year follow-up, between-group difference in CES-D remained statistically significant (from 23.9 to 20.5 in the intervention group vs from 24.3 to 24.4 in the control group; mean -3.63, SD 13.35; 95% CI -6.71 to -0.54; P=.02). No adverse events were reported during the 3-year follow-up period.

CONCLUSIONS: The mHealth intervention, Run4Love, significantly reduced depressive symptoms among people living with HIV, and the intervention effects were sustained at 1-year and 3-year follow-ups. Further research is needed to explore the mechanisms of the long-term effects of mHealth interventions such as Run4Love and to implement these effective interventions among people living with HIV.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-IPR-17012606.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10274.

PMID:35763324 | DOI:10.2196/36809

JAMA Netw Open. 2022 Jun 1;5(6):e2219113. doi: 10.1001/jamanetworkopen.2022.19113.

ABSTRACT

IMPORTANCE: Virtual wards (VWs) include patient assessment in their homes by health care personnel and offer ongoing assessment and case management via home, telephone, and/or clinic visits. The association between VWs and patient outcomes during the transition from the hospital to home are unclear; earlier reviews on this topic have often conflated telemonitoring programs with VW models.

OBJECTIVE: To evaluate the use of VW transition systems for community-dwelling individuals after medical discharge.

DATA SOURCES: English-language articles indexed in PubMed or Cochrane and published between January 1, 2000, and June 15, 2021.

STUDY SELECTION: Randomized clinical trials comparing VW care with usual postdischarge care. Studies were stratified by diagnosis.

DATA EXTRACTION AND SYNTHESIS: Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline, 2 reviewers independently identified studies and extracted data. DerSimonian-Laird inverse variance weighted random-effects models were used to compute relative risks (RRs) for dichotomous outcomes and mean differences for continuous outcomes.

MAIN OUTCOMES AND MEASURES: All-cause mortality, hospital readmissions, emergency department visits, health care costs, readmission length of stay, quality of life, and functional status.

RESULTS: Twenty-four randomized clinical trials (11 in patients with heart failure, 3 in patients with chronic obstructive pulmonary disease, 4 in patients at high-risk for readmission, and 6 in mixed patient populations) with 10 876 patients were included (20 more trials than earlier reviews). In patients with heart failure, VWs were associated with fewer deaths (RR, 0.86; 95% CI, 0.76-0.97) and fewer readmissions (RR, 0.84; 95% CI, 0.74-0.96). However, similar associations were not seen in randomized clinical trials enrolling patients with other diagnoses (RR, 0.93; 95% CI, 0.83-1.04 for mortality and RR, 0.96; 95% CI, 0.88-1.05 for readmissions). Across all studies, VWs were associated with fewer emergency department visits (RR, 0.83; 95% CI, 0.70-0.98) and shorter readmission lengths of stay (mean difference, -1.94 days; 95% CI, -3.28 to -0.60 days). Three of 7 studies that evaluated health care expenses reported statistically significant lower costs with VW transition systems.

CONCLUSIONS AND RELEVANCE: Although postdischarge VW interventions appear to be associated with fewer subsequent emergency department visits, shorter readmission lengths of stay, and lower health care costs, fewer deaths and readmissions were seen only in trials enrolling patients with heart failure.

PMID:35763296 | DOI:10.1001/jamanetworkopen.2022.19113

Radiol Med. 2022 Jun 28. doi: 10.1007/s11547-022-01511-7. Online ahead of print.

ABSTRACT

BACKGROUND: ARTO trial was designed to evaluate the difference in terms of outcomes between patients affected by oligo metastatic castrate resistant prostate cancer (mCRPC) treated with Abiraterone acetate and randomized to receive or not SBRT on all sites of disease. Here, we present a preliminary analysis conducted on patients enrolled at promoting institution.

OBJECTIVE: To present a preliminary overview about population features, clinical outcomes, adverse events, quality of life and explorative translational research.

DESIGN, SETTING, AND PARTICIPANTS: ARTO (NCT03449719) is a phase II trial including patients affected by oligo mCRPC, randomized to receive standard of care (GnRH agonist or antagonist plus abiraterone acetate 1000 mg and oral prednisone 10 mg daily) with or without SBRT on all metastatic sites of disease. All subjects have < 3 bone or nodal metastases. All patients are treated in I line mCRPC setting, no previous lines of treatment for mCRPC are allowed.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Data about a mono-centric cohort of 42 patients enrolled are presented in the current analysis, with focus on baseline population features, PSA drop at 3 months, biochemical response, and quality of life outcomes. Descriptive statistics regarding translational research are also presented.

RESULTS AND LIMITATION: Significant difference in terms of PSA drop at three months was not detected (p = 0.68). Biochemical response (PSA reduction > 50%) was reported in 73.7 versus 76.5% of patients in control vs SBRT arm, respectively (p = 0.84). All patients are alive. Progression occurred in 1 versus 0 patients in the control versus SBRT arm, respectively. After 3 months, an average decrease of 13 points in terms of Global Health Score was reported for the overall population. However, complete recovery was noticed at 6 months. Circulating tumor cells detection rate was 40%.

CONCLUSIONS: SBRT + Abiraterone treatment was safe and well tolerated, non-significant trend in terms of PSA drop and biochemical response at 3 months was detected in SBRT arm. Interestingly, CTCs detection in this selected cohort of oligo-mCRPC was lower if compared to historical data of unselected mCRPC patients.

PMID:35763249 | DOI:10.1007/s11547-022-01511-7

JAMA Netw Open. 2022 Jun 1;5(6):e2219122. doi: 10.1001/jamanetworkopen.2022.19122.

ABSTRACT

IMPORTANCE: Cancer outcomes are relatively poor in adults who belong to minoritized racial and ethnic groups. Survival and long-term outcomes by race and ethnicity in individuals with childhood cancers are less studied.

OBJECTIVE: To evaluate survival and hospitalization among American Indian and Alaska Native, Asian, Black, and Hispanic children compared with non-Hispanic White children with cancer.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study evaluated all individuals born in Washington State who were younger than 20 years (hereafter referred to as children) and had been diagnosed with cancer during 1987 to 2012, with follow-up ranging from 1 to 27 years. The data subset was built in 2019, and statistical analyses were completed in January 2022.

EXPOSURES: Race and ethnicity.

MAIN OUTCOMES AND MEASURES: Mortality and hospitalization events for all other racial and ethnic groups relative to non-Hispanic White children estimated by Cox proportional hazards regressions for the first 5 years after diagnosis and among cancer survivors 5 or more years after diagnosis.

RESULTS: A total of 4222 children (mean [SD] age, 8.4 [6.4] years; 2199 [52.1%] male; 113 American Indian and Alaska Native [2.7%], 311 Asian [7.4%], 196 Black [4.6%], 387 Hispanic [9.2%], and 3215 non-Hispanic White [76.1%]) with cancer diagnosed at younger than 20 years during 1987 to 2012 were included. Mortality was similar across all groups. Compared with non-Hispanic White survivors at less than 5 years after diagnosis, there were no greatly increased hazard ratios (HRs) for hospitalization. Among survivors at 5 or more years after diagnosis, hospitalization HRs were 1.7 (95% CI, 1.0-3.0) for American Indian and Alaska Native survivors and 1.5 (95% CI, 0.9-2.4) for Black survivors. Significantly increased HRs among Hispanic children were observed for infection-related (HR, 1.4; 95% CI, 1.2-1.6), endocrine-related (HR, 1.3; 95% CI, 1.1-1.6), hematologic-related (HR, 1.3; 95% CI, 1.1-1.5), respiratory-related (HR, 1.3; 95% CI, 1.0-1.5), and digestive-related (HR, 1.2; 95% CI, 1.0-1.5) conditions. American Indian and Alaskan Native children had increased HRs for infection-related (HR, 2.3; 95% CI, 1.2-4.5), hematologic-related (HR, 3.0; 95% CI, 1.4-6.5), and digestive-related (HR, 2.6; 95% CI, 1.3-5.4) conditions. Both American Indian and Alaska Native (HR, 3.6; 95% CI, 1.4-9.0) and Black (HR, 2.5; 95% CI, 1.2-5.5) children had increased mental health-related hospitalizations and death.

CONCLUSIONS AND RELEVANCE: In this cohort study, disproportionately increased long-term risks of hospitalization for physical and mental conditions may have contributed to worse outcomes by race. A key component to bridging the morbidity gap by race is improved understanding of reasons for greater cause-specific hospitalizations in some groups, with development of culturally appropriate intervention strategies.

PMID:35763295 | DOI:10.1001/jamanetworkopen.2022.19122

Eur Arch Paediatr Dent. 2022 Jun 28. doi: 10.1007/s40368-022-00724-8. Online ahead of print.

ABSTRACT

AIM: This study aimed to estimate the prevalence of a self-reported history of restraint in children and adolescents when receiving dental care by non-specialist dentists and to assess differences in dental fear and anxiety (DFA), intra-oral injection fear, and trust in dentists between patients with and without a self-reported history of restraint.

METHODS: An electronic cross-sectional survey was distributed to all 9 years old (n = 6686) and 17 years old (n = 6327) in the Public Dental Service in Hordaland County, Norway, in 2019. For statistical evaluation, we generated descriptive statistics and Mann-Whitney U tests.

RESULTS: The response rate ranged between 43.5 and 59.9% for the different questions. The prevalence of a self-reported history of being held still against one’s will during dental treatment and pressured to undergo dental treatment against one’s will was 3.6% and 5.1%, respectively. In general, these patients reported higher DFA, and higher intra-oral injection fear compared with those without such histories of restraint. Patients who had reported being held still against their will during dental treatment had significantly higher distrust in dentists than those who did not report restraint (p < 0.001).

CONCLUSION: To feel pressured to receive dental treatment and to be held still against one’s will overlap with the concepts of psychological and physical restraint. Patients with a self-reported history of restraint recorded significant differences in DFA, intra-oral injection fear, and trust in dentists compared to those who did not report restraint. Future studies should explore the role that restraint may play in relation to a patient’s DFA, intra-oral injection fear, and trust in dentists.

PMID:35763246 | DOI:10.1007/s40368-022-00724-8

Jpn J Radiol. 2022 Jun 28. doi: 10.1007/s11604-022-01301-1. Online ahead of print.

ABSTRACT

PURPOSE: To explore the CT findings and pneumonnia progression pattern of the Alpha and Delta variants of SARS-CoV-2 by comparing them with the pre-existing wild type.

METHOD: In this retrospective comparative study, a total of 392 patients with COVID-19 were included: 118 patients with wild type (70 men, 56.8 ± 20.7 years), 137 with Alpha variant (93 men, 49.4 ± 17.0 years), and 137 with Delta variant (94 men, 45.4 ± 12.4). Chest CT evaluation included opacities and repairing changes as well as lesion distribution and laterality. Chest CT severity score was also calculated. These parameters were statistically compared across the variants.

RESULTS: Ground glass opacity (GGO) with consolidation and repairing changes were more frequent in the order of Delta variant, Alpha variant, and wild type throughout the disease course. Delta variant showed GGO with consolidation more conspicuously than did the other two on days 1-4 (vs. wild type, Bonferroni corrected p = 0.01; vs. Alpha variant, Bonferroni corrected p = 0.003) and days 5-8 (vs. wild type, Bonferroni corrected p < 0.001; vs. Alpha variant, Bonferroni corrected-p = 0.003). Total lung CT severity scores of Delta variant were higher than those of wild type on days 1-4 and 5-8 (Bonferroni corrected p = 0.01 and Bonferroni corrected p = 0.005, respectively) and that of Alpha variant on days 1-4 (Bonferroni corrected p = 0.002). There was no difference in the CT findings between wild type and Alpha variant.

CONCLUSIONS: Pneumonia progression of Delta variant may be more rapid and severe in the early stage than in the other two.

PMID:35763239 | DOI:10.1007/s11604-022-01301-1