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Informed consent | Informed consent was obtained from all subjects involved in the study. | PMC10117252 | ||
Institutional review board statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of Centro Hospitalar de São João. (Approval code: 11/2019, approval date: 15 February 2019). Trial registration number NCT03974477 ( | PMC10117252 | ||
References | PMC10117252 | |||
Highlights | lung cancer | LUNG CANCER |
Our model including six epidemiological components was successfully validated on both internal and external validation.Risk stratification by the model showed significantly different survival patterns even after discharge.Three well-developed interfaces are friendly to both physicians and patients for prognosis-relate... | PMC10451707 |
1. Introduction | lung cancer | LUNG CANCER | In 2022, there were approximately two million new cases of lung cancer diagnosed in the U.S. [For decades, cutting-edge studies in lung cancer treatment focusing on molecular insights, especially in immune checkpoint inhibitors, have resulted in remarkable findings [The scientific development in screening and treatment... | PMC10451707 |
2. Materials and Methods | PMC10451707 | |||
2.1. Data Processing | tumor, primary lung tumors | TUMOR | We accessed the SEER program to retrieve information about patients with primary lung tumors. There was a total of 523,941 patients with clinical data, including age, gender, race, tumor size, TNM stages, AJCC stages, overall survival (OS) time, and OS status. We excluded cases with Tis and T0 in the T stage ( | PMC10451707 |
2.2. Defining In-Hospital Mortality | lung cancer, death | LUNG CANCER | We defined in-hospital mortality in SEER as (1) OS time is ≤ 1 month after diagnosis and (2) OS status is death. Patients without OS time or OS status were excluded from the analysis. Of note, patients who passed after 1 month (OS time > 1 month) were considered to have no in-hospital mortality. Although the definition... | PMC10451707 |
2.3. Model Training | tumor, AJCC | REGRESSION, TUMOR | We divided the training process into 3 phases: statistical selection, information selection, and model fitting. The statistical selection phase included univariate and multivariate logistic regression analyses of interested variables with regard to in-hospital mortality. The information selection phase considered the v... | PMC10451707 |
2.4. Model Evaluation | The model evaluation section consisted of 3 parts, (1) internal validation, (2) external validation with data imputation, and (3) sensitivity analysis. In internal validation, we performed receiver operating characteristics (ROC) analysis and bootstrap-estimated calibration in both training data and validation data. In... | PMC10451707 | ||
2.5. Analysis Platform | Descriptive statistics of continuous and categorical variables were median (range) and the number of cases (percentage). We used Wilcoxon and chi-square tests to compare the difference in continuous and categorical features, respectively. The HI-VAE model was trained, using the original pipeline published by Nazabal et... | PMC10451707 | ||
3. Results | PMC10451707 | |||
3.1. Patient Characteristics | We described and compared the clinical features of training ( | PMC10451707 | ||
3.2. Model Training | tumor | TUMOR | First, we listed the interested variables (predictors), including age, gender, race, tumor size, TNM stages, and AJCC stages. The first phase involved the statistical selection of these variables to build a simpler version of the model. | PMC10451707 |
3.3. Model Evaluation | In internal validation, we performed ROC analyses on training and validation data. | PMC10451707 | ||
3.4. Risk Stratification by the Model | We performed a simple K-means clustering algorithm to examine the distribution of the risk values yielded by the model. We then calculated the predictive scores of each patient in the validation ( | PMC10451707 | ||
3.5. Applications of the Model | In this section, we created 3 interfaces to use the model, including a static nomogram ( | PMC10451707 | ||
4. Discussion | NSCLC, SCLC, tumor, primary cancer, lung cancer, primary lung cancer | TUMOR, PRIMARY TUMORS, METASTASIS, SCLC, LUNG METASTASIS, DISEASE, LUNG CANCER, SAID, NSCLC, PRIMARY CANCER | The model with six fundamental variables including age, gender, tumor size, T, N, and AJCC stages which were initially built to predict the in-hospital mortality of new lung cancer cases resulted in promising applications in prognosis to enhance the quality-of-life of patients diagnosed with this challenging disease. F... | PMC10451707 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10451707 | ||
Author Contributions | Conceptualization, Q.N.N.T.; M.-K.L.; T.K.; T.M.; Methodology, Q.N.N.T.; M.-K.L.; Software, M.-K.L.; Validation, M.-K.L.; Formal analysis, M.-K.L.; Investigation, Q.N.N.T.; Resources, Q.N.N.T.; Writing—original draft, Que N.N. Tran; Writing—review & editing, M.-K.L.; T.K.; and T.M.; Supervision, T.K.; T.M.; Project adm... | PMC10451707 | ||
Institutional Review Board Statement | Not applicable. | PMC10451707 | ||
Informed Consent Statement | Not applicable. | PMC10451707 | ||
Data Availability Statement | TCGA, Cancer | CANCER | The datasets generated and analyzed during the current study are available in the Surveillance, Epidemiology, and End Results (SEER) and The Cancer Genome Atlas (TCGA), | PMC10451707 |
Conflicts of Interest | The authors declare no conflict of interest. | PMC10451707 | ||
Introduction | goal-directed behavior | SECONDARY, CORTEX | Non-invasive brain stimulation (NIBS) probing the dorsolateral prefrontal cortex (DLPFC) has been shown to have little effect on working memory. The variability of NIBS responses might be explained by inter-subject brain anatomical variability. We investigated whether baseline cortical brain thickness of regions of int... | PMC10591489 |
Material and Methods | This study was based on data from a previous trial that measured working memory performance of healthy subjects after a course of NIBS protocols. The original study used a factorial, double-blinded, within-subjects design, in which participants were allocated to receive four different NIBS interventions (tDCS, iTBS, co... | PMC10591489 | ||
Participants | In our previous study ( | PMC10591489 | ||
Procedure | First, an anatomical T1-weighted imaging of the brain was performed using a 3T magnetic resonance imaging (MRI) scanner (General Electric PET/MRI equipment, USA), followed by a real-time MRI-guided neuro-navigation system (Brainsight, Rogue Resolutions, Inc., Canada) using the T1-weighted image to target the left and r... | PMC10591489 | ||
Back task | The 2-back task was programmed in E-prime 2.0 software (Psychology Software, Tools Inc., USA). The visual stimulus consisted of letters (A to Z) that appeared in a pseudo-randomized order on a computer screen of 15 inches. The applied protocol consisted of three blocks of 30 letters. Letters were displayed on the scree... | PMC10591489 | ||
NIBS protocols | Based on previous studies investigating cognitive performance after tDCS in healthy volunteers (iTBS protocol used a TMS coil applied with an angle of 45 degrees relative to the midline. The protocol consisted of 54 cycles of 10 triplet bursts with a train duration of 2 s and an interval of 8 s between trains (1620 pul... | PMC10591489 | ||
MRI acquisition | All structural brain MRIs were acquired in a 3-Tesla MR system (General Electric PET/MRI equipment, USA). Volumetric images were based on T1-weighted sequences using a 3D fast-field echo pulse sequence with the following parameters: field of view (FOV) of 25.6, time of repetition (TR) of 7.7 ms, time of echo (TE) of 3.... | PMC10591489 | ||
Neuroimaging processing and cortical thickness quantification | The T1-weighted image of each participant was processed using the CAT12 toolbox (In the RBM step, the Destrieux atlas (According to our | PMC10591489 | ||
Brain regions of interest investigated in this study. PCC: posterior cingulate cortex; DLPFC: dorsolateral prefrontal cortex; mPFC: medial prefrontal cortex. | PMC10591489 | |||
Statistical analysis | Statistical analyses were performed using R version 4.1.2 (USA). Reaction time (in milliseconds (ms)) and accuracy (binary outcome) of the target stimuli were the dependent variables, while ROI thickness and protocol were the independent variables. Missed responses were considered errors, and reaction times <200 ms and... | PMC10591489 | ||
Results | Our prior study included a sample of 24 healthy subjects, two of which were excluded because the T1-image of one subject did not pass the quality check and one subject did not receive the placebo stimulation. Therefore, 22 subjects were included in this study, presenting a mean age of 28.4 years (SD=7.1 years), mean ed... | PMC10591489 | ||
Working memory and ROI thickness | First, we evaluated whether there was an association between working memory performance in the placebo group and cortical thickness, but no significant association was found ( | PMC10591489 | ||
Association of working memory performance and cortical thickness in the placebo group. | REGRESSION | For each region of interest (ROI), a generalized linear mixed models (GLMM) with an inverse-Gaussian error distribution and an inverse link function (same parameters as for main analyses) was set up with reaction time as outcome variable, and a logistic regression was performed with accuracy as the outcome variable. RO... | PMC10591489 | |
Association between cortical thicknesses of regions of interest in the brain and working memory performance. | Statistics: *P<0.05 and **P<0.01; | PMC10591489 | ||
Association between baseline cortical thickness and working memory reaction time following non-invasive brain stimulation protocols. TBS: theta-burst stimulation; tDCS: direct current stimulation. | No significant association between accuracy and ROI thickness was found (The results from the association between cortical thickness and working memory performance after the combined protocol can be found in Supplementary Table S3. | PMC10591489 | ||
Discussion | In this study, based on data from our previous trial (As expected, our results showed that inter-individual anatomical differences were associated with NIBS effects. The findings revealed that subjects with thinner DLPFC regions showed relatively faster reaction times than individuals with greater cortical thickness af... | PMC10591489 | ||
Limitations | Our study has several limitations that should be discussed. First, the sample size was small. Thus, some analyses might have been underpowered, and future studies should use these results as hypothesis-driven. Second, other anatomical measures such as cortical volume could have been used for this study. However, as a p... | PMC10591489 | ||
Conclusion | This study provided initial evidence that individual differences in baseline cortical thickness of the DLPFCs targeted with tDCS and iTBS and deeper regions targeted with iTBS might be associated with reaction time performance. However, no association was found between accuracy and cortical thickness. The findings of o... | PMC10591489 | ||
Acknowledgments | This research project was supported by the São Paulo Research Foundation (FAPESP, Grant: 2018/10861-7). A.R. Brunoni receives grants from the National Council for Scientific and Technological Development (PQ-1B) and FAPESP (Grants: 2018/10861-7 and 2019/06009-6). A.R. Brunoni has a small equity of Flow™, whose devices ... | PMC10591489 | ||
References | PMC10591489 | |||
BACKGROUND: | stroke, patent foramen ovale | STROKE | Right to left shunt (RLS), including patent foramen ovale, is a recognized risk factor for stroke. RLS/patent foramen ovale diagnosis is made by transthoracic echocardiography (TTE), which is insensitive, transesophageal echocardiography, which is invasive, and transcranial Doppler (TCD), which is noninvasive and accur... | PMC10589435 |
METHODS: | RLS, embolic cerebrovascular ischemia | EVENT | We conducted a prospective, single-arm device clinical trial of robot-assisted TCD (raTCD) versus TTE for RLS diagnosis at 6 clinical sites in patients who presented with an event suspicious for embolic cerebrovascular ischemia from October 6, 2020 to October 20, 2021. raTCD was performed with standard TCD bubble study... | PMC10589435 |
RESULTS: | RLS, ischemic stroke | EVENTS, TRANSIENT ISCHEMIC ATTACK, ISCHEMIC STROKE | A total of 154 patients were enrolled, 129 evaluable (intent to scan) and 121 subjects had complete data per protocol. In the intent to scan cohort, mean age was 60±15 years, 47% were women, and all qualifying events were diagnosed as ischemic stroke or transient ischemic attack. raTCD was positive for RLS in 82 subjec... | PMC10589435 |
CONCLUSIONS: | RLS, patent foramen ovale | raTCD was safe and ≈3 times more likely to diagnose RLS than TTE. TTE completely missed or underdiagnosed two thirds of large shunts diagnosed by raTCD. The raTCD device, used by health professionals with no prior TCD training, may allow providers to achieve the known sensitivity of TCD for RLS and patent foramen ovale... | PMC10589435 | |
METHODS | PMC10589435 | |||
Trial Oversight and Funding | HEART | This study comports with the Transparency and Openness Promotion Guidelines for authors publishing in the American Heart Association Journal, and the data sets can be made available by reasonable request to the corresponding author.The study was a multicenter (conducted within 6 clinical sites), prospective, single-arm... | PMC10589435 | |
Patients | embolic acute, embolic stroke, ischemic stroke | TRANSIENT ISCHEMIC ATTACK, EMBOLIC STROKE, ISCHEMIC STROKE | The trial included adult (≥18 years) patients who experienced a clinical episode that, in the opinion of the treatment team, included an embolic acute neurovascular episode (eg, ischemic stroke or transient ischemic attack) on the differential diagnosis prompting patient referral for a TTE with agitated saline bubble c... | PMC10589435 |
Trial Procedures | RLS | Enrolled patients underwent raTCD (NovaGuide Intelligent Ultrasound, NeuraSignal Inc, Los Angeles, CA) in addition to standard of care TTE with agitated saline contrast bubble study, both within 30 days of informed consent. The raTCD is a five-degree-of-freedom robotic unit paired with a signal optimization algorithm t... | PMC10589435 | |
Outcomes | RLS | ADVERSE EVENTS, SECONDARY | The primary outcome was rate of RLS detection with TTE and raTCD in the intent to scan (ITS) cohort, which included site assessment of TTE (eg, local clinical interpretation). The primary safety outcome was any serious device-related adverse events. The key prespecified secondary outcome was rate of detection of large ... | PMC10589435 |
Statistical Analysis | The study was powered based on the results of a meta-analysis | PMC10589435 | ||
RESULTS | PMC10589435 | |||
Outcomes | RLS | SECONDARY | For the primary outcome, in the ITS cohort, raTCD detected any RLS in 82 patients (64%) whereas TTE documented any RLS in 26 (20%) patients (absolute difference 43.4% [95% CI, 35.2%–52.0%]; OutcomesFor the secondary prespecified outcome of large RLS detection, raTCD detected large RLS in 35 patients (27%) and TTE found... | PMC10589435 |
Safety | anxiety | ADVERSE EVENTS | There were no serious adverse events in this study related to the device or microbubble contrast injection. There were 2 nonserious adverse events (anxiety) in the ITS population. | PMC10589435 |
ARTICLE INFORMATION | PMC10589435 | |||
Sources of Funding | This work was funded by NeuraSignal, Inc. | PMC10589435 | ||
Disclosures | Drs Alexandrov, Rubin, Tsivgoulis, and Volpi have received payment as consultants to the study sponsor. C. Douville has received travel support from the study sponsor. The other authors report no conflicts. | PMC10589435 | ||
Supplemental Material | Trial ProtocolStatistical Analysis PlanSupplemental AppendixInvestigatorsSupplemental MethodsTables S1–S4Figure S1Video S1STARD ChecklistCONSORT Checklist | PMC10589435 | ||
Supplementary Material | PMC10589435 | |||
Nonstandard Abbreviations and Acronyms | intent to scanpatent foramen ovaleright to left shuntrobot-assisted transcranial Dopplertranscranial Dopplertransesophageal echocardiographytransthoracic echocardiographyFor Sources of Funding and Disclosures, see page 2848.The podcast and transcript are available at Supplemental Material is available at | PMC10589435 | ||
REFERENCES | PMC10589435 | |||
Introduction | cardiovascular death, fracture, pain, PD, osteoporosis, Osteoporosis, systemic skeletal disease, arthralgia | MYOCARDIAL INFARCTION, STROKE, ADVERSE EVENTS, FRAGILITY, POSTMENOPAUSAL OSTEOPOROSIS, OSTEOPOROSIS, EVENTS, OSTEOPOROSIS | Edited by: Kok Yong Chin, National University of Malaysia, MalaysiaReviewed by: John Krege, Eli Lilly, United States; Jan Josef Stepan, Charles University, Czechia†These authors have contributed equally to this work and share first authorshipThis article was submitted to Bone Research, a section of the journal Frontier... | PMC10116854 |
Methods | PMC10116854 | |||
Study design | This was a randomized, double-blind, placebo-controlled, dose-escalation phase 1 trial of SHR-1222 in women with POP conducted at 11 sites in China (NCT04435158). Subject participation consisted of a 30-d screening period, 24-week treatment period, and 57-d treatment-free follow-up period.The study was conducted in acc... | PMC10116854 | ||
Study participants | fracture, amenorrhea, hypercalcemia, fractures, Osteoporosis, osteoporosis, diabetes | INTRAVENOUS BISPHOSPHONATES, HYPERCALCEMIA, METABOLIC DISEASES, OSTEOPOROSIS, OSTEOPOROSIS, VITAMIN D DEFICIENCY, HYPOCALCEMIA, METABOLIC BONE DISEASES, DIABETES | Eligible subjects were ambulatory women of postmenopausal status for at least 5 years, aged 50–70 years, with evidence of osteoporosis and body weight of no less than 40 kg. Postmenopausal status was defined as having ≥ 12 months of spontaneous amenorrhea or undergoing bilateral oophorectomy 6 weeks prior. Osteoporosis... | PMC10116854 |
Treatment interventions | Women with POP received SHR-1222 or a matching placebo subcutaneously at doses of 100, 200, or 300 mg once monthly (QM) and 400 or 600 mg once every 2 months (Q2M) sequentially (Study design. The decision to proceed to the next dosing cohort was made by the safety review committee (SRC) consisting of sponsor representa... | PMC10116854 | ||
Endpoints and assessments | EVENTS, SECONDARY, BLOOD | The primary endpoint of this trial was the assessment of the safety and tolerability of multiple subcutaneous injections of SHR-1222. The secondary endpoints included PKs, PDs, and the immunogenicity of SHR-1222.Adverse events (AEs), coded according to the preferred terms of the Medical Dictionary for Regulatory Activi... | PMC10116854 | |
Statistical analysis | PD | All subjects who received placebo were included in the placebo group. Safety was assessed in all subjects who received at least one dose of SHR-1222 or a placebo. PK concentration and parameter analyses were performed in subjects who received at least one dose of SHR-1222, with at least one qualified PK concentration/p... | PMC10116854 | |
Results | PMC10116854 | |||
Study participants | Between September 23, 2020, and November 29, 2021, 107 subjects who were eligible underwent randomization to receive different dosing regimens of SHR-1222 or matching placebo. Two subjects in the placebo group, who did not receive the assigned treatment, withdrew from the study. Of the 105 subjects, 21 received placebo... | PMC10116854 | ||
Safety | cardiovascular and cerebrovascular ischemic | HYPOPHOSPHATEMIA, ADVERSE EVENTS, ADVERSE EVENT, SYSTEMIC ALLERGIC REACTION, ADVERSE EVENT, ANAPHYLACTIC SHOCK, EVENTS, HYPOCALCEMIA, INJECTION SITE HEMORRHAGE, LACUNAR INFARCTION | A total of 100 subjects experienced at least one AE, including 81 (96.4%) in the SHR-1222 group and 19 (90.5%) in the placebo group (Adverse events in the safety set.AEs occurring more frequently in the SHR-1222 group with a difference of ≥5% versus pooled placebo.AEs were also predefined as AESI.AE, adverse event; QM,... | PMC10116854 |
PKs | TSD | The PK parameters are summarized in Pharmacokinetics of SHR-1222: noncompartmental parameter estimates.Data are median (range) for TSD, standard deviation; CV, coefficient of variation; TMean serum concentration-time profiles of SHR-1222. After a single dose of SHR-1222, the median TAfter the last dosing of SHR-1222, t... | PMC10116854 | |
Bone turnover markers | Mean percentage changes from baseline in the levels of the bone formation markers P1NP, BSAP, and OST and bone resorption marker β-CTx are presented in Mean (SD) percentage changes from baseline in bone turnover biomarkers. After different dosing regimens of SHR-1222 in the order of 100, 200, and 300 mg QM; 400 and 600... | PMC10116854 | ||
BMD at the lumbar spine, total hip, and femoral neck | Compared with the placebo group, significant increases from baseline in BMD were observed at the lumbar spine across all SHR-1222 dosing groups 2 months after the first administration, which continued to rise throughout the subsequent treatment (Mean (SD) percentage changes from baseline in bone mineral density (BMD). | PMC10116854 | ||
Immunogenicity | Eighty-three subjects with SHR-1222 were included in the immunogenicity analyses, among whom six (7.2%) tested positive for anti-SHR-1222 antibodies after administration (100 mg QM, n=1; 300 mg QM, n=1; 400 mg Q2M, n=1; 600 mg Q2M, n=3). However, the development of anti-SHR-1222 antibodies had no discernible effect on ... | PMC10116854 | ||
Discussion | PD | This randomized, double-blind, placebo-controlled, dose-escalation phase 1 trial is the first clinical evaluation of multiple doses of SHR-1222 for POP treatment. SHR-1222 was generally well tolerated and demonstrated an acceptable safety profile at different dosing regimens from 100 mg QM to 600 mg Q2M. The AE profile... | PMC10116854 | |
Data availability statement | The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding author. | PMC10116854 | ||
Ethics statement | The studies involving human participants were reviewed and approved by the Ethics Committee of the Second Xiangya Hospital of Central South University and all other participating centers. The patients/participants provided their written informed consent to participate in this study. | PMC10116854 | ||
Author contributions | HC | Conceptualization: ZD, RZ, ZS, HC, and ZGZ; Data curation: ZD, RZ, ZS, GQ, XL, QQ, CLS, LL, PJ, GY, YC, DP, CZ, LW, JS, QZ, ZZ, XY, PF, QY, LY, XF, WLiu, BW, RC, XW, YX, and ZGZ; Formal analysis: WW; Supervision: ZD, RZ, ZS, HC, and ZGZ; Project administration: ZD, RZ, ZS, CS, KS, WW, WLu, HC, and ZGZ; Writing – origin... | PMC10116854 | |
Acknowledgments | This study was sponsored by Jiangsu Hengrui Pharmaceuticals Co., Ltd. We thank the subjects and their families, as well as all the investigators and research staff for participating in this study. We also acknowledge Lin Dong, PhD (a medical writer at Hengrui) for medical writing support according to Good Publication P... | PMC10116854 | ||
Conflict of interest | Authors CS, KS, WW, WLu, and HC were employed by Jiangsu Hengrui Pharmaceuticals Co., Ltd.The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.This study received funding from Jiangsu Hengrui... | PMC10116854 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10116854 | ||
References | PMC10116854 | |||
Abstract | PMC10834340 | |||
Background | LITTLE | Little research has been undertaken on the benefits of frailty management within different hospital settings. The objective of this study is to provide evidence on the viability and effectiveness of frailty management in non‐geriatric hospital settings on mortality and functional decline after discharge. | PMC10834340 | |
Methods | delirium, Frailty | REGRESSION | Data from the FRAILCLINIC (NCT02643069) study were used. FRAILCLINIC is a randomized controlled trial developed in non‐geriatric hospital inpatient settings (emergency room, cardiology and surgery) from Spain (2), Italy (2) and the United Kingdom (1). Inpatients must met frailty criteria (according to the Frailty Pheno... | PMC10834340 |
Results | Eight hundred twenty one participants (IG: 416; mean age 83.00 ± 4.91; 51.44% women; CG: 405; mean age 82.46 ± 6.03; 52.35% women) were included. In the IG, 77.16% of the participants followed the geriatric team's recommendations as implemented by the treating physicians. The intervention showed a benefit on functional... | PMC10834340 | ||
Conclusions | An individualized intervention in frail in‐patients reduces the risk of functional deterioration and mortality at 3 months of follow‐up when a care management plan is designed and followed.
Marta Checa‐López and Alba Costa‐Grille equally contributed to this work. | PMC10834340 | ||
Background | Frailty, institutionalization reduction | SYNDROME | Population ageing and the concomitant rise in the number of frail older adults represent a serious health and social care challenge.Frailty is a geriatric syndrome characterized by a diminished capacity to respond to stressors, as a result of a reduced functional reserve.Frailty is highly prevalent among the inpatient ... | PMC10834340 |
Methods | PMC10834340 | |||
Trial design | cognitive impairment, fatigue, and loss of weight, Frailty, involuntary weight loss | ONCOLOGY, RECRUITMENT | FRAILCLINIC (NCT02643069) was a phase III multicentric randomized clinical trial conducted between June 2016 and March 2021. We recruited inpatients older than 75 years admitted to some of the following clinical settings: emergency room (ER), cardiology and surgery (both as an elective‐ES and urgent surgery‐US). The st... | PMC10834340 |
Description of the intervention and control groups |
The geriatric team provided the recommendations for each patient to the treating physician by two concurrent sources: writing them in the clinical record plus explaining to him/her in person, as they were responsible for implementation of the intervention. The team was composed of by a ‘core’ team (geriatrician and nu... | PMC10834340 | ||
Adverse events | delirium, constipation | ADVERSE EVENTS, NOSOCOMIAL INFECTIONS, URINARY INCONTINENCE, HYPOGLYCAEMIA | Information about the following adverse events were collected: constipation, urinary incontinence, instability, falls, adverse drugs reactions, hypoglycaemia, low blood pressure (<100 mmHg of systolic blood pressure), delirium and nosocomial infections. | PMC10834340 |
Outcomes | disability | EVENT | The primary outcomes are the effects of the intervention on functional decline (assessed by the Barthel Index), institutionalization (yes/no) and mortality (yes/no) 3 months after discharge. With reference to functional decline, a worsening in Barthel score (≥5 points) regarding the basal (pre‐hospitalization) score, w... | PMC10834340 |
Statistical analysis | EVENTS | We calculated the sample size to minimize the estimation bias. For doing so, it is recommended to have a minimum of five and seven outcome events per independent variable (intervention, age, gender and Charlson Index) (Peduzzi et al., J Clin Epidemiol 1996). This means that for a 95% confidence interval (alpha error: 0... | PMC10834340 | |
Results | Frailty, constipation | ADVERSE EVENTS, SECONDARY | A total of 821 subjects were recruited with 405 being randomly assigned to the control group and 416 to the intervention group (Figure Study flow chart diagram.Clinical and functional values by treatment group.
Abbreviation: MMSE, Mini‐Mental State Examination.CAG of the participants was followed by the building of a c... | PMC10834340 |
Discussion | death, Frailty, frailty syndrome, ’ | STRESSFUL EVENTS | The benefits of interventions on frail hospital inpatients are far to be proven.This effect was observed when the treating physician followed the recommendations of the geriatric team. It is worthy to mention that, taking into account previous reports showing a low rate of compliant by the treating physician of the rec... | PMC10834340 |
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