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Depression
depressed, depressive symptoms
To detect depressive symptoms during the past 2 weeks (e.g., feeling down, depressed, or hopeless), the German version of the 9-item Patient Health Questionnaire (PHQ-9) [
PMC10031163
Web-based common measures for parents and children
PMC10031163
Sociodemographic and medical assessment
Two self-constructed items are implemented asking the participants about their age and gender. The child questionnaire includes a third item assessing the adolescents’ living situation (“Where do you currently live?”), while the parental questionnaire incorporates three additional questions regarding the child’s year o...
PMC10031163
COVID-19-specific questions
COVID-19-specific questions are included to assess the COVID-19 related impact and burden experienced by the participants. Two self-constructed items adapted from Warschburger et al. [Modified items based on Calvano et al. [
PMC10031163
Psychosocial adjustment: Overall well-being
Two picture-based items using the Self-Assessment Manikin [
PMC10031163
Psychosocial adjustment: Loneliness
The 6-item short version of the De-Jong-Gierveld-Skala [
PMC10031163
Psychosocial adjustment: Child behavior
hyperactivity
To assess the children’s emotional and behavioral problems during the last 12 months, the Strengths and Difficulties Questionnaire (SDQ) is utilized. On a 3-point Likert scale ranging from 0 “not true” to 2 “certainly true”, children are asked to rate problems relating to the subscales hyperactivity (with Cronbach’s α ...
PMC10031163
Web-based extended measures for parents
PMC10031163
Sociodemographic assessment
The parental socioeconomic status (SES) is measured using the MacArthur Scale [
PMC10031163
Psychosocial adjustment
In addition to the measures described above, the extended online survey for parents includes several other questionnaires to measure their psychosocial adjustment. As previously applied in the basic questionnaires, the WHO-5 measures the parents’ overall well-being. Further characteristics of the questionnaire are disc...
PMC10031163
Psychosocial adjustment: Anxiety and depression
depression, anxiety
To assess parent’s anxiety and depression levels, the German version of the PHQ-4, the short version of the PHQ-9 and GAD-7 used for adolescents in the basic survey, is applied as screening instrument. Four Items are to be rated on a 4-point Likert scale ranging from 0 “not at all” to 3 “nearly every day”. An internal ...
PMC10031163
Psychosocial adjustment: Perceived stress
The frequency of distress experienced by the subject will be measured using four items with the German version of the Perceived-Stress Scale (PSS-4). On a 5-point Likert scale, parents are asked to indicate how often they felt stressed during the last year (e.g., “In the last 12 months, how often have you felt difficul...
PMC10031163
Psychosocial adjustment: Quality of life
This study applies 13 items of the German version of the Child Health Questionnaire Parent Form (CHQ) to assess the impact of the child’s health on the parental quality of life across several domains. On a 5-point scale, the emotional impact is assessed with 3 items (e.g., “How much emotional worry or concern did each ...
PMC10031163
Coping and resources
The following instruments are used to assess the coping strategies and the resources and burdens of the parents:
PMC10031163
Coping and resources: Parental disease management
To assess the parental coping style, the German short version of the coping orientation to problems experienced (Brief COPE) inventory [
PMC10031163
Coping and resources: Self-efficacy
The German version of the General self-efficacy scale (in German: Allgemeine Selbstwirksamkeitsskala (ASKU)) [
PMC10031163
Coping and resources: Locus of control
Measuring the internal and external sense of control, a four-item scale for the assessment of locus of control (In German: Internale-Externale-Kontrollüberzeugung-4 (IE-4)) [
PMC10031163
Coping and resources: Social support
The 3-item OSLO social support scale (OSS-3) is implemented to measure the level of social support that parents perceive. The questions assess how many close confidents parents have, the amount of concern they receive from others, and how accessible practical help is from their neighbours. The sum score of 3-8 is categ...
PMC10031163
Coping and resources: Child’s coping and resources
If their child cannot or does not want to participate themselves, parents are asked to rate the child’s coping and resources. Three items, taken from the COVID-19 Snapshot Monitoring questionnaire [
PMC10031163
Family relations and interactions
The following tools are used to consider the potential impact at family level.
PMC10031163
Family relations and interactions: Parenting behaviour
To measure the risk of harmful parenting, 4 items originating from a study by Clemens et al. [
PMC10031163
Family relations and interactions: Family-related quality of life
The survey includes 12 items assigned to two of three subscales of the family-related life questionnaire (FLQ) developed by Tröster [
PMC10031163
Family relations and interactions: Parental burnout
The 5-item Brief Parental Burnout scale (BPBs) is applied to measure the risk of parental burnout. Parents are asked to rate the frequency of feelings related to burn-out (e.g., “I’m so tired out by my role as a parent that sleeping doesn’t seem like enough.“) on a 3-point response scale reaching from daily to more sel...
PMC10031163
Control variables
The short form of the German Scale for Detecting Test Manipulation through Faking Good and Social Desirability Bias (in German: Skala zur Erfassung von Testverfälschung durch positive Selbstdarstellung und sozial erwünschte Antworttendenzen (SEA-K)) [
PMC10031163
Web-based extended measures for children
PMC10031163
Psychosocial adjustment
To measure the child’s health related quality of life (HRQoL), 16 items of the KIDSCREEN-27 [
PMC10031163
Coping and resources: Coping
DISEASE
Children’s coping strategies are assessed with the Coping with a disease questionnaire CODI [
PMC10031163
Coping and resources: Resources
To assess the children’s personal and social resources, the Questionnaire of Resources in Childhood and Youth (in German: Fragebogen zu Ressourcen im Kindes und Jugendalter (FRKJ-8-16)) is applied. The current study uses the subscales “sense of coherence“, “optimism“, “self-efficacy“, and “parental support“, comprising...
PMC10031163
Coping and resources: Social integration
The survey includes 4 items based on self-constructed items from another study [
PMC10031163
Family relations and interactions: Quality of child-parent relationship
The German version of the Parental-Representation-Screening-Questionnaire (PRSQ), in German “Elternbildfragebogen für Kinder und Jugendliche “(EBF-KJ), is administered to assess how the children rate the relationship with their parents. This survey uses two modified scales of the EBF-KJ, namely “autonomy “and “overprot...
PMC10031163
Family relations and interactions: COVID-19-specific social support
CORONAVIRUS
To assess the perceived support during the COVID-19 pandemic, 8 self-constructed items are applied. On a scale ranging from 0 “completely disagree “to 4 “completely agree“, children are asked how much they have talked about the coronavirus with their parents (e.g., “My parents have explained to me what COVID-19 is“) an...
PMC10031163
Sample size
With respect to the baseline survey, we will implement a convenience sampling procedure: That means that all facilities taking part in one of the three patient registries have been informed about the ongoing KICK-COVID study via newsletters and regular meetings of the collaborators. We aim to include (and re-assess) as...
PMC10031163
Statistical analyses
In accordance with common guidelines, we will only include online survey data with a high data quality indication but a “realistic” completion time of the questionnaire (a relative speed indicator higher than 2 and a total completion time of at least 5 minutes [
PMC10031163
Discussion
VIRUS, CURB
The COVID-19 pandemic has led to far-reaching changes in everyday life for everyone worldwide. Families with underage young people in particular are and were affected in many ways: be it the closure of schools and daycare centers with the resulting need for homeschooling or home care, far-reaching contact restrictions ...
PMC10031163
Strengths and limitations
obesity, chronic illness
DISEASE, OBESITY, CHRONIC ILLNESS
To the best of our knowledge, no other national study focuses on the group of children and adolescents with a chronic illness during the COVID-19 pandemic.The KICK-COVID study and its expected results must be viewed in light of its strengths and weaknesses. A major strength of our approach is the large expected sample ...
PMC10031163
Authors’ contributions
CK and RWH had the idea to this study and initiated together with KM and PW the joint project. CS, SL and SW collaborated in the application and all authors contributed to its design. PW and JG designed the web-based survey and wrote the draft of this manuscript. All authors contributed to the further writing and appro...
PMC10031163
Funding
Open Access funding enabled and organized by Projekt DEAL, funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) - Projektnummer 491466077. This study is implemented as part of the joint project “A prospective analysis of the long-term impact of the COVID-19 pandemic on well-being and health c...
PMC10031163
Availability of data and materials
Fully anonymized data will be available from the corresponding author on reasonable request and with the permission of the collaboration partners.
PMC10031163
Declarations
PMC10031163
Ethics approval and consent to participate
The study will be conducted in accordance with the principles of Good Clinical Practice, the Declaration of Helsinki (
PMC10031163
Consent for publication
Not applicable.
PMC10031163
Competing interests
The authors declare that they have no competing interests.
PMC10031163
References
PMC10031163
2. Materials and Methods
PMC10303563
2.1. Participants
ulcer, cellulitis, primary venous ulcers, dementia, necrotic, infection, malignant ulceration, chronic venous diseases, arterial disease, primary venous ulcer
VENOUS INSUFFICIENCY, ULCER, CELLULITIS, RECRUITMENT, DIABETIC FOOT, PERIPHERAL VASCULAR DISEASE (PVD), NECROTIC, SLOUGH, INFECTION, RHEUMATOID VASCULITIS, BLIND, ARTERIAL DISEASE
The study was a three-arm, randomized controlled trial that was carried out on sixty patients (male and female) who had grade two primary venous ulcers, according to the venous clinical severity score. Patients were eligible for inclusion in the study if they had primary venous ulcers in the presence of venous insuffic...
PMC10303563
2.2. Outcome Measures
ulcer
SECONDARY, ULCER
The outcome measures were assessed at three points during the timeline: at baseline, a four-week exercise training period, and a twelve-week period. The primary outcome measure was ulcer surface area. The secondary outcome measure was ulcer volume (UV) measurement in cmPrimary outcome measures: The ulcer surface was me...
PMC10303563
2.3. Interventions
ulcer
ULCER
In this study, the patients were randomly assigned into 1 of the 3 groups for 12 weeks of intervention (a sample of 20 patients in each group). They were randomly allocated to each group with an allocation ratio of 1:1:1 by blindly selecting numbers from sealed envelopes, created by a random block randomization techniq...
PMC10303563
2.4. Sample Size and Statistical Analysis
The G*Power software was used to calculate the sample size (version 3.0.10, Germany). According to F tests (multivariate analysis of variance: MANOVA repeated measures, within–between interactions), a sample size of 60 patients was sufficient, with a Type I error of 0.05, a power of 80%, and an effect size of 0.37. The...
PMC10303563
3. Results
A total of 75 patients were assessed for eligibility, of whom, 66 patients were randomly assigned to 1 of the 3 groups of intervention, and we obtained follow-up data from 60 (90.9%) patients. The study consort diagram is shown in
PMC10303563
Demographic and Clinical Characteristics of the Patients
ulcer
ULCER
Baseline demographics and ulcer surface area and volume were not significantly different across patients (A significant change in ulcer surface area was observed in follow-up univariate ANOVAs, F (4, 96) = 40.07, The between-group analysis revealed a significant difference in all measures (At the 4-week follow-up, the ...
PMC10303563
4. Discussion
VLU, edema, hyperemia, muscle malfunction, ulcer
EDEMA, HYPEREMIA, EPITHELIALIZATION, PATHOPHYSIOLOGY, VENOUS ULCERS, ULCER
According to the study’s findings, the control group did not experience any significant changes over the four-week follow-up period, while the two experimental groups showed a substantial improvement in ulcer surface area and volume. There were significant differences across the 3 groups at the 12-week follow-up, with ...
PMC10303563
Strengths and Limitations
ulcer
ULCER
The findings of this study informed fundamental knowledge and offered a number of advantages, including its originality and use of various ulcer healing measures, such as ulcer surface and ulcer volume, as objective evaluations of ulcer healing. An additional strength is the design of the study, which includes randomiz...
PMC10303563
5. Conclusions
VENOUS LEG ULCER
Combined plantar flexion resistance training and PEMF could be a non-invasive adjuvant treatment for venous leg ulcers and is proven to have more noticeable benefits on the healing process.
PMC10303563
Author Contributions
Conceptualization and methodology. H.M.M. and A.F.A.; thorough analysis, Y.M.A. and M.M.T.; investigation, H.M.M. and A.F.A.; drafting and article preparation, H.M.M., M.M.T., Y.M.A., M.I.A. and A.F.A.; writing—editing and revising, all authors; Funding acquisition, M.I.A. All authors have read and agreed to the publis...
PMC10303563
Institutional Review Board Statement
This study was carried out in accordance with the Helsinki Declaration and was approved by the Institutional Review Board (or Ethics Committee) of (PTREC//012/003629), Registration: Clinicaltrials.gov: NCT05410613.
PMC10303563
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10303563
Data Availability Statement
The corresponding author will provide the identified datasets used in the current study upon reasonable request.
PMC10303563
Conflicts of Interest
The authors declare no conflict of interest.
PMC10303563
References
ulcer
ULCER
Consort diagram for the study.Baseline, 4-week, and 12-week differences in ulcer surface area (USA) and ulcer volume (UV) between groups.Demographic and clinical characteristics of subjects.Abbreviation: PEMF, pulsed electromagnetic field; PRE, plantar flexion resistance exercise (PRE); SD, standard deviation. Level of...
PMC10303563
Key Points
PMC10638646
Question
Can a multidisciplinary ambulatory intensive care unit (A-ICU) with low panel size improve health care utilization and patient-reported outcomes over 6 months for medically and socially complex patients with high rates of homelessness?
PMC10638646
Findings
In this randomized clinical trial with 159 participants, there were no differences in hospitalizations or emergency department visits at 6 months between patient groups randomized to an A-ICU intervention or enhanced usual care. However, the A-ICU group had more primary care visits and improved patient-reported well-be...
PMC10638646
Meaning
Ambulatory intensive care units can have a positive effect on the health and well-being of complex patients, although longer time horizons may be required to reduce hospitalizations and emergency department visits.This randomized clinical trial examines the effect of a multidisciplinary ambulatory intensive care unit i...
PMC10638646
Importance
Intensive primary care interventions have been promoted to reduce hospitalization rates and improve health outcomes for medically complex patients, but evidence of their efficacy is limited.
PMC10638646
Objective
To assess the efficacy of a multidisciplinary ambulatory intensive care unit (A-ICU) intervention on health care utilization and patient-reported outcomes.
PMC10638646
Design, Setting, and Participants
mental illness
DISORDER, MAY
The Streamlined Unified Meaningfully Managed Interdisciplinary Team (SUMMIT) randomized clinical trial used a wait-list control design and was conducted at a health care clinic for patients experiencing homelessness in Portland, Oregon. The first patient was enrolled in August 2016, and the last patient was enrolled in...
PMC10638646
Intervention
The A-ICU included a team manager, a pharmacist, a nurse, care coordinators, social workers, and physicians. Activities included comprehensive 90-minute intake, transitional care coordination, and flexible appointments, with reduced panel size. Enhanced usual care (EUC), consisting of team-based primary care with acces...
PMC10638646
Main Outcomes and Measures
PCP
The main outcome was the difference in rates of hospitalization (primary outcome), emergency department (ED) visits, and primary care physician (PCP) visits per person over 6 months (vs the prior 6 months). Patient-reported outcomes included changes in patient activation, experience, health-related quality of life, and...
PMC10638646
Results
EMERGENCY
This study randomized 159 participants (mean [SD] age, 54.9 [9.8] years) to the A-ICU SUMMIT intervention (n = 80) or to EUC (n = 79). The majority of participants were men (102 [65.8%]) and most were White (121 [76.1%]). A total of 64 participants (41.0%) reported having unstable housing at baseline. Six-month hospita...
PMC10638646
Conclusions and Relevance
PCP
The A-ICU intervention did not change hospital or ED utilization at 6 months but increased PCP visits and improved patient well-being. Longer-term studies are needed to evaluate whether these observed improvements lead to eventual changes in acute care utilization.
PMC10638646
Trial Registration
ClinicalTrials.gov Identifier:
PMC10638646
Introduction
A small number of patients account for a disproportionately large share of health care utilization and costs in the US.Ambulatory intensive care units (A-ICUs) are a form of intensive primary care intervention designed to improve health care utilization and outcomes for medically complex patients.
PMC10638646
Methods
PMC10638646
Setting and Trial Design
This randomized clinical trial was developed through a community-academic partnership and was approved by the Oregon Health & Science University Institutional Review Board. Participants provided written informed consent. The SUMMIT intervention and trial design were described previously,The study took place at Central ...
PMC10638646
SUMMIT Intervention
PCP
The SUMMIT A-ICU comprised a colocated multidisciplinary team with a reduced panel size (up to 150 patients vs 1000 patients in usual primary care physician [PCP] practice) and flexible scheduling (
PMC10638646
Comparison of the SUMMIT A-ICU and EUC Teams
PMC10638646
Enhanced Usual Care
psychiatric, diabetes
DIABETES
The wait-list control group received EUC within Central City Concern. Enhanced usual care consisted of 4 care teams of PCPs, medical assistants, and a care team manager (licensed practical nurse) with access to services including mental health care (staffed by on-site psychiatric nurse practitioners for prescribing and...
PMC10638646
Eligibility and Recruitment
mental illness, end-stage liver disease, cognitive impairment, diabetes, congestive heart failure, aphasia or hearing impairment
DISORDER, METASTATIC CANCER
Patients were eligible if they spoke English, were aged at least 18 years, had 1 or more hospitalizations in the prior 6 months, and had 2 or more chronic medical conditions (eg, uncontrolled diabetes, congestive heart failure, or end-stage liver disease) or a chronic condition and a substance use disorder or mental il...
PMC10638646
Enrollment, Randomization, and Follow-Up
RECRUITMENT
Once the patient was accepted to SUMMIT, research staff reviewed the medical record to confirm study eligibility and then contacted the patient to obtain written informed consent and conduct baseline surveys. Research staff then opened an opaque sealed envelope that contained the group assignment generated by a randomi...
PMC10638646
Measures of Implementation
We assessed implementation
PMC10638646
Health Care Utilization Outcomes
The primary outcome was the change in hospitalization rate over 6 months after randomization compared with the 6 months before randomization. Hospitalization rates were calculated by determining the number of hospitalizations per person during both 6-month prerandomization and postrandomization periods. Secondary outco...
PMC10638646
Patient-Reported Outcomes
We also assessed the change in patient-reported outcomes at 6 months compared with baseline. We measured patient activation using the 10-item Patient Activation Measure (PAM-10),
PMC10638646
Baseline Survey
CORONARY HEART DISEASE
The baseline survey included demographics and psychosocial measures to describe our population. Demographic variables included self-reported age, sex, race and ethnicity, household income, and education. Race and ethnicity are reported as American Indian or Alaska Native, Asian, Black or African American, Hispanic or L...
PMC10638646
Statistical Analysis
We included all randomized participants in our intention-to-treat analysis. For all outcomes, we report mean within-group changes (from baseline to 6 months) and between-group comparisons of changes (ie, difference) with corresponding 95% CIs. We used linear mixed-effects modeling with a random intercept for each patie...
PMC10638646
Results
This study randomized 159 participants (mean [SD] age, 54.9 [9.8] years) to the A-ICU SUMMIT intervention (n = 80) or to EUC (n = 79). Patient baseline sociodemographic characteristics were similar in both groups (
PMC10638646
Baseline Characteristics by Intervention Group
DISORDERS, CORONARY HEART DISEASE, ABUSE
Abbreviations: AUDIT-10, 10-item Alcohol Use Disorders Identification Test; DAST-10, 10-item Drug Abuse Screening Test; ENRICHD, Enhancing Recovery in Coronary Heart Disease Patients Social Support Instrument; EUC, enhanced usual care; HRQOL SF-12, health-related quality of life 12-item Short Form Survey; PAM-10, 10-it...
PMC10638646
Screening, Randomization, and Analysis Flow Diagram
PMC10638646
Implementation Measures
Among participants randomized to the SUMMIT intervention, all completed the initial intake appointment. At 6 months, 70 patients (87.5%) had 3 or more visits with the team. On average, each SUMMIT patient had 36 appointments with team members and averaged 40 minutes per visit. This included 69 patients (86.3%) with 1 o...
PMC10638646
Health Care Utilization Outcomes
SE, reductions in mean (
The SUMMIT and EUC groups experienced similar declines in mean (SE) 6-month hospitalization rates (SUMMIT vs EUC within-group change, −0.6 [0.5] vs −0.9 [0.5] hospitalizations per person; difference, 0.3 [95% CI, −1.0 to 1.5]). Both groups also had similar reductions in mean (SE) 6-month ED visit rates (−2.0 [1.0] vs −...
PMC10638646
Patient-Reported Outcomes
SE
Both groups experienced increases in mean (SE) PAM-10 scores at 6 months (SUMMIT vs EUC within-group change, 3.5 [1.6] vs 2.3 [1.6]; difference, 1.2 [95% CI, −3.3 to 5.7]). Among the 3 CAHPS domains, SUMMIT participants reported increases in access (mean [SE], 5.7 [3.9] vs 4.0 [3.9]; difference, 1.7 [95% CI, −9.1 to 12...
PMC10638646
Discussion
high-functioning
In this community-partnered randomized clinical trial of an A-ICU intervention for medically and socially complex patients experiencing homelessness, we found no differences in hospitalizations at 6 months between those receiving A-ICU care and those receiving EUC. However, the intervention increased outpatient visits ...
PMC10638646
Limitations
deaths
RECRUITMENT
This study has some limitations. First, we were unable to reach our recruitment target. Second, although attrition was balanced across groups and was relatively low for this difficult-to-reach population, it reduced the statistical power of our patient-reported outcomes. However, the lack of change in the primary outco...
PMC10638646
Conclusions
In this randomized clinical trial including medically and socially complex patients at an urban FQHC with high rates of acute care utilization, our A-ICU intervention did not reduce hospitalizations or ED visits at 6 months but increased primary care visits and improved patient-reported social functioning and self-repo...
PMC10638646
Background
Tumor
NASOPHARYNGEAL CARCINOMA, TUMOR
Edited by: Xinqi Huang, Sichuan University, ChinaReviewed by: Jiaxiang Ye, Affiliated Tumor Hospital of Guangxi Medical University, ChinaDa Zhang, Benitec Biopharma, Inc., United StatesMinghan Yang, New York University, United StatesKai Song, University of California, Los Angeles, United StatesXin Xu, Kansas State Univ...
PMC10795162
Methods
Patients with RM-NPC were administered with apatinib at 250 mg orally once every day and with camrelizumab at 200 mg
PMC10795162
Results
pneumonia, stomatitis, myocarditis, anemia, headache, deaths
PNEUMONIA, STOMATITIS, ADVERSE EVENTS, DISEASE, MYOCARDITIS, ANEMIA
This study enrolled 26 patients with RM-NPC between January 14, 2021 and September 15, 2021. At data cutoff (March 31, 2023), the median duration of follow-up was 16 months (ranging from 1 to 26 months). The ORR was 38.5% (10/26), the disease control rate (DCR) was 61.5% (16/26), and the median PFS was 6 months (IQR 3....
PMC10795162
Conclusion
toxicities
In patients with RM-NPC, apatinib plus camrelizumab showed promising antitumor activity and manageable toxicities.
PMC10795162
Introduction
NPC, Epstein-Barr virus, head and neck cancer, infection
NASOPHARYNGEAL CARCINOMA, HEAD AND NECK CANCER, INFECTION
Nasopharyngeal carcinoma (NPC) is a kind of head and neck cancer with special geographical distribution, with the highest incidence in South China, Southeast Asia and North Africa.(A fundamental feature of NPC is the association with Epstein-Barr virus (EBV) infection.(Based on these results, we conducted an open-label...
PMC10795162
Methods
PMC10795162
Design of the study and its participants
tumor, acquired immunodeficiency diseases, swallow disability, infection, mental disorders
TUMOR, RECURRENCE, METASTASIS, HEART DISEASE, AUTOIMMUNE DISEASES, INFECTION, SOLID TUMOR, ONCOLOGY, PATHOLOGY, DISEASES
This was a multicenter, open-label, single-arm, phase II clinical trial conducted at five hospitals in Guangxi, China, where the morbidity and mortality of NPC is high.(Inclusion criteria: (1) Male or female patients: 18–70 years old; (2) patients with NPC confirmed by pathology; (3) local recurrence and/or distant met...
PMC10795162