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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 |
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Web-based common measures for parents and children | PMC10031163 |
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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 of birth, weight and height, and location of their child’s treatment.Furthermore, items adapted from Warschburger [ | PMC10031163 |
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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 |
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Psychosocial adjustment: Overall well-being | Two picture-based items using the Self-Assessment Manikin [ | PMC10031163 |
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Psychosocial adjustment: Loneliness | The 6-item short version of the De-Jong-Gierveld-Skala [ | PMC10031163 |
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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 = .87) and conduct problems (α = .73) [ | PMC10031163 |
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Web-based extended measures for parents | PMC10031163 |
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Sociodemographic assessment | The parental socioeconomic status (SES) is measured using the MacArthur Scale [ | PMC10031163 |
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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 discussed in section “COVID-19-specific well-being in the everyday life”. | PMC10031163 |
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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 consistency of Cronbach’s α = .82 has been reported [ | PMC10031163 |
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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 difficulties were piling up so high that you could not overcome them?“), with a higher score indicating higher chronic stress. The PSS-4 has an internal consistency of Cronbach’s α = .72 [ | PMC10031163 |
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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 of the following cause for you: your child’s physical health?“), the impact on the family with 6 items (e.g., “How often has your child’s health or behavior limited the types of activities you could do as a family?“), and family cohesion with one item (e.g., “In general, how would you rate your family’s ability to get along with one another?“). On a 4-point Likert scale, 3 items measure the impact of the child’s health on the leisure time (e.g., “Were you limited in the amount of time you had for your own needs because of your child’s emotional well-being?“). The German version of the CHQ reports an internal consistency of Cronbach’s α = .76 for parental emotional impact, and α = .81 for parental time impact. For the family impact subscale, an internal consistency of Cronbach’s α = .83 has been reported [ | PMC10031163 |
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Coping and resources | The following instruments are used to assess the coping strategies and the resources and burdens of the parents: | PMC10031163 |
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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 |
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Coping and resources: Self-efficacy | The German version of the General self-efficacy scale (in German: Allgemeine Selbstwirksamkeitsskala (ASKU)) [ | PMC10031163 |
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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 |
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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 categorized as poor social support, from 9 to 11 as moderate social support, and 12-14 as strong social support. In a representative German population, the OSS-3 showed an internal consistency of Cronbach’s α = .64 [ | PMC10031163 |
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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 |
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Family relations and interactions | The following tools are used to consider the potential impact at family level. | PMC10031163 |
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Family relations and interactions: Parenting behaviour | To measure the risk of harmful parenting, 4 items originating from a study by Clemens et al. [ | PMC10031163 |
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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 |
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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 seldom/never. The BPBs reports an internal consistency of Cronbach’s α = .81 to .84 [ | PMC10031163 |
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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 |
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Web-based extended measures for children | PMC10031163 |
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Psychosocial adjustment | To measure the child’s health related quality of life (HRQoL), 16 items of the KIDSCREEN-27 [ | PMC10031163 |
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Coping and resources: Coping | DISEASE | Children’s coping strategies are assessed with the Coping with a disease questionnaire CODI [ | PMC10031163 |
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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 6 items each (e.g., “I make sense of my life“). Responses are measured on 4-point Likert scales ranging from “never true “to “always true“. The internal consistency of the subscales varies between Cronbach’s α = 0.69 to α = 0.89 [Based on self-constructed items from another study [ | PMC10031163 |
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Coping and resources: Social integration | The survey includes 4 items based on self-constructed items from another study [ | PMC10031163 |
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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 “overprotection“, asking children to answer 8 items on 5-point Likert scales. The internal consistency of the subscales ranges from Cronbach’s α = .72 to .85 for patients [ | PMC10031163 |
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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“) and their friends (e.g., “I have talked to my friends about COVID-19″). | PMC10031163 |
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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 many participants as possible in order to get sufficient data sets to make generalizable statements. Therefore, we intend to recruit at least 1000 parents of either children or adolescents per CC. In addition, we assume that around 500 adolescents (> 12 yrs) per CC will fill in the baseline survey. For the web-based psychosocial assessment, the primary goal is to get a deeper understanding of the assumed psychosocial processes that can explain the level of mental and physical strain experienced. Therefore, we aim to include a subsample of participants of the baseline survey. To apply structural equation modeling (SEM) required sample sizes are dependent on various data characteristics such as data distribution, the number of missing data, or parameters that have to be computed. According to Kline [ | PMC10031163 |
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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 |
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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 and lockdowns, or the changed working situation of parents with home offices or part-time work, to name just a few measures that aimed to curb the further spread of the contagious virus. These measures have not spared the health system with the (partial) closure of outpatient clinics, limited contact times, or the establishment of video consultation hours. It is precisely these restrictions that affect those who are most in need of regular medical and psychosocial care: people with CCs.Since the outbreak of the pandemic, numerous studies have examined the consequences for society. There is now meta-analytical evidence on the psychological consequences for children and adolescents [ | PMC10031163 |
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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 size. The short economic questionnaire aims to reach as many of those affected as possible. The large sample size makes it possible to make statements that are as representative as possible, not only in relation to the respective underlying physical disease, but also across the disease groups in order to identify generic and condition-specific patterns. In addition, the extended psychosocial web survey will enrich our database by providing more detailed information on the psychosocial situation and coping strategies of the families. Of note, a follow-up over 1 year will allow us to examine short and longer-term effects and different trajectories over time.With respect to the limitations of the study, it should be mentioned that a self-selection of interested clinicians and patients cannot be ruled out. Thus, clinicians might not approach certain patients, either because they may perceive these persons as too distressed or because they believe that the afflicted patients do not have any problems. Especially, a bias regarding the inclusion of the high-risk group in the obesity sample can be expected for the basic survey and the extended survey in particular. Due to organizational reasons, we are not able to implement the questionnaires as obligatory, and we could not offer monetary compensation for the clinics and patients to mitigate this effect. However, we are aiming for a large sample that may be able to compensate for this effect. Furthermore, the data already available from the registers allow us to characterize our sample in relation to the total population. Of course, self-selection could be even more pronounced when parents are invited to fill in the questionnaire. Due to ethical reasons and German data protection law regulations, we have to ask the parents to forward the children’s questionnaire with their consent to their children.Taken together, the results of the proposed study will provide empirical data on how to support families with a child suffering from a CC and contribute to a more successful and sustainable health system. The identification of determining factors for positive adjustment will offer new opportunities for interventions. The prospective design will not only allow the detection of acute and delayed long-term effects, but also the analysis of mediating and moderator influences. | 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 approved the final manuscript. PW is its guarantor. | PMC10031163 |
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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 care among children with a high-risk chronic condition and their families”, funded by the German Research Foundation (Grant No: HO 3228/2-1; MI 2760/1-1; WA 1143/18-1). | PMC10031163 |
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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 |
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Declarations | PMC10031163 |
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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 |
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Consent for publication | Not applicable. | PMC10031163 |
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Competing interests | The authors declare that they have no competing interests. | PMC10031163 |
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References | PMC10031163 |
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2. Materials and Methods | PMC10303563 |
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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 insufficiency, as diagnosed by the site’s lead clinician and confirmed by clinical assessment and/or duplex ultrasound, in accordance with clinical practice guidelines by the Society for Vascular Surgery and the American Venous Forum [The patients included in this study were diagnosed with a grade 2 primary venous ulcer, according to the venous clinical severity score, which is made up of 10 features that are graded on a 4-point scale (absence (0), mild (1), moderate (2), and severe (3)). It has been demonstrated to be beneficial in assessing treatment responses in chronic venous diseases and is recommended for routine clinical usage in the clinical practice guideline [Following the recruitment of the eligible patients, we randomly assigned the participants using a block randomization approach, according to a preset ratio of 1:1:1 block randomization approach. The participants were divided into three assigned groups (PEMF + PRE, PEMF, or control) in sequence. Participants, outcome evaluators, and data analysts were blind to the research participants’ group assignment. The following participants were excluded: peripheral vascular disease (PVD), arterial disease by ankle brachial pressure index (ABPI < 0.8), VLUs with infection, or cellulitis symptoms, as well as VLUs with necrotic tissue or slough or having more than one ulcer. Other ulcer types, included malignant ulceration, diabetic foot, and rheumatoid vasculitis; corticosteroid use; patients with dementia or who were disoriented; patients who had undertaken another physical therapy modality for ulcer healing. | 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 measured by covering the ulcer with a piece of sterilized transparency film and using a fine-tipped transparency marker to trace the ulcer perimeter on the film. For each ulcer, a different transparency was employed. After that, the tracing was applied to metric graph paper, and the number of 1 mm that it contains was counted (only squares that were exactly 1 mm in size were counted inside the perimeter, and the area was transformed to square centimeters) [Secondary outcome measures: ulcer volume measurement in cmThe ulcer was drawn on clear paper and placed over metric graph paper so that it would have the greatest length and width. Then, a disposable measuring tape was inserted into the ulcer’s bottom part to record the depth of the ulcer [ | 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 technique. All subjects in the three groups received the same conservative treatment for the ulcer in the form of wound cleaning, dressing, debridement if needed by the physician, and compression therapy. The wound dressing was changed 2–3 times a week, following the local protocol. The ulcer was cleaned with regular saline solution, and a nonadherent dressing, such as Vaseline gauze, was used to maintain a moist environment. All participants in the study received the same medical treatment protocol, which included the administration of phlebotropic drugs in the form of flavonoid medications, as well as topical application of antibiotic or antimicrobial agents (octenidine dihydrochloride antiseptic) [PEMF + PRE group: Patients received a local application of pulsed electromagnetic field therapy (PEMF) and a plantar flexion resistance exercise (PRE) therapy by the Step It rocker pedal (Step It System AB, Saltsjöbaden, Sweden) for up to 12 weeks. The entire exercise session duration was 20 min and involved a 10-min interval period for pedaling with the index leg for 1 min, interspersed by passive recovery for 1 min. This routine was performed twice daily (e.g., morning and evening). There would be at least 300 pedals using the minimum recommended 2 s down and 2 s up space [ | 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 sample size for each group was increased by 5 patients to account for the dropout rate. The study’s consort diagram is described in Before conducting the data analysis, the normality and homogeneity of variance were examined, and no deviations were found for any of the dependent variables, according to the results of the Shapiro–Wilk test and Levene’s test. The significant difference in demographic data (age, body mass, height, and BMI) between the three groups was tested with a one-way ANOVA. The overall effect of treatment, time, or the interaction between time and treatment was estimated using a 3 × 3 mixed-design multivariate analysis of variance (MANOVA). Wilks’ lambda was used to calculate the F value, and additional univariate ANOVAs (two-way mixed models) were carried out when the MANOVA showed a significant time group interaction effect. The alpha level of significance was set at | PMC10303563 |
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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 |
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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 within-group analysis revealed a considerable variation in ulcer surface area and ulcer volume relative to baseline in the 2 experimental groups. The control group, however, showed no significant change (At the 12-week follow-up, the within-group analysis revealed a significant variation in ulcer surface area and ulcer volume compared to the baseline (The Bonferroni multiple comparison analysis revealed a significant difference between the three groups (PEMF + PRE, PEMF, and control) on the chosen parameters post-intervention, while the PEMF + PRE group underwent the most significant changes, with mean differences at [95% confidence interval] for ulcer surface area being (−4.75, −3.82, −0.98) and for ulcer volume (−12.63, −9.55, −2.45), respectively, | 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 the PEMF + PRE group experiencing the most significant improvement.These results were in line with the findings of a study by El-Din et al. [Several experimental studies have reported improved wound healing from various causes, including one that compared the histological and morphological differences between electric stimulation and magnetic field treatments in burn-injured rats. The pulsed electromagnetic field therapy group showed more healing signs (burn area, epithelialization, edema, and hyperemia) than the electric stimulation group [The pulsed electromagnetic field has several physiological impacts, which have been well-documented. It has been proposed that PEMF may induce particular, quantifiable biological reactions, such as DNA synthesis, transcription, and protein biosynthesis by modifying or enhancing existing endogenous electrical fields [One important element in the pathophysiology of venous ulcers is the increased generation of oxygen free radicals and lipid peroxides by both entrapped white cells due to decreased perfusion caused by increased venous pressure [According to published research, there is a connection between calf muscle malfunction and the severity of VLU [Several types of physical activity, such as resistance exercise, walking, aerobic exercise, and ankle exercise, are suggested as adjunct therapies to compression therapy for managing VLU [ | 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 randomization, blinding the assessors to the group allocation, and direct investigator monitoring of the intervention, which all increased the validity of the study’s findings. However, we would like to acknowledge some of the limitations, including the lack of long-term follow-up evaluations, which prevented us from analyzing the intervention’s long-term effects. Additionally, we did not assess ulcer size and area using more accurate methods, such as digital planimetry or jeltrate volume measurement. Moreover, the relatively small sample size in our study limits the generalizability of our findings. Therefore, future studies should aim to replicate our findings in larger and more diverse populations to enhance the generalizability of the results. | 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 |
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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 published version of the manuscript. | PMC10303563 |
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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 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10303563 |
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Data Availability Statement | The corresponding author will provide the identified datasets used in the current study upon reasonable request. | PMC10303563 |
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Conflicts of Interest | The authors declare no conflict of interest. | PMC10303563 |
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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 significance at Comparison of outcomes across the three groups at three-point timelines.Abbreviation: PEMF, pulsed electromagnetic field; PRE, plantar flexion resistance exercise (PRE); SD, standard deviation; vs: versus. Level of significance at Within-group pairwise comparisons at baseline, 4 weeks, and 12 weeks.Abbreviation: PEMF, pulsed electromagnetic field; PRE, plantar flexion resistance exercise (PRE); MD: mean difference; CI: confidence interval; vs: versus. Level of significance at | PMC10303563 |
Key Points | PMC10638646 |
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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 |
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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-being. | PMC10638646 |
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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 intervention on health care utilization and patient-reported outcomes among medically and socially complex patients experiencing homelessness. | PMC10638646 |
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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 |
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Objective | To assess the efficacy of a multidisciplinary ambulatory intensive care unit (A-ICU) intervention on health care utilization and patient-reported outcomes. | PMC10638646 |
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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 November 2019. Included patients had 1 or more hospitalizations in the prior 6 months and 2 or more chronic medical conditions, substance use disorder, or mental illness. Data analysis was performed between March and May 2021. | 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 access to community health workers and mental health, addiction treatment, and pharmacy services, served as the comparator. Participants who received EUC joined the A-ICU intervention after 6 months. | PMC10638646 |
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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 self-rated health at 6 months (vs baseline). We performed an intention-to-treat analysis using a linear mixed-effects model with a random intercept for each patient to examine the association between study group and outcomes. | PMC10638646 |
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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 hospitalizations decreased in both the A-ICU and EUC groups, with no difference between them (mean [SE], −0.6 [0.5] vs −0.9 [0.5]; difference, 0.3 [95% CI, −1.0 to 1.5]). Emergency department use did not differ between groups (mean [SE], −2.0 [1.0] vs 0.9 [1.0] visits per person; difference, −1.1 [95% CI, −3.7 to 1.6]). Primary care physician visits increased in the A-ICU group (mean [SE], 4.2 [1.6] vs −2.0 [1.6] per person; difference, 6.1 [95% CI, 1.8 to 10.4]). Patients in the A-ICU group reported improved social functioning (mean [SE], 4.7 [2.0] vs −1.1 [2.0]; difference, 5.8 [95% CI, 0.3 to 11.2]) and self-rated health (mean [SE], 0.7 [0.3] vs −0.2 [0.3]; difference, 1.0 [95% CI, 0.1 to 1.8]) compared with patients in the EUC group. No differences in patient activation or experience were observed. | PMC10638646 |
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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 |
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Trial Registration | ClinicalTrials.gov Identifier: | PMC10638646 |
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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 |
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Methods | PMC10638646 |
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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 City Concern, an urban FQHC designated to provide health care for individuals experiencing homelessness.The clinic engaged its academic partner to conduct an evaluation of the SUMMIT intervention. Over the course of planning meetings among the research team, clinic staff and leadership, and clinic patient advisory board, we determined that a 6-month wait-list control design would allow all participants to eventually receive the SUMMIT intervention while preserving the evaluative benefits of randomization. Here, we present our 6-month outcomes. Clinic staff implemented the SUMMIT intervention and were unaware of the results until trial completion. | PMC10638646 |
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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 |
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Comparison of the SUMMIT A-ICU and EUC Teams | PMC10638646 |
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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 social workers focused on counseling), substance use counseling (brief counseling and referral to treatment completed by certified alcohol and drug counselors), and pharmacy-led interventions (eg, diabetes medication therapy management). In addition, PCPs could refer patients to embedded community health workers who performed short-term (6-month) engagements. | 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 illness. Patients were excluded from participation if they were unable to consent due to cognitive impairment (ie, unable to “teach back” consent) or uncontrolled mental illness, had a diagnosis of metastatic cancer or less than 6 months to live, or were unable to participate as a result of aphasia or hearing impairment (eAppendix 2 in | 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 randomization process in R, version 3.3.1 (R Project for Statistical Computing), and they informed the participant. The SUMMIT and EUC teams were then notified of treatment assignment. Six months after randomization, research staff contacted participants, reconfirmed informed consent, and conducted follow-up surveys. At that point, those randomized to EUC were able to join SUMMIT. Patients received a $5 debit card for each survey completed. The first patient was enrolled in August 2016, and the last patient was enrolled in November 2019. During study planning, a power analysis determined that a sample of 200 participants would be able to detect a 30% reduction in hospitalization. Due to resource constraints and the COVID-19 pandemic, recruitment was halted after 159 participants were randomized. | PMC10638646 |
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Measures of Implementation | We assessed implementation | PMC10638646 |
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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 outcomes included the change in rates of ED, primary care, and behavioral health visits over 6 months. | PMC10638646 |
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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 |
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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 Latino, Native Hawaiian or Other Pacific Islander, White, or other race or ethnicity; these data were collected to provide descriptive information about our study population with regard to generalizability and applicability to other health care settings. Psychosocial variables included perceived social support (using the 7-item ENRICHD [Enhancing Recovery in Coronary Heart Disease Patients] Social Support Instrument), | PMC10638646 |
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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 patient to examine the association between study group and outcomes. We chose this model to account for both within-patient correlation and missing data (eg, due to loss to follow-up). Models included an interaction term of time × study group to test for the significance of between-group (difference) comparisons. To quantify the magnitude of influence of outliers on the difference between groups, we conducted sensitivity analyses of outliers by excluding those with large model-based residuals and comparing results from a model with and without outliers. Testing for all analyses was 2 sided at a significance level of | PMC10638646 |
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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 |
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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-item Patient Activation Measure; PHQ-9, 9-item Patient Health Questionnaire; SUMMIT, Streamlined Unified Meaningfully Managed Interdisciplinary Team; TICS, Telephone Interview Cognitive Status.Unless indicated otherwise, values are presented as No. (%) of patients.Percentages may not total 100% because of rounding and multiple race and ethnicity categories checked.Unstable housing was defined as sleeping outside or in a place not meant for habitation, shelter, or transitional housing; stable housing was defined as permanent housing, staying with friends or family, or living in a nursing facility or assisted living.Inadequate health literacy was defined as the percentage responding “not at all/little bit/moderately” confident in filling out forms by themselves.Food insecurity was defined as an affirmative response on either question 1 (“In the last 12 months, did you ever eat less than you felt you should because there wasn’t enough money for food?”) or question 2 (In the last 12 months, were you ever hungry but didn’t eat because there wasn’t enough money for food?”). | PMC10638646 |
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Screening, Randomization, and Analysis Flow Diagram | PMC10638646 |
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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 or more mental health visits and 67 patients (83.8%) with 2 or more visits with a physician. More than half of visits were with physicians (429 visits [28.2%]) or social workers (374 visits [24.6%]). | PMC10638646 |
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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 −0.9 [1.0]; difference, −1.1 [95% CI, −3.7 to 1.6]). The SUMMIT participants experienced significantly greater increases in mean (SE) primary care visits (4.2 [1.6] vs −2.0 [1.6] visits per person; difference, 6.1 [95% CI, 1.8 to 10.4]) and behavioral health visits (4.7 [1.1] vs −1.1 [1.1] visits per person; difference, 5.8 [95% CI, 2.8 to 8.8]) relative to EUC participants ( | PMC10638646 |
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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 12.5]), communication (mean [SE], 5.2 [3.5] vs −3.7 [3.5]; difference, 9.0 [95% CI, −0.7 to 18.7]), and coordination (mean [SE], 9.8 [4.4] vs 0.5 [4.4]; difference, 9.2 [95% CI, −3.1 to 21.6]) relative to EUC participants, although these differences between groups were not significant. The SUMMIT participants also experienced nonsignificant increases in mean (SE) SF-12 physical health composite scores (2.5 [1.1] vs 0.7 [1.1]; difference, 1.8 [95% CI, −1.3 to 4.9]) and SF-12 mental health composite scores (2.2 [1.7] vs 0.1 [1.7]; difference, 2.2 [95% CI, −2.5 to 6.8]) relative to EUC participants. The SUMMIT participants compared with EUC participants had significantly greater increases in the SF-12 social functioning subdomain (mean [SE], 4.7 [2.0] vs −1.1 [2.0]; difference, 5.8 [95% CI, 0.3 to 11.2]) and in self-rated health (mean [SE], 0.7 [0.3] vs −0.2 [0.3]; difference, 1.0 [95% CI, 0.1 to 1.8]) ( | PMC10638646 |
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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 and improved patient-reported social functioning and self-rated health. These findings suggest that A-ICU and other intensive primary care interventions may have positive effects on the care of high-need, high-cost patients but may not achieve the goal of reduced acute care utilization, at least in the short term.To our knowledge, this is the first randomized clinical trial to assess the effect of an A-ICU model for patients at a FQHC with high rates of poverty and acute care utilization. Our intervention and population were similar to those in the Veterans Affairs (VA) Homeless Patient Aligned Care Team program. Data from that program showed reduced costsSeveral factors may explain why 6-month hospitalization rates did not improve. First, our EUC comparator was a high-functioning patient-centered medical home with high levels of patient access, staff members with experience in culturally appropriate care, and links to CHWsOur results and those of other studies suggest that 6 months may be too short a period to see changes in hospitalization rates. For our population of patients living in high poverty and experiencing high stigmatization with years of negative interactions with the health care system, effective use of primary and acute care services may require years and involve building rapport with clinicians, trust in health care institutions, and skills in navigating complex health care systems. In qualitative interviews, SUMMIT team members noted that our current health care system is not designed to meet the needs of this patient population.The SUMMIT intervention led to more outpatient primary care and behavioral health visits, higher social functioning, and better self-reported health. These findings are consistent with those of prior studies of intensive primary care in the VA, which showed similar increases in outpatient visits and patient satisfaction.Our results must also be interpreted in the context of the social and health-related challenges faced by SUMMIT patients. Although SUMMIT was designed to address social determinants underlying the poor health of its patients, A-ICU interventions like SUMMIT are effectively bandages for deep wounds caused by the social deprivation faced by the patients they serve. The effectiveness of intensive primary care interventions may be limited without larger policy and community-level systems changes necessary to address the living and working conditions that lead to poverty, poor health outcomes, and health inequity. | PMC10638646 |
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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 outcome between groups suggests that we would not have observed a statistically significant improvement in hospitalization rates even if we had reached our sample size target. Third, we had a relatively high number of deaths during the 6-month period, indicating the frailty of our population. Finally, we relied on PCPs to refer patients for the trial; it is unclear how nonreferred complex patients may have fared. Although the intended target was patients with medical complexity as a driver of their hospitalizations, it is difficult to disentangle behavioral health and substance use drivers of hospitalization, which may require different interventions. | 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-reported health status. These programs provide important benefits beyond utilization reductions. Short-term utilization reduction may not be achievable with intensive primary care programs alone, but whether their short-term benefits lead to longer-term effects on utilization merits further study. | PMC10638646 |
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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 University, United StatesShanshan Lin, Johns Hopkins University, United StatesDandan Mao, University of Massachusetts Medical School, United States†These authors contributed equally to this work and share first authorshipPreclinical studies demonstrated that immune checkpoint inhibitors combined with antiangiogenic drugs have a synergistic anti-tumor effect. This present phase II trial aimed to evaluate the efficacy and safety of apatinib combined with camrelizumab in patients with recurrent/metastatic nasopharyngeal carcinoma (RM-NPC). | PMC10795162 |
Methods | Patients with RM-NPC were administered with apatinib at 250 mg orally once every day and with camrelizumab at 200 mg | PMC10795162 |
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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 3.0-20.0). The median OS was 14 months (IQR 6.0-21.25). Treatment-related grade 3 or 4 adverse events occurred in seven (26.9%) patients, and comprised anemia (7.7%), stomatitis (3.8%), headache (3.8%), pneumonia (7.7%), and myocarditis (3.8%). There were no serious treatment-related adverse events or treatment-related deaths. | PMC10795162 |
Conclusion | toxicities | In patients with RM-NPC, apatinib plus camrelizumab showed promising antitumor activity and manageable toxicities. | PMC10795162 |
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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, phase II study to evaluate the anti-tumor activity and safety of apatinib combined with camrelizumab in patients with RM-NPC. | PMC10795162 |
Methods | PMC10795162 |
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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 metastasis after one comprehensive treatment, and progression following at least first-line treatment; (4) Eastern Cooperative Oncology Group (ECOG) physical status score: 0–1; (5) at least one measurable lesion evaluated using Response Evaluation Criteria in Solid Tumor sversion1.1 (RECIST1.1); (6) expected survival ≥ 6 months; (7) the body’s major organs are functioning well; and (8) with satisfactory compliance and follow-up, the subjects willingly participated in the study and completed an informed consent form. The exclusion criteria were as follows: current autoimmune illnesses or a history of autoimmune diseases; diseases requiring immunosuppressive drugs, including congenital or acquired immunodeficiency diseases, active hepatitis B or C virus infection, active infection or uncontrollable heart disease; invaded important blood vessels by tumor; swallow disability; mental disorders; pregnancy; and prior anti-PD-L1 or anti-PD-1 antibody therapy. | PMC10795162 |
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