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Compliance
Our methods followed the Consort-2010 reporting guidelines (Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials).
PMC10334613
Results
PMC10334613
Study participants
insomnia
Of 153 potential participants screened, 53 were enrolled and randomized to MBSI-I or SH (see CONSORT Fig.  Study Consort diagramBaseline demographic and study variables: MBSI-I (mindfulness based sleep intervention for insomnia) vs. SH (sleep hygiene) groups (Fitbit™ data: baseline valuesOverall compliance with the SH ...
PMC10334613
Primary outcome of sleep efficiency: MBSI-I vs. SH at 10 and 16 weeks
SE
MBSI-I did not show superiority over SH in terms over sleep efficiency at 10 or 16 weeks. SE did not improve over the course of the study either within or between cohorts or when the eMBSI-I cohort was analyzed (Tables Baseline to 10 weeks. Change in sleep parameters measured by Fitbit™ (Δ sleep time/Δ time in bed = Δ ...
PMC10334613
Secondary sleep outcomes
The MBSI-I cohort and the eMBSI-I cohort spent significantly less time in bed at 10 weeks relative to baseline when compared to the SH cohort (MBSI-I vs SH:
PMC10334613
MBSI-I, eMBSI-I and SH interventions and self-reported sleep outcomes
The MBSI-I cohort did not show improvement relative to SH at 10 or 16 weeks in the self-reported Global PSQI. However, within group improvements in the Global PSQI scores for the MBSI-I cohorts relative to baseline were significant (10 weeks: MBSI-I: Baseline to 10 weeks. Comparison between MBSI-I, eMBSI-I, SH on self-...
PMC10334613
Secondary outcomes: MBSI-I, eMBSI-I and SH and self-reported quality of life
Cognitive Dysfunction, Expanded Disability Status Scale
Relative to SH, the MBSI-I cohorts showed significant improvement at 10 weeks in bowel control (MBSI-I vs. SH: Baseline to 10 weeks. Comparisons between MBSI-I, eMBSI-I, and SH cohorts on quality of life variablesBaseline to 16 weeks. Comparisons between MBSI-I, eMBSI-I and SH cohorts on quality of life variablesWithin...
PMC10334613
Adverse events
shortness of breath, pain
One participant reported experiencing severe pain and needed to take more pain medications than usual a few hours after attending mindfulness session number eight. Another participant reported pain, a popping sensation under her armpit and shortness of breath after a repositioning herself on a yoga mat while performing...
PMC10334613
Discussion
anxiety, breast cancer, nonMS, sleepiness, daytime fatigue, insomnia, SE, depression
BREAST CANCER, SECONDARY, DYSFUNCTION, CHRONIC INSOMNIA
This pilot study represents the first reported randomized controlled study of mindfulness training compared to an active comparator (SH) to treat chronic insomnia in persons with MS. Outcome measures utilized standard objective and subjective measures of sleep. Additional study design features included a 16 week follow...
PMC10334613
Limitations
RRMS
MINOR, DISEASE, RELAPSING REMITTING MULTIPLE SCLEROSIS
The study is limited by the power to detect differences between MBSI-I and SH due to the low number of participants and the higher number of dropouts in the MBSI-I groups. This was partly compensated by the crossover of 10 SH participants into the extended MBSI-I cohort. MBSR programs require significant commitment of ...
PMC10334613
Acknowledgements
The authors wish to acknowledge the Connecticut Department of Public Health Biomedical Research Trust Fund Grant for providing funding for this study. We also like to acknowledge Ms. Anne Dutton of the Yale Stress Center as the instructor of the mindfulness sessions, Ms. Jackie Hoyle as the instructor of the sleep sess...
PMC10334613
Authors’ contributions
JBG: study design, wrote the main manuscript, evaluating physician. VYN: study design, statistical design and analysis, prepared Tables
PMC10334613
Funding
DISEASE
This study was conducted with funding from the Connecticut Department of Public Health Biomedical Research Trust Fund Grant and from the Centers for Disease Control and Prevention.
PMC10334613
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC10334613
Declarations
PMC10334613
Ethics approval and consent to participate
This study was have been performed in accordance with the Declaration of Helsinki. It was approved by the Griffin Hospital Institutional Review Board (IRB#2017–01). Informed consent was obtained from all subjects.
PMC10334613
Consent to publication
N/A.
PMC10334613
Competing interests
The authors declare no competing interests.
PMC10334613
References
PMC10334613
Objectives
Dens
STENOSES
Academic Editor: Joseph Dens The aim of this retrospective analysis was to compare the patient outcome after interventional therapy of saphenous vein graft (SVG) stenoses in an all-comers population receiving either self-expanding drug-eluting stents (SExS) or balloon expanding drug-eluting stents (BExS).
PMC10101740
Background
friable
CARDIAC EVENT, DEGENERATED
The interventional therapy of degenerated SVGs remains challenging. Diameter variations of stenotic segments and friable plaques can lead to malapposition and distal embolization with increased major adverse cardiac event (MACE) rates.
PMC10101740
Methods
107 patients with a total of 130 SVG interventions were separated into two groups according to either SExS (
PMC10101740
Results
Both patient groups did not differ significantly regarding patient characteristics. The patient outcome was significantly better in the SExS patient group: the MACE rate at 30 days was 1/51 (2.0%) in group SExS vs. 7/56 (12.5%) in group BExS;
PMC10101740
Conclusion
Our findings demonstrate that SVG treatment with SExS is safe and provides clinical benefits by comparatively improving short and especially long-term patient outcomes.
PMC10101740
1. Introduction
Stenosis, restenosis
STENOSIS, DEGENERATED, CORONARY ARTERY DISEASES, STENOSES, RESTENOSIS
Coronary artery bypass graft (CABG) surgery, whilst declining, is still a frequent procedure used worldwide for the treatment of coronary artery diseases. Although guidelines recommend a full arterial revascularization, most patients still receive at least one or more saphenous vein grafts in daily routine practice [An...
PMC10101740
2. Methods
PMC10101740
Patients and SVG-Intervention Procedure (
DER, DEGENERATION, DEGENERATED, PLAQUE
From Jan 2012 to Jan 2018, we performed 131 SVG interventions with DES stents in 108 patients at our institution. One patient receiving one procedure was lost to follow-up within the BExS group. An all-comers retrospective analysis was performed dividing these patients into two groups according to treatment (operator d...
PMC10101740
2.2. Outcomes and Definitions
TIMI, restenosis
MYOCARDIAL INFARCTION (MI), MYOCARDIAL INFARCTION, RESTENOSIS
Technical success was defined as residual restenosis <20% of the target lesion and thrombolysis in myocardial infarction (TIMI) II-III flow at the end of the procedure.Primary endpoints were the MACE rate within 30 days and at one-year follow-up. MACE was defined as a composite of target vessel revascularization (TVR),...
PMC10101740
2.3. Statistical Analysis
For all statistical analyses, the computer programs Excel (Microsoft, Redmond, USA), SPSS (Version 24, IBM, Armonk, USA) and MedCalc (Version 19.2, MedCalc Software, Ostend, Belgium) were used. Continuous data were summarized as mean ± standard deviation (normally distributed data) or median and interquartile range and...
PMC10101740
3. Results
PMC10101740
3.1. Patients and Lesion Characteristics
RECRUITMENT
Patient recruitment details are depicted in All patient and lesion characteristics were not normally distributed according to the Kolmogorov–Smirnov test. Therefore, a Mann–Whitney Overall, 1.4 stents per procedure in both groups,
PMC10101740
3.2. Outcomes
thrombosis, perforation, pericardial tamponade
THROMBOSIS, PERICARDIAL TAMPONADE, COMPLICATION, REGRESSION, COMPLICATIONS
There was no significant difference between the SExS and BExS patient group regarding procedural success, which was defined as TIMI II or TIMI III flow (SExS: 100% vs BExS: 98.6%, No periprocedural complications occurred within the BExS group. Of note, one patient died due to pericardial tamponade related to wire perfo...
PMC10101740
4. Discussion
cardiac deaths
REGRESSION, CARDIOGENIC SHOCK, CARDIAC DEATHS, STENOSES
In our trial, we performed a retrospective analysis of an all-comers patient population in the clinic of Memmingen over a period of six years who received an SVG intervention either by SExS (Both patient groups (SExS and BExS) did not differ significantly regarding baseline characteristics and were therefore comparable...
PMC10101740
5. Conclusion
cardiac death
STENOSES, CARDIAC DEATH, DEGENERATED
In conclusion, we could demonstrate that the interventional therapy of degenerated SVGs by SExS is safe, even in patients with ACS. The SExS showed a clinical benefit over BExS regarding MACE rate at 30-days as well as at one-year follow-up, in particular concerning the rate of MI, TLR, and TVR. Furthermore, cardiac de...
PMC10101740
Acknowledgments
Claudia
The authors thank our medical staff from the catheterization laboratory (Gerhard, Veroica, Marlies, Claudia, and Manuela). Special thanks are due to V. Kammerer and A. Wolf for helping with the database. M. Siry received research funding, consultancy, and/or lecture honorary from STENTYS.
PMC10101740
Data Availability
The data used to support the findings of this study are available upon request from the corresponding author.
PMC10101740
Conflicts of Interest
stenosis
ACUTE MYOCARDIAL INFARCTION, CARDIAC EVENT, EVENT, AMI, STENOSIS
The authors declare that they have no conflicts of interest.Delivery of self-expanding drug-eluting stent. (a) Stent is mounted on a semi-compliant balloon and is restrained by a splittable sheath. (b) Balloon inflation splits the sheath and releases the self-expanding stent. (c) Balloon is then deflated, leaving the 0...
PMC10101740
Background
DISEASE, DISORDERS
If people with episodic mental-health conditions lose their job due to an episode of their mental illness, they often experience personal negative consequences. Therefore, reintegration after sick leave is critical to avoid unfavorable courses of disease, longer inability to work, long payment of sickness benefits, and...
PMC9879869
Methods
psychiatric
DISORDER
The RETURN study was a multi-center, cluster-randomized controlled trial in acute psychiatric wards addressing inpatients suffering from a psychiatric disorder. In intervention wards, case managers (RTW experts) were introduced who supported patients in their RTW process, while in control wards treatment, as usual, was...
PMC9879869
Results
A total of 268 patients were recruited for the trial. Patients in the intervention group had more often returned to their workplace at 6 and 12 months, which was also mirrored in more days at work. These group differences were statistically significant at 6 months. However, for the main outcome (days at work at 12 mont...
PMC9879869
Conclusions
The RETURN intervention has shown the potential of case-management interventions when addressing RTW. Further analyses, especially the qualitative ones, may help to better understand limitations and potential areas for improvement.
PMC9879869
Keywords
PMC9879869
Introduction
stress-related disorders, depression, Mental illness, anxiety
MINOR, DISEASES, DISORDERS
Mental illnesses are among the most common diseases worldwide [Mental illness and employment interact in many ways. On the one hand, mental illnesses prevent persons from finding and keeping regular employment [People with episodic mental health conditions and fixed employment are a large group of society, however, the...
PMC9879869
Methods
PMC9879869
Study design
psychiatric
DISORDER
The study was designed as a multi-center, cluster-randomized controlled trial in acute psychiatric wards in southern Germany addressing inpatients suffering from a psychiatric disorder [
PMC9879869
Setting and participants
affective disorders, anxiety, organic mental disorder, eating disorder, psychotic disorders, mental retardation, obsessive-compulsive disorders, substance abuse
DISORDERS
The study was implemented on Age 18–60 years.Diagnosis of a mental illness (ICD-10 Chapter F2, F3, F4, or F6, i.e., psychotic disorders, affective disorders, anxiety disorders, obsessive-compulsive disorders, or personality disorders).Admission to inpatient treatment.Existing employment.Exclusion criteria were mental r...
PMC9879869
Intervention and control condition
SESSION
The intervention consisted of the implementation of RTW experts in the intervention wards [According to the manual RTW experts offered five structured sessions to patients during the inpatient stay (Session 1: Assessment; Session 2: Information about RTW measures/legal framework; Session 3: Disclosure; Session 4: Plann...
PMC9879869
Data collection and outcomes
The same data were collected at the same time points in the intervention group and control group [In addition, we obtained several potentially mediating factors such as the uptake of available support strategies (e.g., stepwise reintegration into work or specific services for people with disabilities). Furthermore, we ...
PMC9879869
Randomization and blinding
Randomization was done at cluster level (
PMC9879869
Statistical analysis
Baseline comparisons were undertaken using chi-squared- and The primary analysis was a comparison of days at work at 12 months after discharge between the intervention group and control group. To assess the effect of the intervention on the continuous primary outcome (days at work 12 months after discharge), a linear m...
PMC9879869
Ethics, informed consent procedure, and trial registration
Ethikkommission der Technischen Universität
The trial has been approved by the local review board (Ethikkommission der Technischen Universität München) and has been registered at Deutsches Register Klinischer Studien (DRKS00016037). All participating patients had to give written informed consent.
PMC9879869
Results
psychiatric
RECRUITMENT
Recruitment for the RETURN study took place in 28 psychiatric wards from January 2019 until February 2020. A total of 268 patients were recruited for the trial, 137 in the intervention group and 131 in the control group. As expected, there was a considerable number of dropouts during the study period (see CONSORT diagr...
PMC9879869
Baseline characteristics
At baseline, there were no major differences between intervention group and control group regarding sociodemographic and clinical variables (see Baseline characteristics of intervention group and control group: Mean (standard deviation)/frequency (%).
PMC9879869
Clinical outcomes at discharge
At discharge, patients in both groups were comparable in terms of length of inpatient stay and most clinical outcomes. Only for the Health of the Nation Outcome Scales (HONOS) intervention patients were judged to be healthier/less socially impaired (Clinical outcomes at discharge from hospital.Abbreviations: CGI, clini...
PMC9879869
Implementation rate of support resources and patients’ readiness to return to work
Regarding standardized support resources (day clinic, RTW discussion with supervisor, stepwise reintegration, structured RTW process from the employers’ side) there was no higher uptake in the intervention group compared to the control group. Likewise, patients in the intervention group did not feel more prepared for t...
PMC9879869
Intervention effects after 6 and 12 months after discharge
Patients in the intervention group had more often returned to their workplace at 6 months (86% vs. 63%, Intervention effects 6 and 12 months after discharge.
PMC9879869
Discussion
psychiatric
The results of the RETURN-study show that a case-management intervention for psychiatric inpatients can improve the return to existing workplaces after discharge. Intervention group patients returned to work earlier, resulting in significant superiority over TAU in terms of the percentage of patients who went back to w...
PMC9879869
Limitations
psychiatric, IPS
Our study has focused on a subgroup of psychiatric inpatients, that is, those still having workplaces in the competitive labor market. Therefore, our results are not transferable to patients aiming at reentering the labor market. Here, supported employment (IPS) is an established approach [
PMC9879869
Interpretation of results
anxiety
DISORDERS
Our intervention led to patients returning earlier to their workplaces and going to work more frequently compared to control group patients at 6 months follow-up. The patients in the control group returned later to their workplace. Thus, they needed 12 months to reach the share of returned patients that the interventio...
PMC9879869
Implications and conclusion
If we follow the claim that “work is a critical mental health intervention” [To conclude, the intervention studied has shown the potential of case-management interventions when addressing RTW. Further analyses, especially the qualitative ones, may help to better understand limitations and potential areas for improvemen...
PMC9879869
Data Availability Statement
The data that support the findings of this study are available from the first author upon reasonable request.
PMC9879869
Author Contribution
Johannes Hamann, Peter Brieger, Markus Bühner & Reinhold Kilian designed the first draft of the study protocol ad obtained funding. Johannes Hamann, Peter Brieger, Markus Bühner, Reinhold Kilian, Anne Lang, Lina Riedl, Daniela Blank & Monika Kohl wrote the final version of the study protocol, designed the analysis, obt...
PMC9879869
Financial Support
This study was funded by Gemeinsamer Bundesausschuss, Innovationsfonds, Förderkennzeichen 01VSF17012 (to J.H., M.B., R.K., and P.B.).
PMC9879869
Conflicts of Interest
support/honoraria
J.H. received paid speakerships from JnJ, Otsuka/Lundbeck, and ROVI, and research grants from JnJ. A.H. received paid speakerships from AbbVie, Janssen, Otsuka, Rercordati, and Lundbeck. He was a member of Rovi, Recordati, Otsuka, Lundbeck, and Janssen advisory boards. P.F. received research support/honoraria for lectu...
PMC9879869
Ethical Standards
The study was approved by the institutional review board of the Technische Universität München (437/18 S-KK). All participants have given written informed consent.
PMC9879869
References
PMC9879869
2. Materials and Methods
PMC10222752
2.1. Study Design
WBS
This study involved a single-blinded, 2-arm randomized controlled trial (RCT) (NCT05811715) to compare the effect of WBS exercise versus the control group during lunch breaks on reducing symptoms of WRMSDs in healthcare professionals (
PMC10222752
2.2. Participants
pain, acute musculoskeletal symptoms
Eligible healthcare professionals were recruited from Najran University Hospital, Saudi Arabia. Full-time healthcare professionals with more than one year of experience were eligible to participate. Individuals were excluded if they had any acute musculoskeletal symptoms (pain intensity on the visual analogue scale (VA...
PMC10222752
2.3. Interventions
WBS
For the WBS group, each 30-min exercise class was run by one trained physiotherapist to serve a maximum of 10 participants (10 × 3 = 30 participants) working in the hospital. Participants were invited to attend the exercise class three times a week for six weeks in their hospital during lunch breaks. During each sessio...
PMC10222752
2.4. Outcomes
Musculoskeletal pain
Musculoskeletal pain and physical exertion were assessed using the Nordic musculoskeletal questionnaire (NMQ) [
PMC10222752
2.5. Statistical Analyses
WBS, pain
The statistical analysis was carried out with the help of SPSS version 26.0 (SPSS Inc., Chicago, IL, USA). The descriptive data are displayed as a frequency distribution along with the mean and standard deviation for the items of the NMQ. The Shapiro–Wilk test was carried out to validate the normality of the score dist...
PMC10222752
3. Results
Baseline characteristics (e.g., age, gender, height, body mass, etc.) of each group were compared. There was an insignificant difference noted between the two groups (
PMC10222752
4. Discussion
fatigue, WBS, pain, lunchtime WBS, musculoskeletal pain, musculoskeletal symptoms, musculoskeletal complaints
The purpose of this study was to examine the efficacy of lunchtime WBS exercise in reducing musculoskeletal pain and physical exertion among healthcare professionals. Nurses, physiotherapists, dental technicians, and operation theatre technicians were all shown to have significant rates of WRMSDs. The current study fou...
PMC10222752
5. Conclusions
WBS, musculoskeletal pain
This study found that healthcare workers who used their lunch breaks to do WBS exercises experienced less musculoskeletal pain and used less effort when doing a variety of physical tasks. However, more research is needed to confirm our findings on a larger scale and with a more consistent set of healthcare professional...
PMC10222752
Author Contributions
Conceptualization, H.A., A.A. and R.S.A.; methodology, H.A. and A.R.K.; software, H.A. and A.K.; validation, H.A. and R.S.A.; formal analysis, R.S.A.; investigation, H.A.; resources, H.A. and A.A.; data curation, H.A., A.R.K. and R.S.A.; writing—original draft preparation, H.A. and A.A.; writing—review and editing H.A....
PMC10222752
Institutional Review Board Statement
The study was approved by the institutional ethical review board at Najran University, Saudi Arabia (Reference No.: 444-37-25613-DS).
PMC10222752
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10222752
Data Availability Statement
Data will be provided by the corresponding author.
PMC10222752
Conflicts of Interest
The authors declare no conflict of interest.
PMC10222752
References
low back pain, musculoskeletal pain, pain, RPE, work-related musculoskeletal disorders, lower back pain, LBP
Flow diagram of the study procedures.Twelve-month prevalence of low back pain and neck pain among healthcare professionals (Note: PT, physical therapists; DT, dental technicians; LT, laboratory technicians; OT, operation theater technicians; PSN, physician; SN, surgeon; PST, pharmacists).Limitations of work due to LBP ...
PMC10222752
1. Introduction
failure of standard communication methods, cancer, lung cancer, radioactive decay, lung cancer deaths
CANCER, DECAY, LUNG CANCER, REGRESSION, COLD
Introduction: Exposure to residential radon is a preventable cause of cancer. Prevention requires testing, but the percentage of homes that have been tested is small. One reason for the low testing rates may be that printed brochures fail to motivate people to obtain and return a radon test. Methods: We developed a rad...
PMC10178454
2. Methods
REGRESSIONS, BROWN
A randomized, controlled trial design with two arms was used, as described previously [Participants were parents whose children were enrolled in a daycare facility, supplemented by adults recruited by the parents. The daycare was located in Grand Forks, North Dakota (ND), a city with one of the highest radon levels in ...
PMC10178454
4. Discussion
colorectal cancer, radon-induced disease, fecal occult blood
COLORECTAL CANCER
This randomized trial sought to replicate our previous findings of the superiority of the radon app on radon knowledge and behaviors over printed brochures in a broad sample of the population in Grand Forks, ND, a city with one of the highest residential radon levels in the U.S. Our most important findings are that, af...
PMC10178454
5. Conclusions
The results of this randomized controlled trial confirmed the superiority of the radon app over printed brochures in numerous aspects of radon education and especially, in stimulating individuals to obtain a radon test kit, the first step in radon testing. Conversely, our prediction that the app would be more effective...
PMC10178454
Author Contributions
Conception and grant writing, G.G.S. and S.K.; Conduct and supervision of study, S.K. and H.S.-W.; Statistical analysis and graphics, M.G.K.; Writing/editing manuscript, G.G.S., S.K., M.G.K. and H.S.-W.; Approval of final manuscript, G.G.S., S.K., M.G.K. and H.S.-W. All authors have read and agreed to the published ver...
PMC10178454
Institutional Review Board Statement
This study, including the methods for informed consent, was approved by the IRB at the University of North Dakota (IRB # IRB0004359) and was registered in ClinicalTrials.gov (ID: NCT05319457).
PMC10178454
Data Availability Statement
The original data for this trial are not publicly available but could be made available upon reasonable request to the corresponding author.
PMC10178454
Conflicts of Interest
The authors declare that they have no competing interests.
PMC10178454
Abbreviations
Bq/m
PMC10178454
References
Consort diagram of clinical trial.Scores on radon knowledge and attitudes pre- and post-exposure to radon information delivered via brochure and via smartphone. * Indicates Number and percent of individuals ordering and returning radon test kits by experimental condition, smartphone app vs. brochure.Participant charact...
PMC10178454
Background
Mobile health interventions are common in public health settings in Africa, and our preliminary work showed that smartphones are increasing in South Africa. We developed a novel smartphone app—CareConekta—that used GPS location data to characterize personal mobility to improve engagement in HIV care among pregnant and ...
PMC10238954
Objective
We aimed to describe the feasibility, acceptability, and initial efficacy of using the app in a real-world setting.
PMC10238954
Methods
We conducted a prospective randomized controlled trial at a public sector clinic near Cape Town, South Africa. We enrolled 200 pregnant (third trimester) women living with HIV who owned a smartphone that met the required specifications. All participants installed the app, designed to collect 2 GPS heartbeats per day to...
PMC10238954
Results
6/200
A total of 7 participants were withdrawn at enrollment or shortly after because of app installation failure (6/200, 3%) or changing to an unsuitable phone (1/200, 0.50%). During the study period, no participant’s smartphone recorded at least 1 heartbeat per day, which was our primary feasibility measure. Of the 171 par...
PMC10238954
Conclusions
Several key challenges impeded our study feasibility. Although the app was designed to reverse bill participants for any data use, the lack of mobile data was a substantial barrier to our study success. Participants reported purchasing WhatsApp data, which could not support the app. Problems with the web-based dashboar...
PMC10238954
Trial Registration
ClinicalTrials.gov NCT03836625; https://clinicaltrials.gov/ct2/show/NCT03836625
PMC10238954
International Registered Report Identifier (IRRID)
RR2-10.1186/s13063-020-4190-x
PMC10238954
Introduction
PMC10238954
Background
There are an estimated 7.5 million people living with HIV in South Africa, more than the number of people living with HIV in any other country [Continuous engagement in HIV care is a known challenge in South Africa [Mobile health (mHealth) apps are frequently deployed in public health settings in Africa [
PMC10238954