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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 and MBSI-I classes met our prespecified goal. All subjects in the SH group ( | 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 SE)Baseline to 16 weeks. Change in sleep parameters measured by Fitbit (Δ sleep time/Δ time in bed = Δ SE) | 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-reported sleep measuresBaseline to 16 weeks. Comparison between MBSI-I, eMBSI-I, SH on self-reported sleep measuresThe robust effect of MBSI-I was observed for other sleep outcomes. The ISI was significantly improved at 10 weeks relative to baseline for the MBSI-I cohorts (MBSI-I vs. SH: Other component scores of the PSQL showed strong within-in group effects in the mindfulness cohorts. This was observed in sleep latency and overall sleep quality in both MBSI-I and eMBSI-I cohorts at 10-and 16-weeks ( | 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 group MBSI-I cohorts, showed significant improvements in bowel function, the Expanded Disability Status Scale (EDSS) at 10 weeks and the Planning Organization Subscale of the Self-Reported Cognitive Dysfunction scale and EDSS at 16 weeks (Table | 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 a body scan. Her symptoms apparently resolved after chiropractic treatment. Participants were instructed during sessions to avoid or modify any poses that exceeded their known physical limitations, and to ask their health care providers if they had any concerns. | 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 up assessment to determine duration of effect, as well as an expanded eMBSI cohort that included the original MBSI-I cohort and ten individuals who completed the SH program and assessments and then crossed over to join the 10-week MBSI sessions and follow up evaluations. One prospective insomnia study of mindfulness in MS also used actigraphy and self-reported sleep measures to compare mindfulness delivered via videoconferencing vs. in person but used a nonrandomized study design by comparing mindfulness to a wait-list control group [SE in our study did not improve with MBSI-I compared with SH and, therefore, the primary hypothesis was not met. SE also did not improve within the MBSI-I groups nor the SH group. It should be noted that SE was higher than would have been expected for cohorts of persons with insomnia, approaching 90%, suggesting a ceiling effect. By contrast, SE in the Lorenz study was 56.7%. SE reported in other studies ranged from the low 70 s to mid-80 s, with SEs measured by actigraphy tending to be higher than those obtained from sleep diaries [However, one component of SE did change significantly in the mindfulness groups in our study. We found that sleep time decreased significantly in the mindfulness groups, particularly in the post intervention period. Sleep time is a major component of both the numerator and denominator of SE, so overall sleep efficiency remained unchanged. Also of note, evening sleep time in our study averaged 6.8 h, well above that reported in the Lorenz study (5.2 h). This counterintuitive result in our study was also observed in a randomized study comparing a six-week mindfulness program to usual care in 79 breast cancer survivors with chronic insomnia [Our subjective secondary sleep measures confirmed that our study cohort had a moderate level of insomnia both on the PSQI and ISI, which suggest that our participants may have perceived less restful sleep because of overlapping problems with daytime fatigue. Both average scores for the PSQI and ISI, between 9 and 10 and 16 to 17, respectively, indicate moderate insomnia [Results of secondary sleep measures in the study showed significant benefits for the mindfulness cohorts, including the ISI and the component scores of the PSQL, e.g., sleep latency, day dysfunction due to sleepiness and overall sleep quality. Although these outcomes showed stronger within group effects than between mindfulness and SH cohorts.This is consistent with observations found in similar studies of mindfulness treatment in nonMS populations [One interesting observation is that the ISI improved significantly in the SH cohort at the 16-week but not the 10-week assessment. This appears to be a relatively isolated assessment as none of the other sleep parameters showed improvement in the SH group. However, this does not rule out the continued benefits and possible practice effects of sleep hygiene principles, which makes the possibility of carryover benefits of SH participants in the eMBSI-I cohort relevant (discussed below).While our data showed continued positive benefits to mindfulness on subjective sleep parameters extended to six weeks post intervention, one challenge is that the positive effects of mindfulness may not be long lived, or superior to SH over the longer term. A study of an online mindful meditation program in MS showed benefits in terms of quality of life, anxiety, depression and sleep post intervention but these effects were no longer significant at six months [In order to increase the power of the study, given the low numbers of participants, the MBSI-I was expanded to include participants who were originally part of the SH cohort and this eMBSI-I cohort generally showed more robust benefit in some sleep parameters than the smaller MBSI-I cohort. This could reflect greater statistical power to detect differences or carryover effects from the combined treatments. To adequately assess carryover effects in the study design, we would have had to control for this using a parallel extended design for both groups, which would have been impractical.Other outcomes indicated significant benefits for MBSI-I relative to SH in self-report quality of life measures, similar to what has been reported in other studies [ | 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 time and energy. However, this introduces possible carryover effects from the combined treatment. Perhaps, incorporating make up mindfulness classes into the protocol would help retain participants. There may also be inherent limitations with in-person mindfulness training for PWMS who have significant physical impairments and low energy reserves.The study was not designed to differentiate the effects of mindfulness on PWMS by subtype of MS, e.g., relapsing remitting or progressive forms, or disease severity. We did not collect data on MS subtype, and would not have had the power to analyze outcomes based on this parameter. It can be inferred, based on the relatively low EDSS scores, that the participants had relapsing remitting multiple sclerosis (RRMS). Given that this is a preliminary study, we did not have the power to analyze outcomes based on MS subtypes or impairment. However, future studies might collect this data for analysis.Another set of issues are raised by the use of consumer wrist band actigraphy to measure sleep. These devices are not designed for clinical research studies. While there are benefits of using wrist actigraphy, there also exists potential errors in validity, accuracy and reliability compared with PSG, considered the gold standard for sleep assessment [A final challenge in our study was gaps in data collection from some participants as not all wore their Fitbits™ Charge 2 devices consistently or had technical issues uploading their data. Fortunately, this only required minor adjustments to the time intervals used in the data analysis as described in the | 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 sessions and Ms. Susan Acheychek, RDMS for her technical and administrative assistance. We would also like to acknowledge Alicia Kokoszka, MSc for her work in preparing and downloading Fitbit data | 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 [Another important aspect is the difficulty in selecting the adequate coronary device. Until now, it is still unclear whether drug-eluting stents (DES), which proved superior compared to bare metal stents (BMS) for native coronary interventions, have the same advantages in the treatment of SVG stenoses. Although DES performed better compared to BMS in the ISAR-CABG trial at one-year follow-up, after a longer period of observation (5 years), MACE rates in both groups did not differ anymore [Self-expanding drug-eluting stents (SExS) may have some advantages over conventional balloon expandable drug-eluting stents (BExS) due to their unique design (tight stent struts, active outward force, soft expansion, full stent apposition) [A single center observation of 42 patients treated with SExS in degenerated SVG stenoses demonstrated a low restenosis rate of 4.8% after a median follow up of 13.4 months, proving the feasibility of SExS use in daily routine practice, however no peer group was evaluated [Therefore, the Memmingen Coronary Artery bypass Stenosis Trial (MECAST) was initiated to analyze the potential clinical benefit of SExS in comparison to BExS regarding patient outcome for intervention of degenerated SVGs in daily routine practice. | 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 dependent): Group SExS mainly received (91.8%) second generation SExS (STENTYS-SES®; Xposition S®, nitinol alloy, sirolimus coated, cell area of 0.95 mmPatients who had received BMS, drug eluting balloon, or plain old balloon angioplasty (POBA) for SVG treatment were not included in the trial.To analyze and quantify the plaque burden of the degenerated SVG, we used the SVG degeneration score analysis according to a predictive model [The study was approved by the local ethics committee (Ethikkommision bei der Landesärztekammer Hessen, FF 125/2012) and previously registered (clinical registration number DE-ST2012-01; DEusches Sizing Register–DEUS).All participants provided informed written consent. | 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), target lesion revascularization (TLR), myocardial infarction (MI) (according to current ESC guidelines [ | 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 compared using | 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 perforation of a distal coronary artery within the SExS group. This complication was related to retrieval of the SExS stent delivery system. To prevent further SExS-related perforations, we applied the modified floating wire technique [Patient outcomes including the MACE rate are demonstrated in Additionally, one stent thrombosis was noted within the SExS group in comparison to 7 stent thromboses in the BExS group (2.0% vs. 12.5%, The Kaplan–Meier curve analysis regarding MACE rate after 30 days and at one-year follow up demonstrated the superiority of SExS treatment compared to BExS. MACE-free survival was significantly better in the SExS patient group (MACE 30 days Log rank: Cox regression analysis revealed several risk factor covariates with protective or negative effect on patient outcome ( | 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. Of note, patients treated by SExS had slightly more comorbidities (MACE rates in our BExS group were higher than in previous studies such as the ISAR-CABG or BASKET-SAVAGE trial. However, patients presenting with a cardiogenic shock or previous stent implantation or patients under oral anticoagulation were excluded in these trials. In contrast, in our study, we performed an all-comers analysis with no patient exclusions. This may explain the higher MACE-rates regarding the BExS patient group [On the other hand, we were able to demonstrate that patients treated by SExS had a significantly lower MACE rate after 30 days follow up than patients treated by BExS (2.0% vs. 12.5%, The main finding of our study was that after one-year follow-up, the MACE rate was still significantly lower in the SExS group than in the BExS group (15.7% vs. 35.7%, Another major finding of our study was the following: Although the number of cardiac deaths was similarly low in both groups (SExS: Cox regression analysis of risk factor covariates revealed several risk factors with hazard ratios >1, as well as protective factors (hazard ratio <1), however only one was significant: history of previous CABG treatment resulted in a higher one-year MACE rate in both patient groups as compared to de-novo SVG intervention (In summary, our results suggest a potential benefit of SExS treatment in SVG stenoses. SExS may have a positive impact on the patient outcome, in particular by increasing cumulative survival and lowering incidence of the MACE rate.Several limitations need to be mentioned. Our trial was a retrospective analysis of a single center only. The number of patients included in both groups was relatively small, due to the low incidence of patients in need of SVG intervention. The pre- and post-dilatation rates were overall higher within the SExS patient group. We only performed the analysis over a period of one-year follow-up. Post-procedural cardiac markers were not regularly acquired. Of note, the SExS tested in our study is currently no longer available (STENTYS-SES®). | 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 death occurred significantly later after treatment with SExS. The history of previous SVG intervention was an independent risk factor in both groups. Our findings should be further investigated in larger multicentric randomized trials and might enable an alternative interventional strategy in the treatment of SVG stenoses. | 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 0.0032″ sheath between the stent and the vessel wall. (d) Balloon and sheath are then withdrawn leaving the stent opposed to the vessel wall. The two radiopaque stent markers are located at the edges of the stent (red arrows). With permission by STENTYS.(a) SVG of RCA with stenosis located in proximal shaft: (b) modified floating wire technique. (a) SVG-stenosis located in proximal shaft, SExS (Xposition S® 3.0–3.5 ∗ 27 mm) implantation (A), sheath retrieval (B) with support of coronary wire (C). (b) Proximal SVG-RCA stenosis with implantation of Xposition S 3.0–3.5 ∗ 27 mm, sheath retrieval with insertion of an additional wire through the guiding catheter floating free in the ascending aorta => prevention of deep intubation with possible subsequent distal wire perforation. RCA = right coronary artery; SVG = saphenous vein graft; SExS: self-expanding drug eluting stent.Retrospective data analysis. SVG = saphenous vein graft; SExS = self-expanding drug eluting stent; BExS = balloon expanding drug eluting stent; BMS = bare metal stent; DEB = drug eluting balloon; and POBA = plane old balloon angioplasty.(a) MACE timeline of SExS and BExS patient groups. MACE = major adverse cardiac event; SExS = self-expanding drug eluting stent; BExS = balloon expanding drug eluting stent; TVR = target vessel revascularization; TLR = target lesion revascularization; AMI = acute myocardial infarction. (b) Mean event rates in BExS patient group compared to SExS group. SExS = self-expanding drug eluting stent; BExS = balloon expanding drug eluting stent; MACE = major adverse cardiac event; AMI = acute myocardial infarction; TLR = target lesion revascularization; TVR = target vessel revascularization.(a) Kaplan–Meier curve for cumulative MACE-free survival within 30 days in BExS and SExS patient groups (log rank Forest plot depicting hazard ratios of several covariates. Statistical significance (Patient characteristics.Values are number (Procedural characteristics.Values are number (Outcome.Values are number ( | 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 unemployment. Existing return-to-work (RTW) programs have mainly focused on “common mental disorders” and often used very elaborate and costly interventions without yielding convincing effects. It was the aim of the RETURN study to evaluate an easy-to-implement RTW intervention specifically addressing persons with mental illnesses being so severe that they require inpatient treatment. | 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 continued. | 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 months), differences were no longer statistically significant ( | 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, they are often neglected in clinical practice and research [Existing return-to-work (RTW) programs have nearly exclusively focused on “common mental disorders” (e.g., stress-related disorders, anxiety disorders, and minor depression). Their approaches vary substantially including, for example, cognitive behavioral therapy (CBT) programs [ | 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 retardation, insufficient proficiency in German language to engage with the case manager, employment in a mini-job (salary of less than 450€), and a main diagnosis of an organic mental disorder (F0), substance abuse (F1), or an eating disorder (F5). | 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: Planning of RTW talks with supervisors; and Session 5: Planning of further support by RTW expert after discharge from hospital) and three sessions after discharge from hospital (including the possibility of a joint discussion with the employer). The services of the RTW experts could be claimed by the patients during inpatients stay and for up to half a year after discharge. The minimum of intervention was defined as at least two meetings between RTW experts and patients—one appointment during the inpatient stay and one after release (“per protocol”). RTW experts aimed at activating existing support services of the hospitals (e.g., work therapy, cognitive training, and socio-educational counseling) and to offer specific support (e.g., joint meetings between clients, employers, and RTW experts), if there was a limitation of resources. Overall, this intervention was oriented toward the competencies (and capacities) of social workers in mental health in order to facilitate implementation into routine care in case of positive study results.Staff (and patients) of the control wards acted under “TAU” conditions. To avoid contamination bias as much as possible (i.e., staff or patients from control wards getting to know about the RTW intervention), wards were chosen in a way so that there was no overlap in personnel and that there was no regular patient transfer between wards. | 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 documented the patients’ subjective readiness to return to their workplace and their feeling of being supported in this process by using self-rated visual analog scales. Finally, clinical data on illness severity (Clinical Global Impression, CGI, HONOS), social functioning (GAF), quality of life (EuroHisQol), and relapses (patient self-report) are reported. | 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 mixed model was fitted with ward (cluster) as a random effect term to account for non-systematic variance related to the ward and intervention group as a fixed effect using the lme4 R package. The point estimate for the intervention effect is reported together with the corresponding 95% confidence interval. A | 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 diagram, CONSORT flow diagram. | 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, clinical global impression; GAF, global assessment of functioning; HONOS, Health of the Nation Outcome Scales (lower values mean better health/less social impairment); Mini-ICF, mini-international classification of functioning. | 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 their return to work (Patients readiness to return to work and implementation rate of support resources.BEM (Betriebliches Eingliederungsmanagement): In Germany, all employers are legally required to offer BEM to all employees with longer sickness absences. The main aim of BEM is to detect causes of sickness absences and to offer specific support to employees.Hamburger Modell: This model of stepwise integration into work after sickness absence can be offered to all patients insured by the statutory health insurances in Germany. A stepwise integration plan is developed by patients and their physicians and has to be approved by the employer and the insurance company. Usually, patients start with a few hours per day and increase their working hours over several weeks. During stepwise integration patients are not paid by the employer but receive sickness allowances. | 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 work, days at work, and sick leave days at 6 months follow-up. For the main outcome parameter (days at work at 12 months), however, the group difference was not significant. | 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 intervention group reached at 6 months. The numerical difference in days at work persisted within 12 months, however, this difference (main outcome) proved not to be statistically significant.We believe that a number of factors might be responsible for this (negative) finding for the main outcome after 12 months. First, this might be due to a “ceiling effect” as 86% of the patients in the intervention group were already back at work after 6 months. Possibly, we had underestimated the wake of a labor market in the Munich area, which has been increasingly characterized with skills shortage—even during the Corona pandemic (which did not lead to relevant increase in unemployment rates). Second, statistical effects (large confidence intervals, lower number of observed cases at 12 months compared to 6 months) might be responsible for the negative finding.Third, there is evidence that the recovery rate increases, when health insurance benefits end [Regarding potential mediators of the effects observed, we could not find the expected relationships, for example, a higher uptake of structured RTW measures or a better feeling of preparedness in the intervention group. Thus, on the one hand, it might not be the mere uptake of existing measures but rather their (case)managed implementation within a context that sees RTW as a desirable process. On the other hand, intervention patients might have suffered from an increase of anxiety when confronted with RTW [Despite the non-superiority of our intervention regarding the main outcome, our study still yielded stronger/comparable effects compared to other studies focusing on common mental disorders. Thus, for adjustment disorders, CBT alone was found not to reduce time to RTW [ | 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 improvement. | 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, obtained institutional review board approval and set up the study organisation. Johannes Hamann, Peter Brieger, Anne Lang, Lina Riedl, Daniela Blank & Monika Kohl designed the intervention and were responsible for the training of the RTW-experts. Johannes Hamann, Peter Brieger, Anne Lang, Lina Riedl, Daniela Blank, Monika Kohl, Adele Brucks, Peter Falkai, Alkomiet Hasan, Martin E. Keck, Michael Landgrebe & Stephan Heres organized and implemented the intervention, recruited patients and did the data acquisition. Johannes Hamann, Peter Brieger, Markus Bühner, David Goretzko, Reinhold Kilian, Tamara Waldmann, Anne Lang, Lina Riedl, Daniela Blank, Adele Brucks and Monika Kohl set up the database and analysed the data. All authors participated in the interpretation of the data. Johannes Hamann wrote the first draft of the manuscript. All authors critically revised the final version of the manuscript. | 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 lectures or advisory activities from Boehringer-Ingelheim, Janssen, Lundbeck, Otsuka, Recordati, and Richter. All other authors do not report any conflicts of interest. | 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 (VAS) > 7) that precluded participation in the exercise program. Participants were provided written informed consent approved by the institutional ethical review board at Najran University, Saudi Arabia (Reference No.: 444-37-25613-DS). Eligible participants were randomly allocated to either the WBS exercise group or the control group by an independent researcher using concealed random numbers in sealed, opaque envelopes [ | 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 session, participants were asked to perform WBS exercises ( | 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 distribution. The impact of WBS and an education program on pain intensity and physical exertion at the end of week 6 was analyzed using a repeated measures analysis of variance (ANOVA). Additionally, we used a 2 × 3 repeated measures ANOVA with time (at baseline, week 3, and week 6 of the posttest), group (WBS and control), and the interaction effect (time × group), in addition to (time × gender), (time × occupation), and (time × gender × occupation), as our independent variables. The post hoc analysis was not performed if the main effect of the intervention was not significant. Alternatively, a post hoc analysis with the Bonferroni correction was performed on time if the main effect of time was statistically significant. The level of significance was chosen at To determine an adequate sample size, the software application G-Power 3.1 was utilized. A minimum sample size of 26 participants was required for each of the groups, with the alpha level, power, and effect size each being set at 0.05, 0.80, and 0.4, respectively. Considering an attrition rate of 15%, there were a total of 30 participants in each of the groups [ | 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 found that musculoskeletal pain was most common in the lower back, followed by the neck and the knee, over 12 months. Many of the study participants also mentioned that the pain in their lower backs and necks made it difficult for them to do their jobs. Similarly, earlier research has shown that the neck, shoulders, scapular area, shoulders, upper arms, and upper and lower backs are the most common sites of musculoskeletal symptoms among computer users [The lower back was the most common site of WRMSDs among healthcare professionals, acknowledging findings among PTs, nurses, and other health workers [Both WBS and the educational program for healthcare professionals resulted in a reduction in pain intensity and physical exertion. After 6 weeks of WBS exercise and the education program, pain intensity was reduced by 59.8% and 46.2%, respectively, compared to the baseline. After 6 weeks of WBS exercise and an education program, participants had a 34.9% and 26.1% decrease in physical exertion, respectively. A previous study also found a reduction in musculoskeletal discomfort and fatigue after a stretching program for call center operators [It is widely known that regular exercise helps improve physical health. For instance, Machado-Matos et al. [WRMSDs have a detrimental effect on the productivity of healthcare workers, and they also contribute to a longer period of sick absence; therefore, the incidence of WRMSDs has wide-ranging repercussions for the economy of a country [There are some limitations to this study. Results may not be generalizable because of the diverse sample of healthcare professionals. However, our findings provide useful information in this field of study and may influence future studies because this is one of the few investigations on these healthcare professionals available in the Arab and worldwide literature. Another possible shortcoming is that musculoskeletal complaints and physical exertion were measured using only subjective scales. However, such scales are widely used because the symptoms being measured (such as pain and exertion, which are subjective complaints) are so common and so well-established in the literature. Importantly, the researchers’ own biases did not influence the findings because the participants completed the surveys independently. Additionally, a few confounding factors, such as patient interaction and emotional factors, were not considered. Further investigations are required to corroborate our results on a larger scale and in a more homogenous group, considering these findings and the limitations of the current study. In addition to the subjective score employed here, future research should also incorporate objective measurements of physical performance and/or efficacy in the workplace. | 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 professionals, considering the current findings and limitations. | 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., A.K. and R.S.A.; visualization, R.S.A.; supervision, R.S.A.; project administration, R.S.A.; funding acquisition, R.S.A. All authors have read and agreed to the published version of the manuscript. | 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 and neck pain among healthcare professionals (Note: LBP, lower back pain; PT, physical therapists; DT, dental technicians; LT, laboratory technicians; OT, operation theater technicians; PSN, physician; SN, surgeon; PST, pharmacists).Details of stretching programs.Note: Each stretch was held for 20 s with 5 repetitions.Descriptive data.Note: VAS, visual analogue scale; RPE, rating of perceived exertion; PT, physical therapists; DT, dental technicians; LT, laboratory technicians; OT, operation theater technicians; PSN, physician; SN, surgeon; PST, pharmacists.Prevalence of work-related musculoskeletal disorders (WRMSDs) among healthcare professionals.Impacts of work-related musculoskeletal pain among healthcare professionals.Effects of whole-body stretching (WBS) exercises and an education program (control group) on pain intensity (VAS scores) among healthcare professionals.Note: VAS, visual analogue scale; WBS, whole-body stretch; * Statistically significant Effects of whole-body stretching (WBS) exercises and an education program (control group) on physical exertion (Borg RPE scores) among healthcare professionals.Note: RPE, rating of perceived exertion; WBS, whole-body stretch; * Statistically significant Two-way (2 × 3) repeated measures analysis of variance.Note: VAS, visual analogue scale; RPE, rating of perceived exertion; * Statistically significant | 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 radon app for smartphones that contained the same information as printed brochures. We conducted a randomized, controlled trial that compared the app to brochures in a population comprised largely of homeowners. Cognitive endpoints included radon knowledge, attitudes toward testing, perceived severity and susceptibility to radon, and response and self-efficacy. Behavioral endpoints were participants’ requests for a free radon test and the return of the test to the lab. Participants (N = 116) were residents of Grand Forks, North Dakota, a city with one of the nation’s highest radon levels. Data were analyzed by general linear models and logistic regression. Results: Participants in both conditions showed significant increases in radon knowledge (Radon is an invisible, odorless gas produced by the natural decay of uranium and other radioactive elements present in rocks and soil. Radon enters homes via cracks in the foundation and can accumulate indoors, particularly during cold weather, when homes are tightly sealed. Radon gas undergoes further radioactive decay and, if inhaled, can cause cytotoxic and genotoxic damage to respiratory cells. It is the largest cause of lung cancer among non-smokers and causes more than 21,000 lung cancer deaths in the U.S. per year [One in 15 U.S. homes has radon levels that exceed the level recommended by the Environmental Protection Agency (EPA) to prevent lung cancer [The low radon testing rates also may reflect a failure of standard communication methods, e.g., printed brochures, to educate people about radon and to encourage them to test their homes. We therefore developed an alternate radon communication method, an application (app) for smartphones. The app contained the same radon information as printed brochures from the EPA but conveyed that information via smartphone. In a randomized trial (N = 138) comparing the app to brochures, the app was markedly superior in increasing radon knowledge and encouraging users to request free radon tests [The goal of this trial was to attempt to replicate the superiority of the radon app in an older, non-college-age population comprised largely of homeowners. We hypothesized that, compared to participants exposed to print brochures, participants exposed to the radon app would show a higher rate of requests for free radon tests and a higher rate of returning them to the laboratory. | 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 the U.S. The average residential radon in Grand Forks is 11.7 pCi/L (433 Bq/mThe parents of children who attended the daycare facility received an invitation letter. The letter was placed in the children’s cubbies at the daycare and included a web address and QR code for the online, pre-exposure survey. Only one parent per family was eligible. To ensure adequate enrollment, parents could invite neighbors, friends, and/or co-workers to participate by sharing the link and QR code. Once a potential participant entered the web address or scanned the QR code, he/she was directed to the pre-exposure survey on Qualtrics. Upon accessing the survey, participants were asked to read the informed consent form. If participants proceeded with the online survey, it was considered that they had read the form and had agreed to participate.After participants answered questions measuring radon knowledge, radon testing attitudes, perceived severity and susceptibility, response efficacy, and self-efficacy, they were assigned to a condition. Participants randomized to the radon app received instructions on how to install the app and were instructed to use it for the next three months. App installation was verified by app activity data saved in a server maintained by the app developer. App users could request a free radon test at any time by using the app. They would receive a charcoal canister test, instructions for using it, and a pre-addressed, pre-paid envelope to use for returning the test to the lab. We used short-term (48–72 h) radon tests (Alpha Energy, Inc., Carrollton, TX, USA). These were bar-coded so that we could count the number of kits ordered and the number returned to the lab.Brochure condition participants received three EPA brochures during the ensuing three months via U.S. mail. These were: (1) Basic radon facts (All participants answered survey questions regarding demographic data (age, gender, race/ethnicity, housing type, household income, education level, and smoking status). Three months after participants completed the pre-exposure survey, they received an email with a web address for the post-exposure survey. A priori power analyses were performed using PASS (Power Analysis Sample Size Software. 2019, Kaysville, UT, USA) [Participants received $30 gift cards in exchange for participation in each of the pre-exposure and post-exposure surveys. Parents received a $25 gift card per additional participant they attracted, for a maximum of 3 per parent. This study was approved by the IRB at the University of North Dakota (IRB # IRB0004359) and was registered in ClinicalTrials.gov (ID: NCT05319457).The cognitive endpoints were similar to those we described previously [There were two behavioral outcomes: the rate at which participants ordered a free radon test kit and the rate at which they returned it to the testing lab. Both were measured via bar codes on the tests. To create radon knowledge index variables, a correct response was coded as “1” and an incorrect response, or “don’t know,” as “0.” We created two radon knowledge index variables for T1 and T2 whose sums reflect correct responses to 20 True–False radon knowledge statements. Two radon-testing attitudes variables were created by averaging five semantic differential scales in T1 and T2. These showed excellent reliability (Cronbach’s α in T1 = 0.95; Cronbach’s α in T2 = 0.90). Perceived severity variables were created using two Likert scales in T1 (Spearman–Brown coefficient = 0.91) and T2 (Spearman–Brown coefficient = 0.79). Perceived susceptibility, response efficacy, and self-efficacy variables were created similarly (Spearman–Brown coefficient for these variables were ≥0.80). The characteristics of participants in the two conditions were compared by Chi-Square. Changes in the cognitive variables were compared via paired t-tests. General linear models with repeated measures with interaction were used to detect differences in changes over time between the conditions. Differences in the proportion of participants in the two conditions who ordered a free radon test kit and those who returned it to the lab were compared using Z tests. Logistic regressions were used to test these differences while accounting for participant characteristics. Relative risks were estimated using stratified 2 × 2 tables. | 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, after adjustment for income, the app markedly outperformed brochures in stimulating requests for radon tests, a finding consistent with our previous findings. However, contrary to expectations, the app was significantly inferior to brochures in promoting individuals to return the tests to the lab. Together, these findings provide actionable information for future efforts to prevent radon-induced disease.Both the radon app and brochures were effective in improving radon knowledge (We found that individuals with the lowest income were 80% less likely to order free tests, a finding consistent with the sizable literature on radon testing, e.g., [After adjustment for income, brochure recipients were significantly less likely to request test kits. However, brochure recipients who requested kits were almost twice as likely as app users to return them to the lab (68% vs. 39%). Although based on relatively small numbers (19/28 vs. 14/36, brochure and app, respectively), this finding was contrary to expectation. The discrepancy between requesting a test and returning the test underscores the fact that the question, “What are the determinants of radon testing rates?”, is a complex one that encompasses several different questions and behaviors. That is, in order to test for radon, individuals first must learn about radon, then acquire a test, and then return the test to the lab. Regarding the first step, learning about radon, the app was equivalent or slightly superior to brochures (as evidenced by the greater increase in radon knowledge in the app group). With regard to the second step, acquiring a test, the app was clearly superior. Conversely, concerning the third step, returning the test to the lab, the app was inferior. How can this be understood? We suggest that the processes involved in test acquisition and test return are different. The superiority of the app in the initial two steps appears to be due to its superiority in engaging users. This is evidenced by the difference in loss to follow-up in the two conditions. In the present and our previous trial, loss to follow-up after randomization was approximately 50% less in the app than in the brochure condition (15 vs. 23% and 19 vs. 26%, app vs brochure, respectively) [Conversely, behaviors relevant to returning a radon test may be influenced by factors other than engagement. Unlike the app, the brochures have an actual physical presence. We speculate that the brochures may have provided a tangible reminder to follow through. It is noteworthy that physical reminders, e.g., postcards, have been shown to increase test return rates in an analogous setting, i.e., the use of at-home, fecal occult blood tests for colorectal cancer [Our study has several limitations. First, 19% of participants were lost to follow-up, which could introduce some selection bias. This rate is comparable to average losses to follow-up in other trials of behavior change (i.e., 18%) [Conversely, our study has several strengths: it was randomized, adequately powered, and compared a novel intervention (the radon app) to usual care (brochures) with a sample comprised largely of homeowners in a high-radon city. Moreover, unlike the majority of studies regarding radon testing, which measure subjective attitudes and/or “readiness” to test, we measured actual test acquisition and test returns using objective measures (bar-coded tests) that are independent of self-report [ | 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 than brochures in prompting individuals to return the test to the lab was not confirmed. We speculate that the superiority of the printed brochures in prompting test returns is due to their ability to serve as physical reminders. Future studies aimed at maximizing the efficacy of the radon app in stimulating radon testing should test the effect of physical reminders, e.g., postcards, on test return rates. | 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 version of the manuscript. | 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 characteristics by condition.Incidence of test kit ordering between radon app and brochure conditions by income.* | 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 postpartum women living with HIV in South Africa. The app also used the user’s location to map nearby clinics. | 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 geolocate the participant within a random 1-km fuzzy radius (for privacy). We randomized (1:1) participants to a control arm to receive the app with no additional support or an intervention arm to receive supportive phone calls, WhatsApp (Meta Platforms, Inc) messages, or both from the study team when traveling >50 km from the study area for >7 days. In addition to mobility data collected daily through the phone, participants completed questionnaires at enrollment and follow-up (approximately 6 months post partum). | 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 participants who completed follow-up, only half (91/171, 53.2%) reported using the same phone as that used at enrollment, with the CareConekta app still installed on the phone and GPS usually enabled. The top reasons reported for the lack of heartbeat data were not having mobile data, uninstalling the app, and no longer having a smartphone. Acceptability measures were positive, but participants at follow-up demonstrated a lack of understanding of the app’s purpose and function. The clinic finder was a popular feature. Owing to the lack of consistent GPS heartbeats throughout the study, we were unable to assess the efficacy of the intervention. | 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 dashboard meant that we could not consistently monitor mobility. Our study provides important lessons about implementing an ambitious GPS-based study under real-world conditions in a limited-resource setting. | 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 |
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