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Results
Compared to viewing positive images, viewing negative images resulted in significantly greater perceived harm of nicotine (
PMC10540020
Conclusions
Negative imagery in Instagram posts about EVALI may convey the risks of vaporized product use and discourage young adults from this behavior, regardless of the valence of the post’s text. Public health messaging regarding EVALI on Instagram should emphasize the risk of cannabis vaporizer use, as young adults may otherw...
PMC10540020
Introduction
Lung Injury
DISEASES
The prevalence of nicotine vaporizer use (ie, e-cigarette use, commonly called nicotine “vaping”) is higher among young (versus older) adults [Concerns about the health effects of nicotine vaporizer use rose during an outbreak of e-cigarette or Vaping Associated Lung Injury (EVALI) that made headlines in 2019 and 2020 ...
PMC10540020
Methods
PMC10540020
Participants
We recruited participants (N=1229) aged 18 to 25 (mean 21.40, SD 2.22) years through Qualtrics Research Services, oversampling participants who reported ever using nicotine or cannabis vaporizers (618/1229, 50.3%). To be eligible, participants also had to be 18-25 years old and report using Instagram at least weekly.
PMC10540020
Ethics Approval
This study was reviewed and approved by the University of California, San Francisco institutional review board (IRB 11-06516). All participants read and provided electronic informed consent on Qualtrics before proceeding with the survey and random assignment to an experimental condition. Participants were assured confi...
PMC10540020
Experimental Stimuli
POSITIVE
We derived the 3 Instagram posts that participants viewed from images and text posted on Instagram by 3 young adults in the United States whose experiences with EVALI had been featured in news media. We contacted the young adults using Instagram direct messages to inform them of the study and gave them an opportunity t...
PMC10540020
Measures
PMC10540020
Outcomes
With 4 items, participants rated the
PMC10540020
Participant Characteristics
We used 1 item adapted from the Facebook Intensity Scale [Participants reported their age, sex assigned at birth, education, current student status, and race and ethnicity (coded as non-Hispanic White; non-Hispanic Black; Hispanic; Asian, including Native Hawaiian/Pacific Islander; or other/unreported race or ethnicity...
PMC10540020
Statistical Analysis
We compared participant characteristics by condition using chi-square and
PMC10540020
Results
PMC10540020
Discussion
PMC10540020
Principal Findings
lung injuries
In this study, we found that EVALI-related Instagram posts with negative imagery increased young adults’ perceived harmfulness of nicotine and cannabis vaporizer products, increased perceived risks of nicotine vaporizer products, and decreased intentions to use nicotine vaporizers. Regardless of the Instagram post text...
PMC10540020
Limitations and Future Directions
This study has several limitations. First, we recruited a web-based convenience sample, which may not be representative of all US young adults. Yet, quota sampling increased the sample diversity to match US census data. Second, we used real Instagram posts about EVALI from young adults with lived experience. Although t...
PMC10540020
Conclusions
PML
ABUSE, RECRUITMENT, PML
Instagram posts that use negative imagery may discourage young adults from nicotine vaporizer use. Negative imagery in public education campaigns and on vaporizer product warning labels may better convey harms than text. Young adult Instagram users may be promising partners for communicating messages about health risks...
PMC10540020
Abbreviations
e-cigarette or vaping-associated lung injuryFood and Drug AdministrationMonitoring the Futureodds ratiotetrahydrocannabinol
PMC10540020
Data Availability
The data sets generated and analyzed during this study are available from the corresponding author on reasonable request.
PMC10540020
Background
INTERMITTENT CLAUDICATION
Supervised exercise is an integral part of the recommended first-line treatment for patients with intermittent claudication (IC). By reflecting the patients’ perspectives, patient-reported outcome measurements provide additional knowledge to the biomedical endpoints and are important outcomes to include when evaluating...
PMC10594797
Methods
SECONDARY
This secondary exploratory analysis of a multi-center, randomized clinical trial compared three exercise strategies. The primary outcome of the secondary analysis was the one-year change in the 36-Item Short-Form (SF-36). Secondary outcomes were three- and six-months SF-36 changes alongside three, six- and 12-months ch...
PMC10594797
Results
A total of 166 patients with IC, mean age: 72.1 (SD 7.4) years, 41% women, were randomized. No significant between-group differences were observed over time for the SF-36 or the PSFS scores whereas some significant between-group differences were observed in the VascuQoL domain and summary scores over time, favoring SEP...
PMC10594797
Conclusion
Clinically important improvements were observed in SEP using the VascuQoL, while we did not observe any significant between-group differences using the SF-36. Whereas effect sizes for the observed changes over time were generally small, a significantly higher proportion of patients in SEP reached the VascuQoL MID of im...
PMC10594797
Trial registration
NCT02341716, January 19, 2015 (retrospectively registered).
PMC10594797
Supplementary Information
The online version contains supplementary material available at 10.1186/s12955-023-02198-8.
PMC10594797
Keywords
Open access funding provided by University of Gothenburg.
PMC10594797
Background
lower limb peripheral arterial occlusive disease, PAOD
INTERMITTENT CLAUDICATION
Patients with lower limb peripheral arterial occlusive disease (PAOD) and symptoms of intermittent claudication (IC) often experience functional impairments [Patient-reported outcome measurements (PROMs) is an umbrella term for self-rating instruments that measure concepts such as health status, HRQoL, well-being, pati...
PMC10594797
Study procedure
DISEASE
At baseline, all patients received verbal and written disease information, best medical treatment, and a free pair of walking poles [
PMC10594797
Treatment strategies
PMC10594797
Walk advice (WA)
This strategy included best medical treatment and the unsupervised WA of Nordic pole walking for at least 30 min, three times weekly.
PMC10594797
Home-based structured exercise program (HSEP)
This strategy included the WA and an additional HSEP with aerobic walking exercises and resistance exercises. Patients were instructed to perform three 50-min exercise sessions weekly at home, for a total program duration of one year. The first six months was structured, with feedback from the physiotherapist by biweek...
PMC10594797
Hospital-based supervised exercise program (SEP)
This strategy included the WA and an additional SEP. The SEP comprised the same exercise content and dose as HSEP but was undertaken as group sessions at the hospital under supervision from the physiotherapist (0–6 months). In accordance with HSEP, for the remaining six months, patients were instructed to continue with...
PMC10594797
Patient-reported outcome measurements
PMC10594797
The 36-item Short-Form (SF-36)
MH, pain
The SF-36 is a valid and reliable generic questionnaire that includes 36 items covering different aspects of HRQoL in eight different domains: PF = physical functioning; RP = role physical; BP = bodily pain; GH = general health; VT = vitality; SF = social functioning; RE = role emotional and MH = mental health. The res...
PMC10594797
The Vascular Quality of life (VascuQoL)
Pain
The VascuQoL is a disease-specific HRQoL questionnaire, designed and frequently used to evaluate treatment effects in patients with IC. The VascuQoL includes 25 items, categorized into five domains: Pain, Symptoms, Activities, Emotional, and Social. The VascuQoL Summary score is the sum of all items mean scores, divide...
PMC10594797
The Patient-Specific Functional Scale (PSFS)
Physical function is defined as the capacity of an individual to carry out the physical activities of daily living. Physical function reflects motor function and control, physical fitness, and habitual physical activity [
PMC10594797
Statistical methods
SECONDARY
All patients that attended follow-up and completed the SF-36, VascuQoL and PSFS questionnaires were included in this exploratory superiority analysis comparing the three treatment strategies (WA, WA + HSEP and WA + SEP). For all outcomes, the full data set was used without any imputation and all analyses were based on ...
PMC10594797
Results
PMC10594797
Patient-reported outcome measurements
PROM
At baseline, no significant between-group differences were observed for any of the PROM questionnaires.
PMC10594797
The Vascular Quality of Life
Baseline data and changes at three, six and 12 months in the VascuQoL score data are presented by group in Table Figure Proportion of patients reaching a threshold for important deterioration or improvement in the VascuQoL Summary score change from baseline to 1 year
PMC10594797
Discussion
PROM, low back pain, Pain
While the previously reported primary endpoint results in the SUNFIT trial (6MWT) did not differ between treatment strategies [At three months, a significant difference was observed, in favor of both SEP and HSEP versus WA, in the VascuQoL Emotional domain as well as in the overall Summary score. In the VascuQoL Summar...
PMC10594797
Conclusion
PROM, intermittent claudication
INTERMITTENT CLAUDICATION
Potentially important treatment differentials were revealed when analyzing the disease-specific VascuQoL, while we did not observe any significant between-group differences for the SF-36. Whereas effect sizes for the observed changes in the SF-36 and the VascuQoL over time were generally small, a significantly higher p...
PMC10594797
Acknowledgements
We would like to thank Monica Broeren and Jenny Östlund, research nurses at the Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden. We would like to thank Peta Cook, Ingrid Eliasson, Madeleine Ivarsson, Jenny Snickars and Susanna Wittboldt, physical therapists at the Department of Physi...
PMC10594797
Authors’ contributions
LJ, JN, ÅC, MB and AS developed the concept, idea and study design. All authors contributed with data collection, data analysis and interpretation of the results. AS conducted the statistical analyses with guidance from JN and MB. AS drafted the first version of the manuscript, which was critically reviewed by all auth...
PMC10594797
Funding
ALF
HEART, LUNG
Open access funding provided by University of Gothenburg. This study was supported by grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF agreement (ALFGBG-785741 and ALFGBG-822921) and the Swedish Heart–Lung Foundation (20190194 and 20200258).
PMC10594797
Availability of data and materials
The dataset generated and analyzed during the current study is not available due to ethical considerations and General Data Protection Regulation (GDPR). Processed summary data are however available on reasonable request. The primary article for this randomized clinical trial: (DOI number: 10.1093/eurjcn/zvac070.)
PMC10594797
Declarations
PMC10594797
Ethics approval and consent to participate
The study protocol was approved by the Regional Ethical Review Board in Gothenburg (entry no. 349–14, T789-16). Informed, written consent was obtained from all participants.
PMC10594797
Consent for publication
Not applicable.
PMC10594797
Competing interests
The authors declare no competing interests.
PMC10594797
References
PMC10594797
2. Materials and Methods
PMC10304042
2.1. Study Design and Ethical Details
We designed a single-center prospective randomized pilot study at the Urology Unit of the University of Campania “Luigi Vanvitelli” (Naples, Italy) that was conducted between April 2019 and June 2020. No placebo or blinding was applied. The study was approved by the local Ethics Committee. The research was conducted ac...
PMC10304042
2.2. Patient Enrollment
diabetes mellitus, allergy, phimosis, tumors, UTIs
CHRONIC PROSTATITIS, URETHRAL STRICTURES, CARCINOMA IN SITU, INTERSTITIAL CYSTITIS, DIABETES MELLITUS, ALLERGY, URINARY INCONTINENCE, MEATAL STENOSIS, DIFFICULTY SWALLOWING, IMMUNODEFICIENCY DISORDERS, BLADDER STONES, TUMORS, NEUROGENIC BLADDER
Patients undergoing cystoscopy for suspected BCa or follow-up after transurethral resection of the bladder (TURB), with negative urine culture, were enrolled. The exclusion criteria were: bladder catheter present or removed in the last 30 days; bladder stones; diagnostic or therapeutic endoscopic procedures on the urin...
PMC10304042
2.3. Treatment Protocol
STERILE
All cystoscopies were performed by the same expert operator using a 16-Ch flexible cystoscope equipped with a sterile disposable sheath (Vision
PMC10304042
2.4. Patient Evaluation
Demographic data and clinical characteristics were collected for each patient at baseline. A urine culture was prescribed regardless of symptoms 7 days before and 7 days after cystoscopy. The urine culture results were sent by email. The urine culture before cystoscopy had to be negative to allow patients to be include...
PMC10304042
2.5. Statistics
The continuous variables were described as medians and the interquartile range (IQR), while the categorical variables were expressed as frequencies and percentages. The Shapiro–Wilk test was applied as a normality test. The Wilcoxon rank-sum and Wilcoxon signed-rank tests were used to analyze continuous variables in in...
PMC10304042
3. Results
A total of 32 patients were enrolled in the study and randomized into the two treatment groups. No patients or data were lost after enrollment (
PMC10304042
4. Discussion
bladder inflammation, infectious complications, infection, inflammation
HAND INFECTION, INFLAMMATION, ADVERSE EFFECTS, INFECTION, BLADDER INFLAMMATION
Cystoscopy, a widely used diagnostic procedure in urology, can be frustrating for patients and is associated with possible infectious complications [Obviously, the uncertainty on the topic and the concern about the resistance and possible adverse effects of antibiotics has prompted the search for possible alternatives ...
PMC10304042
Author Contributions
Conceptualization, C.Q., C.M. and L.S.; methodology, L.N. and A.F.; data collection, C.D., D.A. and A.D.G.; writing—original draft, C.M. and L.S.; writing—review and editing, C.S. and V.I.; visualization, F.B. and R.L.R.; supervision, M.D.S. All authors have read and agreed to the published version of the manuscript.
PMC10304042
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the local Ethics Committee, University of Naples Federico II. Approval Code: 261/2019. Approval Date: March 2019.
PMC10304042
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10304042
Data Availability Statement
Not applicable.
PMC10304042
Conflicts of Interest
The authors declare no conflict of interest.
PMC10304042
References
UTIs
SECONDARY
CONSORT flow diagram.UTIs 7 days after cystoscopy. Group A: D-Mannose (500 mg) plus Baseline characteristics of patients.Group A: D-Mannose (500 mg) plus Evaluation of secondary outcomes.Group A: D-Mannose (500 mg) plus
PMC10304042
Background
Body dissatisfaction is a global issue, particularly among adolescent girls and young women. Effective body image interventions exist but face barriers to scaling up, particularly in lower- and middle-income countries, such as Indonesia, where a need exists.
PMC10131926
Objective
We aimed to evaluate the acceptability and efficacy of
PMC10131926
Methods
We conducted a web-based, 2-arm randomized controlled trial among 2000 adolescent girls and young women, aged 15 to 19 years, recruited via telephone by an Indonesian research agency. Block randomization (1:1 allocation) was performed. Participants and researchers were not concealed from the randomized arm. Participant...
PMC10131926
Results
There were 1847 participants. Relative to the control condition (n=923), the intervention group (n=924) showed reduced internalization of appearance ideals at T2 (
PMC10131926
Trial Registration
ClinicalTrials.gov NCT05383807, https://clinicaltrials.gov/ct2/show/NCT05383807 ; ISRCTN Registry ISRCTN35483207, https://www.isrctn.com/ISRCTN35483207
PMC10131926
International Registered Report Identifier (IRRID)
RR2-10.2196/33596
PMC10131926
Introduction
See
PMC10131926
Background
Globally, many young people, particularly adolescent girls and young women [Interventions have been developed and rigorously evaluated to reduce body dissatisfaction among adolescent girls and young women, with promising findings [
PMC10131926
Harnessing Social Media for Body Image Interventions
A viable solution to increase the scalability of mental health interventions, including those to reduce body dissatisfaction, is the use of social media platforms [
PMC10131926
The Indonesian Context
Indonesia, a Southeast Asian nation, is the world’s largest archipelago and fourth most populous country [
PMC10131926
This Study
In this study, we evaluated the impact of
PMC10131926
Methods
PMC10131926
Trial Design
A 2-arm, web-based parallel randomized controlled trial was conducted to evaluate the efficacy of
PMC10131926
Ethics Approval
WEST
Ethics approval was obtained from the Faculty of Medicine at Universitas Indonesia (588/UN2.F1/ETIK/PPM.00.002/2021) and the University of the West of England, Bristol (United Kingdom; HAS.21.04.138). The trial protocol was registered (International Registered Report Identifier PRR1-10.2196/33596) [
PMC10131926
Participants
Jakarta-based
A Jakarta-based research agency recruited and enrolled a sample of adolescent girls and young Indonesian women from 10 cities across the western, central, and eastern regions of Indonesia (Balikpapan, Bandung, Jakarta, Makassar, Manado, Medan, Palembang, Pontianak, Semarang, and Surabaya) offline, evenly split across a...
PMC10131926
Procedure
All communication between the research agency and the participants took place on the web via WhatsApp. The day before the study was launched (day 0), the research agency distributed data packages to each of the participants to cover internet data costs incurred. Participants completed web-based self-report questionnair...
PMC10131926
Measures
PMC10131926
Primary Outcome Measure
The primary outcome measure for assessing trait body satisfaction was the Body Esteem Scale for Adolescents and Adults (BESAA) [
PMC10131926
Secondary Outcome Measures
SECONDARY
Three secondary outcome measures were used. The internalization-general subscale of the Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ-3) [
PMC10131926
State Outcome Measures
To assess state body satisfaction and mood, single-item measures on a 101-point visual analog scale [
PMC10131926
Intervention Acceptability
On day 9, the intervention condition participants received 6 self-report items at the end of the T2 questionnaire that assessed the intervention in relation to their overall enjoyment, likability of the characters, understandability, age appropriateness, usefulness, and likelihood of recommending the intervention to a ...
PMC10131926
Adherence
The level of adherence to the intervention was assessed using various metrics that examined video and activity engagement. The following metrics were collected: the percentage of participants who watched each video and all 6 videos (calculated by the number of participants whose dwell time on the Qualtrics page hosting...
PMC10131926
Sample Size
Similar randomized controlled trials assessing body dissatisfaction using the same outcome measure reported a range of small to medium standardized effect sizes, with Hedges
PMC10131926
Analyses
PMC10131926
Overview
Analyses were performed using SPSS 28 (IBM Corp). Any duplicate questionnaire entries were identified by the participants’ unique PIN, and the first entry was retained for analysis. To avoid interpretation bias, condition allocation was concealed from the data analyst throughout data preparation and trait outcome hypot...
PMC10131926
Hypotheses Testing and Post Hoc Analyses
PMC10131926
Trait Outcomes
REGRESSION
The effect of the intervention on trait outcomes was examined by running 4 linear mixed models (LMMs) on an intention-to-treat basis, with baseline measures at T1 as a covariate, randomized group as a 2-level between-subjects factor, study phase (T2 and T3) as a 2-level repeated measures factor, an unstructured covaria...
PMC10131926
State Outcomes
For each state outcome, 6 dependent sample To test for cumulative effects across the 6 videos, we ran two 2 × 6 ([prevideo vs postvideo] × [6 videos]) fully repeated measures ANOVA for state body satisfaction and state mood, checking for linear, quadratic, cubic trends, and repeated contrasts. For both state measures, ...
PMC10131926
Exploratory Analyses
After testing the hypotheses and post hoc analyses, we tested an exploratory mediation model with PROCESS Macro for SPSS (model 4) [
PMC10131926
Data Preparation
REGRESSION, ATTRITION
The trait outcomes data set across conditions had 0.32% (356/112,667) missing item responses at T1, 4.31% (4858/112,667) missing item responses at T2, and 3.12% (3517/112,667) missing item responses at T3 (Independent sample Moreover, the dropout rate never exceeded 5% between time points for any of the variables, supp...
PMC10131926
Results
PMC10131926
Pilot Study and Protocol Amendments
RECRUITMENT
Recruitment for the pilot study was conducted from September 13 to 16, 2021, and executed between September 18 and 26, 2021. A sample spread evenly across age and socioeconomic status (n=150) was obtained from the cities of Jakarta, Medan, and Semarang. As outlined in the trial protocol [
PMC10131926
Adherence
Intervention adherence metrics were also assessed. On average, intervention participants watched 5 of the 6 videos and completed 14 of the 18 activities. See
PMC10131926
Hypotheses Testing and Post Hoc Analyses
PMC10131926
Trait Outcomes
PMC10131926
Body Satisfaction
The LMM with baseline body satisfaction as a covariate, randomized group as a 2-level between-subjects factor, study phase (T2 and T3) as a 2-level repeated measures factor, three 2-way interactions, and one 3-way interaction found a nonsignificant effect of randomized group (The preplanned ANCOVAs showed a nonsignific...
PMC10131926