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Effect sizes correction in significant one-way ANCOVA
The ANCOVA procedure in SPSS by default calculates effect size using partial eta squared (We calculated the The resulting
PMC10306226
Interpretation of corrected partial η
Note. HLL = Haizea-llevant.As can be seen from
PMC10306226
Discussion
SECONDARY
This study was a pilot Q-RCT of parent training for a remote booklet intervention with preschool children at risk of not reaching their developmental potential. Findings in the CARE booklet intervention (CBI) were in line with our prediction that the parental training interventions would enhance children’s developmenta...
PMC10306226
Limitations and future research
RECRUITMENT
All effect sizes in a pilot study should be interpreted with caution because there are several limitations due to the small sample size. A larger sample size is needed for a rigorous and detailed mapping of the effects of similar procedures on poor, low-income families in LMICs, including adequate controls for sociodem...
PMC10306226
Supporting information
(BIN)Click here for additional data file.The author expresses sincere gratitude to the families and mothers at Amiguitos Royal CC in Bogotá, as well as the internship students of the Pasantía de Cuidado y Desarrollo from the Department of Psychology at the Universidad de la Sabana. Special thanks are extended to Dr. Gr...
PMC10306226
Background
Depression
Depression is common among adults who smoke cigarettes. Existing depression-specific cessation interventions have limited reach and are unlikely to improve smoking prevalence rates among this large subgroup of smokers.
PMC10652199
Objective
depression
This study aimed to determine whether a mobile app–based intervention tailored for depression paired with a mailed sample of nicotine replacement therapy (NRT) is efficacious for treating depression and promoting smoking cessation.
PMC10652199
Methods
depression, Depression, depressive symptoms
A 2-arm nationwide remote randomized clinical trial was conducted in the United States. Adults (N=150) with elevated depressive symptoms (Patient Health Questionnaire-8≥10) who smoked were enrolled. The mobile app (“Goal2Quit”) provided behavioral strategies for treating depression and quitting smoking based on Behavio...
PMC10652199
Results
SE, depressive, SD, depressive symptoms
In total, 150 participants were enrolled between June 25, 2020, and February 23, 2022, of which 80 were female (53.3%) and the mean age was 38.4 (SD 10.3) years. At baseline, participants on average reported moderate depressive symptoms and smoked a mean of 14.7 (SD 7.5) cigarettes per day. Goal2Quit usability was stro...
PMC10652199
Conclusions
depression
A mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation. Findings support the utility of this intervention approach for addressing the currently unmet public health treatment need for tailored, scalable depression-specific cessation trea...
PMC10652199
Trial Registration
ClinicalTrials.gov NCT03837379; https://clinicaltrials.gov/ct2/show/NCT03837379
PMC10652199
Introduction
depressive, depression, depressive symptoms
Despite significant declines over the last 50+ years in cigarette smoking prevalence among the general population, smoking rates remain astonishingly high among certain vulnerable subgroups. One such subgroup is the 48 million US adults with depressive symptomatology [Tailored cessation treatments that incorporate depr...
PMC10652199
Methods
PMC10652199
Ethical Considerations
The study and protocol were approved by the Medical University of South Carolina institutional review board (Pro00074015). Participants provided electronic written informed consent before enrollment. Trial information is presented according to the CONSORT (Consolidated Standards of Reporting Trials) and the trial was p...
PMC10652199
Participants
Study participants were recruited nationwide via web-based advertising (2020-2022). Consistent with guidelines for preventing participant deception in web-based nicotine and tobacco research studies [
PMC10652199
Procedures
All study procedures were delivered fully remotely, consistent with a decentralized clinical trial design [To minimize fraud [
PMC10652199
Interventions
PMC10652199
Goal2Quit
Goal2Quit treatment content is consistent with the original BA for smoking cessation group therapy manual [Goal2Quit was paired with a mailed 2-week sample of NRT, inclusive of 14 mg nicotine patches and 4 mg nicotine lozenges. As nicotine lozenges were provided in addition to nicotine patches, we opted for uniform NRT...
PMC10652199
TAU
depression, Cancer
CANCER
We selected TAU as an appropriate control since the central research question herein is whether Goal2Quit improves depression and smoking cessation outcomes relative to existing treatment services. Research staff provided participants with a digital copy of the National Cancer Institute’s “Clearing the Air: Quit Smokin...
PMC10652199
Assessments
PMC10652199
Overview
All participants at baseline completed a general assessment of demographics as well as assessments of confidence in quitting smoking (0-10 Likert scale) [
PMC10652199
Goal2Quit Usability and Uptake
Assessment of Goal2Quit usability and uptake included self-reported app usability and passively collected app analytics. At week 4, participants randomized to the Goal2Quit condition completed the System Usability Scale [
PMC10652199
Depression
depressive symptoms
Participants self-reported depressive symptoms via the Patient Health Questionnaire-8 [
PMC10652199
Smoking Cessation
CPD
At each follow-up, participants self-reported (1) the number of cigarettes smoked per day over the last 7 days (also captured at baseline) and (2) the incidence of quit attempts lasting at least 24 hours since the prior assessment. Data regarding quit attempts were collapsed across time points to indicate any 24-hour q...
PMC10652199
Data Analytic Plan
CPD, depression, depressive symptoms
REGRESSION
All individuals randomized to Goal2Quit or TAU and not removed for fraud were included in analyses. Descriptive statistics for baseline variables, usability metrics, and app uptake were calculated for the overall sample and per group, as appropriate. Between-group changes in depressive symptoms and CPD were compared vi...
PMC10652199
Results
PMC10652199
Participant Characteristics
Depression
PCP
See CONSORT diagram. BDI: Beck Depression Inventory; BL: baseline; NRT: nicotine replacement therapy; PCP: primary care provider; PHQ-8: Patient Health Questionnaire-8.Participant demographics.
PMC10652199
Goal2Quit Usability and Uptake
SD
The mean Goal2Quit usability on the System Usability Scale at week 4 was 78.5 (SD 16.9), with 70% scoring above the ≥68 cutoff for above-average usability [
PMC10652199
Depression
worsening mood, depression, Depression, depressive symptoms
There was no evidence that the association between group and change in depressive symptoms varied over time (Regarding worsening depression over time, 37 participants reported worsening mood, defined as an increase of 10 or more points on the BDI-II since baseline, at some point during the study duration (23 Goal2Quit,...
PMC10652199
Smoking Cessation
Across time points, all cessation outcomes favored Goal2Quit. Goal2Quit participants were more likely to have made a 24-hour quit attempt during the first 4 (17% vs 2%; There was no evidence that the association between group and change in CPD varied over time (Within the Goal2Quit group, total time spent using the app...
PMC10652199
Discussion
CPD, depression, depressive symptoms
ABUSE
These results preliminarily indicate that Goal2Quit paired with a mailed sample of NRT (1) is usable by adults with depressive symptoms who smoke cigarettes, (2) is efficacious for depression treatment, and (3) promotes smoking cessation. Regarding usability and treatment engagement, outcomes can be compared to other a...
PMC10652199
Abbreviations
activationBeck Depression
behavioral activationBeck Depression Inventory-IIConsolidated Standards of Reporting Trialscigarettes per daynicotine replacement therapyodds ratiopoint prevalence abstinenceResearch Electronic Data Capturetreatment as usual
PMC10652199
CONFLICT OF INTERESTS STATEMENT
diabetic retinopathy, cardiovascular comorbidities, CVD, Hanhart, diabetes
DIABETIC RETINOPATHY, MYOCARDIAL INFARCTION (MI), ACUTE MI, CARDIOVASCULAR DISEASE, KIDNEY DISEASE, CVD, ADVERSE EVENTS, ADVERSE EFFECTS, HANHART, DIABETES
Bloomgarden reviewed a variety of relevant studies summarizing new approaches to the treatment of diabetes citing a study showing that anti‐vascular endothelial growth factor (VEGF) treatment of over 14 000 patients with diabetic retinopathy (DR) was associated with increased likelihood of myocardial infarction (MI) a...
PMC10590675
ACKNOWLEDGEMENT
None.
PMC10590675
REFERENCES
PMC10590675
Purpose
esophageal cancer
OESOPHAGEAL CANCER
Participation in a post-treatment exercise program improves cardiorespiratory fitness and aspects of quality of life for esophageal cancer survivors. For optimal effects, high adherence to the exercise intervention is important. We assessed which facilitators and barriers to exercise adherence are perceived by esophage...
PMC10164010
Methods
The current qualitative study was performed within the randomized controlled PERFECT trial, in which we investigated effects of a 12-week supervised exercise program with moderate-to-high intensity and daily physical activity advice. Semi-structured interviews were conducted with patients randomized to the exercise gro...
PMC10164010
Results
Thematic saturation was reached after inclusion of sixteen patients. Median session attendance was 97.9% (IQR 91.7–100%), and relative dose intensity (compliance) to all exercises was ≥90.0%. Adherence to the activity advice was 50.0% (16.7–60.4%). Facilitators and barriers were captured in seven themes. The most impor...
PMC10164010
Conclusions
Esophageal cancer
ESOPHAGEAL CANCER
Esophageal cancer survivors are well capable to attend a moderate-to-high intensity post-treatment exercise program, and to fulfill the exercises according to protocol. This is facilitated by patients’ own intention to engage in exercise and supervision of the physiotherapist, and only minimally affected by barriers as...
PMC10164010
Implications for cancer survivors
cancer
CANCER
When implementing postoperative exercise programs in clinical care, it can be useful to be aware of perceived facilitators and barriers of cancer survivors in order to achieve optimal exercise adherence and maximize beneficial exercise effects.
PMC10164010
Trial registration
Dutch Trial Register NTR 5045
PMC10164010
Keywords
PMC10164010
Introduction
esophageal cancer, cancer, fatigue, Esophageal Cancer
CANCER, OESOPHAGEAL CANCER, ESOPHAGEAL CANCER
Patients who have been treated for cancer may experience cancer-related and treatment-related side effects impairing quality of life in the short and long term. Participation in (post-treatment) exercise programs has been proven to beneficially affect several health-related outcomes, such as fatigue, physical fitness, ...
PMC10164010
Methods
The current research question was investigated within the multicenter randomized controlled PERFECT study (NTR5045). The PERFECT study was approved by the Medical Ethics Committee of the UMC Utrecht and the local Ethical Boards of participating hospitals. Informed consent was obtained from all participants included in ...
PMC10164010
Outcome measures
PMC10164010
Adherence
To monitor session attendance, each physiotherapist reported on presence of the patient at each training session in a case report form. In addition, to monitor the relative dose intensity for the different exercise components, heart rates and duration were documented for the aerobic training and resistance and number o...
PMC10164010
Facilitators and barriers
A topic list and an interview protocol were prepared before the start of the interview series, after examination of relevant literature and discussion within the study team. All semi-structured interviews, except one, were performed within 14 days of completing the exercise program and were audio-recorded and transcrib...
PMC10164010
Data analysis
Descriptive statistics were used to summarize characteristics of the study population. Attendance rates were computed as the number of supervised exercise sessions attended, divided by the number of sessions prescribed. The RDI (i.e., compliance) was calculated as the ratio of total completed to total planned cumulativ...
PMC10164010
Facilitators and barriers
exercisesDiversity
DILATION, HOLIDAYS
We identified 7 overarching themes that captured patients’ perceived facilitators and barriers during their participation in the exercise program: intention to engage in exercise, supervision, psychosocial context, physical condition, logistics, content of the exercise program, and information about the exercise progra...
PMC10164010
Facilitators
First, patients reported their own intention to engage in exercise as the most important facilitator to adhere to the exercise program. Most patients were highly motivated to contribute to their own recovery and were convinced that the exercise program would help them to improve their health. Their own personal goals o...
PMC10164010
Barriers
dizziness, muscle pain
HOLIDAYS, ESOPHAGEAL DILATION
The most important barriers were captured by the themes “physical condition” and “logistics”. Esophageal dilation, commonly performed in post-esophagectomy patients, hampered both attendance and RDI: Due to the hospital visits, appointments with the physiotherapist could be affected and patients needed some time to ful...
PMC10164010
Acknowledgements
We would like to thank all participants, physiotherapists, and the professional staff at UMC Utrecht, Utrecht; Hospital Group Twente (ZGT), Almelo; and Catharina Hospital, Eindhoven for their invaluable participation in this trial.
PMC10164010
Authors’ contributions
AMM
RECRUITMENT
AMM, PDS, and JKV planned the project. RH, JPR, GAPN, EAK, and PDS were responsible for patient recruitment. JKV, ACMH, and LW collected the data. JKV, ACMH, LW, AEH, and AMM were responsible for data handling, data analysis, and interpretation. JKV wrote the first draft, and all authors contributed and approved the fi...
PMC10164010
Funding
Cancer
CANCER
The PERFECT study was funded by the World Cancer Research Fund, The Netherlands (WCRF NL, project number 2013/997). They had no role in the study design, collection, analysis, or interpretation of the data, writing the manuscript, or the decision to submit the paper for publication.
PMC10164010
Declarations
PMC10164010
Ethical approval
This study was performed in line with the principles of the Declaration of Helsinki. The PERFECT study was approved by the Medical Ethics Committee of the UMC Utrecht and the local Ethical Boards of participating hospitals. Informed consent was obtained from all participants included in the study.
PMC10164010
Competing interests
The authors declare no competing interests.
PMC10164010
References
PMC10164010
1. Introduction
Endothelial dysfunction, fasting blood glucose, arterial stiffness
ENDOTHELIAL DYSFUNCTION, ARTERIAL STIFFNESS, DILATION, OXIDATIVE STRESS, COLD, ENDOTHELIAL DYSFUNCTION
Postmenopausal women (PMW) may experience endothelial dysfunction associated with arginine (ARG) deficiency relative to asymmetric dimethylarginine (ADMA) caused by oxidative stress. Endothelial dysfunction contributes to increased blood pressure (BP) responsiveness to sympathoexcitation induced by the cold pressor tes...
PMC10097312
2. Materials and Methods
PMC10097312
2.1. Participants
CVDs
TYPE 2 DIABETES, CARDIOVASCULAR DISEASES
Participants were healthy postmenopausal women aged 51–74 years. All participants had absence of menstruation for at least 1 year and were sedentary (<120 min/week of exercise). Potential participants were excluded if they had diagnosed cardiovascular diseases (CVDs), type 2 diabetes, a body mass index > 34.9 kg/m
PMC10097312
2.2. Experimental Protocol
SECONDARY
This was a double-blind, placebo-controlled, parallel design study. The randomization was performed by a researcher not involved in laboratory measurements using a block scheme stratified by age and systolic BP (SBP) with a computer program [The primary endpoint was the change in endothelial function, as assessed by br...
PMC10097312
2.3. Measurements
All measurements were performed in the morning after an overnight fast and 24 h abstinence from caffeine, alcohol, prescription medications, and physical activity. All vascular measurements were conducted in the supine position after at least 20 min of rest in a quiet, dimly lit, and thermoneutral environment. Followin...
PMC10097312
2.3.1. Flow-Mediated Dilation
Endothelial function was assessed by brachial FMD. The right brachial artery was scanned ~2–3 cm proximal to the antecubital fossa using a 12-MHz linear array Doppler ultrasound probe (LogiQ S7 expert, GE Medical Systems, Milwaukee, WI, USA) at an insonation angle < 60°. Following a 2 min baseline diameter and mean blo...
PMC10097312
2.3.2. Pulse Wave Velocity
Carotid-femoral PWV (cfPWV, aortic), carotid-radial PWV (crPWV, brachial), carotid-distal PWV (cdPWV, systemic), and femoral-ankle (dorsalis pedis artery) PWV (faPWV, leg) were determined by applanation tonometry (Complior Analyse, Alam Medical, Vincennes, France; for faPWV: SphygmoCor CPV, AtCor Medical, Sydney, Austr...
PMC10097312
2.3.3. Brachial and Aortic Blood Pressures at Rest and During the CPT
brachial mean arterial pressure
COLD
Brachial SBP and diastolic BP (DBP) were measured using an automated oscillometric device (HEM-705CP; Omron Healthcare, Vernon Hill, IL, USA). Radial artery pressure waves recorded using applanation tonometry were calibrated with brachial mean arterial pressure (MAP) and DBP. Aortic hemodynamics were obtained via a val...
PMC10097312
2.3.4. Serum Biomarkers
HF Quadrupole-Obitrap mass
INSULIN RESISTANCE
Fasted blood samples were collected from the antecubital vein at baseline and at 4 weeks. Serum samples were collected using silicone-coated tubes and stored at −80 °C until subsequent analysis of the biomarkers. Glucose (EIAGLUC; Invitrogen, Carlsbad, CA, USA) was measured using the glucose oxidase method. Insulin was...
PMC10097312
2.4. Statistical Analysis
Sample size was estimated based on data that showed increased FMD after ARG supplementation in older adults [
PMC10097312
3. Results
PMC10097312
3.1. Participant Characteristics
Participants were recruited from June 2020 to December 2021. Thirty-nine participants randomized to the placebo (Participant characteristics at baseline did not differ among the groups, except for FBG (
PMC10097312
3.2. Flow-Mediated Dilation and Arterial Stiffness
Baseline FMD and PWV segments did not differ among the groups. There was a time-by-group interaction for FMD. CIT+GSH increased the FMD by 2.9% (
PMC10097312
4. Discussion
peripheral muscular arteries [Impaired FMD, hypertension, prediabetes
OXIDATIVE STRESS, HYPERTENSION, PREDIABETES, OXIDATIVE STRESS
This study examined the effects of 4 weeks of CIT and CIT+GSH supplementation on vascular function and BP responsiveness in healthy postmenopausal women. We found that CIT+GSH supplementation improved endothelial function through an increase in the ARG/ADMA ratio. Although CIT supplementation increased serum ARG levels...
PMC10097312
5. Conclusions
EVENTS, PHYSIOLOGICAL STRESS
Four weeks of CIT+GSH supplementation improves brachial artery FMD in apparently healthy postmenopausal women with slightly elevated FBG. CIT+GSH reduced brachial PWV and attenuates BP responses to sympathetic activation. These beneficial effects on the endothelial function and BP reactivity may be attributed to an inc...
PMC10097312
Author Contributions
A.F., M.M. and D.N. were responsible for the study design. A.F. was responsible for the conduction of the study. A.M., S.M.F., M.A.M., Y.K. and K.N.D. performed the experiment and data collection. A.F., A.M., S.M.F., M.A.M., Y.K. and K.N.D. participated in the data analysis and interpretation. A.F., M.A.M., Y.K. and K....
PMC10097312
Institutional Review Board Statement
The experimental protocol and informed consent was approved by Texas Tech University Institutional Review Board.
PMC10097312
Informed Consent Statement
Written informed consent was obtained from all subjects involved in the study.
PMC10097312
Data Availability Statement
The data presented in this study are available upon request from the corresponding author.
PMC10097312
Conflicts of Interest
M.M. and D.N. are employees of Kirin Holdings Co., Ltd. M.M., D.N. and Kirin had no influence on participant handling, data collection, analysis or interpretation, and manuscript writing. The other authors declare no conflict of interest.
PMC10097312
Abbreviations
PMC10097312
References
brachial artery flow-mediated dilation
DILATION, OXIDATIVE STRESS, ARTERIAL STIFFNESS
CONSORT flow chart of participants through the study. CIT, citrulline, CIT+GSH, and CIT+glutathione.Changes (Δ) in brachial artery flow-mediated dilation (ΔFMD%) from 0 to 4 weeks. Abbreviations: CIT, citrulline; CIT+GSH, CIT+glutathione. * Relationship between changes (Δ) in the brachial artery flow-mediated dilation ...
PMC10097312
Introduction and hypothesis
pelvic organ prolapse
The present study describes an extended follow-up study after 12 years and focusses on subjective outcomes of women who underwent surgery for recurrent pelvic organ prolapse in the randomized index study.
PMC10287778
Methods
One hundred and ninety-four (194) women had been randomized in the original study and in the present study, 45 (47%) in the vaginal mesh repair versus 43 (43%) women with conventional vaginal native tissue repair completed the long-term questionnaires. The mesh used was a first-generation non-absorbable mesh kit. All t...
PMC10287778
Results
At 12 years, 30 (71%) women in the mesh group versus 23 (59%) women in the native tissue repair group reported to be PGI-I (very) much improved (
PMC10287778
Conclusions
pelvic organ prolapse
There was no difference in subjective outcome between the groups, but there was a statistically significant higher number of women who had needed further operations. This study confirms that vaginal mesh should not be used in all women with recurrent pelvic organ prolapse.
PMC10287778
Keywords
PMC10287778
Introduction
pain/dyspareunia
PELVIC ORGAN PROLAPSE, COMPLICATIONS
Pelvic organ prolapse (POP) is a common health problem worldwide and has a high impact on quality of life [Mesh exposure and severe pain/dyspareunia are much feared long-term complications of vaginal mesh surgery [A limited number of randomized controlled trials (RCT) compared the safety and efficacy of synthetic non-a...
PMC10287778
Materials and methods
SUI, Defecatory Distress, pain
PROLAPSE, INCONTINENCE
The original trial [An extended follow-up was approved by the Medical Ethics Committee, region Arnhem-Nijmegen, The Netherlands, on 28 April 2014 under no. NL46834. 091.14 and (All participants completed the Dutch version of the validated questionnaires: Patient Global Impression of Improvement questionnaire (PGI-I), E...
PMC10287778
Authors’ contributions
K.B. Kluivers: design of the study, the acquisition, analysis, and interpretation of data, drafting the manuscript and thereby final approval of the version to be published; M. Kamping: acquisition, analysis, and interpretation of data, final approval of the version to be published; A.L. Milani: design of the study, th...
PMC10287778
Funding
An unrestricted educational grant from Ethicon Women’s Health & Urology to Radboud University Medical Center. Ethicon was not involved in the study setup, design, data acquisition, data analysis, data interpretation, editing, or any other aspect of this study.
PMC10287778
Declarations
PMC10287778
Conflicts of interest
None.
PMC10287778
References
PMC10287778
Aims/hypothesis
glucose tolerance [IGT]) and, impaired fasting glucose [IFG] and/or impaired, prediabetes
TYPE 2 DIABETES, PREDIABETES
In sub-Saharan Africa (SSA), 5% of adults are living with type 2 diabetes and this is rising sharply, with a greater increase among people with HIV. Evidence on the efficacy of prevention strategies in this cohort is scarce. We conducted a Phase II double-blind placebo-controlled trial that aimed to determine the impac...
PMC10474205
Methods
coronavirus disease 2019, prediabetes
CORONAVIRUS DISEASE 2019, PREDIABETES
Adults (≥18 years old) who were stable in HIV care and found to have prediabetes (IFG and/or IGT) and who were attending hospitals in Dar es Salaam, Tanzania, were randomised to receive sustained-release metformin, 2000 mg daily, or matching placebo between 4 November 2019 and 21 July 2020. Randomisation used permuted ...
PMC10474205
Results
In total, 364 participants (182 in each arm) were randomised to the metformin or placebo group. At enrolment, in the metformin and placebo arms, mean fasting glucose was 6.37 mmol/l (95% CI 6.23, 6.50) and 6.26 mmol/l (95% CI 6.15, 6.36), respectively, and mean 2 h glucose levels following a 75 g oral glucose load were...
PMC10474205
Conclusions/interpretation
HIV and prediabetes, diabetes
BLOOD, DIABETES
Blood glucose decreased over time in both the metformin and placebo arms during the trial but did not differ significantly between the arms at 12 months of follow up. Metformin therapy was found to be safe for use in individuals with HIV and prediabetes. A larger trial with longer follow up is needed to establish if me...
PMC10474205
Trial registration
The trial is registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry (
PMC10474205
Funding
This research was funded by the National Institute for Health Research using UK aid from the UK Government to support global health research.
PMC10474205
Graphical Abstract
PMC10474205
Keywords
PMC10474205