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Background
Media
Most people now know that physical activity is vital for health. Over the past few decades, if one has seen a physician, read the news, or obtained brochures from their health insurance or flyers from a local gym, they are likely aware of this fact. Indeed, we are constantly reminded of the need to engage in adequate p...
PMC9909519
Mindsets and Their Effects on Health and Well-being
’ motivation, behavior
Mindsets are our core assumptions regarding a domain or category (eg, intelligence, healthy eating, stress, and physical activity) [Decades of psychological research show that mindsets are critical yet often overlooked factors influencing individuals’ motivation, behavior, and performance (eg, mindsets about intelligen...
PMC9909519
Can Wearable Technology Shape AAMs?
Individuals’ AAMs do not simply reflect their objective physical activity levels; indeed, a study found a moderate correlation of 0.32 between actual and perceived activity levels [The basic idea behind wearable activity trackers is simple: help users engage in adequate physical activity by providing feedback about the...
PMC9909519
How Can We Harness Mindsets to Promote Health and Well-being at Scale?
AAMs have the potential to improve health and well-being, but to date, interventions to leverage AAMs at scale are lacking. First, to establish causal effects, research has used deceptive methods to manipulate mindsets [An alternative approach is to share scientific insights about the power of mindsets with individuals...
PMC9909519
This Research
depression, anxiety
This research explored 4 questions arising from the theory and evidence reviewed previously. First, we examined whether receiving step count feedback from a wearable tracker (in this case, Apple Watch [Apple Inc]) affects one’s AAM. Second, we experimentally manipulated step count feedback with the intent of inducing d...
PMC9909519
Methods
PMC9909519
Overview
This study was preregistered on ClinicalTrials.gov [
PMC9909519
Participants and Procedures
WEST
Participants were a diverse sample of 162 West Coast community-dwelling adults recruited via flyers and web-based platforms (ie, Craigslist and Nextdoor) between September 2017 and September 2019. The posting advertised an opportunity to participate in a paid research study to develop more effective fitness trackers. T...
PMC9909519
Ethics Approval
This study was approved by the Stanford University institutional review board (protocol 36098).
PMC9909519
Design and Manipulations
PMC9909519
Overview
This study used a parallel trial design (allocation ratio 1:1:1:1). Participants were assigned to one of four conditions––(1) accurate step count (41/162, 25.3%), (2) deflated step count (40/162, 24.7%), (3) inflated step count (40/162, 24.7%), or (4) meta-mindset intervention plus accurate step count (41/162, 25.3%)––...
PMC9909519
Step Count Feedback Manipulations
After the no-feedback baseline period (week 1), participants in the accurate step count condition started to view their step count as recorded by the Apple Watch (Illustration of an Apple Watch (Apple Inc) with the AccuSteps app displaying the manipulated step count.
PMC9909519
Meta-Mindset Intervention
The meta-mindset intervention was included in the first weekly survey and consisted of 3 videos and reflection activities. The 3- to 5-minute–long videos informed participants about health-related mindsets in general, AAMs in particular, and how mindsets can create self-fulfilling effects. The reflection activity promp...
PMC9909519
Measures
PMC9909519
Overview
All measures (ie, health outcomes, AAM, and affective and behavioral measures) were measured in the laboratory at onboarding and offboarding. In addition, a subset of measures (ie, AAM and affective and behavioral measures) was taken in weekly surveys. Survey scales providing reference periods referred to either the la...
PMC9909519
AAM (Manipulation Check)
A 5-item version of the Activity Adequacy Mindset Scale [
PMC9909519
Affective Processes
The Affect Valuation Index [
PMC9909519
Analytical Approach
The mean within-participant changes in AAM, health and well-being outcomes, and affective and behavioral processes from the baseline period to the treatment period were calculated. First, for each participant separately, all baseline measurements of a particular variable were averaged, all treatment measurements were a...
PMC9909519
Results
PMC9909519
Effects of (Accurate) Step Count Feedback
First, we examined whether AAM, health, affect, and behavior changed from the baseline (no step count) period to the treatment period in the accurate step count condition.
PMC9909519
Changes in AAM
Receiving step count feedback was associated with significant improvements in AAM from the baseline period to the treatment period (baseline mean 3.18, SD 1.05; treatment mean 3.47, SD 1.12;
PMC9909519
Health Outcomes
Receiving step count feedback was associated with significant improvements in
PMC9909519
Affective and Behavioral Processes
No changes were detected in
PMC9909519
Effects of Manipulated Step Count Feedback
Next, we examined whether deflated and inflated step count feedback led to changes in outcomes over time that differed from the changes resulting from accurate step count feedback.
PMC9909519
Health Outcomes
The deflated step count led to slight declines in
PMC9909519
Affective and Behavioral Processes
Changes in
PMC9909519
Effects of the Meta-Mindset Intervention
Finally, we examined whether the meta-mindset intervention improved AAM, affect, behavior, and health outcomes by comparing changes in these outcomes from the baseline period to the treatment period in the meta-mindset condition with changes in the accurate step count condition.
PMC9909519
Changes in AAM
As predicted, AAM improved in the meta-mindset condition, and this improvement was significantly greater than that in the accurate step count condition (baseline mean 3.48, SD 1.19; treatment mean 4.06, 1.13;
PMC9909519
Health Outcomes
Participants in the meta-mindset condition experienced slight improvements in
PMC9909519
Affective and Behavioral Processes
In line with predictions, the meta-mindset intervention improved
PMC9909519
Discussion
PMC9909519
Principal Findings
This 5-week longitudinal field experiment examined the effects of wearable fitness tracker feedback on AAM. In addition, it explored the effects of AAMs on health and well-being and several affective and behavioral determinants of health. Finally, this research developed and tested a transparent, scalable meta-mindset ...
PMC9909519
Limitations
This research was preregistered as an exploratory study seeking to discover uncharted territory and generate novel hypotheses [
PMC9909519
Implications
This research has important theoretical and practical implications. First, we showed that individuals’ AAMs can shape their health and well-being independently of their actual physical activity. Although previous research provided suggestive evidence that AAMs may influence health [Second, this study adds to an emergin...
PMC9909519
Areas for Future Research
Further research is needed to investigate the mechanisms underlying AAMs. This will advance our theoretical understanding of mindsets and facilitate the design of interventions that target the most critical pathways in a given context. We theorize that AAMs induce a range of affective, behavioral, and physiological pro...
PMC9909519
Conclusions
Physical activity is a critical determinant of health and well-being. This research suggests that it is not only our actual physical activity behavior that matters but also our mindsets about the adequacy and health consequences of our physical activity. Moreover, it shows that wearable fitness trackers can shape these...
PMC9909519
Abbreviations
activity adequacy mindsetbehavior change techniquediastolic blood pressureheart ratemean arterial pressurePatient-Reported Outcomes Measurement Information Systemsystolic blood pressure
PMC9909519
1. Introduction
disability, deaths, hypertensive
HIGH BLOOD PRESSURE
Current Institution: Department of Nutrition, Harvard T.H. Chann School of Public Health, Boston, MA 02115, USA.There is sound evidence showing the efficacy of non-pharmacological interventions in lowering blood pressure (BP); however, adherence is usually poor. Interventions to induce behavioral changes aim to improve...
PMC10180840
2. Materials and Methods
Hypertension
HYPERTENSION
This parallel randomized controlled trial included participants from the general population and the Hypertension outpatient clinic at Hospital de Clínicas de Porto Alegre (HCPA). Prior to enrollment, participants provided informed consent, and the study protocol (protocol number 150496) was approved by the hospital’s i...
PMC10180840
2.1. Participants and Randomization
gastrointestinal tract disease, hypertension, cognitive impairment
DIABETES MELLITUS, HYPERTENSION
Participants were recruited from the outpatient clinic or through media advertisements. Potentially eligible participants were screened and those who met the criteria were invited to a clinical visit. Eligible participants were men and women aged 40 to 80 years who had a diagnosis of hypertension and were undergoing BP...
PMC10180840
2.2. Randomization, Allocation Concealment, and Blinding
A randomization list was generated using software (randomization.com) at a 1-to-1 ratio, with participants allocated in blocks of six, and the randomization sequence was created by an independent researcher outside the clinic. The sequence was stored in opaque sealed envelopes which were kept outside the clinical cente...
PMC10180840
2.3. Educational Intervention Group
hypertension
HYPERTENSION
A registered dietitian oversaw the educational intervention and provided participants in the intervention group with detailed guidance and recommendations on adhering to a low-sodium diet. During their initial consultation, the participants received a dietary plan that emphasized the consumption of fruits, vegetables, ...
PMC10180840
2.4. Control Group
hypertension
HYPERTENSION
Participants allocated to the control group had monthly appointments with registered dietitians, in line with standard care practices. During the first visit, participants received an explanatory leaflet on hypertension and provided general recommendations. These recommendations included reducing sodium intake, avoidin...
PMC10180840
2.5. Outcomes
The outcomes were calculated based on the difference between follow-up and baseline estimated 24-h sodium consumption, and systolic and diastolic BP (intervention delta minus control delta) assessed by ABPM. The 24-h sodium excretion was estimated from a spot of urine using a simple formula with high sensitivity to det...
PMC10180840
2.6. Statistical Analysis
To determine the appropriate sample size, the average sodium intake of 3900 ± 1602 mg/day (168.5 mmol) [The characteristics of the sample were presented as mean with standard deviation or absolute numbers and percentages. Group comparisons were conducted using Pearson’s chi-square test for categorical variables and Stu...
PMC10180840
4. Discussion
hypertensive
The aim of this randomized controlled trial was to compare the effectiveness of an educational intervention that used DSRQ with usual care provided by registered dietitians. After six months, the estimated sodium urinary excretion was similarly reduced in both groups. However, no statistically significant reduction was...
PMC10180840
5. Conclusions
HYPERTENSION
In conclusion, implementing an educational intervention for sodium restriction based on the DSRQ by a multidisciplinary team, including a dietitian, improves attitude and subjective norms in patients with hypertension. This intervention also reinforces their knowledge, skills, and perception of the benefits of low-sodi...
PMC10180840
Author Contributions
Conceptualization, L.B.M. and M.P.R.; methodology, L.B.M. and M.P.R.; software, S.L.R. and M.P.R.; validation, L.B.M. and M.P.R.; formal analysis, L.B.M. and M.P.R.; investigation, M.P.R., C.B.F., K.A.M.D.S., and P.N.M.; resources, L.B.M.; writing—original draft preparation, L.B.M. and M.P.R.; writing—review and editin...
PMC10180840
Institutional Review Board Statement
This study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Hospital de Clínicas de Porto Alegre Ethics Committee (protocol CAAE 47912215.8.0000.5327, date of approval 08-24-2015.
PMC10180840
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10180840
Data Availability Statement
The data presented in this study are available on request from the corresponding author.
PMC10180840
Conflicts of Interest
The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.
PMC10180840
References
Study flowchart.Changes in 24-h urinary sodium excretion over time, with adjustments made for baseline SBP and DBP, as well as the use of diuretics, adrenergic blockers, beta-blockers, ACE inhibitors, vasodilators, calcium channel blockers, AT1 receptor antagonists of angiotensin II. The reduction in urinary sodium exc...
PMC10180840
Key Points
PMC9856772
Question
diabetic foot ulcers
DIABETIC FOOT ULCERS
Is adding a novel macrophage-regulating drug, ON101 cream, to general wound care (GWC) cost-effective compared with GWC alone for treating diabetic foot ulcers (DFUs) from a health care sector perspective?
PMC9856772
Findings
EVENTS, COMPLICATIONS
In this economic evaluation, the ON101 with GWC strategy vs GWC alone strategy gained more wound healing events, averted more DFU-related complications, and cost $14 922/quality-adjusted life-year gained.
PMC9856772
Meaning
diabetic foot ulcers
DIABETIC FOOT ULCERS
In this study, ON101-enhanced GWC was cost-effective vs GWC alone at a willingness-to-pay threshold of $32 787/quality-adjusted life-year from the Taiwan health care sector perspective and may be considered in future standard wound care.This economic evaluation assesses the cost-effectiveness of an ON101 cream added on...
PMC9856772
Importance
amputation, DFUs, Diabetic foot ulcers
DIABETIC FOOT ULCERS
Diabetic foot ulcers (DFUs) and subsequent amputation incur enormous health and economic burdens to patients, health care systems, and societies. As a novel macrophage-regulating drug, ON101 is a breakthrough treatment for DFUs, which demonstrated significant complete wound healing effects in a phase 3 randomized clini...
PMC9856772
Objective
comorbidity, ulcer
ULCER
To assess the cost-effectiveness of an ON101 cream added on to general wound care (GWC; ie, conventional treatments for DFUs, which comprised initial and regular foot examinations, ulcer management, comorbidity control, patient education, and multidisciplinary care) vs GWC alone for DFUs from the Taiwan health care sec...
PMC9856772
Design, Setting, and Participants
diabetes
DIABETES
This economic evaluation used a hypothetical cohort of patients with diabetes, with characteristics mirroring those of the participants in the ON101 trial. A Markov state-transition simulation model was constructed to estimate costs and health outcomes associated with the ON101 with GWC and GWC alone strategies over a ...
PMC9856772
Exposures
ON101 with GWC vs GWC alone.
PMC9856772
Main Outcomes and Measures
COMPLICATIONS
DFU-related complications, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio.
PMC9856772
Results
Patients in the hypothetical cohort had a mean age of 57 years and an uninfected DFU of 1 to 25 cm
PMC9856772
Conclusions and Relevance
DISEASE PROGRESSION
In this economic evaluation study using a simulated patient cohort, the ON101 with GWC strategy represented good value compared with GWC alone for patients with DFUs from the Taiwan health care sector perspective and may be prioritized for those with high risks for disease progression of DFUs.
PMC9856772
Introduction
DFUs, amputation, Diabetic foot ulcers, gangrene, ulcer, diabetes
RECURRENCE, HEALED ULCER, DIABETIC FOOT ULCERS, GANGRENE, ULCER, COMPLICATIONS, DIABETES
Diabetic foot ulcers (DFUs) are among the most serious complications among patients with diabetes. The estimated lifetime incidence of a DFU is 19% to 34%, and roughly 40% to 65% of patients with diabetes undergo recurrence within 1 to 5 years after ulcer healing.To ameliorate health and economic burdens of DFUs, the p...
PMC9856772
Methods
This economic evaluation was approved by the institutional review board of National Cheng Kung University Hospital before its commencement. Informed consent was waived because this study did not include any human participants. Economic analyses complied with the International Society for Pharmacoeconomics and Outcomes ...
PMC9856772
Study Model and Simulation
diabetes
EVENTS, DISEASE PROGRESSION, DIABETES
To estimate the cost-effectiveness of ON101 with GWC, a Markov state-transition model, which simulated the chronic and recurrent events in the disease progression of a DFU, was applied to consider a hypothetical cohort of patients with diabetes with a mean age of 57 years who had uninfected DFUs sized 1 to 25 cmThe Mar...
PMC9856772
Six Health States in the Markov State-Transition Model
uninfected diabetic foot ulcer
DIABETIC FOOT ULCER
iDFU indicates infected diabetic foot ulcer; uDFU, uninfected diabetic foot ulcer.
PMC9856772
Transition Probabilities, Health Utilities, Costs, and Odds Ratio for Model Inputs in 1-Month Cycle Length
uninfected diabetic foot ulcer
EVENT, DIABETIC FOOT ULCER
Abbreviations: DFU, diabetic foot ulcer; GWC, general wound care; iDFU, infected diabetic foot ulcer; uDFU, uninfected diabetic foot ulcer.Event costs were for the transition from 1 health state to another.Data were estimated from the efficacy analysis report provided by the pharmaceutical company.
PMC9856772
Model Inputs: Transition Probabilities, Health Utilities, and Costs
infection, gangrene
INFECTION, EVENT, GANGRENE, TRANSITION
Transition probabilities reflecting risks of progression between health states were derived from published literature (Quality-adjusted life-years (QALYs) were the primary effectiveness outcome and estimated by multiplying health utilities with the number of years spent in each health state. Health utilities were obtai...
PMC9856772
Statistical Analysis
PMC9856772
Cost-effectiveness Analysis
postamputation
EVENTS, COMPLICATIONS
In the base-case analysis, total health care costs, life expectancy, and QALYs per patient in both groups were simulated over 5 years from the Taiwan health care sector perspective. The cumulative probabilities of patients with healing, uninfected DFU, infected DFU, and postamputation as well as the mean time of stayin...
PMC9856772
Sensitivity Analyses
A series of sensitivity analyses were performed to assess the impact of parameter uncertainties on the base-case ICER and examine the generalizability of study results. Deterministic sensitivity analyses (DSAs) were conducted in which all input values were varied within a predefined range (ie, ±50% of the base-case val...
PMC9856772
Subgroup Analyses
Subgroup analyses were conducted according to baseline HbA
PMC9856772
Results
PMC9856772
Base-Case Analysis
diabetes
DIABETES
The hypothetical cohort of patients with diabetes had a mean age of 57 years and an uninfected DFU of 1 to 25 cmThe ON101 with GWC vs GWC alone yielded a marginal gain of life expectancy and a gain of 0.038 QALYs at an additional cost of $571, resulting in an ICER of $14 922/QALY gained (
PMC9856772
Base-Case Analysis Results Over a 5-Year Model Simulation
Abbreviations: GWC, general wound care; ICER, incremental cost-effectiveness ratio; NA, not applicable; QALY, quality-adjusted life-year.The probability was against the willingness-to-pay threshold of $98 361/QALY gained.
PMC9856772
Sensitivity Analyses
The DSAs (
PMC9856772
Tornado Diagram for Deterministic Sensitivity Analysis Results
DIABETIC FOOT ULCER
The figure shows the incremental cost-effectiveness ratio (ICER) of ON101 with general wound care (GWC) vs GWC alone for different model input parameters. The influential parameters whose variations yielded a base-case ICER change greater than 40% are illustrated in the figure. DFU indicates diabetic foot ulcer; QALY, ...
PMC9856772
Cost-effectiveness Acceptability Curve
The figure shows the probabilistic sensitivity analysis using Monte Carlo simulation with 10 000 iterations, in which the input parameters varied simultaneously in the plausible statistical distributions that reflected the uncertainty of the cost-effectiveness for ON101 with general wound care (GWC) vs GWC alone at dif...
PMC9856772
Subgroup Analyses
ON101 with GWC vs GWC alone remained cost-effective across different patient subgroups in a range of 65% to 94% of model iterations against the WTP threshold of $98 361/QALY gained. ON101 with GWC was cost-saving among patients with an HbA
PMC9856772
Discussion
DFUs, deteriorative QoL.Given
Given the results of the ON101 trial,Healing of DFUs may take months to years, and without complete healing, patients with DFUs are susceptible to a series of costly health consequences associated with deteriorative QoL.Given the apparent efficacy on wound healing, it is not surprising to find that the healing efficacy...
PMC9856772
Strengths and Limitations
gangrene
DISEASE, GANGRENE
To our knowledge, this is the first model-based simulation economic analysis of the ON101 with GWC vs GWC alone strategies for DFUs. To ensure the applicability of our economic results to the study setting and the health care sector perspective in the Taiwanese context and to reduce heterogeneity arising from multiple ...
PMC9856772
Conclusions
Given the high cost-effectiveness of the ON101 with GWC strategy vs GWC alone for treating DFUs from the Taiwan health care sector perspective, the ON101-enhanced GWC may be considered in future standard wound care. Health care payers can consider the implementation of ON101 therapy to patients with an uninfected DFU w...
PMC9856772
Supplementary Information
pain
COMPLICATIONS
To demonstrate the Tianjin Institute of Urology (TJIU) technique to place and remove the ureteral stent with extraction string after percutaneous nephrolithotomy (PCNL). Additionally, we aim to compare the pain experienced during stent removal, quality of life during stent retention, and stent-related complications bet...
PMC10141830
Keywords
PMC10141830
Introduction
nephrolithiasis, urolithiasis
NEPHROLITHIASIS, UROLITHIASIS
The incidence of urolithiasis is increasing every year, especially in developed countries. Moreover, as one of the high stone prevalence areas, the incidence of nephrolithiasis in China is about 5.8% [
PMC10141830
Materials and methods
PMC10141830
Study population
renal stones
A total of 133 patients with renal stones who underwent PCNL in our hospital were admitted from September 2021 to September 2022 (Fig. Diagram of study enrollment and final analysis cohort
PMC10141830
Surgical procedures
PMC10141830
Fabrication of ureteral stent and catheter with extraction string
The main primary materials included 6 F double-J stent with extraction string (Soft Percuflex™ Stent with HydroPlus™ Coating; Boston Scientific, MA, USA), 5 F ureteral catheter from Cook Medical (Bloomington, IN, USA), 5 ml syringe, scalpel.The extraction string at the end of the double-J stent was snipped from the kno...
PMC10141830
Percutaneous nephrolithotomy
hydronephrosis
HYDRONEPHROSIS, STERILE
Firstly, the patient was placed in the lithotomy position after general anaesthesia. The ureteral catheter was then inserted in the renal pelvis under the surveillance of the 8/9.8 F ureteroscope along a safety guidewire, attached to a sterile urethral catheter and linked to saline to create artificial hydronephrosis (...
PMC10141830
Removal of the ureteral stent
URETHRA
The ureteral stent was removed from all patients within 2–4 weeks postoperatively. For the string group, we removed the ureteral stent by pulling the extraction string out directly. The ureteral stent in non-string group was removed using rigid cystoscopic procedures in lithotomy position, with oxybuprocaine hydrochlor...
PMC10141830
Postoperative follow-up
febrile UTI, pain
COMPLICATIONS
In both groups, the Ureteral Stent Symptom Questionnaire (USSQ) was completed on postoperative days (POD) 7 and the day when stent was removed. It is made up of several domains such as “urinary symptoms”, “pain”, “general health”, “work performance”, “sex”, and “additional problems”. The visual analogue scale (VAS) pai...
PMC10141830
Statistical analysis
pain
The primary endpoint of our study was the VAS pain scores at stent removal. The sample size was calculated using the PASS software based on the results of previous ureteral stent study with a power of 90% and a type-1 error (α) of 0.05. The number of participants was increased to account for patient loss to follow-up a...
PMC10141830
Discussion
Urolithiasis, infection, staghorn calculi
UROLITHIASIS, INFECTION, URETER, URETERAL STONE, COMPLICATIONS
Urolithiasis is a common urological condition. With the development of technology, PCNL has become the preferred treatment for kidney and upper ureteral stones larger than 2 cm, particularly staghorn calculi [Regardless of traditional PCNL (placing both nephrostomy and ureteral stent) or tubeless PCNL (ureteral stent o...
PMC10141830
Conclusion
urethral injury, febrile UTI, pain
COMPLICATIONS
Placing a ureteral stent with extraction string following TJIU technique after PCNL in prone position could reduce the pain associated with ureteral stent removal, and avoid complications such as urethral injury caused by cystoscopic ureteral stent removal, while not increasing complications related to accidental remov...
PMC10141830
Acknowledgements
Not applicable.
PMC10141830
Author contributions
Study concept and design: SYQ, YC; Acquisition of data: YJQ, HNX and HLK; Analysis and interpretation of data: YJQ, HLK and HNX; Drafting of the manuscript: YJQ, HLK; Critical revision of the manuscript for important intellectual content: YC, SYQ; Statistical analysis: YJQ, HNX; Obtaining funding: SYQ; Administrative, ...
PMC10141830
Funding
This work was supported by The National Natural Science Foundation of China (82070725).
PMC10141830