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Identification and Treatment of Underlying Cause by Case Variant
DISEASE PROGRESSION
We next disaggregated the combined DxTx score to explore how well physicians identified and managed the root problems of their patient’s symptoms (medication nonadherence, DDI, or disease progression).
PMC10105436
Medication nonadherence
nonadherence
REGRESSION
At baseline, among the NA patient cases, providers identified NA in their patients only 2.0% of the time, with no difference between study arms (p = 0.414) (Table  Primary Variant Diagnosis and Related Treatment, by Case VariantThe improvement in NA case diagnosis in intervention 1 led to improved clinical care manifes...
PMC10105436
Drug-drug interactions
DDIs
At baseline, identification of DDIs was modest in both control and intervention (7.8% for both arms, p = 0.532). After introduction of the CDM test, intervention significantly improved their ability to identify DDIs, increasing from 6.5 to 57.1% (p < 0.001) compared to contro which did not change (9.2–9.3%, p = 0.979)....
PMC10105436
Disease progression
DISEASE PROGRESSION
Although making the diagnosis of disease progression trended in the right direction for these patient cases at + 3.2%— this trend did not reach statistical significance (p = 0.838) and, in the difference-in-difference estimation, the intervention group was 0.3x as likely to diagnose disease progression and 0.3x as like...
PMC10105436
Intervention 2 Results
nonadherence, DDIs
REGRESSION
We wanted to determine whether the educational materials increased awareness of nonadherence or DDIs and if so, how this impacted practice and test ordering by physicians.Overall, intervention 2 only ordered the CDM test in 12.4% of patient cases with no significant difference by case variant (p = 0.892). When given th...
PMC10105436
Economic Changes in Diagnostic Ordering
When we examined the economic impact of the CDM test, we found that intervention 1 physicians ordered 0.3 fewer low-value tests per case (95% C.I. 0.0 to 0.6). This decrease in test ordering translates to a per case savings of $119 (95% C.I. $20 to $217).
PMC10105436
Discussion
nonadherence, cardiometabolic disease, DM/HTN, DDIs
DISEASE PROGRESSION, DISEASE, DISEASES
In patients with chronic cardiometabolic diseases, healthcare outcomes depend upon correct diagnoses and effective treatment regimens [We conducted a RCT to determine if the test improved the recognition, diagnosis, and medication management of medication nonadherence and DDIs in patients with chronic cardiometabolic d...
PMC10105436
Conclusion
cardiometabolic disease
Medication nonadherence and DDI are preventable sources of patient harm and poor health outcomes in chronic cardiometabolic disease management. Improved diagnosis using a reliable and convenient test potentially improves patient quality of life, medication safety, clinical outcomes, and cost-efficient health delivery.
PMC10105436
Acknowledgements
None.
PMC10105436
Author contributions
Conception: JWP, JS, RH; Design: JWP, CV, CW, JS; Supervision: CV, DG; Data Collection and Validation: CV, RH; Formal Analysis and Interpretation of Data: DP, JWP; Drafting the manuscript: DG, CV, DP, JWP; Critical Revisions of the Manuscript: All authors; Final Approval of the Manuscript: All authors.
PMC10105436
Funding
This study was funded by Aegis Sciences Corporation, Nashville, Tennessee, USA (Grant #N/A).
PMC10105436
Data Availability
Data supporting these results available on reasonable request to the corresponding author.
PMC10105436
Declarations
PMC10105436
Ethical approval and Consent to Participate
This study was conducted in accordance with ethical standards, approved by the Advarra Institutional Review Board, Columbia, MD, USA, and listed in clinicaltrials.gov (NCT05192590). Voluntary, informed consent was obtained from all participants.
PMC10105436
Consent to Publish
Not applicable.
PMC10105436
Competing Interests
CPVs®, QURE Healthcare’s proprietary simulated case tool, were used to collect data and score the responses. Three authors (JS, CW, and RH) are employees of Aegis Sciences Corporation, who funded the study. Otherwise, there are no disclosures.
PMC10105436
List of abbreviations
DISEASE
atrial fibrillationadherent, no drug-drug interactionChronic Disease ManagementClinical Performance and Valuedrug-drug interactiondiabetes mellitusdiagnosis-treatmentheart failurehypertensionnon-adherenceodds ratioprimary care physicianrandomized controlled trial
PMC10105436
References
PMC10105436
Abstract
PMC10323314
Introduction
Person‐centred HIV
Person‐centred HIV prevention delivery models that offer structured choices in product, testing and visit location may increase coverage. However, data are lacking on the actual uptake of choices among persons at risk of HIV in southern Africa. In an ongoing randomized study (SEARCH; NCT04810650) in rural East Africa, ...
PMC10323314
Methods
Using the PRECEDE framework, we developed a persont‐centred, Dynamic Choice HIV Prevention (DCP) intervention for persons at risk of HIV in three settings in rural Kenya and Uganda: antenatal clinic (ANC), outpatient department (OPD) and in the community. Components include: provider training on product choice (predisp...
PMC10323314
Results
A total of 612 (203 ANC, 197 OPD and 212 community) participants were randomized to the person‐centred DCP intervention. We delivered the DCP intervention in all three settings with diverse populations: ANC: 39% pregnant; median age: 24 years; OPD: 39% male, median age 27 years; and community: 42% male, median age: 29 ...
PMC10323314
Conclusions
A person‐centred model incorporating structured choice in biomedical prevention and care delivery options in settings with demographically diverse groups, in rural Kenya and Uganda, was responsive to varying personal preferences over time in HIV prevention programmes.
PMC10323314
INTRODUCTION
Despite a significant reduction in the number of new HIV acquisitions globally, progress has slowed significantly with a drop of only 3.6% in 2021 compared to 2020 [Further, effective integration of prevention options in HIV prevention delivery models requires understanding how to effectively embed choices within perso...
PMC10323314
METHODS
PMC10323314
Study setting, design and population
SEXUALLY TRANSMITTED INFECTION
The study population includes persons randomized to the intervention arms of three ongoing pilot trials to evaluate the effect of DCP intervention versus the standard of care. The studies are being conducted in some of the highest seroprevalence areas in rural Southwestern Uganda and Western Kenya [The inclusion criter...
PMC10323314
Study intervention
HIV rapid blood test
The person‐centred “Dynamic Choice HIV Prevention” (DCP) implementation strategy for delivering existing evidence‐based, biomedical prevention interventions was developed using the PRECEDE framework for health promotion strategies to address “predisposing” factors (i.e. knowledge, attitudes or beliefs) that impact beha...
PMC10323314
Measures
Demographics and self‐reported use of any PrEP or PEP in the prior 6 months were collected by survey at the study baseline. At intervention visits weeks 4, 12 and 24, participant selection of structured choice of prevention option (PrEP, PEP, condoms only and no selection), HIV testing modality (oral self‐test or clini...
PMC10323314
Analysis
Visit attendance was assessed at weeks 4, 12 and 24 among participants enrolled in the three trials. We excluded all participants who seroconverted and withdrew from the trial. We evaluated the proportion of participants selecting each DCP option at each scheduled visit, and the proportion of participants who ever sele...
PMC10323314
Ethical considerations
Ethical approval to conduct the study was received from the University of California, San Francisco Committee on Human Research (UCSF—Sept 2020), Makerere University School of Medicine Research and Ethics Committee (SOMREC—March 2021), Uganda National Institute of Science and Technology (UNCST—April 2021) and the Scien...
PMC10323314
RESULTS
PMC10323314
Study population
A total of 612 (203 ANC, 197 OPD and 212 community) participants were randomized to the person‐centred prevention intervention (Table Baseline characteristics of 612 participants enrolled in the person‐centred Dynamic HIV Choice Prevention (DCP) intervention in three trials: antenatal clinic (ANC), outpatient departmen...
PMC10323314
Visit adherence
Between baseline and week 24, 202/203 (99.5%) of participants in ANC, 192/197 (97.5%) in OPD and 210/212 (99.1%) in community settings remained eligible for intervention delivery (four withdrew and four seroconverted; zero died). At week 4 following randomization, 84% of ANC, 89% of OPD and 98% of eligible community pa...
PMC10323314
Selections among dynamic prevention choices over time
HIV self‐testing
At baseline, PrEP was selected as an initial prevention product by 98% of participants in ANC, 84% of participants in OPD and 40% of participants in the community (Figure Choice of prevention options: (PrEP—pre‐exposure prophylaxis; PEP—post exposure prophylaxis, condoms or nothing) with each bar representing choices a...
PMC10323314
Biomedical covered time and dynamic risk
At week 24, the structured survey to assess the use of PrEP or PEP and HIV risk over the prior 6 months was completed by 91% (554/612) participants overall: 94% ANC participants, 87% OPD participants and 90% community participants. Mean biomedical covered time (proportion of 24‐week follow‐up during which a participant...
PMC10323314
DISCUSSION
We implemented a person‐centred model for dynamic choice in HIV biomedical prevention in three distinct settings with demographically diverse groups and found that uptake of intervention components, including product, product delivery and HIV testing modality, varied between locations and over time. This model was resp...
PMC10323314
CONCLUSIONS
This is one of the first studies to systematically offer a structured intervention for biomedical prevention options using a theory‐based, person‐centred dynamic choice model that adapted services based on client risk and life circumstances over time. This interim analysis demonstrated the intervention was successfully...
PMC10323314
COMPETING INTERESTS
The authors report no competing interests in this work.
PMC10323314
AUTHORS’ CONTRIBUTIONS
LBB
JK, EK, CAK, MN and JA contributed to the study design, data analysis and interpretation, literature search and writing of the manuscript. LBB and MLP contributed to the study design, data analysis and interpretation, literature search and writing of the manuscript. MRK, GC and DVH contributed to the study design, data...
PMC10323314
FUNDING
INFECTIOUS DISEASES, LUNG, ALLERGY, BLOOD, HEART
Research reported in this manuscript was supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Mental Health (NIMH) and co‐funded under award number U01AI150510.
PMC10323314
DISCLAIMER
The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
PMC10323314
Supporting information
Click here for additional data file. Click here for additional data file.
PMC10323314
ACKNOWLEDGEMENTS
We thank the Ministry of Health of Uganda and Kenya; our research and administrative teams in the United States, Uganda and Kenya; collaborators and advisory boards; and especially all the communities and participants involved. We acknowledge funding support from the National Institute of Health Grant# 1U01AI150510‐01A...
PMC10323314
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
PMC10323314
REFERENCES
PMC10323314
Background
diabetes
MORBID OBESITY, CHRONIC DISEASES, DIABETES
Health promotion programs are most beneficial in chronic diseases such as diabetes and morbid obesity, which can be positively affected by changes in attitudes, beliefs, and lifestyle.
PMC10069363
Objectives
This study aimed to develop an internet-based modern Health Promotion model using interactive online applications through continuing education and participation.
PMC10069363
Methods
obesity, depression, anxiety, diabetes
OBESITY, TYPE 2 DIABETES, DIABETES
The goal was to positively impact knowledge, behavior, and quality of life for patients with obesity and/or diabetes. This is a prospective interventional study on patients with obesity or type 2 diabetes. Seventeen two patients who met the inclusion criteria were distributed randomly into two groups (control and inter...
PMC10069363
Results
obesity, Anxiety, diabetes
OBESITY, STILL, DIABETES
The sample comprised 72 patients (36 in control and 36 in the intervention groups). The mean age was 47.8 years for the control group and 42.7 years for the intervention group (p = 0.293). Both study groups had a significant increase in knowledge score on diabetes (Control group:3,24, Intervention group 11,88 p < 0,001...
PMC10069363
Conclusions
depression, anxiety
DISEASE, CHRONIC ILLNESS
The results of the present study showed that the participants in the intervention group showed significant improvement in knowledge, attitudes, and beliefs after using the internet as a learning tool. The intervention group also showed significantly reduced anxiety and depression arising from chronic illness. All of th...
PMC10069363
Keywords
PMC10069363
Introduction
obesity, death, Diabetes, diabetes
OBESITY, DIABETES, DISEASE, METABOLIC DISORDERS, COMPLICATION, INSULIN RESISTANCE, DIABETES TYPE 2, TYPE 2 DIABETES, DISEASES, DIABETES
The development of the World Wide Web and the Information and Communication Technologies in the 1990s helped spread the Internet from one side of the globe to the other. This enabled people to develop applications, to directly access a wide range of information, and to communicate more easily [It is a fact that the num...
PMC10069363
Methods
obesity, cancer, renal failure, diabetes
OBESITY, CANCER, RENAL FAILURE, TYPE 2 DIABETES, DISEASES, DIABETES
This is a prospective interventional study on patients with obesity or type 2 diabetes age group of 18–60 years old, where it was conducted during 2019–2020 in Endocrine Unit, Second Propaedeutic Department of Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece...
PMC10069363
Statistical analysis
obesity, depression, anxiety, diabetes
OBESITY, DIABETES
The analysis of the data was per protocol. Quantitative variables were expressed as mean (Standard Deviation) or as median (interquartile range). Qualitative variables were expressed as absolute and relative frequencies. Independent samples Student’s t-tests were used for the comparison of mean values between the two g...
PMC10069363
Discussion
obesity, anxiety, chronic disease, depression, hypertension, diabetes
OBESITY, CHRONIC ILLNESSES, POSITIVE, HYPERTENSION, DISEASE, CHRONIC DISEASES, CHRONIC DISEASE, TYPE 2 DIABETES, COMPLICATIONS, DIABETES
Education as a public health service is of vital importance. Specifically when prevention and treatment are part of a strategy to control chronic conditions such as type 2 diabetes or obesity. Therapeutic patient education [WHO] is considered of primary importance so that patients can first understand the nature of the...
PMC10069363
Acknowledgements
We thank the medical personnel of the Endocrine Unit, of the 2nd Propaedeutic Department of Internal Medicine, “Attikon” University Hospital,l for their contribution to the study and most specifically Ms Stefania Tsouknida for techical assistance and Ms Georgia Isari, for dietary and further scientific contribution.
PMC10069363
Author Contribution
MP
MC was the principal investigator and wrote the main manuscript, MP supervised the study design, the data collection and the research process, IM, and GD reviewed the manuscript.
PMC10069363
Funding
This is a self-funded study, and no extra funding was used.
PMC10069363
Data Availability
The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.
PMC10069363
Declarations
PMC10069363
Ethics approval and consent to participate
This study was conducted in full accordance with all applicable research policies, and all methods were carried out in accordance with relevant guidelines and regulations.The study was performed following the protocol that the National and Kapodistrian Athens University Medical School, Ethics and licensing committee ap...
PMC10069363
Consent for publication
Not Applicable (NA).
PMC10069363
Competing Interest
All authors declare that they don’t have any conflict of interest.
PMC10069363
References
PMC10069363
Background
eHealth approaches show promising results for smoking cessation (SC). They can improve quit rates, but rigorous research is sparse regarding their effectiveness and the effects of their interactivity, tailoring, and use intensity.
PMC10698653
Objective
We examined the effectiveness of
PMC10698653
Methods
REGRESSIONS
Individuals who smoke were randomized into the IG (563/1115, 50.49%) or CG (552/1115, 49.51%), which received a noninteractive, nontailored, and information-only web-based intervention. Data were collected before the intervention, at the postintervention time point (T1), at the 4-month follow-up (T2), and at T3. We tes...
PMC10698653
Results
In the IG, 11.5% (65/563) and 11.9% (67/563) of participants were smoke free at T1 and T3, respectively. These values were statistically equivalent to the effects in the 2 meta-analyses, which reported 9% (
PMC10698653
Conclusions
TK-SCC is effective for SC. However, its superiority compared with a minimal SC intervention could not be confirmed in the long term. Insufficient implementation of the techniques used and cotreatment bias could explain this outcome. Higher use intensity of TK-SCC was positively related to abstinence. Therefore, additi...
PMC10698653
Trial Registration
German Clinical Trials Register DRKS00020249, Universal Trial Number U1111-1245-0273; https://drks.de/search/de/trial/DRKS00020249
PMC10698653
International Registered Report Identifier (IRRID)
RR2-10.1186/s13063-021-05470-8
PMC10698653
Introduction
PMC10698653
Background
RISK OF PREMATURE DEATH
Smoking cessation (SC) reduces the risk of premature death by 40% if individuals who smoke quit before 60 years of age and by 90% if individuals who smoke quit before 40 years of age [eHealth approaches are highly promising because they provide a readily available, low-cost treatment option. eHealth uses electronic com...
PMC10698653
Purpose and Hypotheses
The purpose of the research presented in this paper was to examine the effectiveness of a tailored and interactive internet-based intervention (intervention group [IG]) compared with a noninteractive, nontailored, and information-only internet-based intervention (CG) for SC in a sample of individuals who smoke. In the ...
PMC10698653
Methods
PMC10698653
Trial Background
Our study was part of a larger project aiming to evaluate an internet-based health coach [
PMC10698653
Ethical Considerations
This study followed the principles of the Declaration of Helsinki. It received a favorable opinion from the ethics commission of Albert-Ludwigs University, Medical Center, Freiburg (vote 237/19) on July 25, 2019. Informed consent of all the participants was acquired before their participation. Data protection for the s...
PMC10698653
Interventions
The 2 interventions used in the IG and CG, respectively, were both developed by a German statutory health insurance and had to be accessed via a web browser on the participants’ personal electronic devices. Participants in the IG had access to a version of TK-SCC [In the CG, participants had access to a nontailored, no...
PMC10698653
Recruitment of Participants and Data Collection
Universität Düsseldorf
RECRUITMENT
Sample size calculations were performed via G*Power (Universität Düsseldorf) [Between January and September 2020, we conducted recruitment campaigns in Germany using various media (Google marketing campaigns, communication channels of the Techniker health insurance fund and the University of Freiburg, flyers, local new...
PMC10698653
Data Cleansing, Missing Values, and Data Analysis
REGRESSION, SECONDARY
We cleaned the collected data to prevent the biasing of our results. During this process, we excluded cases with implausible values and multivariate outliers (through the comparison of the squared Mahalanobis distance of the items of each case with a chi-square distribution, exclusion of case if All remaining randomize...
PMC10698653
Results
PMC10698653
Discussion
PMC10698653
Principal Findings
We compared the effectiveness of a tailored and interactive eHealth intervention for SC with that of a noninteractive, nontailored, and information-only internet-based intervention.In the IG, 11.9% (67/563) of the participants reported 30-day abstinence at 12 months. Although comparisons with different trials have to b...
PMC10698653
Strengths and Limitations
RECRUITMENT
We conducted a study with a thorough methodology (with implementation as an RCT, the coding of missing participants as participants who still smoke, a long period between the end of program and the last measurement point, the incorporation of various confounders, and α error correction for multiple testing). Furthermor...
PMC10698653
Comparison With Prior Work
The effects in our IG were statistically equivalent to the average effects of SMS text messaging interventions and internet-based programs that were either tailored, interactive, or both, as reported in 2 meta-analyses (9% and 10.9% smoke free after 6 to 12 months, respectively [
PMC10698653
Conclusions
Robin Anger
Our study adds to the existing evidence that eHealth SC interventions using BCTs, interactivity, and tailoring can be effective tools for increasing the quit rates of individuals who smoke, but superiority compared with a less intensive intervention could not be proven in the long term. Insufficient implementation of t...
PMC10698653
Abbreviations
behavior change techniquecomplete casecontrol groupConsolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online TelehealthFagerström Test for Cigarette DependenceInstitute of Sport and Sport Scienceintervention groupintention-to-treatodds ratiorandomized controlled trialsmoking ces...
PMC10698653
Data Availability
The data sets generated or analyzed during this study are available from the corresponding author upon reasonable request. The prerequisite for this is that the anonymity rules promised to the participants are adhered to (eg, no publication of data that allows drawing conclusions about the identity of a person).
PMC10698653
Key Points
PMC10134010
Question
myopia
MYOPIA
Does a repeated low-level red-light (RLRL) intervention prevent incident myopia among children with premyopia?
PMC10134010
Findings
myopia
MYOPIA
In this randomized clinical trial including 278 school-aged children with premyopia, the incidence of myopia was lower among children receiving RLRL therapy than among controls.
PMC10134010
Meaning
myopia
MYOPIA
Exposure to RLRL is a novel and effective intervention for myopia prevention among children with premyopia, with good user acceptability and safety.
PMC10134010
Importance
myopia, Myopia
MYOPIA, MYOPIA
Myopia is a global concern, but effective prevention measures remain limited. Premyopia is a refractive state in which children are at higher risk of myopia, meriting preventive interventions.
PMC10134010
Objective
myopia
MYOPIA
To assess the efficacy and safety of a repeated low-level red-light (RLRL) intervention in preventing incident myopia among children with premyopia.
PMC10134010
Design, Setting, and Participants
This was a 12-month, parallel-group, school-based randomized clinical trial conducted in 10 primary schools in Shanghai, China. A total of 139 children with premyopia (defined as cycloplegic spherical equivalence refraction [SER] of −0.50 to 0.50 diopter [D] in the more myopic eye and having at least 1 parent with SER ...
PMC10134010
Interventions
Children were randomly assigned to 2 groups after grade stratification. Children in the intervention group received RLRL therapy twice per day, 5 days per week, with each session lasting 3 minutes. The intervention was conducted at school during semesters and at home during winter and summer vacations. Children in the ...
PMC10134010
Main Outcomes and Measures
myopia
MYOPIA
The primary outcome was the 12-month incidence rate of myopia (defined as SER ≤−0.50 D). Secondary outcomes included the changes in SER, axial length, vision function, and optical coherence tomography scan results over 12 months. Data from the more myopic eyes were analyzed. Outcomes were analyzed by means of an intent...
PMC10134010
Results
myopic, myopia
MYOPIA, SECONDARY
There were 139 children (mean [SD] age, 8.3 [1.1] years; 71 boys [51.1%]) in the intervention group and 139 children (mean [SD] age, 8.3 [1.1] years; 68 boys [48.9%]) in the control group. The 12-month incidence of myopia was 40.8% (49 of 120) in the intervention group and 61.3% (68 of 111) in the control group, a rela...
PMC10134010
Conclusions and Relevance
myopia
MYOPIA
In this randomized clinical trial, RLRL therapy was a novel and effective intervention for myopia prevention, with good user acceptability and up to 54.1% reduction in incident myopia within 12 months among children with premyopia.
PMC10134010
Trial Registration
myopia
MYOPIA
ClinicalTrials.gov Identifier: This randomized clinical trial assesses the efficacy and safety of a repeated low-level red-light intervention in preventing incident myopia among children in China with premyopia.
PMC10134010