Category: Statistics

JMIR Form Res. 2025 Aug 7;9:e53080. doi: 10.2196/53080.

ABSTRACT

BACKGROUND: Fatigue is a common symptom occurring in individuals with visual impairment (VI). Feeling fatigued has a strong impact on an individual’s well-being, with profound consequences. Cognitive and emotional functioning, social roles, and participation are negatively affected in severely fatigued individuals with VI. Therefore, we developed E-nergEYEze, a blended vision-specific eHealth intervention based on cognitive behavioral therapy and self-management to reduce fatigue severity in adults with VI.

OBJECTIVE: We aimed to report the experience of patients and professionals with E-nergEYEze. To complement cost-effectiveness outcomes, the user experiences from both perspectives were considered relevant for a better understanding of the intervention uptake.

METHODS: E-nergEYEze was studied in a randomized controlled trial. User experiences of participants with VI and severe fatigue (51/98, 52%; median age 58.0, IQR 53.0-65.0 years; female participants: 32/51, 63%), who were randomized to the intervention group, and professionals (n=11), who provided blended support, were evaluated. The Dutch Mental Health Care Thermometer questionnaire and a therapist evaluation were used and analyzed using mixed methods. A focus group meeting with social workers (4/7, 57%), a computer trainer (1/7, 14%), and psychologists (2/7, 29%) was held for more in-depth information. The eHealth platform provided data on user engagement from both perspectives.

RESULTS: E-nergEYEze was completed by 63% (32/51) of patients for more than 80% of the module steps. Overall, results on user engagement showed that a median 89% (IQR 45%-100%) of all assigned module steps were completed, with all modules being completed by at least 50% (37/51) of the patients. Completion of the intervention was related to the presence of digital proficiency; having the appropriate expectations; content that matches personal preferences and life context; and the absence of impeding personal circumstances, mental health issues, or other concurrent rehabilitation programs. The intervention was given a median grade of 7.0 out of 10.0 (IQR 6.0-8.0), and 87% (39/45) of the patients reported that they would recommend E-nergEYEze to others. However, improvements in the frequency and quality of guidance were considered highly relevant. Professionals reported that E-nergEYEze required patients’ self-efficacy, motivation, and digital skills; therefore, preselection was seen as essential. Professionals’ affinity with eHealth was considered important to provide appropriate remote support.

CONCLUSIONS: eHealth provides treatment opportunities for individuals with VI for which guidance is considered highly relevant. During participation in E-nergEYEze, patients were engaged, internalized personally relevant topics, and made use of the benefits of eHealth. More attention to the suitability of patients and training of professionals for providing remote support is considered essential. These user experiences underlined the potential of E-nergEYEze to reduce fatigue severity in adults with VI and provided valuable insights to learn from and optimize E-nergEYEze.

TRIAL REGISTRATION: International Clinical Trials Registry Platform (ICTRP) NL7764; https://tinyurl.com/32b3xt74.

PMID:40773749 | DOI:10.2196/53080

JMIR Hum Factors. 2025 Aug 7;12:e70181. doi: 10.2196/70181.

ABSTRACT

BACKGROUND: Cognitive bias modification for interpretation (CBM-I) is a technique to modify interpretation and is used to reduce unhelpful negative biases. CBM-I has been extensively studied in anxiety disorders where interpretation bias has been shown to play a causal role in maintaining the condition. Successful Treatment of Paranoia (STOP) is a CBM-I smartphone app targeting interpretation bias in paranoia. It has been developed following research on the feasibility and acceptability of a computerized version. This qualitative study extended that research by investigating the acceptability of STOP in individuals with paranoia. The study design and implementation were informed by the Evidence Standards Framework for Digital Health Technologies (DHTs) published by the UK National Institute for Health and Care Excellence (NICE).

OBJECTIVE: The aim of the study was to involve service users in the design, development, and testing of STOP and understand the degree of satisfaction with the product. We aimed to establish the extent to which STOP met the NICE minimum and best practice standards for DHTs, specifically its acceptability to intended end users.

METHODS: In total, 12 participants experiencing mild to moderate levels of paranoia were recruited to complete 6 weekly sessions of STOP before being invited to a feedback interview to share their experiences. Interview questions revolved around the acceptability of the app, its perceived usefulness, and barriers to the intervention, as well as practicality and views on the use of a digital intervention in principle. Interviews were coded and analyzed using the framework analysis method, combining both deductive and inductive approaches.

RESULTS: Framework analysis yielded 6 themes: independent use and personal fit; digital versus traditional approaches; user reactions and emotional impact; impact on thinking, awareness, and well-being; design, engagement, and usability; and intervention relevance and practical fit.

CONCLUSIONS: STOP was found to be a broadly acceptable intervention and was positively received by most participants. The study findings are in line with the NICE Evidence Standards Framework for DHTs, as intended end users were involved in the development, design, and testing of STOP and were mostly satisfied with it. These findings will contribute to the further iterative development of this intervention that targets interpretation bias in paranoia.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-024-08570-3.

PMID:40773747 | DOI:10.2196/70181

JMIR Form Res. 2025 Aug 7;9:e77113. doi: 10.2196/77113.

ABSTRACT

BACKGROUND: There is an increasingly diverse range of mobile apps and digital health devices available to help patients manage their health. Despite evidence for the effectiveness of such technologies, their potential has not been fully realized because adoption remains low. Such limited uptake can have direct implications for the intended benefits of these technologies.

OBJECTIVE: This study aimed to understand what matters most to US military veterans when deciding whether to use digital health technologies (DHTs) such as mobile health apps or devices to manage their health and compare these factors between veterans with and without prevalent chronic physical and mental health conditions.

METHODS: We conducted a cross-sectional analysis of survey data collected from a national sample of veterans who receive care from the Veterans Health Administration (VHA), which was predominantly gathered as part of the last wave of a larger longitudinal data collection effort.

RESULTS: Among respondents (n=857), 86.7% (736/849) reported currently using or having previously used ≥1 devices to manage their health, and 78.4% (639/815) also reported using either VHA or non-VHA health apps. Considerations most frequently endorsed as “very important” by veterans when deciding whether to use DHTs included receiving secure messages from their health care team about DHTs, knowing data from DHTs would be used to inform their care, and receiving recommendations from providers to use DHTs. Conversely, considerations most frequently endorsed as “not at all important” included seeing information about DHTs on social media, having community support to use DHTs, and receiving encouragement from peers to use DHTs. Considerations did not significantly differ between veterans with or without prevalent chronic health conditions; however, a greater proportion of veterans with prevalent mental health conditions reported the following considerations to be “very important:” seeing information about DHTs on social media, having community support to use DHTs, having other veterans encourage DHT use, and having help from family, friends, or other important people to use DHTs.

CONCLUSIONS: Understanding what matters most to patients when they are deciding to adopt a technology for their health can, and should, inform implementation strategies and other approaches to enhance health-related technology use. Our results suggest that, for veterans, recommendations from health care team members and knowing that the data from DHTs will be used in clinical care are more important than information from social media, community sources, or peers when deciding to use DHTs, although perceptions of importance regarding the latter may differ among patients with different conditions. Our findings suggest that communication from health care team members to patients, perhaps either in-person or electronically, could help encourage DHT adoption and use.

PMID:40773745 | DOI:10.2196/77113

JMIR Mhealth Uhealth. 2025 Aug 7;13:e70412. doi: 10.2196/70412.

ABSTRACT

BACKGROUND: Health care workers (HCWs) are at risk of experiencing psychological distress, particularly during the COVID-19 pandemic. Psychological self-monitoring apps may contribute to reducing symptoms of depression, anxiety, and trauma exposure by enhancing emotional self-awareness. This study focused on how a basic psychological self-monitoring app was experienced by HCWs during the COVID-19 pandemic in Quebec by exploring users’ experience and factors contributing to their adherence.

OBJECTIVE: This study aimed to explore HCWs’ experiences with a psychological self-monitoring app, including if their satisfaction with the app, their perception of its contribution to self-awareness, and their experience of distress influenced their adherence to the app.

METHODS: HCWs in Quebec were invited to respond weekly to questions about their well-being via a mobile app. A convergent mixed methods design was used. Sample data (N=424) were collected from the app, a postparticipation questionnaire was administered, and 30 semistructured interviews were conducted. Correlations and hierarchical multiple regression models were conducted to examine possible factors influencing participants’ adherence, and a thematic analysis was used to further explore their experience.

RESULTS: Over a 12-week-period, mean adherence to the psychological self-monitoring app was 74.5% (SD 29.4%) and mean satisfaction was 80% (SD 20%). Most participants perceived that the app contributed moderately (165/418, 39.5%) or a lot (140/418, 33.5%) to enhancing their self-awareness. The significant regression model (F_5,401=6.59; P<.001) suggested that around 7.6% of adherence variation could be explained by satisfaction (β=.16; t₄₀₁=3.14; P=.002) and the app’s perceived contribution to self-awareness (β=.15; t₄₀₁=2.88; P=.004). Biological sex (369/419, 88.1% female and 50/419, 11.9% male), age (mean 40.8, SD 9.9 y), and the experience of psychological distress at least once in 12 weeks (228/420, 54.3%) were not statistically significant predictors of adherence. Emergent themes from the 30 interviews highlighted participants’ experiences. Psychological self-monitoring was seen as an introspective practice, with reports of enhanced self-awareness and self-care practices. Interviewees generally considered the app as practical, but it did not suit everyone’s preferences. Potential app enhancements were provided by the participants.

CONCLUSIONS: A simple psychological self-monitoring app could be an interesting tool for HCWs who wish to improve their self-awareness and prevent psychological distress, particularly in health crises such as pandemics.

PMID:40773744 | DOI:10.2196/70412

J Invasive Cardiol. 2025 Aug 5. doi: 10.25270/jic/25.00130. Online ahead of print.

ABSTRACT

OBJECTIVES: Systematic reviews and meta-analyses have highlighted the benefits of distal over proximal transradial access, including lower rates of radial artery occlusion and faster hemostasis. Despite the increasing adoption of distal transradial access by interventionalists, there is a lack of data addressing gender-specific differences. This study aimed to assess those differences in routine coronary procedures via distal transradial access.

METHODS: The authors conducted a retrospective analysis of a large, real-world sample of 6871 consecutive all-comers who underwent coronary procedures via distal transradial access using data from the DISTRACTION registry.

RESULTS: The mean patient ages were 63.8 ± 15.7 years, 63.5 ± 17.7, and 64.4 ± 11.1 years for total, male, and female groups, respectively; 65% of the patients were male. In the female group, there was statistically significant predominance of hypertension (82.2% vs 74%), diabetes (46.8% vs 37%), obesity (29.3% vs 22.2%), severe mitral valve disease (3.1% vs 1.1%), coronary angiography-only (48.7% vs 36%), and access-site crossovers (3.1% vs 1.5%). In the male group, there were more rates of former or current smoking (54.2% vs 40.8%), previous percutaneous coronary intervention (PCI) (29.8% vs 19.7%), previous coronary artery bypass grafting (4.5% vs 1.9%), ST-segment elevation myocardial infarction (24.2% vs 18.5%), PCI (66.1% vs 52.5%), left main PCI (2.6% vs 1.7%), redo right distal transradial access (15.3% vs 9.9%), and 7F sheath size (2.6% vs 0.9%). No major adverse cerebrovascular and cardiac events directly related to distal transradial access, no hand/thumb dysfunction or ischemia after any procedure, and no relevant access-site-related bleeding were recorded.

CONCLUSIONS: The adoption of distal transradial access by proficient operators as the default approach for routine coronary procedures appears to be safe and feasible in both male and female patients, with very low rates of access site crossovers and complications.

PMID:40773706 | DOI:10.25270/jic/25.00130

J Med Internet Res. 2025 Aug 7;27:e71388. doi: 10.2196/71388.

ABSTRACT

BACKGROUND: Electronic health record (EHR) data are widely used in public health research, including in HIV-related studies, but are limited by potential bias due to incomplete and inaccurate information, lack of generalizability, and lack of representativeness.

OBJECTIVE: This study explores how workflow processes among HIV health care providers (HCPs), data scientists, and state health department professionals may potentially introduce or minimize bias within EHR data.

METHODS: One focus group with 3 health department professionals working in HIV surveillance and 16 in-depth interviews (ie, 5 people with HIV, 5 HCPs, 5 data scientists, and 1 health department professional providing retention-in-care services) were conducted with participants purposively sampled in South Carolina from August 2023 to April 2024. All interviews were transcribed verbatim and analyzed using a constructivist grounded theory approach, where transcripts were first coded and then focused, axial, and theoretically coded.

RESULTS: The EHR data lifecycle originates with people with HIV and HCPs in the clinical setting. Data scientists then curate EHR data and health department professionals manage and use the data for surveillance and policy decision-making. Throughout this lifecycle, the three primary stakeholders (ie, HCPs, data scientists, and health department professionals) identified challenges with EHR processes and provided their recommendations and accommodations in addressing the related challenges. HCPs reported the influence of socio-structural biases on their inquiry, interpretation, and documentation of social determinants of health (SDOH) information of people living with HIV, the influence of which is proposed to be mitigated through people living with HIV access to their EHRs. Data scientists identified limited data availability and representativeness as biasing the data they manage. Health department professionals face challenges with delayed and incomplete data, which may be addressed statistically but require consideration of the data’s limitations. Overall, bias within the EHR data lifecycle persists because workflows are not intentionally structured to minimize bias and there is a diffusion of responsibility for data quality between the various stakeholders.

CONCLUSIONS: From the perspective of various stakeholders, this study describes the EHR data lifecycle and its associated challenges as well as stakeholders’ accommodations and recommendations for mitigating and eliminating bias in EHR data. Based upon these findings, studies reliant on EHR data should adequately consider its challenges and limitations. Throughout the EHR data lifecycle, bias could be reduced through an inclusive, supportive health care environment, people living with HIV verification of SDOH information, the customization of data collection systems, and EHR data inspection for completeness, accuracy, and timeliness. Future research is needed to further identify instances where bias is introduced and how it can best be mitigated and eliminated across the EHR data lifecycle. Systematic changes are necessary to reduce instances of bias between data workflows and stakeholders.

PMID:40773672 | DOI:10.2196/71388

JMIR Med Inform. 2025 Aug 7;13:e74415. doi: 10.2196/74415.

ABSTRACT

BACKGROUND: The risk of developing atherosclerotic cardiovascular disease (ASCVD) varies among individuals and is related to a variety of lifestyle factors in addition to the presence of chronic diseases.

OBJECTIVE: We aimed to assess the predictive accuracy of machine learning (ML) models incorporating lifestyle risk behaviors for ASCVD risk using the Korean nationwide database.

METHODS: Using data from the Korea National Health and Nutrition Examination Survey, 5 ML algorithms were used for the prediction of high ASCVD risk: logistic regression (LR), support vector machine, random forest, extreme gradient boosting, and light gradient boosting models. ASCVD risk was assessed using the pooled cohort equations, with a high-risk threshold of ≥7.5% over 10 years. Among the 8573 participants aged 40-79 years, propensity score matching (PSM) was used to adjust for demographic confounders. We divided the dataset into a training and a test dataset in an 8:2 ratio. We also used bootstrapping to train the ML model with the area under the receiver operating characteristics curve score. Shapley additive explanations were used to identify the models’ important variables in assessing high ASCVD risks. In sensitivity analysis, we additionally performed binary LR analysis, in which the ML model’s results were consistent with the conventional statistical model.

RESULTS: Of the 8573 participants, 41.7% (n=3578) had high ASCVD risk. Before PSM, age and sex differed significantly between groups. PSM (1:1) yielded 1976 patients with balanced demographics. After PSM, the high ASCVD risk group had higher alcohol or tobacco use, lower omega-3 intake, higher BMI, less physical activity, and spent less time sitting. In 5 ML models, the extreme gradient boosting model showed the highest area under the receiver operating characteristics curve, indicating superior overall discrimination between high and low ASCVD risk groups. However, the light gradient boosting model demonstrated better performance in accuracy, recall, and F1-score. Variable importance analysis using Shapley additive explanations identified smoking and age as the strongest predictors, while BMI, sodium or omega-3 intake, and low-density lipoprotein cholesterol also had significant variables. Sensitivity analysis using multivariable LR analysis also confirmed these findings, showing that smoking, BMI, and low-density lipoprotein cholesterol increased ASCVD risk, whereas omega-3 intake and physical activity were associated with lower risk.

CONCLUSIONS: Analyzing lifestyle behavioral factors in ASCVD risk with an ML model improves the predictive performance compared to traditional models. Personalized prevention strategies tailored to an individual’s lifestyle can effectively reduce ASCVD risk.

PMID:40773657 | DOI:10.2196/74415

Pain Physician. 2025 Jul;28(4):E385-E391.

ABSTRACT

BACKGROUND: Morton’s neuroma is a compressive neuropathy of the common plantar digital nerve, causing significant pain and limiting patients’ activities.

OBJECTIVES: This study aimed to investigate the effect of pulsed radiofrequency (PRF) on the pain, functionality, and quality of life experienced by patients with Morton’s neuroma.

STUDY DESIGN: This was a prospective study with pre- and post-intervention assessments after one, 3, and 6 months of treatment.

SETTING: The orthopedics department of an affiliated hospital.

METHODS: Patients with Morton’s neuroma underwent treatment with ultrasound-guided PRF in 2 sites around the neuroma for 8 minutes. Clinical outcomes were assessed using the visual analog scale (VAS), the American Orthopedic Foot and Ankle Society (AOFAS) questionnaire for assessing foot function, and the Short Form-36 (SF-36) for quality of life.

RESULTS: A total of 20 patients (29 feet) completed the 6-month minimum follow-up period. The VAS and face scale values at follow-up were statistically lower than the pre-procedure VAS scores (P < 0.05). The AOFAS and SF-36 values at follow-up were statistically higher than the pre-procedure values (P < 0.05). No significant adverse events were recorded during the follow-up.

LIMITATIONS: The prospective research features a limited follow-up duration and lacks an additional group, whether control or treatment, for result comparisons.

CONCLUSION: Applications of PRF decreased the pain and the improved functionality and quality of life experienced by patients with Morton’s neuroma for a 6-month follow-up at minimum.

PMID:40773643

Pain Physician. 2025 Jul;28(4):347-357.

ABSTRACT

BACKGROUND: Knee Osteoarthritis (KOA) is the most common chronic joint disease in old age. Treatment for KOA focuses on symptom relief and improvement of function. Intraarticular hyaluronic acid (HA) is a well-documented treatment for KOA; it provides pain relief and enhances joint function by increasing lubrication and synovial fluid viscosity. Recently, there has been a growing interest toward the medical effects of oxygen-ozone (O3) treatment, especially for musculoskeletal disorders.

OBJECTIVE: We investigated whether a combination of intraarticular O3 and HA could reduce pain and improve functional and clinical outcomes compared with the same treatments administered separately in patients with KOA.

STUDY DESIGN: This is a retrospective, comparative, observational study approved by the institutional review board of the “Sapienza” University of Rome [RS 6599/2021].

SETTING: Physical Medicine and Rehabilitation Unit of Sant’Andrea University Hospital, Rome, Italian Republic.

METHODS: A total of 106 patients with KOA were examined. Of these, 84 patients met the eligibility criteria and were divided into one of 3 treatment groups: intraarticular O3 therapy (n = 28), intraarticular HA injections (n = 26), or a combination of both (n = 30). Outcome measures were assessed using the Numeric Rating Scale (NRS-11) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional disability, Knee Society Scores (KSS) for knee assessment, and the 12-item Short-Form Health Survey (SF-12) for quality of life.

RESULTS: Significant differences occured between groups at various evaluation points. At the end of treatment (T1), O3 alone and O3 combined with HA showed superior pain relief compared to HA alone; HA alone and O3 combined with HA demonstrated better stiffness alleviation compared to O3 alone. The combination therapy showed advantages in the WOMAC physical function score, total WOMAC score, KSS knee score, KSS functional score, 12-item Physical Component Summary (PCS-12) score and 12-item Mental Component Summary (MCS-12) score compared to O3 alone and HA alone treatments (P < 0.05). At the one-month follow-up (T2), O3 combined with HA showed significant differences in NRS-11 and WOMAC physical function scores compared to O3 alone (P = 0.026 and P = 0.011, respectively). The KSS knee score, KSS functional score, PCS-12 score, and MCS-12 score all showed differences between the O3 combined with HA and both the O3 and HA alone groups (P < 0.05). At the 3-month follow-up (T3), HA alone demonstrated superiority in the WOMAC pain and physical function scores over O3 alone (P < 0.001 and P = 0.023, respectively). Compared to O3 alone, O3 combined with HA showed advantages in WOMAC stiffness, WOMAC physical function, and total WOMAC scores, as well as the KSS knee score, KSS functional score, PCS-12 score, and MCS-12 score (P < 0.05).At the 6-month follow-up (T4), significant differences favored HA in the WOMAC pain, physical function, and total WOMAC scores compared to O3 (P = 0.039, P = 0.029, and P = 0.034, respectively). O3 combined with HA demonstrated advantages in total WOMAC and KSS knee score compared to O3 (P = 0.034 and P = 0.004, respectively). Within each group, all outcome measures exhibited statistically significant improvements at every follow-up (P < 0.05).

LIMITATIONS: A limited number of patients were retrospectively recruited.

CONCLUSIONS: Our study suggests that intraarticular O3 therapy and HA, alone or combined, provide distinct and complementary benefits for knee osteoarthritis. O3 therapy offers immediate pain relief, while HA contributes to sustained improvements in pain and function. The combination demonstrates a synergistic effect, enhancing joint functionality and quality of life.

PMID:40773642

Pain Physician. 2025 Jul;28(4):307-320.

ABSTRACT

BACKGROUND: Allergic rhinitis (AR) is a common chronic condition that significantly affects quality of life. Ultrasound-guided sphenopalatine ganglion block (SPGB) is a minimally invasive, safe, and effective treatment gaining clinical attention for symptom relief. Dexamethasone is often used in an SPGB, but its effect on autonomic nerve modulation remains unclear.

OBJECTIVES: This study aimed to assess the therapeutic effect of ultrasound-guided SPGB for treating AR and to compare the clinical efficacy and adverse reactions of dexamethasone used in conjunction with an SPGB.

STUDY DESIGN: A prospective, randomized, single-blind controlled trial.

SETTING: Nanjing Drum Tower Hospital Clinical College of Xuzhou Medical University, People’s Republic of China.

METHODS: This randomized clinical trial, involving 84 patients with AR, was conducted at Nanjing Drum Tower Hospital from February 2024 through May 2024. Patients were randomly assigned to either the experimental group (42 patients) or the control group (42 patients), with blinding applied. A total of 78 patients completed the study (40 in the experimental group, 38 in the control group). Both groups received an ultrasound-guided SPGB once a week for 4 weeks, alternating sides. The experimental group was treated with a combination of bupivacaine and dexamethasone, while the control group received only bupivacaine. Changes in efficacies, Total Nasal Symptom Score (TNSS), nasal symptom Visual Analog Scale (VAS), Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ) scores, Total Nasal Respiratory Volume (TNRV), Total Nasal Volume (TNV), and Total Nasal Resistance (TNR) were measured at pretreatment and at one week, one month, 3 months, and 6 months posttreatment. Additionally, effective rate was calculated as the percentage of patients achieving a clinically meaningful response, defined as a reduction in TNSS of 30% or greater from baseline.

RESULTS: Both groups had significant reductions in TNSS, nasal symptom VAS, and RQLQ scores compared to pretreatment levels at all follow-up points (P < 0.001). At one week, one month, and 3 months posttreatment, the experimental group had higher efficacies, lower TNSS, lower VAS, and lower RQLQ scores than the control group (P < 0.05). At 6 months posttreatment, there were no significant differences between the groups for efficacy rates, VAS, or RQLQ scores (P > 0.05) while the experimental group had lower TNSS scores (P < 0.05). Both groups had significant improvement in nasal ventilation, with increases in TNRV and TNV and reductions in TNR (P < 0.001). At each follow-up, the experimental group had higher TNRV and TNV and lower TNR compared to the control group, with statistical significance observed at most time points (P < 0.05), except for TNRV at 6 months and TNV at 3 and 6 months posttreatment. Safety indicators showed no significant differences between groups (P > 0.05).

LIMITATIONS: We did not assess patient depression and anxiety; how dexamethasone over triamcinolone potentially affected efficacy; and how the absence of 3D navigation would have resulted in a safer, more precise block.

CONCLUSIONS: Ultrasound-guided SPGB is a safe and effective treatment for AR, improving symptoms, quality of life, and nasal airflow. The addition of corticosteroids may enhance short-term efficacy.

PMID:40773638