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Nevin Manimala Statistics

An mHealth Intervention Promoting Physical Activity and Healthy Eating in a Family Setting (SMARTFAMILY): Randomized Controlled Trial

JMIR Mhealth Uhealth. 2024 Apr 26;12:e51201. doi: 10.2196/51201.

ABSTRACT

BACKGROUND: Numerous smartphone apps are targeting physical activity (PA) and healthy eating (HE), but empirical evidence on their effectiveness for the initialization and maintenance of behavior change, especially in children and adolescents, is still limited. Social settings influence individual behavior; therefore, core settings such as the family need to be considered when designing mobile health (mHealth) apps.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a theory- and evidence-based mHealth intervention (called SMARTFAMILY [SF]) targeting PA and HE in a collective family-based setting.

METHODS: A smartphone app based on behavior change theories and techniques was developed, implemented, and evaluated with a cluster randomized controlled trial in a collective family setting. Baseline (t0) and postintervention (t1) measurements included PA (self-reported and accelerometry) and HE measurements (self-reported fruit and vegetable intake) as primary outcomes. Secondary outcomes (self-reported) were intrinsic motivation, behavior-specific self-efficacy, and the family health climate. Between t0 and t1, families of the intervention group (IG) used the SF app individually and collaboratively for 3 consecutive weeks, whereas families in the control group (CG) received no treatment. Four weeks following t1, a follow-up assessment (t2) was completed by participants, consisting of all questionnaire items to assess the stability of the intervention effects. Multilevel analyses were implemented in R (R Foundation for Statistical Computing) to acknowledge the hierarchical structure of persons (level 1) clustered in families (level 2).

RESULTS: Overall, 48 families (CG: n=22, 46%, with 68 participants and IG: n=26, 54%, with 88 participants) were recruited for the study. Two families (CG: n=1, 2%, with 4 participants and IG: n=1, 2%, with 4 participants) chose to drop out of the study owing to personal reasons before t0. Overall, no evidence for meaningful and statistically significant increases in PA and HE levels of the intervention were observed in our physically active study participants (all P>.30).

CONCLUSIONS: Despite incorporating behavior change techniques rooted in family life and psychological theories, the SF intervention did not yield significant increases in PA and HE levels among the participants. The results of the study were mainly limited by the physically active participants and the large age range of children and adolescents. Enhancing intervention effectiveness may involve incorporating health literacy, just-in-time adaptive interventions, and more advanced features in future app development. Further research is needed to better understand intervention engagement and tailor mHealth interventions to individuals for enhanced effectiveness in primary prevention efforts.

TRIAL REGISTRATION: German Clinical Trials Register DRKS00010415; https://drks.de/search/en/trial/DRKS00010415.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/20534.

PMID:38669071 | DOI:10.2196/51201

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Nevin Manimala Statistics

The shared decision-making tool for caregivers of children with prenatal opioid exposure: A pilot and acceptability study

J Child Health Care. 2024 Apr 26:13674935241249770. doi: 10.1177/13674935241249770. Online ahead of print.

ABSTRACT

This pilot and acceptability study sought to report provider acceptability and developmental concerns expressed by caregivers of children with prenatal opioid exposure using the Shared Decision-Making Tool (SDMT), an instrument created by study authors. Data were collected from five health care and early intervention providers and 83 caregivers from a medical clinic and early intervention service center. Descriptive statistics were used to identify frequency, mean level, and prioritization of developmental concerns using the SDMT, and to summarize provider acceptability about integrating the SDMT into their workflow. Communication was the most frequently cited concern in four consecutive age categories, followed by Inattention/impulsivity and Problem behavior. All providers “strongly agreed” or “agreed” with all statements on the provider feedback survey, except two instances. Results of this study support the SDMT as a potential tool to help engage caregivers and providers of children with prenatal opioid exposure in the shared decision-making process by standardizing communication related to areas of developmental concern and caregivers’ priority needs. Findings from this pilot study will inform modifications to the SDMT and administration instructions before our next study, which will examine psychometric properties and caregiver acceptability of the scale.

PMID:38669063 | DOI:10.1177/13674935241249770

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Characterizing Technology Use and Preferences for Health Communication in South Asian Immigrants With Prediabetes or Diabetes: Cross-Sectional Descriptive Study

JMIR Form Res. 2024 Apr 26;8:e52687. doi: 10.2196/52687.

ABSTRACT

BACKGROUND: Type 2 diabetes disproportionately affects South Asian subgroups. Lifestyle prevention programs help prevent and manage diabetes; however, there is a need to tailor these programs for mobile health (mHealth).

OBJECTIVE: This study examined technology access, current use, and preferences for health communication among South Asian immigrants diagnosed with or at risk for diabetes, overall and by sex. We examined factors associated with interest in receiving diabetes information by (1) text message, (2) online (videos, voice notes, online forums), and (3) none or skipped, adjusting for sociodemographic characteristics and technology access.

METHODS: We used baseline data collected in 2019-2021 from two clinical trials among South Asian immigrants in New York City (NYC), with one trial focused on diabetes prevention and the other focused on diabetes management. Descriptive statistics were used to examine overall and sex-stratified impacts of sociodemographics on technology use. Overall logistic regression was used to examine the preference for diabetes information by text message, online (videos, voice notes, or forums), and no interest/skipped response.

RESULTS: The overall sample (N=816) had a mean age of 51.8 years (SD 11.0), and was mostly female (462/816, 56.6%), married (756/816, 92.6%), with below high school education (476/816, 58.3%) and limited English proficiency (731/816, 89.6%). Most participants had a smartphone (611/816, 74.9%) and reported interest in receiving diabetes information via text message (609/816, 74.6%). Compared to male participants, female participants were significantly less likely to own smartphones (317/462, 68.6% vs 294/354, 83.1%) or use social media apps (Viber: 102/462, 22.1% vs 111/354, 31.4%; WhatsApp: 279/462, 60.4% vs 255/354, 72.0%; Facebook: Messenger 72/462, 15.6% vs 150/354, 42.4%). A preference for receiving diabetes information via text messaging was associated with male sex (adjusted odds ratio [AOR] 1.63, 95% CI 1.01-2.55; P=.04), current unemployment (AOR 1.62, 95% CI 1.03-2.53; P=.04), above high school education (AOR 2.17, 95% CI 1.41-3.32; P<.001), and owning a smart device (AOR 3.35, 95% CI 2.17-5.18; P<.001). A preference for videos, voice notes, or online forums was associated with male sex (AOR 2.38, 95% CI 1.59-3.57; P<.001) and ownership of a smart device (AOR 5.19, 95% CI 2.83-9.51; P<.001). No interest/skipping the question was associated with female sex (AOR 2.66, 95% CI 1.55-4.56; P<.001), high school education or below (AOR 2.02, 95% CI 1.22-3.36; P=.01), not being married (AOR 2.26, 95% CI 1.13-4.52; P=.02), current employment (AOR 1.96, 95% CI 1.18-3.29; P=.01), and not owning a smart device (AOR 2.06, 95% CI 2.06-5.44; P<.001).

CONCLUSIONS: Technology access and social media usage were moderately high in primarily low-income South Asian immigrants in NYC with prediabetes or diabetes. Sex, education, marital status, and employment were associated with interest in mHealth interventions. Additional support to South Asian women may be required when designing and developing mHealth interventions.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03333044; https://classic.clinicaltrials.gov/ct2/show/NCT03333044, ClinicalTrials.gov NCT03188094; https://classic.clinicaltrials.gov/ct2/show/NCT03188094.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3711-y.

PMID:38669062 | DOI:10.2196/52687

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Nevin Manimala Statistics

Detection of Urinary Misfolded Proteins for Imminent Prediction of Preeclampsia in Pregnant Women With Suspected Cases: Protocol for a Prospective Noninterventional Study

JMIR Res Protoc. 2024 Apr 26;13:e54026. doi: 10.2196/54026.

ABSTRACT

BACKGROUND: Preeclampsia (PE) is one of the most common hypertensive diseases, affecting 2%-8% of all pregnancies. The high maternal and fetal mortality rates of PE are due to a lack of early identification of affected pregnant women that would have led to closer monitoring and care. Recent data suggest that misfolded proteins might be a promising biomarker for PE prediction, which can be detected in urine samples of pregnant women according to their congophilia (aggregated) characteristic.

OBJECTIVE: The main purpose of this trial is to evaluate the value of the urine congophilia-based detection of misfolded proteins for the imminent prediction of PE in women presenting with suspected PE. The secondary objectives are to demonstrate that the presence of urine misfolded proteins correlates with PE-related maternal or neonatal adverse outcomes, and to establish an accurate PE prediction model by combining misfolded proteins with multiple indicators.

METHODS: At least 300 pregnant women with clinical suspicion of PE will be enrolled in this prospective cohort study. Participants should meet the following inclusion criteria in addition to a suspicion of PE: ≥18 years old, gestational week between 20+0 and 33+6, and single pregnancy. Consecutive urine samples will be collected, blinded, and tested for misfolded proteins and other PE-related biomarkers at enrollment and at 4 follow-up visits. Clinical assessments of PE status and related complications for all participants will be performed at regular intervals using strict diagnostic criteria. Investigators and participants will remain blinded to the results. Follow-up will be performed until 42 days postpartum. Data from medical records, including maternal and fetal outcomes, will be collected. The performance of urine misfolded proteins alone and combined with other biomarkers or clinical variables for the prediction of PE will be statistically analyzed.

RESULTS: Enrollment started in July 2023 and was still open upon manuscript submission. As of March 2024, a total of 251 eligible women have been enrolled in the study and enrollment is expected to continue until August 2024. Results analysis is scheduled to start after all participants reach the follow-up endpoint and complete clinical data are collected.

CONCLUSIONS: Upon completion of the study, we expect to derive an accurate PE prediction model, which will allow for proactive management of pregnant women with clinical suspicion of PE and possibly reduce the associated adverse pregnancy outcomes. The additional prognostic value of misfolded proteins is also expected to be confirmed.

TRIAL REGISTRATION: Chinese Clinical Trials Registry ChiCTR2300074878; https://www.chictr.org.cn/showproj.html?proj=202096.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54026.

PMID:38669061 | DOI:10.2196/54026

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Nevin Manimala Statistics

Assessment of Clinical Outcomes in Patients With Osteoarthritis: Analysis From the UK Medical Cannabis Registry

J Pain Palliat Care Pharmacother. 2024 Apr 26:1-14. doi: 10.1080/15360288.2024.2340076. Online ahead of print.

ABSTRACT

Osteoarthritis accounts for 0.6% of disability-adjusted life years globally. There is a paucity of research focused on cannabis-based medicinal products (CBMPs) for osteoarthritic chronic pain management. This study aims to assess changes in validated patient-reported outcome measures (PROMs) and CBMP clinical safety in patients with osteoarthritis. A prospective case series from the UK Medical Cannabis Registry was analyzed. Primary outcomes were changes in the Brief Pain Inventory (BPI), McGill Pain Questionnaire (MPQ2), EQ-5D-5L, Generalized Anxiety Disorder-7 (GAD-7) questionnaire, and Single-Item Sleep Quality Scale (SQS) at 1-, 3-, 6-, and 12-month follow-ups from baseline. Common Terminology Criteria for Adverse Events v.4.0 was used for adverse event (AE) analysis. Statistical significance was defined as p < 0.050. Seventy-seven patients met inclusion criteria. CBMP initiation correlated with BPI pain severity (p = 0.004), pain interference (p = 0.005), and MPQ2 (p = 0.017) improvements at all follow-ups compared to baseline. There were improvements in the EQ-5D-5L index (p = 0.026), SQS (p < 0.001), and GAD-7 (p = 0.038) up to 6 and 3 months, respectively. Seventeen participants (22.08%) recorded 76 mild AEs (34.86%), 104 moderate AEs (47.71%), and 38 severe AEs (17.43%). Though causality cannot be assumed in this observational study, results support development of randomized control trials for osteoarthritis pain management with CBMPs.

PMID:38669060 | DOI:10.1080/15360288.2024.2340076

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Nevin Manimala Statistics

The Arabic psychosocial impact of assistive devices scale: Development, translation, and evaluation

Assist Technol. 2024 Apr 26:1-8. doi: 10.1080/10400435.2024.2339467. Online ahead of print.

ABSTRACT

This paper describes the development, translation, and early evaluation of the Arabic Psychosocial Impact of Assistive Devices Scale (AR-PIADS), an outcome measure instrument for the subjective impact of Assistive Technology on a person with a disabilities’ quality of life. Developing the AR = PIADS instrument involved forward and backward translation by two independent teams of bilingual, Arabic-English speakers (n = 5) and a quality and usability review by a panel of people with disabilities (n = 18). The emergent version was evaluated with a group of experienced Arabic-speaking Assistive Technology users (n = 67) for its psychometric properties. Initial results demonstrate a favorable comparison for 16 of the 26 questionnaire items with scores recorded for the original, English language version. Internal consistency, measured using Cronbach’s alpha, yielded a range of 0.97-0.99 for AR-PIADS while the new instrument’s reliability was assessed using an intraclass correlation coefficient resulting in scores within the range of 0.86-0.97 for the overall instrument. Despite these positive results however, the translation process did highlight a number of challenges with language and cultural interpretation of the translated instrument. This suggests that further work is warranted to explore its utility in service provision.

PMID:38669058 | DOI:10.1080/10400435.2024.2339467

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Bile Duct Injuries During Urgent Cholecystectomy at a Safety Net Teaching Hospital: Attending Experience and Time of Day May Matter

Am Surg. 2024 Apr 26:31348241248805. doi: 10.1177/00031348241248805. Online ahead of print.

ABSTRACT

Background: Bile duct injury (BDI) is one of the most severe complications during cholecystectomy. Early identification of risk factors for BDI may permit risk reduction strategies and inform patient consent.Objective: This study aimed to define patient, provider, and systemic factors associated with BDI; BDI incidence; and short-term outcomes of BDI after urgent cholecystectomy.Methods: Patients who underwent urgent cholecystectomy for acute cholecystitis were retrospectively screened (2020-2022). All patients who sustained BDI were included without exclusions. Demographics, clinical data, and outcomes were collected and compared with descriptive statistics.Results: During the study period, BDI occurred in 4 (0.5%) of 728 patients who underwent urgent cholecystectomy for acute cholecystitis. Most BDI cases (75%) took place overnight or during the weekend. The attending surgeon was almost exclusively (75%) in their first year of practice. BDI was recognized during index operation in 2 cases (50%). Hepatobiliary surgery performed the bile duct repair in all 4 cases. Two complications occurred (50%). All patients were followed by hepatobiliary surgery in the outpatient setting and returned to their baseline level of function within 2 months of hospital discharge.Conclusion: Most BDI occurred in procedures attended by first-year faculty during after hours cholecystectomies, suggesting a role for increased proctorship in early career attendings in addition to in-hours cholecystectomy for acute cholecystitis. The timely return to baseline function experienced by these patients emphasizes the favorable outcomes associated with early recognition of BDI and involvement of hepatobiliary surgery. Further examination with multicenter evaluation would be beneficial to validate these study findings.

PMID:38669047 | DOI:10.1177/00031348241248805

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Nevin Manimala Statistics

Changes in Buprenorphine Prescribing in Community Health Centers

JAMA Health Forum. 2024 Apr 5;5(4):e240634. doi: 10.1001/jamahealthforum.2024.0634.

NO ABSTRACT

PMID:38669032 | DOI:10.1001/jamahealthforum.2024.0634

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Nevin Manimala Statistics

Preferences for Postacute Care at Home vs Facilities

JAMA Health Forum. 2024 Apr 5;5(4):e240678. doi: 10.1001/jamahealthforum.2024.0678.

ABSTRACT

IMPORTANCE: Two in 5 US hospital stays result in rehabilitative postacute care, typically through skilled nursing facilities (SNFs) or home health agencies (HHAs). However, a lack of clear guidelines and understanding of patient and caregiver preferences make it challenging to promote high-value patient-centered care.

OBJECTIVE: To assess preferences and willingness to pay for facility-based vs home-based postacute care among patients and caregivers, considering demographic variations.

DESIGN, SETTING, AND PARTICIPANTS: In September 2022, a nationally representative survey was conducted with participants 45 years or older. Using a discrete choice experiment, participants acting as patients or caregivers chose between facility-based and home-based postacute care that best met their preferences, needs, and family conditions. Survey weights were applied to generate nationally representative estimates.

MAIN OUTCOMES AND MEASURES: Preferences and willingness to pay for various attributes of postacute care settings were assessed, examining variation based on demographic factors, socioeconomic status, job security, and previous care experiences.

RESULTS: A total of 2077 adults were invited to participate in the survey; 1555 (74.9%) completed the survey. In the weighted sample, 52.9% of participants were women, 6.5% were Asian or Pacific Islander, 1.7% were American Indian or Alaska Native, 11.2% were Black or African American, 78.4% were White; the mean (SD) age was 62.6 (9.6) years; and there was a survey completion rate of 74.9%. Patients and caregivers showed a substantial willingness to pay for home-based and high-quality care. Patients and caregivers were willing to pay an additional $58.08 per day (95% CI, 45.32-70.83) and $45.54 per day (95% CI, 31.09-59.99) for HHA care compared with a shared SNF room, respectively. However, increased demands on caregiver time within an HHA scenario and socioeconomic challenges, such as insecure employment, shifted caregivers’ preferences toward facility-based care. There was a strong aversion to below average quality. To avoid below average SNF care, patients and caregivers were willing to pay $75.21 per day (95% CI, 61.68-88.75) and $79.10 per day (95% CI, 63.29-94.91) compared with average-quality care, respectively. Additionally, prior awareness and experience with postacute care was associated with willingness to pay for home-based care. No differences in preferences among patients and caregivers based on race, educational background, urban or rural residence, general health status, or housing type were observed.

CONCLUSIONS AND RELEVANCE: The findings of this survey study underscore a prevailing preference for home-based postacute care, aligning with current policy trends. However, attention is warranted for disadvantaged groups who are potentially overlooked during the shift toward home-based care, particularly those facing caregiver constraints and socioeconomic hardships. Ensuring equitable support and improved quality measure tools are crucial for promoting patient-centric postacute care, with emphasis on addressing the needs of marginalized groups.

PMID:38669031 | DOI:10.1001/jamahealthforum.2024.0678

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COVID-19 Vaccine Uptake in Undocumented Latinx Patients Presenting to the Emergency Department

JAMA Netw Open. 2024 Apr 1;7(4):e248578. doi: 10.1001/jamanetworkopen.2024.8578.

NO ABSTRACT

PMID:38669022 | DOI:10.1001/jamanetworkopen.2024.8578