Background: The exact cause of penile curvature in hypospadias remains unknown. Resection of the dartos fascia has been observed to straighten the penis, indicating the involvement of the dartos fascia in the superficial chordee. However, the characteristics of dartos tissue in the distal territory of the ventral penile shaft may differ from those in the proximal aspect of the penile shaft.
Objective: This study aims to investigate the distinct histopathological profiles and expression of COL1A1 (collagen type 1), COL3A1 (collagen type 3), and ELN (elastin) in proximal and distal ventral dartos of patients with hypospadias compared to those without hypospadias.
Methods: This prospective case-control study compares the ventral dartos tissue of patients with hypospadias at different locations with that of patients without hypospadias. Dartos samples will be taken during surgery, with age matching. Histopathology examination uses hematoxylin and eosin and Masson's trichrome stain. The mRNA expression of COL1A1, COL3A1, and ELN will be quantified using a 2-step reverse transcription-polymerase chain reaction analysis.
Results: Previous studies have documented different characteristics of dartos tissue between patients with hypospadias and those without hypospadias. Some studies even suggest resection of the dartos tissue during hypospadias repair. However, this is the first study to compare the characteristics of ventral dartos tissue in patients with hypospadias based on its location along the penile shaft, suggesting potential differences between the distal and proximal locations. We have obtained ethical approval to conduct a prospective case-control study aimed at elucidating these differences in dartos tissue characteristics. The findings of the study are anticipated to be available by 2025.
Conclusions: Differences in the characteristics of dartos fascia based on its location may require tailored surgical strategies. If the properties of distal dartos tissue closely mirror those of typical dartos tissue, the possibility of avoiding its excision during hypospadias surgery could be considered.
International registered report identifier (irrid): DERR1-10.2196/70075.
Background: Rheumatoid arthritis (RA) is an autoimmune disease that affects joints and can have extra-articular manifestations. RA usually tends to be progressive and leads to substantial health care burdens, both in terms of disability and economic costs. Despite the various treatment modalities available, there is still an urgent need for safe and effective medicine based on the pattern of disease presentation. The increasing interest in complementary and alternative medicine has created a demand for extensive research in this area.
Objective: This clinical study is designed to evaluate the effectiveness and tolerability of a composite Ayurveda regimen in RA.
Methods: The study is a single-arm (pre-post design), community-based interventional study with a black box design being conducted at 6 study centers. A total of 240 participants aged between 18 and 65 years, diagnosed with RA as per the 2010 American College of Rheumatology and the European League Against Rheumatism criteria are recruited as per the selection criteria. All the participants received Ayush-SG and Rasnasaptak Kashaya for 84 days along with customized treatment as per the disease presentation and associated complaints. The outcome measures include the change in disease activity score (DAS)-28 with erythrocyte sedimentation rate, disease-specific biochemical and inflammatory markers, Disability Index score, change in the participant's assessment of pain and frequency of use of conventional analgesics or nonsteroidal anti-inflammatory drugs from baseline. The tolerability of interventions is assessed through the occurrence of adverse events. Categorical variables will be analyzed with McNemar chi-square test, and continuous variables will be assessed using the paired t test or Wilcoxon test for pre-post assessment. The level of significance will be 5%.
Results: The recruitment of participants was initiated in December 2023. The participant recruitment was completed in March 2024 and out of 240 participants enrolled, 222 (92.5%) completed the study up to the last follow-up. Data verification, compilation, and analysis are under process. After data analysis, the study's findings will be published in a peer-reviewed journal.
Conclusions: This interventional study that incorporates the black box approach may provide a strong framework for managing RA. This design is a more reliable method for evaluating the effectiveness and tolerability of the composite Ayurveda regimen in RA.
Trial registration: Clinical Trial Registry-India CTRI/2023/06/054203; https://tinyurl.com/4prvwr6z.
International registered report identifier (irrid): DERR1-10.2196/57918.
Background: Oral health is a significant indicator of general health, well-being, and quality of life. The prevention of oral health problems requires periodic inspection of the oral cavity. Routine oral health examinations at the individual level appears to be one way to deliver quality oral health care but are too often missed as an opportunity for improved oral health in the nondental health care setting in India. This is because of limited training and inaccessible or lack of specialized oral health assessment tools.
Objective: This study will focus on the development, validation, and implementation of the Basic Oral Health Assessment Tool (BOHAT) to improve the oral health assessment capabilities of nondental health care professionals and thus contribute to improved overall health outcomes of the Indian adult population.
Methods: This study will be a mixed methods, multistage study conducted in 3 stages. The study will be conducted with 708 nondental health care professionals in 33 Primary Health Centers (PHCs) of Mangalore Taluk, Karnataka. Ethical approval was sought from the institutional ethics committee of Manipal College of Dental Sciences Mangalore. Informed consent will be obtained from every participant prior to the study. A literature review and qualitative interviews will be used for item and domain generation with respect to BOHAT, and an expert panel review and pilot testing will be used to refine the items and domains. Finally, statistical analyses will be conducted to validate the reliability and consistency. The second phase will involve capacity building and user experience exploration through comprehensive training for nondental health professionals using audio and visual aids, with hands-on learning methodologies including relevant feedback processes in the form of focus group discussions. The third stage will check the effectiveness of BOHAT regarding the changes in knowledge, attitudes, and practices through pre- and posttraining questionnaires, which will then be followed by a retention analysis 3 months later.
Results: As of January 20, 2025, the study is in its preliminary phase: "Substage A: Item and Domain Development." We have received institutional ethics committee and Institutional Protocol Approval Committee approval for the study. Data collection procedures have not started yet. The study is progressing as per the planned timeline.
Conclusions: The BOHAT study holds considerable potential to promote oral health care through collaborative and interdisciplinary approaches. It will facilitate early diagnosis, timely referrals, and comprehensive care by integrating assessment actions for oral health into routine practices of nondental primary health care professionals.
International registered report identifier (irrid): PRR1-10.2196/63480.
Background: There has been a rapid growth in the literature on the design and evaluation of assistive technologies for people with visual impairments; yet, there is a lack of a comprehensive analysis of the existing literature on the classification of immediate-, short-, medium-, and long-term psychosocial impact of assistive technologies on the quality of life of people with visual impairments.
Objective: This protocol outlines the methodology for a scoping review aimed at identifying and synthesizing the existing literature on the psychosocial impact of assistive technologies on the quality of life of people with visual impairments.
Methods: The review will include primary research studies published in English between 2019 and 2024 that focus on the psychosocial outcomes of assistive technologies for people with visual impairments. Eligible studies will involve participants with visual impairments, of all ages and across various settings, examining psychological (eg, emotional well-being and self-esteem) and social outcomes (eg, social participation and support). Searches will be conducted across 7 electronic research databases: CINAHL (EBSCO), PsycINFO (EBSCO), ACM Digital Library, IEEE Xplore, Scopus, Web of Science, and Google Scholar (first 100 records). Studies will undergo screening and selection based on predefined eligibility criteria, with data extraction focusing on publication details, study design, population characteristics, type of assistive technology, and psychosocial impacts. Results will be summarized using descriptive statistics, charts, and narrative synthesis.
Results: The database search, conducted in July 2024, identified 1145 records, which will be screened and analyzed in subsequent stages of the review process. This protocol outlines the planned approach for identifying, categorizing, and synthesizing evidence. The study findings are anticipated to be finalized and submitted for publication in a peer-reviewed journal by February 2025.
Conclusions: This study will synthesize the recent body of work on the psychosocial impact of assistive technologies for people with visual impairments and recommendations for researchers and designers interested in this research area.
Trial registration: Open Science Framework 10.17605/OSF.IO/SK7N8; https://osf.io/4gc5t.
International registered report identifier (irrid): DERR1-10.2196/65056.
Background: Health inequity is interlinked with the good health and well-being of an individual. Health inequity can be due to various socioeconomic factors like income levels or social status. Digital health interventions have the potential to reduce the existing health inequities.
Objective: This study aims to identify determinants of social, economic, and health inequity in diverse settings to enhance healthy eating and active living. It further aims to design and develop a digital health intervention HEAL (Healthy Eating Active Living) that incorporates a human-centered design framework in order to improve healthy eating and active living among rural and urban population groups in Chennai, Tamil Nadu, India.
Methods: A prospective, 3-year cohort study will be conducted. This study aims to recruit 6350 individuals across rural and urban settings of Chennai. A total of 11 sites have been selected for participation in the study. Data on sociodemographic characteristics; economic inequity; HEAL profile; depression, anxiety, and stress; well-being; sources of health information; perceived access to health care; health literacy; navigation of health literacy; and satisfaction with the health system will be gathered. This study would help to explore the determinants of social, economic, and health inequity across multiple sites. SAS (version 9.3; SAS Institute Inc) will be used for data analysis, and results will be reported as 95% CI and P values. This study's findings will guide the design and development of a tailored, human-centered digital health intervention to enhance the health and well-being of Chennai's population groups.
Results: As of December 2024, the literature review for the development of the intervention has been completed. The recruitment for the baseline data collection will begin shortly, followed by the development of HEAL intervention.
Conclusions: The proposed study will help in examining the role of the proposed HEAL intervention to enhance the health and well-being of the population groups of Chennai.
International registered report identifier (irrid): PRR1-10.2196/41169.
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