A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.

BACKGROUND: Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment. METHOD: The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. DISCUSSION: We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. TRIAL REGISTRATION: ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

Needs and readiness to use tele-practice for identification and rehabilitation of children with hearing and speech-language disorders: perceptions of public sector care providers in South India.

The current study was a first step towards planning the implementation of tele-practice in a South Indian state's public-sector services for childhood hearing and speech, language disorders. The aim was to understand the perceptions of public-sector health care providers (HCPs) regarding their need and readiness to accept and implement tele-practice-based diagnostics and rehabilitation services. A cross-sectional study design was used, which included focus group discussions (FGDs), semi-structured interviews (SSIs) and geo-spatial analysis. Participants in the qualitative component included various cadres of health HCPs in public-sector services. Theoretical saturation and cross-case variance were used to assess the data's sufficiency. A hybrid deductive-inductive thematic analytical approach was used to analyse the data. Geo-tags and geo-locations of addresses of all children with disabilities and all the public-sector service providers were used to generate geospatial maps. The HCPs considered the currently available services for childhood hearing and speech-language disorders to be insufficient and reported shortage of professionals to meet current demands. There was inconsistent availability of suitable equipment and professionals in the existing district-level facilities. HCPs were comfortable using technology, and were willing to investigate tele-practice, but they required training in tele-practice [Q2].

Implementation factors influencing the sustained provision of tele-audiology services: insights from a combined methodology of scoping review and qualitative semistructured interviews.

OBJECTIVES: The objectives of the current study were to (a) identify long-term tele-audiology services reported to be implemented beyond the research phase and determine whether they are sustained, (b) map the implementation process to Standards for Reporting Implementation Studies guidelines and (c) map the factors that influenced its sustainability to the Implementation Outcomes Framework (IOF) to understand the gaps from an implementation research perspective. STUDY DESIGN, SETTING AND PARTICIPANTS: This cross-sectional study included a scoping review of articles describing long-term tele-audiology services from around the world to determine the factors influencing the implementation. Six electronic databases (PubMed, Cochrane Library, Web of Science, Scopus, Google Scholar and ProQuest) were searched for literature published between 2010 and 2023. This was followed by semistructured interviews (SSIs), which were guided by the IOF. Six project implementers were interviewed to obtain an in-depth understanding of factors that influenced sustainability of these tele-audiology services. Thematic analysis of the interview transcripts was carried out using a hybrid inductive-deductive approach. RESULTS: Data were extracted from 32 tele-audiology studies included in the review, which were then mapped to 21 projects. The findings of the scoping review reveal that tele-audiology services were predominantly provided using synchronous telepractice methods. The 'professional-facilitator-patient' model was most commonly used. None of the studies reported the use of implementation research and/or outcome frameworks. Factors that influenced sustainability of tele-audiology services were identified from the combined results of the scoping review and the SSIs. These factors could be mapped to implementation outcomes of acceptability, adoption, feasibility, implementation cost and sustainability. CONCLUSION: Implementation research and/or outcome framework should be used to guide the implementation processes, its evaluation and measurement of outcomes systematically in tele-audiology service delivery. When such frameworks are used, gaps in information regarding the context influencing implementation, reporting of fidelity and adaptability measures can be addressed.

'I don`t need an eye check-up'. A qualitative study using a behavioural model to understand treatment-seeking behaviour of patients with sight threatening diabetic retinopathy (STDR) in India.

Diabetic Retinopathy (DR) affects about 27% of patients with diabetes globally. According to the World Health Organization (WHO), DR is responsible for37 million cases of blindness worldwide. The SMART India study (October 2020-August 2021) documented the prevalence of diabetes, and DR in people40 years and above across ten Indian states and one Union Territory by conducting community screening. About 90% of people with sight threatening diabetic retinopathy (STDR) were referred from this screening study to eye hospitals for management, but failed to attend. This qualitative study, a component of the SMART India study, explored perceptions of referred patients regarding their susceptibility to eye related problems in diabetes and the benefits/barriers to seeking care. Perceived barriers from the viewpoint of ophthalmologists were also explored. Guided by the Health Beliefs Model (HBM), 20 semi structured interviews were carried out with consenting patients diagnosed with STDR. They included nine patients who had sought care recruited from eight eye hospitals across different states in India and eleven patients who did not seek care. Eleven ophthalmologists also participated. Four themes of analysis based on the HBM were, understanding of DR and its treatment, perceptions about susceptibility and severity, perceived barriers, perceived benefits and cues to action. Findings revealed poor understanding of the effects of diabetes on the eye contributing to low risk perception. Prohibitive costs of treatment, difficulties in accessing care services and poor social support were major barriers to seeking care. Ophthalmologists acknowledged that the absence of symptoms and the slow progressive nature of the disease deluded patients into thinking that they were fine. The study attests to the need for greater health literacy around diabetes, DR and STDR; for making treatment more affordable and accessible and for the development of effective patient education and communication strategies towards increasing compliance.

Reduction in prevalence of spousal physical violence against women in India: evidence from three national surveys.

Spousal physical violence (PV) against women is considered to be major health issue in developing countries. Lifetime physical violence is a composite outcome consists of hit, kick, beat, slap and threatened with weapon, perpetrated by the husband. The study aims to examine changes in prevalence and specific risk factors for PV from 1998 to 2016 in India. This study analyzed data from a cross sectional epidemiological survey in 1998-1999, NFHS-3 (2005-2006) and NFHS-4 (2015-2016) data. There was a significant decline of about 10% (95% CI: 8.8%-11.1%) in PV. Major risk factors for change in PV were husband's use of alcohol, illiteracy and socio-economic status of the household. The Protection of Women from Domestic Violence Act may have played a role in reducing the PV. Even though there was a decline in PV, actions have to be implemented from the root level to ensure women empowerment.

Understanding the implementation of telepractice in speech and language services using a mixed-methods approach.

Background: Telepractice emerged as a solution to overcome the challenges of access issues in the delivery of healthcare. Telepractice in speech language pathology (SLP) has existed for nearly a decade yet there is a significant knowledge gap with respect to the factors influencing the implementation of telepractice as a routine or long-term, sustained effort. This mixed-methods study aimed to identify implementation factors that influence the provision of telepractice in SLP services. Method: A mixed-methods study consisting of a scoping review and semi-structured interviews (SSI) was carried out. Articles that described telepractice in SLP were included based on an operational definition of implementation and a set of inclusion criteria. Results: Data was extracted from 11 studies that were mapped to nine projects in telepractice in SLP. The broad focus areas identified included diagnostics and evaluation, therapeutics and comprehensive assessment, management and follow-up care services. Synchronous/ real-time telepractice methods were always used for the provision of diagnostic testing or when providing therapy services using video conferencing. The ' professional-facilitator-patient' model was used most commonly followed by the ' professional-patient' model.  Barriers for long-term sustainability included inadequate initial capital investment, lack of reimbursement and payment options, low internet speed and bandwidth, resistance and hesitancy to use telepractice from the patient's end, lack of organizational policies and uniform regulations. Sustainable source of funding, having a dedicated team of professionals and technicians with clear roles and responsibilities, and inclusion of systematic planning facilitated implementation.  Conclusion: In general, telepractice in SLP was not explicitly guided by implementation science or framework. The use of implementation frameworks ensures systematic planning and feasibility assessment to inform the scale-up of implementation. Therefore, it would be worthwhile for program implementers to consider these aspects when exploring telepractice services.

Exploring the challenges in the management of childhood pneumonia-qualitative findings from health care providers from two high prevalence states in India.

India ranks among the top five countries in the world in child deaths due to pneumonia. Apart from poor public awareness, inadequate health infrastructure and treatment services have compromised effective management. This qualitative study guided by components of the Andersen-Newman's health care utilization framework explored contextual and community challenges faced by health care providers (HCPs) in the delivery of care services for children with pneumonia in select districts of Uttar Pradesh (UP) and Madhya Pradesh (MP). Semi structured interviews (SSIs) and focus groups discussions (FGDs) were carried out with a purposive sample of HCPs selected from three districts in each state. The HCPs included doctors and community health workers (CHWs). All SSIs and FGDs were audio- recorded, with consent, transcribed verbatim, entered into NVivo and analysed using thematic analysis. A total of 15 SSIs were conducted with doctors and eight FGDs were carried out with CHWs. Two themes that best explained the data were:, 1. Health systems: barriers faced in delivery of care services and 2. Evaluated Need: perceptions on community awareness and practices. According to the HCPs inadequacies in government health infrastructure both manpower and equipment, and skill deficits of paramedical staff and CHWs contributed to poor quality of care services for management of childhood pneumonia. This combined with inadequate understanding of pneumonia in the community, dependence on unqualified care providers and distrust of government hospitals acted as barriers to seeking appropriate medical care. Additionally, poor compliance with exclusive breast feeding practices, nutrition and hygiene had contributed to the high prevalence of the disease in these states. Strengthening public health facilities, instilling trust and confidence in people about the availability and the quality of these services and enhancing health literacy around childhood pneumonia would be critical towards protecting children from this disease.

Optimizing Care-Seeking for Childhood Pneumonia: A Public Health Perspective.

OBJECTIVE: This study examined the pattern of care-seeking behavior for childhood pneumonia and factors influencing it, in Madhya Pradesh (MP), Uttar Pradesh (UP) and Tamil Nadu (TN). METHODS: Using a mixed-methods design, consenting mothers of children less than 5 years with probable pneumonia participated in a household survey to assess their care-seeking behavior. A purposively selected sub-sample participated in semi-structured interviews (SSIs) to understand their perceptions on care sought, decision making abilities and cultural influences that governed these behaviors. Health care providers (HCPs) participated in SSIs and focus group discussions. RESULTS: A total of 2194 children were identified with probable pneumonia during the survey. 40 mothers and 41 HCPs participated in semi-structured interviews and focus group discussions. In MP, utilization of private allopathic care was high at 74%, about 8% went to unqualified care providers. In UP, 71% went to unqualified care providers and 5% did not seek care at all. In TN, 75% went to private allopathic doctors, and utilization of government care was higher (19%) compared to MP and UP. Qualitative findings revealed that cultural beliefs coupled with poor decision making abilities, poor understanding of illness and inappropriate care-seeking practices resulted in delays in care seeking, particularly in MP and UP. Inadequacies in government health infrastructure also contributed to their poor utilization. CONCLUSIONS: Promoting health literacy in communities and strengthening the reach of government health facilities will help in optimizing appropriate health care utilization for childhood pneumonia.

Understanding low mobilization for non-communicable diseases among people living with NCDs: A qualitative study on hypertension in urban South India.

There is low civil society mobilization for NCD policies in low- and middle-income countries (LMICs) despite a growing NCD burden. While existing research explains low mobilization largely through constraints such as inadequate funding and capacity at the organizational level, we explore the issue from the perspective of people living with NCDs and ask how lay understandings of hypertension may inform potential mobilization for multisectoral policy actions by people living with hypertension. To explore this question, we develop a theoretical framework that casts mobilization as a function of people's recognition of disease importance, attribution of NCD risk factors to government policies, beliefs about who bears responsibility for NCD prevention and management, and beliefs around efficacy of multisectoral policies. We present findings from 45 semi-structured interviews with people living with hypertension in a qualitative study in Chennai, India. Our thematic analysis reveals that respondents can dedicate limited time and resources to actions around hypertension. People living with hypertension also strongly internalize responsibility for developing and managing their condition and focus primarily on achieving lifestyle changes. Instead of demanding multisectoral policy action around hypertension, respondents recommend that government actions focus on measures that enable their lifestyle changes, such as increasing awareness and health care capacities, and express doubts about the efficacy of government policies. Our findings expand existing theories around mobilization by revealing how people's own understanding of their illness, its risk factors and their underlying drivers, as well as their perception of challenges in NCD policy making can present barriers to mobilization around multisectoral policies. Theory on health social movements would benefit from a deeper integration of individual perspectives and a closer consideration of the specific challenges of living with NCDs given the local context.

Patient and provider perspectives on barriers to screening for diabetic retinopathy: an exploratory study from southern India.

OBJECTIVE: Diabetic retinopathy is one of the leading causes of visual impairment after cataract and uncorrected refractive error. It has major public health implications globally, especially in countries such as India where the prevalence of diabetes is high. With timely screening and intervention, the disease progression to blindness can be prevented, but several barriers exist. As compliance to diabetic retinopathy screening in people with diabetes is very poor in India, this study was conducted to explore understanding of and barriers to diabetic retinopathy screening from the perspectives of patients and healthcare providers. METHODS: Using qualitative methods, 15 consenting adult patients with diabetes were selected purposively from those attending a large tertiary care private eye hospital in southern India. Eight semistructured interviews were carried out with healthcare providers working in large private hospitals. All interviews were audiotaped, transcribed verbatim and analysed using the framework analytical approach. RESULTS: Four themes that best explained the data were recognising and living with diabetes, care-seeking practices, awareness about diabetic retinopathy and barriers to diabetic retinopathy screening. Findings showed that patients were aware of diabetes but understanding of diabetic retinopathy and its complications was poor. Absence of symptoms, difficulties in doctor-patient interactions and tedious nature of follow-up care were some major deterrents to care seeking reported by patients. Difficulties in communicating information about diabetic retinopathy to less literate patients, heavy work pressure and silent progression of the disease were major barriers to patients coming for follow-up care as reported by healthcare providers. CONCLUSIONS: Enhancing patient understanding through friendly doctor-patient interactions will promote trust in the doctor. The use of an integrated treatment approach including education by counsellors, setting up of patient support groups, telescreening approaches and use of conversation maps may prove more effective in the long run.

Where do mothers take their children for pneumonia care? Findings from three Indian states.

Childhood pneumonia accounts for 17% of IMR in India, posing a major health burden. With cultural beliefs influencing care seeking behaviour and disparities existing in health infrastructure across the country, an understanding of the underlying issues merits exploration. Study assessed prevalence of probable pneumonia and examined care seeking behaviour of mothers in three states, Madhya Pradesh (MP), Uttar Pradesh (UP) and Tamil Nadu (TN). This mixed methods study involved a household survey and qualitative interviews with mothers in three districts from each state. Households with children aged 2-59 months were screened to identify those with probable pneumonia; sub-sample of mothers participated in qualitative interviews. Care seeking behaviour was explored in the context of recognition of symptoms, nature of first care provided, time when care was sought outside the home and choice of health provider. Overall 17,442 children from 13,544 households were screened, of which 729 (MP), 752 (UP) and 713 (TN) children respectively, were identified with probable pneumonia; 72 mothers participated in the qualitative interviews. Three months period prevalence was estimated in study districts at 22.2%-MP 13.3%-UP and 8.4%-TN. Most mothers in MP and UP were not perceptive to severity of illness; type of care sought was often inappropriate, delayed, with home remedies and visits to unqualified care providers being their first response. In contrast, in TN, use of home remedies was minimal, going to untrained care providers, non-existent and more than 90% mothers sought appropriate care. Private doctors were the preferred choice among all mothers but utilization of government care was highest in TN (20%). Community health workers were underutilized, with less than 10% mothers consulting them. Need for educating mothers about appropriate care seeking and development of good health infrastructure as essential to attainment of better child health indices are advocated.

Development and validation of a scale to assess attitudes of health care providers towards persons affected by leprosy in southern India.

INTRODUCTION: Assessment of attitudes of health care professionals is important as negative attitude could constitute a major deterrent to care-seeking by persons affected by neglected tropical diseases (NTDs) such as leprosy. Leprosy continues to pose a major disease burden in India with an annual new case detection rate of 10.17 per 100,000 population. This paper reports on the development and validation of a culturally appropriate scale to measure attitude of health care providers (HCPs) towards persons affected by leprosy in Tamil Nadu, India. METHODOLOGY/PRINCIPAL FINDINGS: The Affective, Behavioural and Cognitive (ABC) model of attitudes guided the development of the scale. Steps in scale development included qualitative interviews and focus group discussions with medical officers and paramedical staff selected from high prevalence districts in Tamil Nadu, India which informed the development of the draft scale. Reviews of existing attitude questionnaires in related areas further contributed to scale development and together helped to generate a large pool of items which was then subjected to Thurston's scaling method for selection of items from this pool. Face and content validity were obtained, following which internal consistency and test, re-test reliability were assessed. Scaling exercise resulted in 11 items being discarded from an initial pool of 38, owing to the poor agreement among experts regarding relevance. Face and content validity were good with experts endorsing relevance and applicability of items. The intra-class correlation coefficient (ICC) for test re-test reliability of the 27 item scale was 0.6 (95% CI: 0.20-0.78) indicating marginal intra-class correlation. The overall Cronbach's alpha was 0.85 while the alphas for each of the affective and behavioural components was good at 0.78 and 0.69 respectively indicating a good degree of consistency and homogeneity between items but the alpha for the cognitive component was low at 0.53. CONCLUSIONS: The ABC model of attitudes guided the development of the scale, ensured a mix of 27 items tapping into the three domains of Affect, Behaviour and Cognition which best explained the attitude construct. With good validity and alphas for each of the affective, behavioural components and overall alpha estimates, this scale can be a valuable tool to provide accurate estimates of the true attitudes held by HCPs. This, in turn, would be useful to obtain insights for appropriate intervention programmes that would help change negative attitudes of HCPs towards persons affected by leprosy. With some adaptations, the scales can be validated for other NTDs as well.

Spectacle compliance among adolescents in Southern India: Perspectives of service providers.

Purpose: Compliance to spectacle wear is vital to elimination of avoidable blindness among schoolchildren. This study aims to understand the barriers to compliance and strategies to overcome the barriers from the perspectives of the service providers of the school vision-screening model. Methods: A snapshot qualitative study using focus group discussions (FGDs) was conducted among the service providers including eye care professionals (ECPs) and social workers that are part of the school screening program. Sessions were audio recorded and transcribed. Themes were formed following inductive coding using a conceptual framework. Results: Out of the three FGDs, two were with ECPs and one with social workers. Four subthemes identified under the barriers were poor awareness, spectacle-related, psychosocial, and financial barriers. Unique barriers according to the service providers included nonuse of spectacles by asymptomatic children, children with unilateral refractive errors and those with emmetropic parents. Service providers also brought out parent's feelings of guilt, doubts about their children's impaired vision, the negative self-image among children, and difficulties in obtaining funding to support the costs of screening. Solutions that emerged included the personal visit of professionals for spectacle distribution and counseling parents, demonstration of improvement in vision for activities that were difficult for the children without spectacles and rewarding, and role modeling of compliant children. Conclusion: This study had identified unique barriers and solutions from the perspectives of the service providers. The suggested strategies would aid in an effective schoolchildren vision screening practice to enhance compliance to spectacle wear.

Differential item functioning for items in Berger's HIV Stigma Scale: an analysis of cohorts from the Indian, Swedish, and US contexts.

PURPOSE: To examine whether items in Berger's HIV Stigma Scale function differently with persons of different age, gender, and cultural backgrounds. METHODS: Secondary data from cohorts, collected in South India (n = 250), Sweden (n = 193), and the US (n = 603) were reanalyzed to evaluate DIF within, between, and across these cohorts. All participants had answered the revised version of the HIV stigma scale consisting of 32 items forming the subscales Personalized stigma, Disclosure concerns, Concerns about public attitudes, and Negative self-image. Differential Item Functioning (DIF) for these items was assessed using hybrid ordinal regression-IRT technique. When DIF was detected, the cumulative impact of DIF on individual subscale scores was evaluated. RESULTS: DIF was detected for 9 items within, between, or across cohorts, but the DIF was negligible in general. Detected DIF between the Swedish and Indian cohorts had a cumulative salient impact on individual scores for the subscale Disclosure Concerns; Disclosure concerns were overestimated in the Swedish cohort and both over- and underestimated in the Indian cohort. CONCLUSIONS: The items in the 32-item version of the HIV stigma scale did not seem to be particularly prone to present DIF. The DIF between the Indian and Swedish cohort for items in the subscale Disclosure Concerns could, however, result in both type I and type II errors if scores should be compared between the Indian and Swedish cohort.

Sociocultural and structural perpetuators of domestic violence in pregnancy: A qualitative look at what South Indian women believe needs to change.

In India, reported rates of domestic violence rise as high as 31%. Abuse against pregnant women in India is associated with depressive and PTSD symptoms, and poor birth outcomes, yet no evidence-based interventions have been tested on this population. In this cross-sectional qualitative study, we sought perspective on South Indian women's concerns about abuse during pregnancy and what they believed would help. Participants cited economic dependence on husbands and sociocultural structures as factors perpetuating domestic violence. Women also described resilience factors that can protect against abuse. Our participants highlighted a requisite for interventions within health and social systems.