A community evaluation of post-partum quality of life using a locally adapted mother-generated-index: the Delhi Delivery Care (DELCARE) Survey (2009-2011).

Post-partum quality of life is an inadequately studied and poorly understood outcome of delivery care, especially in low- and middle-income countries. Hence, we evaluated the postpartum quality of life and its clinic-demographic context as part of a 3-stage cluster randomized community survey (DECLARE; covered quality of care as primary outcome) conducted in 2009-2011 in Delhi. In stage 1 of participant selection(sampling), 20 wards (of 150; geographically defined administrative units) were selected using a probability-proportionate-to-size systematic method. In stage 2, one from each income stratum (high, middle, and low; multiple colonies within each ward) was selected from each ward by simple random sampling (total 60 colonies of 2311). In stage 3, a house-to-house survey was conducted to recruit ~1800 recently delivered women for the multidimensional work, which included quality-of-care, cost-of-care, and PPQOL. Among the participants, those with high school or above education were invited to administer the Mother-Generated Index and calculate the primary and secondary index scores (PIS and SIS). A total of 794 (of 857 eligible; 118846 households) women were administered MGI. The mean PIS was 4.6[95 percent CI 4.4-4.7] while the average SIS was 4.0[95 percent CI 3.8-4.2]. The PIS was worse for primiparous vs. multiparous mothers. On multivariate analysis, poorer psychological state, obstetric complications, and premature delivery correlated with poorer QOL scores, while better gestational weight gain, higher age, and labor-pain relief correlated with better QOL scores. The study benchmarks the poor status of post-partum quality-of-life and documents the spectrum, severity, and complexity of its key social, psychological, physical, and demographic determinants.

A stepped wedge cluster randomized trial to evaluate the effectiveness of a community leader-driven kit-based diabetes self-management education approach in improving diabetes control and care: study protocol for the DElhi Diabetes INTervention Trial (DEDINTT).

INTRODUCTION: Diabetes self-management education (DSME) helps patients self-manage their condition and improve outcomes/quality of life. However, access to DSME is limited, particularly in low-income areas. This study aims to develop a DSME training kit (EK-DIN), understand barriers to implementation, and evaluate the effectiveness and sustainability of community leader (CL)-based rollout using a stepped wedge cluster randomized trial format. METHODS AND ANALYSIS: The mixed methods study will begin with a qualitative study to evaluate the facilitators and barriers towards CL-based DSME. The in-depth interview notes will be transcribed for thematic analysis. These results will be utilized for a stakeholder's workshop to develop the EK-DIN kit, a patient-interfacing app, and an implementation plan. Rollout will be conducted in 30 clusters in Delhi, preselected by the DEDICOM-II survey in 5 steps (6 clusters every 3 months: 2 each from each socio-economic category; randomly selected per sequence). A CL from each cluster will be trained in using the EK-DIN kit/app over 1 month. The trained CL will conduct DSME sessions among the cluster residents using the EK-DIN kits provided fortnightly for 3 months. Compliance and blood parameters data will be collected at baseline, 3 months after the intervention, and every quarter thereafter till completion. Change in HbA1c before and after the intervention will be evaluated as the primary outcome using the swCRTdesign package for R version 4.0.2 and the swSummary function. The sustainability of the effects will be evaluated using the change in quarterly parameters after intervention completion. DISCUSSION: A positive result will set the template for a generalizable public health intervention with proven community effectiveness, sustainability, cost-effectiveness, and positive quality-of-life impact. While a negative result will require the testing of alternative approaches, it would still add substantially to existing knowledge on the subject. Given the diverse socio-cultural setting in which the trial is being proposed and the high power of the study, the results (positive or negative) should be widely applicable and have policy implications. TRIAL REGISTRATION: CTRI/2023/07/054963. Date of Registration: 7th July 2023.

Estimated risk of cardiovascular events and long-term complications: The projected future of diabetes patients in Delhi from the DEDICOM-II survey.

PROBLEM: Despite high prevalence and ethnic susceptibility, limited published estimates are available on long term complication risks among known diabetes patients in India. Hence, we undertook evaluation of the cardiovascular risk of known diabetes patients from Delhi. METHODS: The community-survey was conducted using a probability-proportionate-to-size(systematic) 2-stage cluster design. Thirty areas were selected for a house-to-house survey to recruit 25 to 30 subjects (known diabetes ≥1 year; 35-65 years of age) per area. Scores from the UKPDS 2.1, UKPDS 2.0, Framingham, ASCVD, WHO, NHS and SCORE studies were used for 10-year risk calculation. RESULTS: We enrolled 843 subjects of which 800 consented for blood sampling. The mean age of the subjects was 53.0(52.1-54.0) years, the mean duration since diagnosis was 7.1(6.7-7.5) years, with 49.8 % women. 61.8 % were hypertensive, 81.5 % were dyslipidaemic and 53.3 % had poor glycaemic control. Although variable, risk engines estimates were consensual in projecting a high ten-year Coronary-Heart-Disease risk of 10-16 %, a stroke risk of 3.7-5.0 %, and a 5.0-5.7% risk of cardiovascular fatality. These risks were 1.5-3 times the 'risk at target levels' suggesting mitigability. Only 9.3 %, 16.0 %, and 30.0 % were taking aspirin, lipid lowering drugs and antihypertensives respectively. CONCLUSION: The study highlights the impending impact of, and the scope for improvement in the cardiovascular risk profile of diabetes patients in Delhi, including the use of cardioprotective medications. It strengthens the case for developing and testing potential interventions for improvement.

The poor quality of diabetes care in a cluster randomized community survey from Delhi (DEDICOM-II): A crisis, an opportunity.

AIMS: To evaluate the quality of care in known diabetes patients of Delhi. METHODS: A cross-sectional survey was conducted using a two-stage cluster design. In all, 30 of 150 wards were chosen in Stage 1 (using a random computer-generated seed value and then selecting wards at a predefined sampling interval; Probability Proportionate to Size-Systematic) and one colony from each ward was selected randomly in Stage 2. The selected areas were surveyed house-to-house in one-of-four random directions to recruit a minimum of 25 subjects (known diabetes ≥1 year; 35-65 years of age) per area. Data were collected by interview, blood sampling and from medical records by specifically trained research staff. RESULTS: A total of 843 subjects (of 1315 eligible) were enrolled from 11,490 houses. For the intermediate outcome measures, an estimated 33.5% (95% CI 27.3-40.2) had an HbA1c value >10%, 67.2% (95% CI 62.8-71.4) had an LDL cholesterol level >100 mg/dl and 57.3% (95% CI 50.4-63.9) had BP levels >140/90 mmHg. For the processes of care in the last 1 year, 25.6% (95% CI 19.7-32.6) of the patients had an HbA1c (A1c) estimation and 2.4% (95% CI 1.1-4.9) had a dilated eye examination and 4.1% (95% CI 2.6-6.2) had foot examination. Diabetes self-management education was provided to only 11.3% (95% CI 8.6-14.7) while nutrition counselling was provided to 56.0% (95% CI 51.7-60.2). CONCLUSIONS: The glycaemic control, lipid control and BP management of known diabetes patients in Delhi are unacceptably poor and a wide gap exists between practice recommendations and delivery of diabetes care in Delhi.

Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial.

INTRODUCTION: Vitamin B12 deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B12 deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive. METHODS AND ANALYSIS: This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring's neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant's biochemical B12 status at age 9 months and maternal biochemical B12 status in the first and third trimesters. Maternal biochemical B12 status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored. ETHICAL CONSIDERATIONS AND DISSEMINATION: The study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits.Trial registration numberCTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov).

Efficacy of fermented milk and whey proteins in Helicobacter pylori eradication: a review.

Helicobacter pylori (H. pylori) eradication is considered a necessary step in the management of peptic ulcer disease, chronic gastritis, gastric adenocarcinoma and mucosa associated lymphoid tissue lymphoma. Standard triple therapy eradication regimens are inconvenient and achieve unpredictable and often poor results. Eradication rates are decreasing over time with increase in antibiotic resistance. Fermented milk and several of its component whey proteins have emerged as candidates for complementary therapy. In this context the current review seeks to summarize the current evidence available on their role in H. pylori eradication. Pertinent narrative/systematic reviews, clinical trials and laboratory studies on individual components including fermented milk, yogurt, whey proteins, lactoferrin, α-lactalbumin (α-LA), glycomacropeptide and immunoglobulin were comprehensively searched and retrieved from Medline, Embase, Scopus, Cochrane Controlled Trials Register and abstracts/proceedings of conferences up to May 2013. A preponderance of the evidence available on fermented milk-based probiotic preparations and bovine lactoferrin suggests a beneficial effect in Helicobacter eradication. Evidence for α-LA and immunoglobulins is promising while that for glycomacropeptide is preliminary and requires substantiation. The magnitude of the potential benefit documented so far is small and the precise clinical settings are ill defined. This restricts the potential use of this group as a complementary therapy in a nutraceutical setting hinging on better patient acceptability/compliance. Further work is necessary to identify the optimal substrate, fermentation process, dose and the ideal clinical setting (prevention/treatment, first line therapy/recurrence, symptomatic/asymptomatic, gastritis/ulcer diseases etc.). The potential of this group in high antibiotic resistance or treatment failure settings presents interesting possibilities and deserves further exploration.