The aim of this study was to evaluate protocol adherence and its impact on inpatient mortality in patients with diabetic ketoacidosis (DKA) at a tertiary hospital in Karachi. The major hypothesis was that adherence to the DKA protocol reduces inpatient mortality.

This was a retrospective cohort study.

The study was conducted at the Aga Khan University Hospital (AKUH), Karachi, a tertiary care hospital in Pakistan.

The study included patients diagnosed with DKA and admitted to AKUH from 2017 to 2021. Eligibility criteria included patients aged 18 and older, excluding those with incomplete records or referred to other hospitals.

The primary outcome was inpatient mortality. The analysis included Cox proportional hazards regression. Secondary outcome measures included predictors of mortality such as hypertension, intubation, tachycardia and elevated creatinine levels.

Non-compliance with the DKA protocol (

Adherence to the DKA protocol is crucial for reducing inpatient mortality and improving outcomes, especially in low- and middle-income countries. Ensuring at least 70% compliance is vital. Recommendations include continuous training for healthcare providers, adequate staffing and resource optimisation. Future research should focus on interventions to boost compliance and explore other factors affecting protocol adherence to further enhance patient care.

Though prior trials have shown the effectiveness of community-based hypertension detection and care delivery models, their adoption and translation to practice has been slow. In this study, we will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) in Pakistan that comprises health education, blood pressure (BP) monitoring and referrals by lady health workers (LHWs) and hypertension management by physicians in primary care settings.

In this 24-month hybrid type III implementation-effectiveness cluster-randomised controlled trial, we will recruit 3000 adult hypertensive patients from two rural districts of Pakistan. We will engage public health sector managers, physicians and LHWs and use the Consolidated Framework for Implementation Research to identify barriers and facilitators to the implementation of an already proven-to-be-effective MCHI. Using Expert Recommendations for Implementing Change and the modified Delphi technique, a set of implementation strategies addressing barriers will be identified. The strategies will be categorised as level 1 (requiring a change in processes), level 2 (requiring a change in infrastructure) and level 3 (financial restructuring). Basic health units and 250–300 households from their catchment will be considered as clusters. Clusters will be randomised in a ratio of 1:1 to intervention and control. While MCHI will be offered in both trial arms (intervention and control), the aforementioned implementation strategies will be randomised to the intervention arm only, starting with level 1 and moving to levels 2 and 3 as needed. Baseline and 6-monthly follow-up surveys, each of 6 months duration, will be conducted to collect data from the recruited participants on sociodemographics, cardiovascular disease (CVD) risk factors, CVD-related expenses and quality of life. The primary outcome will be the mean difference in BP-lowering medications per participant between the intervention and control arms. The primary outcome will be analysed using a linear mixed model with fixed effects for baseline value of the outcome. Additional outcomes include implementation outcomes: proportion of LHWs conducting health education, BP screening and monitoring, facility referrals and proportion of physicians diagnosing and treating hypertensive patients; effectiveness outcomes: proportion of participants with controlled BP and improved EQ-5D-5L score.

Ethical approval has been obtained from the Ethics Review Committee of Aga Khan University Pakistan (ERC # 2023-9084-26739). Findings will be reported to: (1) study participants; (2) funding body and institutes collaborating and supporting the study; (3) provincial and district health departments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications

NCT06726057.