1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  By personal email of PI Dr Geetanjali Katageri (katagerigm@gmail.com) to the study investigator - 1. Professor Andrew Shennan, Professor of Obstetrics, King’s College London andrew.shennan@kcl.ac.uk


6. For how long will this data be available start date provided 01-05-2026 and end date provided 30-04-2031?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

Title of the Research Project:    Development and evaluation of educational and shared decision-making tools in women with pre-eclampsia: multiple-site multiple-method study.

Objectives:

1. Co-design novel education and Shared Decision Making tools regarding: i) Information about pre-eclampsia during Pregnancy; ii) Shared decision making tool for planning time of birth in Pre-eclampsia; iii) Information about Postnatal care and Pre-eclampsia.

2. Describe introduction of tools into three different settings (India, Sierra Leone and Zambia). 

3. Evaluate the impact of the novel tools based on aspects of the RE-AIM framework (Reach and effectiveness).

Pre-eclampsia continues to be a major cause of maternal and perinatal morbidity and mortality in India. The unpredictable disease progression, and the fact that affected women and their families do not understand the nature of the disease and importance of complying to treatment, makes management even more challenging.

This study hopes to develop education and shared decision-making (SDM) tools regarding antenatal management, timing of delivery and postnatal care in pre-eclampsia. We will include pregnant women, their relatives and healthcare providers in focus group discussions where they will be requested to give inputs into prototypes of SDM tools put together by the researchers.

The finalized SDM tools will be tested in clinal settings and their reach, effectiveness and acceptability will be assessed. The involvement of the patients, their relatives and healthcare personnel in the development of the aids, are likely to make them more appealing to all stakeholders.

With improved patient understanding about pre-eclampsia, we anticipate that they will have better compliance with clinical advice. This in the long run, is expected to decrease the morbidity and mortality associated with pre-eclampsia.

Setting and participants

Pregnant or postpartum women with pre-eclampsia and their principal healthcare professionals (obstetricians, paediatricians, midwives, community health workers), community stakeholders, in three healthcare settings (India, Sierra Leone, Zambia).

This study will be done in two sites in India with differing socio-cultural environment, language, and healthcare infrastructure.

The study sites are 1. Bagalkot, Karnataka and 2. Puri, Odisha.

Health condition studied: Pre-eclampsia Knowledge

Project design and methods:

Mixed methods study

Tools’ Development: Focus Group Discussions

Tools’ Evaluation: Focus Group Discussions; decisional conflict and acceptability questionnaires.

Study Duration: 12 months

Expected Outcome: 

The study hopes to develop shared decision-making tools which will aid in the complex counselling required for effective management of pre-eclampsia. By aiding the understanding of the patients and the relatives about pre-eclampsia, it is anticipated that they will be more ready to comply with treatment and more equipped to take informed decisions during management. If the study proves that healthcare providers find the SDM tools useful in clinical settings, the tools could be adapted for use in different regions of India. Overall, we hope that development and use of the SDM tools decreases the morbidity and mortality associated with pre-eclampsia in the long run.