Beyond Diarrhea: An Indian Expert Panel Delphi Consensus Recommendation

B. Ravinder Reddy¹*, Anant Nigam², Atul Gogia³, Sumit Bhatia⁴, Kamlesh Tewary⁵, Mohandas K. Mallath⁶, Prachee Sathe⁷, Ashwin Dabhi⁸, Babita Goswami Hazarika⁹, Christian Tesado¹⁰, Ayan Chatterjee¹¹, Priti Thakor¹¹, Harshad Malve¹¹

¹Division of Surgical Gastroenterology, Care Hospital, Hyderabad, India; ²Nigam Diabetes Centre, Jaipur, India; ³Internal Medicine and Infectious Diseases, Sir Gangaram Hospital, New Delhi, India; ⁴Institute of Digestive and Hepatobiliary Sciences, Medanta – The Medcity, Haryana, India; ⁵Deo Narayan Hospital & Maternity Center, Muzaffarpur, Bihar, India;  Department of Digestive Diseases, Tata Medical Center, Kolkata, India; ⁷Department of Critical Care Medicine, Ruby Hall Clinic, Pune, India; ⁸Consultant Physician & Nutritionist, Gujarat, India; ⁹Department of Dietetics, Apollo Gleneagles Hospitals, Kolkata, India; ¹⁰Medical Affairs, Johnson and Johnson Pte, Ltd, Singapore; ¹¹Medical Affairs, Johnson and Johnson Pvt Ltd, India.

*Presenting author

Introduction & Objectives

• Dehydration is highly prevalent within the healthcare setting and is often under-recognized and inadequately managed, both in the out-patient department (OPD) and in-patient department (IPD) setting.¹
• Although dehydration is frequently associated with an increased risk of hospitalization and mortality, few international guidelines provide recommendations regarding oral fluids, electrolytes, and energy (FEE) in adults or geriatric population^.2
• Currently, there is a lack of comprehensive recommendations on the role of oral FEE in non-diarrheal illnesses in the Indian adult/geriatric population.
• The objective of this initiative was to develop consensus statements for the management of oral FEE in adults and geriatric Indian patients with dehydration due to acute and chronic non-diarrheal illnesses.

Materials & Methods

Delphi methodology

• A modified Delphi approach designed using an online survey form followed by virtual meeting was used to develop this consensus recommendation. Statements that did not reach consensus were revised and recirculated for a second review.

Expert panel

• The Delphi panel consisted of 10 national experts including a gastroenterology surgeon, diabetologist, infectious disease and critical care specialist, gastroenterologist, internist, and a dietician.

Evidence appraisal and drafting of consensus statement

• Data regarding non-diarrheal dehydration in the adult and geriatric population were extracted from published literature and used to draft the list of statements.
• Overall, two sets of statements were finalized, one set each for the OPD and IPD setting.
• The final list of 109 statements, subject to expert panel voting, and 21 open ended questions were based on review of literature, clinical experience, international guidelines, and prescribing information of oral FEE in adults and geriatrics.

Delphi stages (Figure 1)

In round one, 109 statements (segregated into OPD and IPD) were circulated among ten national experts who were asked to either strongly agree/agree/ disagree/strongly disagree with statements and provide responses to open-ended questions.

Consensus was pre-defined at 75% agreement (pooling ‘strongly agree ‘and ‘agree’ responses).

The 21 open-ended questions (free text; qualitative measure) gave the panellists an opportunity to elaborate on their responses.

Presentation of relevant literature was done during virtual discussion and some statements were actively discussed and deliberately debated to arrive at conclusive statements.

Those statements that did not reach consensus were revised and re-circulated during round two.

Figure 1. Delphi Stages

Results

• The OPD set had 63 statements and 10 open-ended questions and the IPD set had 46 statements and 11 open-ended questions.
• Out of 109 statements, 106 statements (OPD: n=61; IPD: n=45) achieved the pre-defined consensus at the end of round one.
• Responses among the panel experts to all open-ended questions (total 21 questions from both OPD and IPD) were similar.
• The structure and semantics of 7 statements were changed during the virtual panel discussion for clarity.
• Two of the statements (both from OPD) that did not reach consensus during round one were re-structured during the virtual discussion and achieved consensus.
• During round two, one statement (from IPD) was re-circulated after an additional revision which thereafter achieved an 80% consensus. However, since this statement was purely based on the opinion of the expert panel and lacked supporting literature, it was decided not to include that statement as a recommendation in the final consensus.
• At completion of this modified Delphi process, consensus was achieved for all (130/130) statements and questions and the final consensus had 129/130 recommendations.
• The consensus statements covered domains such as assessment of dehydration, dehydration in geriatrics, energy requirements, impact of oral FEE on patient outcome, and fluid recommendations in acute and chronic non-diarrheal illness (6 domains with 16 key statements, Table 1).

Table 1: Topic Domains of Consensus Statements

• Oral rehydration with FEE should be recommended as part of core treatment from day 1 of acute non-diarrheal illnesses for improved outcomes.
• Commercially available appropriately formulated oral drinks based on individual taste preferences with the right balance of FEE are preferred by this panel.³

Challenges and evidence gaps

• There is a need for a product that has ideal characteristics of an oral restorative drink and, from a product perspective, there is still a lack of guidance or set of recommendations considering its salient features.
• The majority of Indian data on dehydration is on the pediatric population and in diarrheal diseases. There is a paucity of such data in the adult/geriatric population; there is an opportunity to develop more data in the population.

Conclusions

• These expert panel recommendations provide consensus statements for the management of oral FEE in Indian adult/geriatric patients with dehydration due to non-diarrheal illnesses.
• Future work should be aimed at developing scientifically formulated fluids in various formats and studying their safety, efficacy, osmolarity, balanced content, and palatability which may impact patient compliance in Indian adult/geriatric patients.

References: 1. Lacey J, et al. Ann Med. 2019;51(3-4):232-51. 2. Volkert D, et al. Clin Nutr. 2019;38:10-47. 3. American Society for Parental and Enteral Nutrition. Nutrition and Hydration: Key Weapons in the Fight Against COVID-19 2020. https://www.nutritioncare.org/uploadedFiles/Documents/Guidelines_and_Clinical_Resources/COVID19/COVID19%20 Patient%20Nutrition%20Paper.pdf.

Clinical trial registration: Not applicable

Conflict of interest:

BR Reddy: speakers bureau for Abbott India, Baxter India, DSM Switzerland, Fresenius-Kabi, Johnson and Johnson Pvt Ltd., and JS Pen Japan; A Nigam: consultant for Johnson and Johnson Pvt Ltd.; A Gogia: consultant for Cipla, Eli Lilly, Johnson and Johnson Pvt Ltd., Natco Pharma, Novo Nordisk, and Pfizer; S Bhatia: speakers bureau for Abbott, Dr. Reddy’s Laboratories Ltd., Johnson and Johnson Pvt Ltd., Mylan, Takeda, and Torrent; and consultant for Johnson and Johnson Pvt Ltd. and Takeda; K Tewary: consultant for Johnson and Johnson Pvt Ltd.; MK Mallath: consultant for Abbott Healthcare Private Ltd., Baxter (India) Private Ltd., Dr. Reddy’s Laboratories Ltd., Eisai Pharmaceuticals India Private Ltd., and Johnson and Johnson Pvt Ltd.; served on advisory board for Dr. Reddy’s Laboratories Ltd.; and contracted researcher for Dr. Reddy’s Laboratories Ltd; P Sathe: has no financial conflicts of interest to disclose; A Dabhi: speakers bureau for Abbott, Hindustan Unilever, Otsuka Pharmaceutical India, Sanofi Bohringer Ingelheim, Sun Pharma, and Zydus Bayer; served on advisory board for Hindustan Unilever, Johnson and Johnson Pvt Ltd., Otsuka Pharmaceutical India, and Zydus Bayer; and consultant for Otsuka Pharmaceutical India; BG Hazarika: consultant for Johnson and Johnson Pvt Ltd.; and speakers bureau for Abbott; C Tesado: employee of Johnson and Johnson Pte, Ltd., Singapore, and may own stock or stock options in Johnson and Johnson Pvt Ltd.; A Chatterjee, P Thakor, and H Malve: employees of Johnson and Johnson Pvt Ltd., India, and may own stock or stock options in Johnson & Johnson.

Acknowledgments: The study sponsor would like to thank Dr. Arindam Kar, Department of Critical Care Medicine, Sir HN Reliance Foundation Hospital, Mumbai, for his collaboration, efforts and contributions towards the development and review of this Delphi consensus. The sponsor is also grateful to Medulla (third party research agency) who provided support for conducting literature search and review, and Priyanka Nair, MDS (SIRO Clinpharm Pvt. Ltd., India), for providing writing assistance during the development of this poster.

Funded by Johnson & Johnson India Private Limited, India; Previously presented at IPHC 2022, March 21-23, 2022, Singapore (Virtual)

Presented at ASPEN 2022, March 26-29, 2022, Seattle, Washington, USA & Virtual