What is research?

Welcome to the Research Participant Information section on the CHAIN Network website. The purpose of this section is to provide general information about research to people who are considering enrolling their children or children under their care for the CHAIN study. The following information will help you understand what a research study is and what it is not, who conducts research, and why people may choose to participate in research.

Why take part in research??

Research helps to answer important questions that can improve the lives of people. The information collected helps to fill gaps in knowledge and allows scientists, doctors, policy makers and leaders make better decisions. Research participation is always voluntary. This means that anyone can accept or refuse to be part of a research project. It is important to know that anyone enrolled in research can choose to stop participating at any time.

Who conducts research?

Research can be done by different types of people. In hospitals, research is done by doctors, nurses and sometimes, field workers who are taught how to ask specific questions or collect special samples that will be used to answer a central question.

What is the CHAIN study about?

The CHAIN study’s research is aimed at understanding why children with malnutrition find it harder to recover from illnesses and return to normal than children without nutritional problems. To learn about this, we are studying children who are admitted to CHAIN partner hospitals with various degrees of malnutrition, and from nearby communities, some children with no malnutrition at all. We are doing this research to help to identify better ways to care for children in the future.

In order to further improve our understanding of children’s experiences before and after hospital discharge, we would like to talk with the parents or carers of some discharged children. We would like to talk about the child’s health over time, how any illnesses have been handled, any challenges families have faced in the household and health facilities that have affected the child’s health or well-being, how families have been coping with any challenges they have faced.

This additional talk does not require any extra visits to the hospital or physical procedures like blood sampling. We would like to talk to a total of 60 families per hospital who live in different places and have had different experiences with illness.

Why do you want to talk to me and what does it involve?

We feel that your experience as a parent/carer can add to our understanding and knowledge of children’s illnesses and how to improve child health in future.

If you are willing to be interviewed:

• Your child will continue to get care and remain involved with the staff at the hospital in the way you have already discussed and agreed with them.
• In addition, you and one other person in your household that you feel would help us improve our understanding of children’s experiences before and after hospital discharge will be interviewed at least once. We would provide those others with the same information being provided to you, and ask if they are willing to help.
• These first interviews could either be today, or in the near future on a day that suits the people involved. If you do not want to answer any of the questions you may say so and the interviewer will move on to the next question. No-one else but the interviewer will be present unless you would like someone else there.
• In 24 of the 60 households, we would like to visit the home again at around the same time as the visits you have been requested to make back to hospital i.e. at around 6 weeks, 3 months and 6 months after discharge. We will select these 24 households based on the information given in first interview and in order to follow up on different experiences that households have had around their child’s health. The topics discussed in the follow up meetings will be the same as those in the first meeting, but continuing to understand these situations over time.

If you are willing, discussions will be recorded to assist in writing up the information later. No-one will be identified by name in the recording.

What can participants expect?

Ill children admitted to hospital who qualify for the study will be identified upon admission and caregivers will be informed of the study and objectives. After initial screening, the child’s caregivers will be invited to participate and asked to provide consent. Both questionnaires and clinical assessments will be used to evaluate the child’s health status and family characteristics at admission, through-out the child’s hospital stay, at discharge and until 6 months after returning to their homes.

In addition to routine tests carried out for care, small amounts of blood and faeces (stool) will be collected for research. These samples will be used to test the function of the child’s body (e.g., to evaluate circulating levels of nutrients, intestine function or markers of infection and inflammation). With samples collected at specific time-points such as at hospital admission and discharge, the effects of treatment and recovery can be studied. Children with poor outcomes can thus be compared to those that recover and the contribution of undernourishment can be evaluated. This will help to identify and treat children that are at risk for poor outcomes. Household visits conducted at hospital discharge will provide social and environmental information.

At 45, 90 and 180 days after discharge, children will be followed-up. These assessments will include health questionnaires and anthropometric measurements to evaluate a child’s growth and recovery. This will help establish why some children either do not recover, become sick again or fail to grow well.

Children who are not sick will also be enrolled from the community. For these, a household visit will be done to invite them to participate as well as obtain social and health information, measure the child’s height and weight. Once invited, the caregivers will be required to bring the children to the hospital facility linked to the CHAIN study where questionnaires will be completed and blood and stool samples collected. This will help establish normal baseline levels for all measurements within communities where the ill children are from. This will also give us an indication of how well a previously ill child can be expected to recover.

What will happen if I refuse to participate?

All participation in research is voluntary. You are free to decide if you want to take part or not. If you do agree you can change your mind at any time without any consequences.

Are there any risks or disadvantages to me/my child of taking part?

The discussions should take approximately one to two hours per person; a total of up to four or five hours if we are talking to several people in the household. We recognise that answers about family experiences and child health can be confidential or sensitive to some individuals. Caregivers have the right to refuse to answer any question that makes them feel uncomfortable. We will compensate everyone for time spent in these interviews and potential lost earnings through the provision of dry food stuffs to the family.

Are there any advantages to me/my child of taking part?

There are no individual benefits to taking part. In talking to us, you will contribute to knowledge of child illness before and after hospital discharge that may help other people in Kenya and elsewhere in the future, for example through developing new health policies or interventions.

Who will have access to the information I give?

• In order to do this study, we will share anonymized individual and summary information we collect or generate with several people named as investigators on the top of this form in ways that do not reveal individual participants’ identities.
• All of our documents/ recordings will be stored securely in locked cabinets and on password protected computers. The knowledge gained from this research will be shared in summary form, without revealing individuals’ identities.
• In future, information collected or generated during this study may be used to support new projects by other researchers in Kenya or other similar countries on families handling child illness. In all cases, we will only share information with other researchers in ways that do not reveal individual participants’ identities. For example, we will remove information that could identify people, such as their names and where they live, and replace this information with number codes. Any future research using information from this study must first be approved by a local or national expert committee to make sure that the interests of participants and their communities are protected.
• Recordings of interviews will be destroyed at the end of the study.