Perceptions of Consent for a Pediatric Tele-health Trial during Emergency Transport in Pakistan

Abstract

Introduction:

Childhood mortality in the emergency setting is disproportionately high in low-middle-income countries (LMIC), with limited research dedicated to improving timely interventions, especially for critically ill children during transport. To perform essential prehospital pediatric research, there is a need for a tailored consent process, which reflects the specific needs and concerns of participants in this challenging research context.

Objective:

To prospectively investigate stakeholder perceptions and preferences regarding consent processes for a specific pediatric ambulance-based telemedicine trial.

Methods:

Exploratory qualitative study design using face-to-face semi-structured interviews and focus group discussions. Data was analyzed using thematic analysis. Participants included healthcare providers (pediatric telemedicine physicians and emergency medical technicians) and parents of children who required emergency transportation in Karachi, Pakistan.

Results:

Forty-seven participants, ranging from 19 to 47 years old, were involved in in-depth interviews or focus group discussions. The participants comprised 29 healthcare workers and 18 parents. Among them, 9 were females and 38 were males. Expressing diverse attitudes towards different consent methods, the majority recommended a prospective written informed consent approach to build trust and provide legal protection. Participants understood the situational incapacity that occurs in emergency settings, emphasized the importance of keeping the consent brief, and recommended a subsequent contact in 2–3 days after the emergency transport to reconfirm consent and answer any questions.

Conclusion:

Our interpretation of the findings revealed that participants preferred a staged consent process for telemedicine trials in LMIC pediatric emergency settings.

INTRODUCTION

In many low- and middle-income countries (LMICs), the absence of clear standards for obtaining appropriate research consent poses a significant challenge^1,2. This is particularly true in research involving pediatric emergency transportation, where shorter time windows and acuity of child illnesses often translate into parental anxiety and stress, limiting their ability to give true informed consent ^1,3. However, there is a pressing need for emergency research ^4,5, especially in LMICs like Pakistan, which has an high rates of childhood mortality and morbidity primarily due to time sensitive illnesses such as pneumonia, diarrhea, complications of childbirth, sepsis and injuries⁶.

Transporting a critically ill child to a healthcare facility is a time of greatest risk. Yet, there is a dearth of studies investigating approaches to improve the quality of care during this phase. The lack of research consent models in out-of-hospital settings is a key barrier to research in this area. The FEAMER trial will explore if implementing telemedicine support during the ambulance transport of critically ill children in Pakistan can help reduce childhood mortality ^7,8 (Figure 1). Besides time constraints and psychological stress, diversity of cultures, socioeconomic status and languages, and a limited understanding of research, adds to the ethical and logistical challenges in determining the appropriate type and timing of consent without compromising treatment ⁹.

Figure 1.

Feasibility and Efficacy of Ambulance-based M-health for Pediatric Emergency intervention schematic (images sourced from a public website). EMTs, emergency medical technicians. CLF, ChildLife Foundation.

To address this gap, a qualitative study was conducted to explore the perceptions and preferences of parents and healthcare providers regarding the most suitable method(s) for obtaining parental consent by EMTs. The study was conducted as part of a trial on telemedicine-assisted pediatric emergency transport in Pakistan. The trial, Feasibility and Efficacy of Ambulance-based M-health for Pediatric Emergency (FEAMER), will explore whether implementing telemedicine support during the ambulance transport of critically ill children can help reduce childhood mortality ^7,8 (Figure 1).

METHODS

Research team and reflexivity

Interviews and focus groups were conducted by three authors (AAHM, SH, and HA). All interviewers were female medical doctors with experience conducting focus group discussions and interviews. The interviewers were fluent in English and Urdu to accommodate the participants’ needs. HA is a pediatric emergency physician at the Aga Khan University Hospital (AKUH). AAHM and SH were research associates at the Aga Khan University at the time of data collection. All interviewers received additional qualitative research training from KW (female social scientist) through recorded interactive online sessions. Recordings were made available for future use. Regular meetings involving the entire study team were held throughout the research process to discuss the developing topic guides, data collection, interpretation, and analysis as part of the iterative approach.

Research team members were not in contact with any of the participants before study enrollment.

Study design

We used an exploratory qualitative study design.

Participant selection

We recruited participants through purposive sampling to enroll three distinct stakeholder groups: pediatric telemedicine physicians (TMPs), emergency medical technicians (EMTs), and parents of children (aged 14 years or less) who had used an ambulance during the last 2 months. EMTs are healthcare professionals trained to provide pre-hospital emergency medical care at the scene and during transportation. . Both EMTs and TMPs had at least six months of work experience in their current role. .

Study participants were identified and recruited by our EMS and telehealth partners. . . None of the participants withdrew from the study after initial consent.

Setting

All interviews and focus group discussions occurred in person in a private designated room or individual participants’ homes. Only the research team and participants were present at these locations during data collection which took place August and October 2022, and February 2023.

Data collection

All interviewers used semi-structured interview guides with relevant probes to elicit detailed information from the participants. Three guides were created- one for each of the three participant groups. Since the research team included bioethicists and researchers from Pakistan, we could ensure that appropriate terminologies were used in the context of the local setting. The guide was also pilot-tested with 2 TMPs, 3 EMTs, and 5 parents, with relevant modifications made to the interview guides. As part of an iterative process, we revised the parent’s interview guide after 9 interviews to incorporate evolving concepts and to help clarify descriptions of consent approaches that EMTs could use to consent parents of sick children. In the original guide, we wished to elicit parents’ preferences between three consent approaches: prospective informed consent, deferred consent, and complete waiver. In the revised guide, we updated the consent to highlight two new approaches through illustration and detailed descriptions (Figure 2): modified informed consent and staged consent. The evolution of our consent approach is illustrated in Figure 3. Researchers conducted and audio recorded the interviews and group discussions in the local language, Urdu. Subsequently, all audio recordings were transcribed and translated into English. To ensure accuracy, all translations were checked twice against their respective audio files.

Figure 2.

Modified Informed and staged consent options.

Figure 3.

Evolution of various consent approaches.

Interviews took up to 36 minutes and 33 seconds and focus group discussions up to 1 hour and 31 minutes.

The data collected was regularly discussed among the research team to determine the point of saturation.

No repeat interviews were carried out, and transcripts were not returned to participants for comment or correction.

Data analysis

We used the qualitative data management software NVivo Release 10. Data was analyzed interpretively and iteratively^10,11. Analysis was informed by the work of Braun and Clarke and their guide to thematic analysis^12–14. In the first phase of the analysis, two researchers (NA and KW) independently read and coded (open and inductive) each transcript. Regular team meetings were held to assess the coding framework and resolve any disagreements, and re-code if necessary. Local team members actively supported these meetings to ensure accurate translation and interpretation of the participants' expressions and language usage (WF and HA). Finally, the results were mapped by themes and subthemes formed by grouping similar codes, with illustrative quotations extracted for presentation.

RESULTS

Sample description

A total of 47 participants (24 Emergency Medical Technicians, 5 telemedicine physicians, and 18 parents) were involved in the focus group discussions and interviews, composed of 9 females and 38 male participants, with age ranges between 19 to 47 years (Table 1).

Table 1:

Demographic characteristics of participants (n=47)

	Participant groups
Characteristic	EMTs (n=24) n (%)	TMPs (n=5) n (%)	Parents (n=18) n (%)
Gender
Male	24 (100)	2 (40)	11 (66)
Female	0 (0)	3 (60)	6 (34)
Age range in years	19 – 43	29 – 40	24 – 47
Work experience (average in months)	11	19	-
Occupation	Paramedics	Physicians	Stay at home mother (n=3), Pharmacists (n=2), Laborer (n=1), Carpenter (n=1), Factory Worker (n=1), Tailor (n=1), Unemployed (n=1), Private employment (n=1), Businessman (n=1), Teacher (n=1), Microbiologist (n=1)

Abbreviation: EMT: Emergency Medical Technician; TMP: Telemedicine physicians;

General views about research and understanding of consent

Most participants across healthcare providers and parent groups described the necessity of research, emphasizing its benefits for future patients.

“I think that permission should be taken and the way we ask them to sign the consent form for the ambulance, in the same way, we take permission for this too.” (EMT focus group discussion 2, Participant 1)

The majority of participants from all cohorts expressed that obtaining the parents’ consent was necessary, whether it was administering an intervention or collecting data for research.

“If we use the data of some children then it is necessary to take the consent of the parents.” (EMT focus group discussion 3, Participant 4)

Consent options for a telemedicine trial

During the interviews and group discussions, we explored participants’ views on their preferred approach to consent for the telemedicine trial. In the second round of interviews, which only involved parents, we introduced alternate options: a modified informed consent and a staged consent process (Figure 3).

Waived Consent

Most participants from across the three groups stated that waived consent was not an option for the proposed trial, or indeed any form of research, as they believed that consent should be sought prior.

“Without any permission, doing some research work is not correct. For that, you will have to tell and email and then this will be informed to the management. And when you use the data of the patient, you have to ask first.” (EMT focus group discussion 1, Participant 8)

EMTs also expressed their concerns about potential legal consequences if consent was not obtained from parents in advance.

“It is not correct, ethically. We have to ask the parents. It is the right of the patient. If we ask permission, then it would be better. Without consent, they can take some action against you. It is that asking permission is necessary.” (EMT focus group discussion 1, Participant 6)

On the flip side, our findings also revealed parents' trust in healthcare professionals, believing that doctors always act with the best interest for their child and that they would never intentionally harm patients.

“We are nothing, we are just neutral beings, but a doctor's education is Masha Allah very good, and he is very educated. So, they know better than us. And if they are taking our consent then it is a very good thing and consent should be given.” (Parent 1st round interviews, Participant 3)

Informed Consent

Participants expressed that obtaining consent early would help to prevent legal issues, but also avoid challenges of approaching parents once they reached the hospital and became occupied with the child’s treatment.

“It should be told at the start so that there is not any issue afterward.” (Parent 1^st round interviews, Participant 1)

Interestingly, the preference for obtaining signed consent in advance was not only requested by healthcare providers but also by parents. Both groups believed that it is essential for the protection of healthcare providers.

“Yes, so that tomorrow nobody says whether you have taken it or not. And if it would be written then it would be better for you. That they had agreed at the time”. (Parent, 1st round interviews, Participant 4)

However, some participants expressed concerns towards the informed consent process, as they understood the urgency of ambulatory transport.

“Some parents can get aggressive about the fact that instead of taking care of their child, staff is busy obtaining permission for research.” (Parent 1st round interviews, Participant 8)

Based on the finding from the first interviews, we provided a modified consent as depicted in figure 2 under “Modified informed Consent”. This consent included a brief consent with a signature, and parents would also receive an extended ‘consent document’ with all details about the study to read after when they are less stressed.

“Signature is better because one thing will be in front of us, we will be aware of it, we will read it, if that thing looks right, then we will sign it.” (Parent 2^nd round interviews, Participant 8)

Deferred & Staged Consent

When introduced to the concept of deferred consent- in which intervention is started as soon as possible with a delayed formal consent-taking process, participants reiterated the need for obtaining consent at the outset, and simultaneously voiced concerns about the emergency transport setting, acknowledging that parents might be in severe distress due to the situation. This demonstrated the participants’ comprehensive understanding of the complex study environment.

Healthcare providers preferred a multi-stage consent approach, where brief information is provided right before the intervention, followed by a more comprehensive and detailed consent after some time has passed. They felt this consent approach would be appropriate particularly in the event the child had passed away to give the parents some time for bereavement.

“If someone who has a life-threatening problem, the attendants are already worried about him, so they just want the patient to reach the hospital quickly. In this case, it is not proper to intervene in the middle for consent of research.” (TMP, Participant 5)

EMTs stated that parents’ primary focus during the transport is their child’s treatment, and additional information would be challenging for them to retain. Given this stressful situation, they thought parents would need more time before considering agreeing to a research study.

“I think that for the critical patient, you can only tell when they are relaxed a bit. Their mind should be a little relaxed. When the attendant relaxes a bit then you can take the consent.” (EMT focus group discussion 3, Participant 1)

In the second round of parent interviews, we changed the research consent for the deferred consent process and presented a 2-stage consent process (figure 2). Ultimately, there was nearly an equal preference for both modified informed and staged consent approaches.

“When you drop the patient to the hospital, you can ask after 48 to 72 hours but during transportation just take verbal consent and ask for a simple signature for your record.” (Parent 2^nd round interviews, Participant 4)

DISCUSSION

This is the first study exploring the perceptions of key stakeholders on a preferred consent process for an ambulance-based pediatric emergency trial in low- and middle-income country. To identify the most acceptable consent process for this trial, we introduced diverse approaches and models from existing literature. Majority of stakeholders were most comfortable with a 2-staged consent which was adopted in the pilot phase of our study and could be applied in other settings with studies involving pediatric emergencies, especially pediatric emergency transport. During the first round of our interviews, it become clear that the majority of participants preferred a form of prospective consent with a signature. However, it was also evident that a detailed informed consent process would be impractical in this setting. Therefore, we developed “modified informed” and “staged” consent options.

Despite an overall unfamiliarity with consenting for research and low literacy levels amongst parents, there was a generally positive attitude toward recognizing the importance of research. When examining participants’ understanding specifically of research consent, they found it challenging to respond directly to the question and instead consistently drew parallels that consent should be taken in the same way as for any other medical interventions. In most interventions, consent is acquired at an early stage, preceding any actions taken, and this approach was also prioritized for research consent by the participants. Kengne-Ouafo et al. found in a study in Northwest Cameroon that participants similarly stressed the importance of receiving information about the research study at the beginning ¹⁵. In the context of Pakistan, stakeholders were also aware of potential follow-up challenges and the difficulties associated with obtaining consent in the event of changes in the child's condition.

Healthcare workers emphasized the need for a signature to document consent, to safeguard against potential blame from parents in the event of unforeseen complications. Also, parents expressed the need for a signature to affirm their decision to participate and to protect healthcare workers. We hypothesize that the participants’ concern is based on factors including fear that some parents may not remember giving consent due to stress of the situation which may lead to complaints or potential violence against the EMTs. Interestingly, these findings contrast the observations in the study by Tekola et al., who reported that respondents in the Wolaita Zone of Ethiopia did not express a preference for the use of signed consent forms ¹⁶. Participants in Ethiopia expressed a belief that their low literacy levels hindered their ability to read the study information or sign a consent form ^16,17.

In our study, participants raised concerns about parents' difficulty in comprehending the information presented during the consent process. However, this challenge was attributed not just to low literacy levels but specifically to situational incapacity; they worried that consenting for research in this context might impact the time dedicated to treating the child. Consequently, this may jeopardize the integrity of informed consent, raising concerns about the voluntary nature of the consent process and the comprehension of associated risks and benefits. The discussions with parents involved with the Fluid Expansion as Supportive Therapy (FEAST) trial revealed similar findings, illustrating parental anxiety and vulnerability during the consent process. This highlights the importance for a consent approach that recognizes and respects this unique emotional situation. These patterns are also observed in other trials in High Income Countries (HIC), where both parents and healthcare providers frequently advocated for prioritizing immediate treatment over obtaining consent¹⁸. However, the findings also leaned towards favoring an early and formalized consent process to improve trust and serve as a safeguard. During initial interviews, when different consent options were presented to the parents, it became apparent that they encountered difficulties in comprehending the nuances of the various consent options. They found it challenging to recall specific differences between the described approaches, which resulted in a tendency to alter their decisions when introduced to a new concept. We aimed to establish a consent process characterized by clarity, considering the emergency situations, and recognizing the complexities associated with understanding consent procedures.

Our modified approach aims to facilitate a suitable consent process within the context of pediatric emergency care in LMICs ¹⁹. This consent includes a brief verbal presentation of the study, followed by signing the consent. Then the EMT will provide a consent document with a detailed description of the study, emphasizing a follow-up within 72 hours to revisit the participant’s willingness to participate. At the 72-hour follow-up participants will be given the opportunity to ask questions and verify their understanding of the study. They will also be given the opportunity to have their child’s data removed as an option to opt-out. This method informs participants about interventions in advance, allowing for autonomous decisions and trust-building. It respects the unique emergency situations, but also offers reconsideration opportunities for the parents. Additionally, we address any concerns about treatment delay, promoting a comprehensive consent approach in LMIC emergency research.

LIMITATIONS

Our findings offer valuable insights for advancing research on obtaining consent in pediatric emergency ambulance transport within a LMIC setting. While our qualitative study did not include the larger community, data saturation was achieved ²⁰. However, we engaged parents with relevant personal experiences in the emergency transportation of their own children and healthcare providers (EMTs and emergency physicians) directly involved in the trial. Since our study focused on identifying the best consent approach for a low-risk telemedicine clinical trial, our findings may not be generalizable to trials and clinical care requiring high-risk decisions. The absence of females in the EMT workforce in Pakistan leaves potential alternative viewpoints unexplored-especially for regions where females significantly represent the workforce of the EMT service. Iťs important to emphasize that children were not involved in our study.

We are not aware if literacy levels among the included parents were representative of the general population. However, our sample size included a wide range of educational backgrounds. Our study is isolated to the large city, social and cultural norms of Karachi, located in one province of Pakistan, which can restrict the findings' transferability to other provinces.

CONCLUSION

Our study identified stakeholder views and perceptions to research consent approaches for a pediatric emergency transport trial in Karachi, Pakistan. They acknowledged the importance of a formal informed consent process for legal protection, but voiced concerns of practicality in emergency situations. Based on these responses, we devised a modified informed consent process consisting of a brief study description with permission during the transport phase, and a subsequent follow-up call to reconfirm consent and ensure an understanding of the study objectives and risks and benefits.

“What is already known on this topic”

• Pediatric emergency research in LMICs face ethical and logistical challenges due to time-sensitive illnesses and parental stress during ambulatory transport.

• Consent processes in emergency settings are complex, with limited research on effective models for pediatric prehospital care.

• Existing studies highlight the need for legally sound yet practical consent approaches that do not delay urgent medical interventions.

“What this study adds”

• A staged consent approach, with brief initial consent and detailed follow-up, was the preferred consent model for a pediatric emergency telemedicine trial.

• The study informs ethical frameworks for pediatric emergency research in LMICs, adapting consent strategies to high-stress environments.

“How this study might affect research, practice, or policy”

• Encourages adoption of staged consent models for pediatric emergency research to enhance ethical compliance and feasibility.

• Informs ethical guidelines on obtaining consent in emergency settings while maintaining patient autonomy.

• Highlights the need for culturally sensitive and context-specific consent frameworks in global health research.

DATA SHARING

Data sharing not applicable as no datasets generated and/or analyzed for this study