Abstract
Background
Although less than 2% of pregnancies require admission to an intensive care unit (ICU), both maternal and fetal mortality are high when critical care is required.1–3 Pre-COVID data from Canada demonstrate that although maternal mortality has remained stable, the rate of pregnancy-related critical illness increased by 1.3% annually to a rate of 20.5/1000 in 2015. 4 The incidence of severe maternal morbidity which often requires critical care unit admissions, varies considerably across the world from (0.01% to 8.2%) due to variations in case-identification criteria. 5
The management of critically ill pregnant individuals is considered different from non-pregnant individuals, due to altered maternal physiology, fetal implications of medical intervention and psychosocial issues. 6 In addition to pitfalls in anticipating maternal critical illness and subsequent death, 7 critical illness during the antepartum period is made more challenging by issues surrounding the safety of interventions, and the maternal and fetal risks associated with continuing the pregnancy. 7 Postpartum considerations such as mother–child bonding, breastfeeding, and family dynamics further complicate decision-making. 8
Research is being conducted to address these specific considerations, but it is limited by the lack of standardisation of outcome reporting and inclusion of patient-important outcomes.9,10 The aim of this study was to elicit outcomes from individuals with lived experience of critical illness in pregnancy and their family members. The findings, in addition to creating awareness among healthcare providers and researchers on the importance of considering patient-important outcomes in clinical care, research, and health policy, will inform the development of a Core Outcome Set for research on Critically ill Obstetric patients (COSCO). 11
Methods
This study used qualitative methodology from an interpretivist paradigm. We conducted individual semi-structured interviews and data were analysed through an interpretive thematic approach. We used an interpretivist paradigm as we aimed to understand social phenomena and complex realities surrounding ICU admission in pregnancy, by interpreting and constructing meaning from subjective experiences and social interactions.
Study participants and recruitment
This qualitative research study received Institutional Research Ethics Board (REB) approval (MSH REB #17-0238-E). Participants who were critically ill during pregnancy or postpartum period were identified by reviewing previous ICU admissions in two large urban university hospitals in Toronto, Canada and Barranquilla Colombia. ICU admission criteria in both centres include the need for hemodynamic monitoring (e.g. preeclampsia, sepsis, haemorrhage) as well as organ support. Family members most involved in medical decision-making were also invited to participate in interviews. Eligibility criteria included willingness to participate in a semi-structured interview, proficiency in English for Canadian participants and proficiency in Spanish for participants in Colombia. Patients were contacted by a study investigator, not involved in their previous clinical care. Participants were recruited between February and June 2018 and all participants provided written consent.
Data collection
Data were collected via one-on-one semi-structured interviews, conducted either in-person or over the telephone using a semi-structured guide (supplementary file – interview guide), soliciting a response to the research question on what individuals with ICU experience valued in relation to the treatments received while in the ICU. Interviews were led by local researchers (JK in Canada and RZS in Colombia), recorded and transcribed for analysis. Participants were provided with an optional demographics form to complete, which included details on their clinical condition.
Analysis
Audio files from the interviews were transcribed by a transcriptionist, and transcriptions were analysed by a qualitative methodologist (CJP) using inductive thematic analysis. Inductive thematic analysis is a systematic approach to analysing qualitative data, without preconceived theories or categories, to identify and refine patterns or themes relevant to the research question. Five themes were identified. The analytical process included close reading of the data, open coding, generation of categories, identification of themes, mapping and organisation of the themes, description of the themes, and interpretive discussion of the themes with the research team.
Transcripts were reviewed again by two independent investigators (RA and JNO) to extract items/phrases that corresponded to patient-important outcomes. Using the definition presented in the Core Outcome Measures in Effectiveness Trials (COMET) handbook, in the context of clinical trials, an outcome was defined as a measurement or observation used to capture and assess the effect of treatment such as assessment of side effects (risk) or effectiveness (benefits). 12 The investigators listed all items and phrases that completed the focus prompt, ‘___ is a measure of the effect of treatment received in the ICU’. The eligible outcomes were then categorised into domains and core outcome areas using the taxonomy for outcomes in medical research. 13 The investigators determined the number of interviews where each outcome was mentioned, in order to determine the frequency of its repetition.
Results
Twelve individual structured interviews were conducted between February and June 2018. Interviews were with patients, and no family members were interviewed. Two interviews took place in Toronto, Canada, and ten in Barranquilla, Colombia. Recruitment from the Canadian centre was low, perhaps due to the higher severity of illness. The demographic characteristics of participants are presented in Table 1.
Characteristics of the interview participants.
*This was an antepartum admission. All others were postpartum.
The analysis showed that based on their experiences, participants prioritised not only their physical and mental health but also the quality of the care was provided to them through their hospital stay. The most-valued areas were as follows: (1) their mental well-being, (2) the quality of care delivered, (3) clinicians’ communication, (4) regaining functional independence, and (5) mother–newborn physical closeness.
Mental well-being
All but one participant characterised the time spent in ICU as a negative experience, although participants’ stories had positive elements that counterbalanced the negative experiences. Participants’ narratives of their time in ICU had common elements that were described as valuable and meaningful for them and which positively or negatively impacted their mental well-being. The following elements were specifically described as having a negative impact on their emotional and mental well-being:
Fear: Participants often expressed fear of death or of invasive procedures. I was scared and desperate when I saw all the machines and that other people were dying, I did not want to see that As a summary, I was really scared. I felt scared and my family was scared too from having tubes in my body or dying
Isolation and loneliness: Participants also described feeling isolated and lonely during their critical illness. The presence of professionals or relatives who communicated with them, made a difference in their experiences counterbalancing their fear and isolation. I was feeling sad, I felt lonely, I was scared. It was negative It was a negative event, I felt sad because I was not able to see my family and I was alone
Participants characterised their experience in the ICU mainly as negative in relation to the fear, isolation and feeling of loneliness. They highly valued the opportunities to interact with their loved ones as well as the interactions with the clinicians providing care. The new environment, the feared unknowns, and the desire to understand and stay informed were important elements in shaping their experience.
Quality of care delivered
In addition to receiving high-quality clinical care, participants emphasised the importance of being treated with respect and professionalism and also emphasised how the relationship between members of the care team made a positive impact in terms of recovery.
Respectful and professional care: When participants explained their recovery process, they emphasised the importance of being treated as a person and not only a patient. They also valued the creation of a plan that allowed them to reach small goals. Being supported by nurses and other team members made a difference and was also very valued. Some nurses and doctors helped me feel not like a number but as a person. That has helped me and my recovery. This helped me feel more positive and motivated me to get better faster. I felt like an individual versus a patient or a number At that point I did not think of recovery as big steps. [..] I asked the nurse what things I needed to do to get better. The nurse told me: a) pass gas, b) move my feet, and so and so. […] It was helpful to find out small things that I could work on, which were manageable to help me get a little bit better
Patients emphasised how they valued their privacy and how uncomfortable and vulnerable they felt when they were undressed or while sharing the physical space with other patients. I would like my privacy to be respected, and that we (patients) could be dressed and not naked all the time I would like to be in a curtained bay for women only and not to be naked, it is uncomfortable
It was really helpful that they (doctors and nurses) always asked me what my pain was on a scale[…] The scale was very helpful to communicate how bad it was or how it was progressing, that itis actually getting better, such as going from 8 to 6. It is still painful but better
Sometimes I wondered if they (nurses and doctors) really knew what was going on. At times we were really frightened and when that happens you just want some kind of answer, but in hindsight things were not as clear as they could have been
Building trust with the nurses from different shifts and trusting physicians from different disciplines who were treating them (i.e. obstetricians, internal medicine physicians, and other providers) was a theme that emerged in both the Canadian participants (data from Colombian interviews was insufficient to get a deep understanding of what patients valued in the information process).
Clinicians’ communication
Communication with the healthcare team, with their loved ones, and between members of the healthcare team, was the most prevalent and valued aspect of the ICU experiences from the patient perspective. Patients highly valued communication from the health care team to know what was going on, what may happen, and how challenges could be overcome. A comparative analysis showed that experiences described as positive were related to relational aspects which enhanced communication between patients and health professionals that strongly contributed to having a positive ICU experience.
An important challenge for participants was receiving different information from different health professionals and different specialities. They sometimes received discordant or incomplete information which induced stress and misunderstandings. They valued the presentation of a holistic view of the situation of both their own health and the baby's health. The information came to me in pieces by different doctors, in conversations, but I’ve never gone through a full story from beginning to end It is really challenging and stressful because you have different doctors having different perspectives. […] It is good to have a lot of discussion and I can appreciate the value of having different perspectives to avoiding potentially missing certain things. At the same time, I was: ‘what is happening?’, ‘do people really know what is going on?’, and that was really scary. […]At times it is really challenging and stressful because you have different doctors having different perspectives
Participants also found switches between healthcare teams challenging because this often required them to make a renewed effort to communicate the same information with the new team. This was sometimes seen as a lack of communication between healthcare teams. Participants highly valued when new teams were knowledgeable of events and discussions with the previous healthcare team. That I would be coughing and people would be standing there watching me and I would panic that I was going to suffocate to death. […]. That was one of the challenges, the switches between nurses and having to re-communicate what I needed with each nurse The first thing was that I could not speak because I had a tube. For me that was the biggest struggle, not being able to communicate, so I asked for a pad of paper and a pen. […]
While participants from both settings expressed how much they valued receiving information on their health and the health of their baby, many Colombian participants described that they did not receive sufficient information about their diagnosis or potential complications, and they did not understand what was happening, while Canadian participants described receiving adequate information about their diagnosis and potential outcomes.
Regaining functional independence
Participants explained how difficult it was for them being unable to independently perform their daily activities such as going to the toilet, taking a shower or getting their phone. Patients valued the opportunity to define a recovery plan in which they had a clear understanding of what was the next step for regaining their functional independence. I felt so out of it. I was focused on ‘can I drink water’, or ‘can I brush my teeth’? For me personally, it was just being myself again. Do I have any damage, am I still able to function as I was before, or close to how I was before, mentally and physically? It was about being able to take care of the baby by myself; and then being able to function again on my own. […] For me, all the small things learning to do meant that I was closer to the bigger goal, which was full independence. Small things added up to big things, like tying my shoes. […] Even showering, I could not it when I wanted to, it depended on who the nurse was and the timing of it definitely helped that I did not have to call to just grab something at the end, I worked with the nurse to do the little things by myself, step by step–.
Mother–newborn separation
One important and unique theme reported by critically ill pregnant individuals was being away from their baby. Although some ICUs may offer the possibility for mother and baby to stay together during the mother's critical phase, mother-newborn separation is the norm in both the Canadian and Colombian centres. While this separation created stress, it also served as a motivation to recovery in order to be able to physically be in shape to be with their baby. I felt lonely. It was a negative experience because I was far from my children It was just… you guys get me to where I can be back down with my baby
Patient-important outcomes
A total of 26 outcomes were identified that represented all five core outcome areas – mortality (
Elicited outcomes based on the taxonomy for medical research. 13
ICU: intensive care unit;
Discussion
Women with a history of critical illness during pregnancy expressed the negative impact of their experiences of fear, isolation and loneliness, related to their time in the ICU. Communication with the clinicians providing care, as well as with their loved ones, was identified as a powerful mitigator of these negative experiences. Participants centred their expectations and efforts on regaining independence, recovering their role functioning, and reducing the separation between mother and newborn. These results highlight the importance of providing high-quality and patient-centred care that holistically puts the well-being of the pregnant individual at the centre while protecting the bond between mother and newborn. The meso-level factors (family and clinical team organisation) appear as pivotal to nurture the well-being of individuals with a critical illness during pregnancy. In addition, this study identified 26 patient-important outcomes, many of which did not feature in a systematic review of the literature conducted by our group to identify outcomes presented in previous studies on critical illness in pregnancy. 14
A comparison of reported outcomes by core outcome area between this study and the systematic review 15 of published studies presented in Table 3 demonstrates that while outcomes reported in published studies were mostly related to the core areas of mortality and physical morbidity with outcomes related to functioning and life impact seldom reported (2.9% of all studies), the latter was the most frequently reported core area, mentioned by 100% of the interview participants.
Proportion of outcomes obtained through interviews and a systematic review of the literature, stratified by core outcome area.
Our study results are consistent with previous studies including a qualitative study exploring the perspectives of pregnant persons with preeclampsia, where respondents considered their condition in relation to the ‘whole person,’ with emphasis on emotional health, and overall well-being of themselves and their infants. 16 Other research into mothers’ experiences in ICU across the United Kingdom (UK) highlighted three themes – being in critical care, being a new mother in critical care and transfer out of critical care. 8 Some of the findings from this study were similar to ours - the implications of mother–newborn separation and need for support following transfer from the ICU for regaining functional independence. In addition, the UK study identified gaps between participants’ expectations of birth and what actually happened, and the value of follow-up after discharge, while our study emphasised the importance of communication, respectful and professional care, and mental well-being. The unique insights provided by these qualitative studies emphasise the importance of conducting qualitative research not just in people with lived experience of critical care in pregnancy, in diverse settings, but in all clinical areas to better understand what outcomes are important to patients. 17 Our study aimed specifically to document patient-identified outcomes of importance to measure in future research in critically ill pregnant patient.
Although there is an overlap between many outcomes considered important by the patients and those available in the published literature, it is evident that many individuals value different outcomes and specific situations related to their pregnancy status. Outcomes like mother–newborn separation and quality of life were reported in both sources, but many outcomes such as pain, psychiatric consequences and those related to role functioning were highly important to participants although they were not reported in the reviewed literature. Instead, fetal and neonatal outcomes such as birthweight, Apgar scores and fetal growth were frequently reported in the literature but did not feature in the interviews. This may be because these outcomes may not have been perceived as directly related to critical illness. Similarly, published literature often reports on ICU interventions, costs and the need for readmission which were not mentioned during the interviews. This could be because interviews were conducted in countries with publicly funded health systems, where costs of ICU stay and interventions and not borne by patients or third-party payers. Studies on critically ill obstetrics patients would certainly benefit from the consideration of these patient-reported outcomes while reporting the benefits and risks of interventions. In general ICU settings, patient-important outcome measures typically include mortality rates, length of stay in the ICU, incidence of complications such as infections, organ failure, and quality of life post-discharge. These measures help to assess the overall effectiveness of critical care interventions and can serve as a benchmark for comparing outcomes in critically ill obstetric patients. However, it is important to consider that the clinical context such as pregnancy-specific conditions, demographic aspects such as age, premorbid conditions, and the absence of the mother–child bond mean these outcomes may not be directly transferable to pregnant individuals. Pregnancy's unique physiological and psychological aspects necessitate tailored outcome measures to reflect the effectiveness of care in this population.
The main limitation of the study is the heterogeneity between data from the two sites, as interviews from Colombia were highly structured limiting dialectic discussion and engagement of participants. The Colombian cohort consisted of patients of diverse ages, and social and educational backgrounds compared to the Toronto cohort. As a result, we needed to paraphrase and customise the wording of the interview tool to ensure clarity and comprehension, leading to differences in the interview style and the themes elicited. Furthermore, ICU admission criteria may differ across the world but as our objective was to broadly identify patient-centred outcomes, the issue of generalisability is less relevant. Only one of our 12 interviewees was admitted to the ICU during pregnancy. While this ratio is similar to that of all obstetric ICU admissions, 2 this may influence the patient experiences identified by our interviews. We do not have access to data relating to length of stay or gestation at the time of critical care admission, two factors which may impact patients’ perception of their ICU stay. Finally, the COVID-19 pandemic occurred after these patient interviews were performed and it is possible that contemporary patient-centred outcome measures may be somewhat different. However, since the development of COSCO was based on the data obtained in this study, we felt our study findings should be published as such.
Despite these limitations, the paper has several strengths and implications for future research. It is the first study specifically conducted with a view to eliciting patient-important outcomes in this population. It explored experiences of individuals with lived experience of critical illness in pregnancy from two countries with diverse cultural and healthcare backgrounds. Furthermore, the use of a thematic analysis allowed to explore patients’ experience and the reasons behind their perspectives. The diverse range of patient-important outcomes identified through this study will allow their inclusion in the next step of COSCO development – the Delphi survey, and their consideration in the final COS.
Conclusion
Critical illness during pregnancy is a devastating event with enormous implications for pregnant patient, their newborn, and their family. Their perspectives are therefore very important and should be considered when designing studies and selecting outcomes pertaining to critical illness in pregnancy. This study reports patient-important themes and outcomes of which many have not been reported in the literature and should be considered when delivering clinical care, conducting new research and drafting health policy for critically ill obstetric patients. The patient important outcomes will be incorporated into the next steps of developing COSCO.
Supplemental Material
sj-docx-1-obm-10.1177_1753495X241290681 - Supplemental material for Patient-reported outcomes in research on critically ill obstetric patients
Supplemental material, sj-docx-1-obm-10.1177_1753495X241290681 for Patient-reported outcomes in research on critically ill obstetric patients by Julien Viau Lapointe, Clara Juando-Prats, Roberto Zapata, Julia Kfouri, Joyamor Ortuno-Nacho, Rizwana Ashraf, Rohan D’Souza, Jose Rojas-Suarez and Stephen E Lapinsky in Obstetric Medicine
Footnotes
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