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Abstract
Objective To understand why surgical decision-making in necrotising enterocolitis (NEC) is challenging and to explore what is required to optimise this.
Design Three semi-structured in-person focus groups exploring surgical decision-making in NEC. Reflexive thematic analysis of the focus group transcript was undertaken.
Participants 22 consultant participants (15 paediatric surgeons and 7 neonatologists).
Main outcome measures Themes addressing what informs, the challenges of and how to improve surgical decision-making in NEC.
Results 10 themes addressed what informs decision-making in NEC, 6 themes addressed why this is challenging and 5 themes explained what is required to address the challenges of decision-making. Themes regarding challenges of decision-making were: diagnostic uncertainty, variable threshold for referral/transfer, lack of continuity of care, absence of clear criteria for surgery, uncertainty surrounding surgery and fear. Subthemes regarding fear were fear of (1) poor clinical outcome, (2) criticism from colleagues and (3) undertaking unnecessary surgery.
Themes in all three areas were related to infant, clinician and system-based factors. These included themes regarding indications for surgical intervention, indications for referral and transfer of infants, and reducing variability in practice.
Conclusions This study identified themes that illuminate the difficulties experienced by neonatologists and surgeons regarding surgical decision-making in NEC. Clinicians of both specialties would welcome changes to current practice focused particularly around standardisation of practice and greater objectivity around several aspects of surgical decision-making. These insights can be used to focus further research and implement practice change around surgical decision-making in NEC with the ultimate aim of facilitating early and accurate decision-making.
- Neonatology
- Gastroenterology
Data availability statement
Data are available upon reasonable request. Qualitative coding reports available by reasonable request to the corresponding author.
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
Recent studies suggest an association between poor clinical outcome and increased time from diagnosis to surgery in necrotising enterocolitis (NEC). This delay may be attributable to challenges in surgical decision-making.
WHAT THIS STUDY ADDS
This study documents a wide range of influences on surgical decision-making in NEC. Challenges include infant, clinician and system-related factors. Approaches to overcome these challenges include standardisation of practice and developing objective criteria to facilitate decision-making.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
Further research could focus on designing, refining and evaluating solutions to the challenges identified. Healthcare providers may wish to consider some of the system factors reported to influence decision-making, such as co-location of surgical neonatal units with maternity units, when designing and developing care pathways to assist clinicians in their decision-making.
Introduction
Outcomes in necrotising enterocolitis (NEC) remain unfavourable with early mortality seen in 34.5% of those who undergo surgery.1 In survivors, as many as 35% have short bowel syndrome, while neurodevelopmental delay is experienced by up to 59% of children.1 Surgical intervention is undertaken in around 40% of infants with confirmed NEC, but deciding who would benefit from this and who should continue medical management is often challenging.2 Recent observational evidence suggests an association between clinical outcome and surgical decision-making in NEC.3 4 One of these studies found that infants with ‘failed medical management’ waited longest from diagnosis to surgery and experienced the worst outcomes, compared with those with pneumoperitoneum or suspected necrotic bowel as an indication for surgery.3 This delay may be due to challenges of surgical decision-making. Additionally, 20% of neonates with NEC die before surgery, which is potentially avoidable with earlier identification of need for transfer to a surgical unit and/or need for surgery.5 Surgery does, however, carry risks, including negative laparotomy, hence correct and timely identification of infants that would benefit from surgery is essential.
Reduction of NEC using probiotics appears to be effective; however, use of these in preterm infants is varied.6 Probiotic use has been shown to significantly reduce the incidence of NEC, yet since NEC remains prevalent, decisions regarding surgery will always be required.7 Surgical decision-making in NEC has been previously explored through surgeon survey.8 9 These surveys were able to report broadly which indications surgeons regard as absolute and relative indications for surgical intervention but, as with all quantitative survey methods, were unable to glean whether relative indications were used together and explore the possibility of other influences on decision-making.
Decision-making strategy has been well studied in many contexts and has been adapted to surgical decision-making by a number of authors.10–12 During clinical decision-making, data are interpreted at both conscious (analytical) and subconscious (intuitive) levels depending on a surgeon’s experience, expertise and importantly, capacity to deal with uncertainty. While some cases of NEC presenting to a surgeon may fit a previously seen pattern potentially leading to a rapid, intuitive decision, it is clear that many do not and a more analytical decision-making process is triggered.12 Precisely which factors influence these analytical thought processes and how surgical decision-making in NEC fits this framework is unclear.
To facilitate accurate and timely surgical decision-making, a better understanding of how surgeons and neonatologists make decisions around surgery, including challenges and how these might be optimised, is required. This study aimed to:
Understand what currently informs surgical decision-making in NEC.
Discover what the challenges are regarding surgical decision-making.
Explore which of these challenges can be overcome and how.
Methods
Study design
Qualitative study of consultant specialist paediatric surgeons and neonatologists using in-person focus groups.
Participants
Consultants based in the UK and Ireland were invited to participate in a single focus group. Invites were distributed via existing research collaborative networks. Clinicians still in training were not included as it is unlikely that they are sole decision-makers in NEC. We intended to hold three focus groups with between five and eight participants at each, which has previously been reported as sufficient to achieve saturation of themes in qualitative research using focus groups.13
Focus group design
Focus groups were designed to be semistructured and a topic guide (online supplemental materials) was followed to ensure coverage of the three study aims. Focus groups were undertaken in person in autumn 2023 and it was decided a priori to conduct separate focus groups for surgeons and neonatologists to promote full, open discussion of factors relevant to each specialty. There were two focus groups for surgeons and one for neonatologists, each lasting for 3 hours. Most participants in each group knew each other professionally and were told that the aim of the focus groups was to discuss surgical decision-making in NEC. They took place at a professional meeting venue separate from any participant’s place of work to promote free discussion. The focus groups were facilitated by a paediatric surgical trainee (GSB) and a consultant paediatric and neonatal surgeon (NJH) who are the lead researchers on this project. There were no non-participants present.
Supplemental material
Thematic analysis
Audio recordings were obtained and transcribed along with field notes produced at focus groups. Given that multiple participants were included in transcripts and the sensitivity of this subject area, transcripts were not returned to participants for checking. An inductive, semantic and critical approach to reflexive thematic analysis was undertaken, which consisted of a six-stage approach to analysis involving familiarisation with data, inductive coding, potential themes exploration, review and confirmation of themes, defining themes and reporting with interpretation of themes.14 This was undertaken within NVivo (QSR International, Massachusetts, USA) with mapping of themes to the stated aims of the study (GSB). Where applicable, subthemes were also generated. Coding reports and themes were discussed and finalised, and we were satisfied that we had reached data saturation with no new themes generated (GSB, A-SD and NJH).15 A reflexive thematic approach was fully adhered to, and a codebook approach or coding reliability approach was not used.14 Representative quotes for each theme are presented with participant number and a full description of generated themes is included in online supplemental materials.
Consent and ethical approval
Participants were given a participant information sheet and written consent was obtained. This study was conducted and reported following the COnsolidated criteria for REporting Qualitative research.16
Results
There were 15 consultant surgeons and 7 consultant neonatologist participants from 15 centres. Of the neonatologist participants, two practiced in non-surgical neonatal units while the others worked at surgical units. No participants dropped out after consenting.
Themes addressing each research question were generated from transcripts and are summarised in figure 1. Each theme is discussed further and identified in text within brackets.
Themes relating to each research aim. NEC, necrotising enterocolitis.
What informs surgical decision-making in NEC?
10 themes were generated that address this question (table 1). They were categorised as either infant, system or clinician factors to aid interpretation. Time, however, was not categorised as it impacts how most of these factors lead to a decision (figure 2).
What informs surgical decision-making in NEC?
Themes related to what informs surgical decision-making in necrotising enterocolitis were categorised as either infant, system or clinician-related factors underpinned by time.
Infant factors
Participants emphasised that NEC is a highly variable and time-critical disease, with unpredictable rate of progression (disease heterogeneity). Participants agreed on absolute indications for surgery, which were pneumoperitoneum, failure to ventilate due to abdominal distension and failed medical management, although no consistent objective criteria were provided for this last indication (developing an absolute indication for surgery). Rapid deterioration was also reported to be a clear indication to undertake surgery.
Concerns were raised about operating too early in the disease process due to intraoperative difficulty in identifying necrotic bowel that had yet to demarcate (time).
Clinician factors
The unpredictable course of NEC created different perspectives on timing of surgical intervention (consultant personal experience and practice). Some participants preferred to undertake surgery as soon as an infant required inotropic support, while others waited for more universally accepted indications, such as pneumoperitoneum or lack of improvement after a significant period of observation. Negative laparotomy was reported by some to be acceptable; however, others expressed a desire to avoid them, even if it meant delaying surgery (perceived benefits and risks of surgery). There was agreement that the aim of surgery is to save life, improve neurological outcome and preserve gastrointestinal autonomy (perceived benefits and risks of surgery).
Most surgeons and neonatologists described good interspecialty working relationships, with surgical decisions generally reached collaboratively with infrequent disagreements (other people’s views). Some, however, felt that the surgeon usually leads on the decision with neonatologist agreement. The threshold of referral from neonatologist to surgeons was reported to vary based on subjective factors, such as the neonatologist’s perception of whether a surgeon is likely to operate and experience/seniority of the referring neonatologist. This directly impacts the point in the disease process where a surgeon becomes aware of the infant and is therefore able to first consider surgery.
Clinical handover between consultant surgeons was a factor reported to both positively and negatively impact decision-making (patient handover between clinicians). On one hand, handover of care to another surgeon, due to on-call or attending patterns, can allow ‘fresh-eyes’ and avoid decision-making biases. Conversely, frequent handover was reported to sometimes delay undertaking a decision to operate as new clinicians preferred to undertake a further period of observation themselves. A number of different on-call/attending patterns were described among participants.
System factors
A system factor reported was referral pathways and infant location at disease onset (referral pathway and location). Specifically, neonatologists revealed that there is an absence of set criteria for when they would refer an infant to a surgeon, some felt that early referral is beneficial, while others did not. Variability in service organisation was reported across different geographical regions (regional service set-up), and participants reported that the availability of neonatal intensive care units (NICUs) at surgical centres influenced decisions significantly. This specifically referred to surgical centres without an onsite NICU where infants with NEC are transferred to a paediatric intensive care unit (PICU) for surgical review. It was reported that deciding not to operate once an infant had arrived at a PICU was very challenging as they would require transfer back to the referring unit or require admission to PICU without involvement of a neonatologist.
Why is surgical decision-making in NEC challenging?
Six themes were generated addressing this question (table 2).
Why is surgical decision-making in NEC challenging?
Participants reported that decision-making is more challenging when the diagnosis of NEC is unclear (diagnostic uncertainty) due to concern of undertaking a negative laparotomy and the risk of this. Challenges of decision-making around referral and transfer of infants were frequently discussed, as these directly impact the timing of surgical review (variable thresholds for referral and transfer). Previous experience of referrals was felt to influence whether a neonatologist felt empowered to refer future infants. If they received criticism regarding prior referrals, participants felt more hesitant about future referrals.
The surgical decision-making process was reported to be subjective and the relationship between relative surgical indications is unclear (absence of clear criteria for surgery). Even with the use of techniques such as abdominal ultrasound participants reported they often found reports difficult to understand with further uncertainty of whether ultrasound findings indicate surgical intervention. Trajectory of clinical signs or biomarkers was reported to be more useful than isolated observations.
Uncertainty around the optimal timing of surgery, the benefits of this and which procedure to undertake was expressed (uncertainty surrounding surgery). Participants felt the optimal time to undertake surgery was when the bowel had become non-viable; however, this is often impossible to identify non-invasively. Concern regarding operating prior to this occurring and finding diseased bowel that may, or may not, recover without resection was expressed. On the other hand, participants acknowledged that little is known about whether delayed surgery does have an adverse impact on outcomes, although the overall perception was that it probably does. A damage control approach to surgery with initial laparostomy and planned relook laparotomy was reported to be a useful option, particularly if it is unclear which definitive procedure to undertake.
Fear of poor clinical outcome, criticism from colleagues and undertaking unnecessary surgery were conveyed to impact decision-making (fear). Fear of an infant not surviving was felt to be a factor important when making a decision to operate as it was felt that some infants who are critically unwell, are unlikely to survive regardless of whether they receive surgery or not. Hence, there was fear that their death might be attributed to surgery. A further reported challenge is that some surgeons feared criticism from colleagues if they did not make what was deemed to be retrospectively, a ‘correct’ decision. There was also fear of intraoperative death occurring; however, this was reported to be very rare. Finally, it was hypothesised that some may defer a decision to operate if they are uncertain of their technical ability to carry out surgery in such a small infant.
What is required to improve this?
Five themes were generated addressing this question (table 3).
What is required to improve this?
Clinicians (neonatologists in particular) felt that reducing variability in practice had the potential to positively impact infants and system-based interventions, which could include standardised surgeon referral criteria (reduced variability in practice), ideally from consultant to consultant. Participants expressed the opinion that criteria would need to be simple and any method would need to highlight infants requiring surgical referral, before they are critically unwell (increased objectivity of referral and transfer process). It was also reported that this would make the process of discussing an infant with a surgeon easier with less fear of personal criticism for unnecessary referral.
Much discussion took place regarding what a new approach to inform the decision to operate, or not, could look like. A decision-making tool such as a pathway with simple criteria was felt to be most useful and easiest to evaluate initially (a simple, objective method to inform surgical decision-making would be most useable). Strict cut-off values for laboratory tests were felt to be challenging in real-world clinical settings. Assessment of a new approach should include utility as well as clinical outcomes. Suggested endpoint for such a pathway included a multidisciplinary team discussion and proceeding with surgery unless contraindicated. It was reported that a more objective method would add consistency and also allow easier comparison of outcomes for infants with NEC.
Unavoidable handover between surgeons was felt to delay undertaking a decision to operate and specific criteria about when a surgeon would recommend that their colleague operates was deemed to be useful (more specific recommendations at handover of care between surgeons).
Perceptions regarding the adoption of new methods of identifying need for referral and surgery were discussed (understanding of clinician attitudes to a new method). Clinicians expressed the opinion that outcomes are currently so unfavourable in NEC that any change to increase objectivity would be welcomed, even if evaluation of this method was ongoing. Others were concerned about negative consequences of this without an underlying evidence base, such as increased unnecessary transfer of infants and negative laparotomies. Commitment to the use of a new method requires engagement from all stakeholders and there was concern that some clinicians appear ‘not interested’ in this topic.
Discussion
This study has documented and described for the first time, using qualitative methodology, influences on surgical decision-making in NEC, challenges of this and what might be required to overcome these challenges. Many challenges of surgical decision-making were identified. Some of these relate directly to the clinical status of the infant, but others clearly do not, and we have unveiled evidence that clinician factors and system factors have a contributory role. In terms of means to overcome the challenges there is a clear call for support, specifically in the form of simple and objective methods to assist decision-making across a number of points in the patient pathway (referral, transfer and surgery) as well as standardisation of approach to treating these infants.
Broadly speaking, themes identified that influence decision-making and contribute to the challenges thereof can be divided into infant factors (those related to the clinical status of the patient), clinician factors (those related to how an individual clinician makes a decision) and system factors (related to the system in which the patient is cared for and the clinician operates). Infant factors feature among themes in all three areas investigated and clearly point towards a need for greater understanding of the disease (disease heterogeneity, anticipated clinical outcome) as well as the impact of treatment on outcome (uncertainty surrounding surgery). Clinician factors provide insight into how clinicians make decisions and may be considered in the context of decision-making frameworks.10–12 We identified evidence of clinicians making rapid intuitive or recognition-primed decisions in the context of a familiar scenario (eg, pneumoperitoneum) with clinicians essentially using a rule-based practice in this context.17 In the absence of a clear indication for surgery, participants reported drawing on a range of other influences including their own ‘personal experience’ and ‘other people’s views’. Some participants discussed their own personal rule-based decision-making procedures which exist even in the absence of supporting widespread evidence, for example, consideration of inotropic support or time since presentation as indications for surgery. The decision-making strategy that could be most frequently applied to the opinions expressed is analytical decision-making which requires conscious thought, concentration and significant time on the part of the decision maker.12 Complexities such as disease heterogeneity and diagnostic uncertainty with absence of clear criteria for surgery and fear require thoughtful and time-consuming analysis to reach a decision. Specifically, fear of criticism from colleagues suggests that decision-makers experience a burden of their personal, analytical decision-making process and it was discussed that increased objectivity could reduce this burden along with the risk of medicolegal repercussions if an infant has an unfavourable outcome. It is likely that there is heterogeneity between clinicians in this analysis resulting in variation between clinicians even when faced with the same clinical data. Clinicians clearly find this challenging. Potential solutions to this arising from our data include objectification of the decision-making process to reduce such variability in approach, a process which would be best supported by evidence.
An unexpected and somewhat concerning finding is that there appear to be a number of system factors that influence surgical decision-making in NEC, inevitably resulting in variation in approach between centres based on how their local infrastructure or clinical service is organised. Examples include varying thresholds for referral and transfer to a surgical centre, the impact of no specialist NICU within the transferring children’s hospital on a surgeon’s ability to transfer a critically unwell baby for assessment (regional service set up) and differing thresholds for surgical intervention between clinicians in the same hospital which may impact decision-making when there is handover from one responsible clinician to another (patient handover between clinicians). While finding solutions to these system-level challenges is possibly even more complex than finding solutions that could be delivered at individual clinician level, it is clear that we must strive to resolve both in order to optimise care for these vulnerable babies.
We acknowledge some limitations of this study. It is possible there was selection bias of participants such that those with strong views were most likely to participate. We made efforts to limit this by distributing invitations nationally and arranging focus groups in two major cities with good transport links. Although there were more surgeons than neonatologists we believe we have captured a holistic insight and uncovered key information about challenges of referral and transfer of infants from a neonatal perspective while also maintaining focus on surgical aspects. This study is strengthened by the use of qualitative methodology applied by an investigator with a working understanding of the clinical field and has been conducted using a checklist for good thematic analysis.18 System-related factors identified are specific to the UK; hence, interpretation of these internationally may be limited.
This work is the first of its kind to describe in detail the complexities of surgical decision-making in NEC from the clinician perspective, while also revealing insights into potential solutions to overcome many of the challenges faced. These data can be used to support the design and implementation of system change such as referral pathways for infants with NEC, as well as more objective and standardised approaches to thresholds for surgery acknowledging that more objective methods should not disregard nursing, parental or clinician concern. External validation of previously reported methods of identifying surgical NEC is currently underway to understand which methods might be effective within clinical practice.19 To be adopted into clinical practice many participants in this current study expressed that such a method should be developed and tested using data of infants, rather than expert opinion alone. Clinical outcomes to be evaluated with the implementation of such a method should include survival, neurodevelopmental impairment and enteral autonomy.20 We have identified areas for further research to overcome the challenges identified, with the ultimate aim of improving outcomes of this devastating condition.
Data availability statement
Data are available upon reasonable request. Qualitative coding reports available by reasonable request to the corresponding author.
Ethics statements
Patient consent for publication
Ethics approval
This study involves human participants and was approved by University of Southampton (ERGO ref: 80973).
Acknowledgments
The authors are incredibly grateful to the paediatric surgeons and neonatologists who attended the focus groups and shared their views, allowing conduct of this research.
References
Footnotes
X @@gbethellUK, @DrCBattersby, @Marianfknight
Contributors GSB: conceptualisation, methodology, investigation, data curation, formal analysis, writing—original draft. NJH: conceptualisation, methodology, investigation, data curation, formal analysis, writing—reviewing and editing. CB: conceptualisation, methodology, writing—reviewing and editing. MK: conceptualisation, methodology, writing—reviewing and editing. A-SD: conceptualisation, methodology, data curation, formal analysis, writing—reviewing and editing. A-SD is the guarantor.
Funding This study was funded by the National Institute of Health Research (NIHR) Doctoral Fellowship programme (George Bethell: NIHR302541). CB is supported by an NIHR Advanced Fellowship. MK is an NIHR Senior Investigator. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.