Patient Safety Incidents Involving Sick Children in Primary Care in England and Wales: A Mixed Methods Analysis

Summary

Using a mixed methods approach, Philippa Rees and colleagues describe patient safety incidents involving sick children in primary care in England & Wales.

Introduction

The United Kingdom (UK) has one of the highest child mortality rates in Western Europe: the 2,000 excess child deaths that occur annually compare unfavorably with Sweden, which is the best performing country in this region [1–3]. Intercountry variability in rates of child mortality is a well-described global problem. Despite this, there has been a dearth of research on the contribution of unsafe care to these potentially preventable child deaths [4,5].

Primary care is responsible for the majority of healthcare encounters in high-income countries. The safety of care provided to children in this setting is not well understood [6]. For example, in the UK, deaths from meningitis and pneumococcal infection—conditions whose outcomes rely heavily on “first access” services—are considerably higher than in other European countries [3,7,8]. Yet, the avoidable causative factors have not been identified with sufficient clarity for planning action that will prevent the delivery of unsafe care. Furthermore, increasing rates of inappropriate hospital admissions and avoidable referrals to hospital pediatric services indicate that primary care is struggling to meet the demands and changing needs of the pediatric population [7,9–12].

To our knowledge, no systematic approach has been taken to studying the burden of iatrogenic harm in children [4,5,13,14]. Methods that have been used include analysis of vital statistics and case note reviews (some guided by trigger tools) [13–17]. These methods are seldom able to explain why incidents occurred, an essential prerequisite to designing interventions to mitigate future unsafe practice [4]. On the other hand, incident reporting systems can provide detailed descriptions of safety incidents and their underlying contributory factors. Analyses of national repositories of patient safety incident reports have enabled detection and mitigation of rare and serious healthcare safety risks [18–24]. These analyses, in turn, can inform recommendations for clinical process redesign [18–22,25].

This study aimed to characterize the nature and severity of patient safety incidents involving sick children in primary care, to identify potential priority areas requiring action, and to make recommendations for improvement.

Methods

Ethical Approval

The Aneurin Bevan University Health Board research risk review committee waived the need for ethics review given the anonymized nature of the data (ABHB R and D reference number SA/410/13), and we therefore did not require informed consent.

National Reporting and Learning System

The National Reporting and Learning System (NRLS) is a national repository of voluntarily submitted patient safety incident reports from healthcare organizations in England and Wales. Patient safety incidents are defined as “any unintended or unexpected incidents that could have, or did, lead to harm for one or more patients receiving NHS care” [26]. The NRLS was established in 2003 and is the largest repository of its kind, receiving approximately 65,000 reports of patient safety incidents involving children each year [4].

Healthcare professionals submit reports to their local healthcare organizations, where the reports are first analyzed and anonymized, and then submitted in batches to the NRLS. Reports can also be submitted directly to the NRLS online [26–28]. Each report captures structured categorical information such as patient age, incident location, incident date, and severity of harm outcome (no harm, low harm, moderate harm, severe harm, or death) [26–28]. In addition, each report contains three unstructured free-text fields where reporters can describe what happened, why they think it happened, and how they think it could have been prevented [26–28].

Sample Selection

All incident reports submitted to the NRLS between 1 January 2005 and 1 December 2013 from primary care and involving sick children less than 18 y old were included. Primary care refers to generalist care in the community including, but not limited to, care provided by general practitioners (GPs) (or family physicians), community nurses, and community pharmacists. Reports involving sick children were broadly defined as any reports with descriptions of diagnoses, signs, symptoms, or prescribed medications implying acute or chronic illness in a child. Reports involving children were identified through applying an age filter, and reports involving sick children were identified through free-text searches using key terms and related permutations (Fig 1; S1 Text).

Methodology

A retrospective cross-sectional mixed methods study was conducted. This involved systematically coding data using multiple coding frameworks to describe the incident, quantitatively exploring coded data to identify important patterns, and thematically analyzing a purposive sample of reports containing new theoretical insights. This methodology has been accepted by the international literature [23,25,28].

Data Coding

Each incident report underwent data coding using multi-axial frameworks to describe incident types (primary and contributory), potential contributory factors, incident outcomes, and harm severity (S2–S4 Texts) [23,25,28]. Primary incidents included those proximal (chronologically) to the patient outcome, whereas contributory incidents included those that contributed to the occurrence of another incident. Multiple codes for incident type, contributory factor, and incident outcome were applied to each report where necessary. The codes were applied systematically and chronologically according to nine recursive incident analysis rules developed by the Australian Patient Safety Foundation (S1 Table) [29]. This permitted modeling of the steps preceding and leading to primary incidents, e.g., contributory incidents and factors, which, in turn, resulted in patient outcomes (S1 Fig). The incident type, contributory factor, and incident outcome frameworks were developed in house [28]. Each incident report in the NRLS comes with a reporter-allocated harm severity; however, where the free-text descriptions conflicted with the reporter-allocated harm severity, harm severity was reclassified using WHO International Classification for Patient Safety definitions (see Table 1 for WHO definitions of harm severity) [3,23,25,30]. The medications involved in medication incidents were recorded and classified using the British National Formulary for Children, and the types of conditions affecting these children were recorded and classified using the International Classification of Diseases (ICD-10) (S2 Table) [31,32]. A random 20% sample of reports was independently double-coded by P. R. and H. W.

Data Analysis

We undertook exploratory descriptive analysis of coded data [33]. The relationships between codes were explored using frequency distributions and cross-tabulations, to identify prevalent patterns in associated incidents and contributory factors (S3 and S4 Tables) [34]. Priority areas were identified based on the frequency and associated severity of harm. Recommendations for addressing these priority areas were informed by the factors reported as contributing to incidents, by focused searches of the literature, and by consultation with subject matter experts [23,25,28].

Thematic Analysis

A purposive sample of reports that corroborated or contradicted emerging theories or contained “new” insights was identified during data coding [35–37]. These reports were exported for qualitative data analysis (NVivo 9, QSR International), and reread for familiarization. New codes were created to capture additional semantic (descriptive and superficial) insights and latent (underlying or inferred) insights present in reports and the contexts in which incidents occurred [25,35,36]. These codes were grouped into themes and sub-themes (by P. R. and A. C-S.) to support our understanding of the data and the underlying reasons for certain incidents [25,35,36].

Results

Overview

Of the 3,636 incident reports potentially involving sick children identified through free-text searches, 2,178 were included; excluded reports involved well children (n = 876), did not describe a patient safety incident (n = 398), or contained insufficient information for coding (n = 184) (Fig 1). Cohen’s kappa (k) statistic of inter-rater (coding) reliability for primary incidents was high, k = 0.72 (95% CI 0.68–0.75; p < 0.01).

The incident reports involved care from the UK national telephone triage service, NHS 111 (formerly NHS Direct) (n = 646; 30%), out-of-hours health centers (n = 604; 28%), community pharmacies (n = 401; 18%), and general practices (n = 218; 10%) (Fig 2). The 2,178 reports described 2,191 primary incidents (hence 2,191 incidents referred to henceforth), largely involving infants between 28 d and 1 y old (n = 491; 22%) and preschool children less than 5 y old (n = 542; 25%). The most frequently described conditions included respiratory conditions (n = 387; 18%), injuries (n = 289; 13%), nonspecific signs and symptoms such as fever (n = 281; 13%), and gastrointestinal or genitourinary conditions (n = 268; 12%) (Table 2). Included reports described harm to 30% (n = 658) of children, including 12 deaths, 41 reports of severe harm, 218 reports of moderate harm, and 387 reports of low harm (Table 1).

Eleven categories of incident types (see Table 1) were evident from included reports. We present a summary of findings related to the priority areas requiring improvement; these include incident types with the highest burden of reported harm in terms of frequency, clinical harm outcomes, and level of harm severity. These priority areas, in descending order of frequency include the unsafe provision of medication, inadequate diagnosis and assessment, and failure of communication with and about the patient (Table 1). Contributory factors for all incidents are summarized in Table 3.

Treatment of Sick Children with Medication

The 674 medication-related incidents (primary and contributory; harmful and nonharmful) were described in the home (e.g., from NHS 111 service calls), general practice, and community pharmacy settings. Most incidents (n = 386; 57%) were related to dispensing errors in community pharmacies; other medication incidents were administration errors (n = 123; 18%) typically in the home setting, prescribing errors (n = 68; 10%) in the general practice setting, and clinical treatment decision-making incidents (n = 66; 10%) in the general practice or out-of-hours setting (Table 1).

Children less than 1 y old were most frequently (n = 131; 19%) involved in reported medication-related incidents, and these children were largely being treated for epilepsy, asthma, and infections (Table 4). As highlighted in Table 4, inhalers for asthma treatment were frequently involved in medication-related incidents: for example, children were dispensed the wrong dose inhaler (n = 27), the wrong brand (n = 18), or the wrong inhaler medication (n = 16). Children with epilepsy were frequently dispensed the wrong dose of anticonvulsant (n = 27) or dispensed anticonvulsants with the wrong instruction labels (n = 11). Errors involving antimicrobial treatment were related to dispensing the wrong dose (n = 13), the wrong medication (n = 22), or medications with incorrect labels (n = 13).

Harm resulted from about one-third (n = 215; 32%) of medication-related incidents, including two deaths, six reports of severe harm, 64 reports of moderate harm, and 143 reports of low harm (Table 1). Incident outcomes included harm necessitating a hospital visit (n = 49), which included admissions to intensive care, e.g., after receiving chlorpromazine rather than chlorphenamine, and deterioration in a child’s condition (n = 21), such as increased seizure frequency after dispensing the wrong brand of lamotrigine. In addition, patient inconvenience was a frequently described incident outcome (n = 108), such as needing to revisit healthcare professionals (n = 52) or experiencing delays in medical management (n = 27), e.g., as a result of being dispensed the wrong medication.

Contributory factors were described for most (n = 242; 63%) dispensing errors. Staff mistakes were described (n = 172), such as confusing medications with similar names or appearances (Examples 1 and 3 in Box 1), e.g., long-acting beta-agonist (LABA) inhalers and LABA/corticosteroid combination inhalers (Example 3). Mistakes occurred in combination with medication factors (n = 39), such as different formulations of the same medication having similar packaging, e.g., beclometasone nasal spray and beclometasone inhalers; organizational factors such as busy or distracting work conditions (n = 28); or both medication factors and poor working conditions (n = 10) (Examples 1, 3, and 4). Other contributing factors included staff failing to follow protocols (n = 31), such as preparing two patients’ medications concurrently, and patient age-specific factors (n = 23) such as weight-based dose calculation errors (Example 5).

Similar contributing factors also underpinned prescribing and administering errors, which often occurred in combination with dispensing errors. For example, most medication administration errors (n = 91; 74%) were described as being the result of other incidents, i.e., contributory incidents, typically other medication errors such as dispensing errors (n = 41), prescribing errors (n = 10), or both (n = 7) (see Examples 1 and 3).

Diagnosis, Assessment, and Referral of Sick Children

The 659 incidents related to diagnosis, assessment, and referral typically occurred in combination and as a result of each other (S3 Table). These incidents occurred via NHS 111 (n = 400; 61%), during telephone assessments provided by out-of-hours general practice care (n = 158; 24%), or in the general practice setting (n = 55; 8%). The children involved were typically young, under 3 y old, and presented acutely with the following: nonspecific signs and symptoms (n = 150), particularly fever (n = 67) and altered consciousness (n = 51); injuries (n = 146), particularly head injuries (n = 84); and skin or musculoskeletal conditions (n = 87), such as rashes (n = 34) and skin discoloration (n = 33).

Incidents associated with diagnosis, assessment, and referral were the most harmful reported in terms of severity, involving 10 deaths, 15 reports of severe harm, and 69 reports of moderate harm (Table 1). The most frequently described incident outcomes were patient inconvenience (n = 179; 27%), particularly as a result of delayed management of conditions (n = 157; 24%), and clinical patient harm (n = 90; 14%), such as deterioration of a child’s condition (n = 43; 7%). Deterioration outcomes also included four cases of potentially fatal diabetic ketoacidosis.

Diagnosis and assessment incidents mostly involved inadequate triaging (n = 232; 52%) of acutely unwell children and delayed assessment (n = 88; 20%) of these children. Most referral-related incidents (n = 154; 73%) involved assessments over the telephone and in the general practice setting, and included delayed referrals (n = 115; 55%) and failure to refer a sick child for escalation of care or specialist input when appropriate (n = 42; 20%). Incidents contributing to unsafe assessments included the following: inadequate history taking (n = 112; 25%); failing to identify high-risk or vulnerable children (n = 51; 11%), e.g., those with a history of repeated self-harming; and communication failures, such as inadequate safety netting with parents and caregivers (n = 118; 26%). Safety netting is defined within healthcare as providing information (as a safety net) to educate patients, parents, or caregivers and make them aware of when to appropriately seek medical attention in the event of illness, failure to improve, or deterioration medically [38].

Key contributory factors underlying diagnosis, assessment, and referral incidents, particularly those involving inadequate telephone assessments, were related to “protocolized” medicine. Staff failing to follow protocols was frequently described (n = 196; 30%), e.g., GPs were described as failing to follow fever and diabetic management guidelines (Examples 6 and 7 in Box 1; Table 3). In the context of telephone assessments, this included non-clinically trained health advisors choosing the wrong protocol, e.g., selecting a “head wound” protocol rather than a “head injury” protocol, or not using the protocol correctly (Examples 8 and 9). Protocols were also described as inadequate (n = 35; 5%), e.g., when they led health advisors to underestimate the urgency of the child’s condition. In the context of staff failing to follow protocols, or the protocols failing to adequately assess the urgency of a child’s condition, staff were criticized for not using critical thinking (n = 84; 13%; Example 10), despite not having any clinical training.

Communication Failures with and about the Patient

Of the 177 communication-related incidents reported, 19% (n = 33) were harmful, including two reports of severe harm, 11 reports of moderate harm, and 20 reports of low harm (Table 1). Communication failures with patients, parents, and caregivers were described in a range of primary care settings; however, most communication-related incidents occurred either via NHS 111 (n = 103; 58%) or in out-of-hours settings (n = 39; 22%), and half involved children less than 3 y old (n = 90; 51%).

For sick children in primary care, communication failures (n = 207) were more commonly reported as contributory rather than as primary incidents. Communication failures frequently underpinned medication incidents, particularly administration errors in the home setting, where parents and caregivers are typically responsible for medication administration, which is influenced by prior communication and instructions from healthcare professionals (Example 3). Communication failures were also frequently implicated in diagnosis and assessment incidents (Example 11), e.g., through inadequate safety netting (Example 12), providing the wrong advice, or not clearly communicating the correct advice (Example 13), particularly with regards to fever management in the context of telephone assessments. The most frequent contributory factor (n = 50; 28%) was staff failing to follow protocols, such as those related to safety netting (Table 3).

Discussion

Summary

Based on the burden of incidents in terms of their frequency and severity, and the relative contribution of each incident type to subsequent incidents, the primary-care-related priority areas requiring improvement to reduce iatrogenic harm to sick children are the following: medication provision in the community pharmacy setting; telephone assessment and subsequent referral of acutely unwell children; and communication with patients and their caregivers.

Context of Current Literature

Medication-related safety incidents are widely reported as the most common medical errors, and are thought to be considerably more prevalent in children than in adults [39–42]. Children are more vulnerable to healthcare harm for numerous reasons, such as weight-based dosing; poor availability of certain pediatric formulations, therefore requiring extemporaneous preparation by pharmacists; and dependency on caregivers to advocate for them [5,7,43–45]. Several high-profile reports highlight serious failures in the management of chronic conditions such as asthma and epilepsy in the community setting [2,46–49]. Our study and previous reports highlight that organizational factors (rather than staff knowledge) underpin such failures, suggesting this issue would benefit from quality improvement interventions in healthcare organizations [50–52].

In the UK, children account for 20% of general practice consultations, and 40% of the 500,000 calls received by NHS 111 (formerly NHS Direct) each month [53–56]. Numerous reports in this study criticized telephone assessors for not using critical thinking to challenge inappropriate outcomes reached using clinical decision support (CDS) protocols, arguably due to poor situational awareness. Many have expressed concerns about the safety of telephone assessment of children [53,57–63]. These concerns exist due to the potentially fatal consequences of underestimating the urgency of a child’s condition, the nonspecific nature of many childhood illnesses, the speed with which children deteriorate, and the lack of face-to-face contact, forcing assessors to depend on caregivers to observe the child, interpret those observations, and communicate them effectively [57,59–61,64]. The safety of CDS software used to triage children over the telephone is unclear, particularly its sensitivity to detect signs of serious illness in children [53,60–62,65–68], although its purpose is to minimize risk by standardization and to reduce assessor autonomy—a factor underlying many incidents [61,62].

Despite a study funded by the World Health Organization that echoes our concerns about iatrogenic harm arising from communication failures in primary care, there is a paucity of evaluative studies on this topic, particularly in relation to pediatric telephone assessments [69]. Numerous communication incidents in our study were related to inadequate safety netting during telephone assessment, and this is a well-acknowledged problem in the literature [39,49,70,71]. NHS 111 safety netting protocols have also been described as generic and not child-specific, and there is currently limited evidence to evaluate their role in healthcare-associated harm [38].

Strengths and Limitations

This is the first national analysis of patient safety incidents focusing on children and young people in the primary care setting, to our knowledge. Exploring problems in primary care as a whole at a national level, and focusing on the combinations of incidents and contributory factors, provides insights into the interaction of factors between various primary care settings that underlie iatrogenic harm and the subsequent trajectory of harm in this heterogeneous setting.

We sought to achieve methodological rigor through independent double-coding of a random 20% sample of reports, weekly meetings to discuss coding, and keeping an audit trail to aid reflexivity [72,73]. Incident report data are limited by underreporting and variable data quality; thus, our findings are not likely to be generalizable. It is not possible to comment on variation in underreporting between incident types or settings, given the unknown true denominator of patient safety incidents in primary care; therefore, we cannot comment on the relative safety of different healthcare settings. However, it is important to note that incident report data provide a considerable body of granular information on incidents and contributory factors perceived to be important by front-line healthcare professionals and staff [41]. In light of this, given the nature of these data, it would be premature to conclude that medication safety is a bigger problem than diagnostic error, or that the GP’s office is a safer care setting than an out-of-hours health center. Longitudinal studies using case note review methods to assess the frequency and burden of unsafe primary care are required to support such claims.

Recommendations for Improvement

Our recommendations to improve primary care for children are drawn from the literature and were chosen to ensure they specifically target not only the priority areas identified in our study as requiring improvement but also the specific factors described as contributing to incidents in these priority areas. We corroborated our recommendations with subject matter experts.

Community pharmacy dispensing errors could be reduced through electronic transmission of prescriptions from general practice to the dispensing community pharmacy, as this would prevent errors at the prescriber–dispenser interface [74]. We also recommend implementing a bar coding system for all medications (as is often done in hospital pharmacies), to reduce the potential for human error by acting as an additional safety check prior to medication dispensing [75–77]. Education and training of all pharmacy staff in human factors could enable staff to recognize weaknesses in their own practice [78–83]. In addition, building improvement capability among staff could prove an effective and efficient method of improving patient safety [84].

This study supports the UK Royal College of Paediatrics and Child Health’s call for a robust evaluation of the effectiveness of NHS 111 for children and mandatory pediatric training for all general practice trainees [85]. Monitoring the safety of CDS used to triage sick children is a necessity to target improvement efforts to effectively prevent iatrogenic harm to children. Such improvement may include earlier clinician involvement in the assessment of younger children, who are more difficult to triage safely [68,85]. The outcomes of children assessed using CDS should be reviewed, and the CDS software updated and amended to improve its sensitivity and specificity for this population [86–90]. In addition, CDS could be amended to reduce the potential for certain errors, e.g., reminders when triaging head wounds to double-check the absence of a head injury (which would require triaging with a different protocol).

A lack of critical thinking was described as a contributory factor in many telephone triaging incidents. This is a form of poor situational awareness, with situational awareness referring to sensitivity to operations or “knowing what is going on” [91,92]. Examples of how situational awareness could be improved among telephone triaging staff include human factors training, daily safety huddles to provide feedback on positive and negative cases, and encouraging staff to recognize and act when CDS protocols and their outcomes seem inappropriate [86,92–94]. Increasing situational awareness among telephone triaging staff could—in combination with CDS—increase identification of high-risk children and enable mitigation of risks and appropriate escalation of care.

This study’s findings point to a clear need for improved communication with patients, parents, and caregivers in the context of explaining treatment plans, telephone assessments, and providing safety netting via the telephone. Parents and caregivers should receive oral and written information (perhaps via email, text messaging, or smart phone applications, whichever mode they prefer) regarding treatment plans and for safety netting purposes [38]. This approach is currently being rolled out for epilepsy care in the UK in the form of the Epilepsy Passport. In the context of telephone assessments, adherence to safety netting protocols could be improved through the use of mnemonics or checklists [95–98].

Future Research

In order to expand on our capability to learn from incident report data, higher quality data are needed from healthcare professionals and staff. This will require them to have an understanding of patient safety and human factors, and training to write incident reports [99]. However, to gain a handle on the frequency and burden of unsafe care in children and target improvement efforts, pediatric safety research must mirror the trajectory of ongoing longitudinal studies into the safety of adult care in hospitals and community settings [100,101].

Conclusion

This study has highlighted opportunities to improve the safety of primary care for children through identifying recurring healthcare failures and commonly reported problems underlying them. Safer, reliable medication dispensing systems, redesigned NHS 111 algorithms that are fit for pediatric purpose, improved situational awareness in triage systems, a deeper understanding of communication failures between parents and primary and secondary care practitioners, and mandatory pediatric training for all general practice trainees are priority areas for redress. Globally, healthcare systems with primary-care-led models of delivery must now examine their existing practices to determine the prevalence and burden of these priority safety issues in care provided to children, in addition to reflecting on our recommendations to address these issues in the context of their own practice.

Supporting Information

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