'Working outside the box'-an interview study regarding manipulation of medicines with registered nurses and pharmacists at a Swedish paediatric hospital.

AIM: Studies on frequencies of manipulated medicines in paediatric care are common, but there is little knowledge of experiences of pharmacists and registered nurses in this area. The aim of this study was to explore registered nurses' and pharmacists' reasoning in the manipulation of medicines to paediatric inpatients. METHODS: Semistructured interviews with twelve registered nurses and seven pharmacists were performed at a Swedish paediatric university hospital. The interviews were transcribed verbatim and analysed using content analysis. RESULTS: Four major categories emerged from the analysis of the interviews: medicines management, knowledge, consulting others and organisation. Medicines management involved the process of drug handling, which is prescribing, reconstitution or manipulation and administration. Knowledge concerned both the knowledge base and how healthcare personnel seek information. Consulting others involved colleagues, registered nurses and pharmacists, between registered nurses, pharmacists and physicians and between registered nurses, pharmacists and caregivers. Organisation covered documentation, time and working environment. CONCLUSION: Both pharmacists and registered nurses stated that manipulation of medicines to paediatric patients was often necessary but felt unsafe due to lack of supporting guidelines. Pharmacists were natural members of the ward team, contributing with specific knowledge about medicines and formulations.

Frequency of paediatric patients administered extemporaneous preparations at a Swedish university hospital: a registry-based study comparing two study-years, 10 years apart.

BACKGROUND: Lack of child-friendly dosage forms and strengths often leads to manipulation of medicines at hospital units or by caregivers in the home setting. One alternative to manipulating dosage forms is the use of extemporaneous preparations. In Sweden, these are produced according to good manufacturing practice by a few extemporaneous pharmacies. OBJECTIVES: To compare frequencies of patients administered extemporaneous preparations in two separate years, 10 years apart. METHODS: This registry-based study describes and compares the frequency of extemporaneous oral preparations administered to paediatric patients in 2009 and 2019 at a Swedish university hospital.The study included 117 023 oral administrations (to 4905 patients) and 128 638 oral administrations (to 4718 patients) from 2009 and 2019, respectively. RESULTS: The frequency of inpatients administered one or more extemporaneous preparations increased from 22% in 2009 to 40% in 2019 (p<0.0001). The increase was observed in all age groups. The use of some active pharmaceutical ingredients increased (eg, captopril, clonidine, hydrocortisone, melatonin and propranolol), and some active pharmaceutical ingredients decreased between the study years (eg, midazolam and sildenafil). CONCLUSIONS: The introduction of new authorised products has decreased the need for manipulation or extemporaneous preparations in some therapeutic groups. There remains, however, a pronounced lack of commercially available child-friendly dosage forms and suitable strengths enabling safe administration of medicines to children, indicated by the large percentage of patients receiving at least one extemporaneous preparation.

Identifying neonatal adverse events in preterm and term infants using a paediatric trigger tool.

AIM: To explore the incidence and characteristics of inpatient neonatal adverse events in a Swedish setting. METHODS: A retrospective record review, using a trigger tool, performed by registered nurses and a neonatologist, at a University Hospital. The identified adverse events were categorised by, for example, preventability, severity and time of occurrence. RESULTS: A random selection of 150 admissions representing 3531 patient days were reviewed (mean [SD] birthweight 2620 [1120]g). Three hundred and sixty adverse events were identified in 78 (52.0%) infants, and 305 (84.7%) of these were assessed as being preventable. The overall adverse event rate was 240 per 100 admissions and 102.0 per 1000 patient days. Preterm infants had a higher rate than term infants (353 versus 79 per 100 admissions, p = 0.001); however, with regard to the length of stay, the rates were similar. Most adverse events were temporary and less severe (n = 338/360, 93.9%) and the most common type involved harm to skin, tissue or blood vessels (n = 163/360, 45.3%). Forty percent (n = 145) of adverse events occurred within the first week of admission. CONCLUSION: Adverse events were common in neonatal care, and many occurred during the first days of treatment. Characterisation of adverse events may provide focus areas for improvements in patient safety.

Incidence and characteristics of adverse events in paediatric inpatient care: a systematic review and meta-analysis.

BACKGROUND: Adverse events (AEs) cause suffering for hospitalised children, a fragile patient group where the delivery of adequate timely care is of great importance. OBJECTIVE: To report the incidence and characteristics of AEs, in paediatric inpatient care, as detected with the Global Trigger Tool (GTT), the Trigger Tool (TT) or the Harvard Medical Practice Study (HMPS) method. METHOD: MEDLINE, Embase, Web of Science and Google Scholar were searched from inception to June 2021, without language restrictions. Studies using manual record review were included if paediatric data were reported separately. We excluded studies reporting: AEs for a specific disease/diagnosis/treatment/procedure, or deceased patients; study protocols with no AE outcomes; conference abstracts, editorials and systematic reviews; clinical incident reports as the primary data source; and studies focusing on specific AEs only. Methodological risk of bias was assessed using a tool based on the Quality Assessment Tool for Diagnostic Accuracy Studies 2. Primary outcome was the percentage of admissions with ≥1 AEs. All statistical analyses were stratified by record review methodology (GTT/TT or HMPS) and by type of population. Meta-analyses, applying random-effects models, were carried out. The variability of the pooled estimates was characterised by 95% prediction intervals (PIs). RESULTS: We included 32 studies from 44 publications, conducted in 15 countries totalling 33 873 paediatric admissions. The total number of AEs identified was 8577. The most common types of AEs were nosocomial infections (range, 6.8%-59.6%) for the general care population and pulmonary-related (10.5%-36.7%) for intensive care. The reported incidence rates were highly heterogeneous. The PIs for the primary outcome were 3.8%-53.8% and 6.9%-91.6% for GTT/TT studies (general and intensive care population). The equivalent PI was 0.3%-33.7% for HMPS studies (general care). The PIs for preventable AEs were 7.4%-96.2% and 4.5%-98.9% for GTT/TT studies (general and intensive care population) and 10.4%-91.8% for HMPS studies (general care). The quality assessment indicated several methodological concerns regarding the included studies. CONCLUSION: The reported incidence of AEs is highly variable in paediatric inpatient care research, and it is not possible to estimate a reliable single rate. Poor reporting standards and methodological differences hinder the comparison of study results.

Manipulated Oral and Rectal Drugs in a Paediatric Swedish University Hospital, a Registry-Based Study Comparing Two Study-Years, Ten Years Apart.

This is a registry-based study with the aim of describing and comparing the frequency of manipulations of solid oral and rectal medicines in 2009 and 2019 at inpatient units and an emergency department in a paediatric hospital within a Swedish university hospital. All patients aged 1 month−18 years with oral or rectal administrations were included. In total, 140,791 oral and rectal administrations were included in 2009, and 167,945 oral and rectal administrations were included in 2019. The frequency of patients receiving at least one manipulated oral medicine decreased between the study years, both in inpatient units and in the emergency department (from 19% to 17%, p = 0.0029 and from 11% to 5%, p < 0.0001, respectively). The frequency of patients receiving a manipulated rectal medicine also decreased between the study years, both in inpatient units and in the emergency department (from 22% to 10%, p < 0.0001 and from 35% to 7% 2019, p < 0.0001, respectively). The results show a decrease in the manipulation of both oral and rectal medicines to paediatric patients in 2019 compared to 2009. Even though this implies a safer practice, there is still a pronounced lack of child-friendly dosage forms and suitable strengths enabling the safe administration of medicines to sick children.

Colliding ideals - an interview study of how intervention researchers address adherence and adaptations in replication studies.

BACKGROUND: For an intervention to be considered evidence-based, findings need to be replicated. When this is done in new contexts (e.g., a new country), adaptations may be needed. Yet, we know little about how researchers approach this. This study aims to explore how researchers reason about adaptations and adherence when conducting replication studies, describe what adaptations they make and how these are reported in scientific journals. METHODS: This was an interview study conducted in 2014 with principal investigators of Swedish replication studies reporting adaptations to an intervention from another country. Studies (n = 36) were identified through a database of 139 Swedish psychosocial and psychological intervention studies. Twenty of the 21 principal investigators agreed to participate in semi-structured telephone interviews, covering 33 interventions. Manifest content analysis was used to identify types of adaptations, and qualitative content analysis was used to explore reasoning and reporting of adaptations and adherence. RESULTS: The most common adaptation was adding components and modifying the content to the target population and setting. When reasoning about adaptations and adherence, the researchers were influenced by four main factors: whether their implicit aim was to replicate or improve an intervention; the nature of evidence outlying the intervention such as manuals, theories and core components; the nature of the context, including approaches to cultural adaptations and constraints in delivering the intervention; and the needs of clients and professionals. Reporting of adaptations in scientific journals involved a conflict between transparency and practical concerns such as word count. CONCLUSIONS: Researchers responsible for replicating interventions in a new country face colliding ideals when trying to protect the internal validity of the study while considering adaptations to ensure that the intervention fits into the context. Implicit assumptions about the role of replication seemed to influence how this conflict was resolved. Some emphasised direct replications as central in the knowledge accumulation process (stressing adherence). Others assumed that interventions generally need to be improved, giving room for adaptations and reflecting an incremental approach to knowledge accumulation. This has implications for design and reporting of intervention studies as well as for how findings across studies are synthesised.

Measurement of peripheral venous catheter-related phlebitis: a cross-sectional study.

BACKGROUND: Many instruments for measurement of peripheral venous catheter (PVC)-related phlebitis are available, but no consensus exists on their applicability in clinical practice. This absence of consensus affects the ability to identify and compare proportions of PVCs causing phlebitis within and across hospitals as the range varies between 2% and 62% in previous studies. We hypothesised that the instruments' ability to identify phlebitis varies. The aim of this study is to illustrate the complexity of application of phlebitis instruments to a clinical dataset. METHODS: In this cross-sectional study, we applied 17 instruments for phlebitis identification (divided into three groups [instruments using definitions, severity rating systems, and scoring systems]) to PVCs in adult patients admitted to 12 inpatient units at Karolinska University Hospital in Sweden. We calculated the proportion of PVCs causing phlebitis on the basis of each instrument's minimum criterion for phlebitis. We also analysed each instrument's face validity. We compared proportions using the Z test. FINDINGS: On the basis of data collected between Feb 2, 2009, and Feb 20, 2009, May 18, 2009, and June 5, 2009, and Feb 8, 2010, and Feb 26, 2010, we applied 17 instruments for phlebitis identification (eight instruments using definitions, seven severity rating systems, and two scoring systems) to 1175 observed PVCs in 1032 patients. The highest number of PVCs causing phlebitis generated by definitions was 137 (11·7%), by severity rating systems was 395 (33·6%), and by scoring systems was 363 (30·9%). The proportion generated by instruments using definitions was significantly different to that of both the severity rating (difference 21·9% [95% CI 18·6-25·2]; p<0·0001) and scoring (19·2% [12·0-26·4]; p<0·0001) systems. Proportions did not differ significantly between severity rating systems and scoring system (difference 2·7% [95% CI -1·1 to 6·6]; p=0·16). The proportion within instruments ranged from less than 1% to 28%. We identified face validity issues, such as use of indistinct or complex measurements and inconsistent measurements or definitions. INTERPRETATION: Our study highlights several concerns regarding instruments to measure phlebitis published in the scientific community. From a work environment and patient safety perspective, clinical staff engaged in PVC management should be aware of the absence of adequately validated instruments for phlebitis assessment. We suggest that researchers within the field of PVC come together in a joint research programme aiming to develop valid and reliable methods that accurately identify PVC-related adverse events that also includes decision support for clinical staff concerning clinical indications for PVC removal. Such actions could lead to a revised view on what is best practice for management of PVCs. FUNDING: None.

Effects of computer reminders on complications of peripheral venous catheters and nurses' adherence to a guideline in paediatric care--a cluster randomised study.

BACKGROUND: Reminder systems in electronic patient records (EPR) have proven to affect both health care professionals' behaviour and patient outcomes. The aim of this cluster randomised trial was to investigate the effects of implementing a clinical practice guideline (CPG) for peripheral venous catheters (PVCs) in paediatric care in the format of reminders integrated in the EPRs, on PVC-related complications, and on registered nurses' (RNs') self-reported adherence to the guideline. An additional aim was to study the relationship between contextual factors and the outcomes of the intervention. METHODS: The study involved 12 inpatient units at a paediatric university hospital. The reminders included choice of PVC, hygiene, maintenance, and daily inspection of PVC site. Primary outcome was documented signs and symptoms of PVC-related complications at removal, retrieved from the EPR. Secondary outcome was RNs' adherence to a PVC guideline, collected through a questionnaire that also included RNs' perceived work context, as measured by the Alberta Context Tool. Units were allocated into two strata, based on occurrence of PVCs. A blinded simple draw of lots from each stratum randomised six units to the control and intervention groups, respectively. Units were not blinded. The intervention group included 626 PVCs at baseline and 618 post-intervention and the control group 724 PVCs at baseline and 674 post-intervention. RNs included at baseline were 212 (65.4 %) and 208 (71.5 %) post-intervention. RESULTS: No significant effect was found for the computer reminders on PVC-related complications nor on RNs' adherence to the guideline recommendations. The complication rate at baseline and post-intervention was 40.6 % (95 % confidence interval (CI) 36.7-44.5) and 41.9 % (95 % CI 38.0-45.8), for the intervention group and 40.3 % (95 % CI 36.8-44.0) and 46.9 % (95 % CI 43.1-50.7) for the control. In general, RNs' self-rated work context varied from moderately low to moderately high, indicating that conditions for a successful implementation to occur were less optimal. CONCLUSIONS: The reminders might have benefitted from being accompanied by a tailored intervention that targeted specific barriers, such as the low frequency of recorded reasons for removal, the low adherence to daily inspection of PVC sites, and the lack of regular feedback to the RNs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN44819426.

What Registered Nurses Do and Do Not in the Management of Pediatric Peripheral Venous Catheters and Guidelines: Unpacking the Outcomes of Computer Reminders.

BACKGROUND: Clinical practical guidelines (CPGs) may enhance evidence-based practice, but require implementation. Computer reminders have previously shown various effects in supporting implementation; in a concomitant study, we found no effect on complications in peripheral venous catheters (PVCs) or registered nurses' (RNs) adherence to a CPG in pediatric care. Yet, there is a need to determine how reminders operate in particular contexts. AIM: To depict if, in what context, and how computer reminders regarding evidence-based management of PVC in pediatric care are applied according to RNs' actions and experience. METHODS: Qualitative data from nonparticipant observations and interviews with 18 RNs in four intervention units at a pediatric hospital were analyzed with content analysis. FINDINGS: Attention given to the computer reminders varied; the RNs noticed them in units where there was an agreement about the management and recording of PVCs, but not elsewhere. Rather, computer reminders did not facilitate adherence to the PVC-CPG where the CPG was not acknowledged from the start. RNs who knew how to manage PVCs had peer support and received additional reminders, which suggested that the computer reminders added to the significance of PVCs in pediatric care. LINKING EVIDENCE TO ACTION: While the computer reminders alone did not support CPG implementation, they further increased the attention to PVCs in contexts where there was a readiness to change along with a supportive culture. We suggest further studies tailoring implementation strategies to include electronic means if there is a beneficial context.

Relationship between work context and adherence to a clinical practice guideline for peripheral venous catheters among registered nurses in pediatric care.

BACKGROUND: It is known that registered nurses' (RNs') work context is related to their use of research and that it can affect nurse and patient satisfaction, as well as the outcomes of care. However, little is known about the relationship between work context and nurses' adherence to clinical practice guidelines. The aim of this study was to describe RNs' adherence to a clinical practice guideline (CPG) on the management of peripheral venous catheters (PVCs), their perceptions of work context, and how nurses' work context and characteristics relate to guideline adherence. METHODS: This cross-sectional survey was conducted at a large pediatric university hospital in Sweden. Data were collected through a questionnaire on RNs' adherence to components of a CPG and by using the Alberta Context Tool to assess the nurses' perceptions of work context, including leadership, culture, feedback processes, and other organizational characteristics. RESULTS: Work context--in the form of structural and electronic resources, information sharing activities, and feedback processes--was in different ways associated with the adherence to the CPG components. The RNs' adherence on unit level varied: half the units demonstrated complete adherence on disinfection of hands, whereas a majority of the units reported less than 70% adherence on the use of disposable gloves and the daily inspection of a PVC site. LINKING EVIDENCE TO ACTION: Our findings indicate that components in one CPG might require diverse implementation strategies because they are linked to different contextual factors.

Accuracy in documentation of peripheral venous catheters in paediatric care: an intervention study in electronic patient records.

AIMS: The aim of this study is to compare the accuracy and completeness in the recording of peripheral venous catheters before and after implementing a template in the electronic patient record in paediatric care. BACKGROUND: As a basis for quality improvement and research purposes and to ensure patient safety, accurate clinical data need to be easily accessible in patient records. Several studies have concluded that the relation between performed care and what is documented in patient records is poor. DESIGN: Before and after study. METHOD: The study took place at a large paediatric university hospital in Sweden. Inclusion criteria were patients who were admitted to one of the included wards, had one or several peripheral venous catheters and were available at the ward at the time for data collection. Data were collected by observations and record audits before and then four and 10 months after the introduction of a template for recording peripheral venous catheters in a structured and standardised way. RESULTS: A significant increase in peripheral venous catheters with complete recording was observed after as compared with before the intervention. The percentage of peripheral venous catheters with recording of any kind was relatively stable (85-93%). The overall recording of peripheral venous catheters insertion did not improve, but there was an increase in the recording of side and size after the intervention. One of the 22 complications observed before the intervention was documented and none of the complications (n = 17 and n = 9) after. CONCLUSION: The electronic patient record did not provide accurate data on peripheral venous catheters in paediatric care neither before nor after the intervention. RELEVANCE TO CLINICAL PRACTICE: Further efforts to increase the documentation of catheter-related complications are needed. Integrated decision support systems in electronic patient records that remind nurses to inspect peripheral venous catheters regularly could be one solution.