Transcutaneous Bilirubin Accuracy Before, During, and After Phototherapy: A Meta-Analysis.

CONTEXT: Transcutaneous bilirubinometry (TcB) is used as a valid screening to identify neonates requiring measurement of total serum bilirubin (TSB) before phototherapy. Its use during and after phototherapy is not advised yet because of unknown reliability. OBJECTIVES: To determine the agreement of TcB and TSB measurements before, during, and after phototherapy. DATA SOURCES: PubMed Medline, Cochrane Library, and references of eligible studies were searched. STUDY SELECTION: Prospective and retrospective cohort and cross-sectional studies reporting Bland-Altman statistics of paired TcB and TSB measurements in term and preterm newborns. DATA EXTRACTION: Meta-analysis was performed using the Mantel-Haenszel weighted approach. The agreement between TcB and TSB in µmol/L was described by pooled mean differences (MDs) and limits of agreement (LoA). RESULTS: Fifty-four studies were included. The pooled MD before phototherapy is 2.5 µmol/L (LoA -38.3 to 43.3). The pooled MD during phototherapy is -0.3 µmol/L (LoA -34.8 to 34.2) on covered skin and -28.6 µmol/L (LoA -105.7 to 48.5) on uncovered skin. The pooled MD after phototherapy is -34.3 µmol/L (LoA -86.7 to 18.1) on covered skin and -21.1 µmol/L (LoA -88.6 to 46.4) on uncovered skin. Subgroup analysis revealed the best agreement at the forehead. We did not find any difference in agreement between term and preterm neonates. LIMITATIONS: Language restriction. CONCLUSIONS: TcB measurements before and during phototherapy on covered skin show good agreement compared with TSB in term and preterm newborns. More studies are needed to evaluate the accuracy after phototherapy.

Severe Pediatric COVID-19 and Multisystem Inflammatory Syndrome in Children From Wild-type to Population Immunity: A Prospective Multicenter Cohort Study With Real-time Reporting.

BACKGROUND: SARS-CoV-2 variant evolution and increasing immunity altered the impact of pediatric SARS-CoV-2 infection. Public health decision-making relies on accurate and timely reporting of clinical data. METHODS: This international hospital-based multicenter, prospective cohort study with real-time reporting was active from March 2020 to December 2022. We evaluated longitudinal incident rates and risk factors for disease severity. RESULTS: We included 564 hospitalized children with acute COVID-19 (n = 375) or multisystem inflammatory syndrome in children (n = 189) from the Netherlands, Curaçao and Surinam. In COVID-19, 134/375 patients (36%) needed supplemental oxygen therapy and 35 (9.3%) required intensive care treatment. Age above 12 years and preexisting pulmonary conditions were predictors for severe COVID-19. During omicron, hospitalized children had milder disease. During population immunity, the incidence rate of pediatric COVID-19 infection declined for older children but was stable for children below 1 year. The incidence rate of multisystem inflammatory syndrome in children was highest during the delta wave and has decreased rapidly since omicron emerged. Real-time reporting of our data impacted national pediatric SARS-CoV-2 vaccination- and booster-policies. CONCLUSIONS: Our data supports the notion that similar to adults, prior immunity protects against severe sequelae of SARS-CoV-2 infections in children. Real-time reporting of accurate and high-quality data is feasible and impacts clinical and public health decision-making. The reporting framework of our consortium is readily accessible for future SARS-CoV-2 waves and other emerging infections.

High-flow oxygen therapy in moderate to severe bronchiolitis: a randomised controlled trial.

BACKGROUND AND OBJECTIVE: High-flow (HF) oxygen therapy is being used increasingly in infants with bronchiolitis, despite lack of convincing evidence of its superiority over low flow (LF). We aimed to compare the effect of HF to LF in moderate to severe bronchiolitis. METHODS: Multicentre randomised controlled trial during four winter seasons (2016-2020) including 107 children under 2 years of age admitted with moderate to severe bronchiolitis, oxygen saturation of <92% and severely impaired vital signs. Crossovers were not allowed. HF was administered at flow rates of 2 L/kg for the first 10 kg, plus 0.5 L/kg for every kg >10 kg, LF with a maximum flow rate of 3 L/min. Primary outcome was improvement of vital signs and dyspnoea severity within 24 hours assessed by a composite score. Secondary outcomes were comfort, duration of oxygen therapy, supplemental feedings, hospitalisation duration and intensive care admission for invasive ventilation. RESULTS: Significant improvement within 24 hours occurred in 73% of 55 patients randomised to HF and in 78% of 52 patients with LF (difference 6%, 95% CI -13% to 23%). Intention-to-treat analysis revealed no significant differences in any secondary outcome: duration of oxygen therapy, supplemental feedings, hospitalisation and need for invasive ventilation or intensive care admission, except for comfort (face, legs, activity, cry, consolability), which was one point (out of a scale of 0-10) higher in the LF group. No adverse effects occurred. CONCLUSION: We found no measurable clinically relevant benefit in the use of HF compared with LF in hypoxic children with moderate to severe bronchiolitis. TRIAL REGISTRATION NUMBER: NCT02913040.

Conservative Treatment of Parapneumonic Effusion in Children: Experience From a 10-Year Consecutive Case Series.

BACKGROUND: In children with parapneumonic effusion (PPE), it remains unclear when conservative treatment with antibiotics suffixes or when pleural drainage is needed. In this study we evaluate clinical features and outcomes of children with PPE. METHODS: A retrospective, multicentre cohort study at 4 Dutch pediatric departments was performed, including patients 1-18 years treated for PPE between January 2010 and June 2020. RESULTS: One hundred thirty-six patients were included (mean age 8.3 years, SD 4.8). 117 patients (86%) were treated conservatively and 19 (14%) underwent pleural drainage. Patients undergoing pleural drainage had mediastinal shift more frequently compared with conservatively treated patients (58 vs. 3%, difference 55%; 95% CI: 32%-77%). The same accounted for pleural septations/pockets (58 vs. 11%, difference 47%; 95% CI: 24%-70%), pleural thickening (47 vs. 4%, difference 43%; 95% CI: 20%-66%) and effusion size (median 5.9 vs. 2.7 cm; P = 0.032). Conservative management was successful in 27% of patients (4 of 15) with mediastinal shift, 54% of patients (13 of 24) with septations/pockets, 36% of patients (5 of 14) with pleural thickening, and 9% of patients (3 of 32) with effusions >3 cm, all radiological signs generally warranting pleural drainage. In patients treated conservatively, median duration of hospitalization was 5 days (IQR 4-112) compared with 19 days (IQR 15-24) in the drainage group ( P < 0.001), without significant difference in readmission rate (11 vs. 4%, difference 6%; 95% CI: -8%-21%). CONCLUSION: This study suggests that the greater amount of children with PPE could be treated conservatively with antibiotics only, especially in absence of mediastinal shift, pleural septations/pockets, pleural thickening or extensive effusions.

Effect of lockdowns on the epidemiology of pediatric respiratory disease-A retrospective analysis of the 2021 summer epidemic.

BACKGROUND: The imposition of lockdowns during the severe acute respiratory syndrome coronavirus-2 pandemic led to a significant decrease in pediatric care utilization in 2020. After restrictions were loosened, a surge in pediatric respiratory disease was observed in pediatric wards. The aim of this study was to quantify the effect of the lockdown(s) on the incidence of pediatric respiratory disease. METHODS: For this multicenter retrospective study, emergency department (ED) visit and admission data between January 2017 and September 2021 was collected from eight general hospitals in the Netherlands. Clinical diagnoses were extracted and categorized in groups ("communicable infectious disease," "all respiratory infections," "upper respiratory tract infection," "lower respiratory tract infection," and "asthma/preschool wheezing"). The incidence of admissions and ED visits during 2020 and 2021 was compared to the incidence in 2017-2019. RESULTS: Successive lockdowns resulted in a maximum decrease of 61% and 57% in ED visits and admissions, respectively. After loosening restrictions during the summer of 2021, a 48% overall increase in ED visits and 31% overall increase in admission numbers was observed in July compared to the average July in 2017-2019. This was explained by a 381% increase in ED visits and a 528% increase in ward admissions due to overall respiratory infections, mainly due to lower respiratory tract infections. CONCLUSIONS: Successive lockdowns in the spring and winter of 2020 and 2021 led to a decreased incidence of communicable infections, especially respiratory tract infections. The resulting lack of pediatric immunity resulted in an off-season surge in care utilization at an unexpected moment.

Adverse effect of lockdowns during the COVID-19 pandemic: increased incidence of pediatric crisis admissions due to eating disorders and adolescent intoxications.

During the COVID-19 pandemic, countries imposed (partial) lockdowns that reduced viral transmission. However, these interventions may have unfavorable effects on emotional and psychological well-being. The aim of this study was to quantify possible adverse effects of the COVID-19 pandemic on psychological wellbeing in children and adolescents. Hospital admission data between January 2017 and September 2021 from eight general hospitals in the Netherlands was collected, comparing the incidences of sub-categorized psychological diagnoses, more specifically eating disorders, intentional intoxications, accidental intoxications, and excessive crying, before (2017-2019) and during the pandemic (2020-2021). Data was summarized per month and per year, and the years 2020 and 2021 were compared to 2017-2019. The relative increase or decrease in diagnoses since the start of the pandemic was calculated. Overall pediatric hospital admissions decreased with 28% since the start of the pandemic. Non-infectious diagnoses showed a decrease of 8%. Of these non-infectious diagnoses, overall psychosocial admissions were increased (+ 9%), mostly caused by an increase in admissions for eating disorders (+ 64%) and intoxications in adolescents (+ 24%). In addition, the proportion of admissions due to psychosocial diagnoses increased post-pandemic (6% vs 4%, p < 0.001). Overall admissions for intoxications in children (- 3%) and excessive crying (- 1%) did not increase, although peaks in incidence were found at the start of the second lockdown. CONCLUSION: During the COVID-19 pandemic, admission rates for eating disorders and intentional intoxications showed a substantial increase, indicating a high burden of pediatric psychiatric diseases. WHAT IS KNOWN: • The COVID-19 pandemic has had an impact on psychosocial wellbeing in children and adolescents. WHAT IS NEW: • There was an increase in admissions due to psychosocial problems in the Netherlands in the period after the pandemic. • This was mainly caused by an increase in crisis admissions due to eating disorders and intoxications in adolescents.

[Chronic non-infectious osteomyelitis in children]. / Chronische niet-infectieuze osteomyelitis bij kinderen.

Musculoskeletal pain in common and the differential diagnosis is broad. It is important to recognize the harmful and/or treatable pathology, without performing unnecessary diagnostics. Pattern recognition is crucial. One of the differential diagnostic considerations is chronic non-infectious osteomyelitis (CNO). A relatively unknown auto-inflammatory disease. By presenting three cases, we want to draw attention to this condition and contribute to a better recognition of this disease. We emphasize the importance of doing a total body MRI, when CNO is considered.

Patterns and seasonality in pediatric referrals for functional somatic symptoms.

Functional somatic symptoms (FSS), or medically unexplained physical symptoms, are common in children and it has been suggested that the incidence is increasing. To determine the incidence and pattern of referrals for FSS to pediatricians, we performed a retrospective analysis including newly referred pediatric patients to our secondary pediatric practice in Zwolle, The Netherlands, ultimately diagnosed with FSS between 2013 and 2018. FSS was defined as functional abdominal pain, chronic fatigue, chronic musculoskeletal pain and chronic headache without an underlying medical diagnosis. In the 6-year period, 10.4% of elective referrals were related to FSS without a significant upward trend. We found clear seasonal variation with peaks in incidences in March (+31%) and November (+21%) and a nadir around August (-48%). In conclusion, FSS account for 1 in 10 non-acute pediatric referrals, without an increase in incidence in the past 6 years. The seasonal pattern is remarkable and warrants further analysis.

[Tongue tie: to cut or not to cut?] / Tongriem over de tong: klieven of niet?

Cleavage of tongue tie (ankyloglossia) in newborns is controversial and has known varying degrees of popularity over time. The last decade frenotomy is advocated and increasingly performed in infants with breastfeeding problems. However, evidence for an association between ankyloglossia and breastfeeding is dubious. Moreover, evidence for the effect of frenotomy on breastfeeding is lacking. Well-conducted controlled trials are sparse and methodological quality of reported trials is weak and merely hindered by lack of equipoise. Thus, the tongue tie and frenotomy are prone for overdiagnosis and overmedicalization. Until robust, well conducted, randomized controlled trials have been performed frenotomy should not routinely nor easily be recommended.

[Health care evaluation and guideline research]. / Zorgevaluatie en richtlijnenonderzoek.

Health care evaluation is essential in improving patient care. This as a continuous process, in which randomized studies can be used to answer unambiguous knowledge gaps and observational quantitative studies for structural evaluation of guideline use in daily practice. Several conditions need to be fulfilled before these observational studies can be part of routine clinical practice. An important issue is awareness among healthcare providers and Boards of Directors to support and facilitate these relevant observational studies.

Cephalocaudal progression of neonatal jaundice assessed by transcutaneous bilirubin measurements.

OBJECTIVE: The cephalocaudal progression in neonatal jaundice is a well-known phenomenon. Since transcutaneous bilirubin measurements (TcB) are increasingly applied, for which different body site can be used, we aimed to quantify the cephalocaudal progression of neonatal jaundice through TcB and to assess the influence of gestational age, postnatal age and the degree of hyperbilirubinemia on this cephalocaudal progression. STUDY DESIGN: In jaundiced neonates ≥32 weeks of gestational age, TcB was measured on 5 sites: forehead, sternum, hipbone, proximal tibia and foot, during the first two weeks of life. RESULTS: 58 neonates were included. Mean ratios of TcB on the 5 sites compared to the forehead were: sternum 1,03 (SD 0,14), hipbone 0,80 (SD 0,16), proximal tibia 0,63 (SD 0,14) and foot 0,44 (SD 0,15). Gestational age, postnatal age nor the degree of hyperbilirubinemia were associated with the cephalocaudal progression (ANOVA p > 0,05). CONCLUSION: The cephalocaudal progression of neonatal jaundice is evident, with caudal levels of TcB being less than half of cephalic measurements. This implicates that TcB measurements caudal from the sternum are less reliable, and should be avoided. The degree of cephalocaudal progression is not associated with gestational or postnatal age, nor with height of bilirubin levels.

[Oral glucose in neonates with an increased risk of neonatal hypoglycaemia halves the number of neonates receiving intravenous glucose]. / Orale glucose bij pasgeborenen met een verhoogd risico op neonatale hypoglykemie leidt tot halvering van het aantal glucose-infusen.

OBJECTIVE: Evaluate the effectiveness and safety of application of oral glucose to neonates with an increased risk of neonatal hypoglycaemia. BACKGROUND: Neonatal hypoglycaemia is a common problem in neonates with potential permanent neurological damage. Recent studies show that the use of oral glucose to prevent and treat neonatal hypoglycaemia leads to a decrease in intravenous glucose administration and fewer clinical admissions. However, oral glucose administration is still rarely used. In 2019 Isala hospital implemented the use of oral glucose in neonates with an increased risk of neonatal hypoglycaemia. METHOD: Retrospective evaluation study in Isala hospital between November 1, 2018 and December 31. Neonates with one of the following risk factors for neonatal hypoglycaemia: prematurity (gestational age between 34+0-37+0), maternal diabetes requiring medication, asphyxia with an Apgar score <7 at five minutes and/or a birthweight <2500 grams. The frequency of glucose infusions, the lowest glucose value and the type of food were compared between neonates treated before and after the use of oral glucose. RESULTS: The number of glucose infusions decreased after introduction of oral glucose (14.0% versus 5.9%, -8.1% [-14.1, -2.1]). The lowest measured glucose value (2.2 mmol/l versus 2.5 mmol/l, 0.3 mmol/l [0.15, 0.47]) was significantly higher after introduction of oral glucose. Mild complications (vomiting and food refusal) occurred in 3.8% of neonates receiving oral glucose, all without clinical consequence. CONCLUSION: The use of oral glucose administration in neonates with an increased risk of hypoglycaemia reduces the number of intravenous glucose by half and is safe to use.

The impact of lockdown on pediatric ED visits and hospital admissions during the COVID19 pandemic: a multicenter analysis and review of the literature.

The coronavirus disease 2019 pandemic has enormous impact on society and healthcare. Countries imposed lockdowns, which were followed by a reduction in care utilization. The aims of this study were to quantify the effects of lockdown on pediatric care in the Netherlands, to elucidate the cause of the observed reduction in pediatric emergency department (ED) visits and hospital admissions, and to summarize the literature regarding the effects of lockdown on pediatric care worldwide. ED visits and hospital admission data of 8 general hospitals in the Netherlands between January 2016 and June 2020 were summarized per diagnosis group (communicable infections, noncommunicable infections, (probable) infection-related, and noninfectious). The effects of lockdown were quantified with a linear mixed effects model. A literature review regarding the effect of lockdowns on pediatric clinical care was performed. In total, 126,198 ED visits and 47,648 admissions were registered in the study period. The estimated reduction in general pediatric care was 59% and 56% for ED visits and admissions, respectively. The largest reduction was observed for communicable infections (ED visits: 76%; admissions: 77%), whereas the reduction in noninfectious diagnoses was smaller (ED visits 36%; admissions: 37%). Similar reductions were reported worldwide, with decreases of 30-89% for ED visits and 19-73% for admissions.Conclusion: Pediatric ED utilization and hospitalization during lockdown were decreased in the Netherlands and other countries, which can largely be attributed to a decrease in communicable infectious diseases. Care utilization for other conditions was decreased as well, which may indicate that care avoidance during a pandemic is significant. What is Known: • The COVID-19 pandemic had enormous impact on society. • Countries imposed lockdowns to curb transmission rates, which were followed by a reduction in care utilization worldwide. What is New: • The Dutch lockdown caused a significant decrease in pediatric ED utilization and hospitalization, especially in ED visits and hospital admissions because of infections that were not caused by SARS-CoV-2. • Care utilization for noninfectious diagnoses was decreased as well, which may indicate that pediatric care avoidance during a pandemic is significant.

Multicentre study found that adherence to national antibiotic recommendations for neonatal early-onset sepsis was low.

AIM: Our aim was to evaluate adherence to the Dutch neonatal early-onset sepsis (EOS) guidelines, adapted from UK guidance. We also looked at the effect on antibiotic recommendations and duration. METHOD: This was a multicentre, prospective observational cross-sectional study carried out in seven hospitals in the Netherlands between 1 September 2018 and 1 November 2019. We enrolled 1024 neonates born at 32 weeks of gestation or later if they demonstrated at least one EOS risk factor or clinical signs of infection. RESULTS: The Dutch guidelines recommended antibiotic treatment for 438/1024 (42.8%) of the neonates designated at risk, but only 186/438 (42.5%) received antibiotics. The guidelines advised withholding antibiotics for 586/1024 (57.2%) of neonates and in 570/586 (97.3%) cases the clinicians adhered to this recommendation. Blood cultures were obtained for 182/186 (97.8%) infants who started antibiotics and only four were positive, for group B streptococci. Antibiotic treatment was continued for more than 3 days in 56/178 (31.5%) neonates, despite a negative blood culture. CONCLUSION: Low adherence to the Dutch guidelines meant that the majority of neonates did not receive the antibiotic treatment that was recommended, while some antibiotic use was prolonged despite negative blood cultures. The guidelines need to be revised.

Impact of deliberate practice on evidence-based medicine attitudes and behaviours of health care professionals.

INTRODUCTION: Although evidence-based medicine (EBM) teaching activities may improve short-term EBM knowledge and skills, they have little long-term impact on learners' EBM attitudes and behaviour. This study examined the effects of learning EBM through stand-alone workshops or various forms of deliberate EBM practice. METHODS: We assessed EBM attitudes and behaviour with the evidence based practice inventory questionnaire, in paediatric health care professionals who had only participated in a stand-alone EBM workshop (controls), participants with a completed PhD in clinical research (PhDs), those who had completed part of their paediatric residency at a department (Isala Hospital) which systematically implemented EBM in its clinical and teaching activities (former Isala residents), and a reference group of paediatric professionals currently employed at Isala's paediatric department (current Isala participants). RESULTS: Compared to controls (n = 16), current Isala participants (n = 13) reported more positive EBM attitudes (p < 0.01), gave more priority to using EBM in decision making (p = 0.001) and reported more EBM behaviour (p = 0.007). PhDs (n = 20) gave more priority to using EBM in medical decision making (p < 0.001) and reported more EBM behaviour than controls (p = 0.016). DISCUSSION: Health care professionals exposed to deliberate practice of EBM, either in the daily routines of their department or by completing a PhD in clinical research, view EBM as more useful and are more likely to use it in decision making than their peers who only followed a standard EBM workshop. These findings support the use of deliberate practice as the basis for postgraduate EBM educational activities.

Room Sharing in Hospitalized Children With Bronchiolitis and the Occurrence of Hospital-Acquired Infections: A Prospective Cohort Study.

OBJECTIVES: To determine the prevalence and severity of hospital-acquired infections (HAIs) in children hospitalized for bronchiolitis when patients share a room, irrespective of the causative virus. METHODS: A prospective cohort study during 4 winter seasons (2012-2016) was conducted in a Dutch general pediatric ward including otherwise healthy children <2 years of age hospitalized for bronchiolitis. Patients shared a 1-to-4-bed hospital room irrespective of virological diagnosis. The main outcome measures were HAIs assessed through multiplex polymerase chain reaction and disease severity. RESULTS: HAIs occurred in 28 of 218 included patients (12.8%), most frequently with rhinovirus (17 of 28; 60.7%). In 3 (10.7%) of 28 HAIs, the same virus was identified in roommates. Only 1 patient became cross-infected with respiratory syncytial virus, although this patient never shared a room with a patient infected with respiratory syncytial virus. HAI was not associated with more severe disease. The median length of hospitalization was 3.5 days (interquartile range [IQR] 1-6) compared with 3 days (IQR 2-6; P = .86); the number of PICU admissions was 0% versus 5.3% (P = .21); the median days of oxygen supplementation was 2.5 (IQR 1-4) versus 2 (IQR 1-4; P = .58); the median days of tube feeding was 2 (IQR 0-5) versus 2 (interquartile range: 0-5; P = .77); and the readmission rate was 0% versus 5.8% (P = .19) in patients with and without HAI, respectively. CONCLUSIONS: HAIs among patients with bronchiolitis are common but not associated with more severe disease. Room sharing with appropriate hygiene does not play a relevant role in the transmission of viruses between patients with bronchiolitis, regardless of the viruses involved. On the basis of these findings, we suggest that room sharing of patients with bronchiolitis is safe.

Lidocaine spray as a local analgesic for intravenous cannulation: a randomized clinical trial.

OBJECTIVES: Lidocaine spray is an effective analgesic of mucous membranes. Lidocaine spray is also used during intravenous (i.v.) cannulation, especially in children. However, the analgesic effect of lidocaine spray during i.v. cannulation has not been studied. We aimed to assess the analgesic effectiveness of lidocaine spray during i.v. cannulation. METHODS: We conducted a randomized, double-blinded, placebo-controlled trial in seventeen healthy adults who received an i.v. cannulation in the right and left elbow, respectively, where the order of application of 60 mg lidocaine spray (Xylocaine 10% pump spray) or placebo spray (chlorhexidine gluconate 0.5% in 70% alcohol base) before i.v. cannulation was randomized. Thus, each participant had an i.v. cannulation in both arms: one with lidocaine spray and the other with placebo spray. The primary outcome was pain intensity assessed by a 100 mm Visual Analogue Scale. The secondary outcomes were adverse events, success rate of i.v. cannulation and the degree of difficulty of i.v. cannulation as estimated by the nurse performing the i.v cannulation. RESULTS: The pain score (Visual Analogue Scale) during i.v. cannulation was 18.0 mm (interquartile range: 5.0-34.5 mm) after lidocaine application and 21.0 mm (interquartile range: 11.0-30.5) after placebo application. These scores were not significantly different (95% confidence interval: -9.0-11.0, P=0.698). No adverse events occurred and all i.v. cannulations were successful at first attempt. CONCLUSION: Local administration of lidocaine is not effective in reducing pain during i.v. cannulation.

[Excessively crying infants: do we really need to hospitalize them?] / Horen huilbaby's in het ziekenhuis?

Excessively crying infants are frequently admitted to hospital to break a negative pattern as well as for parental reassurance. In many cases, prior to admission, a large number of mostly unproven interventions have been advised by different health care professionals, when reassurance and support should be actually be the imperative course of action. To enable health-care professionals to offer the necessary reassurance and support, taking the time to build a trustworthy relationship with parents is crucial, and excellent communicative skills are required. Self-reflection and insight in practice variation can help health professionals minimize unnecessary medicalization in excessively crying infants.

[The General Data Protection Regulation and clinical guidelines evaluation]. / Zorgevaluatieonderzoek en de AVG.

The General Data Protection Regulation (GDPR), which has replaced previous privacy legislation, came into full effect in the European Union in May 2018. This paper discusses the implications of the GDPR for the handling of health care data when evaluating clinical guidelines. Guideline evaluation is mandatory in order to improve the quality of health care. Following the implementation of the GDPR, there has been increased awareness that it is now mandatory to obtain consent and to provide patient information letters if patient data are not given anonymously.