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Article ; Online: Potential prediction of formulation performance in paediatric patients using biopharmaceutical tools and simulation of clinically relevant administration scenarios of nifedipine and lorazepam.

Van der Vossen, Anna C / Hanff, Lidwien M / Vulto, Arnold G / Fotaki, Nikoletta

British journal of clinical pharmacology

2019 Volume 85, Issue 8, Page(s) 1728–1739

Abstract: Aims: This study explores the impact of paediatric patient related factors and choice of formulation on the dissolution characteristics of nifedipine and lorazepam, 2 drug substances regularly applied in very young patients and in compounded ... ...

Abstract	Aims: This study explores the impact of paediatric patient related factors and choice of formulation on the dissolution characteristics of nifedipine and lorazepam, 2 drug substances regularly applied in very young patients and in compounded formulations. Methods: Dissolution experiments were designed to reflect clinical practice in a paediatric hospital, with respect to dosage forms, feeding regimens and methods of administration. Solubility studies addressed the influence of age and prandial state. Drug solubility and dissolution experiments were conducted in biorelevant media and adapted age-specific (neonate and infant) media. Dissolution studies were performed with the mini-paddle apparatus and the flow-through cell apparatus. Results: Dissolution of nifedipine formulations was not affected by age-related changes of the fasted state simulated gastrointestinal fluids, and by disintegration of the formulation before administration. However, a significant difference in nifedipine's dissolution rate from commercial tablets and compounded capsules was observed. The dissolution of lorazepam tablets was affected by fasted- vs fed-state media, but it was deemed less likely to be clinically relevant. The significant effect of fed-state media on nifedipine's solubility was considered to have possible clinical relevance since very young patients are almost continuously in a fed state. Conclusion: The in vitro results obtained from these studies reveal the potential of biorelevant solubility and dissolution studies reflecting clinical practice to predict drug performance in paediatric patients.
MeSH term(s)	Administration, Oral ; Age Factors ; Capsules ; Chemistry, Pharmaceutical ; Computer Simulation ; Drug Combinations ; Drug Liberation ; Food-Drug Interactions ; Humans ; Infant ; Infant, Newborn ; Lorazepam/pharmacokinetics ; Models, Biological ; Nifedipine/pharmacokinetics ; Solubility ; Solutions ; Tablets
Chemical Substances	Capsules ; Drug Combinations ; Solutions ; Tablets ; Nifedipine (I9ZF7L6G2L) ; Lorazepam (O26FZP769L)
Language	English
Publishing date	2019-06-18
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.13956
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Article ; Online: Manipulation of oral medication for children by parents and nurses occurs frequently and is often not supported by instructions.

van der Vossen, Anna C / Al-Hassany, Linda / Buljac, Sandra / Brugma, Jan-Dietert / Vulto, Arnold G / Hanff, Lidwien M

Acta paediatrica (Oslo, Norway : 1992)

2019 Volume 108, Issue 8, Page(s) 1475–1481

Abstract: Aim: Due to a lack of age-appropriate formulations, administration of drugs to children remains a challenge. This study aimed to identify the problems experienced in both the outpatient setting and the clinical setting.: Methods: Between June 2017 ... ...

Abstract	Aim: Due to a lack of age-appropriate formulations, administration of drugs to children remains a challenge. This study aimed to identify the problems experienced in both the outpatient setting and the clinical setting. Methods: Between June 2017 and January 2018, we performed a cross-sectional, prospective study at the Sophia Children's Hospital, The Netherlands. The study comprised of a structured interview on drug manipulations with parents visiting the outpatient clinic, and an observational study of drug manipulations by nurses at the wards. Results: A total of 201 questionnaires were collected, accounting for 571 drugs and 169 manipulations (30%). Drug substances that were most often mentioned as manipulated were macrogol (n = 23), esomeprazole (n = 15), paracetamol (n = 8), methylphenidate (n = 7) and melatonin (n = 7). Of all manipulated medicines, 93/169 (55%) were manipulated according to the instructions or recommendations of the Summary of Product Characteristics (SmPC) or patient information leaflet. During the observational study, manipulation was performed by 21/35 of observed nurses (60%), of whom 11 deviated from the hospital protocol for manipulation or SmPC (52%). Conclusion: Manipulation was a widely used method to administer drugs to children. Validated information regarding manipulation of drugs for both parents and nursing staff is needed.
MeSH term(s)	Administration, Oral ; Adolescent ; Child ; Child, Preschool ; Cross-Sectional Studies ; Dosage Forms ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Parents ; Pediatric Nursing/methods ; Pediatric Nursing/statistics & numerical data ; Prospective Studies
Chemical Substances	Dosage Forms
Language	English
Publishing date	2019-03-13
Publishing country	Norway
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	203487-6
ISSN	1651-2227 ; 0365-1436 ; 0803-5253
ISSN (online)	1651-2227
ISSN	0365-1436 ; 0803-5253
DOI	10.1111/apa.14718
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Article ; Online: Use of amlodipine oral solution for the treatment of hypertension in children.

van der Vossen, Anna C / Cransberg, Karlien / de Winter, Brenda C M / Schreuder, Michiel F / van Rooij-Kouwenhoven, Roos W G / Vulto, Arnold G / Hanff, Lidwien M

International journal of clinical pharmacy

2020 Volume 42, Issue 3, Page(s) 848–852

Abstract: Background Amlodipine is a widely used antihypertensive agent for the treatment of paediatric hypertension, but the commercially available tablets are not suitable to treat young patients, who need lower, flexible dosages and a liquid formulation. ... ...

Abstract	Background Amlodipine is a widely used antihypertensive agent for the treatment of paediatric hypertension, but the commercially available tablets are not suitable to treat young patients, who need lower, flexible dosages and a liquid formulation. Objective To determine the pharmacokinetic properties of amlodipine and the acceptability of a standardised, extemporaneous oral solution. Method A newly developed liquid formulation of amlodipine was administered to hypertensive children between the age of 6 months and 11 years. Using a limited sampling strategy, population PK analysis was performed using nonlinear mixed effects modelling. Results Nine children, with a median age of 2.9 years (IQR 1.8-8.4), receiving stable amlodipine therapy in a median dose of 0.15 mg kg
MeSH term(s)	Administration, Oral ; Amlodipine/administration & dosage ; Amlodipine/pharmacokinetics ; Amlodipine/therapeutic use ; Antihypertensive Agents/administration & dosage ; Antihypertensive Agents/pharmacokinetics ; Antihypertensive Agents/therapeutic use ; Body Weight ; Child ; Child, Preschool ; Female ; Hospitals, Pediatric ; Humans ; Hypertension/drug therapy ; Infant ; Male ; Metabolic Clearance Rate ; Netherlands ; Sex Factors ; Solutions
Chemical Substances	Antihypertensive Agents ; Solutions ; Amlodipine (1J444QC288)
Language	English
Publishing date	2020-05-06
Publishing country	Netherlands
Document type	Clinical Trial ; Journal Article ; Multicenter Study
ZDB-ID	2601204-2
ISSN	2210-7711 ; 2210-7703 ; 0928-1231
ISSN (online)	2210-7711
ISSN	2210-7703 ; 0928-1231
DOI	10.1007/s11096-020-01000-9
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Article ; Online: Oral lorazepam can be substituted for intravenous midazolam when weaning paediatric intensive care patients off sedation.

van der Vossen, Anna C / van Nuland, Merel / Ista, Erwin G / de Wildt, Saskia N / Hanff, Lidwien M

Acta paediatrica (Oslo, Norway : 1992)

2018

Abstract: Aim: Intravenous sedatives used in the paediatric intensive care unit (PICU) need to be tapered after prolonged use to prevent iatrogenic withdrawal syndrome (IWS). We evaluated the occurrence of IWS and the levels of sedation before and after ... ...

Abstract	Aim: Intravenous sedatives used in the paediatric intensive care unit (PICU) need to be tapered after prolonged use to prevent iatrogenic withdrawal syndrome (IWS). We evaluated the occurrence of IWS and the levels of sedation before and after conversion from intravenous midazolam to oral lorazepam. Methods: This was a retrospective, observational, single cohort study of children under the age of 18 admitted to the PICU of the Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands, between January 2013 and December 2014. The outcome parameters were the Sophia Observation withdrawal Symptoms (SOS) scale scores and COMFORT Behaviour scale scores before and after conversion. Results: Of the 79 patients who were weaned, 32 and 39 had before and after SOS scores and 77 had COMFORT-B scores. IWS was reported in 15 of 79 patients (19.0%) during the 48 hours before the start of lorazepam and 17 of 79 patients (21.5%) during the 48 hours after treatment started. Oversedation was seen in 16 of 79 patients (20.3%) during the 24 hours before substitution and in 30 of 79 patients (38.0%) during the 24 hours after substitution. Conclusion: The weaning protocol was not able to prevent IWS in all patients, but converting from intravenous midazolam to oral lorazepam did not increase the incidence.
Language	English
Publishing date	2018-03-23
Publishing country	Norway
Document type	Journal Article
ZDB-ID	203487-6
ISSN	1651-2227 ; 0365-1436 ; 0803-5253
ISSN (online)	1651-2227
ISSN	0365-1436 ; 0803-5253
DOI	10.1111/apa.14327
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Article: Bioequivalence study of an extemporaneously prepared oral solution of amlodipine suitable for use in pediatric patients compared to commercial tablets.

van der Vossen, Anna C / van der Velde, Iris / van den Meiracker, Anton H / van der Nagel, Bart C H / Koch, Birgit C P / Vulto, Arnold G / Hanff, Lidwien M

International journal of clinical pharmacology and therapeutics

2016 Volume 54, Issue 1, Page(s) 65–72

Abstract: ... of the geometric means for the primary pharmacokinetic parameters AUC(0-72) (88.24 - 104.37%) and C(max) (99.00 ... C(max) of the tablet was 2.91 (0.84) μg/L with a median (IQR) tmax of 6.0 (4.0 - 14.0) hours ... Intrasubject coefficients of variation were 10.2% (AUC(0-72)) and 12.4% (C(max)).: Conclusions ...

Abstract	Objective: Amlodipine, a long-acting dihydropyridine calcium channel blocker, is frequently prescribed to pediatric patients. To date, no suitable pediatric formulation has been available. In this study, an amlodipine oral solution was developed and tested for bioequivalence to tablets in healthy adult volunteers. Methods: This study was designed as an open-label, single-dose, twosequence, two-period, crossover trial to assess the bioequivalence of a newly developed amlodipine besylate oral solution 0.5 mg/mL compared to Norvasc® 5 mg tablets. 13 adult subjects (mean [standard deviation] age of 23.2 [3.6] years, weight 71.5 [7.7] kg) were included and blood samples were collected for 72 hours. Amlodipine plasma levels were determined using a validated UPLC-MS/MS assay. Non-compartmental pharmacokinetic parameters were compared between the formulations according to European Medicines Agency (EMA) bioequivalence guidelines. Results: The 90% confidence intervals of the test/reference ratios of the geometric means for the primary pharmacokinetic parameters AUC(0-72) (88.24 - 104.37%) and C(max) (99.00 - 121.40%) were within the acceptance range of 80.00 - 125.00% for bioequivalence. Mean (SD) AUC(0-72) was 102.7 (26.8) (26.8) μg × h/L for the solution and 108.2 (30.6) μg × h/L for the tablet. Mean (SD) Cmax of the solution was 3.11(1.06) μg/L with a median (IQR) t(max) of 4.0 (2.6 - 7.5) hours. Mean (SD) C(max) of the tablet was 2.91 (0.84) μg/L with a median (IQR) tmax of 6.0 (4.0 - 14.0) hours. Intrasubject coefficients of variation were 10.2% (AUC(0-72)) and 12.4% (C(max)). Conclusions: The formulations are bioequivalent according to EMA guidelines. This warrants further study of our novel amlodipine oral solution in pediatric patients.
MeSH term(s)	Administration, Oral ; Adult ; Amlodipine/administration & dosage ; Amlodipine/pharmacokinetics ; Area Under Curve ; Calcium Channel Blockers/administration & dosage ; Calcium Channel Blockers/pharmacokinetics ; Cross-Over Studies ; Female ; Humans ; Male ; Solutions ; Tablets ; Therapeutic Equivalency
Chemical Substances	Calcium Channel Blockers ; Solutions ; Tablets ; Amlodipine (1J444QC288)
Language	English
Publishing date	2016-01
Publishing country	Germany
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	124384-6
ISSN	0946-1965 ; 0340-0026 ; 0300-9718 ; 0174-4879
ISSN	0946-1965 ; 0340-0026 ; 0300-9718 ; 0174-4879
DOI	10.5414/CP202449
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Article ; Online: Rapid genotyping of cytomegalovirus in dried blood spots by multiplex real-time PCR assays targeting the envelope glycoprotein gB and gH genes.

de Vries, Jutte J C / Wessels, Els / Korver, Anna M H / van der Eijk, Annemiek A / Rusman, Lisette G / Kroes, Aloys C M / Vossen, Ann C T M

Journal of clinical microbiology

2011 Volume 50, Issue 2, Page(s) 232–237

Abstract: Genotyping of cytomegalovirus (CMV) is useful to examine potential differences in the pathogenicity of strains and to demonstrate coinfection with multiple strains involved in CMV disease in adults and congenitally infected newborns. Studies on ... ...

Abstract	Genotyping of cytomegalovirus (CMV) is useful to examine potential differences in the pathogenicity of strains and to demonstrate coinfection with multiple strains involved in CMV disease in adults and congenitally infected newborns. Studies on genotyping of CMV in dried blood spots (DBS) are rare and have been hampered by the small amount of dried blood available. In this study, two multiplex real-time PCR assays for rapid gB and gH genotyping of CMV in DBS were developed. Validation of the assays with 39 CMV-positive plasma samples of transplant recipients and 21 urine specimens of congenitally infected newborns was successful in genotyping 100% of the samples, with gB1 and gB3 being the most prevalent genotypes. Multiple gB and gH genotypes were detected in 36% and 33% of the plasma samples, respectively. One urine sample from a newborn with symptomatic congenital CMV was positive for gB1 and gB2. DBS of congenitally infected newborns (n = 41) were tested using 9 μl of dried blood, and genotypes were detected in 81% (gB) and 73% (gH) of the samples, with gB3 being the most prevalent genotype. No clear association of specific genotypes with clinical outcome was observed. In conclusion, the CMV gB and gH PCR assays were found to be rapid, sensitive for detecting mixed infections, and suitable for direct usage on DBS. These assays are efficient tools for genotyping of CMV in DBS of congenitally infected newborns.
MeSH term(s)	Adolescent ; Adult ; Aged ; Blood/virology ; Child ; Child, Preschool ; Cytomegalovirus/classification ; Cytomegalovirus/isolation & purification ; Cytomegalovirus Infections/congenital ; Cytomegalovirus Infections/diagnosis ; Cytomegalovirus Infections/virology ; DNA, Viral/genetics ; Desiccation ; Female ; Genotype ; Humans ; Infant, Newborn ; Male ; Middle Aged ; Multiplex Polymerase Chain Reaction/methods ; Real-Time Polymerase Chain Reaction/methods ; Sensitivity and Specificity ; Specimen Handling/methods ; Urine/virology ; Viral Envelope Proteins/genetics ; Young Adult
Chemical Substances	DNA, Viral ; Viral Envelope Proteins ; glycoprotein B, Simplexvirus ; glycoprotein H, Cytomegalovirus
Language	English
Publishing date	2011-11-23
Publishing country	United States
Document type	Evaluation Study ; Journal Article
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.05253-11
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Article: Concomitant EBV-related B-cell proliferation and juvenile myelomonocytic leukemia in a 2-year-old child.

Janik-Moszant, Anna / Barć-Czarnecka, Małgorzata / van der Burg, Mirjam / Langerak, Anton W / Hartwig, Nico G / Vossen, Ann C T M / Niemeyer, Charlotte M / Wachowiak, Jacek / Sońta-Jakimczyk, Danuta / Szczepański, Tomasz

Leukemia research

2008 Volume 32, Issue 1, Page(s) 181–184

Abstract: We present a case of a 2-year-old girl, who developed concomitant EBV-related B-cell proliferation and juvenile myelomonocytic leukemia (JMML). JMML was initially not recognized because of predominant B-cell proliferation. The activating N-RAS mutation ... ...

Abstract	We present a case of a 2-year-old girl, who developed concomitant EBV-related B-cell proliferation and juvenile myelomonocytic leukemia (JMML). JMML was initially not recognized because of predominant B-cell proliferation. The activating N-RAS mutation was retrospectively already detectable at this early stage. Our findings support the hypothesis that EBV may contribute to JMML pathogenesis by stimulating pre-existing malignant clones. However, such stimulation of leukemic clone does not require the direct incorporation of the virus into myeloid progenitors. Most probably a cytokine burst resulting from EBV infection allows expansion of pre-existing malignant myeloid progenitors. Further studies are required to delineate exact mechanisms of EBV-related promotion of the JMML clone.
MeSH term(s)	B-Lymphocytes/virology ; Cell Proliferation ; Child, Preschool ; Epstein-Barr Virus Infections/complications ; Female ; Humans ; Leukemia, Myelomonocytic, Juvenile/complications ; Lymphocytosis/complications ; Lymphocytosis/virology
Language	English
Publishing date	2008-01
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	752396-8
ISSN	1873-5835 ; 0145-2126
ISSN (online)	1873-5835
ISSN	0145-2126
DOI	10.1016/j.leukres.2007.05.017
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Zs.A 1321: Show issues

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Article ; Online: Changing epidemiology of parvovirus B19 in the Netherlands since 1990, including its re-emergence after the COVID-19 pandemic.

Russcher, Anne / van Boven, Michiel / Benincà, Elisa / Verweij, E J T Joanne / Molenaar-de Backer, Marijke W A / Zaaijer, Hans L / Vossen, Ann C T M / Kroes, Aloys C M

Scientific reports

2024 Volume 14, Issue 1, Page(s) 9630

Abstract: Parvovirus B19V (B19V) infection during pregnancy can be complicated by potentially life-threatening fetal hydrops, which can be managed by intrauterine transfusion (IUT). This study investigates the long-term temporal patterns in the epidemiology of ... ...

Abstract	Parvovirus B19V (B19V) infection during pregnancy can be complicated by potentially life-threatening fetal hydrops, which can be managed by intrauterine transfusion (IUT). This study investigates the long-term temporal patterns in the epidemiology of B19V and evaluates the impact on fetal hydrops, by combining data on B19V infections from the Dutch Sentinel Surveillance system in the period 1990 to 2023, Dutch blood banking data and hospital data on fetal hydrops. Using wavelet analysis, we identified annual epidemic cycles in the Netherlands in the period 1990-2019 and we identified superimposed multiannual cycles in the period 1990-2009. After 2009, no multiannual cycle could be identified, although the incidence fluctuated and correlates with number of IUT performed. As of 2020, weekly reports of B19V infection demonstrated a historically low incidence and B19V-DNA positive blood donors were nearly absent. From May 2020 to May 2023, no IUT for B19V-related hydrops was performed. In the spring of 2023, B19V infections re-emerged, reaching pre-pandemic epidemic levels. Due to the changes in B19V epidemiology over the last 30 years and the near-absence of B19V during the COVID-19 pandemic, the resulting low immunity levels may lead to rebound outbreaks. Alertness to severe complications such as fetal hydrops is warranted.
MeSH term(s)	Humans ; Netherlands/epidemiology ; COVID-19/epidemiology ; COVID-19/virology ; Parvovirus B19, Human ; Female ; Pregnancy ; Hydrops Fetalis/epidemiology ; Hydrops Fetalis/virology ; Incidence ; Parvoviridae Infections/epidemiology ; Pregnancy Complications, Infectious/epidemiology ; Pregnancy Complications, Infectious/virology ; SARS-CoV-2/isolation & purification ; Pandemics ; Erythema Infectiosum/epidemiology ; Blood Transfusion, Intrauterine ; Adult
Language	English
Publishing date	2024-04-26
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-024-59582-7
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Article ; Online: Valganciclovir in Infants with Hearing Loss and Clinically Inapparent Congenital Cytomegalovirus Infection: A Nonrandomized Controlled Trial.

Chung, Pui Khi / Schornagel, Fleurtje A J / Soede, Wim / van Zwet, Erik W / Kroes, Aloys C M / Oudesluys-Murphy, Anne Marie / Vossen, Ann C T M

The Journal of pediatrics

2024 Volume 268, Page(s) 113945

Abstract: Objective: To assess the efficacy of valganciclovir in infants with hearing loss and clinically inapparent congenital cytomegalovirus infection (cCMV), as there is no consensus on treatment of this group.: Study design: A nationwide, nonrandomized ... ...

Abstract	Objective: To assess the efficacy of valganciclovir in infants with hearing loss and clinically inapparent congenital cytomegalovirus infection (cCMV), as there is no consensus on treatment of this group. Study design: A nationwide, nonrandomized controlled trial, comparing 6 weeks of oral valganciclovir to no treatment in infants with cCMV, recruited after newborn hearing screening resulted in referral to an audiologist. The choice whether to treat was left to parents of subjects. Eligible subjects were full term infants aged <13 weeks with sensorineural hearing loss and diagnosed with cCMV through dried blood spot testing. The primary outcome, measured by linear and ordinal logistic regression, was change in best-ear hearing from baseline to follow-up at 18-22 months of age. Results: Thirty-seven participants were included in the final analysis, of whom 25 were in the treatment group and 12 in the control group. The majority of subjects in both groups had neuroimaging abnormalities, which were mostly mild. Hearing deterioration was more likely in the control group compared with the treatment group (common OR 0.10, 95% CI 0.02-0.45, P = .003). Mean best-ear hearing deteriorated by 13.7 dB in the control group, compared with improvement of 3.3 dB in the treatment group (difference 17 dB, 95% CI 2.6 - 31.4, P = .02). Conclusions: We investigated treatment in children with hearing loss and clinically inapparent cCMV. Although our study was nonrandomized, it is the first prospective and controlled trial in this population. Valganciclovir-treated children with hearing loss and inapparent cCMV had less hearing deterioration at 18 through 22 months of age than control subjects. Eudract registry number: 2013-003068-30.
MeSH term(s)	Humans ; Valganciclovir/therapeutic use ; Cytomegalovirus Infections/drug therapy ; Cytomegalovirus Infections/congenital ; Cytomegalovirus Infections/complications ; Antiviral Agents/therapeutic use ; Male ; Female ; Infant ; Infant, Newborn ; Hearing Loss, Sensorineural/drug therapy ; Treatment Outcome ; Ganciclovir/analogs & derivatives ; Ganciclovir/therapeutic use ; Neonatal Screening ; Prospective Studies ; Follow-Up Studies ; Administration, Oral
Chemical Substances	Valganciclovir (GCU97FKN3R) ; Antiviral Agents ; Ganciclovir (P9G3CKZ4P5)
Language	English
Publishing date	2024-02-08
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Controlled Clinical Trial
ZDB-ID	3102-1
ISSN	1097-6833 ; 0022-3476
ISSN (online)	1097-6833
ISSN	0022-3476
DOI	10.1016/j.jpeds.2024.113945
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Article ; Online: A Road Map for Attending to Medical Students' Professionalism Lapses.

Mak-van der Vossen, Marianne C / de la Croix, Anne / Teherani, Arianne / van Mook, Walther N K A / Croiset, Gerda / Kusurkar, Rashmi A

Academic medicine : journal of the Association of American Medical Colleges

2019 Volume 94, Issue 4, Page(s) 570–578

Abstract: Purpose: To develop a road map for educators attending to medical students' professionalism lapses, aiming to offer an empirical base for approaching students who display such lapses.: Method: Between October 2016 and January 2018, 23 in-depth ... ...

Abstract	Purpose: To develop a road map for educators attending to medical students' professionalism lapses, aiming to offer an empirical base for approaching students who display such lapses. Method: Between October 2016 and January 2018, 23 in-depth interviews with 19 expert faculty responsible for remediation from 13 U.S. medical schools were conducted about the way they handle students' professionalism lapses. Three researchers independently completed three rounds of coding. Data collection, coding, and analysis were performed in a constant comparative process. A constructivist grounded theory approach was used to develop an explanatory model for attending to students' professionalism lapses. Results: Based on participants' descriptions, the authors developed a three-phase approach for attending to professionalism lapses. In phase 1, experts enacted the role of concerned teacher, exploring the lapse from the student's perspective. In phase 2, they functioned as supportive coach, providing feedback on professionalism values, improving skills, creating reflectiveness, and offering support. In phase 3, if the student did not demonstrate reflectiveness and improvement, and especially if (future) patient care was potentially compromised, participants assumed an opposite role: gatekeeper of the profession. Conclusions: An explanatory model for attending to professionalism lapses that fits in the overarching "communities of practice" framework was created. Whereas phase 1 and 2 aim at keeping students in the medical community, phase 3 aims at guiding students out. These findings provide empirical support to earlier descriptive, opinion-based models and may offer medical educators an empirical base for attending to students who display professionalism lapses.
MeSH term(s)	Education, Medical, Undergraduate/methods ; Education, Medical, Undergraduate/trends ; Grounded Theory ; Humans ; Interviews as Topic/methods ; Professional Misconduct/psychology ; Professional Misconduct/statistics & numerical data ; Professionalism/standards ; Qualitative Research ; Students, Medical/psychology ; Students, Medical/statistics & numerical data
Language	English
Publishing date	2019-01-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	96192-9
ISSN	1938-808X ; 1040-2446
ISSN (online)	1938-808X
ISSN	1040-2446
DOI	10.1097/ACM.0000000000002537
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