Influence of health insurance status on childhood cancer treatment outcomes in Kenya.

BACKGROUND: Survival of childhood cancer in high-income countries is approximately 80%, whereas in low-income countries, it is less than 10%. Limited access to health insurance in low-income settings may contribute to poor survival rates. This study evaluates the influence of health insurance status on childhood cancer treatment in a Kenyan academic hospital. METHODS: This was a retrospective study. All children diagnosed with a malignancy from 2010 until 2012 were included. Data on treatment outcomes and health insurance status at diagnosis were abstracted from patient charts. RESULTS: Of 280 patients, 34% abandoned treatment, 19% died, and 18% had progressive or relapsed disease resulting in 29% event-free survival. The majority of patients (65%) did not have health insurance at diagnosis. Treatment results differed significantly between patients with different health insurance status at diagnosis; 37% of uninsured versus 28% of insured patients abandoned treatment, and 24% of uninsured versus 37% of insured patients had event-free survival. The event-free survival estimate was significantly higher for patients with health insurance at diagnosis compared with those without (P = 0.004). Of patients without health insurance at diagnosis, 77% enrolled during treatment. Among those patients who later enrolled in health insurance, frequency of progressive or relapsed disease and deaths was significantly lower (P = 0.013, P < 0.001, respectively), while the event-free survival estimate was significantly higher (P < 0.001) compared with those who never enrolled. CONCLUSION: Childhood cancer event-free survival was 29% at a Kenyan hospital. Children without health insurance had significant lower chance of event-free survival. Childhood cancer treatment outcomes could be ameliorated by strategies that prevent treatment abandonment and improve access to health insurance.

A tutorial on model informed approaches to cardiovascular safety with focus on cardiac repolarisation.

Drugs can affect the cardiovascular (CV) system either as an intended treatment or as an unwanted side effect. In both cases, drug-induced cardiotoxicities such as arrhythmia and unfavourable hemodynamic effects can occur, and be described using mathematical models; such a model informed approach can provide valuable information during drug development and can aid decision-making. However, in order to develop informative models, it is vital to understand CV physiology. The aims of this tutorial are to present (1) key background biological and medical aspects of the CV system, (2) CV electrophysiology, (3) CV safety concepts, (4) practical aspects of development of CV models and (5) regulatory expectations with a focus on using model informed and quantitative approaches to support nonclinical and clinical drug development. In addition, we share several case studies to provide practical information on project strategy (planning, key questions, assumptions setting, and experimental design) and mathematical models development that support decision-making during drug discovery and development.

Factors influencing time to diagnosis and treatment among pediatric oncology patients in Kenya.

Early diagnosis and start of treatment are fundamental goals in cancer care. This study determines the time lag and the factors that influence the time to diagnosis and start of treatment. Study participants were parents of childhood cancer patients diagnosed between August 2013 and July 2014 in a hospital in Kenya. Patient, physician, diagnosis, treatment, health care system, and total delay were explored using a questionnaire. Demographic and medical data were collected from the patients' medical records. Parents of 99 childhood cancer patients were interviewed (response rate: 80%). Median total delay was 102 (9-1021) days. Median patient delay (4 days) was significantly shorter than health care system delay (median 87 days; P < .001). Diagnosis delay (median 94 days) was significantly longer than treatment delay (median 6 days; P < .001). days. Lack of health insurance at diagnosis and use of alternative medicine before attending conventional health services were associated with a significantly longer patient delay (P = .041 and P = .017, respectively). The type of cancer had a significant effect on treatment delay (P = .020). The type of health facility attended affected only patient delay (P = .03). Gender, age at diagnosis, stage of disease, parents' education level or income, and distance from hospital did not have a significant effect on the length of any type of delay. Training on childhood cancer should be included in the curricula for medical training institutes. In-service workshops should be held for the health workers already working. Families must be obligated to get health insurance. Families should be encourage to attend conventional health facilities and informed on symptoms of cancer through mass media.

Association of placental weight with cerebral palsy: population-based cohort study in Norway.

OBJECTIVE: To study the risk of cerebral palsy (CP) associated with placental weight, and also with placental weight/birthweight ratio and placental weight/birth length ratio. DESIGN: Population-based cohort study. SETTING: Perinatal data in the Medical Birth Registry of Norway were linked with clinical data in the CP Register of Norway. POPULATION: A total of 533 743 singleton liveborn children in Norway during 1999-2008. Of these, 779 children were diagnosed with CP. METHODS: Placental weight, placental weight/birthweight ratio, and placental weight/birth length ratio were grouped into gestational age-specific quartiles. Odds ratios (OR) with 95% confidence intervals (95% CI) for CP were calculated for children with exposure variables in the lowest or in the highest quartile, using the second to third quartile as the reference. MAIN OUTCOME MEASURES: CP and CP subtypes. RESULTS: Overall, children with low placental weight had increased risk for CP (OR 1.5, 95% CI 1.2-1.7). Low placental weight/birthweight ratio (OR 1.2, 95% CI 1.0-1.4) and low placental weight/birth length ratio (OR 1.5, 95% CI 1.2-1.8) were also associated with increased risk for CP. In children born at term, low placental weight was associated with a twofold increase in risk for spastic bilateral CP (including both quadriplegia and diplegia) (OR 2.1, 95% CI 1.5-2.9). In children born preterm, high placental ratios were associated with increased risk for spastic quadriplegia. CONCLUSIONS: Our results suggest that placental dysfunction may be involved in causal pathways leading to the more severe subtypes of CP. TWEETABLE ABSTRACT: Low placental weight increases the risk for cerebral palsy, especially for the spastic bilateral subtype.

Bone mineral density and vitamin D status in ambulatory and non-ambulatory children with cerebral palsy.

UNLABELLED: This study assessed distal femur and lumbar spine bone mineral density (BMD) Z-scores in children with cerebral palsy. BMD z-score was lower in non-ambulatory than in ambulatory children. Somewhat surprisingly, among ambulatory children, those with better walking abilities had higher BMD z-score than those with more impaired walking ability. INTRODUCTION: Children with cerebral palsy (CP) have increased risk for low bone mineral density (BMD). The aim was to explore the difference in BMD at the distal femur and lumbar spine between ambulatory and non-ambulatory children with CP and the relationship between vitamin D status and BMD. METHODS: Fifty-one children (age range 8-18 years; 20 girls) with CP participated. Their BMD Z-scores were measured in the lumbar spine and the distal femur using dual X-ray absorptiometry, and 25-hydroxy-vitamin D (25-OHD) concentrations were measured in serum. Children with GMFCS level I-III were defined as 'walkers' while children with level IV-V were defined as 'non-walkers. RESULTS: Non-walkers had lower mean BMD Z-scores (range -1.7 to -5.4) than walkers at all sites (range -0.8 to -1.5). Among walkers, BMD Z-scores at the distal femur were lower in those with GMFCS level II than with level I (p values < 0.004). A similar difference was found between the affected and unaffected limb in children with hemiplegia. Mean 25-OHD concentration was 45 nmol/L (SD = 18); lower in walkers (mean = 41 nmol/L; SD = 18) than in non-walkers (mean = 53 nmol/L; SD = 19; p = 0.041). There were no correlations between 25-OHD and BMD z-scores. CONCLUSIONS: The main predictor of low BMD Z-scores in the distal femur was the inability to walk, but the results suggest that the degree of the neuromotor impairment may also be a significant predictor. Vitamin D status did not correlate with BMD z-scores.

Thrombophilia testing in children: a 7 year experience.

BACKGROUND: Incidence of venous thromboembolism (VTE) in children is reported to be increasing. We examined thrombophilia testing results in children with VTE that presented in inpatient and outpatient settings to explore patterns of thrombophilia testing. PATIENTS/METHODS: Children, ages 0-20 years with VTE seen at our institution from Jan 2005 to Apr 2012 were studied retrospectively. All patients with VTE confirmed by imaging were eligible and the presence of significant risk factors was evaluated. Thrombophilia was diagnosed if >1 tests confirmed: persistently low protein C (PC), protein S (PS), and antithrombin (AT) following VTE resolution, persistent antiphospholipid antibodies (APA) positivity >12 weeks from first test, factor V Leiden (FVL) and prothrombin mutation (PTm) hetero- or homozygosity, elevated plasminogen activator inhibitor (PAI-1) levels with 4G/5G or 4G/4G polymorphisms, methylene tetrahydrofolate reductase (MTHFR) polymorphisms with elevated fasting homocysteine levels. RESULTS: Three hundred ninety-two patients met inclusion criteria. At least one test was ordered in 157/239 inpatients. All 153 outpatients had >1 test ordered. Thrombophilia rate differences between inpatients and outpatients did not reach statistical significance except for PC deficiency, which was significantly higher in outpatients. Of inpatients, central venous line (CVL) was significantly associated with not having tests done (P < 0.0022). CONCLUSIONS: This study of pediatric VTE demonstrated a low thrombophilia rate in both inpatient and outpatient populations. The role of testing in other pediatric patients should be further explored.

Cytomegalovirus antibody status at 17-18 weeks of gestation and pre-eclampsia: a case-control study of pregnant women in Norway.

OBJECTIVE: To assess the association between maternal cytomegalovirus (CMV) antibodies in mid-pregnancy and pre-eclampsia. DESIGN: Nested case-control study. SETTING: Pregnancies registered in the Norwegian Mother and Child Cohort Study (MoBa): a large population-based pregnancy cohort (1999-2006). SAMPLE: A cohort of 1500 women with pre-eclampsia and 1000 healthy pregnant women. METHODS: Plasma samples and pregnancy-related information were provided by the MoBa. Antibody status (CMV IgG and CMV IgM) and levels (CMV IgG) at 17-18 weeks of gestation were determined by enzyme-linked immunosorbent assay (ELISA). MAIN OUTCOME MEASURE: A diagnosis of pre-eclampsia, as defined in the Medical Birth Registry of Norway. RESULTS: There was no evidence of an effect of CMV IgG seropositivity on the likelihood of developing pre-eclampsia, and CMV IgG antibody levels among women who were seropositive did not differ between groups. Adjusted for maternal age, parity and smoking, the odds ratio for pre-eclampsia in women seropositive for CMV IgG was 0.89 (95% CI 0.74-1.05; P = 0.17). The proportions of women who were seropositive for IgM did not differ between women with pre-eclampsia and women who were healthy (P = 0.98). Among nulliparous women, the proportion of women who were seropositive for CMV IgG was slightly lower among women with pre-eclampsia (53.5%) than among healthy women (59.8%) (P = 0.03). Subgroup analyses were performed for women with early or late onset pre-eclampsia, with preterm delivery and/or with neonates that were small for gestational age, but antibody status did not differ between pre-eclampsia subtypes and controls. CONCLUSIONS: The presence of maternal antibodies to CMV was not associated with pre-eclampsia in our study. The results suggest that CMV infection is unlikely to be a major cause of pre-eclampsia.

Risk-prediction tool for identifying hospitalized children with a predisposition for development of venous thromboembolism: Peds-Clot clinical Decision Rule.

BACKGROUND: The prevalence of VTE is increasing in tertiary pediatric hospitals. Identification of high-risk populations using uniform criteria is required to develop evidence-based VTE prevention guidelines. OBJECTIVE: To develop a VTE risk prediction rule, the Peds-Clot clinical Decision Rule (PCDR), to identify high-risk children who were at increased risk of developing VTE. METHODS: This retrospective case-control study developed the PCDR using a derivation cohort (173 cases, 346 controls) and validated it on a separate validation cohort (100 cases, 100 controls). A uniform data collection strategy was applied to derive both the samples. Conditional logistic regression analyses were used to develop a risk-prediction model. Each significant predictor was assigned a score based on its beta coefficient and the PCDR was developed. ROC curves were derived to test the performance of the PCDR. RESULTS: Characteristics of derivation and validation cohorts were comparable. Six risk factors (positive blood stream infection, central venous catheter, direct admission to ICU/NICU, hospitalization for ≥ 7 days, immobilization for > 72 h, and use of birth control pills) formed the final risk prediction model (risk score range, 0.5-9.5). A risk score of 3 or more identified high-risk children at a sensitivity of 70% and specificity of 80% and AUC of 0.852 (95% confidence interval, 0.814-0.890). The application of a risk score to the validation sample showed sensitivity 57% and specificity 88% and an AUC of 0.875 (95% confidence interval, 0.82-0.924). CONCLUSION: Incorporation of the PCDR in routine clinical care can be an attractive strategy to identify high-risk hospitalized children with a predisposition for VTE. The clinical utility of the PCDR needs validation in prospective studies.

Evaluation of the effects of AZD3480 on cardiac repolarization: a thorough QT/QTc study using moxifloxacin as a positive control.

In order to evaluate their potential effects on cardiac repolarization, all new drugs must undergo clinical electrocardiographic evaluation in a thorough QT/QTc (TQT) study. AZD3480, a central nervous system-selective, neuronal nicotinic receptor (NNR) agonist, is predominantly metabolized by cytochrome P450 2D6 (CYP2D6). Employing an innovative design, this TQT study assessed the effects of supratherapeutic doses of AZD3480, relative to those of placebo, on cardiac repolarization in healthy male volunteers genotyped as either poor metabolizers (PMs) or extensive metabolizers (EMs) of CYP2D6 substrates. Supratherapeutic doses of AZD3480-resulting in ~10- and ~50-fold higher exposures (PMs and EMs, respectively) than achieved with a 20-mg dose-had no pharmacologic effect on cardiac repolarization relative to placebo. Likewise, no safety/tolerability concerns were observed after either supratherapeutic or 20-mg dosing to either population. No clinically relevant treatment-related changes or trends were observed in laboratory parameters, vital signs, or electrocardiogram (ECG). This study demonstrated that AZD3480 does not prolong QT/QTc interval.

Cerebral cortex thickness in 15-year-old adolescents with low birth weight measured by an automated MRI-based method.

Infants with low birth weight are at increased risk of perinatal brain injury. Disruption of normal cortical development may have consequences for later motor, behavioural and cognitive development. The aim of this study was to measure cerebral cortical thickness, area and volume with an automated MRI technique in 15-year-old adolescents who had low birth weight. Cerebral MRI for morphometric analysis was performed on 50 very low birth weight (VLBW, birth weight

Long term cognitive development in children with prolonged crying.

BACKGROUND: Long term studies of cognitive development and colic have not differentiated between typical colic and prolonged crying. OBJECTIVE: To evaluate whether colic and excessive crying that persists beyond 3 months is associated with adverse cognitive development. DESIGN: Prospective cohort study. A sample of 561 women was enrolled in the second trimester of pregnancy. Colic and prolonged crying were based on crying behaviour assessed at 6 and 13 weeks. Children's intelligence, motor abilities, and behaviour were measured at 5 years (n = 327). Known risk factors for cognitive impairment were ascertained prenatally, after birth, at 6 and 13 weeks, at 6, 9, and 13 months, and at 5 years of age. RESULTS: Children with prolonged crying (but not those with colic only) had an adjusted mean IQ that was 9 points lower than the control group. Their performance and verbal IQ scores were 9.2 and 6.7 points lower than the control group, respectively. The prolonged crying group also had significantly poorer fine motor abilities compared with the control group. Colic had no effect on cognitive development. CONCLUSIONS: Excessive, uncontrolled crying that persists beyond 3 months of age in infants without other signs of neurological damage may be a marker for cognitive deficits during childhood. Such infants need to be examined and followed up more intensively.

Psychiatric symptoms and disorders in adolescents with low birth weight.

OBJECTIVE: To evaluate the prevalence of psychiatric symptoms and disorders associated with low birth weight.Design/study groups: A population based follow up study of 56 very low birthweight (VLBW: birth weight < or = 1500 g), 60 term small for gestational age (SGA: birth weight < 10th centile), and 83 term control (birth weight > or = 10th centile) children at 14 years of age. OUTCOME MEASURES: Schedule for affective disorders and schizophrenia for school aged children, attention deficit/hyperactivity disorder (ADHD) rating scale IV, autism spectrum screening questionnaire, and children's global assessment scale. RESULTS: VLBW adolescents had a higher prevalence of psychiatric symptoms (46%) than controls (13%) (odds ratio (OR) 5.7, 95% confidence interval (CI) 2.5 to 13.0) and more psychiatric disorders (25%) than controls (7%) (OR 4.3, 95%CI 1.5 to 12.0), especially anxiety disorders. Although 25% of the VLBW adolescents had attention problems, ADHD was diagnosed in only 7%. Four VLBW adolescents had symptoms of Asperger's disorder, and the VLBW group had a higher sum score than controls on the autism spectrum screening questionnaire. Although more SGA adolescents had psychiatric symptoms than controls (23% v 13%), the difference was not statistically significant. Results remained essentially the same when adolescents with low estimated intelligence quotient were excluded, and persisted after possible psychosocial confounders had been controlled for. CONCLUSION: VLBW, but not SGA adolescents, have a high risk of developing psychiatric symptoms and disorders by the age of 14, especially attention deficit, anxiety symptoms, and relational problems.

Motor skills in adolescents with low birth weight.

BACKGROUND: Minor motor problems have been reported in low birthweight children, but few studies have assessed motor skills in adolescents. OBJECTIVE: To examine the prevalence of motor problems in adolescents with low birth weight. METHOD: Fifty four very low birthweight (VLBW: birth weight < or = 1500 g), 59 term small for gestational age (SGA: birth weight < 10th centile), and 83 control (birth weight > or = 10th centile at term) children were assessed with the Movement assessment battery for children (Movement ABC) at the age of 14 in a population based study. RESULTS: One in four VLBW children (odds ratio (OR) 9.3, 95% confidence interval (CI) 2.5 to 34.5) and one in six SGA children (OR 4.7, 95%CI 1.2 to 18.4) had motor problems compared with controls (3.7%). There were no sex differences in motor problems in the VLBW group, and the increased risk was consistent across the continuum of the Movement ABC. For SGA children, the increased risk of motor problems was particularly in manual dexterity in boys. CONCLUSION: VLBW and SGA adolescents have increased risk of motor problems compared with control children.

Value of professional collaboration in the care of children with cancer and their families.

The aim of this study is to describe professionals' perception of collaboration and their evaluation of a professional collaborative model for children with cancer in mid-Norway. Health and non-health professionals from the families' home communities were invited to participate in the study. The selection was based upon professionals working with children treated for cancer at the Department of Paediatrics, University Hospital in Trondheim between 1990 and 1996. Ninety-one of 142 eligible professionals (64%) responded to a questionnaire. Both health and non-health professionals agreed that collaboration takes care of the family's situation (76%) as well as broadening their own knowledge (77%). Two-thirds considered they had received enough information necessary for follow-up care, however, only 28% believed that families were confident that professionals had this knowledge. More than 80% of professionals considered collaborative meetings and support groups, essential elements of the model, as being effective methods for follow-up care. However, only 39% of professionals had participated in collaborative meetings and 46% in support groups. In addition, only 26% received systematic supervision. Health and non-health professionals regard collaboration as being valuable in follow-up care for children, their families and professionals themselves. However, our results suggest areas of potential improvement in the existing model.

Effect of breastfeeding on cognitive development of infants born small for gestational age.

UNLABELLED: Breastfeeding during infancy appears to result in enhanced cognitive development during childhood, but it is not known whether breastfeeding should be encouraged for infants born small for gestational age (SGA) whose growth might otherwise benefit from nutritional supplementation. To address this issue, duration of exclusive breastfeeding and cognitive development were evaluated prospectively for 220 term children born SGA and 299 term children born appropriate for gestational age (AGA). Cognitive development was assessed using the Bayley Scale of Infant Development at 13 mo and Wechsler Preschool and Primary Scales of Intelligence at 5 y of age. Infants born SGA were given supplemental foods significantly earlier than those born AGA. Growth of infants born SGA was not related to early nutritional supplementation. The salutary effect of exclusive breastfeeding on cognitive development was greater for children born SGA than for those born AGA. Based on a linear association between duration of exclusive breastfeeding and intelligence quotient (IQ), children born SGA and exclusively breastfed for 24 wk were predicted to have an 11-point IQ advantage over those breastfed for 12 wk, as opposed to a 3-point advantage for children born AGA with similar durations of breastfeeding. The IQ distribution of children born SGA and exclusively breastfed for more than 12 wk was not different from that of all children born AGA. CONCLUSION: Duration of exclusive breastfeeding has a significant impact on cognitive development without compromising growth among children born SGA. These data suggest that mothers should breastfeed exclusively for 24 wk to enhance cognitive development.

[Drug treatment of school children with attention deficit and hyperactivity disorder]. / Medikamentell behandling av skolebarn med oppmerksomhetssvikt og hyperaktivitet.

BACKGROUND: The use of stimulants in the treatment of AD/HD has increased dramatically over the last twenty years. We wanted to assess the prevalence of students treated with stimulants in the elementary schools in the city of Trondheim, Norway. MATERIAL AND METHODS: Fifty of 53 schools (94%), representing 16,141 students, answered two questionnaires. Mentally retarded, autistic and otherwise severely handicapped students attending special groups or schools, were excluded. RESULTS: In all, 57 students (3.5 per 1,000) were treated with either methylphenidate or racemic amphetamine. Multivariate analysis suggested that the structure of the classroom was an essential risk factor for being treated with stimulants. The risk was higher in so-called "open schools" (no fixed walls between groups of students) than in schools with traditional classrooms (< 30 students in rooms separated by fixed walls). (Odds ratio: 5.5; 95% confidence interval: 1.1-26.4.) More detailed information was obtained from 47 of the 57 students; only one of whom was female. Teaching resources required for optimal pedagogical treatment were available for about one out of two of these 47 students. INTERPRETATION: Our results do not suggest that an inappropriately high proportion of students in the region are taking stimulants for AD/HD. On the contrary, AD/HD may be underdiagnosed and inadequately treated in girls. It seems likely that students with AD/HD are less likely to be treated with stimulants in schools with traditional classrooms, and our results also suggest a lack of teaching resources for these students.

Breast feeding and cognitive development at age 1 and 5 years.

AIM: To examine whether duration of breast feeding has any effect on a child's cognitive or motor development in a population with favourable environmental conditions and a high prevalence of breast feeding. METHODS: In 345 Scandinavian children, data on breast feeding were prospectively recorded during the first year of life, and neuromotor development was assessed at 1 and 5 years of age. Main outcome measures were Bayley's Scales of Infant Development at age 13 months (Mental Index, MDI; Psychomotor Index, PDI), Wechsler Preschool and Primary Scales of Intelligence (WPPSI-R), and Peabody Developmental Scales at age 5. RESULTS: Children breast fed for less than 3 months had an increased risk, compared to children breast fed for at least 6 months, of a test score below the median value of MDI at 13 months and of WPPSI-R at 5 years. Maternal age, maternal intelligence (Raven score), maternal education, and smoking in pregnancy were significant confounders, but the increased risk of lower MDI and total IQ scores persisted after adjustment for each of these factors. We found no clear association between duration of breast feeding and motor development at 13 months or 5 years of age. CONCLUSION: Our data suggest that a longer duration of breast feeding benefits cognitive development.

[Feeding problems and growth disorders among children with cerebral palsy in south and north Trondelag]. / Spisevansker og vekstforstyrrelser blant barn med cerebral parese i Sør- og Nord-Trøndelag.

BACKGROUND: Growth retardation is common in children with cerebral palsy. This may in part be due to the cerebral injury, but insufficient nutrition may also play a role. The aim of the present study was to estimate the prevalence of feeding problems, growth retardation, underweight and overweight in children with cerebral palsy. MATERIAL AND METHODS: Population-based study of children with cerebral palsy in two Norwegian counties. Information was obtained both from parents and from medical records. 154 children born between 1 January 1982 and 31 December 1996 were included in the study. RESULTS: 30% of the children had height below the 2.5th centile, 10% had weight for height below the 2.5th centile, and 7% were obese (weight above the 97.5th centile). 26% of the children had oral motor dysfunction and 33% were unable to self-feed. Although these problems were more prominent in children with severe forms of cerebral palsy, the results of the multivariate analyses suggested that lack of ability to self-feed was a significant independent risk factor for height growth retardation and underweight. Parents of 24 (15%) children reported that the family's quality of life was significantly impaired by the feeding problems of the child. INTERPRETATION: Our results are consistent with previous hospital-based studies and suggest that assessment of nutrition and growth should receive particular attention in the rehabilitation of children with cerebral palsy, in particular if the child is unable to self-feed.

[The problem-based medical curriculum in Trondheim--did it turn out as planned?]. / Det problembaserte legestudiet i Trondheim--ble det slik det var planlagt?

BACKGROUND: A problem-based (PBL) medical curriculum was implemented in 1993 at the Medical School of the Norwegian University of Science and Technology. The objective of this study was to examine how the planned reduction in scheduled activities, the emphasis on student-centred learning, and the integration of disciplines have been implemented. MATERIAL AND METHODS: The schedules in the old and new programmes were the main sources of data. Each scheduled activity was coded according to discipline taught and chosen learning method. RESULTS: The number of hours spent on scheduled activities was much higher in the new programme (n = 4,009) than in the intended (n = 2,974), and it was even slightly higher than in the old programme (n = 3,785). In contrast to plans there was less student-centered learning, and basic science was mainly taught during the two first years. INTERPRETATION: Contrary to plans, the new curriculum in Trondheim has not become a pure PBL curriculum. It is a hybrid model involving a number of learning methods. A high degree of autonomy of the individual faculty members in the planning, and resistance to change among faculty members may have caused less radical changes. This is not necessarily negative; the new model may be a pragmatic synthesis between new and traditional medical education.