Validity of self-reported hysterectomy and oophorectomy in a population-based cohort: The HUNT study.

OBJECTIVE: To validate self-reported hysterectomy and bilateral oophorectomy. DESIGN: Validation study. SETTING: Large population-based cohort study in Norway: The Trøndelag Health Study (HUNT). POPULATION: The Trøndelag Health Study 2 and 3 (HUNT2 and HUNT3) included questions on gynaecological history. Women who answered questions regarding hysterectomy and/or oophorectomy were included. In total, 30 263 women were included from HUNT2 (1995-1997) and 23 138 from HUNT3 (2006-2008), of which 16 261 attended both HUNT2 and HUNT3. METHODS: We compared self-reported hysterectomy and bilateral oophorectomy with electronic hospital procedure codes. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive predictive value and negative predictive value of self-reported hysterectomy and bilateral oophorectomy, by comparing with hospital procedure codes. RESULTS: Self-reported hysterectomy and bilateral oophorectomy in HUNT2 and/or HUNT3 both had specificity and negative predictive value above 99%. Self-reported hysterectomy had a sensitivity of 95.9%, and for bilateral oophorectomy sensitivity was 91.2%. Positive predictive value of self-reported hysterectomy was 85.8%, but for self-reported bilateral oophorectomy it was 65.4%. CONCLUSIONS: Self-reported hysterectomy corresponded quite well with hospital data and can be used in epidemiological studies. Self-reported bilateral oophorectomy, on the other hand, had low positive predictive value, and results based on such data should be interpreted with caution. Women who report no previous hysterectomy or bilateral oophorectomy can safely be classified as unexposed to these surgeries.

A practical guide to estimating treatment effects in patients with rheumatic diseases using real-world data.

OBJECTIVE: Randomized controlled trials are considered the gold standard in study methodology. However, due to their study design and inclusion criteria, these studies may not capture the heterogeneity of real-world patient populations. In contrast, the lack of randomization and the presence of both measured and unmeasured confounding factors could bias the estimated treatment effect when using observational data. While causal inference methods allow for the estimation of treatment effects, their mathematical complexity may hinder their application in clinical research. METHODS: We present a practical, nontechnical guide using a common statistical package (Stata) and a motivational simulated dataset that mirrors real-world observational data from patients with rheumatic diseases. We demonstrate regression analysis, regression adjustment, inverse-probability weighting, propensity score (PS) matching and two robust estimation methods. RESULTS: Although the methods applied to control for confounding factors produced similar results, the commonly used one-to-one PS matching method could yield biased results if not thoroughly assessed. CONCLUSION: The guide we propose aims to facilitate the use of readily available methods in a common statistical package. It may contribute to robust and transparent epidemiological and statistical methods, thereby enhancing effectiveness research using observational data in rheumatology.

Detection of severe congenital heart defects in live-born infants in Norway 2017-2020.

AIM: The aims of this nationwide retrospective cohort study were to determine the time and causes of detection of severe congenital heart defects (CHDs) in live-born infants in Norway between 2017 and 2020. METHODS: Information regarding live-born infants with severe CHDs was retrieved from national registries and medical records. RESULTS: A total of 219 776 infants were born in Norway from 01.01.2017 to 31.12.2020. Severe CHDs were diagnosed in 442 (0.2%) infants. Of these, 376 (85%) infants were diagnosed either prenatally (n = 203, 46%) or before discharge from hospital after birth (n = 173, 39%). A total of 56 (13%) infants were discharged with undetected CHDs. Time of detection was unknown in 10 cases (2%). The most frequent undetected CHDs at discharge were coarctation of the aorta/aortic arch hypoplasia (n = 24), atrioventricular septal defect (n = 13), anomalous pulmonary venous connection (n = 5) and coronary artery anomalies (n = 4). Seven (13%) children with undetected CHD experienced circulatory collapse out of hospital. CONCLUSION: Most infants with severe CHDs in Norway were identified prior to hospital discharge. However, some infants were discharged undiagnosed. Awareness of undetected CHDs and immediate cardiac assessment in infants with signs of circulatory failure early in life are still important.

Do maternal anxiety and depressive symptoms predict anxiety in children with and without ADHD at 8 years?

Maternal anxiety and depression during pregnancy and early childhood have been associated with child anxiety and attention-deficit/hyperactivity disorder (ADHD). However, previous studies are limited by their short follow-up, few assessments of maternal symptoms, and by not including maternal and child ADHD. The present study aimed to fill these gaps by investigating whether maternal anxiety and depressive symptoms from pregnancy to child age 5 years increase the risk of child anxiety disorders at age 8 years. This study is part of the population-based Norwegian Mother, Father, and Child Cohort Study. Maternal anxiety and depressive symptoms were assessed by the Hopkins Symptom Checklist (SCL) six times from pregnancy through early childhood, and ADHD symptoms by the Adult Self-Report Scale (ASRS). At age 8 years (n = 781), symptoms of anxiety disorders and ADHD were assessed, and disorders classified by the Child Symptom Inventory-4. Logistic regression models estimated the risk of child anxiety depending on maternal symptoms. The mothers of children classified with an anxiety disorder (n = 91) scored significantly higher on the SCL (at all time points) and ASRS compared with the other mothers. In univariable analyses, maternal anxiety and/or depression and ADHD were associated with increased risk of child anxiety (odds ratios = 2.99 and 3.64, respectively), remaining significant in the multivariable analysis adjusted for covariates. Our findings link maternal anxiety, depression, and ADHD during pregnancy and early childhood to child anxiety at age 8 years.

Parental Stress, Infant Feeding and Well-being in Families Affected by Cleft Lip and/or Cleft Palate: The Impact of Early Follow-up.

OBJECTIVE: To document the impact of early follow-up by specialized cleft nurses (SCNs) provided to families affected by cleft lip and/or palate (CL/P) and the status of parental stress, infant feeding and well-being. DESIGN: Prospective inclusion of a control group, which only received standard care, followed by an intervention group that also received early SCN follow-up. SETTING: The cleft lip and palate team at Oslo University Hospital, Norway. PARTICIPANTS: Seventy families (69 mothers and 57 fathers) distributed into an intervention group (n = 32) and a control group (n = 38). INTERVENTION: SCNs provided a consultation at the maternity ward and a follow-up conversation by phone or face-to-face at scheduled times for six months. OUTCOME MEASURES: Parental Stress Index (PSI), Perceived Stress Scale (PSS-14), feeding questionnaire, survey of infant diets, weight percentiles. RESULTS: The mothers reported higher stress scores than the fathers, but in the control group only in the PSI parent domain at T2 and T3 (P = .007, P = .018). Infants in the intervention group used pacifiers less frequently than in the control group (55.2% vs. 81.1%, P = .023). Otherwise, no significant differences were found between the groups. Overall, the infants received less breast milk than norms. CONCLUSION: Contextual strategies for early follow-up of families affected by clefts need to be developed, with an emphasis on involving fathers and those parents reporting elevated stress and/or feeding difficulties. There is a need for diagnosis-specific guidelines about the use of pacifiers as well as collaboration between the health professionals involved to increase breastmilk feeding.

Deep Brain Stimulation for Arm Tremor: A Randomized Trial Comparing Two Targets.

OBJECTIVE: Deep brain stimulation (DBS) of the thalamic ventral intermediate nucleus (VIM) effectively suppresses arm tremor. Uncontrolled studies suggest the posterior subthalamic area (PSA) may be superior. We compared the intra-individual efficacy of VIM- versus PSA-DBS on tremor suppression and arm function. METHODS: We performed a randomized, double-blind, crossover trial at Oslo University Hospital in patients (18-80 years) with isolated or combined action tremor affecting at least one arm. Four-contact DBS leads were implanted (bi- or unilaterally) with a trajectory to cover the VIM (upper two contacts) and PSA (lower two contacts). Patients were randomized (1:1 ratio) post-surgery to: Group 1, VIM-stimulation months 0-3 (period 1), then PSA-stimulation months 4-6 (period 2); Group 2, PSA-stimulation first, then VIM-stimulation. Primary endpoint was the difference in improvement from baseline to the end of the VIM- versus PSA-period in the sum of the dominant arm tremor scores of the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS), items 5/6 + 10-14. RESULTS: Forty-five patients were randomized to Group 1 (n = 23) or 2 (n = 22). In the primary endpoint per-protocol analysis (mixed model, n = 40), mean difference in the sum FTMTRS score improvement for the dominant arm was -2.65 points (95% CI -4.33 to -0.97; p = 0.002). The difference in favour of PSA stimulation was highly significant in period 2, but not period 1. INTERPRETATION: Our randomized trial demonstrated that PSA stimulation provided superior tremor suppression compared with VIM stimulation. A period effect reducing tremor for up to three months in both groups was most likely attributed to a post-surgery stun effect. ANN NEUROL 2022;91:585-601.

Prospective T1 mapping to assess gadolinium retention in brain after intrathecal gadobutrol.

PURPOSE: A possible pathway behind gadolinium retention in brain is leakage of contrast agents from blood to cerebrospinal fluid and entry into brain along perivascular (glymphatic) pathways. The object of this study was to assess for signs of gadolinium retention in brain 4 weeks after intrathecal contrast enhanced MRI. METHODS: We prospectively applied standardized T1 mapping of the brain before and 4 weeks after intrathecal administration of 0.5 mmol gadobutrol in patients under work-up of cerebrospinal fluid circulation disorders. Due to methodological limitations, a safety margin for percentage change in T1 time was set to 3%. Region-wise differences were assessed by pairwise comparison using t-tests and forest plots, and statistical significance was accepted at .05 level (two-tailed). RESULTS: In a cohort of 76 participants (mean age 47.2 years ± 17.9 [standard deviation], 47 women), T1 relaxation times remained unchanged in cerebral cortex and basal ganglia 4 weeks after intrathecal gadobutrol. T1 was reduced from 1082 ± 46.7 ms to 1070.6 ± 36.5 ms (0.98 ±2.9%) (mean [standard deviation]) (p=0.001) in white matter, thus within the pre-defined 3% safety margin. The brain stem and cerebellum could not be assessed due to poor alignment of posterior fossa structures at scans from different time points. CONCLUSION: Gadolinium retention was not detected in the cerebral hemispheres 4 weeks after an intrathecal dose of 0.5 mmol gadobutrol, implying that presence of contrast agents in cerebrospinal fluid is of minor importance for gadolinium retention in brain.

Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial.

BACKGROUND: Randomized controlled trials (RCT) comparing long-term outcome after laparoscopic (LF) and open fundoplication (OF) in children are lacking. Here we report recurrence rates and time to recurrence, frequency of re-interventions, use of antisecretory drugs, gastrointestinal symptoms, and patient/parental satisfaction a decade after children were randomized to LF or OF. METHODS: Cross-sectional long-term follow-up study of a two-center RCT that included patients during 2003-2009. Patients/parents were interviewed and medical charts reviewed for any events that might be related to the fundoplication. If suspicion of recurrence, further diagnostics were performed. Informed consent and ethical approval were obtained. CLINICALTRIALS: gov: NCT01551134. RESULTS: Eighty-eight children, 56 (64%) boys, were randomized (LF 44, OF 44) at median 4.4 [interquartile range (IQR) 2.0-8.9] years. 46 (52%) had neurological impairment. Three were lost to follow-up before first scheduled control. Recurrence was significantly more frequent after LF (24/43, 56%) than after OF (13/42, 31%, p = 0.004). Median time to recurrence was 1.0 [IQR 0.3-2.2] and 5.1 [IQR 1.5-9.3] years after LF and OF, respectively. Eight (19%) underwent redo fundoplication after LF and three (7%) after OF (p = 0.094). Seventy patients/parents were interviewed median 11.9 [IQR 9.9-12.8] years postoperatively. Among these, use of anti-secretory drugs was significantly decreased from preoperatively after both LF (94% vs. 35%, p < 0.001) and OF (97% vs. 19%, p < 0.001). Regurgitation/vomiting were observed in 6% after LF and 3% after OF (p = 0.609), and heartburn in 14% after LF and 17% after OF (p = 1.000). Overall opinion of the surgical scars was good in both groups (LF: 95%, OF: 86%, p = 0.610). Patient/parental satisfaction with outcome was high, independent of surgical approach (LF: 81%, OF: 88%, p = 0.500). CONCLUSIONS: The recurrence rate was higher and recurrence occurred earlier after LF than after OF. Patient/parental satisfaction with outcome after both LF and OF was equally high.

Patients with depression symptoms are more likely to experience improvements of internet-based cognitive behavioral therapy: a secondary analysis of effect modifiers in patients with non-cardiac chest pain in a randomized controlled trial.

BACKGROUND: Non-cardiac chest pain is common and associated with increased anxiety and reduced health-related quality of life. Randomized controlled trials on psychological interventions for patients with non-cardiac chest pain have reported mixed results. Patients with non-cardiac chest pain are a heterogeneous group. Identifying sub-groups that could potentially benefit more (or less) from an intervention would be valuable knowledge. We have conducted a randomized controlled trial where internet-based cognitive behavioural therapy (iCBT) had effect on reducing cardiac anxiety and increasing health-related quality of life at 12-month follow-up. The aim of the present study was to explore potential effect modifiers of iCBT in patients with non-cardiac chest pain on cardiac anxiety and/or health related quality of life at 12-month follow-up. METHODS: We analysed data from our randomized, controlled trial where 161 patients with non-cardiac chest pain were included and randomized to either iCBT or a treatment as usual (control). Cardiac anxiety measured by the Cardiac Anxiety Questionnaire and health-related quality of life measured by the EuroQol Visual Analog Scale at 12 month follow-up were the primary outcomes. Four potential baseline characteristics where identified as potential effect modifiers by a theory-based approach: (1) depression measured by the Patient Health Questionnaire; (2) anxiety measured by the Body Sensations Questionnaire; (3) prior healthcare contacts measured by a self-developed question; and (4) chest pain frequency measured by a self-developed question. Each potential effect modifier was analysed in a linear regression model where cardiac anxiety and EQ-VAS scores at 12-month follow-up, separately, were used as dependent variables. The potential differential treatment effect for each effect modifier was assessed by the interaction term: effect modifier x treatment group. RESULTS: Depression symptoms at baseline predicted a differential treatment effect at 12-month follow-up on health-related quality of life in favor of the iCBT group (regression coefficient of the interaction term: -1.85 (CI -3.28 to -0.41), p = 0.01), but not on cardiac anxiety at 12-month follow-up. Fear of bodily symptoms, chest pain frequency and prior health care contacts at baseline did not predict a treatment effect on either health-related quality of life or cardiac anxiety. CONCLUSIONS: Depression symptoms at baseline predicted a positive treatment effect of iCBT on health-related quality of life in patients suffering from non-cardiac chest pain. This indicates that it is important to identify patients with non-cardiac chest pain and co-occurring depression symptoms given that they are particularly likely to benefit from iCBT. TRIAL REGISTRATION: ClinicalTrials.gov NCT03096925 .

All-cause and cardiovascular mortality after hysterectomy and oophorectomy in a large cohort (HUNT2).

INTRODUCTION: Hysterectomy and bilateral oophorectomy are common major surgical procedures that have been associated with increased mortality risk. We aimed to assess the association of hysterectomy and/or bilateral oophorectomy with all-cause and cardiovascular mortality in a Norwegian population. MATERIAL AND METHODS: Cohort study with data from The Trøndelag Health Study (HUNT2) linked to the Norwegian Cause of Death Registry, with follow-up from 1996 until 2014 or death. The unexposed group (n = 18 673) included women with both their ovaries and uterus intact, while the two exposed groups included women with hysterectomy alone (n = 1199), or bilateral oophorectomy with or without hysterectomy (n = 907). We compared mortality in exposed vs unexposed groups and adjusted for relevant covariates by Cox regression. Further, we performed analyses stratified by age at surgery (≤39, 40-52, ≥53 years) and subgroup analyses among women ≤52 years of age at inclusion. RESULTS: Among the 47 312 women in HUNT2 (1995-1997), 20 779 provided complete information regarding gynecological surgery and previous health. The hysterectomy group had increased all-cause mortality (hazard ratio [HR] 1.30, 95% confidence interval [CI] 1.06-1.58) and cardiovascular mortality (HR 1.47, 95% CI 1.09-1.97). We found no significant association between bilateral oophorectomy and all-cause or cardiovascular mortality in the total population. However, among women ≤52 years at inclusion, cardiovascular mortality was increased in the hysterectomy group (HR 2.71, 95% CI 1.19-6.17) with a similar, but less precise estimate in the bilateral oophorectomy group (HR 2.42, 95% CI 0.84-6.93). CONCLUSIONS: Hysterectomy was associated with increased all-cause and cardiovascular mortality, whereas bilateral salpingo-oophorectomy was not. Among women ≤52 years at inclusion, both hysterectomy and bilateral oophorectomy were associated with a twofold increased risk of cardiovascular mortality, but the results were imprecise. Women after hysterectomy and/or bilateral salpingo-oophorectomy constitute a group with increased cardiovascular mortality that may need closer attention to cardiovascular disease risk from the healthcare system to ensure timely and effective preventive interventions.

Exploring pain catastrophizing and its associations with low disease activity in rheumatic inflammatory disorders.

Pain catastrophizing is a maladaptive mechanism associated with the exaggerated experience of pain, increased rumination and feelings of helplessness. The main objective of this study was to explore whether increased pain catastrophizing is independently associated with a lower proportion of low disease activity (LDA) in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA). Demographics, comorbidities, treatment, disease activity measures and patient-reported outcome data were recorded in RA, PsA and axSpA patients. Pain catastrophizing score (PCS) was assessed using a standardised questionnaire. For each diagnosis, composite disease activity scores with distinct cut-off values for LDA, i.e. DAS28-CRP (RA), DAPSA (PsA) and ASDAS-CRP (axSpA) were calculated and used as the dependent variable in logistic regression reflecting LDA achieved. A total of one thousand two hundred and twenty nine patients were included: 580 with RA, 394 with PsA and 255 with axSpA. In the multivariable analysis, pain catastrophizing was independently associated with LDA rates in axSpA (OR 0.33, 95% CI [0.12, 0.88]) amongst tested groups. In RA (OR 0.90, 95% CI [0.64, 1.28]) and PsA (OR 0.77, 95% CI [0.55, 1.07]), a statistically significant association was not observed. Higher PCS was independently associated with not achieving LDA in axSpA. Our data, however, indicate that pain catastrophizing, which also reflects a patient's personality traits and coping abilities, plays a less important role for the patient than general pain perception.

Real-world experience of rituximab biosimilar GP2013 in rheumatoid arthritis patients naïve to or switched from reference rituximab.

Randomized controlled trials showed high comparability of biosimilar rituximab (bs-RTX) GP2013 to biologic originator RTX (bo-RTX). Data on effectiveness of switching from bo-RTX to bs-RTX, starting therapy with bs-RTX, and bs-RTX drug survival in real-world setting are sparse. To explore long-term drug effectiveness and survival of bs-RTX GP2013 in rheumatoid arthritis (RA) patients both naïve to and mandatory switched from bo-RTX, and to clarify reasons for treatment cessation. Retrospective observational cohort study including RA outpatient clinic patients treated with bs-RTX between 2018 and 2021 in Norway. Patients were examined and monitored using recommended measures for disease activity and patient-reported outcomes (PROs). For description of population medians and interquartile range were used. Difference between observation times was assessed with Signed-Rank test, drug survival with Kaplan-Meier survival analysis. Reasons for discontinuation were ascertained. Among 110 patients, at baseline, 88 were mandatory switched from bo-RTX and 22 were RTX-naïve. During 2-year follow-up, disease activity and PROs measures remained stable in switchers subgroup and improved in subgroup starting bs-RTX for the first time. Overall drug survival was 80.0% after 1 year and 57.7% after 2 years and was significantly higher in bs-RTX-switched than in bs-RTX-naïve patients (p = 0.036). Two most frequently reported reasons for drug discontinuation were remission (38.6%) and doctor's decision (27.1%). RA patients treated with bs-RTX had satisfactory treatment response and drug retention rates which supports equivalence of bs-RTX GP2013 to bo-RTX, both in patients naïve to and mandatory switched from bo-RTX.

Attention-deficit/hyperactivity disorder from preschool to school age: change and stability of parent and teacher reports.

Identifying attention-deficit/hyperactivity disorder (ADHD) in pre-schoolers may improve their development if treated, but it is unclear whether ADHD symptoms from this age are stable enough to merit treatment. We aimed to investigate the stability of parent- and teacher-reported ADHD symptoms and ADHD classified above the diagnostic symptom thresholds, including for hyperactivity-impulsivity (HI), inattention and combined presentations from age 3 to 8 years. This study is part of the longitudinal, population-based Norwegian Mother, Father and Child Cohort Study. At child age 3 years, parents were interviewed and teachers rated ADHD symptoms. At age 8 years, parents (n = 783) and teachers (n = 335) reported ADHD symptoms by the Child Symptom Inventory-4. We found a significant reduction in the mean number of parent-reported ADHD and HI symptoms from age 3 to 8 years, but otherwise similar mean numbers. Parent-reported ADHD symptoms were moderately correlated between ages, while correlations were low for teachers. A total of 77/108 (71%) of the children classified with parent-reported HI presentation at age 3 years were no longer classified within any ADHD presentation at age 8 years, the only clear trend across time for either informant. There was a low to moderate parent-teacher-agreement in the number of reported symptoms, and very low informant agreement for the classified ADHD presentations. Overall, clinicians should exercise caution in communicating concern about HI symptoms in preschool children. Age 3 years may be too early to apply the ADHD diagnostic symptom criteria, especially if parents and teachers are required to agree.

Early and repeated screening detects children with persistent attention-deficit/hyperactivity disorder.

Preschool screening of attention-deficit/hyperactivity disorder (ADHD) has been found too inaccurate to be clinically useful. This may be due to the known instability of ADHD symptoms from preschool onwards, and the use of a single screening only. We hypothesized that by identifying a group of children with persistent ADHD from preschool to school age and repeating the screening, the clinical usefulness of screening would increase. This study is part of the prospective longitudinal, population-based Norwegian Mother, Father and Child Cohort Study, with a diagnostic parent interview at 3.5 years and follow-up with parent questionnaires at ages 5 and 8 years (n = 707). We identified a group classified with ADHD at all three time points (persistent ADHD). We then used the Child Behavior Checklist ADHD DSM-oriented scale at ages 3.5 and 5 years to investigate the accuracies of single- and two-stage screening at different thresholds to identify children with persistent ADHD. About 30% of the children were classified with ADHD at least once across time (at ages 3.5, 5, and/or 8 years), but only 4% (n = 30) had persistent ADHD. At all thresholds, the two-stage screening identified children with persistent ADHD more accurately than single screening, mainly due to a substantial reduction in false positives. Only a small group of children were classified with persistent ADHD from preschool to school age, underlining that future screening studies should distinguish this group from those with fluctuating symptoms when estimating screening accuracies. We recommend a two-stage screening process to reduce false positives.

Comparison of Different Bone Age Methods and Chronological Age in Prediction of Remaining Growth Around the Knee.

BACKGROUND: Bone age (BA) has been shown to be superior to chronological age (CA) when predicting remaining growth. However, it is not known whether the calculations are more accurate when BA is assessed by the Greulich and Pyle (GP) or the Sauvegrain (SG) methods. The aim of our study was to identify the method which gives an estimate closest to actual growth in the lower extremities. METHODS: Leg length radiographs, hand radiographs, and elbow radiographs were simultaneously obtained during the adolescent growth spurt (10 to 16 years) in 52 children treated for LLD, with radiographic follow-up of segmental length (femur, tibia, and foot) until skeletal maturity, were randomly selected from a local institutional register. BA, according to GP and SG, were manually rated, and BA based on the GP method was additionally assessed by the automated BoneXpert (BX) method. The remaining growth was calculated based on the White-Menelaus method for both BA methods (GP, SG), the combination of the 2 methods, GP by BX, CA, and the combination of CA and GP by BX. Estimated growth was compared with the actual growth in the distal femur and proximal tibia from the time of BA determination until skeletal maturity. RESULTS: For all included methods, the average calculated remaining growth was higher compared with the actual growth. The mean absolute difference between calculated remaining growth and actual growth in the femur and tibia was lowest using GP by BX [0.66 cm (SD 0.51 cm) and 0.43 cm (SD 0.34 cm)] and highest using CA [1.02 (SD 0.72) and 0.67 (SD 0.46)]. It was a significant association between calculated growth and the difference between actual and calculated growth for the SG method ( P =<0.001). CONCLUSION: During the adolescent growth spurt, the GP method compared with the SG method and CA gives the most accurate estimate of remaining growth around the knee according to our results. CLINICAL RELEVANCE: In calculations of remaining growth around the knee, BA assessment by the GP atlas or BX method should be used as the parameter of biological maturity.

Early Follow-up of Parents by a Specialized Cleft Nurse After the Birth of an Infant with Cleft lip and/or Palate.

OBJECTIVE: To document the impact of early follow-up by specialized cleft nurses (SCNs) to families of infants with cleft lip and/or cleft palate (CL/P). DESIGN: Prospective inclusion of a control group, which received standard care alone, followed by an intervention group, which in addition received early SCN follow-up. SETTING: The cleft lip and palate team at a University hospital. PARTICIPANTS: 70 families (69 mothers and 57 fathers); control group (n = 38); intervention group (n = 32). INTERVENTION: SCNs offered a consultation at the maternity ward and follow-ups by phone or face-to-face at one, three, eight weeks and six months after birth. OUTCOME MEASURES: Use of Internet-Questionnaire, Quality of discharge teaching scale (QDTS), Post discharge coping difficulty scale (PDCDS), Response on follow-up by health professionals. RESULTS: Infants in the intervention group were admitted less frequently to a Neonatal Intensive Care unit (NICU); 21.9% vs 51.4%, P = .012. Parents in the intervention group used internet for cleft-related reasons less frequently (74.6% vs 85.9%), P = .112 and the mothers benefitted less from cleft-related activity on the internet (P = .013). The intervention group reported higher mean score for satisfaction with total cleft care (P = .001). There were no significant group differences regarding mean total score for discharge teaching (P = .315) and coping difficulties (P = .919). CONCLUSION: Early follow-up by a SCN with expertise in cleft care is highly valued by parents. Closer cooperation between the cleft team and health professionals at birth hospitals and Child health centers is necessary for optimal follow-up.

Why Not Lonely? A Longitudinal Study of Factors Related to Loneliness and Non-Loneliness in Different Age Groups Among People in the Second Part of Life.

Age-related changes and losses may lead to loneliness. However, some people do not become lonelier, even after negative life events. This study examines the development of loneliness based on Norwegian panel data (N = 2,315), age 40-80 years at baseline, and the impacts of partnership and health measured in 2002, 2007, and 2017. We ask: How does loneliness develop over time, and who resists becoming lonely? In the total group, loneliness decreased from 2002 to 2007 and then leveled off. In the eldest age group, 70-80 years at baseline, loneliness increased but only in the last period, from 2007 to 2017. In all age groups and at all three times, those who were not lonely more often had a partner and were more often in good health compared to those who were lonely. Period effects, cohort, and age-related changes influencing the development in loneliness over time are discussed.

CT-based migration analysis is more precise than radiostereometric analysis for tibial implants: a phantom study on a porcine cadaver.

BACKGROUND AND PURPOSE: Radiostereometric analysis (RSA) is the gold standard for migration analysis, but computed tomography analysis methods (CTRSA) have shown comparable results in other joints. We attempted to validate precision for CT compared with RSA for a tibial implant. MATERIAL AND METHODS: RSA and CT were performed on a porcine knee with a tibial implant. Marker-based RSA, model-based RSA (MBRSA), and CT scans from 2 different manufacturers were compared. CT analysis was performed by 2 raters for reliability evaluation. RESULTS: 21 double examinations for precision measurements for RSA and CT-based Micromotion Analysis (CTMA) were analysed. Mean (95% confidence interval) precision data for maximum total point motion (MTPM) using marker-based RSA was 0.45 (0.19-0.70) and 0.58 (0.20-0.96) using MBRSA (F-statistic 0.44 [95% CI 0.18-1.1], p = 0.07). Precision data for total translation (TT) for CTMA was 0.08 (0.03-0.12) for the GE scanner and 0.11 (0.04-0.19) for the Siemens scanner (F-statistic 0.37 [0.15-0.91], p = 0.03). When comparing the aforementioned precision for both RSA methods with both CTMA analyses, CTMA was more precise (p < 0.001). The same pattern was seen for other translations and migrations. Mean effective radiation doses were 0.005 mSv (RSA) (0.0048-0.0050) and 0.08 mSv (CT) (0.078-0.080) (p < 0.001). Intra- and interrater reliability were 0.79 (0.75-0.82) and 0.77 (0.72-0.82), respectively. CONCLUSION: CTMA is more precise than RSA for migration analysis of a tibial implant, has overall good intra- and interrater reliability but higher effective radiation doses in a porcine cadaver.

Dose reduction does not impact the precision of CT-based RSA in tibial implants: a diagnostic accuracy study on precision in a porcine cadaver.

BACKGROUND AND PURPOSE: Radiostereometric analysis (RSA) is the gold standard for evaluation of migration of implants. CT-RSA has been shown to have precision at the level of RSA in hip, shoulder, and knee joint replacements. We aimed to assess the impact of dose reduction on precision of CT-RSA on tibial implants, comparing it with previously published data on precision of standard dose CT-RSA on tibial implants. MATERIAL AND METHODS: We performed a total knee arthroplasty on a porcine knee cadaver, and subsequent CT-RSA with low effective doses (0.02 mSv). We compared the results with previously published CT-RSA data with standard (0.08 mSv) dose. The primary outcome variable was the difference in precision of the maximum total translation (MTT). Secondary variables included ratios of variances and standard deviations, and precision of peripheral point translations, center-of-mass translations, and rotations. A difference of more than 0.1 mm in precision was defined as clinically relevant. Our hypothesis was that precisions of low and standard CT-RSA doses were equal. RESULTS: Low dose (mean 0.07, 95% confidence interval [CI] 0.06-0.08) and standard dose CT-RSA (0.08, CI 0.07-0.09) achieve similar precision, with difference in precision of MTT of 0.01, CI 0.00-0.02 mm. The F-statistic (0.99, CI 0.63-1.55) and sdtest (1.05, CI 0.43-2.58) also supported this. CONCLUSION: We conclude that the precision of low dose CT-RSA for tibial implants on a porcine cadaver is equal to standard dose CT-RSA. However, these findings should be confirmed in clinical trials.

Six versus 2 weeks treatment with doxycycline in European Lyme neuroborreliosis: a multicentre, non-inferiority, double-blinded, randomised and placebo-controlled trial.

BACKGROUND: There is limited evidence regarding optimal duration of antibiotic treatment in neuroborreliosis. We aimed to compare efficacy and safety of oral doxycycline for 2 and 6 weeks in European Lyme neuroborreliosis (LNB). METHODS: The trial had a randomised, double-blinded, placebo-controlled, non-inferiority design. Patients with LNB were recruited from eight Norwegian hospitals and randomised to doxycycline 200 mg once daily for 2 weeks, followed by 4 weeks of placebo, or doxycycline 200 mg once daily for 6 weeks. The primary endpoint was clinical improvement as measured by difference in a Composite Clinical Score (0-64 points) from baseline to 6 months. The non-inferiority margin was predetermined to 0.5 points. RESULTS: One hundred and twenty-one patients were included. Fifty-two treated for 2 weeks and 53 for 6 weeks were included in the intention-to-treat analyses, and 52 and 51 in per-protocol analysis. Mean difference in clinical improvement between the groups was 0.06, 95% CI -1.2 to 1.2, p=0.99 in the intention-to-treat population, and -0.4, 95% CI -1.4 to 0.7, p=0.51 in the per-protocol population and non-inferiority could not be established. There were no treatment failures and no serious adverse events. The groups did not differ in secondary outcomes including clinical scores at 10 weeks and 12 months, cerebrospinal fluid data and patient-reported outcome measures. Patients receiving 6 weeks doxycycline reported slightly more side effects in week 5. CONCLUSION: Our results strongly indicate that there are no benefits of doxycycline treatment beyond 2 weeks in European LNB. TRIAL REGISTRATION NUMBER: 2015-001481-25.