Implementation of an algorithm for tapering analgosedation reduces iatrogenic withdrawal syndrome in pediatric intensive care.

BACKGROUND: Proper analgosedation is a cornerstone in the treatment of critically ill patients in Pediatric Intensive Care Units (PICUs). Medications, such as fentanyl, morphine, and midazolam, are essential to safe and respectful care. The use of these medications over time may lead to side effects such as iatrogenic withdrawal syndrome (IWS) in the tapering phase. The aim of the study was to test an algorithm for tapering analgosedation to reduce the prevalence of IWS in two Norwegian PICUs at Oslo University Hospital. METHODS: A cohort of mechanically ventilated patients from newborn to 18 years with continuous infusions of opioids and benzodiazepines for 5 days or more were included consecutively from May 2016 to December 2021. A pre- and posttest design, with an intervention phase using an algorithm for tapering analgosedation after the pretest, was used. The ICU staffs were trained in using the algorithm after the pretest. The primary outcome was a reduction in IWS. The Withdrawal Assessment Tool-1 (WAT-1) was used to identify IWS. A WAT-1 score ≥3 indicates IWS. RESULTS: We included 80 children, 40 in the baseline group, and 40 in the intervention group. Age and diagnosis did not differ between the groups. The prevalence of IWS was 95% versus 52.5% in the baseline group versus the intervention group, and the peak WAT-1 median was 5.0 (IQR 4-6.8) versus 3.0 (IQR 2.0-6.0) (p = .012). Based on SUM WAT-1 ≥ 3, which describes the burden over time better, we demonstrated a reduction of IWS, from a median of 15.5 (IQR 8.25-39) to a median of 3 (IQR 0-20) (p = <.001). CONCLUSION: We suggest using an algorithm for tapering analgosedation in PICUs since the prevalence of IWS was significantly lower in the intervention group in our study.

Meditative-based diaphragmatic breathing vs. vagus nerve stimulation in the treatment of fibromyalgia-A randomized controlled trial: Body vs. machine.

Importance: Vagus nerve innervation via electrical stimulation and meditative-based diaphragmatic breathing may be promising treatment avenues for fibromyalgia. Objective: Explore and compare the treatment effectiveness of active and sham transcutaneous vagus nerve stimulation (tVNS) and meditative-based diaphragmatic breathing (MDB) for fibromyalgia. Design: Participants enrolled from March 2019-October 2020 and randomly assigned to active tVNS (n = 28), sham tVNS (n = 29), active MDB (n = 29), or sham MDB (n = 30). Treatments were self-delivered at home for 15 min/morning and 15 min/evening for 14 days. Follow-up was at 2 weeks. Setting: Outpatient pain clinic in Oslo, Norway. Participants: 116 adults aged 18-65 years with severe fibromyalgia were consecutively enrolled and randomized. 86 participants (74%) had an 80% treatment adherence and 107 (92%) completed the study at 2 weeks; 1 participant dropped out due to adverse effects from active tVNS. Interventions: Active tVNS is placed on the cymba conchae of the left ear; sham tVNS is placed on the left earlobe. Active MDB trains users in nondirective meditation with deep breathing; sham MDB trains users in open-awareness meditation with paced breathing. Main outcomes and measures: Primary outcome was change from baseline in ultra short-term photoplethysmography-measured cardiac-vagal heart rate variability at 2 weeks. Prior to trial launch, we hypothesized that (1) those randomized to active MDB or active tVNS would display greater increases in heart rate variability compared to those randomized to sham MDB or sham tVNS after 2-weeks; (2) a change in heart rate variability would be correlated with a change in self-reported average pain intensity; and (3) active treatments would outperform sham treatments on all pain-related secondary outcome measures. Results: No significant across-group changes in heart rate variability were found. Furthermore, no significant correlations were found between changes in heart rate variability and average pain intensity during treatment. Significant across group differences were found for overall FM severity yet were not found for average pain intensity. Conclusions and relevance: These findings suggest that changes in cardiac-vagal heart rate variability when recorded with ultra short-term photoplethysmography in those with fibromyalgia may not be associated with treatment-specific changes in pain intensity. Further research should be conducted to evaluate potential changes in long-term cardiac-vagal heart rate variability in response to noninvasive vagus nerve innervation in those with fibromyalgia. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03180554, Identifier: NCT03180554.

SARS-CoV-2 antibody persistence after five and twelve months: A cohort study from South-Eastern Norway.

OBJECTIVES: To assess total antibody levels against Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS CoV-2) spike protein up to 12 months after Coronavirus Disease (COVID-19) infection in non-vaccinated individuals and the possible predictors of antibody persistence. METHODS: This is the first part of a prospective multi-centre cohort study. PARTICIPANTS: The study included SARS-CoV-2 real-time polymerase chain reaction (RT-PCR) positive and negative participants in South-Eastern Norway from February to December 2020. Possible predictors of SARS-CoV-2 total antibody persistence was assessed. The SARS-CoV-2 total antibody levels against spike protein were measured three to five months after PCR in 391 PCR-positive and 703 PCR-negative participants; 212 PCR-positive participants were included in follow-up measurements at 10 to 12 months. The participants completed a questionnaire including information about symptoms, comorbidities, allergies, body mass index (BMI), and hospitalisation. PRIMARY OUTCOME: The SARS-CoV-2 total antibody levels against spike protein three to five and 10 to 12 months after PCR positive tests. RESULTS: SARS-CoV-2 total antibodies against spike protein were present in 366 (94%) non-vaccinated PCR-positive participants after three to five months, compared with nine (1%) PCR-negative participants. After 10 to 12 months, antibodies were present in 204 (96%) non-vaccinated PCR-positive participants. Of the PCR-positive participants, 369 (94%) were not hospitalised. The mean age of the PCR-positive participants was 48 years (SD 15, range 20-85) and 50% of them were male. BMI ≥ 25 kg/m2 was positively associated with decreased antibody levels (OR 2.34, 95% CI 1.06 to 5.42). Participants with higher age and self-reported initial fever with chills or sweating were less likely to have decreased antibody levels (age: OR 0.97, 95% CI 0.94 to 0.99; fever: OR 0.33, 95% CI 0.13 to 0.75). CONCLUSION: Our results indicate that the level of SARS-CoV-2 total antibodies against spike protein persists for the vast majority of non-vaccinated PCR-positive persons at least 10 to 12 months after mild COVID-19.

Improving Health Knowledge Through Provision of Free Digital Health Education to Rural Communities in Iringa, Tanzania: Nonrandomized Intervention Study.

BACKGROUND: Community health education is one of the most effective measures to increase health literacy worldwide and can contribute to the achievement of specific targets of the Sustainable Development Goal 3. Digitalized health education materials can improve health knowledge as a dimension of health literacy and play an important role in disease prevention in rural sub-Saharan settings. OBJECTIVE: The objective of this research is to assess the effect of a digital health education intervention on the uptake and retention of knowledge related to HIV/AIDS, tuberculosis (TB), and Taenia solium (neuro)cysticercosis and taeniosis in rural communities in Iringa, Tanzania. METHODS: We conducted a nonrandomized intervention study of participants aged 15 to 45 years, randomly selected from 4 villages in Iringa, Tanzania. The intervention consisted of 2 parts. After the baseline assessment, we showed the participants 3 animated health videos on a tablet computer. After a period of 6 months, free access to community information spots (InfoSpots) with an integrated digital health education platform was provided to the intervention villages. Participants in the control group did not receive the intervention. The primary outcome was the difference in disease knowledge between the intervention and control groups, 12 months after baseline. Data were collected using an open-ended questionnaire, with correct or incorrect answers before and after intervention. RESULTS: Between April and May 2019, a total of 600 participants were recruited into the intervention (n=298, 49.7%) or control (n=302, 50.3%) groups. At baseline, no statistically significant differences in knowledge of the target diseases were observed. At 12 months after intervention, knowledge about HIV/AIDS, TB, and T. solium (neuro)cysticercosis and taeniosis was 10.2% (95% CI 5.0%-15.4%), 12% (95% CI 7.7%-16.2%), and 31.5% (95% CI 26.8%-36.2%) higher in the intervention group than in the control group, respectively. In all 4 domains (transmission, symptoms, treatment, and prevention), an increase in knowledge was observed in all the 3 diseases, albeit to varying degrees. The results were adjusted for potential confounders, and the significance of the primary results was maintained in the sensitivity analysis to assess dropouts. The participants who reported using the InfoSpots in the 12-month assessment further increased their knowledge about the target diseases by 6.8% (HIV/AIDS), 7.5% (TB), and 13.9% higher mean proportion of correct answers compared with the participants who did not use the InfoSpots. CONCLUSIONS: Digital health education based on animated health videos and the use of free InfoSpots has significant potential to improve health knowledge, especially in rural areas of low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT03808597; https://clinicaltrials.gov/ct2/show/NCT03808597. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25128.

Quality of life and emotional vulnerability in a national cohort of adolescents living with Fontan circulation.

INTRODUCTION: To investigate quality of life and mental health after Fontan completion, we aimed to characterise outcomes in a representative group of adolescent patients. The study was part of the pre-transition clinical work-up in adolescents with Fontan-type palliation of univentricular CHD. The programme covers the entire paediatric Fontan patient population in Norway. METHODS: Our cross-sectional study included 42 adolescents with Fontan circulation aged 15-18. We recruited a control group of 29 healthy peers. Quality of life was measured by the Pediatric Quality of Life Inventory Questionnaire, while mental health was assessed with the Strength and Difficulties Questionnaire. RESULTS: Fontan patients scored lower than healthy controls on the Pediatric Quality of Life Inventory total (p = 0.004), the physical (p < 0.001) and social (p = 0.001) functioning subscale, and the Strength and Difficulties Questionnaire subscale of emotional symptoms (p = 0.035). Compared to two of the healthy teens (7%), seven patients (16%) in the Fontan group scored as having impaired mental health (p = 0.224). The female/male ratio for individuals with impaired health was 7:2 (p = 0.003). CONCLUSIONS: Compared to healthy controls, adolescents after Fontan-type palliation in Norway have good health-related quality of life and mental health, despite having slightly lower score than healthy individuals, mainly in physical domains and school functioning. Compared to healthy controls and healthy teenagers, these adolescents have somewhat more emotional problems, and compared to male patients, female patients more often have impaired mental health.

Robotic salvage pelvic lymph node dissection for locoregional recurrence after radical prostatectomy: a single institution experience.

OBJECTIVES: To assess treatment response (PSA < 0.2 ng/ml), need for additional therapy and complication rate after robot assisted salvage pelvic lymph node dissection (sPLND). MATERIAL AND METHODS: Analysis of outcomes data from radical prostatectomy (RP) patients consecutively operated with robot assisted sPLND due to biochemical recurrence and positron-emission tomography (PET)/computed tomography (CT)-detected nodal recurrence of pelvic lymph nodes. RESULTS: Sixty-nine patients underwent robotic sPLND after a median time of 47 months post- RP. Sixty-four patients (93%) had malignant lymph nodes upon histological assessment of sPLND specimen. Twenty patients (29%) achieved PSA < 0.2 ng/ml 6 weeks postoperatively. After median (IQR) follow-up of 15 months (10-27), fourteen patients (20%) still had PSA < 0.2 ng/ml without additional therapy and forty-one patients (59%) had started additional therapy. No significant predictor for treatment response was found. Postoperative complications occurred in 14 patients (20%). Eleven of these complications were classified as Clavien-Dindo grade 1. CONCLUSION: Oncological benefit of sPLND as the only salvage procedure seems to be limited, though almost one third of patients achieved treatment response. Clinical trials are needed to determine if sPLND as part of a multimodal treatment may improve outcome.

Digital Health Intervention to Increase Health Knowledge Related to Diseases of High Public Health Concern in Iringa, Tanzania: Protocol for a Mixed Methods Study.

BACKGROUND: Traditionally, health promotion and health education have been provided to communities in the global south in the form of leaflets or orally by health care workers. Digital health interventions (DHIs) such as digital health messages accessed by smartphones have the potential to reach more people at a lower cost and to contribute to strengthening of health care systems. The DHI in this study focuses on disseminating digital health education regarding 3 disease complexes of high public health concern: HIV/AIDS, tuberculosis, and Taenia solium (neuro)cysticercosis or taeniasis, a parasitic zoonotic disease that requires a One Health approach. The DHI presents the participants with animated health videos (animations) and provides access to information spots (InfoSpots) with a free-of-charge digital health platform containing messages about health to rural Tanzanian communities. OBJECTIVE: The objective of this study is to measure the effect of the DHI on health knowledge uptake and retention over time in the rural communities. METHODS: This is a mixed methods study including a nonrandomized controlled trial and qualitative interviews conducted in rural Tanzania. A health platform containing digital health messages for the communities was developed prior to the study. The health messages consist of text, pictures, quizzes, and animations of everyday stories, aimed at disease prevention and early treatment. The baseline and immediate postintervention assessments were completed in Iringa, Tanzania in May 2019. The participants were interviewed by enumerators and completed questionnaires regarding health knowledge. Participants in the intervention group were exposed to 3 different health animations once on a tablet device. The participants' health knowledge was assessed again immediately after the exposure. The first follow-up survey was undertaken in August 2019. The InfoSpots with the digital health platform were thereafter launched in the intervention villages in November 2019. Qualitative interviews were undertaken in February 2020. The second follow-up was completed in June 2020. RESULTS: A total of 600 participants have been enrolled in the trial. We will assess (1) the difference in knowledge scores between baseline and the immediate postintervention assessments in the intervention group and (2) the difference in knowledge scores between the intervention and control groups at baseline, 3 and 6 months post-DHI rollout. Since a randomized design did not prove feasible, potential confounders (eg, age, gender, education, and time of exposure) may be introduced, and results will be adjusted. Data analysis for the 35 qualitative interviews is currently ongoing, and perspectives and experiences related to use and nonuse of the InfoSpots are being explored. CONCLUSIONS: The data have been collected, and the analysis is ongoing in this digital health study, aimed at evaluating the effects of a DHI based on relevant health messages. The publications of results can be expected this year. TRIAL REGISTRATION: ClinicalTrials.gov NCT03808597; https://clinicaltrials.gov/ct2/show/NCT03808597. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/25128.

Three-month follow-up effects of a medication management program on nurses' knowledge.

This quasi-experimental study examined the effects of a medication management program on nurses knowledge of medication management, three months after program completion. Fifty-seven nurses took a multiple-choice test both immediately after the program and three months later. Changes in test performance were assessed using McNemar's test and generalized estimating equations for binary outcomes. Test results were generally consistent from immediately post-program to three months later, though four items differed significantly. From immediately post-program to three months later, fewer nurses correctly answered the items: documenting no medication administration (98.2 vs 86.6, p = 0.04); documenting opioid administration (56.1 vs 33.3, p = 0.01); and observation after opioid administration (35.1 vs 19.3, p = 0.08. Significantly more nurses correctly answered the item concerning the pharmacology of medication administered with food (64.9 vs 77.2, p = 0.09). We recommend both continuous medication management training and focusing on the correspondence between theory-based knowledge and clinical practice routines.

Heart rate during the first 24 hours in term-born infants.

OBJECTIVE: Heart rate (HR) is an important clinical parameter in newborn infants, but normal ranges are poorly defined. Our aim was to establish normal reference ranges and individual variations in HR as obtained by auscultation in healthy term-born infants during the first 24 hours of life. DESIGN: Observational study. SETTING: Single hospital in Norway. METHODS: HR was assessed by auscultation for 30 s at 2, 4, 8, 16 and 24 hours of age. Auscultation was validated against ECG recordings. SUBJECTS: Healthy term-born infants who were asleep or awake in a quiet resting state. MAIN OUTCOME MEASURES: Construction of percentile curves for resting HR. RESULTS: The study included 953 infants. The 50th percentile was 126 beats per minute (bpm) at age 2 hours and thereafter 120-122 bpm. The respective 2nd and 98th percentiles were 102 (thereafter 96-100) bpm and 162 (thereafter 150-156) bpm. The mean HR was 5.6 bpm higher when awake than asleep, 4.9 bpm higher when on the mother's chest than in the cot, 1.6 bpm higher in girls than in boys, and increased by 0.5 bpm per 0.1°C increase in rectal temperature. Mode of delivery, meconium staining, birth weight and maternal smoking during pregnancy were of no significance. For each infant, HR varied considerably during the first 24 hours (intraclass correlation 0.21 (95% CI 0.18 to 0.24), coefficient of variation 9.2%). CONCLUSIONS: The HR percentiles allow for a scientifically based use of HR when assessing newborn infants born at term.

Music therapy as an adjunct in cardiac device lead extraction procedures: A randomized controlled trial.

BACKGROUND: Evidence of music therapy as an effective supportive therapy in invasive cardiac procedures is increasing, but more research is needed. AIMS: To evaluate the impact of music therapy on stress responses during cardiac device lead extraction procedures performed in local anaesthesia. METHODS: Sixty-four patients undergoing cardiac implantable electronic device lead extraction at Oslo University Hospital Ulleval from March 2018 to September 2019 were randomized to music therapy (n = 32) or control (n = 32). Primary endpoints were patient satisfaction with pain management and average pain intensity during the procedure. Secondary endpoints were average anxiety intensity, need for analgesic/anxiolytic drugs, blood pressure, heart and respiration rate. RESULTS: All patients in the music therapy group completed the intervention. Patient satisfaction with pain management was 10.00 (8.00, 10.00) in the music therapy vs. 10.00 (9.00, 10.00) in the control group (p = 0.85), and average level of pain 0.89 (0.22, 1.13) vs. 0.96 (0.36, 1.58), respectively (p = 0.38). Average anxiety score was 1.00 (0.33, 2.17) in the music therapy vs 1.67 (0.71, 3.35) in the control group (p = 0.056). The use of analgesic/anxiolytic drugs and physiological parameters were similar across groups. CONCLUSIONS: In this study of music therapy during cardiac device lead extractions, no effect was found on patient satisfaction with pain management or average pain level. A decrease in patient anxiety of borderline significance was observed in the music therapy group. More studies with more sensitive measures of pain and anxiety are needed to determine the value of music therapy in invasive cardiac procedures.

Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial.

BACKGROUND: Chronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different noninvasive vagal nerve stimulation techniques for the treatment of FM. METHODS: The study will use a randomized, single-blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRB™) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N = 112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N = 56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N = 56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography-measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life. DISCUSSION: The described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited. TRIAL REGISTRATION: ClinicalTrials.gov NCT03180554 . Registered on August 06, 2017.

Effects of the Collaborative Assessment and Management of Suicidality (CAMS) Model: A Secondary Analysis of Moderation and Influencing Factors.

In a randomized controlled trial, we found that suicidal patients who received Collaborative Assessment and Management of Suicidality (CAMS) reported greater improvements in suicidal ideation and mental health distress compared to participants who received treatment as usual (TAU). Here, we explored moderators and mediators of the effectiveness of CAMS. Compared to TAU, CAMS was more effective in reducing suicidal ideation when the working alliance, in particular its bond subcomponent, was low. In terms of reducing mental health distress, CAMS was superior to TAU only for participants who did not use illicit drugs and, more tentatively, only for patients without borderline personality traits. We suggest that CAMS may repair a difficult vantage point in terms of poor working alliance in patients with suicide ideation. To obtain superior benefits of CAMS upon more general mental health distress in patients with drug abuse or borderline traits, these problems may need to be more explicitly targeted in parallel.

The Associations Between Pre- and Postnatal Maternal Symptoms of Distress and Preschooler's Symptoms of ADHD, Oppositional Defiant Disorder, Conduct Disorder, and Anxiety.

Objective: The objective of this article is to examine the associations between pre- and postnatal maternal distress and preschooler's symptoms of ADHD, Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), and anxiety, by timing and gender. Method: Children, aged 3.5 years (N = 1,195), recruited from the Norwegian Mother and Child Cohort Study, were assessed with a semistructured parental psychiatric interview. Perinatal maternal symptoms of distress were assessed by Symptom Checklist (SCL-5); Poisson regression was used to examine the associations. Results: Mid-gestational maternal distress significantly increased the average number of child symptoms, ranging between 3.8% for ADHD hyperactive-impulsive (ADHD-HI) and 8.7% for anxiety. The combination of high maternal scores of distress both pre- and postnatally were associated with increased risk of child symptoms of anxiety (relative risk [RR] = 2.10; 95% confidence interval [CI] = [1.43, 3.07]), CD (RR = 1.83; 95% CI = [1.33, 2.51]), and ODD (RR = 1.30; 95% CI = [1.03, 1.64]), with minor sex differences. Conclusion: Maternal distress during mid-gestation was associated with ADHD, behavioral, and emotional symptoms in preschool children. Continued exposure into the postnatal period may further increase these risk associations .

Improving Maternal and Neonatal Health by a Midwife-led Continuity Model of Care - An Observational Study in One Governmental Hospital in Palestine.

BACKGROUND: From 2013 a midwife-led continuity model of care was implemented in the Nablus region in occupied Palestine, involving a governmental hospital and ten rural villages. This study analysed the relation between the midwife-led model and maternal and neonatal health outcomes. METHOD: A register-based, retrospective cohort design was used, involving 2201 singleton births between January 2016 and June 2017 at Nablus governmental hospital. Data from rural women, with singleton pregnancies and mixed risk status, who either lived in villages that offered the midwife-led continuity model and had registered at the governmental clinic, or who lived in villages without the midwife-led model and received regular care, were compared. Primary outcome was unplanned caesarean section. Secondary outcomes were other modes of birth, postpartum anaemia, preterm birth, birth weight, and admission to neonatal intensive care unit. FINDINGS: Statistically significant less women receiving the midwife-led model had unplanned caesarean sections, 12·8% vs 15·9%, adjusted risk ratio (aRR) 0·80 (95% CI 0·64-0·99) and postpartum anaemia,19·8% vs 28·6%, aRR 0·72 (0·60-0·85). There was also a statistically significant lower rate of preterm births within the exposed group, 13·1% vs 16·8, aRR 0·79 (0·63-0·98), admission to neonatal intensive care unit, 7·0% vs 9·9%, aRR 0·71 (0·52-0·98) and newborn with birth weight 1500 g and less, 0·1% vs 1·1%, aRR 0·13 (0·02-0·97). INTERPRETATION: Receiving the midwife-led continuity model of care in Palestine was associated with several improved maternal and neonatal health outcomes. The findings support further implementation of the model. Implementation research, including randomised studies, would be useful to further investigate the effect and feasibility of the model in a low resource setting. FUNDING: This study was partly funded by the Research Council of Norway through the Global Health and Vaccination Program (GLOBVAC), project number 243706. The implementation received public funding through Norwegian Aid Committee (NORWAC).

Early experiences with PD-1 inhibitor treatment of platinum resistant epithelial ovarian cancer.

OBJECTIVE: In this study, we evaluated the toxicity and clinical efficacy of nivolumab, a programmed cell death protein 1 (PD-1) inhibitor, on patients with platinum resistant ovarian cancer. METHODS: Every second week, 18 patients with platinum resistance ovarian cancer received nivolumab until disease progression occurred. We assessed toxicity, disease control rate, progression free survival (PFS) and overall survival (OS). Radiological response evaluation according to irRECIST was performed every 12th week, while clinical evaluation was done every second week. RESULTS: The disease control rate was 44% (95% confidence interval [CI]=19-87) as 8 showed stable disease, 6 showed progressive disease and 4 died before the first radiological response evaluation. The median OS was 30 weeks (95% CI=14-42; range, 3-95), and PFS was 15 weeks (95% CI=13-17). The median follow-up time was 30 weeks (range, 3-123). The rate of grade 2-5 adverse events was 28% (5 out of 18). Two patients (11%) developed grade 2 and 3 adverse events, respectively, while no grade 4 events were observed. One patient died from intestinal perforation, believed to be caused by concomitant bevacizumab rather than nivolumab. CONCLUSION: This study shows few adverse events, and promising clinical efficacy when using nivolumab for ovarian cancer.

Managing suicidality within specialized care: A randomized controlled trial.

BACKGROUND: Suicide prevention is a core task in mental health services. Our objective was to determine whether Collaborative Assessment and Management of Suicidality (CAMS) reduced suicidal thoughts and behaviors and mental health distress more effectively than treatment as usual (TAU) in a heterogeneous patient population within specialized mental health care services. METHODS: In this observer-blinded pragmatic randomized controlled trial participants who scored 13 or above on Beck's Scale for Suicide Ideation-Current (BSSI-C) were included from seven in- and outpatient units. Primary outcome was suicidal ideation (BSSI-C). Secondary outcomes were mental health distress measured by the Outcome Questionnaire-45, and suicidal behaviors measured by the Suicide Attempt Self-Injury Count. Patients were assessed at baseline and after 6 and 12 months. RESULTS: The final intent-to-treat analyses included 78 participants (mean age 35.9 years, SD = 14.5, 41 females). The majority were depressed (65%), had a secondary diagnosis (73%) and 32% suffered from borderline personality disorder or borderline traits. After 6 months, CAMS participants reported lower levels of suicidal ideation compared to TAU (ß = -4.29, 95% CI = -8.32 to -0.27, p = .036). Larger changes in mental health distress were observed for CAMS participants after 6 months (ß = -11.87, 95% CI = -22.99 to -0.76, p = .036) and 12 months (ß = -13.70, 95% CI = -24.88 to -2.51, p = .017). LIMITATIONS: The modest sample size rendered the trial unable to detect small between-group differences. CONCLUSIONS: CAMS reduced suicidal ideation and mental health distress more efficiently than TAU in a heterogeneous patient population within specialized care.

Reliability and Construct Validity of the Adapted Norwegian Version of the Early-Onset Scoliosis 24-item Questionnaire.

BACKGROUND: The Early-Onset Scoliosis 24-item Questionnaire (EOSQ-24) reflects issues important for patients with early-onset scoliosis (EOS) and their parents. The aim of this study was to translate the original EOSQ-24 into Norwegian and to evaluate the resulting questionnaire's reliability and construct validity. METHODS: The EOSQ-24 was translated using a forward-backward translation method, followed by an expert review. One hundred parents of a heterogenic group of patients with EOS answered the EOSQ-24 and scored Numeric Rating Scales (NRSs) to evaluate the children's general health, pain, and physical function. Two weeks later, 55 parents (55%) answered the retest questionnaire. Data quality, internal consistency, and test-retest reliability were assessed, including the minimal detectable change. Construct validity was evaluated by predefined hypotheses and correlations with NRS scores. RESULTS: There were considerable ceiling (19.0% to 63.0%) and floor effects (zero to 26.0%). The internal consistency was excellent (Cronbach α = 0.95). The minimal detectable change for the EOSQ-24 total score was 15.2 and ranged from 21.6 to 33.0 for the subdomains scores. The EOSQ-24 showed discriminate capabilities among patients with different etiology, treatment status, and severity of deformity. High correlations were found between the EOSQ-24 total score and the NRS scores for general health (r = -0.66), pain (r = -0.63), and physical function (r = -0.78). CONCLUSION: The Norwegian version of the EOSQ-24 has acceptable reliability and validity for measuring quality of life and caregiver burden among EOS children. The EOSQ-24 total score is acceptable for evaluation of these patients over time. LEVEL OF EVIDENCE: Level III, diagnostic study.

Psychosocial and clinical outcomes of percutaneous versus surgical pulmonary valve implantation.

Objective: This prospective non-randomised study was performed to compare the psychosocial function and clinical outcomes following surgical and percutaneous implantation of a pulmonary valve at 3 months and 1 year after treatment. Methods: All patients were consecutively admitted for treatment by either method from June 2011 to October 2014. The data of 20 patients treated with the percutaneous technique and 14 patients treated with open heart surgery were compared. Psychosocial function was measured by the Achenbach System of Empirically Based Assessment (ASEBA). We used linear mixed-effect models to investigate group changes between the psychosocial function and clinical data of 34 patients with congenital pulmonary valve disease. Results: A significant difference in favour of the percutaneous pulmonary valve implantation group was observed regarding the ASEBA scores, specifically in the Thought problems subscale at 1 year (p=0.015), Attention problems subscale at 3 months (p=0.016) and 1 year (p=0.007) after treatment. After adjustment for the right ventricle to pulmonary artery pressure gradient at 3 months, a significant change in the Attention problems subscale (p=0.038) was noted in the percutaneous group. The New York Heart Association functional score significantly improved in both groups. The measured right ventricle to pulmonary artery pressure gradient was reduced significantly in both groups at 1 year. Conclusions: Both methods led to significant clinical improvement. Thought and attention problems such as intrusive behaviour significantly decreased only in patients who underwent the percutaneous procedure. Complications as reintervention, bleeding and arrhythmia were only observed in the open surgery group.

Can a midwife-led continuity model improve maternal services in a low-resource setting? A non-randomised cluster intervention study in Palestine.

OBJECTIVES: To improve maternal health services in rural areas, the Palestinian Ministry of Health launched a midwife-led continuity model in the West Bank in 2013. Midwives were deployed weekly from governmental hospitals to provide antenatal and postnatal care in rural clinics. We studied the intervention's impact on use and quality indicators of maternal services after 2 years' experience. DESIGN: A non-randomised intervention design was chosen. The study was based on registry data only available at cluster level, 2 years before (2011and2012) and 2 years after (2014and2015) the intervention. SETTING: All 53 primary healthcare clinics in Nablus and Jericho regions were stratified for inclusion. PRIMARY AND SECONDARY OUTCOMES: Primary outcome was number of antenatal visits. Important secondary outcomes were number of referrals to specialist care and number of postnatal home visits. Differences in changes within the two groups before and after the intervention were compared by using mixed effect models. RESULTS: 14 intervention clinics and 25 control clinics were included. Number of antenatal visits increased by 1.16 per woman in the intervention clinics, while declined by 0.39 in the control clinics, giving a statistically significant difference in change of 1.55 visits (95% CI 0.90 to 2.21). A statistically significant difference in number of referrals was observed between the groups, giving a ratio of rate ratios of 3.65 (2.78-4.78) as number of referrals increased by a rate ratio of 3.87 in the intervention group, while in the control the rate ratio was only 1.06.Home visits increased substantially in the intervention group but decreased in the control group, giving a ratio of RR 97.65 (45.20 - 210.96) CONCLUSION: The Palestinian midwife-led continuity model improved use and some quality indicators of maternal services. More research should be done to investigate if the model influenced individual health outcomes and satisfaction with care. TRIAL REGISTRATION NUMBER: NCT03145571; Results.