Vitamin D oral intermittent treatment (DO IT) study, a randomized clinical trial with individual loading regimen

Comparison of several regimens of oral vitamin D including an individually calculated loading regimen with the aim of achieving serum values > 75 nmol/l. Interventional, randomized, 3-arm study in vitamin D-deficient outpatients. Participants were allocated to supplementation of 24,000 IU vitamin D monthly over three months, using either a monthly drinking solution (Vi-De 3) or capsule (D3 VitaCaps), or an individualized loading regimen with the capsules taken weekly. For the loading regimen, the cumulative dose was calculated according to baseline 25-hydroxy-vitamin D (25(OH)D) serum value and body weight. Main inclusion criteria were age ≥ 18 years and 25(OH)D serum concentration < 50 nmol/l. The primary outcome was 25(OH)D serum concentration one week after treatment termination. Secondary endpoints were patient’s preferences and adverse events. Full datasets were obtained from 52 patients. Mean 25(OH)D values were statistically significant higher after a loading regimen compared to a monthly administration of 24,000 IU vitamin D (76.4 ± 15.8 vs 61.4 ± 10.8 nmol/l; p < 0.01). All patients treated with the loading regimen reached sufficient 25(OH)D values > 50 nmol/l. Serum 25(OH)D values > 75 nmol/l were observed more frequently in patients taking the loading regimen (47% vs 11% drinking solution vs 12% capsules). Vitamin D-related adverse effects did not occur in any treatment groups. Capsules were preferred by 88.5% of the patients. Compared to treatments with monthly intake of 24,000 IU vitamin D, the intake of an individually calculated weekly loading regimen was able to raise serum concentrations > 50 nmol/l in all cases within a safe range.

Treatment practices and implementation of guidelines for hyperbilirubinemia and rebound hyperbilirubinemia

BACKGROUND: Hyperbilirubinemia (HB), defined as elevated total serum bilirubin (TSB) levels, commonly affects neonates and requires prompt treatment to prevent neurological complications. Up to 10%of neonates experience rebound hyperbilirubinemia (RHB), requiring re-initiation of treatment. Unfortunately, treatment guidelines lack practical recommendations surrounding subthreshold phototherapy, treatment termination, and RHB investigations. We examined local management practices for HB and RHB treatment in a well newborn nursery. As a secondary aim, we investigated the association between treatment practices and RHB rates. METHODS: Retrospective chart review identified neonates treated for hyperbilirubinemia between January 2015 and December 2019 during their birth hospitalization at a tertiary care centre. Standardized data collection sheets were used to record treatment parameters. RESULTS: Over the 5-year period, there were 9683 births and 305 (3.15%) neonates received phototherapy. Of the treated cases, 20–25%were subthreshold to practice guideline values. Upon treatment termination 25–55%of cases had TSB levels within 3 mg/dL, which may increase the risk of RHB. In our cohort, 20.3%of treated cases experienced one episode of RHB and 3.9%experienced two episodes of RHB. Although clinicians evaluated neonates for RHB 0–12 hours following treatment termination prior to discharge, many cases were identified in outpatient settings and required re-admission for phototherapy. CONCLUSION: When managing HB and RHB, treatment practices such as when to terminate treatment in relation to threshold values, and timing of RHB investigations, are largely inconsistent amongst clinicians. Future studies are required to better understand the landscape of hyperbilirubinemia treatment beyond initiation of phototherapy.

Specific Bacterial Immunotherapy in Treating Chronic Osteomyelitis

The immunological experience is treating osteomyelitis chronic forms at the Istituto Putti in Cortina starts in 1963 by introducing immunotherapy, applied by the progressive administration in growing doses of a staphylococci pool, that had been collected from some patients with bone infections by the same germ and then inactivated in an aqueous solution suspension. This therapy is coadjutant of antibiotics, surgical and hyperbaric therapy and not substitutive of these. This study ascertained indeed a reduction of the phagocytic activity as a whole, and especially the opsonisation activity It has been thought therefore that in immunotherapy more factors are involved; their principal property is to reduce the allergising effect and therefore to desensitise vs. the germ proteins and to increase the phagocytic activity. This condition, neither whose entity nor its lasting may be defined, does not appear to be unlimited. Obviously this desensitisation can be obtained also by the right antibiotic choice that, as already said mainly in acute forms, may develop their bactericidal properties and sterilise the focus. In the chronic forms it is possible to provoke this mechanism by carrying out a surgical toilette that restores the vascularization and stimulation conditions needed for a correct antibiotic action. Checks upon immuno-stimulation treatment termination clearly showed corresponding results between laboratory deficit corrected and clinical conditions bettering. The casuistry is based on 50 patients with hematogenic osteomyelitis, all under the age of 16, age at which the growth plate is still active, and 117 post-traumatic septic non-union, where this term was adopted for cases that showed a lack of non-solidification at 6 months after trauma. We have expressly made a distinction between hematogenic and post-traumatic forms, since the relationships between bacterial counts vs. host response do differ.

Preliminary outcomes of the Motivation and Skills Support (MASS) mobile app: An Ecological Momentary Intervention for social functioning in schizophrenia (Preprint)

BACKGROUND People with schizophrenia and other serious mental illnesses often lack access to evidence-based interventions, particularly interventions that target meaningful recovery outcomes, such as social functioning and quality of life. Mobile technologies, including smartphone applications, have the potential to provide scalable supports that place elements of evidence-based interventions at the palm of patients’ hands. OBJECTIVE We developed a smartphone app to provide targeted social goal support (e.g., making new friends, improving existing relationships) for people with schizophrenia, called Motivation and Skills Support (MASS), in a standalone open trial. METHODS In this study we present preliminary outcomes in 31 participants who used the MASS app for a period of eight weeks, including social functioning pre- to post-intervention, and momentary reports of treatment targets (social motivation, appraisals) during the intervention. RESULTS Findings suggest the intervention improved self-reported social functioning from baseline to treatment termination, particularly in women participants. Gains were not maintained at three-month follow-up. Furthermore, increased social functioning was predicted by momentary reports of social appraisals, including perceived social competence and the extent to which social interactions were worth the effort. CONCLUSIONS We discuss implications of these findings and future directions for addressing social functioning in schizophrenia using mobile technology. CLINICALTRIAL NCT03404219

High-Resolution CT Findings as Predictive Factors for Recurrent Nontuberculous Mycobacterial Pulmonary Disease after Successful Treatment

Despite long-term treatment for nontuberculous mycobacterial pulmonary disease (NTM-PD), recurrence is common. We aim to identify computed tomography (CT) findings that predict recurrence after successful treatment of NTM-PD. This retrospective study included 44 patients (12 men, 60 ± 11.2 years) successfully treated for NTM-PD between March 2009 and September 2016. Recurrence developed in 18 patients (40.9%) during follow-up (median, 852 days). CT scores for bronchiectasis, bronchiolitis, consolidation, cavities, and nodules at the initiation and termination of treatment were evaluated, then determined association with recurrence. We also assessed the diagnostic performance and reproducibility of CT scores. Patients with recurrent NTM-PD showed higher CT scores for bronchiectasis (p = 0.008), nodules (p = 0.006), consolidation (p = 0.033), and total CT scores (p = 0.017) at the time of treatment termination. On the contrary, only nodule score differed among the initial CT scores (p = 0.014). Regression analysis showed that the scores for bronchiectasis (odds ratio (OR) = 1.638, 95% confidence interval (CI) = 1.049–2.558, p = 0.030) and nodules (OR = 5.246, 95% CI = 1.370–20.087, p = 0.016) at treatment termination were significant predictors. The AUC of the regression model was 0.814 (95% CI = 0.689–0.939, p = 0.005). The interreader agreement for the total CT score was excellent (intraclass correlation coefficient = 0.841, p < 0.001). CT scores at the time of treatment termination can predict disease recurrence with good reproducibility.

Completion and adverse drug events of latent tuberculosis infection treatment in patients receiving dialysis: predictors and impacts of different regimens in a prospective cohort study

Objectives: Although patients with end-stage renal disease receiving maintenance hemodialysis are at high risk for tuberculosis, the optimal treatment regimen for latent tuberculosis infection (LTBI) in this group has scarcely been studied for predictors of completion rate and adverse drug events (ADE). Methods: We prospectively enrolled dialysis patients for LTBI intervention from three medical centers in Taiwan. LTBI treatments were three-month weekly rifapentine plus isoniazid (3HP) and nine-month daily isoniazid (9H). Completion rate, ADE, and reasons for treatment termination were recorded. Factors associated with treatment termination and ADE were analyzed using multivariate logistic regression. Results: In all, 91 treatment courses (41 9H and 50 3HP) were surveyed. The completion rates were 61% for 9H and 82% for 3HP (p=0.046). Use of 9H and development of ≥grade 2 ADEs were associated with treatment termination. Hypersensitivity occurred in 29.2% of subjects in the 3HP group and 10.8% in the 9H group (p=0.035) and independently correlated with 3HP regimen, diabetes mellitus (DM) and peritoneal dialysis (PD). Similarly, the independent predictors of ≥grade 2 ADEs were use of 3HP regimen, presence of DM, and use of PD, whereas ≥grade 3 ADEs were associated with eosinophil >700/mm3 after 2 weeks of LTBI treatment even after adjustment for age and gender. Conclusions: For patients on dialysis, 3HP showed a higher rate of completion but also a higher rate of ≥grade 2 ADE than 9H. In addition, DM and PD were risk for ≥grade 2 ADE. Eosinophilia after 2-week treatment might be an alert for severe ADE.

Anakinra treatment in patients with familial Mediterranean fever: a single-centre experience

Objectives Anakinra is proven to be effective in controlled trials in terms of attack frequency and subclinical inflammation in colchicine-resistant patients. The objective of this study was to review the patients followed in our single centre with FMF who received anakinra because of insufficient colchicine response. Methods The study was conducted at a tertiary rheumatology centre experienced in autoinflammatory diseases. The patients were treated for at least 1 month with anakinra. Patients with amyloidosis and pregnancy were not included. Attack frequency, patient global assessment scales of disease severity and acute phase reactants were recorded before and throughout anakinra treatment. Criteria of treatment termination were side effects, disease remission, inadequate response, pregnancy plan and non-compliance. Results One hundred and six patients diagnosed with FMF were treated with anakinra; 45.92% of the patients had a homozygous M694V mutation; 83 of the 98 patients tested for MEFV carried at least one copy of M694V. Attack frequency decreased while on anakinra treatment; in fact, no attacks were observed in 75 patients. Visual analogue scale score decreased from 7.49 (2.03) to 3.08 (2.82) (P = 0.001). Currently, 71 patients are still on anakinra treatment. Treatment of 34 patients was discontinued (32%). Insufficient response and side effects were the most common reasons for treatment discontinuation. All of the side effects observed were reversible and the patients alleviated after treatment cessation. In four patients, leukopenia was observed. Conclusion In patients who were refractory to colchicine, anti-IL-1 agent anakinra was shown to be effective and safe. The effectiveness of anakinra stems from preventing attacks and increasing the quality of life.

Therapeutic Relationship and Dropout in High-Risk Adolescents’ Intensive Group Psychotherapeutic Programme

ObjectiveDropout rates are a prominent problem in youth psychotherapy. An important determinant of dropouts is the quality of the therapeutic relationship. This study aimed to evaluate the association between the therapeutic relationship and dropouts in an intensive mentalization-based treatment (MBT) for adolescents with personality disorders.MethodsPatients (N = 105) included were either dropouts (N = 36) or completers (N = 69) of an intensive MBT. The therapeutic relationship was measured with the child version of the Session Rating Scale (C-SRS), which was completed by the patient after each group therapy session. For each patient, the treatment termination status (dropout or completer) was indicated by the treatment staff. The reliable change index (RCI) was calculated for the C-SRS to determine significant changes in the therapeutic relationship.ResultsWhile both groups started with similar scores on the C-SRS, the scores between dropouts and completers differed significantly at the end of the treatment period. On average, during therapy, an increase was seen in the scores of completers, and a decrease was seen in the scores of dropouts. While dropouts could not be predicted based on the C-SRS scores, a significant decrease (RCI) in C-SRS scores during the last two sessions occurred more often for dropouts than for completers.ConclusionOur findings show that to prevent dropouts, the patient’s judgment of the quality of the therapeutic relationship should be monitored continuously, and decreases discussed with the patient and the group.