Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well).

BACKGROUND: Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined. METHODS: This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment). DISCUSSION: The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I. TRIAL REGISTRATION: Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

Hyponatremia after trans-sphenoidal surgery.

Fluid and electrolyte imbalances are the most frequent complications following pituitary surgery. Among the several patterns of occurrence, hyponatremia can occur in an isolated fashion or as part of a bi- or triphasic pattern. The frequency of hyponatremia after trans-sphenoidal surgery is between 2% and 25%, according to the literature. However, these numbers are probably underestimating the real prevalence, since mild hyponatremia does not lead to symptoms and measurement of sodium level. No association has been described between entity of the pituitary tumor or tumor size and hyponatremia. Therefore no predictors exist to determine patients with a higher risk for electrolyte imbalances after surgery. However, since delayed hyponatremia occurs mainly around the 8-10th day after surgery, routine measurement of sodium should be recommended on the day of hospital dismission. In case of a symptomatic hyponatremia, insufficiency of the corticotrophe pituitary function as the leading differential diagnosis needs to be ruled out. If the patient is euvoleme, pretest probability of syndrome of inadequate antidiuretic hormone production (SIADH) is very high and therapy may be started according to this. In case of SIADH, therapeutic options include fluid restriction or vaptane therapy. Only in severe cases infusion of hypertonic saline is appropriate. Usually SIADH following pituitary surgery is a self-limiting condition and will cease within 2-5 days.

[Renal diseases in rheumatology]. / Renale Erkrankungen in der Rheumatologie.

Renal involvement and renal function disorders are commonplace in patients with rheumatic diseases and are often decisive for the prognosis. Typical nephrological complications in rheumatology are renal manifestations or delayed sequelae of the underlying disease in addition to drug-induced renal failure, e.g. by nonsteroidal anti-inflammatory drugs (NSAIDs). The differentiation from other common causes of disturbed renal function (e.g. diabetes and hypertension) is important and often difficult in individual cases. Renal involvement can be clinically manifested in many different ways. The spectrum ranges from slight functional disorders with, for example discrete erythrocyturia/proteinuria and normal renal function up to rapidly progressive renal failure. The probability of renal damage also varies greatly between different underlying diseases. For example, renal involvement in rheumatoid arthritis is a rarity but in contrast relatively normal in systemic lupus erythematosus. In the course of the differential diagnostics urine sediment, protein values and sonography are still the most important factors and the indications for kidney biopsy should be generously applied. Early initiation of immunosuppression can substantially improve the renal prognosis of inflammatory systemic diseases.

[Renal emergencies in cases of collagenosis and vasculitis]. / Renale Notfälle bei Kollagenosen und Vaskulitiden.

Renal involvement or complications in systemic diseases occur frequently and crucially influence patient outcomes. In addition to functional renal failure caused by medications (especially nonsteroidal antirheumatic agents), typical nephrological complications in rheumatology include manifestations of the underlying condition which range from mild disorders of renal function to severe and partially irreversible disease progression. The primary physician thus plays a key role in ensuring rapid and specific diagnostic workup and initiating appropriate treatment measures. Sonography and examination of urine sediment still take priority in the differential diagnosis. The indication for kidney biopsy should be broadly defined. Early initiation of immunosuppression in systemic diseases can decisively improve renal prognosis. Despite the current availability of considerably improved pharmacological options, numerous questions about the ideal therapeutic regimen still remain open.