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.

[A model for estimation of productivity and costs at a deparment of histopathology]. / Model til beregning af produktion og omkostninger på patologisk anatomisk afdeling.

Two cost calculation models were used. The "top down" model calculated an average cost of all investigations; this proved suitable for the calculation of the costs of autopsies and electron microscopical specimens. The "bottom up" model calculated the cost of an individual investigation, depending on the resources used in handling each particular specimen; it was necessary to adopt this model for specimens sent for microscopy. Information about the type of specimen and technical details were registered in a computer system. Production was registered in points and the costs were distributed between the clinical departments. The study showed that the cost of the histological specimens varied considerably depending on the material received from the clinical departments. A model using points for technical details in a department of cyto- and histopathology is suitable for calculating production and cost.

[EDP registration of the types of tests, working procedures and diagnosis in a department of histopathology. Minimum dataset for assessment of the workload]. / Edb-registering af prøvetyper, arbejdsprocedurer og diagnoser på patologisk anatomisk afdeling.Minimumdatasoet for opgørelse af ressourceforbrug.

The aim of the study was to develop a computer-based system for measuring workload in a department of histo- and cytopathology using routine registration of a minimum dataset. A group with representatives from the laboratory technicians, the pathologists and the secretaries defined 18 types of specimens. By studying each step of specimen processing it was shown, that 14 items for technical details could cover all the work done in the department. This information was collected in a computer-based system connected to the hospital network. The measurement of workload is essential for the efficient management of laboratory services. The registration of specimen types and a minimum dataset for specimen processing describes the work done in a department of histo- and cytopathology.

The effect of antacid on gastric and duodenal bulb acidity.

A small glass pH electrode was positioned in the duodenal bulb and connected to a digital pH meter. The pH registered every half second was stored on a minidiskette with a capacity of 32.400 pH data on a single mini-disc. A microcomputer controlled electrode calibration, data collection, formating and storage. Four patients with duodenal ulcer were given a liquid test meal, and one hour later when gastric and duodenal acidity had reached high levels they were given 10 ml of antacid. From the stored pH data the mean pH and the mean hydrogen ion concentration was calculated. During the 10 min. period before antacid was given gastric pH was on average 1.5 and the duodenal pH on average 4 with a CH+ of 2.500 mumol/. Ingestion of antacid reduced gastric acidity to around pH 3, and the duodenal pH to 6 with a CH+ of 250 mumol/l. This effect of antacid was observed in all subjects, but the degree and the duration of the effect varied very much between the individuals.

Duodenal bulb pH in normal subjects.

Four pH electrodes strapped together at 1 X 5 cm intervals were positioned in the pyloric region. Electrodes situated in the stomach record steady acid pH while electrodes distal to the pylorus show fluctuating pH, thereby enabling the electrodes to be localized from the pH pattern. Digital pH values were sampled and stored at a rate of 2/s from each electrode. For each 10-min period, the mean hydrogen ion activity, the percentage of time that the pH was at less than 3.0 and number of pH spikes were computed. Fourteen healthy subjects were studied in the fasting state and for 3 h after 300 ml chocolate milk. Log mean hydrogen ion activity in the proximal part of the duodenal bulb was (median and interquartile range): fasting pH 2.40 (2.23-3.00); 0-60 min after meal: pH 5.7 (4.92-5.95); 60-120 min: pH 2.31 (1.95-3.20) 120-180 min: pH 2.20 (1.99-2.44). Repeated studies in twelve subjects showed a linear correlation between 1st and 2nd study, r = 0.87. A significant linear correlation was found between peak acid output to pentagastrin and postprandial bulb acidity.

Transfer of large data sets from biomedical research: proposal for a universal data header (UNIDAT 1.0).

A universal data header for computerized data transfer between different research centers has been developed and successfully tested. The structure of this data header allows for data interchange irrespective of the internal data representation of the processor used. The first 128 byte are used for description of data structure followed by dynamically allocated space for string variables, event data, and measured data. Test programs written in Turbopascal and C are available on floppy disk (formatted for MS-DOS or OS/9) from the authors upon request.