Treatment for preschool age children who stutter: Protocol of a randomised, non-inferiority parallel group pragmatic trial with Mini-KIDS, social cognitive behaviour treatment and the Lidcombe Program-TreatPaCS.

Stuttering is a speech disorder in which the flow of speech is disrupted by involuntary repetitions of sounds, syllables, words or phrases, stretched sounds or silent pauses in which the person is unable to produce sounds and sound transitions. Treatment success is the highest if stuttering is treated before the age of 6 years, before it develops into "persistent" stuttering. Stuttering treatment programs that focus directly on the speech of the child, like the Lidcombe Program, have shown to be effective in this age group. Mini-KIDS is also a treatment that focuses directly on the speech of the child. It is possible that capturing the increased brain plasticity at this age in combination with creating optimal conditions for recovery underlie these treatments' success rate. A treatment focusing on the cognitions, emotions and behaviour of the child, the social cognitive behaviour treatment (SCBT), is also frequently delivered in Belgium. In this study we want to compare, and collect data on the effectiveness, of these three treatment programs: Mini-KIDS, SCBT and the Lidcombe Program (protocol registered under number NCT05185726). 249 children will be allocated to one of three treatment groups. Stuttering specialists will treat the child (and guide the parents) with Mini-KIDS, the SCBT or the Lidcombe Program. They will be trained to deliver the programs meticulously. At 18 months after randomisation, the speech fluency of the child and the attitude of the child and parent(s) towards speech will be measured. It is expected that the three programs will achieve the same (near) zero levels of stuttering in nearly all children and a positive attitude towards speech at 18 months after the start of treatment. The amount of treatment hours to reach the (near) zero levels of stuttering will be compared between the different programmes. For families as well as for the health system this could generate important information.

Belgian Endothelial Surgical Transplant of the Cornea (BEST cornea) protocol: clinical and patient-reported outcomes of Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) - a multicentric, randomised, parallel group pragmatic trial in corneal endothelial decompensation.

OBJECTIVES: Corneal blindness is the third most frequent cause of blindness globally. Damage to the corneal endothelium is a leading indication for corneal transplantation, which is typically performed by lamellar endothelial keratoplasty. There are two conventional surgical techniques: Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK). The purpose of this study is to compare both techniques. METHODS AND ANALYSIS: The trial compares UT-DSAEK and DMEK in terms of clinical and patient reported outcomes using a pragmatic, parallel, multicentric, randomised controlled trial with 1:1 allocation with a sample size of 220 participants across 11 surgical centres. The primary outcome is the change in best-corrected visual acuity at 12 months. Secondary outcomes include corrected and uncorrected vision, refraction, proportion of high vision, quality of life (EQ-5D-5L and VFQ25), endothelial cell counts and corneal thickness at 3, 6 and 12 months follow-up appointments. Adverse events will also be compared 12 months postoperatively. ETHICS AND DISSEMINATION: The protocol was reviewed by ethical committees of 11 participating centres with the sponsor centre issuing the final definitive approval. The results will be disseminated at clinical conferences, by patient partner groups and open access in peer-reviewed journals. GOVERNANCE OF THE TRIAL: Both, trial management group and trial steering committee, are installed with representatives of all stakeholders involved including surgeons, corneal bankers, patients and external experts. TRIAL REGISTRATION NUMBER: NCT05436665.

Randomised, controlled, open-label pragmatic trial evaluating changes in functional exercise capacity after primary care PUlmonary REhabilitation in patients with long COVID: protocol of the PuRe-COVID trial in Belgium.

INTRODUCTION: Long COVID is a prevalent condition with many multisystemic symptoms, such as fatigue, dyspnoea, muscle weakness, anxiety, depression and sleep difficulties, impacting daily life and (social and physical) functioning. Pulmonary rehabilitation (PR) may improve physical status and symptoms of patients with long COVID, yet the evidence is limited. Therefore, this trial aims to study the effect of primary care PR on exercise capacity, symptoms, physical activity and sleep in patients with long COVID. METHODS AND ANALYSIS: PuRe-COVID is a prospective, pragmatic, open-label, randomised controlled trial. A sample of 134 adult patients with long COVID will be randomised to a 12 week PR programme in primary care, supervised by a physiotherapist or to a control group, following no PR. A 3 month and 6 month follow-up period is foreseen. The primary endpoint will be the change in exercise capacity measured by 6-minute walk distance (6MWD) at 12 weeks, hypothesising a more significant improvement in the PR group. Other parameters, such as pulmonary function tests (including maximal inspiratory pressure/maximal expiratory pressure), patient-reported outcomes (COPD Assessment Test, modified Medical Research Council Dyspnoea Scale, Checklist Individual Strength, post-COVID-19 Functional Status, Nijmegen questionnaire, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment Questionnaire and EuroQol-5D-5L), physical activity measured by an activity tracker, hand grip strength and sleep efficiency, are secondary and exploratory outcomes.The recruitment started on 19 April 2022, and 52 patients were included as of 14 December 2022. ETHICS AND DISSEMINATION: Ethical approval was obtained in Belgium from the relevant institutional review boards on 21 February 2022 (Antwerp University Hospital, approval number 2022-3067) and on 1 April 2022 (Ziekenhuis Oost-Limburg in Genk, approval number Z-2022-01). Findings from this randomised controlled trial will be disseminated in peer-reviewed publications and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: NCT05244044.