Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m². Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

To assess the effects of behaviourally informed short message service (SMS) reminders on demand for human papillomavirus (HPV) immunisation.

Individually randomised, five-group, controlled parallel trial.

A country-wide trial in Georgia.

55 176 girls aged 10–12, the entire population of unvaccinated girls of this age in the country, for whom there existed caregiver contact details.

Girls were randomised into five arms (four with n=11 035, with one n=11 036). Caregivers of the girls in four of the arms (treatment groups) were sent different versions of an SMS reminder (SMSR), reminding them that the girl was due to receive the HPV vaccine. The control group was sent no SMSR.

The primary outcome was a girl’s HPV vaccination status at the end of the trial.

Girls and their caregivers were blinded to group assignment.

The number of participants analysed in the four treatment groups was 10,784, 10,802, 10,794 and 10,820, with 10 828 analysed in the control group.

Each of the SMSRs was more effective than the control (no reminder) in encouraging HPV vaccination. Girls whose caregiver(s) were sent version 3 had 65% greater odds of receiving the vaccine relative to the control group (OR=1.65; 95% CI 1.38 to 1.97). Among girls whose caregivers received version 1, version 2 and version 4 of the SMS, the odds of receiving the HPV vaccine were respectively 42% (OR=1.42; 95% CI 1.18 to 1.70), 34% (OR=1.34; 95% CI 1.12 to 1.61) and 35% (OR=1.35; 95% CI 1.13 to 1.62) higher compared with the girls in the control arm.

We find a positive and statistically significant effect for each version of the SMSR, relative to the control condition.

NCT05536674.

Metacognitive strategy training is a crucial approach for addressing metacognitive deficits and enhancing metacognitive abilities, which can help mitigate age-related cognitive decline and optimise cognitive functioning. The present scoping review aims to systematically examine and synthesise the existing evidence on metacognitive strategy training programmes designed for both neurotypical adults and individuals with cognitive-communication disorders (CCDs).

A scoping review following the JBI methodology.

A literature search was conducted systematically across PubMed, Embase and Web of Science between June and August 2024.

Studies involving metacognitive strategy training for neurotypical adults or individuals with CCDs, measuring cognition, communication or metacognitive skills.

Two reviewers independently screened studies in a two-step process, that is, title and abstract screening followed by full-text screening. Data extraction included study characteristics, participant demographics, intervention details and outcome measures.

A total of 32 studies met the selection criteria, revealing diverse metacognitive training approaches that varied in component and dosage. The most frequently used approaches are the Cognitive Orientation to Occupational Performance approach and the Multicontext approach. The reported outcome measures included cognitive outcomes, metacognitive outcomes, well-being measures and feasibility measures. The majority of interventions targeted occupational goals, followed by cognitive skills, with fewer studies addressing cognitive-communicative skills. Studies have focused primarily on individuals with CCDs, with only a few targeting neurotypical adults.

Studies examining the efficacy of metacognitive strategy training are heterogeneous in terms of population, intervention approaches, and outcome measures. There is significant potential to expand the focus of these interventions to include neurotypical adults, aiming to counteract age-related cognitive-communicative disorders. The limited research within the field of speech-language pathology presents a valuable opportunity for speech-language pathologists to broaden the application of metacognitive strategy training, particularly in enhancing cognitive-communicative abilities.

Transitions of care (TOC) between hospital, ambulatory and home settings for high-risk adults with chronic diseases are complex, costly and often result in poor health outcomes. Suboptimal care transitions lead to medication errors, non-adherence, decreased self-management skills and inadequate follow-up, all of which contribute to readmissions or emergency department visits. The Transitional Care Model aims to address these challenges through patient-centred, in-home interventions. We propose to implement and evaluate TELE-TOC: Telehealth Education Leveraging Electronic Transitions Of Care for Chronic Obstructive Pulmonary Disease (COPD) patients. This study will evaluate the added value of a virtual, pharmacy-based intervention integrated into an existing COPD TOC program within a single healthcare system.

Informed by the Proctor Framework implementation, service and health outcome domains, we will conduct a randomised controlled trial comparing the addition of at-home pharmacy team-based virtual visits to the standard of care (ie, our existing COPD TOC programme). Adult patients hospitalised for a COPD exacerbation will be randomised to receive the standard COPD TOC programme alone or the standard programme plus TELE-TOC virtual at-home pharmacy visits. We will use a pragmatic type II hybrid effectiveness-implementation trial. The primary effectiveness outcome is inhaler technique at 30 days postdischarge, and the primary implementation outcome is the proportion of patients receiving the intervention. Intention-to-treat analysis will be applied to all outcomes with ² and logistic regression models adjusting for demographic factors. Treatment effects through 30 days will be assessed with generalised estimating equations and generalised linear mixed models.

This study, the waiver of consent and the opt-out flyer were approved by the University of Chicago Institutional Review Board (23–0934). Dissemination of the findings is planned for up to 4 years of completion of the study to local, regional and national conferences and peer-reviewed journals.

NCT05897125.

Distal radius fractures (DRFs) are common injuries, especially in older adults due to age-related frailty. Most DRFs in patients aged 60 and older are treated non-operatively since surgery offers no clinically important benefits. Although anatomical alignment has traditionally been the goal of the treatment, evidence suggests that in older populations, radiographic outcomes do not reliably correlate with functional outcomes. Current evidence, including one randomised trial, shows no functional benefit of closed reduction compared with casting alone, calling into question the routine use of the procedure in older patients. The primary objective is to evaluate whether no reduction is equivalent to closed reduction in patients aged 65 years or older with a displaced DRF, based on wrist-related pain and disability measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months.

This is a multi-centre, randomised controlled, equivalence trial conducted in hospitals in Finland, Denmark, Sweden and Estonia. We aim to enrol 532 patients aged ≥65 years with a displaced DRF (AO/OTA 23A/23C). Participants will be randomised (1:1) to receive either a dorsal cast without reduction (experimental intervention) or closed reduction followed by casting (control comparator). The primary endpoint is the difference between groups assessed using the PRWE outcome score at 12 months. The equivalence margin will be set at 6 PRWE points. Key secondary endpoints will include the Numeric Rating Scale for pain, patient satisfaction, quality of life (EQ-5D-5L Index) and serious adverse events at 3 months and 12 months and cosmesis at 3 months. Our main analyses will follow an intention-to-treat principle, analysed using repeated measures mixed model.

Ethical approval has been granted by the Ethics Committee of Tampere University Hospital (R25001). Results of the trial will be disseminated through peer-reviewed journals.

6 July 2025, v1.0.

NCT07042139.

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.

This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.

Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.

Older crime victims may be particularly vulnerable to psychological distress.

To compare the clinical effectiveness of a Victim Improvement Package (VIP) to treatment as usual (TAU) for reducing continued crime-associated distress.

A three-step parallel-group single-blind randomised controlled trial.

Police-reported victims of community crime aged 65 and over were recruited from 12 local authority areas in a major urban city in England, UK.

Selection criteria—inclusion: victims of community crime aged 65 years or more, with significant Generalised Anxiety Disorder (GAD-2) and Patient Health Questionnaire (PHQ-2) distress associated with the crime. Exclusion: type of crime, diagnosis, receipt of cognitive–behavioural therapy (CBT) in the last 6 months; an inability to participate in CBT; cognitive impairment. Participants were typical of our local authority population; 71% were female, 69% white, with the majority of crimes associated with burglary (35%) and theft (26%). 67% (88/131) of the randomised participants were included in the primary analysis.

TAU was compared with TAU plus up to 10 sessions of a cognitively-behaviourally informed VIP, delivered by a mental health charity over 12 weeks.

Timings are in relation to the crime; baseline (3 months), post-VIP intervention (6 months) and follow-up (9 months). The primary outcome was a composite of the Beck Anxiety and Beck Depression Inventories. The primary endpoint was 6 months.

24% (4255/17 611) of reported crime victims were screened, 35% (1505/4255) were distressed. Of 60% (877/1505) rescreened at 3 months, 49% (427/877) remained distressed. Out of our target of 226, 131 participants were randomised; 65 to VIP and 66 to TAU alone. 68% (89/131) completed the primary outcome (post-intervention). The VIP showed no overall benefit; mean VIP –0.41 (SD 0.89) vs mean TAU –0.19 (SD 1.11); standardised mean difference –0.039; 95% CI (–0.39, 0.31), although stratified analyses suggested an effect in burglary victims (n=27, standardised mean difference –0.61; 95% CI (–1.22, –0.002), p=0.049).

Community crime had long-lasting impacts. The police are ideally placed to screen for distress, present in 35% of victims, but only 58% of participants were recruited and the cognitive–behavioural therapy was not delivered competently. Further research on victim care and improving the delivery and quality of therapy is required.

All procedures were approved by the University College London (UCL) Research Ethics Committee on 17 March 2016 (6960/001). International Standard Randomised Controlled Trial Number is ISRCTN16929670: https://doi.org/10.1186/ISRCTN16929670.