The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

NCT06042621.

Infection prevention and control (IPC) interventions are multifactorial and are used to prevent healthcare-associated infections in healthcare facilities. However, patient views and enabling patient and public involvement (PPI) in their development has been minimal.

This systematic review aims to identify peer-reviewed publications reporting patient satisfaction outcomes in the context of IPC interventions, to document the methods used to assess patient satisfaction and to conduct a meta-analysis on reported satisfaction outcomes.

Systematic review and meta-analysis following the Joanna Briggs Institute (JBI) methodology and the PRISMA statement, with oversight from a steering group including PPI partners. Studies in peer-reviewed journals were included based on eligibility criteria.

MEDLINE, Scopus, Web of Science, EMBASE, Cochrane Library, CINAHL and PsycINFO were searched in June 2024.

Included studies investigated satisfaction among hospitalised patients in acute care settings following IPC measures, including isolation, cohorting, screening, hand hygiene, antimicrobial stewardship, patient flagging, education, personal protective equipment use, visiting restrictions and treatment delays

Titles and abstracts were screened independently by two reviewers; disagreements were resolved by a third. Study quality was assessed using the JBI manual for evidence synthesis. A meta-analysis was conducted where four or more studies used comparable designs and methods within the same areas of IPC, with heterogeneity evaluated using Cochran’s Q statistic and I² and pooled estimates calculated with 95% CIs using the Wilson (score) method.

Twenty-nine studies were identified. Among IPC measures, isolation precautions were the most commonly reported intervention (11 studies, 38%). The Likert scale was the predominant assessment method (13 studies, 45%). Patient satisfaction with IPC interventions ranged from 58.3% to 97.2%. Meta-analysis of four studies using the Hospital Consumer Assessment of Healthcare Providers and Systems survey showed substantial heterogeneity (I², 55%, p=0.08) and a pooled patient satisfaction level of 69% (95% CI 63.6% to 74.4%) for isolation precautions.

Sixty-nine percent of isolated patients reported satisfaction with their care. Patient satisfaction with IPC interventions varies widely, highlighting limitations in current measurement approaches. Strengthening PPI in the design and evaluation of satisfaction measures is essential to capture meaningful data and improvements in IPC programmes.

IS 2024 CRD42024558385.

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 examine the effects of 12 weeks group-based peer-led aquatic high-intensity interval training (AHIIT) compared with aquatic moderate continuous training (AMICT) on patient-reported outcome measures (PROMs) and quality-adjusted life-years (QALYs).

A single-blind, parallel-group, randomised trial with a 1:1 allocation ratio.

Community-based setting.

89 participants (mean age 62 (SD 13) years) with rheumatic and musculoskeletal diseases, including hip and knee osteoarthritis, fibromyalgia, rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, were randomly allocated to an AHIIT (n=44) or an AMICT (n=45) group.

The intervention consisted of AHIIT (four intervals of 4 min at high intensity, Borg scale 14–18) or AMICT (Borg scale 12–13), conducted twice weekly for 12 weeks.

Outcomes included disease activity (measured by the Patient Global Assessment), fatigue, pain and health-related quality of life (HRQoL), measured by the EQ-5D utility index (five-dimensional health status measure) and EQ VAS (self-rated overall health scale) for overall health, physical and social activities. All outcomes were assessed at baseline, 3 months and 6 months. To compare the overall benefit of these interventions, QALYs were estimated based on HRQoL. Linear mixed models for repeated measures were used to estimate the mean difference (95% CI) in outcomes.

No statistically significant differences between the groups were found in any outcomes at either three or 6 months (p>0.05).

No difference between the groups was found on PROMs and QALYs. Future research should include larger sample sizes and a non-exercising control group to better determine the efficacy of AHIIT and clarify the role of exercise intensity in symptom management.

NCT05209802.

To explore perceptions regarding the approved and actual prescribed doses of protein kinase inhibitors (PKIs) in clinical practice in the European Union among medicine regulators and healthcare professionals (HCPs).

A qualitative descriptive study was conducted using semistructured interviews, continuing until thematic saturation was reached. Thematic analysis was undertaken using a combined deductive-inductive approach. Deductive main analytical themes were derived from the theoretical framework of questioning-based policy design, namely problem sensing, problem categorisation and problem decomposition. Subthemes were generated inductively and could coherently be situated within these main analytical themes.

Interviews were held online or in person at a location convenient for the interviewee, depending on the participant’s preference.

Seven medicine regulators involved in the regulation of cancer medicines—including PKIs—and 10 HCPs prescribing PKIs in clinical practice, from various countries within Europe, were included.

Regulators highlighted insufficient attention to optimal dose finding, yielding approved doses often based on outdated maximum tolerated dose concepts, leading to uncertainties in efficacy and safety. HCPs reported using alternative dosing strategies in clinical practice to improve tolerability and quality of life (QoL) but noted a lack of robust evidence to guide such adjustments and faced legal constraints to deviate from the approved dose. Participants emphasised the need for improved pre-approval and post-approval dose optimisation to improve safety, enhance QoL and bridge gaps between trial data and real-world patient diversity.

Collaborative efforts involving multistakeholders including HCPs, regulators, pharmaceutical companies, insurers, governments and patient representatives are essential to advance dose optimisation and improve patient-centric outcomes, with further research needed to understand these stakeholders’ perspectives.

The aim of this study was to prioritise a set of indicators to measure World Health Organization (WHO) quality-of-care standards for small and/or sick newborns (SSNB) in health facilities. The hypothesis is that monitoring prioritised indicators can support accountability mechanisms, assess and drive progress, and compare performance in quality-of-care (QoC) at subnational levels.

Prospective, iterative, deductive, stepwise process to prioritise a list of QoC indicators organised around the WHO Standards for improving the QoC for small and sick newborns in health facilities. A technical working group (TWG) used an iterative four-step deductive process: (1) articulation of conceptual framework and method for indicator development; (2) comprehensive review of existing global SSNB-relevant indicators; (3) development of indicator selection criteria; and (4) selection of indicators through consultations with a wide range of stakeholders at country, regional and global levels.

The indicators are prioritised for inpatient newborn care (typically called level 2 and 3 care) in high mortality/morbidity settings, where most preventable poor neonatal outcomes occur.

The TWG included 24 technical experts and leaders in SSNB QoC programming selected by WHO. Global perspectives were synthesised from an online survey of 172 respondents who represented different countries and levels of the health system, and a wide range of perspectives, including ministries of health, research institutions, technical and implementing partners, health workers and independent experts.

The 30 prioritised SSNB QoC indicators include 27 with metadata and 3 requiring further development; together, they cover all eight standard domains of the WHO quality framework. Among the established indicators, 10 were adopted from existing indicators and 17 adapted. The list contains a balance of indicators measuring inputs (n=6), processes (n=12) and outcome/impact (n=9).

The prioritised SSNB QoC indicators can be used at health facility, subnational and national levels, depending on the maturity of a country’s health information system. Their use in implementation, research and evaluation across diverse contexts has the potential to help drive action to improve quality of SSNB care. WHO and others could use this list for further prioritisation of a core set.

Equitable access to healthcare technology is a major public health issue. For adults with type 2 diabetes (T2D), continuous glucose monitoring (CGM) technology can improve diabetes self-management and clinical outcomes. Even though CGM is now recommended by professional guidelines for all patients with diabetes on insulin therapy, evidence suggests that CGM is underutilised and inequitably prescribed across health systems. As CGM is an emergent technology, it is vital to understand what approaches have been studied to overcome inequities in CGM access for adults with T2D, what aspects of equitable access have yet to be addressed and what are facilitators and barriers to CGM access at the individual, facility and health system levels.

We will use the Joanna Briggs Institute’s revised scoping review framework to conduct our analysis. The protocol is registered with Open Science Framework (https://osf.io/z2exn). We will search for peer-reviewed literature containing empirical evidence for the facilitators and barriers to equitable access to CGM technology for patients with T2D. Findings will be organised according to research objectives and the Framework for Digital Health Equity, and summarised using narrative synthesis of descriptive statistics for quantitative findings, and themes for qualitative findings. This review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews.

The findings from this review will provide valuable information and support for future research into the equitable implementation and use of CGM for patients with T2D. We will disseminate findings at conferences and publish in a peer-reviewed journal.

https://osf.io/z2exn.

Coronary artery bypass grafting (CABG) remains one of the most commonly performed cardiac surgeries worldwide. Despite surgical advancements, a significant proportion of patients experience psychological distress following surgery, with depression being particularly common. Current evidence regarding the effectiveness of preoperative psychological interventions in improving postoperative mental health outcomes remains inconclusive. There is a critical need for predictive models that can identify patients at risk of developing clinically significant depressive symptoms (CSDSs) and related psychological conditions after CABG. This multicentre observational study aims to develop and validate prognostic models for predicting CSDSs and other psychological outcomes, including anxiety, post-traumatic stress symptoms and quality of life, 6 weeks after elective CABG surgery.

The study will recruit 300 adult patients undergoing elective CABG (with or without valve intervention) across two Swiss hospitals. Data collected will include demographic, clinical, psychometric, inflammation-related and interoceptive variables. A training set (n=200) will be used to develop predictive models using machine learning, while a held-out test set (n=100) will be used for model validation. The primary outcome prediction will focus on CSDSs, assessed using the Patient Health Questionnaire-9 (PHQ-9), with analyses conducted both categorically (PHQ-9 total score ≥10) and continuously as complementary approaches. Secondary models will address anxiety, using the General Anxiety Disorder Scale-7, post-traumatic stress, using the post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Disorders-5 and health-related quality of life, using the 12-item Short Form Survey. A simplified ‘light solution’ model with fewer predictors will also be developed for broader applicability. This study will address an important gap in perioperative mental healthcare by identifying key predictors of psychological morbidity following CABG, particularly CSDSs. The resulting models may inform future screening and preventive strategies and improve postsurgical outcomes through early identification and intervention in high-risk individuals.

The responsible ethics committee has reviewed and approved this project (Kantonale Ethikkommission Zürich, BASEC number: 2023-02040). The study minimises participant burden by integrating brief validated instruments and limiting psychiatric interviews to relevant outcomes, while ensuring ethical safeguards and respect for participant rights (including written consent). Results will be shared through peer-reviewed publications, conference presentations and stakeholder meetings involving clinicians and mental health professionals. Findings will also be communicated to participating centres and patient communities in accessible formats.

To evaluate the effectiveness of nutrition care delivered by general practitioners (GPs) compared with usual or no care on dietary and health outcomes in adults with diet-related chronic conditions or risk states and to examine which intervention components are associated with effectiveness.

A systematic review of randomised controlled trials (RCTs).

CINAHL, Embase, MEDLINE and ProQuest Nursing and Allied Health databases were searched in October 2021 and updated in February 2024 for articles related to GPs, nutrition care and diet-related health outcomes.

Published RCTs were included according to the following criteria: adults with or at risk of diet-related chronic conditions; nutrition care delivered by GPs in the primary care setting; usual or no care as comparators; and dietary and/or health outcomes with a minimum 3-month follow-up. No restriction was placed on the date of publication.

Duplicates were reconciled in EndNote. Two reviewers independently screened the titles, abstracts and full texts in Covidence. Two independent reviewers completed the critical appraisal and data extraction. Disagreements were resolved through discussion or with a third reviewer. The Motivation Actions and Prompts (MAP) framework was used to analyse the behaviour change components of study interventions. Results were reported using narrative synthesis and certainty in findings was summarised using GRADEpro GDT software.

Seven RCTs met the inclusion criteria (5744 patients). The trials were conducted in Australia, Italy and the USA from 1991 to 2013, with follow-up periods from 3 to 12 months. A consistent effect in favour of the intervention was found for diet scores (2 RCTs, 3038 participants). Other outcomes had mixed effects: (1) fat intake (2 RCTs, 2299 participants) – one study with an effect in favour of the intervention and one with mixed effects; (2) blood pressure (3 RCTs, 3063 participants) – one study with mixed effects and two with no effect; (3) body mass index (6 RCTs, 5538 participants) – two studies with an effect in favour of the intervention, two with no effect and two reporting no between group differences; (4) body weight (2 RCTs, 511 participants) – one study with an effect in favour of the intervention and one with no effect and (5) cholesterol (4 RCTs, 2505 participants) – one study with an effect in favour of the intervention and three with mixed effects and/or limited reporting. All studies had a motivation and action route to behaviour change and two had a prompted component, according to the MAP framework. The interventions spanned nine behaviour change groupings and 16 behaviour change techniques. There was a very low certainty of findings in all cases and the studies were of low to moderate methodological quality.

There is mixed evidence of the effectiveness of GP-delivered nutrition care among adults with diet-related chronic conditions or risk states. Additionally, most interventions did not include prompting and had a limited range of behaviour change techniques. The effectiveness of nutrition care delivered by GPs is an understudied area that warrants greater experimental investigation and requires more robust methods and reporting.

CRD42021289011.

As the opioid crisis continues, people who use drugs (PWUD) experience a disproportionate burden of both HIV and overdose, driven by increased injection-related HIV outbreaks and an opaque and rapidly evolving drug market, respectively. Pre-exposure prophylaxis (PrEP) for HIV and point-of-care drug checking services are underused yet potentially impactful interventions to address the harms of the opioid crisis. Implementing such interventions using known strategies to enhance client engagement and reduce access barriers, such as street outreach, mobile services and peer navigation, can optimise intervention and maximise their impact.

The Substance Checking Outreach and PrEP Engagement (SCOPE) Study is a non-randomised clinical trial evaluating the impact of the Check It intervention, a mobile community PrEP and drug checking intervention in Baltimore, Maryland, USA. SCOPE will recruit a cohort of 500 PWUD at risk for HIV through street-based recruitment methods. Cohort members will be followed semi-annually for 18 months. The primary study outcomes are engagement with the PrEP continuum of care and the number of non-fatal overdoses. We will use both random effects models and marginal structural models to estimate the effects of Check It on participant engagement on the PrEP continuum and the number of non-fatal overdoses over time.

Study procedures have been approved by the Johns Hopkins Bloomberg School of Public Health Institutional Review Board. Risks to participants are low, with the most serious risk being potential data confidentiality breaches. This risk was minimised through the use of secure data storage platforms with limited user access. Study findings will be disseminated through peer-reviewed manuscripts, academic presentations, and reports and fact sheets designed for lay audiences.

This study was registered with clinicaltrials.gov (study ID: NCT05977881; Protocol ID: 00017498).

Spinal manipulative therapy (SMT) is a common manual therapy intervention provided by healthcare providers for patients with low back pain (LBP). Responses to SMT are influenced by interactions between the patient and provider. Contextual factors may be specific to the patient, provider, patient-provider relationship or environment in which treatment is provided, with all capable of influencing clinical outcomes. The overall goal of this study is to gain a deeper understanding of contextual factors associated with manual therapy utilisation, perception and outcomes, from both patient and provider perspectives. A better understanding of modifiable contextual factors will inform future studies testing the impact on how SMT is delivered to patients influences clinical outcomes that could potentially advance the clinical science of manual therapy.

A prospective, single-arm study design with follow-up measures assessed up to 26 weeks after initiation of physical therapy for LBP will be used to assess relationships between physical therapy clinical outcomes and contextual factors related to the patient (preference, expectation, pain beliefs, pain associated distress and prior manual therapy experiences), the provider (equipoise, expectation, pain beliefs and clinical experience) and the interaction between the two (therapeutic alliance). Multimodal treatment approach of SMT (required during initial three treatment sessions within a 2week period), exercise and education supported by recent clinical practice guidelines will be encouraged for this study.

Ethics approval for the study was obtained from the University of Florida Institutional Review Board. Informed consent is required for physical therapist and patient participant enrolment in this project. The results of this study will be disseminated at professional scientific conferences and submitted for publication in peer-reviewed journals. Reference or approval number: IRB#: IRB202301700

NCT06590116.