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This study evaluates how participants experienced and assessed a three-round Delphi study on the terminology of developmental language disorders in childhood. It compares participants who completed all rounds (completers) with those who withdrew early (dropouts) and aims to derive methodological quality criteria for future Delphi studies.
The evaluation is based on a Delphi study conducted in 2021/2022 across five German-speaking countries. After the final round, n=179 experts (40% response rate) completed a standardised survey assessing their expertise, motivation, reasons for discontinuation, time commitment and perceptions of questionnaire and feedback design. Responses from completers (n=156) and dropouts (n=23) were analysed descriptively.
Most participants had no prior experience with Delphi methods but rated the study positively and considered the topic highly relevant. Completers reported their subjective time commitment to be lower and rated the handling of the questionnaire more positively than dropouts. Feedback was used by nearly half of all experts and was more actively considered by completers. Lack of time was the most common reason for discontinuation.
The findings confirm the feasibility and acceptance of the Delphi method in interdisciplinary health research. In addition to established methodological principles, topic relevance, clear communication and time commitment emerged as key areas for expert motivation and engagement.
To explore the perspectives of librarians and information specialists (LIS) on their experience and impact as peer reviewers of systematic reviews (SRs), and on facilitators and barriers to LIS methodological peer review.
Survey and focus groups.
We surveyed LIS who completed a peer review of an SR in a randomised controlled trial conducted in BMJ, BMJ Open and BMJ Medicine from 3 January 2023 to 2 January 2024. The questionnaire sought to understand their experience, what aspects of manuscripts they focused on, perceived impact on editorial decision-making and authors’ revisions and willingness to peer review again. To better understand factors that might impact decisions to review again, we contacted survey respondents to participate in a focus group concentrating on facilitators and barriers to peer reviewing SRs.
88 LIS were eligible for participation. From the survey respondents, 27 LIS who had volunteered were randomly selected and invited to participate in a follow-up focus group.
Of the 88 LIS invited to participate in the survey, 70 (80%) responded. Most respondents had six or more years of experience as an LIS (67/70; 96%) and advising researchers on doing SRs (55/70; 79%) and had peer reviewed for a journal prior to the study (57/70; 81%). Most focused on the search and SR methods when reviewing but also commented on aspects such as research question formulation, plagiarism, study results and conclusions. Two-thirds (44/66; 67%) believed they impacted editors’ decision-making and 59% (39/66) believed they impacted the authors’ revisions. Only three factors were considered extremely or very likely to impact their decision to review again: their schedule and/or lack of time, review turnaround time and their sense of professional duty. 17 LIS (63.0%) participated in a focus group. Time was the primary barrier identified in the focus groups, followed by a sense of intimidation. LIS reported being motivated by feeling valued by editors, the enjoyment of peer reviewing, the desire to improve SR quality and peer review as a learning experience. Several expressed surprise and delight at being asked to peer review for the journals.
LIS may be an underused peer reviewing resource with methodological experience that can help editors make decisions and improve the quality of SRs. Efforts to engage LIS as peer reviewers by journal editors are likely to be well-received when LIS expertise is clearly valued, sought and heeded. We encourage both journal editors and LIS to creatively advance efforts to promote LIS as methodological peer reviewers.
Non-inferiority (NI) trial designs, which assess whether an experimental intervention is no worse than the standard of care, have become increasingly prevalent in recent years. Current thinking suggests that the intention-to-treat (ITT) analysis is considered anti-conservative in the presence of protocol violations when compared with the per-protocol (PP) analysis.
We aim to conduct a methodological review of NI trials to compare the results from ITT and PP analysis in NI trials. A comprehensive electronic search strategy will be used to identify studies indexed in MEDLINE, Embase and Cochrane Central Register of Controlled Trials databases. We will include 390 NI trials published prior to 31 December 2024. The primary outcomes are the treatment effect estimates from ITT and PP analyses. Secondary outcomes are the CI widths and the bounds of the CIs from the ITT and PP analyses. Analysis will calculate the relative difference in the point estimates, CI widths and CI bounds between the two approaches. Linear models will be used to investigate the relationship between the outcomes and the proportion of patients excluded from the PP analysis.
This is a methodological review that has been registered on the International Prospective Register for Systematic Reviews (PROSPERO, CRD420251125360). Research ethics is not required as the project is a methodological review of previously published trials. Study findings will be shared via peer-reviewed publications and presentations at academic conferences.
Increased popularity of stepped-wedge cluster randomised trials (SW-CRT) highlights the importance of understanding and appropriate mitigation of sources of bias within this trial design. While current evidence suggests that ‘conventional’ cluster randomised controlled trials (RCTs) are at a higher risk of recruitment bias than individually randomised trials, this review aims to estimate the risk of recruitment bias in SW-CRTs.
Systematic review with search conducted on four databases. Risk of bias (RoB) was assessed using subdomain 1a (randomisation process) and 1b (timing of identification or recruitment of participants) of the Cochrane RoB tool 2.0 (extension for cluster RCTs).
MEDLINE, Embase, CINAHL, Cochrane Library were searched on 9 February 2024.
SW-CRTs published in 2023 were included.
Two independent reviewers screened and extracted all eligible papers. RoB was assessed with the Cochrane RoB tool.
Overall, 808 papers were screened, and 64 studies were included in the review. Most studies were deemed to have a high RoB (n=35, 55%), some concerns were noticed in 20 studies (31%), and 9 (14%) were considered to have a low RoB. The description of the randomisation process in the included papers was sometimes poorly reported (in 15 studies (23%) problems with the randomisation process were identified), and 21 studies (33%) had issues with sampling strategy (recruiting participants after randomisation by unmasked staff).
The review revealed that SW-CRTs are prone to recruitment bias, but the risks are comparable to cluster RCTs. When SW-CRTs are unable to recruit prior to randomisation, mitigation strategies could be implemented to reduce bias. A separate tool for RoB assessment in SW-CRTs is required to address the complexities of this trial design.
First Nations communities in Canada are disproportionately impacted by prenatal opioid exposure (POE) and neonatal abstinence syndrome (NAS). In response, we developed a research partnership with 13 First Nations communities in Ontario. Phase I of the research project, initiated in 2018, included the development of mixed-methods reports on the impact of POE for each community. This protocol outlines the evaluation of phase II, during which nine communities individually co-designed and implemented community-specific knowledge mobilisation (KMb) plans informed by findings from phase I. The evaluation aims to assess advisory working group engagement, KMb implementation and perceived community-level impacts.
This mixed-methods evaluation integrates survey and qualitative data to assess First Nations-led KMb products and activities. The Public and Patient Engagement Evaluation Tool, a validated survey instrument, will be administered to advisory group members and analysed descriptively. Focus groups and interviews will be conducted to explore advisory working group members’ experiences and analysed using phenomenological methods. Qualitative findings will be mapped to the Engage with Impact framework to assess outcomes across engagement domains.
Ethics approval has been granted by Vancouver Island University. All community contacts and advisory working group members will provide informed consent prior to data collection. Phase II activities are governed by formal community agreements. In alignment with First Nations Principles of OCAP (Ownership, Control, Access and Possession), First Nations community partners retain ownership of their KMb products and are actively involved in the design, implementation and dissemination of the project evaluation. Results will be shared through peer-reviewed publications, community reports and knowledge-sharing events.
To map the landscape of decentralised clinical trials (DCTs) by summarising characteristics, methods and reported challenges of published DCTs.
Scoping review, reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) checklist.
Ovid MEDLINE and PubMed were searched through to 21 August 2024.
We included reports of completed DCTs (defined as a trial of an intervention, with a comparison arm, in which some or all trial activities occurred away from the trial centre). All intervention types were included.
A single reviewer extracted data to a structured extraction sheet. Descriptive statistics (frequencies) are reported for study characteristics and the terminology used to describe trial methods. Decentralised methods used were coded separately for each trial stage.
53 papers met inclusion criteria. Most studies (34/53) were conducted in the USA. Mental health (18 studies) and COVID-19 (11 studies) were the predominant research areas. 24 (of 53) studies investigated pharmaceutical interventions, while others examined nutritional interventions, medical devices and behavioural interventions. Recruitment, screening and consent were commonly conducted remotely. A range of methods, including online, in-person and telemedicine, was used to collect outcome measures. Several studies experienced challenges related to participant retention and biased recruitment. Terminology regarding decentralisation was inconsistent across studies.
DCTs are rapidly increasing in use, and commonly cited advantages include reduced costs and reduced participant burden. This review identifies key research areas using DCTs and highlights a need for standardised terminology, comprehensive reporting of methods and limitations, and robust regulatory frameworks. Development of formal ethical and reporting standards is essential to ensure effective and responsible implementation of DCTs in clinical research.
In Arizona, chronic diseases, mental health conditions, haemorrhage and infections remain significant causes of severe maternal morbidity (SMM). Community health worker (CHW) interventions address social determinants of health and enhance healthcare access, which is particularly important for improving maternal health among high-risk Medicaid beneficiaries.
The Arizona Health Start Programme (HSP), a home-visiting intervention, uses CHWs to improve maternal and child health outcomes through health education, referral support and advocacy services for at-risk pregnant and postpartum women with children up to age 2 years. Over 80% of HSP participants are insured by Medicaid. The goal of this evaluation is to determine if, among Arizona Medicaid beneficiaries, participation in HSP improves (1) the risk of experiencing SMM, (2) the care management of pregnant women diagnosed with chronic conditions (eg, diabetes, hypertension) and (3) the care management of pregnant women diagnosed with depression, compared with pregnant women who did not participate in HSP. To test our hypothesis, we employ a quasi-experimental design using retrospective data and propensity score matching to establish comparison groups using Arizona Medicaid claims and enrolment records spanning the study period (2008–2019).
No primary data will be collected. This work is supported through an inter-agency contract from Arizona Department of Health Services (ADHS); approved by the ADHS Human Subjects Review Board, Project #17–00010, determined as non-human subjects research. Evaluation of the proposed outcomes will be completed by June 2027, and findings will be disseminated to HSP directors, managers and CHWs, as well as through academic journals and conferences.
Cluster randomised trials (CRTs) can be at risk of bias driven by differential identification and recruitment of participants across treatments, posing a threat to the validity of findings. We explored the awareness and importance, among CRT researchers, of the recommended bias mitigation measures.
Qualitative interview study using semistructured interviews.
Participants were researchers involved in conducting CRTs, including investigators, statisticians and trial coordinators. 24 participants, including statisticians (n=13, 54.2%), clinical investigators (n=9, 37.5%) and trial coordinators (n=2, 8.3%), were interviewed; with representation from the UK (n=10, 41.7%), Australia (n=5, 20.8%) and the USA (n=4, 16.7%).
Participants exhibited differing levels of knowledge related to biases. Some participants demonstrated high levels of knowledge, but we also identified prevalent misconceptions, with some evidence of superficial knowledge. While some participants worked in collaborative teams, other teams’ responsibilities were delineated, and this impacted on how knowledge of biases was shared and acted on. Logistical and practical issues could prevent known solutions to mitigate biases being implemented. Biases also manifested because of a perception from participant recruiters that the purpose of research is for participant benefit rather than producing generalisable knowledge; and a normalisation or expectation that CRTs produce a lower level of evidence.
There is an urgent need to ensure that CRTs are free from risks of bias. Mitigation measures are either not known, not practical or unconsciously subverted. More education and collaborative working might help. Preventing subconscious bias during participant recruitment and dispelling the myth that CRTs produce lower levels of evidence would require a change in culture.
Cognitive impairments, such as dementia and Alzheimer’s disease, are considered a significant public health challenge as they affect mental functions like memory, attention, language and decision-making. With the growing number of older individuals, the prevalence of these diseases is also increasing and is projected to reach 152 million worldwide by 2050. These disorders result in difficulties with judgement, communication and daily activities, leading to more hospitalisations and risks such as disorientation in the environment and a higher likelihood of falls. Current hospital safety assessment tools mainly focus on physical aspects and overlook other crucial factors. Therefore, this study aims to clarify the concept of safety challenges for patients with cognitive impairment and to develop and psychometrically validate a multidimensional instrument for use in hospital settings.
A sequential exploratory study with mixed methods will be conducted. In the first qualitative phase, based on a content analysis approach, the aim is to explain and clarify safety issues in patients with cognitive impairment. Participants will be purposively selected until saturation is reached in educational-therapeutic centres affiliated with the University of Medical Sciences, and unstructured in-depth interviews will be conducted. The data will be analysed simultaneously using MAXQDA V.20 software. Additionally, a literature review on safety issues in patients with cognitive impairment will be conducted to supplement aspects that may not have emerged in the interviews.
In the second phase, an instrument based on the inductive–deductive method will be developed. The items will be created based on the participants’ experiences and the literature review. Face, content and construct validity, as well as reliability, will be assessed. Data synthesis will involve a linkage strategy, where the qualitative data will be linked to the quantitative data immediately after the completion of the qualitative phase, once the protocols are developed.
This study is part of a postdoctoral project approved by the Tehran University of Medical Sciences Research Ethics Board (IR.TUMS.FNM.REC.1403.006). Findings will be disseminated at the local, national and international levels.
The development of the target trial emulation (TTE) methodology has enhanced the conduct of non-randomised studies. By leveraging readily available routinely collected data, TTEs offer opportunities for complementing randomised controlled trials (RCTs), providing more precise estimates and improving the external validity of RCTs. To explore this potential, we selected a successfully completed RCT as a case study. In the FIRST-line support for Assistance in Breathing in Children (FIRST-ABC) step-up RCT, high flow nasal cannula (HFNC) was found to be non-inferior to continuous positive airway pressure (CPAP) in terms of time to liberation from respiratory support in the paediatric critical care setting. We will emulate the FIRST-ABC step-up trial using routinely collected data from the Paediatric Intensive Care Audit Network (PICANet) database.
This is a protocol for a TTE that will use longitudinally collected data from the PICANet database. The study aims to emulate the FIRST-ABC step-up RCT using an observational study design in a frequentist framework. We will benchmark the results against the published trial. The study will apply a new-user design by selecting children admitted to paediatric intensive care units that started HFNC or non-invasive ventilatory support (as a surrogate for CPAP). The eligibility criteria and selected outcomes will reflect those of FIRST-ABC within the constraints of the available routinely collected data. We will use advanced quantitative doubly robust methods to minimise the impact of confounding by indication and allow for heterogeneity according to child characteristics. The analysis will be repeated using a Bayesian approach for follow-up research.
The research received ethics approval from the London School of Hygiene & Tropical Medicine Research Ethics Committee. This study will expand the findings from the FIRST-ABC step-up RCT, providing additional insight from a large representative sample using real-world data. The frequentist and Bayesian approaches will enable a discussion about the advantages and drawbacks of the two strategies. The results will be disseminated to the research and clinical community and made accessible to the public. In addition, the study results will be used in future research, which aims to supplement RCTs with additional evidence from a TTE.
Prophylactic ileostomy plays a critical role in the radical resection of low rectal cancer, but the incidence of stoma site incisional hernia (SSIH) after stoma closure remains high. No study has been reported in which radiomics has been used to predict SSIH. The primary aim of this study is to evaluate the safety and efficacy of biological mesh in preventing incisional hernia in patients with high-risk incisional hernia factors, as identified by image-based deep learning model, undergoing ileostomy closure surgery.
40 patients who need to undergo ileostomy closure and have been identified with high risk factors for SSIH by image-based deep learning model will be selected for this study. Patients will be randomly assigned equally to the prophylactic biological mesh placement group and the control group, and outcomes will be tracked via clinic review at 1 month, 3 months, 6 months and 12 months postoperatively. The outcome measures are the rate of postoperative incisional hernia, local pain, incisional infection, seroma and so on. This study demonstrates that prophylactic placement of biological mesh with ileostomy closure reduces the incidence of SSIH. Furthermore, it validates the feasibility of image-based deep learning models in predicting postoperative complications and identifying high-risk SSIH patients.
Informed consent has been obtained from all subjects. This protocol has been approved by the Ethics Committee of Renji Hospital, Shanghai Jiao Tong University School of Medicine (KY2022-087-B). The findings will be disseminated through peer-reviewed manuscripts, reports and presentations.
ChiCTR2200064995. Registration date: October 2022. Registration authority: Chinese Clinical Trial Registry.
In order to prevent chronic kidney disease (CKD), it is crucial to identify temporal trends in CKD incidence at the global level, both past and future.
An observational cross-sectional study.
We retrieved data on annual cases of CKD from the Global Burden of Disease (GBD) online database for the period between 1990 and 2021. To assess the trends in age-standardised incidence rates (ASRs) of CKD, we applied the average annual percentage change (AAPC) for both observed data (1990–2021) and projected data (2022–2030). Bayesian age-period-cohort models were employed to predict CKD ASRs and case numbers through 2030.
From 1990 to 2021, the number of newly diagnosed CKD cases worldwide rose from 7 758 599 (95% CI: 7 721 790 to 7 795 410) to 19 950 853 (95% CI: 19 914 040 to 19 987 670). During that same period, the CKD ASR increased from 145.66 to 252.93 per 100 000 people, with an AAPC of 0.74% (95% CI: 0.73 to 0.75). By 2030, the number of CKD cases is projected to reach 25 057 700 (95% credible interval (CrI: 23 389 630 to 26 725 770), and the ASR is expected to increase to 297.62 per 100 000 (AAPC: 0.15%, 95% CrI: 0.14 to 0.16). The most significant ASR increases are expected among individuals with type two diabetes mellitus (AAPC: 0.17%, 95% CI: 0.01 to 0.34), hypertension (AAPC: 0.17%, 95% CI: 0.05 to 0.28%), older adults (aged ≥60) (AAPC: 0.21%, 95% CI: 0.20 to 0.22) and individuals in middle- (AAPC: 0.19%, 95% CI: 0.11 to 0.27) and high-middle socio-demographic index (SDI) countries (AAPC: 0.18%, 95% CI: 0.09 to 0.27). Of the six WHO regions, the largest increase is predicted to occur in the Western Pacific region by 2030 (AAPC: 0.21%, 95% CrI: 0.11 to 0.32), followed by Eastern Mediterranean (AAPC: 0.18%, 95% CrI: 0.06 to 0.31). Of the 204 countries and territories examined, 201 showed an increasing trend between 1990 and 2030, while only three experienced a decrease.
CKD incidence rates and case numbers are predicted to increase globally through 2030. Women; people with type two diabetes mellitus and hypertension; people over 60 years of age; people living in high, middle and high-middle-SDI countries, as well as those from the region of the USA, Europe and the Western Pacific, are projected to have the highest ASR of CKD in 2030. This highlights the need to consider these subgroups in future plans for global control of CKD.
Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.
This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.
The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.
ClinicalTrials.gov ID: NCT06090552.
Advarra Pro 00070994.
23-38948.
Protocol Date: 24 October 2024. Protocol Version: 4.
Given that low retention rates are a prevalent challenge in clinical trials, which ultimately affects trial validity, it is recommended that interventions be developed and evaluated to increase trial retention. In the context of trial retention, incorporating behavioural science is endorsed, as it provides a theoretical foundation for considering human behaviour. We hypothesised that an intervention informed by self-determination theory could increase retention in a randomised allergy trial on intralymphatic immunotherapy, as the support of basic psychological needs for autonomy, competence and relatedness is anticipated to lead to more sustained engagement and better outcomes.
To assess the acceptability and feasibility of the intervention and evaluation design, following the complex intervention framework by the Medical Research Council, before proceeding to a randomised evaluation.
A parallel two-arm randomised feasibility study was conducted within the randomised allergy trial.
All participants at one Danish site were eligible for recruitment.
The intervention was a web app informed by self-determination theory to support the basic psychological needs through its thoughtfully designed features. Participants were allocated unblinded across treatment groups to complete daily online questionnaires over a 100-day period from May to August 2022. All participants received a daily text message with a link for the questionnaires. On completion, participants in the control group received a confirmation message, while participants in the intervention group had a browser with the menu of the web app opened for them. The features within the menu were voluntary to use.
The prespecified assessments included evaluating the recruitment rate, retention rate (which reflected both sustained participation and the proportion of completed daily questionnaire entries), the suitability of outcome measures and the acceptability of the intervention and evaluation design to both participants and staff. Qualitative data were collected through a collaborative learning process with participants from the intervention group in November 2022.
A total of 30 participants were invited, randomly assigned 1:1 and analysed, resulting in a recruitment rate of 100%. None were lost to follow-up as all remained in the study for the entire duration. The response rate was 84.5% in the intervention group and 79.1% in the control group, indicating satisfactory retention. Outcome measures were deemed appropriate. No unintended adverse events were identified. The collaborative learning meetings involved three participants in the first meeting and two in the second, comprising a total of five different individuals. Participants found the intervention acceptable. They used it differently but agreed that its components were useful. Technical issues needed fixing, and voluntary free text boxes and registration of medication dosage should be added.
The intervention and evaluation design were assessed as acceptable and feasible. Technical issues were fixed, and additional response options were added before a randomised evaluation.
ILIT.NU: EudraCT 2020-001060-28. ClinicalTrials.gov NCT05191186.
Blue light (peak wavelength 442 nm) has been shown to modulate the immune response in preclinical models of intra-abdominal sepsis and pneumonia. In vivo pathways involve optic nerve stimulation with transmission to the central nervous system, activation of parasympathetic pathways terminating at the spleen, and downstream immune effects including decreased inflammatory tissue damage and improved pathogen clearance. Related effects on pain mediators including proinflammatory cytokines (interleukin 6, TNF- α) and autonomic tone (increased parasympathetic outflow) suggest possible analgesic properties that would be highly relevant to a trauma population.
This is a randomised controlled trial in which adult trauma inpatients (
Full ethical approval for this trial has been granted by the University of Pittsburgh Institutional Review Board. On study completion, results will be published in the peer-reviewed literature and at ClinicalTrials.gov.
Cluster analysis, a machine learning-based and data-driven technique for identifying groups in data, has demonstrated its potential in a wide range of contexts. However, critical appraisal and reproducibility are often limited by insufficient reporting, ultimately hampering the interpretation and trust of key stakeholders. The present paper describes the protocol that will guide the development of a reporting guideline and checklist for studies incorporating cluster analyses—Transparent Reporting of Cluster Analyses.
Following the recommended steps for developing reporting guidelines outlined by the Enhancing the QUAlity and Transparency Of health Research Network, the work will be divided into six stages. Stage 1: literature review to guide development of initial checklist. Stage 2: drafting of the initial checklist. Stage 3: internal revision of checklist. Stage 4: Delphi study in a global sample of researchers from varying fields (n=) to derive consensus regarding items in the checklist and piloting of the checklist. Stage 5: consensus meeting to consolidate checklist. Stage 6: production of statement paper and explanation and elaboration paper. Stage 7: dissemination via journals, conferences, social media and a dedicated web platform.
Due to local regulations, the planned study is exempt from the requirement of ethical review. The findings will be disseminated through peer-reviewed publications. The checklist with explanations will also be made available freely on a dedicated web platform (troca-statement.org) and in a repository.
If clinical trials measure and report the outcomes included in core outcome sets (COS) for a given condition/disease as a minimum, this has the potential to improve comparability between trials and prevent research waste. Until now, the uptake of the Bronchiectasis and Hidradenitis Suppurativa (HS) COS has not been assessed.
This study assessed the uptake of Bronchiectasis and HS COS using a review of trial registries, with entries taken from ClinicalTrials.gov and the WHO International Clinical Trial Registry Platform. This uptake assessment provides valuable information to inform COS refinement and uncover areas lacking uptake to inform further dissemination requirements.
For each trial, the outcomes included in the trial registry entry were extracted and compared with those included in the corresponding Bronchiectasis or HS COS. The Bronchiectasis COS consists of 18 outcomes, and the HS COS, 6.
Of the trials registered after both COS were developed in 2018, 63% (12/19) of HS trials planned to measure the full COS, whereas for Bronchiectasis, 0% (0/24) of trials planned to measure the full COS. However, of the five priority outcomes to be measured for Bronchiectasis, 4% (1/24) of trials planned to measure all five outcomes.
Both COS publications’ focus was to reach consensus on what outcomes should be measured. Despite both publications referring to the Core outcome Measures for Effectiveness Trials (COMET) Handbook, which discusses the importance of COS dissemination, implementation plans were not included in either publication.
The results suggest that uptake of the HS COS is relatively good, despite yearly fluctuations, whereas for Bronchiectasis, COS uptake is limited. Further research into standardised measurement tools for HS is expected to increase uptake. The focus for Bronchiectasis, however, will be to refine the COS for feasible application in clinical trials. Future COS development publications should use all resources from the COMET initiative to ensure feasible dissemination of the COS.
Opioid agonist treatment (OAT) prescribing patterns have shifted in recent years in British Columbia (BC), Canada due to the increasingly toxic unregulated drug supply. Experimental evidence to support guidelines on the effectiveness of maintaining clients at different maintenance dosage levels is incomplete and outdated for the fentanyl era. Our objective is to assess the risk of treatment discontinuation and mortality among individuals receiving different maintenance dosage strategies for OAT with methadone, buprenorphine/naloxone or slow-release oral morphine (SROM) at the population level in BC, Canada.
We propose a retrospective population-level study of BC residents initiating OAT on methadone, buprenorphine/naloxone or SROM between 1 January 2010 and 31 December 2022 who were ≥18 years of age with no known pregnancy, no history of cancer diagnosis or receiving palliative care and not currently incarcerated. Our study will employ health administrative databases linked at the individual level to emulate a target trial per OAT type where individuals will be assigned to discrete maintenance dosing strategies, according to the full range observed in BC during the study period. Primary outcomes include treatment discontinuation and all-cause mortality. To determine the effectiveness of alternative maintenance doses, we will emulate a ‘per-protocol’ trial using a clone-censor-weight approach to adjust for measured time-dependent confounding by indication.
The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. All data are deidentified, securely stored and accessed in accordance with provincial privacy regulations. Results will be disseminated and shared with local advocacy groups and decision-makers, developers of national and international clinical guidelines, presented at national and international conferences and published in peer-reviewed journals electronically and in print.
Aphasia is a language impairment that affects one-third of people who experience a stroke. Aphasia can impact all facets of language: speaking, understanding, reading and writing. Around 60% of people with aphasia have persistent language impairments 1 year after their stroke, requiring ongoing healthcare and support. In recent years, the internet has become a key resource for the self-management of chronic health conditions. Navigating web content, however, requires language use, and as such, people living with aphasia are more likely to be excluded from digital health and support services. Web Content Accessibility Guidelines exist; however, they do not fully address the unique and diverse needs of people with aphasia, and a significant proportion of websites (over 90%) do not fully adhere to them. This protocol paper describes the first two stages of the Bridging the Digital Divide project, which aims to codesign and develop (a) a web-browser extension to re-render webpages to an ‘aphasia-friendly’ (accessible) format, (b) training tools to help users and health professionals customise the web-browser extension and (c) guidelines for developing communication-accessible websites.
The research will be conducted using experience-based codesign. In Stage 1a, focus groups will be held with (1) people with aphasia, (2) family members or significant others and (3) health professionals working with people with aphasia. Participants will be asked to share their experiences of accessing (or supporting a person with aphasia to access) healthcare, information and support services on the web. The nominal group technique (NGT) will be used to identify priorities for improving web accessibility for people with aphasia. Focus group data will be analysed using reflexive thematic analysis, and prioritisation data will be analysed using inductive qualitative content analysis. In Stage 1b, eight codesign workshops will be held with representatives of the three key stakeholder groups to iteratively codesign and develop a web-browser extension, training tools and guidelines to support web accessibility.
Ethical clearance for Stage 1a and Stage 1b of this project has been approved by the University of Queensland Human Research Ethics Committee (Stage 1a approval number: 2023/HE000528, Stage 1b approval number: 2024/HE000721). The outcomes of this research will be disseminated in peer-reviewed journals and presented at national and international conferences. A dissemination and celebration event will be held at the completion of the project.
Research suggests that hormonal fluctuations may contribute to sleep-related physiological and psychological outcomes that differentially affect women’s overall health and well-being. Yet, systematic enquiries on this potential interaction across the menstrual cycle are scant.
This protocol paper describes a pilot observational study investigating changes in objective and subjective sleep measures, metabolic biomarkers (body temperature, blood glucose and hormonal concentrations) and psychological outcomes (depressive symptoms, menstrual cycle-related pain and psychological distress), in a cohort of healthy premenopausal women aged 18–35, regularly menstruating, and without sleep disorders. Participants’ sleep is monitored every night over the course of two full menstrual cycles using a Food and Drug Administration (FDA)-approved diagnostic ring from SleepImage and via next morning self-reports (ie, sleep diaries). To minimise the likelihood of undiagnosed sleep disorders, participants also complete two nights of at-home polysomnography. Daily hormonal concentrations are assessed via morning urinalysis using the Mira Fertility Monitor while transitions between hormonal phases are further confirmed by biochemical assays. Body temperature, blood glucose concentrations, diet and physical activity behaviours are continuously recorded using wearable devices and smartphone apps from Oura and Levels. The primary outcomes of this study are total sleep time and sleep quality. Secondary outcomes include sleep onset latency, wakefulness after sleep onset, sleep staging, daytime sleepiness, respiratory rate, resting heart rate, heart rate variability and subjective mood. This study will provide novel data to disentangle the intricate relationship between sleep behaviours, mental well-being and menstrual health in premenopausal women.
The study was approved by the Institutional Review Board at Parker University (protocol number PUIRB-2025-3). Study findings will be presented in peer-reviewed publications and at academic conferences.
FreshRSS 