Parents and youth across Alberta were engaged to identify specific research questions that are a priority to them. Two lists, containing 27 topics were developed with local parent and youth advisory groups, and sent to participants via online questionnaires. Topics were rated from one (least important) to five (most important) and ranked in order of priority. Initial questionnaires were completed by 263 (46%) parents and 308 (54%) youth. Parents rated five topics (behaviour, learning, and developmental disorders; mental health; food, environment and lifestyle; quality of health care; and vaccines) and youth rated four topics (brain and nerve health; mental health; quality of health care; and vaccines) as a high priority. Research questions stemming from 4 parent (12 [5%]) and 6 youth (21 [7%]) focus group discussions were then ranked in a second questionnaire, completed by 43 (43%) parents and 56 (56%) youth. Parents' highest ranked research question was 'What is the effect of screen time on cognition and neurodevelopment for children and adolescents?', while the highest ranked question from youth was 'What are the early signs of anxiety and depression and when should an individual seek help?'. These topics highlight areas that are important to parents and youth where funding, research, and knowledge mobilization efforts should be directed.

Policy decision-making should use the best evidence obtained with the most rigorous and reproducible science and should be applied with minimal bias to maximize positive outcomes. This is particularly important in public health and other major decisions. Reality, however, is usually far from this ideal. The quality and use of scientific evidence to address wicked problems and sticky crises have been the focus of intense debate. Policymakers often succumb to fallacies, leading to suboptimal decision-making and maladaptive practices. We map the key biases involved at three different, but communicating, domains: the scientific evidence itself, the policymakers and the citizens. Biases may be classified along two axes pertaining to the perception of the risk and the perception of the effectiveness of the intervention: minimizing risk (e.g. crisis denial), maximizing risk (e.g. moral panic), minimizing intervention effectiveness (e.g. anti-medicine, anti-government) and maximizing effectiveness (e.g. drug lobbyism). We discuss common cognitive biases, including normalcy bias, ostrich effect, negativity bias, Just World Fallacy, false consensus effect, action bias and death spiral effect. Furthermore, we present an overview of potential debiasing processes and tools. Debiasing may help enhance the quality of implementations and trust in institutions, to the benefit of both science and society at large.

Few personalized behavioral treatments are available to reduce the risk of prescription opioid-related harm among patients with chronic noncancer pain.

We aimed to report on the second phase of the co-design of a digital brief intervention (BI) based on patient and health professional preferences.

Eligible patients with chronic noncancer pain (n=18; 10 women; mean age 49.5, SD 6.91 y) from public hospital waitlists and health professionals (n=5; 2 women; mean age 40.2, SD 5.97 y) from pain and addiction clinics completed semistructured telephone interviews or participated in focus groups exploring BI preferences, needs, and considerations for implementation. Grounded theory was used to thematically analyze the data.

We identified 5 themes related to intervention content from patient reports: relevance of the biopsychosocial model and need for improved awareness and pain psychology education; nonpharmacological strategies and flexibility when applying coping skills training; opioid use reflection and education, with personalized medication and tapering plans; holistic and patient-inclusive assessment measures and feedback; and inclusion of holistic goals targeting comfort and happiness. Five themes related to the process and guiding principles were identified: therapist guided; engaging features; compassionate, responsive, person-centered care; a digital solution is exciting, maximizing reach; and educate and normalize system and policy challenges. Finally, 5 themes were reflected in the health professionals' reports: digital health use is rare but desired; digital health is useful for patient monitoring and accessing support; patient motivation is important; a digital BI app is likely beneficial and at multiple care points; and safe medication use and managing pain goals. The reported barriers from health professionals were intervention intensity, potential costs, and patient responsiveness; factors facilitating the implementation were the alignment of digital BIs with clinical models, a stepped-care approach, and feedback.

This co-design study identified key content areas, guiding principles, enabling factors, and barriers from both patients and health professionals to guide the development of digital BIs. The knowledge gathered should inform future iterations of co-designing digital BIs for the population most at risk of the harmful effects of opioid medications.

Occupational workload can contribute to significant health problems such as chronic stress, fatigue and burnout. To investigate the underlying mechanisms, it is necessary to monitor brain activity in real work environments. Functional near-infrared spectroscopy (fNIRS) is a portable, non-invasive neuroimaging method that captures neural correlates of occupational workload under natural conditions. However, despite its increasing application, a comprehensive overview of fNIRS-based research in this field is lacking. Therefore, this systematic review examines how fNIRS can be utilized to investigate occupational workload.

Following PRISMA 2020 guidelines, we conducted our systematic review by searching Web of Science, PubMed, and Scopus between November 15, 2023 and March 20, 2025. We included all studies published in English or German at any date, as long as they examined healthy adult professionals performing occupational tasks with functional near-infrared spectroscopy (fNIRS). Extracted data included study characteristics, workload details, signal processing methods, main fNIRS findings, and study quality, assessed using the JBI Critical Appraisal Tool.

We included 41 studies. Of these, 23 reported a significant increase in oxygenated hemoglobin (HbO) concentration and functional connectivity in the prefrontal cortex (PFC) under higher occupational workload conditions. Only five studies examined typical office tasks. Nine studies analyzed differences in cortical activation between experts and novices, with experts showing increased HbO concentration in the PFC than novices. Regarding methodology, 26 studies used standardized optode placements, while only 17 applied systemic and extracerebral artifact correction. Small sample sizes and the absence of randomized controlled trials limited the reliability and reproducibility of the findings.

Functional near-infrared spectroscopy effectively detects neural correlates of occupational workload and provides objective insights into cognitive demands in real-world work settings. Standardizing optode placement, harmonizing signal-processing methods, and increasing sample sizes would enhance the validity and comparability of future research. Expanding investigations to typical office environments is also crucial for understanding daily workload and for developing interventions that promote employee well-being and productivity. Overall, fNIRS represents a promising tool for establishing evidence-based workplace health promotion strategies across diverse occupational settings.

Patient and caregiver involvement can optimize the relevance and uptake of research. However, there is little guidance on approaches for reporting the involvement of patients and caregivers in the identification and design of health care interventions. This study aims to develop a reporting framework for involving patients and caregivers in identifying and designing health care interventions to improve transparency in the approaches used.

Electronic literature databases were extensively searched for guidelines, frameworks, reviews, and primary studies that reported patient and caregiver involvement in interventions; studies identified up to April 2024 were identified. A comprehensive list of reporting items was inductively developed. The IDEntifying And designing healthcare interventionS (IDEAS) framework was piloted with a diverse range of primary studies that reported patient and caregiver involvement in interventions.

Nineteen secondary studies (eg, guidelines, frameworks, and reviews) and 41 primary studies were used to develop the reporting items for the IDEAS framework. The IDEAS framework includes 14 reporting items that cover five domains: purpose (ie, role of patients or caregivers, type and scope of interventions, criteria considered eg, acceptability, feasibility); theory or framework used; population (ie, inclusion criteria, identification and selection, and characteristics); mode of involvement (ie, process of involvement, frequency, duration, and reimbursement); and output and impact. Each reporting item includes a descriptor and examples.

The IDEAS framework can help ensure transparency in describing the process of reporting patients and caregivers in identifying and designing health care interventions. Ultimately, this may support the design of interventions that address the needs, preferences and priorities of patients and caregivers.

Patient and caregiver involvement in identifying and designing health care interventions can help improve acceptability, uptake, and impact of interventions. However, there is little guidance that addresses the reporting of the involvement of patients and caregivers in developing health care interventions. We carried out a detailed search for guidelines, frameworks, and primary studies to develop the reporting of the involvement of patients and caregivers in IDEentifying And designing healthcare interventionS (IDEAS) framework. The IDEAS framework consists of 14 reporting items that cover five domains: the purpose of involvement, the theory or framework used, the population of patients and caregivers who were involved, mode of involvement (ie, process of involvement), and output and impact. The IDEAS framework can be used to describe the involvement of patients and caregivers in identifying and designing health care interventions.

While clinical trials have evolved and improved over time producing significant advances in diagnosis, treatment and prevention of diseases, there are equally key challenges such as feasibility of some clinical trials and most importantly the issue of trust in the conduct of clinical trials. Thus, this study provides scientific evidence to address challenges associated with clinical trials conduct as well as a framework describing appropriate trust building strategies to guide the conduct of future clinical trial studies in Ghana and beyond. The study used qualitative research approach where 48 in-depth and Key informant interviews were conducted with participants between June and August, 2019. The interviews were recorded, transcribed and coded into themes using QSR Nvivo 12 software before thematic content analysis. The results revealed low level of trust in the conduct of clinical trials in Ghana. Participants recommended several trust building strategies to improve trust across the clinical trial cycle. Pre-implementation strategies such as effective stakeholder engagement and strengthening clinical trial regulatory bodies were recommended to build community trust. Implementation strategies such as effective monitoring, addressing issues of untrustworthiness and misconceptions regarding drawing and use of blood samples, improved informed consent procedures as well as post-implementation strategy such as timely feedback to clinical trial communities were highly recommended to build trust in clinical trials conduct. Trust is an important factor affecting clinical trials conduct especially in developing countries. The need to invest in national and community level trust-building activities through appropriate stakeholder engagement and effective monitoring systems by clinical trial regulatory bodies are critical strategies to improve trust in clinical trials conduct.

Introduction. Spending on drugs to treat cancer will increase by 9-12% annually until 2025. For health systems in high and middle-income countries –such as Colombia– and with an increasing trend of new cancer cases, clinical research can contribute to the efficient use of the system resources available without undermining the timeliness and quality of healthcare. Objective. To calculate the savings generated to the Colombian health system by the implementation of externally funded clinical trials for cancer. Materials and methods. We conducted an observational, longitudinal, descriptive, and retrospective study analyzing participant’s medical records of clinical trials between 2016 and 2022 at the Clínica IMAT Oncomédica Auna, Colombia. Results. The total savings to the health system for external financing of oncology drugs was USD $1,526,320, and the monthly weighted average savings per patient was USD $3,257. The participation of breast cancer patients in randomized controlled clinical trials (n = 138) accounted for 24% (USD $369,363) of the total savings. Participants with clinical stage IV and III accounted for 41.7% (USD $636,475) and 31.06% (USD $473,159), respectively, of the total savings to the general social security health system in Colombia from external financing of oncological drugs. Conclusion. The participation of cancer patients in clinical trials mitigated costs to the Colombian health system, especially in women with breast cancer and in those patients with clinical stage IV of the disease.

Low levels of patient physical activity during a hospital stay are linked to a variety of poor outcomes. Wearable activity trackers can help to boost patient activity and improve other outcomes during a hospitalisation, but a range of implementation barriers exist. Co-design research methodologies provide opportunities to bridge evidence-practice gaps, such as the implementation of wearable activity trackers to promote patient activity, by developing solutions and strategies in collaboration with key stakeholders. This co-design study aimed to develop a protocol and resources to support the implementation of wearable activity trackers into a rehabilitation service at a South Australian hospital.

Three co-design workshops that employed an involvement partnership with 26 rehabilitation clinicians were conducted. User journey storyboards, empathy maps, and world café activities were used to understand processes of using technology with patients in the hospital, identify protocol components for using WATs, and create resources to support its implementation.

Using a co-design approach, this study developed a protocol for using WATs in a hospital rehabilitation services, identified key themes underpinning its implementation, and created a set of resources to support its delivery.

This study identified key elements to support implementation of WATs in hospital rehabilitation, and expands the evidence base for using co-design approaches in health research, and may support WAT implementation in other settings.

Low back pain (LBP) poses global health management and economic challenges. Self-management of LBP is critical, and smartphone apps have great potential to facilitate LBP self-management. This study aimed to co-design a LBP Self-Management App Review Tool (LBP-SMART) for consumers to assess the quality, behaviour change and self-management potential of LBP self-management apps for LBP rehabilitation.

Two-phase prospective cross-sectional design. Consumers and health professionals participated in four online co-design workshops, underpinned by the Co-KT framework, to develop a consumer-level assessment tool for LBP self-management smartphone apps. User evaluation of the tool (LBP-SMART) was then undertaken.

Four stakeholders (consumers n = 2, health professionals n = 2) with the guidance of researchers (n = 3) participated in the workshops. The LBP-SMART was developed, consisting of seven categories: 1)Safety; 2)Download process; 3)Look, function and feel; 4)Customisation; 5)Goals and self-monitoring; 6)Enabling sharing and 7)Additional features. Five additional participants undertook user evaluation. All reported that the tool was easy to use/understand, and the order/sequencing was appropriate. The LBP-SMART has content validity based on evidence, stakeholder and expert views.

The LBP-SMART guides consumers and health professionals on appropriate app choice with quality, and self-management and behaviour change potential features that may improve LBP rehabilitation outcomes.

Due to the limited data from clinical trials and real-world settings in the realm of nusinersen, there is a need for further evidence. This study seeks to assess the impact of nusinersen, when combined with standard care, on bulbar function, respiratory function, and the necessity for respiratory support among pediatric patients with spinal muscular atrophy (SMA).

Prospective observational study, involving pediatric SMA patients (Types 1-3) undergoing nusinersen treatment at the Hospital Universitario Virgen del Rocío in Spain over at least 24 months. The cohort included 11 SMA type 1 patients, comprising 6 type 1b and 5 type 1c, 12 SMA type 2 patients, and 5 SMA type 3 patients.

Twenty-eight pediatric patients were enrolled with the majority being male (n = 20). Patients with type 1 were diagnosed and received treatment significantly earlier than those with types 2 and 3 (p < 0.001). Additionally, there was a longer period between diagnosis and the start of treatment in types 2 and 3 (p = 0.002). Follow-up revealed statistically improved functional and respiratory outcomes associated with earlier initiation of nusinersen treatment at 6, 12, and 24 months in all phenotypes. The ability to swallow and feed correctly remained unchanged throughout the study, with SMA type 1c patients maintaining oral feeding in contrast to patients with SMA type 1b. Notably, no deaths were recorded.

This study provides important insights into the real-world clinical progress of pediatric SMA patients and their response to nusinersen treatment, highlighting the significance of early intervention for better functional and respiratory outcomes.

Opioid medications are important for pain management, but many patients progress to unsafe medication use. With few personalized and accessible behavioral treatment options to reduce potential opioid-related harm, new and innovative patient-centered approaches are urgently needed to fill this gap.

This study involved the first phase of co-designing a digital brief intervention to reduce the risk of opioid-related harm by investigating the lived experience of chronic noncancer pain (CNCP) in treatment-seeking patients, with a particular focus on opioid therapy experiences.

Eligible patients were those aged between 18 and 70 years with CNCP at a clinically significant level of intensity (a score of ≥4 of 10). Purposive sampling was used to engage patients on public hospital waitlists via mail or through the treating medical specialist. Participants (N=18; n=10 women; mean age 49.5 years, SD 11.50) completed semistructured telephone interviews. Interviews were transcribed verbatim, thematically analyzed using grounded theory, and member checked by patients.

Eight overarching themes were found, listed in the order of their prominence from most to least prominent: limited treatment collaboration and partnership; limited biopsychosocial understanding of pain; continued opioid use when benefits do not outweigh harms; a trial-and-error approach to opioid use; cycles of hopefulness and hopelessness; diagnostic uncertainty; significant negative impacts tied to loss; and complexity of pain and opioid use journeys.

The findings of this study advance progress in co-designing digital brief interventions by actively engaging patient partners in their lived experiences of chronic pain and use of prescription opioid medications. The key recommendations proposed should guide the development of personalized solutions to address the complex care needs of patients with CNCP.

The oral health of over 90,000 individuals in UK prisons is four times worse than the general population. A recent scoping review on the oral health of prisoners inside the justice system highlighted the lack of research about what happens when they transition out of prison to become community returners.

To co-design a film to showcase the dental experiences of community returners before and after they transition out of prison, change perceptions and inform oral health research priorities.

This action research involved five community returners, recruited through third sector organisations, who attended virtual workshops. Participants in the first workshop designed the storyboard; community returners incorporated their own stories into fictional characters to portray their lived experiences. They developed the character stories and wrote the script in the second workshop. A community film production company produced the film and used professional actors who had contact with the justice system to depict the characters in the film.

The final film, titled "My Story, My Words, My Mouth" explored themes such as self-care oral health behaviours, dental care provision in prison, access to healthcare, stigmatisation, disclosure and improving oral health to support societal reintegration. The film was screened at an open event for stakeholders and included a question-and-answer session and recorded videos where viewers shared their feedback to inform future research projects.

Co-design can be an empowering platform to hear the voices of community returners. Using the medium of film an oral health promotion tool can build understanding about the oral health needs of underrepresented groups. This egalitarian and power-sharing approach can also provoke critical discussion and actively involve underrepresented people in research that impacts their lives to develop strategies, to set priorities and improve their oral health.

Recent advances in multivariate pattern recognition have fostered the search for reliable neuroimaging-based biomarkers in psychiatric conditions, including schizophrenia. These approaches consider the complex pattern of alterations in brain function and structure, overcoming the limitations of traditional univariate methods. To assess the reliability of neuroimaging-based biomarkers and the contribution of study characteristics in distinguishing individuals with schizophrenia spectrum disorder (SSD) from healthy controls (HCs), we conducted a systematic review of the studies that used multivariate pattern recognition for this objective.

We systematically searched PubMed, Scopus, and Web of Science for studies on SSD classification using multivariate pattern analysis on magnetic resonance imaging data. We employed a bivariate random-effects meta-analytic model to explore the classification of sensitivity (SE) and specificity (SP) across studies while also evaluating the moderator effects of clinical and non-clinical variables.

A total of 119 studies (with 12,723 patients with SSD and 13,196 HCs) were identified. The meta-analysis estimated a SE of 79.1% (95% confidence interval [CI], 77.1%-81.0%) and a SP of 80.0% (95% CI, 77.8%-82.0%). In particular, the Positive and Negative Syndrome Scale and the Global Assessment of Functioning scores, age, age of onset, duration of untreated psychosis, deep learning, algorithm type, features selection, and validation methods had significant effects on classification performance.

Multivariate pattern analysis reliably identifies neuroimaging-based biomarkers of SSD, achieving ∼80% SE and SP. Despite clinical heterogeneity, discernible brain modifications effectively differentiate SSD from HCs. Classification performance depends on patient-related and methodological factors crucial for the development, validation, and application of prospective models in clinical settings.

This study aimed to explore how incorporating shared decision-making (SDM) can address recruitment challenges in clinical trials. Specifically, it examines how SDM can align the trial process with patient preferences, enhance patient autonomy and increase active patient participation. Additionally, it identifies potential conflicts between SDM and certain clinical trial aspects, such as randomization or blinding, and proposes solutions to mitigate these issues.

We conducted a comprehensive review of existing literature on patient recruitment challenges in clinical trials and the role of SDM in addressing these challenges. We analysed case studies and trial reports to identify common obstacles and assess the effectiveness of SDM in improving patient accrual. Additionally, we evaluated three proposed solutions: adequate trial design, communication skill training and patient decision aids.

Our review indicates that incorporating SDM can significantly enhance patient recruitment by promoting patient autonomy and engagement. SDM encourages physicians to adopt a more open and informative approach, which aligns the trial process with patient preferences and reduces psychological barriers such as fear and mental stress. However, implementing SDM can conflict with elements such as randomization and blinding, potentially complicating trial design and execution.

The desire for patient autonomy and active engagement through SDM may clash with traditional clinical trial methodologies. To address these conflicts, we propose three solutions: redesigning trials to better accommodate SDM principles, providing communication skill training for physicians and developing patient decision aids. By focussing on patient wishes and emotions, these solutions can integrate SDM into clinical trials effectively.

Shared decision-making provides a framework that can promote patient recruitment and trial participation by enhancing patient autonomy and engagement. With proper implementation of trial design modifications, communication skill training and patient decision aids, SDM can support rather than hinder clinical trial execution, ultimately contributing to the advancement of evidence-based medicine.

To evaluate the reporting quality of randomized controlled trials (RCT) of acupuncture for knee osteoarthritis and explore factors associated with the reporting.

Eight databases were searched from inception to August 2024 to assess the quality of acupuncture for knee osteoarthritis RCTs based on the CONSORT, the STRICTA, and the CONSORT-Outcomes. We performed regression analyses on pre-specified study characteristics to explore factors associated with reporting quality.

One hundred and seventy-four RCTs were evaluated by 69 items from 3 checklists. Seventeen of 37 items on the CONSORT were under-reported (reported in less than 20% of RCTs), and the weakest reported item was why the trial ended or was stopped (0%). Four of 17 items on the STRICTA were under-reported, and the weakest reported item was the number of needle insertions per subject per session (9.2%). Eight of 17 items on the CONSORT-Outcomes were under-reported, and the weakest reported item was identifying any outcomes that were not pre-specified in a trial registry or trial protocol (0.6%). RCT locations include countries other than China, published in English, or funded were more likely to have better reporting.

RCTs of acupuncture for knee osteoarthritis need to focus more on reporting details of acupuncture interventions, the reporting of protocol amendment, and the complete reporting of outcome-related content. Journals should encourage authors to adhere strictly to reporting guidelines, which is necessary to improve the quality of reporting, which is very important for Chinese journals.

People with stroke and their families face numerous challenges as they leave hospital to return home, often experiencing multifaceted unmet needs and feelings of abandonment. The essential elements of an intervention intended to support transition-to-home after stroke are unclear.

The aim of the project was to engage in a co-design process to identify the key components of a pragmatic intervention to inform a transition-to-home support pathway following stroke.

The study was conducted using a co-design process engaging multiple stakeholders, including 12 people with stroke, 6 caregivers, 26 healthcare professionals and 6 individuals from stroke organisations in a series of three workshops, facilitated by the primary researcher, a wider team of researchers and an individual with lived experience of stroke. World Café methodology and Liberating Structures facilitation techniques were adapted to meet the aim of the workshops. Data collection involved observations during workshops, followed by summarising of findings and reaching group consensus agreement on outputs. Facilitated consensus on a prioritisation task resulted in the final output.

The co-design group identified 10 key intervention components of a transition-to-home support pathway following stroke. These components focussed on enhancing collaboration, streamlining transition processes and facilitating post-discharge support. While a stroke coordinator was considered a top priority, increased cross-setting information sharing and community in-reach, where community-based healthcare staff extended their services into hospital settings to provide continuity care, were considered most feasible to implement.

The co-design approach, involving a multi-stakeholder group and strengthened by patient and public involvement, ensured that the identified transition-to-home intervention components are meaningful and relevant for people with stroke and their families. Further co-design workshops are required to refine, and feasibility test the components for generalisability within the wider Irish healthcare setting.

Individuals who have experienced a stroke actively contributed to shaping the methodological design of this study and the ethics process. They engaged in the analysis of co-design outputs and provided input for the discussion and recommendations regarding future research. An individual who had experienced a stroke formed part of the research team, co-facilitating the co-design workshops and co-authoring this article.

To evaluate where orthodontic research papers are published and to explore potential relationships between the journal of publication and the characteristics of the research study and authorship.

An online literature search of seven research databases was undertaken to identify orthodontic articles published in English language over a 12-month period (1 January-31 December 2022) (last search: 12 June 2023). Data extracted included journal, article, and author characteristics. Journal legitimacy was assessed using a ternary classification scheme including available blacklists and whitelists, cross-checking of indexing claims and history of sending unsolicited emails. The level of evidence (LOE) of all included studies was assessed using a modified Oxford LOE classification scale. Univariable and multivariable ordinal logistic regression analyses were performed to examine possible associations between the level of evidence, journal discipline, and authorship characteristics.

A total of 753 studies, published by 246 unique journal titles, were included and further assessed. Nearly two-thirds of orthodontic papers were published in non-orthodontic journals (62.8%) and over half (55.6%) of the articles were published in open-access policy journals. About a fifth of the articles (21.2%) were published either in presumed predatory journals or in journals of uncertain legitimacy. Journal discipline was significantly associated with the level of evidence. Higher-quality orthodontic studies were more likely published in established orthodontic journals (likelihood ratio test P < .001).

The identification and classification of predatory journals are challenging due to their covert nature.

The majority of orthodontic articles were published in non-orthodontic journals. In addition, approximately one in five orthodontic studies were published in presumed predatory journals or in journals of uncertain legitimacy. Studies with higher levels of evidence were more likely to be published in established orthodontic journals.

Randomized controlled trials (RCTs) widely considered the gold standard for evidence-based healthcare may be limited in their clinical usefulness in lifestyle interventions for adults with overweight, obesity, or metabolic syndrome.

In this systematic review of lifestyle intervention RCTs we delineated trial usefulness.

Following prospective registration in PROSPERO (CRD4202347896), we conducted a comprehensive search across Medline, Scopus, Web of Science, and the Cochrane Library databases, covering the period from inception to December 2023. RCTs involving dietary interventions, with or without physical activity, and with or without behavioural support were included. Two reviewers independently performed study selection and data extraction. Study usefulness was assessed using a multidimensional 14 item questionnaire. Percentage compliance with usefulness items was computed.

Of 1175 records, 30 RCTs (12,841 participants) were included. Among these, 13 (43%) RCTs complied with half of the usefulness items and only 3 (10%) complied with two-thirds of the items. For each usefulness item individually: 30 (100%) reported the burden of the problem addressed, 15 (50%) contextualized the trial through a systematic review, 18 (60%) presented an informative trial with clinically meaningful outcomes evaluated at a stated statistical power, 17 (57%) had low risk of bias, 2 (7%) exhibited pragmatic features pertaining to the trial methodologies and outcomes relevant to real-world application.18 (60%) were patient centred with formal patient involvement, none (0%) demonstrated value for money, 17 (57%) were completed according to their feasibility assessment achieving at least 90% of the estimated sample size, and 30 (100%) reported at least one of five transparency or openness features.

Only one in 10 lifestyle RCTs met two-thirds of the usefulness features. It is imperative to meet these criteria when devising future trials within the field of nutrition to reduce research waste.

Co-design with consumers and healthcare professionals is widely used in applied health research. While this approach appears to be ethically the right thing to do, a rigorous evaluation of its process and impact is frequently missing. Evaluation of research co-design is important to identify areas of improvement in the methods and processes, as well as to determine whether research co-design leads to better outcomes. We aimed to build on current literature to develop a framework to assist researchers with the evaluation of co-design processes and impacts.

A multifaceted, iterative approach, including three steps, was undertaken to develop a Co-design Evaluation Framework: 1) A systematic overview of reviews; 2) Stakeholder panel meetings to discuss and debate findings from the overview of reviews and 3) Consensus meeting with stakeholder panel. The systematic overview of reviews included relevant papers published between 2000 and 2022. OVID (Medline, Embase, PsycINFO), EBSCOhost (Cinahl) and the Cochrane Database of Systematic reviews were searched for papers that reported co-design evaluation or outcomes in health research. Extracted data was inductively analysed and evaluation themes were identified. Review findings were presented to a stakeholder panel, including consumers, healthcare professionals and researchers, to interpret and critique. A consensus meeting, including a nominal group technique, was applied to agree upon the Co-design Evaluation Framework.

A total of 51 reviews were included in the systematic overview of reviews. Fifteen evaluation themes were identified and grouped into the following seven clusters: People (within co-design group), group processes, research processes, co-design context, people (outside co-design group), system and sustainment. If evaluation methods were mentioned, they mainly included qualitative data, informal consumer feedback and researchers' reflections. The Co-Design Evaluation Framework used a tree metaphor to represent the processes and people in the co-design group (below-ground), underpinning system- and people-level outcomes beyond the co-design group (above-ground). To evaluate research co-design, researchers may wish to consider any or all components in the tree.

The Co-Design Evaluation Framework has been collaboratively developed with various stakeholders to be used prospectively (planning for evaluation), concurrently (making adjustments during the co-design process) and retrospectively (reviewing past co-design efforts to inform future activities).

It is vital that health service delivery and health interventions address patients' needs or preferences, are relevant for practice and can be implemented. Involving those who will use or deliver healthcare in priority-setting can lead to health service delivery and research that is more meaningful and impactful. This is particularly crucial in rural communities, where limited resources and disparities in healthcare and health outcomes are often more pronounced. The aim of this study was to determine the health and healthcare priorities in rural communities using a region-wide community engagement approach.

This multi-methods study was conducted in five rural communities in the Grampians region, Western Victoria, Australia. It involved six concept mapping steps: (1) preparation, (2) generation (brainstorming statements and identifying rating criteria), (3) structuring statements (sorting and rating statements), (4) representation of statements, (5) interpretation of the concept map and (6) utilization. Community forums, surveys and stakeholder consultations with community members and health professionals were used in Step 2. An innovative online group concept mapping platform, involving consumers, health professionals and researchers was used in Step 3.

Overall, 117 community members and 70 health professionals identified 400 health and healthcare issues. Six stakeholder consultation sessions (with 16 community members and 16 health professionals) identified three key values for prioritizing health issues: equal access for equal need, effectiveness and impact (number of people affected). Actionable priorities for healthcare delivery were largely related to access issues, such as the challenges navigating the healthcare system, particularly for people with mental health issues; the lack of sufficient general practitioners and other health providers; the high travel costs; and poor internet coverage often impacting technology-based interventions for people in rural areas.

This study identified actionable health and healthcare priorities from the perspective of healthcare service users and providers in rural communities in Western Victoria. Issues related to access, such as the inequities in healthcare costs, the perceived lack of quality and availability of services, particularly in mental health and disability, were identified as priorities. These insights can guide future research, policy-making and resource allocation efforts to improve healthcare access, quality and equity in rural communities.

A significant amount of published clinical research has no measurable impact on health and disease outcomes, and research in undergraduate medical education is viewed as especially susceptible. The aims of this mixed methods study were to (a) to use group concept mapping (GCM) to explore key features identified by hospital physicians, medical educators, and medical students as central to clinical usefulness in an undergraduate medical research context, and (b) review a sample of undergraduate medical research projects based on usefulness criteria described by Ioannidis (2016). In the GCM procedure, 54 respondents (39 students, 15 physicians) from an Irish medical school participated across each of three phases: brainstorming, sorting, and rating. Data was analysed using multidimensional scaling and hierarchical clustering. A retrospective analysis of 252 student projects was also completed using a rubric based on Ioannidis's (2016) six domains of "clinical usefulness": problem base, context placement and information gain, pragmatism, patient-centredness, feasibility, and transparency. Projects were scored for each domain by three assessors. Results were analysed and presented using descriptive analysis.GCM analysis revealed the following "clinically useful" research characteristics: optimal design and methodology, practicality, research skills development, translational impact, patient-centredness, and asking a clinical question. Following a rubric-based analysis of projects, the highest scoring categories (mean rating; range of 1-4) were feasibility (3.57), transparency (3.32), and problem base (3.05). The lowest scoring areas were context placement and information gain (2.73), pragmatism (2.68), and patient-centredness (212). We identified considerable conceptual overlap between stakeholder consensus views on "clinical usefulness" as applied to undergraduate research and Ioannidis's criteria. Patient-centredness was identified as a domain requiring greater emphasis during the design of undergraduate medical research.

The online version contains supplementary material available at 10.1007/s40670-024-02035-7.

The number of medical research publications by Chinese clinical investigators has risen substantially, contributing to 14.63% of the global total in 2019; however, their tangible impact on clinical decision-making remains limited. Various evaluation methods have been developed to measure hospital research competence in China, such as Fudan University's China hospital ranking and Science and Technology Evaluation Metrics (STEM) ranking, which predominantly focuses on factors such as academic reputation, volume of publications and patents, and research resources. However, composite indices may not fully capture the actual clinical value generated by medical research. To address this gap, we introduced the "Clinical Influence and Timeliness Evaluation (CITE)" metric to assess both the clinical importance of a given medical research study and the clinical influence of the hospital where it originated. The methodology used relies on the premise that influential medical research would be referenced in clinical guidelines, which serve as critical resources for clinicians.

The CITE metric was applied for 78,636 medical studies concerning chronic obstructive pulmonary disease (COPD) published between 2000 and 2020 and referenced in both Chinese and international clinical guidelines for COPD. Specific indexes and formulas were derived to quantify the clinical weight of a medical research study (W) and its timeliness (T), enabling a dynamic assessment of the clinical value of each study and the overall contribution of a particular hospital.

In this analysis, we incorporated 499 hospitals in China and quantitatively identified their dynamic clinical influence in COPD from 2000 to 2020. Our findings offer objective and targeted evaluation metrics by focusing on clinical relevance and recognizing the collaborative nature of medical research.

The CITE metric provides an innovative method to gauge the true impact of medical research in China, with potential applications across different medical specialties. CITE can serve as a useful tool for understanding the relationship between research input and practical clinical outcomes, ultimately promoting more clinically relevant research endeavors.

Clinical researchers should help respect the autonomy and promote the well-being of prospective study participants by helping them make voluntary, informed decisions about enrollment. However, participants often exhibit poor understanding of important information about clinical research. Bioethicists have given special attention to "misconceptions" about clinical research that can compromise participants' decision-making, most notably the "therapeutic misconception." These misconceptions typically involve false beliefs about a study's purpose, or risks or potential benefits for participants. In this article, we describe a misconception involving false beliefs about a study's potential benefits for non-participants, or its expected social value. This social value misconception can compromise altruistically motivated participants' decision-making, potentially threatening their autonomy and well-being. We show how the social value misconception raises ethical concerns for inherently low-value research, hyped research, and even ordinary research, and advocate for empirical and normative work to help understand and counteract this misconception's potential negative impacts on participants.

The response of Canada's research community to the COVID-19 pandemic provides a unique opportunity to examine the country's clinical health research ecosystem. We sought to describe patterns of enrolment across Canadian Institutes of Health Research (CIHR)-funded studies on COVID-19.

We identified COVID-19 studies funded by the CIHR and that enrolled participants from Canadian acute care hospitals between January 2020 and April 2023. We collected information on study-and site-level variables from study leads, site investigators, and public domain sources. We described and evaluated factors associated with cumulative enrolment.

We obtained information for 23 out of 26 (88%) eligible CIHR-funded studies (16 randomized controlled trials [RCTs] and 7 cohort studies). The 23 studies were managed by 12 Canadian and 3 international coordinating centres. Of 419 Canadian hospitals, 97 (23%) enrolled a total of 28 973 participants - 3876 in RCTs across 78 hospitals (median cumulative enrolment per hospital 30, interquartile range [IQR] 10-61), and 25 097 in cohort studies across 62 hospitals (median cumulative enrolment per hospital 158, IQR 6-348). Of 78 hospitals recruiting participants in RCTs, 13 (17%) enrolled 50% of all RCT participants, whereas 6 of 62 hospitals (9.7%) recruited 54% of participants in cohort studies.

A minority of Canadian hospitals enrolled the majority of participants in CIHR-funded studies on COVID-19. This analysis sheds light on the Canadian health research ecosystem and provides information for multiple key partners to consider ways to realize the full research potential of Canada's health systems.

Objective An innovative approach by two Queensland health services was taken to establish a shared maternity services' research agenda by partnering with consumers and clinicians. The objective was to set the top five research priorities to ensure that the future direction of maternity research was relevant to end-user and organisational needs. Methods A modified James Lind Alliance (JLA) methodology was applied between August 2022 and February 2023 across two south-east Queensland Health Services which included five participating maternity units and involved partnership with consumers, healthcare professionals and clinician researchers. The reporting guideline for priority setting of health research (REPRISE) was followed. Results There were 192 respondents to the initial harvesting survey, generating 461 research suggestions. These were aggregated into 122 unique questions and further summarised into a list of 44 research questions. The 157 eligible interim prioritisation survey respondents short-listed 27 questions ready for ranking at a final consensus workshop. The top five question themes were: (1) maternity care experience, engagement and outcomes of priority populations; (2) increasing spontaneous vaginal birth; (3) experiences and perceptions of woman/person-centred care; (4) best practice care during the 'fourth' trimester; and (5) antibiotic use during labour and birth. Conclusion Applying an adapted JLA framework can successfully shape and establish a research agenda within Australian health services, through partnership with consumers and practicing clinicians. This is a transparent process that strengthens the legitimacy and credibility of research agendas, and it can form a replicable framework for other settings.

The fight against cervical cancer requires effective screening together with optimal and on-time treatment along the care continuum. We examined the impact of cervical cancer testing and treatment guidelines on testing practices, and follow-up adherence to guidelines.

Data from Estonian electronic health records and healthcare provision claims for 50,702 women was used. The annual rates of PAP tests, HPV tests and colposcopies during two guideline periods (2nd version 2012-2014 vs 3rd version 2016-2019) were compared. To assess the adherence to guidelines, the subjects were classified as adherent, over- or undertested based on the timing of the appropriate follow-up test.

The number of PAP tests decreased and HPV tests increased during the 3rd guideline period (p < 0.01). During the 3rd guideline period, among 21-29-year-old women, the adherence to guidelines ranged from 38.7% (44.4…50.1) for ASC-US to 73.4% (62.6…84.3) for HSIL and among 30-59-year-old from 49.0% (45.9…52.2) for ASC-US to 65.7% (58.8…72.7) for ASCH. The highest rate of undertested women was for ASC-US (21-29y: 25.7%; 30-59y: 21.9%). The rates of over-tested women remained below 12% for all cervical pathologies observed. There were 55.2% (95% CI 49.7…60.8) of 21-24-year-olds and 57.1% (95% CI 53.6…60.6) of 25-29-year-old women who received HPV test not adherent to guidelines.

Our findings highlighted some shortcomings in guideline adherence, especially among women under 30. The insights gained from this study help to improve the quality of care and, thus, reduce cervical cancer incidence and mortality.

Sickle cell disease (SCD) remains a public health problem especially in sub-Saharan Africa including Ghana. While pilot initiatives in Africa have demonstrated that neonatal screening coupled with early intervention reduces SCD-related morbidity and mortality, only 50-70% of screen-positive babies have been successfully retrieved to benefit from these interventions. Point-of-care testing (POCT) with high specificity and sensitivity for SCD screening can be integrated into existing immunization programs in Africa to improve retrieval rates. This study explored community acceptability of integrating POCT to screen for SCD in children under 5 years of age in primary healthcare facilities in Northern Ghana.

This was an exploratory study using qualitative research approach where 10 focus group discussions and 20 in-depth interviews were conducted with community members and health workers between April and June 2022. The recorded interviews were transcribed verbatim after repeatedly listening to the recordings. Data was coded into themes using QSR Nvivo 12 software before thematic analysis.

Most participants (70.9%) described SCD as serious and potentially life-threatening condition affecting children in the area. Of 148 community members and health workers, 141 (95.2%) said the screening exercise could facilitate diagnosis of SCD in children for early management. However, discrimination, fear of being tested positive, stigmatization, negative health worker attitude linked with issues of maintaining confidentiality were reported by participants as key factors that could affect uptake of the SCD screening exercise. Most participants suggested that intensive health education (78.3%), positive attitude of health workers (69.5%), and screening health workers not being biased (58.8%) could promote community acceptability.

A large majority of participants viewed screening of SCD in children as very important. However, opinions expressed by most participants suggest that health education and professionalism of health workers in keeping patients' information confidential could improve the uptake of the exercise.

Given the high prevalence of lung cancer, an accurate diagnosis is crucial. In the diagnosis process, radiologists play an important role by examining numerous radiology exams to identify different types of nodules. To aid the clinicians' analytical efforts, computer-aided diagnosis can streamline the process of identifying pulmonary nodules. For this purpose, medical reports can serve as valuable sources for automatically retrieving image annotations. Our study focused on converting medical reports into nodule annotations, matching textual information with manually annotated data from the Lung Nodule Database (LNDb)-a comprehensive repository of lung scans and nodule annotations. As a result of this study, we have released a tabular data file containing information from 292 medical reports in the LNDb, along with files detailing nodule characteristics and corresponding matches to the manually annotated data. The objective is to enable further research studies in lung cancer by bridging the gap between existing reports and additional manual annotations that may be collected, thereby fostering discussions about the advantages and disadvantages between these two data types.

Conflicts of interest inherent in industry funding can bias medical research methods, outcomes, reporting and clinical applications. This study explored the extent of funding provided to American physician researchers studying surgical mesh used to treat uterine prolapse or stress urinary incontinence, and whether that funding was declared by researchers or influenced the ethical integrity of resulting publications in peer reviewed journals.

Publications identified via a Pubmed search (2014-2021) of the terms mesh and pelvic organ prolapse or stress urinary incontinence and with at least one US physician author were reviewed. Using the CMS Open Payments database industry funding received by those MDs in the year before, of and after publication was recorded, as were each study's declarations of funding and 14 quality measures.

Fifty-three of the 56 studies reviewed had at least one American MD author who received industry funding in the year of, or one year before or after publication. For 47 articles this funding was not declared. Of 247 physician authors, 60% received > $100 while 13% received $100,000-$1,000,000 of which approximately 60% was undeclared. While 57% of the studies reviewed explicitly concluded that mesh was safe, only 39% of outcomes supported this. Neither the quality indicator of follow-up duration nor overall statements as to mesh safety varied with declaration status.

Journal editors' guidelines re declaring conflicts of interest are not being followed. Financial involvement of industry in mesh research is extensive, often undeclared, and may shape the quality of, and conclusions drawn, resulting in overstated benefit and overuse of pelvic mesh in clinical practice.

Rapid translation of research findings into clinical practice through innovation is critical to improve health systems and patient outcomes. Access to efficient systems of learning underpinned with real-time data are the future of healthcare. This type of health system will decrease unwarranted clinical variation, accelerate rapid evidence translation, and improve overall healthcare quality.

This paper aims to describe The HARMONY model (acHieving dAta-dRiven quality iMprovement to enhance frailty Outcomes using a learNing health sYstem), a new frailty learning health system model of implementation science and practice improvement. The HARMONY model provides a prototype for clinical quality registry infrastructure and partnership within health care.

The HARMONY model was applied to the Western Sydney Clinical Frailty Registry as the prototype exemplar. The model networks longitudinal frailty data into an accessible and useable format for learning. Creating local capability that networks current data infrastructures to translate and improve quality of care in real-time.

This prototype provides a model of registry data feedback and quality improvement processes in an inpatient aged care and rehabilitation hospital setting to help reduce clinical variation, enhance research translation capacity, and improve care quality.

Pragmatic trials are increasingly recognized for providing real-world evidence on treatment choices.

The objective of this study is to investigate the use and characteristics of pragmatic trials in multiple sclerosis (MS).

Systematic literature search and analysis of pragmatic trials on any intervention published up to 2022. The assessment of pragmatism with PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) is performed.

We identified 48 pragmatic trials published 1967-2022 that included a median of 82 participants (interquartile range (IQR) = 42-160) to assess typically supportive care interventions (n = 41; 85%). Only seven trials assessed drugs (15%). Only three trials (6%) included >500 participants. Trials were mostly from the United Kingdom (n = 18; 38%), Italy (n = 6; 13%), the United States and Denmark (each n = 5; 10%). Primary outcomes were diverse, for example, quality-of-life, physical functioning, or disease activity. Only 1 trial (2%) used routinely collected data for outcome ascertainment. No trial was very pragmatic in all design aspects, but 14 trials (29%) were widely pragmatic (i.e. PRECIS-2 score ⩾ 4/5 in all domains).

Only few and mostly small pragmatic trials exist in MS which rarely assess drugs. Despite the widely available routine data infrastructures, very few trials utilize them. There is an urgent need to leverage the potential of this pioneering study design to provide useful randomized real-world evidence.

The major goal of translational research is to evaluate the efficacy and effectiveness of treatments and interventions that have emerged from exhaustive preclinical evidence. In 2007, a major clinical trial was started to investigate the impact of paravertebral analgesia on breast cancer recurrence. The trial was based on preclinical evidence demonstrating that spinal anesthesia suppressed metastatic dissemination by inhibiting surgical stress, boosting the immunological response, avoiding volatile anesthetics, and reducing opioid use. However, that trial and three more recent randomized trials with a total of 4,770 patients demonstrate that regional analgesia does not improve survival outcomes after breast, lung, and abdominal cancers. An obvious question is why there was an almost complete disconnect between the copious preclinical investigations suggesting benefit and robust clinical trials showing no benefit? The answer is complex but may result from preclinical research being mechanistically driven and based on reductionist models. Both basic scientists and clinical investigators underestimated the limitations of various preclinical models, leading to the apparently incorrect hypothesis that regional anesthesia reduces cancer recurrence. This article reviews factors that contributed to the discordance between the laboratory science, suggesting that regional analgesia might reduce cancer recurrence and clinical trials showing that it does not-and what can be learned from the disconnect.

The majority of adolescents do not meet guidelines for healthy behaviours, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway. How to develop and implement sustainable and effective interventions focused on adolescent health and well-being in urban vulnerable life situations is a key challenge. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions.

In diverse urban environments in Denmark, the Netherlands, Nigeria and South Africa, we will engage a dynamic group of 15-20 adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (eg, policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system; tailoring; implementing and evaluating interventions during participatory meetings over the course of 3 years. YoPA applies a participatory mixed methods design guided by a novel Systems, User perspectives, Participatory co-creation process, Effects, Reach, Adoption, Implementation and Maintenance framework assessing: (i) the local systems, (ii) user perspectives, (iii) the participatory co-creation process, (iv) effects, (v) reach, (vi) adoption, (vii) implementation and (viii) maintenance of interventions. Through a realist evaluation, YoPA will explore why and how specific outcomes were reached (or not) in each setting (n=800-1000 adolescents in total).

This study received approval from the ethics committees in Denmark, the Netherlands, Nigeria and South Africa and will be disseminated via various collaborative dissemination activities targeting multiple audiences. We will obtain informed consent from all participants. We envision that our YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally.

NCT06181162.

More than a decade after the Consolidated Standards of Reporting Trials group released a reporting items checklist for non-inferiority randomized controlled trials, the infectious diseases literature continues to underreport these items. Trialists, journals, and peer reviewers should redouble their efforts to ensure infectious diseases studies meet these minimum reporting standards.

Co-design methodology seeks to actively engage end-users in developing interventions. It is increasingly used to design stroke interventions; however, limited guidance exists, particularly with/for individuals with stroke who have diverse cognitive, physical and functional abilities. Thus, we describe 1) the extent of existing research that has used co-design for stroke intervention development and 2) how co-design has been used to develop stroke interventions among studies that explicitly used co-design, including the rationale, types of co-designed stroke interventions, participants involved, research methodologies/approaches, methods of incorporating end-users in the research, co-design limitations, challenges and potential strategies reported by researchers.

A scoping review informed by Joanna Briggs Institute and Arksey & O'Malley methodology was conducted by searching nine databases on December 21, 2022, to locate English-language literature that used co-design to develop a stroke intervention. Additional data sources were identified through a hand search. Data sources were de-duplicated, and two research team members reviewed their titles, abstracts and full text to ensure they met the inclusion criteria. Data relating to the research objectives were extracted, analyzed, and reported numerically and descriptively.

Data sources used co-design for stroke intervention development with (n = 89) and without (n = 139) explicitly using the term 'co-design.' Among studies explicitly using co-design, it was commonly used to understand end-user needs and generate new ideas. Many co-designed interventions were technology-based (65%), and 48% were for physical rehabilitation or activity-based. Co-design was commonly conducted with multiple participants (82%; e.g., individuals with stroke, family members/caregivers and clinicians) and used various methods to engage end-users, including focus groups and workshops. Limitations, challenges and potential strategies for recruitment, participant-engagement, contextual and logistical and ethics of co-designed interventions were described.

Given the increasing popularity of co-design as a methodology for developing stroke interventions internationally, these findings can inform future co-designed studies.

Lung cancer diagnosis affects an individual's quality of life as well as physical and emotional functioning. Information on survivorship care tends to be introduced at the end of treatment, but early intervention may affect posttreatment adjustment. However, to the best of our knowledge, no study has explored the effect of early information intervention on the return to work, family, and societal roles of lung cancer survivors.

We report the study protocol of a comprehensive care prehabilitation intervention designed to facilitate lung cancer survivors' psychological adjustment after treatment.

A comprehensive care program was developed based on a literature review and a qualitative study of patients with lung cancer and health professionals. The Lung Cancer Comprehensive Care Program consists of educational videos and follow-up visits by a family medicine physician. To prevent contamination, the control group received routine education, whereas the intervention group received routine care and intervention. Both groups completed questionnaires before surgery (T0) and at 1-month (T1), 6-month (T2), and 1-year (T3) follow-up visits after surgery. The primary outcome was survivors' psychological adjustment to cancer 6 months after pulmonary resection.

The historical control group (n=441) was recruited from September 8, 2021, to April 20, 2022, and the intervention group (n=350) was recruited from April 22, 2022, to October 17, 2022. All statistical analyses will be performed upon completion of the study.