Consumer perspectives on implementing falls prevention and management in rehabilitation hospitals: protocol for a qualitative study

Introduction
High-quality clinical practice guidelines and hospital standards on falls prevention and management now exist, yet their implementation into clinical practice is variable. Insights from consumers could help to guide the development of a process to improve the implementation of falls prevention and management, particularly in rehabilitation hospitals where fall rates are high.

Methods and analysis
A qualitative descriptive study will incorporate semistructured interviews and focus groups to explore the perspectives of hospital consumers on how hospital falls prevention evidence can best be implemented into rehabilitation practice. Thematic analysis of the data will be conducted in NVivo using a six-phase thematic coding process guided by Braun and Clarke. Evaluation and synthesis of the data will also follow the Consolidated Criteria for Reporting Qualitative Research checklist. Consideration of the results from the interviews and focus groups will provide insights into the views of people with lived experience of hospitalisation and falls. Thematic analysis will be supported by direct quotes for each key theme and will highlight how the themes relate to the study aims and the rehabilitation context.

Ethics and dissemination
The study was approved by La Trobe University Human Research Ethics Committee (HEC24526). The study will be published in a peer-reviewed journal, and findings will be presented at conferences, workshops and online events.

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Insurance type and risk of dementia diagnosis after traumatic brain injury: a study of 267 473 US civilians from 2000 to 2022

Objectives
To evaluate how insurance influences the risk of a dementia diagnosis among a large, diverse cohort of US civilian adults with traumatic brain injury (TBI) over a 22-year period.

Design
This is a retrospective cohort study involving individuals diagnosed with TBI.

Setting
The study used the Merative MarketScan Research Database, specifically drawing from the Commercial Claims and Encounters, Medicare Supplemental and Medicaid databases, from 2000 to 2022 in the USA. These databases provide comprehensive insights into healthcare services received by enrollees, including inpatient and outpatient services, outpatient prescription claims, clinical utilisation records and healthcare expenditures.

Participants
267 473 adults aged 55 and older who were diagnosed with a TBI between 1 January 2000 and 31 December 2022. Individuals with unknown TBI severity and dementia claims 2 years preceding TBI were excluded. TBI and dementia diagnoses were identified using International Classification of Disease 9th and 10th editions codes from inpatient and outpatient admission records.

Interventions
None.

Primary and secondary outcome measures
We compared the incidence of all-cause dementia across different insurance types to assess potential disparities in diagnosis following TBI. Cox proportional hazards models, with age as the time scale, were used to study the association between insurance type and dementia diagnosis following a TBI. Models were adjusted for key demographic variables, medical comorbidities and psychiatric conditions to account for potential confounding.

Results
Of the 267 473 individuals with TBI, 12.7% were diagnosed with dementia over a mean follow-up period of 40 months (SD of 42 months). Dementia incidence differed significantly by insurance type, with 18.2% for Medicaid recipients, 17.3% for Medicare beneficiaries and only 2.3% among individuals with commercial insurance. The adjusted HR for dementia was notably higher among individuals enrolled on Medicaid (HR 2.9, 95% CI: 2.8 to 3.1) and Medicare (HR 2.1, 95% CI: 2.0 to 2.2), when compared with those with commercial insurance.

Conclusions
Individuals with TBI covered by Medicaid and Medicare are significantly more likely to be diagnosed with dementia, with a 2.9-fold and 2.1-fold increase risk, respectively, compared with those with commercial insurance. Addressing insurance-related disparities in dementia diagnosis is crucial for building a more equitable healthcare system. It is essential that individuals with TBI cases, regardless of their insurance type, have access to comprehensive care and preventive interventions to achieve the best possible long-term outcomes.

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Methods of assessment of diabetic retinopathy in low- and middle-income countries: a protocol for scoping review

Introduction
Globally, over a hundred million people are estimated to suffer from diabetic retinopathy (DR), which is a major complication of diabetes mellitus (DM). The prevalence of DM is projected to increase from the current 537 million by almost 50%, to 783 million by 2045. As a result, DR is one of the fastest rising causes of preventable blindness. Three out of four people suffering from DM live in low- and middle-income countries (LMICs), where resources for both diagnosis and treatment are lacking. There has been a reduction in the rate of blindness from DR in high-income countries, while an opposite trend has been noted in LMICs, contributing to this massive morbidity burden. This scoping review aims to ascertain the methods used to assess DR in LMICs.

Methods and analysis
The scoping review will adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Review (PRISMA-ScR) guidelines and the Arksey and O’Malley (2005) methodology framework. A systematic search of peer-reviewed literature will be carried out for all papers up to 15 May 2025 by identifying studies from electronic databases, including Embase, Medline and CENTRAL (Cochrane Library). A hand search of the associated reference lists of included studies and grey literature will also be conducted. The identified studies will be screened based on agreed eligibility (inclusion/exclusion) criteria by two independent reviewers, with any disagreements resolved via arbitration from a third reviewer. The data will be thematically summarised according to different aspects of DR assessment methods, and key findings will be elicited. The key findings will provide a comprehensive and clear understanding of the assessment methods used to identify DR in LMICs.

Ethics and dissemination
Ethical approval was not sought for this work as only publicly available information is used. The results will be disseminated through a peer-reviewed publication, conference presentations and meetings with stakeholders.

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Objectivity in Medicine vs Inference in Poetry

A compelling aspect of both medicine and poetry is how each incites us to articulate our perceptions through specific applications of expressive language. In medicine, words are firmly grounded upon what we directly observe; assumptions are discouraged, for concern that unconscious biases might lead to erroneous conclusions. In poetry, on the other hand, what we see is often just a touchstone for what we can infer, our imaginations unbounded by an idiom that senses as much as it describes. These two modes of comprehending are instructively contrasted in “The Morning After the Election.” We are at first dropped into a narrative about a father and a daughter, reckoning momentarily that the daughter “who had once been his son” and now living far away has been rejected by her family—until the poetically appreciated detail of “the mustache obscuring his lip quivered” as he describes her new imperilment leads us to a deeper inference instead that he must accept and love her. Additional surprising implications that further test objectivity follow, from the reference to another “perfect” son whose death during childbirth ended the patient’s marriage, which underscores how the speaker may have wrongly construed that the transgender child caused familial strife, to the oversimplified and also partly true (yet in retrospect not entirely so, and thus all the more poignant) reason for the patient’s clinic visit as solely “because his blood pressure is high.” Poetry, by transcending the ostensible and harkening to the intuited, allows us to more fully grasp the complexities of our patients’ experiences.

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Increasing Colorectal Cancer Screening Participation

Although national guidelines have recommended colorectal cancer (CRC) screening for nearly 3 decades, only about 72% of adults aged 50 to 74 years are up to date on screening. Persistent underuse of CRC screening presents an opportunity for applying the principles of implementation science to improve appropriate screening practices. The primary care setting is an ideal focus for these efforts. Before patients complete a primary care appointment, their eligibility for CRC should be ascertained, they should be informed about screening options, and testing should be ordered for those who are interested.

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A World Without WHO—Reply

In Reply We greatly appreciate the thoughtful Letter by Mr Blakley and Dr Schluger about our recent Viewpoint, “A World Without WHO—A Crossroads for US Global Health Leadership.” Our Viewpoint was developed in the uncertain days leading up to the presidential transition, and we are grateful for this opportunity to consider the global health challenges that have arisen rapidly in President Trump’s second term.

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Blood-Based Colorectal Cancer Screening

Despite a significant decline in colorectal cancer (CRC) incidence and mortality over the past several decades in the US, CRC remains the second leading cause of cancer deaths. Most of these deaths could be prevented if the 42% of Americans aged 45 to 75 years who are not up to date with screening would participate. There is strong evidence supporting screening with lower intestinal endoscopy (ie, colonoscopy or flexible sigmoidoscopy) or repeated rounds of occult blood–based stool screening tests. These screening tests are effective in detecting cancer at early, curable stages as well as preventing cancer through detection and removal of advanced precancerous lesions, including adenomas and serrated colorectal lesions. Despite public awareness campaigns, organized screening (eg, programmatic mailed stool-based tests), and patient decision aids and navigation, participation is suboptimal, and closing the screening gap remains elusive. This gap may result from reluctance to complete screening due to inconvenience, discomfort, embarrassment, aversion to handling stool, or fear of complications. The ideal CRC screening test would be noninvasive and acceptable to those being screened, be highly sensitive for both early cancer and advanced precancerous lesions, have excellent specificity, and be widely accessible. All of the currently available CRC screening test options fall short of this ideal in at least 1 way, limiting their effectiveness. Thus, there is an ongoing search for more agreeable screening test options.

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Time to Study Implementation of AI-Generated Discharge Summaries

Discharge summaries are a form of communication between hospital-based and outpatient clinicians. In addition to providing an overview of the hospital course, discharge summaries frequently include information such as abnormal test results, necessary follow-up testing, and medication changes—critical information for ensuring safe continuity of care. Although discharge summaries are a recognized patient safety tool, they are also time-consuming to generate and contribute to the substantial administrative burden placed on clinicians—2 factors strongly associated with the national physician burnout crisis. Enter large language models (LLMs).

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Protocol for a multicentre, open-label, dose-escalation phase I/II study evaluating the tolerability, safety, efficacy and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with aggressive natural killer cell leukaemia

Introduction
Aggressive natural killer cell leukaemia (ANKL) is a rare form of NK cell lymphoma with a very low incidence and poor prognosis. While multi-agent chemotherapy including L-asparaginase has been used to treat ANKL patients, they often cannot receive adequate chemotherapy at diagnosis due to liver dysfunction. PPMX-T003, a fully human monoclonal antibody targeting the transferrin receptor 1, shows promise in treating ANKL by helping patients recover from fulminant clinical conditions, potentially enabling a transition to chemotherapy. This study aimed to evaluate the tolerability, safety, efficacy, and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with ANKL.

Methods and analysis
This multicentre, open-label, dose-escalation phase I/II study will be conducted at nine hospitals in Japan. Patients diagnosed with ANKL (whether as a primary or recurrent disease) and exhibiting abnormal liver function or hepatomegaly due to the primary disease will be included. The primary endpoint is the tolerability and safety of repeated continuous intravenous administration of PPMX-T003 in the first course, based on adverse events and dose-limiting toxicities. PPMX-T003 will be administered as a continuous intravenous infusion every 24 hours for five consecutive days, followed by a 2-day break. Pretreatment will be provided to minimise the risk of infusion-related reactions. Initial doses of PPMX-T003 will be 0.5, 1.0 or 2.0 mg/kg, with subsequent dose increases determined by the Data and Safety Monitoring Committee. The sample size is set at seven participants, with enrolment increased to up to 12 participants if dose-limiting toxicities occur, based on feasibility due to the rarity of ANKL. Descriptive statistics will summarise data according to initial dose, and pharmacokinetic analysis will be conducted based on administered dose.

Ethics and dissemination
This study was approved by the institutional review boards at participating hospitals. The results will be disseminated in peer-reviewed journals.

Trial registration number
jRCT2061230008 (jRCT); NCT05863234 (ClinicalTrials.gov).

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Identifying and reporting modifications to surgical innovation: a systematic review of IDEAL/IDEAL-D studies

Objectives
The Idea, Development, Evaluation, Assessment and Long-term follow-up (IDEAL) framework was designed to improve the quality of surgical research and evaluation of surgical innovation. It has become a widely cited tool for evaluating innovative devices and procedures, yet challenges remain concerning the definition and reporting of incremental innovative modifications, hindering evolution and evaluation of innovations and potentially risking patient safety. This systematic review examined IDEAL studies to identify such modifications and establish recent practices around modification reporting to inform the development of future guidance to facilitate safe, transparent and efficient surgical innovation.

Design
Systematic review and thematic synthesis of studies reporting surgical innovation.

Data sources
Web of Science and Scopus were searched in July 2023 using citation tools to identify studies following the IDEAL framework (citing any of 13 key IDEAL/IDEAL framework publications and guideline papers).

Eligibility criteria
Primary research studies of any design that involved invasive innovative devices or procedures.

Data extraction and synthesis
Study characteristics and verbatim text for all reported modifications, including contextual information, were extracted. Data were analysed and synthesised using thematic synthesis.

Results
Of 1071 records screened, 104 studies published between 2011–2023 were included (n=87 (83.6%) study reports; n=17 (16.3%) protocols). 425 modifications were reported in 76 (73.1%) studies, including modifications to procedures (n=283, 66.6%), devices (n=94, 22.1%) and patient selection (n=48, 11.3%). Procedure/device modifications included technical, non-technical and cessation (conversion to other procedures or abandonment). Modifications were most often reported within IDEAL stage 2a (n=30/44, 68.2%), whereas there was considerable variation across other stages, such as stage 0 (n=2/3, 66%) and stage 2b (n=4/12, 33.3%).

Conclusion
Reporting modifications is imperative for evaluating surgical innovation. However, this review found inconsistent approaches to reporting and describing modifications. Findings will inform the development of a checklist for reporting modifications that aims to complement the IDEAL framework and further promote shared learning, avoiding the repetition of harmful/ineffective modifications and enhancing patient safety.

PROSPERO registration number
CRD42023427704.

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Qualitative study on postbariatric surgery follow-up in France: a new patient-physician relationship

Background
Most studies on bariatric patients to date have only examined mortality and morbidities in terms of surgery or no surgery. Few have investigated loss to follow-up in post-surgery patients.

Purpose
This study aimed to describe the dynamics behind non-adherence to follow-up in bariatric patients postsurgery.

Design
Using semi-structured interviews, we performed a qualitative study. Using a thematic analysis, we described themes involved in patient adherence to postsurgery follow-up.

Setting
Participants were recruited from a university hospital near Paris and via social networks.

Participants
17 patients who had undergone surgery, some of whom were lost to follow-up, 15 women and 2 men, were interviewed, during a mean time of 90 min. 10 were adherent, and 7 were lost to follow-up.

Results
Follow-up was seen as a support in which the care provider–patient relationship can act on the four following themes: (1) regaining control, (2) knowledge acquisition, (3) management of fears and (4) overall restructuring of one’s life postsurgery.

Conclusions
Patients’ experiences and representations of postsurgery follow-up should be documented in detail in order to define the specific roles of the various care providers offering support to this population, and to strengthen the coordination of care pathways between these actors. In addition, improving the quality of communication could improve adherence to follow-up after bariatric surgery.

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Comparative efficacy and acceptability of nonpharmacological interventions for sleep disturbance among pregnant women: protocol for a systematic review and network meta-analysis

Introduction
Sleep disturbance is prevalent in pregnancy and can result in significant adverse outcomes for women and their infants. Numerous clinical trials of various nonpharmacotherapies for preventing or treating sleep disturbances have been conducted previously; however, previous systematic reviews with direct comparisons have failed to demonstrate the best options for different kinds of treatments. This systematic review and network meta-analysis (NMA) aims to explore the comparative efficacy and acceptability of nonpharmacological interventions for sleep disturbances in pregnancy and to assist clinical decision-making through ranking interventions concerning critical clinical outcomes.

Methods and analysis
We will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. Two reviewers will systematically search five major bibliographic databases (PubMed, Embase, Cochrane Library, Web of Science and Cumulative Index to Nursing and Allied Health Literature) and registries for published and unpublished randomised controlled trials (RCTs) of any nonpharmacological interventions for sleep disturbances from inception to 24 June 2025. To ensure the search is up to date, we will also perform an updated search up to the time of final analysis submission. Primary outcomes will consider efficacy (the overall mean change of any predefined sleep disturbances, including sleep quality, sleep duration and sleep-specific symptoms) and acceptability (all-cause discontinuation). The risk of bias of each included RCT will be assessed using the Cochrane Risk of Bias 2.0 Tool (RoB2). Traditional pairwise meta-analyses and NMAs will be performed to compare the efficacy and acceptability of different nonpharmacological interventions. Surface under the cumulative ranking curve for the outcomes of interest will be used to rank the competing interventions. The Grading of Recommendations, Assessment, Development and Evaluation system will be used to assess the quality of evidence associated with the main results.

Ethics and dissemination
This review is a secondary analysis of published data and, therefore, does not require ethical approval. The results will be disseminated in a peer-reviewed journal.

PROSPERO registration number
CRD42024546340.

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