Conectar
The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.
We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.
This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.
Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.
This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.
Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.
Traumatic musculoskeletal injuries are common and often life changing. The 6-month period following injury is a critical phase in recovery, during which engagement with rehabilitation professionals can be key to achieving positive outcomes. However, there is limited understanding of which aspects of recovery matter most to patients, how they define a successful recovery and what this looks like when captured during the lived recovery process. The aim of this study was to explore patients’ views and perceptions of recovery following musculoskeletal trauma and to understand what constitutes successful recovery at 6 months postinjury.
Qualitative study using interpretative phenomenological analysis through semi-structured interviews.
Major trauma centre in the UK.
13 participants (mean age (SD) 51 (17) years, 69% male) completed the interview. Eligibility criteria: adults
Three main themes were identified: (1) The recovery journey: participants reflected on their recovery while still processing the accident/injuries. They often drew on other people’s experiences to make sense of their recovery. Recovery was accompanied by a range of negative emotions and personal challenges. (2) The outcome: participants used multiple strategies to work towards recovery, guided by personalised individual goals. A successful recovery was defined as their ‘normal’. (3) Healthcare/clinicians impact recovery: Participants reported confusion and mixed messages from healthcare professionals, leading to uncertainty around injury management. Fragmented care pathway and difficulties accessing healthcare and support were also highlighted.
Recovery at 6 months post injury involves a complex interplay of physical and emotional factors. This period can be particularly challenging to navigate, often with no or limited support. There is a need for a targeted, individualised approach to guide patients through this period of recovery. Participants’ focus was on the outcome following their injury, setting goals for the future, with successful recovery defined as ‘normal’. Further research is needed to support clinicians in developing effective psychologically informed rehabilitation plans.
Adolescent idiopathic scoliosis (AIS) is a common paediatric spinal deformity with large curves surgically managed through spinal fusion. However, postoperative rehabilitation remains inconsistent and varies depending on clinician, hospital or location. Our international e-Delphi consensus established a broad range of statements from preoperative care until 12 months postoperatively. However, rehabilitation and graded return to sport between 3 and 12 months remains vague and further consensus work is needed. This study aims to understand the intermediate and late stages of rehabilitation in order to guide return to sport, exercise and physical activity. The primary objective is to explore content of rehabilitation and milestones between 3 and 12 months postoperatively. This understanding of postoperative care will form the basis for future postoperative guidance.
This protocol for a nominal group technique (NGT) study is written in accordance with the Accurate Consensus Reporting Document guidelines. A national sample of expert surgeons, physiotherapists and nurses in AIS will be recruited. The NGT will take place virtually and will consist of six stages: stage 1: idea generation; stage 2: round robin idea sharing; stage 3: discussion and clarification; stage 4: anonymous voting; stage 5: results feedback; and stage 6: discussion and final voting. This NGT will be preceded by a scoping review which will be disseminated a priori to inform stage 1 idea generation. The population, concept, context framework will be used to explore postoperative rehabilitation towards sports, exercise or physical activities following any kind of spinal surgery. The study steering group and patient and public involvement representative have been involved from conceptualisation and will continue to be involved until final dissemination.
The University of Birmingham has provided ethical approval: ERN_4201-Jun2025. Dissemination will take place through conference presentation and peer-reviewed publications.
There is a pressing need for effective interventions that can support healthcare workers and caregivers in the challenging yet crucial task of disclosing the HIV status to infected children and adolescents. Previously, we developed and tested a successful disclosure intervention called Sankofa in Ghana. In an ongoing 5-year follow-up study, Sankofa 2, we aim to build on the successful Sankofa trial by testing the intervention on a larger scale.
This study is a pragmatic, stepped-wedge cluster randomised trial.
It is being conducted in 12 HIV paediatric clinics in Ghana to examine the effectiveness, health benefits, cost and implementation of the Sankofa intervention. Caregiver–child dyads (n=700) will be enrolled. Evaluation of effectiveness, health benefits, cost and implementation of the Paediatric HIV disclosure intervention, Sankofa 2, is posed to offer valuable insights for scale-up and sustainability.
Ethical clearance has been obtained from the Ghana Health Service Ethics Review Committee, the University of Ghana Ethical and Protocol Review Committee, the Committee on Human Research Publication and Ethics of the Kwame Nkrumah University of Science and Technology, the Johns Hopkins Medicine Institutional Review Board and the Yale School of Medicine Human Investigation Committee. The clinical trial was registered on ClinicalTrials.gov on 5 March 2021. All caregiver participants are required to provide written informed consent and the children assent before enrolment. If either the child or caregiver says no to the study, the dyad is not eligible for the study. No study-related procedures are performed until consent is obtained. The results of the trial will be added on ClinicalTrials.gov, published in peer-reviewed journals and presented at international conferences.
Research on the impact of smoking behaviour across generations has primarily focused on grandmaternal smoking during pregnancy. However, the broader multigenerational effects of smoking behaviour, notably through environmental and behavioural pathways, remain underexplored. This study evaluated previous studies on the possibility of transgenerational transmission, rather than in utero transmission, regarding the effects of grandparental smoking behaviour on offspring’s development outcomes.
This study is a systematic review with qualitative evidence synthesis.
A comprehensive search was conducted across multiple online databases, including PubMed, EBSCOhost, Web of Science and Scopus. To ensure a broad scope of relevant studies, publication dates, study locations and language were restricted to English only.
After duplicates were removed, 3916 articles remained from the 4133 identified articles. Based on the predefined eligibility criteria, 38 articles were selected for full-text assessment. The selection process involved multiple reviewers, with disagreements resolved through consensus.
Multiple reviewers independently extracted data using a standardised protocol. The Joanna Briggs Institute critical appraisal tool was used to assess the quality of the included studies, with inter-rater reliability tests indicating moderate-to-high agreement. Extracted data included study design, participant demographics, exposure details and measured outcomes.
This systematic review included seven studies because of heterogeneity in reported outcomes and effect measures. Three independent reviewers extracted data using a standardised coding sheet. The synthesis compared methodologies, identified gaps, key findings and conclusions across studies.
Seven included articles examined grandchildren’s behaviour, such as hyperactivity disorder, oppositional defiant disorder and conduct problems, body composition and IQ concerning grandparents’ smoking habits. Most studies used robust statistical methods; two included parental factors as mediators. The synthesis of results indicated that the associations were primarily indirect. Key findings revealed that grandparents’ smoking status was significantly associated with their grandchildren’s physical and cognitive outcomes. Furthermore, the reviewed studies demonstrated sex-specific transgenerational effects of ancestral smoking on grandchildren’s health, with stronger effects often observed in male descendants.
This review highlights the methods and findings of previous studies on the potential transgenerational transmissions through which grandparents’ smoking behaviour may influence grandchildren’s behavioural, physical and cognitive development. Although the findings emphasise the importance of environmental and behavioural factors, further research is needed to address existing gaps and clarify mechanisms.
This systematic review protocol was registered in the PROSPERO database under registration number CRD42024571725.
Early-life exposures, such as nutritional deficiencies, stress, smoking, toxins, medications, diseases, infections and inflammation may affect multiple physiological and metabolic systems in the offspring, including hormonal regulation, bone metabolism and mineralisation, and body composition. Moreover, the effect of these early-life exposures on later health may potentially be mediated through adverse neonatal epigenetic reprogramming of bone-related genes affecting health later in life, especially skeletal development and bone density. Thus, to advance this research further, the overall aim of the project is to investigate if (a) neonatal epigenetic and genetic signature; (b) maternal risk factors during preconception and pregnancy, such as medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle; (c) risk factors at birth, such as instrumental delivery, mode of delivery, medicine use, injuries, diseases, weight, size for gestational age, ponderal index, gestational age; and (d) childhood risk factors, such as diseases, medicine use, major life events, weight, growth and lifestyle are associated with hormonal status, lipids, bone turnover markers, bone mineral density, fat mass and lean body mass at age 18–19 years.
Population-based, nationwide, cross-sectional clinical study with potential for longitudinal reassessment. Danish women and men aged 18–19 years old will be selected at random from the Danish National Population Registry and invited if they have available neonatal dried blood spot cards. A total of 2000 individuals will be enrolled. The study combines register data, and neonatal epigenetic and genetic analyses from stored blood with clinical and survey data. Body composition will be measured using dual-energy X-ray absorptiometry. Adult blood and hair samples will be obtained to assess hormonal status, lipids and bone turnover markers. Height, weight, waist and hip circumference, and blood pressure will be measured. Questionnaires on well-being, sleep patterns, dietary and exercise habits, onset of puberty, use of cannabis, nicotine, alcohol and pain medication will be included. Information on medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle will be obtained from the national administrative and health registers at the time of conception and during pregnancy for the parents, as well as from the participants throughout their lifetime. Health registries include the Danish Medical Birth Register, the National Patient Register, the Danish National Prescription Register, the National Child Health Register and Statistics Denmark. Multivariate regression analyses will be performed.
This nationwide study has been approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-20230105). The study participants will be enrolled in the study following their informed written consent. Results will be submitted for publication. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guidelines will be used for reporting.
Providing care management, treatment and support to patients with Alzheimer’s Disease and Related Dementias (ADRD) is a difficult task for health systems. Over the past 20 years, interventions designed to improve outcomes for patients living in the community with dementia and their care partners have moved progressively, but separately, from large scale trials and pragmatic models of collaborative care. Given the projected increase in the number of people living with dementia coupled with the realignment of payment for services to be value-based and provided in the community, system-level approaches are needed to address the complex needs of patients with a dementia diagnosis and their care partners. We designed a statewide, pragmatic trial to evaluate virtual delivery of an evidence-based dementia collaborative care program on patient healthcare utilization and medication use.
The Aging Brain Care Virtual (ABCV) program is a 12-month embedded, cluster randomized, usual care controlled trial designed to test the effectiveness of a virtual dementia collaborative care program in 24 Indiana University Health primary care clinics (12 intervention, 12 control) across the state of Indiana, enrolling 860 persons living with dementia (430 intervention, 430 control) and their care partners. ABCV relies on a tailored approach in which dyad needs are identified during virtual visits and addressed with standardized protocols previously tested in a randomized controlled trial delivered in person. The ABCV trial will measure emergency department utilization (primary outcome) and appropriate medication use (secondary outcome) at 12 months using electronic medical record data. Additionally, this study will use semi-structured interviews with care partners and clinicians to explore the implementation context, process and outcomes of the ABCV program.
Ethics approval was obtained from the Indiana University Institutional Review Board (20249). Research findings will be published in peer-reviewed journals and presented at scientific conferences.
To gain insight into patients’ views, perceptions, experiences and expectations postlumbar discectomy.
A qualitative study using interpretative phenomenological analysis (IPA) purposively recruited patients undergoing lumbar discectomy at one UK spinal centre. Purposive criteria included age, sex, ethnicity, symptom duration, work/sick leave, education level and co-existing psychological issues. Semi-structured interviews were conducted using a patient co-constructed topic guide. Interview transcriptions were analysed in accordance with IPA. Strategies enhancing trustworthiness included suspension of judgements and presuppositions, reflexivity, iterative coding process and critique from co-investigators.
Data from 14 participants (eight elective, 6 emergency surgery) informed four themes. The theme ready to move forwards was characterised by high satisfaction with post-operative improvement, positivity and optimism, with readiness to work towards personal goals. The theme post-operative fear and uncertainty was characterised by reflections on pre-operative difficulties fuelling fear about potential recurrence and long-term impacts. The theme of advice and guidance considered important was characterised by the expectation and value of support provided (verbal, written); instances of negative influences from healthcare interactions and access to unregulated patient information sources suggest scope for future improvement. The final theme, heterogeneity in peri-operative needs, was characterised by variation in depth/access to patient information, perceived post-operative support and wide-ranging preoperative activity/fitness.
Surgery offers physical and psychosocial changes which could be better harnessed to positively influence recovery through high quality verbal/written communication. Peri-operative advice and guidance was valued; while this was sufficient for some, personalised rehabilitation should be available owing to the identified heterogeneity.
FreshRSS 