Type 2 diabetes (T2DM) and cognitive impairment are common long-term chronic conditions affecting older people in hospital. Cognitive impairment can complicate glucose monitoring and lead to diabetes-related emergencies in T2DM. Traditionally, point of care test measurements of capillary blood glucose are conducted in-hospital for T2DM while continuous glucose monitoring (CGM) is not widely used.
To understand the feasibility, acceptability and tolerability of using CGM in older inpatients with T2DM and cognitive impairment.
32 older people (mean age=78.7±6.7 years) with comorbid T2DM and cognitive impairment (Abbreviated Mini-Mental Test ≤8/10 and Mini-Addenbrooke’s Cognitive Examination ≤22/30) were recruited within a tertiary care hospital in the UK. All participants were naive to CGM and were asked to wear blinded Dexcom G7 sensors for up to 10 days. Participants were asked about feasibility, acceptability and tolerability questions at the point of sensor removal.
29 participants (96%) reported no pain during CGM fitting. All participants (100%) agreed that they did not notice wearing the sensor, and it did not affect their day-to-day hospital activities. All participants (100%) found it ‘very easy’ or ‘easy’ to have the sensor fitted and wearing it for 10 days, with 27 participants (90%) finding CGM convenient. 17 participants (57%) reported favourable perceptions of the subcutaneous sensor sensation.
CGM use in older inpatients with T2DM and cognitive impairment is highly feasible and acceptable for patients. Future studies and trials are now needed to evaluate the clinical use of CGM for glucose monitoring in hospitalised or community-dwelling older individuals with T2DM and cognitive impairment.
To investigate changes in lateral hip pain following a 3-month, physiotherapist-led, education and exercise programme in patients with clinically and MRI-verified hip abductor tendon pathology.
Prospective cohort study.
Secondary care, Danish public teaching hospital.
From May 2024 to July 2025, 60 patients (100% women) with lateral hip pain duration of >6 months, aged 18–75 years (mean age 58.2), MRI-verified hip abductor tendon pathology were included; 55 patients completed the intervention.
Patient education on load management and modification of daily activity was provided through seven physiotherapist-led sessions over 3 months. Additionally, patients followed an individually progressed daily home-based exercise programme.
The primary outcome was change in the subscale pain of the revised Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes included hip-related patient-reported outcomes and health-related quality of life, isometric hip muscle strength and a 30-second Chair Stand Test (30s-CST).
Adherence to the exercise protocol was 85%. The mean (95% CI) score in the revised HAGOS pain improved from 46.4 (41.5 to 51.2) to 60.1 (54.4 to 65.7) at 3 months follow-up. Clinically relevant improvements were observed in secondary hip-related patient-reported outcomes, alongside improvements in generic patient-reported outcomes. Minor strength improvements were observed, while the 30s-CST improved from 11.7 (10.6 to 12.9) to 14.2 (12.8 to 15.6) repetitions.
Following 3 months of physiotherapist-led, combined patient education and exercise therapy, patients with clinically and MRI-verified hip abductor tendon pathology, seen in secondary care, experienced clinically relevant changes in lateral hip pain measured by the revised HAGOS pain.
Cardiovascular disease risk accelerates in women after the menopausal transition, coinciding with the cessation of endogenous oestrogen production. The accompanying decline in vascular function is considered a key driver of this shift. However, longitudinal studies investigating the impact and time course of changes in cardiovascular and skeletal muscle function during the menopausal transition and in the subsequent years are warranted.
The Women in Healthy Transition (KiSO) Deep Phenotyping (DP) study is a multidisciplinary prospective longitudinal cohort study with the objective to determine cardiovascular changes from the late reproductive stage through 20 years of postmenopause. The primary outcome is quantification of endothelium-dependent vascular function. Secondary outcomes include evaluating endothelium-independent vascular function, conduit artery endothelial function, mitochondrial function, circulating skeletal muscle vascular markers and sociological factors. The overall aim is to provide deep mechanistic, longitudinal insight into menopause-related vascular ageing to inform future cardiovascular disease prevention strategies in women.
200 healthy women will be examined at the late reproductive stage and at 1, 3, 5, 10 and 20 years postmenopause. At each test round vascular function is evaluated using invasive intra-arterial infusion protocols, including acetylcholine and epoprostenol infusions, as well as flow-mediated dilation. Additional measures include arterial blood pressure, arterial compliance, echocardiography, cardiorespiratory fitness, whole-blood rheology, dual-energy X-ray absorptiometry-derived body composition, circulating reproductive and cardiometabolic biomarkers, skeletal muscle biopsies for assessment of mitochondrial capacity and proteins related to skeletal muscle and cardiometabolic health. Menopausal staging is determined using Stages of Reproductive Aging Workshop (STRAW)+10 criteria supported by follicle-stimulating hormone, anti-Müllerian hormone concentrations and antral follicle count.
The study is conducted in accordance with the Declaration of Helsinki and has been approved by the regional ethics committee: Ethics Committee of Copenhagen (H-22025286) and is registered with ClinicalTrial.gov (NCT05647876). Findings from the study will be disseminated through publications in peer-reviewed scientific journals, presentations at national and international conferences and through PhD theses. The results are expected to provide novel insights into the development of vascular and skeletal muscle function across the menopausal transition and may contribute to future strategies for prevention of cardiovascular disease in women.
Study of TOfacitinib for the treatment of chronic PouchITis (STOPit) is a national, investigator-led, multicentre, open-label induction with randomised, double-blind, placebo-controlled maintenance trial to determine the effectiveness of tofacitinib to induce and maintain clinical remission in chronic pouchitis patients. The primary objective of STOPit is to evaluate the clinical response to tofacitinib, compared with placebo, using the validated modified Pouchitis Disease Activity Index score. Secondary objectives include clinical response and remission rates, endoscopic response and mucosal healing rates in induction and maintenance phases; rates of flare and recapturing response in open label extension phase; the effect of tofacitinib on clinical biomarkers and quality of life; and safety of tofacitinib use for treatment of chronic pouchitis. Study period is up to ten months, with five visits and three pouchoscopies.
Adults with ulcerative colitis who have undergone total proctocolectomy and ileal pouch-anal anastomosis and have chronic pouchitis are eligible. Participants receive open-label 10 mg two times per day tofacitinib for 8 weeks. Clinical responders at the end of week 8 will be randomised to either tofacitinib or placebo in the maintenance phase. Non-responders will receive extended induction dosing for a further 8 weeks. Persistent non-responders exit the study and responders will proceed to maintenance randomisation. Randomised individuals will be followed for 24 weeks. Patients experiencing a flare of symptoms during the maintenance phase will be eligible to receive open-label tofacitinib. Efficacy and safety data will be evaluated at 12 weeks after termination from the study. Target sample size is 72 patients to be randomised into maintenance to achieve sufficient power. Data analysis is planned to commence in October 2026.
Ethics approval was granted (Project ID 66809) and the trial was notified (CTN: CT-2020-CTN-04866-1; ANZCTR: 381128) prior to commencement. The study will be conducted in accordance with National Health and Medical Research Council (NHMRC) guidelines, and findings will be published in a peer-reviewed journal.
CTN: CT-2020-CTN-04866-1.
The initiation of buprenorphine for patients with opioid use disorder (OUD) in the emergency department (ED) has been associated with improved outcomes including reduced ED visits and increased treatment engagement. Though both standard-dose (8 mg buprenorphine equivalent) and high-dose (24 mg buprenorphine equivalent) strategies to initiate buprenorphine have been used in the ED, no prospective trials comparing outcomes among patients receiving these treatments have been reported.
This multisite randomised clinical trial is a multisite double-blind, double-dummy, randomised clinical trial enrolling 360 emergency department patients with moderate-to-severe OUD. Enrolled patients will be randomised to one of two study arms: standard-dose induction or high-dose induction, both provided in the ED. This study will engage, train and provide resources to five EDs throughout the US to recruit patients with untreated OUD into a randomised clinical trial. The primary aim is to evaluate the effects of the standard-dose induction and high-dose induction on rates of OUD treatment participation within 10 days post-randomisation. The secondary aims are to evaluate differences between standard-dose induction and high-dose induction on the outcomes of opioid craving, opioid withdrawal symptoms and illicit drug use assessed during 10 days post randomisation and evaluate the effects between treatment arms on rates of OUD treatment participation within 30 days post randomisation.
This study is funded by the National Institute on Drug Abuse and has been approved by the WCG Instutitional Review Board. It has been registered at clinicaltrials.gov. This study will inform the strategy for treatment initiation with buprenorphine among diverse ED settings and will provide ongoing evidence to support the safety and efficacy of initiating treatment for OUD in the ED.
To develop a core information set for induction of labour. Rates of induction of labour for childbirth are rising in many high-income countries. In England, a third of women have their labours induced. National guidelines recommend women receive information to make informed decisions about induction.
Two-stage consensus study using modified Delphi.
UK.
Pregnant people, parents and professionals.
Stage 1: A long list of information points was identified through a systematic review of reviews, reviewing patient leaflets, qualitative interviews and a stakeholder survey, with ongoing patient, public and professional involvement. Stage 2: Think-aloud interviews were undertaken to refine the Delphi survey before a two-round modified Delphi process where participants voted on the importance of the information items. Pre-specified criteria were used to select items taken forward to a consensus meeting.
199 information points were identified through systematic review (110), patient information leaflets (162), qualitative interviews (58) and a survey (93). 46 unique information items entered the first Delphi round after four think-aloud interviews, 2 items were added following round 2. 368 people (310 parents/58 professionals) participated in round 1 and 177 people (154 parents/23 professionals) in round 2. 44 items met inclusion criteria; one item excluded, and three items were carried forward for consensus meeting discussion where 12 overarching information points were agreed on.
This study has established a consensus-based core information set for induction of labour from a sample of the birthing population and staff providing their care. The resultant set has been populated with evidence in line with national guidelines. It can be used by women and clinicians as a standardised starting point from which to personalise discussions about birth.
COMET Initiative registration 2600: Developing a core information set for induction of labour.
To explore priorities, barriers to and experiences of palliative and end-of-life care from the perspectives of people living with HIV.
Cross-sectional online survey conducted in the UK between September 2024 and November 2024.
Online survey of people living with HIV.
The sample (N=90) was adults living with HIV in the UK. The majority of participants were male (82.4%), gay men (77.8%) and white (88.1%).
The majority of participants (58.9%) reported knowing what palliative care was and that they could explain it to someone else; however, a misconception about palliative care being only for the end of life was evident. Over a quarter of respondents (27.8%) reported that their HIV status ‘Sometimes’ negatively affected their experiences of care in general practitioner, hospital and dental settings. The top three priorities for end of life were (1) being in a calm atmosphere, (2) being free of pain and (3) support with psychological well-being. Not being judged was also identified as a priority.
To promote integration of palliative and end-of-life care into care pathways for people living with HIV, partnerships with HIV services and charities may be needed as well as tailored messaging and training for staff in generalist services.
Although evidence on whether particular birthing positions offer advantages over others remains inconclusive, the majority of women give birth in the supine position. Earlier research associates maternal satisfaction with autonomy and active participation in choosing positions, irrespective of the clinical outcome. In practice, however, autonomy may be limited by the dynamics of labour, insufficient information and sociocultural norms. Against this background, the intervention aims to enhance maternal autonomy in childbirth through the provision of activating information materials and psychological nudges. Women shall be encouraged to explore various positions enabling them to autonomously choose positions that best align with their individual needs.
Using an exploratory pre-post design, this controlled intervention is carried out as a multicentre study in six German obstetrics departments. The intervention will include various ways to inform and nudge women to move and try out various positions autonomously during childbirth. Due to its minimally invasive character, it should easily integrate into organisational processes and everyday care. The primary endpoint of the study is the proportion of mothers who indicate that their final birthing position felt appropriate. Secondary endpoints include the proportion of upright positions as final birthing positions and maternal and neonatal health outcomes among others. Data sources include maternal longitudinal data, birth companions’ and midwives’/physicians’ perspectives as well as clinical sheets and aggregated comparisons.
This study obtained ethical approval from the Ethics Committee of the Medical Faculty of the University of Bonn and the Medical Chamber of Nordrhein (2025–325 BO). All study procedures will adhere to relevant data protection regulations. Dissemination of project information, materials and results will take place through the project homepage, social media and peer-reviewed journals.
DRKS00036899; (https://drks.de/search/en/trial/DRKS00036899/entails).
Bipolar II disorder (BDII) accounts for the majority of patients with bipolar disorder (BD), yet evidence supporting first-line mood stabilising treatment with lithium and lamotrigine is scarce, and the certainty of the evidence is very low. This highlights a critical evidence gap within psychiatric care. The lithium versus lamotrigine-bipolar randomised controlled trial (RCT) aims to compare lithium and lamotrigine on self-rated day-to-day mood instability (MI) and other patient-centred outcomes in BDII, hypothesising the superiority of lithium.
A two-arm, single-blind, parallel-group, superiority RCT with a target sample size of 200 patients (accounting for attrition), recruiting patients with newly diagnosed BDII from specialised outpatient mood disorder clinics in the capital region of Copenhagen, Denmark. Participants are randomised in a 1:1 ratio to receive either lithium or lamotrigine for 6 months. The primary outcome is MI, assessed via daily smartphone-based mood ratings. MI is chosen as the primary outcome measure due to its internal validity as a real-life measure for patients and external validity as it reflects both illness severity and functional impairment. Secondary outcomes include the proportion of participants showing a non-response to treatment and observer-rated changes in depressive symptoms over 6 months, measured using the six-item version of the Hamilton Depression Rating Scale. Primary analyses will follow the intention-to-treat principle using linear mixed models. The trial is monitored by the good clinical practice.
Recruitment commenced on 8 May 2024, and the final participant follow-up (last patient last visit) is expected on 1 December 2027.
The trial has received approvals from the Danish Research Ethics Committee, the Danish Medicines Agency (EU CT No. 2023–5 09 607-32-00) and the Capital Region Data Agency (P-2023-307). Results will be published in peer-reviewed journals.
Clinicaltrials.gov/NCT06184581.
To investigate how patients with sarcoma present prior to diagnosis—through a general practitioner (GP) or another healthcare professional (HCP)—and describe presenting symptoms.
International observational cohort study.
Data were obtained from the longitudinal ‘QUality of life and Experiences of Sarcoma Trajectories’ (QUEST) cohort study, conducted across the Netherlands, the United Kingdom (UK), Australia and New Zealand.
Among 572 patients, 487 (85.1%) started their diagnostic trajectory at the GP (subcohort 1) and 85 (14.9%) with another HCP (subcohort 2)—mainly medical specialists treating unrelated conditions (36/85; 42.4%). Soft tissue sarcoma patients most often reported swelling, whereas bone sarcoma patients reported unexplained pain. Notably, 31/85 (36.5%) of subcohort 2 were asymptomatic. Reasons for delaying GP visits included assuming symptoms were minor and expecting them to resolve. Patients sought care when, among others, symptoms persisted and worsened.
Most patients first consulted a GP, underlining the role of primary care in sarcoma diagnosis internationally. Due to rarity and nonspecific symptoms, faster diagnosis remains challenging, requiring improvements in both primary and specialist care.
NCT03441906; Results.