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Background Older patients often experience safety issues when transitioning from hospital to home. The ‘Your Care Needs You’ (YCNY) intervention aims to support older people to ‘know more’ and ‘do more’ whilst in hospital so that they are better prepared for managing at home. Methods A multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention. Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data. A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention’s underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards. Discussion This study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts. Trial registration UK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020.

Background The ‘Your Care Needs You’ (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay. Methods A cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward. Results Ten wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% ( n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients’ health, capacity, and preferences. Conclusions If implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home. Trial registration ISRCTN: 51154948.

Abstract Aims Morphine is shown to relieve chronic breathlessness in chronic obstructive pulmonary disease. There are no definitive data in people with heart failure. We aimed to determine the effectiveness and cost-effectiveness of 12 weeks morphine therapy for the relief of chronic breathlessness in people with chronic heart failure compared with placebo. Methods and results Parallel group, double-blind, randomized, placebo-controlled, phase III trial of 20 mg daily oral modified release morphine was conducted in 13 sites in England and Scotland: hospital/community cardiology or palliative care outpatients. The primary analysis compared between-group numerical rating scale average breathlessness/24 hours at week 4 using a covariance pattern linear mixed model. Secondary outcomes included treatment-emergent harms (worse or new). The trial closed early due to slow recruitment, randomizing 45 participants [average age 72 (range 39–89) years; 84% men; 98% New York Heart Association class III]. For the primary analysis, the adjusted mean difference was 0.26 (95% confidence interval, −0.86 to 1.37) in favour of placebo. All other breathlessness measures improved in both groups (week 4 change-from-baseline) but by more in those assigned to morphine. Neither group was excessively drowsy at baseline or week 4. There were no between-group differences in quality of life (Kansas) or cognition (Montreal) at any time point. There was no exercise-related desaturation and no change between baseline and week 4 in either group. There was no change in vital signs at week 4. The natriuretic peptide measures fell in both groups but by more in the morphine group [morphine 2169 (1092, 3851) pg/mL vs. placebo 2851 (1694, 5437)] pg/mL. There was no excess serious adverse events in the morphine group. Treatment-emergent harms during the first week were more common in the morphine group; all apart from 1 were ≤ grade 2. Conclusions We could not answer our primary objectives due to inadequate power. However, we provide novel placebo-controlled medium-term benefit and safety data useful for clinical practice and future trial design. Morphine should only be prescribed in this population when other measures are unhelpful and with early management of side effects.

Extracellular ATP is implicated in numerous sensory processes ranging from the response to pain to the regulation of motility in visceral organs 1 . The ATP receptor P2X 3 is selectively expressed on small diameter sensory neurons 2 , 3 , 4 , supporting this hypothesis. Here we show that mice deficient in P2X 3 lose the rapidly desensitizing ATP-induced currents in dorsal root ganglion neurons. P2X 3 deficiency also causes a reduction in the sustained ATP-induced currents in nodose ganglion neurons. P2X 3 -null mice have reduced pain-related behaviour in response to injection of ATP and formalin. Significantly, P2X 3 -null mice exhibit a marked urinary bladder hyporeflexia, characterized by decreased voiding frequency and increased bladder capacity, but normal bladder pressures. Immunohistochemical studies localize P2X 3 to nerve fibres innervating the urinary bladder of wild-type mice, and show that loss of P2X 3 does not alter sensory neuron innervation density. Thus, P2X 3 is critical for peripheral pain responses and afferent pathways controlling urinary bladder volume reflexes. Antagonists to P2X 3 may therefore have therapeutic potential in the treatment of disorders of urine storage and voiding such as overactive bladder.

In blended care, digital mental health interventions (DMHIs) integrate with face-to-face psychotherapy provided in person or via telehealth. To incorporate DMHIs into routine care for depression and anxiety, it is important to understand the needs and expectations of mental health professionals for blended DMHIs. The study objective was to partner with Australian mental health professionals in the design of a transdiagnostic, cognitive behavioral therapy-based blended model of care for adults experiencing depression and anxiety. Participants were Australian health professionals who treat adults with depression and anxiety. The participatory design process included a web-based survey (N=258), one-on-one interviews (N=14), and a 2-part focus group (N=6). Quantitative and qualitative data were collected through the web-based survey. In-depth qualitative feedback from interviews and the 2-part focus group was subjected to reflexive thematic analysis. Mental health professionals found blended care with face-to-face therapy more acceptable than telehealth and blended care with telehealth, with standalone DMHIs being the least preferred option. The most common ways in which mental health professionals thought a DMHI could integrate with face-to-face psychotherapy included homework completion (129/178, 72.5%), skills practice to support in-session therapy (128/178, 71.9%), and psychoeducation (127/178, 71.3%). Mental health professionals expect the blended DMHI to be easy to use, flexible, protective of client data, and to include evidence-based content from several therapeutic modalities (eg, cognitive behavioral therapy and mindfulness). Other preferences included mental health professionals being able to prescribe specific program modules to their clients, track the treatment progress of clients, and receive alerts if their clients' symptoms worsened. In terms of implementation, mental health professionals were concerned about the time and effort needed to use blended care. They suggested that ongoing training and support would help mental health professionals implement blended care with their clients. Monitoring client risk and progress via a web-based dashboard and downloadable summaries was also important. Designing DMHIs that support psychotherapy for adults with depression and anxiety has the potential to increase access to evidence-based treatment. Involving mental health professionals in DMHI design is expected to increase their acceptance of DMHIs and facilitate the integration of these digital products into routine care.

Background Patients, particularly older people, often experience safety issues when transitioning from hospital to home. Although the evidence is currently equivocal as to how we can improve this transition of care, interventions that support patient involvement may be more effective. The ‘Your Care Needs You’ (YCNY) intervention supports patients to ‘know more’ and ‘do more’ whilst in hospital in order that they better understand their health condition and medications, maintain their daily activities, and can seek help at home if required. The intervention aims to reduce emergency hospital readmissions and improve safety and experience during the transition to home. Methods As part of the Partners At Care Transitions (PACT) programme of research, a multi-centred cluster randomised controlled trial (cRCT) will be conducted to explore the feasibility of the YCNY intervention and trial methodology. Data will be used to refine the intervention and develop a protocol for a definitive cRCT. Ten acute hospital wards (the clusters) from varying medical specialties including older peoples’ medicine, trauma and orthopaedics, cardiology, intermediate care, and stroke will be randomised to deliver YCNY or usual care on a 3:2 basis. Up to 200 patients aged 75 years and over and discharged to their own homes will be recruited to the study. Patients will complete follow-up questionnaires at 5-, 30-, and 90-days post-discharge and readmission data up to 90-days post-discharge will be extracted from their medical records. Study outcomes will include measures of feasibility (e.g. screening, recruitment, and retention data) and processes required to collect routine data at a patient and ward level. In addition, interviews and observations involving up to 24 patients/carers and 28 staff will be conducted to qualitatively assess the acceptability, usefulness, and feasibility of the intervention and implementation package to patients and staff. A separate sub-study will be conducted to explore how accurately primary outcome data (30-day emergency hospital readmissions) can be gathered for the definitive cRCT. Discussion This study will establish the feasibility of the YCNY intervention which aims to improve safety and experience during transitions of care. It will identify key methodological and implementation issues that need to be addressed prior to assessing the effectiveness of the YCNY intervention in a definitive cluster randomised controlled trial. Trial registration UK Clinical Research Network Portfolio: 42191; ISTCRN: ISRCTN51154948 . Registered 16/07/2019.

There is evidence to suggest that component randomized controlled trials (RCTs) within systematic reviews may be biased. It is important that these reviews are identified to prevent erroneous conclusions influencing health care policies and decisions. To assess the likelihood of bias in trials in 12 meta-analyses. A review of 12 systematic reviews. Twelve recently published systematic reviews with 503 component randomized trials, published in the British Medical Journal, The Lancet, Journal of the American Medical Association, and The Annals of Internal Medicine before May 2012. Systematic reviews were eligible for inclusion if they included only RCTs. We obtained the full text for the component RCTs of the 12 systematic reviews (in English only). We extracted summary data on age, number of participants in each treatment group, and the method of allocation concealment for each RCT. Five of the 12 meta-analyses exhibited heterogeneity in age differences (I2 > 0.30), when there should have been none. In two meta-analyses, the age of the intervention group was significantly greater than that of the control group. Inadequate allocation concealment was a statistically significant predictor of heterogeneity in one trial as observed by a metaregression. Most of the sample of recent meta-analyses showed that there were signs of imbalance and/or heterogeneity in ages between treatment groups, when there should have been none. Systematic reviewers might consider using the techniques described here to assess the validity of their findings.