Randomised controlled trials (RCTs) are the gold standard study design used to evaluate the safety and effectiveness of healthcare interventions. The reporting quality of RCTs is of fundamental importance for readers to appropriately analyse and understand the design and results of studies which are often labelled as practice changing papers. The aim of this article is to assess the reporting standards of a representative sample of randomised controlled trials (RCTs) published between 2019 and 2020 in four of the highest impact factor general medical journals. A systematic review of the electronic database Medline was conducted. Eligible RCTs included those published in the New England Journal of Medicine, Lancet, Journal of the American Medical Association, and British Medical Journal between January 1, 2019, and June 9, 2020. The study protocol was registered on medRxiv (https://doi.org/10.1101/2020.07.06.20147074). Of a total eligible sample of 498 studies, 50 full-text RCTs were reviewed against the CONSORT 2010 statement and relevant extensions where necessary. The mean adherence to the CONSORT checklist was 90% (SD 9%). There were specific items on the CONSORT checklist which had recurring suboptimal adherence, including in title (item 1a, 70% adherence), randomisation (items 9 and 10, 56% and 30% adherence) and outcomes and estimation (item 17b, 62% adherence). Amongst a sample of RCTs published in four of the highest impact factor general medical journals, there was good overall adherence to the CONSORT 2010 statement. However there remains significant room for improvement in areas such as description of allocation concealment and implementation of randomisation.

Background Heart failure with reduced ejection fraction (HFrEF) lowers patients' quality of life (QoL) [1]. Digital interventions such as ESC's “Heart Failure Matters” website aim to encourage patient-engagement & self-management [2], which remain major challenges in HFrEF care. Although remote monitoring (RM) has been tested in HFrEF with inconclusive impact on prognosis [3], its impact on patients' experience and engagement is unclear [4]. Furthermore, the perspective of clinicians using RM technologies remains unknown. We present users' experience of Luscii, a novel smartphone-based RM platform enabling HFrEF patients to submit clinical measurements, symptoms, complete educational modules, & communicate with HF specialist nurses (HFSNs). Purpose (I) To evaluate the usage-type & user experience of patients and HFSNs. (II) To assess the impact of using the RM platform on self-reported QoL Methods A two-part retrospective analysis of HFrEF patients from our regional service using the RM platform: Part A: Thematic analysis of patient feedback provided via the platform and a focus group of six HFSNs. Part B: Scores for a locally-devised HF questionnaire (HFQ), depression (PHQ-9) & anxiety (GAD-7) questionnaires were extracted from the RM platform at two timepoints: at on-boarding and 3 months after. Paired non-parametric tests were used to evaluate difference between median scores across the two time points. Results 83 patients (mean age 62 years; 27% female) used the RM platform between April and November 2021. 2 dropped out & 2 died before 3 months. Part A: Patients and HFSNs exchanged information on many topics via the platform, including patient educational modules (Figure 1). Thematic analysis revealed positive and negative impacts with many overlapping subthemes between the two user groups (Figure 2). Part B: At 3 months there was no difference in HFQ score (19 vs. 18, p=0.57, maximum possible score = 50). PHQ-9 (3 vs. 3, p=0.48, maximum possible score = 27) and GAD-7 (5 vs. 3, p=0.54. maximum possible score = 21) scores were low at onboarding and follow-up. Conclusions This evaluation shows smartphone-based RM is feasible in HFrEF with good retention (2% drop-out rate over 3 months, albeit in a cohort with low baseline depression and anxiety levels). The platform serves as an integrated solution for symptom reporting, patient-clinician communication & education. Positive impacts include patient engagement, convenience, admission avoidance & medication optimisation, but there was no corresponding change in QoL scores in the short-term. We find potential pitfalls: information overload for patients & increased workload for clinicians. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Sameer Zaman is supported by UK Research and Innovation [UKRI Centre for Doctoral Training in AI for Healthcare grant number EP/S023283/1].

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Aims Specialist cardiology care is associated with a prognostic benefit in patients with heart failure (HF) with reduced ejection fraction (HFrEF) admitted with decompensated HF. However, up to one third of patients admitted with HF and normal ejection fraction (HFnEF) do not receive specialist cardiology input. Whether this has prognostic implications is unknown. Methods and results Data on patients hospitalized with HFnEF from two tertiary centres were analysed. The primary outcome measure was all‐cause mortality during follow‐up. The secondary outcome was in‐hospital mortality. A total of 1413 patients were included in the study. Of these, 23% (n = 322) did not receive in‐hospital specialist cardiology input. Patients seen by a cardiologist were less likely to have hypertension (73% vs. 79%, P = 0.03) and respiratory co‐morbidities (25% vs. 31%, P = 0.02) compared with those who did not receive specialist input. Similarly, clinical presentation was more severe for those who received specialist input (New York Heart Association III/IV 83% vs. 75% respectively, P = 0.003; moderate‐to‐severe peripheral oedema 65% vs. 54%, P < 0.001). Medical management was similar, except for a higher use of diuretics (90% vs. 86%, P = 0.04) and a longer length of stay for patients who received specialist input (9 vs. 4 days, P < 0.001). Long‐term outcomes were comparable between patients who received specialist input and those who did not. However, specialist input was independently associated with lower in‐hospital mortality (hazard ratio 0.19, confidence interval 0.09–0.43, P < 0.001). Conclusions In‐hospital cardiology specialist input has no long‐term prognostic advantage in patients with HFnEF but is independently associated with reduced in‐hospital mortality.