Measuring the impact introducing NHS 111 online had on the NHS 111 telephone service and the wider NHS urgent care system: an observational study.

Objectives: To explore what impact introducing the National Health Service (NHS) 111 online service had on the number of phone calls to the NHS 111 telephone service and the NHS urgent care system.

Design: Observational study using a dose-response interrupted time series model and random-effects meta- analysis to estimate the average effect.

Setting And Participants: NHS 111 telephone and online contacts for 18 NHS 111 area codes in England.

Infective endocarditis following invasive dental procedures: IDEA case-crossover study.

Background: Infective endocarditis is a heart infection with a first-year mortality rate of ≈ 30%. It has long been thought that infective endocarditis is causally associated with bloodstream seeding with oral bacteria in ≈ 40-45% of cases. This theorem led guideline committees to recommend that individuals at increased risk of infective endocarditis should receive antibiotic prophylaxis before undergoing invasive dental procedures.

Analysis of Prosthetic Joint Infections Following Invasive Dental Procedures in England.

Importance: Dentists in the United States are under pressure from orthopedic surgeons and their patients with prosthetic joints to provide antibiotic prophylaxis before invasive dental procedures (IDP) to reduce the risk of late prosthetic joint infection (LPJI). This has been a common practice for decades, despite a lack of evidence for an association between IDP and LPJI, a lack of evidence of antibiotic prophylaxis efficacy, cost of providing antibiotic prophylaxis, and risk of both adverse drug reactions and the potential for promoting antibiotic resistance.

Objective: To quantify any temporal association between IDP and subsequent LPJI.

Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.

Background: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges.

Objectives: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials.

Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE).

Objectives: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration.

Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs.

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise.

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges.

The impact of closing emergency departments on mortality in emergencies: an observational study.

Background: In England the demand for emergency care is increasing, while there is also a staffing shortage. This has implications for quality of care and patient safety. One solution may be to concentrate resources on fewer sites by closing or downgrading emergency departments (EDs).

Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.

Background: Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials.

Characterising non-urgent users of the emergency department (ED): A retrospective analysis of routine ED data.

Background: The pressures of patient demand on emergency departments (EDs) continue to be reported worldwide, with an associated negative impact on ED crowding and waiting times. It has also been reported that a proportion of attendances to EDs in different international systems could be managed in settings such as primary care. This study used routine ED data to define, measure and profile non-urgent ED attendances that were suitable for management in alternative, non-emergency settings.

Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression.

Background: Trials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to the design and conduct of pragmatic trials which seeks to address some of these challenges.

Main Text: In this article, we report our experiences with the first completed randomised controlled trial (RCT) using the cmRCT design.

Depressed patients treated by homeopaths: a randomised controlled trial using the "cohort multiple randomised controlled trial" (cmRCT) design.

Background: Despite controversy regarding homeopathy, some patients consult homeopaths for depression. Evidence is required to determine whether this is an effective, acceptable and safe intervention for these patients.

Methods: A pragmatic trial using the "cohort multiple randomised controlled trial" design was used to test the effectiveness of adjunctive treatment by homeopaths compared to usual care alone, over a period of 12 months in patients with self-reported depression.

Support and Assessment for Fall Emergency Referrals (SAFER) 2: a cluster randomised trial and systematic review of clinical effectiveness and cost-effectiveness of new protocols for emergency ambulance paramedics to assess older people following a fall with referral to community-based care when appropriate.

Background: Emergency calls are frequently made to ambulance services for older people who have fallen, but ambulance crews often leave patients at the scene without any ongoing care. We evaluated a new clinical protocol which allowed paramedics to assess older people who had fallen and, if appropriate, refer them to community-based falls services.

Objectives: To compare outcomes, processes and costs of care between intervention and control groups; and to understand factors which facilitate or hinder use.

Paramedic Assessment of Older Adults After Falls, Including Community Care Referral Pathway: Cluster Randomized Trial.

Study Objective: We aim to determine clinical and cost-effectiveness of a paramedic protocol for the care of older people who fall.

Methods: We undertook a cluster randomized trial in 3 UK ambulance services between March 2011 and June 2012. We included patients aged 65 years or older after an emergency call for a fall, attended by paramedics based at trial stations.

Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial.

Objective:  To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies.

Design:  Pragmatic, multicentre, randomised controlled trial.

Setting:  42 general practices in three areas of England.

Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention.

Background: Many countries are exploring the potential of telehealth interventions to manage the rising number of people with chronic disorders. However, evidence of the effectiveness of telehealth is ambiguous. Based on an evidence-based conceptual framework, we developed an integrated telehealth service (the Healthlines Service) for chronic disorders and assessed its effectiveness in patients with depression.