SPIRIT 2025 statement: updated guideline for protocols of randomized trials.

The protocol of a randomized trial is the foundation for study planning, conduct, reporting and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols.

SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.

High quality protocols facilitate proper planning, conduct, reporting, and external review of randomised trials, yet their completeness varies and key elements are often not considered. To strengthen good reporting of trial protocols, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement has been updated to incorporate new evidence and emerging perspectives. This SPIRIT 2025 explanation and elaboration document provides users with exemplars of reporting in contemporary trial protocols, contextual elaboration, more detailed guidance on reporting, references to key empirical studies, an expanded checklist, and a link to a website for further information.

SPIRIT 2025 statement: updated guideline for protocols of randomised trials.

Importance: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols.

SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials.

Importance: The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols.

SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.

Importance: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols.

The Digital Health Competencies in Medical Education Framework: An International Consensus Statement Based on a Delphi Study.

Importance: Rapid digitalization of health care and a dearth of digital health education for medical students and junior physicians worldwide means there is an imperative for more training in this dynamic and evolving field.

Objective: To develop an evidence-informed, consensus-guided, adaptable digital health competencies framework for the design and development of digital health curricula in medical institutions globally.

Evidence Review: A core group was assembled to oversee the development of the Digital Health Competencies in Medical Education (DECODE) framework.

Remote Vital Sign Monitoring in Admission Avoidance Hospital at Home: A Systematic Review.

Objectives: To examine randomized controlled trials (RCTs) of "hospital at home" (HAH) for admission avoidance in adults presenting with acute physical illness to identify the use of vital sign monitoring approaches and evidence for their effectiveness.

Design: Systematic review.

Setting And Participants: This review compared strategies for vital sign monitoring in admission avoidance HAH for adults presenting with acute physical illness.

Clustering by multiple long-term conditions and social care needs: a cross-sectional study among 10 026 older adults in England.

BACKGROUND   : People with multiple long-term conditions (MLTC) face health and social care challenges. This study aimed to classify people by MLTC and social care needs (SCN) into distinct clusters and quantify the association between derived clusters and care outcomes. METHODS : A cross-sectional study was conducted using the English Longitudinal Study of Ageing, including people with up to 10 MLTC.

Patient stratification for determining optimal second-line and third-line therapy for type 2 diabetes: the TriMaster study.

Precision medicine aims to treat an individual based on their clinical characteristics. A differential drug response, critical to using these features for therapy selection, has never been examined directly in type 2 diabetes. In this study, we tested two hypotheses: (1) individuals with body mass index (BMI) > 30 kg/m, compared to BMI ≤ 30 kg/m, have greater glucose lowering with thiazolidinediones than with DPP4 inhibitors, and (2) individuals with estimated glomerular filtration rate (eGFR) 60-90 ml/min/1.

The potential for utilising in-hospital glucose measurements to detect individuals at high risk of previously undiagnosed diabetes: Retrospective cohort study.

Background: Many people with undiagnosed diabetes have hyperglycaemia when admitted to hospital. Inpatient hyperglycaemia can be an indication of diabetes mellitus but can also indicate a stress response. This study reports the extent to which an in-hospital maximum observed random glucose measurement is an indicator of the need for in-hospital (or subsequent) HbA1c measurement to look for undiagnosed diabetes.

Performance of guidelines for the screening and diagnosis of gestational diabetes mellitus during the COVID-19 pandemic: A scoping review of the guidelines and diagnostic studies evaluating the recommended testing strategies.

Aim: The COVID-19 pandemic has necessitated less resource-intensive testing guidelines to identify gestational diabetes mellitus (GDM). We performed a scoping review of the international evidence reporting the ability of diagnostic tests recommended during the pandemic to accurately identify patients with GDM, compared to pre-pandemic reference standards, and associated test and clinical outcomes.

Methods: A comprehensive search of the literature was carried out in Embase, LitCovid, Cochrane Covid-19 study register, and medRxiv on 14 June 2021.

Assessment of glycaemic status in adult hospital patients for the detection of undiagnosed diabetes mellitus: A systematic review.

Aim: In-hospital blood glucose testing is commonplace, particularly in acute care. In-hospital screening for hyperglycaemia may present a valuable opportunity for early diabetes diagnosis by identifying at-risk individuals. This systematic review investigates the extent to which random blood glucose testing in acute and inpatient hospital settings predicts undiagnosed diabetes.

Understanding acceptability in the context of text messages to encourage medication adherence in people with type 2 diabetes.

Background: Acceptability is recognised as a key concept in the development of health interventions, but there has been a lack of consensus about how acceptability should be conceptualised. The theoretical framework of acceptability (TFA) provides a potential tool for understanding acceptability. It has been proposed that acceptability measured before use of an intervention (anticipated acceptability) may differ from measures taken during and after use (experienced acceptability), but thus far this distinction has not been tested for a specific intervention.

Reducing weight and BMI following gestational diabetes: a systematic review and meta-analysis of digital and telemedicine interventions.

Women with past gestational diabetes mellitus (GDM) are at risk of subsequent type 2 diabetes and adverse cardiovascular events. Digital and telemedicine interventions targeting weight loss and reductions in body mass index (BMI) may help reduce risk for women with GDM. The aim was to compare the effectiveness of digital or telemedicine intervention with usual care.

Correction: System Architecture for "Support Through Mobile Messaging and Digital Health Technology for Diabetes" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies.

[This corrects the article DOI: 10.2196/18460.].

Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials.

Routinely collected data about health in medical records, registries and hospital activity statistics is now routinely collected in an electronic form. The extent to which such sources of data are now being routinely accessed to deliver efficient clinical trials, is unclear. The aim of this study was to ascertain current practice amongst a United Kingdom (UK) cohort of recently funded and ongoing randomised controlled trials (RCTs) in relation to sources and use of routinely collected outcome data.

System Architecture for "Support Through Mobile Messaging and Digital Health Technology for Diabetes" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies.

Background: Diabetes is a highly prevalent long-term condition with high morbidity and mortality rates. People with diabetes commonly worry about their diabetes medicines and do not always take them regularly as prescribed. This can lead to poor diabetes control.

Application of the National Institute for Health and Care Excellence Evidence Standards Framework for Digital Health Technologies in Assessing Mobile-Delivered Technologies for the Self-Management of Type 2 Diabetes Mellitus: Scoping Review.

Background: There is a growing role of digital health technologies (DHTs) in the management of chronic health conditions, specifically type 2 diabetes. It is increasingly important that health technologies meet the evidence standards for health care settings. In 2019, the National Institute for Health and Care Excellence (NICE) published the NICE Evidence Standards Framework for DHTs.

Independent effects of 2hPG, FPG and HbA1c on cardiovascular risk: Analysis of a nationally representative sample from China.

Aims: To evaluate the independence of the effect of 2-hour post-load plasma glucose (2hPG), fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) on cardiovascular disease (CVD) after adjusting for each other and non-glycemic factors.

Methods: We analyzed data from a nationally representative sample of 174,329 Chinese adults from a survey conducted in 2013-2014. The associations of glycemic measures with the risk of CVD were examined and compared by using logistic regression analyses.

Monitoring activity of hip injury patients (MoHIP): a sub-study of the World Hip Trauma Evaluation observational cohort study.

Background: Hip fracture is common, affecting 20% of women and 10% of men during their lifetime. The trajectory of patients' recovery as they transition from the acute hospital setting to their usual residence is poorly understood. Recently, the use of activity trackers to monitor physical activity during recovery has been investigated as a way to explore this trajectory.

Screening for Hypertension in the INpatient Environment(SHINE): a protocol for a prospective study of diagnostic accuracy among adult hospital patients.

Introduction: A significant percentage of patients admitted to hospital have undiagnosed hypertension. However, present hypertension guidelines in the UK, Europe and USA do not define a blood pressure threshold at which hospital inpatients should be considered at risk of hypertension, outside of the emergency setting. The objective of this study is to identify the optimal in-hospital mean blood pressure threshold, above which patients should receive postdischarge blood pressure assessment in the community.

Mood Monitoring Over One Year for People With Chronic Obstructive Pulmonary Disease Using a Mobile Health System: Retrospective Analysis of a Randomized Controlled Trial.

Background: Comorbid anxiety and depression can add to the complexity of managing treatment for people living with chronic obstructive pulmonary disease (COPD). Monitoring mood has the potential to identify individuals who might benefit from additional support and treatment.

Objective: We used data from the sElf-management anD support proGrammE (EDGE) trial to examine: (1) the extent to which the mood-monitoring components of a mobile health system for patients with COPD were used by participants; (2) the levels of anxiety and depression symptoms among study participants; (3) the extent to which videos providing advice about coping with low mood were viewed; and (4) the characteristics of participants with differing levels of mood and utilization of mood monitoring.

What do people with type 2 diabetes want from a brief messaging system to support medication adherence?

Background: Many people with type 2 diabetes do not take their treatment as prescribed. Brief messages to support medication use could reach large numbers of people at a very low cost per person, but current interventions using brief messages rarely adequately describe the content of the messages, nor base these messages on explicit behavior change principles. This study reports the views of people with type 2 diabetes concerning the acceptability of 1) a messaging system and 2) proposed messages based on behavior change techniques (BCTs) and beliefs and concerns around taking medication.