Rachel L Knowles
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View article: Rethinking ethical reflexivity and oversight in health research through an ecosystem approach: A workshop report
Rethinking ethical reflexivity and oversight in health research through an ecosystem approach: A workshop report Open
As the scope of morally relevant considerations widens and new challenges emerge at the frontiers of health innovation, there are questions about the appropriate role and remit for research ethics review, within the broader context of the …
View article: A Crowdsourced Megastudy of 12 Digital Single-Session Interventions for Depression in American Adults
A Crowdsourced Megastudy of 12 Digital Single-Session Interventions for Depression in American Adults Open
Digital self-guided single-session interventions (SSIs) provide a structured psychological intervention within one interaction. We crowdsourced 66 diverse 10-minute SSIs for depression and selected 11 for testing in a pre-registered “megas…
View article: CONSORT 2025 statement: updated guideline for reporting randomized trials: a Korean translation
CONSORT 2025 statement: updated guideline for reporting randomized trials: a Korean translation Open
배경잘 설계되고 적절하게 실행된 무작위 배정 임상시험은 의료 개입의 효과에 대한 가장 신뢰할 수 있는 증거라고 할 수 있다. 그러나 연구 보고의 질이 미흡하다는 많은 증거가 있다. CONSORT(통합 임상시험 보고 기준)는 이러한 보고의 질을 개선하기 위해 고안되었으며, 무작위 임상시험 보고서가 포함해야 할 최소한의 항목을 제시한다. CONSORT는 1996년에 처음 발표된 후 2001년과 2010년에 개정되었다. 여기에서는…
View article: CONSORT 2025 statement: Updated guideline for reporting randomised trials
CONSORT 2025 statement: Updated guideline for reporting randomised trials Open
BACKGROUND: Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. …
View article: SPIRIT 2025 statement: Updated guideline for protocols of randomised trials
SPIRIT 2025 statement: Updated guideline for protocols of randomised trials Open
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. T…
View article: SPIRIT 2025 statement: Updated guideline for protocols of randomised trials
SPIRIT 2025 statement: Updated guideline for protocols of randomised trials Open
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. T…
View article: SPIRIT 2025 Statement
SPIRIT 2025 Statement Open
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. T…
View article: SPIRIT 2025 statement: updated guideline for protocols of randomised trials
SPIRIT 2025 statement: updated guideline for protocols of randomised trials Open
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. T…
View article: SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials Open
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 …
View article: CONSORT 2025 statement: updated guideline for reporting randomised trials
CONSORT 2025 statement: updated guideline for reporting randomised trials Open
Background Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. T…
View article: CONSORT 2025 statement: Updated guideline for reporting randomised trials
CONSORT 2025 statement: Updated guideline for reporting randomised trials Open
Background Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. T…
View article: CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials
CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials Open
Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be a…
View article: Developing the evidence-base to inform policy on inclusive research design
Developing the evidence-base to inform policy on inclusive research design Open
Considering diversity when designing and conducting research is fundamental to the responsible conduct of research and ensures that outputs from scientific research are reproducible, minimize bias and enable everyone within society the opp…
View article: Airway management in infants with Robin sequence in the United Kingdom and Ireland: A prospective population‐based study
Airway management in infants with Robin sequence in the United Kingdom and Ireland: A prospective population‐based study Open
Objective There is currently no consensus about managing upper airway obstruction (UAO) in infants with Robin sequence (RS), in terms of treatment efficacy or clinical outcomes. This study describes UAO management in UK/Ireland, and explor…
View article: Airway management in infants with Robin sequence in the United Kingdom and Ireland: a prospective population-based study
Airway management in infants with Robin sequence in the United Kingdom and Ireland: a prospective population-based study Open
Objective There is currently no consensus about managing upper airway obstruction (UAO) in infants with Robin sequence (RS), in terms of treatment efficacy or clinical outcomes. This study describes UAO management in UK/Ireland, and explor…
View article: Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations
Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations Open
In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team,…
View article: Global birth prevalence of Robin sequence in live-born infants: a systematic review and meta-analysis
Global birth prevalence of Robin sequence in live-born infants: a systematic review and meta-analysis Open
Robin sequence (RS), a congenital disorder of jaw maldevelopment and glossoptosis, poses a substantial healthcare burden and has long-term health implications if airway obstruction is suboptimally treated. This study describes the global b…
View article: 2 Pathways to detection of non-infectious childhood uveitis in the UK: findings from the UNICORN cohort study
2 Pathways to detection of non-infectious childhood uveitis in the UK: findings from the UNICORN cohort study Open
Prompt detection of childhood uveitis is key to minimising negative impact. From an internationally unique inception cohort, we report pathways to disease detection.UNICORNS is a national childhood non-infectious uveitis study with longitu…
View article: UNICORNS: Uveitis in childhood prospective national cohort study protocol
UNICORNS: Uveitis in childhood prospective national cohort study protocol Open
Background: Childhood uveitis is a rare inflammatory eye disease which is typically chronic, relapsing-remitting in nature, with an uncertain aetiology (idiopathic). Visual loss occurs due to structural damage caused by uncontrolled inflam…
View article: COVID-19 in congenital heart disease (COaCHeD) study
COVID-19 in congenital heart disease (COaCHeD) study Open
Background COVID-19 has caused significant worldwide morbidity and mortality. Congenital heart disease (CHD) is likely to increase vulnerability and understanding the predictors of adverse outcomes is key to optimising care. Objective Asce…
View article: Epidemiology of Robin sequence in the UK and Ireland: an active surveillance study
Epidemiology of Robin sequence in the UK and Ireland: an active surveillance study Open
Background Birth prevalence of Robin sequence (RS) is commonly reported as 1 case per 8000–14 000 live births. These estimates are based on single-source case ascertainment and may miss infants who did not require hospital admission or tho…
View article: Establishing risk factors and outcomes for congenital hypothyroidism with gland in situ using population-based data linkage methods: study protocol
Establishing risk factors and outcomes for congenital hypothyroidism with gland in situ using population-based data linkage methods: study protocol Open
Introduction There has been an increase in the birth prevalence of congenital hypothyroidism (CH) since the introduction of newborn screening, both globally and in the UK. This increase can be accounted for by an increase in CH with gland …
View article: 1692 Congenital hypothyroidism with gland in situ: examining risk factors, health, and education outcomes using linked administrative data
1692 Congenital hypothyroidism with gland in situ: examining risk factors, health, and education outcomes using linked administrative data Open
Background Since the introduction of newborn screening 40 years ago, the birth prevalence of Congenital Hypothyroidism (CH) has doubled in the UK. This appears to be due to an increase in screen-detected congenital hypothyroidism with glan…
View article: Maternal ethnicity and the prevalence of British pregnancies affected by neural tube defects
Maternal ethnicity and the prevalence of British pregnancies affected by neural tube defects Open
Background Few data are available on the prevalence of neural tube defects (NTDs) within different ethnic communities of the United Kingdom. This study aimed to calculate prevalence estimates for NTD‐affected pregnancies, classified by mat…