The importance of patient-reported outcomes in clinical trials and strategies for future optimization

R Mercieca-Bebber, MT King, MJ Calvert… - Patient related …, 2018 - Taylor & Francis
Patient-reported outcomes (PROs) can be included in clinical trials as primary or secondary
endpoints and are increasingly recognized by regulators, clinicians, and patients as …

A systematic scoping review of the choice architecture movement: Toward understanding when and why nudges work

B Szaszi, A Palinkas, B Palfi… - Journal of Behavioral …, 2018 - Wiley Online Library
In this paper, we provide a domain‐general scoping review of the nudge movement by
reviewing 422 choice architecture interventions in 156 empirical studies. We report the …

Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension

M Calvert, D Kyte, R Mercieca-Bebber, A Slade… - Jama, 2018 - jamanetwork.com
Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable
evidence to inform shared decision making, labeling claims, clinical guidelines, and health …

[HTML][HTML] Treatment of Middle East respiratory syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized …

YM Arabi, A Alothman, HH Balkhy, A Al-Dawood… - Trials, 2018 - Springer
Background It had been more than 5 years since the first case of Middle East Respiratory
Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has …

[HTML][HTML] CONSORT-SPI 2018 explanation and elaboration: guidance for reporting social and psychological intervention trials

S Grant, E Mayo-Wilson, P Montgomery, G Macdonald… - Trials, 2018 - Springer
Abstract Background The CONSORT (Consolidated Standards of Reporting Trials)
Statement was developed to help biomedical researchers report randomised controlled …

Smartphone app in self-management of chronic low back pain: a randomized controlled trial

HS Chhabra, S Sharma, S Verma - European Spine Journal, 2018 - Springer
Background Mobile health (mHealth) is emerging as the most convenient way to deliver
rehabilitation services remotely, and collect outcomes in real time, thus contributing to …

[HTML][HTML] The Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial: A study of crenezumab versus placebo in preclinical PSEN1 E280A …

PN Tariot, F Lopera, JB Langbaum, RG Thomas… - Alzheimer's & Dementia …, 2018 - Elsevier
Abstract Introduction Autosomal-dominant Alzheimer's disease (ADAD) represents a crucial
population for identifying prevention strategies that might modify disease course for …

Intense exercise for survival among men with metastatic castrate-resistant prostate cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study …

RU Newton, SA Kenfield, NH Hart, JM Chan… - BMJ open, 2018 - bmjopen.bmj.com
Introduction Preliminary evidence supports the beneficial role of physical activity on prostate
cancer outcomes. This phase III randomised controlled trial (RCT) is designed to determine …

Cochrane Qualitative and Implementation Methods Group guidance series—paper 6: reporting guidelines for qualitative, implementation, and process evaluation …

K Flemming, A Booth, K Hannes, M Cargo… - Journal of Clinical …, 2018 - Elsevier
Objectives To outline contemporary and novel developments for the presentation and
reporting of syntheses of qualitative, implementation, and process evaluation evidence and …

Proposal for standardized prenatal ultrasound assessment of the fetus with congenital diaphragmatic hernia by the European reference network on rare inherited and …

FM Russo, AG Cordier, L De Catte, J Saada… - Prenatal …, 2018 - Wiley Online Library
Congenital diaphragmatic hernia is a rare disease associated with high mortality and
morbidity. Antenatal ultrasound screening identifies more than 70% of cases, providing the …