Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial-Reference-Cited by-同舟云学术

Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial

Published:2017-03-24 Issue:6 Volume:12 Page:667-670
ISSN:1747-4930
Container-title:International Journal of Stroke
language:en
Short-container-title:International Journal of Stroke

Author:

Billot Laurent¹²,Woodward Mark¹²³⁴,Arima Hisatomi¹⁵,Hackett Maree L¹²⁶,Muñoz Venturelli Paula¹²⁷,Lavados Pablo M⁷⁸,Brunser Alejandro⁷,Peng Bin⁹,Cui Liying⁹,Song Lily¹⁰¹¹,Heritier Stephane¹²,Jan Stephen¹²,Middleton Sandy¹³,Olavarría Verónica V⁷,Lim Joyce¹,Robinson Thompson¹⁴,Pontes-Neto Octavio¹⁵,Watkins Caroline⁶¹³,Anderson Craig S¹²¹¹¹⁶

Affiliation:

1. The George Institute for Global Health, Sydney, Australia

2. Sydney Medical School, University of Sydney, Australia

3. The George Institute for Global Health, University of Oxford, UK

4. Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA

5. Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan

6. College of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK

7. Unidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile

8. Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile

9. Department of Neurology, Peking Union Medical College Hospital, Beijing, China

10. Department of Neurology, 85 Hospital of People's Liberation Army, Shanghai, China

11. The George Institute China, Peking University Health Science Center, Beijing, China

12. Department of Epidemiology and Preventative Medicine, School of Public Health and Preventative Medicine, Monash University, Melbourne, Australia

13. Nursing Research Institute, St Vincents Health Australia (Sydney) and Australian Catholic University, Australia

14. Department of Cardiovascular Sciences and NIHR Biomedical Research Unit for Cardiovascular Sciences, University of Leicester, Leicester, UK

15. Stroke Service, Neurology Division, Department of Neuroscience and Behavioural Sciences, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil

16. Neurology Department, Royal Prince Alfred Hospital, Sydney, NSW, Australia

Abstract

Background There is evidence to indicate that the lying flat head position increases cerebral blood flow and oxygenation in patients with acute ischemic stroke, but how these physiological effects translate into clinical outcomes is uncertain. The Head Position in Stroke Trial aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 h of hospital admission for patients with acute stroke. Design An international, pragmatic, cluster-randomized, crossover, open, blinded outcome assessed clinical trial. Each hospital with an established acute stroke unit (cluster) site was required to recruit up to 140 consecutive cases of acute stroke (one phase of head positioning before immediately crossing over to the other phase of head positioning), including both acute ischemic stroke and intracerebral hemorrhage, in each randomized head position as a ‘business as usual’ policy. Objective To outline in detail the predetermined statistical analysis plan for the study. Methods All accumulated data will be reviewed and formally assessed. Information regarding baseline characteristics of patients, their process of care and management will be outlined, and for each item, statistically relevant descriptive elements will be described. For the trial outcomes, the most appropriate statistical comparisons are described. Results A statistical analysis plan was developed that is transparent, verifiable, and predetermined before completion of data collection. Conclusions We developed a predetermined statistical analysis plan for Head Position in Stroke Trial to avoid analysis bias arising from prior knowledge of the findings, in order to reliably quantify the benefits and harms of lying flat versus sitting up early after the onset of acute stroke. Trial registration ClinicalTrials.gov identifier NCT02162017; ANZCTR identifier ACTRN12614000483651

Publisher

SAGE Publications

Subject

Neurology

Link

http://journals.sagepub.com/doi/pdf/10.1177/1747493017701943

Reference26 articles.

1. Head Position in the Early Phase of Acute Ischemic Stroke: An International Survey of Current Practice

2. What do nurses and therapists think about the positioning of stroke patients?

3. A comparison study on nurses' and therapists' perception on the positioning of stroke patients in Singapore General Hospital

4. Comprehensive Overview of Nursing and Interdisciplinary Care of the Acute Ischemic Stroke Patient

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. What are this patient's problems? A problem-based approach to the general management of stroke;Warlow's Stroke;2019-01-28

2. Guidelines for evaluation and management of cerebral collateral circulation in ischaemic stroke 2017;Stroke and Vascular Neurology;2018-05-30