Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): Challenges of conducting a feasibility trial

Pediatric Blood and Cancer

Volumn 62, Issue 3, 2015, Pages 395-401

  Galadanci, Najibah A ^a   Abdullahi, Shehu U ^a   Tabari, Musa A ^a   Abubakar, Shehi ^a   Belonwu, Raymond ^a   Salihu, Auwal ^a   Neville, Kathleen ^b   Kirkham, Fenella ^c   Inusa, Baba ^d   Shyr, Yu ^e   Phillips, Sharon ^e   Kassim, Adetola A ^e   Jordan, Lori C ^f   Aliyu, Muktar H ^f   Covert, Brittany V ^e   Debaun, Michael R ^e  

^a AMINU KANO TEACHING HOSPITAL   (Nigeria)

^b UNIVERSITY OF MISSOURI KANSAS CITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

^d EVELINA LONDON CHILDREN S HOSPITAL   (United Kingdom)

^e VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Hydroxyurea; Nigeria; Primary stroke prevention; Sickle cell disease

Indexed keywords

HYDROXYUREA; PLACEBO; ANTISICKLING AGENT;

AFRICA SOUTH OF THE SAHARA; ARTICLE; ASSESSMENT OF HUMANS; CEREBROVASCULAR ACCIDENT; CHILD; CHILDHOOD DISEASE; CONTROLLED STUDY; FEASIBILITY STUDY; FEMALE; HOSPITALIZATION; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MIDDLE CEREBRAL ARTERY; MORISKY SCALE; NATIONAL HEALTH ORGANIZATION; NIGERIA; NIGERIAN; PHASE 3 CLINICAL TRIAL; PILOT STUDY; PRIMARY PREVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SICKLE CELL ANEMIA; TEACHING HOSPITAL; TRAINING; UNSPECIFIED SIDE EFFECT; ANEMIA, SICKLE CELL; CLINICAL TRIAL; COMPLICATION; DOPPLER ECHOGRAPHY; ECHOGRAPHY; FOLLOW UP; MULTICENTER STUDY; PRACTICE GUIDELINE; PRESCHOOL CHILD; PROCEDURES; STROKE;

ANEMIA, SICKLE CELL; ANTISICKLING AGENTS; CHILD; CHILD, PRESCHOOL; FEASIBILITY STUDIES; FEMALE; FOLLOW-UP STUDIES; GUIDELINE ADHERENCE; HUMANS; HYDROXYUREA; MALE; MIDDLE CEREBRAL ARTERY; NIGERIA; PILOT PROJECTS; STROKE; ULTRASONOGRAPHY, DOPPLER, TRANSCRANIAL;

EID: 84921439346     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.25289     Document Type: Article

References (21)

1. Organization WH. Guidelines for the Control of Haemoglobin Disorders; 1994.
2. Anie KA, Egunjobi FE, Akinyanju OO. Psychosocial impact of sickle cell disorder: Perspectives from a Nigerian setting. Globalization and Health 2010; 6:2.
3. Earley CJ, Kittner SJ, Feeser BR, Gardner J, Epstein A, Wozniak MA, Wityk R, Stern BJ, Price TR, Macko RF, Johnson C, Sloan MA, Buchholz D. Stroke in children and sickle-cell disease: Baltimore-Washington Cooperative Young Stroke Study. Neurology 1998; 51:169-176.
4. Adams RJ, McKie VC, Hsu L, Files B, Vichinsky E, Pegelow C, Abboud M, Gallagher D, Kutlar A, Nichols FT, Bonds DR, Brambilla D. Prevention of a first stroke by transfusions in children with sickle cell anemia and abnormal results on transcranial Doppler ultrasonography. N Engl J Med 1998; 339:5-11.
5. Diallo D, Tchernia G. Sickle cell disease in Africa. Curr Opin Hematol 2002; 9:111-116.
6. Ohene-Frempong K, Weiner SJ, Sleeper LA, Miller ST, Embury S, Moohr JW, Wethers DL, Pegelow CH, Gill FM. Cerebrovascular accidents in sickle cell disease: Rates and risk factors. Blood 1998; 91:288-294.
7. Commission NP. 2006. State Population. .
8. Oliveira-Filho AD, Barreto-Filho JA, Neves SJ, Lyra Junior DP. Association between the 8-item Morisky Medication Adherence Scale (MMAS-8) and blood pressure control. Arq Bras Cardiol 2012; 99:649-658.
9. Thornburg CD, Files BA, Luo Z, Miller ST, Kalpatthi R, Iyer R, Seaman P, Lebensburger J, Alvarez O, Thompson B, Ware RE, Wang WC, Investigators BH. Impact of hydroxyurea on clinical events in the BABY HUG trial. Blood 2012; 120:4304-4310, quiz 448.
10. Control CfD. CDC/NHSN Surveillance Definitions for Specific Types of Infections; 2014; p 1-63.
11. Bell D. Malaria Diagnosis WHO Guidelines and their implementation. European Commission Research Workshop: World Health Organization; 2010.
12. Scott JA, Berkley JA, Mwangi I, Ochola L, Uyoga S, Macharia A, Ndila C, Lowe BS, Mwarumba S, Bauni E, Marsh K, Williams TN. Relation between falciparum malaria and bacteraemia in Kenyan children: A population-based, case-control study and a longitudinal study. Lancet 2011; 378:1316-1323.
13. Zarkowsky HS, Gallagher D, Gill FM, Wang WC, Falletta JM, Lande WM, Levy PS, Verter JI, Wethers D. Bacteremia in sickle hemoglobinopathies. J Pediatr 1986; 109:579-585.
14. U. S. Department of Health and Human Services NIoH, National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). Volume Version 4. 0201 0. 2010.
15. Kitchen L, Westmacott R, Friefeld S, MacGregor D, Curtis R, Allen A, Yau I, Askalan R, Moharir M, Domi T, deVeber G. The pediatric stroke outcome measure: A validation and reliability study. Stroke 2012; 43:1602-1608.
16. Lagunju IA, Brown BJ, Sodeinde OO. Chronic blood transfusion for primary and secondary stroke prevention in Nigerian children with sickle cell disease: A 5-year appraisal. Pediatric Blood Cancer 2013; 60:1940-1945.
17. West J, Wright J, Tuffnell D, Jankowicz D, West R. Do clinical trials improve quality of care? A comparison of clinical processes and outcomes in patients in a clinical trial and similar patients outside a trial where both groups are managed according to a strict protocol. Quality Safety Health Care 2005; 14:175-178.
18. Kwiatkowski JL, Yim E, Miller S, Adams RJ, Investigators SS. Effect of transfusion therapy on transcranial Doppler ultrasonography velocities in children with sickle cell disease. Pediatr Blood Cancer 2011; 56:777-782.
19. Fottrell E, Osrin D. Sickle cell anaemia in a changing world. PLoS Med 2013; 10:e1001483.
20. Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med 2010; 38:S512-S521.
21. World Health Organization. Management of Haemoglobin Disorders. Rep. Nicosia, Cyprus: World Health Organization (WHO); 2007.