A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data

BMC Research Notes

Richard Harding¹  Lucy Selman¹  Rachel Jenkins³  Lorraine Sherr²  Hellen Kariuki⁴  Gaudencia Afuande⁵  Zipporah Ali⁷  Aabid Ahmed⁵  Nancy Gikaara⁷  Victoria Simms⁶  Irene J Higginson¹  Keira Lowther¹ 

[1] Department of Palliative Care and Rehabilitation, Cicely Saunders Institute, King’s College London, Bessemer Road, London SE5 9PJ, UK;Health Psychology Unit, University College London, London, UK;Institute of Psychiatry, Kings College London, London, UK;Department of Medical Physiology, University of Nairobi, Nairobi, Kenya;Bomu Hospital, Mombasa, Kenya;London School of Hygiene and Tropical Medicine, London, UK;Kenyan Hospice Palliative Care Association, Nairobi, Kenya

关键词: Antiretroviral therapy;    RCT;    Palliative care;    HIV/AIDS;   

Others  :  1129900
DOI  :  10.1186/1756-0500-7-600

 received in 2014-01-06, accepted in 2014-08-27,  发布年份 2014

【 摘 要 】

Background

Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy, the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown.

Findings

A randomised controlled trial (RCT) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa, Kenya. The intervention was a minimum of seven sessions of multidimensional, person-centred care, given by HIV nurses trained in the palliative care approach over a period of 5 months. Rates of recruitment and refusal, the effectiveness of the randomisation procedure, trial follow-up and attrition and extent of missing data are reported.

120 patients (60 randomised to control arm, 60 randomised to intervention arm) were recruited over 5.5 months, with a refusal rate of 55.7%. During the study period, three participants died from cancer, three withdrew (two moved away and one withdrew due to time constraints). All of these patients were in the intervention arm: details are reported. There were five additional missing monthly interviews in both the control and intervention study arm, bringing the total of missing data to 26 data points (4.3%).

Discussion

The quality and implications of these data are discussed extensively and openly, including the effect of full and ethical consent procedures, respondent burden, HIV stigma, accurate randomisation, patient safety and the impact of the intervention. Data on recruitment randomisation, attrition and missing data in clinical trials should be routinely reported, in conjunction with the now established practice of publishing study protocols to enhance research integrity, transparency and quality. Transparency is especially important in cross cultural settings, in which the sources of funding and trial design are often not based in the country of data collection. Findings reported can be used to inform future RCTs in this area.

Trial registration

Clinicaltrials.gov NCT01608802.

【 授权许可】

   
2014 Lowther et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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