title: 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.
abstract: 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.
  
  
  RESULTS
  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%).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01608802.
authors.affiliation: Department of Palliative Care and Rehabilitation, Cicely Saunders Institute, King's College London, Bessemer Road, London SE5 9PJ, UK. keira.lowther@kcl.ac.uk.
authors.forename: Keira
authors.initials: K
authors.lastname: Lowther
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson
authors.forename: Victoria
authors.initials: V
authors.lastname: Simms
authors.forename: Nancy
authors.initials: N
authors.lastname: Gikaara
authors.forename: Aabid
authors.initials: A
authors.lastname: Ahmed
authors.forename: Zipporah
authors.initials: Z
authors.lastname: Ali
authors.forename: Gaudencia
authors.initials: G
authors.lastname: Afuande
authors.forename: Hellen
authors.initials: H
authors.lastname: Kariuki
authors.forename: Lorraine
authors.initials: L
authors.lastname: Sherr
authors.forename: Rachel
authors.initials: R
authors.lastname: Jenkins
authors.forename: Lucy
authors.initials: L
authors.lastname: Selman
authors.forename: Richard
authors.initials: R
authors.lastname: Harding
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy / Q000451:nursing*; D064946:Hospice and Palliative Care Nursing; D006801:Humans; D018579:Patient Selection; D016312:Treatment Refusal
chemical_list: D019380:Anti-HIV Agents