Assessing effectiveness of home care for persons with AIDS: Analysis of methodological problems

P. Borgia, P. Schifano, T. Spadea, G. Milanese, E. Fabrizi, D. Abeni, C. Perucci, G. Rocchi

Research output: Contribution to journalArticlepeer-review

Abstract

The aim of this paper is to assess the methodological problems of an unsuccessful randomized controlled trial (RCT) conducted to evaluate the effectiveness, in terms of survival and quality of life, of the early offer of home care (HC) to persons with AIDS (PWA). The study carried out was an intention-to-treat RCT. Persons in the treatment group (TG) received the offer of HC at the moment of AIDS diagnosis; those in the control group (CG) received it six months from diagnosis. Many problems have hindered the progress of the study: particularly, the low compliance to the offer and the failure to enroll the required sample size have made the results unreliable. Analogous problems have been reported within other trials evaluating HC in different fields. The present study thoroughly evaluates the specific ethical and methodological problems encountered in designing and conducting a RCT on HC for PWA. We conclude that, before designing and conducting a RCT in this field, it is advisable to examine some main issues carefully, such as the acceptability of the offer of treatment, the expected compliance and the required size of the study population. If one or more of these elements prove to be problematic, the results of the trial risk being seriously compromised, and alternative approaches should be considered.

Original languageEnglish
Pages (from-to)645-650
Number of pages6
JournalAIDS Care - Psychological and Socio-Medical Aspects of AIDS/HIV
Volume14
Issue number5
DOIs
Publication statusPublished - Oct 2002

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health(social science)
  • Health Professions(all)
  • Social Sciences (miscellaneous)

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