Early in the epidemic, numerous cohort studies described the natural evolution of HIV disease among those infected, and later described the impacts of prophylaxis for opportunistic infections and therapy for HIV itself. But as the epidemic spread, currently affected populations did not necessarily conform to these original observations, making it more difficult to describe affected populations. The population living with HIV/AIDS is much less homogenous than it was at the outset; witness the heterosexual spread of the epidemic worldwide. Likewise, while the demographics of affected populations have shifted, principles of disease, prevention, diagnosis, treatment and management have all been dramatically modified since the advent of HAART, and indeed are in constant evolution. Although some literature from the pre-HAART era remains relevant, there is a need to re-evaluate care needs and psychosocial aspects of the disease.
The current research for HIV/AIDS is focused on disease-specific therapies and coping techniques, with a dearth of attention to palliative and end-of-life care concerns. Now, with significant improvement in response to combination antiretroviral therapy and survival time, it is imperative to investigate the management of both short and long-term consequences of therapies, as well as to clarify methods for optimizing quality of life through the very end of life. Existing research needs to be complemented by new research pertinent to HAART, particularly related to the prevention and control of side effects that impact adherence. Concurrent studies to evaluate the effectiveness of controlling side effects of ARV therapy would be useful for improving adherence.
Research to identify sentinel events in the trajectory of dying for patients for whom HAART begins to fail, or for whom other illnesses such as liver failure supervene, is critical. Research is needed to address symptom management concurrent with salvage therapy when antiretroviral therapy regimens have failed. With thorough informed consent, it is ethically acceptable and clinically essential to incorporate study designs that include groups receiving "no antiretroviral therapy with intensive palliative and supportive care" and groups treated with "new antiretroviral therapy with intensive palliative and supportive care."
Effectively integrating palliative care into HIV care will dictate a need
for a continuing focus on pain management and symptom control for all populations
affected by HIV. Studies are needed to target how to prevent or to eliminate
symptoms recognizing that they may be disease-related, therapy-related or unrelated
to the disease process. Symptom surveys done in the pre-HAART era document
a problem incidence similar to that in the HAART era, but symptom prevalence
is not the same now for those with controlled disease.[6,7] While
those in care may now have long-term effects, e.g., lipodystrophy and increased
problems, those unable to adhere to therapy experience clinical decline parallel
to the experience of the pre-HAART era. The field needs to examine these
HAART era populations to characterize the daily impact of symptoms of HIV itself,
as well as those due to the medicines used to control HIV.
The AIDS Clinical Trials Group (ACTG), the largest HIV clinical trials organization in the world, plays a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV/AIDS in the U.S. and the developed world. Established by the National Institutes of Health to conduct controlled evaluation of new therapies with the primary goal of improved HIV disease management, the ACTG has also evaluated the prevalence of symptoms and of quality of life. The ACTG Outcomes Committee has collected quality of life data in drug trials for the past decade. Health-related Quality of Life (HrQoL) now includes two components—the ability to perform daily activities (function) and how one experiences daily life (well-being).
The Pediatric AIDS Clinical Trials Group "Pediatric Late Outcomes Protocol" follows HIV-infected children and youth into young adulthood to determine the incidence and severity of disease and treatment specific symptoms and conditions. It measures quality of life and includes specific data collection regarding palliative and end-of-life care for pediatric patients. All recommendations for the Adult ACTG must apply also to the Pediatric ACTG.
Two areas of potential focus to be explored in collaboration with the ACTG include symptom management and end-of-life management. Much like other chronic disease entities, there are barriers to completing this type of research that could provide direction on how to provide the best care and support to patients at the end of their lives. Qualitative studies are needed to capture more of the experience of advanced HIV/AIDS disease care and life challenges and survival strategies of people living with disease, caregivers and professional care providers. New tools need to be developed and tested to assist surveying people living with cognitive impairment associated with long-term HIV infection. One barrier that exists is the vast variation of definitions that clinicians apply to palliative care.
Clinical and health service delivery studies into palliative domains of care and quality of life for HIV patients and their families are essential. Further study is necessary to investigate the potential advantages (in terms of quality of life and survival) of intensive palliative care with and without antiviral treatment for patients with advanced disease. ACTG investigations might also incorporate a category of "desire for intensive palliative care" as a study endpoint or reasons for withdrawal from clinical trials.
The Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol allows patients who are on treatment protocols to be followed despite the end of the original or "parent" protocol. This ongoing study will contribute prospective data about HIV positive patients and the disease process for an additional five years. The secondary objectives of this study include quality of life and outcomes information. While the objectives were not designed to specifically address "palliative care or end-of-life issues," much of the information collected is related to these issues. However, a standard of care must be advanced in HIV trials that includes palliative care and encompasses assessment of palliative outcomes.
Appropriate management of HIV or treatment-related side effects, such as diarrhea, could improve study subject retention in clinical trials. The same clinicians conducting HIV clinical trials provide care to a cohort of patients who are at the end of the spectrum of HIV disease. Research on this cohort of patients could benefit future patients facing physical, emotional and spiritual end-of-life issues.
Now that people with HIV can expect a longer life with treatment and prevention, more focus must be directed at maximizing the disease-free interval. In the same manner of treatment for cancer twenty years ago, studies must systematically evaluate the effectiveness of supportive therapies for those undergoing multi-drug regimens as well. All of these issues have implications for policy-makers and funders as well as researchers.
The Workgroup on Palliative and End-of-Life Care in HIV/AIDS proposes to the field the research agenda in Appendix C.
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Promoting Excellence in End-of-Life Care was a national program of the Robert Wood Johnson Foundation dedicated to long-term changes in health care institutions to substantially improve care for dying people and their families. Visit PromotingExcellence.org for more resources.