title: A review of the trials which examine early integration of outpatient and home palliative care for patients with serious illnesses.
abstract: BACKGROUND
  Palliative care has emerged as care that specifically aims to address gaps inherent in disease-centered approaches in order to enhance care quality in serious illness, both for patients and families and for health care systems. Late palliative care for patients with serious illness mitigates benefits to patients, families, and health care systems. Efforts have been made by investigators to define the impact of earlier palliative care interventions on patient, family and health care systems outcomes. We conducted a systematic review of randomized trials of outpatient and home palliative care, two locations where earlier palliative care do occur, to examine the evidence for palliative care benefits.
  
  
  METHODS
  Various terms were used; the search was performed in PubMed. From this search randomized trials were selected from 62 references derive from this search which appeared to be primary studies. Hand searches were done on references. Fifteen randomized control trials of outpatient palliative care and 13 randomized control trials of palliative home care were collected and collated into tables. Seven systematic reviews obtained and outcomes summarized in a table.
  
  
  RESULTS
  Advantages to palliative care include improvement in certain symptoms such as depression, improved patient quality of life, reduced aggressive care at the end of life, increased advanced directives, reduced hospital length of stay and hospitalizations, improved caregiver burden and better maintenance of caregiver quality of life and reduction in the medical cost of care as well as patient and family satisfaction. There are randomized trials which demonstrate that symptoms and quality of life are not improved, and resource utilization and costs are not different from "usual" care. Seven systematic reviews of randomized trials came to similar conclusions.
  
  
  CONCLUSIONS
  Notable methodological issues account for differences in results. Definitions of "early" palliative care vastly differed. There were no descriptions of what was meant by "usual" care in the control arm. Study designs and procedures were frequently flawed. Populations were heterogeneous in many studies and imbalances between randomly-allocated occurred frequently. Direct patient care versus consultation only, played a role. The assumption that the same model of care was equally effective across different diseases was unsubstantiated. Attrition was on average 40% and blinding of individuals who assessed outcomes frequently not mentioned. Power calculations were infrequent. Intention to treat analysis was often not done. Current studies fell short of the goal of measuring all relevant factors to assessing costs-benefits, having largely ignored the cost to the patient and family and instead focused narrowly on patient medical costs.
  
  
  CONCLUSIONS
  Multiple studies have demonstrated several benefits to early outpatient palliative care for patients with newly diagnosed metastatic cancer. However, better designed and executed studies are needed to determine the best time to intervene and the best model of care.
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio, USA. davism6@ccf.org.
authors.forename: Mellar P
authors.initials: MP
authors.lastname: Davis
authors.affiliation: Department of Hematology/Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Temel
authors.affiliation: Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
authors.forename: Tracy
authors.initials: T
authors.lastname: Balboni
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Glare
mesh_terms: D006699:Home Care Services; D006801:Humans; D008495:Medical Oncology / Q000379:methods; D009369:Neoplasms / Q000628:therapy*; D010045:Outpatients; D010166:Palliative Care / Q000379:methods*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D013727:Terminal Care / Q000379:methods*
keywords: Palliative; early; home; outcomes; outpatient