Implementation of supportive care and best supportive care interventions in clinical trials enrolling patients with cancer†.

BACKGROUND: With the growing and evolving role of palliative care in oncology, we examined how supportive care (SC) and best supportive care (BSC) are implemented in clinical trials when used as a comparison treatment arm. METHODS: We conducted a systematic review of the literature for clinical trials published between 1980 and 2012 in which systemic anticancer therapy was compared with an SC-only arm and compared SC implementation with World Health Organization (WHO) published guidelines. RESULTS: Our search identified 189 articles, 73 of which met our inclusion criteria with the following cancer types: 29 lung, 7 colorectal, 6 pancreatic, 5 gastric and 26 others. Fifty-five studies (75%) provided some definition of SC, and 48 studies (66%) used the term BSC. Twenty-one of the 55 studies that provided a definition described the use of palliative therapies as being 'at the discretion of the treating physician' without standardization. Only two studies provided SC that incorporated routine physical, psychological and social assessments including rapid referral to SC specialists. SC interventions most commonly included analgesics (47%) and radiotherapy (44%). Trials using the term BSC versus SC were more likely to include blood transfusions (P = 0.002) and antibiotics (P = 0.033), but less likely to include steroids (P = 0.05) and palliative specialists (P = 0.047). CONCLUSIONS: The implementation of SC in clinical trials in this systematic review is highly variable. The vast majority of the studies did not meet the WHO guidelines on SC because palliative care therapies were not recommended or integrated into care. Future clinical trials utilizing a SC intervention arm should define these interventions in a standardized approach that meets current guidelines such as the WHO recommendations.

Functional dyspepsia: subgroups, history and outcomes.

Dyspepsia is a symptom complex common both in the population and in clinical practice. Persons with dyspeptic symptoms who have not been evaluated are considered to have uninvestigated dyspepsia. If, after investigation, no structural or biochemical explanation is identified to explain the person's symptoms, the diagnosis of functional dyspepsia is made. While substantial efforts have been made to provide symptom-based criteria for the diagnosis of functional dyspepsia, the etiology and natural history of the disorder remains elusive. Population-based studies have often had difficulty distinguishing functional dyspepsia from irritable bowel syndrome. Clinically, there is clearly substantial overlap and many persons with functional dyspepsia either present with symptoms consistent with the irritable bowel syndrome or will develop such symptoms at a later date. Even if one can accept functional dyspepsia as an entity separate from irritable bowel syndrome, it is clearly a heterogeneous disorder. Unfortunately attempts using different strategies to subcategorize functional dyspepsia have not made progress with respect to elucidating pathophysiology or directing therapy. Importantly, most persons with functional dyspepsia experience symptom variability resulting in subgroup reassignment over time. Persons presenting with functional dyspepsia will likely remain symptomatic over time. Sadly, at the present time, gastroenterologists have little ability to predict what those symptoms will be, to understand the mechanism for their existence or to offer therapies that offer a reasonable likelihood of success based on a pathophysiologic rationale.