Control Groups in RCTs of Psychoeducational Palliative Care Interventions: A Systematic Review (S830)

Abstract

1.Explain the purpose of a control group that is neither usual care nor no-treatment.2.Describe the current practice using control groups that are neither usual care nor no-treatment in RCTs of psychoeducational palliative care interventions.3.Compare the explanations of the active intervention and the more-than-usual-care control in trial reports of RCTs of psychoeducational palliative care interventions. In randomized controlled trials (RCTs) an active intervention’s efficacy is determined relative to a control condition; thus the control condition’s design is as important as the intervention’s. In RCTs of psychoeducational palliative care interventions, researchers often use a control condition that is neither usual care nor no-treatment, but little is known about the extent of research practices in designing such control conditions. Therefore, this study examined: 1) the current research practice using control conditions that are neither usual care nor no-treatment controls in RCTs of psychoeducational palliative care interventions, and 2) the rationale and completeness of the description of those control conditions in trail reports. PubMed, Embase, PsychINFO, and Web of Science were searched. The final sample included nine trial reports. For quality assessment, a modified Delphi list was used. The descriptions of both the active interventions and the control conditions were assessed using a modified version of Schulz et al's Intervention Taxonomy checklist. Four trials used attention controls designed to be equivalent to the structure of the active interventions. An additional four trials used a control condition with some aspects of attention control, but neither the amount nor the intensity of attention were similar to the intervention. Only three trial reports stated the rationale for choice of control conditions. Most reports contained delivery mode, materials, duration, frequency, and sequence of both the intervention and control conditions; but none described the qualifications or training required to deliver the control condition. Only one report mentioned the fidelity monitoring method, and no report included fidelity monitoring data. Our review of RCTs in psychoeducational palliative care interventions calls for researchers’ attention to appropriate selection, design, conduct and report of control conditions.