Control Conditions That Are Neither Usual Care Nor No Treatment in Randomized Trials of Psychoeducational Palliative Care Interventions: A Systematic Review.

BACKGROUND

: Determining intervention efficacy depends as much on the control group as on the intervention, but little attention has been given to the control condition in psychoeducational trials in palliative care.

OBJECTIVES

: To examine (1) research practice regarding control conditions that are neither usual care nor no-treatment controls in randomized trials of psychoeducational palliative care interventions and (2) the rationale and completeness of the descriptions of control conditions in trial reports.

METHODS

: PubMed, EMBASE, PsycINFO, and Web of Science were searched. After screening 1603 articles, 70 full-text articles were assessed for eligibility. The final sample included 9 trial reports. We used the Delphi list for quality assessment and the modified intervention taxonomy checklist to assess active intervention and control conditions.

RESULTS

: Four trials used an attention control designed to be equivalent to the structure of the active intervention. In another 4, the control condition included some aspects of attention control such that the mode of contact was similar to that in the active intervention, but either the amount or the intensity of attention was not similar. Only 3 trial reports explicitly stated the rationale for the choice of control condition. Although most reports contained delivery mode, materials, duration, frequency, and sequence, none described the qualifications or training required to deliver the control condition. Only 1 report mentioned the fidelity monitoring method, and none included fidelity data.

CONCLUSION

: Our review of psychoeducational trials in palliative care calls for researchers' attention to appropriate selection, design, conduct and report of control conditions.