Kroenke 2010.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Specialist Diagnosis: At least moderately severe depression, defined as a PHQ‐9 score of 10 or higher and endorsement of either depressed mood, anhedonia; or both Inclusion criteria: Patients presenting for oncology clinic visits who screened positive for either pain or depression. Pain had to be (1) definitely or possibly cancer related; (2) at least moderately severe, (3) persistent despite trying at least 1 pain medicine Exclusion criteria: Unable to speak English, moderately severe cognitive impairment, schizophrenia or other psychosis, had a pending pain related disability claim, were pregnant, or were in hospice care Age: Mean 58.9 years Gender: 68% female Ethnicity: 80% White Country: United States Sample size (randomised): Total participants 405, intervention 202, control 203 |
|
| Interventions | Intervention: Care management Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Oncologist (PCP), nurse (CM), pain‐psychiatrist (MH specialist) 2) a structured management plan: CMs assessed symptom response and medication adherence; provided pain and depression specific education; and made treatment adjustments according to evidence based guidelines. Automated symptom monitoring was also performed between sessions using interactive voice recorded telephone calls or web based surveys. Participants who preferred not to take ADs were encouraged to consider a referral for psychotherapy and speak to their oncologist re this 3) scheduled patient follow‐ups: 4 in 12 weeks: at baseline, 1, 4 and 12 weeks plus automated contact 4) enhanced inter‐professional communication: Treatment recommendations were provided to PCP. CM had weekly supervision with MH specialist who was available between sessions Control: Treatment as usual enhanced as patients were informed of their depressive and pain symptoms, and their screening results were provided to PCP |
|
| Outcomes | Depression (HSCL‐20): 1, 3, 6, 12 months Quality of Life (mental and physical health): 1, 3, 6, 12 months |
|
| Notes | AD: antidepressant; CM: case manager; HSCL: Hopkins Symptom Checklist; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire‐9 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated in blocks of 4, 8 and 12 (randomly selected) |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information available to assess |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (HSCL‐20) was: overall 182/405(45%), 92/202(46%) intervention and 90/203(44%) control. Reasons for loss to follow‐up provided, with similar reasons for missing data across groups. Intention‐to‐treat analysis reported with appropriate imputation methods to manage missing data |
| Selective reporting (reporting bias) | Low risk | Protocol available and all prespecified outcomes reported |
| Other bias | Unclear risk | Insufficient information available to assess |
| Implementation Integrity | Unclear risk | Insufficient information available to assess |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor was not aware of treatment allocation |