Trowbridge 1997.
Methods | RCT; Unit of allocation: Patient | |
Participants | Outpatients with a pathologic diagnosis of carcinoma or sarcoma and having recurrent or metastatic disease. Setting / country: 23 clinics in Indiana / USA Type of cancer: Any type Phase of care: Recurrence Sample size at randomisation: 510 |
|
Interventions | Summary of pain assessment included in clinical charts: Patients completed assessments of average and worst pain in the previous seven days, satisfaction with their current pain regimen and degrees of relief received at baseline and four weeks later. A summary sheet of these evaluations was included in the patients' clinical charts. Oncologists who treated these patients were instructed to review the summary sheet prior to an evaluation. Control: Patients completed assessments of average and worst pain in the previous seven days, satisfaction with their current pain regimen and degrees of relief received at baseline and four weeks later, but the summary was not available for the oncologists. |
|
Outcomes | Patient: Pain Professional: Pain management |
|
Notes | Length of follow‐up: 1 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding (performance bias and detection bias) All outcomes | High risk | Patients completed survey by mail and could not be blinded to assignment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details on attrition were presented. |
Selective reporting (reporting bias) | Low risk | All outcomes described in Methods are reported in Results. |
Other bias | Low risk | No evidence of any other bias. |
Baseline outcomes similar? | Low risk | Quote: "No other significant difference was found between the groups in their assessments of their pain, pain regimens, and relief received at baseline and at the four‐week follow‐up." |
Baseline characteristics similar? | Low risk | Quote: "The two groups were similar with respect to cancer sites and performance status" Comment: Gender and age were similar as well. They were all entered in analysis as covariates. However, values were not reported. |
Protected against contamination? | Unclear risk | Quote: "The ten oncologists treating these patients [intervention] were instructed to review the summary sheet prior to an evaluation. Such summaries were not available to the 12 oncologists treating the control patients." The patient was the unit of allocation, and treating oncologists were in the same facility. An oncologist may have treated control and intervention group patients. From the quote, it seems that different oncologists treated the patients in two groups, but this is not explicit. |