Jefford 2008.
Methods | Cluster‐RCT; Unit of allocation: General practitioner | |
Participants | General practitioners patients receiving chemotherapy. Setting / country: Peter MacCallum Cancer Centre / Australia Type of cancer: Not mentioned Phase of care: Treatment, discharge, surveillance Sample size at randomisation: 97 |
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Interventions | Tailored chemotherapy information faxed to general practitioners (GPs): In addition to usual correspondence, a cover letter and a chemotherapy information sheet relevant to their patients' regimen were faxed to the patients' GP. The GP practice was then contacted to confirm receipt of information and asked to file it in the patient's record. The cover letter was generic but contained several patient‐specific fields: name of the patient, name of treating doctor, type of cancer, treatment intent (to cure the disease, to increase the chance of long‐term, disease‐free survival [adjuvant treatment], or to palliate symptoms/improve quality‐of‐life/extend survival), and type of CT. The sheet also included the telephone number of the drug information service and listed a number of relevant, reputable Internet sites. The chemotherapy sheets were developed for 23 CT regimens, used to treat haematological and solid tumours. Each sheet named component drugs, explained the treatment cycle, listed common adverse effects, suggestions for management and advice about when to call the cancer centre, how to contact relevant staff, and had a further information section. They were developed by a medical oncologist and behavioural scientist in collaboration with pharmacy staff following a focus group of 10 GPs and following a review by medical, nursing and pharmacy staff. Control: Usual correspondence to GPs from their patient's oncologist |
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Outcomes | Professional: Satisfaction with communication received from the treatment centre, perceived confidence in managing chemotherapy adverse effects Process: Perceptions on the utility of correspondence |
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Notes | Length of follow‐up: 0.25 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation lists were developed by biased coin procedure." |
Allocation concealment (selection bias) | Low risk | Quote: "Sequentially numbered, opaque envelopes concealed experimental group allocation from the research assistant until after baseline data collection." |
Blinding (performance bias and detection bias) Satisfaction | High risk | Self‐report measure |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Participants who withdrew from the study, reported not receiving information, or did not read the information, had their last observation carried forward for any analysis that compared baseline and follow‐up scores." The proportions of missing data were different between experimental (21%) and control (12%) groups. Reasons of withdrawal are not described. Imputation was not appropriate. However, missing data were found not have an impact on the observed effect size (confidence or satisfaction), i.e. if missing data for outcomes found to be significant (confidence or satisfaction) were replaced with the same values found in the control group, and they remained significant (Cochrane Handbook; Section 8.12.2.1.). This highlights that there exists only a small chance of bias from missing values. |
Selective reporting (reporting bias) | Low risk | All outcomes in the methods section are reported in the results section. |
Other bias | Low risk | No evidence of other sources of bias were found. |
Baseline outcomes similar? | Low risk | Quotes: "Similarly, no significant differences were observed for any of the major outcome variables at baseline." "All reported means, SEs, and 95% CIs for the major outcome variables were adjusted for the effect of baseline as a covariate." |
Baseline characteristics similar? | Low risk | Quotes: "Overall, there were no significant differences between the two groups with respect to age, sex, overall experience, or oncology caseload (Table1)." "Comparisons of follow‐up scores were tested by an analysis of covariance with baseline added as a covariate." |
Protected against contamination? | Unclear risk | Allocation was by GP so it is impossible that a patient received the wrong treatment. There is a risk that some GPs in the two groups also practiced in the same clinic. |