Beney 2002.
Methods | RCT; Unit of allocation: Patient | |
Participants | Patients having haematological or solid tumour malignancies, receiving chemotherapy and discharged home after completing a chemotherapy cycle. Setting / country: Public teaching hospital (University of California San Francisco) / USA Type of cancer: Any type Phase of care: Discharge, surveillance Sample size at randomisation: 150 |
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Interventions | Telephone follow‐up: A comprehensive and detailed operations manual reinforcing standardised study methodology, procedures, and data collection forms was created and distributed to each clinical pharmacist. Patients received a telephone follow‐up call from the clinical pharmacist 48 to 72 hours after hospital discharge. Information was solicited regarding drug‐related and non‐drug‐related problems. Problems were addressed, and advice and support were given. Drug‐related questions addressed concerns about access to drugs and adverse drug events. Adequate understanding about and adherence to drug regimens were assessed. When appropriate, patients were given advice, support, and reinforcement of education provided at the time of discharge. Non‐drug‐related problems were triaged, and appropriate follow‐up recommended. Control: No telephone follow‐up after discharge from the oncology service. |
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Outcomes | Patient: QoL, symptoms including psychological status (distress) | |
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: "After the patient was discharged, the clinical pharmacist obtained a subject number and study assignment from the investigational drug pharmacist. Patients were randomised using a spreadsheet with a block size of four. This approach guaranteed that patient allocation would not influence the discharge process." Quote from the author e‐mail: "The allocation sequence was generated electronically (bloc of 4) in the centralised pharmacy." |
Allocation concealment (selection bias) | Low risk | Quote: "After the patient was discharged, the clinical pharmacist obtained a subject number and study assignment from the investigational drug pharmacist." Comment: The investigator was the person responsible for giving assignment. |
Blinding (performance bias and detection bias) All outcomes | High risk | Comment: The first questionnaire seems to have been administered in person (no mention of blinding of outcome assessors), whereas it was mailed at follow‐up (patients could not have been blinded for follow‐up measures). |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "A total of 161 patients were randomised; of these, 11 were excluded after randomisation because of protocol violations. Of the remaining 150 patients, 76 were assigned to the call‐back group and 74 to the control group, who received no telephone follow‐up. In the control group, 17 patients did not return the survey; therefore, 57 control patients were included in the analyses. Of the 76 patients assigned to call back, three could not be reached after three attempts, two were not called because of logistical problems, and one refused further discussion. We used an intent‐to‐treat approach and therefore included patients assigned to the call‐back group who did not actually receive telephone follow‐up. Of the 76 patients in the call‐back group, 10 did not return the survey; therefore, 66 call‐back patients were included in the analyses." Comment: There were more missing outcomes in the intervention group (77% retention) than in the control group (87% retention). Reasons for attrition are not reported. The statistical analysis only included patients that completed follow‐up (no imputation was used). It is impossible to judge if missing data could have an impact on the effect estimate because the type of variability measures presented in the Table 2 was not specified. |
Selective reporting (reporting bias) | Low risk | All relevant outcomes in the methods section are reported in the results section. |
Other bias | Low risk | No evidence of other bias. |
Baseline outcomes similar? | Low risk | Comment: No significant difference at baseline in primary and secondary outcomes between groups (Table 2). |
Baseline characteristics similar? | Low risk | Comment: No significant difference in baseline characteristics between the 2 groups at baseline (Table 1). |
Protected against contamination? | Low risk | It is unlikely that the clinical pharmacists provided the call‐back intervention to patients allocated to the control group since a detailed manual on methodology and procedures was provided to them. |