Beney 2002.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: To improve patients' symptoms and/or side effects, such as delayed nausea and vomiting, as well as to detect and correct new symptoms that develop after discharge. AIM OF STUDY: To evaluate the effect of telephone follow‐up on the physical well‐being dimension of health‐related quality of life in patients with cancer. STUDY DESIGN: RCT. METHODS OF RECRUITMENT OF PARTICIPANTS: all patients admitted within a 1 year period; informed consent obtained during hospital stay. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: patients with hematologic or solid tumor malignancies/ chemotherapy/ speak English/ access to telephone. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: speech or hearing impairment/ mental or cognitive disorder/ live outside USA/ receiving weekly chemotherapy/ having allogeneic bone marrow transplant. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: unclear. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT:adequate EPOC‐ QUALITY CRITERIA 2002: B.moderate risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: spreadsheet with a block size of 4. METHOD OF CONCEALMENT OF ALLOCATION: each patient received a number and study assignment from the investigational pharmacist BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: yes. INTENTION TO TREAT ANALYSIS: yes. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: anova/t‐test/chi‐square/wilcoxon. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION: oncology patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 161. RANDOMISED TO INTERVENTION: 76. RANDOMISED TO CONTROL: 57. INCLUDED IN ANALYSIS INTERVENTION GROUP: 66. INCLUDED IN ANALYSIS CONTROL GROUP: 57. AGE: RANGE OR MEAN (SD): 53 (14). GENDER (% MALE): 73. ETHNICITY: 87% Caucasian, PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: hematologic or solid tumor malignancy, OTHER HEALTH PROBLEM/S: none. TREATMENT RECEIVED/RECEIVING: chemotherapy. OTHER SOCIAL/DEMOGRAPHIC DETAILS: 44% inpatient/mean Karnofsky score 83
Interventions	DETAILS OF INTERVENTION: TFU 48‐72 hours after discharge by PHARMACIST. During the call patients were asked if they had experienced any problems since discharge. Information was solicited on both drug‐related and non‐drug related problems. When appropriate, patients were given advice, support and reinforcement of education provided at the time of discharge, and appropriate follow‐up was recommended. DETAILS OF CONTROL: usual care. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: usual care. DELIVERY OF INTERVENTION Frequency: 1. First time at day 2‐3 after discharge. Period: PROVIDERS: pharmacist. INTERVENTION QUALITY: call‐back duration was 7.4 minutes (range 0‐30). FIDELITY/INTEGRITY: intervention was given in 80% by pharmacist as intended; in 20% by student.
Outcomes	NUMBER OF OUTCOMES: 5 OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..): social well‐being / Fact‐G scale (Cella 1993) / yes / questionnaire / 3 weeks after discharge; emotional well‐being / Fact‐G scale (Cella 1993) / yes / questionnaire / 3 weeks after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): functional well‐being / Fact‐G scale (Cella 1993) / yes / questionnaire / 3 weeks after discharge. Physical well‐being / Fact‐G scale (Cella 1993) / yes / questionnaire / 3 weeks after discharge. C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): symptom distress / Memorial Symptom Assessment Scale (Portenoy 1994) / yes / questionnaire / 3 weeks after discharge. D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..):
Notes	·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR ·POWER CALCULATION? yes. ·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH. ·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate