Fallis 2001.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: To assess the patient's level of recuperation, evaluate the care received and identify inadequacies of the process; furthermore it demonstrates a sense of caring about patients and assists in marketing an ambulatory surgery program. AIM OF STUDY: To investigate the post‐discharge follow‐up required for patients who have undergone laparoscopic cholecystectomy on an outpatient basis and to determine if there was a significant difference in mean concern scores and satisfaction level of patients followed up by a home visit versus a telephone call. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: a convenience sample of patients scheduled for elective or urgent laparoscopic cholecystectomy. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not requiring postoperative admission; willing to be discharged on the day of operation, have a responsible caregiver and have a telephone. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: open cholecystectomy. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: yes. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: adequate. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: predetermined schedule; patients allocated by an operating room slating clerk. METHOD OF CONCEALMENT OF ALLOCATION: patients allocated by an operating room slating clerk. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: no. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: chi‐square/t‐test. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION: surgery patients. GEOGRAPHIC LOCATION: Canada. SETTING: discharged home from an acute care setting. NUMBER OF PARTTICIPANTS: ELIGIBLE: 152. RANDOMISED TO INTERVENTION: 78. RANDOMISED TO CONTROL: 72. INCLUDED IN ANALYSIS INTERVENTION GROUP: 77. INCLUDED IN ANALYSIS CONTROL GROUP: 72. AGE: RANGE OR MEAN (SD): 42 (13). GENDER (% MALE): 20. ETHNICITY: unclear. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: unclear. OTHER HEALTH PROBLEM/S: unclear. TREATMENT RECEIVED/RECEIVING: cholecystectomy. OTHER SOCIAL/DEMOGRAPHIC DETAILS: 25% smoker.
Interventions	DETAILS OF INTERVENTION: not specified. DETAILS OF CONTROL: home visit by a nurse. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: usual care. DELIVERY OF INTERVENTION Frequency: 1. First time at day 0 after discharge. Period: PROVIDERS: nurse. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear.
Outcomes	NUMBER OF OUTCOMES: 4 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, ..): Satisfaction / self‐developed / no / telephone interview / 2 days after discharge patient concerns / self‐developed / no / telephone interview / 2 days after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..): Readmission / hospital record / unclear / status analysis / 4 weeks after discharge. ED‐visits / hospital record / unclear / status analysis / 4 weeks after discharge.
Notes	·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR ·POWER CALCULATION? ·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