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. 2012 Jul 11;2012(7):CD007672. doi: 10.1002/14651858.CD007672.pub2

Bohnenkamp 2004.

Methods RCT; Unit of allocation: Patient
Participants Patients with ostomies resulting from treatment for a cancer diagnosis and discharged from hospital after surgery.
Setting / country: Large tertiary care centre (South Western university teaching hospital) / USA
Type of cancer: Bladder, colorectal, cervical / ovarian
Phase of care: Discharge, surveillance
Sample size at randomisation: 28
Interventions Home health visits plus tele‐nursing contact: Tele‐nursing aims to improve patient access to nurses who specialise in ostomy care. Nurses who specialise in ostomy care are extremely important to the continuum of care for patients with ostomies and their families. These nurses determine the proper equipment, educate the patient and family member, and provide supportive counselling. These activities cannot be accomplished only during hospital stay and the specialised nurses are integral to patients' follow‐up care and education. The telenursing group received twice weekly contacts by an ostomy clinical nurse specialist until patients or family members were competent with the care of the ostomy. All patients in this group were supplied with a home health 8" x 8" monitor and equipment for connecting to a television. Instructions and a demonstration regarding the equipment were done with the patient and family either prior to discharge or in their home after discharge, whichever was easier for the patient. Patients in this group had home health nursing visits as per routine plus twice‐weekly telenursing visits.
Control: Traditional home health visits only: this group received home health visitation by a nurse who continued evaluation and education according to current management protocols. The enterostomal therapy nurse was available for consultation as needed.
Outcomes Patient: Delay to independence with pouch change, readjustment after having an ostomy
Process: Number of home health visits, number of tele‐nursing contacts, amount of supplies used
Notes Length of follow‐up: 3 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "After discharge from the hospital, patients were assigned to one of two groups: (a) home health visits only or (b) home health plus tele‐nursing contact."
Quote from author email message: "The patients were randomised using the flip of the coin process".
Allocation concealment (selection bias) Unclear risk Quote from author email‐message: " The study was not blinded.  It is hard to conceal if a patient received telemedicine or not."
Comment: The author did not get exactly what was meant by allocation concealment.
Blinding (performance bias and detection bias) 
 All outcomes High risk Comment: Only a single subjective outcome (readjustment after having an ostomy) was assessed using a postal survey. Since the patients could not be blinded and the patients were the assessors, than assessors could not have been blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There were no missing data.
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 characteristics similar? Low risk Quote: "No statistically significant differences were evident between the two groups."
Comment: This quote relates to patients demographics (Table 1).
Quote: "No statistically significant differences existed between the two groups on type of cancer, LOS, or support source."
Protected against contamination? Low risk Because of the nature of the intervention (very heavy organization), it is unlikely that control group participants received intervention.