Wiggins 2009.

Methods	Randomized controlled trial
Participants	The study location was 2 different ambulatory settings in the Midwest, USA 7 participants were randomized to the intervention group and 6 participants were randomized to the control group The inclusion criteria were patients aged 12 through 18 years and admitted for a tonsillectomy or T & A; with no risks or complications due to the surgical procedure and no history of bleeding disorders; discharged home with analgesia prescription that included instructions for administration every 4 hours for moderate to severe pain; discharged the same day as the surgery; both parent and child are able to speak, read, and write using the English language; and access to a telephone in the home for purpose of 2 follow‐up interviews.
Interventions	Intervention: AROUND‐THE‐CLOCK INTERVENTION The intervention was alarms to remind administering analgesic 4 hours after going to bed on the night of surgery and next 2 postoperative nights as instructed by the research nurse. In addition to the study procedure, all children and families received discharge education from their ear, nose, and throat (ENT) physician/clinic and from the professional nurses in each of the ambulatory centers. Discharge education in both ambulatory settings included use of around‐the‐clock prescribed analgesia for pain during the early days of recovery; increased fluid intake; monitoring for infection and bleeding; and returning to their specialist at a designated time in the recovery process. In addition, all ENT specialists encouraged families to contact them with concerns. All families received a phone call from a registered nurse from their ambulatory surgery center 24 hours after discharge Control: USUAL CARE The usual care group (UCG) was not given any specific intervention, but was offered the same discharge education as the intervention group. Discharge education materials included information about ear pain and the length of the recovery, mothers and children expressed self doubt about their ability to provide adequate symptom management when painful experiences continued
Outcomes	The measures of adherence were a diary. Each child recorded daily pain and symptom information in a diary from the day of surgery (after returning home) through the second postoperative day The patient outcomes were pain intensity, fluid intake, and night‐time awakenings by as self report diary. Pain intensity was recorded for the night of the surgery and postoperative day one and 2 using the Poker chip tool (PCT). Each child was given 4 red poker chips prior to discharge from the ambulatory setting. Both the parent and child were instructed by the research nurse that zero poker chips indicated no pain and 4 poker chips was the worst pain. Fluid intake and awakening were also recorded in the diary. Children were instructed record the number of awakening they remembered through the night. Fluid intake was measured per 8 ounce glass. Night time sleep was also measured using an Actigraph wrist device, which the patient had to wear from the time of discharge through the second postoperative day
Notes	Clinical outcomes reported as median only
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random numbers used. "The research nurse used a computer‐generated random numbers table to assign children to either the RTC group or the UCG at the time of discharge." (pg 167)
Allocation concealment (selection bias)	Unclear risk	No information was provided about how allocation was handled
Selective reporting (reporting bias)	Unclear risk	No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ DIARY ‐ No blinding of outcome assessment is mentioned in the article. Patients entered the data themselves. They were unblinded. "Children and parent(s) were informed during the consent/assent process that there were two different group assignments and after the final interview they would be told about the differences."
Blinding of outcome assessment (detection bias) Patient outcome	High risk	(PRIMARY) DIARY RECORDING: PAIN AND SLEEP ‐ Measurements were recorded by the patient who was instructed by the research nurse how to use the Poker chip tool. There is no information as to blinding of the nurse but any blinding could have been broken due to the nature of the intervention. "Children and parent(s) were informed during the consent/assent process that there were two different group assignments and after the final interview they would be told about the differences." It is possible that patients and families were aware of the groups ‐ not clear in the manuscript" (pg 167)
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ DIARY ‐ Children and parent(s) were informed during the consent/assent process that there were 2 different group assignments and after the final interview they would be told about the differences
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) DIARY RECORDING: PAIN AND SLEEP ‐ Measure was recorded by patient themselves. Children and parent(s) were informed during the consent/assent process that there were 2 different group assignments and after the final interview they would be told about the differences." (pg 167)
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ DIARY ‐ Research nurse is aware of group assignment. Other health care providers were blinded. "Allhealth care providers in the ambulatory setting were blinded to group assignment." (pg 167)
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) DIARY RECORDING: PAIN AND SLEEP ‐ "All health care providers in the ambulatory setting were blinded to group assignment" (pg 167)
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ DIARY ‐ 1 child in the RTC group did not choose to use the alarm intervention. This child reported having minimal pain and administering only a few doses of the prescribed pain medication during the postoperative recovery. (pg 170) If this child did not adhere to the intervention, he/she should have been removed from the analysis. The reason for missing data does not introduce any bias
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) DIARY RECORDING: PAIN AND SLEEP ‐ 1 child in the RTC group did not choose to use the alarm intervention. This child reported having minimal pain and administering only a few doses of the prescribed pain medication during the postoperative recovery. (pg 170) If this child did not adhere to the intervention, he/she should have been removed from the analysis. The reason for missing data does not introduce any bias