Boker 2012.

Methods	Randomized controlled trial
Participants	The study location was University of Texas Southwestern Medical Center, Texas, and University of California at Davis, California, USA 20 participants were randomized to the intervention group and 20 participants were randomized to the control group The inclusion criteria were healthy patients 12 to 35 years of age with mild to moderate facial acne suitable for treatment with topical medications; male or female of any ethnic background; a clinical diagnosis of acne vulgaris with facial involvement for at least 6 months; a minimum of 30 non‐inflammatory facial lesions (open and/or closed comedones) and at least 20 inflammatory lesions (papules or pustules); a score of 2 or 3 on the Investigator Global Assessment (IGA) scale; and possession of a personal mobile telephone with SMS text messaging capabilities. Women of childbearing potential were required to use an acceptable birth control measure such as abstinence, condoms, or vaginal diaphragms. Hormonal‐based oral contraception was only allowed if treatment had been initiated at least 5 months before study enrollment and was given for reasons other than specific treatment of acne. Minors (less than 18 years) were required to have parental or legal guardian consent to participate The exclusion criteria were known pregnancy, the presence of nodular or cystic acne, acne conglobata or acne fulminans, exposure to environmental or chemical comedogenic agents, women with hyperandrogenism (polycystic ovarian syndrome) or on any form of specific acne‐directed hormonal therapy, a history of Cushing syndrome or congenital adrenal hyperplasia, and use of tanning beds within 4 weeks of enrollment. All female patients of childbearing potential were required to undergo a baseline urine pregnancy test that was repeated at each follow‐up visit. Required washout periods included: acne‐specific systemic antibiotics, 2 months; isotretinoin, 6 months; and topical acne medications (prescription or over the counter), 4 weeks
Interventions	Intervention: TEXT MESSAGE REMINDERS 20 patients were then randomized to receive daily, customized text‐message reminders at a predetermined time. The website LetterMeLater.com was used to create an automated and customized electronic reminder schedule for each patient in this group at their baseline visit. Individual texting schedules were chosen based on each patient's preference and the anticipated time of each medication use. Once the schedule was created, patients in the reminder group received a customized text message twice daily (morning and evening), reminding them to apply the Duac (Stiefel Laboratories) or Differin (Galderma) gels, respectively. The content of each text message was identical for each patient and varied only by including the recipient's first name at the start of the message. Patients in the reminder group were asked to text back a reply if and when each application was completed in an attempt to compare actual adherence (measured by MEMS caps opening/closing events) and self reported adherence. All medication tubes and their corresponding MEMS caps were clearly labeled to avoid mix‐ups Control: USUAL CARE Control group patients received usual care and were not provided with text message reminders
Outcomes	The measures of adherence were MEMS. Patients were given medication tubes. Each medication tube was fitted with a customized Medication Event Monitoring System (MEMS) cap(MEMS, Aardex Group, Sion, Switzerland) that has the ability to record the date and time of every opening/closing of the medication cap. Each opening/closing is recorded as one individual event (date/time stamp). Patients were not informed that their adherence was monitored electronically. Data were downloaded at the 12‐week exit visit The patient outcomes were acne severity assessed by Investigator Global Assessment, Patient Global Assessment, and quality of life assessed by Dermatology Quality of Life Index questionnaire. All questionnaires were administered by a blinded investigator at baseline 6 and 12 weeks
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not enough information given. Patients were randomized in a 1:1 ratio and assigned in a sequential manner to either receive electronic text message reminders or to serve as control subjects
Allocation concealment (selection bias)	Unclear risk	Not enough information provided. ('sequential manner' = possibly high bias?). Patients were randomized in a 1:1 ratio and assigned in a sequential manner to either receive electronic text message reminders or to serve as control subjects
Selective reporting (reporting bias)	Unclear risk	None detected. Protocol not available
Other bias	Low risk	None noted
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ Unblinded, but MEMS data unlikely to be biased by the data collectors
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) ACNE SEVERITY ‐ it is unclear from description if the investigator was only blinded at baseline or was blinded at follow‐up as well
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) MEMS ‐ Patients were not informed that their adherence was monitored electronically, but nature of intervention might have unblinded them
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) ACNE SEVERITY ‐ it is unlikely patient could bias this measure
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ Unblinded, but MEMS data unlikely to be biased by the study staff
Blinding of personnel (performance bias) Patient outcome	High risk	(PRIMARY) ACNE SEVERITY ‐ study co‐ordinator was not blinded
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) MEMS ‐ Attrition not balanced between groups; not enough information provided on reasons for dropout
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) ACNE SEVERITY ‐ Attrition rates imbalanced; not enough information provided to judge