Duncan 2012.

Methods	Randomized controlled trial
Participants	The study location was not available 40 participants were randomized to the intervention group and 36 participants were randomized to the control group The inclusion criteria were currently taking a recognized ART regimen and reporting a level of side effect‐related bother for the previous 30 days at or above 8 (corresponding to the 40th percentile in another sample) on the side effect and symptom distress scale The exclusion criteria were enrollment in another behavioral coping or HIV adherence intervention research study or MBSR program, severe cognitive impairment, active psychosis, or active substance abuse that would interfere with capacity to participate in MBSR
Interventions	Intervention: MINDFULNESS‐BASED STRESS REDUCTION MBSR aims to teach participants to respond to stressful situations "mindfully" ‐ a state in which one focuses on the present moment, accepting and acknowledging it without getting caught up in thoughts that are about the situation or emotional reactions. This enables people to respond to the situation by making conscious choices to respond instead of reacting automatically. The MBSR program consists of the following elements: (1) individual pre‐program intake interviews performed by the course instructor with each participant, lasting 30 minutes; (2) 8 weekly classes of 2.5 to 3 hours; (3) an all‐day silent retreat during the 6th week of the program; and (4) daily home assignments including a minimum of 45 minutes per day of formal mindfulness practice and 5 to 15 minutes of informal practice, 6 days per week for the entire duration of the course. The total in‐class contact is approximately 30 hours, and the total home assignments are a minimum of 42 to 48 hours. In addition, one to 2 additional individual interview sessions may be provided, at instructor discretion, to individual participants during the course. In addition to teaching mindfulness practices, the course includes didactic presentations that include information on stress physiology and stress reactivity. The course also addresses the effects of perception, appraisal, and attitude on health habits and behavior and on interpersonal communication Control: STANDARD CARE Control group received standard care and went through the same assessment procedure as the intervention group
Outcomes	The measures of adherence were AIDS Clinical Trials Group self report adherence measure to assess pills and doses skipped in the last 3 days for each ART medication and a visual analog scale (VAS) developed by Walsh et al to assess 30‐day adherence. The instruments were administered as audio computer‐administered self interview (ACASI) and computer‐assisted personal interviewing (CAPI) at 3 time points: baseline, 3 and 6 months The patient outcomes were side effects, perceived stress, depression, positive and negative affect, and mindfulness assessed at baseline, 3 and 6 months. Side effects was measured using a AIDS clinical trial group checklist in which respondents were asked whether they had experienced each of 25 possible symptoms in the preceding 30 days, and whether they attributed these to their ART medications, their HIV infection, or to other causes. Symptoms were coded as: 0 = did not experience the symptom versus 1 = experienced the symptom; the individual symptoms were then summed to create overall counts of symptoms and symptoms attributable to ART medications. To measure severity, participants were asked how much each symptom bothered them (on a Likert‐type scale: 0 = not present; 1 = present but does not bother me; ranging to 4 = present and bothers me terribly). Average symptom bother scores were computed as the mean of these individual Likert items to quantify the overall average bother and bother attributable to ART medications. Residual plots of the sum of symptoms attributable to ART medications variable appeared skewed and heteroskedastic in our data, so log transformation was applied to this outcome. The residual plots of log‐transformed symptoms attributable to ART and their average related bother/distress appeared close to normal and homoskedastic. Depression was assessed using the Beck Depression Inventory (BDI). Perceived stress was assessed using the Perceived Stress Scale (PSS). The Positive and Negative Affect Schedule (PANAS), was used to assess the intensity of positive and negative affect during the previous week. Mindfulness was assessed using a 5‐factor mindfulness questionnaire. The instruments were administered as audio computer‐administered self interview (ACASI) and computer‐assisted personal interviewing (CAPI) at 3 time points: baseline, 3, and 6 months
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	(pg 163) "Randomization was performed in blocks of six using the SAS system's PLAN procedure (SAS Institute, Cary, NC). Groups of six participant IDs were sorted in ascending order and aligned with the treatment output from the procedure. When less than six participants were available, dummy participant IDs were used to complete the block."
Allocation concealment (selection bias)	Unclear risk	Insufficient information about allocation concealment
Selective reporting (reporting bias)	Unclear risk	None detected; protocol not available
Other bias	Unclear risk	(pg 8) Authors report: low level of intervention participation with only one third sample completing the 5 or more of the 8 sessions
Blinding of outcome assessment (detection bias) Adherence measure	Unclear risk	(PRIMARY) AIDS CLINICAL TRIALS GROUP SELF REPORT ADHERENCE MEASURE ‐ No mention of outcome assessor blinding
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) SIDE EFFECTS ‐ No mention of outcome assessor blinding
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) AIDS CLINICAL TRIALS GROUP SELF REPORT ADHERENCE MEASURE ‐ Patients likely to be aware of interventions
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) SIDE EFFECTS ‐ Insufficient information about the blinding of participants. The outcome is self reported. Thus, the outcome could be biased
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) AIDS CLINICAL TRIALS GROUP SELF REPORT ADHERENCE MEASURE ‐ No mention of study staff blinding
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) SIDE EFFECTS ‐ No mention of study staff blinding
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) AIDS CLINICAL TRIALS GROUP SELF REPORT ADHERENCE MEASURE ‐ The number of missing participants is similar in both groups and for similar reasons. Refer to Figure 1: at 3‐month assessment, 6 participants in the intervention group and 5 participants in the control group were lost to follow‐up because they were unable to contact/schedule. At 6‐month follow‐up, 3 from the intervention and 3 from the control group were lost to follow‐up because unable to contact/schedule, move outs, or health problems(pg 166)
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) SIDE EFFECTS ‐ The number of missing participants is similar in both groups and for similar reasons