Jarab 2012 b.

Methods	Randomized controlled trial
Participants	The study location was an outpatient COPD clinic at the Royal Medical Services, Jordan 66 participants were randomized to the intervention group and 67 participants were randomized to the control group The inclusion criteria were patients attend only the outpatient COPD clinic at the Royal Medical Services, confirmed diagnosis of COPD by the hospital consultant for at least 1 year, over 35 years old, having a forced expiratory volume in 1 second (FEV1) of 30% to 80% of the predicted normal value and hospital consultant agreement that the patient is suitable for entering the trial The exclusion criteria were moderate to severe learning difficulties, mobility problems, confusion, disorientation or terminal illness, congestive heart failure or if they attended a pulmonary rehabilitation program or had consulted a pulmonary nurse or clinical pharmacist in the last 6 months
Interventions	Intervention: PHARMACIST INTERVENTION Intervention participants received structured education about chronic obstructive pulmonary disease (COPD) and management of its symptoms from a clinical pharmacist in a separate room at the outpatient clinic. The pharmacist also completed a medication table designed specifically to discuss types, indications, doses, frequency of administration, and possible side effects for each prescribed medication. The importance of simple exercises symptoms control and the technique for expectoration were discussed with the intervention patients. A booklet on these techniques was prepared to assist in the education session and the patients were given a copy to take home with them. The clinical pharmacist used the motivational interviewing technique with the aim of improving adherence to the prescribed treatment. Patients who still smoked were referred to a special smoking cessation program within the hospital Control: TREATMENT AS USUAL Controls did not receive pharmacists care
Outcomes	The measures of adherence were the Morisky scale. The measure was administered at baseline and at 6 months by the researcher. This simple 4‐question survey assesses the likelihood that patients take their medications as prescribed. On scoring of the questionnaire, each 'yes' response is given a score of 1 and each 'no' response is given a score of 0. Adherence scores can therefore range between 0 and 4. For the purpose of the present analysis, the patients were divided into 2 groups: those scoring 0 were considered adherent and those scoring 1 to 4 were considered non‐adherent The patient outcomes were health‐related quality of life (St George's Respiratory Questionnaire), and healthcare utilization. Arabic version of the questionnaires were administered at baseline and 6 months by the researcher
Notes	Insufficient information about how long or how many sessions pharmacist care was given to intervention participants. Not enough information about the controls. The FEV1 and BMI data are reported as outcomes but it is not clear where these data were collected
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Minimization. (pg 55) "Study participants were randomly assigned to intervention and control groups via a minimisation technique using MINIM software"
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment of 'Low risk' or 'High risk' of bias. "The patients were asked to sign a consent form if they were willing to participate in the study. Study participants were randomly assigned to intervention and control groups via a minimisation technique using MINIM software." (pg 55)
Selective reporting (reporting bias)	Unclear risk	None detected but protocol unavailable
Other bias	Unclear risk	The authors noted the following: (pg 60) "The study was limited in that the length of time required to complete the battery of questionnaires used in the present study may have encouraged bias in the responses gained from the participants, as in an effort to finish quickly, participants may have selected answers without giving due consideration to the questions posed. Furthermore, social desirability and recall bias associated with the use of a selfreport method to assess medications adherence could have affected the results. Another limitation was that the target sample size was not attained because the capacity for inclusion was limited in this trial with a single investigator. However, increasing the sample size therefore may allow more robust conclusions to be drawn about the findings."
Blinding of outcome assessment (detection bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information about the blinding of data collectors to permit judgment of 'Low risk' or 'High risk' of bias
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) HEALTH‐RELATED QUALITY OF LIFE (SGRQ) ‐ This is a subjective outcome. Insufficient information about the blinding of the data collectors to permit judgment of 'Low risk' or 'High risk' of bias
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Patients likely to be aware of intervention, due to its nature. The authors also note that one of the limitations of study was social desirability as a possible bias signaling that patients may not have been blinded or blinding could have been broken
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) HEALTH‐RELATED QUALITY OF LIFE (SGRQ) ‐ Patients likely to be aware of intervention, due to its nature. The limitations also notes social desirability as a possible bias signaling that patients may not have been blinded or blinding could have been broken
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information about the blinding of key personnel to permit judgment of 'Low risk' or 'High risk' of bias
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) HEALTH‐RELATED QUALITY OF LIFE (SGRQ) ‐ This is a subjective outcome. Insufficient information about the blinding of the key personnel to permit judgment of 'Low risk' or 'High risk' of bias
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Missing data are balanced
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) HEALTH‐RELATED QUALITY OF LIFE (SGRQ) ‐ Missing data are balanced