Khdour 2009.

Methods	Randomized controlled trial
Participants	The study location was outpatient COPD clinic at the Mater Hospital, Belfast, Northern Ireland 86 participants were randomized to the intervention group and 87 participants were randomized to the control group The inclusion criteria were confirmed diagnosis of COPD for at least 1 year, having a forced expiratory volume in 1 second (FEV1) of 30% to 80% of the predicted normal value and > 45 years old The exclusion criteria were having congestive heart failure, moderate to severe learning difficulties, attended a pulmonary rehabilitation program in the last 6 months, and severe mobility problems or terminal illness
Interventions	Intervention: PHARMACIST INTERVENTION The intervention was individualized and tailored for each patient by the clinical pharmacist based on disease knowledge, smoking status, medication adherence, self efficacy in managing breathing difficulty, and exercise and diet habits. Intervention patients were educated individually by the clinical pharmacist (in a structured fashion) on COPD, their prescribed medication, the importance of adherence, inhaler technique (written information was provided) and the management of COPD symptoms. The clinical pharmacist ensured that the patient knew the indications and doses of each medicine, and was able and willing to use the inhaler devices prescribed. The clinical pharmacist also discussed with the intervention patients the importance of simple exercises that patients can do at home (e.g. upper and lower limb exercises and relaxation techniques), symptom control (pursed lip technique) and the technique for expectoration (huff and puff technique). The pharmacist demonstrated these techniques and then asked the patients to carry out the techniques to ensure that they fully understood how to perform them. 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. Advice, using the motivational interviewing technique, was provided to the patients who still smoked and referral to a special smoking cessation program run within the hospital was made. A customized action plan for acute exacerbations, including advice to GPs to provide a prescription for an antibiotic (amoxicillin/clavulanic acid) and an oral corticosteroid to be initiated promptly by patients for exacerbations,was developed for each patient. The clinical pharmacist through motivational interviewing attempted to increase the intervention patients' self efficacy to manage or avoid breathing difficulty while participating in certain activities. The interventions were tailored according to the preliminary assessment, i.e. checklists of patients' needs were prepared by the research pharmacist and forwarded to the clinical pharmacist to discuss with the patients. The initial intervention lasted for approximately 1 hour for nonsmoker patients and slightly longer for patients who currently smoked. At each outpatient clinic visit (every 6 months arranged by the hospital consultant), intervention group patients received reinforcement of the education on COPD and its treatment from the clinical pharmacist. In addition, follow‐up telephone calls by the clinical pharmacist to reinforce the education and motivate the patients to achieve their goals were made at 3 and 9 months, i.e. between outpatient clinic appointments Control: USUAL CARE Control patients received usual hospital outpatient care from medical and nursing staff
Outcomes	The measures of adherence were self reported Morisky adherence scale, which measures adherence through 4 Yes/No response items, reflects the number of ways medication omission can occur: forgetting, carelessness, stopping when feeling better, and stopping when feeling worse.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. In the present study, 2 adherence classifications were used. The Morisky self report adherence scale has been shown to have good validity (a reliability = 0.61) The patient outcomes were utilization of health resources, disease‐specific health‐related quality of life, BMI, and FEV1. Patients charts were consulted to determine their use of health resources over the 12 months of the study (ED visits, hospital admissions), their BMI, and the FEV1. The SGRQ was administered by the research pharmacist at baseline, 6 months, and 12 months to measure QOL. A change in the mean total score of 4 units was used as a clinically significant threshold. If a patient could not self complete the questionnaire, a strict protocol was used to read the questions to the patients
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomization was carried out using the minimization method described by Gore. The software used in the minimization process can be accessed on: http://www‐users.york.ac.uk/˜mb55/guide/minim.htm
Allocation concealment (selection bias)	Unclear risk	Not enough information given. The randomization was carried out using the minimization method described by Gore. The software used in the minimization process can be accessed on: http://www‐users.york.ac.uk/˜mb55/guide/minim.htm
Selective reporting (reporting bias)	Unclear risk	No protocol available
Other bias	Unclear risk	The manuscript does not explicitly give any limitations
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ "Patients who had difficulty self‐completing questionnaires, e.g. forgot reading glasses, had the questionnaires read to them. If this occurred, a strict protocol was followed, i.e.the questions were read to the patients and their answers sought without any interpretation of the questions being given. This helped minimize potential bias related to the fact that, for operational reasons, the researcher could not be blinded to the group to which the patient belonged." (pg 590)
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) ST GEORGE'S RESPIRATORY QUESTIONNAIRE ‐ "Patients who had difficulty self‐completing questionnaires, e.g. forgot reading glasses, had the questionnaires read to them. If this occurred, a strict protocol was followed, i.e.the questions were read to the patients and their answers sought without any interpretation of the questions being given. This helped minimize potential bias related to the fact that, for operational reasons, the researcher could not be blinded to the group to which the patient belonged." (pg 590). This outcome is self reported by the participant. The lack of blinding is not likely to affect the outcome
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) HEALTH RESOURCES UTILIZATION ‐ Objective measure, unlikely to be biased; obtained data from computerized hospital records
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ The manuscript does not explicitly state whether participants were blinded. The outcome is self reported and therefore the lack of blinding will interfere with the outcome
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) HEALTH RESOURCES UTILIZATION ‐ This is an objective measure of outcome. The lack of blinding is not likely to affect the outcome
Blinding of participants (performance bias) Patient outcome	Unclear risk	(PRIMARY) ST GEORGE'S RESPIRATORY QUESTIONNAIRE ‐ Insufficient information to permit judgment
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ "The researcher could not be blinded to the group to which the patient belonged." (pg 590). However, the questionnaire was answered by the participant
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) ST GEORGE'S RESPIRATORY QUESTIONNAIRE ‐ Insufficient information to permit judgment
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) HEALTH RESOURCES UTILIZATION ‐ This is an objective measure of outcome. The lack of blinding is not likely to affect the outcome
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Equal number of participants discontinued the study from both groups at the end of 12 months for the same reasons. Refer to Figure 1. "During the study period, three patients from the intervention group and five from the control group died and a total of 22 patients withdrew from the study; 12 patients from the intervention group and 10 from the control group (Figure 1). Therefore, the total number of patients lost to follow‐up over the complete study was 30, leaving 72 patients in the control group and 71 participants in the intervention group at the end of the study." (pg 591)
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) HEALTH RESOURCES UTILIZATION ‐ Equal number of participants discontinued the study from both groups at the end of 12 months for the same reasons. Refer to Figure 1. "During the study period, three patients from the intervention group and five from the control group died and a total of 22 patients withdrew from the study; 12 patients from the intervention group and 10 from the control group (Figure 1). Therefore, the total number of patients lost to follow‐up over the complete study was 30, leaving 72 patients in the control group and 71 participants in the intervention group at the end of the study." (pg 591)
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) ST GEORGE'S RESPIRATORY QUESTIONNAIRE ‐ Equal number of participants discontinued the study from both groups at the end of 12 months for the same reasons. Refer to Figure 1. "During the study period, three patients from the intervention group and five from the control group died and a total of 22 patients withdrew from the study; 12 patients from the intervention group and 10 from the control group (Figure 1). Therefore, the total number of patients lost to follow‐up over the complete study was 30, leaving 72 patients in the control group and 71 participants in the intervention group at the end of the study." (pg 591)