Wilson 2010.

Methods	Randomized controlled trial
Participants	The study location was Kaiser Permanente (KP) Center for Health Research in Portland, Oregon; Honolulu, Hawaii; Oakland/Richmond, California; San Francisco, California, USA 204 participants were randomized to the Shared Treatment Decision Making (SDM) intervention group and 204 participants were randomized to the Clinician Decision Making (CDM) control group The inclusion criteria were KP members aged 18 to 70 years with evidence suggestive of poorly controlled asthma, who used rescue medications and had at least 3 beta‐agonist dispensings in the past year, or were recently admitted to the ED or hospital for asthma‐related reasons The exclusion criteria were intermittent asthma, primary diagnosis of chronic obstructive pulmonary disease or emphysema, insufficient pulmonary function reversibility, regular use of oral corticosteroids, and current asthma care management
Interventions	Intervention: SHARED DECISION MAKING Session 1 involved setting the stage, gathering patient information, providing information and negotiating a treatment plan. In session 2 (1 month after session 1), and in 3 brief phone calls 3, 6, and 9 months later, patient progress was assessed and medications were adjusted, as necessary, using the assigned care management approach. Researchers used identical standardized interventionist scripts and materials. The patient's asthma history was elicited using a standardized patient information form, the patient's level of asthma control was classified, and asthma education was provided. Once treatment was negotiated, patients were instructed in the correct use of the relevant inhaler medication devices using methods previously shown by this team to improve inhaler technique and eliminate common usage errors. At the end of session 1, a written asthma management and action plan was created, and potential barriers to medication adherence were elicited and addressed using motivational interviewing techniques. Any subsequent changes made at session 2 or in a follow‐up phone call were documented in the plan. The SDM model implemented the 4 key defining features. The care manager elicited the patient's goals for treatment and relative priorities regarding symptom control, regimen convenience, avoidance of side effects, and cost. The patient was then shown a list of the full range of regimen options for all levels of asthma severity, based on the then‐current national asthma guidelines and KP pharmacopeia. These options differed with respect to the number and type(s) of medications, dosing, and schedule. Using a simple worksheet, the patient and clinician then compared the pros and cons of all of the options the patient wished to consider, which included the option of continuing the patient's current regimen to arrive at a treatment that best accommodated the patient's and care manager's goals. A SABA was always prescribed for rescue use as needed. If indicated, treatment of allergic rhinitis and/or gastroesophageal reflux disease was negotiated Intervention: CLINICIAN DECISION MAKING Session 1 of the intervention involved prescribing the patient a therapy rather than negotiating a therapy. In session 2 (1 month after session 1), and in 3 brief phone calls 3, 6, and 9 months later, patient progress was assessed and medications were adjusted, as necessary, using the assigned care management approach. Researchers used identical standardized interventionist scripts and materials. The patient's asthma history was elicited using a standardized patient information form, the patient's level of asthma control was classified, and asthma education was provided. Once treatment was decided (CDM), patients were instructed in the correct use of the relevant inhaler medication devices using methods previously shown by this team to improve inhaler technique and eliminate common usage errors. At the end of session 1, a written asthma management and action plan was created, and potential barriers to medication adherence were elicited and addressed using motivational interviewing techniques. Any subsequent changes made at session 2 or in a follow‐up phone call were documented in the plan. In the CDM model, the care manager prescribed an appropriate regimen based on the patient's level of asthma control, and explained that decision to the patient. A SABA was always prescribed for rescue use as needed. If indicated, treatment of allergic rhinitis and/or gastroesophageal reflux disease was prescribed Control: USUAL CARE Usual asthma care at KP medical centers was based on a stepped‐care approach to pharmacotherapy with the aim of long‐term asthma control, as recommended by the National Asthma Education Prevention Program's Expert Panel Report 2. At some KP sites, physicians also had the option to refer patients to an asthma care management program, typically of less than 6 months' duration, in which a licensed health professional (non‐physician) provided asthma education and addressed adherence and other medication use and self management issues in a manner similar to, but less structured than, the CDM intervention. However, asthma care management was neither a required aspect of usual care nor necessarily available at all BOAT sites, and current participation in that program was an exclusion criterion for the study. Once enrolled in BOAT, usual care and SDM or CDM patients (after the intervention phase) still had access to KP's existing care management services, if available, based on their physician's referral
Outcomes	The measure of adherence was pharmacy data. These data provided information about medication acquisition and were extracted from KP dispensing records 1 year pre‐randomization and 2 years post‐randomization. Fill/refill adherence was measured using a continuous medication acquisition (CMA) index for each year, calculated as the total days' supply acquired in a given year divided by 365 days. The index represents the proportion of the prescribed medication supply acquired by the patient during each 365‐day period, and may potentially overestimate, but not underestimate, actual use. The patient outcomes were pharmacy data. These data provided information about medication acquisition and were extracted from KP dispensing records 1 year pre‐randomization and 2 years post‐randomization. Fill/refill adherence was measured using a continuous medication acquisition (CMA) index for each year, calculated as the total days' supply acquired in a given year divided by 365 days. The index represents the proportion of the prescribed medication supply acquired by the patient during each 365‐day period, and may potentially overestimate, but not underestimate, actual use
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization sequence computer‐generated. "A computer‐based adaptive randomization algorithm (25) was used to ensure concealment from randomization staff and better‐than chance balance among the 3 groups on age (18–34, 35–50, and 51–70 yr), sex, race/ethnicity, hospitalization in the prior two years (yes/ no), and frequency of asthma controller use in the past week (none, 1–3,>4d)." (pg 567)
Allocation concealment (selection bias)	Low risk	Randomization sequence kept separate from those involved in the study and done using a computer sequence. "A computer‐based adaptive randomization algorithm (25) was used to ensure concealment from randomization staff and better than chance balance among the three groups on age (18–34, 35–50, and 51–70 yr), sex, race/ethnicity, hospitalization in the prior two years (yes/ no), and frequency of asthma controller use in the past week (none, 1–3,>4d)". "Allocation was concealed from staff randomizing patients. Randomization was implemented by having a designated, non‐blinded re search staff member at the site enter the relevant patient descriptors into the randomization module on the BOAT website, which immediately performed the randomization, stored the result, and return ed the patient's study assignment for implementation of the experimental assignment as indicated (e.g., referral to the designated care manager). All other study personnel, with the exception of the care managers, were blinded to patient's study assignment." (protocol).
Selective reporting (reporting bias)	Low risk	All outcomes specified in the protocol were reported
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) PHARMACY RECORD ‐ Blinded assessors. "All other study personnel, with the exception of the care managers, were blinded to patient's study assignment." (pg 3, suppl)
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) ASTHMA‐RELATED QUALITY OF LIFE ‐ Blinded assessors. "All other study personnel, with the exception of the care managers, were blinded to patient's study assignment." (pg 3, suppl)
Blinding of participants (performance bias) Adherence measure	Low risk	(PRIMARY) PHARMACY RECORD ‐ This is an objective measure of outcome
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) ASTHMA‐RELATED QUALITY OF LIFE ‐ This is a subjective measure; there is no information on blinding
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) PHARMACY RECORD ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) ASTHMA‐RELATED QUALITY OF LIFE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) PHARMACY RECORD ‐ Missing outcome data only for ICS canister equivalents and LABA acquisition. Missing data for ICS canister acquisition is fairly similar across the groups but no reasons are given. There are a lot of data missing for the LABA acquisition and there is a large discrepancy between the groups. The number of patients per group at pre‐randomization and follow‐up Year 2 is: SDM, n = 204; CDM, n = 202; UC, n = 204; and at follow‐up Year 1 is: SDM, n = 204; CDM, n = 202; UC, n = 203 for ICS canister equivalents. The number of patients per group at each time point is: pre‐randomization, SDM, n = 40; CDM, n = 44; UC, n = 52; follow‐up Year 1: SDM, n = 112; CDM, n = 108; UC, n = 59 for LABA acquisition
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) ASTHMA‐RELATED QUALITY OF LIFE ‐ Missing outcome data are fairly balanced in numbers across intervention groups but no reasons given for missing data. Refer to Figure 2. "The number of patients per group with no missing values at either time point is SDM n = 182, CDM n = 180, UC n = 189 for quality of life measure." (pg 574)