Watson 1997.

Methods	Study design: Parallel‐group randomised study Location, number of centres: New Zealand, 12 practices, 22 GPs Duration of study: 6‐month follow‐up. Year study performed: 1993‐July 1994 Time points: follow‐up at 6 and 12 months
Participants	Diagnosis: COPD defined according to American Thoracic Society: diagnosis of COPD as major functionally limiting disease; smoking history > 10 pack‐years; FEV1 < 65%; FEV1/FVC < 70%; current use of bronchodilator therapy Screened: 93 patients screened for possible inclusion; 24 did not meet inclusion criteria Randomised: 69 Completed: 56. Intervention 29; CONTROL 27 Drop‐outs: 13. 4 offended by questionnaire; 3 experienced complications from concurrent medical problems; 3 felt study protocol was too demanding; 1 left the country; 2 died M = INT 62%, CONTROL 67% Age: INT 68, CONTROL 67 Inclusion criteria: COPD by ATS criteria, smoking history > 10 pack‐years COPD severity: FEV1 < 65% predicted, current use of bronchodilator therapy Exclusion criteria: primary diagnosis of asthma (onset < 35 years), primary diagnosis of cardiac disease (uncontrolled heart failure); primary or secondary diagnosis of another functionally limiting disease (except cor pulmonale) that could significantly affect patient mortality within 6 months of entry to the study (malignant neoplasm) or participation in the study (psychoses); continuous use of oral corticosteroid; long‐term antibiotic therapy; rest home residents Baseline details Intervention: age 68 (SD 10); male 62%; married 52%; current smoker 24%; FEV1 % predicted 37 (SD 14); access to nebuliser 17%; own a peak flow meter 76%; influenza vaccine in last year 72% Control: age 67 (SD 8), male 67%; married 37%; current smoker 33%; FEV1 % predicted 36 (SD 16); access to nebuliser 26%; own a peak flow meter 70%; influenza vaccine in last year 44% Participation in study Intervention group: days in study: 186 (SD 13); days recorded in symptom diary: 144 (SD 62) Control group: days in study: 187 (SD 7); days recorded in symptom diary: 160 (SD 51)
Interventions	Action plan (AP) intervention: AP = recognition of respiratory symptoms when well and during exacerbations of COPD and medication instructions for worsening symptoms, a booklet on self‐management; supply of prednisone and antibiotic from GP. The booklet, "A Guide to Living Positively With COPD", was developed and circulated among participants' GPs and family. Covered smoking cessation, control of breathlessness, exercise, daily activities, diet, sleep, clearing of mucus, planning for future, medications, O2 and contact details for support services Control: usual care; access to AP and booklet specifically denied
Outcomes	Daily diary cards, which rated respiratory status as usual, mild, moderate or severe; prednisone use, antibiotic use and contact with GP, PN, hospital specialist, pharmacist. Participants were interviewed about access to and use of treatments, services and self‐management strategies. FEV1 and FVC spirometry HRQoL: SGRQ Healthcare utilisation Lung function Functional capacity Symptom scores Mortality Days on antibiotics/prednisone Outcomes were reported as absolute means and standard deviations from baseline.
Notes	Funding: Study was funded in part by the Southern Regional Health Authority. Additional funding and resources were provided by The Canterbury Respiratory Research Group. 85% of participants were given AP by practice nurse (PN), 15% by GP. 90% positive acceptability for AP. Time to provide AP 10‐20 minutes 40%, 20‐30 minutes 35%. 94% GPs and PNs had no difficulty explaining action plan use to participants.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants meeting entry criteria were randomly allocated to the intervention or control group. Permuted block randomisation was used, in blocks of 10. Order within the block was randomly generated by a computer.
Allocation concealment (selection bias)	Low risk	Participant level allocated by research staff according to randomisation list. GPs and PNs recruited participants and were blind to group allocation.
Blinding (performance bias and detection bias) Participants	High risk	Participants could not be blinded to allocation. Participants completed daily diary cards recording healthcare utilisation and symptoms. Knowledge of allocation to intervention may have biased reporting.
Blinding (performance bias and detection bias) Study personnel	Unclear risk	Study staff was not blinded.
Blinding of outcome assessment (detection bias) Objective outcomes, e.g. healthcare utilisation	Unclear risk	Participants completed daily diary cards recording healthcare utilisation.
Blinding of outcome assessment (detection bias) Subjective outcomes eg quality of life, anxiety	Unclear risk	Exit study visit in clinic for QoL was provided by study staff who were not blinded.
Incomplete outcome data (attrition bias) Health care utilisation (objective)	Unclear risk	60 randomised, 56 completed. Group allocation status of 13 withdrawals was not given.
Incomplete outcome data (attrition bias) Subjective e.g. Quality of life	Unclear risk	60 randomised, 56 completed. Group allocation status of 13 withdrawals was not given. Reasons: 4 participants offended by questionnaires; 3 experienced complications associated with concurrent medical problems; 3 believed the study protocol was too demanding; 1 left the country; 2 died.
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but it appears that published reports include all expected outcomes, including those prespecified.
Other bias	Unclear risk	Baseline access to and use of a variety of treatments, services and self‐management strategies showed no statistically significant differences between groups, except for influenza vaccination in last year: 72% INT, 44% CONTROL