Rootmensen 2008.

Methods	Study design: parallel group Location, number of centres: single centre, pulmonary outpatient recruitment, Netherlands Duration of study: outcome assessment after 6 months
Participants	N screened: 805 outpatient files screened, 386 excluded on previous respiratory nurse contact, 187 patients did not attend outpatient appointment, 19 refused to participate (2 because information on purpose of study was postponed), 22 other reasons given N randomised: 191 (111 COPD) N completed: 157 COPD and asthma. INT 11 did not receive intervention, 13 withdrew consent, 4 died. CONTROL 14 withdrew consent, 3 died M = 105 (55%) F = 86 (45%) Age: AP asthma and COPD mean 60 (SD 15), CONTROL asthma and COPD mean 61 (SD 15) Baseline details: COPD severity GOLD classification ‐ AP GOLD 1/2 = 33 (57%), 3/4 = 22 (39%), CONTROL GOLD 0 = 6 (11%), 1/2 = 30 (55%), 3/4 = 18 (33%); mean FEV1 % predicted AP 57 (SD 19), CONTROL 64 (SD 26); mean FEV1/IVC AP = 0.47 (SD 0.12), CONTROL = 0.50 (SD 0.16) Inclusion criteria: diagnosis of asthma or COPD by respiratory physician, age over 18, ability to understand Dutch questionnaires, never consulted a pulmonary nurse Exclusion criteria: none listed
Interventions	Intervention: AP = protocol‐based 45‐minute educational programme on individual basis given by experienced pulmonary nurse. Content (in checklist): information on COPD, underlying pathophysiology, action and proper use of medications and oxygen, avoiding triggers, influenza vaccination, self‐monitoring instructions, smoking cessation. Individual instructions on how to prevent and act for management of exacerbation. Inhalation technique checked. Emergency oral steroids and antibiotics provided to some participants Control: usual care
Outcomes	Primary specified outcomes • Knowledge ‐ self‐administered 18‐item questionnaire designed by trialists, including items from 4 previously used questionnaires referenced plus self‐formulated questions. Response true/false/do not know. Score 0‐100% • Inhalation technique ‐ scored by blinded well‐trained observer from videotape demonstration by patient. Score 0‐100% from previously validated criteria • Self‐management knowledge ‐ self‐administered questionnaire on 3 exacerbation scenarios, questions adapted from validated interview‐based questionnaire • Exacerbation incidence ‐ definition exacerbation = worsening of respiratory symptoms that required treatment with oral steroids as judged and prescribed by general practitioner or pulmonary physician Outpatient Clinic Satisfaction Questionnaire ‐ Pulmonology (OCSQ‐P) was used to measure satisfaction with care ‐ general and pulmonary physician subscales
Notes	Funding: Netherlands Asthma Foundation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation procedure was based on a minimisation procedure. Minimisation factors were diagnosis (asthma or COPD), treated or not by pulmonary physician in previous 2 years
Allocation concealment (selection bias)	Low risk	Randomised in advance of clinic attendance. Randomisation results were reported to pulmonary physician just before the participant's visit.
Blinding (performance bias and detection bias) Participants	Low risk	Participants were masked for the trial objective to avoid more favourable assessment of participants in additional care group. Participants were told they would be informed about the additional research question only after follow‐up because informing during recruitment would affect the results. Participants asked after visit about length of consultation to detect potential differences in attention between groups. "The number of visits and duration of the first visit were the same for both groups”.
Blinding (performance bias and detection bias) Study personnel	Low risk	Investigators "used blind observers to assess adequacy of inhalational techniques”.
Blinding of outcome assessment (detection bias) Objective outcomes, e.g. healthcare utilisation	Low risk	Outcome assessors were blinded to outcomes.
Blinding of outcome assessment (detection bias) Subjective outcomes eg quality of life, anxiety	Low risk	Outcome assessors were blinded to outcomes.
Incomplete outcome data (attrition bias) Health care utilisation (objective)	Unclear risk	No data were measured for participants with COPD. Exacerbation frequency was measured but was not available for COPD only.
Incomplete outcome data (attrition bias) Subjective e.g. Quality of life	Unclear risk	Data were available for only 90 of 117 participants with COPD randomised.
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but it is clear that published reports include all expected outcomes, including those prespecified.
Other bias	Low risk	No other issues of bias are known.