Methods

Study design: parallel group

Location, number of centres: participants recruited through their general practitioners and district nurses in catchment area of single hospital in New Zealand

Duration of study: 12 months

Participants

N screened: not available

N randomised: 96

N completed: 93 (44 INT, 49 UC)

M = INT 15 (34%), UC 32 (65%)

F = INT 29 (66%), UC 17 (35%) (P < 0.1)

Age: INT 71.1 (95% CI 68.7 to 73.5), UC 69.1 (95% CI 63.5 to 74.7)

Baseline details: FEV₁ % PRED 35.4 (95% CI 31.6 to 39.2), UC 34.3 (95% CI 31.2 to 37.4)

Smoking exposure PYH: INT 35.4 (95% CI 29.4 to 41.4), UC 48.2 (95% CI 39.1 to 57.3) (P = 0.03)

Inclusion criteria: diagnosis of moderate or severe COPD, aged 55 years or older,at least 1 hospital admission or 2 acute exacerbations of COPD requiring GP care during previous 12 months. Mini Mental State Examination (MMSE) score ≥ 23

Exclusion criteria: terminal illness, coexisting lung cancer, admission to hospital with cardiac disease within previous 12 months, receiving home oxygen therapy

Interventions

Intervention: A generic care plan was developed by a group comprising a general practitioner, a community‐based respiratory nurse, a respiratory physician, an emergency department consultant, the local  St John's Ambulance paramedical staff director and the after hours GP service director. This results in 5 separate sections within the plan with specific instructions for patient and/or career, GP and/or community nurse, ambulance service, and emergency department and medical staff of Dunedin Hospital. Although sections showed significant overlap, it was recognised that the language and content of each section had to be appropriate for different users of the plan. Thereafter, the care plan was individualised and was 'signed off' for each participant allocated to the intervention group. This was done on the basis of an interview between participant and respiratory nurse (FRS), a review of hospital notes in relation to previous admissions by the respiratory specialist (DRT) and a review by the participant's own GP.

Control: UC = usual care by own GP

Treatment period: 12 months

Follow‐up time points: 3, 6, 9 and 12 months

Outcomes

Primary outcomes: utilisation of primary care services and hospital admissions; quality of life as measured by St George's Respiratory Questionnaire (SGRQ)

Notes

Not stated if hospital admissions were COPD‐related or all‐cause

Funding: Study was supported by South Link Health Inc., a non‐profit consortium of general practitioners.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Patients were randomly assigned to the intervention (care plan) or control (usual care) groups". No method of randomisation was described.

Allocation concealment (selection bias)

Unclear risk

No method of allocation was published.

Blinding (performance bias and detection bias)
Participants

High risk

Participants were not blinded to the care plan intervention. Lack of blinding may have affected participants' perception for quality of life measurements.

Blinding (performance bias and detection bias)
Study personnel

Unclear risk

Study personnel were not blinded to the care plan intervention. "All patients (both intervention and control groups) were visited by the research nurse (DMcN) at the study start and thereafter at three, six and 12 months to provide routine support, and, for the care plan group, further education regarding use of the plan."

Blinding of outcome assessment (detection bias)
Objective outcomes, e.g. healthcare utilisation

Low risk

All participants (both intervention and control groups) were visited by the research nurse (DMcN) at the study start and thereafter at 3, 6 and 12 months.

Blinding of outcome assessment (detection bias)
Subjective outcomes eg quality of life, anxiety

Unclear risk

Research nurse who administered quality of life questionnaires was not blinded.

Incomplete outcome data (attrition bias)
Health care utilisation (objective)

Low risk

GP visits: data for 41/44 INT, 47/49 UC participants. Ambulance call data for 42/44 INT, 47/49 UC. Hospital admission data for 44/44 INT, 49/49 UC

Incomplete outcome data (attrition bias)
Subjective e.g. Quality of life

Low risk

96 participants were recruited, 93 completed the study, 3 withdrew for personal reasons (group allocation unknown).

Selective reporting (reporting bias)

Unclear risk

The study protocol is not available, and it is not clear whether published reports include all expected outcomes, including those that were prespecified.

Other bias

Unclear risk

Number of practices from which participants were recruited is not available. Pilot study, no sample size calculation performed and no attempt made to examine clustering within practices

Methods

Study design: parallel‐group cluster‐randomised study in an intervention group of practices and a control group of practices

Location, number of centres: participants attending 2 groups of general practices in Christchurch, New Zealand

Duration of study: 12 months. Year study performed: July 2002‐December 2003

Participants

N screened: 257

N randomised: 159

N completed: 152. INT 84, 1 died, 1 withdrew consent; CONTROL 68, 2 died, 2 withdrew consent, 1 unable to be contacted

M = INT 45 (52%), CONTROL 49 (67%)

Age: INT 69.8 (11.6), CONTROL 72.1 (9.9)

Baseline details: current smoker INT 27 (31%), CONTROL 17 (23%); ex‐smoker INT 59 (69%), CONTROL 56 (77%); pneumococcal vaccination (last 5 years) INT 34 (40%), CONTROL 30 (43%); FEV₁ % predicted INT 54.6 (18.7), CONTROL 53.1 (18.1); BMI INT 25.9 (4.6), CONTROL 25.4 (4.1); HADS anxiety INT 6.2 (4.2), CONTROL 5.3 (3.6); HADS depression INT 4.6 (3.7), CONTROL 4.1 (2.9); SGRQ total INT 43.3 (18.8), CONTROL 36.8 (17.6); P = 0.03
Inclusion criteria: GP database searched for diagnosis or use of bronchodilator and inhaled corticosteroid prescriptions. COPD according to ATS criteria (history of cough, sputum, SOB, > 10 pack‐year smoking); plus FEV₁/FVC < 70%, weekly symptoms, history or 1+ exacerbations in previous 12 months requiring increased therapy

Exclusion criteria: unable/unwilling to sign consent, primary diagnosis asthma, other primary functionally limiting disease, other medical condition likely to affect patient mortality, hospital level residential care, already using self‐management plan, on domiciliary O₂, attending GP who already uses self‐management plans more than occasionally, exacerbation of COPD requiring increased treatment within 6 weeks or admission to general hospital within 3 months, cognitive impairment as per 3 MS < 75%, alpha1‐antitrypsin deficiency

Interventions

Intervention: AP intervention: usual care and individual standardised educational session from practice nurse or respiratory educator on the use of a self‐management plan, which includes methods of early recognition of exacerbations and appropriate self‐initiated interventions including antibiotics and short course oral corticosteroids; instruction to make early contact with GP.

Control: usual care, specifically denied access to written self‐management plan. Non‐standard education on smoking cessation, exercise, controlling breathlessness, nutrition, use of inhaled therapy and immunisation was given according to practice standards.

Treatment period: 12 months

Follow‐up time points: assessments at baseline, 12 months; telephone interviews at 3, 6 and 9 months

Outcomes

Medications: % people used courses of antibiotics and oral steroids at 6 and 12 months
HRQoL: SGRQ measured at 6 and 12 months
Healthcare utilisation: % participants who attended GP visits, ED visits and hospital admissions at 6 and 12 months;
% participants who took courses of antibiotics/prednisone at 12 months
Hospital Anxiety and Depression Scale (HADS): recorded at baseline and at 12 months
COPD Self‐Management Interview (COPD‐SMI): 30‐minute structured interview at baseline and at 12 months, comprising 3 written descriptions of situations (read to participants) based on stages of an exacerbation.

• Feeling of wellness

• Early exacerbation

• Severe exacerbation

In each scenario, investigators assessed 3 self‐management domains of medication use, healthcare‐seeking decisions and self‐care. They scored each of 13 items per situation on a 3‐point scale (0–2), separately scoring responses for knowledge (knowing what to do) and actions (whether participants would actually do the task and when they would do it), yielding a maximum possible score of 26 for each in all 3 situations.

Study visits at baseline and at 12 months, with telephone interviews at 3, 6 and 9 months

Notes

Funding: Study was funded by Pegasus Health, an independent practitioner association, The Canterbury Respiratory Research Trust and The Asthma and Respiratory Foundation of New Zealand. No funding was received from any pharmaceutical company.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Randomisation sequence generation was not described. Practices were randomised via 1 investigator. Individual participants were also randomised by a random numbers table if too many were included in a single practice. Participants were screened after randomisation by standardised history and spirometry.

Allocation concealment (selection bias)

Unclear risk

Participants were allocated by practice attendance, but information on allocation of practices was not available. If too many patients were identified in each practice, a random numbers table was used to allocate individual participants. An aspect of concern regarding this method was that if the same GP was implementing both intervention and usual care, confounding between treatment methods may occur, possibly diluting effects of active intervention.

Blinding (performance bias and detection bias)
Participants

High risk

Researchers were unable to blind participants to educational intervention; patient questionnaire outcomes may be influenced by perception of receiving extra intervention.

Blinding (performance bias and detection bias)
Study personnel

Unclear risk

Nursing staff administering assessments were not blinded to whether participants were included in intervention or control groups.

Blinding of outcome assessment (detection bias)
Objective outcomes, e.g. healthcare utilisation

Low risk

Although it was not clear how healthcare utilisation data were collected, this was unlikely to be affected by bias.

Blinding of outcome assessment (detection bias)
Subjective outcomes eg quality of life, anxiety

Unclear risk

Nursing staff administering assessments were not blinded to whether participants were included in intervention or control groups; this may potentially affect collection of questionnaire data.

Incomplete outcome data (attrition bias)
Health care utilisation (objective)

Low risk

Analysis: INT 84/86 (1 death, 1 WD consent), CONTROL 70/73 (2 WD consent, 1 no contact). Small losses to follow‐up, balanced across groups

Incomplete outcome data (attrition bias)
Subjective e.g. Quality of life

Low risk

Analysis: INT 84/86 (1 death, 1 WD consent), CONTROL 70/73 (2 WD consent, 1 no contact). Small losses to follow‐up, balanced across groups

Selective reporting (reporting bias)

Low risk

Study protocol was not available, but all expected outcomes were reported.

Other bias

Unclear risk

Sample size calculation was based on the assumption that about 10 patients would be recruited for each surgery, and that no additional between‐participant variation would be due to clustered‐randomisation of surgeries. Analysis of the 12‐month change in outcome variables was based on a mixed‐model repeated measures ANOVA. This analysis enabled estimation of any additional variation in outcome measures as a consequence of clustered‐randomisation of surgeries rather than individuals. Analyses of outcome variables showed no additional variation from this source beyond that anticipated by between‐participant variation. Analysis of the 12‐month change in outcome variables was based on a mixed‐model repeated measures ANOVA. This analysis enabled estimation of any additional variation in outcome measures as a consequence of clustered‐randomisation of surgeries rather than individuals. Analyses of outcome variables showed no additional variation from this source beyond that anticipated by between‐participant variation. For this reason, all analyses were based on use of participants as replicates. When baseline differences in outcome measures were evident, ANCOVA for repeated measures was used to test the relative effects of treatments.

Methods

Study design: parallel‐group randomised controlled trial

Location, number of centres: United States of America. Five Veteran Affairs medical centres

Duration of study: 12 months

Participants

N screened: 1739 eligible, 1316 attempted telephone contact

N randomised: 743 (AP 372, UC 371)

N completed: AP 336 completed 1 year, 36 deaths; UC 323 completed 1 year, 48 deaths

Baseline characteristics: mean age, years (SD) AP 69.1 (9.4), UC 70.7 (9.7); male, n (%) AP 363 (97.6), UC 365 (98.4); mean FEV₁, % predicted (SD) AP 36.1 (14.5), UC 38.1 (14.4); current smoker, n (%) AP 80 (21.6), UC 85 (23.0); hospitalised for COPD in the past year, n (%) AP 133 (35.8), UC 145 (39.1); ED visit for COPD in the past year, n (%) AP 218 (58.6), UC 195 (52.6); systemic steroid for COPD in the past year, n (%) AP 210 (56.6), UC 197 (53.5); home oxygen, n (%) AP 200 (53.9), UC 209 (56.6); number in group AP 372, UC 371

Inclusion criteria: diagnosis of COPD and 1 or more of the following during previous year: (1) hospital admission or ED visit for COPD; (2) long‐term home oxygen use; (3) course of systemic corticosteroids for COPD. Additional inclusion criteria: ability to complete the consent process, postbronchodilator spirometry showing FEV₁ < 70% predicted, FEV₁/FVC < 0.70

Exclusion criteria: any condition that might preclude effective participation in the study or that would reduce life expectancy to less than a year. No access to a telephone

Interventions

AP group: education: attended a single 1 to 1.5‐hour group educational session conducted by a case manager; respiratory therapist completed a 1‐day training session. Educational content: ACCP material on general information about COPD, causes, symptoms and treatment of exacerbations, direct observation of inhaler techniques, review and adjustment of outpatient COPD medications, smoking cessation counselling when appropriate, recommendations concerning influenza and pneumococcal vaccinations, encouragement of regular exercise, instruction in hand hygiene. Telephone call follow‐up: case manager monthly phone calls to reinforce general principles of COPD management, review details of the action plan and answer questions. Action plan: individualised written action plan including: (1) description of signs and symptoms of an exacerbation that should prompt initiation of self‐treatment, (2) refillable prescriptions for prednisone and an oral antibiotic, (3) contact information for a case manager, and (4) telephone number of the 24‐hour VA help line. Participants were instructed to begin action plan medications for symptoms that were substantially worse than usual.

UC group: education: received 1‐page handout containing a summary of the principles of COPD care according to published guidelines. Telephone call follow‐up: given telephone number for 24‐hour VA nursing help line, a service available to all VA patients. No action plan

Follow‐up time points: assessment at baseline and at 12 months. Educational session for AP participants only at the start of the trial, monthly phone calls by a case manager to participants in the AP group; participants were encouraged to contact case manager when they used action plan medications or if they had questions regarding their action plan.

Outcomes

Primary outcome: combined number of hospital admissions and ED visits for COPD

All outcomes

• SGRQ

• Hospital admissions and ED visits for COPD

• Hospitalisations and ED visits for other causes

• Hospital and ICU lengths of stay

• Respiratory medication use

• Mortality all‐cause

• Hospital admissions and ED visits outside of VA hospitals

Notes

Details of method, intervention and usual care obtained from online supplement

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Online data supplement reports methods of sequence generation as "assigned subjects in equal proportions to each of the two treatment arms by permuted‐block randomisation".

Allocation concealment (selection bias)

Unclear risk

No details of allocation concealment were given in the paper or in the trial registration entry.

Blinding (performance bias and detection bias)
Participants

Low risk

Participants were not blinded, but this is not likely to affect mortality or primary outcomes of healthcare utilisation measures (objective).

Blinding (performance bias and detection bias)
Study personnel

Low risk

Assessors were blinded: "Blinded pulmonologists independently reviewed all discharge summaries and ED reports and assigned a primary cause for each".

Blinding of outcome assessment (detection bias)
Objective outcomes, e.g. healthcare utilisation

Low risk

Assessors were blinded: "Blinded pulmonologists independently reviewed all discharge summaries and ED reports and assigned a primary cause for each". Mortaility, healthcare utilisation measures, objective data. Thus low risk of bias

Blinding of outcome assessment (detection bias)
Subjective outcomes eg quality of life, anxiety

Unclear risk

SGRQ self‐administered patient assessment, with greater potential for bias with lack of blinding

Incomplete outcome data (attrition bias)
Health care utilisation (objective)

Low risk

The status of all 743 participants was determined after 1 year.

Incomplete outcome data (attrition bias)
Subjective e.g. Quality of life

Low risk

Only reason for missing data was death (48 in usual care, 36 in intervention). Investigators were unable to perform intention‐to‐treat analysis.

Selective reporting (reporting bias)

Low risk

All primary and secondary outcomes were reported in trial registration.

Other bias

Low risk

No other issues of bias are known.

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.

Methods

Study design: parallel‐group randomised controlled trial

Location, number of centres: Netherlands, University Medical Centre Ultrecht. Participants were recruited from 7 regional hospitals and 5 general practices in the Netherlands.

Duration of study: 6 months

Participants

N screened: 391

N randomised: 233 (AP 111, UC 122)

N completed: AP 91 completed 6 months, 21 dropped out (11 withdrew consent, 2 died, 5 comorbidity, 2 moved/logistics, 1 invalid); UC 102 completed 6 months, 20 dropped out (15 withdrew consent, 2 died, 2 comorbidity, 1 invalid)

Baseline characteristics: mean age, years (SD) AP 66.1 (11.2), UC 65.1 (10.0); male, n (%) AP 65 (59), UC 69 (57); mean FEV₁, % predicted (SD) AP 56.7 (20.3), UC 56.5 (20.6); current smoker, n (%) AP 31 (28), UC 37 (30); hospitalised for COPD in past year, n (%) AP 22 (20), UC 21 (18); number in group AP 111, UC 122; BMI (SD) AP 26.1 (5.5), UC 26.7 (6.5); living alone, n (%) AP 27 (23), UC 22 (18); education: lower secondary or less, n (%) AP 69 (62), UC 83 (68); higher secondary, n (%) AP 29 (26), UC 31 (25); college/university, n (%) AP 13 (12), UC 8 (7); GOLD stage: I, n (%) AP 14 (13), UC 13 (11); II, n (%) AP 55 (50), UC 58 (47); III, n (%) AP 30 (27), UC 38 (31); IV, n (%) AP 11 (10), UC 12 (10); FEV₁, mean (SD) AP 1.55 (0.60), UC 1.59 (0.71); FVC, mean (SD) AP 3.03 (0.79), UC 3.17 (0.91); recruited from: GP, n (%) AP 18 (16), UC 17 (14); outpatient clinic, n (%) AP 93 (84), UC 105 (86)

Inclusion criteria: postbronchodilator ratio of forced expiratory volume in 1 second to forced vital capacity (FEV₁/FVC) < 70%. Age > 40 years. Smoking history > 20 years or 15 pack‐years. Diagnosis of COPD as a major functionally limiting disease. Current use of bronchodilator therapy

Exclusion criteria:

primary diagnosis of asthma. Primary diagnosis of cardiac disease. Presence of disease that could affect mortality or participation in the study (e.g. confusional states)

Interventions

AP group: At inclusion, participants were seen by the nurse case manager (respiratory nurse), who systematically checked and discussed; aspects of COPD care: vaccination, optimisation of medication, inhalation techniques, exercise, nutritional aspects, smoking (cessation) and exacerbation management. Participants in the AP group were encouraged to contact their case manager if they needed further information or wanted to ask a question. Two standardised reinforcement sessions were held by telephone at 1 and 4 months to evaluate participant understanding of and adherence to AP and, when needed, additional information was provided. An action plan for participants was individualised by a respiratory nurse and included: (1) a list of important contact persons and telephone numbers; resource persons: family physician, respiratory physician and respiratory nurse; (2) stable symptom severity (individual stable/normal green zone symptom status); (3) regular medication/lifestyle prescriptions (green zone); (4) additional medication/breathing exercises and energy preservation in case of symptom increase (yellow zone, orange zone); (5) a name contact person/telephone number in case of an exacerbation (orange zone). For individual participants, it was optional for the case manager (in consultation with the attending physician) to provide self‐treatment medication (course of corticosteroids and/or antibiotics). Participants also received usual care, which included pharmacological and non‐pharmacological care according to the most recent evidence‐based guidelines.

UC group: At inclusion, participants were seen by a nurse case manager (respiratory nurse), who systematically checked and discussed aspects of COPD care: vaccination, optimisation of medication, inhalation techniques, exercise, nutritional aspects, smoking (cessation) and exacerbation management. No additional contacts with nurse educator. Participants in control group did not receive additional telephone sessions. Participants did not receive an action plan. Received usual care including pharmacological and non‐pharmacological care according to the most recent evidence‐based guidelines

Follow‐up time points: assessments at baseline and at 6 months. All participants were contacted by telephone monthly; participants in the AP group received additional telephone follow‐up at 1 and 4 months to evaluate understanding and adherence to the action plan.

Outcomes

Primary outcome: time to recovery of health status in the event of an exacerbation

All outcomes

• Number of exacerbations

• Time to recovery from exacerbation

• Exacerbation rates

• Anthonisen classification of COPD exacerbations

• Percentage of exacerbations reported to a healthcare provider

• Number respiratory‐related hospital admissions

• Hospital days

• Emergency room visits

• Scheduled visits

• Unscheduled visits

• Telephone calls to respiratory or family physicians

• Symptom diary

• Health‐related quality of life

• Anxiety and depression

• Self‐management exacerbation‐related self‐efficacy*

Notes

Funding: not declared in protocol/trial registration or in results publication

*Exacerbation‐related self‐efficacy measured by study‐developed questionnaire, consisting of 11 items for which confidence in self‐management capability in the occurrence of an exacerbation is graded on a 5‐point Likert scale. Lower scores indicate high confidence in adequate exacerbation‐related self‐management behaviour. No validity or responsiveness data published for this questionnaire

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomisation was carried out using the minimisation technique to balance the control and intervention groups for centre and gender." Probably done, as earlier reports from the same study authors clearly describe randomisation stratified by centre and gender

Allocation concealment (selection bias)

Low risk

"To conceal the assignment sequence, a central web‐based service was used." Probably done, as earlier reports from the same investigators clearly describe use of a central web‐based service for allocation concealment

Blinding (performance bias and detection bias)
Participants

Low risk

"The modified informed consent procedure (postponed information) meant that patients were unaware of the major aim of the study." Probably done. Postponing receipt of information from participants allowed for adequate blinding of participants. Risk of cross‐contamination between members of intervention and control groups was reduced by stratification of randomisation by centre

Blinding (performance bias and detection bias)
Study personnel

Low risk

Health professionals would have been aware of which participants were receiving the intervention. This is unlikely to be a significant source of bias.

Blinding of outcome assessment (detection bias)
Objective outcomes, e.g. healthcare utilisation

Low risk

"All patients were contacted for monthly evaluation by telephone to assess healthcare utilisation and to evaluate proper use of the diary (figure 1)" (healthcare utilisation). Assessors were not blinded, as participants may have disclosed whether or not they were receiving an action plan.

"To ensure rigorous and complete exacerbation counts, all diaries were reviewed by three blinded investigators who adjudicated events by consensus" (exacerbations). Unclear from information in the diary whether assessors would have been aware if the participant was receiving an action plan

Blinding of outcome assessment (detection bias)
Subjective outcomes eg quality of life, anxiety

Low risk

"All patients were instructed to record daily in a diary whether symptoms were increased over their baseline condition" (patient‐reported outcomes). Participants were unaware of the major aim of the study, hence self‐reported outcomes were unlikely to be biased.

Incomplete outcome data (attrition bias)
Health care utilisation (objective)

Low risk

Drop‐outs 19% intervention and 16% control group. Reasons for withdrawals were given and were balanced in both groups.

Incomplete outcome data (attrition bias)
Subjective e.g. Quality of life

Low risk

Drop‐outs 19% intervention and 16% control group. Reasons for withdrawals were given and were balanced in both groups.

Selective reporting (reporting bias)

Low risk

Medical Research Council Dyspnoea Scale (MRC scale) was reported as a secondary outcome in the protocol but is not listed in the report. All other outcomes listed in the protocol are reported.

Other bias

Low risk

No other issues of bias

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

Methods

Study design: parallel‐group cluster‐randomised trial

Location: All GPs registered with Southern Tasmanian Division of General Practitioners (N = 255) were contacted and invited to participate.

Duration of study: 12 months. Year study performed: 2002

Participants

N screened: 262
N randomised: 139
N completed: 112 (54 in intervention group and 58 in control group). Drop‐outs: intervention group: 5 deaths; 8 withdrawals. Control group: 4 deaths; 8 withdrawals; 2 lost to follow‐up

Inclusion criteria: diagnosis of COPD as primary functionally limiting illness, aged > 50 years, tobacco smoking history > 10 pack‐years, FEV₁ < 65% predicted and/or FEV₁/FVC ratio < 70%

Exclusion criteria: nursing home residents
Baseline characteristics
Intervention : N = 67: age 69 (SD 7.8); 49 male; 46 married; 37 widowed; 12 separated/divorced; 5 never married; 40 labourers; 19 clerical, sales and service industry workers; 16 tradespersons; 11 managers, admin and professional workers; 9 production and transport; 5 never worked; 36 current smokers; smoking history: 55 (SD 26) pack‐years; BMI 25.9 (SD 5.8); COPD severity: FEV₁ % predicted 46.3 (SD 16), FEV₁/FVC 56.8 (SD 15.7). Daily steps 4751 (IQR 4473); SGRQ symptoms 59.9 (SD 22.7), activity 62.3 (SD 25.2), impacts 33.4 (SD 21.3), total 46.5 (SD 20.4); participation in pulmonary rehab 30; medications prescribed at enrolment: SABA 97, LABA 36, ipratropium 67, methylxanthine 8, inhaled corticosteroid 60, oral corticosteroid 8, O₂ 10
Control : N = 72: Age 71 ± 8.4; 67 males; 51 married; 33 widowed; 10 separated/divorced; 6 never married; 27 labourers; 28 clerical, sales and service industry workers; 27 tradespersons; 11 managers, admin and professional workers; 7 production and transport; 0 never worked; 22 current smokers; smoking history: 59 (SD 33.7) pack‐years ; BMI 25.2 ± 5.4; COPD severity: FEV1% predicted 44.2 (SD 15.8), FEV1/FVC 50.9 (SD12.2). Daily steps 3454 (IQR = 3041); SGRQ symptoms ‐ 62.7 (SD 20.6), activity ‐ 66.4 (SD 20.2), impacts 32.1 (SD 17.3), total 47.3 (SD 16.6); participation in pulmonary rehab 24; medications prescribed at enrolment: SABA 78, LABA 24, ipratropium 57, methylxanthine 7, inhaled corticosteroid 43, oral corticosteroid 7, O₂ 4.

Interventions

Intervention: Action plan (AP) ‐ COPD information booklet and individual educational session with respiratory nurse (covered basic COPD pathology, smoking cessation, immunisations, nutrition, exercise, clearing of mucus from lungs, control of breathlessness during ADLs, stress management, medications, correct use of inhalers and contact details of community support services). Also written self‐management plan listing maintenance medications and individual AP based on early recognition of exacerbations. 76% of participants received instructions to start short course oral corticosteroids and an antibiotic; remaining 24% received instructions to initiate antibiotics only (N = 10), double dose of inhaled corticosteroids and start antibiotic (2), initiate short course oral corticosteroids only (1) or contact GP (3). Prescriptions were provided as necessary. All were encouraged to present to GP early during exacerbation.
Control: usual care, action plan specifically denied
Number intervention group: 54
Number control group: 58

Outcomes

Health‐related QoL: absolute mean and standard deviation at baseline and mean change in SGRQ and standard deviation at 6 and 12 months
Physiological impairment: lung function spirometry at baseline, at 6 and 12 months
Physical activity measured on digital pedometer over 7 day period at baseline, at 6 and 12 months
Healthcare utilisation: diary used to record GP consults, hospitalisations and attendances to ER, exacerbations
Medications: diary to record antibiotic use, use of short course corticosteroids
Mortality

Outcome measurement: 3, 6, 9 and 12 months, 6 and 12 month assessments were face‐to‐face at GP, surgery or participant's home, 3 and 9 months by standardised telephone interviews

Notes

Not stated if hospitalisation or ED visits were related to COPD or all‐cause

Funding: not known

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Practices were randomised to intervention (action plan) or control group by a computer‐generated randomisation software package.

Allocation concealment (selection bias)

Unclear risk

Practice level was allocated but no information was published on method of allocation to groups.

Blinding (performance bias and detection bias)
Participants

High risk

Participants could not be blinded to allocation. Participants completed daily diary cards to record 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 were not blinded.

Blinding of outcome assessment (detection bias)
Objective outcomes, e.g. healthcare utilisation

Low risk

Objective assessments were not likely to be affected by lack of blinding.

Blinding of outcome assessment (detection bias)
Subjective outcomes eg quality of life, anxiety

Unclear risk

Study visits for QoL were handled by study staff who were not blinded.

Incomplete outcome data (attrition bias)
Health care utilisation (objective)

Low risk

INT 67 randomised, 5 died, 8 withdrew for personal reasons. 61 completed 6‐month and 54 completed 12‐month assessment. CONTROL 72 randomised, 4 died, 8 withdrew for personal reasons, 2 lost to follow‐up. 62 completed 6‐month and 58 completed 12‐month assessment. Similar proportions in both groups completed.

Incomplete outcome data (attrition bias)
Subjective e.g. Quality of life

Low risk

INT 67 randomised, 5 died, 8 withdrew for personal reasons. 61 completed 6‐month and 54 completed 12‐month assessment. CONTROL 72 randomised, 4 died, 8 withdrew for personal reasons, 2 lost to follow‐up. 62 completed 6‐month  and 58 completed 12‐month assessment. Similar proportions in both groups completed.

Selective reporting (reporting bias)

Low risk

The study protocol is available, and published reports include all expected outcomes, including those prespecified.

Other bias

Unclear risk

Unit of randomisation was participant's GP. Intervention and control groups were similar in terms of age, smoking history, airways limitation and QoL scores. Analysis did not take into account clustering by GP.