Supplementary material 8 to: Focused review format prototype

Flemyng E, Mitchell D
https://doi.org/null

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Intervention treatment format in included studies

Study ID

Maintenance ICS

Exacerbation inhaler

Study treatment details

Action plan activation

Action plan compliance

Fitzgerald 2004

Budesonide 100, 200 or 400 mcg twice daily

(mean 635 mcg/d BDP)

Additional inhaler used with the maintenance inhaler.

Intervention: Budesonide 100, 200 or 400 mcg to double dose

Control: placebo

Home setting; intervention administered by participants; measurements, symptoms and inhaler use recorded in an electronic diary morning and night each day.

Exacerbation defined as a combination of 2 of the following on 2 consecutive days: PEF ≤ 80% mean baseline morning value (or 2 consecutive mornings); bronchodilator ≥ 4 inhalations/day; nocturnal awakenings; total asthma symptom score ≥ 3 (combines chest tightness, breathlessness, coughing and wheezing); inability to go to school or work; or unscheduled physician visit.

Electronic diary alerted participants of an exacerbation depending on the data entered; at this point, the participant alerted a study nurse or practitioner to confirm they needed to take the intervention inhaler. Participants used study inhaler for 14 days. 3 month surveillance period monitored participants once they were stable again.

Monthly check up visit independent of exacerbation status ensured none where missed and to check compliance; all visits encouraged compliance.

Compliance was > 97% for the total randomised population, 99% and 97% in the control and intervention groups, respectively, after an exacerbation.

Foresi 2000

Budesonide 100 mcg twice daily (200mcg)

Additional inhaler used with the maintenance inhaler.

Intervention: Budesonide 200 mcg four times daily to add 800mcg

Control: placebo

Home setting; intervention administered by participants; participants kept daily record of respiratory symptoms (wheeze, cough, chest tightness, and shortness of breath), number of asthmatic exacerbations, morning and evening PEF values, and daily use of additional treatments.

Exacerbation defined as a fall in PEF < 70% baseline on 2 consecutive days.

Following an exacerbation, participants used study inhaler for 7 days. If PEF remains < 70% for 2 additional consecutive days, participants administered oral steroids.

Monthly check up visit independent of exacerbation status assessed diaries.

Compliance was between 75-94% in 18% of patients and > 95% in 80%. 2% of patients took < 75% of their scheduled doses.

Garrett 1998

Beclomethasone < 800 mcg/d

Additional inhaler used with the maintenance inhaler.

Intervention:

Beclomethasone < 800 mcg/d

Control: placebo

Home setting; intervention administered by participants and parents; participants kept daily diaries of morning and evening PEFR, cough and wheeze symptom scores, daily activities, medication use and presence of upper respiratory tract infection or other illnesses. Diary was used to calculate baseline

Each child received a three zone asthma action plan: green (>80% baseline PEFR and no other symptoms); orange (exacerbation criteria as described); and red (>60% baseline PEFR)

Exacerbation defined as one of: PEFR > 80% of baseline for 24 hours or more, woken at night with a cough or wheeze, or bronchodilator requirement doubled.

Following an exacerbation, child used the study inhaler in addition to their maintenance inhaler for 3 days and was visited at home. Symptom review 1 week after exacerbation in paediatric outpatient department.

Parents recorded an opinion score of the effectiveness of the study inhaler on a visual analogue scale that ranged from −3 (made asthma worse) through to +3 (made asthma better).

No details on how compliance was monitored reported.

For the two-week period after an exacerbation, mean diary completion rate was 95%. 86% of patients who had an exacerbation followed the protocol correctly.

Harrison 2004

Usual ICS dose

(mean 710 mcg/d BDP)

Additional inhaler used with the maintenance inhaler.

Intervention: Matching ICS inhaler to double dose

Control: placebo

Home setting; intervention administered by participants; participants kept daily diaries and recorded morning peak flow and daytime symptoms scores.

Exacerbation defined as fall of morning peak flow by 15% or daily symptom score increased by 1 from mean peak flow and median symptom score from run-in.

Following an exacerbation, the study inhaler was used for 14 days in addition to the maintenance inhaler. Patients continued to record morning peak flow and daytime symptoms scores for 28 days.

The importance of following study instructions were emphasised at each visit but no details on how compliance was monitored.

Jackson 2018

Fluticasone 88 mcg twice daily

Maintenance inhaler stopped and study inhaler started.

Intervention: Fluticasone 440 mcg twice daily

Control: Fluticasone 88 mcg twice daily

Home setting; intervention administered by participants and parents; participants kept daily electronic diaries (completed nightly) of daily symptoms and medication use. No electronic link between inhaler and diary. Participants provided with action plan to start study inhaler even if no electronic diary alert (to prevent delays). Peak expiratory flow obtained nightly, with results blinded to participants.

Exacerbation defined by one of: 4 inhalations of rescue albuterol in 6 hours, 6 inhalations of rescue albuterol in 24 hours, or one wakening in the night due to asthma treated with albuterol.

Following an exacerbation, the study inhaler was used for 7 days (maintenance inhaler stopped).

Four week run-in established adherence of more than 75% to the medication and electronic diary completion.

Electronic diaries were completed 73% and 72% of days by the intervention and control group, respectively. Adherence to the daily therapy with ICS was reported on 98% of the days in both groups.

Martinez 2011

Beclomethasone 40 mcg twice daily

Additional inhaler used with the maintenance inhaler.

Intervention: Beclomethasone 40 mcg twice daily to double dose

Control: placebo

Home setting; intervention administered by participants and parents; participants kept daily diaries of peak flow, medications (electronic monitoring).

Exacerbations defined as one of: use of < 12 puffs of albuterol in 24 h (excluding preventive use before exercise), a peak expiratory fl ow of less than 70% of consecutive days, a peak expiratory flow of less than 50% of reference value despite relief treatment, or an emergency room visit because of worsening of asthma symptoms.

Following an exacerbation, study inhaler was taken until symptoms returned to baseline.

Run-in period established adherence of more than 75% to the medication and diary completion.

4-8 week check up visits independent of exacerbation status ensured review diaries.

Oborne 2009

Usual ICS dose

(mean 520 mcg/d BDP)

Additional inhaler used with the maintenance inhaler.

Intervention: Matching ICS inhaler to double dose

Control: placebo

Home setting; intervention administered by participants and parents; participants only recorded symptoms (inc morning PEF) if their asthma deteriorated, they developed upper respiratory tract infection symptoms.

Exacerbations defined as one of: PEF fell by ≥ 15% on 2 consecutive days, or 30% on 1 day.

Following an exacerbation, the study inhaler was used for 7 days in addition to the maintenance inhaler, and a daily diary of morning PEF kept. Study inhaler taken for a further 7 days if morning PEF had not returned to baseline. Participants contacted research team after using the study inhaler to submit completed diary and obtain replacements.

Reports that due to the pragmatic trial design they accepted variable compliance (no details about how compliance was monitored reported).

Rice-McDonald 2005

Usual fluticasone dose (range not specified)

Additional inhaler used with the maintenance inhaler.

Intervention: Matching ICS inhaler to double dose

Control: placebo

Home setting; intervention administered by participants and parents; participants kept daily diaries of symptoms and medication, and PEF were recorded electronically.

Asthma exacerbation was defined as: (i) nocturnal awakening for 2 out of any 3 nights due to asthma, or requiring reliever medication on four occasions more than baseline requirements in any 24-h period, or symptoms due to asthma necessitating cessation of usual activities of daily living, or decrease in PEF to less than 80% of run-in morning pre-bronchodilator best on two occasions in any 24-h period or on 2 days out of any 3-day period.

Following an exacerbation, the study inhaler was used for 14 days in addition to the maintenance inhaler.

2-4 week run-in ensured patients didn't provide erroneous or falsified diary entries (those who did were excluded). Five participants were excluded due to inadequate compliance.

Compliance was monitored by symptom and medication diaries, downloading PEF recordings from electronic diaries, and counting completed/returned treatments packs. However, compliance data not reported.

Participants contacted fortnightly by research nurse and reviewer by a study investigator every 8 weeks.

Wainwright 2009

Fluticasone 125 mcg/d, or usual higher dose

Additional inhaler used with the maintenance inhaler.

Intervention: Matching fluticasone to double dose for 14 days

Control: placebo

Home setting; intervention administered by participants and parents; during exacerbations, participants kept daily diaries of symptoms and peak flow.

Exacerbation confirmed by participants ringing study team at first sign of URTI or change in asthma symptoms.

Following an exacerbation, the study inhaler was used in addition to the maintenance inhaler until return to baseline. Called weekly by study nurse.

Routine check-in visits occurred every 3 months or 2 weeks after every exacerbation.

No other details about compliance reported.