3. Compliance with autoinflation.
Study | Treatment requirements | Compliance monitoring and definition | Age | Compliance |
Arick 2005 | Twice a day, alternating nostrils with each treatment for 7 weeks | Daily log to track compliance | 4 to 11 years | Complete compliance in 46 of 47 experimental patients (97.9%), moderate compliance in remaining patient |
Banigo 2016 | Use twice a day and on each occasion to be used twice in each nostril for 7 weeks | Diary card, no definition | Treatment Mean 5.94 years (range 4.36 to 8.19) Control Mean 5.55 (range 3.96 to 7.79) |
94% on average |
Bidarian‐Moniri 2014 | Use the device twice a day to perform 20 inflations at each session (approximately 5 to 10 minutes) for 4 weeks | Diary and full compliance was defined as using the device twice a day to perform 20 inflations at each session (approximately 5 to 10 minutes) during a period of 4 weeks | Treatment: 68 months Control: 53 months |
All children from 2 years and 9 months of age were able to use the device after demonstration by a doctor or nurse. In one case, the compliance was not satisfactory to complete the 4‐week treatment. The overall compliance for the total treatment time was satisfactory. |
Blanshard 1993 | One nostril 3 times a day | Compliance was measured as the number of times the device was used as a percentage of the maximum possible | Treatment HC (high compliance) n = 19 Mean 62.7 months (SD 17.5) LC (low compliance) n = 23 Mean 52.8 months (SD 8.9) Control n = 41 Mean 59.9 months (SD 18.3) |
Of 42 children in the treatment group, 19 (45%) used it as prescribed (> 70%), 18 (43%) used it irregularly and 5 (12%) were unable to use it at all. Treatment group was divided into those with a high compliance (HC) of greater than 70%, (n = 19) and those with a low compliance (LC) of < 70% (n = 23). In the LC group compliance deteriorated from 45% to 29% over the course of the treatment. See table 1 in Blanshard 1993 for further information |
Brooker 1992 | Inflate balloon nasally 3 times a day for 3 weeks | No information on compliance | Age 3 to 10 years, mean 5.7 | No information on compliance |
Chan 1989 | 3 times daily for 2 weeks | Participants stratified according to their ability of tubal opening during autoinflation Parents asked to record number of exercise cycles completed each day and to hand in a score card at the end of the 2‐week study as a method to monitor patient compliance Ability to autoinflate Autoinflation No 4 (21.1) Yes 15 (78.9) Control No 5 (22.7) Yes 17 (77.3) |
Age between 3 and 18 years of age Autoinflation 3 to 6 years: 14 (73.6) 7 to 11 years: 4 (21.1) > 12 years: 1 (5.3) Control 3 to 6 years: 13 (59.1) 7 to 11 years: 7 (31.8) > 12 years: 2 (9.2) |
No further details on compliance |
Ercan 2005 | Autoinflation 3 times a day for 6 weeks | — | Mean age 6.2 years (range 4 to 10 years) | “The compliance of the children to the autoinflation was satisfactory and the autoinflation was somehow amusing for the children” |
Scadding 2014 | Otovent 3 times daily for approximately 4 to 5 weeks | Compliance assessed by questioning child and parent/guardian and by number of bottles used. Those who reported spray use on at least 3 days a week remained in the study. | Aged between 4 and 8 years Treatment 5.7 (SD 1.3) Placebo 5.7 years (SD 1.3) |
Those who reported spray use on at least 3 days a week remained in the study |
Stangerup 1992 | 3 times a day for 2 weeks | At second visit the use of the nose balloon was scored: 0 not used, 1 used a few times, 2 used as prescribed | Aged 3 to 10 years “some children younger than 3 years of age had difficulty performing autoinflation” Median age 5.3 years |
3 children had not performed autoinflation, 10 only once, 33 had followed instructions |
Williamson 2015a | Otovent 3 times per day for 1 to 3 months | Weekly diary of compliance, sticker book | Autoinflation group: mean 5.4 years (SD 1.24) Control group: mean 5.4 years (SD 1.04) |
89% (116/130) used ‘most’ or ‘all of the time’ in the first month 80% in months 2 and 3 (68/85, 805) See table 22 in Williamson 2015a for more information |
Williamson 2015b | Otovent 3 times per day for 1 to 3 months | Recorded using a daily sticker reward chart | Age: Autoinflation group: 4 to 5 years: 3 5 to 6 years: 4 6 to 10 years: 0 7 to 11 years: 2 Control group: 4 to 5 years: 2 5 to 6 years: 8 6 to 10 years: 0 7 to 11 years: 0 |
Compliance described as “excellent” and pilot study answered major unknown issue about “whether or not children were able to perform the technique and achieve sufficient compliance over 1 month in a primary care setting” See table 4 in Williamson 2015a for more information |
SD: standard deviation