Asthma
Conditions
Keywords
Spirometry, Exhaled Nitric Oxide, Primary Care
Brief summary
What are the capacity and training needs in general practice to implement routine spirometry and eNO testing in children aged 5-16 years? Asthma is the commonest long-term disease of childhood in the United Kingdom (UK). Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been reported from several European countries including the UK. This can result in poor symptom control and increased risk of asthma related deaths. It has been suggested that both under- and over- diagnosis of childhood asthma in general practice could be improved by routinely using objective lung function testing for diagnosis and monitoring. The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements - eNO) are already used routinely in UK hospitals, but are not usually available in general practice where most children are cared for. Why is it important? - Availability of these tests will help health professionals in general practice to look after children with asthma better, and hopefully improve asthma control. What will this study achieve? - Though it is believed that providing spirometry and eNO in general practice would be beneficial, there is little data on how this can be achieved. This study will employ both qualitative and quantitative measures in order to evaluate the resources required to implement routine spirometry and eNO testing for children in primary care; and to investigate the impact this would have on diagnosis in children with suspected asthma. How? - The investigators will work with general practices in and around Leicestershire, UK. Firstly, to identify what the barriers are to implementing these tests, and secondly to train the practices to perform and interpret spirometry and eNO independently in children. Children with suspected or previously diagnosed asthma will be invited for review and lung function testing. The investigators will record the time it takes to train general practices to perform and interpret spirometry and eNO independently, and the additional clinic capacity required to provide these tests.
Interventions
None listed
Sponsors
Aerocrine AB
University of Leicester
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. On the practice asthma register or 2. Are prescribed regular (on repeat prescription) inhaled corticosteroids including beclometasone, fluticasone and budesonide and also search specifically for 'brands' that are commonly prescribed to include 'clenil', 'seretide', 'symbicort', and 'qvar' or 3. Have been prescribed ≥ 2 Salbutamol MDI's in the last 12 months or 4. Had a documented exacerbation of asthma in the last 12 months 5. Able and willing, in the opinion of the Investigator, to give informed consent
Exclusion criteria
1. Children who are unable to perform lung function tests for any reason 2. Children and young people \<5 years and \>16 years 3. Unable or unwilling, in the opinion of the Investigator, to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice | 12 months | Time (minutes) to perform both spirometry and eNO test in children |
| Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained | 12 months | Number of children (out of 612) able to perform objective tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment | CHU9D score was assessed at enrolment and then again at 3-6 months post-enrolment. | Timepoints - measured at enrolment and at 3-6 months post-enrolment Purpose: The CHU9D is a paediatric generic preference based measure of health related quality of life. It consists of a descriptive system and a set of preference weights, giving utility values for each health state described by the descriptive system, allowing the calculation of quality adjusted life years (QALYs) for use in cost utility analysis. Format: Consists of nine dimensions of health-related quality of life, including worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine, and activities. The child completes the questionnaire, or a proxy can complete it for younger children Scoring: Scores can range from -0.1059 (min) to 1 (max); with a score of 1 indicating a state of perfect health, and a lower score indicating worse health. A minimally important difference (MID) of 0.03 is used to assess the magnitude of mean difference when comparing CHU9D scores. |
| Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment | PAQLQ score was assessed at enrolment and then again at 3-6 months post enrolment | Timepoints - Assessed at enrolment and at 3-6 months post enrolment Purpose: The Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was developed to measure the functional problems (physical, emotional and social) that are most troublesome to children with asthma. Format: The PAQLQ can be administered by an interviewer or self-administered by the child Content: The PAQLQ contains 23 questions that cover three domains: activity limitation, symptoms, and emotional function Scoring: Children are asked to think about how they have been during the previous week and to respond to each of the 32 questions on a 7-point scale (7 = not bothered at all - 1 = extremely bothered). The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. A change in score greater than 0.5 on the 7-point scale can be considered clinically important. |
| The Number of Children in Whom a Diagnosis of Asthma Can be Confirmed Using Spirometry and eNO Testing | 12 months | Number of children in whom an asthma diagnosis could be confirmed on objective testing |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Number of Primary Care Staff Who Found Providing Spirometry and eNO Testing for Children Acceptable After Being Trained | 12 months | Based on responses to a questionnaire administered at the end of their training using pre-determined responses along a 5-point likert scale. |
| The Number of Participants Who Found Spirometry and eNO Testing Acceptable | 12 months | Based on responses to a questionnaire administered at the end of their asthma review using pre-determined responses along a 5-point likert scale. |
Countries
United Kingdom
Participant flow
Recruitment details
Primary care practices based in the the East Midlands, England. Recruitment between June 2016 and August 2017
Pre-assignment details
N/A - single group observational study only
Participants by arm
| Arm | Count |
|---|---|
| Study Cohort Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \
3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations.
Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months.
In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February.
Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices. | 612 |
| Total | 612 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Study Cohort |
|---|---|
| Age, Continuous | 10.0 Years STANDARD_DEVIATION 3.3 |
| Number of children with existing asthma diagnosis Asthma Diagnosed Previously (on asthma register) | 456 Participants |
| Number of children with existing asthma diagnosis Asthma not diagnosed previously (not on asthma register) | 156 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 82 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 21 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed | 20 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 9 Participants |
| Race/Ethnicity, Customized Ethnicity White | 480 Participants |
| Sex: Female, Male Female | 280 Participants |
| Sex: Female, Male Male | 332 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 612 |
| other Total, other adverse events | 0 / 612 |
| serious Total, serious adverse events | 0 / 612 |
Outcome results
Primary
Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained
Number of children (out of 612) able to perform objective tests
Time frame: 12 months
Population: Objective tests attempted in all 612 children with consent
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Cohort | Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained | 575 Participants |
Primary
Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice
Time (minutes) to perform both spirometry and eNO test in children
Time frame: 12 months
Population: Spirometry attempted in all 612 children but only successful in 575
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Cohort | Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice | Time to perform spirometry | 4.3 Minutes | Standard Deviation 1.3 |
| Study Cohort | Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice | Time to perform reversibility test | 3.1 Minutes | Standard Deviation 1 |
| Study Cohort | Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice | Time to perform eNO | 2.4 Minutes | Standard Deviation 1 |
Secondary
Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment
Timepoints - measured at enrolment and at 3-6 months post-enrolment Purpose: The CHU9D is a paediatric generic preference based measure of health related quality of life. It consists of a descriptive system and a set of preference weights, giving utility values for each health state described by the descriptive system, allowing the calculation of quality adjusted life years (QALYs) for use in cost utility analysis. Format: Consists of nine dimensions of health-related quality of life, including worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine, and activities. The child completes the questionnaire, or a proxy can complete it for younger children Scoring: Scores can range from -0.1059 (min) to 1 (max); with a score of 1 indicating a state of perfect health, and a lower score indicating worse health. A minimally important difference (MID) of 0.03 is used to assess the magnitude of mean difference when comparing CHU9D scores.
Time frame: CHU9D score was assessed at enrolment and then again at 3-6 months post-enrolment.
Population: Number of children with follow up data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Cohort | Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment | CHU9D score at follow up | 0.85 score on a scale | Standard Deviation 0.18 |
| Study Cohort | Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment | CHU9D score at baseline | 0.88 score on a scale | Standard Deviation 0.16 |
Secondary
Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment
Timepoints - Assessed at enrolment and at 3-6 months post enrolment Purpose: The Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was developed to measure the functional problems (physical, emotional and social) that are most troublesome to children with asthma. Format: The PAQLQ can be administered by an interviewer or self-administered by the child Content: The PAQLQ contains 23 questions that cover three domains: activity limitation, symptoms, and emotional function Scoring: Children are asked to think about how they have been during the previous week and to respond to each of the 32 questions on a 7-point scale (7 = not bothered at all - 1 = extremely bothered). The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. A change in score greater than 0.5 on the 7-point scale can be considered clinically important.
Time frame: PAQLQ score was assessed at enrolment and then again at 3-6 months post enrolment
Population: Number of children with follow up data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Cohort | Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment | PAQLQ score at baselines | 5.92 units on a scale | Standard Deviation 1.06 |
| Study Cohort | Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment | PAQLQ score at follow up | 6.02 units on a scale | Standard Deviation 1.04 |
Secondary
The Number of Children in Whom a Diagnosis of Asthma Can be Confirmed Using Spirometry and eNO Testing
Number of children in whom an asthma diagnosis could be confirmed on objective testing
Time frame: 12 months
Population: Spirometry and FeNO data were available from 109 children who had received asthma medications in the previous year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Cohort | The Number of Children in Whom a Diagnosis of Asthma Can be Confirmed Using Spirometry and eNO Testing | 13 Participants |
Other Pre-specified
The Number of Participants Who Found Spirometry and eNO Testing Acceptable
Based on responses to a questionnaire administered at the end of their asthma review using pre-determined responses along a 5-point likert scale.
Time frame: 12 months
Population: Feedback forms were completed by 554 (91%) families
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Cohort | The Number of Participants Who Found Spirometry and eNO Testing Acceptable | 537 Participants |
Other Pre-specified
The Number of Primary Care Staff Who Found Providing Spirometry and eNO Testing for Children Acceptable After Being Trained
Based on responses to a questionnaire administered at the end of their training using pre-determined responses along a 5-point likert scale.
Time frame: 12 months
Population: Following training and implementation, 23 (85%) staff members responded to the online feedback questionnaire. Please note: healthcare providers were not considered enrolled within the study but did contribute feedback to this assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Cohort | The Number of Primary Care Staff Who Found Providing Spirometry and eNO Testing for Children Acceptable After Being Trained | 23 Participants |