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| Name | Class |
|---|---|
| Aerocrine AB | INDUSTRY |
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice | Time (minutes) to perform both spirometry and eNO test in children | 12 months |
| Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained | Number of children (out of 612) able to perform objective tests | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| The Number of Participants Who Found Spirometry and eNO Testing Acceptable |
Inclusion Criteria:
Exclusion Criteria:
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Patients registered to participating general practices in Leicestershire and Northamptonshire
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| Name | Affiliation | Role |
|---|---|---|
| Erol Gaillard, PhD MRCPCH | National Institute for Health Research, Leicester Respiratory Biomedical Research Unit, University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Countesthorpe Health Centre | Leicester | Leicestershire | LE8 5QJ | United Kingdom | ||
| Lakeside Surgery |
N/A - single group observational study only
Primary care practices based in the the East Midlands, England.
Recruitment between June 2016 and August 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice | Time (minutes) to perform both spirometry and eNO test in children | Spirometry attempted in all 612 children but only successful in 575 | Posted | Mean | Standard Deviation | Minutes | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Erol Gaillard | University of Leicester | +44116 252 3261 | eag15@le.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2016 | Jan 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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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. |
| PAQLQ score was assessed at enrolment and then again at 3-6 months post enrolment |
| 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. | CHU9D score was assessed at enrolment and then again at 3-6 months post-enrolment. |
Based on responses to a questionnaire administered at the end of their asthma review using pre-determined responses along a 5-point likert scale. |
| 12 months |
| Corby |
| Northamptonshire |
| NN17 2UR |
| United Kingdom |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Number of children with existing asthma diagnosis | Count of Participants | Participants |
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| 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 | Objective tests attempted in all 612 children with consent | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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 | Spirometry and FeNO data were available from 109 children who had received asthma medications in the previous year | Posted | Count of Participants | Participants | 12 months |
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| 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. | Number of children with follow up data | Posted | Mean | Standard Deviation | units on a scale | PAQLQ score was assessed at enrolment and then again at 3-6 months post enrolment |
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| 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. | Number of children with follow up data | Posted | Mean | Standard Deviation | score on a scale | CHU9D score was assessed at enrolment and then again at 3-6 months post-enrolment. |
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| 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. | 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. | Posted | Count of Participants | Participants | 12 months |
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| 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. | Feedback forms were completed by 554 (91%) families | Posted | Count of Participants | Participants | 12 months |
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| 0 |
| 612 |
| 0 |
| 612 |
| 0 |
| 612 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |