Quality of RecoveryNCT02456519
Quality of Postoperative Recovery in Children and Young People
An observational study of Quality of Recovery, run by Great Ormond Street Hospital for Children NHS Foundation Trust.
Trial summary
Provision of high-quality anaesthesia is a fundamental goal of all anaesthetic services. Establishing whether this is being achieved requires validated measures of anaesthetic outcomes but few of these exist, particularly for children. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Quality of Recovery
- What is being tested?
- PaedQoR-15 questionnaire
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children/ young people aged between 10 and 18 years undergoing general anaesthesia for surgery or diagnostic imaging
Who may be able to join
- Child/ young person undergoing general anaesthesia for surgery or diagnostic imaging
Who cannot join
- English language skills of either parent/guardian or child inadequate to allow informed consent and/or comprehension of the questionnaire
- Intellectual disability precluding adequate comprehension of the questionnaire
- Clinical condition of child precluding adequate comprehension of the questionnaire e.g. preoperative ventilation, reduced level of consciousness
- Emergency admissions where there is insufficient time to allow informed consent
About this study
Official title: Quality of Postoperative Recovery in Children and Young People: The Modified QoR-15 Questionnaire
Provision of high-quality anaesthesia is a fundamental goal of all anaesthetic services. Establishing whether this is being achieved requires validated measures of anaesthetic outcomes but few of these exist, particularly for children.
QoR-15 (quality of recovery, 15 items) is a questionnaire that has been validated in adults and assesses the quality of postoperative recovery from surgery. The investigators have developed a modified version, the PaedQoR-15, that the investigators hope is capable of performing the same task in children and young people. The principle aim of this study is to assess whether PaedQoR-15 is a valid, reliable and clinically acceptable measure of the quality of postoperative recovery in children and young people.
The investigators would also like to consider whether parent/guardian assessments of their child's recovery correlate with self-reports. At Great Ormond Street a significant proportion of children are unable to answer for themselves. If parent/guardian responses represent a good approximation then this questionnaire may have a role in assessing the quality of recovery in a population of children who are difficult to care for.
Read the detailed description
In adults a number of instruments have been developed that measure quality of recovery following surgery. The best of these, and the most extensively utilised in other studies, is the QoR-40 (quality of recovery questionnaire with 40 items) developed by Myles and colleagues. QoR-40 is a global measure of recovery incorporating five dimensions; patient support, comfort, emotions, physical independence and pain. They developed this questionnaire from their database of 10,000 patients who had been contemporaneously interviewed about their postoperative experiences. A recent meta-analysis found QoR-40 to be a high-quality instrument, sensitive to clinical change and appropriate for purpose.
The only significant problem with QoR-40 is the time taken to complete it; an average of just over 6 minutes. In response to this the same group developed a shorter version, QoR-15 (quality of recovery questionnaire with 15 items) incorporating elements from all five original domains. The QoR-15 has been validated in adults and correlates well with QoR-40 and takes only 2.5 minutes to complete. However, the average age of the test population was 56 years (+/- 16 years) with a range from 18 to 85 years.
QoR-15 has not been used previously in children, so in preparation for this study the investigators trialed it in ten children to assess its basic acceptability. The investigators also carried out more extensive cognitive interviews in 5 children to assess whether children interpreted the meaning of the questions as intended. As a consequence, minor modifications have been made to the wording of some questions. For example, a question about feeling able to return to work has been changed to a question about feeling able to return to school/ college. The investigators also changed a question asking about the presence of moderate pain to a question about any pain, as children did not distinguish between moderate and mild pain and interpreted the original question as meaning low levels or any pain.
The visual representation of the scoring scheme has also been modified, as children found the original QoR-15 scales confusing. This will not affect the final scoring or the weighting given to any question in any way, it simply makes the scoring easier for children to understand. This modified questionnaire has been termed the PaedQoR-15 and it is this version that will be assessed in our patient population.
- Conditions
- Quality of Recovery
- Being tested
- PaedQoR-15 questionnaire
- Keywords
- children, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaedQoR-15 questionnaireOther
Children/ young people and one parent/ guardian will complete the questionnaire before and after general anaesthesia for surgery or diagnostic imaging.
| Study group | Role | What they receive |
|---|---|---|
| PaedQoR-15 Questionnaire | Questionnaire to be completed by all participants Receives: Other: PaedQoR-15 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaedQoR-15 between preoperative and one-day postoperative scores
Measured: 24 hours
Secondary outcomes (2)
Efficacy of PaedQoR-15; measured by validity, reliability, responsiveness and acceptability
Psychometric evaluation of modified questionnaire in this new patient population
Measured: 24 hours
Parental responses
Correlation of child/ young person with parent/ guardian scores
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Rawlinson, FRCA MA, Principal investigator, Great Ormond Street Hospital for Children NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456519
- Sponsor's protocol ID
- 15HS03
- Status last verified
- May 2015
- First submitted
- 19 May 2015
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Postoperative Recovery in Children and Young People: The Modified QoR-15 Questionnaire
- ClinicalTrials.gov ID
- NCT02456519
- Acronym / sponsor ID
- 15HS03
- Conditions
- Quality of Recovery
- Keywords
- children, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Provision of high-quality anaesthesia is a fundamental goal of all anaesthetic services. Establishing whether this is being achieved requires validated measures of anaesthetic outcomes but few of these exist, particularly for children.
QoR-15 (quality of recovery, 15 items) is a questionnaire that has been validated in adults and assesses the quality of postoperative recovery from surgery. The investigators have developed a modified version, the PaedQoR-15, that the investigators hope is capable of performing the same task in children and young people. The principle aim of this study is to assess whether PaedQoR-15 is a valid, reliable and clinically acceptable measure of the quality of postoperative recovery in children and young people.
The investigators would also like to consider whether parent/guardian assessments of their child's recovery correlate with self-reports. At Great Ormond Street a significant proportion of children are unable to answer for themselves. If parent/guardian responses represent a good approximation then this questionnaire may have a role in assessing the quality of recovery in a population of children who are difficult to care for.
Detailed description
In adults a number of instruments have been developed that measure quality of recovery following surgery. The best of these, and the most extensively utilised in other studies, is the QoR-40 (quality of recovery questionnaire with 40 items) developed by Myles and colleagues. QoR-40 is a global measure of recovery incorporating five dimensions; patient support, comfort, emotions, physical independence and pain. They developed this questionnaire from their database of 10,000 patients who had been contemporaneously interviewed about their postoperative experiences. A recent meta-analysis found QoR-40 to be a high-quality instrument, sensitive to clinical change and appropriate for purpose.
The only significant problem with QoR-40 is the time taken to complete it; an average of just over 6 minutes. In response to this the same group developed a shorter version, QoR-15 (quality of recovery questionnaire with 15 items) incorporating elements from all five original domains. The QoR-15 has been validated in adults and correlates well with QoR-40 and takes only 2.5 minutes to complete. However, the average age of the test population was 56 years (+/- 16 years) with a range from 18 to 85 years.
QoR-15 has not been used previously in children, so in preparation for this study the investigators trialed it in ten children to assess its basic acceptability. The investigators also carried out more extensive cognitive interviews in 5 children to assess whether children interpreted the meaning of the questions as intended. As a consequence, minor modifications have been made to the wording of some questions. For example, a question about feeling able to return to work has been changed to a question about feeling able to return to school/ college. The investigators also changed a question asking about the presence of moderate pain to a question about any pain, as children did not distinguish between moderate and mild pain and interpreted the original question as meaning low levels or any pain.
The visual representation of the scoring scheme has also been modified, as children found the original QoR-15 scales confusing. This will not affect the final scoring or the weighting given to any question in any way, it simply makes the scoring easier for children to understand. This modified questionnaire has been termed the PaedQoR-15 and it is this version that will be assessed in our patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PaedQoR-15 Questionnaire | – | Other: PaedQoR-15 questionnaireQuestionnaire to be completed by all participants |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children/ young people aged between 10 and 18 years undergoing general anaesthesia for surgery or diagnostic imaging
Key inclusion criteria (1 listed)
- Child/ young person undergoing general anaesthesia for surgery or diagnostic imaging
Key exclusion criteria (4 listed)
- English language skills of either parent/guardian or child inadequate to allow informed consent and/or comprehension of the questionnaire
- Intellectual disability precluding adequate comprehension of the questionnaire
- Clinical condition of child precluding adequate comprehension of the questionnaire e.g. preoperative ventilation, reduced level of consciousness
- Emergency admissions where there is insufficient time to allow informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaedQoR-15 questionnaireChildren/ young people and one parent/ guardian will complete the questionnaire before and after general anaesthesia for surgery or diagnostic imaging. | Other | PaedQoR-15 Questionnaire |
Primary outcome
Change in PaedQoR-15 between preoperative and one-day postoperative scores
Time frame: 24 hours
2 secondary outcomes
Efficacy of PaedQoR-15; measured by validity, reliability, responsiveness and acceptability
Time frame: 24 hours
Parental responses
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Rawlinson, FRCA MA principal investigator
Great Ormond Street Hospital for Children NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Recovery, run by Great Ormond Street Hospital for Children NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PaedQoR-15 between preoperative and one-day postoperative scores (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.