Quality of Postoperative Recovery in Children and Young People: The Modified QoR-15 Questionnaire

Quality of Postoperative Recovery in Children and Young People

Sponsors

Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Source Great Ormond Street Hospital for Children NHS Foundation Trust
Brief 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.

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.

Overall Status Completed
Start Date June 2015
Completion Date December 2015
Primary Completion Date December 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Change in PaedQoR-15 between preoperative and one-day postoperative scores 24 hours
Secondary Outcome
Measure Time Frame
Efficacy of PaedQoR-15; measured by validity, reliability, responsiveness and acceptability 24 hours
Parental responses 24 hours
Enrollment 150
Condition
Intervention

Intervention type: Other

Intervention name: PaedQoR-15 questionnaire

Description: Children/ young people and one parent/ guardian will complete the questionnaire before and after general anaesthesia for surgery or diagnostic imaging.

Arm group label: PaedQoR-15 Questionnaire

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Child/ young person undergoing general anaesthesia for surgery or diagnostic imaging

Exclusion Criteria:

- 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

Gender: All

Minimum age: 10 Years

Maximum age: 18 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ellen Rawlinson, FRCA MA Principal Investigator Great Ormond Street Hospital for Children NHS Foundation Trust
Verification Date

May 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Arm Group

Arm group label: PaedQoR-15 Questionnaire

Description: Questionnaire to be completed by all participants

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov