Quality of Postoperative Recovery in Children and Young People

• ClinicalTrials.gov Identifier: NCT02456519
• Recruitment Status: Completed
• First Posted: May 28, 2015
• Last Update Posted: February 10, 2016
• Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
• Information provided by (Responsible Party): Great Ormond Street Hospital for Children NHS Foundation Trust

Study Description

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.

Condition or disease	Intervention/treatment
Quality of Recovery	Other: PaedQoR-15 questionnaire

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

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Quality of Postoperative Recovery in Children and Young People: The Modified QoR-15 Questionnaire
• Study Start Date: June 2015
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Groups and Cohorts

Group/Cohort	Intervention/treatment
PaedQoR-15 Questionnaire; Questionnaire to be completed by all participants	Other: PaedQoR-15 questionnaire; Children/ young people and one parent/ guardian will complete the questionnaire before and after general anaesthesia for surgery or diagnostic imaging.

Outcome Measures

Primary Outcome Measures :

1. Change in PaedQoR-15 between preoperative and one-day postoperative scores [ Time Frame: 24 hours ]

Secondary Outcome Measures :

1. Efficacy of PaedQoR-15; measured by validity, reliability, responsiveness and acceptability [ Time Frame: 24 hours ]
   Psychometric evaluation of modified questionnaire in this new patient population
2. Parental responses [ Time Frame: 24 hours ]
   Correlation of child/ young person with parent/ guardian scores

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Children/ young people aged between 10 and 18 years undergoing general anaesthesia for surgery or diagnostic imaging

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

Contacts and Locations

Sponsors and Collaborators

Great Ormond Street Hospital for Children NHS Foundation Trust

Investigators

• Principal Investigator: Ellen Rawlinson, FRCA MA; Great Ormond Street Hospital for Children NHS Foundation Trust

More Information

• Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT02456519 History of Changes
• Other Study ID Numbers: 15HS03
• First Posted: May 28, 2015
• Last Update Posted: February 10, 2016
• Last Verified: May 2015

Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:

children; surgery