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Quality of Postoperative Recovery in Children and Young People

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

Tracking Information
First Submitted Date May 19, 2015
First Posted Date May 28, 2015
Last Update Posted Date February 10, 2016
Study Start Date June 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2015)
Change in PaedQoR-15 between preoperative and one-day postoperative scores [ Time Frame: 24 hours ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02456519 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 27, 2015)
  • 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
  • Parental responses [ Time Frame: 24 hours ]
    Correlation of child/ young person with parent/ guardian scores
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Postoperative Recovery in Children and Young People
Official Title Quality of Postoperative Recovery in Children and Young People: The Modified QoR-15 Questionnaire
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children/ young people aged between 10 and 18 years undergoing general anaesthesia for surgery or diagnostic imaging
Condition Quality of Recovery
Intervention 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.
Study Groups/Cohorts PaedQoR-15 Questionnaire
Questionnaire to be completed by all participants
Intervention: Other: PaedQoR-15 questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 27, 2015)
150
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02456519
Other Study ID Numbers 15HS03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Great Ormond Street Hospital for Children NHS Foundation Trust
Study Sponsor Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: Ellen Rawlinson, FRCA MA Great Ormond Street Hospital for Children NHS Foundation Trust
PRS Account Great Ormond Street Hospital for Children NHS Foundation Trust
Verification Date May 2015