Evaluating Outcomes from Genetic Counselling
Research type
Research Study
Full title
Evaluating outcomes from Genetic Counselling: Finding the Minimum Clinically Important Difference (MCID) for the GCOS-24 (Genetic Counselling Outcome Scale).
IRAS ID
180856
Contact name
Marion McAllister
Contact email
Sponsor organisation
Cardiff University
Clinicaltrials.gov Identifier
SPON 1476-15, Sponsorship number; Y016458QBE0115/165, Employers' liability
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
The GCOS-24 is a questionnaire that measures patient empowerment, a construct that has been found to be relevant and important as an outcome of genetic counselling. The GCOS-24 can be completed before and after genetic counselling to understand if there has been an increase in empowerment. It is not currently understood how much of an improvement in scores deems genetic counselling beneficial for patients. This research is aiming to find out how much of an improvement in GCOS-24 scores is deemed important and valuable to patients by asking patients to complete the GCOS-24 before (T1) and after genetic counselling (T2) and the GCOS Change questionnaire (T2) asking patients to rate the benefit of genetic counselling. The GCOS Change questionnaire asks patients to rate how they feel after genetic counselling on a 5-point likert style scale. The response ‘a little better’ on the scale does not mean anything that is explicitly important but it is the point where patients are beginning to notice a change. This is the point we can say there has been the minimal important difference that can be attributed to genetic counselling. The mean of the differences between GCOS-24 scores (T2-T1) for those responding 'a little better’ is the MCID (King 2011).
To understand if the group ‘a little better’ is independent from the group 'neutral', further statistics including a t-test will determine if GCOS-24 pre and post scores significantly differ from each other for each of the change categories i.e. GCOS-24 scores in the ‘neutral’ group are not expected to differ significantly from each other between T1 and T2 however those in the ‘little better’ group are expected to have significantly different scores between T1 and T2.
Patients will be recruited from the All Wales Medical Genetics Service based at Cardiff & Vale University Health Board.
Lay Summary of Results:
Introduction
The aim of the project was to determine the Minimum Clinically Important Difference (MCID) for the GCOS-24, an important patient reported outcome measure (PROM) in Clinical Genetics Services (CGS). Secondary aims were to understand what patients deem important for reaching this score and to understand the differences between participants in reporting this.
Methods
Participants were new patients from the All Wales Medical Genetics Service. An anchor-based, global transition question methodology was used to identify the MCID, through asking patients themselves how much change they felt following their appointment with CGS. This ensured that the established score was clinically meaningful to patients, rather than a statistical calculation. Statistical measures were also calculated for comparison and comments from a free text response box were analysed. The mean score of the group who felt ‘a little better’ was determined to be the MCID. An independent samples t-test was used to compare the scores from this group to the ‘neutral’ group to ensure they were significantly different from each other.
Approximately 500 individuals were invited to take part. The number of individuals who returned their pre-appointment research pack was 102 (20.4% response rate to the pre-appointment research pack). Fifty-four of these individuals also returned their post-appointment research pack (52.9% response rate to the post-appointment research pack). The overall response rate for participant completing both responses was approximately 10.8%.
Results
The MCID was established as an increase of 9 points between pre and post GCOS-24 appointment scores. This score was significantly different from the group ‘neutral’ (p=.003). Themes that were identified as important for reaching the MCID included, ‘future and family’. There were substantial differences between the amount of change in GCOS-24 scores between participants within the same groups of the global transition scale question.
Discussion
This research has contributed to the interpretability of the GCOS-24. Knowledge provision alone was not enough to cause participants to feel a clinical difference, giving insights into implications for future practice. The research also contributed to the literature on the MCID.
This has been the first study to investigate the MCID for the GCOS-24 and has not only addressed this gap in the literature but also improved the interpretability of an important PROM for use in CGS clinical evaluation and research. There has been limited research into the interpretability of PROMs in CGS, though an important aspect to address when assessing the quality of such instruments (Terwee et al. 2007). Focus on improving the interpretability for the GCOS-24 specifically was intentional as its development of a psychological model for outcomes in CGS makes it a valuable and relevant PROM. Improving the psychometric properties of an already important PROM is a change from the cycle of development of new PROMs where the majority are reported just once in the literature (Payne et al. 2008). Although the GCOS-24 may not capture all of the PROs from CGS (McAllister and Dearing 2014), very few PROMs have been assessed for interpretability (Barr et al. 2015) and this may emphasise the importance of the GCOS-24 and improve consensus on its use in CGS.
The research also contributed to the literature on the MCID.
Conclusion
This project has contributions for future practice as it has determined the MCID which can be used as a cut off for clinical improvement and has also given the insight that knowledge provision alone is not enough to make a clinical difference. Future research with a larger sample size could look further at the variability in scores for those who felt better following their appointment.Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: Study is not registered
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fonlinelibrary.wiley.com%252Fdoi%252F10.1002%252Fjgc4.1152%2FNBTI%2FDy6-AQ%2FAQ%2Fadddda3f-1985-4fa5-a9e4-d536bae797d1%2F1%2FlApMC3QvDb&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C4d04198e613f468b98e608ddd4ffdada%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638900917546300522%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=szrsmtQ1kSdE82V6KY4lXDOZAjE275iuvRYuphZo0LA%3D&reserved=0
The research was presented at a seminar at the All Wales Medical Genetics Service at the University Hospital of Wales.
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: No
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected:
If no, explain why they haven't: This was not part of what the Protocol approved by the REC stipulated
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: This was not part of what the Protocol approved by the REC stipulated
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: N/A
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London - Surrey Borders Research Ethics Committee
REC reference
15/LO/2157
Date of REC Opinion
15 Dec 2015
REC opinion
Favourable Opinion