What is OPAL all about?
OPAL is a large cohort study of community dwelling adults (n= 4,000) aged 65 years and over, with and without low back pain. The study aims to describe the prevalence, severity, course and prognosis of back pain in older people and to evaluate the impact of back pain and comorbidities on important health outcomes for older people (quality of life, mobility, falls and pain).
GP practices are supporting the OPAL study by identifying and contacting potential participants for the study, and supporting follow up activities.
This study falls under the BOOST (Better Outcomes for Older People with Spinal Trouble) programme of research which is funded by the National Institute for Health Research (NIHR). The study is included in the NIHR Clinical Research Network portfolio (Portfolio ID 30343).
We are grateful for the support of GP practices who helped to identify and contact potential participants for the study.
Aim of the study
To develop a prognostic tool using the cohort data that will help older people, GPs and other health professionals identify when low back pain is a risk factor for disability, functional limitation and loss of mobility, and when it should be prioritised as a treatment target.
Estimated numbers
Patients per practice to be screened: 400
Patients per practice to be invited: 350
Patients per practice to be recruited: 125
Practices in England involved in recruitment: approx 40
Study recruitment period: October 2016 – April 2018 (18 months)
Summary inclusion/exclusion criteria
Inclusion criteria:
- Registered with a Primary Care Practice.
- 65 years and over.
Exclusion criteria:
- Living in a residential care or nursing home.
- Has a terminal condition with a life expectancy of less than 6 months.
- Any substantial health concern that, in the opinion of the patient’s GP, would place the patient at increased risk or inability to participate including known ability to provide informed consent e.g. dementia.
What is involved?
The OPAL study team will have research passports permitting them to visit and support practices with the filtering of search results and, if required, preparation for mail-outs.
What GPs and other Practice staff will be required to do (summary):
- Initial meeting/telecon with study team for site set up.
- Conduct a search of the patient list for patients meeting the eligibility criteria and hand over the resulting list to study team when they visit the practice (so that they can take a random stratified sample). Detailed search instructions will be provided.
- Screen the list of randomly selected patients (approx. 400) to exclude those patients unsuitable to be invited to participate. Record reason for exclusion (selected from broad categories).
- Prepare invitation letters (and reminder letters), each showing the patient’s screening number, and put letters into their corresponding patient packs. Patient packs will be prepared by the OPAL study team and delivered to the practice; each will be numbered with a screening number.
- Frank and post patient invitation packs (approx. 350) and reminder patient packs (to non-responders, approx. 175).
- Provide support to the study on an ad-hoc basis, including; providing details of patients who have consented to participate via secure email, an annual check (for 5 years following recruitment) for participant deaths, changes of address, and any substantial health concern that would make the patient unsuitable to be contacted.
- Conduct a limited number of notes reviews.
What participating patients will be asked to do:
- Complete and return (via freepost) a survey at baseline and then annually for five years.
What we (the OPAL study team) will do:
- Visit practice to take random, stratified sample of 400 patients from the practices’ initial search results and provide GP with the sample of patients to screen.
- Provide list of screening numbers for the practice to allocate to patients suitable to be invited to participate.
- Provide pre-numbered patient invitation packs containing all study materials. (Provide support to practice in generating numbered invitation letters via Mail Merge, if required).
- Monitor responses from patients and provide a report to the practice listing screening numbers of patients requiring a reminder letter.
- Provide pre-numbered patient reminder packs containing all study materials. (Provide support to practice in generating numbered reminder letters via Mail Merge, if required).
- Provide the practice with a list of screening numbers of patients who have consented to participate so that the practice can provide their contact details.
Reimbursement
Practices supporting this study will be appropriately reimbursed. NHS Service Support payments will be made by the practices' local NIHR Clinical Research Network. Payment for activities not covered by NHS Service Support Costs will be made by the University of Oxford from the research grant. Please contact us for more information on this.
Potential benefits for the practice
- Opportunity for developing research at the practice
- GCP training available
- Opportunity for patients to engage in research
- Opportunity to raise practice profile
- Professional development for staff involved
Patient confidentiality
Participant data will only be accessed upon notification of consent being obtained. Data collected will be securely stored in compliance with all national and local regulations. All Staff adhere to the principles of Good Clinical Practice (GCP) and the Data Protection Act, 1998. All study documents will be anonymised and patients will only be identified by unique Participant ID. Any documents holding Patient Identifiable Data (PID) are held securely with restricted access either electronically or in paper format and kept securely, and will be used only for patient follow-up, e.g. if a member of the research team needs to make a follow up phone call to a patient or recall them for a follow-up visit. In the event that the study team require access to PID as part of an agreed protocol, explanation of this will take place at the point of consent.
How to express your interest
As recruitment to the OPAL study has now closed we are not currently seeking new sites to support patient identification. If you have any questions about the study or would like to express interest in potentially supporting the study in the future please contact the OPAL Research Team at the University of Oxford.
