NICE guidelines development Low back pain and sciatica: Management of non-specific low back pain and sciatica Steven Vogel Vice Principal (Research), The British School of Osteopathy Editor-in-Chief, The International Journal of Osteopathic Medicine
Aims of the presentation • Brief overview of clinical guidelines • Summary of current NICE guidelines for the management of persistent non specific low back pain • Scope of the new guideline currently in development • Brief description of the development process
Guidelines and back pain • Clinical guidelines aim to improve quality of care by translating best evidence into practice • Provide guidance for clinicians • Provide guidance for purchasers A clinical guideline is not the same as a protocol….
Reviewed guidelines from 13 countries • and 2 international guidelines
2009 NICE guidelines persistent non specific back pain Keep diagnosis under review at all times AND Promote self-management AND Offer drug treatments as appropriate AND Follow the care pathway
Key points for implementation • Provide people with advice and information to promote self-management: Nature of back pain, encourages normal activities, stay physically active and to exercise • Offer one of the following treatment options, taking patient preference into account: an exercise programme a course of manual therapy a course of acupuncture If improvement is not satisfactory, consider offering another of these
Combined physical and psychological treatment programme CPP • Consider referral for combined physical and psychological treatment for people who: have received at least one less intensive treatment and have high disability and/or significant psychological distress.
Do not • Offer injections of therapeutic substances into the back for non-specific low back pain. • Refer for intradiscal electrothermal therapy (IDET) • Refer for radiofrequency facet jt denervation • Refer for percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) • SSRIs, Laser, Interferential therapy, Ultrasound, TENS, Supports, Traction
Assessment and imaging • Do not offer X-ray of the lumbar spine • Only offer an MRI scan within the context of a referral for an opinion on spinal fusion
Referral for surgery • Consider referral for an opinion on spinal fusion for people who: have completed an optimal package of care and would consider surgery for their low back pain.
Controversy • Injections • Acupuncture • Manipulation • Unclear to what extent the guideline has been implemented
Update in progress Low back pain and sciatica: management of non-specific low back pain and sciatica This is an update of Low back pain: early management of persistent non-specific low back pain (NICE clinical guideline 88).
Scope • The scope: • NHS England – topic selection • Update after 3 year review (GDG and high level review) • Identifies the key clinical issues • Sets the boundaries of the development work • Provides information to healthcare professionals about the expected content of the guideline • Informs the development of the detailed review questions from the key clinical issues
Population • Groups that will be included: • People aged 16 or older presenting with symptoms of ‘non-specific’ low back pain. The pain may (or may not) radiate to the limbs and is not associated with progressive neurological deficit • People aged 16 or older with suspected sciatica
Settings • All settings in which NHS-funded care is received.
Groups that will not be covered low back pain or sciatica related to specific spinal pathologies, including: • inflammatory causes of back pain (for example, ankylosing spondylitis or diseases of the viscera) • serious spinal pathology (for example, neoplasms, infections or osteoporotic collapse) • neurological disorders (including cauda equina syndrome or mononeuritis) • adolescent scoliosis. • People aged under 16 years.
Key issues that will be covered Assessment to identify ‘non-specific’ low back pain and sciatica and any prognostic factors that could guide management. Use of pharmacological treatments for low back pain. Non-pharmacological interventions. • Manual therapies • CAM therapies • Orthotics and appliances • Patient education • Electrotherapy Self management • • • • continued •
Key issues that will be covered • Combined therapies • The use of invasive procedures • Psychological interventions • Surgery
Key issues that will not be covered • post-surgery care • spinal cord stimulation • Pharmacological treatments for sciatica.
Main outcomes • Pain severity (for example, visual analogue scale [VAS] or numeric rating scale [NRS]) • Function measured by disability scores (for example, the Roland-Morris disability questionnaire or the Oswestry disability index) • Health-related quality of life (for example, SF-12 or EQ-5D) • Adverse events • Healthcare utilisation
Developing clinical guidelines overview • Scoping: Identify and refine the subject area • Convene multi disciplinary guideline development groups (GDGs) • Develop clinical questions • Retrieve, analyse and present the evidence to the GDG • Translate the evidence into recommendations • Consultation: external review of the guideline
Guideline Development Group (GDG) • Multidisciplinary group, including health care professionals and patient/carer members. • Should represent the perspectives of the health care professionals involved in the care of patients affected by the condition • Not expected to represent the views of their professional organisations • Are required to declare conflicts of interest and follow a code of conduct
Appointment to the GDG • Open application: statement and CV • Interview • Appointment • No remuneration • Approximately one meeting per month for 2 years
Name Background Dr Stephen Ward Prof. Gary McFarlane Consultant in Pain Medicine, Chair Epidemiologist Dr Ian Bernstein Dr Simon Somerville Mr Steven Vogel Mr Babak Arvin Mrs Helen Taylor Dr Chris Wells Dr Neil O’Connell Dr Patrick Hill Prof. David Walsh Mr Phillip Sell Mr Mark Mason Ms Wendy Menon General Practitioner General Practitioner Manual Therapist Neurosurgeon Clinical Nurse Specialist Pain Medicine Specialist Physiotherapist Clinical Psychologist Rheumatologist Spinal Surgeon Patient Member Patient Member
GDG • Supported by technical team • Research fellows • Health economists • Information scientist • Project manager, and • Guideline lead. • Technical team are members of the group with voting rights
Clinical questions • Each recommendation needs to relate to a question • Each question has to be addressed with a systematic review of the evidence • The most widely used structure is PICO – Population – Intervention – Comparison – Outcome • This implies the minimum requirements for a clinical question
Example from the 2009 clinical guideline Question: What is the effectiveness of manual therapies compared with usual care on functional disability, pain, or distress? Adults presenting with non specific back pain > than 6 weeks duration and < one year Population Manual therapies Usual care Disability scores Pain scores Psychological distress Intervention Comparison Outcome
Determine type of review question Assess quality by outcome (GRADE) Present results to GDG Analysis: including meta- analysis where appropriate Produce review protocol Interpret the evidence and apply context Recommendations Search medical literature databases Extract data “Sift” search results; then obtain full papers Include /exclude full papers
Assessing the quality of the evidence for interventions using GRADE Randomised trials are best study design for intervention reviews • Study design • Study limitations (risk of bias) Consider randomisation method, allocation concealment, blinding, missing data, etc Patient population and intervention do not fit directly with those of the guideline • Indirectness • Inconsistency Differences in effect size between studies and explanations by subgroup analysis Results are consistent with more than one conclusion, relative to the clinically important effect May be funding issue or only publishing studies with significant results • Imprecision • Publication bias
GRADE classifies evidence quality as: • High: We are very confident that the true effect lies close to that of the estimate of the effect • Moderate: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different • Low: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect • Very low: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
What information do the GDG consider? Evidence report Exclusion list Forest plots (meta-analysis) GRADE Evidence profiles Evidence statements Evidence tables Health economic evidence • • • Paperwork • (sent out prior to each GDG meeting) • • •
Why consider cost-effectiveness? The NHS does not have enough resources to do everything If it spends more on one thing, it has to do less of something else Could we do more good by spending money differently? Prioritise interventions with a high health gain per £ spent (QALY) • • • •
Recommendations and NICE principles: • Recommendations must reflect the evidence • ‘Offer’ vs ‘Consider’ • Clinical and cost effectiveness considered • Can make recommendation for a subgroup of population if clear evidence for effectiveness • Must consider equalities issues • Transparency
Options when poor quality / no evidence • Expert group discussion (informal consensus / vote) • Extrapolate if possible (indirect evidence) • Formal consensus decision making • Transparency and acknowledgement • No recommendation
Validation • Draft guideline sent out for stakeholder consultation as part of the clinical guideline development • Key part of the quality assurance and peer- review processes • Important that stakeholder comments are addressed appropriately
Acknowledgements Grateful acknowledgement is given to the following people who have kindly allowed me to use their slides as part this presentation. • Dr Stephen Ward – Chair, Consultant in Pain Medicine, Brighton & Sussex University Hospitals NHS trust • Serena Carville – Associate Director, Guideline Lead, National Clinical Guideline Centre
Thank you for your attention Questions? • https://www.nice.org.uk/ • http://www.ncgc.ac.uk/