Title: Safe and effective gradual reduction (tapering) of opioids in people with chronic non-cancer pain: systematic review of effects, barriers and facilitators and inequalities to inform service design in the NHS
Funder: Department of Health and Social Care

Abstract: People who have persistent (chronic) pain may be offered drugs to help reduce pain. Some drugs might not offer strong enough pain relief, so people are offered stronger pain relief such as drugs called opioids. But these drugs have a number of drawbacks. The amount of pain relief reduces with longterm use, people can feel dependant on opioids and they cause other side effects (adverse effects). To continue pain relief people may use more of the opioid drug, but this increases the risk of adverse effects._x000D_ _x000D_ If people are informed about the options and agree to gradually reduce their use of opioids, research suggests that they may not experience increased pain (when taking less drug) and may experience fewer side effects. Some people can stop taking opioids altogether._x000D_ _x000D_ People need support to gradually reduce their use of opioids. They will also need support to manage their chronic pain without regular opioids. This support can be by taking other types of drugs, psychological support or wide range of options such as peer support, education or being physically active._x000D_ _x000D_ Research hasn’t identified the best ways to help people gradually reduce their use of opioids for chronic pain. There is a lot of uncertainty about what might work in different settings or for different people._x000D_ _x000D_ Research indicates that people in different parts of England or who are less well-off may be more likely to be using opioid drugs for chronic pain. This may widen differences in peoples’ wellbeing and opportunities._x000D_ _x000D_ Design and methods_x000D_ We will do a systematic review to bring together and assess the evidence on what ways work well for the safe and acceptable reduction in use of opioid drugs. No new studies will be started. We will use existing evidence that hasn’t been brought together to answer these important questions for people with chronic pain and their care professionals._x000D_ _x000D_ We will also do a systematic review of barriers and facilitators to reducing use of opioid drugs. Some factors help things to work well; some factors hinder._x000D_ _x000D_ In both reviews we will examine links to avoidable and unnecessary differences (inequalities) in access to, experiences of and benefits of reducing use of opioid drugs experienced by different groups of people._x000D_ _x000D_ Before our project is finished, we will ask what people think about the findings of our reviews and if the ways to help people reduce their use of opioid drugs would be acceptable to them and are difficult or easy to access for them._x000D_ _x000D_ Patient and public involvement_x000D_ We will ensure our work is relevant to people with chronic pain and their families. We will involve a small group of people with experience of use of opioids in developing the final proposal, interpreting evidence, plain-language summary and dissemination._x000D_ _x000D_ One of our co-applicants is a person with chronic pain who has gradually reduced her opioid use. She will work as a member of our research team offering advice and sharing her experiences. She has helped us develop this application and advised on this summary._x000D_ _x000D_ Dissemination_x000D_ These reviews will help practice and future research. We will work with our public advisers and communications team to tell people about our work. This could include our public advisers writing blogs about our reviews and their findings, using social media, producing short visual summaries, providing short summaries to stakeholder groups involved in our surveys and publishing in academic journals.

Lay abstract: Research questions_x000D_ The key question for the NHS to be addressed is: _x000D_ How can opioids be safely, satisfactorily and effectively reduced in people with chronic non-cancer pain?_x000D_ In addition, our research will explore the barriers to and facilitators of effective reduction of opioids and inequalities people experience in accessing and benefiting from interventions to reduce opioid use._x000D_ _x000D_ Background_x000D_ Opioids have been used for pain management for centuries, but opioids have important limitations and can cause harm. Opioid dose needs to be increased to achieve pain relief, opioids can lead to dependency and some people may experience increased sensitivity to pain. _x000D_ The long-term use of opioid therapy for the management of non-cancer pain has been questioned as current evidence does not support the effectiveness of this treatment and there is a dose-dependent risk for serious harms and costs._x000D_ People taking opioids may need support to reduce their use of opioids. Low quality evidence indicates that people can reduce their opioid use and experience reduced pain, but research has focused on limited effectiveness outcomes and not on factors that influence outcomes for, and the experiences of, different groups of people._x000D_ _x000D_ Aims and objectives_x000D_ The research aims to inform better practice, pathways and service design to support people with chronic pain to reduce their use of opioids and reduce inequalities._x000D_ We will undertake evidence synthesis which includes a suite of systematic reviews of the quantitative and qualitative evidence complemented with the use of an emerging method - qualitative comparative analysis (QCA). The reviews will synthesise evidence on effectiveness, safety (including adverse effects, AE) and acceptability of interventions to reduce opioid use; barriers to and facilitators of (B&F) effective intervention; inequalities in access to or benefiting from intervention. The QCA will identify components of interventions that are linked to the safe reduction of opioids._x000D_ We will also consult with selected public and professionals stakeholders to refine our findings and ensure relevance to patients and care in the NHS and to reducing inequalities._x000D_ _x000D_ Methods_x000D_ We will use standard systematic review methods including meta-analysis (where appropriate) and GRADE/ CERQual for presenting evidence. Evidence will be selected and extracted by 2 researchers independently. We will work with public advisers throughout._x000D_ We will search CINAHL, Embase, MEDLINE, PsycINFO and Cochrane from inception and trial registries for controlled and uncontrolled studies of effectiveness as well as case reports for AE and qualitative studies for B&F reviews._x000D_ Outcomes will consider core sets and include pain severity, adverse effects, acceptability and patient satisfaction. B&F will include views and experience, accessibility. PROGRESS+ will be used to assess inequalities._x000D_ _x000D_ Timelines_x000D_ Key phases of the project are:_x000D_ Months_x000D_ 1-2 topic refinement and protocol_x000D_ 2-12 evidence identification and analysis _x000D_ 11-14 report development, including focused consultation_x000D_ 13-14 dissemination and engagement_x000D_ _x000D_ Impact and dissemination _x000D_ We will engage widely with stakeholder groups, publish a number of reports, present at conferences, and support dissemination using digital media. _x000D_ Our structured approaches will provide evidence in a way guideline developers and service providers can use to develop practical, effective actions in the NHS.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: GENERIC HEALTH RELEVANCE