"It's just part of who I am…" Living with chronic headache: voices from the CHESS trial, a qualitative study.

BACKGROUND: Between 2015 and 2019 the Chronic Headache Education and Self-management Study (CHESS) developed and tested a supportive self-management approach that aimed to improve outcomes for people with chronic migraine or chronic tension type headache with/without episodic migraine. However, a paucity of qualitative research which explored the lived experiences of people with chronic headache was evidenced. In response, we undertook to explore the experiences of living with chronic headaches of people who participated in the CHESS study. METHODS: We adopted qualitative methodologies, inviting participants in the CHESS study to participate in semi-structured interviews. In phase 1 (feasibility study), a thematic analysis was conducted. In phase 2 (main CHESS trial), interviews were informed by topic guides developed from our learning from the phase 1 interviews. Pen portrait methodology and thematic analysis was employed allowing us to explore the data longitudinally. RESULTS: Phase 1, 15 interviews (10 female) age range 29 to 69 years (median 47 years) revealed the complexities of living with chronic headache. Six overarching themes were identified including the emotional impact and the nature of their headaches. Phase 2, included 66 interviews (26 participants; median age group 50s (range 20s-60s); 20 females. 14 were interviewed at three points in time (baseline, 4 and 12 months) Through an iterative process four overlapping categories of headache impact emerged from the data and were agreed: i) 'I will not let headaches rule my life'; ii) 'Headaches rule my life'; iii) 'Headaches out of control-something needs to change'; and iv) 'Headaches controlled-not ruling my life'. One of these categories was assigned to each pen portrait at each timepoint. The remaining 12 participants were interviewed at two time points during a year; pen portraits were again produced. Analysis revealed that the headache impact categories developed above held true in this sample also providing some validation of the categories. CONCLUSIONS: These data give an insight into the complexities of living with chronic headache. Chronic headache is unpredictable, permeating all aspects of an individual's life; even when an individual feels that their headache is controlled and not interfering, this situation can rapidly change. It shows us that more work needs to be done both medically and societally to help people living with this often-hidden condition. TRIAL REGISTRATION: ISRCTN79708100

Effective health care for older people living and dying in care homes: A realist review

Background: Care home residents in England have variable access to health care services. There is currently no coherent policy or consensus about the best arrangements to meet these needs. The purpose of this review was to explore the evidence for how different service delivery models for care home residents support and/or improve wellbeing and health-related outcomes in older people living and dying in care homes. Methods: We conceptualised models of health care provision to care homes as complex interventions. We used a realist review approach to develop a preliminary understanding of what supported good health care provision to care homes. We completed a scoping of the literature and interviewed National Health Service and Local Authority commissioners, providers of services to care homes, representatives from the Regulator, care home managers, residents and their families. We used these data to develop theoretical propositions to be tested in the literature to explain why an intervention may be effective in some situations and not others. We searched electronic databases and related grey literature. Finally the findings were reviewed with an external advisory group. Results: Strategies that support and sustain relational working between care home staff and visiting health care professionals explained the observed differences in how health care interventions were accepted and embedded into care home practice. Actions that encouraged visiting health care professionals and care home staff jointly to identify, plan and implement care home appropriate protocols for care, when supported by ongoing facilitation from visiting clinicians, were important. Contextual factors such as financial incentives or sanctions, agreed protocols, clinical expertise and structured approaches to assessment and care planning could support relational working to occur, but of themselves appeared insufficient to achieve change. Conclusion: How relational working is structured between health and care home staff is key to whether health service interventions achieve health related outcomes for residents and their respective organisations. The belief that either paying clinicians to do more in care homes and/or investing in training of care home staff is sufficient for better outcomes was not supported.This research was funded by National Institute of Health Research Health Service Delivery and Research programme (HSDR 11/021/02)

The lived experience of chronic headache: a systematic review and synthesis of the qualitative literature.

OBJECTIVE: To systematically review the qualitative literature of the lived experience of people with a chronic headache disorder. BACKGROUND: Chronic headaches affect 3%-4% of the population. The most common chronic headache disorders are chronic migraine, chronic tension-type headache and medication overuse headache. We present a systematic review and meta-ethnographic synthesis of the lived experience of people with chronic headache. METHODS: We searched seven electronic databases, hand-searched nine journals and used a modified Critical Appraisal Skills Programme checklist to appraise study quality. Following thematic analysis we synthesised the data using a meta-ethnographic approach. RESULTS: We identified 3586 unique citations; full texts were examined for 86 studies and 4 were included in the review. Included studies differed in their foci: exploring, patient-centred outcomes, chronic headache as a socially invisible disease, psychological processes mediating impaired quality of life, and the process of medication overuse. Initial thematic analysis and subsequent synthesis gave three overarching themes: 'headache as a driver of behaviour' (directly and indirectly), 'the spectre of headache' and 'strained relationships'. CONCLUSION: This meta-synthesis of published qualitative evidence demonstrates that chronic headaches have a profound effect on people's lives, showing similarities with other pain conditions. There were insufficient data to explore the similarities and differences between different chronic headache disorders.National Institute for Health Research Programme Grants for Applied Research (Chronic Headache Education and Self-management Study (CHESS) ISRCTN Number: 79708100)

Identifying back pain subgroups: developing and applying approaches using individual patient data collected within clinical trials

There is good evidence that therapist delivered interventions have modest beneficial effects for people with low back pain (LBP). Identification of subgroups of people with LBP who may benefit from these different treatment approaches is an important research priority

Facet joint injections for people with persistent non-specific low back pain (Facet Injection Study): a feasibility study for a randomised controlled trial

Background: The National Institute for Health and Care Excellence (NICE) 2009 guidelines for persistent low back pain (LBP) do not recommend the injection of therapeutic substances into the back as a treatment for LBP because of the absence of evidence for their effectiveness. This feasibility study aimed to provide a stable platform that could be used to evaluate a randomised controlled trial (RCT) on the clinical effectiveness and cost-effectiveness of intra-articular facet joint injections (FJIs) when added to normal care. Objectives: To explore the feasibility of running a RCT to test the hypothesis that, for people with suspected facet joint back pain, adding the option of intra-articular FJIs (local anaesthetic and corticosteroids) to best usual non-invasive care is clinically effective and cost-effective. Design: The trial was a mixed design. The RCT pilot protocol development involved literature reviews and a consensus conference followed by a randomised pilot study with an embedded mixed-methods process evaluation. Setting: Five NHS acute trusts in England. Participants: Participants were patients aged >= 18 years with moderately troublesome LBP present (> 6 months), who had failed previous conservative treatment and who had suspected facet joint pain. The study aimed to recruit 150 participants (approximately 30 per site). Participants were randomised sequentially by a remote service to FJIs combined with 'best usual care' (BUC) or BUC alone. Interventions: All participants were to receive six sessions of a bespoke BUC rehabilitation package. Those randomised into the intervention arm were, in addition, given FJIs with local anaesthetic and steroids (at up to six injection sites). Randomisation occurred at the end of the first BUC session. Main outcome measures: Process and clinical outcomes. Clinical outcomes included a measurement of level of pain on a scale from 0 to 10, which was collected daily and then weekly via text messaging (or through a written diary). Questionnaire follow-up was at 3 months. Results: Fifty-two stakeholders attended the consensus meeting. Agreement informed several statistical questions and three design considerations: diagnosis, the process of FJI and the BUC package and informing the design for the randomised pilot study. Recruitment started on 26 June 2015 and was terminated by the funder (as a result of poor recruitment) on 11 December 2015. In total, 26 participants were randomised. Process data illuminate some of the reasons for recruitment problems but also show that trial processes after enrolment ran smoothly. No between-group analysis was carried out. All pain-related outcomes show the expected improvement between baseline and follow-up. The mean total cost of the overall treatment package (injection 419.22 pound and BUC 264.00) pound was estimated at 683.22 pound per participant. This is similar to a NHS tariff cost for a course of FJIs of 686.84 pound. Limitations: Poor recruitment was a limiting factor. Conclusions: This feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain

Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS).

INTRODUCTION: Chronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches. METHODS AND ANALYSIS: Chronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. ETHICS AND DISSEMINATION: This trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West - Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019. TRIAL REGISTRATION NUMBER: ISRCTN79708100

The CHESS trial: protocol for the process evaluation of a randomised trial of an education and self-management intervention for people with chronic headache

BackgroundProcess evaluation is increasingly common alongside complex randomised controlled trials (RCTs). This evaluation helps in understanding the mechanisms of impact and how the study processes were executed, and it includes any contextual factors which may have implications for the trial results and any future implementation. This process evaluation is for the Chronic Headache Education and Self-management Study (CHESS) RCT, which is evaluating an education and self-management group behavioural intervention for people with chronic headache. Chronic headache is defined as headaches which are present for 15 or more days per month. The most common types are chronic migraine and chronic tension type and medication overuse headaches.MethodsWe will use a mixed methods approach. Quantitative data will be taken from routine trial data which will help us to assess the reach of the study; i.e. did we reach those whom we expected and from where? Intervention attendance (dose received) and attrition and qualitative data will augment our understanding about reasons why people may not wish to take part in or failed to attend sessions. Interviews with intervention facilitators and trial participants will gain different perspectives on taking part in the trial.Fidelity will be assessed through listening to audio recordings for adherence to course content and competence of the facilitation of a sample of sessions.DiscussionOur process evaluation will allow us to gain insight into how the trial was delivered, the obstacles and enablers encountered and the possible reasons why the interventions may or may not be effective.Trial registrationISRCTN79708100. Registered on 16 December 2015

Non-pharmacological educational and self-management interventions for people with chronic headache: the CHESS research programme including a RCT

Background: Headaches are a leading cause of years lived with disability. For some people, headaches become chronic and disabling, with treatment options being primarily pharmaceutical. Non-pharmacological alternative treatment approaches are worthy of exploration. Aim: To develop and test an educational and supportive self-management intervention for people with chronic headaches. Objectives: To develop and evaluate a brief diagnostic interview to support diagnosis for people with chronic headaches, and then to develop and pilot an education and self-management support intervention for the management of common chronic headache disorders (the CHESS intervention). To select the most appropriate outcome measures for a randomised controlled trial of the CHESS intervention, and then to conduct a randomised controlled trial and economic evaluation of the CHESS intervention with an embedded process evaluation. Design: Developmental and feasibility studies followed by a randomised controlled trial. Setting: General practice and community settings in the Midlands and London, UK. Participants: For our feasibility work, 14 general practices recruited 131 people with chronic headaches (headaches on ≥15 days per month for >3 months). People with chronic headaches and expert clinicians developed a telephone classification interview for chronic headache that we validated with 107 feasibility study participants. We piloted the CHESS intervention with 13 participants and refined the content and structure based on their feedback. People with chronic headaches contributed to the decisions about our primary outcome and a core outcome set for chronic and episodic migraine. For the randomised controlled trial, we recruited adults with chronic migraine or chronic tension-type headache and episodic migraine, with or without medication overuse headache, from general practices and via self-referral. Our main analyses were on people with migraine. Interventions: The CHESS intervention consisted of two 1-day group sessions focused on education and self-management to promote behaviour change and support learning strategies to manage chronic headaches. This was followed by a one-to-one nurse consultation and telephone support. The control intervention consisted of feedback from classification interviews, headache management leaflet and a relaxation compact disc. Main outcome measures: The primary outcome was headache-related quality of life measured using the Headache Impact Test-6 at 12 months. The secondary outcomes included the Chronic Headache Quality of Life Questionnaire; headache days, duration and severity; EuroQol-5 Dimensions, five-level version; Short Form Questionnaire-12 items; Hospital Anxiety and Depression Scale; and Pain Self-Efficacy Questionnaire scores. We followed up participants at 4, 8 and 12 months. Results: Between April 2017 and March 2019, we randomised 736 participants from 164 general practices. Nine participants (1%) had chronic tension-type headache only. Our main analyses were on the remaining 727 participants with migraine (376 in the intervention arm and 351 in the usual-care arm). Baseline characteristics were well matched. For the primary outcome we had analysable data from 579 participants (80%) at 12 months. There was no between-group difference in the Headache Impact Test-6 at 12 months, (adjusted mean difference –0.3, 95% confidence interval –1.23 to 0.67; p = 0.56). The limits of the 95% confidence interval effectively exclude the possibility of the intervention having a worthwhile benefit. At 4 months there was a difference favouring the CHESS self-management programme on the Headache Impact Test-6 (adjusted mean difference –1.0, 95% confidence interval –1.91 to –0.006; p = 0.049). However, the self-management group also reported 1.5 (95% confidence interval 0.48 to 2.56) more headache days in the previous 28 days. Apart from improved pain self-efficacy at 4 and 12 months, there were few other statistically significant between-group differences in the secondary outcomes. The CHESS intervention generated 0.031 (95% confidence interval –0.005 to 0.063) additional quality-adjusted life-years and increased NHS and Personal Social Services costs by £268 (95% confidence interval £176 to £377), on average, generating an incremental cost-effectiveness ratio of £8617 with an 83% chance of being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year. The CHESS intervention was well received and fidelity was good. No process-related issues were identified that would explain why the intervention was ineffective. Limitations: Only 288 out of 376 (77%) of those randomised to the CHESS intervention attended one or more of the intervention sessions. Conclusions: This short, non-pharmacological, educational self-management intervention is unlikely to be effective for the treatment of people with chronic headaches and migraine. Future work: There is a need to develop and test more sustained non-pharmacological interventions for people with chronic headache disorders. Patient and public involvement: Substantial patient and public involvement went into the design, conduct and interpretation of the CHESS programme. This helped direct the research and ensured that the patient voice was embedded in our work. Trial registration: This trial is registered as ISRCTN79708100. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 2. See the NIHR Journals Library website for further information

Supportive Self-Management Program for People With Chronic Headaches and Migraine: A Randomized Controlled Trial and Economic Evaluation

Background and Objectives: Chronic headache disorders are a major cause of pain and disability. Education and supportive self-management approaches could reduce the burden of headache disability. We tested the effectiveness of a group educational and supportive self-management program for people living with chronic headaches. / Methods: This was a pragmatic randomized controlled trial. Participants were aged 18 years or older with chronic migraine or chronic tension-type headache, with or without medication overuse headache. We primarily recruited from general practices. Participants were assigned to either a 2-day group education and self-management program, a one-to-one nurse interview, and telephone support or to usual care plus relaxation material. The primary outcome was headache related-quality of life using the Headache Impact Test (HIT)-6 at 12 months. The primary analysis used intention-to-treat principles for participants with migraine and both baseline and 12-month HIT-6 data. / Results: Between April 2017 and March 2019, we randomized 736 participants. Because only 9 participants just had tension-type headache, our main analyses were on the 727 participants with migraine. Of them, 376 were allocated to the self-management intervention and 351 to usual care. Data from 586 (81%) participants were analyzed for primary outcome. There was no between-group difference in HIT-6 (adjusted mean difference = -0.3, 95% CI -1.23 to 0.67) or headache days (0.9, 95% CI -0.29 to 2.05) at 12 months. The Chronic Headache Education and Self-management Study intervention generated incremental adjusted costs of £268 (95% CI, £176-£377) (USD383 [95% CI USD252-USD539]) and incremental adjusted quality-adjusted life years (QALYs) of 0.031 (95% CI -0.005 to 0.063). The incremental cost-effectiveness ratio was £8,617 (USD12,322) per QALY gained. / Discussion: These findings conclusively show a lack of benefit for quality of life or monthly headache days from a brief group education and supportive self-management program for people living with chronic migraine or chronic tension-type headache with episodic migraine

Supportive Self-Management Program for People With Chronic Headaches and Migraine: A Randomized Controlled Trial and Economic Evaluation.

BACKGROUND AND OBJECTIVES: Chronic headache disorders are a major cause of pain and disability. Education and supportive self-management approaches could reduce the burden of headache disability. We tested the effectiveness of a group educational and supportive self-management program for people living with chronic headaches. METHODS: This was a pragmatic randomized controlled trial. Participants were aged 18 years or older with chronic migraine or chronic tension-type headache, with or without medication overuse headache. We primarily recruited from general practices. Participants were assigned to either a 2-day group education and self-management program, a one-to-one nurse interview, and telephone support or to usual care plus relaxation material. The primary outcome was headache related-quality of life using the Headache Impact Test (HIT)-6 at 12 months. The primary analysis used intention-to-treat principles for participants with migraine and both baseline and 12-month HIT-6 data. RESULTS: Between April 2017 and March 2019, we randomized 736 participants. Because only 9 participants just had tension-type headache, our main analyses were on the 727 participants with migraine. Of them, 376 were allocated to the self-management intervention and 351 to usual care. Data from 586 (81%) participants were analyzed for primary outcome. There was no between-group difference in HIT-6 (adjusted mean difference = -0.3, 95% CI -1.23 to 0.67) or headache days (0.9, 95% CI -0.29 to 2.05) at 12 months. The Chronic Headache Education and Self-management Study intervention generated incremental adjusted costs of £268 (95% CI, £176-£377) (USD383 [95% CI USD252-USD539]) and incremental adjusted quality-adjusted life years (QALYs) of 0.031 (95% CI -0.005 to 0.063). The incremental cost-effectiveness ratio was £8,617 (USD12,322) per QALY gained. DISCUSSION: These findings conclusively show a lack of benefit for quality of life or monthly headache days from a brief group education and supportive self-management program for people living with chronic migraine or chronic tension-type headache with episodic migraine. TRIAL REGISTRATION INFORMATION: Registered on the International Standard Randomized Controlled Trial Number registry, ISRCTN79708100 16th December 2015 doi.org/10.1186/ISRCTN79708100. The first enrollment was April 24, 2017. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that a brief group education and self-management program does not increase the probability of improvement in headache-related quality of life in people with chronic migraine