Experiences of people taking opioid medication for chronic non-malignant pain : a qualitative evidence synthesis using meta-ethnography

Objective To review qualitative studies on the experience of taking opioid medication for chronic non-malignant pain (CNMP) or coming off them. Design This is a qualitative evidence synthesis using a seven-step approach from the methods of meta-ethnography. Data sources and eligibility criteria We searched selected databases—Medline, Embase, AMED, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Web of Science and Scopus (Science Citation Index and Social Science Citation Index)—for qualitative studies which provide patients’ views of taking opioid medication for CNMP or of coming off them (June 2017, updated September 2018). Data extraction and synthesis Papers were quality appraised using the Critical Appraisal Skills Programme tool, and the GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation working group - Confidence in Evidence from Reviews of Qualitative research) guidelines were applied. We identified concepts and iteratively abstracted these concepts into a line of argument. Results We screened 2994 unique citations and checked 153 full texts, and 31 met our review criteria. We identified five themes: (1) reluctant users with little choice; (2) understanding opioids: the good and the bad; (3) a therapeutic alliance: not always on the same page; (4) stigma: feeling scared and secretive but needing support; and (5) the challenge of tapering or withdrawal. A new overarching theme of ‘constantly balancing’ emerged from the data. Conclusions People taking opioids were constantly balancing tensions, not always wanting to take opioids, and weighing the pros and cons of opioids but feeling they had no choice because of the pain. They frequently felt stigmatised, were not always ‘on the same page’ as their healthcare professional and felt changes in opioid use were often challenging

Intrathecal drug delivery systems for the management of chronic non-cancer pain : a systematic review of economic evaluations

Background: Intrathecal drug delivery (ITDD) systems are one of a limited number of management options for chronic non-cancer pain, cancer pain and spasticity. Concerns over their effectiveness and high initial costs led NHS England to decommission ITDD for patients with chronic non-cancer pain. However, the extent to which this decision is in line with existing economic evidence is unclear. The aim of this systematic review is to identify and review the existing evidence on the cost-effectiveness of ITDD for chronic non-cancer pain. Methods: Full and partial economic evaluations on ITDD were identified through systematic searches in MEDLINE, EMBASE, Web of Science and the National Health Service Centre for Reviews and Dissemination databases. Database searches were complemented by hand searching of reference lists of relevant studies and searches of grey literature. Study selection was carried out by two assessors, independently. Study quality assessment was performed to inform critical appraisal of health economics studies. Data were extracted using a data extraction form developed for this study. Results: 4464 unique studies were identified, of which seven met the inclusion criteria. With the exception of one study, the studies found ITDD to be either cost-saving or cost-effective compared to conventional medical management. ITDD becomes cost-ineffective in one further study following price year adjustment to 2016. Conclusions: Study findings show ITDD as not cost-effective only in extremely conservative scenarios. There is limited evidence on the effectiveness of ITDD in non-cancer pain; however, the available economic evidence controverts arguments to refute the treatment on economic grounds

Rethinking clinical trials of transcranial direct current stimulation: Participant and assessor blinding is inadequate at intensities of 2mA

Copyright @ 2012 The Authors. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and 85 reproduction in any medium, provided the original author and source are credited. The article was made available through the Brunel University Open Access Publishing Fund.Background: Many double-blind clinical trials of transcranial direct current stimulation (tDCS) use stimulus intensities of 2 mA despite the fact that blinding has not been formally validated under these conditions. The aim of this study was to test the assumption that sham 2 mA tDCS achieves effective blinding. Methods: A randomised double blind crossover trial. 100 tDCS-naïve healthy volunteers were incorrectly advised that they there were taking part in a trial of tDCS on word memory. Participants attended for two separate sessions. In each session, they completed a word memory task, then received active or sham tDCS (order randomised) at 2 mA stimulation intensity for 20 minutes and then repeated the word memory task. They then judged whether they believed they had received active stimulation and rated their confidence in that judgement. The blinded assessor noted when red marks were observed at the electrode sites post-stimulation. Results: tDCS at 2 mA was not effectively blinded. That is, participants correctly judged the stimulation condition greater than would be expected to by chance at both the first session (kappa level of agreement (κ) 0.28, 95% confidence interval (CI) 0.09 to 0.47 p = 0.005) and the second session (κ = 0.77, 95%CI 0.64 to 0.90), p = <0.001) indicating inadequate participant blinding. Redness at the reference electrode site was noticeable following active stimulation more than sham stimulation (session one, κ = 0.512, 95%CI 0.363 to 0.66, p<0.001; session two, κ = 0.677, 95%CI 0.534 to 0.82) indicating inadequate assessor blinding. Conclusions: Our results suggest that blinding in studies using tDCS at intensities of 2 mA is inadequate. Positive results from such studies should be interpreted with caution.GLM is supported by the National Health & Medical Research Council of Australia ID 571090

The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial

Background: Patients with “refractory angina” (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health‐related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost‐effectiveness of SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting. Methods: RA patients deemed suitable were randomized in a 1:1 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization. Results: We failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42‐month period across four sites. None of the study participants chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow‐up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the SCS group. Conclusions: While patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial

Process evaluation protocol for the I-WOTCH study : an opioid tapering support programme for people with chronic non-malignant pain

Introduction The Improving the Wellbeing of people with Opioid Treated CHronic Pain (I-WOTCH) randomised controlled trial uses a multicomponent self-management intervention to help people taper their opioid use. This approach is not widely used and its efficacy is unknown. A process evaluation alongside the trial will help to assess how the intervention was delivered, looking at the dose of intervention received and the fidelity of the delivery. We will explore how the intervention may have brought about change through the experiences of the participants receiving and the staff delivering the intervention and whether there were contextual factors involved. Methods and analysis A mixed methods process evaluation will assess how the processes of the I-WOTCH intervention fared and whether these affected the outcomes. We will collect quantitative data, for example, group attendance analysed with statistical methods. Qualitative data, for example, from interviews and feedback forms will be analysed using framework analysis. We will use a ‘following a thread’ and a mixed methods matrix for the final integrated analysis. Ethics and dissemination The I-WOTCH trial and process evaluation were granted full ethics approval by Yorkshire and The Humber—South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). All data were collected in accordance with data protection guidelines. Participants provided written informed consent for the main trial, and all interviewees provided additional written informed consent. The results of the process evaluation will be published and presented at conferences

The incidence and healthcare costs of persistent post-operative pain following lumbar spine surgery in the United Kingdom: a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) : a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES)

OBJECTIVE: To characterise incidence and healthcare costs associated with persistent postoperative pain (PPP) following lumbar surgery. DESIGN: Retrospective, population-based cohort study. SETTING: Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) databases. PARTICIPANTS: Population-based cohort of 10 216 adults who underwent lumbar surgery in England from 1997/1998 through 2011/2012 and had at least 1 year of presurgery data and 2 years of postoperative follow-up data in the linked CPRD-HES. PRIMARY AND SECONDARY OUTCOMES MEASURES: Incidence and total healthcare costs over 2, 5 and 10 years attributable to persistent PPP following initial lumbar surgery. RESULTS: The rate of individuals undergoing lumbar surgery in the CPRD-HES linked data doubled over the 15-year study period, fiscal years 1997/1998 to 2011/2012, from 2.5 to 4.9 per 10 000 adults. Over the most recent 5-year period (2007/2008 to 2011/2012), on average 20.8% (95% CI 19.7% to 21.9%) of lumbar surgery patients met criteria for PPP. Rates of healthcare usage were significantly higher for patients with PPP across all types of care. Over 2 years following initial spine surgery, the mean cost difference between patients with and without PPP was £5383 (95% CI £4872 to £5916). Over 5 and 10 years following initial spine surgery, the mean cost difference between patients with and without PPP increased to £10 195 (95% CI £8726 to £11 669) and £14 318 (95% CI £8386 to £19 771), respectively. Extrapolated to the UK population, we estimate that nearly 5000 adults experience PPP after spine surgery annually, with each new cohort costing the UK National Health Service in excess of £70 million over the first 10 years alone. CONCLUSIONS: Persistent pain affects more than one-in-five lumbar surgery patients and accounts for substantial long-term healthcare costs. There is a need for formal, evidence-based guidelines for a coherent, coordinated management strategy for patients with continuing pain after lumbar surgery

The need for and provision of intrathecal baclofen therapy for the management of spasticity in England : an assessment of the Hospital Episode Statistics database

OBJECTIVES: The aim of this study was to evaluate changes in the uptake of intrathecal baclofen (ITB) following commissioning of this therapy by the National Health Service (NHS) England in April 2013. The specific objectives of this study were: (i) to explore the gap between the need for and the actual provision of ITB services; and (ii) to compare England figures with other European countries with comparable data available. SETTING: Data for ITB -related procedures were obtained from the Hospital Episode Statistics (HES) database from 2009/2010 to 2013/2014. PARTICIPANTS: Patients receiving ITB for the management of spasticity. RESULTS: The available data for implantation of ITB from 2009/2010 to 2013/2014 for the treatment of spasticity due to varied aetiologies show that there has not been an increase in uptake of this therapy. The estimated need for this treatment based on the incidence and prevalence of conditions susceptible to ITB therapy is between 4.6 and 5.7 per million population. Our analysis of the data available from the HES database showed that the actual number of implants is around 3.0 per million population. The same period 2009–2014 has seen an increase in the delivery of other neuromodulation techniques including spinal cord stimulation, deep brain stimulation and sacral nerve stimulation. CONCLUSIONS: There is a considerable gap between the need for and provision of ITB figures nationally. Additionally, within the same area, we have observed important differences in the ITB service delivery between the various trusts. The reasons for this can be multifactorial, including individual experience and opinions, organisational structures, resource and financial limitations. Further research analysing the efficacy and cost-effectiveness of this treatment in the UK might inform the development of Technology Appraisal Guidance for ITB, potentially leading to an improvement in service provision

Best practice in radiofrequency denervation of the lumbar facet joints : a consensus technique

Background Radiofrequency denervation is used to treat selected people with low back pain. Recent trials have been criticised for using a sub-optimal intervention technique. Objectives To achieve consensus on a best practice technique for administering radiofrequency denervation of the lumbar facet joints to selected people with low back pain. Study design A consensus of expert professionals in the area of radiofrequency denervation of the lumbar facet joints. Methods We invited a clinical member from the 30 most active UK departments in radiofrequency pain procedures and two overseas clinicians with specific expertise to a 1 day consensus meeting. Drawing on the known anatomy of the medial branch, the theoretical basis of radiofrequency procedures, a survey of current practice and collective expertise, delegates were facilitated to reach consensus on the best practice technique. Results The day was attended by 24 UK and international clinical experts. Attendees agreed a best practice technique for the conduct of radiofrequency denervation of the lumbar facet joints. Limitations This consensus was based on a 1 day meeting of 24 clinical experts who attended and took part in the discussions. The agreed technique has not been subject to input from a wider community of experts. Conclusions Current best practice for radiofrequency denervation has been agreed for use in a UK trial. Group members intend immediate implementation in their respective trusts. We propose using this in a planned Randomised Controlled Trial (RCT) of radiofrequency denervation for selected people with low back pain