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.

Correction to: Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial.

Following publication of the original article [1], we have been notified that the final specification of randomisation implemented in the study is slightly different to that stated in the protocol and needs to be corrected as follows.

Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial.

BACKGROUND: The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and cost-effectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device. METHODS/DESIGN: The TRIAL-STIM Study is a superiority, parallel-group, three-centre, randomised controlled trial in patients with chronic neuropathic pain with a nested qualitative study and economic evaluation. The study will take place in three UK centres: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital); Basildon and Thurrock University Hospitals NHS Foundation Trust; and Leeds Teaching Hospitals NHS Trust. A total of 100 adults undergoing SCS implantation for the treatment of neuropathy will be included. Subjects will be recruited from the outpatient clinics of the three participating sites and randomised to undergo a screening trial prior to SCS implant or an implantation-only strategy in a 1:1 ratio. Allocation will be stratified by centre and minimised on patient age (≥ 65 or < 65 years), gender, presence of failed back surgery syndrome (or not) and use of high frequency (HF10™) (or not). The primary outcome measure is the numerical rating scale (NRS) at 6 months compared between the screening trial and implantation strategy and the implantation-only strategy. Secondary outcome measures will include diagnostic accuracy, the proportion of patients achieving at least 50% and 30% pain relief at 6 months as measured on the NRS, health-related quality-of-life (EQ-5D), function (Oswestry Disability Index), patient satisfaction (Patients' Global Impression of Change) and complication rates. A nested qualitative study will be carried out in parallel for a total of 30 of the patients recruited in each centre (10 at each centre) to explore their views of the screening trial, implantation and overall use of the SCS device. The economic evaluation will take the form of a cost-utility analysis. DISCUSSION: The TRIAL-STIM Study is a randomised controlled trial with a nested qualitative study and economic evaluation aiming to determine the clinical utility of screening trials of SCS as well as their cost-effectiveness. The nested qualitative study will seek to explore the patient's view of the screening trials, implantation and overall use of SCS. TRIAL REGISTRATION: ISRCTN, ISRCTN60778781 . Registered on 15 August 2017.

Preconception care for women with type 1 or type 2 diabetes mellitus: a mixed-methods study exploring uptake of preconception care.

BACKGROUND: Diabetes mellitus is a global health problem and one of the most common medical conditions in pregnancy. A wide range of modifiable risk factors are associated with diabetes mellitus in pregnancy, and it is widely acknowledged that preconception care (PCC) is beneficial for women with pre-existing diabetes mellitus. However, uptake of PCC services is low. OBJECTIVES: To systematically review qualitative research on PCC for women with pre-existing diabetes mellitus of childbearing age, identify facilitators of and barriers to uptake of PCC and establish themes and gaps in knowledge. Through qualitative interviews explore views on the provision of, and facilitators of and barriers to the uptake of, PCC. DESIGN: Mixed methods encompassing a systematic review and qualitative interviews. SETTING: Two secondary care sites and 11 primary care sites. PARTICIPANTS: Women of childbearing age with pre-existing type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) of white British or Pakistani origin. INTERVENTIONS: None. ANALYSIS: A narrative synthesis of the literature using thematic analysis and a thematic analysis of the qualitative interview data using the method of constant comparison. RESULTS: Eighteen qualitative studies were included in the systematic review and a quality appraisal was carried out using relevant criteria for qualitative research appraisal, including a narrative summary of study quality. Twelve interviews with women with pre-existing T1DM or T2DM were carried out. This fell short of the original aim of interviewing 48 women owing to challenges in recruitment, especially in primary care. A synthesis of these data shows that uptake of PCC is influenced by a range of factors, including the complexity of pregnancy planning, the skill and expertise of health professionals who provide care to women with diabetes mellitus, the role of health professionals in the delivery of PCC, and the quality of relationships between women and health professionals. LIMITATIONS: Owing to significant challenges with recruitment of participants, particularly in primary care, 12 interviews with women with pre-existing T1DM or T2DM were carried out, which fell short of the a priori sample size. CONCLUSIONS: Reconceptualising PCC to place greater emphasis on pregnancy planning, fertility and contraception would lower some of the existing barriers to uptake of care. It is important to clarify who is responsible for the delivery of PCC to women with pre-existing diabetes mellitus and to ensure that the correct expertise is available so that opportunities for advice giving are maximised. Relationships between women and health professionals should be based on a partnership approach that encourages mutual trust and respect, focusing on positive change rather than negative outcomes. FUTURE WORK: Further research is needed to investigate the views and experiences of stakeholders that commission, design and deliver PCC services for women with pre-existing diabetes mellitus; to explore experiences of women from minority or ethnically diverse backgrounds; to investigate the role of family support in contraception, pregnancy planning and PCC; and to investigate the management of diabetes mellitus in neonatal care and its role in breastfeeding. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014015592 and ISRCTN12983949. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial.

BACKGROUND: For most cancers, only a minority of patients have symptoms meeting the National Institute for Health and Clinical Excellence guidance for urgent referral. For gastro-oesophageal cancers, the 'alarm' symptoms of dysphagia and weight loss are reported by only 32 and 8 % of patients, respectively, and their presence correlates with advanced-stage disease. Electronic clinical decision-support tools that integrate with clinical computer systems have been developed for general practice, although uncertainty remains concerning their effectiveness. The objectives of this trial are to optimise the intervention and establish the acceptability of both the intervention and randomisation, confirm the suitability and selection of outcome measures, finalise the design for the phase III definitive trial, and obtain preliminary estimates of the intervention effect. METHODS/DESIGN: This is a two-arm, multi-centre, cluster-randomised, controlled phase II trial design, which will extend over a 16-month period, across 60 general practices within the North East and North Cumbria and the Eastern Local Clinical Research Network areas. Practices will be randomised to receive either the intervention (the electronic clinical decision-support tool) or to act as a control (usual care). From these practices, we will recruit 3000 adults who meet the trial eligibility criteria and present to their GP with symptoms suggestive of gastro-oesophageal cancer. The main measures are the process data, which include the practitioner outcomes, service outcomes, diagnostic intervals, health economic outcomes, and patient outcomes. One-on-one interviews in a sub-sample of 30 patient-GP dyads will be undertaken to understand the impact of the use or non-use of the electronic clinical decision-support tool in the consultation. A further 10-15 GPs will be interviewed to identify and gain an understanding of the facilitators and constraints influencing implementation of the electronic clinical decision-support tool in practice. DISCUSSION: We aim to generate new knowledge on the process measures regarding the use of electronic clinical decision-support tools in primary care in general and to inform a subsequent definitive phase III trial. Preliminary data on the impact of the support tool on resource utilisation and health care costs will also be collected. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN12595588 .