Jane A Dennis

The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials

BackgroundThere is a concern in the literature that harm from interventions is insufficiently documented in clinical trials in general, and in those assessing psychological treatments in particular. A recent decision by a trial steering committee to stop recruitment into a randomized controlled trial (RCT) of a psychological intervention for personality disorder led to an investigation of the recording of harm in trials funded by the National Institute for Health Research (NIHR).MethodsThe protocols and final reports of all 82 NIHR trials funded between 1995 and 2013 were examined for the reporting of adverse events. These were subdivided by category of intervention.ResultsNone of the psychological intervention trials mentioned the occurrence of an adverse event in their final report. Trials of drug treatments were more likely to mention adverse events in their protocols compared with those using psychological treatments. When adverse events were mentioned, the protocols of psychological interventions relied heavily on severe adverse events guidelines from the National Research Ethics Service (NRES), which were developed for drug rather than psychological interventions and so may not be appropriate for the latter.ConclusionsThis survey supported the belief that the reporting of adverse events in psychological treatments is weak and the criteria used may not be appropriate. Recommendations are made as to how current practice might be improved.

Systematic review of management of chronic pain after surgery

Pain present for at least 3 months after a surgical procedure is considered chronic postsurgical pain (CPSP) and affects 10–50 per cent of patients. Interventions for CPSP may focus on the underlying condition that indicated surgery, the aetiology of new‐onset pain or be multifactorial in recognition of the diverse causes of this pain. The aim of this systematic review was to identify RCTs of interventions for the management of CPSP, and synthesize data across treatment type to estimate their effectiveness and safety.

Development of a complex intervention for people with chronic pain after knee replacement: the STAR care pathway

BackgroundApproximately 20% of people who have total knee replacement experience chronic pain afterwards, but there is little evidence about effective interventions for managing this type of pain. This article describes the systematic development and refinement of a complex intervention for people with chronic pain after knee replacement. The intervention is a care pathway involving an assessment clinic and onward referral, with telephone follow-up as required. In the design of this multistage study, we chose to focus on ensuring that the intervention was deliverable, implementable and acceptable.MethodsIn line with the UK Medical Research Council’s recommendations for comprehensive development of complex interventions, multiple phases of work were undertaken. Following on from initial development work to design the intervention, the draft intervention content was refined through consensus questionnaires with 22 health professionals and discussion at meetings with 18 healthcare professionals. Testing of intervention delivery and acceptability to patients was undertaken by two health professionals delivering the assessment clinic to ten patients. Views about future implementation within the context of a randomised trial were evaluated through a questionnaire based on the Normalisation Measure Development (NoMAD) instrument with ten health professional stakeholders.ResultsConsensus work with health professionals ensured the components of the intervention were appropriate and informed a number of substantive changes to improve the intervention. Testing of intervention delivery identified a number of logistical issues that were then addressed in the development of a comprehensive intervention training manual. Engagement with stakeholders indicated that the intervention could be successfully implemented in a clinical setting for evaluation in a randomised trial.ConclusionsThis work has informed the development and refinement of a complex intervention for people with chronic pain after knee replacement. The next stage is to evaluate the clinical and cost-effectiveness of the STAR care pathway in a multicentre randomised trial.

The place of evidence in the treatment of sex offenders

Controversy remains about whether sex offenders can be treated effectively, as shown by recent exchanges in this journal (Hickey, 2012; Ho and Ross, 2012; Mann et al., 2012) and elsewhere (Rice and Harris, 2003; Marshall and Marshall, 2007; Seto et al., 2008; Rice and Harris, 2013). The main areas of disagreement are on quality of evidence and its interpretation. The gold standard for evidence is considered to be the randomised controlled trial (RCT). Having recently completed Cochrane Reviews into psychological and pharmacological interventions for sex offenders (Dennis et al., 2012; Khan et al., 2014), confined to RCTs, we propose to examine the place of such ‘gold standard evidence’ in determining the role of treatment of sex offenders.

Speech and language therapy interventions for children with primary speech and/or language disorders

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To determine the effectiveness of speech and language therapy interventions for children with a primary diagnosis of speech and/or language disorders. The review will focus on comparisons between active interventions and controls.

Clinical and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: Study protocol for a UK randomised controlled trial

BackgroundApproximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care.MethodsThis is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway.DiscussionIf shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement.Trial registrationISRCTN registry (ISRCTN92545361), prospectively registered on 30 August 2016.

Post-operative patient-related risk factors for chronic pain after total knee replacement: a systematic review

Objective To identify postoperative patient-related risk factors for chronic pain after total knee replacement (TKR). Design The systematic review protocol was registered on the International Prospective Register of Systematic Reviews (CRD42016041374). MEDLINE, Embase and PsycINFO were searched from inception to October 2016 with no language restrictions. Key articles were also tracked in the Institute for Scientific Information (ISI) Web of Science. Cohort studies evaluating the association between patient-related factors in the first 3 months postoperatively and pain at 6 months or longer after primary TKR surgery were included. Screening, data extraction and assessment of methodological quality were undertaken by two reviewers. The primary outcome was pain severity in the replaced knee measured with a patient-reported outcome measure at 6 months or longer after TKR. Secondary outcomes included adverse events and other aspects of pain recommended by the core outcome set for chronic pain after TKR. Results After removal of duplicates, 16 430 articles were screened, of which 805 were considered potentially relevant. After detailed evaluation of full-text articles, 14 studies with data from 1168 participants were included. Postoperative patient-related factors included acute pain (eight studies), function (five studies) and psychosocial factors (four studies). The included studies had diverse methods for assessment of potential risk factors and outcomes, and therefore narrative synthesis was conducted. For all postoperative factors, there was insufficient evidence to draw firm conclusions about the association with chronic pain after TKR. Selection bias was a potential risk for all studies, as none were reported to be conducted at multiple centres. Conclusion This systematic review found insufficient evidence to draw firm conclusions about the association between any postoperative patient-related factors and chronic pain after TKR. Further high-quality research is required to provide a robust evidence base on postoperative risk factors, and inform the development and evaluation of targeted interventions to optimise patients’ outcomes after TKR.

Effectiveness of postdischarge interventions for reducing the severity of chronic pain after total knee replacement: systematic review of randomised controlled trials

Objective Approximately 20% of patients experience chronic pain after total knee replacement (TKR). The aim of this systematic review was to evaluate the effectiveness of postdischarge interventions commenced in the first 3 months after surgery in reducing the severity of chronic pain after TKR. Design The protocol for this systematic review was registered on PROSPERO (registration number: CRD42017041382). MEDLINE, Embase, CINAHL, PsycINFO and The Cochrane Library were searched from inception to November 2016. Randomised controlled trials of postdischarge intervention which commenced in the first 3 months after TKR surgery were included. The primary outcome of the review was self-reported pain severity at 12 months or longer after TKR. Risk of bias was assessed using the Cochrane risk-of-bias tool. Results Seventeen trials with data from 2485 randomised participants were included. The majority of trials evaluated physiotherapy interventions (n=13); other interventions included nurse-led interventions (n=2), neuromuscular electrical stimulation (n=1) and a multidisciplinary intervention (n=1). Opportunities for meta-analysis were limited by heterogeneity. No study found a difference in long-term pain severity between trial arms, with the exception of one trial which found home-based functional exercises aimed at managing kinesiophobia resulted in lower pain severity scores at 12 months postoperatively compared with advice to stay active. Conclusion This systematic review and narrative synthesis found no evidence that one type of physiotherapy intervention is more effective than another at reducing the severity of chronic pain after TKR. Further research is needed to evaluate non-physiotherapy interventions, including the provision of care as part of a stratified and multidisciplinary care package. PROSPERO registration number CRD42017041382.