Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions.Background
Objectives
Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, and trial registries up to 26 March 2020. We included randomized controlled trials (RCTs), comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: pain, function, serious adverse events (SAEs), blood loss, implant stability, duration of surgery, and length of hospital stay.Aims
Methods
A 2011 Cochrane review concluded that spinal manipulative therapy (SMT) is no better than other interventions for reducing pain and improving function in chronic low back pain (CLBP). Using individual participant data (IPD) from trials has advantages, among others: a more precise estimate of the effect and the potential to identify moderators. Our objective was to assess the effect of SMT in adults with CLBP and to identify relevant moderators. All trials from the 2011 Cochrane review were included in this IPD. We updated the search (April 2016) IPD from eligible studies was requested. Primary outcomes were pain intensity (VAS/NRS) and back-specific function (RMDQ). Risk of bias was assessed. For the treatment effect, an one-stage approach (mixed model technique, intention-to-treat principle) was used; a second-stage approach was conducted as confirmation. For the moderator analyses, one-stage approach was conducted for 19 variables.Purpose of the study and background
Methods
The evidence base to inform the management of Achilles tendon
rupture is sparse. The objectives of this research were to establish
what current practice is in the United Kingdom and explore clinicians’
views on proposed further research in this area. This study was
registered with the ISRCTN (ISRCTN68273773) as part of a larger
programme of research. We report an online survey of current practice in the United
Kingdom, approved by the British Orthopaedic Foot and Ankle Society
and completed by 181 of its members. A total of ten of these respondents
were invited for a subsequent one-to-one interview to explore clinician
views on proposed further research in this area.Objectives
Methods
The available treatments for NSLBP (Non-Specific Low Back Pain) provide, typically, small to moderate average benefits to patients. The aim of this pilot cluster RCT was to test the hypothesis that the use of a patient decision aid together with an informed shared decision making consultation would produce better outcomes in satisfaction with treatment at four month follow-up. We developed a DSP (Decision Support Package). We randomised the physiotherapists and trained those in the intervention arm in informed shared decision making and communication. Participants were recruited from a local physiotherapy department and those allocated to an appointment with an intervention therapist were sent a copy of the DSP in the post. Participants then attended their appointment as usual.Background
Methods
To review systematically review literature on the early diagnosis of spinal metastases and prediction of spinal cord compression (SCC) due to spinal metastases From 13 electronic bibliographic databases were searched we identified 2,425 potentially relevant articles of which 31 met the inclusion criteria. These were quality appraised. Seventeen studies reported retrospective data, 10 were prospective studies, and three were other study designs. There was one systematic review. There were no randomised controlled trials. There were approximately 7,900 participants in the included studies and 5,782 participants were analysed. The sample sizes ranged from 41 to 859. Cancers reported were: lung alone (n=3); prostate alone (n=6); breast alone (n=7); mixed cancers (n=13); and unclear (n=1). Ninety-three prognostic factors were identified as potentially significant in predicting risk of SCC or collapse. Many of the included studies provided limited information about patient population and selection criteria and they varied in methodological quality, rigour and transparency. Several studies with mixed case populations identified type of cancer (e.g. breast, lung or prostate cancer) as a significant factor in predicting SCC, but determining the risk differential is difficult because of residual bias in studies. Overall the quality of the research was poor. The only predictors identified for SCC were number of spinal metastases, duration of disease, total disease burden and immediate symptomatology of cord involvement.Study Purpose
Methods and results
We have developed a LBP (low back pain) repository with IPD (individual patient data) from therapist-delivered intervention RCT's from various institutions, nationally and internationally (19 trials, 9328 patients). We will perform IPD meta-analyses to identify and determine the most effective and cost-effective treatments for subgroups of patients. Disability due to LBP is a key outcome of interest. However, there was no common disability measurement that was used in all the RCT's. We report here our assessment as to whether different disability measures are sufficiently comparable to allow pooling across trials. We used data from seven trials (n = 5015 patients) that had at least two of the following measurements: RMDQ (Roland Morris Disability Questionnaire), MVK (Modified Von Korff disability score), physical component scale of SF-12/36, Patient Specific Functional Scale, and Hannover Functional Ability Questionnaire. Within each trial, the change score between baseline and short-term follow-up was computed. These change scores were then converted from one outcome measure to another with linear regression and ridge-reroughed linear models. They were also tested for correlation and responsiveness (the ability to detect changes in condition, measured by standardised response means).Background
Method
There is on-going debate about a possible link between manipulation and stroke in patients, and a growing interest in other treatment reactions such as increased pain. Evidence about manipulation is contradictory. There is little published information about outcomes in osteopathy. We aimed to address this gap. A survey was sent to all UK practising osteopaths. Another survey was sent to patients recruited by osteopaths. Patients were surveyed before treatment, one day and two days after treatment and at six weeks. 1,082 (27.8%) osteopaths completed the practitioner survey. 2,057 patients, recruited from 212 osteopaths, completed questionnaires before, and directly after their treatment. 1,387 patients provided data six weeks after treatment. Between 10% and 20% of patients experienced increased symptoms/pain related to their main complaint in the days directly following treatment. This was highest for new patients. At 6 weeks, 4% of patients reported temporary disability, which they attributed to osteopathic treatment. 10% of patients reported seeking further consultation for worsening symptoms associated with osteopathic care. The comparison between those that received manipulation and those that did not suggests that manipulation was not linked to worsening outcomes. In the preceding year, 4% of osteopaths reported that they had patients who experienced a range of serious events. The most common event described was the occurrence of peripheral neurological symptoms. There were also 7 reports of stroke-like symptoms.Background and purpose
Methods and results
There is growing concern that current outcome measures of back pain trials do not comprehensively capture what is important to patients. Some researchers believe we need to incorporate patients in the development of ‘next-generation’ outcomes. As a preliminary step to patient-interviews, we aimed to articulate ‘important change’ from the patients' perspective, as represented in reports of qualitative investigations inadvertently or directly exploring this. We adopted a multi-strand search of electronic databases, and citation and reference tracking. Two researchers identified qualitative investigations relating to low back pain. Data were abstracted and synthesised using meta-ethnographic processes. Provisional results, based on 41 studies, indicate few studies have directly addressed this issue, but that data regarding experience and expectations may be useful. Whilst results suggest that practically, patients are concerned with (re-)engagement in meaningful activities, the more experientially focused literature suggests that patients want to be believed and have validated their experiences and identity as someone ‘doing battle’ with pain. Patients seek not only diagnoses, treatment and cure, but simultaneously reassurance of the absence of pathology. In the absence of tenable diagnoses, some feel they must not adopt a ‘sick role’. Some struggle, but manage to meet others' expectations; thereby undermining the credibility of their pain/disability claims. Others withdraw, fearful of disapprobation and unable or unwilling to accommodate social demands. Patients generally seek to regain their pre-pain healthy, and emotionally robust state.Study purpose and background
Summary of methods used and results
Effective reassurance is an essential element of treatment for conditions that do not require further investigations, referrals and on-going monitoring. However, research defining what reassurance should consist of and how to deliver it is scarce. The aim of this review was to identify consultation-related processes that improved patients' outcomes, in order to build an evidence-based model of effective reassurance in primary care. A literature search identified prospective observational studies that explicitly measured consultation-related factors in appropriate primary care patient groups. The findings from empirical studies were combined with theoretical and systematic reviews to develop a model of effective reassurance. Scrutiny of 8193 Abstracts yielded 29 empirical studies fitting inclusion criteria, and 64 reviews. The majority of studies measured patient satisfaction. Clinical outcomes (e.g. health status / symptom reduction) appear to improve with patients' active participation in the consultation. Behavioural outcomes (e.g. adherence/ health care utilization) were only measured in a handful of studies, but may improve when information was given in the final stage of the consultation. Psychological outcomes (e.g. health concerns) were consistently improved by patient-centred approaches.Purpose and background
Method and results
To develop a decision aid - Decision Support Package (DSP) - that will provide low back pain (LBP) patients, and their treating physiotherapists with information on the treatment options available to the patients To develop a training package for physiotherapists on how to use the DSP To encourage and evaluate the informed shared decision making (ISDM) process between patients and physiotherapists during consultation. We developed a DSP informed by existing research and collaboration with physiotherapists, patients and experts in the field of decision aids and LBP. We did six pieces of exploratory work: literature review; 2009 NICE LBP guidelines review; qualitative screening of transcripts of interviews of LBP patients; focus groups (patients); nominal group (physiotherapists), and Delphi study (experts). We collated these data to develop the DSP. We also developed a training package for physiotherapists.Aims
Method
Patients’ who had consulted both mainstream and CAM practitioners reported the poorest health outcomes (EQ 5D = 0.55), followed by those who consulted just mainstream practitioners (EQ 5D = 0.61), and those who had consulted no one (EQ 5D = 0.72). The best health outcomes were reported amongst those who had just consulted CAM practitioners (EQ 5D =0.78). In multivariate analyses, the most powerful predictors of consulting both mainstream and CAM practitioners were working and having high levels of pain related disability.
