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.
Randomised controlled trials (RCTs) of non-specific low back pain (LBP) interventions commonly estimate sizes of treatment effect from subjective scales. It is not clear which scales are most commonly used. Moreover, the standardized effect sizes, d, of interventions are typically small (d ≈0.3) and many trials may be underpowered to detect d at this magnitude, regardless of scale used. We identified RCTs reported between 1980 and 2000 from the European guidelines for low back and extended the search to 2006 using MEDLINE, EMBASE, PsycINFO, Cochrane, and Lilacs. We extracted data from identified studies concerning outcome measure use and power to detect d. Following analysis of 222 papers, the most commonly used outcome measure was the visual analogue pain scale (VAS-P), used by 42% of trials, followed by the Roland Morris disability questionnaire (RMDQ), used by 34% of trials. Secondary measure use was diverse; 5% of trials included 10 or more measures and 40% involved at least one objective measure. 57% of the trials were powered to detect d = 0.8, only 37% could detect d = 0.5, only 6% were able to detect d = 0.3 and only one trial could detect Cohen’s definition of a small effect, d = 0.2. In sum, the VAS-P is the most commonly used outcome measure in trials of non-specific LBP and the majority of trials are too small to show effect sizes that might realistically occur.
The steering committee produced checklists of predictors and outcomes based on systematic reviews and a Delphi focus group. The international teams of experts coded each item for inclusion or exclusion, and recommended new items. This process was iterated twice to resolve disagreement between teams, and to receive scores for new items. The steering committee carried out a consensus synthesis and produced the final lists for predictors and outcome. Finally, the measurements for each factor were selected based on:
original systematic review recommendations from existing systematic review Recommendations from consensus statements and narrative reviews consultation with independent experts.
The effect of pain on lifestyle is paramount to the patient, physical symptoms for the clinician. Acknowledging this disparity may reduce frustration experienced in consultations as both have different communication and management needs. Indicating treatment success by focusing on lifestyle improvement in patients rather than reductions in physical symptoms may be more appropriate.
reported practice (based on a vignette of a patient with non-specific LBP) beliefs and attitudes about LBP(using the HC-PAIRS, Rainville et al 1995)
We conducted a community survey of the prevalence, health impact and location of chronic pain. We explored the relationship and patterns of chronic pain that commonly occur, with a view to understanding why some treatment approaches may be more appropriate than others for particular patterns of pain. In 2002, 2504 randomly sampled patients from 16 General Practices in the South East of England responded to a postal questionnaire about chronic pain. Those with chronic pain completed a pain drawing. We calculated descriptive statistics, relative risk and correlations to identify the associations and risks of having linked pain. The highest prevalences were low back (23%), shoulder (20%) and knee (18%) pain. The number of pain sites experienced was age related in men but less so in women. Lower body pain was more age related than upper body and non musculoskeletal pain. Multi site pain was more common than single site pain. Of those with low back, knee and shoulder pain, 14%, 4.5 % and 1.9% had only low back, knee and shoulder pain respectively. Correlations and minimum spanning trees showed that chronic upper and lower body pain are distinct and axial pain link the two. Chronic pain is more likely to be multi site, especially at middle age. Research, physical treatments and approaches to managing chronic pain are often site specific, therefore specialising treatment to one area eg low back pain often negates the bigger issue. This may help explain the self perpetuating problem of persistent chronic pain.
Patients who consulted complementary practitioners were more likely to be female, to be psychologically distressed, to work, to have left school aged over 16 and to have severe pain (p<
0.05 in all cases). Working was independently associated with consulting a complementary practitioner (Exp (B) = 2.0, p=0.00)
11/19 studies reported inconclusive results, 8/19 showed a statistical association between drawings and the psychological assessment tool. However the more clinically relevant, sensitivity data ranged from 24–93%, specificity 44–91%, positive predictive values 28–93%, and negative predictive values 35–92%. The range of this data is too wide to be acceptable clinically as predictive of psychological state.
1) beliefs and attitudes about LBP 2) reported practice (using a clinical vignette)
A total of 3602 questionnaires were posted to simple random samples of UK registered chiropractors (n=611), osteopaths (n=1367) and physiotherapists (n=1624). Intervention packages were sent to consenting practitioners in March 2004, and the follow-up is planned for September 2004.
Explored patient’s or practitioners; beliefs and expectations, or both. Studied patients with chronic musculoskeletal pain, which does not have a known systemic, inflammatory or malignant origin treated in primary or community care. The full review group resolved disagreements. Full text articles meeting the inclusion criteria will be obtained and coded further into non-randomised studies, randomised studies and qualitative studies. Data abstraction forms will be developed for each type of study. Data abstraction will be undertaken by two members of the group working independently.
To determine the most powerful predictors of consultation for CLBP from pain severity, troublesomeness, health related quality of life and psychological distress
Chi square tests will be undertaken to explore the relationship between troublesomeness of CLBP and consultations for pain in general and with whether consulted mainstream or complementary practitioners. Multiple logistic regression will be undertaken to explore the most powerful predictors of consultation for CLBP.
Participants were identified from respondents reporting chronic pain in a postal questionnaire survey administered through a local general practice. Participants were allocated to groups according to the severity of their pain, as measured by the Chronic Pain Grade. Those with grades II and I were allocated to group one and those with grades III and IV to group two.
Conclusions: There appears to be inadequate randomised controlled trial (RCT) evidence to justify diversion of NHS resources from proven interventions to expand services for acute simple back pain. An RCT to show that an intervention for acute back pain decreases the proportion disabled at one year from 10% to 5% requires 1,250 randomised participants (a = 0.05, b=0.2). Obtaining RCT evidence to confirm or refute that these interventions will have meaningful health impact may be impossible. We need to consider other ways of obtaining evidence to inform the development of models of care for those with acute back pain.
The traditional biomedical model of managing musculoskeletal problems, such as low back pain (LBP), tends to be pathology driven, in which the aim is to locate an objectively identified disturbance. Appropriate treatment is conceptualised as a physical intervention that will compensate for or correct the identified disturbance. There is growing appreciation of the need to consider other factors, e.g. the meaning of the problem to the patient and professional, his/her experiences, cognitions, motivations and preferences. Improving the understanding about the beliefs and expectations of patients and health professionals is fundamental, since a better understanding of these factors, and any mismatch between professionals and patients, will facilitate improved management. A multidisciplinary group of researchers (chiropractor, GP, osteopath, physiotherapist, psychologist, sociologist) have developed a collaborative research programme to investigate the decision-making processes in the care of patients with musculoskeletal pain. The programme uses mixed methods, including systematic reviews, survey research, focus groups and semi-structured interviews with patients and practitioners. Three studies have already started: patient and health professional beliefs and expectations for the causes and treatment of chronic musculoskeletal pain. 1) Funded by the ARC, the purpose is to develop an understanding of the relationships between the different, professional and lay, theoretical frameworks used to diagnose and treat chronic musculoskeletal pain, and how these affect care. 2) Clinicians cognitions in apparently ineffective treatment of low back pain: funded by the ESRC, the purpose is to identify the reasons clinicians continue to treat LBP in the absence of improvement. Research on risk factors for the transition from acute to chronic LBP has concentrated on patient characteristics (psychological and social). It is possible that clinicians’ behaviour, advice and even treatment contribute to maintaining the problem indirectly. 3) Overcoming barriers to evidence-based practice (EBP) in LBP management in the physical therapy professions; funded by the Department of Physiotherapy Studies, Keele University, this study aims to explore the perceptions of physiotherapists, chiropractors and osteopaths, about the opportunities and threats of taking an EBP approach to LBP management and identify methods by which implementation of evidence can be facilitated. This collaboration is the first of its kind and was developed through shared interests in the decision-making processes in the healthcare of people with musculoskeletal pain. We are keen to share the ideas and work in progress with the wider musculoskeletal pain research community.
There is some evidence to suggest that, spinal manipulation, and general exercise may help patients with back pain. We are conducting a randomised controlled trial to compare usual care in general practice for low back pain patients with exercise classes, a package of treatment by a manipulator, manipulation followed by exercise and to compare manipulation’s effect in private and NHS facilities. Participants were recruited from 167 general practices belonging to the Medical Research Council General Practice Research Framework in 15 sites across the UK with a total registered population of 1,140,000 patients. A total of 1,334 correctly randomised participants have been recruited. Mean age of participants is 43 years, 55% are female and Mean Roland Morris score 8. Follow up rates at one and three months are 83% and 78% respectively. Follow up finishes in May 2002 It is possible to recruit large numbers of back pain patients for trials of physical therapy in primary care.
There is a desire to reduce the economic burden of low back pain. This in is part because of the 226% increase in invalidity benefits paid out for spinal disorders in the ten years to 1994/5. This paper examines the effect of the change from Invalidity Benefit to Incapacity Benefit in 1995, and considers the utility of these figures as a means of assessing changing patterns of back pain disability. Data were obtained from the DSS on how benefit data were collected and numbers of days of Invalidity/Incapacity Benefits that were paid from 1983/4 to 1998/9. The data suggest that since 1995 that the rate of spinal disability has fallen and has now been stable at 90 million days per year for four years. The headline Incapacity Benefit figures have a very loose relationship with health impact of low back pain. Around 30,000 people per year make the transition to claiming long term Incapacity Benefit from claiming short term Incapacity Benefit. Incapacity Benefit figures are of little utility in assessing changes in low back pain disability. Numbers making the transition to Long Term Incapacity Benefit may be a more useful indicator.