The effects of supported employment interventions in populations of people with conditions other than severe mental health: a systematic review.

AIM: To assess the effectiveness of supported employment interventions for improving competitive employment in populations of people with conditions other than only severe mental illness. BACKGROUND: Supported employment interventions have been extensively tested in severe mental illness populations. These approaches may be beneficial outside of these populations. METHODS: We searched PubMed, Embase, CINAHL, PsycInfo, Web of Science, Scopus, JSTOR, PEDro, OTSeeker, and NIOSHTIC for trials including unemployed people with any condition and including severe mental illness if combined with other co-morbidities or other specific circumstances (e.g., homelessness). We excluded trials where inclusion was based on severe mental illness alone. Two reviewers independently assessed risk of bias (RoB v2.0) and four reviewers extracted data. We assessed rates of competitive employment as compared to traditional vocational rehabilitation or waiting list/services as usual. FINDINGS: Ten randomised controlled trials (913 participants) were included. Supported employment was more effective than control interventions for improving competitive employment in seven trials: in people with affective disorders [risk ratio (RR) 10.61 (1.49, 75.38)]; mental disorders and justice involvement [RR 4.44 (1.36,14.46)]; veterans with posttraumatic stress disorder (PTSD) [RR 2.73 (1.64, 4.54)]; formerly incarcerated veterans [RR 2.17 (1.09, 4.33)]; people receiving methadone treatment [RR 11.5 (1.62, 81.8)]; veterans with spinal cord injury at 12 months [RR 2.46 (1.16, 5.22)] and at 24 months [RR 2.81 (1.98, 7.37)]; and young people not in employment, education, or training [RR 5.90 (1.91-18.19)]. Three trials did not show significant benefits from supported employment: populations of workers with musculoskeletal injuries [RR 1.38 (1.00, 1.89)]; substance abuse [RR 1.85 (0.65, 5.41)]; and formerly homeless people with mental illness [RR 1.55 (0.76, 3.15)]. Supported employment interventions may be beneficial to people from more diverse populations than those with severe mental illness alone. Defining competitive employment and increasing (and standardising) measurement of non-vocational outcomes may help to improve research in this area.

Shared decision making by United Kingdom osteopathic students: an observational study using the OPTION-12 instrument.

Background: At the crux of patient centred care is Shared Decision Making (SDM), which benefits patient and practitioner. Despite external pressures, studies indicate that SDM remains poorly practised across a variety of healthcare professions. The degree of SDM engagement within United Kingdom osteopathic undergraduate teaching clinics is currently unknown. Methods: In 2014 we used the reliable and validated OPTION-12 (O12) instrument to calculate a score that reflected the degree of SDM utility in one United Kingdom Osteopathic Educational Institute's teaching clinic. We also aimed to compare these scores with those previously obtained for physiotherapists working within the United Kingdom's National Health Service. Student-patient initial and follow-up encounters were audio recorded, transcribed and scored using the O12. Comparisons between the following O12 scores were performed: the Osteopathic Educational Institute's 4th and 3rd year students; the Osteopathic Educational Institute's student's initial and follow-up patient encounters; the Osteopathic Educational Institute's students and National Health Service physiotherapists. Results: We analysed 35.5 h of transcribed data from 30 student-patient encounters (7 initial: 23 follow-up). An O12 score of 0.6% (range 0-10.4%) was calculated. No significant differences were found between year groups or encounter types. Significant differences were found compared to National Health Service physiotherapist (score = 24.4%): (U = 144, z = 4.25, p < 0.0005); although both scores are below the 60% threshold for competent SDM behaviour. Conclusions: Undergraduate osteopaths did not appear to engage in competent SDM behaviours, implying traditional and paternalistic styles of decision making that align with results from other manual therapy professions. Students in this study did not practise competent SDM behaviours. Effective educational strategies are required to ensure SDM behaviours reach competent levels.

Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012.

BACKGROUND: Low back pain is a common health complaint resulting in substantial economic burden. Each year, upwards of 20 randomised controlled trials (RCTs) evaluating interventions for non-specific low back pain are published. Use of the term non-specific low back pain has been criticised on the grounds of encouraging heterogeneity and hampering interpretation of findings due to possible heterogeneous causes, challenging meta-analyses. We explored selection criteria used in trials of treatments for nsLBP. METHODS: A systematic review of English-language reports of RCTs in nsLBP population samples, published between 2006 and 2012, identified from MEDLINE, EMBASE, and the Cochrane Library databases, using a mixed-methods approach to analysis. Study inclusion and exclusion criteria were extracted, thematically categorised, and then descriptive statistics were used to summarise the prevalence by emerging category. RESULTS: We included 168 studies. Two inclusion themes (anatomical area, and symptoms and signs) were identified. Anatomical area was most reported as between costal margins and gluteal folds (n = 8, 5%), while low back pain (n = 150, 89%) with or without referred leg pain (n = 27, 16%) was the most reported symptom. Exclusion criteria comprised 21 themes. Previous or scheduled surgery (n = 84, 50%), pregnancy (n = 81, 48%), malignancy (n = 78, 46%), trauma (n = 63, 37%) and psychological conditions (n = 58, 34%) were the most common. Sub-themes of exclusion criteria mostly related to neurological signs and symptoms: nerve root compromise (n = 44, 26%), neurological signs (n = 34, 20%) or disc herniation (n = 30, 18%). Specific conditions that were most often exclusion criteria were spondylolisthesis (n = 35, 21%), spinal stenosis (n = 31, 18%) or osteoporosis (n = 27, 16%). CONCLUSION: RCTs of interventions for non-specific low back pain have incorporated diverse inclusion and exclusion criteria. Guidance on standardisation of inclusion and exclusion criteria for nsLBP trials will increase clinical homogeneity, facilitating greater interpretation of between-trial comparisons and meta-analyses. We propose a template for reporting inclusion and exclusion criteria.

Quiet dissent: The attitudes, beliefs and behaviours of UK osteopaths who reject low back pain guidance - A qualitative study.

INTRODUCTION: Clinical guidelines are derived from best research evidence and aim to: improve quality of non-specific low back pain (nsLBP) management and identify patients at risk of suffering chronic pain. However, guideline discordant attitudes and beliefs have been identified in healthcare students and practitioners, including osteopaths. DESIGN: A qualitative approach with elements of grounded theory was used to explore underlying attitudes and beliefs of practitioners/students working in a British osteopathic education institution. All participants rejected guideline recommendations for managing nsLBP. A constant comparative method was used to code and analyse emergent themes from transcript data. SUBJECTS: Purposive sampling identified 5 clinic tutors and 7 students; all participated in semi-structured interviews. INTERPRETATION: Our central theme was a 'Precedence of Osteopathy' over medicine and other manual therapies. Three subthemes were: 1) beliefs about self; 2) perceptions of others; 3) attitudes to guidelines and research. CONCLUSION: Participants possess a strong professional identity fostered by their education. This bestows autonomy, authority and distinctness upon them. The central theme was modelled as a lens through which participants viewed research: the evidence pyramid appears inverted, explaining why participants value expert opinion above all other evidence. Guidelines and research are perceived to threaten professional identity. In contractual situations that oblige practitioners to follow guidelines management, perhaps reflecting a pragmatic response to health-care market forces, clinical practice is modified. Developing further understanding of osteopaths' attitudes and beliefs and behaviour in respect of evidence-based guidance in education is important to enhance the quality of clinical practice in osteopathy.

The Power of Low Back Pain Trials: A Systematic Review of Power, Sample Size, and Reporting of Sample Size Calculations Over Time, in Trials Published Between 1980 and 2012.

STUDY DESIGN: A systematic review of nonspecific low back pain trials published between 1980 and 2012. OBJECTIVE: To explore what proportion of trials have been powered to detect different bands of effect size; whether there is evidence that sample size in low back pain trials has been increasing; what proportion of trial reports include a sample size calculation; and whether likelihood of reporting sample size calculations has increased. SUMMARY OF BACKGROUND DATA: Clinical trials should have a sample size sufficient to detect a minimally important difference for a given power and type I error rate. An underpowered trial is one within which probability of type II error is too high. Meta-analyses do not mitigate underpowered trials. METHODS: Reviewers independently abstracted data on sample size at point of analysis, whether a sample size calculation was reported, and year of publication. Descriptive analyses were used to explore ability to detect effect sizes, and regression analyses to explore the relationship between sample size, or reporting sample size calculations, and time. RESULTS: We included 383 trials. One-third were powered to detect a standardized mean difference of less than 0.5, and 5% were powered to detect less than 0.3. The average sample size was 153 people, which increased only slightly (∼4 people/yr) from 1980 to 2000, and declined slightly (∼4.5 people/yr) from 2005 to 2011 (P < 0.00005). Sample size calculations were reported in 41% of trials. The odds of reporting a sample size calculation (compared to not reporting one) increased until 2005 and then declined (Equation is included in full-text article.). CONCLUSION: Sample sizes in back pain trials and the reporting of sample size calculations may need to be increased. It may be justifiable to power a trial to detect only large effects in the case of novel interventions. LEVEL OF EVIDENCE: 3.

A Systematic Review of Outcome Measures Use, Analytical Approaches, Reporting Methods, and Publication Volume by Year in Low Back Pain Trials Published between 1980 and 2012: Respice, adspice, et prospice.

BACKGROUND: Increasing patient-reported outcome measures in the 1980s and 1990s led to the development of recommendations at the turn of the millennium for standardising outcome measures in non-specific low back pain (LBP) trials. Whether these recommendations impacted use is unclear. Previous work has examined citation counts, but actual use and change over time, has not been explored. Since 2011, there has been some consensus on the optimal methods for reporting back pain trial outcomes. We explored reporting practice, outcome measure use, and publications over time. METHODS: We performed a systematic review of LBP trials, searching the European Guidelines for the management of LBP, extending the search to 2012. We abstracted data on publications by year, outcome measure use, analytical approach, and approaches taken to reporting trials outcomes. Data were analysed using descriptive statistics and regression analyses. RESULTS: We included 401 trials. The number of published trials per year has increased by a factor of 4.5 from 5.4 (1980-1999) to 24.4 (2000-2012). The most commonly used outcome measures have been the Visual Analogue Scale for pain intensity, which has slowly increased in use since 1980/81 from 20% to 60% of trials by 2012, and the Roland-Morris Disability Questionnaire, which rose to 55% in 2002/2003, and then fell back to 28% by 2012. Most trialists (85%) report between-group mean differences. Few (8%) report individual improvements, and some (4%) report only within-group analyses. Student's t test, ANOVA, and ANCOVA regression, or mixed models, were the most common approaches to analysis. CONCLUSIONS: Recommendations for standardising outcomes may have had a limited or inconsistent effect on practice. Since the research community is again considering outcome measures and modifying recommendations, groups offering recommendations should be cognisant that better ways of generating trialist buy-in may be required in order for their recommendations to have impact.

Myofascial techniques: What are their effects on joint range of motion and pain? - A systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: This systematic review aimed to determine the evidence for the effect of a single manually applied myofascial technique (MFT) on joint range of motion (JROM) and pain in non-pathological symptomatic subjects. METHODS: Authors independently searched the following databases: PEDro; Cochrane Library; NLM PubMed; EMBASE; Academic Search Premier; MEDLINE; Psychology and Behavioural Sciences Collection; PsycINFO; SPORTSDiscus; CINAHL Plus from 2003 to 2015. All randomised controlled trials (RCTs) that used JROM as an outcome measure were identified. RCT quality was independently evaluated using PEDro and Cochrane Risk of Bias tools and all reported outcome data were independently abstracted and presented. If post-intervention central tendencies and variance were reported, these were assessed for heterogeneity with a view to performing a meta-analysis. RESULTS: Nine RCTs (n = 534) were systematically reviewed and outcome data presented; all trials concluded that MFT increased JROM and reduced pain levels in symptomatic patients. Two RCTs (n = 161) were judged 'moderately' heterogeneous (I(2) = 47.2%; Cochran's Q = 5.69; p = 0.128, df = 3) and meta-analysis using a fixed effects model suggested a 'moderate' effect size of MFTs on jaw opening (ES = 0.578; 95%CI 0.302 to 0.853). CONCLUSION: Although results reported by each RCT indicate that MFT increases JROM and reduces pain scores, there are a number of threats that challenge the statistical inferences underpinning these findings. Only two trials could be meta-analysed, the results of which suggest that applying MFTs to symptomatic patients diagnosed with latent trigger-points in masseter muscle can increase jaw JROM.

Deep Vein Thrombosis and Pulmonary Embolism in a Mountain Guide: Awareness, Diagnostic Challenges, and Management Considerations at Altitude.

High intensity exercise is associated with several potentially thrombogenic risk factors, including dehydration and hemoconcentration, vascular trauma, musculoskeletal injuries, inflammation, long-distance travel, and contraceptive usage. These are well documented in case reports of venous thrombosis in track and field athletes. For mountaineers and those working at high altitude, additional risks exist. However, despite there being a high degree of vigilance for "classic" conditions encountered at altitude (eg, acute mountain sickness, high altitude pulmonary edema, and high altitude cerebral edema), mainstream awareness regarding thrombotic conditions and their complications in mountain athletes is relatively low. This is significant because thromboembolic events (including deep vein thrombosis, pulmonary embolism, and cerebral vascular thrombosis) are not uncommon at altitude. We describe a case of deep vein thrombosis and pulmonary embolism in a male mountain guide and discuss the diagnostic issues encountered by his medical practitioners. Potential risk factors affecting blood circulation (eg, seated car travel and compression of popliteal vein) and blood hypercoagulability (eg, hypoxia, environmental and psychological stressors [avalanche risk, extreme cold]) relevant to the subject of this report and mountain athletes in general are identified. Considerations for mitigating and managing thrombosis in addition to personalized care planning at altitude are discussed. The prevalence of thrombosis in mountain athletes is uncharted, but lowlanders increasingly go to high altitude to trek, ski, or climb. Blood clots can and do occur in physically active people, and thrombosis prevention and recognition will demand heightened awareness among participants, healthcare practitioners, and the altitude sport/leisure industry at large.

The effect of journal impact factor, reporting conflicts, and reporting funding sources, on standardized effect sizes in back pain trials: a systematic review and meta-regression.

BACKGROUND: Low back pain is a common and costly health complaint for which there are several moderately effective treatments. In some fields there is evidence that funder and financial conflicts are associated with trial outcomes. It is not clear whether effect sizes in back pain trials relate to journal impact factor, reporting conflicts of interest, or reporting funding. METHODS: We performed a systematic review of English-language papers reporting randomised controlled trials of treatments for non-specific low back pain, published between 2006-2012. We modelled the relationship using 5-year journal impact factor, and categories of reported of conflicts of interest, and categories of reported funding (reported none and reported some, compared to not reporting these) using meta-regression, adjusting for sample size, and publication year. We also considered whether impact factor could be predicted by the direction of outcome, or trial sample size. RESULTS: We could abstract data to calculate effect size in 99 of 146 trials that met our inclusion criteria. Effect size is not associated with impact factor, reporting of funding source, or reporting of conflicts of interest. However, explicitly reporting 'no trial funding' is strongly associated with larger absolute values of effect size (adjusted ß=1.02 (95 % CI 0.44 to 1.59), P=0.001). Impact factor increases by 0.008 (0.004 to 0.012) per unit increase in trial sample size (P<0.001), but does not differ by reported direction of the LBP trial outcome (P=0.270). CONCLUSIONS: The absence of associations between effect size and impact factor, reporting sources of funding, and conflicts of interest reflects positively on research and publisher conduct in the field. Strong evidence of a large association between absolute magnitude of effect size and explicit reporting of 'no funding' suggests authors of unfunded trials are likely to report larger effect sizes, notwithstanding direction. This could relate in part to quality, resources, and/or how pragmatic a trial is.

A systematic review and meta-synthesis of the impact of low back pain on people's lives.

BACKGROUND: Low back pain (LBP) is a common and costly problem that many interpret within a biopsychosocial model. There is renewed concern that core-sets of outcome measures do not capture what is important. To inform debate about the coverage of back pain outcome measure core-sets, and to suggest areas worthy of exploration within healthcare consultations, we have synthesised the qualitative literature on the impact of low back pain on people's lives. METHODS: Two reviewers searched CINAHL, Embase, PsycINFO, PEDro, and Medline, identifying qualitative studies of people's experiences of non-specific LBP. Abstracted data were thematic coded and synthesised using a meta-ethnographic, and a meta-narrative approach. RESULTS: We included 49 papers describing 42 studies. Patients are concerned with engagement in meaningful activities; but they also want to be believed and have their experiences and identity, as someone 'doing battle' with pain, validated. Patients seek diagnosis, treatment, and cure, but also reassurance of the absence of pathology. Some struggle to meet social expectations and obligations. When these are achieved, the credibility of their pain/disability claims can be jeopardised. Others withdraw, fearful of disapproval, or unable or unwilling to accommodate social demands. Patients generally seek to regain their pre-pain levels of health, and physical and emotional stability. After time, this can be perceived to become unrealistic and some adjust their expectations accordingly. CONCLUSIONS: The social component of the biopsychosocial model is not well represented in current core-sets of outcome measures. Clinicians should appreciate that the broader impact of low back pain includes social factors; this may be crucial to improving patients' experiences of health care. Researchers should consider social factors to help develop a portfolio of more relevant outcome measures.

Anatomical landmark position--can we trust what we see? Results from an online reliability and validity study of osteopaths.

BACKGROUND: Practitioners traditionally use observation to classify the position of patients' anatomical landmarks. This information may contribute to diagnosis and patient management. OBJECTIVES: To calculate a) Inter-rater reliability of categorising the sagittal plane position of four anatomical landmarks (lateral femoral epicondyle, greater trochanter, mastoid process and acromion) on side-view photographs (with landmarks highlighted and not-highlighted) of anonymised subjects; b) Intra-rater reliability; c) Individual landmark inter-rater reliability; d) Validity against a 'gold standard' photograph. DESIGN: Online inter- and intra-rater reliability study. SUBJECTS: Photographed subjects: convenience sample of asymptomatic students; raters: randomly selected UK registered osteopaths. METHODS: 40 photographs of 30 subjects were used, a priori clinically acceptable reliability was ≥0.4. Inter-rater arm: 20 photographs without landmark highlights plus 10 with highlights; Intra-rater arm: 10 duplicate photographs (non-highlighted landmarks). Validity arm: highlighted landmark scores versus 'gold standard' photographs with vertical line. Research ethics approval obtained. RATERS: Osteopaths (n = 48) categorised landmark position relative to imagined vertical-line; Gwet's Agreement Coefficient 1 (AC1) calculated and chance-corrected coefficient benchmarked against Landis and Koch's scale; Validity calculation used Kendall's tau-B. RESULTS: Inter-rater reliability was 'fair' (AC1 = 0.342; 95% confidence interval (CI) = 0.279-0.404) for non-highlighted landmarks and 'moderate' (AC1 = 0.700; 95% CI = 0.596-0.805) for highlighted landmarks. Intra-rater reliability was 'fair' (AC1 = 0.522); range was 'poor' (AC1 = 0.160) to 'substantial' (AC1 = 0.896). No differences were found between individual landmarks. Validity was 'low' (TB = 0.327; p = 0.104). CONCLUSION: Both inter- and intra-rater reliability was 'fair' but below clinically acceptable levels, validity was 'low'. Together these results challenge the clinical practice of using observation to categorise anterio-posterior landmark position.

What puts the adverse in 'adverse events'? Patients' perceptions of post-treatment experiences in osteopathy--a qualitative study using focus groups.

Patients commonly report mild to moderate effects following all forms of manual therapy. These are often regarded as adverse events by practitioners but there is limited evidence on how patients view their post-treatment experiences, and what meaning they ascribe to them. This qualitative study used three focus group discussions (19 participants) to explore osteopathic patients' perspectives; a framework approach was used to analyse the data. There were four emergent themes (and 23 sub-themes). Interpretative (level two) analysis of the data led to a conceptual model of meaning with four inter-related components: Expectations; Personal investment; Osteopathic encounter; Clinical change, under an overarching construct, the 'global osteopathic experience'. These four components, designated EPOC, can have a profound impact on a patient's post-treatment experiences and their perception of what is adverse. This model suggests there is disparity between patient perceptions and clinical definitions of adverse events; awareness by practitioners of this disparity is essential for effective clinical management.