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  • Can screening instruments accurately determine poor outcome risk in adults with recent onset low back pain? A systematic review and meta-analysis

    https://bmcmedicine.biomedcentral.co...916-016-0774-4

    Abstract

    Background
    Delivering efficient and effective healthcare is crucial for a condition as burdensome as low back pain (LBP). Stratified care strategies may be worthwhile, but rely on early and accurate patient screening using a valid and reliable instrument. The purpose of this study was to evaluate the performance of LBP screening instruments for determining risk of poor outcome in adults with LBP of less than 3 months duration.

    Methods
    Medline, Embase, CINAHL, PsycINFO, PEDro, Web of Science, SciVerse SCOPUS, and Cochrane Central Register of Controlled Trials were searched from June 2014 to March 2016. Prospective cohort studies involving patients with acute and subacute LBP were included. Studies administered a prognostic screening instrument at inception and reported outcomes at least 12 weeks after screening. Two independent reviewers extracted relevant data using a standardised spreadsheet. We defined poor outcome for pain to be ≥ 3 on an 11-point numeric rating scale and poor outcome for disability to be scores of ≥ 30% disabled (on the study authors' chosen disability outcome measure).

    Results
    We identified 18 eligible studies investigating seven instruments. Five studies investigated the STarT Back Tool: performance for discriminating pain outcomes at follow-up was ‘non-informative’ (pooled AUC = 0.59 (0.55–0.63), n = 1153) and ‘acceptable’ for discriminating disability outcomes (pooled AUC = 0.74 (0.66–0.82), n = 821). Seven studies investigated the Orebro Musculoskeletal Pain Screening Questionnaire: performance was ‘poor’ for discriminating pain outcomes (pooled AUC = 0.69 (0.62–0.76), n = 360), ‘acceptable’ for disability outcomes (pooled AUC = 0.75 (0.69–0.82), n = 512), and ‘excellent’ for absenteeism outcomes (pooled AUC = 0.83 (0.75–0.90), n = 243). Two studies investigated the Vermont Disability Prediction Questionnaire and four further instruments were investigated in single studies only.

    Conclusions
    LBP screening instruments administered in primary care perform poorly at assigning higher risk scores to individuals who develop chronic pain than to those who do not. Risks of a poor disability outcome and prolonged absenteeism are likely to be estimated with greater accuracy. It is important that clinicians who use screening tools to obtain prognostic information consider the potential for misclassification of patient risk and its consequences for care decisions based on screening. However, it needs to be acknowledged that the outcomes on which we evaluated these screening instruments in some cases had a different threshold, outcome, and time period than those they were designed to predict.

    Systematic review registration
    PROSPERO international prospective register of systematic reviews registration number CRD42015015778.
    Keywords

    Low back pain Screening Prognosis Risk Predictive validity




    Reliability and screening ability of the StarT Back screening tool in patients with low back pain in physiotherapy practice, a cohort study

    https://bmcmusculoskeletdisord.biome...891-017-1553-x

    Abstract

    Background
    Low back pain (LBP) is the most common reported musculoskeletal disorder, with large prevalence numbers and high costs. Focus on early identification of patients at risk of developing chronic LBP has increased. The Keele Start Back Tool (SBT) is a questionnaire aiming at screening prognostic indicators in LBP patients, categorizing patients into risk-groups and guide treatment. The aim of this study was to explore the Norwegian version of the SBT with regard to reliability of the SBT-scoring and the screening ability in LBP patients in primary care physiotherapy.

    Methods
    LBP patients answered a package of questionnaires twice, with 1-3 days in between, containing SBT, Hannover functional ability questionnaire, pain intensity questions and demographics. The relative and absolute reliability of SBT was calculated using intraclass correlation coefficient (ICC) and the smallest detectable change respectively. Independent sample t-tests were used for group comparisons.

    Results
    Fifty-two patients with LBP. Mean age (SD) was 45 (12) years and 62% were female. The ICC (95% CI) for SBT total score and psychosocial subscore was 0.89 (0.82, 0.94) and 0.82 (0.70, 0.90) respectively. None of the participants were allocated to the high risk group. The medium risk group reported significantly more pain last week and more activity limitations than the low risk group at both test and retest (0.001 ≤ p ≤ 0.003), whereas no significant difference between the groups was found on pain now (0.05 ≤ p ≤ 0.16).

    Conclusions
    The Norwegian version of the SBT was reliable and the screening ability was good as the subgrouping of patients into risk-groups reflected the severity of their back problems. The SBT may be an applicable and useful tool in physiotherapy practice.
    Keywords

    Low back pain Physical function Reliability Validity Test-retest Physiotherapy Primary health care Prognostic indicators

    Update 01/06/2017



    The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581)

    https://bmcmusculoskeletdisord.biome...891-017-1513-5

    Abstract

    Background
    Sciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of ‘wait and see’ for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care.

    Methods/Design
    Multicentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the acceptability of stratified care.

    Discussion
    This paper presents the details of the rationale, design and processes of the SCOPiC trial. Results from this trial will contribute to the evidence base for management of patients with sciatica consulting in primary care.
    Update 27/04/2017



    Associations between disc space narrowing, anterior osteophytes and disability in chronic mechanical low back pain: a cross sectional study

    https://bmcmusculoskeletdisord.biome...891-017-1562-9

    Abstract

    Background
    Radiographic features of lumbar disc degeneration (LDD) are common findings in patients with chronic mechanical low back pain; however, its role in disability and intensity of pain is debatable. This study aims to investigate the associations of the x-ray features of LDD and lumbar spondylolisthesis with severity of disability and intensity of pain.

    Methods
    A cross-sectional study was conducted on 439 patients with chronic mechanical low back pain who attended the rheumatology clinic, National Hospital of Sri Lanka, Colombo, from May 2012 to May 2014. Severity of disability was measured using Modified Oswestry Disability Index and intensity of pain was assessed using numeric rating scale (0–100). X-ray features of LDD (disc space narrowing, anterior osteophytes and overall LDD) and spondylolisthesis were assessed in lateral recumbent lumbar x-rays (L1/L2 to L5/S1) and graded by a consultant radiologist blinded to clinical data. Generalised linear model with linear response was used to assess the associations of x-ray features of LDD with severity of disability and intensity of pain adjusting for age, gender, body mass index and pain radiating into legs.

    Results
    Mean age was 48.99 ± 11.21 and 323 (73.58%) were females. 87 (19.82%) were obese. Mean severity of disability was 30.95 ± 13.67 and mean intensity of pain was 45.50 ± 20.37. 69 (15.72%), 26 (5.92%) and 85 (19.36%) patients had grade 2 disc space narrowing, anterior osteophytes and overall LDD, respectively. 51 (11.62%) patients had lumbar spondylolisthesis. Grade of disc space narrowing and overall LDD were not associated with severity of disability or intensity of pain. The presence of lumbar spondylolisthesis was associated with severity of disability. Female gender and pain radiating into legs were associated with severity of disability and intensity of pain. Advancing age was associated with x-ray features of LDD and lumbar spondylolisthesis.

    Conclusions
    Lumbar spondylolisthesis is associated with severity of disability in patients with chronic mechanical low back pain. Associations of x-ray features of LDD with severity of disability and intensity of pain are inconclusive. Female gender and pain radiating into legs are significant confounders.
    Keywords

    Disability Disc space narrowing Anterior osteophytes Low back pain Lumbar disc degeneration

    Update 16/05/2017
    Last edited by Jo Bowyer; 02-06-2017, 12:35 AM.
    Jo Bowyer
    Chartered Physiotherapist Registered Osteopath.
    "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

    Comment


    • Why traditional statistics are often “counterproductive to research the human sciences”

      http://retractionwatch.com/2017/02/0...uman-sciences/

      Doing research is hard. Getting statistically significant results is hard. Making sure the results you obtain reflect reality is even harder. In this week’s Science, Eric Loken at the University of Connecticut and Andrew Gelman at Columbia University debunk some common myths about the use of statistics in research — and argue that, in many cases, the use of traditional statistics does more harm than good in human sciences research.

      Retraction Watch: Your article focuses on the “noise” that’s present in research studies. What is “noise” and how is it created during an experiment?
      Jo Bowyer
      Chartered Physiotherapist Registered Osteopath.
      "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

      Comment


      • Shaun Treweek: Why is there growing hostility towards EBM?

        http://blogs.bmj.com/bmj/2017/02/09/...y-towards-ebm/
        Jo Bowyer
        Chartered Physiotherapist Registered Osteopath.
        "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

        Comment


        • Research led by participants: a new social contract for a new kind of research

          http://jme.bmj.com/content/42/4/216.long

          Abstract
          In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.
          Jo Bowyer
          Chartered Physiotherapist Registered Osteopath.
          "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

          Comment


          • Adjusted Analyses in Studies Addressing Therapy and Harm... Users’ Guides to the Medical Literature

            http://jamanetwork.com/journals/jama...stract/2603936

            Abstract
            Observational studies almost always have bias because prognostic factors are unequally distributed between patients exposed or not exposed to an intervention. The standard approach to dealing with this problem is adjusted or stratified analysis. Its principle is to use measurement of risk factors to create prognostically homogeneous groups and to combine effect estimates across groups.

            The purpose of this Users’ Guide is to introduce readers to fundamental concepts underlying adjustment as a way of dealing with prognostic imbalance and to the basic principles and relative trustworthiness of various adjustment strategies.

            One alternative to the standard approach is propensity analysis, in which groups are matched according to the likelihood of membership in exposed or unexposed groups. Propensity methods can deal with multiple prognostic factors, even if there are relatively few patients having outcome events. However, propensity methods do not address other limitations of traditional adjustment: investigators may not have measured all relevant prognostic factors (or not accurately), and unknown factors may bias the results.

            A second approach, instrumental variable analysis, relies on identifying a variable associated with the likelihood of receiving the intervention but not associated with any prognostic factor or with the outcome (other than through the intervention); this could mimic randomization. However, as with assumptions of other adjustment approaches, it is never certain if an instrumental variable analysis eliminates bias.

            Although all these approaches can reduce the risk of bias in observational studies, none replace the balance of both known and unknown prognostic factors offered by randomization.
            via @Eric Topol
            Jo Bowyer
            Chartered Physiotherapist Registered Osteopath.
            "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

            Comment


            • Bayesian prediction of placebo analgesia in an instrumental learning model

              http://journals.plos.org/plosone/art...l.pone.0172609

              Abstract

              Placebo analgesia can be primarily explained by the Pavlovian conditioning paradigm in which a passively applied cue becomes associated with less pain. In contrast, instrumental conditioning employs an active paradigm that might be more similar to clinical settings. In the present study, an instrumental conditioning paradigm involving a modified trust game in a simulated clinical situation was used to induce placebo analgesia. Additionally, Bayesian modeling was applied to predict the placebo responses of individuals based on their choices. Twenty-four participants engaged in a medical trust game in which decisions to receive treatment from either a doctor (more effective with high cost) or a pharmacy (less effective with low cost) were made after receiving a reference pain stimulus. In the conditioning session, the participants received lower levels of pain following both choices, while high pain stimuli were administered in the test session even after making the decision. The choice-dependent pain in the conditioning session was modulated in terms of both intensity and uncertainty. Participants reported significantly less pain when they chose the doctor or the pharmacy for treatment compared to the control trials. The predicted pain ratings based on Bayesian modeling showed significant correlations with the actual reports from participants for both of the choice categories. The instrumental conditioning paradigm allowed for the active choice of optional cues and was able to induce the placebo analgesia effect. Additionally, Bayesian modeling successfully predicted pain ratings in a simulated clinical situation that fits well with placebo analgesia induced by instrumental conditioning.
              According to the framework of predictive coding, the brain actively makes inferences based on prior experiences and expectations [17]. An inferential process in the brain is conceptualized as perception, in which information from prior experiences is used to generate expectations about future perception and to interpret sensory inputs [18]. Within the Bayesian theoretical and mathematical framework, the brain constantly interprets sensory inputs through the method of minimizing the average of prediction errors across the whole sensory system [19]. Thus, employing a Bayesian framework of brain function would benefit the current understanding of placebo analgesia in instrumental conditioning paradigms. Placebo analgesia is then regarded as a probabilistic integration between top-down expectations of prior pain and bottom-up sensory signals [17]; from this perspective, it is important to consider not only the averaged magnitude of previous pain experiences but also the precision of the constructed expectation. Recently, a computational investigation of pain supported the idea that the Bayesian model reflects the strategies used during pain perception by showing that modulation due to disparate factors is intrinsic to the pain process [20]. However, no studies have attempted to predict the placebo response during instrumental conditioning using such a predictive coding framework.
              Jo Bowyer
              Chartered Physiotherapist Registered Osteopath.
              "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

              Comment


              • No publication without confirmation

                http://www.nature.com/news/no-public...EwMzY4MzEwNQS2

                Concern over the reliability of published biomedical results grows unabated. Frustration with this 'reproducibility crisis' is felt by everyone pursuing new disease treatments: from clinicians and would-be drug developers who want solid foundations for the preclinical research they build on, to basic scientists who are forced to devote more time and resources to newly imposed requirements for rigour, reporting and statistics. Tightening rigour across all experiments will decrease the number of false positive findings, but comes with the risk of reducing experimental efficiency and creativity.

                Bolder ideas are needed. What we propose here is a compromise between the need to trust conclusions in published papers and the freedom for basic scientists to explore and innovate1. Our proposal is a new type of paper for animal studies of disease therapies or preventions: one that incorporates an independent, statistically rigorous confirmation of a researcher's central hypothesis. We call this large confirmatory study a preclinical trial. These would be more formal and rigorous than the typical preclinical testing conducted in academic labs, and would adopt many practices of a clinical trial.



                The seven deadly sins of statistical misinterpretation, and how to avoid them

                https://theconversation.com/the-seve...=twitterbutton

                Update 13/04/2017




                Increasing the reproducibility of science through close cooperation and forking path analysis

                http://journal.frontiersin.org/artic...017.01332/full

                Within multiple fields alarming reproducibility problems are now obvious to most: The majority of the reported effects are either false positives or the population effect size is much smaller than expected based on the initial studies (e.g. Baker, 2016; Button et al., 2013; Ioannidis, 2005; Nichols et al., 2017; Open Science Collaboration, 2015). Assuming that neither outright scientific fraud (Fanelli, 2009) nor severe deficits in methodological training are the norm, likely reasons for this inacceptable status quo include the following: (A) a high prevalence of severely underpowered studies (e.g. Button, 2013), (B) hypothesizing after results are known (HARKing; Kerr, 1998), (C) intentionally or unintentionally exploiting researcher degrees of freedom (Simmons et al., 2011) in data processing and analysis and thereby pushing the p-value of statistical tests below the conventional significance level without being transparent concerning all the variables and approaches that have been tried out (P-HACKING), and (D) selective reporting of research findings and publication bias. Several options for pre-registration of hypotheses are now readily available providing the opportunity to effectively prevent HARKing (e.g., OSF.io, AsPredicted.org). However, suggestions to address the other three issues have so far met with the following challenges:

                (A) A practical approach to promote cooperative data collection as the default approach in everyday scientific practice is lacking. Increasing sample sizes enough to ensure appropriate statistical power not only requires more financial resources, it is also more time-consuming. Investing more money per study to increase power is inevitable. However, for work involving restricted access to methodology and/or lengthy paradigms the time requirements may oftentimes make it undesirable or even impossible for individual researchers to conduct appropriately powered studies. Sharing the load of data collection among several labs is an obvious solution, albeit one that is currently mostly limited to large international consortia (e.g. Thompson et al., 2014).
                (B) A practical approach to systematically draw on the joint expertise of larger and more diverse groups of researchers in designing studies is currently lacking. Both selective reporting and publication bias can be quite effectively reduced by combining pre-registration of both hypotheses and all relevant details of the research design with a system of peer-review and in-principle acceptance for publication before data collection. However, this approach typically lays the burden of deciding for the most appropriate research design on a small number of authors from one work group. In addition, reviewers of research designs by authors within the same field may not always be optimally motivated to detect and correct potential design flaws, because they compete with these authors for grants and faculty positions.

                (C) A practical approach to maintaining flexibility in data analysis, while at the same time ensuring the absence of p-hacking and assessing the influence of various data processing and analysis decisions is currently lacking. The benefits of methodological guidelines, pre-registration of analysis steps, transparency, and open data are indisputable (Nosek et al., 2015). However, limiting researcher degrees of freedom through methodological guidelines and pre-registration of all processing/analysis steps comes at the price of reduced flexibility in adopting novel approaches and in dealing with unexpected data patterns. Especially for studies with large-scale data collections lasting for months or even years the requirement to stick to a pre-registered analysis plan may get into conflict with the desire to make reasonable adjustments according to recent methodological or empirical developments.
                Transparency concerning all variables assessed and all analysis decisions made may aid a highly motivated and/or specialized reader in identifying relevant researcher degrees of freedom (for a list of 34 researcher degrees of freedom see Wicherts et al., 2016). Furthermore, when this transparency principle is combined with open access to all relevant raw data, readers may even have the opportunity to verify hypotheses concerning the relevance of certain processing and analysis decisions for the final outcome. However, investing considerable amounts of time in probing an individual paper’s approach to the data is currently neither rewarded during the review process nor does it typically add much to the reputation of researchers. Under these circumstances and given the high rate of publication in most fields of empirical research it is likely that individual empirical papers will rarely receive the level of scrutiny necessary to identify relevant but undisclosed researcher degrees of freedom. Moreover, even a shattering critique of a highly visible paper may not receive sufficient attention to effectively avert other researchers from building their own work on the questionable results.

                To address these issues and to increase the reproducibility of scientific findings in multiple fields cooperative forking path analysis (cFPA) studies may be a useful scientific standard for empirical research. cFPA studies may be complemented by open access to data, pre-registration of hypotheses, and in-principle acceptance before data collection and they adhere to the following five principles:

                COOPERATIVE. cFPA studies are conducted in teams consisting of researchers from different laboratories that agree on a set of research questions and have access to laboratory equipment allowing them to produce relevant data in a sufficiently similar format. Members of a cFPA team work jointly on all steps of scientific research from specifying the research questions to writing up the final report. Teams are formed informally aided by (online) social networks and aiming to maximize the diversity of theoretical and methodological preferences while maintaining a constructive and rewarding work atmosphere. Shared authorship of all team members on grant proposals and papers with first authorship of the person who initially proposed the general idea, initiated the collaborative endeavour, and took the lead writing (both the grant proposal and) the manuscript may often be a useful ground rule.

                AGREED-UPON DESIGN. cFPA teams openly and thoroughly discuss (in person or in an online forum) and then agree upon a precise formulation of all research hypotheses and all specific features of the research design relevant to data collection. Whenever an agreement cannot be reached, the team goes through with the majority vote while all minority votes are documented along with the names of the team members supporting them. The final version of the agreed-upon design is summarized as a sufficiently detailed guideline to direct data collection within each of the laboratories. Minority votes are inserted as footnotes in the appropriate sections of the guidelines and the guidelines are published as online supplementary methods.

                MULTICENTER. cFPA teams share the load of data collection equally among laboratories with each laboratory contributing at least enough data to achieve sufficient statistical power (e.g. 1-beta = .80) to detect a “large” effect (e.g. r = .50) with the conventional criterion of alpha = .05. Total sample size (and thus the minimum number of contributing laboratories) is determined such that high statistical power (> .95) is achieved for a conservative estimate of the population effect size of interest, which will usually not exceed the average size of replication effects in a given field (e.g., r = .20 in Psychology, see Open Science Collaboration, 2015). All data are converted to an equivalent format and then integrated into a single data file including laboratory identifiers and information on all potentially relevant variables that vary across laboratories before all analyses.

                SCRIPTED PROCESSING AND ANALYSIS. All processing and analysis steps from the raw data to the tables and figures in the final publication are fully automatized and do not require any user intervention apart from starting the respective routines. Whenever possible this is done with open source software and algorithms to ensure complete transparency at every step (for examples from neuroimaging literature see Waskom et al., 2014; Whitaker et al., 2016).

                FORKING PATHS ANALYSIS. cFPA teams openly and thoroughly discuss every single step in data processing and analysis aiming to identify as many defensible alternative approaches as possible while taking votes on which approach should be used in the present study. If necessary, this may be facilitated by collectively working with a representative subsample of data randomly drawn from each of the contributors and together amounting to the sample size collected by a single lab; in that case, data from the subsample used to establish analysis procedures is not included in the final analysis, but should either be made openly available or analysed separately in a supplement. Each defensible processing and analysis approach is scripted (preferably in open source code). This process continues until all forking analysis paths arrive at their final statistical test of the effect of interest. [Note that even with relatively complex fMRI methods the number of defensible alternative statistical tests for a given effect of interest does not seem to exceed 35.000 (Carp, 2012).] The one path consisting of the processing and analysis steps that the majority of the cFPA team agreed upon (and that includes appropriate tests of and controls for inter-laboratory variance) is then flagged as the result to be written up for publication. However, along with this result the relative frequency of defensible processing and analysis paths leading to the same significant finding is reported. Also, the most influential processing and analysis decisions are labelled, for instance, with a beta weight indicating the degree to which the final effect size changed due to the respective analysis decision and with the level of agreement among the team members. The complete table of effect size beta weights and non-anonymous vote counts could be published as a supplement.

                cFPA studies bear at least the following advantages:

                Reduced likelihood of fraud and questionable research practices. The level of social control inherent in having several laboratories cooperate for data collection and analysis helps to reduce the likelihood of fraud and questionable research practices. Also, the conception of science as a fundamentally cooperative process may run a lower risk of attracting individuals motivated more by narcissistic motives (e.g. outshining others with a stream of baffling ideas and findings) rather than gaining knowledge.

                Increased statistical power. cFPA studies aim for sample sizes at least ten times the sample size of a study with sufficient statistical power only for large effects within the same time frame. The resulting reduction in the percentage of severely underpowered studies would lead to a decrease in the likelihood of false positive findings and to less exaggerated effect size estimates (Loken & Gelman, 2017). Also, because larger samples cost more, fewer but larger studies would be conducted if the cFPA principles were widely adopted, which could ultimately lessen the burden on (grant) reviewers and readers trying to keep track of the relevant literature in their field.

                Facilitated identification of best practices. Publications of cFPA studies routinely include a systematic assessment of inter-laboratory variance and (if this variance component is significant) of the influence of specific differences across labs (e.g. laboratory equipment) that may explain part of this variance. The consensual data processing and analysis approach as well as the most influential decisions concerning single steps in the stream are documented in a highly accessible fashion. These features could aid considerably in identifying best practices of data acquisition, processing and analysis, and they are formative for research in the field.

                Facilitated direct replications. The requirement to devise highly specific data collection guidelines that are later published as supplementary material along with the research findings will facilitate direct replications.

                Facilitated assessment of reproducibility. Final processing and analysis paths containing one or even more nodes with extremely high beta weights for standardized changes in effects sizes due to methodological choices (especially ones that were controversial within the group) may aid in identifying reproducibility issues.

                Facilitated and more focused communication on relevant methodological issues. The requirement to conduct expert discussions among individuals with diverse views for both planning the study and processing/analysing the data will foster communication on important methodological issues, helping to disseminate superior methodological innovations and standards more quickly (especially if these discussions were integrated as new formats in scientific conferences).

                For these reasons it seems that multiple areas of empirical science could benefit considerably from doing more cFPA studies. The principles described here may be instrumental in reducing waste of research efforts in a wide range of contexts ranging from low-cost collaborative student projects to large collaborative research projects with substantial funding.
                Update 21/07/2017
                Last edited by Jo Bowyer; 21-07-2017, 11:18 PM.
                Jo Bowyer
                Chartered Physiotherapist Registered Osteopath.
                "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

                Comment


                • In search for the fountain of youth, a lesson in doing good science

                  https://www.statnews.com/2017/02/22/...e-replication/

                  The study promised to be a big step toward cracking the code of aging: In 2000, scientists reported that giving roundworms a compound that blunted the effects of oxygen on their cells could boost their lifespans by 44 percent. After publishing their paper in Science, team leader Gordon Lithgow recalls, “We felt our work had moved the field on into seriously thinking about chemical slowing of aging.”

                  But soon after, they started getting phone calls from another lab. Researchers led by David Gems at University College London couldn’t get the same results, no matter what they tried. And in 2003, they published a paper saying so.

                  That dashing of hopes was “exceedingly disappointing,” Lithgow tells STAT.

                  But the story has a happy ending, one that illustrates the way science works best. The experience jolted Lithgow to join with researchers around the United States to standardize testing of potential anti-aging compounds in roundworms. That project, known as the Caenorhabditis Intervention Testing Program (CITP), has led to its first results published this week: that, in carefully controlled side-by-side testing, most “fountain-of-youth” chemicals gave mixed results at best, but one drug did in fact extend the worms’ lifespan.
                  So Lithgow’s lab at the Buck Institute in Novato, Calif., catalyzed the beginnings of the CITP, joining forces with a lab at Rutgers and another at the University of Oregon to test 21,000 worms from 22 strains, just to see whether their lifespans — untreated — were consistent.

                  They weren’t. The lifespans of roundworms turn out to vary greatly, even within labs. In fact, the largest variation was when the same researchers repeated experiments. Suddenly, it made sense that testing the same compound on what seemed like the same worms would lead to a different result: The worms weren’t identical after all.

                  Armed with that information, Lithgow and his colleagues started doing things differently, making sure they were working on the same strains of worm, and under the same conditions. They bought identical incubators, all from the same source. They worried about whether the heat from the lamps in their microscopes would affect results. “For quite a while, one of the three labs appeared to be an outlier with three days’ difference in lifespan,” Lithgow said. “Then one day on a conference call someone said, ‘Wait a minute, you call Day 1 the egg stage? We call Day 1 the first day of adulthood.’ That solved that particular mystery.”
                  And this week, in Nature Communications, they reported that they were able to extend lifespan consistently, in all strains, across all their various labs, with a compound called Thioflavin T.
                  But the lessons of this project are less about a particular anti-aging compound, and more about how to do reproducible science.

                  Courtesy of the CITP experience, Lithgow said, “I think we know a lot more about how to standardize experiments and to document what we are doing. We also know that building replication into the experiment (including multiple labs) helps a lot when trying to interpret the emerging data.”

                  That’s not the way most science is done now; replication tends to be seen as something that happens after publication, if it’s done at all. That’s changing, at least in some labs. And replication has taken more prominence in recent projects in psychology and cancer biology, albeit after publication.

                  As those projects are showing, then, the worms of science turn slowly — but they do turn.



                  ‘Replication grants’ will allow researchers to repeat nine influential studies that still raise questions

                  http://www.sciencemag.org/news/2017/...et_cid=1434352

                  Replication grants are badly needed!
                  Last edited by Jo Bowyer; 12-07-2017, 12:28 PM.
                  Jo Bowyer
                  Chartered Physiotherapist Registered Osteopath.
                  "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

                  Comment


                  • The Neural Correlates of Humor Creativity

                    http://journal.frontiersin.org/artic...016.00597/full

                    Unlike passive humor appreciation, the neural correlates of real-time humor creation have been unexplored. As a case study for creativity, humor generation uniquely affords a reliable assessment of a creative product’s quality with a clear and relatively rapid beginning and end, rendering it amenable to neuroimaging that has the potential for reflecting individual differences in expertise. Professional and amateur “improv” comedians and controls viewed New Yorker cartoon drawings while being scanned. For each drawing, they were instructed to generate either a humorous or a mundane caption. Greater comedic experience was associated with decreased activation in the striatum and medial prefrontal cortex (mPFC), but increased activation in temporal association regions (TMP). Less experienced comedians manifested greater activation of mPFC, reflecting their deliberate search through TMP association space. Professionals, by contrast, tend to reap the fruits of their spontaneous associations with reduced reliance on top-down guided search.

                    Introduction
                    A handful of studies have recently begun exploring the neural correlates of creativity, with tasks ranging from narrative generation (Howard-Jones et al., 2005) to jazz improvisation (Limb and Braun, 2008) to creative drawing (Schlegel et al., 2015). Unfortunately, the cortical regions reported by the various studies to be associated with “creativity” were as diverse as the tasks employed, save for the often observed involvement of the prefrontal cortex (Dietrich and Kanso, 2010). It has been suggested that activation of the medial prefrontal cortex (mPFC) and a deactivation of the dorsolateral prefrontal cortex (dlPFC) were the hallmarks of creative processing, along with regions associated with the particular type of creative task (e.g., Limb and Braun, 2008; Liu et al., 2012, 2015). However, a one-dimensional comparison between creative and non-creative control conditions (e.g., jazz improvisation vs. playing from memory; Limb and Braun, 2008) may be inadequate for revealing the roles played by different brain regions in a creative endeavor, as it can only reveal a set of regions, typically unsurprising (e.g., visual regions for book cover design, Ellamil et al., 2012; language regions for poetry composition, Liu et al., 2015), associated with a particular creative task (as well as, commonly, the mPFC). Exploring two additional dimensions of a creative domain can further enhance its value as a testbed for the study of creativity: quality and expertise. With humor, the quality of the creative product (i.e., funniness) can be easily evaluated by a spontaneous laugh as well as a readily generated judgment. Although the laugh reflects a subjective state, it is one that is readily accessible for ratings and typically has high agreement across individuals. Unlike the study of passive humor appreciation (e.g., Goel and Dolan, 2001; Watson et al., 2007; Samson et al., 2008; Chan et al., 2013; Vrticka et al., 2013; Amir et al., 2015), the rarity and spontaneous origin of humor creation have rendered that domain an unlikely target of fMRI investigation (Martin, 2010). To meet this challenge, we recruited professional “improv” comedians who routinely generate humorous ideas rapidly and on cue.

                    Previous studies of creativity rarely examined expertise effects, since often the tasks have no experts, e.g., generate alternative uses of objects, and others would be too challenging for a control group, e.g., improvise jazz. Imaging studies comparing experts to non-experts are typically limited to perceptual/technical judgments requiring no creativity (e.g., Calvo-Merino et al., 2005; Kirk et al., 2009). Generating humorous ideas, however, is a task nearly anyone can attempt, and participants with different levels of expertise/talent can be identified. Thus far, only the acts of poetry composition and creative drawing have been studied with the aim of determining the neural correlates of both quality and expertise (Liu et al., 2015; Schlegel et al., 2015). Finally, a humorous creation based on a particular stimulus—a captionless cartoon in the present study–affords a natural and tighter control than most creativity studies: the generation of a mundane statement that would be appropriate for the same cartoon drawing. Such a control allows a distinction between standard problem solving and creative thinking (Mednick, 1962).
                    Jo Bowyer
                    Chartered Physiotherapist Registered Osteopath.
                    "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

                    Comment


                    • When does animal research become unnecessary and cruel? A paper’s methods give a biologist pause

                      http://retractionwatch.com/2017/02/2...ologist-pause/
                      Jo Bowyer
                      Chartered Physiotherapist Registered Osteopath.
                      "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

                      Comment


                      • Maintaining primacy of the patient perspective in the development of patient-centered patient reported outcomes

                        http://journals.plos.org/plosone/art...l.pone.0171114

                        Abstract

                        The objectives of this study were to describe and demonstrate a new model of developing patient reported outcomes (PROs) that are patient-centered, and to test the hypothesis that following this model would result in a qualitatively different PRO than if the typical PRO development model were followed. The typical process of developing PROs begins with an initial list of signs or symptoms originating from clinicians or PRO developers; patient validation of this list ensures that the list (i.e., the new PRO) is interpretable by patients, but not that patient perspectives are central or even represented. The new model begins with elicitation from clinicians and patients independently and separately. These perspectives are formally analyzed qualitatively, and the results are iteratively integrated by researchers, supporting clinical relevance and patient centeredness. We describe the application of this new model to the development of a PRO for urinary signs and symptoms in individuals with neuropathic bladder, and test the hypothesis that the two processes generate qualitatively different instruments using a national validation sample of 300 respondents. Of its 29 items, the new instrument included 13 signs/symptoms derived from existing clinical practice guidelines, with 16 others derived from the patient/focus groups. The three most-endorsed items came from the patients, and the three least-endorsed items came from clinical guidelines. Thematic qualitative analysis of the elicitation process, as well as the results from our national sample, support the conclusion that the new model yields an instrument that is clinically interpretable, but more patient-centered, than the typical model would have done in this context.


                        Patient-defined desired outcome, success criteria, and expectation in outpatient physical therapy: a longitudinal assessment

                        https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5282693/

                        Abstract
                        Background

                        Patient-centered approaches offer an alternative method in evaluating treatment outcomes. This study investigated; 1) if patient’s criteria for success (satisfaction of clinical outcomes) changes from pre to post treatment, 2) whether patients who met their success criteria also meet minimal clinical important difference scores (MCIDs), and 3) if patient’s success criteria differed from their expected (what the patient believes will occur) and desired (what the patient wants to occur) outcomes following intervention.

                        Methods

                        A consecutive sample of 225 subjects with complaints of musculoskeletal pain was referred to an outpatient, sports medicine physical therapy clinic. Participants completed the Patient Centered Outcome Questionnaire (PCOQ) prior to their initial evaluation session and a follow-up PCOQ at discharge. The PCOQ asks subjects to rate their pain, fatigue, emotional distress, and interference with daily activities for usual, desired, successful, and expected levels, and how important improvement is for each domain on a 101-point numerical rating scale. Paired-sample T-test were used to determine patient’s pre and post success criterion and whether success criteria differed from desired and expected outcomes following intervention. Chi-squared were used to determine if individuals desired, expected, and success criteria for treatment outcome differed from established MCIDs.

                        Results

                        The results revealed no change in success criteria pre to post treatment for all domains. Chi-square test revealed patients desired, expected, and success criteria were independent of established MCIDs (P > .01). There were no differences between patients expected outcomes and success criteria. However, there were differences between patient’s desired outcomes and expected and success outcomes, with patients reporting lower desired levels of pain, emotional distress, fatigue, and interference with daily activities following physical therapy intervention (P < .01).

                        Conclusion

                        Patients in this setting do not appear to modify their success criteria throughout the course of outpatient physical therapy. Additionally, individually defined success criterion differs from established clinically important changes. Clinicians interested in a broader assessment of outcome need to consider patient determined criterion in addition MCIDs. Furthermore, desired outcomes are lower than both expectation and success criteria. In this setting, outcomes following physical therapy episodes were likely to meet patient’s expectations and success criteria but not desired criterion.
                        Update 18/04/2017



                        Expectations of pain and functioning in patients with musculoskeletal disorders: a cross-sectional study

                        https://bmcmusculoskeletdisord.biome...891-016-1386-z

                        Abstract

                        Background
                        Research has suggested that patient expectations are associated with treatment outcome and evolve along with patient communication within the musculoskeletal field. However, few studies have investigated if or how physical medicine and rehabilitation (PMR) consultations affect the attending patients’ expectations regarding pain and functional improvement. Hence, the aims of the present study were to compare patient expectations regarding pain and functional improvement before and after a PMR consultation and to assess patient characteristics, including diagnosis, that could perhaps predict changes in expectations.

                        Methods
                        The study design was cross-sectional. Eligible participants were first-time patients with neck/back or shoulder complaints who were referred to a PMR outpatient clinic between January and June 2013. Questionnaires (the Patient Shoulder Outcome Expectancies, or PSOE, questionnaire and a numeric rating scale, or NRS) focused on expectations regarding pain and functioning were completed immediately prior to and after a consultation with a PMR specialist.

                        Results
                        In total, 257 patients were included. In total, 24% of the subjects expected a more positive outcome after the PMR consultation compared with before the consultation, while 10% of the subjects exhibited a negative change in expectations. Few patient characteristics other than sick leave were associated with changes in expectations; however, patients with shoulder complaints seemed to be more optimistic than patients with neck/back complaints.

                        Conclusion
                        Expectations can be influenced by a single specialist consultation. Among clinical prognostic factors, only sick leave influenced the change expectations. However, patients with shoulder complaints seemed to be more optimistic than patients with neck/back complaints.
                        Background

                        An expectation can be defined as “a person’s subjective opinion about an outcome” [1]. From a medical perspective, many symptoms and diagnoses are often accompanied by expectations about the medical complaint, the subsequent treatment [2], and the prognosis and outcome [3]. Expectations are typically individual and heterogeneous. However, conceptualized categories such as socioeconomic background [4], previous health experiences [5], personality and emotional distress [6] and musculoskeletal pain [7] can affect expectations.

                        Patient expectations are notable for several reasons, but predominantly due to the suggested association with treatment outcomes [8]. This relationship is mainly observed within the musculoskeletal field in patients with low back pain [9], neck pain [10] and shoulder pain [8]. In a systematic review by Mondloch et al., positive treatment expectations were associated with improved health outcomes in 15 of 16 studies [11]. Unrealistic expectations, whether high or low, are suggested to negatively influence outcomes [12]. This concept has inspired hypotheses regarding clinical utilizations of expectations, e.g., as described by Mondloch et al. [11] and Myers et al. [13], suggesting that adjustments of negative, unrealistic and/or non-beneficial expectations [14] could improve outcomes [9]. However, few clinical trials have examined these hypotheses. Mancuso and coworkers [15] attempted to modify expectations in a randomized controlled trial (RCT), and their results suggested that expectations are adjustable. This trial was, however, a surgical trial, so the results may be less applicable to conservative approaches [16]. Additionally, in a systematic review of patient-physician relationships, ten of the 19 included studies demonstrated that positively enhancing patient expectations significantly improved health outcomes [17]. However, this review did not specifically target musculoskeletal patients or expectations specifically regarding pain and functioning.

                        Furthermore, patient expectations have been noted to be relevant in patient communication, especially in reducing misunderstanding [18], increasing satisfaction [19] and encouraging shared decision making [20]. Patients with musculoskeletal conditions with pain and functional complaints have been shown to require careful provision of information [21], and the inclusion of a discussion of expectations in clinical consultations could be useful for further improvement of patient communication and care. Health care professionals have been shown to have a strong influence on patient attitudes and beliefs [22], and it is likely that the dialog during a consultation can influence patient expectations. Finally, little is known about how expectations vary among different patient groups, and we were unable to find literature comparing different joint conditions within the musculoskeletal system in this context.

                        The aims of the present study were to compare expectations regarding pain and function before and after a consultation with a physical medicine and rehabilitation (PMR) physician and to assess whether changes in expectations varied among patients with neck/back or shoulder complaints, and/or were associated with patient characteristics.
                        17/05/2017
                        Last edited by Jo Bowyer; 17-05-2017, 05:43 PM.
                        Jo Bowyer
                        Chartered Physiotherapist Registered Osteopath.
                        "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

                        Comment


                        • Cervical traction therapy with and without neck support: A finite element analysis

                          http://www.mskscienceandpractice.com...Rehabilitation

                          Highlights

                          •This study analyzed the biomechanics of two cervical traction therapies.

                          •Tension was uniformly distributed from C4-C6 with neck support.

                          •Tension was uniformly distributed at the C6-C7 levels without neck support.

                          •The intradiscal pressure decreased during both traction therapies.
                          Abstract
                          Background
                          Cervical traction is commonly used for treating neck pain. However, few studies have investigated the biomechanical impact such traction has on soft tissues.

                          Objectives
                          To analyze the biomechanics of cervical traction therapy in a supine position with and without neck support (NS and non-NS).

                          Methods
                          A finite element model of the cervical spine was constructed to investigate the mechanism behind cervical traction therapy. An axial traction force of 100-N was loaded on the upper surface of C0 to simulate traction weight. Neck support traction was simulated by additionally constraining anterior-posterior motion of the surface of the C4 vertebral lamina. The average von Mises stress, tensile force and motions of related tissues were calculated and compared between the two conditions. Stress in the posterior annulus fibers under flexion was also recorded for comparison.

                          Results
                          At the C4-C5 and C5-C6 levels, NS traction resulted in less of a decrease in the lordotic angle. At these levels, the highest average stress was distributed in the posterior annulus fibers with non-NS traction and both traction therapies produced greater stress on the posterior annulus fibers than physical flexion. The intradiscal pressure in all intervertebral discs between C4-T1 decreased during both traction therapies.

                          Conclusion
                          Neck support traction therapy produced less tension on the posterior annulus fibers and ligaments posterior to it at the C4-C5 and C5-C6 levels. In order to minimize the potential harm to soft tissue in clinical practice, it may be beneficial to use a neck support according to the targeted level.
                          Keywords:
                          Neck pain, Traction therapy, Finite element analysis, Cervical spine
                          Jo Bowyer
                          Chartered Physiotherapist Registered Osteopath.
                          "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

                          Comment


                          • TISSUE CHANGES AND PAIN: EXPLAINING THEIR RELEVANCE

                            http://www.greglehman.ca/blog/2017/3...heir-relevance

                            via @TaylorAlanJ
                            Jo Bowyer
                            Chartered Physiotherapist Registered Osteopath.
                            "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

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