Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care : Back Skills Training Trial

Background Low back pain (LBP) is a major public health problem. Risk factors for the development and persistence of LBP include physical and psychological factors. However, most research activity has focused on physical solutions including manipulation, exercise training and activity promotion. Methods/Design This randomised controlled trial will establish the clinical and cost-effectiveness of a group programme, based on cognitive behavioural principles, for the management of sub-acute and chronic LBP in primary care. Our primary outcomes are disease specific measures of pain and function. Secondary outcomes include back beliefs, generic health related quality of life and resource use. All outcomes are measured over 12 months. Participants randomised to the intervention arm are invited to attend up to six weekly sessions each of 90 minutes; each group has 6–8 participants. A parallel qualitative study will aid the evaluation of the intervention. Discussion In this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain

Target for improvement: a cluster randomised trial of public involvement in quality-indicator prioritisation (intervention development and study protocol)

<p>Abstract</p> <p>Background</p> <p>Public priorities for improvement often differ from those of clinicians and managers. Public involvement has been proposed as a way to bridge the gap between professional and public clinical care priorities but has not been studied in the context of quality-indicator choice. Our objective is to assess the feasibility and impact of public involvement on quality-indicator choice and agreement with public priorities.</p> <p>Methods</p> <p>We will conduct a cluster randomised controlled trial comparing quality-indicator prioritisation with and without public involvement. In preparation for the trial, we developed a 'menu' of quality indicators, based on a systematic review of existing validated indicator sets. Participants (public representatives, clinicians, and managers) will be recruited from six participating sites. In intervention sites, public representatives will be involved through direct participation (public representatives, clinicians, and managers will deliberate together to agree on quality-indicator choice and use) and consultation (individual public recommendations for improvement will be collected and presented to decision makers). In control sites, only clinicians and managers will take part in the prioritisation process. Data on quality-indicator choice and intended use will be collected. Our primary outcome will compare quality-indicator choice and agreement with public priorities between intervention and control groups. A process evaluation based on direct observation, videorecording, and participants' assessment will be conducted to help explain the study's results. The marginal cost of public involvement will also be assessed.</p> <p>Discussion</p> <p>We identified 801 quality indicators that met our inclusion criteria. An expert panel agreed on a final set of 37 items containing validated quality indicators relevant for chronic disease prevention and management in primary care. We pilot tested our public-involvement intervention with 27 participants (11 public representatives and 16 clinicians and managers) and our study instruments with an additional 21 participants, which demonstrated the feasibility of the intervention and generated important insights and adaptations to engage public representatives more effectively. To our knowledge, this study is the first trial of public involvement in quality-indicator prioritisation, and its results could foster more effective upstream engagement of patients and the public in clinical practice improvement.</p> <p>Trial registration</p> <p><a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2496">NTR2496</a> (Netherlands National Trial Register, <url>http://www.trialregister.nl</url>).</p

Optimising the use of caesarean section: a generic formative research protocol for implementation preparation

BACKGROUND: Caesarean section rates are rising across all geographical regions. Very high rates for some groups of women co-occur with very low rates for others. Both extremes are associated with short and longer term harms. This is a major public health concern. Making the most effective use of caesarean section is a critical component of good quality, sustainable maternity care. In 2018, the World Health Organization published evidence-based recommendations on non-clinical interventions to reduce unnecessary caesarean section. The guideline identified critical research gaps and called for formative research to be conducted ahead of any interventional research to define locally relevant determinants of caesarean birth and factors that may affect implementation of multifaceted optimisation strategies. This generic formative research protocol is designed as a guide for contextual assessment and understanding for anyone planning to take action to optimise the use of caesarean section. METHODS: This formative protocol has three main components: (1) document review; (2) readiness assessment; and (3) primary qualitative research with women, healthcare providers and administrators. The document review and readiness assessment include tools for local mapping of policies, protocols, practices and organisation of care to describe and assess the service context ahead of implementation. The qualitative research is organized according to twelve identified interventions that may optimise use of caesarean section. Each intervention is designed as a "module" and includes a description of the intervention, supporting evidence, theory of change, and in-depth interview/focus group discussion guides. All study instruments are included in this protocol. DISCUSSION: This generic protocol is designed to underpin the formative stage of implementation research relating to optimal use of caesarean section. We encourage researchers, policy-makers and ministries of health to adapt and adopt this design to their context, and share their findings as a catalyst for rapid uptake of what works

Large expert-curated database for benchmarking document similarity detection in biomedical literature search

Document recommendation systems for locating relevant literature have mostly relied on methods developed a decade ago. This is largely due to the lack of a large offline gold-standard benchmark of relevant documents that cover a variety of research fields such that newly developed literature search techniques can be compared, improved and translated into practice. To overcome this bottleneck, we have established the RElevant LIterature SearcH consortium consisting of more than 1500 scientists from 84 countries, who have collectively annotated the relevance of over 180 000 PubMed-listed articles with regard to their respective seed (input) article/s. The majority of annotations were contributed by highly experienced, original authors of the seed articles. The collected data cover 76% of all unique PubMed Medical Subject Headings descriptors. No systematic biases were observed across different experience levels, research fields or time spent on annotations. More importantly, annotations of the same document pairs contributed by different scientists were highly concordant. We further show that the three representative baseline methods used to generate recommended articles for evaluation (Okapi Best Matching 25, Term Frequency–Inverse Document Frequency and PubMed Related Articles) had similar overall performances. Additionally, we found that these methods each tend to produce distinct collections of recommended articles, suggesting that a hybrid method may be required to completely capture all relevant articles. The established database server located at https://relishdb.ict.griffith.edu.au is freely available for the downloading of annotation data and the blind testing of new methods. We expect that this benchmark will be useful for stimulating the development of new powerful techniques for title and title/abstract-based search engines for relevant articles in biomedical research

Novel order patterns recurrence plot-based quantification measures to unveil deterministic dynamics from stochastic processes

Forbidden ordinal patterns are known to be useful to discriminate between chaotic and stochastic systems. However, while uncorrelated noise can be separated from deterministic signals using forbidden ordinal patterns, correlated noise exhibits apparently forbidden ordinal patterns, which can impede distinguishing noise from chaos. Here, we introduce order patterns recurrence plots to visualise the difference among deterministic chaotic systems, and stochastic systems of uncorrelated and correlated noise. In an order pattern plot of a chaotic system with an optimal embedding dimension, the diagonal lines remain preserved, while uncorrelated noise shows up as thinly isolated dots and correlated noise forms clusters. We propose two measures, the mean and the median of relative frequencies of order patterns that appear in a time series to distinguish those dynamics. The effectiveness of the two measures is analysed using bifurcation diagrams of the logistic map, the tent map, the delayed logistic map and the Hénon map. Our results show, that both, the mean and the median, distinguish chaos from quasiperiodicity in the delayed logistic map. The mean of relative frequencies of order pattern is reciprocal to the number of order patterns that occur in a given time series and thus can be a measure of forbidden structures—which becomes unbounded. While the mean is robust to the change of parameters in the bifurcation diagrams, the median exhibits sensitive changes, which is significant to characterise chaotic signals