Paper 3: Selecting rapid review methods for complex questions related to health policy and system issues

Approaches for rapid reviews that focus on streamlining systematic review methods are not always suitable for exploring complex policy questions, as developing and testing theories to explain these complexities requires configuring diverse qualitative, quantitative, and mixed methods studies. Our objective was therefore to provide a guide to selecting approaches for rapidly (i.e., within days to months) addressing complex questions related to health policy and system issues. We provide a two-stage, transdisciplinary collaborative process to select a rapid review approach to address complex policy questions, which consists of scoping the breadth and depth of the literature and then selecting an optimal approach to synthesis. The first stage (scoping the literature) begins with a discussion with the stakeholders requesting evidence to identify and refine the question for the review, which is then used to conduct preliminary searches and conceptually map the documents identified. In the second stage (selection of an optimal approach), further stakeholder consultation is required to refine and tailor the question and approach to identifying relevant documents to include. The approach to synthesizing the included documents is then guided by the final question, the breadth and depth of the literature, and the time available and can include a static or evolving conceptual framework to code and analyze a range of evidence. For areas already covered extensively by existing systematic reviews, the focus can be on summarizing and integrating the review findings, resynthesizing the primary studies, or updating the search and reanalyzing one or more of the systematic reviews. The choice of approaches for conducting rapid reviews is intertwined with decisions about how to manage projects, the amount of work to be done, and the knowledge already available, and our guide offers support to help make these strategic decisions

Climate for evidence-informed health systems: A print media analysis in 44 low- and middle-income countries that host knowledge-translation platforms

<p>Abstract</p> <p>Background</p> <p>We conducted a print media analysis in 44 countries in Africa, the Americas, Asia, and the Eastern Mediterranean in order to understand one dimension of the climate for evidence-informed health systems and to provide a baseline for an evaluation of knowledge-translation platforms. Our focus was whether and how policymakers, stakeholders, and researchers talk in the media about three topics: policy priorities in the health sector, health research evidence, and policy dialogues regarding health issues.</p> <p>Methods</p> <p>We developed a search strategy consisting of three progressively more delimited phases. For each jurisdiction, we searched <it>Major World Publications </it>in LexisNexis Academic <it>News </it>for articles published in 2007, selected relevant articles using one set of general criteria and three sets of concept-specific criteria, and coded the selected articles to identify common themes. Second raters took part in the analysis of Lebanon and Malaysia to assess inter-rater reliability for article selection and coding.</p> <p>Results</p> <p>We identified approximately 5.5 and 5 times more articles describing health research evidence compared to the number of articles describing policy priorities and policy dialogues, respectively. Few articles describing health research evidence discussed systematic reviews (2%) or health systems research (2%), and few of the policy dialogue articles discussed researcher involvement (9%). News coverage of these concepts was highly concentrated in several countries like China and Uganda, while few articles were found for many other jurisdictions. Kappa scores were acceptable and consistently greater than 0.60.</p> <p>Conclusions</p> <p>In many countries the print media, at least as captured in a global database, are largely silent about three topics central to evidence-informed health systems. These findings suggest the need for proactive-media engagement strategies.</p

Gastric emptying following Finney pyloroplasty and vagotomy

Gastric emptying was evaluated in a series of unanesthetized dogs in the intact state, following Finney pyloroplasty, and with the addition of vagotomy. Sodium chromate labeled test meals of glucose, trisodium citrate, and trisodium citrate-fat were used. Finney pyloroplasty resulted in a trend for delayed emptying of fat from the stomach. The trisodium citrate test meal increased the levels of gastric secretion after pyloroplasty.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/44373/1/10620_2005_Article_BF02239291.pd

Selective amplification of Brucella melitensis mRNA from a mixed host-pathogen total RNA

<p>Abstract</p> <p>Background</p> <p>Brucellosis is a worldwide anthropozoonotic disease caused by an in vivo intracellular pathogen belonging to genus <it>Brucella</it>. The characterization of brucelae transcriptome's during host-pathogen interaction has been limited due to the difficulty of obtaining an adequate quantity of good quality eukaryotic RNA-free pathogen RNA for downstream applications.</p> <p>Findings</p> <p>Here, we describe a combined protocol to prepare RNA from intracellular <it>B. melitensis </it>in a quantity and quality suitable for pathogen gene expression analysis. Initially, <it>B. melitensis </it>total RNA was enriched from a host:pathogen mixed RNA sample by reducing the eukaryotic RNA..Then, to increase the <it>Brucella </it>RNA concentration and simultaneously minimize the contaminated host RNA in the mixed sample, a specific primer set designed to anneal to all <it>B. melitensis </it>ORF allows the selective linear amplification of sense-strand prokaryotic transcripts in a previously enriched RNA sample.</p> <p>Conclusion</p> <p>The novelty of the method we present here allows analysis of the gene expression profile of <it>B. melitensis </it>when limited amounts of pathogen RNA are present, and is potentially applicable to both <it>in vivo </it>and <it>in vitro </it>models of infection, even at early infection time points.</p

Function after spinal treatment, exercise and rehabilitation (FASTER): improving the functional outcome of spinal surgery

Background: The life-time incidence of low back pain is high and diagnoses of spinal stenosis and disc prolapse are increasing. Consequently, there is a steady rise in surgical interventions for these conditions. Current evidence suggests that while the success of surgery is incomplete, it is superior to conservative interventions. A recent survey indicates that there are large differences in the type and intensity of rehabilitation, if any, provided after spinal surgery as well as in the restrictions and advice given to patients in the post-operative period. This trial will test the hypothesis that functional outcome following two common spinal operations can be improved by a programme of post-operative rehabilitation that combines professional support and advice with graded active exercise and/or an educational booklet based on evidence-based messages and advice.Methods/Design: The study design is a multi-centre, factorial, randomised controlled trial with patients stratified by surgeon and operative procedure. The trial will compare the effectiveness and cost-effectiveness of a rehabilitation programme and an education booklet for the postoperative management of patients undergoing discectomy or lateral nerve root decompression, each compared with "usual care" using a 2 x 2 factorial design. The trial will create 4 sub-groups; rehabilitation-only, booklet-only, rehabilitation-plus-booklet, and usual care only. The trial aims to recruit 344 patients, which equates to 86 patients in each of the four sub-groups. All patients will be assessed for functional ability (through the Oswestry Disability Index - a disease specific functional questionnaire), pain (using visual analogue scales), and satisfaction pre-operatively and then at 6 weeks, 3, 6 and 9 months and 1 year post-operatively. This will be complemented by a formal analysis of cost-effectiveness.Discussion: This trial will determine whether the outcome of spinal surgery can be enhanced by either a postoperative rehabilitation programme or an evidence-based advice booklet or a combination of the two and as such will contribute to our knowledge on how to manage spinal surgery patients in the post-operative period

Community-based knowledge transfer and exchange: Helping community-based organizations link research to action

<p>Abstract</p> <p>Background</p> <p>Community-based organizations (CBOs) are important stakeholders in health systems and are increasingly called upon to use research evidence to inform their advocacy, program planning, and service delivery efforts. CBOs increasingly turn to community-based research (CBR) given its participatory focus and emphasis on linking research to action. In order to further facilitate the use of research evidence by CBOs, we have developed a strategy for community-based knowledge transfer and exchange (KTE) that helps CBOs more effectively link research evidence to action. We developed the strategy by: outlining the primary characteristics of CBOs and why they are important stakeholders in health systems; describing the concepts and methods for CBR and for KTE; comparing the efforts of CBR to link research evidence to action to those discussed in the KTE literature; and using the comparison to develop a framework for community-based KTE that builds on both the strengths of CBR and existing KTE frameworks.</p> <p>Discussion</p> <p>We find that CBR is particularly effective at fostering a climate for using research evidence and producing research evidence relevant to CBOs through community participation. However, CBOs are not always as engaged in activities to link research evidence to action on a larger scale or to evaluate these efforts. Therefore, our strategy for community-based KTE focuses on: an expanded model of 'linkage and exchange' (<it>i.e</it>., producers and users of researchers engaging in a process of asking and answering questions together); a greater emphasis on both producing and disseminating systematic reviews that address topics of interest to CBOs; developing a large-scale evidence service consisting of both 'push' efforts and efforts to facilitate 'pull' that highlight actionable messages from community relevant systematic reviews in a user-friendly way; and rigorous evaluations of efforts for linking research evidence to action.</p> <p>Summary</p> <p>Through this type of strategy, use of research evidence for CBO advocacy, program planning, and service delivery efforts can be better facilitated and continually refined through ongoing evaluations of its impact.</p

Differences across health care systems in outcome and cost-utility of surgical and conservative treatment of chronic low back pain: a study protocol

<p>Abstract</p> <p>Background</p> <p>There is little evidence on differences across health care systems in choice and outcome of the treatment of chronic low back pain (CLBP) with spinal surgery and conservative treatment as the main options. At least six randomised controlled trials comparing these two options have been performed; they show conflicting results without clear-cut evidence for superior effectiveness of any of the evaluated interventions and could not address whether treatment effect varied across patient subgroups. Cost-utility analyses display inconsistent results when comparing surgical and conservative treatment of CLBP. Due to its higher feasibility, we chose to conduct a prospective observational cohort study.</p> <p>Methods</p> <p>This study aims to examine if</p> <p>1. Differences across health care systems result in different treatment outcomes of surgical and conservative treatment of CLBP</p> <p>2. Patient characteristics (work-related, psychological factors, etc.) and co-interventions (physiotherapy, cognitive behavioural therapy, return-to-work programs, etc.) modify the outcome of treatment for CLBP</p> <p>3. Cost-utility in terms of quality-adjusted life years differs between surgical and conservative treatment of CLBP.</p> <p>This study will recruit 1000 patients from orthopaedic spine units, rehabilitation centres, and pain clinics in Switzerland and New Zealand. Effectiveness will be measured by the Oswestry Disability Index (ODI) at baseline and after six months. The change in ODI will be the primary endpoint of this study.</p> <p>Multiple linear regression models will be used, with the change in ODI from baseline to six months as the dependent variable and the type of health care system, type of treatment, patient characteristics, and co-interventions as independent variables. Interactions will be incorporated between type of treatment and different co-interventions and patient characteristics. Cost-utility will be measured with an index based on EQol-5D in combination with cost data.</p> <p>Conclusion</p> <p>This study will provide evidence if differences across health care systems in the outcome of treatment of CLBP exist. It will classify patients with CLBP into different clinical subgroups and help to identify specific target groups who might benefit from specific surgical or conservative interventions. Furthermore, cost-utility differences will be identified for different groups of patients with CLBP. Main results of this study should be replicated in future studies on CLBP.</p

Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach

<p>Abstract</p> <p>Background</p> <p>Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM) and conventional therapies, while also incorporating patient choice, has yet to be tested for chronic LBP.</p> <p>The primary aim of this study is to determine the relative clinical effectiveness of 1) monodisciplinary chiropractic care and 2) multidisciplinary integrative care in 200 adults with non-acute LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure is patient-rated back pain. Secondary aims compare the treatment approaches in terms of frequency of symptoms, low back disability, fear avoidance, self-efficacy, general health status, improvement, satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods, and cost-effectiveness and cost utility will be assessed.</p> <p>Methods and Design</p> <p>This paper describes the design of a randomized clinical trial (RCT), with cost-effectiveness and qualitative studies conducted alongside the RCT. Two hundred participants ages 18 and older are being recruited and randomized to one of two 12-week treatment interventions. Patient-rated outcome measures are collected via self-report questionnaires at baseline, and at 4, 12, 26, and 52 weeks post-randomization. Objective outcome measures are assessed at baseline and 12 weeks by examiners blinded to treatment assignment. Health care cost data is collected by self-report questionnaires and treatment records during the intervention phase and by monthly phone interviews thereafter. Qualitative interviews, using a semi-structured format, are conducted with patients at the end of the 12-week treatment period and also with providers at the end of the trial.</p> <p>Discussion</p> <p>This mixed-methods randomized clinical trial assesses clinical effectiveness, cost-effectiveness, and patients' and providers' perceptions of care, in treating non-acute LBP through evidence-based individualized care delivered by monodisciplinary or multidisciplinary care teams.</p> <p>Trial registration</p> <p>ClinicalTrials.gov NCT00567333</p

Expectations, perceptions, and physiotherapy predict prolonged sick leave in subacute low back pain

<p>Abstract</p> <p>Background</p> <p>Brief intervention programs for subacute low back pain (LBP) result in significant reduction of sick leave compared to treatment as usual. Although effective, a substantial proportion of the patients do not return to work. This study investigates predictors of return to work in LBP patients participating in a randomized controlled trial comparing a brief intervention program (BI) with BI and physical exercise.</p> <p>Methods</p> <p>Predictors for not returning to work was examined in 246 patients sick listed 8-12 weeks for low back pain. The patients had participated in a randomized controlled trial, with BI (n = 122) and BI + physical exercise (n = 124). There were no significant differences between the two intervention groups on return to work. The groups were therefore merged in the analyses of predictors. Multiple logistic regression analysis was used to identify predictors for non return to work at 3, 12, and 24 months of follow-up.</p> <p>Results</p> <p>At 3 months of follow-up, the strongest predictors for not returning to work were pain intensity while resting (OR = 5.6; CI = 1.7-19), the perception of constant back strain when working (OR = 4.1; CI = 1.5-12), negative expectations for return to work (OR = 4.2; CI = 1.7-10), and having been to a physiotherapist prior to participation in the trial (OR = 3.3; CI = 1.3-8.3). At 12 months, perceived reduced ability to walk far due to the complaints (OR = 2.6; CI = 1.3-5.4), pain during activities (OR = 2.4; CI = 1.1-5.1), and having been to a physiotherapist prior to participation in the trial (OR = 2.1; CI = 1.1-4.3) were the strongest predictors for non return to work. At 24 months age below 41 years (OR = 2.9; CI = 1.4-6.0) was the only significant predictor for non return to work.</p> <p>Conclusion</p> <p>It appears that return to work is highly dependant on individual and cognitive factors. Patients not returning to work after the interventions were characterized by negative expectations, perceptions about pain and disability, and previous physiotherapy treatment. This is the first study reporting that previous treatment by physiotherapists is a risk factor for long-term sick leave. This has not been reported before and is an interesting finding that deserves more scrutiny.</p

Dlk1 Is Necessary for Proper Skeletal Muscle Development and Regeneration

Delta-like 1homolog (Dlk1) is an imprinted gene encoding a transmembrane protein whose increased expression has been associated with muscle hypertrophy in animal models. However, the mechanisms by which Dlk1 regulates skeletal muscle plasticity remain unknown. Here we combine conditional gene knockout and over-expression analyses to investigate the role of Dlk1 in mouse muscle development, regeneration and myogenic stem cells (satellite cells). Genetic ablation of Dlk1 in the myogenic lineage resulted in reduced body weight and skeletal muscle mass due to reductions in myofiber numbers and myosin heavy chain IIB gene expression. In addition, muscle-specific Dlk1 ablation led to postnatal growth retardation and impaired muscle regeneration, associated with augmented myogenic inhibitory signaling mediated by NF-κB and inflammatory cytokines. To examine the role of Dlk1 in satellite cells, we analyzed the proliferation, self-renewal and differentiation of satellite cells cultured on their native host myofibers. We showed that ablation of Dlk1 inhibits the expression of the myogenic regulatory transcription factor MyoD, and facilitated the self-renewal of activated satellite cells. Conversely, Dlk1 over-expression inhibited the proliferation and enhanced differentiation of cultured myoblasts. As Dlk1 is expressed at low levels in satellite cells but its expression rapidly increases upon myogenic differentiation in vitro and in regenerating muscles in vivo, our results suggest a model in which Dlk1 expressed by nascent or regenerating myofibers non-cell autonomously promotes the differentiation of their neighbor satellite cells and therefore leads to muscle hypertrophy