GRADE Evidence to Decision (EtD) frameworks : a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines

Funding: Work on this article has been partially funded by the European Commission FP7 Program (grant agreement 258583) as part of the DECIDE project. Sole responsibility lies with the authors; the European Commission is not responsible for any use that may be made of the information contained therein.Peer reviewedPublisher PD

GRADE Evidence to Decision (EtD) frameworks : A systematic and transparent approach to making well-informed healthcare choices. 1. Introduction

Funding: Work on this article has been partially funded by the European Commission FP7 Program (grant agreement 258583) as part of the DECIDE project. Sole responsibility lies with the authors; the European Commission is not responsible for any use that may be made of the information contained therein.Peer reviewedPublisher PD

Extending an evidence hierarchy to include topics other than treatment: revising the Australian 'levels of evidence'

Background: In 1999 a four-level hierarchy of evidence was promoted by the National Health and Medical Research Council in Australia. The primary purpose of this hierarchy was to assist with clinical practice guideline development, although it was co-opted for use in systematic literature reviews and health technology assessments. In this hierarchy interventional study designs were ranked according to the likelihood that bias had been eliminated and thus it was not ideal to assess studies that addressed other types of clinical questions. This paper reports on the revision and extension of this evidence hierarchy to enable broader use within existing evidence assessment systems. Methods: A working party identified and assessed empirical evidence, and used a commissioned review of existing evidence assessment schema, to support decision-making regarding revision of the hierarchy. The aim was to retain the existing evidence levels I-IV but increase their relevance for assessing the quality of individual diagnostic accuracy, prognostic, aetiologic and screening studies. Comprehensive public consultation was undertaken and the revised hierarchy was piloted by individual health technology assessment agencies and clinical practice guideline developers. After two and a half years, the hierarchy was again revised and commenced a further 18 month pilot period. Results: A suitable framework was identified upon which to model the revision. Consistency was maintained in the hierarchy of "levels of evidence" across all types of clinical questions; empirical evidence was used to support the relationship between study design and ranking in the hierarchy wherever possible; and systematic reviews of lower level studies were themselves ascribed a ranking. The impact of ethics on the hierarchy of study designs was acknowledged in the framework, along with a consideration of how harms should be assessed. Conclusion: The revised evidence hierarchy is now widely used and provides a common standard against which to initially judge the likelihood of bias in individual studies evaluating interventional, diagnostic accuracy, prognostic, aetiologic or screening topics. Detailed quality appraisal of these individual studies, as well as grading of the body of evidence to answer each clinical, research or policy question, can then be undertaken as required.Tracy Merlin, Adele Weston and Rebecca Toohe

Music therapy for people with substance use disorders (Protocol)

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: Main objective To assess the effects of music therapy, as a primary or a supportive intervention, compared to standard care, wait-list control or no treatment, for people with substance use disorders, to reduce substance use,the severity of substance dependence/abuse, psychological symptoms, and substance craving; to enhance motivation for change/treatment; and for retention in treatment. Secondary objective To assess the impact of the number of music therapy sessions on study outcome

FORM: An Australian method for formulating and grading recommendations in evidence-based clinical guidelines

Extent: 8p.BACKGROUND: Clinical practice guidelines are an important element of evidence-based practice. Considering an often complicated body of evidence can be problematic for guideline developers, who in the past may have resorted to using levels of evidence of individual studies as a quasi-indicator for the strength of a recommendation. This paper reports on the production and trial of a methodology and associated processes to assist Australian guideline developers in considering a body of evidence and grading the resulting guideline recommendations. METHODS: In recognition of the complexities of clinical guidelines and the multiple factors that influence choice in health care, a working group of experienced guideline consultants was formed under the auspices of the Australian National Health and Medical Research Council (NHMRC) to produce and pilot a framework to formulate and grade guideline recommendations. Consultation with national and international experts and extensive piloting informed the process. RESULTS: The FORM framework consists of five components (evidence base, consistency, clinical impact, generalisability and applicability) which are used by guideline developers to structure their decisions on how to convey the strength of a recommendation through wording and grading via a considered judgement form. In parallel (but separate from the grading process) guideline developers are asked to consider implementation implications for each recommendation. CONCLUSIONS: The framework has now been widely adopted by Australian guideline developers who find it to be a logical and intuitive way to formulate and grade recommendations in clinical practice guidelines.Susan Hillier, Karen Grimmer-Somers, Tracy Merlin, Philippa Middleton, Janet Salisbury, Rebecca Tooher and Adele Westo

Initial arch wires used in orthodontic treatment with fixed appliances

Background: Initial arch wires are the first arch wires to be inserted into the fixed appliance at the beginning of orthodontic treatment and are used mainly for the alignment of teeth by correcting crowding and rotations. With a number of different types of orthodontic arch wires available for initial tooth alignment, it is important to understand which wire is most efficient, as well as which wires cause least amount of root resorption and pain during the initial aligning stage of treatment. This is an update of the review entitledInitial arch wires for alignment of crooked teeth with fixed orthodontic braces, which was first published in 2010. Objectives: To assess the effects of initial arch wires for the alignment of teeth with fixed orthodontic braces, in terms of the rate of tooth alignment, amount of root resorption accompanying tooth movement, and intensity of pain experienced by patients during the initial alignment stage of treatment. Search methods: Cochrane Oral Health\u27s Information Specialist searched the following databases: Cochrane Oral Health\u27s Trials Register (to 5 October 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 9), MEDLINE Ovid (1946 to 5 October 2017), and Embase Ovid (1980 to 5 October 2017. The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. Selection criteria: We included randomised controlled trials (RCTs) of initial arch wires to align teeth with fixed orthodontic braces. We included only studies involving participants with upper or lower, or both, full arch fixed orthodontic appliances. Data collection and analysis: Two review authors were responsible for study selection, \u27Risk of bias\u27 assessment and data extraction. We resolved disagreements by discussion between the review authors. We contacted corresponding authors of included studies to obtain missing information. We assessed the quality of the evidence for each comparison and outcome as high, moderate, low or very low, according to GRADE criteria. Main results: For this update, we found three new RCTs (228 participants), bringing the total to 12 RCTs with 799 participants. We judged three studies to be at high risk of bias, and three to be at low risk of bias; six were unclear. None of the studies reported the adverse outcome of root resorption. The review assessed six comparisons. 1. Multistrand stainless steel versus superelastic nickel-titanium (NiTi) arch wires. There were five studies in this group and it was appropriate to undertake a meta-analysis of two of them. There is insufficient evidence from these studies to determine whether there is a difference in rate of alignment between multistrand stainless steel and superelastic NiTi arch wires (mean difference (MD) -7.5 mm per month, 95% confidence interval (CI) -26.27 to 11.27; 1 study, 48 participants; low-quality evidence). The findings for pain at day 1 as measured on a 100 mm visual analogue scale suggested that there was no meaningful difference between the interventions (MD -2.68 mm, 95% CI -6.75 to 1.38; 2 studies, 127 participants; moderate-quality evidence). 2. Multistrand stainless steel versus thermoelastic NiTi arch wires. There were two studies in this group, but it was not appropriate to undertake a meta-analysis of the data. There is insufficient evidence from the studies to determine whether there is a difference in rate of alignment between multistrand stainless steel and thermoelastic NiTi arch wires (low-quality evidence). Pain was not measured. 3. Conventional NiTi versus superelastic NiTi arch wires. There were three studies in this group, but it was not appropriate to undertake a meta-analysis of the data. There is insufficient evidence from these studies to determine whether there is any difference between conventional and superelastic NiTi arch wires with regard to either alignment or pain (low- to very low-quality evidence). 4. Conventional NiTi versus thermoelastic NiTi arch wires. There were two studies in this group, but it was not appropriate to undertake a meta-analysis of the data. There is insufficient evidence from these studies to determine whether there is a difference in alignment between conventional and thermoelastic NiTi arch wires (low-quality evidence). Pain was not measured. 5. Single-strand superelastic NiTi versus coaxial superelastic NiTi arch wires. There was only one study (24 participants) in this group. There is moderate-quality evidence that coaxial superelastic NiTi can produce greater tooth movement over 12 weeks (MD -6.76 mm, 95% CI -7.98 to -5.55). Pain was not measured. 6. Superelastic NiTi versus thermoelastic NiTi arch wires. There were three studies in this group, but it was not appropriate to undertake a meta-analysis of the data. There is insufficient evidence from these studies to determine whether there is a difference in alignment or pain between superelastic and thermoelastic NiTi arch wires (low-quality evidence). Authors\u27 conclusions: Moderate-quality evidence shows that arch wires of coaxial superelastic nickel-titanium (NiTi) can produce greater tooth movement over 12 weeks than arch wires made of single-strand superelastic NiTi. Moderate-quality evidence also suggests there may be no difference in pain at day 1 between multistrand stainless steel arch wires and superelastic NiTi arch wires. Other than these findings, there is insufficient evidence to determine whether any particular arch wire material is superior to any other in terms of alignment rate, time to alignment, pain and root resorption

The systematic guideline review: method, rationale, and test on chronic heart failure

Background: Evidence-based guidelines have the potential to improve healthcare. However, their de-novo-development requires substantial resources-especially for complex conditions, and adaptation may be biased by contextually influenced recommendations in source guidelines. In this paper we describe a new approach to guideline development-the systematic guideline review method (SGR), and its application in the development of an evidence-based guideline for family physicians on chronic heart failure (CHF). Methods: A systematic search for guidelines was carried out. Evidence-based guidelines on CHF management in adults in ambulatory care published in English or German between the years 2000 and 2004 were included. Guidelines on acute or right heart failure were excluded. Eligibility was assessed by two reviewers, methodological quality of selected guidelines was appraised using the AGREE instrument, and a framework of relevant clinical questions for diagnostics and treatment was derived. Data were extracted into evidence tables, systematically compared by means of a consistency analysis and synthesized in a preliminary draft. Most relevant primary sources were re-assessed to verify the cited evidence. Evidence and recommendations were summarized in a draft guideline. Results: Of 16 included guidelines five were of good quality. A total of 35 recommendations were systematically compared: 25/35 were consistent, 9/35 inconsistent, and 1/35 un-rateable (derived from a single guideline). Of the 25 consistencies, 14 were based on consensus, seven on evidence and four differed in grading. Major inconsistencies were found in 3/9 of the inconsistent recommendations. We re-evaluated the evidence for 17 recommendations (evidence-based, differing evidence levels and minor inconsistencies) - the majority was congruent. Incongruity was found where the stated evidence could not be verified in the cited primary sources, or where the evaluation in the source guidelines focused on treatment benefits and underestimated the risks. The draft guideline was completed in 8.5 man-months. The main limitation to this study was the lack of a second reviewer. Conclusion: The systematic guideline review including framework development, consistency analysis and validation is an effective, valid, and resource saving-approach to the development of evidence-based guidelines

Memory rehabilitation for people with multiple sclerosis

Background: This is an update of the Cochrane review ‘Memory rehabilitation for people with multiple sclerosis’ (first published in the Cochrane Library 14 March 2012, Issue 3). Impairments in cognitive function, particularly memory, are common in people with multiple sclerosis (MS) and can potentially affect their ability to complete functional activities. There is evidence from single-case or small group studies that memory rehabilitation can be beneficial for people with MS, but findings from randomised controlled trials (RCTs) and systematic reviews have been inconclusive. Objectives: To determine whether people with MS who received memory rehabilitation showed: 1. better outcomes in their memory functions compared to those given no treatment or receiving a placebo control; and 2. better functional abilities, in terms of activities of daily living, mood, and quality of life, than those who received no treatment or a placebo. Search methods: We searched the Trials Specialised Register of the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group (2 June 2015) and the following electronic databases: The NIHR Clinical Research Network Portfolio database (NIHR CRN) (from 2010 to June 2015), The Allied and Complementary Medicine Database (AMED) (2010 to June 2015), British Nursing Index (BNI) (2010 to June 2015), PsycINFO (2011 to June 2015), and CAB Abstracts (2010 to June 2015). Start dates for the electronic databases coincided with the last search for the previous review. We handsearched relevant journals and reference lists. Selection criteria: We selected RCTs or quasi-randomised trials ofmemory rehabilitation or cognitive rehabilitation for people with MS in which a memory rehabilitation treatment group was compared to a control group. Selection was conducted independently first and then confirmed through group discussion. We excluded studies that included participants whose memory deficits were the result of conditions other than MS unless we could identify a subgroup of participants with MS with separate results. Data collection and analysis: Three review authors were involved in this update in terms of study selection, quality assessment, and data extraction. We contacted investigators of primary studies for further information where required. We conducted data analysis and synthesis in accordance with the Cochrane Handbook for Systematic Reviews ofInterventions (Higgins 2011). We performed a ’best evidence’ synthesis based on the methodological quality of the primary studies included. Main results: We added seven studies during this update, bringing the total to 15 studies, involving 989 participants. The interventions involved various memory retraining techniques, such as computerised programmes and training on internal and external memory aids. Control groups varied in format from assessment-only groups, discussion and games, non-specific cognitive retraining, and attention or visuospatial training. The risk of bias of the included studies was generally low, but we found eight studies to have high risk of bias related to certain aspects of their methodology. We found significant effect of intervention on objective assessments of memory in both the immediate and long-term follow-ups: standardised mean difference (SMD) 0.23 (95% confidence interval (CI) 0.05 to 0.41) and SMD 0.26 (95% CI 0.03 to 0.49), respectively. We also found significant effect of intervention for quality of life in the immediate follow-up (SMD 0.23 (95% CI 0.05 to 0.41)). These findings showed that the intervention group performed significantly better than the control group. We also found a significant difference for activities of daily living (ADL) in the long-term follow-up (SMD -0.33 (95% CI -0.63 to -0.03)), showing that the control groups had significantly less difficulty completing ADLs than the intervention groups. We found no significant effects, either immediate or long-term, on subjective reports of memory problems (SMD 0.04 (95% CI -0.19 to 0.27) and SMD 0.04 (95% CI -0.19 to 0.27)); on mood (SMD 0.02 (95% CI -0.16 to 0.20) and SMD -0.01 (95% CI -0.21 to 0.20)); and on immediate follow-up for ADL (SMD -0.13 (95% CI -0.60 to 0.33)) and in the long term for quality of life (SMD 0.16 (95% CI -0.03 to 0.36)). We could not complete a sensitivity analysis of intention-to-treat in comparison with per-protocol analysis, due to insufficient information from the included papers. However, a sensitivity analysis of high- versus low-risk studies suggested that while quality of the trials did not affect most outcomes, differences were seen in the objective memory outcomes (both at immediate and long term) and quality of life (immediate) outcome, with studies with higher risk of bias inflating the overall effect size estimates for these outcomes, and the test of overall effect changing from being statistically significant to not significant when studies at high risk of bias were excluded. This suggests that lower-quality studies may have positively influenced the outcomes. Authors’ conclusions: There is some evidence to support the effectiveness of memory rehabilitation on memory function, as well as on quality of life. However, the evidence is limited and does not extend to subjective reports of memory functioning or mood. Furthermore, the objective measures used are not ecologically valid measures, and thus potentially limit generalisability of these findings into daily life. Further robust RCTs of high methodological quality and better quality of reporting, using ecologically valid outcome assessments, are still needed

Improving the use of research evidence in guideline development: 8. Synthesis and presentation of evidence

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the eighth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on the synthesis and presentation of research evidence, focusing on four key questions. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: We found two reviews of instruments for critically appraising systematic reviews, several studies of the importance of using extensive searches for reviews and determining when it is important to update reviews, and consensus statements about the reporting of reviews that informed our answers to the following questions. How should existing systematic reviews be critically appraised? • Because preparing systematic reviews can take over a year and require capacity and resources, existing reviews should be used when possible and updated, if needed. • Standard criteria, such as A MeaSurement Tool to Assess Reviews (AMSTAR), should be used to critically appraise existing systematic reviews, together with an assessment of the relevance of the review to the questions being asked. When and how should WHO undertake or commission new reviews? • Consideration should be given to undertaking or commissioning a new review whenever a relevant, up-to-date review of good quality is not available. • When time or resources are limited it may be necessary to undertake rapid assessments. The methods that are used to do these assessments should be reported, including important limitations and uncertainties and explicit consideration of the need and urgency of undertaking a full systematic review. • Because WHO has limited capacity for undertaking systematic reviews, reviews will often need to be commissioned when a new review is needed. Consideration should be given to establishing collaborating centres to undertake or support this work, similar to what some national organisations have done. How should the findings of systematic reviews be summarised and presented to committees responsible for making recommendations? • Concise summaries (evidence tables) of the best available evidence for each important outcome, including benefits, harms and costs, should be presented to the groups responsible for making recommendations. These should include an assessment of the quality of the evidence and a summary of the findings for each outcome. • The full systematic reviews, on which the summaries are based, should also be available to both those making recommendations and users of the recommendations. What additional information is needed to inform recommendations and how should this information be synthesised with information about effects and presented to committees? • Additional information that is needed to inform recommendations includes factors that might modify the expected effects, need (prevalence, baseline risk or status), values (the relative importance of key outcomes), costs and the availability of resources. • Any assumptions that are made about values or other factors that may vary from setting to setting should be made explicit. • For global guidelines that are intended to inform decisions in different settings, consideration should be given to using a template to assist the synthesis of information specific to a setting with the global evidence of the effects of the relevant interventions