Grading quality of evidence and strength of recommendations

Atkins, David C.; Best, Dana; Briss, Peter A.; Eccles, Martin; Falck‐Ytter, Yngve; Flottorp, Signe; Guyatt, Gordon; Harbour, Robin; Haugh, Margaret; Henry, David; Hill, Suzanne; Jaeschke, Roman; Leng, Gillian; Liberati, Alessandro; Magrini, Nicola; Mason, James; Middleton, Philippa; Mrukowicz, Jacek; O’Connell, Dianne; Oxman, Andrew D; Phillips, Bob; Schünemann, Holger J.; Edejer, Tessa Tan-Torres; Varonen, Helena; Vist, Gunn Elisabeth; Williams, John W; Zaza, Stephanie

doi:10.1136/bmj.328.7454.1490

Cited by 6,546 publications

(2,247 citation statements)

References 23 publications

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“…We evaluated the quality of evidence for all primary outcome parameters, regardless of quantitative analysis, using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach [21,22]. In short, we judged the quality of evidence using the following criteria:…”

Section: Data Synthesismentioning

confidence: 99%

Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis

et al. 2015

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Purpose To compare the effectiveness of techniques of posterior decompression that limit the extent of bony decompression or to avoid removal of posterior midline structures of the lumbar spine versus conventional facetpreserving laminectomy for the treatment of patients with degenerative lumbar stenosis. Methods A comprehensive electronic search of the Cochrane Central Register of Controlled Trials, MED-LINE, EMBASE, Web of Science, and the clinical trials registries ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform was conducted for relevant literature up to June 2014. Results A total of four high-quality RCTs and six lowquality RCTs met the search criteria of this review. These studies included a total of 733 participants. Three different techniques that avoid removal of posterior midline structures are compared to conventional laminectomy; unilateral laminotomy for bilateral decompression, bilateral laminotomy and split-spinous process laminotomy. Evidence of low or very low quality suggests that different techniques of posterior decompression and conventional laminectomy have similar effects on functional disability and leg pain. Only perceived recovery at final follow-up was better in patients that underwent bilateral laminotomy compared with conventional laminectomy. Unilateral laminotomy for bilateral decompression and bilateral laminotomy resulted in numerically fewer cases of iatrogenic instability, although in both cases, the incidence of instability was low. The difference in severity of postoperative low back pain following bilateral laminotomy and split-spinous process laminotomy was significantly less, but was too small to be clinically important. We found no evidence to show that the incidence of complications, length of the procedure, length of hospital stay and postoperative walking distance differed between techniques of posterior decompression. Conclusion The evidence provided by this systematic review for the effects of unilateral laminotomy for bilateral decompression, bilateral laminotomy and split-spinous process laminotomy compared with conventional laminectomy on functional disability, perceived recovery and leg pain is of low or very low quality. Therefore, further research is necessary to establish whether these techniques provide a safe and effective alternative for conventional laminectomy. Proposed advantages of these techniques regarding the incidence of iatrogenic instability and postoperative back pain are plausible, but definitive conclusions are limited by poor methodology and poor reporting of outcome measures among included studies.

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Section: Data Synthesismentioning

confidence: 99%

Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis

et al. 2015

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“…The evidence grade was determined using the guidelines of the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) working group [1]. Although the GRADE system acknowledges the primacy of RCTs, it also recognizes circumstances in which observational studies generate high-quality evidence of treatment effects [24].…”

Section: Evidence Synthesismentioning

confidence: 99%

“…Although there are a limited number of RCTs, several non-randomized controlled trials (nonRCTs) have been published. The purpose of this systematic review is to evaluate the evidence from RCT and non-RCT studies that compared the safety and efficacy of KP and VP for treating OVCF patients and to develop GRADE (Grading of Recommendations, Assessment, Development and Evaluation)-based recommendations for using the procedures to treat OVCF [1,2].…”

Section: Introductionmentioning

confidence: 99%

Balloon kyphoplasty versus percutaneous vertebroplasty in treating osteoporotic vertebral compression fracture: grading the evidence through a systematic review and meta-analysis

Xing

et al. 2012

Eur Spine J

115

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Objective To assess the safety and efficacy of balloon kyphoplasty (KP) compared with percutaneous vertebroplasty (VP) and provide recommendations for using these procedures to treat osteoporotic vertebral compression fractures (OVCF). Methods A systematic search of all studies published through March 2012 was conducted using the MEDLINE, EMBASE, OVID, ScienceDirect and Cochrane CENTRAL databases. The randomized controlled trials (RCTs) and non-randomized controlled trials that compared KP to VP and provided data on safety and clinical effects were identified. Demographic characteristics, adverse events and clinical outcomes were manually extracted from all of the selected studies. The evidence quality levels and recommendations were assessed using the GRADE system. Results Twelve studies encompassing 1,081 patients met the inclusion criteria. Subgroup meta-analyses were performed according to the study design. In the RCT subgroup, there were significant differences between the two procedures in short-term visual analog scale (VAS), long-term kyphosis angles, operative times and anterior vertebrae heights. In the cohort study subgroup, there were significant differences between the two procedures in short-and longterm VAS, short-and long-term Oswestry Disability Index (ODI), cement leakage rates, short-and long-term kyphosis angles, operative times and anterior vertebrae heights. However, there were no significant differences in long-term VAS or adjacent vertebral fracture rates in the RCT subgroup. There were no significant differences in short-or long-term VAS, short-or long-term ODI, cement leakage rates, adjacent vertebral fracture rates, short-or long-term kyphosis angles or anterior vertebrae heights in the CCT subgroup, and the adjacent vertebral fracture rates did not differ significantly in the cohort study subgroup. The overall GRADE system evidence quality was very low, which lowers our confidence in their recommendations. Conclusions KP and VP are both safe and effective surgical procedures for treating OVCF. KP may be superior to VP in patients with large kyphosis angles, vertebral fissures, fractures in the posterior edge of the vertebral body or significant height loss in the fractured vertebrae. Due to the poor quality of the evidence currently available, highquality RCTs are required.

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“…If the conclusion that we look for in answer to the question in the title of this section is to be a causal claim (as opposed to a merely probabilistic claim) about T and O, then here is at least one valid conclusion that can be drawn using Mill's methods, 3 Consider as a smattering of examples the evidence use guideliness from the U.S. Dept of Education (2003), the Scottish Intercollegiate Guideline Network (2008), Sackett et al (2000), Atkins et al (2004) or the Cabinet Office (2000). 4 Exactly what counts as changing T versus changing additional factors that were in place in the study but are not in place in the target implementation is a little arbitrary.…”

Section: What Can Mill's Methods Of Difference Establish Even In Thementioning

confidence: 99%

Predicting ‘It will work for us’: (Way) beyond statistics

Cartwright¹

2011

Causality in the Sciences

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Grading quality of evidence and strength of recommendations

Cited by 6,546 publications

References 23 publications

Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis

Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis

Balloon kyphoplasty versus percutaneous vertebroplasty in treating osteoporotic vertebral compression fracture: grading the evidence through a systematic review and meta-analysis

Predicting ‘It will work for us’: (Way) beyond statistics

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