BackgroundIn 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.MethodsA 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.ResultsA 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.ConclusionThe 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.

Skeletal muscle buffering capacity (beta m), enzyme activities and exercise performance were measured before and after 4 weeks of high-intensity, submaximal interval training (HIT) undertaken by six well-trained competitive cyclists [mean maximal oxygen consumption (VO2max) = 66.2 ml.kg-1.min-1]. HIT replaced a portion of habitual endurance training and consisted of six sessions, each of six to eight repetitions of 5 min duration at 80% of peak sustained power output (PPO) separated by 1 min of recovery. beta m increased from 206.6 (17.9) to 240.4 (34.1) mumol H+.g muscle dw-1.pH-1 after HIT (P = 0.05). PPO, time to fatigue at 150% PPO (TF150) and 40-km cycle time trial performance (TT40) all significantly improved after HIT (P < 0.05). In contrast, there was no change in the activity of either phosphofructokinase or citrate synthase. In addition, beta m correlated significantly with TT40 performance before HIT (r = -0.82, P < 0.05) and the relationship between change in beta m and change in TT40 was close to significance (r = -0.74). beta m did not correlate with TF150. These results indicate that beta m may be an important determinant of relatively short-duration (< 60 min) endurance cycling activity and responds positively to just six sessions of high-intensity, submaximal interval training.

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BackgroundClinical 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.MethodsIn 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.ResultsThe 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.ConclusionsThe 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.

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