Tracy Merlin

Australian guidelines for the treatment of adults with acute stress disorder and post-traumatic stress disorder

Over the past 2–3 years, clinical practice guidelines (CPGs) for post-traumatic stress disorder (PTSD) and acute stress disorder (ASD) have been developed in the USA and UK. There remained a need, however, for the development of Australian CPGs for the treatment of ASD and PTSD tailored to the national health-care context. Therefore, the Australian Centre for Posttraumatic Mental Health in collaboration with national trauma experts, has recently developed Australian CPGs for adults with ASD and PTSD, which have been endorsed by the National Health and Medical Research Council (NHMRC). In consultation with a multidisciplinary reference panel (MDP), research questions were determined and a systematic review of the evidence was then conducted to answer these questions (consistent with NHMRC procedures). On the basis of the evidence reviewed and in consultation with the MDP, a series of practice recommendations were developed. The practice recommendations that have been developed address a broad range of clinical questions. Key recommendations indicate the use of trauma-focused psychological therapy (cognitive behavioural therapy or eye movement desensitization and reprocessing in addition to in vivo exposure) as the most effective treatment for ASD and PTSD. Where medication is required for the treatment of PTSD in adults, selective serotonin re-uptake inhibitor antidepressants should be the first choice. Medication should not be used in preference to trauma-focused psychological therapy. In the immediate aftermath of trauma, practitioners should adopt a position of watchful waiting and provide psychological first aid. Structured interventions such as psychological debriefing, with a focus on recounting the traumatic event and ventilation of feelings, should not be offered on a routine basis.

Systematic review of endovenous laser treatment for varicose veins

The safety and effectiveness of endovenous laser treatment (EVLT) for varicose veins are not yet fully evaluated.

Systematic review of the safety and effectiveness of methods used to establish pneumoperitoneum in laparoscopic surgery

A systematic review was conducted to determine which of the methods of obtaining peritoneal access and establishing pneumoperitoneum is the safest and most effective.

Systematic review of safety and effectiveness of an artificial bowel sphincter for faecal incontinence

The aim was to determine the safety and effectiveness of the implantation of an artificial bowel sphincter for the treatment of severe faecal incontinence.

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

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.

Comparison of the clinical effectiveness of different off‐loading devices for the treatment of neuropathic foot ulcers in patients with diabetes: a systematic review and meta‐analysis

Effective off‐loading is considered to be an important part of the successful clinical management of diabetic foot ulcers. The aim of this systematic review is to investigate the safety and effectiveness of different off‐loading devices for the treatment of diabetic foot ulcers. The medical literature was extensively searched from January 1966 to May 2012. Systematic reviews and controlled studies that compared the use of different off‐loading devices formed the evidence base. Studies were critically appraised to determine their risk of methodological bias, and data were extracted. Results were pooled using random effects meta‐analysis and tested for heterogeneity. When compared with removable devices, non‐removable off‐loading devices were found, on average, to be more effective at promoting the healing of diabetic foot ulcers (RRp = 1.43; 95% CI 1.11, 1.84; I2 = 66.9%; p = 0.001; k = 10). Analysis, stratified by type of removable device, did not detect a statistically significant difference between non‐removable off‐loading devices and removable cast walkers; however, on average non‐removable off‐loading devices performed better than therapeutic shoes at promoting the healing of diabetic foot ulcers (RRp = 1.68; 95% CI 1.09, 2.58; I2 = 71.5%; p = 0.004; k = 6). The two types of non‐removable off‐loading devices i.e. total contact casts and instant total contact casts (removable cast walker rendered irremovable by securing with bandage or lace), were found to be equally effective (RRp = 1.06; 95% CI 0.88, 1.27; I2 = 3.3%; p = 0.31; k = 2). In conclusion, non‐removable off‐loading devices regardless of type, are more likely to result in ulcer healing than removable off‐loading devices, presumably because patient compliance with off‐loading is facilitated. Copyright

Assessing personalized medicines in Australia: a national framework for reviewing codependent technologies

Background. Since the mapping of the human genome in 2003, the development of biomarker targeted therapy and clinical adoption of “personalized medicine” has accelerated. Models for insurance subsidy of biomarker/test/drug packages (“codependent technologies” or technologies that work better together) are not well developed. Our aim was to create a framework to assess the safety, effectiveness, and cost-effectiveness of these technologies for a national coverage or reimbursement decision. Methods. We extracted information from assessments of recent Australian reimbursement applications that concerned genetic tests and treatments to identify items and evidence gaps considered important to the decision-making process. Relevant international regulatory and reimbursement guidance documents were also reviewed. Items addressing causality theory were included to help explain the relationship between biomarker and treatment. The framework was reviewed by policy makers and technical experts, prior to a public consultation process. Results. The framework consists of 5 components—context, clinical benefit, evidence translation, cost-effectiveness, and financial impact—and a checklist of 79 items. To determine whether the biomarker test, the drug, both, or neither should be subsidized, we considered it crucial to identify whether the biomarker is a treatment effect modifier or a prognostic factor. To aid in this determination, the framework explicitly allows the linkage of different types of evidence to examine whether targeting the biomarker varies the likely clinical benefit of the drug, and if so, to what extent. Conclusions. The first national framework to assess personalized medicine for coverage or reimbursement decisions has been developed and introduced and may be a suitable model for other health systems.

The "linked evidence approach" to assess medical tests: A critical analysis

OBJECTIVES A linked evidence approach (LEA) is the synthesis of systematically acquired evidence on the accuracy of a medical test, its impact on clinical decision making and the effectiveness of consequent treatment options. We aimed to assess the practical utility of this methodology and to develop a decision framework to guide its use. METHODS As Australia has lengthy experience with LEA, we reviewed health technology assessment (HTA) reports informing reimbursement decisions by the Medical Services Advisory Committee (August 2005 to March 2012). Eligibility was determined according to predetermined criteria and data were extracted on test characteristics, evaluation methodologies, and reported difficulties. Fifty percent of the evidence-base was independently analyzed by a second reviewer. RESULTS Evaluations of medical tests for diagnostic (62 percent), staging (27 percent), and screening (6 percent) purposes were available for eighty-nine different clinical indications. Ninety-six percent of the evaluations used either the full LEA methodology or an abridged version (where evidence is linked through to management changes but not patient outcomes). Sixty-one percent had the full evidence linkage. Twenty-five percent of test evaluations were considered problematic; all involving LEA (n = 22). Problems included: determining test accuracy with an imperfect reference standard (41 percent); assessing likely treatment effectiveness in test positive patients when the new test is more accurate than the comparator (18 percent); and determining probable health benefits in those symptomatic patients ruled out using the test (13 percent). A decision framework was formulated to address these problems. CONCLUSIONS LEA is useful for evaluating medical tests but a stepped approach should be followed to determine what evidence is required for the synthesis.

The Australia and New Zealand horizon scanning network.

Linda Mundy, Tracy L. Merlin, Adriana Parrella, Wendy J. Babidge, Dianne E. Roberts and Janet E. Hiller

Rapid evidence assessment: increasing the transparency of an emerging methodology

RATIONALE, AIMS AND OBJECTIVES Within the field of evidence-based practice, policy makers, health care professionals and consumers require timely reviews to inform decisions on efficacious health care and treatments. Rapid evidence assessment (REA), also known as rapid review, has emerged in recent years as a literature review methodology that fulfils this need. It highlights what is known in a clinical area to the target audience in a relatively short time frame. METHODS This article discusses the lack of transparency and limited critical appraisal that can occur in REA, and goes on to propose general principles for conducting a REA. The approach that we describe is consistent with the principles underlying systematic review methodology, but also makes allowances for the rapid delivery of information as required while utilizing explicit and reproducible methods at each stage. RESULTS Our method for conducting REA includes: developing an explicit research question in consultation with the end-users; clear definition of the components of the research question; development of a thorough and reproducible search strategy; development of explicit evidence selection criteria; and quality assessments and transparent decisions about the level of information to be obtained from each study. In addition, the REA may also include an assessment of the quality of the total body of evidence. CONCLUSIONS Transparent reporting of REA methodologies will provide greater clarity to end-users about how the information is obtained and about the trade-offs that are made between speed and rigour.