Comparative Effectiveness Research (CER)

Randomized controlled trials are considered as gold standard for comparing a new technology with the existing technology. However, when data is not available from trials, the best available evidence must be collected and synthesized in the form of systematic reviews or meta-analysis.

Comparative effectiveness research (CER) is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions. The goal of CER is to improve health outcomes by developing and disseminating information based on Evidence-Based Medicine (EBM) to clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

Regulatory bodies around the world (FDA, CADTH, NICE, PBAC) acknowledge the value of utilizing these methods to establish the comparative effectiveness of health technologies, especially when direct head-to-head evidence is limited or unavailable.

At MarksMan Healthcare Solutions, we support and coordinate the preparation of individual work steps to final Health Technology Assessment (HTA) report. Our CER evidence synthesis services include:

Systematic Reviews

A systematic review will allow you to clearly formulate a question that uses systematic and explicit methods to identify, select and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review.

Benefits of systematic reviews

  • Provide up to date summary of all published research literature
  • Allow large amounts of data to be assimilated
  • Provide an objective collation of results of research
  • Provide reliable recommendations

Systematic reviews are prepared in multiple work steps that are built on one another:

  • Define an appropriate questionnaire: Formulating the problem and developing a protocol to identify, appraise and collate evidence. The methods that will be used to answer the question are decided before gathering the necessary data and drawing inferences.
  • Literature search: A laborious literature search strategy is applied to summarize the available scientific evidence about a topic; we perform a protocoled systematic search through literature databases like PubMed, EMBASE and the Cochrane library.
  • Assessment of Quality: A protocol for carrying out a review is equivalent to, and as important as, a protocol for a primary research study. A review is less likely to be biased if the questions are well developed beforehand, the eligibility of a study is determined by screening the titles and abstracts of search results for relevance and adherence to a predefined set of inclusion and exclusion criteria, and retrieve full text versions of elected papers and reports.
  • Summary of evidence: We adhere to PRISMA guidelines for systematic literature reviews, and when appropriate we also use the guidelines issued by local health authorities.
  • We then write a comprehensive summary of all included material, focusing on the research question of the review.
  • We subject our reviews to sensitivity analysis to ensure the assumptions or decisions made have a major effect on the results of the review.

MarksMan Healthcare Solutions distinguishes between the types of systematic reviews offered to address specific client need, some of our services include:

  • Clinical systematic review of randomized control trial data
  • Systematic review of observational studies, to assess real-world effectiveness or safety
  • Systematic review of economic analysis, utility weights, resource use and costs
  • Systematic review of health-related quality of life
  • Systematic review of burden of disease
  • Systematic review of patient-reported outcomes
  • Systematic review of epidemiologic studies
  • Systematic review of economic models (incidence, prevalence, risk factors)
  • Systematic review of clinical guidelines or HTA submissions in a particular therapeutic area

Meta-analysis

Meta-analysis refers to a group of statistical techniques to combine results from multiple studies, to obtain a quantitative estimate of the overall effect of a particular technology on a defined outcome.

The use of meta-analysis in determining the cost and clinical effectiveness of your product may produce a stronger conclusion than can be provided by any individual study.

The purpose of meta-analysis is to:

  • Encourage systematic organization of evidence
  • Increase statistical power for primary end points
  • Increase general applicability (external validity) of findings
  • Resolve uncertainty when reports disagree
  • Assess the amount of variability among studies
  • Provide quantitative estimates of effects (e.g., odds ratios or effect sizes)
  • Identify study characteristics associated with particularly effective treatments
  • Call attention to strengths and weaknesses of a body of research in a particular area
  • Identify needs for new primary data collection

Types of meta-analysis
We offer specialized services in meta-analysis to suit your needs:

  • Direct comparisons (DC): Pair-wise meta-analysis are conducted using direct evidence to compare one treatment with another, or treatment v/s placebo.
  • Simple indirect comparisons (IC): Results of individual trials or pair-wise meta-analysis are used to conduct simple indirect comparisons via a common comparator.
  • Meta-regression: Meta-analysis adjusting for modifiers of treatment effect in the presence of heterogeneity.
  • Network meta-analysis (NMA): NMA can be used to produce summary measures of treatment effect for all interventions identified in a systematic review, taking into account both direct and indirect evidence.

Our Health Economics team has extensive experience in conducting systematic reviews and meta-analysis, and also have a wealth of experience in providing statistical services using industry standard statistical techniques and software packages, such as STATA 12, Winbugs and R.