Literature-based Research Services

IBM Watson Health Literature-based Research Services 1 Literature-based research services

Scientific reviews can address your research questions and inform primary studies and data analyses. If you require rigor in your research for peer-reviewed publications, regulatory submissions, and internal documentation, our team of experts and academically trained scientists can provide you with a variety of literature research solutions.

We work with you to develop the most appropriate design for your project.

Systematic reviews Market landscape assessment • Traditional • Gap analysis systematic reviews • Evidence mapping • Systematic reviews with meta-analysis Regulatory and market • Systematic reviews access support with network meta-analysis • Health technology • Umbrella reviews assessments • Comparative • Clinical Evaluation Reports effectiveness reviews • Global and regional value dossiers Custom reviews (non-systematic) Knowledge dissemination • Rapid reviews • Manuscripts • Targeted literature reviews • Presentation slide decks • Scoping reviews • Conference abstracts • Narrative reviews and posters

IBM Watson Health Literature-based Research Services 2 A systematic review follows a specific sequential process, designed Systematic reviews to eliminate bias, once research questions have been defined:

1 Develop protocol Systematic reviews are the foundation of evidence-based medicine. They are designed to synthesize all available information on a research question. 2 Run searches

Conducting a systematic review is like conducting a clinical research study, except data are collected from other studies 3 Screen records rather than directly from patients. 4 Extract data

5 Assess risk of bias Systematic reviews/meta-analyses

RCTs 6 Analyze data

Cohort studies 7 Synthesize evidence Case control studies

Cross-sectional studies Figure 2. Systematic review roadmap

Case series/case reports

Expert opinions/editorials 1. A protocol is created before starting the project, outlining detailed methods for each step of the review process.

Figure 1. Hierarchy of evidence, from least to most valid 2. Search strategies, including search terms, sources, and and reliable (adapted from Evans, 2003) any restrictions or filters to be applied, are developed and executed.

3. All articles identified by the searches are assessed for their relevancy to the research question(s) based on screening of (a) titles and abstracts and (b) full text articles.

4. Relevant data are extracted from each included study using custom-designed and pilot-tested forms to minimize bias and errors.

5. Risk of bias assessment is performed to evaluate the methodological quality of each included study.

6. Data analysis, including a detailed examination of all data elements using qualitative (how similar and/or different included studies are) and quantitative (meta-analysis) methods, is performed.

7. The evidence is synthesized from all included studies. The evidence synthesis is composed into a report detailing the methods and results.

IBM Watson Health Literature-based Research Services 3 Meta-analysis of treatments

A meta-analysis is performed as part of a systematic review Treatment A Study 1 to quantitatively synthesize the results of multiple studies. It tells you not only whether an intervention works, but also how well it works. In some cases, meta-analysis can suggest Treatment Effect 1, which patients may benefit most from a specific intervention. with confidence interval

Treatment B Why do a meta-analysis?

Treatment A • A meta-analysis provides • Their results may be Study 2 the best estimate of more generalizable than how effective or safe a individual studies because Treatment Effect 2, treatment is. It improves they include multiple with confidence interval the precision of your results studies with a variety because it uses more data of patient populations. than individual studies. Treatment B Meta-analyses may be • Because risks are often able to detect significant rare, they may be difficult differences between two to identify in small primary Treatment A treatments where individual studies. Meta-analysis Study 3 studies cannot. combines the available data and can provide Treatment Effect 3, • Meta-analyses help to the best evidence for with confidence interval explore trends in study risk-benefit analyses.* results based on study and patient characteristics, as well Treatment B as variations in treatments.

* Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews Treatment Effect 1 of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.handbook.cochrane.org.

Treatment Effect 2 Other types of meta-analysis Treatment Effect 3 Meta-analyses can be performed as part of systematic reviews of screening and diagnostic tests or the prevalence Meta-Analysis or incidence of a disease. They employ the same rigorous Treatment Effect and transparent steps and have the same advantages as meta-analyses of treatments.

Figure 3. Meta-analysis statistically combines the results of individual studies to give a single summary result

IBM Watson Health Literature-based Research Services 4 Network meta-analysis Umbrella reviews

Network meta-analysis (NMA), also called mixed treatment An umbrella review is a synthesis of existing systematic comparison (MTC), can be performed as part of a systematic reviews and meta-analyses. review to compare three or more treatments and rank their effects. The systematic reviews included in the umbrella review should include most, if not all, primary studies available. In some cases, systematic reviews may need to be performed or updated in conjunction with the umbrella review to ensure all relevant information is included. Treatment Treatment A A

Studies Studies comparing comparing Direct Indirect treatments treatments comparison comparison Why do an umbrella review? A and B A and B • It summarizes topic • It provides a ready means Treatment Treatment Treatment Treatment areas where there is an for busy decision makers B Studies C B Direct C established literature base to a gain quick and clear comparing comparison treatments and several systematic understanding of a large B and C reviews have already topic area and allow findings been performed. from multiple reviews to Figure 4. Direct and indirect treatment comparisons: Treatments A and be compared. C have both been compared with Treatment B in clinical trials (direct comparison), but never with each other. NMA allows us to evaluate the relative effect of Treatment A compared with Treatment C (indirect comparison). Comparative

Why do NMA? effectiveness reviews

• There are often several • NMA allows for the indirect treatments for a single comparison of treatments Comparative effectiveness (CE) reviews are a specific type condition. While traditional that have never been of systematic review. CE reviews examine exclusively active meta-analyses can help compared directly in interventions (i.e., excluding placebo and other types of clinical determine which of two clinical studies. questions). They are designed to inform healthcare decisions by treatments is better, providing evidence on the relative benefits and harms of different NMA can identify the best • NMA can help identify treatment options. Like other systematic reviews, they may or available treatment and gaps in the literature where may not include meta-analysis or NMA. give you a numerical no clinical trial has been value for how well each performed. treatment works. Why do a CE review?

CE reviews compare different treatments and products, communicate their value, and are useful for helping consumers, clinicians, payers, and policy makers make informed decisions.

IBM Watson Health Literature-based Research Services 5 Custom reviews Why do a custom review? Custom reviews are tailored to meet your needs. Although they do not follow the same strict methodological requirements as systematic reviews, they provide valuable information to those While systematic reviews have clearly defined methods to looking for an overview of treatments, screening and diagnostic reduce bias in gathering, summarizing, presenting, interpreting, tests, or a clinical specialty area. and reporting the research evidence, non-systematic reviews use less stringent methodology, omitting various methodological Benefits: requirements to balance comprehensiveness with limited time and resources. • Less resource intensive • Can address broader topics and, therefore, less costly or research questions The characteristics of custom reviews broadly overlap and take less time than systematic reviews and may be referred to as any of the following: • Can address new topics • Rapid reviews where little formal research • Targeted literature reviews has been completed • Scoping reviews • Narrative reviews Trade-offs:

• Increase in uncertainty; • Might be more susceptible Systematic custom reviews employ less to bias reviews The more steps omitted from the methodological rigor than Systematic Review Roadmap systematic reviews the lower the methodological Rapid rigor of the review reviews

Targeted A custom review might be best for you if: reviews • There are time constraints • The current state of a field Factors that reduce the rigor of a review: Scoping is not well understood Poorly defined research question reviews Vague eligibility criteria • Product teams need Limited search algorithm, use of search evidence to guide • Working definitions and restrictions or filters Narrative Single screening, data extraction, or risk reviews strategy and support conceptual boundaries of of bias assessment decision-making a topic or field are unclear Lack of risk of bias assessment Lack of qualitative synthesis Inappropriate analysis Conclusions not supported by results

Figure 5. The different types of literature reviews and the sliding scale of methodological rigor

IBM Watson Health Literature-based Research Services 6 More complex gap analyses also examine characteristics Market landscape of each identified study: assessment • Sample size • Designs • Consistency of results • Patient population or treatment setting Gap analysis • Quality

Gap analysis is used to determine where research was focused These complex gap analyses are best conducted after or absent in a specific clinical area or on specific medical performing a systematic review to ensure all relevant products. Knowing the research landscape can provide studies have been identified to inform the analysis. competitive intelligence. Knowing where research is weak or absent provides information about where future research is needed. Evidence mapping In their simplest form, gap analyses tally the number of studies examining specific outcomes and interventions. This evidence The results of a gap analysis are depicted in an evidence map, could inform companies about how to position their products. which displays the available literature and any additional characteristics of interest (e.g., study quality, sample size).

Treatment A

Treatment B

Treatment C

Treatment D

Treatment E

Treatment F

Outcome 1 Outcome 2 Outcome 3 Outcome 4 Outcome 5 Outcome 6

Low risk of bias Unclear risk of bias High risk of bias

Figure 6. Evidence map: In this figure, each circle represents one study that examines a treatment and an outcome. The size of the circle represents the number of patients (smaller circle means fewer patients). The color of the circle represents the quality of the study. This is an easy way to see where there are no studies (e.g., on Treatment A and Outcome 1), only low-quality studies (e.g., Treatment E and Outcome 3), or high-quality studies (e.g., Treatment F and Outcome 4). This figure is highly adaptable and can be used to represent the existing literature using any characteristics of interest.

IBM Watson Health Literature-based Research Services 7 Regulatory and market Clinical Evaluation Reports A Clinical Evaluation Report describes the safety and access support effectiveness of a medical device based on assessment and analysis of clinical data.

• Clinical Evaluation Reports • They also provide a Health technology assessment are based on the results comprehensive analysis of clinical studies of the current standard of Health technology assessment (HTA) represents a specific performed by the device care or best practice for field in which systematic reviews of clinical effectiveness manufacturer, an analysis the treatment for which the play a fundamental role in healthcare decision-making. of existing literature on the device is used (the “state medical device, or both. of the art”). HTAs differ from traditional systematic reviews in that they are often produced within a specific policy-making context • They are required for (e.g., reimbursement determinations) which has implications medical devices in Europe for timelines, tools, and resources. HTA can cover a range and are performed in of fields, including: strict adherence to the European Medical Device • Clinical effectiveness and safety Vigilance System (MEDDEV) • Cost-effectiveness and budget impact requirement. • Organizational and social aspects • Ethical and legal issues

IBM Watson Health Literature-based Research Services 8 Global and regional Academy of Managed Care Pharmacy dossiers An Academy of Managed Care Pharmacy (AMCP) dossier is value dossiers a single-source document that communicates clinical, safety, economic, and quality-of-life value propositions to payers and providers. Global value dossiers Pharmaceutical, biotechnology, and device companies present AMCP dossiers to private insurance companies when seeking Global value dossiers (GVDs) seek to present all available data coverage decisions for their products in the United States. on a specific product. They are updated frequently to ensure the These companies may also use similar dossiers when seeking information included is comprehensive and current. They are coverage determinations. used by pharmaceutical, biotechnology, and device companies when seeking coverage decisions. An AMCP dossier:

A GVD: • Follows a format outlined • May be submitted prior to in “The AMCP Format for FDA approval with publicly • Is used to communicate • May be used internally for Formulary Submissions” available information and the value of a product product launch education updated upon FDA approval to global payers • Is used by healthcare decision-makers, including • Is a powerful tool to present • Uses a modular format health plans, hospital cost and comparative to report clinical benefit, systems, and payers, effectiveness data budget impact, and to guide formulary cost-effectiveness of considerations and pharmaceuticals, tests, support coverage and or medical devices reimbursement decisions for drugs (pharmaceuticals, biologics, and vaccines), Why do a GVD? tests, and medical devices

• To assist with global • To communicate the reimbursement value of your product Why do an AMCP dossier? • To gather all evidence • To use as a resource about your product into for your employees • AMCP dossiers can be used • Payers want concise a single document as a key source of evidence dossiers, submitted as soon for payers as possible and updated as quickly as possible

IBM Watson Health Literature-based Research Services 9 Knowledge Our Team

dissemination Our methodological experts collaborate on all projects to deliver the highest quality work. Collectively, they have published more When you are ready to disseminate your research findings than 200 peer-reviewed articles and contributed to hundreds to a variety of audiences and stakeholders, we can help of systematic reviews. In addition, our team has conducted you prepare the following: research focused on understanding and improving systematic review methodology. They have extensive experience in a variety of clinical areas, including oncology, obesity, psychology and psychiatry, rheumatology, eyes and vision, public health, Manuscripts infectious diseases, and cardiovascular health. Our team will work with you every step of the way to determine the best Whether you want to disseminate your findings in a white paper approach for your project, develop a research plan, and deliver or a manuscript in a highly ranked peer-reviewed publication, we the best possible product. have expertise to write the manuscript that will suit your needs.

For more information, please contact: Presentation Slide Decks [email protected] If you need to turn your research into a slide presentation for internal ibm.com/life-sciences and/or outside stakeholder communication, we can create impactful content and graphics.

Conference abstracts and posters

If you need help preparing an abstract or poster for a conference, we can summarize your findings and turn them into a conference abstract or an eye-catching poster ready to be presented to the scientific community, the general public, or any other stakeholder.

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IBM Watson Health Literature-based Research Services 11 Notes

IBM Watson Health Literature-based Research Services