Module 1: The Role of Systematic Reviews in HTA and Market Access

HTA bodies, regulators and payers expect structured, transparent evidence synthesis as the basis for coverage, reimbursement and procurement decisions. This module explains why systematic reviews carry such importance.

• the methodological standards expected by NICE, G-BA, HAS and other agencies, and how these differ from the less formal evidence summaries
• where systematic reviews sit in the evidence hierarchy and how they relate to rapid reviews, scoping reviews and targeted literature reviews
• the specific challenges of systematic reviewing in medical devices and diagnostics — small trial sizes, heterogeneous comparators, device iteration and sparse evidence bases
• an overview of the systematic review lifecycle from protocol registration through to publication and the key decision points where commissioners need to engage

Module 2: Framing the Question and Developing the Protocol

A systematic review stands or falls on the precision of its research question and the rigour of its protocol. This module covers the structured frameworks used to define a review question and the process of developing, refining and registering a protocol that will guide every subsequent stage.

• structuring the research question using PICO, PICOS and related frameworks — and why the choice of comparator and outcomes matters more than most people realise
• developing an a priori protocol — what it should contain, how much flexibility to build in and why deviations need documenting
• registering the protocol on PROSPERO — why registration matters for credibility and what HTA bodies expect to see
• defining inclusion and exclusion criteria that are specific enough to be reproducible but broad enough to capture the relevant evidence

Module 3: Designing and Executing the Search Strategy

The search strategy determines what evidence a review will find — and what it will miss. This module covers the principles of designing a comprehensive, reproducible search across multiple databases and grey literature sources.

• combining free-text terms, controlled vocabulary and Boolean operators across MEDLINE, Embase, the Cochrane Library and specialist device registries
• the role of grey literature, conference abstracts, regulatory submissions and company-held data
• balancing sensitivity and precision — designing a search that satisfies peer reviewers and HTA bodies without generating unmanageable volumes of irrelevant records
• how AI-powered search and deduplication tools are changing the efficiency of this stage — what works now and where human oversight remains essential

Module 4: Screening, Study Selection and Data Extraction

With potentially thousands of records identified, the review team must screen titles, abstracts and full texts against pre-defined eligibility criteria, then extract data from included studies consistently. This module covers the methodology and practical management of these labour-intensive stages.

• title and abstract screening — applying eligibility criteria consistently, managing disagreements between reviewers and documenting the process for PRISMA reporting
• full-text screening and the PRISMA flow diagram — recording reasons for exclusion and maintaining a transparent audit trail from search results to included studies
• designing extraction forms, deciding what to extract and ensuring consistency across reviewers, with attention to the heterogeneous reporting common in device studies
• how AI-assisted screening and extraction tools can accelerate these stages — current capabilities, validation requirements and the quality assurance protocols needed

Module 5: Assessing Risk of Bias and Certainty of Evidence

Not all included studies are created equal. This module covers the tools used to assess risk of bias in individual studies and the certainty of the overall body of evidence — assessments that directly determine how much weight HTA bodies place on a review’s conclusions.

• risk of bias at the study level — using the Cochrane Risk of Bias tool (RoB 2) for randomised trials and ROBINS-I for non-randomised studies, with examples from the device literature
• common sources of bias in device studies — learning curves, operator effects, lack of blinding, single-centre designs and industry sponsorship
• appraising certainty using the GRADE framework — understanding the five domains (risk of bias, inconsistency, indirectness, imprecision and publication bias)
• presenting GRADE assessments — Summary of Findings tables, the four-circle certainty rating and how these outputs feed into HTA decision-making

Module 6: Narrative Synthesis and Reporting

When meta-analysis is not appropriate — which is common in the device literature — narrative synthesis provides the structured alternative. This module covers how to synthesise evidence qualitatively and report the review to the standards expected by peer reviewers and HTA bodies.

• when narrative synthesis is required — the conditions under which pooling data statistically is inappropriate and what structured narrative synthesis involves
• organising findings thematically — by outcome, intervention or population rather than study-by-study — using evidence tables and visual summaries to support interpretation
• reporting to PRISMA 2020 standards — the checklist items that peer reviewers and HTA bodies scrutinise and the most common reporting failures that lead to rejection
• presenting conclusions in HTA submissions, value dossiers and clinical evaluation reports so that the implications for coverage and reimbursement are clear

Module 7: Meta-Analysis — Pooling, Interpreting and Presenting Quantitative Evidence

When included studies are sufficiently similar, meta-analysis produces a statistical synthesis that is more precise than any individual study. This module covers how meta-analyses work, how to interpret their outputs and how to select the right approach — including proportional meta-analysis for single-arm studies reporting event rates.

• the logic of meta-analysis — how pooling produces a more precise estimate of effect, the assumptions that must hold and the distinction between fixed-effect and random-effects models
• reading forest plots — understanding pooled effect sizes, confidence intervals, weighting, heterogeneity (I² and τ²) and what a prediction interval adds that a confidence interval does not
• proportional meta-analysis — when and why to pool proportions rather than comparative effect sizes, and why this matters where the evidence consists of single-arm case series and registry studies
• subgroup analyses, sensitivity analyses and funnel plots — when these should be pre-specified versus exploratory, how to assess publication bias and a brief introduction to indirect comparisons and network meta-analysis

Module 8: Systematic Reviews of Economic Evaluations

Reviewing published economic evaluations is an increasingly important component of HTA submissions and market access strategies. Drawing directly on real-world practice, this module covers the distinct methodology involved.

• why systematic reviews of economic evaluations matter — how HTA bodies use them to contextualise de novo models and assess whether existing evidence supports a product’s value proposition
• methodological differences from clinical systematic reviews — searching health economics databases (NHS EED, CEA Registry, EconLit), different eligibility criteria and the challenges of synthesising studies with different model structures
• quality assessment using CHEERS 2022 and the Drummond checklist — appraising methodological quality and transferability across healthcare systems and jurisdictions
• presenting findings for HTA and market access — summarising cost-effectiveness evidence to support the economic case and anticipate the questions HTA committees will ask