Brief Overview of the Guideline Methods

This page includes a brief overview of the methods used to develop the fourth edition Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline.

The fourth edition of the International PI Guideline was developed using GRADE methodology, as outlined in detail in the GRADE Handbook. The GRADE approach to guideline development is the gold standard for international guidelines. In brief, the GRADE process includes:

  • Establishing clinical questions using a PICO format that focus on a comparison between two interventions (or an intervention and usual care/placebo).

  • Conducting PICO searches for studies (Tiers 1, 2 and 3 evidence). The guideline project uses a broad search strategy to scope the full body of PI-related literature, and then a PICO search within that body of evidence (as well as additional PICO searches).

  • Conducting risk of bias assessment for individual studies

  • Performing the GRADE Certainty of Evidence evaluation

  • Completing an Evidence to Decision Framework

  • Reaching agreement on a recommendation

  • Determining the Strength of Recommendation

Looking for more information? Check these detailed descriptions of the guideline development methods:

Evidence for clinical questions was selected using a hierarchy pyramid. The simplified pyramid outlines the study designs considered for intervention studies (that is, studies exploring an intervention). Selection of evidence for clinical questions associated with diagnosis and assessment is described in the full methodology.

Tiers of evidence

Risk of bias assessment

The methodological quality of studies was evaluated by the Core Review Group (CRG). Where a meta-analysis or systematic review addressing the clinical question was identified and considered eligible for inclusion based on the risk of bias assessment, the risk of bias assessment of individual studies that was published in the eligible meta-analysis or systematic review was used. The following recognized ROB tools were used for risk of bias assessments conducted by the CRG:

Need more information about risk of bias assessment? Watch this video on using risk of bias assessment tools.

Data Analysis and Certainty of Evidence

Data was extracted from the studies data using a standardized table that included study tier, description of participants, interventions and comparator, outcome measures, length of follow up, and the study results in the form of effects estimates (i.e. a risk ratio or odds ratio).

When no meta-analysis meeting the inclusion criteria was identified, the CRG used RevMan to perform a meta-analysis. Where there was an existing meta-analysis addressing the clinical question, the data from that analysis was used. If additional studies meeting the meta-analysis inclusion criteria had been published, the CRG incorporated these into the existing meta-analysis. Meta-analysis results were imported into Summary of Findings (SoF) tables. You can access the meta-analysis for evidence-based recommendations in the Process documents inked throughout the guideline chapters.

The CRG and GGG evaluated the SoF tables using GRADE methods to determine the Certainty of Evidence (CoE). The CoE reflects the extent of confidence the GGG has that an estimate of the effect is adequate to support a particular recommendation. In determining the CoE, consideration is given to:

An analysis of RCTs commences at a CoE of HIGH and is downgraded where there are concerns regarding any of the components listed above. In the evidence summaries provided in the guideline chapters, the term “downgraded” refers this process. If there are no RCTs in the analysis, the CoE commences at LOW and will be downgraded using the same evaluation process, or may be upgraded based on magnitude of effect, opposing plausible residual bias or confounding, or dose-dependent gradient. The final CoE will be high, moderate, low or very low. This is indicated through the guideline chapters using the symbols to the right.

You can access the CoE assessments in the Process documents linked throughout the guideline chapters.

Need more information about Certainty of Evidence? Watch this video on how factors considered in a Certainty of Evidence evaluation.

Evidence to Decision Frameworks

Evidence-to-Decision (EtD) frameworks were used to consider the full body of evidence to assist the GGG in reaching a recommendation and determining its strength in the most transparent manner possible.

The EtD framework includes: the CoE the value that stakeholders place on the potential benefit of an intervention, desirable and undesirable effects of the intervention, cost implications, and feasibility and acceptability to stakeholders. Evidence on the EtD framework came from:

The full EtD frameworks are available for all the evidence-based recommendations. You can access these using the navigation menus.

Need more information about Evidence to Decision Frameworks? Watch this video on how different factors are considered when making recommendations.

Strength of Recommendation

The GGG used the EtD Frameworks to reach agreement on whether to make a recommendation, and if so, how certain they were that the recommendation would do more good than harm for the majority of individuals. Within the GRADE methods, five types of recommendations are defined, as detailed in the table to the right. Additionally, the GRADE methods suggest that a strong recommendation should generally not be made when the certainty of evidence is low, although some cases where this is acceptable are defined. When the GGG has made a strong recommendation based on low certainty of evidence, a specific justification is made. (See GRADE table 6.3).

Note that the wording of each recommendation indicates its strength, as indicated in the table.

Supporting Implementation

The evidence based recommendations in the guideline address specific clinical questions. These cannot provide an overview of the comprehensive and detailed clinical care that is required to prevent pressure injuries. Many areas of clinical practice have not yet been explored (or may not ever be!) using appropriate designs for meta-analysis. However, clinicians still require practical guidance. To bridge this gap, the guideline includes good practice statements and implementation considerations.

Good Practice Statements

The Guideline Governance Group has made good practice statements to cover gaps in the recommendations. Good practice statements describe clinical care for which there is a high level of certainty that the practice will do more good than harm, but for which there is not a substantial body of direct evidence. This might be because it is not possible to conduct comparative research, or because the clinical issue is based on indisputable best clinical care practices, or because the evidence is indirect (e.g. benefits such as reduced pressure or increased tissue perfusion are demonstrated, but direct evidence of reducing PI occurrence is not available).

Implementation Considerations

Implementation considerations provide guidance on how a recommendation or good practice statement should be implemented, for example describing how, when, where, who or how often to implement a recommended practice, or core principles to consider. The implementation considerations are based on comparative and observational studies, and the practical experience and knowledge of the Expert Panel Groups.