Guidelines

Augment PRO data with contextual information

Augmenting PRO data with additional relevant information can add context and meaning to ePRO reports to enhance understanding and usefulness for patient monitoring and decision-making.

Strategy A
Include key augmenting information in ePRO reports to enhance understanding of patient context and meaning of PRO data

Various information sources (e.g., clinical data, practice guidelines) may be relevant and useful for augmenting PRO data to provide a holistic view of patient status. For example, annotating ePRO reports with clinical data (e.g., time of surgery) and demographic data can facilitate their usefulness, particularly in contexts involving an intervention (see Figure 4F). In addition to clinical data, there are many forms of contextual information (e.g., dates, qualitative score labels, timing of interventions, descriptive notes about patient scores) that may help contextualize PRO data presented in ePRO reports, as illustrated in Figures 4G and 4H.

Figure 4F–4H

Figure 4F: Clinical parameters (in red box) supplement PRO data presented in graphs

Graphic showing a patient's clinical parameters such as age, smoking status, etc. alongside bar charts showing their disability, back pain, and leg pain scores.

Figure 4G: Supplemental contextual information in red boxes

Graphic showing a patient's QOL scores on a bar graph with the axes labeled with scale anchor points and the intervention date notated.

Figure 4H: Descriptive text - showing minimal clinically important difference

Graphic showing mean improvement in back and leg pain scores on bar charts, with MCID indicated on both.

The most relevant data to add will depend upon the clinical context, diagnosis, and other factors. Table 4D lists options to consider for supplementing reports with contextual information in various clinical contexts.

Table 4D: Strategy considerations for contextual information in a clinical context
Strategy Consideration PRO Tips
Minimal clinically important difference (MCID) MCIDs (as opposed to statistically significant differences) reflect changes in a clinical intervention that are meaningful for the patient (i.e., may result in a change in patient management). Indicating MCID with a visual cue (See Figure 4H) can help providers discern meaningful changes in PRO scores.
Logistical information

Logistical information about the collection of the PRO score can help to facilitate accurate interpretation. Such information may include:

  • Date of score
  • Date of intervention
  • Time before/since intervention
  • Annotation of baseline score
  • Reference values/text to anchor PRO score to context (e.g., severity level)
Scale interpretation cues

Contextual information to help interpret PRO scales may include:

  • A key or legend describing scoring method
  • Reference values/text to anchor PRO score to context (e.g., severity level – such as minimal, moderate, severe, crippling, bedridden)
  • Upper and lower normal range thresholds
Cues to designate improved versus worsening score

An increase in score for certain PRO instruments represents a positive change, whereas on other instruments, an increase in score may represent a decline. Visual cues to provide clarity may include:

  • Reference values
  • Clinical qualitative definitions (e.g., severe)
  • Color to distinguish between positive and negative score changes (see Enhance Key Information guideline regarding use of color)
  • Percentile scores
Additional patient-provided data

Patient-provided data that can aid in accurate interpretation may include:

  • Photographs (series over time has been noted as particularly useful)
  • Qualitative statements that accompany a score allowing the patient to provide additional explanation of symptoms and activities
Clinical data

Data from the patient’s health record can support a more complete picture, enabling decision-making related to clinical program development and modification. Data may include:

  • Intervention (e.g., medication prescribed, type of surgery)
  • Additional providers within the patient’s care network
  • Discharge symptoms (e.g., temperature, pain level, wound drainage)
  • Clinical conditions (e.g., diagnostic code, chronic conditions)
  • Demographic details
  • Lifestyle information (e.g., smoking)
  • Hospital admit and discharge
  • Lab results
  • Medical event (e.g., stroke)
  • Range of motion assessments
  • Vital signs and biomarkers (e.g., body mass index, blood pressure level)
Response instructions Possibilities for enhancing score representation include augmenting graphical information with guidance on how to respond to scores or changes in scores. For example, these might include indications that additional diagnostics or consultation with a specialty care provider may be helpful.

Some of the prevailing challenges are listed below, along with tactics to consider to address these challenges:

Challenges and Tactics Contextualize Data

Challenges

  • Including MCID: Not all PRO scores have MCIDs available, or existing MCIDs may be difficult to apply.
  • Customization requirements: Some systems require customization to include information to augment PRO data.
  • Balancing quantity of augmenting information: Too much information can contribute to “visual clutter.”

Tactics

  • Consider whether MCID adds meaningful information for clinical decision making.
  • Determine system capabilities for augmenting PRO data. Weigh process and costs to benefits of customization.
  • Determine what additional information is key to the clinical process to avoid clutter.

For additional insight on how to augment PRO data with clinical data on ePRO reports, see Recommended Resources related to: