To establish a standardised protocol for using blood biomarkers to predict stroke recovery outcomes. This study looks at the feasibility of creating a theoretical framework and selecting the appropriate biomarkers among many blood biomarkers that are important for stroke rehabilitation, for a particular patient, Based on its biomarker profile, systemic personalised rehab is envisaged as a system biology approach to be created by a team of physiotherapists along with neurologists, nutritionists, and biotechnologists in an OPD setting at a tertiary care centre in a developing nation.
Scope: This SOP applies to healthcare professionals involved in stroke patient care.
Step Frame work
1. Biomarker Selection: Choose biomarkers with established evidence linking them to stroke recovery outcomes. Examples:
- Neurofilament light chain (NfL)
- Tau protein
- S100B
- C-reactive protein (CRP)
- Interleukin-6 (IL-6)
2. Blood Sample Collection: Standardize blood sampling procedures:
- Timing: Acute phase (0-72 hours), subacute phase (7-14 days), and chronic phase (≥ 30 days)
- Volume: 5-10 mL
- Tube type: Serum or plasma
- Storage: -80°C freezer
3. Biomarker Measurement: Utilize validated assays:
- Enzyme-linked immunosorbent assay (ELISA)
- Multiplex bead arrays
- Mass spectrometry
4. Data Analysis: Apply statistical models to correlate biomarker levels with stroke recovery outcomes:
- Multivariate regression
- Machine learning algorithms
- Receiver operating characteristic (ROC) curves
5. Interpretation: Establish cutoff values for biomarkers:
- Dichotomize patients into high/low risk groups
- Predict recovery outcomes (e.g., modified Rankin Scale)
6. Clinical Integration: Incorporate biomarker results into stroke care pathways:
- Inform rehabilitation strategies
- Guide pharmacological interventions
- Enhance patient counseling
SOP Steps:
1. Patient identification and consent
2. Blood sample collection and processing
3. Biomarker measurement and analysis
4. Data interpretation and reporting
5. Clinical decision-making and integration
6. Documentation and quality control
Quality Control:
1. Regular assay validation
2. Inter-laboratory comparisons
3. Proficiency testing
4. Biomarker stability monitoring
Training and Competency:
1. Healthcare professionals: Familiarization with SOP and biomarker interpretation
2. Laboratory personnel: Training on assay protocols and quality control
Revision and Update:
1. Regular review of literature and updates on biomarker evidence
2. Revision of SOP as needed
.Summary
Patient Assessment
1. Initial evaluation: medical history, physical exam, imaging studies
2. Blood sampling: acute phase (0-72 hours), subacute phase (7-14 days), and chronic phase (≥ 30 days)
II. Biomarker Analysis
1. Laboratory testing: ELISA, multiplex bead arrays, or mass spectrometry
2. Data interpretation: correlate biomarker levels with stroke severity and outcomes
created the following framework
1. Regular review of biomarker data and treatment outcomes created personalised treatment
2. Quality improvement initiatives: optimize biomarker testing, rehabilitation protocols
Interdisciplinary Collaboration: new Research studies: investigate novel biomarkers, rehabilitation strategies
Interdisciplinary collaboration and communication
Enhanced personalized medicine
