How To Select An Intervention?

Selecting an appropriate clinical intervention requires a thorough understanding of the available types and levels of evidence and how it applies to individual patients.

According to the 6S hierarchy of evidence, as published by DeCenso et al. (2009), there are six distinct levels of evidence designed to guide clinical decision-making: Single Studies, Synopses of Studies, Syntheses (such as systematic reviews and meta-analyses), Synopses of Syntheses, Summaries (including clinical guidelines), and Systems (integrated clinical decision-support systems). This hierarchy of evidence starts with single studies at the base and progresses up to systems at the top, providing a clear structure for accessing the most relevant and reliable information. As you move up the levels from single studies to systems, the evidence becomes more synthesized and directly applicable to patient care. This approach helps you make more efficient and effective clinical decisions by using the best available evidence.

Figure 1: The 6S Hierarchy of Evidence (From: DiCenso A et al. 2006).

Next, when selecting an intervention from available evidence, it is important to match your patient’s characteristics with those of the study cohort to ensure the findings are applicable. This involves comparing factors such as age, gender, comorbidities, disease severity, and treatment history. Understanding the inclusion and exclusion criteria of studies helps determine whether the evidence is relevant to your patient, thereby enhancing the likelihood of a successful outcome.

Below is a structured approach to selecting an intervention, utilizing various levels of evidence from single studies to comprehensive guidelines.

1. Single Studies

Single studies are original research investigations such as a randomized controlled study or a cohort study designed to answer specific clinical questions. They provide unique insights into particular clinical scenarios, offering detailed data on methodologies, populations, and outcomes. However, single studies can vary in quality, and their findings may not always be generalizable. Therefore, clinicians should critically appraise these studies for their validity, impact, and applicability before applying their results to patient care.

Example Reference: A randomized controlled trial by Moseley et al. (2004) examined the effects of intensive neurophysiology education on patients with chronic lower back pain and found significant improvements in pain cognition and physical performance compared to back school type education.

2. Synopses of Single Studies

Synopses of single studies provide concise summaries of the evidence from high-quality individual studies. These synopses are designed to highlight the main findings and implications for clinical practice, often with a critical appraisal of the study’s strengths and weaknesses. Evidence-based abstract journals, such as Evidence-Based Medicine and ACP Journal Club, are valuable resources for accessing these synopses. They offer quick and reliable information to help clinicians make informed decisions without needing to review the full text of original studies.

Example Reference: An abstract in the ACP Journal Club (Kirshner HS, 2010) summarized the findings of a randomized trial (Gitlin LN et al. 2010) on patients with dementia and their caregivers (dyads) that a nonpharmacologic biobehavioral environmental intervention led to better outcomes for community-living dyads at the 4-month follow-up compared to the control group.

3. Syntheses

Syntheses, commonly known as systematic reviews and meta-analysis, provide a comprehensive summary of all the available evidence on a specific research question. They employ rigorous methodologies to identify, appraise, and synthesize studies to provide an overall conclusion. Systematic reviews are highly valued in clinical decision-making because they reduce bias and provide a higher level of evidence than individual studies.

A meta-analysis is a statistical method used within systematic reviews to quantitatively combine results from multiple studies addressing the same question, providing a more precise estimate of treatment effects. Meta-analyses often include a forest plot, which visually represents the individual and combined results of the studies. They also consider heterogeneity, or the degree of variability among study results, which can influence the overall conclusions. An assessment of publication bias, which occurs when studies with positive results are more likely to be published, is also critical in meta-analyses.

Example Reference: A systematic review and a meta-analysis by Zecheng Li et al. (2024) on the effectiveness of aerobic exercise for patients with stroke concluded that moderate and vigorous aerobic exercise significantly improves cognitive and walking ability of patients with stroke compared to low intensity routine exercises, with evidence from 15 randomized controlled trials.

4. Synopses of Syntheses

Synopses of syntheses summarize the information found in systematic reviews, drawing conclusions from evidence at lower levels of the evidence pyramid. These synopses often provide enough information to support clinical actions without needing to review the full systematic review. They are useful for clinicians who need quick, evidence-based summaries to guide decision-making.

Example Reference: A synopsis in Translational Behavioral Medicine by Johnston et al. (2014) summarized a systematic review by Fanning et al. (2012) on increasing physical activity using mobile devices, concluding that the review provides a solid foundation for developing effective mobile-based interventions to improve health behaviors.

5. Summaries

Summaries are regularly updated clinical guidelines or textbooks that integrate evidence-based information about specific clinical problems. These resources are often developed by expert panels and provide comprehensive guidance on diagnosis, management, and follow-up. Summaries are invaluable for clinicians as they consolidate vast amounts of information into practical recommendations.

Example Reference: The National Clinical Guidelines by Stochkendahl MJ et al. (2018) on the treatment of recent onset low back pain or lumbar radiculopathy provide an evidence-based summary of recommended practices, including the use of physical therapy, medications, and lifestyle modifications.

6. How To Select An Intervention From Research Evidence?

6.1 Step-by-Step Process of Selecting An Intervention and Applying Evidence From A Single Study

In this section, I will break down the process of selecting and applying evidence from a single study such as a Randomized Controlled Trial (RCT) to a clinical scenario. This involves matching your patient’s characteristics and clinical situation with the study cohort, intervention, and outcomes.

The example below focuses on the study by Moseley et al. (2004) that examined the effects of intensive neurophysiology education on patients with chronic lower back pain.

Step 1: Identify the Clinical Question

Before applying evidence from a study, it is essential to define a clear clinical question that addresses the specific needs of your patient. This question should be structured using the PICO format (Patient, Intervention, Comparison, Outcome).

Patient: Adults with chronic lower back pain
Intervention: Intensive neurophysiology education
Comparison: Standard back school type education
Outcome: Improvement in pain cognition and physical performance

Clinical Question: “In adults with chronic lower back pain, does intensive neurophysiology education improve pain cognition and physical performance more effectively than standard back school education?”

Step 2: Search for Relevant Evidence

Conduct a literature search to find studies that answer the clinical question. Use databases like PubMed, Cochrane Library, and MEDLINE to search for relevant research. For this example, the study by Moseley et al. (2004) was identified as relevant because it specifically investigates the effect of an educational intervention on patients with chronic lower back pain.

Step 3: Critically Appraise the Study

Critically appraising the study is important to determine its validity, reliability, and applicability to your patient.

Consider the following aspects:

1. Study Design:
Moseley et al. conducted a randomized controlled trial (RCT), which is considered a high level of evidence for determining the efficacy of interventions. RCTs reduce bias by randomly assigning participants to intervention or control groups.

2. Population and Sample Size:
The study included adults with chronic lower back pain. Review the inclusion and exclusion criteria to ensure the study population matches your patient’s characteristics. Assess the sample size to determine if it is sufficient to detect a statistically significant difference between groups.

3. Intervention and Comparison:
The intervention was intensive neurophysiology education, and the comparison was standard back school education. Review the specifics of each intervention to ensure that the study’s definition aligns with your planned clinical intervention.

4. Outcome Measures:
The study measured outcomes in pain cognition and physical performance. Ensure these outcomes are relevant to your clinical question and that they were assessed using valid and reliable methods.

5. Results and Statistical Analysis:
Review the study’s results to determine whether the intervention had a statistically and clinically significant effect on the outcomes. Check for the use of appropriate statistical analyses and whether confidence intervals and p-values are reported.

6. Limitations and Bias:
Consider any limitations or potential biases in the study. Moseley et al. (2004) may have limitations such as participant adherence, the generalizability of findings, or biases in reporting outcomes.

7. Standardized Methodological Quality Assessment:
Consider using standardized methodological quality assessment tools such as the PEDro scale to assess the methodological quality of randomized controlled trials (RCTs). A trial is considered to have moderate to high quality if it scores at least 6 out of 10 on this scale. The PEDro score for the study “A randomized controlled trial of intensive neurophysiology education in chronic low back pain” by Moseley et al. is 6 out of 10, indicating a moderate quality of methodological rigor.

I have explained the steps to follow while critically appraising a randomized controlled study in detail here.

Step 4: Determine Applicability to Your Patient

Compare the study’s population, intervention, and outcomes to your patient’s characteristics and clinical situation:

Patient Characteristics: Ensure your patient’s age, gender, comorbidities, and chronicity of pain match those of the study population.

Relevance of Intervention: Confirm that the neurophysiology education intervention described in the study is feasible in your clinical setting and aligns with your treatment goals.

Relevance of Outcomes: Check that the outcomes measured in the study (pain cognition and physical performance) are relevant to your patient’s goals and health status.

Step 5: Apply the Evidence to Your Patient

If the study is applicable, integrate the evidence into your patient’s care plan:

1. Discuss with the Patient:
Explain the evidence from the study to the patient, including the potential benefits and risks of the intervention. Discuss how the intervention might improve their pain cognition and physical performance.

2. Develop a Care Plan:
Based on the study’s findings, incorporate intensive neurophysiology education into your patient’s treatment plan. Adjust the educational content and delivery method to match the patient’s preferences and needs.

3. Implement the Intervention:
Provide the neurophysiology education intervention as outlined in the study. This may involve a structured program with specific content, duration, and delivery format.

4. Monitor and Evaluate:
Continuously monitor the patient’s progress and evaluate the effectiveness of the intervention. Use the same outcome measures (pain cognition and physical performance) as in the study to assess improvements and adjust the care plan as needed.

By following these steps, clinicians can ensure that they are selecting appropriate clinical interventions based on the best available evidence and that they are applying this evidence in a way that is tailored to their individual patient’s needs and circumstances.

6.2 Step-by-Step Process of Selecting An Intervention and Applying Evidence From A Synthesis (Systematic Review And Meta-Analysis) Of Evidence

In this section, I will break down the process of selecting and applying evidence from a synthesis of evidence such as a meta-analysis to a clinical scenario. This involves matching your patient’s characteristics and clinical situation with the meta-analytic study cohort, intervention, and outcomes.

The example below focuses on the systematic review and meta-analysis by Zecheng Li et al. (2024), which evaluated the effectiveness of moderate and vigorous aerobic exercise for patients with stroke.

Step 1: Identify the Clinical Question

The first step in applying evidence from a systematic review or meta-analysis is to clearly define your clinical question. This can be done using the PICO format (Patient, Intervention, Comparison, Outcome).

Patient: Patients with stroke
Intervention: Moderate and vigorous aerobic exercise
Comparison: Low-intensity routine exercises
Outcome: Improvement in cognitive function and walking ability

Clinical Question: “In patients with stroke, does moderate and vigorous aerobic exercise improve cognitive function and walking ability more effectively than low-intensity routine exercises?”

Step 2: Search for Relevant Syntheses

Conduct a search for systematic reviews and meta-analyses that answer your clinical question. Use databases like Cochrane Library, PubMed, and PEDro to find relevant syntheses. In this example, the systematic review and meta-analysis by Zecheng Li et al. (2024) was identified as relevant because it comprehensively examines the impact of aerobic exercise on cognitive and physical outcomes in stroke patients.

Step 3: Critically Appraise the Synthesis

Before applying the findings from the systematic review and meta-analysis, it is important to critically appraise the synthesis to ensure it is trustworthy and applicable.

1. Quality of the Review:
Search Strategy: Check that the systematic review used a comprehensive and reproducible search strategy, covering multiple databases and including both published and unpublished studies with positive and negative findings to minimize publication bias.
Study Selection: Ensure that the inclusion and exclusion criteria for studies were clearly defined and appropriate for the clinical question.
Assessment of Bias: Look at how the review assessed the risk of bias in the included studies, such as using tools like the Cochrane Risk of Bias tool.

2. Relevance of the Studies Included:
Population: Review whether the populations in the included studies match your patient’s characteristics. For instance, consider the age, gender, severity of stroke, and comorbidities of the study participants.
Intervention: Examine whether the types of aerobic exercises used in the studies (e.g., walking, cycling, swimming) are feasible and relevant for your clinical setting.
Outcomes: Ensure that the outcomes measured in the review, such as cognitive function and walking ability, are relevant to your clinical question and patient goals.

3. Heterogeneity:
Review the level of heterogeneity reported in the meta-analysis. High heterogeneity (I² > 50%) indicates significant variability among study results, which could affect the generalizability of the findings. Consider whether the sources of heterogeneity were explored and addressed.

4. Publication Bias:
Check if the meta-analysis assessed publication bias, such as using funnel plots or statistical tests (e.g., Egger’s test). If publication bias is detected, consider how it might influence the results.

Step 4: Determine Applicability to Your Patient

Evaluate whether the findings of the systematic review and meta-analysis are applicable to your specific patient:

Patient Characteristics: Compare the demographics and clinical characteristics of your patient to those in the included studies. If your patient closely matches the study populations, the findings are more likely to be applicable.

Relevance of Intervention: Assess whether the aerobic exercise protocols studied in the review are feasible and appropriate for your patient, considering their current physical condition and functional abilities.

Relevance of Outcome: Ensure that improving cognitive function and walking ability are priority goals for your patient’s rehabilitation.

Step 5: Apply the Evidence to Your Patient

If the systematic review and meta-analysis are applicable, integrate the evidence into your patient’s care plan:

1. Discuss with the Patient:
Explain the evidence from the systematic review and meta-analysis to the patient, including the potential benefits of moderate and vigorous aerobic exercise. Discuss how this intervention could help improve their cognitive function and walking ability.

2. Develop a Care Plan:
Based on the findings, design an exercise program for your patient that includes moderate and vigorous aerobic activities. Tailor the intensity, duration, and frequency of the exercises to match the patient’s current abilities and recovery goals.

3. Implement the Intervention:
Begin the exercise program, ensuring that the patient is adequately monitored for safety and that the exercises are progressively challenging to promote improvement.

4. Monitor and Evaluate:
Regularly assess the patient’s cognitive function and walking ability using standardized outcome measures similar to those used in the studies. Adjust the exercise program as needed based on the patient’s progress and tolerance.

By following these steps, clinicians can effectively use syntheses like systematic reviews and meta-analyses to inform clinical decision-making, ensuring that the selected interventions are supported by the highest levels of evidence and are tailored to the individual needs of their patients.

6.3 Step-by-Step Process of Selecting An Intervention and Applying Evidence From A Summary (Clinical Practice Guideline) Of Evidence

In this section, I will break down the process of selecting and applying evidence from a summary of evidence such as a clinical practice guideline to a clinical scenario. This involves matching your patient’s characteristics and clinical situation with the participants of studies included in the clinical practice guideline, interventions recommended, and outcomes used.

The example below focuses on the National Clinical Guidelines by Stochkendahl MJ et al. (2018), which provide evidence-based recommendations for the treatment of recent onset low back pain or lumbar radiculopathy.

Step 1: Identify the Clinical Question

The first step in applying evidence from clinical guidelines is to clearly define your clinical question using the PICO format (Patient, Intervention, Comparison, Outcome).

Patient: Patients with recent onset low back pain or lumbar radiculopathy
Intervention: Non-surgical treatment options, including physical therapy, medications, and lifestyle modifications
Comparison: Usual care or alternative non-surgical interventions
Outcome: Reduction in pain, improvement in function, and quality of life

Clinical Question: “In patients with recent onset low back pain or lumbar radiculopathy, what are the recommended non-surgical treatments that lead to the best outcomes in terms of pain relief, functional improvement, and quality of life?”

Step 2: Search for Relevant Summaries

Locate clinical guidelines or summaries that address your clinical question. These may be found in sources like professional organization websites (e.g., National Institute for Health and Care Excellence – NICE, American College of Physicians – ACP), reputable medical textbooks, or databases like PubMed and the Cochrane Library.

In this example, the National Clinical Guidelines by Stochkendahl MJ et al. (2018) were identified as a relevant and reliable source for managing recent onset low back pain or lumbar radiculopathy.

Step 3: Critically Appraise the Summary

Before applying the recommendations from the clinical guidelines, critically appraise the quality and relevance of the summary:

Guideline Development Process:

Review how the guidelines were developed. Look for transparency in the process, including how evidence was selected and evaluated, how expert consensus was achieved, and whether the guidelines were peer-reviewed or endorsed by professional bodies.

Regular Updates:

Check the publication date and whether the guidelines are regularly updated. Clinical practice evolves, so using the most current guidelines ensures that your treatment decisions are based on the latest evidence.

Relevance to the Clinical Question:

Ensure that the guidelines directly address your clinical question. For example, the Stochkendahl MJ et al. (2018) guidelines specifically cover non-surgical treatment options for low back pain and lumbar radiculopathy, making them highly relevant.

Grading of Recommendations:

Examine how the recommendations are graded based on the strength and quality of the evidence. Higher-grade recommendations (e.g., Grade A or Level 1) are based on strong evidence and should be prioritized in clinical decision-making.

Step 4: Determine Applicability to Your Patient

Assess whether the guidelines’ recommendations are applicable to your specific patient:

Patient Characteristics: Consider whether your patient’s age, gender, comorbidities, and severity of symptoms are similar to the populations addressed in the guidelines. If your patient differs significantly, consider how this might affect the applicability of the recommendations.

Relevance of Intervention: Evaluate whether the recommended interventions (e.g., specific physical therapy techniques, medications, or lifestyle changes) are feasible and suitable for your patient. Consider your patient’s preferences, resources, and setting (e.g., outpatient vs. inpatient care).

Relevance of Outcome: Confirm that the outcomes prioritized in the guidelines align with your patient’s goals, such as pain reduction, improved mobility, or enhanced quality of life.

Step 5: Apply the Guidelines to Your Patient

Integrate the guideline recommendations into your patient’s care plan:

Discuss with the Patient:
Explain the evidence-based recommendations to the patient, ensuring they understand the rationale for the suggested interventions. Address any concerns or preferences they may have.

Develop a Care Plan:
Create a care plan based on the guideline recommendations. For instance, if the guidelines suggest a combination of physical therapy and medication, outline a specific treatment schedule that includes targeted exercises, manual therapy, and appropriate medications.

Implement the Intervention:
Begin the recommended treatment, ensuring that each intervention is tailored to the patient’s specific needs and abilities. For example, if physical therapy is recommended, the intensity and frequency of exercises should be adjusted according to the patient’s current condition and progress.

Monitor and Evaluate:
Regularly assess the patient’s response to the treatment using objective measures (e.g., pain scales, functional assessments) and patient-reported outcomes. Adjust the care plan as needed based on the patient’s progress and any new evidence or changes in guidelines.

By following these steps, clinicians can effectively use summaries such as clinical guidelines to inform clinical decision-making.

This structured approach ensures that the interventions selected are based on the highest levels of evidence and are tailored to the specific needs of individual patients, ultimately leading to better patient outcomes.

Applying the evidence to your patients is both an art and a science because it involves integrating clinical research findings (the science) with personalized care tailored to the individual patient’s preferences, needs, and circumstances (the art). This requires not only understanding the statistical evidence but also communicating it effectively and adapting it to each unique patient for optimal outcomes.

In the next article, I have explained the steps to follow while prescribing an intervention selected from research evidence in detail.

Reference:

  1. DiCenso A, Bayley L, Haynes RB (2009). Accessing pre-appraised evidence: fine-tuning the 5S model into a 6S model. Evidence-Based Nursing, 12(4),99-101.
  2. Moseley, G. L., Nicholas, M. K., & Hodges, P. W. (2004). A randomized controlled trial of intensive neurophysiology education in chronic low back pain. The Clinical journal of pain, 20(5), 324-330.
  3. Kirshner HS. ACP Journal Club. A biobehavioral intervention improved caregiver well-being and some measures of functioning in patients with dementia. Ann Intern Med. 2010 Dec 21;153(12):JC6-4. doi: 10.7326/0003-4819-153-12-201012210-02004. PMID: 21173405.
  4. Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers: the COPE randomized trial. JAMA. 2010 Sep 1;304(9):983-91. doi: 10.1001/jama.2010.1253. PMID: 20810376; PMCID: PMC4091681.
  5. Li Z, Guo H, Yuan Y, Liu X (2024) The effect of moderate and vigorous aerobic exercise training on the cognitive and walking ability among stroke patients during different periods: A systematic review and meta-analysis. PLOS ONE 19(2): e0298339. https://doi.org/10.1371/journal.pone.0298339.
  6. Johnston W, Hoffman S, Thornton L. Mobile health: a synopsis and comment on “Increasing physical activity with mobile devices: a meta-analysis”. Transl Behav Med. 2014 Mar;4(1):4-6. doi: 10.1007/s13142-014-0254-3. PMID: 24653771; PMCID: PMC3958593.
  7. Fanning J, Mullen SP, McAuley E. Increasing physical activity with mobile devices: a meta-analysis. J Med Internet Res. 2012 Nov 21;14(6):e161. doi: 10.2196/jmir.2171. PMID: 23171838; PMCID: PMC3514847.
  8. Stochkendahl MJ, Kjaer P, Hartvigsen J, Kongsted A, Aaboe J, Andersen M, Andersen MØ, Fournier G, Højgaard B, Jensen MB, Jensen LD, Karbo T, Kirkeskov L, Melbye M, Morsel-Carlsen L, Nordsteen J, Palsson TS, Rasti Z, Silbye PF, Steiness MZ, Tarp S, Vaagholt M. National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy. Eur Spine J. 2018 Jan;27(1):60-75. doi: 10.1007/s00586-017-5099-2. Epub 2017 Apr 20. PMID: 28429142.

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