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Moving past limitations: Strengthening the evidence for clinical pathways

A few months ago, Acta Biomed published a systematic review and meta-analysis of the evidence for clinical pathways in hospital-based settings. The conclusion: While clinical pathways appear to be associated with a reduced length of stay, it remains unclear whether adoption could improve quality of life and satisfaction.

So, does this mean that the enthusiasm and support for clinical pathways is unjustified? Definitely not. In my view, this research does not paint the full picture for three reasons:

  1. There are very few clinical studies exploring clinical pathways
  2. Implementation of clinical pathways in these studies is hugely variable
  3. Methodology for randomized controlled trials (RCTs) does not work well for clinical pathways

The review highlights an important opportunity for new, pioneering research programs that explore the true potential.

Increasing the evidence pool

The research paper is based on an extensive literature search into clinical pathways, looking at data from 2010-2019. In almost a decade of care teams implementing pathways around the world, the search identified only 11 clinical studies that matched the inclusion criteria. Of those studies, eight measured quality of life, and only four included length of stay and satisfaction measurements.

Clearly, the sample size is too limited to draw any real conclusions on the impact of clinical pathways. Due to the small number, it is also currently impossible to analyze the role of clinical pathways across different medical conditions, specialties and settings.

Comparing like for like

The authors used four criteria to define and identify clinical pathways that could be included within the review:

  • A multi-disciplinary approach to translating guidelines into practical interventions
  • Precise time-frames or criteria-based algorithms
  • Focus on specific populations
  • Local adaption to existing best practice clinical pathways

Having clear parameters is important. And although only a small number of studies were identified, the definition is arguably too broad, allowing for large variability between different clinical pathways and studies.

Although pathways are built on best practice from guidelines organizations such as WHO and NICE, in practice they differ extensively for numerous reasons. Examples include:

  • Pathways start and end points
  • Type of patients and the severity of their condition
  • Involvement of healthcare professionals with different areas of practice e.g. GP, nurse, physician, dietician, physiotherapist etc
  • Level of technological support and implementation

Additionally, benefits differ significantly between different care settings: acute vs. chronic, low-volume complex care vs. high-volume standardized care, multimorbidity patients vs. patients with a single condition, etc.

It is unrealistic to think that care pathways will bring value to every patient and every care team in exactly the same way, yet we still need to be able to evaluate impact and success.

This is where research should focus – understanding the differences, similarities and benefits across the same and different clinical settings.

Opportunities for Real World Evidence

The Randomized Controlled Trials (RCT) generate the highest quality evidence in clinical research and have had an enormous impact on clinical practice. However, there are limitations that have cast some doubt on its status as “gold standard”. Because RCTs are so tightly controlled, the data rarely reflects real-world experience, which is fundamental to care pathways. Added to this, RCTs are complex and expensive, which makes it difficult to track long-term results across a large sample size.

Real-world data (RWD) and real-world evidence (RWE) on the other hand are gaining momentum as they don’t have the same limitations as RCTs. The use of computers, mobile devices, wearables and the availability of sophisticated, new analytical capabilities have accelerated the importance of real-world evidence. In 2018, the FDA launched a framework for its new real-world evidence program, aiming to evaluate the potential use of RWD to evidence efficacy of treatments.

The nature of clinical pathways means they cannot be effectively measured using RCT methodologies. Double-blinded trials are impossible as it is clear to the patient and care team who is in the treatment and control groups. Secondly, very few care teams are willing to split their patient cohort into two different groups, with and without a clinical pathway as this also causes massive disruption to care delivery.

Building on the growing volume of real-world evidence, emphasis on well-designed observational studies would prove the value of clinical pathways.

Conclusion

The existing data on the impact of clinical pathways is still too limited to draw any real conclusions. However, from my experience, building pathways across numerous different healthcare services, I know that care pathways deliver significant benefits when used in the right way, in the right setting. Our customers have seen strong improvements towards the quadruple aim:

  • Lower costs: e.g., reduction of consultation time thanks to patients being able to provide answers to standardized questionnaires by phone before consultations
  • Improved patient experience: e.g., patients notice a shorter reaction time, feel more supported and find it easier to communicate with HCPs
  • Better outcomes: e.g., 25-30% reduction of ER admissions for lung cancer patients
  • Better HCP experience: e.g., caregivers experience better collaboration within the multidisciplinary team and have more time available for patients

The value of clinical pathways is resolutely clear in my mind. However, we must complement RCTs with RWD & RWE to build widespread confidence in this approach, across all healthcare services, to help provide the best care for patients.

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