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Patient Safety

A new approach to clinical guidance in the era of personalization

How can health systems adapt to today’s environment, in which patients look for personalization?

Válter Fonseca

April 20, 2021 · 6 min read

Válter Fonseca, Director of Healthcare Quality Department, Directorate-General of Health

How did we get here?

Quality - as a notion applied to management - was initially focused on the inspection and control of a product, and evolved, throughout the second half of the 20th century, to be applied in an audit perspective, that is, for compliance verification. Quality then became a timeless issue and got increased recognition within healthcare organizations.
Historically, the concept of healthcare quality evolved from industry and engineering bringing standards-based conformity to health care provision worldwide. The reasoning behind the quality concept is that standardized procedures lead to greater management efficiency and a greater guarantee that the final product corresponds to customers’ needs.
Looking for uniform, evidence-based clinical procedures and practices were, and still are, perceived as a guarantee of good health outcomes.
Thus, transposed to the healthcare field by Avedis Donabedian, healthcare quality considers that, by standardization, care provision corresponds to actual needs of the people who receive care, based on three pillars:
  1. Structure: physical and organizational characteristics where healthcare occurs
  2. Process: focus on how care is delivered to patients, by sequential procedures
  3. Outcome: healthcare effect on the status of patients and populations
Within this framework, from a healthcare manager’s perspective, standardization helps foster an environment of patient-centered care: minimizes the risk of errors, increases patient safety, disconnects care delivery from subjective factors (increasing the use of evidence-based medicine principals), and can improve patients' experience.

Clinical Practice Guidelines and Guidance documents: tools to clinical care standardization

  • Clinical Practice Guidelines

    Are relevant documents, usually drafted and published by scientific societies, that carefully summarize the available scientific evidence, providing to health professionals, namely doctors, useful information so that they know how to decide based on the best scientific evidence. These documents aim to guide a decision, which is always balanced by individual clinical judgment. Usually, clinical guidelines are issued to topics for which there are plenty, robust and structured evidence.
  • Clinical guidance documents

    Establish a set of recommendations for good clinical practice, through a broad experts’ consensus, based on the best scientific evidence. However, clinical guidance may be issued for topics for which the evidence is sparse or even lacking. Also, clinical guidance documents can go a step further, maintaining the goal to support clinical decisions, but incorporating an organizational component striving to improve the health system as a whole.
That’s saying the scientific evidence is of paramount important for clinical decision and healthcare provision but is not enough. Additional principals – which can be addressed in clinical guidance documents – such as public health, efficiency, patient safety, organizational quality, people-centered care and clinical pathways to guide a better navigation throughout the health system. Finally, guidance is a living document that evolves over time to progressive quality improvement.

21st century healthcare challenges

Our world changed a lot in the last years. The 21st century has the most advanced medical technology compared to any previous century, but it also has unique features, regarding social sciences and people’s life and habits, that urge a transformational view of the healthcare system in order to improve its sustainability.
  • Demographic evolution

    The world’s population aged 60 years and older is expected to total 2 billion in 2050 (up from 900 million in 2015), representing an additional risk factor for multiple chronic diseases and overuse of the healthcare system. In fact, the number of patients with multiple diseases is projected to increase and demand 40 million additional health workers globally by 2030.
  • Technological innovation

    Health technologies encompass all devices, medicines, vaccines, and information systems designed to streamline healthcare delivery, and enhance the quality of care. Artificial intelligence (AI), blockchain, voice search, chatbots, and virtual reality (VR) are among the most promising health technologies that make the current health systems radically different from the ones we had in the 20th century. Additionally, with information technology services, healthcare is becoming more predictable, manageable, and connected, but at the same time, more complex.
  • Patients’ expectations

    Patient experience evolves in all social and cultural domains as a consequence of the era of 4th industrial revolution and digital transformation.  This change also impacts the healthcare system. Patients’ expectations for convenience, affordability, quality, value, and cost transparency are redefining how they engage at each stage of care. Recent reports found that younger consumers are not satisfied with healthcare’s status quo and consumers of all generations are more willing to try non-traditional services. People express their desire for a collaborative provider-patient relationship. All in all, consumers increasingly expect their experience with healthcare organizations to be personalized and seamless, allowing them to access the information they need when they need it.
Thus, healthcare stakeholders have a great challenge on their hands: find a way to clinical practice based on high quality standards supported by scientific evidence (balancing subjective and individual judgment), while provide care in a patient-centered way (personalized care). Personalized medicine is one of the biggest challenges of healthcare systems. How to use the classical way of thinking healthcare quality in this era?

How can health systems overcome these challenges?

Standardized care and personalized care do not have to be mutually exclusive. Standardization, for instance, can enhance personalization by eliminating unnecessary work for healthcare providers and giving them more time to spend with patients.
There are certainly several options to answer this question but let me highlight one: the process of guidance's drafting must be adapted, taking advantage of technology to improve quality, that is to say keep standards close to people’s needs and expectations.
  • Needs identification

    Since clinical guidelines provide useful and accurate information to support healthcare workers’ decision-making on the best scientific evidence available, guidance documents should bring more to bear. Namely, these documents must adapt the information to each health system’s specific features – needs, resources and capacity –, listen to healthcare teams and patients and ensure that each guidance address real-world, concrete situations and adds value to the health system as a whole.
  • Scientific evidence collection

    Given all the evidence available about how technology empowers human work, at this point, competent authorities cannot ignore that scientific literature review methodologies that can be much more automated than they currently are when done on an individual basis. Local health entities need robust, automated, validated, and independent methods of gathering scientific literature research and I strongly believe that there are many unexploited impacting partnerships to be done between health policymakers and academic institutions at this step.
  • Expert agreement

    After being collected, scientific evidence must be adapted to a concrete health system by a group of experts that deeply understand the system and its needs. As we all intuitively figure out, the evidence collection process is critical to make sure that this step is based on strict, independent, and robust data.
  • Institutional partners and civil society consultation

    Trying to optimize an assertive proposal and duly adapted to different perspectives and characteristics of health systems, the process of guidance's drafting shouldn’t be finished without listening to institutional partners and those the guidance addresses to - care providers patients, and caregivers.
  • Publication, dissemination and implementation

    Finally, many challenges remain when it comes to guidelines and guidance’s implementation. Technology information systems offer us means to create more dynamic, visual, and granular documents which surely impacts its applicability in the daily clinical routines. On the other hand, the NICE experience, in the UK, provides us with an interesting model of how to improve conformity rates by working at the regional and local levels to adapt a national document to particular settings. And, last but not least, if we are striving for more participative health systems, it’s essential to improve the understanding – and acceptability – of these guidance documents by  laypeople.

Final remarks

  1. Health services should be effective, safe, people-centered, timely, equitable, integrated, and efficient.
  2. Throughout the ages, several industries have responded to major safety crises by standardizing processes to reduce variation and ensure consistency among the workforces.
  3. Uniformity allows managers to work with predictable overall results.
  4. Transposed to the healthcare field, care quality considers that, by standardized procedures, care provision will be consistent to patients’ needs.
  5. Healthcare quality is not just about clinical care: all healthcare managers – national, regional, and local - should be involved in a quality culture to ensure that the healthcare system is evidence-based, efficient and patient-centered.
  6. National policies and strategies must work to break down fragmented systems. For this, digital technologies play an increasingly relevant role to build patient-centered systems.
  7. Quality needs to be continuously measured and monitored to drive improvement.
  8. Quality measurement must take into account two variables: 1) clinical conformity to guidelines and guidance documents, and 2) clinical outcomes. How to take the best of quality instruments to improve personalized care in the new era of digital transformation is the challenge of the Department of Healthcare Quality.

Válter Fonseca

Head of Medical Decision and Health Quality

M.D., Lisbon Faculty of Medicine, 2010. Ph.D., Medicine/Immunology, Lisbon Faculty of Medicine, 2018. PGDip., Health Management, Católica Lisbon School of Business and Economics, 2019. Internal Medicine Specialist. Assistant Professor, Lisbon Faculty of Medicine. Director, Health Quality Department, Directorate-General of Health, 2018-2022. Chair, COVID-19 National Immunization Technical Advisory Group, 2020-2022. Author of more than 100 communications, articles, and book chapters.

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