In the quest to improve healthcare for older adults, it's critical to minimize the gap between research and practice. To address this gap, researchers face a constant challenge, not just to discover if interventions work in research settings, but how they work in the real world, in the range of healthcare environments that older adults often use, such as community centers, hospitals, and doctor's offices. This brings us into the world of pragmatic trials.

Imagine two worlds, one highly controlled, the other chaotic and unpredictable. Pragmatic trials navigate the latter, aiming to test healthcare interventions in conditions that mirror everyday life. Unlike traditional trials, which often exclude older adults due to age-related complexities like frailty, chronic conditions, or disabilities, pragmatic trials strive to reflect the realities of those most affected.

The result? A growing movement to ensure that the evidence for an intervention includes effects seen in pragmatic, real-world conditions. Explanatory trials take place in controlled environments and are designed to give an intervention it's best shot at success. They answer the question, how does this intervention work under ideal conditions?

These trials are an important starting point. After all, if an intervention doesn't work in a controlled setting, there's little point testing it in the real world. But when an intervention does show promise in explanatory trials, it can move into the pragmatic phase, where it's tested in settings that resemble the usual care environment more closely.

This answers the question, will this intervention work under real-world conditions? In these trials, participants are similar to those seen in day-to-day practice. There's flexibility in how the treatment is delivered, and outcomes measured include those that matter most to older adults. But here's the catch. Over 100 clinical trials are registered every day, and they don't all fit neatly into one world or the other.

Instead, they exist on a continuum, the Pragmatic Explanatory Continuum. The PRECII-2 tool, short for Pragmatic Explanatory Continuum Indicator Summary 2, provides a common language and criteria to determine where a trial falls on this continuum. It helps researchers design trials that align with their goals, and helps decision-makers evaluate and interpret results.

Think of PRECII-2 as a navigator, pointing us toward how relevant a study is for real-world healthcare. But remember, being more pragmatic doesn't necessarily mean better. A trial design should match its intended purpose and stage of the research evidence. If a treatment is brand new, or being tested in a population often left out, like older the design may need to be more explanatory.

On the other hand, if we already have strong evidence for an intervention, we may design more pragmatic trials to confirm how it works in real life conditions. Even the most pragmatic trial won't guarantee the same results in practice, given the complexity of real world healthcare, especially in older populations, where changing health needs and multiple healthcare professionals introduce variability and uncertainty. The Prec2 tool is represented as a wheel.

It breaks trial design into nine domains, each representing a key element that trial teams can discuss and reach a consensus on. This affects how pragmatic or explanatory a trial is. Each domain is scored on a scale from one, very explanatory, ideal conditions, to five very pragmatic real-world conditions. Starting at the top of the wheel is eligibility.

Who's selected to participate? Are they similar to patients seen in everyday practice? Pragmatic trials involving older adults often aim to include people with common real-world complexities, such as multiple chronic conditions, functional limitations, transportation barriers, or social isolation. As we move around the wheel, the domains include how participants are recruited, the setting of the trial, the organization needed to implement the intervention, the flexibility of the intervention, how participants are followed up, the primary outcomes evaluated, and how data are analyzed.

The more pragmatic the trial, the more the findings reflect what would likely happen in practice. That's represented by a large round wheel, ready to roll across real world terrain. In contrast, a very controlled trial, for example, scoring ones in most domains, creates a small wheel that may roll smoothly in the lab, but may not hold up outside.

The Pre-C2 tool has been instrumental in designing a wide range of healthcare studies. For example, here's a pragmatic trial that tested whether daily reminders sent by SMS or text messages could improve blood pressure medication adherence in older adults. Researchers used the PRECII-2 tool extensively during the design phase to make sure the intervention could demonstrate effectiveness in everyday practice.

They published their PRECII-2 scores and rationales as a supplement to their trial protocol. We won't review all the scores, but here are some highlights. Recruitment path. Researchers assign a score of five, very pragmatic, because participants were recruited from community pharmacies nationwide, both urban and rural, during regular prescription pickups.

Organization of the intervention, a score of three was assigned to this domain. The trial included a study pharmacist, and while time and cost demands were low, the SMS software wasn't yet in use at the pharmacies, so health system changes would be needed. Researchers can register to add their trial at the protocol phase or after completion to the Prec2 tool online.

They can also explore the Prec2 database online to view published trials, their scores, summaries, and references. So what, why does all this matter? To bridge the gap between research and practice, we need more pragmatic trials and better tools to align trial designs with current healthcare needs. This means being intentional about when to conduct pragmatic trials, typically after a successful proof of concept study, while recognizing that some populations, like older adults, may require earlier real-world testing due to complexity of their health and social care needs and care delivery.

Understanding pragmatic trials and tools like Pre-C2 empowers you to critically interpret research, asking not just if a treatment works under ideal conditions, but whether it may work under conditions more like those seen in everyday practice. Thanks for joining us on this journey into pragmatic trials and the Pre-C2 tool. Stay curious, stay informed, and let's make healthcare research meaningful for everyone.

In our ongoing quest to improve healthcare and bridge the gap from research to practice, we face a crucial challenge, understanding not just if interventions work in controlled environments, but how they perform in the real world, such as in community settings, hospitals, and primary care practices. Here's a tool that helps design trials to address this challenge, the Pragmatic Explanatory Continuum Indicator Summary 2, or PRECIS-2. This tool offers a common language and criteria for gauging where a trial design falls on the continuum, from highly controlled to real-world conditions.

It's like a navigator, guiding researchers on the selection of design features that align with the stage of the research and its intended purpose. The Pre-C2 tool is visualized as a wheel, with nine domains each representing a key pragmatic consideration in a trial design. These include who is selected to participate in a trial, how participants are recruited, where the trial is taking place, what expertise and resources are needed to deliver the intervention, how the intervention is delivered, how adherence is assured, method of follow-up post-trial, relevance to trial participants, and data inclusion.

Each domain is rated from one very controlled to five very pragmatic to reflect the degree of pragmatism for the design choices made that pertain to the domain. Each domain represents a design option that impacts how similar a study is to real-world conditions. A trial scoring high across these domains forms a robust large wheel, indicating strong alignment with real-world conditions.

Studies testing new interventions, such as proof-of-concept studies, often lean towards the highly controlled end of the spectrum, because the aim is to provide evidence of effect that can be used to justify a larger, more expensive trial. Studies testing well-established interventions typically aim for the highly pragmatic end of the spectrum, because the aim is to confirm the promising effects seen in controlled settings in a study more similar to real-life and clinical practice. Understanding pragmatic trials and tools like PRECII can empower you to critically design and interpret research, so we can better align research with healthcare needs, ensuring that interventions are designed with a degree of pragmatism appropriate for the stage of the research and knowledge user needs.

Thank you for joining us and exploring the vital role of the Pre-C2 tool. Stay curious, stay informed, and let's continue advancing healthcare research together.