Appunti - Innovation in Health and Social Care

How Patient Involvement Works and Why

Users can be involved at 3 different decision-making levels:

• Micro-level Example: It's based on the relationship between the clinician and the patient. In this level, patients are involved in the definition of the care treatment.
• Meso-level Example: A group of patients is involved in the co-production or co-delivery of a product/service. For example, they participate in the definition of a service/care pathway.
• Macro-level Example: This is the most discussed level. Here, there is a complex involvement of (expert) patients or patients' organizations to expand the point of view on a specific topic. For instance, they participate in the definition of new policies.

We conclude this part with some practical reflections (5 best practices):

1. If you want to involve patients, you need to train them.
2. Sometimes patients are very vulnerable and fragile, so it's important to translate their needs into practical contribution.
3. Co-production involves cultural change: clinicians need to accept to sit

At the same table with patients (top-down culture as a difficulty for co-production). It's very important to:

1. Create long-lasting relationships: motivate patients through a trustful relationship!
2. Some patients cannot be involved (habits and language differences or other barriers, for example): when this occurs, try to use the so-called representative co-production, i.e., a small group of people that represent other patients that can't be involved (note that this is a very innovative approach and there's currently a discussion about it).

"Value" BUT co-production can also have negative effects Value co-destruction: co-destruction refers to a failed interaction process that has a negative outcome. Value co-destruction can emerge, for example, when the actors involved in a relationship do not possess a certain resource, such as information.

This was an exercise done in class using Miro: https://miro.com/app/board/o9J_lrLa_rI=/1.

1. Characterize the persona.
2. ...

Define the characteristics of the persona that you like the most.

1. Innovation in Health and Social Care (A.Y. 2021/2022)
2. Think about possible challenges (not only for the persona, but for the whole ecosystem) before, during and after the visit.
3. Define the most relevant (and feasible) challenges.
4. Think about possible innovative solutions to these challenges.

One of the main reasons why co-production fails is because the goal is not clear. Be sure that the actors involved have the competences to face it or, otherwise, provide them with the competences needed.

- Lecture 06 From Clinical Research to Systemic Reviews and Meta-Analysis (Chiara Gerardi, Researcher)

Part 1. Study Design in Clinical Research

Let's start with some definitions (clinical study, interventional study and observational study). Note that with interventional study, differently from what happens with observational study, we have an intervention by the practitioner that modifies the clinical practice: the

or other types of interventions, but the investigator does not assign specific interventions to the study groups.

or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.

Observational studies can be prospective or retrospective (in which observation and outcome are both in the past). Retrospective data, compared to prospective ones, are not so expensive, easier to collect, and there's a growing interest for them in the scientific community (e.g., researchers and pharmaceutical companies).

BUT observational studies have a problem: they can be subject to biases that affect the results of the study itself. Some clinical studies are not really able to generalize because of these biases: (for more details, search for "gender medicine") and old people are generally less indeed, females represented. Of course, this can represent a risk due to the fact that different human beings can react in different ways.

See the differences between case control studies and cohort studies in the

The key point is the research question, which is the most difficult one. Also, you need to work with physicians to bring innovations in healthcare. In fact, this is an interdisciplinary activity: job without them; they are experts and the only ones that know the clinical question they would like to answer (researchers just know the methodologies).

Randomized Controlled Trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Although no study is likely on its own to prove causality, randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome. This is because the act of randomization balances participant characteristics (both observed and unobserved) between the groups allowing attribution of any differences in outcome to the study intervention. (it's very complicated)

Here, usually we talk about millions of euros, and this is a big problem for

The start-ups for them to run RCT!). How does this change in the era of digital innovation? How does digital revolution impact on this scenario?

Innovation in Health and Social Care (A.Y. 2021/2022)

Part 2. Systematic Review

A systematic review is a review of a clearly formulated question that uses systematic and explicit methods to identify, select and critically appraise relevant research, and to collect and analyze data from the studies a sort of review of that are included in the review. If well conducted, it includes also RCTs. In other words, it's many different studies that summarizes and collects all the papers already published and the PICO through a systematic, reproducible and standard approach. It is not possible to be conducted without studies.

Systematic reviews were born when the Cochrane organization was created, whose aim is to publish evidence about specific topics. Cochrane is an international organization born in 1993 that aims to help people make well-informed decisions.

about health care by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of healthcare interventions. Cochrane contributors -37,000 from more than 130 countries - work together to produce credible, accessible health information that is free from commercial sponsorship and other conflicts of interest. There are different types of reviews. The steps of a systematic review are: 1. Definition of the clinical question We start from a hypothesis to be tested. It is divided into 3 parts: a patient with a problem, an intervention, and an outcome. The "PICO" slide is super important: it stands for participants, intervention, comparison, and outcome. Remember: you can't start a systematic literature review without the definition of the PICO. Not all the outcomes will be supported by evidence. Why? In the clinical trials, the clinicians are more interested in collecting data about the clinical side, while, for example, they think organizational things.andwe can't find thiscost are not so relevant, thus missing these numbers (in the last majorities of the studiesinformation). 2. Plan eligibility criteria (our PICO).→ 3. Plan methods They include specific definitions of the PICO. 4. Search for studies. 5. Apply eligibility criteria. P (cyclists), I (helmets), C (no helmets) and O (% head and facial injuries). Note that the efficacy is theobjective, but the outcomes are numbers. Reproducibility is very important: another researcher should be able to reproduce the same steps of yoursystematic review and get the same results (every step must be described and everything must be clarified). 6. Collect data. → 7. Assess studies for risk of bias To assess the quality of the study. In fact, these studies can be verydifferent one another. Some biases can be very small, others can be substantial. There're different sourcesof biases. The slide named "trial as a flow" is very important (we can't trust all the

public papers in the sameway: being published is not enough to say that it's relevant.Remember that the statistical combination of the results is not mandatory.

8. Analyze and present results. Be careful with words and avoid words like "positive" and "negative", just describe your findings, just rely on evidence. No evidence doesn't mean something is notmaybe it's working, but we don't know yet.working:

10. Improve and update review.

Innovation in Health and Social Care (A.Y. 2021/2022) - Lecture 07 (part 1) How to assess innovation and the Cost-Utility Analysis

Part 1. How to assess innovation?

This is a very important chapter. Why? Because we need to assess and evaluate innovation in order to gain evidence through a multidisciplinary process. We are in the phase before the market entry and so the technology is very mature, and we are enlarging the scale of our study. Note that, conceptually,

The HTA should be used before the commercialization, but in reality, also after the commercialization we still use the "long-term benefits of a technology", HTA. Outcomes are key here. In the healthcare setting, they are and so not just the output. The concept of outcome is connected to the one of value, but what is value? What do we really mean with this word? Michael Porter tried to define it:

VALUE = HEALTH OUTCOMES THAT MATTER TO PATIENTS / COST OF DELIVERING THE OUTCOMES.

With this formula Porter is telling us that hospitals are competing one against the other, even if this thing of "competition" between hospitals is not so well accepted in Italy and in Europe, but more in the USA. Even if for example, it doesn't work in Italy. It seems a very easy computation, in reality it is not as simple as it appears; Italy. Why? The problem is the denominator: indeed, just the 6% perc