Version: 10.x (Current)

Therapy and Monitoring Manager

The therapy and monitoring manager (TMM) is a service that enables health care professionals to manage patients therapies and monitor patients health conditions, adherence and compliance to therapy. The service allows you to define thresholds and send notifications to alert the involved entities, typically physician and patient, of events which occur during the therapy and monitoring period.

In addition to therapies and monitorings, there are also observations. Observations are entered by the patient to whom the therapy and monitoring are directed, and represent the steps taken by the patient to meet the plan.

The adherence and compliance metrics will be calculated based on the observations entered by the patient. These metrics will trigger the sending of notifications, as set by the physician who created the therapy or monitoring.

note

Sending notifications based on adherence and compliance metrics is a feature currently under development and planned to be released in the future.

For such observations, you can define an archetype, called prototype, to act as a validator. For example, you could define a prototype to validate observations related to body temperature, verifying that the observation value is a number between 34 and 42 °C.

In the documentation, when you encounter any of the terms listed below, you should assume they have the described meaning, unless stated otherwise.

Term	Meaning
Adherence	A therapy or monitoring metric indicating if the patient is performing the tasks according to the timeframe defined by the physician.
Compliance	A therapy or monitoring metric indicating if the patient is performing the correct tasks as prescribed by the physician.
Doctor	See Physician.
Monitoring	A physician prescription to monitor health conditions (blood pressure, body temperature, vital signs, etc.).
Notification	A message sent via email, SMS, etc. to one or more users regarding events occurring during the therapy or monitoring period.
Observation	A patient feedback on a therapy (e.g. I took the drug at 9) or monitoring (e.g. the minimum and maximum blood pressure measured).
Patient	A person undergoing therapy or monitoring.
Physician	A doctor prescribing therapies or monitorings to a patient.
Plan	A therapy or monitoring plan prescribed by a physician.
Prototype	An archetype for an observation, should provide generic (related to all patients) specifications to validate an observation value, for example to ensure a medical device is reporting correctly.
Therapy	A physician prescription for some therapies (taking drugs, etc.).
Threshold	Monitoring thresholds specific for a patient therapy or monitoring, for example his/her expected blood pressure.
TMM	Common abbreviation for the Therapy and Monitoring Manager.
Validation service	The integrated or external service used to validate observations against monitoring thresholds.

Adherence and compliance

The Therapy and Monitoring Manager models the concepts of adherence and compliance. These two metrics define how well the patient is adhering to the guidelines given by the physician for a monitoring or therapy.

Let us define the two metrics. Formally:

A patient is considered adherent to a therapy or monitoring if that patient performs the assigned tasks within the timeframe defined by the physician, net of tolerances that may be defined.
A patient is considered compliant to a therapy or monitoring if that patient performs the tasks exactly as described in the description of the plan by the physician (e.g. takes the correct drug in the correct amount).

note

Please note that the compliance with a therapy or monitoring is not influenced by the timeframe.

In order to better clarify the difference between the two metrics, let's make a couple of examples:

Let us suppose that a physician prescribes the following therapy:
```
The patient must takes the pill X with dosage Y twice a day.
```
where the adherence tolerance frequency is 1, minimum adherence percentage is 90% and minimum compliance percentage is 80%.
The patient is considered:
- adherent to therapy if, for at least 90% of the days, that patient complies with the frequency of observations, thus twice a day, plus or minus the given tolerance, which in this example means taking the pill at least once and at most three times a day;
- compliant to therapy if, for at least 80% of the days, that patient complied exactly what the physician defined in the notes, so take exactly the pill X with dosage Y.
Let us suppose that a physician prescribes the following therapy:
```
The patient must takes the pill X at 10am and 2pm.
```
where the adherence tolerance time (in hours) is 1, minimum adherence percentage is 90% and minium compliance percentage is 80%.
The patient is considered:
- adherent to therapy if, for at least 90% of the days, the patient complies with the timeframes of observations, thus at 10am and 2pm, also considering tolerance, which in this example is 1 hour, so it is allowed to take pill between 9am and 11am and between 1pm and 3pm;
- compliant to therapy if, for at least 80% of the days, the patient does exactly what the physician defined in the notes, so take exactly the pill X with dosage Y.

The adherence and compliance metrics are not necessary linked. Being compliant does not mean being adherent. This is true for the reverse as well.

Indeed, a patient can be adherent but not compliant. Looking at the above example, this is the case if the patient takes drug twice per day but not the correct drug.

A patient can also be compliant but not adherent. Considering the above example, this is the case if the patient takes the correct drug but not at the right hours, for instance if he takes it at 5pm and 9pm.

Therapies

The service allows you to create, update and delete therapies for patients, such as administering a medication for a specific time frame, by defining:

the name of the plan;
the notes and directives of the doctor drafting the therapy;
the reference to the prototype containing the validation rules for the observations entered by the patient;
the start date of the therapy;
the end date of the therapy (this value is not required if the therapy has an indefinite time frame);
the frequency or the timeframes of therapy (this value is not required if the therapy does not include a periodic performance of the actions described by the physician);
the reference to the physician who created the therapy;
the reference to the patient to whom the therapy is addressed;
the tolerance on the frequency or time of intake for which a particular observation entered by the patient is still considered adherent to the therapy;
the minimum percentage value for which a patient is considered adherent to therapy with respect to reported observations;
the minimum percentage value for which a patient is considered compliant to therapy with respect to reported observations.

Monitorings

The service allows you to create, update and delete monitorings for patients, such as monitoring blood pressure for a specific period of time, by defining:

the name of the plan;
the notes and directives of the physician writing the monitoring;
the reference to the prototype containing the validation rules for the observations entered by the patient;
the start date of the monitoring;
the end date of the monitoring (this value is not required if the monitoring has an indefinite duration);
the frequency of monitoring operations (this value is not required if the monitoring does not include periodic performance of the actions described by the physician);
the reference of the physician who created the monitoring;
the reference of the patient to whom the monitoring is addressed;
the tolerance on the frequency or time of intake for which a particular observation entered by the patient is still considered adherent or compliant to the monitoring;
the minimum percentage value for which a patient is considered adherent to monitoring with respect to reported observations;
the minimum percentage value for which a patient is considered compliant to monitoring with respect to reported observations;
the observations thresholds.

Observations

The service allows tracking actions performed by the patient concerning a specific therapy or monitoring, such as reporting body temperature or taking certain medication at specific time. The observation is defined by:

the reference to the therapy or monitoring to which the observation is linked;
the value of the observation (this value is an arbitrary object; for example, an observation for the blood pressure could have two fields, the minimum and a maximum value measured);
the compliance of the observation with respect to what prescribed by the physician;
the date of the observation;

note

Please note that the date the observation was entered may be different from the date the observation was conducted.

the reference to the referring physician for the therapy or monitoring;
the reference to the patient to whom the therapy or monitoring relates.

Prototypes

The prototypes define the specifications of acceptable values related to certain observations. These prototypes are nothing but JSON Schema that are applied to the input observations to validate the related values. These prototypes are defined at the microservice configuration level.

The prototypes should be used to validate the patient input and ensure it is reliable, to prevent human errors when submitting values read from a medical device.

tip

If your medical device can report measurements between a well-defined range, you should use the range maximum and minimum to validate the observation submitted by the user.

danger

Prototypes should not be used to monitor the expected vital signs of patients subject to monitorings, but thresholds should be used instead. Check the Thresholds section for more details.

For each prototype you need to define:

the unique identifier;
the type (can be measurement or therapy);
the name;
the schema;
the labels for the schema fields (required only if you use the TMM with the companion FE component).

TMM supports localization for name and labels, using a syntax like the following (en is ISO 639-1 language code for English, it for Italian):

{
  "name": {
    "en": "English name",
    "it": "Italian name"
  },
  "labels": {
    "bodyTemperature": {
      "en": "Body Temperature",
      "it": "Temperatura corporea",
    }
  }
}

caution

If you plan to use the TMM in combination with the companion FE component, be aware that, if you replace the string with a translation object, you must provide a translation for all languages that you want to support.

Let's see a couple of examples:

a prototype to ensure the body temperature reported by the patient is between 34 and 42: in this example we expect the observation value to be an object with a field bodyTemperature;

{
  "identifier": "bodyTemperature",
  "type": "measurement",
  "name": "Body Temperature",
  "schema": {
    "type": "object",
    "properties": {
      "bodyTemperature": {
        "type": "number",
        "minimum": 34,
        "maximum": 42
      }
    },
    "required": [
      "bodyTemperature"
    ]
  },
  "labels": {
    "bodyTemperature": {
      "en": "Body Temperature",
      "it": "Temperatura corporea",
    }
  }
}

a prototype to ensure the reported blood pressure has a minimum between 60 and 150 and a maximum between 80 and 250: in this example we expect the observation value to be an object with two fields, minimumBloodPressure and maximumBloodPressure;

{
  "identifier": "bloodPressure",
  "type": "measurement",
  "name": {
    "en": "Blood Pressure",
    "it": "Pressione Sanguigna"
  },
  "schema": {
    "type": "object",
    "properties": {
      "minimumBloodPressure": {
        "type": "integer",
        "minimum": 60,
        "maximum": 150
      },
      "maximumBloodPressure": {
        "type": "integer",
        "minimum": 80,
        "maximum": 250
      }
    },
    "required": [
      "minimumBloodPressure",
      "maximumBloodPressure"
    ]
  },
  "labels": {
    "minimumBloodPressure": "Minimum pressure",
    "maximumBloodPressure": "Maximum pressure"
  }
}

Thresholds

When a new observation is created or the value of an existing observation is updated, the TMM checks if the observation value exceeds any of the monitoring thresholds and optionally send a notification to the physician (specified in the doctorId field of the monitoring plan) if one or more thresholds are exceeded.

The validation process should check all the monitoring thresholds and return, for each one of them, if it was exceeded or not by the given observation.

We currently support two operating modes:

the thresholds validation is performed directly by TMM according to the rules described below (default);
the thresholds validation is performed by an external service, which must satisfy certain API requirements.

The integrated validation system currently supports the following threshold validation rules:

maximum value (gt, gte): allows you to specify a maximum value for an observation property, if the actual observation property has a value strictly greater (when using the gt operator) or greater or equal (when using the gte operator), the threshold is considered exceeded;
minimum value (lt, lte): allows you to specify a minimum value for an observation property, if the actual observation property has a value strictly lower (when using the lt operator) or lower or equal (when using the lte operator), the threshold is considered exceeded;
exact value (eq): allows you to specify the exact value for an observation property, if the actual observations property has a different value, the threshold is considered exceeded.

danger

The integrated validation system is designed under the assumption that the property of the observation value referred by a threshold contains a numeric value. If the value is not a number, an error is returned.

Additional information about the API requirements and the setup of the external validation service are available in the Configuration section.

Notifications

The TMM allows you to send notifications on different channels to patients and physicians when certain events occur during the lifetime of a monitoring or therapy plan.

For example, when a patient submits an observation and its value exceeds one or more monitoring thresholds, the TMM can send a notification to the physician.

More details about the configuration of the notification service are available in the Configuration section.

Adherence and compliance​

Therapies​

Monitorings​

Observations​

Prototypes​

Thresholds​

Notifications​

Adherence and compliance

Therapies

Monitorings

Observations

Prototypes

Thresholds

Notifications