Healthy Route Implementation Guide
0.1.0 - ci-build

Healthy Route Implementation Guide, published by Savannah Informatics. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/savannahghi/healthy-route-ig/ and changes regularly. See the Directory of published versions

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

Healthy Route Blood Pressure

One blood pressure reading, or the mean of several.

Healthy Route Consent

The record that a participant granted or refused one permission, and the index to the page they signed.

Healthy Route Consent Evidence

The photographed page a participant signed, referenced by the consent it evidences.

Healthy Route Document

Any document held by the study, in the form common to all of them.

Healthy Route Investigation Request

A request for a laboratory investigation arising from the screening visit.

Healthy Route Laboratory Report

What a laboratory returned for one participant, gathering the individual results.

Healthy Route Location

A clinic within a study site, where participants are approached.

Healthy Route Measurement

Any measurement taken from a participant during the screening visit.

Healthy Route Organization

A hospital running the study, or another party to it.

Healthy Route Patient

A study participant as held within a site tenant.

Healthy Route Patient (Export)

A study participant in the form transferred out of a site tenant.

Healthy Route Practitioner

A member of the study team.

Healthy Route Reported Condition

A diagnosis the participant reports at interview.

Healthy Route Reported Medicine

One medicine the participant reports taking at the time of the visit.

Healthy Route Retinal Imaging

The retinal photographs taken from one participant, one series per eye.

Healthy Route Sample

A blood or urine sample drawn from a participant for the study's laboratory investigations.

Healthy Route Screening Visit

The single visit at which a participant is screened, measured and photographed, or one dated part of it.

Healthy Route Study

A country's approved protocol, and the parties, sites and targets it names.

Healthy Route Study Participation

One participant's enrolment onto one country's protocol, and the consent that permitted it.

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

Age in Years

Participant age in completed years at the time of enrolment.

Reading Device

Which of the study's blood pressure monitors took the reading.

Reading Position

Whether the reading was taken before or after retinal capture.

Reading Sequence

Which of the three blood pressure readings this is.

Tenant

Identifies the site tenant that owns the resource.

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Blood Pressure Monitors Value Set

The monitors the protocol names.

Blood Pressure Reading Position Value Set

Before or after retinal capture.

Consent Permission Value Set

The permissions a Healthy Route participant is asked to grant.

Dose Form Value Set

The form a medicine is supplied in.

Eye Value Set

Right or left.

Frequency Scale Value Set

How often a dietary habit occurs.

Laboratory Units Value Set

The UCUM units a site's laboratory may report the study's results in.

Medicine Frequency Value Set

How often a medicine is taken.

Medicine Route Value Set

How a medicine is taken.

Physical Activity at Work Value Set

How physically demanding a person's work is.

Reactive or Non-reactive Value Set

Reactive or non-reactive.

Urine Dipstick Protein Value Set

Permitted results for urine dipstick protein, as printed on the data collection tool.

Use Status Value Set

Current, past or nil.

Visit Part Value Set

The visit and its dated parts.

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

Blood Pressure Monitors

The monitors the protocol names, selected by participant size.

Blood Pressure Reading Position

Whether a blood pressure reading was taken before or after retinal capture.

Consent Permission

The permissions a Healthy Route participant is asked to grant, each recorded as a separate Consent.

Dose Form

The form a medicine is supplied in. Provisional.

Eye

Which eye. The programme does not license SNOMED CT, so laterality takes a local code rather than the SNOMED codes the base resource suggests.

Frequency Scale

How often a dietary habit occurs. Provisional: the wording follows the Uganda data collection tool and awaits the study team's confirmation.

Healthy Route Measurement Codes

Codes for the questions on the visit forms that LOINC does not cover, and for the values the study derives from them.

Medicine Frequency

How often a medicine is taken. Provisional.

Medicine Route

How a medicine is taken. Provisional.

Physical Activity at Work

How physically demanding a person's work is. Provisional: the wording follows the Uganda data collection tool and awaits the study team's confirmation.

Reactive or Non-reactive

The result of a screening test as the laboratory reports it.

Urine Dipstick Protein Scale

The ordinal scale printed on the study's data collection tool for urine dipstick protein.

Use Status

Whether a person currently uses something, used to, or never has. The history form asks it of alcohol and tobacco.

Visit Part

The visit, and the parts of it that carry their own date.

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

Blood pressure, derived value

The value carried forward to analysis, with derivedFrom naming the readings it used. Here it is the mean of the second and third, which is one protocol's rule; the other averages all three. The rule belongs to the study, and what is recorded here is which readings were actually used, so the calculation can be checked rather than trusted.

Blood pressure, first reading

The first of three readings. Timing matters: one protocol positions its readings relative to the retinal photography.

Blood pressure, second reading

The second reading. One protocol discards the first and takes the mean of readings two and three.

Blood pressure, third reading

The third reading.

Blood sample

The venous blood the creatinine and HbA1c were measured on. Its collection time is what the 28-day window is checked against, and what the results refer to.

Example consent to study participation

One permission, recorded as its own resource so that it can be withdrawn without touching the permissions the participant kept.

Example general out-patient clinic

The general out-patient clinic of the example site, recorded separately from the renal clinic because the two recruit from populations with different disease prevalence.

Example participant

A participant as held within a site tenant, carrying the identifiers the site needs to recognise them on return.

Example participation ending in screen failure

A participant who consented and was then found ineligible. This is a recorded outcome with a count attached to it, not an absence of data, and it is distinguishable here from a withdrawal and from an enrolment still in progress.

Example renal clinic

The nephrology clinic of the example site. Participants approached here are drawn from a population with a higher prevalence of chronic kidney disease than the site as a whole.

Example screening visit

The single cross-sectional visit at which everything is collected. The clinic is recorded because disease prevalence differs between clinics, and predictive values move with prevalence.

Example study site

A teaching hospital acting as a study site, holding its own data partition and the paper records of its participants.

Example study team member

A nurse on the delegation log, trained to take consent and to capture retinal images.

Example study, country A

One country's approved protocol, sponsored by a local clinician, with a pharmaceutical collaborator funding the analysis and receiving the exported data.

Example study, country B

A second country's protocol, structurally identical to country A and differing in region, sponsor and period. Both instances reference the same example site, because the guide defines one; the real studies run three sites and two respectively.

Example visit part: imaging

The day the retina was photographed, as a part of the visit with its own date.

Example visit part: samples

The day the blood and urine were drawn, as a part of the visit with its own date. Here it is the visit day; the protocols allow it up to 28 days after consent.

HbA1c

The protocols define type 2 diabetes as HbA1c above 6.5% or on the basis of clinical history.

History: diabetes, as reported

The answer to the diabetes question on the history form, kept under its item code.

History: tobacco smoking status

A coded answer on the study's use-status scale, under the LOINC code whose meaning the question has.

Laboratory report

What the laboratory returned, gathering the four results it issued together. issued is separate from effective: the interval between a sample being drawn and a result being released is what a site is asked about once the participant has left.

Reported condition: diabetes

What the Yes on the history form asserts. The interview does not ask the type, so the code is diabetes of unspecified type. Unconfirmed, because nothing in the study checks it against a record, and traceable to the answer through evidence.

Reported medicine: amlodipine

One medicine from the medications form. The catalogue entry identifies the product with its strength and form; how it is taken is on the study's own scales.

Request for laboratory investigations

One order covering the blood and urine investigations the protocol specifies. authoredOn carries its own timestamp so that ordering before consent is detectable.

Retinal photography, both eyes

The material the algorithm under validation consumes. One series per eye, each carrying its own laterality, because a prediction attributed to the wrong eye is not detectable after the fact.

Serum creatinine

The measured value the eGFR is calculated from.

Urine albumin-to-creatinine ratio

Measured for risk stratification. One protocol states explicitly that it is not used for exclusion.

Urine dipstick protein

A coded ordinal result on the scale printed on the data collection tool. In one protocol this gates eligibility; in the other it is the comparator the algorithm is measured against, and is recorded for every participant regardless of the result.

Urine sample

The spot urine the dipstick and the albumin-to-creatinine ratio were measured on.

eGFR by CKD-EPI 2021

A calculated value, not a measured one. derivedFrom names the creatinine it was computed from and method names the equation, because neither is recoverable from the number. LOINC 98979-8 is the 2021 revision with the race coefficient removed; 62238-1 is the generic CKD-EPI code and would understate what was done.