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
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
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 Retinal Imaging |
The retinal photographs taken from one participant, one series per eye. |
| Healthy Route Screening Visit |
The single visit at which a participant is screened, measured and photographed. |
| 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. |
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. |
| Tenant |
Identifies the site tenant that owns the resource. |
These define sets of codes used by systems conforming to this implementation guide.
| Consent Permission Value Set |
The permissions a Healthy Route participant is asked to grant. |
| Urine Dipstick Protein Value Set |
Permitted results for urine dipstick protein, as printed on the data collection tool. |
These define new code systems used by systems conforming to this implementation guide.
| Consent Permission |
The permissions a Healthy Route participant is asked to grant, each recorded as a separate Consent. |
| Urine Dipstick Protein Scale |
The ordinal scale printed on the study's data collection tool for urine dipstick protein. |
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. |
| 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. |
| HbA1c |
The protocols define type 2 diabetes as HbA1c above 6.5% or on the basis of clinical history. |
| 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. |
| 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. |
| 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. |