The inclusion and exclusion criteria of the Ghana protocol (v6.0) as the site records them, as the 6 November 2026 review settled them: the urine dipstick does not decide eligibility and is recorded on the laboratory results, and established CKD is not asked. The outcome is not an item: the rules in force compute it from the answers.

The inclusion and exclusion criteria as the site records them. The outcome is not an item: the rules in force compute it from the answers. The urine dipstick is a laboratory result and does not decide eligibility, so it is recorded on the laboratory results.

The pack both eyes were written to, when they were captured, whether they were taken with dilation, and the three answers about them, given against what is in the device's cloud storage. An eye counts as captured once its image passes the device's quality check, in up to five attempts. The investigator's confirmation is not an item.

The pack both eyes were written to, and the four answers about it, given against what is in the device's cloud storage. The investigator's confirmation is not an item.

Serum creatinine, HbA1c, uACR and the urine dipstick as the laboratory reported them, in the unit it reported. The dipstick is recorded for characterisation and is not required. The eGFR is calculated on the form by CKD-EPI 2021 from the creatinine, shown with the creatinine in mg/dL and the age and sex it used, and none of them can be typed. The age and sex come from the participant's record when the form opens.

Serum creatinine, HbA1c, uACR and the urine dipstick as the laboratory reported them, in the unit it reported. The dipstick is recorded for characterisation and is not required. The eGFR is calculated on the form by CKD-EPI 2021 from the creatinine, shown with the creatinine in mg/dL and the age and sex it used, and none of them can be typed. The age and sex come from the participant's record when the form opens.

Retired in 0.2.0. The 6 November 2026 review of the Uganda and Ghana protocols removed the dietary, physical-activity and occupational questions, which the Uganda protocol v3.1 does not collect. No study is tagged with this form, so no study serves it. It was: dietary habits and physical activity in a usual week, with whether fruit and vegetables are both eaten five days or more, the weekly minutes of activity and whether they meet the WHO recommendation calculated on the form.

Conditions and exposures, as the participant reports them. The previously documented eGFR is on the eligibility checklist and is not asked again.

Conditions and exposures, as the participant reports them.

The participant's current medication list. The protocol counts treatment for high blood pressure towards hypertension, so the list is asked at every visit; the strength and what a medicine is taken for help tell a treatment apart.

Every medicine taken now, including over-the-counter medicines. Recorded at the clinician's discretion.

Three timed blood pressure readings around the retinal capture, all taken before blood is sampled. The Ghana protocol records the average of the three, which is calculated on the form and cannot be typed. Whether the readings fit the protocol's timing is the rule set's.

Three timed blood pressure readings around the retinal capture. The mean of readings two and three, which the Uganda protocol takes as the true blood pressure, is calculated on the form and cannot be typed. Whether the readings fit the protocol's sequence is the rule set's.

The socio-demographic questions of the Ghana data collection tool that registration does not ask. The address is not on this form: it identifies the participant, so it belongs with the participant's details rather than with the study data that is exported.

One blood pressure reading, or the mean of several.

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

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

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

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

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

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

Any measurement taken from a participant during the screening visit.

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

A study participant as held within a site tenant.

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

A member of the study team.

A diagnosis the participant reports at interview.

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

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

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

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

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

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

Participant age in completed years at the time of enrolment.

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

Whether the reading was taken before or after retinal capture.

Which of the three blood pressure readings this is.

Identifies the site tenant that owns the resource.

The monitors the protocol names.

Before or after retinal capture.

The clinics a participant can be recruited from.

The permissions a Healthy Route participant is asked to grant.

The form a medicine is supplied in.

The kinds of encounter the study records.

Akan, Ga, Ewe, Hausa, Dagomba or other.

Right or left.

How often a dietary habit occurs. Retired in 0.2.0: no form asks this any more.

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

How often a medicine is taken.

How a medicine is taken.

The categories the study adds to FHIR's observation categories.

How physically demanding a person's work is. Retired in 0.2.0: no form asks this any more.

Reactive or non-reactive. Retired in 0.2.0: no form asks this any more.

Urban or rural.

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

Current, past or nil.

The monitors the protocol names, selected by participant size.

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

The clinics the Ghana protocol recruits from: general out-patient, hypertension, diabetes and renal.

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

The form a medicine is supplied in. Provisional.

The kinds of encounter the study records. Today there is one, the study visit.

The ethnic groups the Ghana data collection tool lists, and other for a group it does not.

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

How often a dietary habit occurs. Provisional: the wording follows the Uganda data collection tool and awaits the study team's confirmation. Retired in 0.2.0: no form asks this any more.

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

How often a medicine is taken. Provisional.

How a medicine is taken. Provisional.

Categories the study adds to FHIR's observation categories. Today there is one, for values worked out rather than measured or asked.

How physically demanding a person's work is. Provisional: the wording follows the Uganda data collection tool and awaits the study team's confirmation. Retired in 0.2.0: no form asks this any more.

The result of a screening test as the laboratory reports it. Retired in 0.2.0: no form asks this any more.

How a form counts towards signing a visit. Carried as a tag on the form.

Whether a participant lives in an urban or a rural area.

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

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

An Observation per answer; the derived values are the rule set's.

Every criterion as an Observation under its item code; the documented eGFR dated by the day it was documented.

An Observation per answer, and a Condition for each of diabetes, hypertension and chronic kidney disease answered Yes.

One ImagingStudy for the pack with a series per eye captured, and the four answers as Observations.

Two specimens, an Observation per result in the reported unit with the LOINC code chosen by the unit, and a report gathering them.

No current medication as an Observation; each medicine as a MedicationStatement against the catalogue code.

The clinic, the ethnicity and the type of domicile as Observations; an ethnicity answered other keeps the named group as text.

Three timed blood pressure readings with their number, position and monitor, the time of retinal capture, and the mean the form calculates.

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.

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

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

The third reading.

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.

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

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.

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

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.

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.

Every question of the retired diet and activity form answered.

Every inclusion met, a documented eGFR inside the window, no exclusion.

Every inclusion met, a documented eGFR at least 3 months old, no exclusion.

Every history question answered; two of the reported diagnoses are Yes.

Hypertension and CKD reported; a past drinker who has never smoked.

Both eyes captured and synced.

The left eye not captured, with the reason.

Both eyes captured and synced.

Results in the units the laboratory reported, creatinine in umol/L, and a trace on the urine dipstick.

Creatinine in umol/L and uACR in mg/mmol, sampled after the last blood pressure reading.

Two medicines, one from the catalogue and one the catalogue does not list.

No current medication.

One medicine from the catalogue, with its strength and what it is taken for.

Recruited at the renal clinic; an ethnicity the list does not name, given as text.

Three timed readings around the retinal capture and the mean of readings two and three.

Three timed readings around the retinal capture and their average.

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.

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

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

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

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.

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

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

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

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.

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.

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.

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

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.

The measured value the eGFR is calculated from.

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

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.

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

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.