SDV Patient Pools

Conceptually, SDV auto-selection uses patient pools that correspond to a patient's current SDV selection status and eligibility status. You can see the current Selection and Eligibility statuses for each patient in the published version of the SDV plan.

You can also see current patient statuses in a draft version of the patient SDV plan if there is one in progress and you also have a published patient SDV plan. The draft version lists all patients assigned to the site, while the published version lists only those patients already selected for SDV.

Patient pools and their corresponding patient statuses are as follows:

Exclusion Pool — Contains patients explicitly excluded by the patient SDV plan, which may have been excluded individually or through an import list. These patients may or may not be eligible. The Selection status in the patient SDV plan can be either Excluded or Import Excluded.

Manual Pool — Contains patients explicitly selected in the RDC Onsite SDV Plan, either individually or in an import list. These patients may or may not be eligible. The Selection status in the patient SDV plan can be either Selected or Imported.

Newly Eligible Pool — Contains patients that became eligible since the last time auto-selection was executed. For a patient to be included in this pool, SDV Eligibility must show a valid date. The Selection status in the patient SDV plan can be null, an Exclusion Pool status, or a Manual Pool status.

Initial Pool — Contains patients which have been auto-selected for SDV as one of the first patients to have become eligible at the site. The number of patients to be included in this pool is specified in the patient SDV plan as the Number of Initial Patients. For a patient to be included in this pool, SDV Eligibility must show a valid date. The Selection status in the patient SDV plan is Initial.

Auto-selected Pool — Contains patients which have been auto-selected based on the auto-select rate specified in the published patient SDV plan. For a patient to be included in this pool, SDV Eligibility must show a valid date. The Selection status in the patient SDV plan is Auto-Selected.

Discard Pool — Contains SDV-eligible patients that went through auto-selection, but were not selected. The Discard pool is revisited if the auto-select rate is increased while the study is in progress. There is no information in the patient SDV plan that can certainly distinguish a discarded patient from a newly eligible patient that is not in the Exclusion or Manual pools because in both cases the Selection status is null and a valid eligibility date is present. While not always accurate, you can assume a patient is discarded if it has a null Selection status and the eligibility date precedes the last run of the Pending Patients Updates job.

Note:

Depending on your methodology for populating patient eligibility dates, you could have a patient become eligible after the last run of the Pending Patient Updates job with a date in the past.

Active SDV Pool — Contains patients in the combined Auto-selected and Initial pools, plus those patients in the Manual pool which are SDV-eligible. These patients are further called out in the patient SDV plan with a value of Active in the Active SDV? column of the patient SDV plan. The Active SDV Patients table in the patient SDV plan reports the total count of Active SDV patients, broken down by selection type. These are the patients that are retrieved in RDC Onsite when a search for Patients Requiring 100% SDV is conducted. Patients in this pool must have a valid SDV Eligibility date. Patients in the Active SDV pool can have a Selection status of Auto-Selected, Initial, Selected, or Imported.