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. 2020 Jan 13;9(1):e13835. doi: 10.2196/13835

Table 1.

Variables, outcomes, and process measures with definitions.

Variables, outcomes, and process measures Definition Rationale
Independent variables

Basic demographics Age, gender, race and ethnicity, language, and insurance Assess patient population

Diagnoses Atrial fibrillation, atrial flutter, stroke, DVTa, mitral valve replacement, atrial valve replacement, pulmonary arterial hypertension, and PEb Assess prevalence of indications for anticoagulation

SAMe-TT2R2 score (sex, age, medical history, treatment, tobacco use, and race) A clinical scoring system designed to predict which patients on oral vitamin K antagonists (eg, warfarin) will reach an adequate TTRc (>65%-70%) Assess baseline likelihood of achieving/maintaining anticoagulation control
Outcomes

TTR Days in range divided by total days on warfarin Assess overall treatment efficacy

Proportion in range INRd values in range divided by total INR values measured Secondary measure of treatment efficacy

TWTRe Days from first administration of warfarin to first therapeutic INR value Assess efficiency of achieving therapeutic control
Process measures

Time from out-of-range INR value to patient contact Days until patient outreach after abnormal INR value Assess responsiveness of the clinic to abnormal values

Attendance rate to scheduled visits Proportion of visits attended (completed visits divided by scheduled visits) Assess efficiency of clinical operations

Proportion of patients meeting monitoring guidelines Proportion of patients who receive regular 56-day monitoring Assess adherence to treatment guidelines (ie, nomogram)

Appropriate duration of therapy Observed duration (days) of anticoagulation therapy divided by recommended total duration Assess the extent of overtreatment

Provision of telephonic or other remote visit for anticoagulation managementf Proportion of patients transitioned from in-person to phone visits (related to TWTR) Assess adherence to workflow protocol and overall clinic performancef

DOACg transitions Proportion of eligible patients screened and/or transitioned to DOACs Assess adherence to screening and transition protocols
Other clinical outcomes

Bleeding complications Incidence of bleeding during treatment Assess the incidence of adverse events

DVT Incidence of DVT during treatment Assess the incidence of adverse events

PE Incidence of PE during treatment Assess the incidence of adverse events

Ischemic stroke Incidence of stroke during treatment Assess the incidence of adverse events

aDVT: deep venous thrombosis.

bPE: pulmonary embolism.

cTTR: time in therapeutic range.

dINR: international normalized ratio.

eTWTR: time from warfarin initiation to first therapeutic INR.

fThe workflow protocol recommends that patients with international normalized ratio values consistently in range must be transitioned from in-person to telephone visits. If the intervention is effective, we would expect an increase in patients switched to remote telephonic monitoring.

gDOAC: direct-acting oral anticoagulant.