Table 1

Summary of data acquisition strategy

Data sourceInstrument typeOutcomes collectedAdministration scheduleEstimated completion time (min)
ProfileN/ADemographics
  • Date of birth (full or partial depending on country)

  • Sex

  • Home postcode

  • Healthcare system identifier (eg, NHS number) (outcome only collected in countries where permitted)

  • Current enrolment in any MG registries


MG characteristics
  • Ocular or generalised

  • Presence of any thymus involvement (eg, thymoma, follicular hyperplasia)

  • MG antibody status

  • Usual symptom severity in months preceding study enrolment (MGFA classification)

  • Age at MG symptom onset

  • MG symptom severity at diagnosis (MGFA classification)

  • Presence of any comorbidities


MG diagnosis and treatment
  • Age at seeking care or a diagnosis for MG

  • Age when diagnosed with MG

  • Diagnostic tests performed to achieve MG diagnosis

  • Healthcare professionals involved in diagnosis

  • Routine and rescue MG treatments at any time since diagnosis

  • Routine and rescue MG treatments within preceding 12 months

  • Need for any regular informal care

  • Person providing informal care

  • Hours of informal care needed per week

  • Impact on person providing informal care (eg, inability to work, stress)

  • Impact of MG on family and friends (eg, limited ability to make plans or socialise)

  • Living situation (eg, living independently or in a care home)

  • Past or current participation in MG clinical trials

  • Treatments received in any MG clinical trials


Healthcare resource use
  • Hospital visits for MG exacerbations at any time since diagnosis (emergency department, inpatient, intensive care)

  • Hospital visits for MG exacerbations within preceding 12 months (emergency department, inpatient, intensive care)


Work/study
  • Time off work/study

At enrolment; optional update at any time; both previous and updated data retained in study database and date of update logged to permit changes to be tracked15
TrackerN/AMG diagnosis and treatment
  • Routine and rescue MG treatments during study

  • Treatment dose (for corticosteroids only)

  • Satisfaction with treatment during study

  • Reasons for satisfaction level

  • Reasons for stopping treatments during study

  • Duration of rescue treatment during study


MG-related healthcare resource use
  • MG-related healthcare visits during study (eg, family doctor, specialist, hospital inpatient or outpatient visit, emergency department visit)

  • Duration of any hospital stays for MG exacerbations during study

  • Travel time to healthcare visits during study


Adverse events
  • Treatment-related adverse events experienced during study

  • Severity of any adverse events


Work/study
  • Work/study time missed during study due to MG

Monthly
3-week completion window
10
EQ-5D-5LCoreHRQoLAt enrolment then monthly; 1-week completion window2.5
EQ-5D-5L bolt-onsHRQoLAt enrolment then monthly; 1-week completion window1
MG-ADLMG symptomsAt enrolment then four times per 6 months; 2-week completion window4
MG-QoL15rHRQoLAt enrolment then once per 6 months; 3-week completion window7.5
HADSPsychological functioningAt enrolment then once per 6 months; 3-week completion window7
HUI3HRQoLAt enrolment then once per 12 months; 3-week completion window4
COVID-19 surveyImpact of COVID-19 outbreakAt enrolment then once per month; 3-week completion window6
PROMIS dyspnoea characteristicsOpt-inShortness of breathAt enrolment then once per 6 months; 3-week completion window2.5
FACIT-FatigueFatigueAt enrolment then once per 6 months; 3-week completion window7.5
PROMIS Sleep Disturbance short form 6aSleep qualityAt enrolment then once per 6 months; 3-week completion window3
  • FACIT, Functional Assessment of Chronic Illness Therapy; HADS, Hospital Anxiety and Depression Scale; HRQoL, health-related quality of life; HUI3, Health Utilities Index III; MG, myasthenia gravis; MG-ADL, Myasthenia Gravis Activities of Daily Living; MGFA, Myasthenia Gravis Foundation of America; MG-QoL15r, Myasthenia Gravis Quality of Life 15-item revised scale; N/A, not applicable; NHS, National Health Service; PROMIS, Patient-Reported Outcomes Measurement Information System.