Appendix BData Abstraction Elements

Publication Details

  1. Citation identifiers
    • Total number of subjects across all arms
    • Study design
    • Funding source
  2. Study sites
    • Geographical location
    • Number of sites
    • General setting
  3. Study population characteristics
    • Stroke
    • Myocardial infarction
    • Both stroke and MI
    • Other mix (specify)
    • Severity description provided? (Y/N/NR)
      • If Y, admission, discharge, NR
      • How measured?
    • Age (mean, median, range)
    • Sex (%)
    • Ethnicity
    • Race
    • Living arrangement (alone, with someone)
    • Has support system?
    • Work status
      • Home by choice
      • Home not by choice
      • Working
      • NR
      • Other (specify)
  4. Insurance status
    • Medicare
    • Medicaid
    • Private insurance
    • VA
    • National healthcare system
    • None
    • NR
    • Other (specify)
  5. Followup assessments
    • 3 months
    • 6 months
    • 1 year
    • NR
    • Other (specify)
  6. Intervention characteristics
    • FROM specific setting—Defined as the specific setting or environment FROM which the patient or population is transitioning:
      • Hospital (includes stroke unit and CCU)
      • Inpatient rehabilitation
      • Outpatient rehabilitation
      • Skilled nursing facility
      • ED
      • Other setting (specify)
    • TO specific setting—Defined as the specific setting or environment TO which the patient or population is transitioning:
      • Inpatient rehabilitation
      • Outpatient rehabilitation
      • Skilled nursing facility
      • Home
      • Home care
      • Long-term care
      • Other setting (specify)
  7. Components of transitional services
    • Education and training of provider
    • Education and training of caregiver
    • Discharge planning (including procurement of equipment and services, referrals for followup care, and education about community resources)
    • Self-management tools (alleviate patient and caregiver burden managing transitions between care environments)
    • Care pathways( to organize treatment and rehabilitation across care settings)
    • Systems for shared access to patient information to allow multiple health care providers across settings to access patient information and to coordinate care
    • Referrals to specialty care providers based on patient needs
    • Referral back to primary care providers
    • Home caregiver support
    • Post discharge followup (phone, mail, etc.)
    • Other service (specify)
  8. Intervention provider
    • Generalist (MD/DO)
    • Specialist (MD/DO) (specify specialty)
    • Advance practice nurse (APN)
    • Nurse
    • Nurse practitioner/physician assistant
    • Pharmacist
    • Physical therapist
    • Occupational therapist
    • Case manager
    • Lay practitioner
    • Other provider (specify)
  9. Comparator
    • Has comparator of usual care (care that does not include transitional services that coordinate care among multiple providers; for example, a simple recommendation for followup with primary care and other HCPs, or direct discharge to home or other health care facility)
    • Other comparator (specify)
  10. Study arm characteristics
    • # of arms
    • N per arm
    • Mean age per arm
    • Median age per arm
    • Age range per arm
    • Sex distribution per arm
    • Ethnicity per arm
    • Race per arm
    • Other (specify)
  11. Intervention impact
    • Intervention improved outcome
    • Intervention worsened outcome
    • Intervention had no impact
    • Not reported
  12. KQ applicability
    • KQ 1 (Y/N)
    • KQ 2 (Y/N)
    • KQ 3 (Y/N)
    • KQ 4 (Y/N)
    • KQ 5 (Y/N)
  13. KQ outcomes and results
    • KQ 1: Theoretical framework? If Y, specify
    • KQs 2–5 (primary outcomes):
      • Death at 3 months, 6 months, or 1 year following the event
      • Hospital readmission at 3 months, 6 months, or 1 year following the event
      • Continuity of health care with specialist
      • Continuity of health care with general HCPs
    • KQs 2–5 (secondary outcomes):
      • Hospital-free days
      • Increase total # of services for a patient
      • Return to premorbid status
      • Return to premorbid functional ability
      • Return to premorbid quality of life (if Y, how measured?)

        Barthel index

        SF-36, SF-12, etc.

        Modified Rankin score

        PHQ depression scale



        Other (specify)

  14. Adverse events/harms/risks
    • Hospital readmission
    • Delayed discharge
    • Failure to improve from baseline
    • Increased utilization with failure to improve
    • Increased patient/caregiver burden
    • Lost to followup
    • Overreferred
    • Dropped from insurance
    • Other harm [specify]
  15. Improvements (specify results for all that apply)
    • Efficiency of referrals for followup care
    • Timely appointments
    • Communication among HCPs
    • Coordination of patient care across HCPs
    • Care pathways
    • Shared access to patient information
    • Other (specify)
  16. Reductions (specify results for all that apply)
    • ER visits
    • Hospital readmissions
    • Morbidity
    • Mortality
    • Delayed discharge
    • Caregiver burden
    • Insurance issues
    • Other (specify)
  17. Quality and applicability assessments
    1. Study-level quality assessment: Please assign each study an overall quality rating of “Good,” “Fair,” or “Poor” based on the following definitions:
      • A Good study has the least bias and results are considered valid. A good study has a clear description of the population, setting, interventions, and comparison groups; uses a valid approach to allocate patients to alternative treatments; has a low dropout rate; and uses appropriate means to prevent bias; measure outcomes; analyze and report results.
      • A Fair study is susceptible to some bias, but probably not sufficient to invalidate the results. The study may be missing information, making it difficult to assess limitations and potential problems. As the fair-quality category is broad, studies with this rating vary in their strengths and weaknesses. The results of some fair-quality studies are possibly valid, while others are probably valid.
      • A Poor rating indicates significant bias that may invalidate the results. These studies have serious errors in design, analysis, or reporting; have large amounts of missing information; or have discrepancies in reporting. The results of a poor-quality study are at least as likely to reflect flaws in the study design as to indicate true differences between the compared interventions.
      If a study is rated as “Fair” or “Poor,” please note any important limitations on internal validity based on the USPSTF criteria, as adapted here:
      • Initial assembly of comparable groups:
        • For RCTs: adequate randomization, including concealment and whether potential confounders were distributed equally among groups.
        • For cohort studies: consideration of potential confounders with either restriction or measurement for adjustment in the analysis; consideration of inception cohorts.
      • Maintenance of comparable groups (includes attrition, crossovers, adherence, contamination)
      • Important differential loss to followup or overall high loss to followup.
      • Measurements: equal, reliable, and valid (includes masking of outcome assessment).
      • Clear definition of interventions.
      • All important outcomes considered.
      • Analysis: adjustment for potential confounders for cohort studies, or intention-to-treat analysis for RCTs.
    2. Applicability assessment: Do not assign an overall applicability score. Instead, list the most important (up to 3) limitations affecting applicability, if any, based on the following list. (Bolded criteria are prioritized for this project.)
      1. Setting of the study
        • In which country (or countries) was the study conducted?
        • In what health care system (or systems) was the study conducted?
        • Were patients recruited from the primary, secondary, or tertiary care settings?
        • How were study centers selected for participation?
        • How were study clinicians selected for participation?
      2. Selection of participants
        • How were participants diagnosed and identified for eligibility screening before random allocation?
        • What were the study eligibility criteria?
        • What were the study exclusion criteria?
        • Did the study require a run-in period with the control or placebo intervention?
        • Did the study require a run-in period with the active intervention?
        • Did the study selectively recruit participants who demonstrated a history of favorable or unfavorable response to drug or other interventions for the condition?
        • Did the study report the ratio of randomly allocated participants to nonallocated participants (who were eligible)?
        • Did the study report the proportion of eligible participants who declined random allocation?
      3. Characteristics of study participants
        • Did the study report participants’ baseline characteristics?
        • Did the study report participants’ race?
        • Did the study report participants’ underlying pathology?
        • Did the study report participants’ stage in the natural history of the disease?
        • Did the study report participants’ severity of disease?
        • Did the study report participants’ comorbid conditions?
        • Did the study report participants’ absolute risk of a poor outcome in the control arm?
      4. Differences between the study protocol and routine clinical practice
        • Were the study interventions (active arm) similar to interventions used in routine clinical practice?
        • Was the timing of the intervention similar to the timing in routine clinical practice?
        • Was the study’s control arm appropriate and relevant in relation to routine clinical practice?
        • Were the study’s cointerventions—which were not randomly allocated— adequate to reflect routine clinical practice?
        • Were any interventions prohibited by the study routinely used in clinical practice?
        • Have there been diagnostic or therapeutic advances used in routine practice since the study was conducted?
      5. Outcome measures and followup
        • If applicable, did the study use a clinically relevant surrogate outcome?
        • If applicable, did the study use a scale that is clinically relevant, valid, and reproducible?
        • If applicable, was the intervention beneficial on the most relevant components of the composite outcome?
        • Which clinician measured the outcome (e.g., treating physician or surgeon)?
        • Did the study use patient-centered outcomes?
        • How frequently were participants followed in the study?
        • Was the duration of participant followup adequate?
      6. Adverse effects of treatment
        • How completely did the study report the occurrence of relevant adverse effects?
        • Did the study report the rates of treatment discontinuations?
        • Were the study centers and/or clinicians selected on the basis of their skill or experience?
        • Did the study exclude participants at elevated risk of intervention complications?
        • Did the study exclude participants who suffered adverse effects during the run-in period?
        • Did the study monitor participants intensively for early signs of adverse effects?