Appendix F: Conceptual Definition of Outcomes

Timothy J Wilt; Kathleen F Carlson; Gary D Goldish; Roderick MacDonald; Catherine Niewoehner; Indulis Rutks; Tatyana Shamliyan; James Tacklind; Brent C Taylor; Robert L Kane

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Wilt TJ, Carlson KF, Goldish GD, et al. Carbohydrate and Lipid Disorders and Relevant Considerations in Persons with Spinal Cord Injury. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Jan. (Evidence Reports/Technology Assessments, No. 163.)

This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Appendix F: Conceptual Definition of Outcomes

Cardiovascular diseases¹ (CVD). Pathological conditions involving the cardiovascular system including the heart; the blood vessels; or the pericardium.

Operational definition: Prevalence of CVD and diabetes and incidence rate of CVD events. Definitions of CVD events are presented below.

Variable	Definition
Arrhythmia	Any variation from the normal rhythm or rate of the heartbeat
Arrhythmia, sinus	Irregularity of the heart rate related to functioning of the sinoatrial node
Atrial fibrillation	Disorder of cardiac rhythm characterized by rapid, irregular atrial impulses and ineffective atrial contractions
Atrial flutter	Rapid, irregular atrial contractions due to an abnormality of atrial excitation
Bradycardia	Excessive slowness in the action of the heart, usually with a heart rate below 60 beats per minute
Cardiac complexes, premature	A premature contraction of the heart that is initiated somewhere other than the sinoatrial node
Atrial premature complexes	Premature contractions of the heart arising from an ectopic atrial focus
Ventricular premature complexes	Premature contractions of the ventricle, the most common of all arrhythmias
Heart block	Impairment of conduction in heart excitation. It is often applied specifically to atrioventricular heart block
Long QT syndrome	A syndrome characterized by history of syncopal episodes and a long QT interval, sometimes leading to sudden death due to paroxysmal ventricular arrhythmia
Sick sinus syndrome	Dysfunction of the sinoatrial node manifested by persistent sinus bradycardia, sinus arrest, sinoatrial exit block, chronic atrial fibrillation and inability of the heart to resume sinus rhythm following cardioversion for atrial fibrillation
Tachycardia	Excessive rapidity in the action of the heart, usually with a heart rate above 100 beats per minute
Ventricular fibrillation	Turbulent, disorganized electrical activity of the heart in such a way that the recorded electrocardiographic deflections continuously change in shape, magnitude, and direction
Heart arrest	Abrupt cessation of cardiac pump function which may be reversible by a prompt intervention but will lead to death in its absence
Cardiovascular collapse	A sudden loss of effective blood flow due to cardiac and/or peripheral vascular factors which may reverse spontaneously (e.g., neurocardiogenic syncope; vasovagal syncope) or only with interventions (e.g., cardiac arrest)
Congestive heart failure	Defective cardiac filling and/or impaired contraction and emptying, resulting in the heart's inability to pump a sufficient amount of blood to meet the needs of the body tissues or to be able to do so only with an elevated filling pressure
Coronary disease	An imbalance between myocardial functional requirements and the capacity of the coronary vessels to supply sufficient blood flow Coronary artery abnormalities 1. Chronic atherosclerotic lesions 2. Acute (active) lesions (plaque fissuring, platelet aggregation, acute thrombosis) 3. Anomalous coronary artery anatomy
Myocardial infarction	Gross necrosis of the myocardium, as a result of interruption of the blood supply to the area 1. Healed 2. Acute
Pericarditis	Inflammation of the pericardium
Stroke	Sudden, nonconvulsive loss of neurological function due to an ischemic or hemorrhagic intracranial vascular event. In general, cerebrovascular accidents are classified by anatomic location in the brain, vascular distribution, etiology, age of the affected individual, and hemorrhagic vs. nonhemorrhagic nature.
Hypertension	Persistently high systemic arterial blood pressure. Based on multiple readings, hypertension is currently defined as when systolic blood pressure is consistently greater than 140 mm Hg or when diastolic pressure is consistently 90 mm Hg or more.
Death	Irreversible cessation of all biologic functions
Cardiovascular mortality	Death from cardiovascular diseases (considered as immediate and underlying cause of death)

International Classification of Diseases Codes to Identify Outcomes²

404	Hypertensive heart and kidney disease
	Includes: disease: cardiorenal; cardiovascular renal; any condition classifiable to 402 with any condition classifiable to 403
	Additional code to specify type of heart failure (428.0–428.43), if known
	Additional code to identify the stage of chronic kidney disease (585.1–585.6), if known
	The following fifth-digit sub-classification is for use with category 404:
	0 without heart failure or chronic kidney disease
	1 with heart failure
	2 with chronic kidney disease
	3 with heart failure and chronic kidney disease
402	Hypertensive heart disease
	Includes: hypertensive: cardiomegaly; cardiopathy; cardiovascular disease; heart (disease) (failure), any condition classifiable to 429.0–429.3, 429.8, 429.9 due to hypertension
	Use additional code to specify type of heart failure (428.0–428.43), if known
427	Cardiac dysrhythmias
427.0	Paroxysmal supraventricular tachycardia
	Paroxysmal tachycardia: atrial [PAT]; atrioventricular [AV]; junctional nodal
427.1	Paroxysmal ventricular tachycardia
	Ventricular tachycardia (paroxysmal)
427.2	Paroxysmal tachycardia, unspecified
	Bouveret-Hoffmann syndrome
	Paroxysmal tachycardia
427.3	Atrial fibrillation and flutter
427.31	Atrial fibrillation
427.32	Atrial flutter
427.5	Cardiac arrest
	Cardiorespiratory arrest
427.6	Premature beats
427.60	Premature beats, unspecified
	Ectopic beats
	Extrasystoles
	Extrasystolic arrhythmia
	Premature contractions or systoles NOS
427.8	Other specified cardiac dysrhythmias
427.81	Sinoatrial node dysfunction
	Sinus bradycardia: persistent severe
	Syndrome: sick sinus; tachycardia-bradycardia
427.9	Cardiac dysrhythmia, unspecified
	Arrhythmia (cardiac) NOS
428.0	Congestive heart failure, unspecified
	Congestive heart disease
	Right heart failure (secondary to left heart failure)
428.1	Left heart failure
	Acute edema of lung with heart disease NOS or heart failure
	Acute pulmonary edema with heart disease NOS or heart failure
	Cardiac asthma
	Left ventricular failure
428.9	Heart failure, unspecified
	Cardiac failure NOS
	Heart failure NOS
	Myocardial failure NOS
	Weak heart
428	Heart failure
	Code, if applicable, heart failure due to hypertension first (402.0–402.9, with fifth-digit 1 or 404.0–404.9 with fifth-digit 1 or 3)
429.2	Cardiovascular disease, unspecified
	Arteriosclerotic cardiovascular disease [ASCVD]
	Cardiovascular arteriosclerosis
	Cardiovascular: degeneration (with mention of arteriosclerosis) disease (with mention of arteriosclerosis)
	Sclerosis (with mention of arteriosclerosis)
	Additional code to identify presence of arteriosclerosis
794	Nonspecific abnormal results of function studies
250	Diabetes mellitus
250.0	Diabetes mellitus without mention of complication
	Diabetes mellitus without mention of complication or manifestation classifiable to 250.1–250.9
	Diabetes (mellitus) NOS
250.6	Diabetes with neurological manifestations
	Additional code to identify manifestation, as:
	diabetic:
	amyotrophy (358.1)
	gastroparalysis (536.3)
	gastroparesis (536.3)
	mononeuropathy (354.0–355.9)
	neurogenic arthropathy (713.5)
	peripheral autonomic neuropathy (337.1)
	polyneuropathy (357.2)
250.7	Diabetes with peripheral circulatory disorders
	Use additional code to identify manifestation, as:
	diabetic:
	gangrene (785.4)
	peripheral angiopathy (443.81)
250.8	Diabetes with other specified manifestations
	Diabetic hypoglycemia
	Hypoglycemic shock
	Use additional code to identify manifestation, as:
	any associated ulceration (707.10–707.9)
	diabetic bone changes (731.8)

International Classification of Diseases Codes to Identify Outcomes in Individual Studies:

Groah, 2001:³ Cardiovascular disease outcomes defined by ICD/9 codes 390–448 and 745–747:

DISEASES OF THE CIRCULATORY SYSTEM (390–459)

ACUTE RHEUMATIC FEVER (390–392)

CHRONIC RHEUMATIC HEART DISEASE (393–398)

HYPERTENSIVE DISEASE (401–405)

ISCHEMIC HEART DISEASE (410–414)

Includes: that with mention of hypertension

Additional code to identify presence of hypertension (401.0–405.9)

DISEASES OF PULMONARY CIRCULATION (415–417)

OTHER FORMS OF HEART DISEASE (420–429)

CEREBROVASCULAR DISEASE (430–438)

Includes: with mention of hypertension (conditions classifiable to 401–405)

DISEASES OF ARTERIES, ARTERIOLES, AND CAPILLARIES (440–448)

745 Bulbus cordis anomalies and anomalies of cardiac septal closure

746 Other congenital anomalies of heart

747 Other congenital anomalies of circulatory system

McGlinchey-Berroth, 1995⁴ Hospitalization due to myocardial infarction (ICD-9-CM 410.9), diabetes (ICD 250.00 to 250.9), and hypertension (ICD 401.0 to 401.9).

410 Acute myocardial infarction

Includes: cardiac infarction; coronary (artery):embolism; occlusion; rupture; thrombosis; infarction of heart, myocardium, or ventricle; rupture of heart, myocardium, or ventricle;

ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction; any condition classifiable to 414.1–414.9 specified as acute or with a stated duration of 8 weeks or less

The following fifth-digit subclassification is for use with category 410:

0 episode of care unspecified

1 initial episode of care

The fifth-digit 1 to designate the first episode of care (regardless of facility site) for a newly diagnosed myocardial infarction. The fifth-digit 1 is assigned regardless of the number of times a patient may be transferred during the initial episode of care.

2 subsequent episode of care

The fifth-digit 2 to designate an episode of care following the initial episode when the patient is admitted for further observation, evaluation or treatment for a myocardial infarction that has received initial treatment, but is still less than 8 weeks old.

410. 0 Of anterolateral wall

ST elevation myocardial infarction (STEMI) of anterolateral wall

410. 1 Of other anterior wall

Infarction:

anterior (wall) NOS (with contiguous portion of intraventricular septum)

anteroapical (with contiguous portion of intraventricular septum)

anteroseptal (with contiguous portion of intraventricular septum)

ST elevation myocardial infarction (STEMI) of other anterior wall

410.2 Of inferolateral wall

ST elevation myocardial infarction (STEMI) of inferolateral wall

410.3 Of inferoposterior wall

ST elevation myocardial infarction (STEMI) of inferoposterior wall

410.4 Of other inferior wall

Infarction: diaphragmatic wall NOS (with contiguous portion of intraventricular septum)

inferior (wall) NOS (with contiguous portion of intraventricular septum)

ST elevation myocardial infarction (STEMI) of other inferior wall

410.5 Of other lateral wall

Infarction: apical-lateral; basal-lateral; high lateral; posterolateral

ST elevation myocardial infarction (STEMI) of other lateral wall

410.6 True posterior wall infarction

Infarction: posterobasal; strictly posterior

ST elevation myocardial infarction (STEMI) of true posterior wall

410.7 Subendocardial infarction

Non-ST elevation myocardial infarction (NSTEMI)

Nontransmural infarction

410.8 Of other specified sites

Infarction of: atrium; papillary muscle; septum alone

ST elevation myocardial infarction (STEMI) of other specified sites

410.9 Unspecified site

401 Essential hypertension

Includes: high blood pressure; hyperpiesia; hyperpiesis; hypertension (arterial) (essential) (primary) (systemic); hypertensive vascular: degeneration; disease

DeVivo, 1993:⁵ Ischemic heart disease (ICD codes 410–414); Non ischemic heart disease (ICD codes 420–429); Cerebrovascular diseases (ICD codes 430–438); Diseases of arteries (ICD codes 440–448)

ISCHEMIC HEART DISEASE (410–414)

Includes:

that with mention of hypertension

Additional code to identify presence of hypertension (401.0–405.9)

410 Acute myocardial infarction

Includes:

cardiac infarction

coronary (artery):

embolism

occlusion

rupture

thrombosis

infarction of heart, myocardium, or ventricle

rupture of heart, myocardium, or ventricle

ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

any condition classifiable to 414.1–414.9 specified as acute or with a stated duration of 8 weeks or less

The following fifth-digit subclassification is for use with category 410:

0 episode of care unspecified

Use when the source document does not contain sufficient information for the assignment of fifth-digit 1 or 2.

1 initial episode of care

Use fifth-digit 1 to designate the first episode of care (regardless of facility site) for a newly diagnosed myocardial infarction. The fifth-digit 1 is assigned regardless of the number of times a patient may be transferred during the initial episode of care.

2 subsequent episode of care

Use fifth-digit 2 to designate an episode of care following the initial episode when the patient is admitted for further observation, evaluation or treatment for a myocardial infarction that has received initial treatment, but is still less than 8 weeks old.

411 Other acute and subacute forms of ischemic heart disease

412 Old myocardial infarction; Healed myocardial infarction

Past myocardial infarction diagnosed on ECG [EKG] or other special investigation, but currently presenting no symptoms

413 Angina pectoris

414 Other forms of chronic ischemic heart disease

Excludes:

arteriosclerotic cardiovascular disease [ASCVD] (429.2)

cardiovascular:

arteriosclerosis or sclerosis (429.2)

degeneration or disease (429.2)

OTHER FORMS OF HEART DISEASE (420–429)

420 Acute pericarditis

Includes:

acute:

mediastinopericarditis

myopericarditis

pericardial effusion

pleuropericarditis

pneumopericarditis

Excludes:

acute rheumatic pericarditis (391.0)

postmyocardial infarction syndrome [Dressler's] (411.0)

421 Acute and subacute endocarditis

422 Acute myocarditis

Excludes:

acute rheumatic myocarditis (391.2)

423 Other diseases of pericardium

Excludes:

that specified as rheumatic (393)

424 Other diseases of endocardium

Excludes:

bacterial endocarditis (421.0–421.9)

rheumatic endocarditis (391.1, 394.0–397.9)

syphilitic endocarditis (093.20–093.24)

425 Cardiomyopathy

Includes:

Myocardiopathy

426 Conduction disorders

427 Cardiac dysrhythmias

428 Heart failure

Code, if applicable, heart failure due to hypertension first (402.0–402.9, with fifth-digit 1 or 404.0–404.9 with fifth-digit 1 or 3)

CEREBROVASCULAR DISEASE (430–438)

Includes:

with mention of hypertension (conditions classifiable to 401–405)

Use additional code to identify presence of hypertension

430 Subarachnoid hemorrhage

Meningeal hemorrhage

Ruptured:

berry aneurysm

(congenital) cerebral aneurysm NOS

432 Other and unspecified intracranial hemorrhage

433 Occlusion and stenosis of precerebral arteries

The following fifth-digit subclassification is for use with category 433:

0 without mention of cerebral infarction

1 with cerebral infarction

Includes:

embolism of basilar, carotid, and vertebral arteries

narrowing of basilar, carotid, and vertebral arteries

obstruction of basilar, carotid, and vertebral arteries

thrombosis of basilar, carotid, and vertebral arteries

434 Occlusion of cerebral arteries

The following fifth-digit subclassification is for use with category 434:

0 without mention of cerebral infarction

1 with cerebral infarction

435 Transient cerebral ischemia

Includes:

cerebrovascular insufficiency (acute) with transient focal neurological signs and symptoms

insufficiency of basilar, carotid, and vertebral arteries

spasm of cerebral arteries

436 Acute, but ill-defined, cerebrovascular disease

Apoplexy, apoplectic:

NOS

attack

cerebral

seizure

Cerebral seizure

437 Other and ill-defined cerebrovascular disease

438 Late effects of cerebrovascular disease

Note: This category is to be used to indicate conditions in 430–437 as the cause of late effects. The “late effects” include conditions specified as such, or as sequelae, which may occur at any time after the onset of the causal condition.

DISEASES OF ARTERIES, ARTERIOLES, AND CAPILLARIES (440–448)

440 Atherosclerosis

Includes:

arteriolosclerosis

arteriosclerosis (obliterans) (senile)

arteriosclerotic vascular disease

atheroma

degeneration:

arterial

arteriovascular

vascular

endarteritis deformans or obliterans

senile:

arteritis

endarteritis

Excludes:

atheroembolism (445.01–445.89)

atherosclerosis of bypass graft of the extremities (440.30–440.32)

440.0 Of aorta

440.1 Of renal artery

440.2 Of native arteries of the extremities

440.3 Of bypass graft of the extremities

440.8 Of other specified arteries

440.9 Generalized and unspecified atherosclerosis

Garshick, 2005:⁶ Diseases of the heart (390–398, 402, 404, 410–14, 420–429); Other diseases of the circulatory system (401, 403, 405, 415–417, 430–38, 440–459); Diseases of the arteries, veins, and pulmonary circulation (415–417,440–459).

DISEASES OF THE CIRCULATORY SYSTEM (390–459)

ACUTE RHEUMATIC FEVER (390–392)

CHRONIC RHEUMATIC HEART DISEASE (393–398)

402 Hypertensive heart disease

403 Hypertensive kidney disease

405 Secondary hypertension

415 Acute pulmonary heart disease

416 Chronic pulmonary heart disease

417 Other diseases of pulmonary circulation

CEREBROVASCULAR DISEASE (430–438)

DISEASES OF ARTERIES, ARTERIOLES, AND CAPILLARIES (440–448)

DISEASES OF VEINS AND LYMPHATICS, AND OTHER DISEASES OF CIRCULATORY SYSTEM (451–459)

Analytical framework for pooled analysis of prevalence of cardiovascular diseases in adults with chronic SCI.

Prevalence was calculated as number of CVD events among total number of SCI patients in the study, standard error and confidence interval for population prevalence were calculated with Wilson estimate as followed:⁷

SEρ=√ [ρ*(1-ρ)]/[n+4]

95% level C confidence interval ρ±1.96*SEρ

Where p - prevalence, n- sample size

Pooled estimate as a weighted average:⁸

Weights are inverse of variance (standard error):

Standard error of pooled estimate:

Heterogeneity (between-study variability) measured by:

Assumptions for random effects model: true effect sizes qi have a normal distribution with mean q and variance t2; t2 is the between-study variance

Between study variance:

Where:

wi are the weights from the fixed effect inverse-variance method

Q is the heterogeneity test statistic from before (either from inverse-variance method or Mantel-Haenszel method)

k is the number of studies, and

t2 is set to zero if Q<k-1

Random effect pooled estimate is weighted average:

Weights used for the pooled estimate are similar to the inverse-variance, but now incorporate a component for between-study variation:

Standard error of pooled estimate

Heterogeneity between studies was quantified using the I-squared statistic.⁹. Statistical significance was analyzed at the 95% confidence level. All calculations were conducted using STATA software.¹⁰

References for Appendix E

1.: National Library of Medicine (U.S.), National Center for Biotechnology Information (U.S.), National Institutes of Health (U.S.). PubMed central: an archive of life science journals. NCBI U.S. National Library of Medicine NIH Dept. of Health and Human Services [Digital archive searchable database]. Available at: http://www.pubmedcentral.nih.gov/
2.: Centers for Disease Control and Prevention (U.S.) NCfHSUS. ICD-9-CM, international classification of diseases, ninth revision, clinical modification. U.S. Dept. of Health and Human Services Centers for Disease Control and Prevention Health Care Financing Administration.
3.: Groah SL, Weitzenkamp D, Sett P. et al. The relationship between neurological level of injury and symptomatic cardiovascular disease risk in the aging spinal injured. Spinal Cord. 2001 Jun;39(6):310–7. [PubMed: 11438852]
4.: McGlinchey-Berroth R, Morrow L, Ahlquist M. et al. Late-life spinal cord injury and aging with a long term injury: characteristics of two emerging populations. J Spinal Cord Med. 1995 Jul;18(3):183–93. [PubMed: 7552423]
5.: DeVivo MJ, Black KJ, Stover SL. Causes of death during the first 12 years after spinal cord injury. Arch Phys Med Rehabil. 1993 Mar;74(3):248–54. [PubMed: 8439250]
6.: Garshick E, Kelley A, Cohen SA. et al. A prospective assessment of mortality in chronic spinal cord injury. Spinal Cord. 2005 Jul;43(7):408–16. [PMC free article: PMC1298182] [PubMed: 15711609]
7.: Moore DS, McCabe GP. Introduction to the practice of statistics. 4th ed. New York: W.H. Freeman and Co.; 2003.
8.: Der Simonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986 Sep;7(3):177–88. [PubMed: 3802833]
9.: Higgins JP, Thompson SG, Deeks JJ. et al. Measuring inconsistency in meta-analyses. BMJ. 2003 Sep 6;327(7414):557–60. [PMC free article: PMC192859] [PubMed: 12958120]
10.: Egger M, Smith GD, Altman DG. Systematic Reviews in Health Care. London: NetLibrary, Inc. BMJ Books; 2001.

Bookshelf ID: NBK38461

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