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February 12, 2008; 70 (7) Articles

Impact of comorbidity on headache-related disability

K. Saunders, K. Merikangas, N.C.P. Low, M. Von Korff, R. C. Kessler
First published February 11, 2008, DOI: https://doi.org/10.1212/01.wnl.0000297192.84581.21
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Abstract

Objective: To assess and compare the extent to which comorbid conditions explain the role disability associated with migraine and other severe headaches.

Methods: A probability sample of US adults (n = 5,692) was interviewed. Presence of headaches, other chronic pain conditions, and chronic physical conditions was assessed in a structured interview administered by trained interviewers. Diagnostic criteria for migraine were based on the International Headache Society classification. Mental disorders were ascertained with the Composite International Diagnostic Interview that collected diagnostic criteria according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Role disability was assessed with World Health Organization Disability Assessment Schedule questions about days out of role and days with impaired role functioning.

Results: Eighty-three percent of migraineurs and 79% of persons with other severe types of headache had some form of comorbidity. Compared with headache-free subjects, migraineurs were at significantly increased risk for mental disorders (odds ratio [OR] 3.1), other pain conditions (OR 3.3), and physical diseases (OR 2.1). Compared with headache-free subjects, persons with nonmigraine headache were also at significantly increased risk for mental disorders (OR 2.0), other pain conditions (OR 3.5), and physical diseases (OR 1.7). Migraineurs experienced role disability on 25.2% of the last 30 days compared with 17.6% of the days for persons with nonmigraine headaches and 9.7% of the days for persons without headache. Comorbid conditions explained 65% of the role disability associated with migraine and all of the role disability associated with other severe headaches.

Conclusions: Comorbidity is an important factor in understanding disability among persons with headache.

GLOSSARY: CIDI = Composite International Diagnostic Interview; GAD = generalized anxiety disorder; ICHD-II = International Classification of Headache Disorders, second edition; NA = not applicable; NCS-R = National Comorbidity Survey Replication; OR = odds ratio; PTSD = post-traumatic stress disorder; WHO = World Health Organization.

Migraine and other severe headaches have been shown to lead to substantial disability.1–5 However, most prior studies of disability have not accounted for the high magnitude of both physical and mental comorbidity associated with headache. Identifying the extent to which headache-related disability is explained by comorbid conditions has major implications for prevention and intervention.

A recent population-based study found that disability is greater among migraineurs with comorbid anxiety and depression compared with migraineurs without these mental disorders.6 This headache-specific finding is consistent with other research showing that comorbidity is associated with disability for a number of mental and physical conditions.7–9 The current study investigates how much of headache-related disability is explained by comorbidity—mental or physical. In addition, building on prior research that compares patterns of comorbidity10–15 and disability16,17 among those with migraine and tension-type headache, this study investigates patterns of mental and physical comorbidity and their impact on disability for the two headache subtypes.

Specifically, this report presents data from the US adult household population to address two questions: 1) To what extent do three types of comorbidity (mental disorders, chronic physical diseases, and chronic pain conditions) influence disability associated with migraine and other severe headache disorders? 2) Do migraine and tension-type headache differ in their effect on disability, after accounting for the contribution of comorbid conditions?

METHODS

Sample.

The National Comorbidity Survey Replication (NCS-R) is a nationally representative, face-to-face household survey of 9,282 respondents aged 18 years or older conducted between February 2001 and December 2002.18,19 Respondents were selected from a multistage area probability sample of the noninstitutionalized civilian population in the 48 contiguous states. The response rate was 70.9%. All respondents were administered a Part 1 psychiatric diagnostic interview as described below, while 5,692 respondents also received a Part 2 interview that included assessment of chronic physical diseases, chronic pain conditions, and disability. The sample receiving Part 2 consisted of all respondents who screened positive for any mental disorder found in Part 1 plus a probability sample of the remaining Part 1 respondents. More complete information on the methods of the NCS-R are presented elsewhere.19

Recruitment.

Recruitment to the initial NCS-R interview began with a letter and study fact brochure mailed to sample households followed by an in-person interviewer visit. Participants received $50 as a gift to thank them for participating. Recruitment and consent procedures were approved by human subjects committees of Harvard Medical School and the University of Michigan.

Weighting.

The Part 1 sample was weighted to adjust for differential probabilities of selection within households and for differences in intensity of recruitment effort among hard-to-recruit cases. The Part 2 sample was then weighted to adjust for the lower selection probabilities for Part 1 respondents without a mental disorder. A final weight adjusted the sample to match the 2000 census population on a cross-classification of a number of geographic and sociodemographic variables. All analyses reported in this article use these weights.

Definition of migraine and nonmigraine headaches.

The NCS-R included an interview of physical conditions based on the chronic conditions assessed in the US National Health Interview Survey.20 Respondents were asked whether they ever in their life experienced each of the symptom-based conditions in this checklist and, if so, whether they experienced them at any time in the past 12 months. Checklists of this sort have been widely used in prior population-based studies and have been shown to yield more complete and accurate reports than estimates derived from responses to open-ended questions.21 Methodologic research has demonstrated that self-report of chronic physical conditions shows moderate to high agreement with medical records data22 and that information collected from physical disorder checklists predicts outpatient health care use, hospitalization, and mortality.23

Headaches were assessed by asking whether respondents ever experienced “frequent or severe headaches” and, if so, whether such headaches occurred in the prior 12 months. Migraine status was assessed for persons reporting headache in the past year. Migraine was defined according to the International Headache Society (International Classification of Headache Disorders, second edition [ICHD-II]),24 criteria, except our definition did not include 1) a minimum of five lifetime attacks or 2) aggravation by, or causing avoidance of, routine physical activity (e.g., walking or climbing stairs). The survey did not include questions designed to discriminate between other types of headaches besides migraine, but we presume that the large majority of these subjects had tension-type headache because this is the most common type of headache and its diagnosis is typically made by excluding/ruling out migraine-specific symptoms. We applied a diagnostic, mutually exclusive hierarchy in assigning the headache diagnosis, with migraine at the top of the hierarchy. Persons with chronic daily headache, defined as 180 or more headache days in the past year, were deleted from both headache groups because of their unique comorbidity profile.25–27 For secondary analyses referred to in the Discussion, we defined migraine with aura as the presence of spots, lines, or heat waves and a partial loss of vision before the headache. The survey did not include all of the criteria to identify aura.28

Comorbid chronic pain.

The NCS-R interview also included arthritis or rheumatism, chronic back or neck problems, and a general category of any other chronic pain. Persons were counted as current cases if they reported these conditions in the prior 12 months (arthritis was presumed to be present in the past 12 months if reported during the lifetime).

Comorbid chronic physical conditions.

The interview also included lifetime and 12-month questions about a wide range of chronic physical conditions that included respiratory conditions (asthma, tuberculosis, other lung disease), digestive conditions (irritable bowel syndrome, ulcer), cardiovascular conditions (high blood pressure, heart disease, heart attack, stroke), cancer, diabetes, epilepsy, hearing impairment, and vision impairment. In the case of conditions typically identified by medical diagnosis, respondents were asked whether a doctor or other health professional had ever told them they had the condition and, if so, whether they still had the condition in the past 12 months. The 12-month follow-up questions were omitted for conditions that persist throughout the life course (e.g., asthma, epilepsy)—these conditions were presumed to be present in the past 12 months if reported during the lifetime. To qualify as being present in the past year, cancer had to be under treatment. Persons were counted as current cases if the conditions were present in the last 12 months.

Comorbid mental disorders.

The NCS-R diagnostic instrument was an expanded version of the World Health Organization (WHO) Composite International Diagnostic Interview (CIDI),29 a fully structured instrument designed for use by trained interviewers who do not have clinical experience. Diagnoses are based on Diagnostic and Statistical Manual of Mental Disorders, fourth edition, criteria.30 Organic exclusions and diagnostic hierarchy rules were both applied in making diagnoses. The diagnoses considered in this report include mood disorders (major depression, dysthymia, bipolar disorder I or II), anxiety disorders (panic disorder, agoraphobia without panic, social anxiety disorder, specific phobia, generalized anxiety disorder, post-traumatic stress disorder), and substance use disorders (alcohol abuse and dependence, drug abuse and dependence) present in the past 12 months. Previous methodologic research documented acceptable to good concordance between the NCS-R CIDI diagnoses and blind clinical diagnoses, with the CIDI generally making diagnoses that are conservative in comparison with blind clinical diagnoses.31

Disability.

All Part 2 respondents completed the WHO Disability Assessment Schedule II32 and additional questions about functional disability during the past 30 days. In this article, we used a measure of role disability derived from the following questions included in the larger disability assessment:

  • How many days out of the last 30 …

  • 1)… were you totally unable to work or carry out normal activities?

  • 2)… were you able to work or carry out normal activities, but had to cut down on what you did, or not get as much done as usual?

  • 3)… did you cut back on the quality of your work or how carefully you worked?

  • 4)… did it take extreme effort to perform up to your usual level at work or at your other normal daily activities?

This disability measure, ranging from 0 to 100, can be interpreted as the percent of days in the last month that the person performed his or her major roles.33,34

Sociodemographics.

Age, sex, education, race/ethnicity, and employment status were used in analyses for this article.

Interviewer training and field quality control.

Professional lay interviewers from the Institute for Social Research at the University of Michigan administered the interview. More than 300 interviewers participated in the study, each receiving 7 days of study-specific training and successfully completing two practice interviews before beginning fieldwork. Interviews were administered using laptop computer–assisted software that included built-in skip logic, timing flags, and consistency checks. Regional supervisors recontacted a random 10% of respondents for quality control.

Data analysis.

We report 12-month prevalence rates of migraine and nonmigraine headaches and specific forms of 12-month physical and mental comorbidity based on weighted data. Logistic regression analysis35 was used to estimate the association of migraine and nonmigraine headaches with the prevalence of each comorbid condition after adjusting for demographic variables. The logistic regression coefficients were transformed to odds ratios (ORs) for ease of interpretation. Significance of each logistic regression effect was determined using a Wald χ2 test statistic. The association of migraine and nonmigraine headaches with role disability was assessed using linear regression.36

All analyses were based on weighted data and implemented in SUDAAN.37 Significance tests, SEs, and 95% CIs were estimated using the Taylor series method to adjust for the weighting and clustering of the NCS-R data. All significance tests were made using two-sided tests evaluated at the 0.05 level of significance.

RESULTS

As shown in table 1, 4.3% of the US adult population was estimated to have frequent or severe migraine headaches in the prior 12 months, whereas 5.7% reported frequent or severe nonmigraine headaches during the same period. Migraine headaches were more than three times more common in women (6.5%) than in men (1.8%), whereas nonmigraine headaches were more common in women than in men to a lesser extent. Migraine prevalence (6.4%) peaked among 30 to 44 year olds, whereas rates of nonmigraine headache decreased with age. Table 1 also shows the distribution of both types of headache among education groups, racial/ethnic groups, and employment categories, which, along with age and sex, were included in the regression models.

View this table:

Table 1 Twelve-month prevalence of frequent and severe migraine and nonmigraine headaches in the US adult population by sociodemographic variables

Table 2 shows the average percentage of days in the past 30 that subjects performed their major roles in the presence and absence of various forms of comorbidity. These percentages are presented for three groups: 1) migraineurs, 2) other headache subjects, and 3) headache-free subjects. Overall, migraineurs performed their major roles an average of 74.8% of the past 30 days, compared with 82.4% of the days for other headache subjects and 90.3% of the days for headache-free subjects. Differences in levels of role performance among the three groups narrowed when considering only persons without any comorbid conditions, whether mental or physical. In this case, persons with “pure” migraine or “pure” nonmigraine headaches performed their major roles an average of approximately 93% of the time, compared with 97% of the days for headache-free subjects without comorbid conditions.

View this table:

Table 2 Percent of full role performance for persons with frequent and severe migraine headache, nonmigraine headache, and no headache: Overall and by presence or absence of comorbidity

Table 2 also shows role performance levels for the three groups by type of comorbidity. For example, headache-free subjects with a comorbid physical condition performed their major roles 85% of the time (note that these subjects could also have a comorbid chronic pain condition or mental disorder). Generally, within each of the three groups, the impact on role disability did not vary much by the specific type of comorbidity—physical, pain, or mental. Role performance levels for each of the three types of comorbidity were roughly 82% to 85% for headache-free subjects, 74% to 78% for persons with other severe headaches, and 65% to 67% for migraineurs.

Table 3 provides estimates of the percent of the US adult population with specific mental disorders among persons with migraine, nonmigraine headaches, and no headaches. In general, mental disorder prevalence rates are highest for migraineurs and lowest for headache-free subjects. For example, among persons with migraine headaches, 18.8% also had major depression, compared with 13.0% of respondents with nonmigraine headaches and 5.5% of persons without headache.

View this table:

Table 3 Prevalence of mental disorder comorbidity among US adults with frequent and severe migraine, nonmigraine headache, and no headache in the past 12 months

Table 3 also provides estimates of ORs, adjusted for age, sex, race/ethnicity, education, and employment status for having each mental disorder for 1) persons with migraine headaches vs persons without any kind of severe headache, 2) persons with nonmigraine headaches vs headache-free subjects, and 3) migraineurs vs persons with nonmigraine headaches. Among the mental disorders examined, all of the mood disorders and all of the anxiety disorders except agoraphobia without panic were significantly more common among persons with migraine headaches compared with people without severe headaches; all of the mood and anxiety disorders, except social phobia, were significantly more common among persons with nonmigraine headaches compared with people without severe headaches. Relative to headache-free subjects, persons with migraine and nonmigraine headache were at increased risk for drug dependence but none of the other substance abuse measures. Among the migraineurs, more than half were found to have a current mood, anxiety, or substance use disorder, compared with 38% of persons with nonmigraine headache and 21% of persons without headache.

Comparisons of migraineurs with persons with nonmigraine headache did not show statistically significant increased risks for mood or substance abuse disorders but did show a 50% to 80% increased risk for certain anxiety disorders (post-traumatic stress disorder, social phobia), any anxiety disorder, and any mental disorder (e.g., a mood, anxiety, or substance abuse disorder).

The prevalence rates of other chronic pain and chronic physical disorders among persons with migraine, nonmigraine headaches, and no headaches are presented in table 4. Nearly 60% of respondents with both migraine and nonmigraine headaches had at least one of the other pain conditions—arthritis, back, or neck pain or other chronic pain—compared with 36% of headache-free subjects. Migraineurs and persons with nonmigraine headaches were at significantly increased risk for all of the chronic pain conditions relative to headache-free subjects.

View this table:

Table 4 Prevalence of pain and physical comorbidity among US adults with frequent and severe migraine, nonmigraine headache, and no headache in the past 12 months

Regarding the chronic physical disorders, analyses comparing headache subjects with headache-free subjects showed that migraine was significantly associated with high blood pressure, irritable bowel syndrome, ulcers, and hearing and vision problems, and nonmigraine headaches were associated with ulcers and vision problems. Stroke, epilepsy, and asthma were not associated with migraine or with nonmigraine headache. Relative to headache-free subjects, the increased risk of having any comorbid chronic physical disease was 2.1 for migraine and 1.7 for nonmigraine headaches. Compared with persons with nonmigraine headaches, migraineurs were not at significantly increased risk for any of the chronic pain or physical disorders except hypertension. When all forms of comorbidity were considered, including mental disorders, other chronic pain conditions, and chronic physical diseases, 82.5% of persons with migraine and 78.9% of persons with nonmigraine headaches had at least one comorbid condition, compared with approximately half of headache-free subjects.

To test the effects of comorbid conditions on role performance, a series of progressive adjustments for demographics and the three types of comorbidity—mental disorders, physical diseases, and pain conditions—were made. Table 5 provides estimates of the adjusted mean difference in percent of full role performance comparing persons with migraine with persons without any type of headache. Before adjusting for sociodemographic variables or comorbid conditions, the mean difference in percent of full role performance between persons with and without migraine was 15.5%, replicating the observed mean difference shown in table 2. Controlling for sociodemographic variables reduced the adjusted mean difference to 12.2%. Adjusting for sociodemographic variables and chronic physical diseases yielded an adjusted mean difference in percent of full role performance of 10.8% between persons with and without migraine. Two separate analyses adjusting for 1) sociodemographic variables and mental disorders and 2) sociodemographic variables and chronic pain conditions resulted in the same adjusted mean difference—7.4%. Controlling for sociodemographic variables and all forms of comorbidity reduced the estimated decrement in percent of full role performance between persons with and without migraine from 15.5% to 4.3%. Thus, the specific decrement in percent of full role performance attributed to migraine was 4.3%, whereas all forms of comorbidity accounted for a decrement of 7.9% (i.e., 12.2%-4.3%), after controlling for sociodemographic variables.

View this table:

Table 5 Difference in role performance between those with either migraine or nonmigraine headache and those without headache

Table 5 also provides the corresponding estimates of role performance reduction for nonmigraine headaches. Before adjusting for sociodemographic variables or comorbid conditions, the adjusted mean difference in percent of full role performance between persons with nonmigraine headaches vs those without any severe headaches was 7.8%, approximately half of the difference observed between migraineurs and people without severe headaches. After controlling for all comorbidity (mental disorders, chronic physical diseases, chronic pain conditions) and sociodemographic variables, nonmigraine headaches were no longer significantly associated with decreased ability to perform major roles—that is, physical and mental comorbidity accounted for all of the decrement in percent of full role performance associated with nonmigraine headaches after adjusting for sociodemographic variables.

DISCUSSION

Both migraine and nonmigraine headaches were associated with substantial role disability and comorbidity. Disability among headache sufferers was greater when the headache was accompanied by some form of comorbidity. After adjusting for sociodemographics, comorbid conditions explained all of the disability associated with nonmigraine severe headaches and approximately 65% of the disability associated with migraine headaches.

Consistent with prior research, migraine and nonmigraine severe headaches were associated with substantial disability.1–5,16,38–44 Overall, migraineurs experienced role disability an average of approximately one-quarter of the past 30 days compared with approximately one-sixth of the days for persons with nonmigraine headaches and one-tenth of the days for persons without headache. Our finding that the disability associated with migraine exceeded that associated with nonmigraine headache is consistent with the majority of the literature.5,16,45,46

Our results also demonstrate the large magnitude of comorbidity between migraine and other severe headaches with mental disorders in the US adult population. The high level of comorbidity between migraine and major depression reported here (OR 2.8) confirms the results of prior community studies.10,13,47–51 Whereas evidence to date is inconclusive regarding the association between migraine and bipolar disorder,10,47,52 we observed a strong association between these two disorders (OR 3.9). Our results are also consistent with earlier reports of a strong association between migraine and anxiety disorders.14,53–56 Regarding substance use disorders, our findings confirm the results of prior community studies that have shown that migraine is associated with prescription drug dependence but not with alcohol use disorders.50

Persons with nonmigraine headaches were also at increased risk for virtually all of the mood and anxiety disorders compared with persons without headaches, although the ORs tended to be smaller than those observed for the migraine vs headache-free analysis. In a direct comparison of migraineurs with persons with nonmigraine headache, migraineurs were at significantly increased risk for some anxiety disorders but not for mood or substance abuse disorders. These results partially confirm findings from clinic-based studies that found no significant differences between people with migraine and tension headache in terms of psychiatric comorbidity.11,12

The strong and consistent association between both types of headache and other chronic pain conditions is also in line with a previous report that migraine is associated with back pain, neck pain, chest pain, and abdominal pain.57 Compared with mental disorders and other chronic pain conditions, chronic physical diseases were less consistently associated with either type of headache. The association between migraine and hypertension confirms the results of several recent population-based studies58–60 that reported prospective associations between migraine and cardiovascular endpoints. Our finding that migraine is not comorbid with asthma, epilepsy, and stroke is not consistent with prior studies.61 However, overlap in these conditions would not be expected for the 12-month prevalence period assessed herein because of differences in the age-specific expression of these conditions.

This article is one of the few to present evidence of the impact of comorbidity on headache-related disability in a population sample. Basically, functioning of “pure” headache subjects (i.e., no comorbid conditions) was comparable to that of headache-free persons who, likewise, had no comorbid conditions. But introduction of comorbidity—whether mental or physical—substantially reduced headache patients' functioning compared with headache-free subjects with the same form of comorbidity. The three forms of comorbidity—mental disorders, pain conditions, and chronic physical diseases—had roughly the same impact on headache patients' functioning.

A prior population-based study showed that disability was greater among migraineurs with comorbid anxiety and depression.6 The current research also found higher rates of disability among migraineurs with comorbid mental disorders using quite different methodology: an interview-based survey vs mailed questionnaire and different measures and time frames for assessing migraine, disability, and mental disorder status. Further, the current study expanded the scope of the earlier study to include physical comorbidity and persons with tension-type headache.

Adjusting for all types of comorbidity reduced the impact of disability attributable to migraine and nonmigraine severe headaches. Thus, when addressing disability associated with headache, it is important for policy makers and researchers to recognize that some of that burden is attributable to comorbid conditions. Clinically, these results underscore the conclusions of previous research that treatments of migraine and other severe headaches should take into account comorbid chronic conditions.10,56,62,63 A review article cited the effect of comorbid depression on pain patients' outcomes, especially functioning, and pointed to evidence that neglecting to treat any underlying depression might explain some pain treatment failures.64 Indeed, results from a randomized trial showed that treating the underlying depression experienced by elderly people with arthritis had a significant impact on functioning.65

A significant limitation of this study is that the prevalence of migraine was substantially lower than the rates obtained from prior population-based US surveys.38,66,67 Some of this disparity may be caused by differences in survey methodology (e.g., direct interviews in the current study vs telephone interviews in the American Migraine Studies, differences in diagnostic criteria applied, different sampling strategies, assessment of headaches/migraine as part of a broad spectrum of physical and mental disorders vs headache-specific surveys). However, the major reason for the disparity in migraine rates is most likely because the headache case definition in this research was based on persons with “frequent or severe” headaches rather than the full spectrum of severity of headache disorders.

It is unclear how our focus on a selected group of headache cases may bias our main finding that most of the disability among persons with headache is explained by mental and physical comorbidities. On the one hand, our exclusion of those with less severe or less frequent headaches could have increased the proportion of disability explained by headaches and decreased the proportion explained by comorbid conditions. On the other hand, because it is likely that comorbid conditions would be greater in those experiencing more severe or frequent headaches, the proportion of disability explained by comorbidity might be less than what was found in this study.

This research has other limitations. The assessment of mental and physical comorbidity was conducted among a selected subgroup of headache subjects—those reporting “frequent or severe” headaches in the past year. The diagnostic criteria for migraine were only an approximation of the ICHD-II criteria. In addition, although we did subtype the migraine sample by an approximation of migraine with aura, the numbers were too small for meaningful statistical analyses. Our interview did not ascertain the diagnostic criteria for tension-type headache. Finally, the 1-year headache prevalence period is not optimal for investigation of comorbid disorders with different age-specific patterns of expression.

ACKNOWLEDGMENT

The National Comorbidity Survey Replication (NCS-R) is supported by the National Institute of Mental Health (NIMH; U01-MH60220) with supplemental support from the National Institute on Drug Abuse (NIDA), the Substance Abuse and Mental Health Services Administration, the Robert Wood Johnson Foundation (Grant 044708), and the John W. Alden Trust. Preparation of the current report was additionally supported by NIMH Grant R01-MH069864. Collaborating NCS-R investigators include Ronald C. Kessler (Principal Investigator, Harvard Medical School), Kathleen Merikangas (Co-Principal Investigator, NIMH), James Anthony (Michigan State University), William Eaton (The Johns Hopkins University), Meyer Glantz (NIDA), Doreen Koretz (Harvard University), Jane McLeod (Indiana University), Mark Olfson (Columbia University College of Physicians and Surgeons), Harold Pincus (University of Pittsburgh), Greg Simon (Group Health Cooperative), Michael Von Korff (Group Health Cooperative), Philip Wang (Harvard Medical School), Kenneth Wells (University of California, Los Angeles), Elaine Wethington (Cornell University), and Hans-Ulrich Wittchen (Max Planck Institute of Psychiatry). A complete list of NCS publications and the full text of all NCS-R instruments can be found at http://www.hcp.med.harvard.edu/ncs. The NCS-R is carried out in conjunction with the World Health Organization World Mental Health (WMH) Survey Initiative. The authors thank the staff of the WMH Data Collection and Data Analysis Coordination Centres for assistance with instrumentation, fieldwork, and consultation on data analysis. These activities were supported by the John D. and Catherine T. MacArthur Foundation, the Pfizer Foundation, the US Public Health Service (R13-MH066849, R01-MH069864, and R01 DA016558), the Pan American Health Organization, Eli Lilly and Company, and GlaxoSmithKline. A complete list of WMH publications can be found at http://www.hcp.med.harvard.edu/wmhcidi.

Footnotes

  • See the acknowledgment for complete funding and support information and a list of collaborating NCS-R investigators.

    Disclosure: The authors report no conflicts of interest.

    The views and opinions expressed in this report are those of the authors and should not be construed to represent the views of any of the sponsoring organizations, agencies, or US Government.

    Received September 1, 2006. Accepted in final form July 19, 2007.

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