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Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that increase successful quit attempts among depressed smokers with chronic medical illnesses are particularly important for the VA healthcare system because rates of tobacco use, depression, and chronic medical illnesses are significantly higher among Veterans compared to the general population. Providing smoking cessation services augmented with mood management to Veterans via telephone may increase access to, and utilization of, evidence-based smoking cessation counseling and decrease rates of smoking-related complications for Veterans with chronic medical illnesses and depression. Yet, the reach of smoking cessation telephone counseling has been limited among populations with mental illness. The investigators intend to combine the potency of co-delivered mood management and reach of telephone-delivered interventions by testing the telephone delivery of behavioral mood-management for smoking cessation among smokers with depression and chronic medical illness.
Purpose: Cigarette smoking is the single greatest cause of preventable deaths. In the VA health care system, patients with chronic medical illnesses represent an important population on which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses can substantially decrease morbidity and mortality. Despite these benefits, many patients with chronic medical illnesses continue to smoke. There is a strong interrelationship between depression and chronic medical illness. Depression can derail sustained smoking cessation and may be an important barrier to smoking cessation for Veterans with chronic medical illness. Despite the barriers they face, smokers with depression are motivated to quit smoking. Smokers with histories of depression may respond better to smoking cessation interventions that are augmented with mood-management adjuncts such as mood-management counseling. Thus, depressed smokers are more likely to quit when behavioral mood-management is added to traditional cessation approaches. Yet, the augmentation of smoking cessation with behavioral mood management is not yet firmly established. Also these intensive interventions have limited reach when conducted in person. Telephone counseling can deliver intensive and effective treatment to people who smoke, yet its implementation has been limited among smoker with depression. There is a need to develop novel proactive telephone-delivered approaches that can broadly deliver intensive smoking cessation interventions to Veterans who may not respond to standard care, such as those with chronic medical illnesses and depressive symptoms.
Methodology: The investigators propose a randomized comparative effectiveness trial with a two-group design in which 350 Veteran smokers with depression and chronic medical illness will be randomized to either: 1) smoking cessation plus adjunctive behavioral mood management (SMK-MM group), an intervention that includes a proactive telehealth intervention that combines evidence-based smoking cessation counseling augmented with behavioral mood management and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking cessation telephone counseling control (SMK CONTROL), a contact-equivalent control that provides the same smoking cessation telephone counseling intervention augmented with health education (instead of mood-management) and a tele-medicine clinic for accessing NRT. Patients with chronic medical illnesses will be identified from patient intake systems of the Durham Veteran's Affairs Hospital and screened for tobacco use and depressive symptoms.
The main outcome in this trial is prolonged abstinence at 6-month and 12-month follow-up. Logistic regression will be used to test for a between-group difference in the proportion of patients with self-reported prolonged abstinence from cigarettes at 6 months. A general linear mixed model will be used to estimate changes depressive symptoms between groups. If there is a significant intervention effect on smoking cessation, mediational analysis will be conducted to examine whether changes in self-efficacy or affect mediate the impact of the mood management intervention.
Objectives: The specific aims of the study are to 1) evaluate the impact of a telephone-delivered smoking cessation intervention augmented with behavioral mood management on rates of prolonged and point prevalence abstinence from cigarettes among Veterans with chronic medical illnesses and depression; 2) monitor the impact of behavioral mood management intervention on depressive symptoms; 3) if effective, assess whether change in self-efficacy as well as positive and negative affect mediate the impact of behavioral mood management intervention on smoking cessation among Veterans; and 4) assess the cost-effectiveness if the mood-enhanced intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mood management enhancement | Experimental | In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. |
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| Health education control | Other | In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with personal health care. Participants also will receive chronic-disease-specific self-management information. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral mood management | Behavioral | The mood-management sessions are informed by CBT and emphasize psycho-educational and skills-based approaches to CBT. CBT has been used extensively to address mood management. Specifically, SMK-MM enhancement includes behavioral activation, cognitive restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant manual will also include additional worksheets developed for the investigator's pilot based on Lewinsohn's self-help guide to controlling depression. The main objective of the worksheets will be to provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive skills thought to facilitate mood management. As is customary in CBT, homework based on the worksheets will be discussed during counseling calls. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Prolonged Abstinence | In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 6-month follow-ups, patients will be asked about prolonged abstinence, "Since [end of the grace period] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After [end of the grace period] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no." | 6 month |
| Number of Participants With Prolonged Abstinence | In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 12-month follow-ups, patients will be asked about prolonged abstinence, "Since [end of the grace period] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After [end of the grace period] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no." | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 7 Day Point Prevalent Abstinence | At each follow-up (6 month), participants will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will then be asked whether the participant has smoked a cigarette, even a puff, in the past 30 days. Data presented below represents those who self-reported not smoking. | Month 6 |
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria:
Exclusion Criteria:
Patients who meet any one of the following exclusion criteria will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer M Gierisch, PhD MA | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mood Management Enhancement | In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral mood management: The mood-management sessions are informed by CBT and emphasize psycho-educational and skills-based approaches to CBT. CBT has been used extensively to address mood management. Specifically, SMK-MM enhancement includes behavioral activation, cognitive restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant manual will also include additional worksheets developed for the investigator's pilot based on Lewinsohn's self-help guide to controlling depression. The main objective of the worksheets will be to provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive skills thought to facilitate mood management. As is customary in CBT, homework based on the worksheets will be discussed during counseling calls. |
| FG001 | Health Education Control | In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with personal health care. Participants also will receive chronic-disease-specific self-management information. Health education: In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mood Management Enhancement | US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms randomized to the mood management enhanced smoking cessation arm |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Prolonged Abstinence | In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 6-month follow-ups, patients will be asked about prolonged abstinence, "Since [end of the grace period] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After [end of the grace period] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no." | Posted | Count of Participants | Participants | 6 month |
|
12 months from time of consent
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mood Management Enhancement | US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitlization | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased feelings of irritation, stress, or anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Gierisch | Durahm VA Health Care System | 919-286-0411 | 176936 | jennifer.gierisch@va.gov; j.gierisch@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2018 | Jun 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Health education | Other | In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information. |
|
| Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months | Patients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 6 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden. | change from baseline to 6 month follow up |
| Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up | Patients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 12 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden. | change from baseline to 12 month follow up |
| Biochemical Verification of Smoking Cessation at 6 Month Follow up | Saliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 6 months via biochemical validation of of saliva samples. | 6 month follow up |
| Number of Participants With 7 Day Point Prevalent Abstinence | At each follow-up (12-month), participants will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will then be asked whether the participant has smoked a cigarette, even a puff, in the past 30 days. Data presented below represents those who self-reported not smoking. | 12 month |
| Biochemical Verification of Smoking Cessation at 12 Month Follow up | Saliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 12 months via biochemical validation of of saliva samples. | 12 month follow up |
| Excluded post rand: cognitive impairment |
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| Death |
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| Health Education Control |
US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms randomized to the health education attention control smoking cessation arm |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Cigarettes per day | self-report of cigarettes per day at study entry | Count of Participants | Participants |
|
| OG001 | Health Education Control | In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with personal health care. Participants also will receive chronic-disease-specific self-management information. Health education: In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information. |
|
|
| Primary | Number of Participants With Prolonged Abstinence | In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 12-month follow-ups, patients will be asked about prolonged abstinence, "Since [end of the grace period] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After [end of the grace period] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no." | Posted | Count of Participants | Participants | 12 month |
|
|
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| Secondary | Number of Participants With 7 Day Point Prevalent Abstinence | At each follow-up (6 month), participants will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will then be asked whether the participant has smoked a cigarette, even a puff, in the past 30 days. Data presented below represents those who self-reported not smoking. | US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms | Posted | Count of Participants | Participants | Month 6 |
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| Secondary | Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months | Patients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 6 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden. | Posted | Mean | Standard Error | score on a scale | change from baseline to 6 month follow up |
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| Secondary | Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up | Patients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 12 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden. | Posted | Mean | Standard Error | units on a scale | change from baseline to 12 month follow up |
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| Secondary | Biochemical Verification of Smoking Cessation at 6 Month Follow up | Saliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 6 months via biochemical validation of of saliva samples. | There were 23 participants who returned a sample and were not on NRT. We used a cotinine cutpoint of 15ng/mL for those not on NRT and not exposed to secondhand smoke. For those who self-reported secondhand smoke exposure, we used a cutpoint of 18ng/mL. This outcome is the number of participants whose cotinine results confirm self-report status of not smoking at the 6-month assessment. | Posted | Count of Participants | Participants | 6 month follow up |
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| Secondary | Number of Participants With 7 Day Point Prevalent Abstinence | At each follow-up (12-month), participants will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will then be asked whether the participant has smoked a cigarette, even a puff, in the past 30 days. Data presented below represents those who self-reported not smoking. | Posted | Count of Participants | Participants | 12 month |
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| Secondary | Biochemical Verification of Smoking Cessation at 12 Month Follow up | Saliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 12 months via biochemical validation of of saliva samples. | There were 32 participants who returned a sample and were not on NRT. We used a cotinine cutpoint of 15ng/mL for those not on NRT and not exposed to secondhand smoke. For those who self-reported secondhand smoke exposure, we used a cutpoint of 18ng/mL. This outcome is the number of participants whose cotinine results confirm self-report status of not smoking at the 12-month assessment. | Posted | Count of Participants | Participants | 12 month follow up |
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| 7 |
| 175 |
| 15 |
| 175 |
| 82 |
| 175 |
| EG001 | Health Education Control | US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptom | 5 | 175 | 15 | 175 | 105 | 175 |
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
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| Hospitalization | Infections and infestations | Non-systematic Assessment |
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| Hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Hospitalization | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Hospitalization | Nervous system disorders | Non-systematic Assessment |
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| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hospitalization | Surgical and medical procedures | Non-systematic Assessment |
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| Hospitalization | Vascular disorders | Non-systematic Assessment |
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| Prolongation of Hospitalization | Infections and infestations | Non-systematic Assessment |
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| Prolongation of Hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Flu, cold, virus, seasonal allergies, or general illness | General disorders | Non-systematic Assessment |
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| Bodily Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Craving for cigarettes | General disorders | Non-systematic Assessment |
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