Study Characteristics

• Study Identifiers
  • Study Name or Acronym
  • Last name of first author
• Additional Articles Used in This Abstraction
• Recruitment Dates (month and year)
  • Start of recruitment
  • End of recruitment
• Number of Sites
• Geographic Location (Select all that apply)
  • US, Canada, UK, Europe, S. America, C. America, Asia, Africa, Australia/NZ, Not reported/Unclear, Other (specify)
• Funding Source (Select all that apply)
  • Government, Private Foundation, Industry, Not reported/Unclear, Other (specify)
• Setting (Select all that apply)
  • Outpatient mental health settings; Outpatient general medical settings; Community settings (e.g., community center, clubhouse); Integrated care setting (e.g., mental health and primary care provider work together to provide care to SMI population); Not reported; Other (specify)
• Study Inclusion and Exclusion Criteria
  • Study Inclusion Criteria (Check all that apply)
    • Schizophrenia or schizoaffective disorder (or other related primary psychotic disorder: Psychotic D/O NOS, Delusional Disorder, Schizophreniform disorder, Brief psychotic disorder)
    • Bipolar disorder
    • Psychotic depression
    • No specified diagnosis but are classified as having SMI or SPMI
    • Taking an antipsychotic medication
    • Obese (BMI ≥ 30)
    • Overweight (BMI = 25–29.9)
    • Diabetes or elevated glucose
    • Hyperlipidemia or elevated lipids
    • Hypertension
    • Metabolic syndrome
    • Elevated CVD risk (mix or not specified by conditions above)
    • Age (specify)
    • None of the above
  • Copy/paste inclusion criteria as reported in article
  • Study Exclusion Criteria (Check all that apply)
    • Active substance abuse
    • Unstable psychiatric illness (acute illness)
    • Pregnant or breastfeeding
    • Participating in formal weight loss program
    • On additional medication other than study medications (specify)
    • Mental retardation
    • Treatment refractory mental illness
    • Chronic medical condition (specify)
    • Unable to provide informed consent
    • Suicidality
    • Homicidality
    • Obese (BMI ≥ 30)
    • Overweight (BMI = 25–29.9)
    • Diabetes or elevated glucose
    • Hyperlipidemia or elevated lipids
    • Hypertension
    • Metabolic syndrome
    • Elevated CVD risk (mix or not specified by conditions above)
    • None of the above
  • Copy/paste exclusion criteria as reported in article
• Study Enrollment/Study Completion
  • N Assessed for eligibility
  • N Eligible
  • N Randomized
  • N Completed followup (most distal time point of the primary outcome)
• Comments

Population Characteristics – Record the following elements for Total Population, Intervention Arm 1, Comparator Arm 1, and Comparator Arm 2

• Number of patients
• Descriptive name for group
• Gender (N)
  • Female
  • Male
• Ethnicity (N)
  • Hispanic or Latino
  • No Hispanic or Latino
• Race (N)
  • American Indian or Alaskan Native
  • Asian
  • Black or African American
  • Native Hawaiian or other Pacific Islander
  • White
  • Multiracial
  • Other
  • Not reported
• Age
  • Mean
  • Median
  • SD
  • Min Age
  • Max Age
  • 25% IQR
  • 75% IQR
  • Categorical
• Education (specify units)
  • Mean
  • Median
  • SD
  • Categorical
• SMI Symptom severity for Schizophrenia
  • Indicate Scale Used
    • Clinical Global Impression (CGI) scale for psychosis
    • Brief Psychiatric Rating Scale (BPRS)
    • Positive and Negative Syndrome Scale (PANSS)
    • Global Assessment of Functioning (GAF)
    • Other (specify)
  • Mean
  • Median
  • SD
  • 25% IQR
  • 75% IQR
  • Categorical
• SMI Symptom severity for Bipolar disorder
  • Indicate Scale Used
    • Clinical Global Impression – Bipolar Version (CGI-BP)
    • Young Mania Rating Scale (YMRS)
    • Global Assessment of Functioning (GAF)
    • Other (specify)
  • Mean
  • Median
  • SD
  • 25% IQR
  • 75% IQR
  • Categorical
• SMI Symptom severity for Psychotic Depression
  • Scales Used
    • Hamilton Rating Scale for Depression (HAM-D)
    • Montgomery-Asberg Depression Rating Scale (MADRS)
    • Other (specify)
  • Mean
  • Median
  • SD
  • 25% IQR
  • 75% IQR
  • Categorical
• Smoking Status (N)
  • Non-Smoker
  • Current Smoker
  • Former Smoker
• Weight as BMI
  • Mean
  • Median
  • SD
  • 25% IQR
  • 75% IQR
  • Categorical
• Weight (indicate kg or lbs)
  • Mean
  • Median
  • SD
  • 25% IQR
  • 75% IQR
  • Categorical
• HbA1c (%)
  • Average
  • Variance
• Lipids
  • Total Cholesterol (mg/dl)
    • Average
    • Variance
  • LDL (mg/dl)
    • Average
    • Variance
• Blood Pressure
  • Systolic (mmHg)
    • Average
    • Variance
  • Diastolic (mmHg)
    • Average
    • Variance
• Number of patients classified as obese/overweight at baseline
• Number of patients classified as having Diabetes (type not specified) at baseline
• Number of patients classified as having Type 1 Diabetes at baseline
• Number of patients classified as having Type 2 Diabetes at baseline
• Number of patients classified as having Hyperlipidemia at baseline
• Number of patients classified as having Metabolic Syndrome at baseline
• Number of patients classified as having hypertension at baseline
• SMI classification (N)
  • Schizophrenia
  • Bipolar
  • Psychotic
  • Not Specified
• SMI medication use (N)
  • 1^st Gen Antipsychotics
  • 2^nd Gen Antipsychotics
  • Mood stabilizers
  • Antidepressants
  • Mixed or combination therapy
• Describe other relevant comorbid conditions

Intervention Characteristics

• Background Context of Interventions
• Intervention Arm – Indicate the target chronic medical illness for the intervention
  • Weight (obese or overweight at baseline)
  • Obesity prevention
  • Diabetes (not specified)
  • Type 1 Diabetes
  • Type 2 Diabetes
  • Hyperlipidemia
  • Hypertension
  • Multimodal cardiovascular disease
  • Other (specify)
• Intervention Components per Arm
  • For the Intervention Arm
    • Descriptive Name
    • Components (Check all that apply)
      • Patient-focused behavioral interventions for one condition of interest
        • Were drugs used in behavioral intervention? (Yes/No)
      • Pharmacological treatments for chronic medical condition
      • Antipsychotic medication switching
      • Multimodal lifestyle intervention targeting multiple CVD risk factors
        • Were drugs used in lifestyle intervention? (Yes/No)
  • For Comparator Arm 1 and Comparator Arm 2
    • Descriptive Name
    • Components (Check all that apply)
      • Usual
      • Enhanced usual care (please describe)
      • Attention control (please describe)
      • Placebo control
      • Patient-focused behavioral interventions for one condition of interest
        • Were drugs used in behavioral intervention? (Yes/No)
      • Pharmacological treatments for chronic medical condition
      • Antipsychotic medication switching
      • Multimodal lifestyle intervention targeting multiple CVD risk factors
        • Were drugs used in lifestyle intervention? (Yes/No)
  • If ‘Patient-focused behavioral interventions for one condition of interest’ or ‘Multimodal lifestyle intervention targeting multiple CVD risk factors’ are selected, specify the following:
    • Patient-focused behavioral interventions for one condition of interest
      • Total planned contacts
      • Mean (SD) contacts delivered
      • Mode (check all that apply)
        • In person; Phone; Internet; Text messaging
          • Frequency of planned contact
      • Theoretical orientation or health behavioral theory informing interventions (e.g., Health Belief Model, Social Cognitive Theory, Transtheoretical Model)
        • Not reported/No
        • Yes (specify)
      • Therapeutic Model or orientation
        • Not reported/No
        • Cognitive Behavioral therapy (CBT)
        • Dialectic Behavioral Therapy (DBT)
        • Motivational Interviewing (MI)
        • Psychodynamic therapy
        • Behavioral Therapy
        • Cognitive Therapy
        • Problem-solving Therapy (PST)
        • Insight-oriented therapy
        • Interpersonal Psychotherapy (IPT)
        • Acceptance and Commitment Therapy (ACT)
        • Rational Emotive Behavior Therapy (REBT)
        • Relaxation
        • Emotion-focused therapy
        • Solution-focused therapy
        • Token economy
        • Social-skills training
        • Family therapy
        • Other (specify)
      • Intervention delivered by (interventionist type)
        • NA
        • Not reported
        • Nurse
        • Behavioral health profession (e.g., social worker, psychologist)
        • Health educator
        • Peer support specialist
        • Peer educator (intervention provider has a current or past history of mental illness)
        • Nutritionist
        • Physical therapist
        • Physician
        • Other (specify)
      • Level of training for interventionist
        • NA
        • Not reported
        • Describe level of training
      • Are family members engaged in the intervention?
        • Yes
        • No
        • Unclear
      • Content Covered
        • Patient psychoeducational (education about mental illness provided to patient)
        • Family psychoeducational (education about mental illness provided to family members)
        • Chronic physical health condition education (e.g. diabetes education on prevalence and etiology)
        • Diet/nutrition
        • Physical activity/exercise
        • Smoking cessation (e.g. behavioral strategies for quitting, NRT)
        • SMI medication management/adherence
        • Medical management for chronic physical health condition (e.g. insulin, statins)
        • Other (specify)
        • Not reported
      • Strategies Used
        • Not reported
        • Problem solving skills
        • Goal setting (e.g. weight goals, minutes of physical activity a week)
        • Motivational techniques
        • Self-monitoring (e.g. getting on home scale for weight, glucose or BP monitoring)
        • Activity scheduling
        • Stress management techniques
        • Telemonitoring
        • Economic incentives
        • Personalized or tailored written communications for home use (e.g. personalized health plan)
        • Strategies to enhance social support
        • Homework assignments
        • Other (specify)
      • Other non-patient directed strategies (i.e., organization or structural changes directed at providers or systems)
        • NA
        • Provider education (e.g. CME, clinical guideline)
        • Care management (e.g. nurse case manager)
        • Integration or co-location of care model
        • Other (describe)
      • Description of intervention sufficient for replication?
        • Yes (e.g. manualized intervention)
        • No (insufficient details)
  • If ‘Pharmacological treatments for chronic medical condition’ is selected, specify the following:
    • Pharmacological treatments for chronic medical condition
      • Psychotropic drug(s): Aripiprazole, Asenapine, Chlorpromazine, Glozapine, Haloperidol, Iloperidone, Loxapine, Molindone, Olanzapine, Olanzapine and Fluoxetine (Symbyax), Paliperidone, Pimozide, Quetiapine, Risperidone, Thiothixene, Trifluoperazine, Ziprasidone
        • Dose range (mg/day)
        • Fixed dose (Yes/No)
        • Mean dose (mg/day)
        • Treatment duration (weeks)
      • Weight loss drug(s): Orlistat, Metformin, Topiramate, Other (specify)
        • Dose range (mg/day)
        • Fixed dose (Yes/No)
        • Mean dose (mg/day)
        • Treatment duration (weeks)
      • Diabetes drug(s): Bromocriptine, Colesevelam, Exenitide, Glimepiride, Glyburide, Insulin, Insulin aspart, Insulin detemir, Insulin glargine, Insulin glulisine, Insulin isophane, Insulin lispro, Linagliptin, Liraglutide, Metformin, Miglitol, Nateglinide, Pioglitazone, Pramlinitide, Repaglinide, Rosiglitazone, Saxagliptin, Sitagliptin
        • Dose range (mg/day)
        • Fixed dose (Yes/No)
        • Mean dose (mg/day)
        • Treatment duration (weeks)
      • Hyperlipidemia drug(s): Atorvastatin, Atorvastatin/amlodipine, Cholestyramine, Colesevelam, Colestipol, Ezetimibe, Fenofibrate, Fluvastatin, Lovastatin, Pitavastatin, Pravastatin, Rosuvastatin, Simvastatin
        • Dose range (mg/day)
        • Fixed dose (Yes/No)
        • Mean dose (mg/day)
        • Treatment duration (weeks)
      • Other drug for chronic medical condition: specify
        • Dose range (mg/day)
        • Fixed dose (Yes/No)
        • Mean dose (mg/day)
        • Treatment duration (weeks)
  • If ‘Antipsychotic medication switching’ is selected, specify the following:
    • Antipsychotic switch strategy
      • Dose range (mg/day)
      • Fixed dose (Yes/No)
      • Mean dose (mg/day)
      • Treatment duration (weeks)
    • Current therapy
      • Dose range (mg/day)
      • Fixed dose (Yes/No)
      • Mean dose (mg/day)
      • Treatment duration (weeks)
• Comments

Outcomes

Record the following elements for Total Population, Intervention Arm 1, Comparator Arm 1, and Comparator Arm 2 as applicable

• Select the outcome reported on this form:
  • BMI
  • Weight in lbs
  • Weight in kilograms
  • HbA1c (%)
  • HBA1c (<7%)
  • Total Cholesterol (mg/dl)
  • LDL (mg/dl)
  • Systolic blood pressure (mm Hg)
  • Diastolic blood pressure (mm Hg)
  • Systolic blood pressure (<130 mm Hg)
  • Diastolic blood pressure (<80 mm Hg)
  • Smoking cessation
  • Framingham risk score
  • Other CVD summary risk score
  • Psychiatric symptom severity
  • All-cause mortality
  • CVD-only mortality
  • HRQOL/Physical function (specify in Details field)
  • Adverse event/ significant worsening of psychiatric status (as defined by the study author)
  • Adverse event/ Discontinuation due to adverse event or serious adverse event
  • Adverse event/Death
  • Adverse event/Hospitalization
  • Adverse event/other
  • Other potentially relevant outcome (specify)
• Is this a special population? (Yes/No)
  • If yes: Define special population
• Additional details describing outcome definition
• Time points abstracted
  • Time point closest to 3 months
  • Time point closest to 6 months
  • Most distal time point
• For each time point record the following elements as applicable
  • Specify actual timing of outcome
  • N Analyzed
  • Unadjusted Result
    • Mean
    • Median
    • Mean within group change
    • Mean between group change
    • Number of patients with outcome
    • % of patients with outcome
    • Events/denominator
    • Odds ratio
    • Hazard ratio
    • Relative risk
    • Other (specify)
  • Unadjusted Result Variability
    • Standard Error (SE)
    • Standard Deviation (SD)
    • Range
    • Other (specify)
  • Unadjusted Result, CI or IQR
    • 95% CI
    • Other % CI (specify)
    • IQR
  • Unadjusted Result, p-value between groups
  • Unadjusted Result, Reference group (for comparisons between groups)
  • Adjusted Result
    • Mean
    • Median
    • Mean within group change
    • Mean between group change
    • Number of patients with outcome
    • % of patients with outcome
    • Events/denominator
    • Odds ratio
    • Hazard ratio
    • Relative risk
    • Other (specify)
  • Adjusted Result Variability
    • Standard Error (SE)
    • Standard Deviation (SD)
    • Range
    • Other (specify)
  • Adjusted Result, CI or IQR
    • 95% CI
    • Other % CI (specify)
    • IQR
  • Adjusted Result, p-value between groups
  • Adjusted Result, Reference group (for comparison between groups)
• Indicate adjustments applied
• Was data reported for this outcome at any other time points? (Yes/No)
  • If Yes: List other time points
• Does the study report any subgroup analyses for this outcome? (Yes/No)
  • If Yes: Describe the subgroup analyses and summarize results
• Contact Study Author
  • Are there critical variables that have missing or confusing information such that we should contact the study authors for additional information? (Yes/No)
    • If Yes: List information needed
• Comments

Quality Assessment

• Selection Bias
  • Was the allocation sequence adequately generated? (Yes/No/Unclear)
  • Was the allocation adequately concealed? (Yes/No/Unclear)
  • Did the strategy for recruiting participants into the study remain the same across study groups? (Yes/No/Unclear)
  • Was there an absence of systematic differences observed in baseline characteristics and prognostic factors across the groups compared? If no, did the analysis control for differences? (Yes/No/Unclear)
• Performance Bias
  • Did researchers rule out any impact from a concurrent intervention or an unintended exposure (e.g., some members of control group get intervention), that might bias results? (Yes/No/Unclear)
  • Was execution of the intervention a close match for plans in the study protocol (i.e., no variation from the study protocol which could compromise conclusion of the study)? (Yes/No/Unclear)
• Attrition Bias
  • Was there a low rate of differential attrition (defined as less than 10% difference between groups)? (Yes/No/Unclear)
  • Was incomplete outcome data adequately addressed? (Yes/No/Unclear)
• Detection Bias
  • Were outcome assessors blind to treatment assignment of weight, laboratory measurements (e.g., LDL, HbA1c), and mortality? (Yes/No/Unclear)
  • Were outcome assessors blind to treatment assignment of all other outcomes (psychiatric symptom severity, adverse effects, HRQL)? (Yes/No/Unclear)
  • Are the inclusion/exclusion criteria measured using reliable and valid measures, implemented consistently across groups? (Yes/No/Unclear)
  • Are primary outcomes assessed using reliable and valid measures, implemented consistently across groups? (Yes/No/Unclear)
• Reporting Bias
  • Are the potential outcomes pre-specified by the researchers? Are all pre-specified outcomes reported? (Yes/No/Unclear)
• Conflict of Interest
  • Was there the absence of potential important conflict of interest? (Yes/No/Unclear)
• Study ratings:
  • 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, and analyze and report results.
  • A “Fair” study is susceptible to some bias but probably not enough 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.
• Study rating for weight, laboratory measurements (e.g., LDL, HbA1c), and mortality
  • Good
  • Fair
  • Poor
  • No outcomes of this type reported
  • If the study is rated as ‘Fair’ or ‘Poor,’ provide rationale for decision
• Study rating for all other outcomes (i.e., Adverse effects, HRQL, psychiatric symptom severity)
  • Good
  • Fair
  • Poor
  • No outcomes of this type reported
  • If the study is rated as ‘Fair’ or ‘Poor,’ provide rationale for decision
• Comments

Applicability

• Population
  • Is the study eligibility criteria narrowly defined such that it excludes those with comorbidities common in the SMI population? (Yes/No/Unclear)
• Interventions
  • Is the intervention team highly selected or at a level of training and proficiency not widely available? (Yes/No/Unclear)
• Comparator
  • Was the comparator composed of a substandard therapy not used in usual care of condition (e.g., statin for lipids, brief counseling for smoking)? (Yes/No/Unclear)
• Outcomes
  • Were only short-term outcomes (<6 months) measured? (Yes/No/Unclear)
• Setting
  • Were the majority of patients recruited in the US? (Yes/No/Unclear)

Efficacy-Effectiveness Rating

• Setting/Practitioner expertise (Efficacy/Effectiveness/Unclear)
  • Efficacy/Explanatory Trial
    • Highly specialized setting: Research clinic/ integrated MH-Gen Med Health OR referral population OR Academic medical Center OR restricted to practitioners with additional training in the intervention
  • Effectiveness/Pragmatic Trial
    • Reflects typical care setting: Community settings (e.g. CMHC, PC) or full range of usual care settings AND practitioners do not have any special intervention training
• Eligibility criteria (Efficacy/Effectiveness/Unclear)
  • Efficacy/Explanatory Trial
    • Captures narrow spectrum of SMI population: Convenience sample OR sample selection criteria that excludes typical psychiatric comorbidities (e.g., mood or anxiety disorder), medical comorbidities (e.g., stable DM, HTN) or medications (e.g., antidepressants, mood stabilizers) OR those less likely to adhere to treatment (fail run-in period); OR small proportion of those evaluated are eligible (<25%)
  • Effectiveness/Pragmatic Trial
    • Captures full spectrum of SMI population: Consecutive patients OR allows usual comorbidities and those less likely to be adherent, AND a high proportion of those evaluated are eligible
• Health Outcomes (Efficacy/Effectiveness/Unclear)
  • Efficacy/Explanatory Trial
    • Focus on intermediate outcomes: Does not include clinical events (e.g., MI, stroke, major DM complications), physical function, mortality or health-related quality of life
  • Effectiveness/Pragmatic Trial
    • Clinically important outcomes included: In the methods section, specifies ≥ 1 of the following outcomes: clinical events, mortality, physical function, or HRQOL
• Study Duration/clinically relevant intervention (Efficacy/Effectiveness/Unclear)
  • Efficacy/Explanatory Trial
    • Short duration/Fixed intervention: Intervention duration and dose is fixed, OR outcomes are short-term only (<6 months)
  • Effectiveness/Pragmatic Trial
    • Longer duration/Flexible intervention: Intervention dose or duration given to clinical endpoints or Intervention is flexible and responds to clinical status, AND outcomes are longer-term (≥ 6 months)
• Assessment of adverse events (Efficacy/Effectiveness/Unclear)
  • Efficacy/Explanatory Trial
    • Adverse events are not measured/reported carefully: Does not report discontinuation due to AE and ≥ 1 other predefined, important AE; OR measures are not obtained with a scale.
  • Effectiveness/Pragmatic Trial
    • Adverse events are measured/reported carefully: Reports discontinuation due to AE, and ≥ 1 other predefined, important AE; measures are obtained with a scale.
• Adequate sample size for health outcomes (Efficacy/Effectiveness/Unclear)
  • Efficacy/Explanatory Trial
    • Inadequate/Unspecified sample size: Sample size not given for clinical events, physical function, mortality or HRQOL
  • Effectiveness/Pragmatic Trial
    • Adequate sample size: Sample size calculation given clinical events, physical function, mortality or HRQOL
• ITT analysis (Efficacy/Effectiveness/Unclear)
  • Efficacy/Explanatory Trial
    • No ITT analysis: Completers analysis or excludes those with protocol deviations.
  • Effectiveness/Pragmatic Trial
    • ITT analysis: Follows intent-to-treat principle for analysis (includes all patients regardless of compliance, eligibility)
• Study quality: Captured from quality rating tool
• Experimental domain - Comparison intervention (Efficacy/Effectiveness/Unclear)
  • Efficacy/Explanatory Trial
    • Comparison is placebo rather than the best alternative management strategy
  • Effectiveness/Pragmatic Trial
    • Usual practice or the best alternative management strategy, offering practitioners considerable leeway in deciding how to apply it.
• Comments