DM: MNT (2007)
Unclear, as this was a description of the tracking program by using the specific population.
Outcomes were evaluated for patients who:
- were in the system (participated in at least one class session)
- were at least 1 year out from program entry
- had a HbA1c at baseline (defined below) and approximately 1 year.
Comparison was made with a random sample of the general diabetes population from the department of medicine, the programs's major referral source.
Recruitment - All patients in system (who participated in at least one class session) at least one year ago. A random sample of the general diabetes population in the department of medicine (the program major referral source) was used for comparison.
Design - Descriptive Study of system for tracking patient outcomes through computer technology at Metro Health Medical Center. Outcomes of a more homogenous group were evaulated.Data from the HbA1c value closest to one year from program entry was examinedand compared to baseline data.
Blinding used (if applicable) not applicable
Intervention (if applicable) not applicable
Statistical Analysis - Mean HbA1c values compared by paired t-test
Timing of Measurements Baseline for those in the program roster was HbA1c within 6 months before or 1 month after entering program. Follow-up was HbA1c value closest to one year out from program entry.
Dependent Variables
- HbA1c
Independent Variables - Programs's core curriculum is based on American Diabetes Association content areas:
- three 2-hour group classes taught by dietitians or nurse CDE's,
- two to three individual medical nutrition therapy sessions.
- Program options include education on use of the blood glucose monitor, insulin teaching, heart-healthy classes, and preconception guidelines.
Control Variables - not specified
Initial N: Unclear. Described in relation to program tracking. 216 had pre-and post program HbA1c data, 72 were evaluated with preprogram data & ~ 1 year follow-up. plus the 200 random sample.
Attrition (final N): as above
Age: Not specified for the 216 or the random sample. Of all entered into program (438), age range was 20 - 85 years.
Ethnicity: Not specified for the 216 or the random sample. The Medical Center's diabetic population as a whole is listed as 45% white, 43% African American, 9% Hispanic, and 3% other (n=435).
Other relevant demographics: Not specified for the 216 or the random sample. The Medical Center's diabetic population as a whole is listed as 62% women, 38% men; 32% married, 68% single, separated, widowed or divorced.
Anthropometrics Mean body mass index (BMI) for patients at referral was 35.8 ± 9.1 (range 18 to 70). More than 75% are classified as obese based on BMI at baseline.
Location: Cleveland, Ohio MetroHealth Medical Center
Other Findings
Mean HbA1c at baseline for patients (n=72) in program: 9.8% ± 2.9%
Mean HbA1c at ~ 1 year for patients (n=72) in program: 7.4% ± 1.7%
In the program group (n=72), p<.001 by paired t-test.
In random sample of 200, 25% had HbA1c less than 7%; 32% had HbA1c greater than or equal to 7% and less than or equal to 9.5%; and 43% had HbA1c greater than 9.5%
In this medical center, participants in the program appear to achieve better blood glucose control than the general diabetes population. Providers of medical nutrition therapy and diabetes self-management training share the challenge of devising effective outcomes management systems that can be used in live clinical settings. Continuous data collection allows quick retrieval of data to answer clinical questions, and to provide alerts to physicians when diagnosis and clinical indicators indicate risk (ie, a diagnosis of diabetes and an HbA1c over 8.5% will send a message recommending a referral to the diabetes self-management program).
|
Quality Criteria Checklist: Primary Research
|
|||
| Relevance Questions | |||
| 1. | Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) | Yes | |
| 2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? | Yes | |
| 3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? | ??? | |
| 4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | ??? | |
| Validity Questions | |||
| 1. | Was the research question clearly stated? | No | |
| 1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | ??? | |
| 1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
| 1.3. | Were the target population and setting specified? | ??? | |
| 2. | Was the selection of study subjects/patients free from bias? | ??? | |
| 2.1. | Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? | No | |
| 2.2. | Were criteria applied equally to all study groups? | No | |
| 2.3. | Were health, demographics, and other characteristics of subjects described? | No | |
| 2.4. | Were the subjects/patients a representative sample of the relevant population? | ??? | |
| 3. | Were study groups comparable? | ??? | |
| 3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | ??? | |
| 3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | ??? | |
| 3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | ??? | |
| 3.4. | If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? | N/A | |
| 3.5. | If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) | N/A | |
| 3.6. | If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? | N/A | |
| 4. | Was method of handling withdrawals described? | N/A | |
| 4.1. | Were follow-up methods described and the same for all groups? | N/A | |
| 4.2. | Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) | N/A | |
| 4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | N/A | |
| 4.4. | Were reasons for withdrawals similar across groups? | N/A | |
| 4.5. | If diagnostic test, was decision to perform reference test not dependent on results of test under study? | N/A | |
| 5. | Was blinding used to prevent introduction of bias? | N/A | |
| 5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | N/A | |
| 5.2. | Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) | N/A | |
| 5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | N/A | |
| 5.4. | In case control study, was case definition explicit and case ascertainment not influenced by exposure status? | N/A | |
| 5.5. | In diagnostic study, were test results blinded to patient history and other test results? | N/A | |
| 6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | ??? | |
| 6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | No | |
| 6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | N/A | |
| 6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | ??? | |
| 6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | ??? | |
| 6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | N/A | |
| 6.6. | Were extra or unplanned treatments described? | N/A | |
| 6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | ??? | |
| 6.8. | In diagnostic study, were details of test administration and replication sufficient? | N/A | |
| 7. | Were outcomes clearly defined and the measurements valid and reliable? | ??? | |
| 7.1. | Were primary and secondary endpoints described and relevant to the question? | N/A | |
| 7.2. | Were nutrition measures appropriate to question and outcomes of concern? | N/A | |
| 7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | N/A | |
| 7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | ??? | |
| 7.5. | Was the measurement of effect at an appropriate level of precision? | ??? | |
| 7.6. | Were other factors accounted for (measured) that could affect outcomes? | N/A | |
| 7.7. | Were the measurements conducted consistently across groups? | N/A | |
| 8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | ??? | |
| 8.1. | Were statistical analyses adequately described and the results reported appropriately? | No | |
| 8.2. | Were correct statistical tests used and assumptions of test not violated? | ??? | |
| 8.3. | Were statistics reported with levels of significance and/or confidence intervals? | ??? | |
| 8.4. | Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? | N/A | |
| 8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | N/A | |
| 8.6. | Was clinical significance as well as statistical significance reported? | No | |
| 8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
| 9. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
| 9.1. | Is there a discussion of findings? | Yes | |
| 9.2. | Are biases and study limitations identified and discussed? | ??? | |
| 10. | Is bias due to study's funding or sponsorship unlikely? | ??? | |
| 10.1. | Were sources of funding and investigators' affiliations described? | ??? | |
| 10.2. | Was the study free from apparent conflict of interest? | ??? | |