DM: MNT (2007)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
Description of a mobile diabetes clinic aimed to provide comprehensive, interdiciplinary care to patients with diabetes in a semi-rural area. Most of the patients had not visited a diabetes center before the mobile clinic.
Inclusion Criteria:
Attendance at the Western Negev Mobile Diabetes Care Clinic (WNMDCP) on at least two occasions.
Exclusion Criteria:
Not specified.
Description of Study Protocol:

Recruitment - Patients attending the WNMDCP on at least two occasions.

Design - Time Series. 

Blinding used (if applicable) not applicable

Intervention (if applicable) Clinic visits:  description of the interdisciplinary clinic program, which included laboratory analysis of biochemistry determination, lipoprotein analysis, HbA1c, thyroid stimulating hormone (TSH) and 24-hour microalbumin excretion. Patients receiving insulin undergo routine fasting plasma C-peptide determination. A standardized, computer-based clinical protocol was applied.

Statistical Analysis - The paired t test was used for analysis of data, results with p less than or equal to 0.05 were considered statistically significant. Statistical analysis were performed on all patients as one group, regardless of number of visits or length of treatment at the mobile clinic.

 

Data Collection Summary:

Timing of Measurements -two visits (first and last) to the clinic within the two calendar years 1998-99. 

Dependent Variables

  • Hgb A1c 
  • Fasting plasma glucose
  • Blood pressure

Independent Variables

  • visit to the mobile clinic

 Control Variables- not specified

 

Description of Actual Data Sample:

Initial N: 492; men 42%

Attrition (final N): 492

Age: Mean age 60 years (SD of 11)

Ethnicity: not specified other than rural residents of Western Negev

Other relevant demographics: duration of diabetes 10 years (SD 8); Percent of patients with other diagnoses: 52% obesity; 39% hypertension; 22% dyslipidemia;22% retinopathy; 21% nephropathy; 12% coronary artery disease.

Anthropometrics  not specified

Location: Western Negev of Israel

 

Summary of Results:

Clinical and lab parameters of the 492 patients at first and last visits. Values are mean (SD).

Parameter

Patients, n

First visit

Last visit

p

BMI, kg/m2

475

30.05 (5.35)

29.82 (5.17)

<0.0001

SystolicBP, mmHg

470

143 (22)

140 (20) 

 <0.001

Diastolic BP, mmHG 470 85 (12) 84 (11) <0.05
Plasma glucose, mg/dl 480 206 (72) 185 (84) <0.001
HbA1c, % 412 9.6 (2.4) 8.7 (3.3) <0.01
Triglycerides, mg/dl 422 222 (183) 205 (146) 0.06
LDL- cholesterol, mg/dl 390 137 (42) 129 (37) <0.01
HDL-cholesterol, mg/dl 390 40 (11) 46 (13) <0.0001

Cholesterol, mg/dl

422

220 (56) 

 216 (51)

 NS

Other Findings

The A1c reduction of 0.9% for the whole group is of clinical significance, since a 1% reduction in A1c is associated with a 21% reduction in risk for end points related to diabetes.

Plasma lipids and lipoproteins showed significant improvement.

Author Conclusion:
The implementation of a mobile diabetes clinic in an area of low-density population is feasible, bringing the mobile diabetes clinic's interdisciplinary diabetes care team to the patients' area of residence. Significant improvement in parameters of clinical practice and modifiable variables of diabetes control was achieved. Limited manpower answered the requirement of a geographically spread population.
Funding Source:
Reviewer Comments:
Good description of the model clinic and measured results of interdisciplinary intervention.
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? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
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? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? N/A
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  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? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  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? Yes
  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? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  6.6. Were extra or unplanned treatments described? ???
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  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? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  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? Yes
  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? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes