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MNT: RDN in Medical Team (2015)

Citation:

Bonarek-Hessamfar M, Benchimol D, Lauribe P, Hadjo A, Matis P, Dartigues JF, Bonnet J, Benchimo H. Multidisciplinary network in heart failure management in a community-based population: Results and benefits at two years. Int J Cardiol. 2009 May; 134(1): 120-122.

PubMed ID: 18374431
 
Study Design:
Non-Randomized Controlled Trial
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
To study the effects of a network for heart failure management in a community-based population while using simple, routine tools.
Inclusion Criteria:
  • Consecutive patients with severe CHF
  • A history of hospitalization within 12 months for acute heart failure
  • No indication of surgical or interventional treatment
  • Either an ejection fraction higher than 50% or a radiological cardiomegaly.
Exclusion Criteria:
  • Major diseases reducing the vital prognosis to within three months
  • Psychiatric disorders.
Description of Study Protocol:

Design

Non-randomized controlled study.

Intervention

  • Patients included in the network received the optimal medical treatment according to recommendations with ACE inhibitors (or ARA), beta-blockers and diuretics, anticoagulants or anti-platelet agents. The network patients received a handbook with:
    • Information about CHF
    • Daily self records for symptoms such as lower limb edema and weight
    • Professional records, respectively, for the:
      • Nurse
      • Dietician
      • Physical therapist
      • General practitioner
      • Cardiologist.
  • A home nurse visit was planned every four weeks to control:
    • Lower limb edema
    • Lower limb edema
    • Cardiac rate
    • Blood pressure
    • Weight
    • Treatment observance
    • Any other complaints.
  • A visit of the general practitioner was planned so that patients were visited by either the nurse or the GP every two weeks so treatment could be rapidly modified if necessary
  • Also planned were:
    • A visit to the cardiologist every six months
    • A visit of the dietician twice a year to assess low sodium and specific regimens
    • A total of 20 meetings a year with a a physical therapist for muscular training.
  • Subjects in the UC control group received the same type of treatment when discharged from the hospital, and were to be regularly followed by their GP and a cardiologist
  • The follow-up for the network group and control group (by phone calls to their GP) recorded:
    • Recorded hospitalizations (number, duration and causes)
    • NYHA grade of CHF
    • Death.

Statistical Analysis

Survival rates by:

  • Log-rank test
  • Kaplan Meier Survival Curves
  • Multivariate survival analyses using Cox proportional hazard ratio model.
Data Collection Summary:

Timing of Measurements

  • Patients had to fill in the Duke University Quality of Life questionnaire every six months. Once or twice a year, a phone conference was organized between the professionals enabling coordination of the management.
  • The follow-up for the network group and control group (by phone calls to their GP) recorded:
    • Hospitalizations (number, duration and causes)
    • NYHA grade of CHF
    • Death.

Dependent Variables

Survival.

Independent Variables

Group (Network vs Control).

Control Variables

  • Timing of measurements
  • D/C treatment in both groups
  • Follow-up by GP and cardiologist in both groups
  • Follow-up for both groups to measure survival.
Description of Actual Data Sample:
  • Initial N: Among 409 patients hospitalized for heart failure, 24 died during the hospitalization and 23 were excluded according to the defined criteria 
  • Attrition (final N): A total of 129 were included in the network group and 233 were included in the UC (control) group
  • Age: The groups were different in baseline characteristics for age (median was: 78 years for the network and 80 years in the non-network group)
  • Other relevant demographics: The groups were different in baseline characteristics for the NYHA stage (Stage IV for all non-network patients and a median of Stage III for the network group)
  • Location: Bordeaux Cedex, France.

 

Summary of Results:

Key Findings

The re-admission rate was 2.5 days per patient included in the network vs. 4.8 days in the control group. A total of 24 patients (19%) died in the network and 82 (35%) in the control group (P=0.001). Survival analysis estimated a median survival time of 24 months (median survival not achieved within the follow-up) for the network group and 20 months for the non-network group (P=0.0004). The Cox model, adjusting on gender, age and NYHA stage determined the independent role of the network on longer survival since, the adjusted hazard ratio was of 0.37 for the network group (P=0.02). The Duke Quality of Life score marked a global improvement since admission, at months six, 12, 18 and 24.

Author Conclusion:
Cardiosaintonge network permits less re-admissions and longer survival with better quality of life for patients with chronic heart failure.
Funding Source:
Other: Not Reported.
Reviewer Comments:
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? Yes
  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? No
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  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? Yes
  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%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  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? Yes
  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? 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? 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? 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? N/A
  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? 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? 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? N/A
  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)? Yes
  8.6. Was clinical significance as well as statistical significance reported? N/A
  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? No
  10.2. Was the study free from apparent conflict of interest? Yes