EAL

MNT: Weight Management (2015)

Citation:

Olsen J, Willaing I, Ladelund S, Jorgensen T, Gundgaard J, Sorensen J. Cost-effectivenss of nutritional counseling for obese patients and patients at risk of ischemic heart diease. Int J Technol Assess Health Care. 2005; 21(2): 194-202.

PubMed ID: 15921059

Study Design:

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To compare the costs and effects (in terms of life years gained) of providing nutritional counseling by a general practitioner or a dietitian.

Inclusion Criteria:

Patients with:

High body mass index (more than 30kg/m²)
Large waist circumference (men, more than 102cm; women, more than 88cm)
Dyslipidemia
Type 2 diabetes.

Exclusion Criteria:

Patients who did not fit into the inclusion criteria.

Description of Study Protocol:

Recruitment

The Health Technology Assessment study was conducted in Copenhagen County between April 2000 and December 2001. Recruitment methods for general practitioners (GPs) were not described. All patients were included by their GP if inclusion criteria was met.

Design

A total of 60 GPs, who accepted to participate, were randomized either to give nutritional counseling or to refer the patients to a dietitian for counseling. Costs were estimated on the basis of registered use of time (dietitians) or agreed salaries (GPs). The effects of nutrition counseling were measure in terms of life years gained and life years gained without ischemic heart disease (IHD).

Intervention

The GP intervention consisted of counseling in terms of general advice and delivery of commercially available written information on healthy diet. Initial counseling session was approximately 30 minutes, and the following session was approximately 12 minutes.
The Dietitian intervention consisted of individual counseling based on the indication for referral, dietary history and diet routines. Focus was on principles of food nutrition, advice on food shopping, cooking methods, meal planning and exercise. Recommendations included restriction of total dietary energy, reduction of the fat component, or a cholesterol-lowering diet. The initial counseling session was approximately one hour and the following session was approximately 30 minutes.

Statistical Analysis

Life years gained was estimated using a Cox regression model. To determine the precision of the Incremental Cost-Effectiveness Ratios, confidence intervals were estimated applying the boot strapping method with 10,000 replications.

Data Collection Summary:

Timing of Measurements

Five counseling sessions over a 12-month period.

Dependent Variables

Life years gained
Life years gained without IHD
Incremental cost-effectiveness ratios in relation to life years gained.

Independent Variables

GPs randomized their patients to give nutritional counseling or refer patient to dietitian who gave the patient nutrition counseling.

Control Variables

Sex
Cholesterol
Systolic blood pressure
Smoking
BMI
Diabetes
Familial pre-disposition
Previous heart disease.

Description of Actual Data Sample:

Initial N: N=60 general practitioners, 30 in each group, with 503 patients (312 from RD, 191 from GP)
Attrition (final N): N=29 GPs who referred to RD, 22 GPs did counseling, with 401 patients (121 male, 280 female)
Location: Denmark.

Summary of Results:

Key Findings

**Predicted Average Life Years Gained and Average Intervention Costs According to Counseling Group**
Group	N	Change in Years	95% CI	Costs (DKK)
Total	401	0.0528	0.0317 to 0.0739	1,293
Dietitian counseling	243	0.0274	0.0013 to 0.0534	1,642
GP counseling	158	0.0919	0.0569 to 0.1269	755

**Predicted Average Life Year Gained Without IHD and Average Intervention Costs According to Counseling Group**
Group	N	Change in Year Without IHD	95% CI	Costs (DKK)
Total	377	0.1023	0.0439 to 0.1306	1,325
Dietitian counseling	243	0.0700	0.0388 to 0.1011	1,642
GP counseling	134	0.1608	0.1054 to 0.2162	751

**Incremental Cost-effectiveness Ratios in Relation to Life Years Gained According to Counseling Group**
Group	N	ICER (DKK per Year)	Bias-corrected 95% CI (DKK per Year)
Total	401	24,481	17,359 to 41,014
Dietitian counseling	243	59,987	30,545 to 996,368
GP counseling	158	8,213	5,910 to 12,850

Other Findings

GP counseling is more cost effective; the cost of gaining one extra life year was estimated to be 8,213 DKK compared with the dietitian group for which the incremental cost-effectiveness ratio was estimated to be 59,987 DKK
Effect of nutritional counseling comparing GPs and dietitians is greatest when counseling is performed by a GP (0.0919 years vs. 0.0274). These effects appear to be moderate, but they are significant.

Author Conclusion:

The general practitioners group was the most cost-effective counseling strategy, but it must be concluded that both counseling strategies were relatively cost-effective. The effects in terms of life year gained and life years gained without IHD were greatest and most distinct in the GP group, and the costs were greatest in the dietitian group given the applied costing method. Even though the cost of gaining an extra life year was estimated to be 59,987 in the dietitian group, this might be an acceptable price.

Funding Source:

Reviewer Comments:

Recruitment methods for GPs was not described. Subjects were not well described.

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?	???
	2.2.	Were criteria applied equally to all study groups?	???
	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?	Yes
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)	Yes
	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.)	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?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	Yes
	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.)	Yes
	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?	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?	Yes
	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)?	Yes
	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?	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?		???
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	???