A cost effectiveness study of enteral immune modulating nutrition in intensive care patients
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A cost-effectiveness study of enteral immune modulating nutrition in intensive care patients. Elizabeth Coates Clare Hibbert Medical Economics and Research Centre, Sheffield (MERCS) CIMC 2001. What is immunonutrition?. The term given to describe special enteral feeds containing: Arginine

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A cost effectiveness study of enteral immune modulating nutrition in intensive care patients

A cost-effectiveness study of enteral immune modulating nutrition in intensive care patients

Elizabeth Coates

Clare Hibbert

Medical Economics and Research Centre, Sheffield (MERCS)

CIMC 2001


What is immunonutrition
What is immunonutrition? nutrition in intensive care patients

The term given to describe special enteral feeds containing:

  • Arginine

  • Omega-3 fatty acids

  • Nucleotides

  • (and sometimes, glutamine)

Ref: Barbul A. Immunonutrition comes of age. Crit Care Med 2000;28:3:884-885 (editorial).


What is cost-effectiveness analysis? nutrition in intensive care patients

Treatment A

Treatment B

Differences

Costs

Costs

COST:OUTCOME

Outcomes

Outcomes

Ref: Drummond MF, O’Brien B, Stoddart GL, Torrance GW. Methods for the economic evaluation of

health care programmes. 2nd edition. Oxford University Press, 1997.


Rationale nutrition in intensive care patients


1 the nature of critically ill patients conditions
1. nutrition in intensive care patientsThe nature of critically ill patients’ conditions

  • Malnutrition

  • Compromise of immune system

  • Infection


All these increase
All these increase: nutrition in intensive care patients

  • Length of ICU and hospital stay

  • Morbidity

  • Mortality

  • Resource consumption

  • Costs of care


2. nutrition in intensive care patientsGrowing evidence on the benefits of immunonutrition…


3. nutrition in intensive care patientsDespite these findings, and the increasing pressure to curtail expenditure

The cost-effectiveness issue has rarely been explored…


Aim of the study
Aim of the study nutrition in intensive care patients

To estimate the cost-effectiveness of immunonutrition (IMN)

in reducing infection rates in critically ill adult patients

when compared with standard enteral nutrition.


Outcome measure
Outcome measure nutrition in intensive care patients

A reduction in the duration of days of infection in ICU patients with sepsis

(from NHS perspective)


Rationale nutrition in intensive care patients

Literature review


Literature search
Literature search nutrition in intensive care patients

Databases

  • MedLine

  • Embase

  • CINAHL

    Search terms

  • Immunonutriton

  • Nutrition

  • Enteral feed

  • Intensive care

  • Critical care

  • Costs

  • Cost-effectiveness (analysis)

Review of the literature…


Studies of imn
Studies of IMN nutrition in intensive care patients

  • Atkinson (1998) reduced ICU & hospital LOS and duration of ventilation

  • Bower (1995) reduction in acquired infections and hospital LOS

  • Galban (2000) reduction in infection rate and lower mortality rate


Key paper
Key paper nutrition in intensive care patients

Beale et al. Immunonutrition in the critically ill: A systematic review of clinical outcome.

Critical Care Medicine 1999; 27:12: 2799-2805.


Benefits of immunonutrition

Ref: Beale et al. Immunonutrition in the critically ill: A systematic review of clinical outcome.

Crit Care Med 1999;27:12:2799-2805

Benefits of immunonutrition?

IMN

Hospital

LOS

2.8 days,

CI=1.3, 4.4 days

P=0.0003

Infection

Relative risk

0.60, CI=0.41,0.86

P=0.006

Ventilator

Days

2.9 days, CI=0.1, 5.9 days

P=0.04


Rationale systematic review of clinical outcome.

Literature

review

Methods


Methodology
Methodology systematic review of clinical outcome.

The evaluation of cost-effectiveness was based on two factors:

  • Evidence of effectiveness of IMN from the 12 RCTs included in the meta-analysis (1482 patients)

  • Retrospective cost data on individual ICU patients at the Royal Hallamshire Hospital


Rationale systematic review of clinical outcome.

Literature

review

Methods

Clinical

effectiveness


Rcts included in the meta analysis
RCTs included in the meta-analysis systematic review of clinical outcome.

  • Atkinson S, Sieffert E, Bihari D on behalf of the Guy’s Hospital Intensive Care Group: A prospective randomised double-blind clinical trial of enteral immunonutrition in the critically ill. Critical Care Medicine 1998; 26:1164-1172

  • Bower RH, Cerra FB, Bershadsky B et al: Early enteral administration of a formula (IMPACT) supplemented with arginine, nucleotides, and fish oil in intensive care unit patients: Results of a multicenter, prospective, randomised, clinical trial. Critical Care Medicine 1995; 23:436-449

  • Cerra FB, Lehman S, Konstantinides N, et al: Effect of enteral nutrient on in vitro tests of immune function in ICU patients: A preliminary report. Nutrition 1990; 6:84-87

  • Daly JM, Lieberman MD, Goldfine J, et al: Enteral nutrition with supplemental arginine, RNA and omega-3 fatty acids in patients after operation: Immunologic, metabolic, and clinical outcome. Surgery 1992; 112:56-67

  • Daly JM, Weintraub FN, Shou J, et al: Enteral nutrition during multimodality therapy in upper gastrointestinal cancer patients. Annals of Surgery 1995; 221:327-338

  • Galban C, Carlos Montejo J, Mesejo A, et al: An immune-enhancing enteral diet reduces mortality and episodes of bacteremia in septic intensive care unit patients. Critical Care Medicine 2000; 28, 3:643-648

  • Kudsk KA, Minard G, Croce MA, et al: A randomised trial of isonitrogenous enteral diets after severe trauma: An immune-enhancing diet reduces septic complications. Annals of Surgery 1996; 224:531-540

  • Moore FA, Moore EE, Kudsk KA, et al: Clinical benefits of an immune-enhancing diet for early post injury enteral feeding. Journal of Trauma 1994; 37:607-615

  • Schilling J, Vranjes N, Fierz W et al: Clinical outcome and immunology of postoperative arginine, omega-3 fatty acids, and nucleotide-enriched enteral feeding: A randomised prospective comparison with standard enteral and low calorie/low fat solutions. Nutrition 1996; 12:423-429

  • Senkal M, Mumme A, Eickhoff U, et al: Early postoperative enteral immunonutriton: Clinical outcome and cost-comparison analysis in surgical patients. Critical Care Medicine 1997; 25:1489-1496

  • Weimann A, Bastian L, Grotz M, et al: Influence of arginine, omega-3 fatty acids and nucleotide-supplemented enteral support on systematic inflammatory response syndrome and multiple organ failure in patients after severe trauma. Nutrition 1998; 14:165-172

  • Braga M, Gianotti L, Vignali A et al: Artificial nutrition after major abdominal surgery: Impact of route of administration and composition of the diet. Critical Care Medicine 1998; 26:24-30.

12


Evaluation of the clinical evidence
Evaluation of the clinical evidence systematic review of clinical outcome.

  • Assessment of the studies’ quality using the CONSORT statement

  • This provides a standard method for the reporting (and assessment) of randomised controlled trials

Ref: The Standards of Reporting Trials Group. Improving the quality of reporting of randomized

controlled trials. The CONSORT statement. JAMA 1996; 28:8:637-9


Translate the benefits into s

Ref: Beale et al. Immunonutrition in the critically ill: A systematic review of clinical outcome.

Crit Care Med1999;27:12:2799-2805

Translate the benefits into %s

IMN

Infection

40% Reduction

Worst-case

Scenario

@ 14%

Best-case

Scenario

@ 59%


Rationale systematic review of clinical outcome.

Literature

review

Methods

Clinical

effectiveness

Cost data


Infection
Infection systematic review of clinical outcome.

  • Decided to use sepsis as the case study in my economic analysis for three reasons:

  • Most frequent type of infection in the meta-analysis

  • Availability of previously published data (from RHH) on costs of sepsis.

  • Significance of the infection

Ref: Edbrooke et al. The patient-related costs of care for sepsis patients in a United Kingdom adult general intensive care unit. Crit Care Med 1999; 27:9:1760-1767


What is sepsis
What is sepsis? systematic review of clinical outcome.

  • Defined as severe sepsis; associated with at least two of the following:

    • Elevated plasma lactate or metabolic acidosis, arterial pH <7.3 or base excess -5mEq/L

    • Hypoxemia, either PaO2/F102 <280 or hypoxemia requiring mechanical ventilation

    • Platelet count decrease to less than half of a previous count or <100,000/mm3 or unexplained coagulopathy

    • Oliguria, urine output <30 mL/hr or <0.5 mL/kg/hr for at least 2hrs that is refractory to an adequate fluid challenge (>500 mL)

  • Or early septic shock:

    • Severe sepsis associated with hypotension (systolic blood pressure <90 mm Hg or reduction in systolic blood pressure of >40 mm Hg in the absence of causes other than septic shock) receiving vasopressors at therapeutic doses for up to 2hrs before study drug dosing

Ref: American College of Chest Physicians and the Society of Critical Care Medicine held in August

1991 and adapted by Hoffman La Roche AG


The patients
The patients systematic review of clinical outcome.

  • 213 admitted to the ICU at RHH over ten months during 1995-96.

  • 36 with evidence of sepsis at any point during their ICU stay (16.9%)

  • 177 without evidence of sepsis (83.1%)

Ref: Edbrooke et al. The patient-related costs of care for sepsis patients in a United Kingdom adult

general intensive care unit. Crit Care Med 1999; 27:9:1760-1767


Cost analysis
Cost analysis systematic review of clinical outcome.

Calculated total costs for each cost component:

  • Drugs

  • Fluids

  • Consumables

  • Medical Imaging


Cost analysis1
Cost analysis systematic review of clinical outcome.

Calculated total costs for each cost component:

  • Nurses

  • Doctors

  • Other staff

    (technical and admin)


Rationale systematic review of clinical outcome.

Literature review

Results

Methods

Clinical

effectiveness

Cost data


Cost differences
Cost differences systematic review of clinical outcome.

Sepsis patients

Non-sepsis patients

S

£112

£537 per day

£425 per day

LOS = 14.08 days

LOS = 3.31 days

£6154

£7560

per patient

£1407

per patient


Cost effectiveness of imn
Cost-effectiveness of IMN? systematic review of clinical outcome.


Cost effectiveness

Enteral Feed systematic review of clinical outcome.

Reduction in rate of infection (%)

Cost (£) (per patient)

Estimated change in cost (£) (per patient)

Number of days of infection avoided

Estimated change in cost (£) (per day of infection avoided)

Daily additional cost of IMN=£35

Standard

7558

Immunonutrition

14

7830

+273

1.97

+138

40

7421

-137

5.63

-24

59

7122

-436

8.31

-52

Cost-effectiveness


Reduction in duration of sepsis

Costs Before systematic review of clinical outcome.

(using standard enteral feed)

Reduction in duration of sepsis

On a larger scale: per 100 patients

Sepsis rate 16.9%

Using standard feed = (cost per sepsis patient x 16.9)

+

(cost per non-sepsis patient x 83.1)

=

£244,621

X 10


Costs After systematic review of clinical outcome.

(using immunonutrition)

Reduction in duration of sepsis

On a larger scale: per 100 patients

Sepsis rate 16.9%

Using IMN = (cost per sepsis patient + cost of feed x 16.9)

+

(cost per non-sepsis patient x 83.1)

=

£242,311

X 10


A difference of systematic review of clinical outcome.

£2310/100 patients


Rationale systematic review of clinical outcome.

Sensitivity

analysis

Literature

review

Methods

Results

Clinical

effectiveness

Cost data


Sensitivity analysis
Sensitivity analysis systematic review of clinical outcome.

  • With cheapest patients, IMN always more expensive, e.g.

  • 14% reduction = +£469: per patient

  • 40% reduction = +£425: per patient

  • 59% reduction = +£393: per patient


Sensitivity analysis1
Sensitivity analysis systematic review of clinical outcome.

  • With most expensive patients, IMN can be cost-effective, e.g.

  • 14% reduction = +£76: per patient

  • 40% reduction = -£698: per patient

  • 59% reduction = -£1265: per patient


Problems systematic review of clinical outcome.

Rationale

Literature

review

Sensitivity

analysis

Methods

Results

Clinical

effectiveness

Cost data


Problems with this approach (i) systematic review of clinical outcome.

  • Assumptions about:

  • Infection type

  • Duration of infection

  • Costs associated with treating infection

  • Cost of the treatment

  • These will all vary between ICUs


Problems with this approach systematic review of clinical outcome.(ii)

  • Ignores the potential length of stay reduction

  • Therefore, small cost savings

  • Doesn’t account for the recurrence of infection.


Rationale systematic review of clinical outcome.

Conclusion

Problems

Literature

review

Sensitivity

analysis

Methods

Results

Clinical

effectiveness

Cost data


Conclusion systematic review of clinical outcome.

  • IMN can be cost-effective

  • Need to ensure a certain level of clinical efficacy

  • Need to identify safe population who can demonstrate benefits worth the additional costs


Recommendation systematic review of clinical outcome.

  • In an ideal situation, an economic evaluation would be completed alongside a multicentre RCT…


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