Health Care Use and Costs of Functional Somatic Disorders

Health Care Use and Costs of Functional Somatic Disorders: A Population-based Study (DanFunD)

The goal of this observational case-control study is to learn about direct healthcare use and costs of functional somatic disorders.

The aim of the proposed study is to investigate the use and costs of direct healthcare for individuals with functional somatic disorders.

Researchers will compare direct healthcare use and costs of individuals with functional somatic disorders and compare them with that of healthy controls and individuals with other severe physical disease, respectively.

Study Overview

• Status: Completed
• Conditions: Chronic Widespread Pain; Fibromyalgia; Chronic Fatigue Syndrome; Bodily Distress Syndrome; Irritable Bowel

Detailed Description

Functional somatic disorders (FSD) are common conditions characterized by persistent patterns of physical symptoms that cannot be better explained by other physical or mental conditions. The conditions may cause severe impairment for the patients who are often characterized by impaired physical and mental health, lower social status, and poor labour market association.

In 2005, it was estimated that FSD accounted for 3% of hospitalizations and 10-20% of health care expenses in Denmark, and a newer Danish primary care study has shown patients with FSD to have higher annual health care costs compared with conventionally-defined conditions. In foreign nations, studies in clinical samples have shown increased direct and indirect health care costs of FSD which showed a dose-response relationship with severity of the FSD. One Canadian population-based study found increased health care use and costs in children, adolescents, and young adults with a first health record diagnosis of somatic symptom and related disorders. Even though these previous studies provide valuable knowledge to the field of FSD, their methodology may give rise to bias, i.e. inclusion of highly selected patient samples, the use of various diagnostic criteria for defining FSD, and the establishment of FSD by means of self-report. Evidently, studies investigating the socioeconomic burden in terms of direct health care use and costs of FSD in a randomly obtained population-based sample using solid methodology such as validated symptom criteria and diagnostic interviews for establishing FSD are highly lacking.

The objectives of this proposed study are:

To describe and investigate the healthcare use and healthcare costs for individuals with FSD and compare them with

1. individuals without FSD, and
2. individuals with severe physical disease

• Study Type: Observational
• Enrollment (Actual): 9656

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Marie Weinreich Petersen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Data from the DanFunD baseline cohort will be included. For this cohort, a total of 25,368 men and women aged 18-72 years living in the Western part of Greater Copenhagen were randomly obtained from the nationwide Danish registries and invited to participate; 9656 accepted. All of them answered questionnaires about physical symptoms, physical and mental health as well as social components. A stratified sub sample consisting og every tenth participant together with every high score on the symptoms questionnaires were invited to participate in a diagnostic interview performed over telephone by trained family physicians. A total of 2450 were invited and 1590 accepted and participated in the interview.

Description

Inclusion Criteria:

• None

Exclusion Criteria:

• not born in Denmark
• not being a Danish citizen
• pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

DanFunD baseline; Data from the DanFunD baseline cohort will be included. It comprises a total of 9,656 (33.7% of the invited participants) men and women aged 18-76 years born in Denmark and living in the Western part of greater Copenhagen. Individuals with FSD are identified by means of self-reported questionnaires (n=9,656) and diagnostic research interviews (n=1,590). Participants with FSD will be defined as follows: FSD operationalised by the Bodily Distress Syndrome single- and multi-organ type will be defined with both self-reported questionnaires and diagnostic interviews. Three functional somatic syndromes, i.e. irritable bowel, chronic widespread pain, and chronic fatigue will be defined with questionnaires. Severe physical disease will be defined by means of self-report as having received at least one of the following five diagnoses: Cancer, stroke, myocardial infarction, other heart disease, and obstructive pulmonary disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of primary healthcare resources 10 years before baseline	Data on use of healthcare in primary care will be extracted from the Danish National Health Service Register for Primary Care. This category will include number of face-to-face consultations in general practise, medical specialists, physiotherapists, chiropractors, and psychologists.	10-year period before the day the participant participated in the DanFunD baseline investigation
Costs of primary healthcare resources 10 years before baseline	Data on costs of healthcare in primary care will be extracted from the Danish National Health Service Register for Primary Care. This category will include number of face-to-face consultations in general practise, medical specialists, physiotherapists, chiropractors, and psychologists.	10-year period before the day the participant participated in the DanFunD baseline investigation
Use of primary healthcare resources 4 years after baseline	Data on use of healthcare in primary care will be extracted from the Danish National Health Service Register for Primary Care. This category will include number of face-to-face consultations in general practise, medical specialists, physiotherapists, chiropractors, and psychologists.	4-year period after the day the participant participated in the DanFunD baseline investigation
Costs of primary healthcare resources 4 years after baseline	Data on costs of healthcare in primary care will be extracted from the Danish National Health Service Register for Primary Care. This category will include number of face-to-face consultations in general practise, medical specialists, physiotherapists, chiropractors, and psychologists.	4-year period after the day the participant participated in the DanFunD baseline investigation
Use of secondary healthcare resources 10 years before baseline	Data on use of healthcare in secondary care will be extracted from the National Patient Registry.	10-year period before the day the participant participated in the DanFunD baseline investigation
Costs of secondary healthcare resources 10 years before baseline	Data on costs of healthcare in secondary care will be extracted from the National Patient Registry.	10-year period before the day the participant participated in the DanFunD baseline investigation
Use of secondary healthcare resources 4 years after baseline	Data on use of healthcare in secondary care will be extracted from the National Patient Registry.	4-year period after the day the participant participated in the DanFunD baseline investigation
Costs of secondary healthcare resources 4 years after baseline	Data on costs of healthcare in secondary care will be extracted from the National Patient Registry.	4-year period after the day the participant participated in the DanFunD baseline investigation
Use of prescription medication 10 years before baseline	Data on number of prescriptions will be extracted from The Danish Register Prescription Sales.	10-year period before the day the participant participated in the DanFunD baseline investigation
Costs of prescription medication 10 years before baseline	Data on costs of prescriptions will be extracted from The Danish Register Prescription Sales.	10-year period before the day the participant participated in the DanFunD baseline investigation
Use of prescription medication 4 years after baseline	Data on number of prescriptions will be extracted from The Danish Register Prescription Sales.	4-year period after the day the participant participated in the DanFunD baseline investigation
Costs of prescription medication 4 years after baseline	Data on costs of prescriptions will be extracted from The Danish Register Prescription Sales.	4-year period after the day the participant participated in the DanFunD baseline investigation

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen
• Investigators: Study Chair: Per W Fink, DMSc, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2011
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): August 30, 2015

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Estimate): April 13, 2023

Study Record Updates

• Last Update Posted (Estimate): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fibromyalgia; Fatigue Syndrome, Chronic
• Other Study ID Numbers: DanFunD direct healthcare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No