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(1)

Susanne Schlademann

University of Luebeck

European Doctoral Workshop on Health Economics, Social Medicine and Health Policy -Kiel Institute for World Economics; November 24, 2005

Early Rehabilitation of Rheumatoid Arthritis (RA)

Results and Hands-On Experiences with the Implementation of a

Randomized Controlled Trial in Health Services Research

(2)

Background

Disease Pattern

- With an incidence rate of 0.03 % and a point prevalence of 0.5 % to 1 % RA is the most prevalent inflammatory rheumatic disease (cf. Kvien 2004).

- Gender differences: In women the prevalence and incidence rates are 2- to 4-fold higher and

the clinical symptoms are more severe than in men.

- Up to now, the cause of disease remains unclear, but there seem to be connections to genetic and autoimmunological processes.

- Seven American Rheumatism Association criteria for the classification of RA: morning

stiffness (≥ 1 h), arthritis of ≥ 3 joint areas, symmetric, arthritis of hand joints, rheumatoid nodules, positive rheumatoid factor, radigraphic changes Æ 4 criteria present for at least six weeks : RA (Arnett et al.1988)

- Disease progression might result in the affection of other joints, joint distortion or (rarely) the involvement of other organs like eyes, lachrymal and salivary glands, skin, heart or lung.

(3)

Background

Social Medical Consequences

- limited participation of the individual: functional disability, pain,

joint destruction Æredefinition of social roles, fatigue, low self-esteem, mental distress, depression

- high direct costs: 1/3 of patients requires surgery within 10 yrs after disease onset

- substantial indirect costs: Within the first 3 to 4 yrs of RA up to 40% of the patients gainfully employed at disease onset become work disabled (cf. Mau et al. 1996). Compared to the general population the SER (Standardised Employment Rate) is significantly lower in RA (SER=.78; cf. Mau et al. 2005).

- In Germany, the suspicion of undersupply, escpecially in in-patient and regional care (cf. Raspe et al.1994 and 1996, Mau et al. 1996), is strengthened by data of the National Database of the German Collaborative Arthritis Centres (nationwide documentation of clinical and patient derived data on RA since 1993 in 24 centers; cf. Zink et al. 2004).

- International clinical studies and evidence-based guidelines emphasize the importance of an early multimodal multidisciplinary team care as in Germany provided by specialised clinics through medical in-patient rehabilitation (cf. Schneider et al. 2004).

(4)

Object of Research

- The randomized controlled trial explores the efficacy of a counselling

interview on a 3-week multimodal multidisciplinary in-patient rehabilitation

to significantly improve somatic, mental and social medical parameters in gainfully employed members of statutory health and pension insurances with RA.

- Additionally, to avoid the problem of a selection bias caused by a recruitment via clinics or doctors, the feasibility to recruit a study population via databases of the co-operating statutory health insurances is examined.

- The project is funded by the German Federal Ministry of Education and Research (BMBF). - The trial has been registered at www.clinicaltrials.gov(NCT00229541).

(5)

Flowchart

R

Counselling interview on a 3-week in-patient rehabilitation

Search run in databases of health insurances (ICD-10, medical prescriptions)

Æscreening questionnaire; without reminder

Selection of eligible participants

combination of ACR-criteria and expert decision

Baseline measurement

Æhealth status (questionnaire); two reminders

Control group Intervention group

12-months follow-up

Æhealth status (questionnaire); two reminders

12-months follow-up

Æhealth status (questionnaire); two reminders

usual care

Data transmission

Health insurances: work disability, hospitalisation,occupational rehabilitation Pension insurances: applications for & decisions on pension and in-patient rehabilitation

Implementation

agreement on data security

(6)

Co-operating Institutions

Statutory Health Insurances AOK S-H *

BEK Nord

BKK Draeger & Hanse DAK S-H

IKK S-H TK S-H

Statutory Pension Insurances BfA LVA S-H Professional Association BDRh e.V. Self-help Group DRL S-H e.V Clinic

Rheumaklinik Bad Bramstedt

(7)

A)

Continuousness of Contact Persons

- Multiple changes of contact persons led to loss of important information.

B) Legal

Basis

- The discussion on questions of data security caused a 3-months delay of the project. - It took us about five months (!) to reach an agreement on the legal foundation of

the recruitment search runs within databases of the six co-operating health insurances on work disability (ICD-10 diagnoses), hospital discharge (ICD-10 diagnoses) and medical prescriptions plus

the data transmission by health and pension insurances to the Institute for Social Medicine at the end of the project

(8)

Recruitment

Search Runs

- The co-operating health insurances received

standardised search criteria to identify potential participants within their databases:

• age 20-62

• currently gainfully employed

• RA-specific medical prescriptions and/or

• ICD-10 diagnoses M05 / M06 / M13 / M79.0 in case of work disability and/or • ICD-10 diagnoses M05 / M06 / M13 / M79.0 in case of hospital discharge

- For all identified insurants data on age, sex and the source(s) of identification were transmitted to the Institute for Social Medicine (Ænonresponse analysis).

Results

- N=2200 insurants could be identified (61.8% female; age M=45.9, SD=10.3).

- The range of N=23 to N=1132 identified persons per health insurance reflects differences in the implementation of the given search criteria and the strategy of searching.

- The most important source were data on work disability (66%) and on medical prescriptions (24%).

within the past 2 yrs

(9)

Screening Questionnaire

- Each of the N=2200 potential participants was given an ID code by her/his health insurance. Exclusively, this code has been used to personalize all questionnaires and data transmitted to the Institute for Social Medicine. - All identified insurants received a two-page screening

questionnaire to check the in-/ exclusion criteria and verify the ACR criteria for the

classification of RA (Arnett et al. 1988).

- The questionnaire was mailed by the health insurance and included a cover letter plus some short information on the study.

- Response questionnaires were returned directly to the Institute for Social Medicine in a

self-addressed envelope.

Response Number Percentage

refusals N = 14 0.6 %

no reaction N = 1243 56.5 %

valid responses N = 943 42.9 %

(10)

Screening - Nonresponse Analysis

Screening Nonresponse Analysis Total (N=2200) Responders (N=943) Nonresponders (N=1257) Level of Significance Age (years) M = 45.9 SD = 10.3 M = 46.9 SD = 9.8 M = 45.1 SD = 10.7 p < .001 Sex female male N 1360 840 % 61.8 38.2 N 643 300 % 47.3 35.7 N 717 540 % 52.7 64.3 p < .001 Health Insurance AOK BEK BKK DAK IKK TK N 23 24 271 1131 66 685 % 1.0 1.1 12.3 51.4 3.0 31.2 N 7 13 111 476 36 300 % 30.4 54.2 41.0 42.1 54.5 43.8 N 16 11 160 655 30 385 % 69.6 45.8 59.0 57.9 45.5 56.2 p = .199
(11)

- The recruitment phase was followed by a two-stage selection of eligible participants.

- Initially, all responders were checked in terms of fulfillment of the following in- /exclusion criteria:

- Secondly, the questionnaires of the remaining responders were given to two experts. They reviewed these cases and selected eligible participants by the clinical symptom pattern described in the questionnaire (e.g. joint mannequin).

- ÆN=82 „early RA“Æ discontinue or change inclusion criteria ?ÆN=176 „RA“ (8% of N=2200)

Inclusion

• Member of a co-operating statutory pension insurance • currently gainfully employed

• maximal duration of RA: five years • 3 or more ACR-criteria fulfilled

• fulfillment of all criteria pursuant to insurance law to receive a medical in-patient care programme

Exclusion

• permanent incapacity for work

• participation in a medical in-patient care programme within the past four years

(12)

Baseline Measurement

- All of the N=176 selected insurants were contacted directly by their health insurance for the

baseline measurement.

- The mailed documents consisted of: • a questionnaire on health status

information on the focus, aim and process of the study

a form sheet to declare informed consent

- If necessary, up to two reminders were sent out (three and six weeks after initial mailing).

Æ N=20 insurants had to be excluded subsequently (N=19 incorrect mailing; N=1 status of insurance). N=156 baseline questionnaires were mailed out correctly.

• functional capacity • pain • somatic disorders • depression • quality of life • employment

• in-patient rehabilitation (demand, participation) • health care utilisation

• medical prescriptions • non-medical prescriptions • sociodemographics

(13)

Baseline Measurement - Nonresponse Analysis

Response

Number

Percentage

direct response

N = 78

50.0 %

response on first reminder

N = 37

23.7 %

response on second reminder

N = 14

9.0 %

refusal

N = 9

5.8 %

no reaction

N = 18

11.5 %

Total

N = 156

100 %

82.7 %

Responders (N=129) and nonresponders (N=27) did not differ significantly in age,

sex, and health insurance.

(14)

Baseline Measurement - Sample

Sample Female (N, %) 94 (72.9) Age (M, SD, Range) 49.2 (9.1) [21-62] Educational level (N, %) high intermediate low 15 (11.6) 61 (47.3) 53 (41.1)

Currently gainfully employed (N, %)

full-time

at least half-day less than half-day not gainfully employed

72 (55.8) 48 (37.2) 4 (3.1) 5 (3.9) Current occupation (N, %) blue-collar worker white-collar worker appointee self-employed other 13 (10.1) 111 (86.0) --2 (1.6) 3 (2.3)

(15)

Baseline Measurement – Results I

0 20 40 60 80 100 %

very good good fair poor very poor VERA (N=128)

Nationwide Telephone Survey 2004 (N=8318)

General Health Status (SF-36, Scale 1-5)

0 20 40 60 80 100 Mean

VERA (N=129) RA sample National Database 2002 (N=7100) general population

Functional Capacity (FFbH, Scale 0-100)

In general, the VERA population shows higher levels of

impairment than the general population.

Compared to other RA samples (e.g. National Database) VERA participants report less impairment in some

parameters.

In some parameters the described study population and reference samples are on comparable level.

(16)

Baseline Measurement - Results II

0 20 40 60 80 100 % 0 or 1 2 3

SPE sum score

VERA (N=129)

LVA insurants Mittag & Raspe 2003 (N=4279)

SPE-Scale

Score 2: 3-fold higher probability of

application for a pension (5-yrs follow-up) and 2-fold higher probability of pension

Score 3: 8-fold higher probability of

application for a pension / pension (5-yrs follow-up; N=4.225, Mittag et al. 2005)

Subjective Prognosis of Work Capacity (SPE-Skala 0-3)

0 10 20 30 40 50 60 70 80 90 100

% "yes"

VERA (N=129)

LVA insurants Zimmermann et al. 1999 (N=4400) Nationwide Telephone Survey 2004 (N=8318) Mau et al. 1996 (N=34)

subjective demand ever participated

… because of RA

Medical in-patient rehabilitation

66.4 % have never participated in any in-patient rehabilitation

54.4 % report a subjective demand on an in-patient rehabilitation

(17)

Randomization and Intervention

Randomization

- The N=129 responders of the baseline measurement were randomly allocated to the intervention and control group, respectively, by external computer based block by block stratified randomization.

Result

- Adjusted for multiple testing, intervention group (IG; N=64) and control group (CG; N=65) were comparable in all variables. Æsuccessfull randomization

Intervention

Health insurance: invitation (IG) Health insurance: counselling Interview

Insurants (IG): apply for in-patient care

(18)

Acceptance of Intervention

- 84.4 % (N=54) made use of the offer of a counselling interview.

- Similar response rates were observed in a study of comparable design (PETRA; 84 %) - But N=46 (48 %) of the interview participants refused to apply for a medical in-patient

rehabilitation (Ù PETRA: 1/3), especially for occupational reasons (N=11).

Conclusion

- A large percentage of responders is subjectively on high risk of work incapacity (SPE-Scale) and makes use of a counselling interview by health insurances on medical in-patient rehabilitation.

- High rates in refusal to apply for medical in-patient rehabilitation for occupational reasons indicate the necessity of alternative care programs appropriate for gainfully employed patients !

(19)

Status Quo

Follow-Up

- All N=129 responders of the baseline measurement were sent a follow-up questionnaire in October 2005.

- Again, up to two reminders will be sent out (three and six weeks after initial mailing). - Data entry closure is planned for December 2005.

- The current response rate is 68.2 % (N=88), we expect about N=100 (78 %) to respond.

- The data transmission by health insurances and pension insurances will be completed in Feburary 2006.

(20)

Resumee

I.

RCT in Health Services Research are possible !

II.

Several problems in the process of recruitment via databases of health

insurances emphasize the urgency to define mandatory standards on legal

foundations of data management and data processes (cf. Raspe 2005, in press).

III.

Alternative care programs for gainfully employed patients have to be

(21)

Thank you

www.clinicaltrials.gov

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