Inter- Rater Reliability of Icf in Knee Replacement Artroplasty During First Post-Operative

INTER- RATER RELIABILITY OF ICF IN KNEE REPLACEMENT ARTROPLASTY DURING FIRST POST-OPERATIVE WEEK.

Protocol submitted to

HOSMAT HOSPITAL EDUCATIONAL INSTITUTE

Bangalore

DISSERTATION RESEARCH PROJECT

Micheal varghese

M.P.T. 1st year

M.P.T (Musculoskeletal and sports)

Guide: Dr. R. Dev Anand (PT)

INTER- RATER RELIABILITY OF ICF IN KNEE REPLACEMENT ARTROPLASTY DURING FIRST POST-OPERATIVE WEEK.

RESEARCH APPROVAL

Research proposal approved by Institutional ethics Committee

13/12/2011

INSTITUTIONAL ETHICS COMMITTEE

HOSMAT HOSPITAL EDUCATIONAL INSTITUTE

BANGALORE -25.

CONTENTS

Page No.

1INTRODUCTION 04

1.1 Background of the study 04

1.2 Statement of the problem 04

1.3 Objective of the study 04

1.5 clinical significance 05

2REVIEW OF LITERATURE 06

3METHODOLOGY 10

3.1Study Design 10

3.2Study Setting 10

3.3Inclusion Criteria 10

3.4Exclusion Criteria 10

3.5Materials 10

3.6Sampling 10

3.7Sample size 10

3.8Procedure 11

3.9 Outcome measures 11

3.10 Data analysis 11

4REFERENCES 12

5APPENDIX

Appendix I 15

Appendix II 16

Appendix III 21

INTRODUCTION

1.1Background of the study

Knee replacement arthroplastyKRA is a common procedure that despite low level of mortality and complication. Major joint arthroplasty is normally performed to improve patient’s quality of life. Patient’s perspective is vital in assessing the effect of the procedure. Functional status of subject can be quantified before and after procedure 1 .

Common Patient concerns after knee replacement arthroplasty include, decrease in pain, reduction of swelling, avoiding of infections, better sleep at night, increase ROM at knee, increase strength in legs, getting in and out of bed, getting in and out of bath, self-dressing, walking on flat surface, walking on uneven surface, descending stairs, ascending stairs, doing own house work2.the most common anticipated impairments and functional limitation after KRA are Pain, immobilized postoperatively in bed,edema,limited strength, limited bed mobility and transfer, limited gait3.

Impairment and functional limitations have to be quantified to guide interventional program and measure the improvements. Impairments and functional limitation have been measured by various outcome measures. In recent years the International Classification of Functioning, Disability and Health (ICF) has been widely adopted as a conceptual model for describing outcome measures. Briefly, the ICF is a bio psychosocial model of health that focuses on the consequences of disease and includes two parts, with each part containing separate components. The first part covers functioning and disability and includes the components of Body Structure and Function, Activities, and Participation. The second part covers contextual factors and includes the components of Environmental Factors and Personal Factors. The ICF provides a unified framework for evaluating health and health related states of populations in both clinical practice and research.4..ICF has been shown to link disciplines by providing common language for measurement of function.5

1.2 Statement of problem:

Inter rater reliability of ICF in knee replacement arthroplasty in first post-operative week

1.3Objective of the study

The purpose of this study is to use ICF core set as a outcome tool after knee replacement arthroplasty.

Check the inter rater reliability

1.4Clinical significance

ICF core sets can be used as outcome tool after KRA for education, goal setting and managing expectations about return to participation roles.

ICF applicability in clinical practise.

2. Review of Literatures

Arthroplasty is a surgical procedure for construction of a new movable joint6.Knee replacement arthroplasty is a common procedures that is despite low level of mortality and complications1.Arthritis of a joint is a major cause for arthroplasty78 .Knee replacement arthroplasty is the second most popular orthopaedic surgeries9.total joint arthroplasty for management of end stage arthritis has been shown to be effective in improving physical functioning and reducing pain in over 90% of patients 10.

Common indications for knee replacement arthroplasty are osteoarthritis, ankylosis, jointstiffness, rheumatoidarthritis, traumatized and misaligned joint4611.Goals of rehabilitation after knee replacement arthroplasty are, prevention of hazards of bed rest, guard against dislocation ofimplant, strengthen hip and knee musculature, gain functional strength, assist with adequate and functional range of motion ROM,assist patient in achieving functional independent activities of daily living, independent ambulation with an assistive device12.

Examination and evaluation procedures require assessment of quantifiable outcome measures. These measures identify the level of impairments. Common impairments after KRA and their quantification are, Pain (visual analogue scale13,Western Ontario and McMaster Universities WOMAC14 ,Knee injury and Osteoarthritis Outcome Score KOOS15,The Pain Disability Index (PDI)16,The McGill Pain Questionnaire17), Strength (muscle strength scale18,isometric dynamometer19,isokinetic dynamometer20,manual muscle testingMMT21).Stiffness(WOMAC14).Activities of daily living(ADL)(The Lower Extremity Functional Scale (LEFS)22,BARTHEL INDEX23,KOOS15,WOMAC14).Quality of life( QOL), SF-36(tm) Health Survey24.

ICF provides common language and frame work for describing health and health-related states.ICF is used to describe how functional problems can result in difficulties carrying out tasks and how these problems are manifested in a person’senvironment, rather than focussing on the consequences of disease.ICF frame work is based on a bio psychosocial model of functioning and disability, functional status information (FSI) relates to an individual’s capacity to carry out a set of task or actions, and to changes in body structure and functions arising from a health condition25.

FLOW CHART DEPICTING ICF FRAME-WORK:

ICF core sets used in arthroplasty 26

Body Function / Body Structure
b 130 / Energy and drive fn / s 750 / Structure of lower ext
b 134 / Sleep function / S770 / AddtnMS str related to movement
b 152 / Emotional function / s 799 / Str related to movement unspecified
b 280 / Sensation of pain
b 710 / Mobility of joint fn / Activity & Participation
b 715 / Stability of joint fn / d 410 / Change basic position
b 720 / Mobility of bone fn / d 415 / Maintaining a body position
b 730 / Muscle power fn / d 430 / Lifting and carrying objects
b 735 / Muscle tone function / d 450 / walking
b 740 / Muscle endurance fn / d 455 / Moving around
b 760 / Control of vol. movement fn / d 470 / Using transportation
b 770 / Gait pattern function / d 475 / driving
b 780 / Sensation rel. to muscle&mvt fn / d 510 / Washing oneself
d 530 / Toileting
Environmental / d 540 / Dressing
e 110 / Product for consumption / d 620 / Acquisition of good and services
e 115 / Product technology for ADL / d 640 / Doing housework
e 120 / Products technology for personal indoor and outdoor mobility and transportation / d 660 / Assisting others
e 135 / Product technology for employment / d 770 / Intimate relationship
e 150 / Design , construction building products technology of building for public use / d 850 / Remunerative employment
e 155 / Design , construction and building products and technology of building for private use / d 910 / Community life
e 225 / Climate / d 920 / Recreation and leisure
e 310 / Immediate family
e 320 / Friends / Environmental (Contd)
e 340 / Personal care providers and personal assistance / e 460 / Societal attitudes
e 355 / Health professionals / e 540 / Transportation services system and policies
e 410 / Individual attitude of immediate family members / e 575 / General social support services, systems and policies
e 450 / Individual attitude of health professional s / e 580 / Health services, systems and policies

Reliability and validity of ICF in orthopaedic conditions.

1)ICF core sets for osteoarthritis were shown to be valid and reliable through rasch analysis and classical psychometric methodsr =0.79, 0.86, 0.8827 .

2)Reliability of ICF core set of rheumatoid arthritis was low to moderate. The metric of the qualifiers scale may be improved by reducing the number of qualifiers to three for all the component Weighted kappa statistics showed reliability of 0.4 or higher

in 82/95 ICF categories (86%) within raters, but only in 41/95ICF categories (43%) between raters,28.

3)ICF is valid and reliable in low back ach (LBA) patients for symptom and functional limitation of LBA patient highestCronbach’s alpha (0.90–0.95) and all items had item–total,29.

4)The ICF has showed at least moderate inter-rater and excellent intra-rater reliability in patients with multiple injuries,Kappas above 0.8030.

3.METHODOLOGY

3.1 Study design

Observational study

3.2 Study setting

Departmentof physiotherapy, HOSMAT HOSPITAL,Bangalore

3.3 Sample size:

Minimum 30

3.4 sampling:

Subjects who are electively selected for arthroplasty between January 2012-december 2012.

3.5 Inclusion criteria

Subjects with knee replacement arthroplasty.
Independent mobility with assistive aid under supervision
Age: 40-80 years.
Gender :male & female.

3.6Exclusion criteria

Psychological disorder/unco-operative subjects.
Severe systemic disease, cognitive impairment.
Unstable vitals
Infections post-operative
Bed sores
Auditory & visual deficits

3.7Materials:

VAS (Visual analogue scale)
Goniometer
ICF core sets
Questionnaire

3.8Procedure:

Phase 1 :Two raters will be selected. One rater is the researcher and the other will be an intern or staff from physiotherapy department. They will be trained about ICF core set and methods of measuring. (Annexure II). The duration of training will be for one week. 10 knee arthroplasty subjects will be selected and the raters will familiarize in scoring the ICF core sets, in a supervised training program. The difficulties faced and discrepancies in scoring shall be discussed in academic postgraduate meeting and a consensus shall be reached.

Phase 2 :Rating of subjects will be done by two raters R1 and R2,subjects will be chosen from post-operative day by screening with inclusion and exclusion criteria’s, these subjects will be explained the procedure and asked about their willingness to participate in the study. Subjects will be taken in to study after signing a written consent.

Knee arthroplasty subjects commonly stay as in-patients for 4-8 days after surgery. The subjects shall be rated when they are independently mobile under supervision

Subjects shall be rated by two raters on subsequent days ,coin toss method will be used in the selection of order of rater assessment, if the coin shows heads R1will assess the patient on first day and R2 on second day. If the coin shows tails R2 will assess the patient on first day and R1 on second day.The rater documents will be blinded from each other till the end of the study.

Measures of impairment like pain, range of motion (ROM) ,stiffness,activitys of daily living (ADL),quality of life (QOL),will be taken during the assessment period for 1-8 days and measured by using measurement scales. (Annexure II)

ICF categories like body function, activityand participation, environment will be quantified by rater at the end of the day, once the rater procedure comes to an end R1-R2 observation will be analysed for inter-rater reliability of ICF .

3.9 outcome measure:

ICF Core set

3.10 Data analysis:

Reliability coefficient: Cronbach’s alphas coefficient

REFERENCES

1.Peter Salmon, DPhil, FBPsS, George M. Hall, PhD, FRCA, Denise Peerbhoy, BSc, Alan Shenkin, PhD, FRCP, FRCPath, Christopher Parker, MD, FRCA, Recovery From Hip and Knee Arthroplasty: Patients’ Perspective on Pain, Function, Quality of Life, and Well-Being Up to 6 Months Postoperatively, Arch Phys Med Rehabil Vol 82, March 2001.

2. Ravi Rastogi*1, Bert M Chesworth2 and Aileen M Davis3, Change in patient concerns following total knee arthroplasty described with the International Classification of Functioning, Disability and Health: a repeated measures design, Health and Quality of Life Outcomes 2008, 6:112.

3. Lisa maxey,jim Magnusson, text book of rehabilitation of post surgical orthopaedics page no 180 and 274 ,A Harcourt Health Sciences Company.

4.Ravi Rastogi1, Aileen M Davis2 and Bert M Chesworth. A cross-sectional look at patient concerns in the first six weeks following primary total knee arthroplasty. Health and Quality of Life Outcomes 2007, 5:48 .

5. International classification of functioning, disability and health, world health organisation, Geneva.

6.J maheshwari,Text book of essential orthopaedics ,3rd edition page no 68-69.

7.Chung-Wei Christine Lin,MaximLyn March2, Jack Crosbie3, Ross Crawford4,Stephen Graves5, Justine Naylor6, Alison Harmer3, Stephen Jan1,Kim Bennell7, Ian Harris8, David Parker9, Helene Moffet10 and Marlene Fransen*1,11um recovery after knee replacement – the MARKER study rationale and protocol,BMC Musculoskeletal Disorders 2009, 10:69.

8.Canadian Institute for Health Information: Canadian Joint Replacement Registry (CJRR) 2007 annual report – hip and knee replacements in CanadaOttawa: CIHI; 2008.

9.François Desmeules*1,2, Clermont E Dionne†1,3, Étienne Belzile†4,Renée Bourbonnais†3,5 and Pierre Frémont,Waiting for total knee replacement surgery: factors associated with pain, stiffness, function and quality of life,BMC Musculoskeletal Disorders 2009, 10:52.

10.Robert B. Bourne MD,Patient Satisfaction after Total Knee ArthroplastyPublished online: 21 October 2009 The Association of Bone and Joint Surgeons1 2009.

11.Elaine Trudelle-Jackson, PT, PhD1 Outcomes of Total Hip Arthroplasty: A Study of Patients One Year Post surgery,Orthop Sports Phys Ther 2002;32:260–267.

12.S.brent brotzman,clinical orthopaedic rehabilitation, chapterseven, page no 284-302

13.Shaun O` Leary, Deborah Falla, Paul W. Hodge, Gwendolyn Jull, Bill Vicenzino. A specific therapeutic exercise of the neck induces immediate local hypoalgesias. The journal of pain.2007; 8(11):832-39.

14. Bellamy N Buchanan WW . Validation study of WOMAC: A health status instrument for measuring clinically important patient relevant outcomes to ant rheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988; 15: 1833-1840.

15.E Roos, S Toksvig-Larsen: Knee injury and Osteoarthritis Outcome Score (KOOS) -validation and comparison to the WOMAC in total kneereplacement. Health and Quality of Life Outcomes 2003, 1.

16. Chibnall JT Tait RC. The Pain Disability Index: Factor Structure and Normative Data. Arch Phys Med Rehabil. 1994; 75: 1082-1086.

17.Melzack R. The McGill Pain Questionnaire: Major properties and scoring methods. Pain. 1975; 1: 277-299.

18.Miller DW Hahn JF. Chapter 1: General methods of clinical examination. pags 31-32. IN: Youmans JR. Neurological Surgery 4 edition. W.B. Saunders Company. 1996

19.CAROLYN KISNER, PT, MS.Therapeutic Exercise Foundations and Techniques ,5th edition.

20.John W. Chow,ISOKINETIC EXERCISES AND KNEE JOINT FORCES DURING ISOKINETIC KNEE EXTENSIONS,Department of Exercise and Sport Sciences, University of Florida, Gainesville, FL 32611

21.Florence kendall,muscle testing and function,4th edition.

22.Binkley JM Stratford PW. The Lower Extremity Functional Scale (LEFS): Scale development measurement properties and clinical application. Physical Therapy. 1999; 79: 371-383 (Appendix page 383)..

23.Mahoney FI, Barthel D. “Functional evaluation: The Barthel Index.” Maryland State Medical Journal 1965;14:56-61.

24.SF-36(tm) Health Survey.

25.RITA KUKAFKA DRPH, MA, MICHAEL E. BALES, MPH, ANN BURKHARDT, OTD, OTR/L, BCN,CAROL FRIEDMAN, PHD,Human and Automated Coding of Rehabilitation Discharge Summaries According to the International Classification of Functioning, Disability, and Health,Journal of the American Medical Informatics Association Volume 13 Number 5 Sep / Oct 2006.

26.C.pison,A giaridini,g.ma jani,m.maini,international classification of functioning, disability and health core sets for osteoarthritis, a useful tool in the follow-up of patients after arthroplasty,European journal of physical and rehabilitation medicine vol.44-no.4

27.Yeşim Kurtaiş,Reliability, construct validity and measurement potential of the ICFcomprehensive core set for osteoarthritis.Kurtaiş et al. BMC Musculoskeletal Disorders 2011, 12:255.

28.Till Uhlig,RSolva° r Lillemo, Rikke Helene Moe, Tanja Stamm, Alarcos Cieza, Annelies Boonen, Petter Mowinckel, Tore Kristian Kvien, Gerold Stuckieliability of the ICF Core Set for rheumatoid arthritis,Ann Rheum Dis 2007;66:1078–1084. doi: 10.1136/ard.2006.058693.

29.Martin Bjo¨rklund Æ Jern Hamberg Æ Marina Heiden Æ,Margareta Barnekow-Bergkvist,The assessment of symptoms and functional limitations in low back pain patients: validity and reliability of a new questionnaire,Eur Spine J (2007) 16:1799–1811.

30.Soberg HL, Sandvik L, Ostensjo S,Reliability and applicability of the ICF in coding problems, resources and goals of persons with multiple injuries.Department of Physical Medicine and Rehabilitation, Oslo University College, Oslo, Norway.

31.Hauser SL, Dawson DM, Lehrich JR, Beal MF, Kevy SV, Propper RD, Mills JA,Weiner HL. Intensive immunosuppression in progressive multiple sclerosis. A randomized, three arm study of high-dose intravenous cyclophosphamide, plasma exchange, andACTH.N Engl J Med. 1983 Jan 27;308(4):173-80.

32.Cynthia norkins,Pamela K. Levangie,,Joint structure and function,forth edition.

33.Valeria.m.pomeeroy,David Dean,Laura sykes,E.brah=n faragher,martin yates,pippa j tyrrell,Sylvia moss,Raymond tallis,The unreliability of clinicle measures of muscle tone implication for stroke patient,Age and ageing 2000;29:229-333.

34.Jann M. Fielden, RCpN, MA,P. H. Gander, PhD, J. G. Horne, MBChB, FRACS,B. M. F. Lewer, MBChB, FANZCA,R. M. Green, BSc,and P. A. Devane, MBChB, MSc, FRACS.An Assessment of Sleep Disturbance in Patients Before and After Total Hip Arthroplasty.The Journal of Arthroplasty Vol. 18 No. 3 2003.

APPENDIX – I

HOSMAT College of Physiotherapy

Rajiv Gandhi University

Consent Form

I ______agree to take part in the research study conducted , by Micheal Varghese Postgraduate student (M.P.T. Musculoskeletal & Sports), HOSMAT College of Physiotherapy, Rajiv Gandhi University, entitled Inter- rater reliability of ICF in Knee replacement arthroplasty during 1st week post-operatively

I acknowledge that the research study has been explained to me and I understand that agreeing to participate in the research means that I am willing to

Provide information about my health status to the researcher
Allow the researcher to have access to my medical records, pertaining to purpose of the study
Participate in evaluator program
Make myself available for further follow up

I have been informed about the purpose; procedures, measurements and risks involved in the research and my queries towards the research have been clarified.

I provide consent to the researcher to use the information, video or audio recordings, for research and educational purpose only.

I understand that my participation is voluntary and can withdraw at any stage of the research project.

I understand that no monitory benefit will be given for participation in this research study.

Name of the applicant –

SignatureDate

Signature of the researcher:

APPENDIX II

Data collection Form:

Name: age/ sex:

Occupation: patient number:

Hospital number:

Research study number:

Date of surgery :

Date of assessment:

Date of discharge:

Type of surgery: KNEE______

Contact no :

QUESTIONER

ICF core sets used for data collection

b 130 / Energy and drive function
b 134 / Sleep function
b 152 / Emotional function
b 280 / Sensation of pain
b 710 / Mobility of joint function
b 730 / Muscle power function
b 735 / Muscle tone function
b 740 / Muscle endurance function
b 770 / Gait pattern function
s 750 / Structure of lower extremity
d 410 / Changing basic position
d 415 / Maintaining a body function
d 450 / Walking
d 455 / Moving around
d 510 / Washing one self
d 530 / Toileting
d 540 / Dressing
e 115 / Product and technology for personal use in daily living
e 340 / Personal care provider & personal assistance
e 355 / Health professional

Questionnaire

b 130 Energy and drive function (sf36,Q9)

All of time / Most of time / A good bit of time / Some of time / A little of time / None of time
1.Did you feel full of pep
2.Have you been a nervous person
3.Have you felt down that nothing to cheer you
4.Have you felt calm & peaceful
5.Did u have a lot of energy
6.Have you felt downhearted and blue

b 134 sleep function (Measurement on 0 – 10 VAS)

knee pain disturbs sleep
other pain disturbs sleep
difficulty in falling asleep
difficulty in waking
waken refreshed
get enough sleep34

b 152 Emotional function(womac)

None (0) / Slight(1) / Moderate(2) / Severe(3) / Extreme(4)
1.Anxiety
2.Irritability
3.Frustration
4.Depression
5.Relaxation
6.Insomnia
7.Boredom
8.Loneliness
9.Stress
10.Well-being

b 280 sensation of pain (koos)

NONE / MILD / MODERATE / SEVERE / EXTREME
1.Straightening knee fully
2.Bending knee fully
3.Walking on flat surface
4.At night while in bed
5.sitting or lying
6.standing upright

b 710 Mobility of joint function –Goniometer, it is performed during the assessment32.
b 730 Muscle power function –(Isometric muscle grading) performed for quadriceps and hamstrings.

0-none
1-trace
2-poor
3-fair
4-good
5-normal

7. b 735 Muscle tone function VAS33.