Appropriateness of joint replacement:

A multi-stakeholder decision-support tool

Research in Waiting Time Management

March 23, 2011Ottawa, Ontario

Why Appropriateness?

• Traditional focus on supply-side management of waiting times

• Increasing supply increases demand

• Demand-side management requires definition and management of appropriateness

• Perspective matters

Scoping Review: Findings

• Appropriateness is that which is expected to contribute to patients’ health in a positive manner

• Almost exclusively a ‘clinical perspective’

• Apparent absence of patient/public perspective

• Desirability/acceptability/expectations – under researched

• ‘Cost’ and decision-makers’ (payers’) perspective to be considered

Int J HTA 24(3):342-9, 2008

Agenda – WCWL Appropriateness research

• To provide an update on a program of research oriented toward the development of a multi-stakeholder decision-support tool for appropriateness of total knee and hip replacement– Systematic literature review– Patient focus groups– Surgeon interviews– Development of concept map– Next steps

Appropriateness of TJRResults of Systematic Literature

Review

Team Members: Diane Lorenzetti, Deborah Marshall, Claudia Sanmartin, Barb Spady, Kellie Langlois,

Jennifer Yelland, Ken Fyie, Carla Rodrigues,

Mike Drummond

Literature Synthesis

• Objective 1: Clinical Perspective– What are the concepts, constructs, criteria and/or tools used

to define appropriateness for joint replacement surgery from the clinical perspective (i.e. net clinical benefit)?

• Objective 2: Patient Perspective– What are the concepts, constructs, criteria and/or tools used

to define appropriateness for joint replacement surgery from the patient and public perspectives?

• Objective 3: Decision-maker perspective– What are the concepts, constructs, criteria and/or tools used

to define appropriateness for joint replacement surgery from the decision-maker perspective (e.g. value)?

Methods

• Searched the following DB: MEDLINE, EMBASE, Cochrane Library, CINAHL, EconLit, Social Sciences Abstracts, Sociological Abstracts and reference list.

• Peer reviewed articles published between Jan 1, 1995 and Jan 1, 2010.

• Abstracts/titles reviewed: >6000 (incld outcomes)

• Primary hip and knee replacements (exclude revisions)

• Full articles included: – Clinical perspective (24)– Decision-maker perspective (24)– Patient (0)

Clinical Perspective – Risk vs benefit

Most often mentioned• Age (not criteria per se but considered)

• Pain: severity at rest, night, frequency– WOMAC, pain scales

• Functional limitations: walking distance, stairs, mobility, use of aids, shoes and socks

– WOMAC, Functional class (I-IV)

• Joint condition: space, stability (TKR), range of motion

– X-ray, physical exam

• Comorbidities and Surgical risk– Charlson Index, ASA index

Mentioned, less often– Mental health (psych

disorders, depression)– Motivation– Patient expectations– Non-compliance– System level factors (i.e.

lack of resources)

Patient Perspective

• All articles represent the patient perspective

• Appropriateness – no information on patient perspective

• Concepts – (un)willingness (12), expectations (6), decision-making (5), satisfaction (2)

• Findings:– Vary depending on purpose and type of study

Literature Review - Summary

• Literature review provides some information regarding key criteria to determine appropriateness of care – Reinforces standard criteria and provides some evidence of need to

expand them

• Provides information regarding methods and measures commonly used

• Key gaps remain:– Clinical perspective: other criteria?, risks vs benefit valuation?– Patient: no relevant information from literature regarding

appropriateness– Decision-maker perspective: other considerations than economic

• Point to the need to obtain more “direct information” from stakeholder groups.

Appropriateness of TJR: Patients’ Views

Gillian Hawker, Lucy Frankel, Claudia Sanmartin, Deborah

Marshall, Barb Spady

Objective

• To understand the patients’ perspective on ‘appropriateness’ for TJR including if, and how, appropriateness relates to willingness to undergo this procedure

Methods - Participant Recruitment

• Qualitative focus group study • Recruited participants from community,

investigators’ practices, existing cohorts• Ensured ~ equal representation of:

– 40 – 64 and 65+ years– men and women – urban and rural residents

Participant Eligibility

• English-speaking men and women

• 40 + years

• Moderately severe hip or knee OA (WOMAC summary score ≥ 30; radiographic OA)

• No absolute contraindication to surgery (e.g. major mental illness, stroke with paralysis)

Focus Group Format

• Focus groups conducted separately in people with / without prior TJR

• Discussion of participants’ perceptions of:– their own appropriateness for TJR– the hypothetical ideal candidate– the patients’ role in decision making– relationship, if any, between appropriateness

and willingness to consider TJR

Analysis

• Focus groups audio-taped, transcribed verbatim by a single transcriptionist

• Transcripts reviewed independently by 2 researchers to identify distinct themes

• Themes were compared & consensus reached

Participant Characteristics

• 11 focus groups in 58 participants – 36 with a prior TJR

– Mean age 72 yrs; 79% female

– Mean WOMAC summary score 43.1

– 50% willing to consider TJR

– 43% considered themselves appropriate for TJR

Appropriate for surgery?

• Appropriateness for TJR was equated with one’s perceived candidacy for the procedure

PAIN (pain coping) was the main factor to be considered

• Pain intensity, and ability to cope with the pain, was identified as the most important factor determining surgical candidacy– But felt to be inadequately evaluated by

currently physicians

Pain is a highly individual experience that is difficult to quantify

• “…different people have different pain thresholds, and they fit themselves on this 1 to 10 scale in different places. One person may say it’s a 10, and the other person who’s got the same amount of pain says it’s a 6….you know it’s hurting, you know it’s affecting your life, and I don’t care what your pain scale is, you need to have something done.”

• “some people can tolerate much more pain than others…I’ve grown accustomed …to living with the pain. But I know other people…maybe it’s something they are not accustomed to, and mentally it’s far more serious to them and maybe they are the ones that require an operation sooner…”

The concept of symptoms being ‘bad enough’

• Participants evaluated their pain against some invisible marker – even though many described high levels of discomfort, the pain they experienced was often described as ‘not bad enough’

• “I’m in pain all the time but most of the time I can sleep at night. So I don’t feel I’m ready. But I have a brother and sister-in-law - both have had their knees replaced and I know what they were going through so I don’t think I’m anywhere near where they were”

Appropriateness and willingness were distinct, yet related, concepts

Appropriateness vs Willingness

• An individual may consider themselves a good candidate for surgery (thus appropriate) yet be unwilling to consider surgery for other reasons, e.g. care giving responsibilities

Appropriateness vs Willingness

• However, willingness played an important role in determining patients’ sense of appropriateness– Those who were unwilling had stricter rules

about candidacy for TJR than those who were willing• for unwilling, TJR was a treatment for extremes of

pain and disability

Impact of pain on quality of life

• Younger participants (50s and 60s) and older participants (70s and up) discussed their quality of life in different terms– Younger: hobbies, mental health, relationships,

enjoyment of life

– Older: ability to perform basic activities, e.g. dressing, bathing, housework

Older Individual

• “If you can function properly, then you’re fine…but once you stop, you can’t do this (housework, dressing, bathing) anymore, …that’s when you need the help”

Younger Individual

• “But the most difficult health issue was the knee. And so this caused me anxiety. I mean great anxiety. I felt like my life was being taken away from me and I had to do something.”

The Importance of Outlook

• All participants stressed the importance of outlook when considering suitability for surgery

• This notion was expressed many ways– Being psychologically ready, motivated, having a

good attitude • Seen as a necessary ingredient of a successful

outcome

Unethical to deny surgery because of ‘bad attitude’, but…

• Participants felt there should be more counseling pre-surgery about what to expect after surgery so that patients could make an informed decision

Influence of Physicians’ Opinions

• Participants’ perceptions of TJR appropriateness were strongly influenced by what their physicians told them – x-ray & clinical findings

• “I said, why are you sending me to a surgeon? I just want some pain medication for the arthritis and he said look, you need it, take it, have it, and I said, okay..”

Need for patient advocacy

• While participants placed a lot of faith in their physicians, they felt that when their symptoms reached ‘bad enough’ this should trump all other considerations, including age and weight

• This is when they needed to get vocal and advocate on behalf of themselves

Other Important Factors

• Balance of risks and benefits, including impact on employment, independence, burden on / ability to care for others

• Availability of social support to manage post-op rehab identified by TJR recipients

What we didn’t hear

• Didn’t hear much about physical function, except in context of impact of pain on quality of life

• Obesity as a contraindication to surgery– But lack of ability to lose weight was seen as

a possible proxy for ‘lack of motivation’

• Age as a contraindication to surgery– It’s all about how the person feels (concerns

about inappropriate demand for surgery?)

Summary – Key Findings

• Consistent with previous studies in physician experts, patients with hip/knee OA identified arthritis severity & motivation as key considerations when evaluating appropriateness for TJR – spoke less about capacity to benefit (risks versus benefits)

• Patients’ pain experience (impact on quality of life, ability

to cope) was seen as the most important determinant– Inadequately evaluated by clinicians

Implications

• Enhanced patient-physician communication to better elaborate the impact of OA pain, possibly through use of more comprehensive and standardized pain assessment tools and patient decision aids, has potential to improve access to and outcomes following TJR by those who may benefit

39

Appropriateness of Total Joint Replacement:

The View of Surgeons

Lucy Frankel, Claudia Sanmartin, Carolyn DeCoster, and Lois Freeman-Collins

40

Objective

• To understand the surgeon’s perspective on appropriateness for joint replacement

– To identify the full range of criteria (risks and benefits) used by surgeons when determining who is and who is not a good candidate for surgery

– To understand how they weigh risks and benefits

- To solicit their views on a decision-making tool for appropriateness.

– To determine their views on the role of other stakeholders in determining appropriateness (i.e. patients and decision-makers)

41

Methods

• Sample:– Orthopaedic surgeons who are currently conduting hip and/or knee joint

replacements (14)

– Three provinces: Alberta, Manitoba, Nova Scotia

– Representation of surgeons:• Age (≤50, 51-64, 65+)• Men and women• Academic and community based hospitals• Urban and Rural

• Interview: – 20-30 minute semi-structured telephone interviews conducted by investigators (CS,

CD)– Interviews were taped and contents transcribed

• Analysis:– Data analyzed using qualitative thematic analysis– Transcripts reviewed independently by 2 researchers to identify distinct themes –

compare results for consensus– Transcripts coded using NVivo software

42

Methods – Interview Questions

• Questions:– How would you define “appropriateness” in the context of joint

replacement?

– What are the key factors that you consider when determining whether or not a patient is an appropriate candidate for surgery?

– Are there situations when joint replacement is NOT appropriate? Can you describe some of the more common scenarios.

– Besides clinicians, are there other points of views that you do or should be considered in determining appropriateness of joint replacement for individual patients?

– To our understanding, there currently does not exist a standard decision-making tool used by orthopaedic surgeons to determine whether or not specific patients are appropriate for joint replacement. Do you use a specific tool or set of criteria to determine whether or not patients are appropriate? Is this tool used by others?

43

Results - Summary

• Part 1: Criteria used to determine appropriateness– Age – overarching theme used to interpret and assess other criteria

which may differ for younger versus older patients– Pain and function (quality of life)– Surgery as a last resort– Patient expectation– Social situation– Mental or psychological health– Comorbidities

• Part 2: Risks versus Benefits– Immediate risk (comorbidities) versus benefits– Long-term risk (health of joint) versus benefits– Risks versus potential to benefit

• Part 3: Views on ……– Role of other key stakeholders – Usefulness of a decision-making tool

44

Age

Younger patients

• Only 1 surgeon felt that age was a contraindication to surgery“So, the ones I wouldn’t consider doing a joint

replacement on, generally people under 50. That’s not a hard and fast rule, but generally I wouldn’t.” (ID4)

• Age was considered alongside– Disease progression– Whether patient had exhausted conservative measures– Whether patient had realistic expectations (more later..)

• Sociological considerations such as employment were only discussed by one surgeon

45

Age cont.

Older patients• Significant older age (80+) was not considered a

contraindication on its own.

• It also needed to be considered alongside other factors, most significantly the patient’s physical and mental health status.

• Surgeons were concerned about patients’ comordidities that would increase their risk of life threatening complications or would impair their ability to carry out post-operative protocols

• Patient’s physiological age was seen as being more pertinent

46

Age cont.

• “We have not been told at this point, do not do anybody over 90 or you’re not doing anybody under 40. I would find it hard to think that that would be an appropriate way to deal with it because I’ve had people who are 93 and are physiologically better off than some of the 60 year olds.” (ID13)

47

Pain

• Pain is identified as “the number one indication for any type of total joint surgery”

• Pain relief is seen as the most predictable outcome of sugery

• However surgeons agree that pain is hard to quantify

• “What you feel for pain and what your neighbour feels for pain and what your mother-in-law feels for pain and what they can tolerate are wholly different…… Now, you can’t really put a number on it.” (ID2)

48

Quality of life

• As discussed, patients’ quality of life is seen as an important indicator of pain level

• However this term was defined differently by different surgeons

• Majority discussed it terms of patient’s ability to perform their most basic day to day activities and whether pain interfered with their sleep

“An appropriate patient is one with severe arthritis….who has significant pain that persistently impairs the activities of daily living.”(ID12)

•

49

Quality of life cont.

• Some discussed it in much broader terms to include hobbies and employment, identifying a different kind of patient

“I mean there are patients who have reached their retirement years and want to be active in walking and do some things, travel perhaps. They can get out and get the groceries and they can do their basic personal care but they can’t do these other things because of their disabling symptomology … I think some people will apply rigid guidelines and say well if you’re not having interference with your sleep and you can get out and do your groceries and do your housework then you don’t need this operation. I think that’s kind of unreasonable quite frankly”(ID10)

50

Surgery as a last resort • Majority of the surgeons felt that a total joint

replacement should be considered as a last resort in terms of treatment options.

• 11 out of 14 surgeons discussed this in terms of a factor to be considered

• 10 of those felt that a patient who had not exhausted conservative treatment options was contraindicated to surgery.

• As was previously mentioned, this was a particularly important criteria for younger patients

51

Patient expectations

• 11 out of the 14 surgeons felt that patients’ expectations were an important issue to address

• Expectations were discussed in two different ways.

– Rehabilitation period

– Quality of life and activity level post surgery

52

Patient expectations

• Important for patients to have realistic expectations about the rehabilitation process

• Many surgeons emphasized the need for counseling pre-surgery so that patients understand “what they are getting into”.

“I use the pre-hab clinic quite extensively for that other education facet so that they can get a good appreciation of what they’re getting into. ….I need to know from their point of view they know what they’re getting into.” (ID1)

53

Patient expectations

• Expectations were also discussed in relation to quality of life and activity level post surgery

• Discussed more specifically in relation to younger patients.

• Patients now seeking TJR at a younger age and have higher expectations as to their quality of life post-surgery

• Unrealistic expectations seen as a temporary contraindication to surgery

• Surgeons agreed that realistic expectations and more education pre-surgery leads to better outcomes in terms of coping during the recovery period and patient satisfaction

54

Patient expectations

• “ We have a lot more young people ….and their expectations of the outcome as far as their activity level regards to work and sports and so forth are not what I call appropriate. They don’t really understand the situation and until they do I would not offer them a joint replacement. So that’s a temporary contraindication and relies on education and time. ….. If people think they’re going to have a certain result and they’re not going to get that and I know from the outcome that I won’t offer them an operation.” (ID5)

55

Risks versus benefits

• It is the process by which physicians assess the information they have gathered to decide if someone is an appropriate candidate

• Risk vs. benefit assessment was expressed in 3 different ways by surgeons depending on the type of patient:

– Risk from doing surgery because of co-morbidities (immediate risk) – older patients

– Risks associated with the possibility of having to do a revision. (Immediate benefits vs. long-term risks)

– Risk vs. benefit in terms of the patient’s capacity to benefit.

56

Risks versus benefits3. Risk vs. benefit in terms of the patient’s capacity to

benefit.

• Applies to the majority of patients – much more grey area in this category

• These patients do not have any specific medical contraindications to surgery and but there are other factors to consider.

• Is their capacity to benefit from TJR is great enough that it outweighs the more general risks that are associated with this type of procedure (e.g. risk of infection)

• Capacity to benefit was defined in a variety of ways• Condition bad enough that patient believes surgery worth doing• Patient expectations met – i.e. not too high pre-op• Patients with no mobility and loss of motion but little pain.

57

Views on a decision support toolMixed results:

Some surgeons not interested in using a decision making tool

– 6 out of the 14 surgeons interviewed stated that they would not personally be interested in using a standardized decision making tool and expressed doubt re: utility – their experience was enough.

– However they all conceded that there may be use for a tool in some other capacity

• Screening tool for GPs and other health care professionals

• Prioritization tool• Less clear cut cases

58

Views on a decision support tool• Some surgeons interested in using a standardized decision making

tool

– 8 out of 14 surgeons expressed interest in the development and the use of a tool in their practice, conveying that they were open to the process and being educated further.

“I think we all think we pick patients the same way or that we have all the same criteria but I’m sure that’s not true. I’m sure people have very different criteria when they make a decision of who they think is a candidate and who isn’t. And you know I think to kind of quantify that and then if there is a way to kind of pick out the common threads that everyone uses then maybe there is a form or a simple way to go okay, well every surgeon said that these five questions came up every single time.” (ID14)

-But…not interested in a « cut-point » or threshold

“No, I think there’s always going to be some judgment involved. So, you know, I don’t think an absolute number would be helpful” (ID4)

Summary of findingsNext Steps

Phase 1: Summary of findings

Criteria/Concepts Literature Review Clinical Perspective Patient Perspective

Pain X X

X (need better measure,

coping)

Function XX

(related to pain)

Quality of Life X

(difference by age)

X (impact of pain, difference

by age)

Joint condition X XX

(influence of md)Adequacy of pre-op treatment X

X (surgery as last resport)

Social circumstancesX

(consideration not criteria)

X (rehab support, employment,

independence)

Patient expectations XX

(rehab, post-op QofL)

Mental/Psychological Health

X (dementia/depression;

motivation, compliance) (some mention)X

(readiness, motivation)Co-morbidities X X Surgical risk X X Capacity to benefit X X Joint longevity X X

Age (consideration) X X X

Qualitative studies

PAIN/FUNCTION

JOINT CONDITION

Patient Information: Age, gender, joint/side, previous joints

COPING(Patients: related to pain,

difference by age)

SOCIALCIRCUMSTANCES

(support current and post-op

PATIENT EXPECTATIONS

(rehab and and post-op

“READINESS”/MOTIVATION

CO-MORBIDITIES

(Include mental health)

SURGICAL RISK

CAPACITY TO BENEFIT

Patient reported Surgeon/Clincian reported

APPROPRIATENESS CRITERIA– CONCEPT MAP

PRE-OPMANAGEMENT

PATIENT SATISFACTION?

‘Map’ of related work (i.e. indications, criteria, priority)

GP Visit Specialist/ surgical

Consultation

TJR Surgery

GP referral tool

(WCWL - DeCoster)

Shared Decision –

making Tools

(U of Ottawa –

O’Connor)

Determining ‘candidacy’

(U of T – Hawker

CIHR grant)

TJR Priority Tool

(WCWL)

OMERACT/ OARSI -

Define states of severity of OA (need for surgery)

(International - Hawker

Appropriateness criteria for TJR

(Spain – Quintana)

‘Toolkit’ for pathways – Bone and Joint Canada

Care pathways – Alberta Bone and Joint Institute (Frank)

Appropriateness decision-making tool –

what is the value added? • “One-stop” assessment tool:

– Includes all criteria for appropriateness identified via lit review and qualitative work – other related tools have some but not all criteria

– Makes explicit some criteria that are currently implicit or not measured at all (e.g. patient expectations)

– Ensure tool can be used at point of surgeon contact regardless of the nature of pre-consult processes (i.e. referral forms, intake/consultation processes)

• Measurement/tool:– Change/improve on current measures used to assess criteria - should we be using the

“same old measures” (e.g. WOMAC) or are there better ones?– Can we reduce existing tools for better use in clinical setting– Introduce new measures (e.g. patient expectations)

• Defining criteria/constructs of appropriateness:– Better define currently “fuzzy” or undefined criteria of appropriateness -

• capacity to benefit – is it about change in pain/function (MCID) or about meeting patient expectations, or meeting specific pre-determined patient specific goals?

• Development of predictive models:– Use existing data sources to determine the association between pre-op information and

(some) appropriateness criteria• Predictive model of surgical risk – can use existing data to categorize individuals in terms of risk of

adverse outcomes (complications, infections) based on pre-op information

Next steps

• Review of initial list of criteria/concepts of appropriateness – Missing anything? Redundancies?– Incorporate findings from data analysis to confirm existing criteria and/or add

information

• Identify tools/instruments to measure concepts (“bubbles”)– Value added – explore use of new measures

• Identify who will provide what pieces of information and who will use the tool (multi-stakeholder approach)

• Involve key stakeholder groups (i.e. surgeons, patients, decision-makers) at key points of tool development to ensure face validity and uptake

Extra slides

Decision-maker (economic) perspective

• Overall:– TJR found to be cost-effective

• Decrease pain and improve overall quality of life• Decrease long-term costs

• Patient subgroup analysis (17):– Lower costs associated with –

• Age (younger) (cost of revision?)• No comorbidities• Earlier stage of disease progression

• Need for better economic evaluation for patient subgroups to help in the identification of key criteria for (in)appropriate cases

Existing tools to measure/estimate appropriateness criteria

Pain/Function/Quality of Life VAS score PCS (?) WOMAC (hip and knee) Oxford Knee/Hip OARSI/OMERACT Lequense Am. Coll of Rheumatology WCWL priority and referral tools Knee-Patient Specific Indix (KSPI)

Knee Injury and Osteo Outcome Score (KOOS) KOOS - Short-form SF-36/12 (Q of L) HUI (Q of L) EQ-5D Coping Pain catastrophizing (?)Co-morbidities (1) Charlson Index Index of Coexistent Disease Functional Comorbidity Index ASA score Charnley classification BMISocial Circumstances WCWL priority tool Availability of post-op support???Patient Expectations

Hospital for Special Surgery Hip/Knee Replacement Expectation Survey (2)

Expectation WOMAC (?) Reasons for and against surgery - OHRI tool

Goal attainment - (Rehab)"Readiness" (Measure??)

Identified in appropriateness studies

Joint condition/Structure X-ray (space) Ahlback Radographic score (Chang et al) Physical assessment (Mike's measures)Adequacy of Pre-op treatment

Aequacy assessment (Quintana et al (2009) WCWL Primary care tool Manitoba referral tool Halifax - HipBooklet

Joint Longevity Age (?)

Surgical Risk Co-morbidity measures ASA scoreCapacity to Benefit (definition?) Change in pain/function

Minimally important clinical difference (MICD) (3) BLISS (WOMAC Meet Patient expectations Goal attainment - (Rehab)