ARTICLE IN PRESS

0277-9536/$ - se

doi:10.1016/j.so

�CorrespondE-mail addr

acass@george.o

joan.cunningha

paul.snelling@e

jeannie.devitt@

cpreece@thegeo

Social Science & Medicine 64 (2007) 2107–2114

www.elsevier.com/locate/socscimed

The use of psychosocial criteria in Australian patient selectionguidelines for kidney transplantation

Kate Andersona,�, Alan Cassa, Joan Cunninghamb, Paul Snellingc,Jeannie Devittd, Cilla Preecea

aThe George Institute, University of Sydney, Sydney, NSW, AustraliabMenzies School of Health Research, Australia

cRoyal Prince Alfred Hospital, AustraliadCooperative Research Centre for Aboriginal Health, Australia

Available online 21 March 2007

Abstract

Psychosocial criteria are increasingly being included in practice guidelines for determining patient suitability for kidney

transplantation. Although intended to promote evidence-based decision-making, if poorly defined, the inclusion of

psychosocial criteria has the potential to reduce transparency in patient selection and equity of access. We reviewed all

Australian practice guidelines concerning patient suitability for kidney transplantation and qualitatively analysed their

inclusion of, and approach towards, psychosocial criteria.

Transplant Directors from all Australian adult transplant units were invited to submit their unit’s guidelines for this

national research audit. All 16 units (100%) submitted some form of documentation. We analysed only those documents

that were purposely structured tools for directing patient selection (eight guidelines used in 10 transplant units). Content

analysis was performed on the abstracted psychosocial criteria. Psychosocial criteria—particularly non-compliance and

smoking—were commonly included. In general, the psychosocial criteria were ill-defined and lacking in substantiating

evidence and recommendations for assessment or action.

Our results reveal that current Australian patient selection guidelines for kidney transplantation incorporate poorly

defined psychosocial criteria that vary greatly. Furthermore, there appears to be a weak evidence base underpinning their

inclusion. The use of psychosocial criteria in this manner decreases the transparency of patient selection and increases the

potential for subjective estimates of social worth to influence patient selection. The priority given to such criteria in

transplant guidelines requires attention and debate.

r 2007 Elsevier Ltd. All rights reserved.

Keywords: Healthcare rationing; Kidney transplantation; Patient selection; Practice guidelines; Psychosocial criteria; Australia

e front matter r 2007 Elsevier Ltd. All rights reserved

cscimed.2007.02.012

ing author. Tel.: +612 9993 4500.

esses: kanderson@george.org.au (K. Anderson),

rg.au (A. Cass),

m@menzies.edu.au (J. Cunningham),

mail.cs.nsw.gov.au (P. Snelling),

menzies.edu.au (J. Devitt),

rgeinstitute.org (C. Preece).

Introduction

Over recent decades, the evidence-based medicine(EBM) movement has pervasively influenced main-stream biomedical and clinical research cultures.EBM’s appeal has been its promise of improvingpatient care through clinical standardisation and

.

ARTICLE IN PRESSK. Anderson et al. / Social Science & Medicine 64 (2007) 2107–21142108

‘best practice’ based on scientific evidence (Evi-dence-Based Medicine Working Group, 1992). Thisemphasis on evidence-based practice has triggeredthe growth in the number and scope of clinicalpractice guidelines (Norheim, 1999).

Clinical practice guidelines have been defined as‘systematically developed statements to assist prac-titioner and patient decisions about the mostappropriate healthcare for specific clinical circum-stances’ (Field & Lohr, 1990). Today, practiceguidelines are used not only to influence clinicaldecision-making, but also in wider health policyareas such as the allocation of resources. Withinorgan transplantation programmes, clinical deci-sion-making and resource allocation are oftenconnected, which can put practitioners in thedifficult situation of dual loyalty—needing tobalance their duty of care to the patient with theirsocial responsibility to manage scarce resourcesjudiciously (McKneally, Dickens, Meslin, & Singer,1997). Ideally, practice guidelines relating to patientsuitability for transplantation should assist practi-tioners to reconcile their competing responsibilitiesand ensure equitable access to transplant for allsuitable patients.

Transplant programs commonly include psycho-social criteria alongside physiological criteria intheir patient selection practice guidelines (Dewet al., 2000; Levenson & Olbrisch, 1993). As describedby Dew et al. (2000), the term psychosocial has beenused in organ transplant contexts to encompassvirtually all nonmedical aspects of the patient.

Including psychosocial criteria in patient selectionguidelines has the potential to reduce fairness andequity in the reconciliation of practitioners’ dualloyalty. On the one hand, a personal understandingof the patient can assist the practitioner indetermining their suitability for transplantation.On the other, ethical concerns emerge whenpsychosocial criteria weigh heavily in the allocationof scarce resources. These concerns stem from theopportunity for socially- and/or culturally specificvalues and attitudes to affect patients’ access totreatment (Giacomini, Streiner, & Anand, 2000).Increasing the scope for subjectivity to inappropri-ately influence patient selection might reduce accessfor patients belonging to minority or socially‘undervalued’ groups (Institute of Medicine, 2003).

While this dilemma is relevant to many organtransplantation contexts, it can be clearly illustratedin the treatment of end-stage kidney disease(ESKD). While the optimal treatment for many

patients with ESKD is kidney transplantation, thedemand for organs far outweighs supply. Kidneyspecialists, therefore, make decisions about patientsuitability against a background of a chronicscarcity. While practice guidelines ideally assistpractitioners to navigate these difficult suitabilitydecisions, the inclusion of psychosocial criteria—particularly when imprecise and/or ambiguous—might weaken the intended objectivity of EBMand the fairness of the resultant decisions. It is,therefore, important to examine if, how andwhy psychosocial characteristics are included inguidelines.

As part of a larger investigation of IndigenousAustralian patients’ access to kidney transplanta-tion, we conducted a review of all Australianpractice guidelines relating to patient suitabilityfor kidney transplantation. Qualitative analysis wasundertaken to investigate the inclusion of andapproach towards psychosocial criteria.

Methods

Study design

In July 2005, a letter from two of the investigatorswas sent to the Directors of all 16 adult renaltransplant units in Australia, requesting copies oftheir ‘clinical guidelines relating to patient suitabil-ity for transplant’ for inclusion in a cross-sectionalresearch audit. Follow up for non-response was viareminder emails. No information was collectedabout adherence to guidelines.

Approval to undertake the study was receivedfrom the Human Research Ethics Committee of theUniversity of Sydney.

Qualitative analysis

All submitted documents were read by twoinvestigators—a kidney specialist/researcher and aresearch psychologist. Those documents that werepurposely structured tools for directing patientselection were deemed to be clinical practice guide-lines and included in the analysis; work-up proto-cols or test lists were excluded. In line with thecharacterisation of psychosocial described by Dewet al. (2000), any reference to nonmedical aspects ofthe patient or their circumstance was deemed to be apsychosocial criterion and the relevant text wasabstracted for further analysis. Both investigatorsabstracted data. Although no formal test of

ARTICLE IN PRESSK. Anderson et al. / Social Science & Medicine 64 (2007) 2107–2114 2109

agreement was undertaken, consensus was achievedwithout any substantive disagreement.

The abstracted psychosocial criteria thus identifiedwere grouped into broad categories: compliance,psychological issues, psychiatric conditions, socialsupport, financial/vocational circumstances, smok-ing, and substance abuse. The abstracted passagesrelating to these categories were then analysed andcompared in terms of the following attributes:

�

type of criterion cited, � level of priority given (i.e. absolute contraindica-

tion, relative contraindication or recommenda-tion for further investigation),

� extent of descriptive detail, � recommendations for assessing patient suitability

based on the criterion,

� recommendations for treatment or action to

rectify a contraindicated behaviour or condition,

� evidence cited to substantiate its inclusion.

The process of categorisation and use of attri-butes was informed by the conceptual framework ofrelationships employed by Giacomini, Cook, Strei-ner, and Anand (2001) to describe and interprettheir particular content. Similarly however, theactual content of the Australian guidelines was theprimary influence on the ultimate set of categoriesthat emerged. The specific attributes used here werederived by the investigators for their utility in termsof (i) analysing the scope of current psychosocialcriteria and (ii) developing useful recommendationsfor transplant programs. Both investigators ana-lysed data. Again consensus was achieved withoutsubstantive disagreement.

Results

All 16 (100%) units returned some documenta-tion. Ten units (63%) submitted guidelines thatwere analysed. The other six had no explicitguidelines for directing patient selection. We ex-cluded patient work-up checklists from our analysis.Of the 10 units providing guidelines, three used acommon set, leaving eight distinct sets for analysis.

Styles of presentation varied across the guide-lines; some expressed criteria in dot points, otherswere more expansive. All eight included at least onepsychosocial criterion. Criteria referring to smokingand non-compliance were most commonly included,appearing in eight and seven sets, respectively(Table 1). However, the priorities accorded to

non-compliance and to smoking varied, rangingfrom a recommendation for inquiry to an absolutecontraindication (Table 1). A variety of psychiatricconditions were included in six of the guidelines(Table 1). Criteria relating to social support andfinancial/vocational circumstances were each in-cluded in only one set (Table 1). Few psychosocialcriteria were accompanied by descriptions ordefinitions (see Table 1) and those included werevague and non-specific. Similarly, only two of theguidelines offered recommendations for assessmentor remedial action for psychosocial contraindica-tions. These recommendations were referrals forpsychosocial/psychiatric assessment for variousissues and encouragement to stop and referral tocessation programmes for smoking. One guidelinecited evidence for inclusion of one psychosocialcriterion—smoking (Table 1). This evidence con-sisted of two single centre, retrospective cohortstudies (Cosio et al., 1999a; Sung, Althoen, Howell,Ojo, & Merion, 2001), which, according to Aus-tralian National Health and Medical ResearchCouncil guidelines (Australian Government, 2005),provide low-level evidence. None of the otherguidelines referred to evidence substantiating theinclusion of any psychosocial criteria (Table 1).

Discussion

Our analysis shows that psychosocial criteria,especially relating to non-compliance and smoking,are commonly included in Australian practice guide-lines relating to patient suitability for kidney trans-plantation. The 63% of transplant programmes usingformal criteria for patient selection in this study was fargreater than the 7% found by Levenson and Olbrisch(1993) in a survey of North American kidneytransplant programs conducted in 1990. This findingcorresponds with the general increase in prevalence andusage of practice guidelines. In terms of the psychoso-cial criteria analysed in this study, the inconsistencybetween units again echoes Levenson and Olbrisch’sfindings. The most notable departure from thisprevious survey is the markedly greater importancegiven to smoking status in the current study.

Four main issues relating to the nature andpresentation of the included psychosocial criteriaemerged from our analysis:

(i)

a lack of detail concerning the specific beha-viours or characteristics of the patient, to whichthe psychosocial criteria refer,

ARTIC

LEIN

PRES

S

Table 1

Inclusion details and illustrative examples of psychosocial criteria in eigth Australian practice guidelines for determining patient suitability for kidney transplantation (n ¼ 8)

Category of

criterion

No. of guidelines

with criterion type

Priority Extent of

descriptive/defining

detail

Assessment

recommendation

Treatment/action

recommendation

Evidence cited Illustrative examples

Non-compliance 7 � 1 absolute

contraindication

� 4 relative

contraindication

� 2

recommendationa

� 7 had no

definition� 1 recommended

a psychosocial

assessment

� 6 had no

recommendation

� 7 had no

recommendation� 7 cited no

supporting

research

� ‘Non-compliance’

� ‘Patients who have displayed

significant, recalcitrant,

previous non-compliant

behaviour may be at high

risk of graft loss.

Consultants need to assess

the likelihood of substantial

compliance with therapy.’

� ‘Non-compliance which is

felt likely to reduce the

chance of successful long

term transplantation’

Psychological issues 4 � 2 relative

contraindication

� 2

recommendationa

� 3 cited specific

characteristics—

no definitions

� 1 cited general

psychological

state—no

definition

� 2 recommended

evaluation by

social worker,

clinical

psychologist, or

psychiatrist

� 2 had no

recommendation

� 4 had no

recommendation� 4 cited no

supporting

research

� ‘Patient assessment:

yemotional functioning,

major life stresses y’

Psychiatric

conditions

6 � 3 relative

contraindication

� 3

recommendationa

� 6 had no

definition� 1 recommended

a psychiatric

evaluation

� 5 had no

recommendation

� 6 had no

recommendation� 6 cited no

supporting

research

� ‘Patients with cognitive and

personality disorders require

a psychiatric evaluation to

ascertain the likelihood of

compliance post

transplantation.’

� Psychiatric disturbance

Social support 1 � 1

recommendationa� 1 moderately

detailed� 1 recommended

evaluation by� 1 had no

recommendation� 1 cited no

supporting� ‘Support System Assessment

y Family—members, roles,

K.

An

derso

net

al.

/S

ocia

lS

cience

&M

edicin

e6

4(

20

07

)2

10

7–

21

14

2110

ARTIC

LEIN

PRES

Sdefinition social worker or

clinical

psychologist

research interactions, functioning and

problem solving skills y

Social—extended family,

friends, social support

network’

Financial/vocational

circumstance

1 � 1

recommendationa� 1 had

moderately

detailed

definition

� 1 recommended

evaluation by

social worker or

clinical

psychologist

� 1 had no

recommendation� 1 cited no

supporting

research

� ‘Patient Assessment: y

Vocational—Type of

occupation, length of

employment, stability of

present job. Financial—

Sources of income and

adequacy for future medical

needs.’

Smoking 8 � 3 absolute

contraindication

� 3 relative

contraindication

� 2

recommendationa

� 2 had specific

smoking status

with time

parameters

� 4 had specific

smoking status

without time

parameters

� 2 had

ambiguous

smoking status

� 8 had no

recommendations� 1 recommended

treatment via

QUIT smoking

program

� 2 recommended

treatment via

strong

encouragement

� 5 had no

recommendations

� 1 cited

supporting

research

� 7 cited no

supporting

research

� ‘continuing cigarette

smoking’

� ‘Non-smoker (for X3

months; if smoking history

X10 pack years’

� ‘Non smoker and remains a

Non smoker’

Substance abuse 4 � 2 relative

contraindication

� 2

recommendationa

� 1 had

moderately

detailed

definition

� 3 had no

definition

� 1 recommended

psychological

assessment

� 3 had no

recommendations

� 4 had no

recommendations� 4 cited no

supporting

research

� ‘Psychological evaluation

may be required to determine

long term avoidance of illicit

drug use due to the high rate

of reuse.’

aRecommendation for further investigation.

K.

An

derso

net

al.

/S

ocia

lS

cience

&M

edicin

e6

4(

20

07

)2

10

7–

21

14

2111

ARTICLE IN PRESSK. Anderson et al. / Social Science & Medicine 64 (2007) 2107–21142112

(ii)

a lack of clear methods for assessing thesecriteria,

(iii)

a lack of recommendations for treating orremedying contraindicated conditions, and

(iv)

a lack of evidence justifying the inclusion of thecriteria.

These findings echo those of a similar survey ofguidelines for cardiac procedures (Giacomini et al.,2001).

Lack of detail

The brevity of the descriptions of the psychoso-cial criteria included in the guidelines renders themvulnerable to both subjective and idiosyncraticinterpretation. Even when some description wasincluded, the criteria generally remained vague andambiguous. This increases the potential for incon-sistent interpretation and for personal values andattitudes to colour these interpretations. Arguably,this decreases the transparency of the patientselection process, rendering it less open to publicscrutiny (Institute of Medicine, 2003).

Lack of assessment methods and treatment

recommendations

The almost universal lack of recommendations onhow to assess psychosocial criteria is perhaps notsurprising. Psychosocial characteristics are, by theirnature, difficult to observe and measure. This islikely to increase clinical uncertainty and thereliance on heuristics and stereotypes, particularlyin a busy hospital (Stangor, 2000). It has beensuggested that such reliance results in the differ-ential treatment of patient groups—particularlyminority groups—and that it exacerbates disadvan-tage in access to treatment (Institute of Medicine,2003).

The absence of any recommendations for treat-ment or action to remedy contraindicated beha-viours or conditions—with the exception ofsmoking—suggests a system of selection thatfocuses on ruling people out of transplant suitabilityrather than working towards ruling them in. Thisimplies widespread use of a utilitarian system ofhealth distribution that prioritises treatment forthose likely to derive the greatest benefit, ratherthan for those most in need (Giacomini et al., 2000).Applying such a principle to healthcare allocation isethically contentious (Giacomini et al., 2000).

Lack of substantiating evidence

Contrary to the prevailing doctrine of EBM,almost no research evidence in support of theinclusion of psychosocial criteria was cited in thepractice guidelines. This might reflect the lack of anevidence base (Dobbels et al., 2001). What evidencesupports the inclusion of those psychosocial criter-ia—smoking and non-compliance—that featuremost commonly in Australian clinical practiceguidelines?

A number of retrospective case reviews or case-control studies provide some evidence of anassociation between smoking and post-transplanta-tion outcomes, mostly from single-transplant cen-tres (Chuang, Chan, Ho, & Parikh, 2004; Cosioet al., 1999b; Gill, Kausz, & Pereira, 2002; Kasiske& Klinger, 2000; Matas et al., 2001; Ponticelli,Cesana, Montagnino, & Tarantino, 2002). There isno supporting evidence from randomised controlledtrials or prospective cohort studies which explored,as one of their primary objectives, the associationbetween pre-transplant smoking and post-trans-plantation outcomes (Australian Kidney Founda-tion & Australia New Zealand Society ofNephrology, 2005).

There is little evidence to support an associationbetween pre-transplant non-compliance and poorpost-transplant outcomes. Although a robust asso-ciation has been demonstrated between post-trans-plant non-compliance and late acute rejection andgraft loss (Vlaminck et al., 2004), the associationbetween pre- and post-transplant non-complianceremains unclear (Brickman & Fins, 1996; Butkus,Dottes, Meydrech, & Barber, 2001; Douglas,Blixen, & Bartucci, 1996).

Butkus and colleagues reported an associationbetween pre-transplant substance abuse, but notpre-transplant non-compliance, and post-transplantnon-compliance (Butkus et al., 2001). Two small,retrospective, case–control studies reported anassociation between pre-transplant non-complianceand transplant outcomes (Brickman & Fins, 1996;Douglas et al., 1996). Significant concerns regardingthe quality of these studies include the lack of astandardised assessment of non-compliance, poten-tial observer bias and non-standard reporting ofresults. Consistent with the findings of literaturereviews (Dobbels et al., 2001), it would appear thatthe failure to cite supporting evidence reflects thelack of evidence that psychosocial factors measur-able before transplantation affect outcomes.

ARTICLE IN PRESSK. Anderson et al. / Social Science & Medicine 64 (2007) 2107–2114 2113

As no information was collected about adherencewith the patient selection guidelines collected in thisstudy, we cannot determine to what degree theyreflect real-life practice. Furthermore, our analysiscannot take into account the patient selectionprocesses of the six transplanting units lackingdocumented guidelines. That said, the guidelinescollected in this study provide important informationabout professional bodies’ and clinical managers’views of ‘ideal’ practice and are likely to influence, ifnot dictate, clinical practice in most Australian units.

Comparison with other national guidelines

Psychosocial criteria are also commonly includedin American (Kasiske et al., 2001), Canadian (Knollet al., 2005) and European (ERA-EDTA, 2000)national/regional-level guidelines. However, thesenational/regional guidelines included substantiallymore descriptive detail and recommendations forassessment and remediation. While efforts toprovide levels of supporting evidence are apparentin those national guidelines, the overall paucity ofsuch evidence is equally apparent.

Conclusions

A transparent and equitable system of patientselection should be a key objective of organtransplantation programmes. In the absence of astrong evidence base to support the inclusion ofpsychosocial criteria in clinical guidelines, theirpriority requires attention and debate.

Pending further research, we strongly recommendthat transplant programs review their patientselection guidelines to identify unclear and untestedpsychosocial criteria and resolve them. Such analy-sis could verify psychosocial characteristics relevantto suitability for transplantation, and clarify therationale for their inclusion. Meanwhile, in theabsence of a compelling case for including anyparticular psychosocial criterion, considerationshould be given to removing it from existingguidelines.

Equitable access to treatment requires furthermultidisciplinary analysis of the true relevance ofpsychosocial characteristics to transplant outcomes.

Acknowledgements

This study was undertaken as part of the IMPAKTStudy, funded by the National Health and Medical

Research Council (NHMRC), Project Grant#236204. Kate Anderson is supported by an Aus-tralian Postgraduate Award. Alan Cass is supportedby a Jacquot Research Establishment Award fromthe Royal Australasian College of Physicians. JoanCunningham is supported by an NHMRC CareerDevelopment Award #283310. Dr. Peter Arnoldassisted in the preparation of this paper.

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