Ingredients for a Successful Evidence-based a Qualitative Study. Barriers to the Evidence-based Patient Choice (EBPC) vs EBM. Paper Study. Evidence based medicine interest

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    Social Science & Medicine 56 (2003) 589602

    What are the ingredients for a successful evidence-based

    patient choice consultation?: A qualitative study

    Sarah Ford*, Theo Schofield, Tony Hope

    The Ethox Centre, Institute of Health Sciences, University of Oxford, Old Road, Headington, Oxford OX3 7LF, UK

    Abstract

    The evidence-based patient choice (EBPC) approach is one of a number of newly emerging templates for medicalencounters that advocate evidence-informed choice and shared decision-making. These models emphasise respect for

    patient preferences for involvement in health care decisions and advocate the sharing of good quality evidence-based

    information. In the medical consultation EBPC involves providing patients with evidence-based information in a way

    that facilitates their ability to make choices or decisions about their health care. Whereas the key principles of shared

    decision-making have been conceptualised, so far, no qualitative investigations have been undertaken to establish the

    key components of an EBPC consultation. Therefore, a series of semi-structured interviews were carried out with key

    informants to identify the elements and skills required for a successful EBPC consultation to occur. The interviews were

    conducted with purposively selected UK general practitioners (n 11), hospital doctors (n 10), practice nurses

    (n 5), academics (n 11) and lay people (n 8). Qualitative analysis of participants responses was conducted using

    the constant comparative method. Six main themes emerged from the data, these were research evidence/medical

    information, the doctorpatient relationship, patient perspectives, decision-making processes, time issues and

    establishing the patients problem. All respondents placed importance on doctors and patients being well informedand appraised of the latest available medical evidence. There was a general view that evidence-based information

    regarding diagnosis and treatment options should be shared with patients during a consultation. However, there were

    no suggestions as to how this might be achieved in practice. Participants opinions relating to which model of decision-

    making should be adopted ranged from favouring an informed choice model, to the view that decision-making should

    be shared equally. Similarly, there was no clear view on how much guidance a doctor should offer a patient during

    decision-making concerning the most appropriate treatment option for that patient. r 2002 Elsevier Science Ltd. All

    rights reserved.

    Keywords: Evidence-based medicine; Patient-centred care; Shared decision-making

    Introduction

    The term evidence-based patient choice (EBPC)

    was first described by Hope (1996) as the merging

    together of two important modern movements in

    western health care, namely evidence-based medicine

    and patient-centred care. This approach is one of several

    newly emerging models of the medical encounter which

    advocate evidence informed patient choice (Entwistle,

    Sheldon, Sowden, & Watt, 1998; Towle & Godolphin,1999) and shared decision-making (Braddock, Edwards,

    Hasenberg, Laidley, & Levinson, 1999; Charles, Gafni,

    & Whelan, 1999; Elwyn, Edwards, Kinnersley, & Grol,

    2000). EBPC is not limited to what has been termed the

    neglected second half of the consultation (Elwyn,

    Edwards, & Kinnersley, 1999), like most other ap-

    proaches it encompasses the whole consultation of

    which an important component is patient involvement

    in decision-making.

    Evidenced-based medicine (EBM) requires the use of

    current best evidence to make decisions about the care

    of individual patients (Sackett, Straus, Richardson,

    *Corresponding author. Tel.: +44-1865-227049; fax: +44-

    1865-226938.

    E-mail address:[email protected] (S. Ford).

    0277-9536/03/$ - see front matter r 2002 Elsevier Science Ltd. All rights reserved.

    PII: S 0 2 7 7 - 9 5 3 6 ( 0 2 ) 0 0 0 5 6 - 4

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    Rosenberg, & Haynes, 2000). Clinical interventions are

    recommended on the strength of evidence for their

    effectiveness derived mostly from randomised-controlled

    trials and systematic reviews. Five basic tenets of EBM

    have been identified:

    1. clinical decisions should be based on the bestavailable scientific evidence,

    2. the clinical problem determines the evidence to be

    sought,

    3. identifying the best evidence involves epidemiological

    and biostatistical ways of thinking,

    4. conclusions based on the available evidence are

    useful only if put into action for individual patients

    or for population health care decisions,

    5. performance should be constantly evaluated (David-

    off, Haynes, Sackett, & Smith, 1995).

    However, in this biomedical approach the individualqualities, needs and preferences of patients have tended

    to be neglected as relevant factors in the decision-

    making process (Bensing, 2000). Whilst, EBM addresses

    the biomedical perspective of diagnosis, mostly from a

    doctor-centred paradigm (Jacobson, Edwards, Granier,

    & Butler, 1997), doctors also need evidence that is

    derived from a patient-centred paradigm that takes into

    account the personal and contextual elements of

    decision-making in practice. Patient-centred medicine,

    is derived from a humanistic, biopsychosocial perspec-

    tive and combines ethical values on the ideal doctor,

    with psychotherapeutic theories on the facilitation of

    patients disclosure of concerns and negotiation theories

    on decision-making (Bensing, 2000). This model of care

    places a strong emphasis on patient participation in

    clinical decision-making by taking into account the

    patients needs and preferences. Therefore, in order for

    cognitively competent patients to have the power to

    make evidence-based choices, as well as being evidence-

    based, the medical consultation must be patient-

    centred. Providing patients with evidence-based knowl-

    edge should enhance their power and aid the develop-

    ment of an increasingly effective patient-centred health

    care system (Hope, 1996). However, there is a need to

    ensure that evidence-based information is conveyed topatients in a way that will increase their understanding

    and enable them to make informed choices about their

    treatment and management. In the medical consultation,

    evidence-based patient choice requires providing pa-

    tients with good quality information to facilitate their

    ability to make choices or decisions about their health

    care. The original theory combines evidence-based

    medicine with patient-centred care, so that information

    that is of value and personal importance to patients

    when making choices (e.g. process of delivery of care) is

    considered in parallel with scientific evidence-based

    information. However, the term evidence-based is

    increasingly becoming outdated as consensus grows that

    EBM should acknowledge multiple dimensions of

    evidence including practical evidence based on indivi-

    duals interpretation of experience (Buetow & Kenealy,

    2000). Therefore, evidence-based patient choice must

    embrace a broader definition of EBM that includes

    evidence produced outside science.

    The origins of patient choice

    The concept of patient choice originates from

    the doctrine of informed consent. In English and US

    law a competent person has a legal right to refuse

    treatment (even life saving). Valid consent is achieved

    only if the individual concerned has been given the

    relevant information. Over the last 20 years, medical

    ethicists have stressed the importance of the principle of

    patient autonomy (Veatch, 1982; Brody, 1985; Dworkin,

    1988; Quill & Brody, 1996). This emphasises thatpatients should be in a position to choose whether to

    accept an intervention or not as part of their general

    right to determine their own lives (Hope, 1996). A

    central ethical principle behind evidence-based patient

    choice is that the information is being given in order

    to enhance choice. Patient choice goes beyond consent

    and involves the patient in the decision-making

    process. However, the move towards increasing patient

    involvement is not driven simply by a theoretical

    concern for respect for patient autonomy. Rather, it is

    a recognition of the fact that individuals differ both in

    what they value and in their propensity to take risks

    (Hope, 1996).

    Trends in Western health care

    Models of shared decision-making and EBPC reflect a

    growing trend in health care towards patient empower-

    ment and greater patient choice (Department of Health,

    2000). This has been fostered by the increasing patient

    access to information about treatments and the con-

    sumerist trends in modern society (Ballard-Reisch, 1993;

    Elwyn et al., 1999). Over the last 20 years or so there has

    been a call for more patient choice and personal control

    in medical care (Reiser, 1993). Current National HealthService (NHS) initiatives advocate active partnerships

    between health professionals and patients (NHS Execu-

    tive, 1996) and the improvement of information to help

    patients choose between options (NHS Executive, 1995).

    Nowadays, most theorists acknowledge that unilateral

    decision-making by doctors is unacceptable (except in

    certain situations, for example, when a patient is

    comatose or in urgent need of life-saving action). The

    old paternalistic models of doctorpatient relations have

    been rejected by policy makers, and medical academics

    in favour of more equitable and collaborative relation-

    ships characterised by informed choice. There is a

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    growing consensus that sharing decisions is desirable on

    humanistic grounds alone (Guadagnoli & Ward, 1998).

    Benefits of involving patients

    There is also empirical evidence that giving patients

    information and involving them in decisions about theirhealth care can result in beneficial psychological and

    physical outcomes. For example, enhanced patient

    satisfaction Roter (1983), adherence to treatment plans

    (Janis, 1982), greater confidence in health care recom-

    mendations (Brody, 1980), psychological adjustment to

    illness (Fallowfield, Hall, Maguire, & Baum, 1990) and

    symptom resolution (Bass et al., 1986). It has also been

    found that if patients are actively involved in making

    decisions about their care, physiological outcomes such

    as diabetic control can be improved (Greenfield,

    Kaplan, Ware, Yano, & Frank, 1988). Further evidence

    suggests that allowing patients to choose their medicaltreatment can enhance psychological well-being (Ash-

    croft, Leinster, & Slade, 1986; Fallowfield et al., 1990,

    1994).

    In her comprehensive review of health outcomes,

    Stewart (1995) concluded that four key dimensions of

    communication were related to positive patient out-

    comes (emotional health, symptom resolution, function

    and physiological health):

    * the provision of clear information,* questions from the patient,* willingness to share (discuss) decisions,

    * agreement between patient and doctor about theproblem and the plan.

    There is also evidence that giving patients information

    about the choices open to them can sometimes lead to

    fewer prescriptions for specific drugs such as warfarin

    (Protheroe, Fahey, Montgomery, & Peters, 2000) and

    less demand for some surgical treatments as in the case

    of benign prostatic hyperplasia (Barry, Fowler, Mulley,

    Henderson, & Wennberg, 1995).

    However, there are other studies that show that

    although patients prefer patient-centred care, it does not

    necessarily enhance physiological outcome. For example

    Kinmonth, Woodcock, Griffin, Spiegal, & Campbell(1998) carried out an intervention study to assess the

    effect of additional training of practice nurses and GPs

    (for abbreviation see Fig. 1) in patient-centred care on

    outcomes of patients with newly diagnosed type 2

    diabetes. In this study patients in the intervention group

    reported better communication with doctors, greater

    treatment satisfaction and wellbeing than the compar-

    ison group. However, their body mass index was

    significantly higher as were triglyceride concentrations.

    There is a clear need for more robust studies to

    investigate the effects of patient involvement in different

    disease groups on a variety of health care outcomes,

    including those of a psychological, physiological and

    financial nature.

    Patient preferences for evidence-based information

    Little is known about patients preferences for

    evidence-based information during consultations. Thelimited work in this area suggests that for some

    conditions, the majority of patients value being given

    information about the effectiveness of treatment and

    care options (Wagner, Barrett, Barry, Barlow, & Fowler

    1995). Inevitably patient preferences are increasingly

    being influenced by the consumerist trends in modern

    society which, in turn, have fostered better access to

    medical information. Developments in Britain such as

    local consumer health information services (Sheppard,

    Charnock, & Gann, 1999) have improved awareness of,

    and access to, evidence-based consumer health informa-

    tion. More recently, innovations such as the recentlylaunched National Electronic Library for Health

    (NeLH) (Muir Gray & de Lusignan, 1999), now provide

    health professionals and patients with easy access to the

    most up-to-date evidence of the effectiveness of health-

    care interventions. Not surprisingly, patients are becom-

    ing increasingly better informed about health care issues

    and expect to be given comprehensive information

    concerning their diagnosis, prognosis and treatment

    options (Jenkins et al., 2001).

    Patient involvement in health care

    Despite the current trends that advocate greater

    patient involvement in health care, whether patients

    actually want this is yet to be conclusively demonstrated.

    For example, Savage and Armstrong (1990) conducted a

    study involving 359 randomly selected patients consult-

    ing with one general practitioner to compare the effect

    of directing and sharing styles of consultation on patient

    satisfaction. The authors found that patients in the

    directive group with self-limiting problems or chronic

    conditions and those receiving a prescription, reported

    significantly higher levels of satisfaction on several

    outcome measures. These included: satisfaction with

    the GPs perceived understanding of their problem andthe explanation they received.

    The results of a study investigating Australian, UK

    and US preferences for participation in medical deci-

    sion-making suggested that mutuality was the preferred

    method of decision-making for participants in all 3

    countries (Smith, Garko, Bennett, Irwin, & Schofield,

    1994). The authors found that if the question was asked,

    Do patients prefer to decide for themselves or delegate

    decisions to their doctors? participants chose to

    delegate, but if respondents were asked if they preferred

    joint decision-making, delegating or deciding they

    preferred joint decisions.

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    Most of the empirical research evaluating patient

    preferences for participation has been conducted in

    North America using high stake scenarios, for

    example, decisions concerning treatment for cancer.

    Therefore, it is not known whether these findings can be

    applied to other patient populations and different

    medical contexts, such as patients in general practice.Much of the research is based on surveys using different

    assessment measures which makes comparisons difficult

    (Deber, 1994a, b; Guadagnoli & Ward, 1998). Studies

    conducted using hypothetical questions or contrived

    scenarios may not truly reflect patients preferences

    during a real clinical interview.

    The desire to be involved (or not) in decision-making

    may depend on the type and severity of a patients

    condition. For example, Beaver et al. (1996) surveyed

    150 women recently diagnosed with breast cancer using

    a role-preference card-sort (Degner & Sloan, 1992)

    which consisted of five cards with a written statementand cartoon depicting increasing levels of patient

    involvement. The women were asked to choose their

    preferred decision-making role from all possible pairings

    of the five cards (ten in total). Results showed that 20%

    wanted an active role in deciding their treatment, 28%

    preferred a joint decision, and just over half (52%)

    wanted their surgeon to decide for them. In contrast a

    control group of patients with benign breast disease

    wanted to share responsibility for decision-making with

    the surgeon. The cancer patients were assessed at an

    early stage and had no definite knowledge about their

    type of cancer, prognosis or treatment. Therefore, this

    lack of information may have contributed to their

    reluctance to be more involved in the decision-making

    process. In an extension of the above study (Beaver,

    Bogg, & Luker, 1999) a comparison of the decision-

    making preferences and information needs of colorectal

    (n 48) versus breast cancer patients (n 150) was

    conducted. Once again a decisional role preference card

    sort was used and an information needs questionnaire. It

    was found that the majority (78%) of the colorectal

    patients preferred to play a passive role in decision-

    making, in contrast to 52% of the breast cancer patients.

    Of note is the fact that both groups had similar

    information needs relating to cure, spread of diseaseand treatment options.

    The majority of patients desire for information is

    stronger than their desire to be involved in

    decision-making (Ende, Kazis, Ash, & Moskowitz,

    1989; Strull, Lo, & Charles, 1984; Degner et al., 1997;

    Beaver et al., 1999). Furthermore, many patients

    would like to receive more information than they

    currently do from health care professionals (Audit

    Commission, 1993; Meredith et al., 1996). Whether

    they wish to be involved in decision-making or not,

    patients increasingly expect to be told their diagnosis

    and details concerning pathophysiology, treatment

    options and prognosis (Laine & Davidoff, 1996;

    Meredith et al., 1996).

    The purpose of this qualitative study was to identify

    the elements and skills required for a successful EBPC

    consultation to occur. We stress that we were testing

    reactions to a theoretical concept rather than to the

    actual existence of the EBPC consultation. The keyprinciples of shared decision-making have already been

    conceptualised (Charles et al., 1997; Towle & God-

    olphin, 1999). However, no qualitative investigations

    have yet been undertaken to establish the key compo-

    nents of an EBPC consultation. Therefore, a series of

    semi-structured interviews were carried out with key

    informants in an attempt to establish these criteria.

    Methods and sample

    Purposeful sampling was used to recruit participants

    who were anticipated to be good informants, i.e., those

    likely to have an interest in patient involvement in

    decision-making, evidence-based medicine and patient-

    centred care. Those invited to take part included UK

    general practitioners, hospital doctors, academics, lay

    people and nurse practitioners. The GPs and hospital

    doctors were medical student tutors affiliated to the UK

    Oxford medical communication skills teaching pro-

    gramme. Academics were established commentators on

    patient involvement in health care. Lay people were

    recruited through the Oxfordshire Community Health

    Council and had keen interests in issues connected withpatient empowerment. Nurse practitioners were selected

    from the surgeries of participating GPs.

    All potential participants received a letter which

    included basic information about the concept of EBPC

    and which invited them to take part in semi-structured

    interviews. The explanation of EBPC was presented as

    follows:-

    In the medical consultation, EBPC means providing

    patients with evidence-based information to enable

    them to make choices or decisions about their health

    care. By combining evidence-based medicine withpatient-centred care, information that is of value and

    personal importance to patients is considered in

    parallel with scientific evidence-based information as

    part of the decision-making process. We would like

    your views on the elements and skills needed for

    EBPC to take place in the medical consultation.

    Those who were willing to take part received a pre-

    interview prompt sheet one week before being inter-

    viewed. This was to enable them to familiarise them-

    selves with the concept of evidence-based patient choice

    and make notes on the implications of this approach.

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    Eleven GPs (3 of whom were women) agreed to take

    part and 10 hospital consultants (4 of whom were

    women). Participating academics (4 of whom were part-

    time GPs) numbered 11 (7 of whom were women). Eight

    lay people agreed to be interviewed (1 of whom was a

    male) and 5 nurse practitioners all of whom were

    women. In total, the responses of 45 interviewees wereincluded in the qualitative analysis, 26 of whom were

    women.

    The semi-structured interviews, which were audio-

    taped, took place at respondents place of work except

    for the lay people, most of whom were interviewed in

    their own homes. At the start of each interview the

    researcher explored respondents personal understand-

    ing of the concept of EBPC. Interviewees were then

    asked their opinion on the key components (including

    skills) needed for a successful EBPC medical consulta-

    tion to occur in practice.

    Analysis and coding

    The interviews were analysed using the constant

    comparison method, a qualitative technique which

    involves the systematic sifting and comparison of items

    of recorded data to reveal and establish the mutual

    relationships and internal structure of categories (Green,

    1998). Responses were transcribed and divided into

    simpler text units that were entered into a database for

    ease of coding. Units of text (at least one complete

    thought) referring to similar issues were separated fromdissimilar units and systematically grouped together by

    one coder. Each grouping represented a provisional

    theme. When all the text units had been coded into the

    emergent categories these were tested by being re-

    applied by an independent coder. The level of agreement

    between the coders for these preliminary codes was

    88%. A series of discussions were held and reorganisa-

    tion of some of the data took place, before the final

    codes were agreed.

    Results

    Overall, participants had a clear understanding of the

    theoretical principles behind evidence-based patient

    choice, but perhaps unsurprisingly, were less clear about

    the specific processes that might be involved to achieve it

    during a medical consultation. Furthermore, GPs and

    hospital doctors in particular were rather sceptical about

    the successful application of this model in practice. This

    scepticism was reinforced by the expression of several

    types of barriers to the implementation of this approach

    (reported elsewhere, Ford, Schofield, & Hope, 2001).

    This general finding is exemplified by the selection of

    responses concerning the meaning of EBPC shown in

    Fig. 1.

    Fig. 2 shows the 6 main themes that emerged from the

    data. These are presented below in order of importance,

    according to the numbers of respondents and responses

    within each one. The categories drawn from each theme

    are outlined in Table 1. Due to the exploratory nature ofthis study there are considerable overlaps between some

    of the categories and these are emphasised.

    Research evidence/medical information

    All respondents placed importance on doctors being

    well informed and appraised of the latest available

    medical evidence. It was also considered desirable for

    doctors to have fast and easy access to reliable sources of

    evidence, e.g. an NHS desk-top computer link to the

    latest research evidence. Related to this, a need wasidentified for doctors to be trained in computerised data

    retrieval and to attend training courses on how to

    practice evidence-based medicine. Critical appraisal

    skills were considered necessary for doctors to enable

    them to find the correct evidence, interpret it,

    appraise its limitations and apply it appropriately.

    It was important for patients to have access to good

    sources of evidence, e.g. a reliable internet source.

    There was a feeling particularly from academics and lay

    people that the quality of written patient information

    and internet health sites was generally poor and required

    some form of quality control. Good quality evidence for

    use by doctors was defined in terms of needing to be

    reliable, up-to-date, accurate and comprehen-

    sible. This evidence was considered to stem mostly

    from randomised clinical trials and evidence-based

    guidelines. Other sources of evidence such as patient

    experience of care and illness were also acknowledged,

    particularly by lay people and academics.

    There was a general view that evidence-based

    information regarding diagnosis and treatment options

    must be shared with patients during a consultation.

    Patients should expect to be informed/educated about

    the nature of their illnesses/problems and be directed by

    the doctor to other sources of information relevant tothe diagnosis. Treatment options were considered best

    given in accordance with the strength of the evidence

    and choices clearly identified including the option of no

    treatment. Fundamental was a description of the

    processes, risks/side effects, benefits, possible outcomes

    and chances of success for each option. The importance

    of honesty was emphasised mostly by academics and lay

    people in the context of options, some of which might

    not be available on the NHS, and the description of

    risks and side effects associated with each treatment

    alternative. The sharing of information by doctors

    included giving patients graphical representations of

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    the evidence, which could aid comprehension, and

    providing written evidence-based information about

    treatment alternatives. Three academics, 1 GP and 1

    hospital doctor suggested that decision aids and/or

    written information should be available to help patients

    decide which option would be best for them.

    Thirty five respondents mentioned ability to convey

    complex information as being an essential skill for the

    EBPC consultation. There was a strong belief that a

    doctor should have the flexibility to adjust the amount

    and type of information according to a patients level of

    need and understanding. One GP stated that it was

    important not to overload the patient with informa-

    tion and another insisted that facts and figures should

    not dominate the consultation process.

    The final category derived from this theme involves

    just under half of the total number of respondents. It

    concerns fitting or tailoring the evidence to the patient in

    question. This was perceived not just in medical terms,

    but also involved taking into account the views,

    "Well I think it's a fairly utopian concept {yeah} but how actual how pragmatic and realistic it is um I'm probably less sure of {hmm}. I think probably thinking about it, whilst it's an ideal and I think we shouldalways try and achieve ideals and aim high {hmm}. The trouble is that I think the single biggest restraint on itis time and pressure {yeah} and I think its the type of thing which in an ideal circumstance whereby you hadvery long consultations with patients and very small numbers of patients to sort of look after and devotemuch more time to them and their queries then it's something that can be achieved {hmm}; but, the umbut there's a problem at the coal face, of the you know of the NHS in trying to get that done {yeah}."[GP 5]

    "Um well given that they have a choice there must be at least two ways of approaching managementum and I guess what we do in the simplest form is say we can either do nothing or we can give you thistreatment , if we do nothing we know from experience this is what will happen {hmn} . If we give you thistreatment we think it will make it better or we know it will make it better and in it's simplest form it's based onthe clinician's interpretation of the available evidence in very simple forms and impressions {ahuh} butand I think that's how it works currently {yes}. There's obviously enormous potential for elaborating that{hmn}, but I have I'm sure some patients would welcome that, but I have to say a lot of patients

    particularly in my field when we've tried that just switch off, don't listen, don't want to know and if we go into itin any detail become uncertain um and nervous and full of doubts ."[HD 4]

    "Well I think two things, one is the evidence um .. and the other is patient choice, I think that um evidence should be available, I mean first of all as far as is possible clinical decisions should be based onevidence .. um .. and that means that the evidence has to be available both to the doctor and to the patientand sometimes to the patients carers as well - there may be other people involved and there may be morethan one clinician involved um but ideally decisions should be informed by the evidence, I don't thinkthey're necessarily driven by the evidence {ahuh} because the evidence is usually incomplete {ahuh} so theyshould be informed by it {yes}." [AC 1]

    "For me it means giving the patient the opportunity to discuss choices of treatment {yup} and then being ableto make an informed decision giving the patient information about treatment and medication which has ascientific track record. This means assessing criteria for different types of treatment whether it's based on asurgical option or a drug based option {ahuh}, and this would mean that for any patient who has any sort of

    problem um I think if it has been tried and tested and it has worked for other people {hmm} that's alsonice to know. I can think of examples like arthritis and other sorts of conditions where there are lots of sortsof options, lots of sorts of drugs and even possibly surgery for when it's really bad {yeah}, but I think again a

    patient sit ting there would like to have some information about well what's happened in the past - hassomebody tried this {yes} and has it worked, would it work if I had an operation and things like thathaving some kind of proof as to whether something works or not."[LP 3]

    "It means trying to present to patients what the evidence is for their problem and listening to their concernsand giving them time to discuss all the options, but at the end of the day it is down to the patient to make thatdecision {yes}. Um for example, I work a lot with students and one of the things is the new introduction ofa new emergency contraception {hmm}, you know and that has huge costing implications {yes}, but youneed to discuss with them the benefits of it, the research that has been shown and advising them in thatrespect {yeah}."[PN 4]

    Key: GP = General practitioner, HD = Hospital Doctor, AC = Academic, LP = Lay Person, PN = PracticeNurse

    Fig. 1. What does evidence-based patient choice mean to you? (interviewer) (Note: the interviewers speech appears in curly

    brackets).

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    preferences and personal circumstances of the individual

    patient. For example:

    You need to apply the evidence to the patient as a

    person not just a disease. [HD11]

    A doctor needs to apply the evidence according to the

    patient as an individual. [AC3]

    Doctorpatient relationship

    The general characteristics of the doctorpatient

    relationship concerned issues, which ideally should be

    present in any doctorpatient encounter such as trust,

    respect, honesty and partnership building. These issues

    were mentioned by the majority of respondents in each

    group, exemplified by the following statements:

    There should be openness and trust between a doctor

    and a patient. [NP5]

    The patient should be treated as an individual and an

    equal partner. [GP5]

    The relationship between a doctor and a patient

    should be built up on mutual trust. [LP3]

    As with the general characteristics of the doctor

    patient relationship, it was felt by respondents that

    doctors should have effective communication and

    relationship building skills whatever the type of con-

    sultation. Therefore, the skills stated are not specifically

    those necessary for an EBPC consultation, but could

    apply to most doctorpatient encounters. These are

    displayed in Table 2, Section 1.

    The most frequently mentioned skill was the ability to

    listen. Listening to patients was seen as a basic skill to

    enable assessment of the language that patients use in

    order to pitch information level and to encourage

    discussion by listening to patients views without

    interruption. Lay people in particular felt that doctors

    had a tendency to interrupt and talk over patients. Two

    respondents felt that listening was also desirable for

    patients:

    patients can help doctors by listening and asking

    questions when they do not understand. [LP5]

    you need to have a sensible patient who listens and

    retains information. [HD11]

    Patients perspective

    Forty two respondents made at least one comment

    which related to issues concerning the patients perspec-

    tive. Responses related mostly to exploring patients

    individual qualities and circumstances. Gaining an

    understanding of the patients perspective during a

    consultation involved exploration and considera-

    tion of expectations, assumptions, anxieties,

    concerns, beliefs and values. This was linked to

    elicitation of the patients agenda and establishing

    patient ideas and level of knowledge concerning the

    illness and possible courses of action. Several lay

    Responses from 45interviewees

    Patients'

    Perspectives

    Research Evidence/Medical Information

    Time Issues

    Doctor-Patient

    Relationship

    Decision MakingProcess

    Establishing nature ofthe problem

    Fig. 2. Main themes from analysis of elements of a successful EBPC consultation.

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    people emphasised the importance of the acknowl-edgement by doctors that patients bring certain personal

    qualities to the consultation. For example:

    Doctors should acknowledge that patients bring

    knowledge to the consultationFthey have life

    experiences. [LP1]

    The doctor needs to understand that patients have

    hopes and fears which often become acute when

    illness is an issue. [LE5]

    Allied to patient perspectives were preferences for

    information and involvement in decision-making. There

    were strong views that the doctor must ascertain howmuch and at what level a patient wants to receive

    information concerning the medical problem and treat-

    ment options. Related to this, it was felt that patients

    should have the choice not to be presented with

    evidence and should only be given the information

    they want and not given details they dont want.

    Similarly, ascertaining how much involvement patients

    would like in the final decision-making process was

    seen as desirable to enable involvement for those that

    want it. It was frequently stated by hospital doctors

    and GPs that the preferences of patients who wanted

    little or no involvement in decision-making should be

    Table 1

    Main themes and associated categories

    Theme Category

    Research evidence/medical

    information

    Access to & knowledge of the evidenceFdoctor needs fast and easy access to the evidence.

    Doctor must be well informed of the latest research data; patients also need access to the

    latest medical evidence e.g. reliable internet site.QualityFthe evidence must be of good quality (i.e. up-to-date, accurate; reliable;

    comprehensible) for doctors and patients.

    Appraisal and InterpretationFdoctor must be able to critically appraise evidence in order to

    interpret and apply it correctly.

    Sharing the evidenceFeducating patient about the condition; guiding him/her to other

    sources of information relevant to the diagnosis. Description of the evidence for different

    treatment options including implications of no treatment, risks and benefits.

    Information-giving skillsFability to: convey/translate complex Information re: evidence/

    options; tailor information to patients needs; convey non-directive information, etc.

    Fitting the evidence to the patientFdoctor must tailor the evidence/options to the patient in

    question taking into account his/her views, values, preferences and personal circumstances.

    Doctorpatient relationship General characteristicsFequal partnership, mutual respect, honesty, openness and trust

    between both parties; maintenance of privacy and confidentiality, etc.

    Interpersonal skills of doctorF

    listening, negotiation, cue recognition (verbal and non), useof open and reflective questions, eye contact, ability to put patients at ease, empathy and

    appropriate reassurance, non-directive style, etc.

    Personal attributes required by doctorFattitude conducive to practising this type of

    approach, energy, motivation, confidence, approachability, sensitivity, etc.

    Practical issues/settingFenvironment conducive to uninhibited communication; continuity

    of care (seeing the same doctor), etc.

    Patients perspectives Exploration and consideration of patients perspectivesFexpectations, prior beliefs, anxieties

    and concerns, etc.

    Patient preferences for information and involvementFspecifically information concerning

    medical condition/treatment options and level of involvement desired in decision-making

    process

    Decision-making process Model of decision-makingFinformed choice, shared decision, etc.

    Pre-decision deliberationF

    allowing patient time to consider and discuss the options;deferring decision if necessary, etc.

    Decision aids/written informationFthese should be available to help patient decide which

    option

    Level of doctor guidance versus patient autonomy

    Post-decision tasksFtime may be needed to reflect on why and how the decision was made;

    follow-up arranged if necessary, etc.

    Time issues Time needed to seek out evidence

    Time needed to discuss options with patients

    Establishing nature of problem Obtaining full story from patient

    Enabling Patients to tell their own stories

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    respected; whereas academics and lay people tended to

    emphasise respect for a patients final choice of

    treatment.

    Decision-making process

    Responses concerning the decision-making process

    were divided into 4 categories relating to: model of

    decision-making, pre-decision deliberations, level of

    doctor guidance versus patient autonomy and post-

    decision tasks. Thirty five respondents made at least 1

    comment for this theme. A range of descriptors was used

    to describe the ideal model for deciding the appropriate

    treatment for a patient. For example:

    The patient must be given the chance to make an

    informed choice if he or she wants to. [AC9]

    A treatment decision should be negotiated between

    doctor and patient. [AC2]

    A joint management plan should be worked towards.

    [GP12]

    If possible decision-making should be shared. [GP8]

    Ideally, there should be a partnership approach to

    decision-making. [LE1]

    There should be a shared discussion of alternatives

    resulting in a decisions as to the best option for the

    patient. [LE7]

    Patients should be encouraged to be part of decision-

    making if desired. [PN3]

    Commonly mentioned terms were negotiation,

    shared and joint. There was overall agreement that

    patients should be given the opportunity to be involved

    in the final decision-making process if that was what

    they desired.

    Pre-decision deliberations included allowing patientstime to take in and consider the information; and

    providing an opportunity to discuss the choices.

    There was general agreement that doctors should help

    patients reflect on and assess the impact of

    alternative decisions with regard to their individual

    circumstances, values and lifestyle. Several aca-

    demics felt that patients should be able to defer a

    decision and attend for another appointment if neces-

    sary.

    Responses relating to level of doctor guidance versus

    patient autonomy were concerned with how much input

    a doctor should have (compared to the patient) after the

    options had been discussed, but before a decision hadbeen made.

    Responses ranged from: y the doctor should steer

    the patient in the direction of the most appropriate

    option [HD9] toy need to allow the patient the level

    of freedom they need in order to decide on a course

    of action [GP12].

    It was noticeable that hospital doctors tended to

    frown upon providing all the options and then expecting

    patients to decide which one was best for them. The

    majority felt that doctors should advise patients on the

    best course of action for them. On the other hand, laypeople tended to state that doctors should give an

    opinion as to which treatment would be the most

    appropriate, but the patient should have the right to

    reject this. There were two academics who raised the

    issue of scientific equipoise, i.e. when there is more than

    one equally effective treatment option. One felt that

    equipoise should be declared in order to legitimise

    patient involvement in decision-making and the other

    felt it was important for a doctor to state if patient

    choice was arising from a position of scientific equipoise.

    Post-decision tasks involved giving patients time to

    reflect on why and how the decision was made and

    Table 2

    EBPC consultation skills

    (1) General Communication and relationship building skills

    Use of open and reflective questioning techniques

    Use of good eye contact

    Letting the patient set the pace

    Listening skillsPicking up on patients emotional cues and non-verbal clues

    Summarising

    Clarifying skills

    Orienting the patient

    Putting patients at ease

    Conducting the consultation without clock watching or rushing

    the patient

    Building up a good rapport

    Use of appropriate reassurance

    (2) Skills required for evidence-based shared decision-making

    Ability to communicate complex information using non-

    technical language;Tailoring the amount and pace of information to the patients

    needs/preferences;

    Drawing diagrams to aid patient comprehension;

    Checking patient understanding

    Ability to weigh up medical evidence about treatment options

    whilst considering the values of the patient;

    Conveyance of objective, non-directive information regarding

    possible options;

    Explanation of probability and risk for each option;

    Facilitative skills to encourage patient involvement;

    Evaluation of internet information that patients might bring

    with them;

    Creation of an environment whereby patients feel able to ask

    questionsNegotiation skills

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    eliciting their understanding of the rationale behind the

    decision. It was viewed as being important to arrange a

    follow-up visit to check on patients progress and

    reconsider the decision if necessary. This was commonly

    referred to as an opportunity for more in-put on both

    sides.

    It was stated by over two thirds of respondents thatdoctors require certain abilities and skills in order to

    achieve an evidence-based shared decision (Table 2,

    Section 2). Some of these skills overlap with the

    information-giving skills previously cited under the

    research evidence theme.

    Time issues

    Overwhelmingly, it was considered important to have

    enough time to practice the EBPC approach. In

    particular, plenty of time is needed during the consulta-tion to find and discuss the evidence. It was also felt

    that a doctor should be willing to see a patient on more

    than one occasion to discuss the evidence and options.

    One GP said: ideally consultation length should not be

    an issue as patients need time to talk and ask questions

    about options. Another lay expert believed that

    patients could spend a little time preparing for the

    consultation beforehand.

    Establishing nature of the problem

    This theme was the smallest in terms of the number of

    contributing respondents. This may be because it was

    taken for granted that the primary purpose of the doctor

    during any consultation is to ascertain the patients

    reason for attending. At least 1 member of each response

    group is represented. GPs responses predominate

    followed by those of hospital doctors. A common

    response concerned obtaining the full story from the

    patient in conjunction with checking family history,

    background and social circumstances. Lay people

    felt it important to let patients describe the problem in

    their own words. One hospital doctor emphasised

    eliciting psychosocial in addition to medical detailsand information about the patient as an individual.

    There was a clear view that the current problem must be

    clearly formulated.

    Discussion

    The analysis of 45 semi-structured interviews brought

    to light 6 main themes relating to the essential

    ingredients for an EBPC consultation (see Fig. 2). Some

    categories were difficult to delineate and as a result there

    is some overlap between some of the themes. For

    example, recurrent responses running through several

    themes were the importance of eliciting the patients

    perspective and good communication skills for the

    health professional. The elicitation of the patients

    values is a precursor of the decision-making process

    and is necessary before applying evidence. The patients

    perspective is also salient when attempting to establishthe nature of the problem. Similarly, sharing evidence-

    based information is a prerequisite for shared decision-

    making, which in turn requires the health professional to

    have the ability to convey complex medical information.

    Therefore, our 6 identified themes are far from concrete

    and very much open to further interpretation. Further-

    more, participants tended to compartmentalise their

    responses so that these related either to the patient-

    centred elements of EBPC or the evidence-based

    medicine components, but they struggled to join the

    two parts of the model together in any depth. Conse-

    quently, much of the framework that emerged is inkeeping with a patient-centred model of the consultation

    and evidence-based medicine rather than specifically

    EBPC. This is an indication that respondents found it

    difficult to consider or had no clear idea of how EBPC

    could work in reality. Undoubtedly, this reflects the

    problematic nature of defining this type of theoretical

    approach in practice and this should be borne in mind

    when considering the results.

    An important theme in terms of number of responses

    was research evidence/medical information. This

    concerned doctors and patients having the skills to

    access and gain knowledge of good quality evidence.

    Information giving skills were needed by doctors to

    share the evidence with patients and educate them about

    their condition. Fitting the evidence to the patient was

    also an important component whereby the patients

    preferences and personal circumstances are taken into

    account in addition to medical criteria. However, recent

    research indicates that many doctors are not in touch

    with the evidence-base. For example, in a recent a survey

    of 302 English GPs (McColl, Smith, White, & Field,

    1998) there was a reluctance to acquire the necessary

    critical appraisal skills needed in order to track down,

    assess and apply evidence to patients. Similarly, Mayer

    & Piterman (1999) found that out of the 27 GPS theysurveyed, none expressed a need for critical appraisal

    skills. In McColl and colleagues survey (1998), only

    20% of GPs had access to Medline or other biblio-

    graphic databases and 17% had access to the world wide

    web.

    Doctors are not the only individuals who need access

    to good quality medical evidence. Patients also need

    good quality health information to enable them to

    become more involved in their medical care. However,

    recent studies of patient information materials and

    internet health information have found that few sources

    meet patients information needs in terms of presenting

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    information about the range of relevant treatment

    options, and providing a non-biased, evidence-based

    view of the effectiveness of each treatment (Coulter,

    Entwistle, & Gilbert, 1998; Sacchetti, Zvara, & Plante,

    1999; McKinley, Cattermole, & Oliver, 1999).

    Communication skills were viewed as particularly

    important in relation to sharing the evidenceF

    specifi-cally the ability to interpret complex information for

    patients. The information sharing stage of a consulta-

    tion if it contains probabilistic data is termed risk

    communication (Elwyn et al., 1999). The development

    of risk communication tools for a course on shared

    decision-making has revealed some of the difficulties in

    portraying the risks and benefits of commonly encoun-

    tered problems (Edwards, Elwyn, & Gwyn, 1999).

    Improved ways of communicating risk to patients and

    the acquisition of communication skills conducive to

    evidence-based patient choice are needed to take this

    approach forward.Exploring patient preferences for information and

    involvement in decision-making are common stages in

    models of shared decision-making (Charles et al. (1997);

    Entwistle et al. (1998); Towle & Godolphin, 1999;

    Braddock et al., 1999). For some patients the right not

    to receive information is an important part of their care

    and should be respected (Laine & Davidoff, 1996).

    Elwyn, Edwards, and Kinnersley (1999) argue that it

    is illogical to ask about a patients preferred role in

    decision-making until they have information concerning

    the possible harms and benefits of the choices they face.

    Only when they are armed with this information will

    they be in a position to decide what is best for them. The

    majority of patients have a desire for more information

    about their illness and treatment options, but only a

    small number appear to express a preference to

    participate in treatment decisions. More research is

    needed to investigate the reasons behind these findings.

    The doctorpatient relationship was viewed as an

    important element of the EBPC consultation. General

    characteristics included mutual respect, honesty and

    trust between both parties. Interpersonal skills were key

    to the maintenance of a good relationship between

    doctor and patient. These included listening, recognising

    verbal and non-verbal cues, putting patients at ease,empathy and appropriate reassurance. Basic interview-

    ing skills can be learned at undergraduate and post-

    graduate level, providing effective methods are used

    (Maguire, 1990). These include demonstration of key

    skills, practice under controlled conditions and audio or

    video-tape feedback of performance by a tutor in small

    groups. More complex skills can also be learned but may

    not be used or maintained without ongoing training and

    supervision. The most effective training programmes use

    simulated patients, role play, video play back and

    feedback from experienced facilitators (Bird, Hall,

    Maguire, & Heavy, 1993; Silverman, Kurtz, & Draper,

    1998; Fallowfield, Lipkin, & Hall, 1998). In its 1993

    guidelines on undergraduate medical education, the

    General Medical Council recognised the need for

    teaching medical students to communicate clearly,

    sensitively and effectively with patients, relatives and

    fellow professionals (GMC, 1993).

    There were differences of opinion amongst partici-pants relating to which model of decision-making should

    be adopted. Some favoured an informed choice model,

    whereas others expressed the view that decision-making

    should be shared. Related to this, there was no clear

    view as to how much guidance a doctor should give a

    patient in relation to the most appropriate option. In

    the informed choice model (Emanuel & Emanuel, 1992),

    the physician is obliged to provide all available

    information and the patients values then determine

    which treatments should be given. The physicians

    values have no place as he or she is purely a purveyor

    of technical expertise, thus providing the patient withthe knowledge needed to exercise control. The physician

    must provide accurate, truthful information and consult

    others when his or her knowledge is lacking. The

    conception of patient autonomy is patient control over

    medical decision-making.

    However, there is concern from some commentators

    that because control over decision-making resides

    entirely with the patient, this may lead to increased

    anxiety and if taken to its extreme may lead to patients

    feeling that they have been abandoned (Quill & Brody,

    1996). Furthermore, the doctor may feel constrained

    from giving a treatment recommendation for fear of

    imposing his or her will on the patient and thereby

    competing for the autonomy which has been given to the

    patient. Perhaps more realistic and equitable is the

    shared model (Charles et al., 1997), where ideally

    there is a two-way exchange of information so that both

    doctor and patient reveal treatment preferences and

    both agree on the decision to implement. Whilst this

    approach necessitates a patient being fully informed of

    all the available options, the doctor and patient both

    have a legitimate investment in the treatment decision,

    therefore both declare treatment preferences and their

    rationale whilst building a consensus on the appropriate

    treatment to implement. Lupton (1997) has hi-lightedthe indecision that patients feel between wanting to

    behave in a consumerist manner and their equally

    strong desire at other times to take on the passive

    role.

    As Elwyn et al. (1999) argue, shared decision-making

    may offer a balance to these opposing roles by actively

    involving patients in decision-making and by requiring

    the doctor to use his or her expertise and experience to

    guide the patient and make decisions if desired.

    Participants commonly stated that more consultation

    time would be needed to practice EBPC. It is doubtful

    that the pressurised nature of NHS hospital clinics and

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    general practice surgeries will allow the time needed to

    discuss all the options fully, ensure patients understand

    them, and support them in their decision-making

    (Schartz & Grubb, 1985). It seems likely that a

    restructuring of appointments systems will need to take

    place before the time needed for this approach is

    realised. Studies to-date indicate that more time in theconsultation would be worth striving for. For example,

    Howie, Heaney, and Maxwell (1997) have shown that

    time spent within consultations seems to be directly

    related to the quality of care, with more time increasing

    the ability of patients to understand and cope with their

    health problems. Beisecker and Beisecker (1990) have

    also found that the degree to which patients sought

    information from their doctors was dependent in part on

    how long the consultation lasted and whether they were

    encouraged to raise queries.

    Establishing the nature of the patients problem was

    mentioned by a relatively small number of participantsas an important element. It seems likely that this was

    seen as an obvious component of the consultation and

    hence was not specifically identified. In order to

    formulate a research question and obtain the correct

    evidence-based information, it is essential for the doctor

    to elicit the patients reason for attendance. Research

    conducted in the early 1980s reminds us that doctors

    tend to interrupt patients after their opening statement

    so that patients fail to disclose significant facts relating

    to their problem (Beckman & Frankel, 1984). In one

    study in 50% of the consultations reviewed, the patient

    and doctor did not agree on the nature of the main

    presenting problem (Starfield et al., 1981). Elicitation of

    the patients problem(s) seems an obvious task, but

    unless it is done effectively, using appropriate data

    gathering skills there is a chance that vital information

    will be missed.

    Whilst theoretical models provide thought provoking

    arguments for the on-going debate concerning doctor

    control versus patient autonomy, little work has been

    carried out to introduce these approaches into the

    consultation process. This is not helped by the lack of a

    coherent strategy for introducing the evidence base into

    the consultation and conveying it effectively to the

    patient. Although our respondents stressed the impor-tance of conveying probability and risks when discussing

    treatment options, there was no mention of the

    processes involved to achieve this. For example, should

    the health professional talk in terms of relative risk,

    absolute risk, numbers needed to treat and so on. In

    fairness to them, it was not the aim of our study to

    grapple with these specific issues, but to explore the

    main components for an EBPC consultation. Formulat-

    ing the specific processes involved in this approach poses

    a complex and challenging exercise, but must be

    achieved if evidence-based patient choice is to be

    implemented in practice.

    Acknowledgements

    We thank all those who gave their time to participate

    in the interviews and our colleagues who gave advice

    throughout the study, in particular Professor Paul

    Salkovskis and Joyanne MacInnes. This project

    was funded by the NHS Anglia and OxfordshireRegional R & D.

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