Breaking Bad News 2: What Evidence Is Available to Guide Clinicians?

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Breaking Bad News 2: What Evidence Is Available to GuideClinicians?Raoul A. Walsh PhD , Afaf Girgis PhD & Rob W. Sanson-Fisher PhDPublished online: 25 Mar 2010.

To cite this article: Raoul A. Walsh PhD , Afaf Girgis PhD & Rob W. Sanson-Fisher PhD (1998) Breaking Bad News 2: What Evidence IsAvailable to Guide Clinicians?, Behavioral Medicine, 24:2, 61-72, DOI: 10.1080/08964289809596382

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Breaking Bad News 2: What Evidence Is Available to Guide Clinicians?

Raoul A. Walsh, PhD; Afaf' Girgis, PhD; and Rob W. Sanson-Fisher, PhD

Literature related to breaking bad news to medical patients was reviewed, An analysis of citations appearing between I994 and August I997 updated earlier work and indicated that a minority (24%) of the studies on the subject were designed to collect original data. Ten randomized controlled trials (RCTs) evaluating communication strategies with cancer patients in the diagnostic phase have been published since 1980. These RCTs were analyzed for methodological adequacy and their clinical implications. The sampling methods of the RCTs presented particular problems. Although patients liked the experimental interventions, there was little evidence of any effect on the patients 'psychological adjustment; the effects on patients' knowledge and satisfaction levels were inconsistent. Healthcare consequences c$ issues con- cerned with patient selection, cultural factors, medical-legal requirements, and intervention costs are outlined and specific suggestions offered for future research testing the effects of different approaches to breaking bad news. Index Terms: bad news, physician-patient relations, review, truth disclosure

Breaking bad news to someone is a task that confronts most people during their lives. Bad news that concerns a life- threatening diagnosis or death poses important psychoso- cia1 implications for clinicians, hospital personnel, patients, and their relatives. Conveying such information is widely regarded as one of the more difficult tasks confronting healthcare providers.',2 Physician behavior in English- speaking countries has shifted in recent decades from wide- spread reluctance to inform gravely ill patients of their diagnosis and prognosis toward general support of the need for relatively full discl~sure.~

At the same time, observers have increasingly recognized that communicating bad news can be mishandled with potentially distressing results for clinicians and, especially, for patient^.^."^ Yet, few health professionals have received formal training in this area,6 and it is evident that many

Dr Walsh is a consultunt with New South Wales Cancer Council Cancer Educution Research Program (CERP) in Newcastle, Aus- tralia. with which Drs Girgis and Sanson-Fisher are afiliuted.

physicians and nurses feel ill prepared to perform the task of communicating bad news effe~tively.~-' Furthermore, surveys in different countries have demonstrated that many cancer patients are not satisfied with the way they were informed about their true condition or with the quality and quantity of information they received about their diagnosis or prognosis.I' l3

It is not surprising, therefore, that many commentators have advocated that clinicians improve their performance in the area of giving bad news.l.lJ-16 A number of problems arise when it comes to developing guidelines or training programs on this topic. First, most of the literature on diagnostic disclosure is written from the perspective of the expert or physician^.'^.^^ The receivers' perspectives have been less studied. Second, the recommendations published by different experts reveal substantial variations, and some recommendations are diametrically opposed to others. I s

Third, the emphasis has been on the dearth of empirical research data on which to base strategies for communicating bad new^.'.^^.^^ Researchers have strongly recommend-

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ed that guidelines about medical care should be evidence Randomized controlled trials (RCTs), which are

less subject to bias or misinterpretation, are at the top of the hierarchy for assessing evidence.I9

Our objectives in this review are (a) to update the earlier study' by retrieving publications appearing in relevant databases during the period from I994 to August 1997 (a description of the classification system used in that study has been provided elsewherel); and (b) to examine the methodological quality of relevant clinical trials and discuss the implications of their findings for practice. To put the review in a wider context, we also examined patient selection, cultural factors, medical-legal requirements, and intervention costs

Sources of Material Locating articles on the topic of breaking bad news is not

a straightforward task.2n For example, it has been suggested that the search strategy used in a recent reviewI7 may have been too narrow.21 Ptacek and Eberhardt17 primarily used the descriptor bad news and restricted their search to the MEDLINE database. In an effort to ensure as many citations as possible, we also used the additional descriptors truth disclosure and physician-patient relations, as well as searching two additional databases-PsycLIT and Current Contents. We also undertook searches using the names of key authors known to have published on the subject and by checking the reference lists of relevant publications, especially reviews. We included presentations with only a partial, specific focus on breaking bad news, but we excluded non-English articles, conference abstracts, and publications focusing mainly on nonpatients, such as the parents of chil- dren who are seriously disabled or ill.

'Qpes of Citations We identified 123 citations related to conveying bad news

published during the 44-month period under study. This number appears to represent an increased rate of publication, compared with two previous comprehensive reviews, which found 302 citations over 21 years' and 181 citations (67 judged relevant) over approximately 10 years.17 See Figure I for a summary of the percentage of the latest 123 citations in each category.

Nonclassifiable citations were substantially more fre- quent when we compared the recent review with the earlier studies.l However, most of these citations appeared in a sin- gle issue of the Annals qf the New York Academy of Sci- ences22 that included a host of contributions from different countries on cultural and national aspects of communicating with cancer patents. Thirty-four of these contributions were listed with titles only and showed no abstracts.

With the nonclassifiable citations deleted from consider- ation, the proportion of articles was similar to that in the earlier review.' One third were categorized as opinion, and a further 29% were letters, reviews, case reports, and non- data-based descriptive reports. Empirical, original studies consisted of 25 data-based descriptive studies, mainly surveys of patient and provider perspectives on breaking bad news, and 4 RCTs dealt with aspects of health provider- patient communication in the diagnostic phase or soon after diagnosis.

Methodological Quality of Randomized Controlled Trials

Because of the importance attached to RCTs in providing evidence for clinical care guidelines, we shall examine the trials in some detail. Ten RCTs relevant to the issue of breaking bad news have been published, including the 4 from the present review p e r i ~ d . ~ ~ ~ * In this article, we examine all 10 relevant RCTs because our objective was to identify all potentially effective strategies to guide healthcare providers.

From a practical viewpoint, it is difficult to divide studies neatly into those dealing with patients who were mainly in the diagnostic phase and studies involving patients in the postdiagnostic but pretreatment phase. Even new referrals to an oncology clinic are likely to be at different stages along a continuum related to awareness and acceptance of their diagnoses. Patients differ, for example, in their denial or information-seeking behavior and information received earlier from other healthcare providers.

The RCTs included in this review are all those studies examining communication with a range of patients in the initial phases of cancer medical interventions. Methodolog- ical features and outcomes of these RCTs are summarized in Table 1, including 1 trial that departed somewhat from strict random allocation to balance group sizes.26

We reviewed two aspects of the RCTs: (a) their methodological quality and (b) the implications of their findings for cancer-care programs. From the viewpoint of the rigor of the methodology, we considered sampling issues, measurement quality, and the appropriateness and replicability of the intervention and control procedures. These criteria have been pre- viously used to assess RCTs of healthcare delivery.33

Sampling Issues In general, we found major deficiencies in sampling.

Group sizes were relatively small: fewer than 50 in 6 studies.23-28 Authors of only I RCT2* indicated that they had undertaken a priori sample size calculations, and authors of 1 RCTZ4 noted that the small sample size used in the study provided for poor power to detect and weigh any possible

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- Descriptive’

- Descriptive’

-

Type of Citation r

n = 2

1 n = 25

Letter n = 14

Opinion n = 25

0 5 10 15 20 25 30 35 40 45 50

% of Citations (n = 123)

Figure 1. Types and proportions of publications related to the topic of breaking bad news, identified through a search of MEDLINE, PsycLIT, and Current Contents for 1994-August 1997. RCT = randomized controlled trials; NC = nonclassifiable. * Not data based. Data based.

effects of several important variables. Five of the RCT authors failed to provide any data on eligibility or consent rates, making it difficult to determine how representative the study population was of the clinic’s patients as a whole.23~24~2*~30~.” In 4 of the RCTs, the description of the recruitment procedure implied that all eligible patients were initially recruited, but this was not explicitly ~ t a t e d . ~ ’ , ~ ~ . ~ ~ , ~ ’

In any RCT, the baseline characteristics of the randomized groups”3 must be compared to ensure that no potential sources of bias that could affect the outcomes are included. In 7 RCTs, the researchers failed to present statistical comparisons of the experimental and control groups on sociode- mographic or disease-related variable^^'.^"^^; in another of the RCTs. the researchers tested only for baseline differences in psychological status, although other data presented suggested the groups were similar.29 Tabulated data in another RCT also indicated the groups were similar.26

Measurement Quality More attention appeared to be paid to the quality of mea-

surements than to sampling issues. Data in most RCTs

reported on the selected psychometric properties of measures of patient satisfaction or psychological adjustment used. Reynolds et a123 noted in 1 RCT that the global mea- sure of satisfaction employed might not have been very sensitive. Subsequent research with cancer patients has found that, to identify areas of dissatisfaction.”.34 Assessments of patient needs should focus on specific items in major domains of need. Some studies have used scales with demonstrated validity and reliability in general medical patients, but their suitability for cancer patients was not clearly ~ t a t e d . ~ ~ . ~ ’ , ~ ~

The time of cancer diagnosis has been identified as a period of crisis with resultant high psychological distress.3s Thus, it is appropriate that all RCTs include short-term measures of psychological adjustment or satisfaction. In only 3 RCTS,~~, 26*31 however, did the authors report on following up on patients for longer than 1 month. Clearly, little information is currently available about the longer term effects of communication interventions. Short-term measures may also be more subject to bias from patient reactiv- ity, especially in an RCT24 where the research assistants

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TABLE 1 Randomized, Controlled Trials of Communication Interventions, Including Cancer Patients in DiagnostidAssesment Phase

Trial Sample, Interventions, Measures, and Process/Outcome

Reynolds et aI2' 1981 Medical oncology clinic Australia

DerdiarianZ4 1989 Surgical oncology clinic USA

Damian & Tattersallz5 1991 General oncology outpatient clinic Australia

Hogbin et aI2" 1992 Brighton health authority United Kingdom

Sample: New patients; consent rate not stated; Group 1 = 14, Groups 1 & 3, n not given, total N = 67; group comparability not examined; randomization method not stated. Interventions: Group I , oncologist used direct questioning and explicit categorization; detailed, tailored postconsultation handout; consultations audiotaped; Group 2, same as Group 1 without audiotape, Group 3, standard procedures. Measures: Audiotape analysis of facts presented; patient assessment by independent reviewer at 5 d and 6 wk, self-report of satisfaction and desired information level; actual knowledge of illness and management. Process/outcome, significant intergroup differences: Groups I and 2 recalled more detailed information, presented more facts: Group 3 recalled greater percentage of presented facts; all groups highly satisfied with information; Group I valued audiotapes.

Sample: Recently diagnosed (3-10 d) male cancer patients & spouses, 25-55 y, living with partner, no other serious illness, no serious life event in past 6 mo, no major treatment initiated; consent rate not stated; Group 1 = 30 couples, Group 2 = 30 couples; age, education not significantly different, similar disease/treatment characteristics; coded questionnaire packets (clinic nurse blind to study purpose). Interventions: Group I-individualized, formal information, counseling, and referral, literature packet; list of times and names for phone questions; 1-2 phone calls by research assistant to check on information adequacy; Group 2-routine, informal oral or printed information, counseling, referral or follow-up care from usual providers. Measures: Questionnaires at baselines and 5-10 d later; self-reports of informational needs, using Patient-Informational Needs Assessment and Spouse-Informational Needs Assess- ment: self-report of satisfaction and coping, using patient satisfaction and spouse satisfaction instruments; data support content validity and reliability of four measures listed. Process/outcome, significant intergroup differences: Group I (patients and spouses) had lower informational needs and higher satisfaction scores; no differences in coping scores (patients and spouses).

Sample: English speakers, not too ill, attending follow-up consultation (not check-up only); 100% consent to participation; Group I = 24, Group 2 = 24; age, gender, primary cancer site demonstrated to be similar; prerandomized forms. Intervention: Group I-tailored letter summarized salient points in consultation, Group 2-no letter. Measures: Structured telephone interview 3-1 9 d later by first author assessed self-report of satisfaction with consultation, recall of consultation; Group 1's attitude to letter; Group 2's opinion of letter concept. Pmcess/outcome, sign$cant intergroup differences: Group I were more satisfied with information amount and consultation overall; no differences in percentage of items recalled (Group 1 had more items to recall); Group I mainly responded positively to letter, read average 2.6 times; those receiving bad news found letter more helpful than good news recipients but were made more anxious; 67% of Group 2 thought letter would be useful.

Sample: Referrals to consultant surgeon, Caucasian, early breast cancer; 95% consent; Group 1 = 33, Group 2 = 34 completed study; data on 5 variables, no tests for differences; pseudorandomization with equal numbers in batches of 10: health providers initially blind

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TABLE 1 (continued)

Trial Sample, Interventions, Measures, and ProcesslOutcome

Dunn et aIz7 I993 Depts of radiation oncology and

Australia cancer medicine

Dunn et a12x I993 Medical oncology clinic Australia

Intervention: Group I-audiotape of consultation; Group 2-no audiotape. Measures: Audiotape analysis to calculate correct subject responses; questionnaires at baseline (T I ), preoperatively approximately 12 d later (T2), and 6 wk postoperatively (T3); understanding questionnaire, patients at TI , T2, partners at T2; Hospital Anxiety and Depression (HAD) scale to patients at TI , T2, T3, to partners at T2 and T3; Rotter- dam Symptom Checklist to patients T1, T2, T3. Procesdoutcome. significant intergroup diflerences: Group 1 women only significantly increased understanding TI -T2; no between-group partner differences; no differences in anxiety and depression scores (patients and partners); no differences on Rotterdam scale; Group I less likely to seek information from physician; 86% of Group I found the tape helpful.

Sample: New diagnoses, English language, physically, mentally capable, knew their diagnosis, outpatients; consent rate not stated; N = 165; approximately equal numbers in each group; comparability not examined, respondents similar to all clinic patients in age, gender, diagnoses; randomized 6-block design, clinic staff blind to group allocations. intervention: Testing conditions varied in explicitness and ambiguity of cues to diagnosis; contrasts were (a) written self report v interview by staff member, (b) use of the word cancer v euphemism, (c) identified v anonymous questionnaire. (d) questionnaire completion at home v under clinic supervision. Measures: Questionnaire assessing psychological adjustment to cancer adapted from diabetes scale after using pilot responses and psychometric techniques; Spielberger State-Trait Anxiety (STAI) administered after questionnaire. Procedoutcome, .signific.ant intergroup differences: Overall anxiety levels lower than published norms for general medical and surgical patients; reported adjustment was poorer in the interview v self-report condition; anxiety was higher in the word cuncer v euphemism (adjustment was not altered); ambiguous instructions resulted in poorer adjustment.

Sample: First consultation attendees aged 1 6 7 5 y; English speaking, available for follow-up, without advanced incapacity; consent rate not stated, 35% lost to follow-up; randomization method not stated but "equal numbers in each group," total N = 142; at follow-up, Group 1 = 30; Group 2 = 3 I , Group 3 = 3 I ; group comparability not examined, patients lost to follow-up were significantly younger and more likely to have 1 st cancer diagnosis; random number tables using block design with oncologist blind. Interventions: Group I-audiotape of consultation, Group 2-audiotape about cancers generally, Group 3-no audiotape. Measures: Telephone interview 1-3 wk postconsultation and mailed questionnaires; self- report of satisfaction with information and consultation; spontaneous and prompted recall of information presented using coded data from consultation audiotapes as denominator; salient recall based oncologist's identification of significant points; patients completed Psychological Adjustment to Cancer scale. Process/ourcome, s i g n i j k n t intergroup d1fftfSt.rence.s: Satisfaction increased linearly but marginally with more individualized feedback; satisfaction with tape itself lower in Group 2 than in Group 1 ; total recall lower in Group 2; no intergroup difference in salient recall (Group 1 = 43.5%. Group 2 = 40.5%; Group 3 = 41.7%); psychological adjustment to cancer unaffected by group.

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TABLE 1 (continued)

Trial

Tattersall et aV9 1994 Medical oncology clinic Australia

Butow et alJO 1994 Medical oncology clinic Australia

McHugh et at-” 1995 Medical oncology dept. United Kingdom

Sample, Interventions, Measures, and ProcesslOutcome

Sample: Newly referred inpatients, outpatients aged 16-80, English speaking, not advanced incapacity; available for follow-up; participation consent 100%; Group 1 = 94, Group 2 = 88; data on I 1 variables, no tests for differences except anxiety and depression; Group 1 more depressed; randomization method not stated, oncologist blind to assign- ment. Intervention: Crossover design; Group I-audiotapes of consultation, summary letter 7- 10 d later, Group 2-summary letter, then audiotape. Measures: Self-report via phone 10 days postconsultation assessed frequency of intervention use, perception of news, and salient recall; self-report via mailed questionnaires assessed patient satisfaction with tape or letter and anxietyldepression (HAD); patients’ postconsultation communication preferences. Process/outcome, signi’cant intergroup differences: Both groups used first intervention more than second; two thirds shared tape or letter with familylfriend; Group 2 patients read letter less often if news perceived bad; no differences in salient recall, anxiety/depression, or satisfaction; 82% of patients ranked tapes as first option, 38% pre- ferred letter as first option; patients with higher anxiety or worse news liked intervention less.

Sample: First consultation attendees, aged 2 16; English speaking, not advanced incapacity; cancer diagnosis, available for follow-up, consent rate not stated; N = 142, group sizes not stated; comparability not examined; randomization not stated, physician blind to majority of randomizations. Intervention: Patients received question prompt sheet (Group 1 ), or handout about community services available (Group 2), usually 10 m or more before consultation, and handout about community services available. Measures: Audiotape analysis of facts presented; telephone assessment 1-3 wk after consultation to assess spontaneous and prompted recall; mailed questionnaires assessed patient satisfaction and psychological adjustment (Psychological Adjustment to Cancer scale). Procesdoutcome, signi’cant intergroup differences: 35% Group I v 16% Group 2 asked at least one question about prognosis; no other significant differences in total number and duration of questions, patient satisfaction, psychological adjustment, and recall.

Sample: Newly referred outpatients receiving primary or secondary bad news, aged 21- 75 y, English speakers, free of brain disease; consent rate not stated; Group 1 = 63, Group 2 = 54; data on 6 variables, no tests for differences; postconsultation used trials center phone randomization service; clinicians blind. Intervention: Group 1- Audiotapes of consultation; Group 2, no audiotapes provided Measures: General Health Questionnaire (GHQ-30) and HAD scale at baseline, immediately before 2nd consultation, and mailed 5 mo later; Group I-mailed attitude-to-tape questionnaire; questionnaire assessed recall using tape transcripts as denominator. Process/outcome. signiJicant intergroup differences: No differences on GHQ-30 or HAD; Group I-at I st follow-up, 79% listened to tape, 54% in company; at 2nd follow-up, 76% reported tapes were helpful; 16% were upset by tapes; Group 1 poor prognosis patients improved less in psychological distress at 2nd follow-up than similar nontape controls; Group 1 recalled more facts overall and in 5 of 9 information categories.

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TABLE 1 (continued)

Trial Sample, Interventions, Measures, and ProcesslOutcome ~~ ~ ~~~ ~

Mohide et al” I996 Tertiary cancer center Canada

~~ ~~ ~~ ~~ ~ ~

Sumple: New referrals before 1st attendance; 99% consent; Group 1 = 100, Group 2 = 102, Group 3 = 102; patients comparable in age, sex, employment, marital status, disease site, and activity level; Group 1 experienced more pain, Group 2 more college educated; prerandomized with stratification by disease site. Infervention: Group I-package mailed out containing personalized letter, name and phone number of center contact, question/answer to act as prompt; general procedural information about 1 st visit; Group ’-minipackage as above, with condensed procedural and background information, Group 3-no information package. Measures: Interview by research assistant at I st consultation, followed by administration of Brief Symptom Inventory (BSI), Sherer Self-Efficacy scale, questionnaire assessing patient’s expectations of care and fear regarding initial appointment, preference for information, understanding and usefulness of package and prompt sheet; economic costs/patient/y. Process/outcome, signijicunt intergroup differences: No differences in mean scores for psychological distress overall or on any subscales; no differences in fear regarding first appointment, expectations of good quality care; both packages were highly acceptable but more Group 2 (73% v 49%) patients found their package extremely easy to understand and very useful (61% v 49%, nu); Group 1 and Group 2 patients were more likely to prefer information before their 1st visit and by mail; Group 2 package cost 44% of Group 1 package.

who provided part of the intervention were also involved in collecting follow-up data.

In 6 RCTs that assessed information recall and needs, consultation audiotapes were used as objective measures of the information pre~ented.?’.?~.’~-~I Direct measurements of the provider-patient interaction are useful because of evidence that self-reports by physicians consistently overstate levels of healthcare pr~vided.’~,’~

Intervention and Control Procedures All RCTs tested strategies related to providing informa-

tion about the oncology clinic visit and the cancer diagnosis. In most cases, the experimental and control procedures were adequately described and potentially replicable. Prob- lems arose in 2 RCTs2”l4 in which oncologists used “nor- mal” communication practice. Although some attempt was made to define the parameters of the “usual care conditions,” the possibility remains that these could vary substantially, resulting in some contamination of the control group and making replication difficult. Contamination could also have occurred to some extent in the RCT30 in which the oncologist was not blind in a minority of the consultations. Fortunately, audiotapes in 2 of the above studiesZ3.’O should have enabled significant contamination to be identified. We

recognize that ethical constraints make i t impossible to define healthcare providers’ behavior too rigidly in cancer- care control conditions.

In the matter of methodology, in summary, it appears that there is considerable scope for improving features of the RCTs associated with sample determination, recruitment, and group comparability. In relation to measurement quality, authors of some RCTs need to document more fully the suitability of psychometric scales used for cancer patients in the diagnostic phase. Fuller descriptions of control conditions would also be helpful in some cases to permit ade- quate replication.

Clinical Implications of the Findings of Randomized Controlled fiials

We examined findings of the RCTs across the following patient domains: knowledge levels, psychological adjustment, and satisfaction, in an effort to consider their implications for the issue of conveying bad news.

Knowledge Levels and Information Needs

Effects on recall of knowledge levels and information needs appeared to be inconsistent in the 8 RCTs in which this issue was e ~ a m i n e d . ? ~ - ~ ~ . * ~ - ~ ’ Overall knowledge levels

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were not significantly affected by group allocation in 2 studies.28.30 They were significantly increased in the experimental group in 2 ~ t u d i e s ~ ~ . ~ ’ and could not be directly examined in 2 other s t ~ d i e s ~ ~ . ~ ~ in which percentage recall of presented items rather than total knowledge was the outcome reported. Two ~ t u d i e s ~ * . ~ ~ found that salient recall was not affected by group allocation, whereas a third study23 reported that patients in the experimental group recalled more patient-desired information.

The above knowledge findings can be compared with those outlined in a review of psychosocial interventions in general cancer care.3x Fawzy et a13* reviewed 5 controlled trials of educational interventions; 2 did not include knowledge a s s e s ~ r n e n t s ~ ~ ~ ~ ~ ; 1 showed no intergroup knowledge difference at 3-month follow-up4’; 1 showed an initial significant increase in the knowledge levels of the experimental group that did not persist at the 4- to 6-week follow-up4’; and 1 demonstrated knowledge levels that were higher at 3- month follow-up in the group receiving a booklet and newsletter than in control patients.43

Psychological Adjustment

Data on aspects of psychological adjustment were reported in 8 s t ~ d i e s . ~ ~ . ~ ” ~ ~ In 7 of these, no significant intergroup differences were found. The only exception was Dunn et al,27 who reported immediate postintervention effects- poorer adjustment in an interview condition, compared with self-completion of a questionnaire and higher anxiety in the condition when the term cancer was used, compared with the euphemism condition. These findings stand in contrast to the Fawzy et a1 review”8 and the results of a meta-analy-

Fawzy and associates found that all 4 educational studies involving diagnosed cancer patients, which examined coping and affective states, found a significant advan- tage in favor of the experimental group.3s

The meta-analysis of 45 studies of psychosocial interventions with adult cancer patients found beneficial effect sizes for treatment-control comparisons in terms of emo- tional and functional adjustment.44 Interestingly, the effect sizes did not differ significantly among several categories of treatment that included informational and educational methods, as well as behavioral interventions, nonbehavioral counseling and therapy, organized social support provided by other patients, and other nonhospice interventions.

It is important to consider why RCTs for conveying grave prognoses have generally shown no differential effects on psychological adjustment, whereas information and educational methods appear to be beneficial psycho- logically in other areas of cancer are.^^.^ Two potential reasons are worth highlighting: first, the educational inter-

ventions tested to date in relation to breaking bad news, for example, letters and audiotapes, may not have been suffi- ciently potent. Second, the crisis produced by the diagnosis of cancer may generate such high levels of psychological distress that any effects on adjustment resulting from modifying the communication intervention are swamped by background factors.

Patient Satisfaction

Effects on patient satisfaction levels, as was true for knowledge, were not consistent in the 6 RCTs that reported on this domain.23-25*28-30 Half of the studies showed satisfaction was significantly increased in the experimental group or groups, compared with the control group, although in 1 RCT the result was only borderline statistically significant.28 The 3 RCTs that showed no intergroup differences in satisfaction levels included 1 with a crude, global mea- sure of satisfaction,231 with a crossover design in which all participants received the full interventi~n?~ and 1 in which the active intervention consisted of only a preconsultation question prompt sheet.30 The prompt sheet is not a maneu- ver that might be expected to have a powerful influence on satisfaction per se.

To summarize briefly the main clinical implications of RTCs dealing with breaking bad news, it can be said that interventions tested to date appeared to have had little effect on psychological adjustment and inconsistent effects on patient knowledge levels and satisfaction with care. These findings stand in contrast to the apparently more clear-cut beneficial effects of psychosocial interventions, including education/information programs in general cancer are.^*.^ However, an additional point worth making is that in all 7 RCTs in which patients were asked their opinions of the experimental intervention, the patients’ ratings were largely positive.23.25.26.28,29,31.32 A number of commentators have stressed the importance of the patient perspective on the process of conveying a poor p r o g n o ~ i s . ~ . ~ ~ Favorable ratings of the tested communication strategies are therefore worth acknowledging. Of course, it is not possible to be certain how much these positive assessments could be influenced by social desirability or by well-developed “control” conditioning.

Patient Selection Issues Patients preferences for information about their cancer

and its treatment have been shown to vary ~ i d e l y . 4 ~ 7 ~ For example, in a study involving 109 women with metastatic breast cancer, 18% declined to receive any written information, and a further 36% did not request the detailed information sheets that were available.46 Patients also vary in


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their psychological response to cancer information, with a significant proportion finding diagnostic and prognostic details di~tressing.~“~ However, short-term anxiety may not necessarily be undesirable if it is associated with reduc- ing the patient’s ambivalence about his or her situation.27

Available evidence indicates that the same communication strategies should not be used unvaryingly with all cancer patients. Three of the RCTs we reviewed tended to support the need for healthcare providers to assess the patients’ preferences for information in the consultation at which the bad news was In an RCT of patients with early breast cancer, Hogbin et a126 found that in the group exposed to consultation audiotapes, anxiety levels increased postoperatively in those patients conservatively treated, compared with mastectomy patients. Hogbin and associates speculated that the intervention using consultation audiotapes might be unhelpful for patients who use denial as a coping mechanism. In another RCT involving consultation audiotapes and summary letters, patients experiencing higher anxiety or receiving worse news liked the audiotape intervention less.29 A third RCT involving consultation audiotapes found that patients with a poor prognosis in the experimental group improved less in psychological distress at 5-months follow-up than controls with similar prognoses who did not receive the audiotape.3’

Cultural Factors Cultural factors present another issue to be considered in

the bad-news consultation. Although the vast majority of patients in English-speaking countries want to know about their cancer and its treatment,30.48 the proportions who want and receive relatively full disclosure in other countries are much l~wer.~’-~’

The situation becomes more complex with members of some ethnic groups who live in English-speaking countries. For example, a survey of senior citizens in California found that Korean Americans (35%) and Mexican Americans (48%) were less likely than African Americans (63%) and European Americans (69%) to believe that patients should be told about a terminal prognosis.s2 The Korean Americans and Mexican Americans were more likely to have a family- centered model of medical decision making, and the authors of the study suggested that physicians should ask patients if they want to delegate receiving information and treatment decisions to their families. An Australian study found that length of residence, group cohesion, religious affiliation and socioeconomic background affected responses within I6 ethnic communities to issues dealing with death and dyings3 The author noted that individual differences within ethnic groups should be expected.

These cultural issues, taken together with the general findings about substantial individual variations in patient preferences and reactions to cancer information, emphasize the need for healthcare providers to assess the quantity, style, format, and timing of diagnostic, prognostic, and treatment details they provide with great care.

Medical-Legal Issues In addition to humanitarian considerations, ethical

guidelines and legal requirements are community impera- tives that have a direct impact on the issue of breaking bad news. In Australia, the National Health and Medical Research Council (NHMRC)54 has published general guidelines for physicians on providing information that are fairly typical of those in existence in other English-speaking countries. One of the basic principles of the guidelines is that “Patients should be encouraged to make their own decisions” regarding their medical care. However, this rec- ommendation has been tempered by the recognition that some patients will choose to delegate aspects of making this decision to their physicians or their families, and that others may no longer be legally competent to make such decisions.

The outcome of a 1992 Australian court case states that there is a legal requirement for physicians to advise patients of any serious risk or risks associated with medical treatment, even if the risks are extremely rare.ss The NHMRC guidelines also recommend that the risk of even slight potential detriments of a treatment procedure should be dis- closed when an adverse outcome is common.s4

The situation with regard to breast cancer treatment and disclosure of information is subject to further regulation in the United States. By 1994, at least 18 states had enacted legislation requiring physicians to disclose information about treatment alternatives to breast cancer patientss6

However, requirements for fully informed consent have not been without their critics. It has been argued that for- malistic consent requirements can be needlessly cruels7 and may be inconsistent with the belief systems of cultural and ethnic rninoritie~.’~ There is also some evidence that full disclosure may be associated with patients’ reduced will- ingness to agree to randomized t~-eatment.’~.~~

Clearly, guidelines and laws about informed consent have implications for clinicians and researchers generally. In the area of breaking bad news, the guidelines are particularly important. For example, an RCT comparing full disclosure with some form of partial, individualized disclosure may be ethically justified because the scientific evidence is truly inconclusive, but, depending on how the trial is conducted, it may not be legally defensible.


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Cost Issues

As in other areas of medical care, cost issues have been identified as important in relation to psychosocial interventions with cancer patients.30.'''' Some potential approaches to improving patient participation in the cancer consultation, such as involving specialist staff trained in communication skills, have been described as too expensive for inclusion in usual care programs.'"

Unfortunately, only one RTC3? evaluating communication of bad news included an assessment of the costs of different interventions. That trial demonstrated that a less complex educational package cost only 44% of the cost of the more detailed version. The cheaper package was also more popular, being rated as extremely easy to understand and very useful by higher percentages of patients.

In summary, given the increasing importance of economic appraisals in healthcare,6" future studies in the area of breaking bad news should include at least minimal data on the relative economic costs of different communication interventions.

CONCLUSION

In the general area of cancer care, Meyer and Mark''" argued that it would be an inefficient use of research resources to conduct more studies to ask whether psychosocial interventions have an effect on the adjustment and symptoms of cancer patients. However, our review indicates that in the "bad news" area, such a question is worthy of further research, particularly because psychoso- cia1 interventions influence patient levels of knowledge and satisfaction.

Patients clearly value aspects of physician-patient communication other than the pure presentation of valid information. Specific features of the bad-news consultation influence the patients' levels of h o p e f u l n e ~ s . ~ ~ . ~ ~ Given these findings, it should be possible to design and evaluate interventions that produce clinically significant improve- ments in patient satisfaction, psychological adjustment, and knowledge following the disclosure of the cancer diagnosis, compared with a usual-care control group. This also seems achievable because psychosocial interventions have demonstrated efficacy in the general area of cancer care.'''',61

Various approaches could be used to develop appropriate research strategies. Although some may view a list of pre- scriptions for how to disclose a cancer diagnosis as too simplistic,62 one strategy would be to follow the suggestion by Girgis and Sanson-Fisher1 for an RCT involving their consensus guidelines contrasted with existing care. These guidelines can be tailored to the patients' needs by a pre-

liminary assessment of knowledge levels and information preferences.

A second approach would be to base further research on the theoretical model of stress and coping described by Ptacek and Eberhardt.17 A third pragmatic approach could be to identify various potentially modifiable elements of the bad news consultation and manipulate these scientifically. Such elements could include the sender of the news, the receiver (patient and family), the quality and quantity of information provided, the interactional style used in the communication, the environment(s) where the communication occurs, the format(s) and technologies used in the communication process, and the timing of issues covered in the initial communication and any follow-up.

The potential heuristic value of this elemental approach can be illustrated with several examples. Considering the sender of the news first, one might note that in many countries, the physician in charge of a particular aspect of treatment is also primarily responsible for disclosing the diagnosis and obtaining informed consent for treatment. How- ever, an RCT similar to those conducted in other areas of cancer care could examine the efficacy of supplementing the physician consultations with input from another healthcare provider, such as a clinical nurse consultant or a health edu- cator. Economic appraisal would obviously be an integral part of such a study.

Focusing next on the receiver of the bad news, we sug- gest that an RCT that focused specifically on the potential supportive role of the family seems like an obvious area for research. There is also a pressing need to develop a psycho- metrically robust scale to assess patients' preferences for the quantity and timing of information in the bad news process. This research would assist both healthcare providers and patients and ensure that the communication process is more effectively tailored to the patients' situation and needs.

It is surprising that little use has been made of technologies other than audiotapes, such as videotape and the computer, to assist in the bad news communication process. An RCT that examined factors affecting patient involvement in consultations about early breast cancer treatment indicated that women tended to learn more after using an interactive computer multimedia program than after reading a bro- chure.63 The algorithmic method that computers use pro- vides an excellent option for pacing and tailoring cancer information to the individual's needs. As a supplement to the physician-patient interaction, computer technology is worth testing in the bad news communication process.

Hall and associates' finding that most women are offered no support after the diagnosis of breast cancer recurrenceu


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WALSH ET AL

offers another worthwhile area for further study. An RCT in which the experimental group was offered systematic follow-up and the control group received usual care would be of particular clinical relevance.

Butow” noted that few studies have documented the more subtle aspects of communication with cancer patients. For example, one such aspect involves the use of touch, which has been recommended for use in bad news consultations.”’ At this stage, it would seem appropriate to under- take descriptive research in such potentially sensitive and largely unexplored areas.

In summary, at present empirical data to assist healthcare providers, patients, and families in meeting the challenges of communicating bad news are limited. In this review, we have attempted to assess the clinical significance of the limited evidence available. Clearly, productive research in this important area of healthcare is urgently needed.

ACKNOWLEDGMENTS The authors wish to express their thanks to Anne Sullivan for

assistance in locating relevant publications and to Lyn Mathie and Anna Di Legge for typing the manuscript.

NOTE This project was undertaken by the New South Wales Cancer

Council Cancer Education Research Program team. The views expressed are not necessarily those of the Cancer Council.

For further information, please address correspondence to the Secretary, NSW Cancer Council Cancer Education Research Pro- gram, Locked Bag No. 10, Wallsend, NSW, Australia, 2287.

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Documents

Breaking Bad News 2: What Evidence Is Available to Guide Clinicians?