Patient Autonomy Problems in Palliative Care: Systematic Development and Evaluation of a Questionnaire

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1 264 Journal of Pain and Symptom Management Vol. 30 No. 3 September 2005 Original Article Patient Autonomy Problems in Palliative Care: Systematic Development and Evaluation of a Questionnaire Myrra J.F.J. Vernooij-Dassen, PhD, Bart H.P. Osse, MD, Egbert Schadé, MD, and Richard P.T.M. Grol, PhD Center of Quality of Care Research (M.J.F.J.V.-D., B.H.P.O., R.P.T.M.G.), University of Nijmegen, Nijmegen; and Department of General Practice (E.S.), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Abstract No instrument to assess autonomy problems in palliative care is currently available. The purpose of this study was to develop a comprehensive and concise questionnaire to measure autonomy problems in palliative cancer patients and to study its validity and reliability. We systematically developed a questionnaire through: a) a literature review of the concepts and elements of autonomy; b) qualitative analysis of interviews with patients and professional carers; c) the construction of questionnaires; and d) testing validity and reliability. The basic conceptual elements were: dependency, losing control, and limitation of activities. Patients with disseminated cancer in the palliative stage of the disease (n 5 64) participated in the study. A 9-item Patient Autonomy Questionnaire (PAQ) was developed (Cronbach s alpha 0.86), followed by a concise 4-item version (PAQs) (Cronbach s alpha 0.71). Autonomy problems were more prevalent than pain problems. The development of the PAQ may help draw attention to autonomy problems. J Pain Symptom Manage 2005;30: Ó 2005 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. Key Words Personal autonomy, psychometrics, measurement, palliative care, questionnaire, dependency assessment Address reprint requests to: Myrra J.F.J. Vernooij- Dassen, PhD, WOK 229, P.O. Box 9101, 6500HB Nijmegen, The Netherlands. Accepted for publication: March 15, Ó 2005 U.S. Cancer Pain Relief Committee Published by Elsevier Inc. All rights reserved. Introduction Early detection and improved methods of treatment are prolonging the lives of patients with a diagnosis of cancer. They cannot all be cured, however, and a progression of cancer is likely to restrict a patient s functioning. Gradually, patients have to hand over tasks to others: family members, friends, professional caregivers. Dependency on others may induce autonomy problems. Although respect for autonomy is considered a core element of all normative views on good care, 1 there is no consensus about the operationalization of the concept of autonomy, and no specific instruments to assess autonomy problems in palliative care. 2,3 Consequently, autonomy problems may remain unrecognized and the attention paid to autonomy problems may be inadequate. The word autonomy is derived from the Greek auto-nomos: independent, according to one s own free will. 4 For persons receiving palliative care, autonomy might have a special /05/$--see front matter doi: /j.jpainsymman

2 Vol. 30 No. 3 September 2005 Patient Autonomy Problems in Palliative Care 265 meaning. Despite the constraints they perceive, patients in the palliative phase of a disease may wish to act according to their own free will, following their own norms and habits. We considered that autonomy might be an important aspect of the quality of life of patients in the palliative phase of the disease. The achievement of the best quality of life for patients and their families is a central goal of palliative care. 5 Quality of life refers to those aspects of an individual s subjective experience that relate both directly and indirectly to health, disease, disability, and impairment. 6 Assessing autonomy problems might help to focus on what is beyond medical and even psychological problems represented in quality-of-life scales. Autonomy problems reflect the impact of receiving palliative care. These problems represent the challenge of sustaining living according to one s own free will while health is seriously declining. Autonomy is not opposed to, but should rather be part of, quality-of-life measurement in palliative care situations. As part of a more comprehensive questionnaire, we have developed an autonomy questionnaire focusing on the assessment of the problems concerning loss of autonomy of patients with cancer in the palliative stage of the disease. 7 We have also developed a concise version of this questionnaire to facilitate its use under conditions of time constraint in clinical care and in research. Time constraints in clinical care are caused by practitioners lack of time and by patients frailty. Patients frailty is also a compelling reason to use concise instruments in palliative care research. Moreover, the short version is suitable to be included as an autonomy domain in a quality-of-life instrument. The aim of this study is to describe the development of the comprehensive autonomy questionnaire and the short, concise form designed to measure the autonomy problems of cancer patients receiving palliative care, and to assess the questionnaire s validity, reliability, and relationship with other quality-of-life domains. Methods Development of the Patient Autonomy Questionnaire (PAQ) The development of the Patient Autonomy Questionnaire (PAQ) included a literature review on concepts of autonomy in chronic diseases and a selection of its conceptual elements, and the selection of empirical data that represent these elements in palliative care. The concepts referred to independence, 8 the right to self-governance and self-determination, and attaining meaningful goals, personal rights, the freedom of choice, and expression. 8 In palliative care, independence refers not only to physical independence, 13 but also to social independence. 14,15 We concluded on the basis of our literature review that the autonomy problems concept in palliative care should include the following elements: dependency (as opposed to independence); losing control (as opposed to self-governance); and limitation of activities (as opposed to attaining meaningful goals). These three elements of autonomy problems were used to select problems mentioned by patients and to formulate hypotheses to test the validity of the PAQ. The selection of problems mentioned by patients was made in the process of the development of a comprehensive questionnaire to measure the Problems and Needs for the Palliative Care (PNPC) of cancer patients. The PNPC measures health-related quality of life (HRQoL) problems and the care needs related to these problems. The construction of the questionnaire, including the autonomy domain, was carried out in a two-step qualitative study. 16 The first step was fully explorative: in-depth interviews of nine cancer patients and their closest life companion (usually their partner). Interviews were also held of professionals working in the field: members of a home care organization, pain teams, and specialist oncology nursing teams. In addition, the item content of existing needs assessment instruments was analyzed. Two researchers supported by a team of experts combined the results of all these activities to construct the domains and items of the PNPC, including the autonomy domain and the items in it. In the second step, structured interviews were held with 31 patients after they had completed a draft version of the new instrument under construction, to confirm the validity of the questionnaire or to enable adjustments to be made where necessary. Development of PAQs The concise version (PAQs) was developed to assess autonomy problems in clinical care

3 266 Vernooij-Dassen et al. Vol. 30 No. 3 September 2005 and in empirical studies. PAQs should be as short as possible, portray the key elements of autonomy problems in palliative care, and meet psychometric requirements (see Validity section). Sample and Procedure The questionnaire was tested on a sample of Dutch cancer patients (with a variety of cancer diagnoses) in a palliative phase, and living at home. The study used a consecutive sampling approach. General physicians, internists in outpatient clinics, and cancer-patient organizations recruited cancer patients with distant metastases. The formal inclusion criteria were: 1) adult, non-institutionalized patients, residing in their own homes; 2) cancer with distant metastases, regardless of specific cancer type; and 3) patients had to be able to complete a questionnaire in the Dutch language. The exclusion criteria were: 1) a physical or mental condition impeding the use of a questionnaire; and 2) a life expectancy which, in the judgment of the physician, was too short to allow the PNPC to be completed and properly discussed (minimal estimated life expectancy of about a week). Eligible patients (having given their informed consent) were asked to complete the PAQ at home at their own pace, together with some additional questionnaires for research purposes. The medical ethics committee of the University of Nijmegen gave the study their approval. Validity Construction and Evaluation of the Concise Version. Criteria and methods for selection of PAQs were: 1) the questionnaire should be as short as possible, and 2) the questionnaire should portray the key elements of autonomy problems in palliative care. Content validity of PAQs was ensured by including only items already systematically selected for PAQ. A high Pearson correlation between PAQ and PAQs (O0.80) was required to support the construct validity. 17 The requirements for domain structure, convergent validity, discriminant validity, and reliability were similar to those for the 9- item version. In addition, correlations between PAQ and predicting characteristics were intended to be similar to those between PAQs and predicting characteristics. The validity and reliability of both the 9-item and 4-item autonomy questionnaires were evaluated as follows: The relevance of items was evaluated through the item-response frequencies. An item was judged suitable if at least 10% of the patients recognized it as a problem. Regarding the validity of the domain structure, we aimed to have a single domain scale addressing the key elements of autonomy problems in palliative care. Factor loadings should exceed The item-total correlations for an individual item had to exceed 0.20 for that item to be accepted as part of the domain. 19 A true criterion-validity test was not possible, because there is no gold standard. Nevertheless, a presumed relationship between problems in autonomy and well-established quality of life measures reflecting the elements of autonomy problems provided an opportunity to examine the validity of the autonomy scale: dependency, losing control, limitation of activities. We assumed that the mean scores of the total scales (both of PAQ and PAQs) correlated positively with scales that assess one of the key elements of autonomy if PAQ and PAQs are coherent scales. In order to test convergent validity, we hypothesized moderate to high correlations between autonomy and two wellestablished HRQL measures: the EORTC- QLQ-C30 questionnaire, 20 and the COOP- WONCA charts. 21 A higher prevalence of problems in the PAQ dimension had to be reflected in lower quality-of-life scores in the EORTC-C30 and higher scores on the COOP- WONCA charts, as follows: 1) Measures reflecting dependency: physical dependency as measured by the EORTC- QLQ-C30 domains of physical functioning and global health status; COOP general health; COOP Wonca daily activities; social dependence as assessed by EORTC negative social experiences. 2) Measures reflecting losing control: EORTC emotional functioning and COOP emotional problems. 3) Measures reflecting limitation of activities: EORTC role functioning and COOP restraints in social activities.

4 Vol. 30 No. 3 September 2005 Patient Autonomy Problems in Palliative Care 267 Discriminant validity was tested by comparing autonomy scores of patients with low scores in PNPC domains with those having high problems scores. PNPC domains were selected that might affect autonomy: physical symptoms, psychological issues, and social issues. We tested the hypothesis that patients perceived more autonomy problems when scoring in the highest quartile of these PNPC domains compared with patients scoring in the lowest quartile of these PNPC. The internal consistency, measured by Cronbach s a coefficient, was considered satisfactory when a O Analysis The completed questionnaires were rendered anonymous and further analyzed statistically with the SPSS program. Factor analysis was carried out using principal component analysis. In order to assess the correlation of autonomy problems with quality-of-life measures, a mean item score was computed. Because the EORTC-scores and the COOP-scores were not normally distributed (Kolmogorov-Smirnov test), the non-parametrical Spearman s rho was used to calculate the correlations. The non-parametrical twosided Mann-Whitney test was used to study discriminant validity by testing differences between high and low scoring groups. Results Table 1 shows the items of the two versions. The autonomy problems questionnaire was tested in a population of 64 cancer patients with metastasized disease. 7 Of these, 49 patients were either married or living together with their life companion. The other 15 were single, widowed, or living separately from their life companion. The ages of the patients ranged from 30 to 87 years, normally distributed around a mean age of 57 years (SD 13). Most patients (81%) were female. A psychometric analysis showed that each of the items met the criterion for relevance: experienced by at least 10% of the patients. Depending on the item, % of the patients experienced the item to be a problem (yes or somewhat) using the 9-item version, and % using the 4-item version. The validity of the autonomy scale structure was ensured by the factor loadings in the range of in the 9-item version, and in the range of in the 4-item version, all exceeding the criterion of 0.40 (Table 2). The explained variance was 47.9% in the 9-item version and 54.7% in the 4-item version. The item-total correlations for individual items were in the range of in the 9-item version and in the 4-item version, all exceeding the criterion of The internal consistency was good for the 9-item version (a ) and satisfactory for the 4-item version. (a ). The Pearson correlation between the 9-item and the 4-item versions was The correlations between the autonomy problems of the 9-item and the 4-item version, and the related HRQoL domains were similar (Table 3). The correlations that had been sought were found. As expected, patients with the highest scores regarding physical, psychological or social problems perceived significantly more autonomy problems than those with the lowest scores (Table 4). These results were similar for the 9-item and the 4-item version, except that patients with the highest scores on social problems only showed a tendency towards having more autonomy problems assessed with the 9-item version. Table 1 Items in Autonomy Questionnaires 9-Item Version 4-Item Version Difficulties in continuing Difficulties in continuing my usual activities a my usual activities a Difficulty in handing tasks Difficulty in handing over to others b tasks over to others b Having to depend Having to depend on on others b others b Experiencing loss Experiencing loss of of control over one s life c control over one s life c Frustration because I can do less than before a Difficulties in continuing social activities a Experiencing difficulties in asking for help b Experiencing loss of control over one s own body c Experiencing difficulties in making one s own decisions c Elements of autonomy problems: a limitation of activities. b dependency. c losing control.

5 268 Vernooij-Dassen et al. Vol. 30 No. 3 September 2005 Table 2 Factor Loadings for 9-Item and 4-Item Version Autonomy Problems 9-Item Version 4-Item Version Discussion The Patient Autonomy Questionnaire (PAQ) can be considered capable of identifying autonomy problems in palliative care. The high percentages of autonomy problems indicate that they are prevalent in palliative cancer patients. Both the PAQ and the PAQs are valid and reliable measures for patients in the palliative phase of cancer. Despite the lack of consensus in the literature about the autonomy concept, key elements of autonomy could be identified and the results of the debate on autonomy problems could be integrated. It has been argued that autonomy was not identical with independence, 13 and that both individual and social aspects determine autonomy in care for patients with a chronic disease. 14,15 The key conceptual elements of autonomy operationalized in the PAQ and its concise version (the PAQs) reflect these aspects. The concept of autonomy problems integrates physical, social, and emotional aspects related to the possibility of acting according to one s own free will. The relevance of the PAQ and the PAQs was indicated by autonomy problems representing the impact of receiving palliative care, the high prevalence of autonomy problems and its amenability to change. Autonomy problems feature among the top 5 problems in palliative care and were mentioned even more frequently than pain problems. 22 The validity of the PAQ and PAQs is supported by the correlations found with the quality-of-life domains related to the key conceptual elements. The highest correlations were found between autonomy problems and problems with social functioning. These problems represent problems with dependency, which is in line with the original meaning of autonomy referring to independence. The lowest correlation occurred with physical functioning. This indicates that although physical dependence is important, it is not the most dominant factor and it might even not be the most crucial aspect in experiencing autonomy problems. In fact, the autonomy problems might represent a core domain of the quality of life of persons receiving palliative care. Discriminant validity of the autonomy problem scale was supported by the finding that patients with the highest scores regarding physical, psychological, or social problems perceived significantly more autonomy problems than those with the lowest scores. The study had several limitations: This attempt to evaluate the PAQ and the PAQs is the first; more studies are needed to confirm the value of the scales. Further limitations are Table 3 Spearman Correlations Between Autonomy and Related Domains of HRQoL Instruments 9-Item Spearman correlation coefficient 9-Item significance 4-Item Spearman correlation coefficient 4-Item significance EORTC Physical functioning Global health status Role functioning Social functioning Emotional functioning Coop Wonca General health Daily activities Restraints in social activities Available social support Emotional problems

6 Vol. 30 No. 3 September 2005 Patient Autonomy Problems in Palliative Care 269 Table 4 Discriminant Validity: Comparison Between Autonomy Problems of Patients with Lowest and Highest Problem Scores in PNPC Domains (Physical, Emotional, Social) Autonomy problems n Mean SD Median Rank Significance Lowest quartile PNPC physical problems a Highest quartile PNPC physical problems a Lowest quartile PNPC physical problems b Highest quartile PNPC physical problems b Lowest quartile PNPC emotional problems a Highest quartile PNPC emotional problems a Lowest quartile PNPC emotional problems b Highest quartile PNPC emotional problems b Lowest quartile PNPC social problems a Highest quartile PNPC social problems a Lowest quartile PNPC social problems b Highest quartile PNPC social problems b a 9-item version. b 4-item version. the sample s composition, and its size. The sample consists predominantly of women with breast cancer and may not have been entirely representative of the total population of palliative cancer patients staying at home. The sample size limits the possibilities of carrying out a subgroup analysis (regarding socio-economic status). Autonomy is a separate and specific domain of patient experiences or patient outcomes. Identifying and addressing autonomy problems might be a powerful means of improving the quality of life of cancer patients in the palliative phase of the disease. The attainment of the central goal of palliative care might thereby be facilitated. Autonomy problems are amenable to interventions, even in the palliative stage. Proot suggests that tailoring interventions to a patient s state of autonomy might be the most suitable approach to enhancing autonomy. 15 This tailoring can be done considering the key elements of autonomy. Feelings of dependency and losing control can be reduced by focusing on patients needs for care and by involving patients in decision making in order to help them maintain control over their own situation. This approach also includes the resolve not to take part in decision making. 23 It should be noted that sharing decisions and respecting a patient s autonomy is not identical with doing what the patient wants. The ethical principle of beneficence, doing good, might not always mean doing what a patient wants. 24 Thus, the consideration of autonomy problems might be complicated. The problems regarding limitation of activities can be addressed by enabling patients to do what they are still capable of doing by drawing on their remaining capabilities. Autonomy can be threatened by the way in which support is given. There is a considerable risk that people receiving support might feel powerless rather than strengthened and this feeling might induce autonomy problems. Providing help without causing autonomy problems in the recipient of care requires special knowledge and skills. Support should be given in a subtle way, as invisible help, without seeming to attach any importance to the actions that are meant to support the patient. 25 Sustaining patient autonomy is a major challenge in palliative care. This study has contributed to the sustaining of autonomy by the development and evaluation of instruments to identify autonomy problems in both a comprehensive and a concise way. The use of the questionnaire as a checklist in clinical practice might stimulate communication on autonomy problems. Further study is needed to assess the value of the PAQ and the PAQs in other settings and to develop and evaluate interventions to reduce autonomy problems. Acknowledgments This research project was funded by The Netherlands Cancer Society (KWF). The authors wish to thank all the participants who enabled this study: the KWF, participating GPs,

7 270 Vernooij-Dassen et al. Vol. 30 No. 3 September 2005 the patient organizations, and, in particular, the patients who devoted their time and effort to this study despite their difficult situation. They also thank Henk van den Hoogen for statistical advice. References 1. van Thiel GJM, van Delden JJM. The principle of respect for autonomy in the care of nursing home residents. Nurs Ethics 2001;8(5): Osse BH, Vernooij-Dassen M, de Vree BP, et al. Assessment of the need for palliative care as perceived by individual cancer patients and their families: a review of instruments for improving patient participation in palliative care. Cancer 2000; 88(4): Keenan J. A concept analysis of autonomy. J Adv Nurs 1999;29(3): Muller F, Thiel JH. Beknopt Grieks-Nederlands woordenboek. [Concise Greek-Dutch dictionary]. Groningen: Wolters, Sepulveda C, Marlin A, Yoshida T, Ullrich A. Palliative care: the World Health Organization s global perspective. J Pain Symptom Manage 2002; 24(2): Carr AJ, Higginson IJ. Are quality of life measures patient centred? BMJ 2001;322: Osse BHP, Vernooij-Dassen M, Schade E, Grol RPTM. Towards a new clinical tool for needs assessment in palliative care of cancer patients: the PNPC instrument. J Pain Symptom Manage 2004; 28(4): Robins CJ, Luten AG. Sociotropy and autonomy: differential patterns of clinical presentation in unipolar depression. J Abnorm Psychol 1991; 100(1): de Ridder D, Depla M, Severens P, Malsch M. Beliefs on coping with illness: a consumer s perspective. Soc Sci Med 1997;44(5): Tuckett AG. Virtuous principles as an ethic for nursing. Contemp Nurs 2000;9(2): Nessa J, Malterud K. Tell me what s wrong with me: a discourse analysis approach to the concept of patient autonomy. J Med Ethics 1998;24(6): Ryan SP. Competence and the elderly patient with cognitive impairments. Aust NZ J Psychiatry 1996;30(6): Michel JP, Kressig R, Gold G. [Dependency: possible risk or inevitable outcome?]. Schweiz Med Wochenschr 1997;127(43): Agich GJ. Autonomy and long-term care. Oxford: Oxford University Press, Proot IM, Crebolder HF, Abu-Saad HH, Ter Meulen RH. Autonomy in the rehabilitation of stroke patients in nursing homes. A concept analysis. Scand J Caring Sci 1998;12(3): Osse BH, Vernooij-Dassen MJ, de Vree BP, et al. Problems to discuss with patients in palliative care: a comprehensive approach. Pat Educ Couns 2002; 47: Vernooij-Dassen MJ, Felling AJ, Brummelkamp E, et al. Assessment of caregiver s competence in dealing with the burden of caregiving for a dementia patient: a Short Sense of Competence Questionnaire (SSCQ) suitable for clinical practice. J Am Geriatr Soc 1999; 47(2): Nunnaly JC, Bernstein IH. Psychometric theory. New York: McGraw-Hill, Kline PA. Handbook of test construction. London: Methuen, Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85(5): Nelson EC, Wasson JH, Johnson DJ, Hays RD. Dartmouth COOP Functional Health Assessment Charts: brief measures for clinical practice. In: Spilker B, ed. Quality of life and pharmacoeconomics in clinical trials. Philidelphia: Lippincott-Raven, 1996: Osse BHP, Vernooij-Dassen MJFJ, Schadé E, Grol R. The problems experienced by patients with cancer and their needs for palliative care. Support Care Cancer (in press). 23. Elwyn G, Edwards A, Kinnersley P. Shared decision-making in primary care: the neglected second half of the consultation. Br J Gen Pract 1999;49: Gallagher R. Commentary: respecting autonomy but avoiding benevolent paternalism. J Pain Symptom Manage 2000;20(3): Bolger N, Zuckerman A, Kessler RC. Invisible support and adjustment to stress. J Pers Soc Psychol 2000;79(6):