PERCEPTIONS OF AUTONOMY, PRIVACY AND INFORMED CONSENT
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1 PERCEPTIONS OF AUTONOMY, PRIVACY AND INFORMED CONSENT IN THE CARE OF ELDERLY PEOPLE IN FIVE EUROPEAN COUNTRIES: GENERAL OVERVIEW Helena Leino-Kilpi, Maritta Välimäki, Theo Dassen, Maria Gasull, Chryssoula Lemonidou, Anja Schopp, P Anne Scott, Marianne Arndt and Anne Kaljonen Key words: elderly people; nursing ethics; patients rights Ethical issues in the care of elderly people have been identified in many countries. We report the findings of a comparative research project funded by the European Commission, which took place between 1998 and The project explored the issues of autonomy (part I), privacy (part II) and informed consent (part III) in nursing practice. Data were collected from elderly residents/patients (n = 573) and nursing staff (n = 887) in five European countries: Finland, Spain, Greece, Germany and the UK (Scotland). Questionnaires were used as the data collection tool (self-completion questionnaires for staff, structured interviews for the elderly participants). Four basic nursing interventions in the care of elderly people were targeted: hygiene, fluid intake and nutrition, medication, and elimination. The data were analysed statistically. The results indicated differences within all five countries between staff and patient perceptions of autonomy, privacy and informed consent. There were also similar differences between individual countries. Conclusions were reached concerning practice, education and research. This is the first of a set of five articles published together in this issue of Nursing Ethics in which the results of this comparative research project are presented. Introduction Demographic trends across Europe indicate an increasingly elderly population. 1 3 Ageing increases the likelihood that individuals will find themselves unable to cope at home and that they will require hospital or nursing home admission for short, intermediate or long-term care. In long-term care in particular, elderly Address for correspondence: Helena Leino-Kilpi, Department of Nursing Science, University of Turku 20014, Turku, Finland. Helena.Leino-Kilpi@utu.fi 2003 Arnold / ne571oa
2 Perceptions of autonomy, privacy and informed consent overview 19 people are dependent on the environment and the activities of staff. This can cause ethical problems, which can be defined from different perspectives. In this study, the analysis concerns the concepts of autonomy, privacy and informed consent, which can be seen as central to nursing and health care ethics 4,5 ; many everyday ethical problems are connected with these concepts. 6 In different cultures, ethical concepts such as autonomy may have varying connotations. 7 The perceptions of patients and staff can also differ, and each group appears to have different priorities These findings give rise to the expectation that there may be differences between countries, as well as between patients and health care staff within the same country, concerning elderly patients perceptions of autonomy, privacy and informed consent. This set of five articles, of which this is the first, presents findings related to patient and staff perceptions of autonomy, privacy and informed consent in nursing practice. Data for this study were collected from patients/residents and nursing staff in five European countries: Finland, Spain, Greece, Germany and the UK (Scotland). The five participating countries, as member states of the European Union, are party to explicit declarations on human rights and have thus formally underlined respect for the rights of elderly patients. 11 In these countries, nurse education is also governed by the same European Directives 12 and the nursing professions have adopted the International Council of Nurses Code of ethics for nurses. 13 In addition, these countries have their own legal norms and ethical codes. 6 In the tradition, amount and the quality of nursing research, however, these countries do differ. 14,15 By recognizing the ethical problems and differences, the goal of this study was to improve both the ethical quality of care given to elderly patients and international collaboration between nurses in Europe. The study also produced information that will be useful for educators and researchers. The research questions were: 1) Are there any differences between the five countries in patient and staff perceptions of the realization of patient autonomy, privacy and informed consent? 2) Are there differences between patient and staff perceptions of autonomy, privacy and informed consent within the five countries? 3) What factors are associated with patient and staff perceptions of autonomy, privacy and informed consent? Instrument This survey was implemented by using questionnaires as the data collection tool (self-completion questionnaires for staff; structured interviews for the elderly participants). Tool development was based on an extensive review of the literature on the concepts of autonomy, privacy and informed consent. 6 The tool included background information and lists of items concerning each of the three concepts (Table 1). Background patient information included: age, gender, marital status, education, length of hospital/institutional stay, number of beds in the patient s room, having relatives or friends to take care of personal affairs, reason for hospital stay, subjectively perceived health status (5-point scale), need for nursing interventions
3 20 H Leino-Kilpi et al. Table 1 consent Concept Questionnaire items concerning autonomy, privacy and informed Item Autonomy: 1) Information received What will be done during treatment Length of residential stay The possible risks of treatment What to eat and drink When to eat and drink Pain relief Names and doses of medication How to support bowel function How to support bladder function How to take care of personal hygiene How to take care of skin 2) Decision making Alternative treatments Length of residential stay Presence of a support person during treatments What to eat and drink When to eat and drink What type of pain relief to use Whether to use sleeping pills Help required in case of difficulties in passing urine Help required in case of difficulties in bowel function How to take care of personal hygiene How to take care of skin Privacy Informed consent Asking only necessary questions by nurses Meeting visitors in private Knocking before entering the room Having meals in private Having coffee/tea breaks in private Not disclosing information about medication to others Discussing medication in private Not having to use the toilet in front of others Not receiving enemas in front of other patients Not receiving a shower/bath in front of other patients Not having to undress in front of other patients Taking blood tests Taking radiographs Changing diet Changing medication Disclosing information to others Giving an enema
4 Perceptions of autonomy, privacy and informed consent overview 21 (long-term health problem, need for artificial feeding, catheter, bedpan/ commode/incontinence pads, skin care), and level of independence (eating, personal hygiene, toileting, ambulation). The background information for nurses included: age, gender, highest qualification, staff grade, length of working experience in nursing generally, and education in nursing ethics (yes/no). For autonomy, privacy and informed consent, the elderly respondents were asked to choose an answer that best corresponded to their situation by using a scale of 5 to 0 (5 = always, 4 = frequently, 3 = occasionally, 2 = seldom, 1 = never, 0 = not applicable). Using parallel questionnaires, the nurses were asked to respond from the perspective of what they thought generally happened in their ward, while patients responses were based on their personal experiences. For autonomy, there were 22 items, divided into two subcategories: information given/received (11 items) and decision making (11 items). The consistency of the autonomy scale was evaluated by using Cronbach s alpha coefficient. For information receiving, the alpha values (patients/staff) were as follows: Finland 0.92/0.89, Spain 0.78/0.91, Greece 0.89/0.88, Germany 0.63/0.83, and the UK 0.59/0.85. The alpha values for decision making also varied (patients/staff): Finland 0.93/0.91, Spain 0.76/0.92, Greece 0.76/0.88, Germany 0.48/0.86, and the UK 0.49/0.88. There were 11 items relating to patient privacy. Cronbach s alpha coefficient (patients/staff) varied in the participating countries as follows: Finland 0.63/0.77, Spain 0.48/0.86, Greece 0.84/0.82, Germany 0.43/0.77, and the UK 0.58/0.75. Six items were offered for informed consent. Patients were asked to answer how often in the hospital/nursing home/residence nursing staff have asked for their consent before certain procedures. There was also a general question asking whether consent had been given in writing or verbally. Cronbach s alpha coefficient (patients/staff) varied in the participating countries as follows: Finland 0.76/0.86, Spain 0.63/0.90, Greece 0.86/0.86, Germany 0.54/0.88, and the UK 0.60/0.92. The instrument was developed in English; it was then translated into Finnish, Spanish, German and Greek. It was piloted in two phases. As a result of feedback received from phase one, the instrument was shortened and the individual items were modified. In pilot phase two, the modified instrument was tested in Finland. No further modifications were found to be necessary. The other methods used to assure that the instrument development processes and psychometric characteristics were rigorously applied are described in Table 2. Data collection procedure Data collection took place in health facilities where elderly patients were cared for (e.g. nursing homes, continuing care units and geriatric hospitals; in Germany, data were also collected on some wards of general hospitals). A convenience sampling method was used. Random sampling was not possible because many patients in these facilities are cognitively impaired and unable to participate in this kind of study. Patients aged 60 years or over who were capable of giving informed consent were invited to participate. The planned sample size in each
5 22 H Leino-Kilpi et al. Table 2 Issues related to development of the instrument and to its psychometric characteristics Type of evaluation Criteria Evaluation Instrument development process Conceptual basis Literature review Leino-Kilpi et al. 6 Item generation Literature review, clinical experience, Pilot test I: 50 elderly patients (n = 10/country) pilot tests I and II and 90 nurses (Finland n = 30, Spain n = 17, Greece n = 16, Germany n = 21, UK n = 6) Pilot test II: Finland; patients n = 5, nurses n = 46 Reliability Internal consistency Cronbach s alpha coefficient: Information: all patients 0.81/nurses 0.89 patients/nurses Decision-making: all patients 0.77/nurses 0.90 Privacy: all patients 0.65/nurses 0.80 Informed consent: all patients 0.73/nurses 0.90 Validity Face validity Feedback: relevance of the items, Pilot tests I and II for patients and nurses wording, content Content validity Relevance of the content and structure Expert judgement Concept validity Definitions of the concept for patients Pilot I: qualitative analysis and nurses Cultural sensitivity Back translation process English vs. Finnish, Spanish, Greek, German vs. English Cultural appropriateness Content, semantic, technical, criteria Pilot I: qualitative analysis and conceptual evidence
6 Perceptions of autonomy, privacy and informed consent overview 23 country was 100. All nursing staff working on the corresponding wards formed the nurse study population. Altogether, 573 patients were interviewed (Finland n = 100, Spain n = 100, Greece n = 152, Germany n = 120, and the UK n = 101). A total of 1394 questionnaires were distributed to nursing staff (specialist nurses, registered general nurses, assistant nurses, staff without formal nursing education) and 903 completed questionnaires were returned (response rate 65%). Sixteen completed questionnaires from Greece were excluded because in one institution no elderly patients were found who had the capacity to give informed consent to be interviewed. Thus the total sample size included in the analysis was 887. Response rates varied by country: Finland 77%, Spain 48%, Greece 71%, Germany 79% and the UK 50%. Analysis The data analysis was carried out in four phases. First, two of the patient background variables were re-analysed. Items relating to patients need for nursing interventions (5 items) were summed (1 = need for intervention; 0 = no need): the higher the sum score, the more nursing interventions were needed (range 0 5). The patients level of independence was also recoded by summing the scores of the four relevant items. Only those cases where the response was 1 = I am totally independent were included in the analysis: the higher the summed value of the variable, the more independent was the patient (range 0 4). Secondly, the mean score values of items were calculated. For autonomy, this included items related to information received (11 items) and decision making (11 items). Only those cases where patients had responded to at least 75% of the items were included in the analysis ( 0 = not applicable responses were excluded for statistical reasons). The higher the mean value (mean range 1 5), the more often nurses had supported patients autonomy by giving information or by offering them the opportunity to make decisions regarding their care, and the more often patients privacy was supported or informed consent sought. In the third phase, the mean values of patient and staff data between countries were analysed using one-way analysis of variance (with post-hoc Tuckey s test). A two-tailed t-test was used to compare the patients and nurses perceptions within each country. In addition, Fisher s exact test and a logistic regression model were used to examine connections between respondents (patients and nurses) background variables and the likelihood of a respondent perceiving that patient autonomy/privacy/informed consent was being undermined. The point at which 10% of the respondents had the lowest mean scores of each subgroup (country) was used as the cut-off point (quantile). In the fourth phase, a comparison of the realization of autonomy, privacy and informed consent was made by using a single-sample t-test. In all the phases of the analysis, p-values of less than 0.05 were interpreted as statistically significant.
7 24 H Leino-Kilpi et al. Demographic information The elderly patients demographic information, and data on their subjective health status, their need for nursing interventions, and their independence level are given in Table 3. The average length of stay in caring institutions for these elderly patients varied in each country, being shortest in Germany (106 days) and the longest in Greece (5.8 years). Long-term illness was the most frequently identified reason for staying in the facility (range from 77% in Greece and Germany to 52% in Finland). A clear majority (range 93% in Germany to 62% in Spain) had relatives or friends who were taking care of their personal affairs. The number of patients sharing rooms varied in each country; it was highest in the UK (mean 3.76, standard deviation (SD) 2.84) and lowest in Spain (mean 2.06, SD 1.99). The patients had given their informed consent to interventions, in writing or verbally, respectively, as follows: Finland 0%, 66%; Spain 28%, 61%; Greece 12%, 33%; Germany 41%, 69%; and the UK 5%, 40%. Demographic information relating to the nurses sample is described in Table 4. Ethical issues The general principles of research ethics were followed. 16,17 Both patients and nurses were provided with written and oral information regarding the purpose of the study, the right to refuse to participate, and the assurance of confidentiality and anonymity. The patients consent was sought in either oral or written form, depending on the country in which data were collected. The return of a completed questionnaire by a member of the nursing staff was taken as evidence of consent to participate. Ethical approval was sought and given according to the national ethics standards in each of the countries and in each of the institutions, from institutional ethics committees, local ethics committees and/or nursing and medical administrators. Acknowledgement This study was funded by the European Commission (no. BMH4-CT ). Helena Leino-Kilpi and Maritta Välimäki, University of Turku, Finland. Theo Dassen, Humbolt University, Berlin, Germany. Maria Gasull, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. Chryssoula Lemonidou, Kapodistrian University of Athens, Greece. Anja Schopp, Humbolt University, Berlin, Germany. P Anne Scott, University of Stirling, UK. Marianne Arndt, Consultant, Germany. Anne Kaljonen, University of Turku, Finland.
8 Perceptions of autonomy, privacy and informed consent overview 25 Table 3 Demographic information about the elderly patients Variable Finland Spain Greece Germany UK (n = 100) (n = 100) (n = 152) (n = 120) (n = 101) Mean age (yr) Gender (%) Male Female Marital status (%) Married Divorced Widowed Single Not available Length of education (yr) < > Not available Health status (%) Very good Good Fair Bad Very bad Not available Need for nursing interventions: mean (SD) 1.53 (0.99) 2.98 (1.41) 2.88 (1.48) 2.05 (1.23) 1.71 (1.01) Independence level: mean (SD) 1.24 (1.06) 2.89 (1.29) 1.82 (1.53) 2.54 (1.33) 1.56 (1.16) Long-term illness as a reason for residential stay (%) No. beds in room: mean (SD) 2.55 (3.85) 2.06 (1.99) 3.19 (2.98) 2.27 (0.91) 3.76 (2.84) Family/friend taking care of personal affairs (%)
9 26 H Leino-Kilpi et al. Table 4 Demographic information about the nurses Variable Finland Spain Greece Germany UK (n = 230) (n = 137) (n = 144) (n = 216) (n = 160) Mean age (yr) Gender (%) Male Female Not available Qualification (%) None Assistant nurse Registered nurse University degree Not available Work status (%) Ward sister Staff nurse Assistant nurse Nurse without qualification Not available Length of working experience: mean (SD) (yr) (10.39) 11.9 (9.91) 8.75 (7.33) 15.5 (9.75) 14.4 (10.25) Participation in nursing ethics education (%) References 1 World Health Organization. Ageing. Exploding the myths. Geneva: WHO, Ageing and Health Programme, Joy JP, Carter DE, Smith LN. The evolving educational needs of nurses caring for the older adult: a literature review. J Adv Nurs 2000; 31: Greengross S, Murphy E, Quam L, Rochon P, Smith R. Ageing: a subject that must be top of the world agendas. BMJ 1997; 315: Chadwick R, Tadd W. Ethics and nursing practice. Basingstoke: Macmillan Press, Downie RS, Calman KC. Healthy respect: ethics in health care. Oxford: Oxford Medical Publications, Leino-Kilpi H, Välimäki M, Arndt M et al. Patients autonomy, privacy and informed consent. (Biomedical and Health Research, vol. 40.) Amsterdam: IOS Press, Norberg A, Hirchfeldt M, Davison B et al Ethical reasoning concerning the feeding of severely demented patients: an international perspective. Nurs Ethics 1994; 1: Hennessy CH. Autonomy and risk: the role of client wishes in community-based long-term care. Gerontologist 1989; 29: Jang G. Autonomy and institutionalized elderly: resident and staff perceptions. Can J Ageing
10 Perceptions of autonomy, privacy and informed consent overview ; 11: Farrell GA. How accurately do nurses perceive patients needs? A comparison of general and psychiatric settings. J Adv Nurs 1991; 16: Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the application of Biology and Medicine: Convention on Human Rights and Biomedicine. (Oviedo, 4.iv, European Treaty Series.) Oviedo: European Commission, European Community Directive 91/507/EEC. London: HMSO, International Council of Nurses. Code of ethics for nurses. Geneva: ICN, Council of Europe, European Health Committee (CDSP). Nursing research. Report and recommendations. Strasbourg: Council of Europe, Workgroup of European Nurse Researchers (WENR). Country reports. Available at: URL: wenr@swe.nurse.se 16 Royal College of Nursing. Research ethics: guidance for nurses involved in research or any investigative project involving human subjects. London: RCN, The Northern Nurses Federation. Ethical guidelines for nursing research in the Nordic countries. Aurskog: The Northern Nurses Federation, 1987.
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