Drug patient information leaflets in anaesthesia: effect on anxiety and patient satisfaction

M. Oldman*,1, D. Moore2 and S. Collins1

1 Department of Anaesthesia, Anaesthetic Department, Musgrove Park Hospital, Taunton, Somerset TA1 5DA, UK. 2 Department of Anaesthesia, Wellington Hospital, Capital and Coast District Health Board, Riddiford Street, Private Bag 7902, Wellington, New Zealand

*Corresponding author. E-mail: oldman{at}globalnet.co.uk

Accepted for publication: February 1, 2004


    Abstract
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Supplementary data
 References
 
Background. Patient information leaflets are produced for all new drugs, including anaesthetic drugs that are licensed solely for physician administration. The effect of this information on patients’ satisfaction and anxiety has not been investigated previously.

Methods. Eighty-five patients were allocated randomly to receive a standard information leaflet about anaesthesia (Group 1) or the standard leaflet plus the manufacturers’ patient information leaflets for propofol and remifentanil (Group 2). Anxiety was assessed using the state trait anxiety index (STAI) and a visual analogue scale (VAS) for anxiety before and after this information had been read. Patients’ attitudes to this information were assessed by a short questionnaire.

Results. There was no significant difference in STAI or VAS scores for anxiety between the two groups before or after the information leaflets. Significantly more patients who received drug patient information leaflets felt that they had received too much information (0% Group 1 vs 18% Group 2, P=0.003). More than 64% of patients in both groups said that they would not wish to receive detailed anaesthetic drug information. There was a correlation between the STAI and the VAS scores for anxiety (R=0.8).

Conclusions. A minority of patients (up to 36%) wish to receive detailed anaesthetic drug information before anaesthesia. Manufacturers’ drug patient information leaflets do not alter preoperative anxiety and may be safely issued to patients requesting such information.

Br J Anaesth 2004; 92: 854–8

Keywords: anaesthesia; complications, anxiety; education, patient; monitoring, anxiety scale


    Introduction
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Supplementary data
 References
 
Many patients wish to be informed in detail about their treatment, and to facilitate this, patients are being provided with increasing amounts of written information. It is now common practice for anaesthetic departments to supply written information about anaesthesia to their patients.1 Recently, the Royal College of Anaesthetists together with the Association of Anaesthetists produced a series of patient information leaflets about anaesthesia, which explain many of the processes and procedures involved during anaesthesia.2 Since 1999 it has been a legal requirement for drug manufacturers to supply patient information leaflets with all products, even those administered solely by physicians, such as anaesthetic drugs. Many of the anaesthetic drugs have predictable pharmacological actions and effects that may sound alarming to patients. The effect of providing patients with detailed information about anaesthetic drugs is not known. This study aims to investigate whether patients wish to receive detailed anaesthetic drug information and to study the effects of this information on their preoperative anxiety.


    Methods
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Supplementary data
 References
 
After local ethics board approval and informed patient consent, 85 patients presenting for general surgical procedures to the day case unit at Musgrove Park Hospital, Taunton, were enrolled. A power calculation suggested that a sample size of 33 in each group would have 80% power to detect a 20% difference in state anxiety score with a significance level of P<0.05. We estimated that up to 25% of cases might have insufficient time to complete both sections of the questionnaire and therefore we aimed to recruit 84 patients, 42 into each group. The patients recruited were aged more than 18 yr and were having ambulatory general surgical, urology or maxillo-facial procedures with a propofol (DiprivanTM, AstraZeneca UK Ltd, UK) and remifentanil (UltivaTM, Elan Pharma International Ltd, Ireland) based anaesthetic. Patients taking anxiolytic, antidepressant, antipsychotic, or beta-blocker medications, or with a known current or past history of psychiatric disorder were excluded. No patient received anxiolytic premedication. Randomization was by numbered sealed envelope from a computer generated randomization sequence.

After admission to the day case unit all patients received a baseline test of their level of anxiety. This was performed using Spielberger’s state trait anxiety inventory3 (STAI) and also a 100 mm visual analogue scale for anxiety (VAS-anxiety). The STAI consists of two separate, 20 item self-reporting scales for measurement of state and trait anxiety (forms Y1 and Y2, respectively).

After completion of the anxiety ratings the patients were asked to read leaflets about anaesthesia. Patients in Group 1 were given the hospital’s standard information leaflet about anaesthesia (Appendix A, see Supplementary data), which is a locally modified version of the Association of Anaesthetists’ patient information leaflet.4 Group 2 patients were given the same standard anaesthesia information leaflet together with manufacturer’s patient information leaflets for propofol (DiprivanTM) and remifentanil (UltivaTM).

Both groups repeated form Y1 of the STAI (state anxiety) 20 min after the information had been read, along with another VAS-anxiety rating. They then completed a short questionnaire.

All patients received total i.v. anaesthesia using propofol and remifentanil. The use of other anaesthetic agents was not restricted and was at the anaesthetist’s discretion.

All patients received routine telephone follow-up on the day after surgery by a member of the nursing staff blinded to the group allocation. Complications and side effects that were spontaneously volunteered by the patient during this consultation were recorded.

Data were entered onto a spreadsheet database and analysed with SPSS (Base 9.0 for Windows; SPSS Inc., Chicago, IL). The change in state anxiety ({Delta}STAI-Y1) and VAS-anxiety scores ({Delta}VAS) after reading the information was calculated for both groups. Categorical data were analysed using the {chi}2-test with Yates’s correction or Fisher’s exact test as appropriate. Parametric data were analysed using an independent sample t-test, and non-parametric data using the Mann–Whitney U-test. A P-value of <0.05 was considered to indicate statistical significance.


    Results
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Supplementary data
 References
 
Eighty-five patients were recruited, 45 in the control group (Group 1) and 40 in the drug information group (Group 2). The age and sex of patients in the two groups were similar (Table 1).


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Table 1 Population characteristics and anxiety scores. STAI and VAS values are median (range). Age is shown as mean (range)
 
There was no significant difference in STAI state or trait anxiety scores or VAS-anxiety scores between the two groups either before or after provision of information. There was no significant difference in the change in anxiety scores ({Delta}STAI-Y1 and {Delta}VAS) between the two groups (Table 1).

Forty-five questionnaires were completed by patients in Group 1 (n=45), and 39 questionnaires by patients in Group 2 (n=40). One patient in Group 2 did not complete the questionnaire. The results are shown in Tables 2 and 3.


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Table 2 Results of telephone questionnaire (all patients). *P<0.05, Fisher’s exact test: received too much information vs right amount or too little
 

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Table 3 Reasons why patients would like to receive detailed anaesthetic drug information: results from telephone questionnaire
 
Detailed results for the patients who expressed a preference for receiving detailed drug information are shown in Table 4.


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Table 4 Patients expressing preference for receiving detailed drug information
 
No patient in either group reported complications attributable to the anaesthetic or anaesthetic drugs used at telephone follow-up.


    Discussion
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 Abstract
 Introduction
 Methods
 Results
 Discussion
 Supplementary data
 References
 
Increasing amounts of written information are being distributed to patients, particularly in relation to the processes and events in the perioperative period. Written information is an important component of patient-centred care as it helps patients make informed choices about their healthcare, and strengthens the process of consent. A recent survey of UK anaesthetic departments indicated that distribution of such information at pre-admission clinics, with admission letters, and on the day of admission was widespread.1 Providing anaesthetic information has been shown to be helpful to patients, but there is evidence that it may paradoxically increase some patients’ anxiety.5

Since January 1, 1999 when European Directive 92/27/EEC6 came into force, it has been a legal requirement for manufacturers to supply information to patients on the therapeutic indications, contraindications, interactions, dosage, route of administration, and undesirable effects of all prescribed medications. This is typically provided as a package insert patient information leaflet. These are specifically written for non-medical readers and are designed to provide information in an easily understood format. In the case of drugs administered by physicians, these leaflets are still included in the drug packaging, but currently most anaesthetists in the UK do not routinely distribute them to patients. Such information might complement the existing body of information given to patients in advance of their surgery. Indeed some patients themselves have suggested that they should be encouraged to read them.7 However, because of the nature of the pharmacological effects of many anaesthetic drugs this information may be potentially alarming for patients. Listed side effects of remifentanil (UltivaTM) include slow and shallow breathing, muscle rigidity, stopping breathing, and low oxygen levels. Those for propofol (DiprivanTM) include, amongst others, a feeling of pain on injection, a decrease in arterial pressure, twitching and shaking, slowing or stopping of the heart, and a feeling of sexual arousal. Some anaesthetists have suggested that it would be counterproductive to issue this information to patients.8 9

Paoloni8 found that patients thought drug information leaflets were difficult to understand, confusing, and likely to increase their anxiety. We were unable to demonstrate a significant change in anxiety after the distribution of this information to patients. This is in agreement with other studies on the provision of detailed risk information.10

Before surgery patients may receive a considerable volume of written information. This may be too much for anxious individuals to adequately take in, particularly if distributed on the day of surgery. The majority of patients (98%) were satisfied with the level of detail provided by the standard anaesthetic information leaflet, When detailed drug information for two drugs was provided, significantly more patients (18%) felt that they had been given too much information. Despite the larger volume of information provided to these patients, comprehension was good with 100% claiming to understand the information provided, and 92% finding the information provided helpful. As this group also received the standard leaflet it is however difficult to know which particular component of the information provided was useful.

Sixty-five per cent of patients in our study did not wish to receive detailed drug information. However, a minority (36%) wish to receive this information in order to understand the uses and effects of the drugs to be given, and the potential undesirable effects. It is therefore perhaps appropriate to offer patients the choice of receiving detailed information. Our results suggest that manufacturers’ drug patient information leaflets may be safely given to patients on the day of surgery without increasing their preoperative anxiety. Giving this information to patients does not appear to significantly alter their satisfaction with the amount of information provided, or their emotional response to the information. Previous studies have suggested that informing patients of potential side effects or complications may lead to increased reporting of these complications.11 12 Our results do not support this view. We did not examine the level of literacy or education of our study population, and it is possible that our results might be different if the study was reproduced in a different population.

Selecting the correct time for the provision of information is difficult. Our findings demonstrate an equal preference for providing information before admission and on the day of admission. As most anaesthetists tailor their choice of anaesthetic agents to the individual patient, it will always be difficult to provide an individual patient with relevant drug information in advance of the day of surgery.

In their current form the existing anaesthetic drug information leaflets fulfil the manufacturers’ obligations under European law but are of limited value to the majority of patients, who consider that they contain too much information. Involvement of both patients and anaesthetists in the design of such leaflets may help to increase their value.

The STAI is considered the gold standard measure of anxiety, and has been extensively used in the perioperative period. State anxiety reflects situational-related anxiety and will vary depending on the stress at a particular moment in time—this is measured by STAI form Y1. State anxiety scores increase in response to physical danger and psychological stress, and decrease as a result of relaxation training. Trait anxiety reflects the underlying level of anxiety in that individual’s personality, and is more stable over time—this is measured by STAI form Y2. A mean STAI state anxiety score of 35 is considered normative for adults of different age groups.3 An important clinical change in state anxiety levels has been defined previously (10 points).13 Nine patients (20%) in Group 1 and 13 patients (32.5%) in Group 2 could be considered as having high levels of preoperative anxiety using these criteria.

Unlike the STAI, which takes 5–10 min to complete, the VAS for anxiety has the advantage of being simple to explain to patients, and quick and easy to administer. The VAS for anxiety has been validated as a measure of preoperative anxiety and found to correlate with the STAI.14 15 Although both the STAI and VAS (for anxiety) may be used to measure preoperative anxiety they have their limitations. The sensitivity of the tests may not be sufficient to detect relatively small changes in a patient’s level of anxiety—up to 18% of patients in our study reported feeling worried by the information provided, yet neither test demonstrated a significant change in anxiety.

In summary our study demonstrates that only 36% of patients wish to receive detailed anaesthetic drug information. When provided with manufacturers’ drug patient information leaflets for two commonly used anaesthetic drugs, propofol and remifentanil, a significant number of patients felt that they had received too much information. Giving manufacturers’ patient information leaflets for anaesthetic drugs to patients before anaesthesia does not increase anxiety as measured by either the STAI or the VAS for anxiety.


    Supplementary data
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Supplementary data
 References
 
The appendix can be found as Supplementary data in British Journal of Anaesthesia online.


    References
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Supplementary data
 References
 
1 Thoms GM, McHugh GA, Lack JA. What information do anaesthetists provide for patients? Br J Anaesth 2002; 89: 917–9[Abstract/Free Full Text]

2 http://www.youranaesthetic.info/. Accessed 2/9/03

3 Spielberger CD, Gorsuch RL, Lushene RE, et al. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press, 1983

4 http://www.aagbi.org/pub_patient.html. Accessed 2/9/03

5 Gillies MA, Baldwin FJ. Do patient information booklets increase perioperative anxiety? Eur J Anaesthesiol 2001; 18: 620–2[CrossRef][ISI][Medline]

6 Document 392L0027 Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. http://europa.eu.int/smartapi/cgi/sga_ doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc= 31992L0027&model=guichett. Accessed 2/9/03

7 Smith AF. Patient information, risk and choice. Anaesthesia 2003; 58: 409–11[ISI][Medline]

8 Paoloni CC, Arrowsmith JE. Patient information leaflets for anaesthetic drugs. Anaesthesia 2000; 55: 911

9 Bamgbade O. Anaesthetic drug information leaflets—for the patient or for the doctor? Anaesthesia 2001; 56: 1213–4

10 Garrud P, Wood M, Stainsby L. Impact of risk information in a patient education leaflet. Patient Educ Couns 2001; 43: 303–6[CrossRef]

11 Daniels AM, Sallie R. Headache, lumbar puncture, and expectation. Lancet 1981; 1: 1003

12 Myers MG, Cairns JA, Singer J. The consent form as a possible cause of side effects. Clin Pharmacol Ther 1987; 42: 250–3[ISI][Medline]

13 Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a ‘gold standard’? Anesth Analg 1997; 85: 783–8[Abstract]

14 Vogelsang J. The visual analog scale: an accurate and sensitive method for self-reporting preoperative anxiety. J Post Anesth Nurs 1988; 3: 235–9[Medline]

15 Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth 2002; 49: 792–8[Abstract/Free Full Text]





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